cardiovascular-agents and Myocardial-Infarction

Colchicine is an ancient herbal drug derived from Colchicum autumnale. It was first used to treat familial Mediterranean fever and gout. Based on its unique efficacy as an anti-inflammatory agent, colchicine has been used in the therapy of cardiovascular diseases including coronary artery disease, atherosclerosis, recurrent pericarditis, vascular restenosis, heart failure, and myocardial infarction. More recently, colchicine has also shown therapeutic efficacy in alleviating cardiovascular complications of COVID-19. COLCOT and LoDoCo2 are two milestone clinical trials that confirm the curative effect of long-term administration of colchicine in reducing the incidence of cardiovascular events in patients with coronary artery disease. There is growing interest in studying the anti-inflammatory mechanisms of colchicine. The anti-inflammatory action of colchicine is mediated mainly through inhibiting the assembly of microtubules. At the cellular level, colchicine inhibits the following: (1) endothelial cell dysfunction and inflammation; (2) smooth muscle cell proliferation and migration; (3) macrophage chemotaxis, migration, and adhesion; (4) platelet activation. At the molecular level, colchicine reduces proinflammatory cytokine release and inhibits NF-κB signaling and NLRP3 inflammasome activation. In this review, we summarize the current clinical trials with proven curative effect of colchicine in treating cardiovascular diseases. We also systematically discuss the mechanisms of colchicine action in cardiovascular therapeutics. Altogether, colchicine, a bioactive constituent from an ancient medicinal herb, exerts unique anti-inflammatory effects and prominent cardiovascular actions, and will charter a new page in cardiovascular medicine.

Topics: Anti-Inflammatory Agents; Cardiovascular Agents; Colchicine; Coronary Artery Disease; COVID-19 Drug Treatment; Humans; Myocardial Infarction

Management of stable coronary artery disease (CAD) centers on medication to prevent myocardial infarction and death. Many anti-anginal medications also have benefit for reducing symptoms, and have been proven to be effective against placebo control. Before effective preventive medications were available, patients with stable CAD often underwent revascularization with coronary artery bypass grafting (CABG) or percutaneous coronary intervention (PCI), on the plausible assumption that these procedures would prevent adverse events and reduce symptoms. However, recent randomized controlled trials have cast doubt on these assumptions.Considering results from the recent ISCHEMIA trial, we discuss the evidence base that underpins revascularization for stable CAD in contemporary practice. We also focus on patient groups at high risk of myocardial infarction and death, for whom revascularization is often recommended. We outline the areas of uncertainty, unanswered research questions, and key areas of potential miscommunication in doctor-patient consultations.

Topics: Cardiovascular Agents; Coronary Artery Bypass; Coronary Artery Disease; Humans; Myocardial Infarction; Percutaneous Coronary Intervention; Treatment Outcome

Myocardial infarction (MI) in the absence of obstructive coronary artery disease (MINOCA) is prevalent in around 5% of acute myocardial infarction (AMI) presentations. MINOCA is a heterogeneous entity with many different etiologies. It is important for health care providers to familiarize themselves with the disease process, presentation, and possible underlying causes in order to guide appropriate management strategies. In this article, the authors review the contemporary definition, etiologies and assessment, and management for AMI patients with MINOCA.

Topics: Aortic Dissection; Cardiomyopathy, Hypertrophic; Cardiovascular Agents; Coronary Artery Disease; Coronary Circulation; Coronary Vasospasm; Coronary Vessels; Humans; Myocardial Infarction; Myocarditis; Platelet Aggregation Inhibitors; Risk Factors; Severity of Illness Index; Takotsubo Cardiomyopathy; Thromboembolism

Coronary artery disease is the leading cause of death worldwide, and its main pathological substrate is represented by atherosclerosis. Inflammation is a major promoter of the atherosclerotic process and is involved in both the initiation and progression of atherosclerosis, as well as in the occurrence of fatal complications. Until the present moment, Colchicine Cardiovascular Outcomes Trial is the largest trial to demonstrate a major benefit of low-dose colchicine on major adverse cardiac events in patients with recent myocardial infarction (MI), but the mechanisms behind this relation are not completely known. The purpose of this review is to emphasize the possible pathways through which colchicine improves the clinical outcomes in the acute setting of acute coronary syndromes by referring to the results of the studies published in the past 5 years. Aside from its stated systemic anti-inflammatory effect, colchicine could be a valuable addition to the therapeutic approach of acute MI by reducing the infarct size, stabilizing the coronary plaque, as well as reducing platelet aggregation. Moreover, colchicine may improve endothelial function, reduce the transcoronary release of cytokines, and prevent a rise in inflammatory markers after percutaneous coronary intervention, thus diminishing the residual inflammatory risk.

Topics: Acute Coronary Syndrome; Animals; Anti-Inflammatory Agents; Cardiovascular Agents; Cardiovascular System; Colchicine; Humans; Myocardial Infarction; Signal Transduction; Treatment Outcome

Background In chronic coronary syndromes, myocardial ischemia is associated with a greater risk of death and nonfatal myocardial infarction (MI). We sought to compare the effect of initial revascularization with percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG) plus optimal medical therapy (OMT) with OMT alone in patients with chronic coronary syndrome and myocardial ischemia on long-term death and nonfatal MI. Methods and Results Ovid Medline, Embase, Scopus, and Cochrane Library databases were searched for randomized controlled trials of PCI or CABG plus OMT versus OMT alone for patients with chronic coronary syndromes. Studies were screened and data were extracted independently by 2 authors. Random-effects models were used to generate pooled treatment effects. The search yielded 7 randomized controlled trials that randomized 10 797 patients. Median follow-up was 5 years. Death occurred in 640 of the 5413 patients (11.8%) randomized to revascularization and in 647 of the 5384 patients (12%) randomized to OMT (odds ratio [OR], 0.97; 95% CI, 0.86-1.09;

Topics: Cardiovascular Agents; Coronary Artery Disease; Humans; Long Term Adverse Effects; Myocardial Infarction; Myocardial Revascularization; Randomized Controlled Trials as Topic; Treatment Outcome

Monoterpenes are one of the most studied plant's secondary metabolites, they are found abundantly in essential oils of aromatic plants. They also have a great range of pharmacological properties, such as antihypertensive, bradycardic, antiarrhythmic and hypotensive. In the face of the burden caused by cardiovascular disease (CVDs) worldwide, studies using monoterpenes to assess their cardiovascular effects have increased over the years.. This systematic review aimed to summarize the use of monoterpenes in animal models of any CVDs.. PubMed, SCOPUS, LILACS and Web of Science databases were used to search for articles that used monoterpenes, in any type of administration, to treat or prevent CVDs in animal models. The PRISMA guidelines were followed. Two independent researchers extracted main characteristics of studies, methods and outcomes. Data obtained were analyzed qualitatively and quantitatively.. At the ending of the search process, 33 articles were selected for the systematic review. Of these, 17 articles were included in the meta-analysis. A total of 16 different monoterpenes were found for the treatment of hypertension, myocardial infarction, pulmonary hypertension, cardiac hypertrophy and arrhythmia. The main actions include hypotension, bradycardia, vasodilatation, antiarrhythmic, and antioxidant and antiapoptotic properties. From our data, it can be suggested that monoterpenes may be a significant source for new drug development. However, there is still a need to apply these knowledge into clinical research and a long path to pursue before putting them in the market.. The variability of cardiovascular effects demonstrated by the monoterpenes highlighted them as a promising candidates for treatment or prevention of CVDs. Nevertheless, studies that investigate their biological sites of action needs to be further encouraged.

Topics: Animals; Cardiovascular Agents; Cardiovascular Diseases; Disease Models, Animal; Humans; Hypertension; Monoterpenes; Myocardial Infarction; Oils, Volatile; Plants

Large cardiovascular outcome trials demonstrated that the cardioprotective effects of sodium-glucose cotransporter 2 (SGLT2) inhibitors might reach beyond glucose-lowering action. In this meta-analysis, we sought to evaluate the potential infarct size-modulating effect of SGLT2 inhibitors in preclinical studies.. In this preregistered meta-analysis (PROSPERO: CRD42020189124), we included placebo-controlled, interventional studies of small and large animal models of myocardial ischaemia-reperfusion injury, testing the effect of SGLT2 inhibitor treatment on myocardial infarct size (percentage of area at risk or total area). Standardised mean differences (SMDs) were calculated and pooled using random-effects method. We evaluated heterogeneity by computing Τ. We identified ten eligible publications, reporting 16 independent controlled comparisons on a total of 224 animals. Treatment with SGLT2 inhibitor significantly reduced myocardial infarct size compared with placebo (SMD = -1.30 [95% CI -1.79, -0.81], p < 0.00001), referring to a 33% [95% CI 20%, 47%] difference. Heterogeneity was moderate (Τ. The glucose-lowering SGLT2 inhibitors reduce myocardial infarct size in animal models independent of diabetes. Future in vivo studies should focus on clinical translation by exploring whether SGLT2 inhibitors limit infarct size in animals with relevant comorbidities, on top of loading doses of antiplatelet agents. Mechanistic studies should elucidate the potential relationship between the infarct size-lowering effect of SGLT2 inhibitors and the intact organ system.

Topics: Animals; Cardiovascular Agents; Disease Models, Animal; Myocardial Infarction; Myocardial Reperfusion Injury; Myocardium; Sodium-Glucose Transporter 2 Inhibitors; Translational Research, Biomedical

In this update of the Canadian Cardiovascular Society heart failure (HF) guidelines, we provide comprehensive recommendations and practical tips for the pharmacologic management of patients with HF with reduced ejection fraction (HFrEF). Since the 2017 comprehensive update of the Canadian Cardiovascular Society guidelines for the management of HF, substantial new evidence has emerged that has informed the care of these patients. In particular, we focus on the role of novel pharmacologic therapies for HFrEF including angiotensin receptor-neprilysin inhibitors, sinus node inhibitors, sodium glucose transport 2 inhibitors, and soluble guanylate cyclase stimulators in conjunction with other long established HFrEF therapies. Updated recommendations are also provided in the context of the clinical setting for which each of these agents might be prescribed; the potential value of each therapy is reviewed, where relevant, for chronic HF, new onset HF, and for HF hospitalization. We define a new standard of pharmacologic care for HFrEF that incorporates 4 key therapeutic drug classes as standard therapy for most patients: an angiotensin receptor-neprilysin inhibitor (as first-line therapy or after angiotensin converting enzyme inhibitor/angiotensin receptor blocker titration); a β-blocker; a mineralocorticoid receptor antagonist; and a sodium glucose transport 2 inhibitor. Additionally, many patients with HFrEF will have clinical characteristics for which we recommended other key therapies to improve HF outcomes, including sinus node inhibitors, soluble guanylate cyclase stimulators, hydralazine/nitrates in combination, and/or digoxin. Finally, an approach to management that integrates prioritized pharmacologic with nonpharmacologic and invasive therapies after a diagnosis of HFrEF is highlighted.

Topics: Canada; Cardiac Resynchronization Therapy; Cardiovascular Agents; Defibrillators, Implantable; Heart Failure; Heart Rate; Hospitalization; Humans; Myocardial Infarction; Randomized Controlled Trials as Topic; Standard of Care; Stroke Volume

Nearly 10 million US adults experience stable angina, which occurs when myocardial oxygen supply does not meet demand, resulting in myocardial ischemia. Stable angina is associated with an average annual risk of 3% to 4% for myocardial infarction or death. Diagnostic tests and medical therapies for stable angina have evolved over the last decade with a better understanding of the optimal use of coronary revascularization.. Coronary computed tomographic angiography is a first-line diagnostic test in the evaluation of patients with stable angina due to higher sensitivity and comparable specificity compared with imaging-based stress testing. Moreover, coronary computed tomographic angiography allows detection of nonobstructive atherosclerosis that would not be identified with other noninvasive imaging modalities, improving risk assessment and potentially triggering more appropriate allocation of preventive therapies. Novel therapies treating lipids (proprotein convertase subtilisin/kexin type 9 inhibitors, ezetimibe, and icosapent ethyl) and type 2 diabetes (sodium-glucose cotransporter 2 inhibitors, glucagon-like peptide 1 receptor agonists) have improved cardiovascular outcomes in patients with stable ischemic heart disease when added to usual care. Randomized clinical trials showed no improvement in the rates of mortality or myocardial infarction with revascularization (largely by percutaneous coronary intervention) compared with optimal medical therapy alone, even in the setting of moderate to severe ischemia. In contrast, revascularization provides a meaningful benefit on angina and quality of life compared with antianginal therapies. Measures of the effect of angina on a patient's quality of life should be integrated into the clinic encounter to assist with the decision to proceed with revascularization.. For patients with stable angina, emphasis should be placed on optimizing lifestyle factors and preventive medications such as lipid-lowering and antiplatelet agents to reduce the risk for cardiovascular events and death. Antianginal medications, such as β-blockers, nitrates, or calcium channel blockers, should be initiated to improve angina symptoms. Revascularization with percutaneous coronary intervention should be reserved for patients in whom angina symptoms negatively influence quality of life, generally after a trial of antianginal medical therapy. Shared decision-making with an informed patient is important for effective treatment of stable angina.

Topics: Angina, Stable; Cardiovascular Agents; Computed Tomography Angiography; Electrocardiography; Healthy Lifestyle; Humans; Hypolipidemic Agents; Myocardial Infarction; Percutaneous Coronary Intervention; Quality of Life

Myocardial infarction (MI) is one of the major contributors to cardiovascular morbidity and mortality. Excess inflammation significantly contributes to cardiac remodeling and heart failure after MI. Accumulating evidence has shown the central role of cellular metabolism in regulating the differentiation and function of cells. Metabolic rewiring is particularly relevant for proinflammatory responses induced by ischemia. Hypoxia reduces mitochondrial oxidative phosphorylation (OXPHOS) and induces increased reliance on glycolysis. Moreover, activation of a proinflammatory transcriptional program is associated with preferential glucose metabolism in leukocytes. An improved understanding of the mechanisms that regulate metabolic adaptations holds the potential to identify new metabolic targets and strategies to reduce ischemic cardiac damage, attenuate excess local inflammation and ultimately prevent the development of heart failure. Among possible drug targets, glucose transporter 1 (GLUT1) gained considerable interest considering its pivotal role in regulating glucose availability in activated leukocytes and the availability of small molecules that selectively inhibit it. Therefore, we summarize current evidence on the role of GLUT1 in leukocytes (focusing on macrophages and T cells) and non-leukocytes, including cardiomyocytes, endothelial cells and fibroblasts regarding ischemic heart disease. Beyond myocardial infarction, we can foresee the role of GLUT1 blockers as a possible pharmacological approach to limit pathogenic inflammation in other conditions driven by excess sterile inflammation.

Topics: Animals; Cardiovascular Agents; Endothelial Cells; Glucose Transporter Type 1; Humans; Immunotherapy; Macrophages; Myocardial Infarction; Myocytes, Cardiac; Oxidative Phosphorylation

Myocardial infarction is a frequent cardiovascular event and a major cause for cardiomyocyte loss. In adult mammals, cardiomyocytes are traditionally considered to be terminally differentiated cells, unable to proliferate. Therefore, the wound-healing response in the infarct area typically yields scar tissue rather than newly formed cardiomyocytes. In the last decade, several lines of evidence have challenged the lack of proliferative capacity of the differentiated cardiomyocyte: studies in zebrafish and neonatal mammals have convincingly demonstrated the regenerative capacity of cardiomyocytes. Moreover, multiple signaling pathways have been identified in these models that-when activated in adult mammalian cardiomyocytes-can reactivate the cell cycle in these cells. However, cardiomyocytes frequently exit the cell cycle before symmetric division into daughter cells, leading to polyploidy and multinucleation. Now that there is more insight into the reactivation of the cell cycle machinery, other prerequisites for successful symmetric division of cardiomyocytes, such as the control of sarcomere disassembly to allow cytokinesis, require more investigation. This review aims to discuss the signaling pathways involved in cardiomyocyte proliferation, with a specific focus on wingless/int-1 protein signaling. Comparing the conflicting results from in vitro and in vivo studies on this pathway illustrates that the interaction with other cells and structures around the infarct is likely to be essential to determine the outcome of these interventions. The extensive crosstalk with other pathways implicated in cardiomyocyte proliferation calls for the identification of nodal points in the cell signaling before cardiomyocyte proliferation can be moved forward toward clinical application as a cure of cardiac disease. SIGNIFICANCE STATEMENT: Evidence is mounting that proliferation of pre-existing cardiomyocytes can be stimulated to repair injury of the heart. In this review article, an overview is provided of the different signaling pathways implicated in cardiomyocyte proliferation with emphasis on wingless/int-1 protein signaling, crosstalk between the pathways, and controversial results obtained in vitro and in vivo.

Topics: Adaptor Proteins, Signal Transducing; Animals; Animals, Newborn; Cardiovascular Agents; Cell Cycle; Cell Differentiation; Cell Proliferation; Cicatrix; Follistatin-Related Proteins; Hippo Signaling Pathway; Humans; Myocardial Infarction; Myocytes, Cardiac; Neuregulins; Protein Serine-Threonine Kinases; Receptors, Notch; Sarcomeres; Trans-Activators; Transcription Factors; Transcriptional Coactivator with PDZ-Binding Motif Proteins; Wnt Signaling Pathway; YAP-Signaling Proteins; Zebrafish

To examine the current clinical evidence behind the use of calcium channel blockers (CCB) and beta-blockers (BB) for the treatment of patients with stable coronary artery disease (SCAD) and their effect on mortality.. Current evidence suggests that BB use as a first line antianginal medication is associated with lower 5-year all-cause mortality only in patients who had MI within a year. This could be driven due to their effects reducing the sympathetic neuro-hormonal activation of more acutely ill patients. The use of CCB as an antianginal therapy, although proven effective in multiple trials both as monotherapy and combined with other agents, has not shown mortality benefit. Both BB and CCB are effective antianginals, and the selection among them depends on the patient clinical presentation and comorbidities. BB are the only ones that have shown survival benefit in SCAD, particularly the first year post-MI.

Topics: Adrenergic beta-Antagonists; Calcium Channel Blockers; Cardiovascular Agents; Coronary Artery Disease; Humans; Myocardial Infarction

It is increasingly recognized that a significant proportion of patients suffered from acute myocardial infraction (AMI) who did not have obstructive coronary artery disease (≥50% diameter stenosis). The term "MINOCA (myocardial infarction with nonobstructive coronary arteries)" was coined for such entity, however, the exact mechanism of MINOCA is still unclear. Herein, we report a patient with MINOCA during bronchoscopy and further review the recent literature.. A 65-year-old woman was hospitalized with the main complaint of chest tightness, nausea and vomiting for 30 min during bronchoscopy under local anesthesia. Immediate electrocardiogram (ECG) showed ST-segments elevation in leads V2-6 compared with those at admission, and the further evolvement of leads V2-3 into pathological Q wave. Serum cardiac biomarkers revealed high-sensitive cardiac troponin T (hs-cTnT) levels of 20.12 ng/L and 674.6 ng/L at the peak (normal range 0-14 ng/L). Emergency coronary angiography (CAG) showed only approximate 30% stenosis in the left anterior descending (LAD) ostium and 40% stenosis in the first diagonal branch (D1), with quantitative flow ratio (QFR) value for LAD of 0.96. Moreover, her echocardiographic examination presented new significant abnormal wall motion (anterior ventricular wall) with an estimated left ventricular ejection fraction (LVEF) of 62.1% after the cardiac attack. Thoracic enhanced CT scanning indicated no obvious sign of pulmonary embolism. Therefore, with confirmed AMI and the absence of significant coronary stenosis simultaneously, MINOCA was diagnosed with the prescription of dual-antiplatelet, statins, beta-blocker, angiotensin receptors antagonist, calcium channel blocker and nitrate. This patient had a good prognosis during a follow-up of 14 months.. In this case, bronchoscopy might have caused extremely tense and anxious which led to a sympathetic hyperfunction and acute coronary thrombosis induced by plaque disruption and coronary artery spasm. QFR value is a feasible technique to evaluate the functional coronary stenosis and assist the diagnose of MINOCA. Also, the diagnosis of MINOCA deems an exploration of underlying causes for proper management and prognostic evaluation.

Topics: Aged; Biomarkers; Bronchoscopy; Cardiovascular Agents; Coronary Angiography; Echocardiography; Electrocardiography; Female; Humans; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Myocardial Infarction; Risk Factors; Treatment Outcome; Troponin T

After an episode of myocardial infarction (MI), patients remain at risk for recurrent ischemic events, heart failure (HF), and sudden death. Post-MI patients with left ventricular systolic dysfunction (LVSD) have an even greater risk of mortality and morbidity. Randomized clinical trials that included post-MI patients with LVSD have demonstrated that pharmacologic therapies aimed at preventing post-MI remodeling with neurohormonal antagonists can significantly improve short- and long-term outcomes, including death, reinfarction, and worsening HF. Recent trials have also demonstrated benefits in terms of cardiovascular event reduction with effective antithrombotic therapies and cholesterol-lowering agents in post-MI setting, especially in patients at very high risk such as those with LVSD. This paper reviews clinical trials that included post-MI patients with LVSD, with or without signs and symptoms of HF, assessing the efficacy of established and emerging pharmacological therapies.

Topics: Cardiovascular Agents; Evidence-Based Medicine; Heart Failure; Humans; Myocardial Infarction; Recovery of Function; Treatment Outcome; Ventricular Dysfunction, Left; Ventricular Function, Left

A wide range of histone deacetylase (HDAC) inhibitors have been studied for their therapeutic potential because the excessive activity and expression of HDACs have been implicated in the pathogenesis of cardiac diseases. An increasing number of preclinical studies have demonstrated the cardioprotective effects of numerous HDAC inhibitors, suggesting a wide variety of mechanisms by which the inhibitors protect against cardiac stress, such as the suppression of cardiac fibrosis and fetal gene expression, enhancement of angiogenesis and mitochondrial biogenesis, prevention of electrical remodeling, and regulation of apoptosis, autophagy, and cell cycle arrest. For the development of isoform-selective HDAC inhibitors with high efficacy and low toxicity, it is important to identify and understand the mechanisms responsible for the effects of the inhibitors. This review highlights the preclinical effects of HDAC inhibitors that act against Zn

Topics: Animals; Antihypertensive Agents; Atrial Fibrillation; Blood Pressure; Cardiomegaly; Cardiovascular Agents; Fibrosis; Heart Rate; Histone Deacetylase Inhibitors; Histone Deacetylases; Humans; Hypertension; Myocardial Infarction; Myocardium; Signal Transduction; Ventricular Remodeling

Coronary stent neoatherosclerosis, thrombosis, and restenosis remain significant concerns with new-generation drug-eluting stents (DES). The Dual-Therapy CD34 antibody-covered sirolimus-eluting stent [dual therapy stent (DTS)] is a sirolimus-eluting stent with CD34 antibodies immobilized on its luminal surface to capture circulating endothelial progenitor cells and promote early endothelialization. We conducted a meta-analysis to determine whether the DTS was superior to standard DES.. We conducted a comprehensive search for controlled randomized and non-randomized studies. We presented data using risk ratios (95% confidence intervals) and measured heterogeneity using Higgins' I. One-year TLR was significantly higher in the DTS arm compared with second-generation DES. There was no difference in the other 1-year clinical outcomes compared with standard DES.

Topics: Antibodies; Antigens, CD34; Cardiovascular Agents; Coronary Artery Disease; Coronary Thrombosis; Coronary Vessels; Drug-Eluting Stents; Endothelial Progenitor Cells; Humans; Myocardial Infarction; Percutaneous Coronary Intervention; Prosthesis Design; Randomized Controlled Trials as Topic; Re-Epithelialization; Risk Factors; Sirolimus; Time Factors; Treatment Outcome

Ultrathin bioresorbable polymer sirolimus-eluting stents (BP SES) have been proposed as an alternative to thin durable polymer drug-eluting stents (DP DES). Although BP SES show a significant decrease in target lesion failure rates, clear superiority with respect to efficacy and safety of BP SES in comparison to DP EES has not been consistently proven.. A comprehensive search of several electronic databases identified studies that assessed efficacy and safety of BP SES, compared with DP EES. Relative risks (RRs) were pooled across studies using a fixed-effects model and a random-effect model, respectively, calculating pooled RRs and associated 95% confidence intervals (CIs). The I statistic was used to assess heterogeneity. We retrieved six studies enrolling >7000 patients. BP SES significantly reduced the risk of target vessel myocardial infarction (RR, 0.79; 95% CI, 0.64-0.97; I = 0%; Test for overall effect: z = 2.24, P = 0.03) in comparison with DP EES using a random-effects model. Use of BP SES was associated with a significant reduction in any myocardial infarction (RR, 0.83; 95% CI, 0.70-0.98; I = 12%; Test for overall effect: z = 2.19, P = 0.03), using a fixed-effects model. The subgroup analyses demonstrated, following-up ≥2 years, a statistically significant 27% RR increase in the risk of all-case death for patients randomized to BP SES (RR, 1.27; 95% CI, 1.01-1.60; I = 0%; Test for overall effect: z = 2.08, P = 0.04). No differences in cardiac death, stent thrombosis events (STE), target lesion revascularization (TLR) and target vessel revascularization (TVR) between BP SES and DP EES were observed.. BP SES significantly reduced the risk of any myocardial infarction and target vessel myocardial infarction in comparison with DP EES. There were no differences in cardiac death, STE, TLR, TVR and all-cause death with its follow-up time <2 year between BP SES and DP EES. Following-up ≥2 years, a statistically significant 27% RR increase in the risk of all-case death for patients randomized to BP SES was observed.

Topics: Cardiovascular Agents; Coronary Artery Disease; Drug-Eluting Stents; Humans; Myocardial Infarction; Percutaneous Coronary Intervention; Polymers; Prosthesis Design; Risk Factors; Sirolimus; Time Factors; Treatment Outcome

The coronary circulation is both culprit and victim of acute myocardial infarction. The rupture of an epicardial atherosclerotic plaque with superimposed thrombosis causes coronary occlusion, and this occlusion must be removed to induce reperfusion. However, ischaemia and reperfusion cause damage not only in cardiomyocytes but also in the coronary circulation, including microembolization of debris and release of soluble factors from the culprit lesion, impairment of endothelial integrity with subsequently increased permeability and oedema formation, platelet activation and leucocyte adherence, erythrocyte stasis, a shift from vasodilation to vasoconstriction, and ultimately structural damage to the capillaries with eventual no-reflow, microvascular obstruction (MVO), and intramyocardial haemorrhage (IMH). Therefore, the coronary circulation is a valid target for cardioprotection, beyond protection of the cardiomyocyte. Virtually all of the above deleterious endpoints have been demonstrated to be favourably influenced by one or the other mechanical or pharmacological cardioprotective intervention. However, no-reflow is still a serious complication of reperfused myocardial infarction and carries, independently from infarct size, an unfavourable prognosis. MVO and IMH can be diagnosed by modern imaging technologies, but still await an effective therapy. The current review provides an overview of strategies to protect the coronary circulation from acute myocardial ischaemia/reperfusion injury. This article is part of a Cardiovascular Research Spotlight Issue entitled 'Cardioprotection Beyond the Cardiomyocyte', and emerged as part of the discussions of the European Union (EU)-CARDIOPROTECTION Cooperation in Science and Technology (COST) Action, CA16225.

Topics: Animals; Cardiovascular Agents; Collateral Circulation; Coronary Circulation; Humans; Ischemic Postconditioning; Ischemic Preconditioning; Ischemic Preconditioning, Myocardial; Microcirculation; Myocardial Infarction; Myocardial Reperfusion Injury; Myocardium; Neovascularization, Physiologic; No-Reflow Phenomenon; Treatment Outcome

The optimal management of patients with coronary chronic total occlusions (CTO) remains controversial. This meta-analysis aims to compare percutaneous coronary intervention of CTO (CTO-PCI) versus optimal medical therapy (OMT) in CTO patients.. A literature search with highly specific terms was conducted using MEDLINE, EMBASE, and Web of Science to identify most relevant randomized controlled trials (RCTs) and observational studies with propensity score matching (PSM) evaluating differences in between CTO-PCI versus OMT. The primary endpoint was the incidence of major adverse cardiac events (MACEs, composite of cardiovascular death, acute coronary syndrome, and repeat PCI, re-PCI) while its single components were defined as secondary endpoints.. A total of eight studies was included, four RCTs and four PSMs. 3,971 patients were included in the analysis (2,050 CTO-PCI versus 1,921 OMT) with a mean follow-up of 3 years. No significant differences were found regarding overall MACE, re-PCI and AMI. Regarding CV-death, CTO-PCI was associated with a better outcome compared with OMT driven by PSMs (OR 0.52, 0.0.81, P < 0.01).. As compared to OMT, CTO-PCI was associated with similar MACE rate; however, CTO-PCI may be associated with reduced CV death, mainly due to PSMs effect.

Topics: Acute Coronary Syndrome; Aged; Cardiovascular Agents; Cause of Death; Chronic Disease; Coronary Occlusion; Female; Humans; Male; Middle Aged; Myocardial Infarction; Percutaneous Coronary Intervention; Randomized Controlled Trials as Topic; Retreatment; Risk Assessment; Risk Factors; Time Factors; Treatment Outcome

Cardiovascular disease (CVD), principally myocardial infarction (MI) and stroke, is the leading clinical and public health problem in the United States and is rapidly becoming so worldwide. Their primary prevention is promising, in theory, but difficult to achieve in practice. The principal modalities that have demonstrated efficacy include therapeutic lifestyle changes (TLCs) and adjunctive drug therapies under the guidance of the health-care provider and tailored to the individual patient. The prevention and treatment of the pandemic of overweight and obesity and lack of regular physical activity, both of which are alarmingly common in the United States, prevention and treatment of hypertension, avoidance and cessation of cigarette smoking, adoption and maintenance of a healthy diet, and avoidance of heavy alcohol consumption all have proven benefits in decreasing the risks of a first MI and stroke as well as other clinical manifestations of CVD. Although adoption of TLCs would avoid the need for adjunctive drug therapies in many primary prevention subjects, this strategy is difficult to achieve or maintain for most and may be insufficient for many, especially those at high risk with metabolic syndrome. The criteria for metabolic syndrome, affecting over 40% of the adult population older than 40 in the United States, include overweight or obesity, dyslipidemia, hypertension, and insulin resistance, a precursor of diabetes. The adjunctive therapies of proven benefit in the primary prevention of MI and stroke include statins, blood pressure medications, aspirin, and drugs to treat insulin resistance and hyperglycemia. Fortunately, even for patients who prefer prescription of pills to proscription of harmful lifestyles, these drug therapies still have net benefits. The adoption and maintenance of TLCs and adjunctive drug therapies into clinical practice will reduce both the incidence of and mortality from a first MI and stroke as well as other major clinical manifestations of CVD.

Topics: Cardiovascular Agents; Healthy Lifestyle; Humans; Incidence; Myocardial Infarction; Primary Prevention; Protective Factors; Risk Assessment; Risk Factors; Risk Reduction Behavior; Stroke; Treatment Outcome

The study estimated the health economic impact of a latest generation coronary stent with ultrathin struts and bioresorbable polymer coating.. The recent BIOFLOW V trial, an international FDA approval trial (ClinicalTrials.gov: NCT02389946), has shown that an ultrathin, bioresorbable polymer sirolimus-eluting stent had a significantly lower rate of target lesion failure and target vessel-related myocardial infarction than a thin, durable polymer everolimus-eluting stent at 12 months, driven by a lower rate of peri-procedural myocardial infarction (ppMI).. We used a Markov model to project mortality and cost outcomes of that lower ppMI rate from a U.S. health system perspective over a 12-month horizon. Model parameters were derived from BIOFLOW V trial data, a systematic literature review and expert interviews.. Use of the bioresorbable polymer sirolimus-eluting stent compared to durable polymer everolimus-eluting stent is associated with net reductions in medical cost of $124 (Interquartile Range (IQR) $97-154) per patient in 2018 US$, of which $115 (IQR $76-124) accrues to the initial admission and $10 (IQR $7-72) to cost of follow-up. The lower rate of ppMI translates into a gain of 0.000017 (IQR 0.000011-0.000022) quality-adjusted life-years (QALY) per patient.. Lower ppMI rates of bioresorbable polymer sirolimus-eluting stent translate into reductions in direct medical cost, while improving patient outcomes. Most of the cost reduction is attributed to the initial admission with moderate savings up to 12 months post-discharge.

Topics: Absorbable Implants; Cardiovascular Agents; Clinical Trials as Topic; Computer Simulation; Coronary Artery Disease; Cost Savings; Cost-Benefit Analysis; Drug Costs; Drug-Eluting Stents; Everolimus; Health Care Costs; Humans; Markov Chains; Models, Economic; Myocardial Infarction; Percutaneous Coronary Intervention; Polymers; Prosthesis Design; Risk Assessment; Risk Factors; Sirolimus; Time Factors; Treatment Outcome

New therapies are required to reduce myocardial infarct (MI) size and prevent the onset of heart failure in patients presenting with acute myocardial infarction (AMI), one of the leading causes of death and disability globally. In this regard, the immune cell response to AMI, which comprises an initial pro-inflammatory reaction followed by an anti-inflammatory phase, contributes to final MI size and post-AMI remodelling [changes in left ventricular (LV) size and function]. The transition between these two phases is critical in this regard, with a persistent and severe pro-inflammatory reaction leading to adverse LV remodelling and increased propensity for developing heart failure. In this review article, we provide an overview of the immune cells involved in orchestrating the complex and dynamic inflammatory response to AMI-these include neutrophils, monocytes/macrophages, and emerging players such as dendritic cells, lymphocytes, pericardial lymphoid cells, endothelial cells, and cardiac fibroblasts. We discuss potential reasons for past failures of anti-inflammatory cardioprotective therapies, and highlight new treatment targets for modulating the immune cell response to AMI, as a potential therapeutic strategy to improve clinical outcomes in AMI patients. This article is part of a Cardiovascular Research Spotlight Issue entitled 'Cardioprotection Beyond the Cardiomyocyte', and emerged as part of the discussions of the European Union (EU)-CARDIOPROTECTION Cooperation in Science and Technology (COST) Action, CA16225.

Topics: Animals; Anti-Inflammatory Agents; Cardiovascular Agents; Dendritic Cells; Fibroblasts; Heart Failure; Humans; Inflammation Mediators; Lymphocytes; Mast Cells; Monocytes; Myocardial Infarction; Myocardial Reperfusion Injury; Myocardium; Neutrophils; Signal Transduction; Ventricular Function, Left; Ventricular Remodeling

Drug-coated balloon as a novel therapeutic strategy has been used to treat restenosis in cases of bare metal and drug-eluting stents. However, evidence of its safety and efficacy is scarce in de novo small coronary artery vessel disease. This meta-analysis aimed to compare the safety and efficacy of the drug-coated balloon and the drug-eluting stent.. The PubMed, EMBASE, Web of Science, and Cochrane library databases were searched for studies published up to October 17, 2018. Studies comparing the drug-coated balloon with the drug-eluting stent strategy in patients with de novo small coronary artery vessel disease (reference diameter, <3 mm) were identified. The clinical outcomes were nonfatal myocardial infarction, cardiac death, all-cause death, target lesion revascularization, and target-vessel revascularization. Data were analyzed using the statistical software RevMan (version 5.3). Fixed effects models were performed to calculate the pooled odds ratios (ORs) and 95% confidence intervals (95% CIs). Sensitivity analyses were used to detect potential sources of heterogeneity, while subgroup analyses were implemented to assess the differential effects.. Three randomized controlled trials and 3 nonrandomized controlled studies were identified. Six studies including a total of 1800 patients compared the differences between the drug-coated balloon and the drug-eluting stent strategies in patients with de novo small coronary artery vessel disease. The results indicated that the drug-coated balloon strategy was associated with a significant reduction in nonfatal myocardial infarction (OR 0.53, 95% CI 0.31-0.90, P = .02) compared with the drug-eluting stent strategy, while insignificant inter-strategy differences were observed in cardiac death (OR 1.56, 95% CI 0.73-3.33, P = .25), all-cause death (OR 0.56, 95% CI 0.25-1.23, P = .15), target lesion revascularization (OR 1.24, 95% CI 0.73-2.1, P = .43), and target-vessel revascularization (OR 0.95, 95% CI 0.59-1.52, P = .84).. This meta-analysis suggests that the drug-coated balloon strategy is noninferior to the drug-eluting stent strategy, delivering a good outcome in nonfatal myocardial infarction, and can be recommended as an optimal treatment strategy in patients with de novo small coronary artery vessel disease. Larger randomized controlled studies with longer follow-up periods are needed to further confirm the benefits of the drug-coated balloon strategy.

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Artery Disease; Coronary Vessels; Drug-Eluting Stents; Female; Humans; Male; Middle Aged; Myocardial Infarction; Non-Randomized Controlled Trials as Topic; Odds Ratio; Postoperative Complications; Prosthesis Design; Randomized Controlled Trials as Topic; Treatment Outcome

This study evaluated the clinical value of drug-coated balloons for patients with small-vessel coronary artery disease (SVD).. A computerized literature search was performed using the databases to conduct a meta-analysis and evaluate the clinical value of drug-coated balloons among patients with SVD.. This review enrolling 1545 patients receiving drug-coated balloons and 1010 patients receiving stents (including drug-eluting stents and bare-metal stents). The meta-analysis results showed that the incidence of major adverse cardiovascular events among patients with SVD did not significantly differ between the drug-coated balloon group and the stent group within 1 postoperative year (odds ratio = 0.81, P = .5). A subgroup analysis showed that the incidence of myocardial infarction among the drug-coated balloon group was significantly lower than that among the stent group (odds ratio = 0.58, P = .04). Nevertheless, the late lumen loss of the drug-coated balloon group was significantly lower than that of the stent group (mean difference = 0.31, P = .01).. Drug-coated balloons can be used to effectively reduce the incidence of myocardial infarction in patients with SVD within 1 year and decrease the extent of late lumen loss without increasing the incidence of major adverse cardiovascular events.

Topics: Angioplasty, Balloon, Coronary; Cardiovascular Agents; Case-Control Studies; Coronary Artery Disease; Coronary Vessels; Drug-Eluting Stents; Female; Humans; Incidence; Male; Myocardial Infarction; Odds Ratio; Postoperative Complications; Randomized Controlled Trials as Topic; Self Expandable Metallic Stents; Treatment Outcome

The NLRP3 inflammasome is an intracellular, multimeric protein complex that initiates a potent inflammatory response to danger signals. After acute myocardial infarction, NLRP3 inflammasome-dependent inflammation promotes adverse left ventricular remodeling and recurrent atherosclerotic events. Selective and nonselective inhibitors of the NLRP3 inflammasome or its downstream effectors (interleukin-1β and interleukin-18) may prevent adverse left ventricular remodeling and recurrent atherosclerotic events. In this review, we highlight strategies to inhibit NLRP3 inflammasome activity and their potential roles in the management of acute myocardial infarction.

Topics: Animals; Anti-Inflammatory Agents; Cardiovascular Agents; Humans; Inflammasomes; Inflammation; Inflammation Mediators; Molecular Targeted Therapy; Myocardial Infarction; NLR Family, Pyrin Domain-Containing 3 Protein; Signal Transduction

An accumulating body of evidence indicates that NLRP3 inflammasome plays a crucial role in the pathophysiology of cardiovascular diseases, including atherosclerosis and acute myocardial infarction (MI). NLRP3 inflammasome is a multimeric protein complex that leads to activation of caspase-1, which further induces maturation of interleukin (IL)-1β and IL-18. Activated caspase-1 also induces a particular form of cell death called pyroptosis by the cleavage of gasdermin D. Our and other groups have shown that inhibition of the NLRP3 inflammasome attenuates the inflammatory response and ameliorates myocardial dysfunction and remodeling in animal models of acute MI. Interestingly, investigations have suggested that NLRP3 inflammasome has cell-specific roles in different cell types, such as inflammatory cells, cardiomyocytes, cardiac fibroblasts, and vascular endothelial cells, after acute MI. Moreover, the recent CANTOS trial showed that inhibition of IL-1β was efficacious in secondary prevention for cardiovascular events in patients with previous MI. These findings suggest that NLRP3 inflammasome may be a potential target for the prevention and therapy of MI. This review summarizes recent knowledge on NLRP3 inflammasome and focuses on its cell-specific roles in acute MI.

Topics: Animals; Anti-Inflammatory Agents; Cardiovascular Agents; Cytokines; Endothelial Cells; Fibroblasts; Humans; Inflammasomes; Inflammation; Inflammation Mediators; Myocardial Infarction; Myocardial Reperfusion Injury; Myocytes, Cardiac; NLR Family, Pyrin Domain-Containing 3 Protein; Pyroptosis; Signal Transduction

Acute myocardial infarction (AMI) is associated with the induction of a sterile inflammatory response that leads to further injury. The NACHT, leucine-rich repeat, and pyrin domain-containing protein 3 (NLRP3) inflammasome is a macromolecular structure responsible for the inflammatory response to injury or infection. NLRP3 can sense intracellular danger signals, such as ischemia and extracellular or intracellular alarmins during tissue injury. The NLRP3 inflammasome is primed and triggered by locally released damage-associated molecular patterns and amplifies the inflammatory response and cell death through caspase-1 activation. Here, we examine the scientific evidence supporting a role for NLRP3 in AMI and the available strategies to inhibit the effects of the inflammasome. Our focus is on the beneficial effects seen in experimental models of AMI in preclinical animal models and the initial results of clinical trials.

Topics: Animals; Anti-Inflammatory Agents; Cardiovascular Agents; Cytokines; Humans; Inflammasomes; Inflammation; Inflammation Mediators; Myocardial Infarction; Myocardium; NLR Family, Pyrin Domain-Containing 3 Protein; Pyroptosis; Signal Transduction

Stable ischemic heart disease (SIHD) is a leading cause of death in the United States and many other countries. The defining pathobiology is an imbalance between the metabolic demands of the myocardium and its oxygen supply, which most often results from coronary artery atherosclerosis. The classic presenting symptom of SIHD is angina, but clinical presentation varies greatly among patients. Since the last In the Clinic on SIHD in 2014, several new drugs have been approved to reduce ischemic complications, such as myocardial infarction and congestive heart failure.

Topics: Cardiovascular Agents; Coronary Artery Bypass; Diagnosis, Differential; Heart Failure; Humans; Myocardial Infarction; Myocardial Ischemia; Patient Education as Topic; Risk Factors; Risk Reduction Behavior

The heart is extremely sensitive to ischaemic injury. During an acute myocardial infarction (AMI) event, the injury is initially caused by reduced blood supply to the tissues, which is then further exacerbated by an intense and highly specific inflammatory response that occurs during reperfusion. Numerous studies have highlighted the central role of the NACHT, LRR, and PYD domains-containing protein 3 (NLRP3) inflammasome in this process. The inflammasome, an integral part of the innate immune system, is a macromolecular protein complex that finely regulates the activation of caspase 1 and the production and secretion of powerful pro-inflammatory cytokines such as IL-1β and IL-18. In this Review, we summarize evidence supporting the therapeutic value of NLRP3 inflammasome-targeted strategies in experimental models, and the data supporting the role of the NLRP3 inflammasome in AMI and its consequences on adverse cardiac remodelling, cytokine-mediated systolic dysfunction, and heart failure.

Topics: Animals; Anti-Inflammatory Agents; Cardiovascular Agents; Cytokines; Humans; Inflammasomes; Inflammation Mediators; Molecular Targeted Therapy; Myocardial Infarction; Myocardium; NLR Family, Pyrin Domain-Containing 3 Protein; Signal Transduction; Ventricular Function, Left; Ventricular Remodeling

Recent studies suggest the Orsiro sirolimus-eluting stent (O-SES), which has ultrathin struts with a biodegradable sirolimus-eluting polymer coating, performed better than contemporary drug-eluting stents (DES). We performed a meta-analysis to compare clinical outcomes for all randomized controlled trials (RCTs) of O-SES vs contemporary DES.. PubMed, Cochrane CENTRAL, and meeting abstracts were searched for all RCTs comparing O-SES with contemporary DES. Pooled estimates of longest available clinical outcomes at a minimum of one-year follow-up, presented as odds ratios (OR) [95% confidence intervals], were generated with random-effect models.. We included 8 RCTs with a total of 11,176 patients (5444 O-SES and 5732 contemporary DES [3537 EES, 1295 ZES, and 1264 BP-BES) with a mean age of 65±11, 74% were male, 40% underwent PCI for stable angina, and 56% for ACS. We assessed outcomes comparing O-SES vs. everolimus-eluting stents, vs. permanent-polymer DES, and vs. all DES including biodegradable-polymer DES. Orsiro performed comparably in all categories with a trend toward a reduction in myocardial infarction (0.83 [0.68, 1.02], p=0.07) and stent thrombosis (0.75 [0.54, 1.04], p=0.08).. Overall, the Orsiro SES had similar clinical outcomes to contemporary DES with a trend toward reduction in myocardial infarction and stent thrombosis.

Topics: Aged; Cardiovascular Agents; Coronary Artery Disease; Coronary Thrombosis; Coronary Vessels; Drug-Eluting Stents; Female; Humans; Male; Middle Aged; Myocardial Infarction; Percutaneous Coronary Intervention; Prosthesis Design; Randomized Controlled Trials as Topic; Risk Factors; Sirolimus; Time Factors; Treatment Outcome

The survivor activating factor enhancement (SAFE) pathway was discovered as an alternative intrinsic pro-survival signaling pathway to the reperfusion injury salvage kinase pathway for cardioprotection against ischemia-reperfusion injury. The delineation of this pathway, made of key components such as cytokines of the immune system and transcription factors, has brought major advancements in our understanding on how the heart is able to protect itself against ischemia-reperfusion injury. In this viewpoint, we describe the major steps leading to the discovery of the SAFE pathway in small animal models to date and we discuss its translation to large animals and humans.

Topics: Animals; Cardiovascular Agents; Drug Design; Humans; Molecular Targeted Therapy; Myocardial Infarction; Myocardial Reperfusion Injury; Myocytes, Cardiac; Receptors, Tumor Necrosis Factor, Type II; Signal Transduction; STAT3 Transcription Factor; Tumor Necrosis Factor-alpha

Non-adherence to medications for the secondary prevention of myocardial infarction (MI) is a major contributor to morbidity and mortality in these patients. This review describes recent advances in promoting adherence to therapies for coronary artery disease (CAD).. Two large randomized controlled trials to "incentivize" adherence were somewhat disappointing; neither financial incentives nor "peer pressure" successfully increased rates of adherence in the post-MI population. Patient education and provider engagement appear to be critical aspects of improving adherence to CAD therapies, where the provider is a physician, pharmacist, or nurse and follow-up is performed in person or by telephone. Fixed-dose combinations of CAD medications, formulated as a so-called "polypill," have shown some early efficacy in increasing adherence. Technological advances that automate monitoring and/or encouragement of adherence are promising but seem universally dependent on patient engagement. For example, medication reminders via text message perform better if patients are required to respond. Multifaceted interventions, in which these and other interventions are combined together, appear to be most effective. There are several available types of proven interventions through which providers, and the health system at large, can advance patient adherence to CAD therapies. No single intervention to promote adherence will be successful in all patients. Further study of multifaceted interventions and the interactions between different interventions will be important to advancing the field. The goal is a learning healthcare system in which a network of interventions responds and adapts to patients' needs over time.

Topics: Cardiovascular Agents; Coronary Artery Disease; Coronary Disease; Humans; Medication Adherence; Myocardial Infarction; Patient Education as Topic; Professional Role; Professional-Patient Relations; Randomized Controlled Trials as Topic; Reminder Systems; Secondary Prevention

Many cytokines are currently under investigation as potential target to improve cardiac function and outcome in the setting of acute myocardial infarction (MI) or chronic heart failure (HF). Here we aim to provide a translational overview of cytokine inhibiting therapies tested in experimental models and clinical studies. In various experimental studies, inhibition of interleukin-1 (IL-1), -6 (IL-6), -8 (IL-8), monocyte chemoattractant protein-1 (MCP-1), CC- and CXC chemokines, and tumor necrosis factor-α (TNF-α) had beneficial effects on cardiac function and outcome. On the other hand, neutral or even detrimental results have been reported for some (IL-1, IL-6, IL-8, and MCP-1). Ambivalence of cytokine function, differences in study designs, treatment regimens and chosen endpoints hamper the translation of experimental research into clinical practice. Human studies are currently limited to IL-1β inhibition, IL-1 receptor antagonists (IL-1RA), IL-6 receptor antagonists (IL-6RA) or TNF inhibition. Despite favorable effects on cardiovascular events observed in retrospective cohort studies of rheumatoid arthritis patients treated with TNF inhibition or IL-1RA, most prospective studies reported disappointing and inconsistent results. Smaller studies (n < 100) generally reported favorable results of anticytokine therapy on cardiac function, but only one of the larger studies (n > 100) evaluating IL-1β inhibition presented positive results on outcome. In conclusion, of the 10 anticytokine therapies tested in animals models beneficial effects have been reported in at least one setting. In larger clinical studies, findings were unsatisfactory in all but one. Many anticytokine therapies with promising animal experimental data continue to require further evaluation in humans.

Topics: Animals; Anti-Inflammatory Agents; Cardiovascular Agents; Cytokines; Heart Failure; Humans; Inflammation Mediators; Myocardial Infarction; Signal Transduction; Translational Research, Biomedical

Randomised clinical trials are the gold standard for testing the effectiveness of clinical interventions. However, increasing complexity and associated costs may limit their application in the investigation of key cardiovascular knowledge gaps such as the re-evaluation of generic pharmacotherapies. The registry-based randomised clinical trial (RRCT) leverages data sampling from nationwide quality registries to facilitate high participant inclusion rates at comparably low costs and, therefore, may offer a mechanism by which such clinical questions may be answered. To date, a number of studies have been conducted using such trial designs, but uncritical use of the RRCT design may lead to erroneous conclusions. The current review provides insights into the strengths and weaknesses of the RRCT, as well as provides an exploratory example of how a trial may be designed to test the long-term effectiveness of beta blockers in patients with myocardial infarction who have preserved left ventricular systolic function.

Topics: Adrenergic beta-Antagonists; Cardiovascular Agents; Drug Costs; Humans; Myocardial Infarction; Randomized Controlled Trials as Topic; Registries; Research Design; Therapeutic Equivalency; Time; Treatment Outcome; Ventricular Function, Left

Topics: Animals; Apoptosis; Cardiolipins; Cardiovascular Agents; Energy Metabolism; Humans; Lipid Peroxidation; Mitochondria, Heart; Mitochondrial Dynamics; Mitochondrial Membrane Transport Proteins; Mitochondrial Permeability Transition Pore; Mitophagy; Myocardial Infarction; Myocardial Reperfusion Injury; Myocytes, Cardiac; Oxidative Stress; Reactive Oxygen Species; Signal Transduction

The Orsiro biodegradable polymer sirolimus-eluting stent (O-SES) is a new-generation biodegradable polymer drug-eluting stent with the thinnest strut thickness to date developed to improve the percutaneous treatment of patients with coronary artery disease. We perform a meta-analysis of randomized clinical trials (RCTs) comparing the efficacy and safety of an ultra-thin, Orsiro biodegradable polymer sirolimus-eluting stent (O-SES) compared with durable polymer drug-eluting stents (DP-DESs).. Medline, Embase, and CENTRAL databases were searched for randomized controlled trials comparing the safety and efficacy of O-SES versus DP-DES. Paired reviewers independently screened citations, assessed risk of bias of included studies, and extracted data. We used the Mantel-Haenszel method to calculate risk ratio (RR) by means of a random-effects model.. Six RCTs with a total of 6949 patients were selected. All included trials were rated as low risk of bias. The O-SES significantly reduced the risk of myocardial infarction (RR 0.78, 95% confidence interval [CI] 0.62-0.98; I. Among patients undergoing percutaneous coronary intervention, O-SES resulted in significantly lower rates of myocardial infarction than DP-DES and had a trend toward reduction in stent thrombosis.

Topics: Absorbable Implants; Cardiovascular Agents; Coronary Artery Disease; Coronary Thrombosis; Drug-Eluting Stents; Humans; Myocardial Infarction; Percutaneous Coronary Intervention; Polymers; Prosthesis Design; Randomized Controlled Trials as Topic; Risk Factors; Sirolimus; Treatment Outcome

Topics: Animals; Biomedical Research; Cardiology; Cardiovascular Agents; Data Accuracy; Data Interpretation, Statistical; Disease Models, Animal; Drug Evaluation, Preclinical; Humans; Ischemic Preconditioning, Myocardial; Myocardial Infarction; Myocardial Reperfusion Injury; Reproducibility of Results; Research Design

Myocardial Infarction (MI) has become a major cause of morbidity and mortality in China, but little is known about the prevalence of guideline-recommended cardiovascular medications after MI events over the last two decades. This systematic review and meta-analysis aims to summarize cardiovascular medication use between 1995-2015 and to assess factors in associated with the trends in cardiovascular medications.. A systematic search was conducted in four databases (Pubmed, Embase, CENTRAL, and CNKI) to obtain observational studies published between 1995 and 2015, reporting on the use of cardiovascular medications in China. Risk of bias of individual studies was appraised and selected studies were pooled for estimated prevalence of cardiovascular medication. Prevalence of cardiovascular medication use for 1995 and 2015 was estimated by random effects meta-regression model.. From 13,940 identified publications, 35 studies, comprising 28,000 patients, were included. The pooled prevalence for aspirin, beta-blockers, statins, ACE-Inhibitors, ACE-Inhibitor/ARBs and nitrates was 92% [95% confidence interval (CI): 0.89-0.95], 63% (95% CI: 0.57-0.69), 72% (95% CI: 0.60-0.82), 49% (95% CI: 0.41-0.57), 59% (95% CI: 0.48-0.69) and 79% (95% CI: 0.74-0.91), respectively. A significant increase in beta-blocker and statin use and a decrease of nitrate use was observed over time. The estimated prevalence of beta-blockers, statins, and nitrates was 78%, 91.1%, and 59.3% in 2015, compared to 32%, 17% and 96% in 1995, respectively.. Cardiovascular medication use after MI is far from optimal in Chinese patients, even though the prevalence of use increased over the period 1995-2015. With a rapidly increasing number of MI patients in China, a comprehensive strategy on secondary prevention is warranted.. PROSPERO (CRD42015025246).

Topics: Cardiovascular Agents; China; History, 20th Century; History, 21st Century; Humans; Myocardial Infarction; Prevalence; Secondary Prevention

Background Long-term use of evidence-based medications is recommended by international guidelines for the management of stable coronary artery disease, however, non-adherence to medications is common. This meta-analysis aims to systematically evaluate the impact of medication adherence on clinical outcomes in patients with stable coronary artery disease. Methods Articles from January 1960-December 2015 were retrieved from the MEDLINE and EMBASE databases without any language restriction. A meta-analysis was performed to investigate the risk ratios of all-cause mortality, cardiovascular mortality, and myocardial infarction/hospitalization between groups with good medication adherence and poor medication adherence. Studies were independently reviewed by two investigators. Data from eligible studies were extracted, and the meta-analysis was performed using R Version 3.1.0 software. Results A total of 10 studies were included in the analysis, with a total of 106,002 coronary artery disease patients. The results showed that good adherence to evidence-based medication regimens, including β-blockers, angiotensin-converting enzyme inhibitors/angiotensin receptor blockers, antiplatelet drugs, and statins, was related to a lower risk of all-cause mortality(risk ratio 0.56; 95% confidence interval: 0.45-0.69), cardiovascular mortality(risk ratio 0.66; 95% confidence interval: 0.51-0.87), and cardiovascular hospitalization/myocardial infarction(risk ratio 0.61; 95% confidence interval: 0.45-0.82). Conclusions This meta-analysis confirms the significant impact of good medication adherence on clinical outcomes in patients with stable coronary artery disease. More strategy and planning are needed to improve medication adherence.

Topics: Aged; Aged, 80 and over; Cardiovascular Agents; Cause of Death; Chi-Square Distribution; Coronary Artery Disease; Female; Hospitalization; Humans; Male; Medication Adherence; Middle Aged; Myocardial Infarction; Odds Ratio; Risk Assessment; Risk Factors; Secondary Prevention; Time Factors; Treatment Outcome

Drug-eluting balloon (DEB) has become an alternative option to drug-eluting stent (DES) for the treatment of in-stent restenosis (ISR). However, the effect of drug-eluting balloon with regular bare-mental stent (BMS) in de novo coronary artery disease (CAD) is unclear. This meta-analysis aimed to evaluate the efficacy of DEB with regular BMS compared to BMS or DES in de novo CAD.. Randomized controlled trials (RCTs) assessing the efficacy of DEB+BMS in comparison with BMS or DES were obtained by searching the PubMed, EMBASE, and Cochrane Library databases through January 2016. Primary endpoints were major adverse cardiac events (MACEs) and late lumen loss (LLL). Secondary endpoints included death, myocardial infarction (MI), target lesion revascularization (TLR), stent thrombosis (ST), binary restenosis, and minimum lumen diameter (MLD). Dichotomous and continuous data were presented as odds ratios (ORs) and mean differences (MDs) with 95% confidence intervals (CIs), respectively, and analyzed using a random-effects model.. A total of 14 RCTs involving 2281 patients were included in this meta-analysis. DEB+BMS showed significantly less MACEs (OR: 0.67, 95%CI 0.45 to 0.99, P = 0.04) and reduced LLL (MD: -0.30 mm, 95%CI: -0.48 mm to -0.11 mm, P = 0.001) compared with BMS. Meanwhile, treatment with DEB+BMS had disadvantages over DES in terms of MACEs (OR: 1.94, 95%CI 1.24 to 3.05, P = 0.004), LLL (MD: 0.20 mm, 95%CI: 0.07 mm to 0.33 mm, P = 0.003), TLR (OR: 2.53, 95% CI 1.36 to 4.72, P = 0.003), and MLD (MD: -0.25 mm, 95%CI: -0.42 mm to -0.09 mm, P = 0.003).. This limited evidence demonstrated that treatment with DEB+BMS appears to be effective in de novo CAD. In addition, DEB+ BMS clearly showed superiority to BMS, but is inferior to DES in the treatment of patients with de novo CAD. Hence, DES (especially new generation DES) should be recommended for patients with de novo CAD.

Topics: Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Artery Disease; Coronary Restenosis; Coronary Thrombosis; Databases, Factual; Drug-Eluting Stents; Humans; Myocardial Infarction; Odds Ratio; Randomized Controlled Trials as Topic

Data regarding the long-term efficacy and safety of everolimus-eluting bioresorbable vascular scaffolds (BVS) compared with everolimus-eluting stents are limited. This meta-analysis aimed to compare the long-term outcomes with both devices.. Randomized trials reporting clinical outcomes beyond 1 year and comparing BVS with everolimus-eluting stents were included. Summary estimates risk ratios (RRs) were constructed. The primary efficacy outcome was target lesion failure, defined as cardiac death, target vessel myocardial infarction, and ischemia-driven target lesion revascularization, and the primary safety outcome was definite or probable stent/scaffold thrombosis. Six trials with 5392 patients were included (mean follow-up, 25 months). BVS had a higher rate of target lesion failure (RR, 1.33; 95% confidence interval [CI], 1.11-1.58) driven by the higher rates of target vessel myocardial infarction (RR, 1.65; 95% CI, 1.26-2.17) and target lesion revascularization (RR, 1.39; 95% CI, 1.08-1.78). The risk of definite or probable stent/scaffold thrombosis (RR, 3.22; 95% CI, 1.89-5.49) and very late stent/scaffold thrombosis (>1 year; RR, 4.78; 95% CI, 1.66-13.8) was higher with BVS. The risk of cardiac and all-cause mortality was similar in both groups.. Compared with everolimus-eluting stents, BVS is associated with increased risk of target lesion failure driven by the increased rates of target vessel myocardial infarction and ischemia-driven target lesion revascularization in these studies (mean follow-up, 25 months). The risk of definite or probable stent/scaffold thrombosis and very late stent/scaffold thrombosis seems to be higher with BVS. Further information from randomized trials is critical to evaluate clinical outcomes with BVS on complete resolution of the scaffold.

Topics: Absorbable Implants; Aged; Cardiovascular Agents; Coated Materials, Biocompatible; Coronary Artery Disease; Coronary Thrombosis; Drug-Eluting Stents; Everolimus; Female; Humans; Male; Metals; Middle Aged; Myocardial Infarction; Odds Ratio; Percutaneous Coronary Intervention; Prosthesis Design; Randomized Controlled Trials as Topic; Risk Assessment; Risk Factors; Time Factors; Treatment Outcome

The size of the myocardial infarction remains an important therapeutic target, because heart attack size correlates with mortality and heart failure. In this era, myocardial infarct size is reduced primarily by timely reperfusion of the infarct related coronary artery. Whereas numerous pre-clinical studies have shown that certain pharmacologic agents and therapeutic maneuvers reduce myocardial infarction size greater than reperfusion alone, very few of these therapies have translated to successful clinical trials or standard clinical use. In this review we discuss both the recent successes as well as recent disappointments, and describe some of the newer potential therapies from the preclinical literature that have not yet been tested in clinical trials.

Topics: Adrenergic beta-Antagonists; Animals; Cardiovascular Agents; Disease Models, Animal; Drug Evaluation, Preclinical; Humans; Hypothermia, Induced; Ischemic Preconditioning, Myocardial; Myocardial Infarction; Myocardial Reperfusion; Myocardium; Translational Research, Biomedical; Treatment Outcome

Osteoporosis and cardiovascular diseases are epidemiologically associated. Calcification phenomena of atherosclerotic plaque involve cytokines and growth factors also involved in bone remodeling. Drugs given for either of these two conditions could act on these mechanisms. Can osteoporosis drugs have an influence on the occurrence of cardiovascular events? Conversely, can the treatment of hypertension alter the course of osteoporosis? It is possible that administration of high doses of calcium (1g/day) in patients who already have important dietary intake can increase the risk of myocardial infarction. Epidemiological studies show links between low serum vitamin D levels and cardiovascular disease but interventional studies show that vitamin D administration in moderately deficient subjects vitamin D does not prevent the occurrence of cardiovascular events. Cohort studies show a beneficial effect of beta-blockers and thiazides administered to hypertensive patients: they reduce by 20% risk of fracture of the proximal femur. Should we focus on these anti-hypertensive treatments for our patients with osteoporosis?

Topics: Adrenergic beta-Antagonists; Antihypertensive Agents; Bone Density Conservation Agents; Calcium; Calcium, Dietary; Cardiovascular Agents; Cardiovascular Diseases; Denosumab; Diphosphonates; Drug Interactions; Humans; Hypercalcemia; Hypertension; Myocardial Infarction; Osteoporosis; Sodium Chloride Symporter Inhibitors; Teriparatide; Vitamin D; Vitamin D Deficiency

Stable angina pectoris is a chronic medical condition with significant impact on mortality and quality of life; it can be macrovascular or microvascular in origin. Ranolazine is a second-line anti-anginal drug approved for use in people with stable angina. However, the effects of ranolazine for people with angina are considered to be modest, with uncertain clinical relevance.. To assess the effects of ranolazine on cardiovascular and non-cardiovascular mortality, all-cause mortality, quality of life, acute myocardial infarction incidence, angina episodes frequency and adverse events incidence in stable angina patients, used either as monotherapy or as add-on therapy, and compared to placebo or any other anti-anginal agent.. We searched CENTRAL, MEDLINE, Embase and the Conference Proceedings Citation Index - Science in February 2016, as well as regional databases and trials registers. We also screened reference lists.. Randomised controlled trials (RCTs) which directly compared the effects of ranolazine versus placebo or other anti-anginals in people with stable angina pectoris were eligible for inclusion.. Two authors independently selected studies, extracted data and assessed risk of bias. Estimates of treatment effects were calculated using risk ratios (RR), mean differences (MD) and standardised mean differences (SMD) with 95% confidence intervals (CI) using a fixed-effect model. Where we found statistically significant heterogeneity (Chi² P < 0.10), we used a random-effects model for pooling estimates. Meta-analysis was not performed where we found considerable heterogeneity (I² ≥ 75%). We used GRADE criteria to assess evidence quality and the GRADE profiler (GRADEpro GDT) to import data from Review Manager 5.3 to create 'Summary of findings' tables.. We included 17 RCTs (9975 participants, mean age 63.3 years). We found very limited (or no) data to inform most planned comparisons. Summary data were used to inform comparison of ranolazine versus placebo. Overall, risk of bias was assessed as unclear.For add-on ranolazine compared to placebo, no data were available to estimate cardiovascular and non-cardiovascular mortality. We found uncertainty about the effect of ranolazine on: all-cause mortality (1000 mg twice daily, RR 0.83, 95% CI 0.26 to 2.71; 3 studies, 2053 participants; low quality evidence); quality of life (any dose, SMD 0.25, 95% CI -0.01 to 0.52; 4 studies, 1563 participants; I² = 73%; moderate quality evidence); and incidence of non-fatal acute myocardial infarction (AMI) (1000mg twice daily, RR 0.40, 95% CI 0.08 to 2.07; 2 studies, 1509 participants; low quality evidence). Add-on ranolazine 1000 mg twice daily reduced the fervour of angina episodes (MD -0.66, 95% CI -0.97 to -0.35; 3 studies, 2004 participants; I² = 39%; moderate quality evidence) but increased the risk of non-serious adverse events (RR 1.22, 95% CI 1.06 to 1.40; 3 studies, 2053 participants; moderate quality evidence).For ranolazine as monotherapy compared to placebo, we found uncertain effect on cardiovascular mortality (1000 mg twice daily, RR 1.03, 95% CI 0.56 to 1.88; 1 study, 2604 participants; low quality evidence). No data were available to estimate non-cardiovascular mortality. We also found an uncertain effect on all-cause mortality for ranolazine (1000 mg twice daily, RR 1.00, 95% CI 0.81 to 1.25; 3 studies, 6249 participants; low quality evidence), quality of life (1000 mg twice daily, MD 0.28, 95% CI -1.57 to 2.13; 3 studies, 2254 participants; moderate quality evidence), non-fatal AMI incidence (any dose, RR 0.88, 95% CI 0.69 to 1.12; 3 studies, 2983 participants; I² = 50%; low quality evidence), and frequency of angina episodes (any dose, MD 0.08, 95% CI -0.85 to 1.01; 2 studies, 402 participants; low quality evidence). We found an increased risk for non-serious adverse events associated with ranolazine (any dose, RR 1.50, 95% CI 1.12 to 2.00; 3 studies, 947 participants; very low quality evidence).. We found very low quality evidence showing that people with stable angina who received ranolazine as monotherapy had increased risk of presenting non-serious adverse events compared to those given placebo. We found low quality evidence indicating that people with stable angina who received ranolazine showed uncertain effect on the risk of cardiovascular death (for ranolazine given as monotherapy), all-cause death and non-fatal AMI, and the frequency of angina episodes (for ranolazine given as monotherapy) compared to those given placebo. Moderate quality evidence indicated that people with stable angina who received ranolazine showed uncertain effect on quality of life compared with people who received placebo. Moderate quality evidence also indicated that people with stable angina who received ranolazine as add-on therapy had fewer angina episodes but increased risk of presenting non-serious adverse events compared to those given placebo.

Topics: Angina, Stable; Cardiovascular Agents; Cause of Death; Humans; Incidence; Middle Aged; Myocardial Infarction; Quality of Life; Randomized Controlled Trials as Topic; Ranolazine

The drug-coated balloon (DCB) has emerged as an additional tool in the arsenal of interventional cardiology devices; it delivers antiproliferative drugs to local arterial tissue by single prolonged coated balloon angioplasty inflation, and prevents restenosis, leaving no implant behind. This strategy theoretically decreases the risk of late inflammatory response to device components, without preventing positive remodelling. DCBs, when used carefully and with a good technique, may have a role in the treatment of lesion subsets, such as in-stent restenosis, small vessel disease or side branch bifurcations, in which the implantation of a drug-eluting stent is not desirable or is technically challenging. Using the latest evidence regarding the effectiveness of the currently available DCBs, this review will discuss the rationale for DCB use, and the effectiveness of DCBs in different clinical and lesion settings, and will give practical tips for their correct use in everyday clinical practice.

Topics: Cardiac Catheters; Cardiovascular Agents; Coated Materials, Biocompatible; Coronary Artery Disease; Coronary Restenosis; Coronary Stenosis; Equipment Design; Humans; Myocardial Infarction; Percutaneous Coronary Intervention; Risk Factors; Treatment Outcome

Cannabinoids can mimic the infarct-reducing effect of early ischemic preconditioning, delayed ischemic preconditioning, and ischemic postconditioning against myocardial ischemia/reperfusion. They do this primarily through both CB1 and CB2 receptors. Cannabinoids are also involved in remote preconditioning of the heart. The cannabinoid receptor ligands also exhibit an antiapoptotic effect during ischemia/reperfusion of the heart. The acute cardioprotective effect of cannabinoids is mediated by activation of protein kinase C, extracellular signal-regulated kinase, and p38 kinase. The delayed cardioprotective effect of cannabinoid anandamide is mediated via stimulation of phosphatidylinositol-3-kinase-Akt signaling pathway and enhancement of heat shock protein 72 expression. The delayed cardioprotective effect of another cannabinoid, Δ9-tetrahydrocannabinol, is associated with augmentation of nitric oxide (NO) synthase expression, but data on the involvement of NO synthase in the acute cardioprotective effect of cannabinoids are contradictory. The adenosine triphosphate-sensitive K(+)channel is involved in the synthetic cannabinoid HU-210-induced cardiac resistance to ischemia/reperfusion injury. Cannabinoids inhibit Na(+)/Ca(2+)exchange via peripheral cannabinoid receptor (CB2) activation that may also be related to the antiapoptotic and cardioprotective effects of cannabinoids. The cannabinoid receptor agonists should be considered as prospective group of compounds for creation of drugs that are able to protect the heart against ischemia-reperfusion injury in the clinical setting.

Topics: Animals; Cannabinoid Receptor Agonists; Cardiovascular Agents; Disease Models, Animal; Drug Design; Endocannabinoids; Humans; Ligands; Myocardial Infarction; Myocardial Reperfusion Injury; Myocardium; Receptor, Cannabinoid, CB1; Receptor, Cannabinoid, CB2; Signal Transduction

To evaluate the effect of cilostazol on major outcomes after carotid artery stenting (CAS).. A systematic literature review was conducted conforming to established criteria in order to identify articles published prior to May 2015 evaluating major post-CAS outcomes in patients treated with cilostazol vs patients not treated with cilostazol. Major outcomes included in-stent restenosis (ISR) within the observation period, the revascularization rate, major/minor bleeding, and the myocardial infarction/stroke/death rate (MI/stroke/death) at 30 days and within the observation period. Data were pooled for all studies containing adequate data for each outcome investigated; effect estimates are presented as the odds ratios (ORs) and 95 confidence intervals (CI).. Overall, 7 studies pertaining to 1297 patients were eligible. Heterogeneity was low among studies so a fixed-effect analysis was conducted. Six studies (n=1233) were compared for the ISR endpoint, showing a significantly lower ISR rate with cilostazol treatment after a mean follow-up of 20 months (OR 0.158, 95% CI 0.072 to 0.349, p<0.001). Five studies (n=649) were compared regarding 30-day MI/stroke/death (OR 0.724, 95% CI 0.293 to 1.789, p=0.484) and 3 studies (n=1076) were analyzed regarding MI/stroke/death within the entire follow-up period (OR 0.768, 95% CI 0.477 to 1.236, p=0.276); no significant difference was found between the groups. Data on bleeding rates and revascularization rates post ISR were inadequate to conduct further analysis.. Cilostazol seems to decrease total ISR rates in patients undergoing CAS without affecting MI/stroke/death events, both in the early and late settings.

Topics: Angioplasty; Cardiovascular Agents; Carotid Stenosis; Chi-Square Distribution; Cilostazol; Humans; Myocardial Infarction; Odds Ratio; Recurrence; Risk Assessment; Risk Factors; Stents; Stroke; Tetrazoles; Time Factors; Treatment Outcome

Despite prompt reperfusion by primary percutaneous coronary intervention (PPCI), the mortality and morbidity of patients presenting with an acute ST-segment elevation myocardial infarction (STEMI) remain significant with 9% death and 10% heart failure at 1 year. In these patients, one important neglected therapeutic target is 'myocardial reperfusion injury', a term given to the cardiomyocyte death and microvascular dysfunction which occurs on reperfusing ischaemic myocardium. A number of cardioprotective therapies (both mechanical and pharmacological), which are known to target myocardial reperfusion injury, have been shown to reduce myocardial infarct (MI) size in small proof-of-concept clinical studies-however, being able to demonstrate improved clinical outcomes has been elusive. In this article, we review the challenges facing clinical cardioprotection research, and highlight future therapies for reducing MI size and preventing heart failure in patients presenting with STEMI at risk of myocardial reperfusion injury.

Topics: Animals; Cardiovascular Agents; Heart Failure; Humans; Ischemic Postconditioning; Ischemic Preconditioning; Myocardial Infarction; Myocardial Reperfusion Injury; Myocardium; Percutaneous Coronary Intervention; Risk Factors; Treatment Outcome

The 30-year anniversary of the discovery of 'ischaemic preconditioning' is in 2016. This endogenous phenomenon can paradoxically protect the heart from acute myocardial infarction by subjecting it to one or more brief cycles of ischaemia and reperfusion. Apart from complete reperfusion, this method is the most powerful intervention known for reducing infarct size. The concept of ischaemic preconditioning has evolved into 'ischaemic conditioning', a term that encompasses a number of related endogenous cardioprotective strategies, applied either directly to the heart (ischaemic preconditioning or postconditioning) or from afar, for example a limb (remote ischaemic preconditioning, perconditioning, or postconditioning). Investigations of signalling pathways underlying ischaemic conditioning have identified a number of therapeutic targets for pharmacological manipulation. Over the past 3 decades, a number of ischaemic and pharmacological cardioprotection strategies, discovered in experimental studies, have been examined in the clinical setting of acute myocardial infarction and CABG surgery. The results from many of the studies have been disappointing, and no effective cardioprotective therapy is currently used in clinical practice. Several large, multicentre, randomized, controlled clinical trials on cardioprotection have highlighted the challenges of translating ischaemic conditioning and pharmacological cardioprotection strategies into patient benefit. However, a number of cardioprotective therapies have shown promising results in reducing infarct size and improving clinical outcomes in patients with ischaemic heart disease.

Topics: Animals; Cardiovascular Agents; Humans; Ischemic Postconditioning; Ischemic Preconditioning; Ischemic Preconditioning, Myocardial; Myocardial Infarction; Myocardial Reperfusion Injury; Treatment Outcome

Mitochondrial reactive oxygen species production has emerged as an important pathological mechanism in myocardial ischemia/reperfusion injury. Attempts at targeting reactive oxygen species by scavenging using antioxidants have, however, been clinically disappointing. This review will provide an overview of the current understanding of mitochondrial reactive oxygen species in ischemia/reperfusion injury. We will outline novel therapeutic approaches designed to directly target the mitochondrial respiratory chain and prevent excessive reactive oxygen species production and its associated pathology. This approach could lead to more effective interventions in an area where there is an urgent need for new treatments.

Topics: Animals; Cardiovascular Agents; Drug Delivery Systems; Humans; Myocardial Infarction; Myocardial Reperfusion Injury; Reactive Oxygen Species

Theoretically, the everolimus-eluting bioresorbable vascular scaffold (BVS) could eliminate stent thrombosis and improve outcomes in patients having percutaneous coronary intervention.. To estimate the incidence of stent thrombosis after BVS implantation and to compare the efficacy and safety of BVSs versus everolimus-eluting metallic stents (EESs) in adults having percutaneous coronary intervention.. PubMed, EMBASE, Cochrane Central Register of Controlled Trials, conference proceedings, and relevant Web sites from inception through 20 January 2016.. 6 randomized, controlled trials and 38 observational studies, each involving at least 40 patients with BVS implantation.. Two reviewers independently extracted study data and evaluated study risk of bias.. The pooled incidence of definite or probable stent thrombosis after BVS implantation was 1.5 events per 100 patient-years (PYs) (95% CI, 1.2 to 2.0 events per 100 PYs) (126 events during 8508 PYs). Six randomized trials that directly compared BVSs with EESs showed a non-statistically significant increased risk for stent thrombosis (odds ratio [OR], 2.05 [CI, 0.95 to 4.43]; P = 0.067) and myocardial infarction (OR, 1.38 [CI, 0.98 to 1.95]; P = 0.064) with BVSs. The 6 observational studies that compared BVSs with EESs showed increased risk for stent thrombosis (OR, 2.32 [CI, 1.06 to 5.07]; P = 0.035) and myocardial infarction (OR, 2.09 [CI, 1.23 to 3.55]; P = 0.007) with BVSs. The relative rates of all-cause and cardiac death, revascularization, and target lesion failure were similar for BVSs and EESs.. Scarce comparative data, no published data from large trials with long-term follow-up, and limited quality and incomplete reporting of observational studies.. Compared with EESs, BVSs do not eliminate and might increase risks for stent thrombosis and myocardial infarction in adults having percutaneous coronary intervention. Results of large trials with long-term follow-up are critically needed to establish the safety or at least the noninferiority of BVSs compared with EESs.. None.

Topics: Absorbable Implants; Cardiovascular Agents; Cause of Death; Comparative Effectiveness Research; Coronary Artery Disease; Drug-Eluting Stents; Everolimus; Humans; Myocardial Infarction; Percutaneous Coronary Intervention; Postoperative Complications; Thrombosis; Tissue Scaffolds

Four years after the latest edition, the 2015 non-ST-segment elevation acute coronary syndromes guidelines of the European Society of Cardiology have been published. Novel aspects include a new diagnostic algorithm for non-ST-segment elevation myocardial infarction using high-sensitivity cardiac troponins as well as guidance on cardiac rhythm monitoring duration. A large section is dedicated to antiplatelet therapy including initiation and duration of dual-antiplatelet therapy as well as the management of patients requiring, at the same time, long-term oral anticoagulation. New sections include the management of antiplatelet agent in patients requiring coronary artery bypass surgery and of acute bleeding events related to antiplatelet agents, vitamin K antagonist (VKA), and non-VKA oral anticoagulant drugs. Current evidence supports the radial access over the femoral one for coronary angiography and percutaneous revascularization.

Topics: Acute Coronary Syndrome; Anticoagulants; Cardiology; Cardiovascular Agents; Combined Modality Therapy; Coronary Angiography; Electrocardiography; Humans; Myocardial Infarction; Practice Guidelines as Topic; Predictive Value of Tests; Societies, Medical

The aim of this meta-analysis was to evaluate the efficacy of drug-eluting balloons (DEBs) plus bare-metal stents (BMS) for the treatment of de-novo coronary lesions.. Eleven trials involving 1279 patients were included in this study. The main endpoints were as follows: late lumen loss (LLL), binary restenosis, stent thrombosis (ST), and major adverse cardiovascular events (MACEs). The definition of MACEs was a composite of death, myocardial infarction (MI), and target lesion revascularization (TLR). Compared with BMS alone, DEB plus BMS showed a lower risk for LLL (P=0.007) and MACEs (P=0.010). There were no significant differences in binary restenosis (P=0.212), ST (P=0.199), death (P=0.141), MI (P=0.439), and TLR (P=0.340). Compared with drug-eluting stents (DES), DEB plus BMS could increase the risk of LLL (P=0.002) and MACEs (P=0.026). The risks of binary restenosis (P=0.113), ST (P=0.832), death (P=0.115), MI (P=0.831), and TLR (P=0.111) were similar between DEB plus BMS and DES.. DEB plus BMS was better than BMS alone in reducing LLL and MACEs, especially when dilatation was performed after stenting for de-novo coronary lesions, but it was inferior to DES. Therefore, the treatment strategy with DEB plus BMS should not be recommended for de-novo coronary lesions, except for patients who have contraindications for DES.

Topics: Angioplasty, Balloon, Coronary; Cardiac Catheters; Cardiovascular Agents; Coated Materials, Biocompatible; Coronary Artery Disease; Coronary Restenosis; Coronary Thrombosis; Humans; Metals; Myocardial Infarction; Odds Ratio; Paclitaxel; Randomized Controlled Trials as Topic; Risk Factors; Stents; Time Factors; Treatment Outcome

Angina pectoris, or symptomatic myocardial ischaemia, reflects an impairment of coronary blood flow, and usually a deficiency of available myocardial energetics. Treatment options vary with the precise cause, which may vary with regards to the roles of increased myocardial oxygen demand versus reduced supply. Traditionally, organic nitrates, β-adrenoceptor antagonists, and non-dihydropyridine calcium antagonists were the only commonly used prophylactic anti-anginal agents. However, many patients failed to respond adequately to such therapy, and/or were unsuitable for their use. Areas covered: A number of 'new' agents have been shown to represent ancillary forms of prophylactic anti-anginal therapy and are particularly useful in patients who are relatively unsuitable for either percutaneous or surgical revascularisation. These include modulators of myocardial metabolic efficiency, such as perhexiline, trimetazidine and ranolazine, as well as high dose allopurinol, nicorandil and ivabradine. The advantages and disadvantages of these various agents are summarized. Expert opinion: 'Optimal' medical treatment of angina pectoris now includes use of agents primarily intended to reduce risk of infarction (e.g. statins, aspirin, ACE inhibitors). In patients whose angina persists despite the use of 'standard' anti-anginal therapy, and who are not ideal for invasive revascularization options, a number of emerging drugs offer prospects of symptomatic relief.

Topics: Angina Pectoris; Animals; Cardiovascular Agents; Drug Design; Humans; Myocardial Infarction; Myocardial Ischemia; Oxygen

LCZ696, a first-in-class angiotensin receptor neprilysin inhibitor (ARNI), is comprised of the angiotensin receptor blocker valsartan and the neprilysin inhibitor pro-drug sacubitril (AHU377). After oral administration, AHU377 is rapidly metabolized to the active neprilysin inhibitor LBQ657. LCZ696 exerts its effects of diuresis, natriuresis, vasodilation and aldosterone secretion inhibition through simultaneous renin-angiotensin-aldosterone system (RAAS) blockade and natriuretic peptides system (NPS) enhancement. Powerful evidence including PARAMETER and PRARDIGM-HF trials have shown that LCZ696 outperforms RAAS inhibition in treating patients with hypertension and heart failure with reduced ejection fraction (HFrEF), and is well tolerated. In addition, accumulating evidence also suggests its potential use in heart failure with preserved ejection fraction (HFpEF), chronic kidney disease (CKD), post-myocardium infarction (post-MI) and stroke. Both the FDA and CHMP have approved LCZ696 for treatment of HFrEF. Despite all this, some special issues (e.g. use in specific subgroups, adverse events, contraindications and cost-effectiveness analysis) should be considered before its implementation in clinical practice.

Topics: Aminobutyrates; Angiotensin Receptor Antagonists; Animals; Biphenyl Compounds; Cardiovascular Agents; Contraindications; Cost-Benefit Analysis; Drug Combinations; Heart Failure; Humans; Hypertension; Myocardial Infarction; Renal Insufficiency, Chronic; Tetrazoles; Valsartan

Heart failure (HF) is a clinical syndrome characterized by dyspnea, fatigue, and poor exercise capacity due to insufficient cardiac function. HF represents the leading cause of hospitalization among adult patients over 65 years of age. Neurohormonal blockade has improved clinical outcomes; however, HF incidence continues to rise, suggesting an urgent need to develop novel drugs that target a different pathophysiological paradigm. Inflammation plays a central role in many cardiovascular diseases. Interleukin-1 (IL-1), a prototypical proinflammatory cytokine, is upregulated in HF and associated with worse prognosis. Preclinical models suggest a beneficial effect of IL-1 blockade, and pilot clinical trials are currently underway to evaluate the role of IL-1 blockade to reduce inflammation, ameliorate ventricular remodeling, and improve exercise capacity in patients with HF.

Topics: Cardiovascular Agents; Heart Failure; Humans; Inflammation Mediators; Interleukin 1 Receptor Antagonist Protein; Interleukin-1; Myocardial Infarction; Myocarditis; Ventricular Remodeling

Coronary artery disease (CAD) and acute myocardial infarction (AMI) are inflammatory pathologies, involving interleukins (ILs), such as IL-1β, IL-6 and tumor necrosis factor (TNF)-α, and acute phase proteins production, such as for C reactive protein (CRP). The process begins with retention of low-density lipoprotein (LDL) and its oxidation inside the intima, with the formation of the "foam cells." Toll-like receptors and inflamassomes participate in atherosclerosis formation, as well as in the activation of the complement system. In addition to innate immunity, adaptive immunity is also associated with atherosclerosis through antigen-presenting cells, T and B lymphocytes. AMI also increases the expression of some ILs and promotes macrophage and lymphocyte accumulation. Reperfusion increases the expression of anti-inflammatory ILs (such as IL-10) and generates oxygen free radicals. Although CAD and AMI are inflammatory disorders, the only drugs with anti-inflammatory effect so far widely used in ischemic heart disease are aspirin and statins. Some immunomodulatory or immunosuppressive promising therapies, such as cyclosporine and colchicine, may have benefits in CAD. Methotrexate also has potential cardioprotective anti-inflammatory effects, through increased adenosine levels. The TETHYS trial (The Effects of mETHotrexate Therapy on ST Segment Elevation MYocardial InfarctionS trial) will evaluate low-dose methotrexate in ST elevation AMI. The CIRT (Cardiovascular Inflammation Reduction Trial), in turn, will evaluate low-dose methotrexate in patients with a high prevalence of subclinical vascular inflammation. The CANTOS (The Canakinumab Antiinflammatory Thrombosis Outcomes Study) will evaluate canakinumab in patients with CAD and persistently elevated CRP. The blockage of other potential targets, such as the IL-6 receptor, CC2 chemokine receptor and CD20, could bring benefits in CAD.

Topics: Acute Coronary Syndrome; Adaptive Immunity; Animals; Anti-Inflammatory Agents; Anti-Inflammatory Agents, Non-Steroidal; Atherosclerosis; Cardiovascular Agents; Coronary Artery Disease; Coronary Thrombosis; Endothelium, Vascular; Evidence-Based Medicine; Humans; Immunity, Innate; Models, Immunological; Myocardial Infarction; Myocardial Reperfusion Injury; Vasculitis

Bioresorbable vascular scaffolds (BVS) are considered the fourth revolution in Interventional Cardiology, thus promising to address some of the pending issues with current-generation drug eluting stents (DES). Notably, most of the potential advantages of BVS over other current devices are due to a peculiar vascular response, called "vascular restoration therapy". The emerging data from real-world expanded use registries suggest that BVS use is feasible in a wide variety of patients (from low- to high- risk), and lesions (from simplex to complex). However, few safety concerns with currently available BVS have arised from initial experiences all over the word. Data from ongoing large-scale randomized controlled trials will be able to demonstrate whether BVS improve patient early and long-term outcomes compared to best-in-class DES.

Topics: Cardiac Catheters; Cardiovascular Agents; Coated Materials, Biocompatible; Coronary Artery Disease; Coronary Restenosis; Coronary Thrombosis; Drug-Eluting Stents; Humans; Myocardial Infarction; Percutaneous Coronary Intervention; Prosthesis Design; Risk Factors; Time Factors; Treatment Outcome

We aimed to evaluate the safety and effectiveness of the novel abluminal groove-filled biodegradable polymer-coated sirolimus-eluting FIREHAWK stent (MicroPort Medical, Shanghai, China) in a large cohort of patients.. Trials on the FIREHAWK stent allowing targeted sirolimus release were not individually powered to reliably estimate low-frequency safety endpoints such as stent thrombosis (ST) or to examine long-term safety and efficacy. Additionally, the China Food and Drug Administration requires an objective performance criterion (OPC) study for new drug-eluting stents.. The primary endpoint, target lesion failure (TLF), was defined as the composite of cardiac death, target vessel myocardial infarction (MI), or clinically indicated target lesion revascularization at 12 months. Patient-level data from 1,007 patients with de novo native coronary lesions exclusively treated with the FIREHAWK stent in the TARGET serial studies (I and II) were prospectively collected, pooled and analyzed throughout a 2-year follow-up.. The 12-month rate of TLF in 1,003 patients (follow-up rate, 99.6%) was 3.9% (upper 95% confidence interval (CI): 5.3%), which was significantly lower than the performance goal of 9.0% (P < 0.0001). The 24-month rates of TLF, PoCE (a composite of all-cause death, all MI, or any revascularization), and ARC definite or probable ST were 4.6%, 7.8% and 0.1%, respectively. In subgroup analysis, long lesion (≥ 30 mm) was an independent predictor of TLF within 2 years (hazard ratio [95%CI]: 2.44 [1.32, 4.53], P < 0.01).. This pooled, patient-level analysis indicates that the FIREHAWK stent exhibits a promising 2-year efficacy and safety profile.

Topics: Absorbable Implants; Aged; Cardiovascular Agents; China; Coronary Artery Disease; Drug-Eluting Stents; Female; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Myocardial Infarction; Percutaneous Coronary Intervention; Polymers; Prospective Studies; Prosthesis Design; Randomized Controlled Trials as Topic; Registries; Risk Factors; Sirolimus; Time Factors; Treatment Outcome

Compared with the zotarolimus-eluting stent (ZES), the everolimus-eluting stent (EES) has reduced the risk of stent restenosis and thrombosis as found in a number of randomized-controlled trials (RCTs). However, the benefits have been variable.. We evaluate the long-term effect of EES and ZES on the risk of stent thrombosis and target lesion revascularization in patients receiving PCI. We identified RCTs by a systematic search of MEDLINE, EMBASE, and Cochrane Database.. Five RCTs (9853 patients) were included. Overall, EES significantly reduced the risk of target lesion revascularization [odds ratio (OR), 0.77; 95% confidence interval (CI), 0.62-0.95; P=0.01] compared with ZES therapy. However, there was no difference in the risk of target vessel revascularization (OR, 0.93; 95% CI, 0.78-1.10; P=0.38) and definite/probable stent thrombosis (OR, 0.83; 95% CI, 0.56-1.25; P=0.37) between the two groups. Furthermore, the risk of mortality (OR, 1.04; 95% CI, 0.84-1.27; P=0.73), myocardial infarction (OR, 0.95; 95% CI, 0.74-1.23; P=0.70), and major adverse cardiac event (OR, 0.96; 95% CI, 0.84-1.10; P=0.53) was similar between the two groups.. The new-generation Resolute-ZES and EES have a similar long-term safety and efficacy profile.

Topics: Cardiovascular Agents; Chi-Square Distribution; Coronary Artery Disease; Coronary Restenosis; Coronary Thrombosis; Drug-Eluting Stents; Everolimus; Humans; Myocardial Infarction; Odds Ratio; Percutaneous Coronary Intervention; Prosthesis Design; Risk Factors; Sirolimus; Time Factors; Treatment Outcome

Cardiogenic shock (CS) is still the predominant cause of in-hospital death in patients with acute myocardial infarction, although mortality has been reduced in recent years. Early percutaneous coronary intervention and coronary artery bypass grafting are causal therapies implemented in CS, supported by catecholamines, fluids, intra-aortic balloon pumping, and also active percutaneous assist devices. There is only limited evidence from randomized studies of any of these treatments in CS, except for early revascularization and the relative ineffectiveness of intra-aortic balloon pumping. This review will present treatment pathways of CS complicating acute myocardial infarction, with a major focus on revascularization, intensive care unit treatment, and mechanical support devices.

Topics: Cardiovascular Agents; Coronary Artery Bypass; Heart-Assist Devices; Hemodynamics; Humans; Intra-Aortic Balloon Pumping; Myocardial Infarction; Percutaneous Coronary Intervention; Prosthesis Design; Recovery of Function; Risk Factors; Shock, Cardiogenic; Time Factors; Treatment Outcome; Ventricular Function, Left

Among adults undergoing non-cardiac surgery who are at risk of a myocardial infarction, a long-standing question has been whether these patients should receive aspirin throughout the perioperative period. A large (n = 10,010 patients) international trial (POISE-2) demonstrated that perioperative aspirin did not prevent myocardial infarction, and the result was consistent both for patients who had been taking aspirin before the trial (continuation stratum, 4382 patients) and for patients who had not been taking aspirin before the trial (initiation stratum, 5628 patients). Aspirin did, however, increase the risk of major bleeding. Therefore, the best evidence does not support the use of aspirin for the prevention of myocardial infarction in patients undergoing non-cardiac surgery. In patients who have an indication for long-term aspirin usage and have their aspirin held during the perioperative period, it is important to ensure aspirin is restarted after the high-risk period for bleeding has passed (i.e., 8-10 days after surgery).

Topics: Animals; Aspirin; Cardiovascular Agents; Drug Administration Schedule; Hemorrhage; Humans; Myocardial Infarction; Perioperative Period; Risk Assessment; Risk Factors; Surgical Procedures, Operative; Time Factors; Treatment Outcome

The purpose of this study was to investigate the differential clinical outcomes after percutaneous coronary intervention (PCI) for coronary bifurcation lesions with 1- or 2-stenting techniques using first- or second-generation drug-eluting stents (DES).. The 2-stenting technique has been regarded to have worse clinical outcomes than the 1-stenting technique after bifurcation PCI with first-generation DES. However, there has been a paucity of data comparing the 1- and 2-stenting techniques with the use of second-generation DES.. Patient-level pooled analysis was performed with 3,162 patients undergoing PCI using first- or second-generation DES for bifurcation lesions from the "Korean Bifurcation Pooled Cohorts" (COBIS [Coronary Bifurcation Stenting] II, EXCELLENT [Registry to Evaluate Efficacy of Xience/Promus Versus Cypher in Reducing Late Loss After Stenting], and RESOLUTE-Korea [Registry to Evaluate the Efficacy of Zotarolimus-Eluting Stent]). The 3-year clinical outcomes were compared between 1- and 2-stenting techniques, stratified by the type of DES.. With first-generation DES, rates of target lesion failure (TLF) or patient-oriented composite outcome (POCO) (a composite of all death, any myocardial infarction, any repeat revascularization, and cerebrovascular accidents) at 3 years were significantly higher after the 2-stenting than the 1-stenting technique (TLF 8.6% vs. 17.5%; p < 0.001; POCO 18.1% vs. 28.5%, p < 0.001). With second-generation DES, however, there was no difference between 1- and 2-stenting techniques (TLF 5.4% vs. 5.8%; p = 0.768; POCO 11.2% vs. 12.9%; p = 0.995). The differential effects of 2-stenting technique on the prognosis according to the type of DES were also corroborated with similar results by the inverse probability weighted model. The 2-stenting technique was a significant independent predictor of TLF in first-generation DES (hazard ratio: 2.046; 95% confidence interval: 1.114 to 3.759; p < 0.001), but not in second-generation DES (hazard ratio: 0.667; 95% confidence interval: 0.247 to 1.802; p = 0.425).. Patient-level pooled analysis of 3,162 patients in Korean Bifurcation Pooled Cohorts demonstrated that the 2-stenting technique showed comparable outcomes to 1-stenting technique with second-generation DES, which is different from the results of first-generation DES favoring the 1-stenting technique.

Topics: Aged; Cardiovascular Agents; Coronary Angiography; Coronary Artery Disease; Coronary Circulation; Coronary Vessels; Drug-Eluting Stents; Female; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Myocardial Infarction; Percutaneous Coronary Intervention; Proportional Hazards Models; Prosthesis Design; Registries; Republic of Korea; Risk Factors; Sirolimus; Time Factors; Treatment Outcome

Little is known about the benefits and risks of the long-term use of cardiovascular drugs. Evidence from randomized clinical trials (RCTs) rarely goes beyond a few years of follow-up, but patients are often given continuous treatment with multiple drugs well into old age. We focus on 4 commonly used cardiovascular drug classes: aspirin, statins, beta-blockers, and angiotensin-converting enzyme inhibitors given to patients after myocardial infarction. However, the issues raised apply more broadly to all long-term medications across cardiovascular diseases and the whole of medicine. The evidence and limitations of RCTs are addressed, as well as current practice in pre-licensing trials, the increasing problems of polypharmacy (especially in the elderly), the lack of trial evidence for withdrawal of drugs, the role of regulatory authorities and other stakeholders in this challenging situation, and the potential educational solutions for the medical profession. We conclude with a set of recommendations on how to improve the situation of long-term drug use.

Topics: Adrenergic beta-Antagonists; Angiotensin-Converting Enzyme Inhibitors; Aspirin; Biomedical Research; Cardiovascular Agents; Cardiovascular Diseases; Drug Administration Schedule; Humans; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Myocardial Infarction; Patient Care; Randomized Controlled Trials as Topic

Acute coronary syndrome is a life-threatening event that affects millions of people each year and accounts for a big portion of hospital visits. With an ever-growing elderly patient population, ischemic heart disease is more prevalent than ever before. It is paramount that physicians of all fields are cognizant of the various presentations of acute coronary syndrome (ACS), as its prompt diagnosis and treatment profoundly decreases mortality and morbidity. Under the American College of Cardiology Foundation and the American Heart Association, guidelines are published for the optimal management of patients with acute coronary syndromes. Guidelines are continuously evolving as more multicenter randomized trials, new medications and new technologies continue to change the way we treat acute coronary syndromes. The focus of this review is ST-elevation myocardial infarction and it provides answers to some of the fundamental questions through evidence-based guidelines.

Topics: Acute Coronary Syndrome; Cardiovascular Agents; Disease Management; Electrocardiography; Humans; Myocardial Infarction; Oxygen Inhalation Therapy; Platelet Aggregation Inhibitors; Time Factors

The sympathetic nervous exerts a key role in cardiovascular homeostasis control by regulating cardiac output, systemic vascular resistance, heart rate and blood pressure.. Data collected during the past 30 years have unequivocally shown that in a considerable number of cardiovascular as well as noncardiovascular disease there is a marked activation of the sympathetic nervous system which exerts in the long-term period unfavourable haemodynamic, metabolic, cardiovascular and renal effects.. This paper will review the current knowledge on the alterations in sympathetic function described in cardiovascular disease, with particular focus on hypertension, heart failure and myocardial infarction.. The consequences of the phoenomenon will be discussed together with its therapeutic implications. This will be done by examining the impact of nonpharmacological as well as pharmacological interventions on sympathetic cardiovascular drive. The effects of new invasive approaches, such as carotid baroreceptor stimulation as well as renal nerves ablation, will be also briefly discussed.

Topics: Autonomic Nervous System Diseases; Cardiovascular Agents; Cardiovascular Diseases; Electric Stimulation Therapy; Heart Failure; Humans; Hypertension; Myocardial Infarction; Pressoreceptors; Sympathectomy

Cardiovascular complications, particularly perioperative myocardial infarction/injury, seem to be major contributors to mortality after noncardiac surgery. With surgical procedures being very frequent (900 000/year in Switzerland), perioperative myocardial injury is common in everyday clinical practice. Over 80% of patients experiencing perioperative myocardial injury do not report symptoms. Therefore perioperative myocardial injury remains undiagnosed and untreated. Moreover, its silent presentation results in limited awareness among both clinicians and the public. Despite being largely asymptomatic, perioperative myocardial injury increases 30-day mortality nearly 10-fold. This review aims to increase the awareness of perioperative myocardial injury/infarction and give an overview of the emerging evidence, including pathophysiology, clinical presentation, prevention, and potential future treatments.

Topics: Awareness; Biomarkers; Cardiovascular Agents; Electrocardiography; Humans; Myocardial Infarction; Perioperative Period; Risk Factors; Switzerland; Vital Signs

Our aim was to evaluate the five-year clinical impact of side branch (SB) stenting with a drug-eluting stent (DES) following Axxess stent implantation in coronary bifurcation lesions.. Four hundred patients treated with Axxess were pooled from the AXXESS Plus and DIVERGE five-year follow-up studies. We compared unadjusted and propensity-adjusted major adverse clinical events (MACE) between Axxess with no SB stenting ("Axxess provisional") versus Axxess with SB stenting ("Axxess additional"). "Axxess additional" had no impact on the MACE rate, with unadjusted and adjusted HR 1.59 (95% CI: 0.95-2.64) and 1.37 (95% CI: 0.88-2.13), respectively. No differences were seen in the individual components of death, myocardial infarction and ischaemia-driven target lesion revascularisation, respectively, both in unadjusted (HR 0.92 [95% CI: 0.38-2.19]; HR 1.73 [95% CI: 0.78-3.82]; HR 1.65 [95% CI: 0.84-3.26]) and adjusted analysis (HR 0.92 [95% CI: 0.41-2.09]; HR 1.13 [95% CI: 0.59-2.17]; HR 1.31 [95% CI: 0.74-2.31]). No differences in definite stent thrombosis were seen with unadjusted HR 2.1 (95% CI: 0.45-9.88) and adjusted HR 1.0 (95% CI: 0.32-3.1).. Stenting the SB following Axxess implantation does not impact on long-term clinical outcomes compared to MV stenting only. The Axxess stent system offers a safe and tailored alternative for the treatment of coronary bifurcation lesions.

Topics: Aged; Cardiovascular Agents; Coronary Angiography; Coronary Artery Disease; Coronary Restenosis; Coronary Thrombosis; Drug-Eluting Stents; Female; Humans; Kaplan-Meier Estimate; Logistic Models; Male; Middle Aged; Myocardial Infarction; Percutaneous Coronary Intervention; Propensity Score; Proportional Hazards Models; Prosthesis Design; Risk Factors; Sirolimus; Time Factors; Treatment Outcome

Drug-coated balloons are a new tool for the treatment of patients with coronary artery disease. The main feature of this technology is a rapid and homogenous transfer of an antiproliferative drug (paclitaxel) to the vessel wall just at the time of balloon inflation, when neointimal proliferation, in response to angioplasty, is the highest. Moreover, drug-coated balloons share adjuntive advantages over stents: the absence of permanent scaffold and polymer, the respect of the original coronary anatomy, and limited inflammatory stimuli, thereby allowing for short-term dual antiplatelet therapy. To this day, a lot of devices are available in the market, with limited scientific data for the vast majority of them. Thus, the Italian scientific society of interventional cardiologists GISE decided to coordinate the efforts of a group of reknown experts on the field, in order to obtain a Position Paper on the correct use of drug-coated balloons in all the settings of coronary artery disease, giving a class of indication to each one, based on the clinical evidence. This Position Paper represents a quick reference for operators, investigators, and manufactures to promote the understanding and the correct use of the drug-coated balloon technology in everyday clinical practice.

Topics: Angioplasty, Balloon, Coronary; Cardiac Catheters; Cardiology; Cardiovascular Agents; Coated Materials, Biocompatible; Coronary Artery Disease; Coronary Restenosis; Drug Administration Schedule; Drug Therapy, Combination; Equipment Design; Humans; Myocardial Infarction; Neointima; Platelet Aggregation Inhibitors; Treatment Outcome

This study sought to investigate the relative safety and efficacy of bioabsorbable polymer (BP)-based biolimus-eluting stents (BES) versus durable-polymer (DP)-drug-eluting stents (DES) and bare-metal stents (BMS) by means of a network meta-analysis.. Studies have suggested that BP-BES might reduce the risk of stent thrombosis (ST) and late adverse outcomes compared with first-generation DES. However, the relative safety and efficacy of BP-BES versus newer-generation DES coated with more biocompatible DP have not been investigated in depth.. Randomized controlled trials comparing BP-BES versus currently U.S.-approved DES or BMS were searched through MEDLINE, EMBASE, and Cochrane databases. Information on study design, inclusion and exclusion criteria, sample characteristics, and clinical outcomes was extracted.. Data from 89 trials including 85,490 patients were analyzed. At 1-year follow-up, BP-BES were associated with lower rates of cardiac death/myocardial infarction (MI), MI, and target vessel revascularization (TVR) than BMS and lower rates of TVR than fast-release zotarolimus-eluting stents. The BP-BES had similar rates of cardiac death/MI, MI, and TVR compared with other second-generation DP-DES but higher rates of 1-year ST than cobalt-chromium everolimus-eluting stents (CoCr-EES). The BP-BES were associated with improved late outcomes compared with BMS and paclitaxel-eluting stents, considering the latest follow-up data available, with nonsignificantly different outcomes compared with other DP-DES although higher rates of definite ST compared with CoCr-EES.. In this large-scale network meta-analysis, BP-BES were associated with superior clinical outcomes compared with BMS and first-generation DES and similar rates of cardiac death/MI, MI, and TVR compared with second-generation DP-DES but higher rates of definite ST than CoCr-EES.

Topics: Cardiovascular Agents; Chromium Alloys; Coated Materials, Biocompatible; Coronary Thrombosis; Drug-Eluting Stents; Everolimus; Humans; Myocardial Infarction; Myocardial Revascularization; Paclitaxel; Polymers; Randomized Controlled Trials as Topic; Sirolimus; Stents

This study sought to study the efficacy and safety of newer-generation drug-eluting stents (DES) compared with bare-metal stents (BMS) in an appropriately powered population of patients with ST-segment elevation myocardial infarction (STEMI).. Among patients with STEMI, early generation DES improved efficacy but not safety compared with BMS. Newer-generation DES, everolimus-eluting stents, and biolimus A9-eluting stents, have been shown to improve clinical outcomes compared with early generation DES.. Individual patient data for 2,665 STEMI patients enrolled in 2 large-scale randomized clinical trials comparing newer-generation DES with BMS were pooled: 1,326 patients received a newer-generation DES (everolimus-eluting stent or biolimus A9-eluting stent), whereas the remaining 1,329 patients received a BMS. Random-effects models were used to assess differences between the 2 groups for the device-oriented composite endpoint of cardiac death, target-vessel reinfarction, and target-lesion revascularization and the patient-oriented composite endpoint of all-cause death, any infarction, and any revascularization at 1 year.. Newer-generation DES substantially reduce the risk of the device-oriented composite endpoint compared with BMS at 1 year (relative risk [RR]: 0.58; 95% confidence interval [CI]: 0.43 to 0.79; p = 0.0004). Similarly, the risk of the patient-oriented composite endpoint was lower with newer-generation DES than BMS (RR: 0.78; 95% CI: 0.63 to 0.96; p = 0.02). Differences in favor of newer-generation DES were driven by both a lower risk of repeat revascularization of the target lesion (RR: 0.33; 95% CI: 0.20 to 0.52; p < 0.0001) and a lower risk of target-vessel infarction (RR: 0.36; 95% CI: 0.14 to 0.92; p = 0.03). Newer-generation DES also reduced the risk of definite stent thrombosis (RR: 0.35; 95% CI: 0.16 to 0.75; p = 0.006) compared with BMS.. Among patients with STEMI, newer-generation DES improve safety and efficacy compared with BMS throughout 1 year. It remains to be determined whether the differences in favor of newer-generation DES are sustained during long-term follow-up.

Topics: Aged; Cardiovascular Agents; Chi-Square Distribution; Drug-Eluting Stents; Everolimus; Female; Humans; Male; Metals; Middle Aged; Myocardial Infarction; Odds Ratio; Percutaneous Coronary Intervention; Prosthesis Design; Randomized Controlled Trials as Topic; Recurrence; Risk Assessment; Risk Factors; Sirolimus; Stents; Time Factors; Treatment Outcome

Human sexuality is an important aspect of health and quality of life. Many patients with ischemic heart disease - and their partners - are concerned that sexual activity could exacerbate their cardiac condition, possibly causing myocardial infarction or cardiac death. Patients with ischemic heart disease who wish to initiate or resume sexual activity should be evaluated with a thorough medical history and physical examination. Sexual activity is reasonable for individuals with no or mild angina and those who can exercise ≥ 3-5 METS without angina, excessive dyspnea, or ischemic ST segment changes. For the patient who is considered not be at low cardiovascular (CV) risk or in whom the CV risk is unknown, an exercise stress test is reasonable in order to determine his or her exercise capacity and to ascertain if symptoms or ischemia may occur. Regular exercise and cardiac rehabilitation can be effective in reducing the risk of CV complications associated with sexual activity for the patient with ischemic heart disease.

Topics: Angina Pectoris; Cardiovascular Agents; Death, Sudden, Cardiac; Exercise Test; Humans; Myocardial Infarction; Myocardial Ischemia; Phosphodiesterase 5 Inhibitors; Risk Assessment; Sexual Behavior

Detection of a rise and/or fall of cardiac troponin (cTn) is the cornerstone in the diagnosis of myocardial infarction (MI). For the acute risk, it is hypothesized that cTn mirrors activated coagulation and platelet reactivity and indicates the presence of a ruptured plaque, which may help to identify patients at high risk who benefit particularly from aggressive pharmacological treatment and early invasive strategy. High-sensitivity assays using the 99th percentile as the threshold for positivity can achieve sensitivity at presentation of 90 % or more, and performance further improves with subsequent measurements within 3 to 6 h. By 3 h, negative predictive values of almost 100 % have been reported. However, use of assays with higher sensitivity lead ultimately to a loss of clinical specificity. Thus, other conditions than MI, such as stroke, pulmonary embolism, sepsis, acute perimyocarditis, Takotsubo, acute heart failure and tachycardia also can go with elevated troponin levels. The detection of brief rise and subsequent fall of troponin concentration in marathon runners, and even in healthy subjects, after a standardized exercise test has cast doubts on the hypothesis that troponin is released only upon irreversible damage. This kind of troponin leakage may originate from a cytosolic compartment of the cells and not from the necrosis of thin filaments.

Topics: Biomarkers; Cardiovascular Agents; Cardiovascular Surgical Procedures; Early Medical Intervention; Humans; Myocardial Infarction; Myocytes, Cardiac; Necrosis; Plaque, Atherosclerotic; Risk Assessment; Rupture, Spontaneous; Sensitivity and Specificity; Time Factors; Time-to-Treatment; Troponin C

The aim of this study was to evaluate 1-year clinical outcomes of diabetic patients treated with the Absorb bioresorbable vascular scaffold (BVS).. Clinical outcomes of diabetic patients after BVS implantation have been unreported.. This study included 101 patients in the ABSORB Cohort B trial and the first consecutive 450 patients with 1 year of follow-up in the ABSORB EXTEND trial. A total of 136 diabetic patients were compared with 415 nondiabetic patients. In addition, 882 diabetic patients treated with everolimus-eluting metal stents (EES) in pooled data from the SPIRIT trials (SPIRIT FIRST [Clinical Trial of the Abbott Vascular XIENCE V Everolimus Eluting Coronary Stent System], SPIRIT II [A Clinical Evaluation of the XIENCE V Everolimus Eluting Coronary Stent System], SPIRIT III [Clinical Trial of the XIENCE V Everolimus Eluting Coronary Stent System (EECSS)], SPIRIT IV Clinical Trial [Clinical Evaluation of the XIENCE V Everolimus Eluting Coronary Stent System]) were used for the comparison by applying propensity score matching. The primary endpoint was a device-oriented composite endpoint (DoCE), including cardiac death, target vessel myocardial infarction, and target lesion revascularization at 1-year follow-up.. The cumulative incidence of DoCE did not differ between diabetic and nondiabetic patients treated with the BVS (3.7% vs. 5.1%, p = 0.64). Diabetic patients treated with the BVS had a similar incidence of the DoCE compared with diabetic patients treated with EES in the matched study group (3.9% for the BVS vs. 6.4% for EES, p = 0.38). There were no differences in the incidence of definite or probable scaffold/stent thrombosis (0.7% for both diabetic and nondiabetic patients with the BVS; 1.0% for diabetic patients with the BVS vs. 1.7% for diabetic patients with EES in the matched study group).. In the present analyses, diabetic patients treated with the BVS showed similar rates of DoCEs compared with nondiabetic patients treated with the BVS and diabetic patients treated with EES at 1-year follow-up. (ABSORB Clinical Investigation, Cohort B; NCT00856856; ABSORB EXTEND Clinical Investigation; NCT01023789; Clinical Trial of the Abbott Vascular XIENCE V Everolimus Eluting Coronary Stent System [SPIRIT FIRST]; NCT00180453; A Clinical Evaluation of the XIENCE V Everolimus Eluting Coronary Stent System [SPIRIT II]; NCT00180310; Clinical Trial of the XIENCE V Everolimus Eluting Coronary Stent System [EECSS] [SPIRIT III]; NCT00180479; Clinical Evaluation of the XIENCE V Everolimus Eluting Coronary Stent System [SPIRIT IV Clinical Trial]; NCT00307047).

Topics: Absorbable Implants; Aged; Cardiovascular Agents; Chi-Square Distribution; Clinical Trials as Topic; Coronary Stenosis; Coronary Thrombosis; Diabetic Angiopathies; Everolimus; Female; Follow-Up Studies; Humans; Incidence; Kaplan-Meier Estimate; Male; Middle Aged; Myocardial Infarction; Propensity Score; Prosthesis Design; Risk Factors; Sirolimus; Time Factors; Treatment Outcome

Although the therapeutic strategies available for treating acute myocardial infarction (AMI) have evolved dramatically in recent decades, coronary artery disease remains the leading cause of death in our society, and the rates of recurrent myocardial infarction and mortality are still unacceptably high. Therefore, exploration of alternative therapeutic strategies for AMI is of utmost importance. One such strategy is to target metabolic pathways via L-carnitine supplementation. L-carnitine is a physiologically essential metabolic cofactor that has been shown to provide a plethora of benefits when administered after AMI. L-carnitine has been shown to lessen infarct size, to reduce ventricular arrhythmias, left ventricular dilation, and heart failure incidence, as well as improve survival. These benefits may, in part, be related to its ability to boost glucose oxidation in ischemic tissues, while moderating increases in fatty acyl-coenzyme A levels that can impair mitochondrial efficiency and promote oxidative stress and inflammation. This article summarizes the evidence pertinent to the therapeutic use of L-carnitine for AMI.

Topics: Acyl Coenzyme A; Animals; Cardiovascular Agents; Carnitine; Energy Metabolism; Glucose; Humans; Myocardial Infarction; Myocardium; Oxidation-Reduction; Treatment Outcome

Sensorineural deafness and vertigo have different causes among them immunological, vascular and infectious. Vascular causes of sensorineural hearing loss are unusual and among them are the vertebral artery aneurysms. Knowledge by neurosurgeons, neurointerventional and otolaryngologists aneurysms involving the development of sensorineural hearing loss is critical to establishing and determining a targeted therapeutics. We report the case of an adult handled with endovascular techniques and review the current literature of similar cases.

Topics: Angioplasty, Balloon, Coronary; Cardiovascular Agents; Cerebral Angiography; Combined Modality Therapy; Endovascular Procedures; Hearing Loss, Sensorineural; Hearing Loss, Unilateral; Humans; Imaging, Three-Dimensional; Intracranial Aneurysm; Magnetic Resonance Angiography; Magnetic Resonance Imaging; Male; Middle Aged; Multimodal Imaging; Myocardial Infarction; Risk Factors; Smoking; Stents; Tinnitus; Vertebral Artery; Vertigo

Topics: Angina Pectoris; Cardiovascular Agents; Combined Modality Therapy; Coronary Disease; Electrocardiography; Humans; Microvascular Angina; Myocardial Infarction

Acute cardiogenic pulmonary edema and cardiogenic shock are two of the main forms of presentation of acute heart failure. Both entities are serious, with high mortality, and require early diagnosis and prompt and aggressive management. Acute pulmonary edema is due to the passage of fluid through the alveolarcapillary membrane and is usually the result of an acute cardiac episode. Correct evaluation and clinical identification of the process is essential in the management of acute pulmonary edema. The initial aim of treatment is to ensure hemodynamic stability and to correct hypoxemia. Other measures that can be used are vasodilators such as nitroglycerin, loop diuretics and, in specific instances, opioids. Cardiogenic shock is characterized by sustained hypoperfusion, pulmonary wedge pressure > 18 mmHg and a cardiac index < 2.2l/min/m(2). The process typically presents with hypotension (systolic blood pressure < 90 mmHg or a decrease in mean arterial pressure > 30 mmHg) and absent or reduced diuresis (< 0.5 ml/kg/h). The most common cause is left ventricular failure due to acute myocardial infarction. Treatment consists of general measures to reverse acidosis and hypoxemia, as well as the use of vasopressors and inotropic drugs. Early coronary revascularization has been demonstrated to improve survival in shock associated with ischaemic heart disease.

Topics: Acute Disease; Cardiovascular Agents; Combined Modality Therapy; Diagnosis, Differential; Diuresis; Heart Failure; Humans; Hypotension; Hypoxia; Myocardial Infarction; Myocardial Revascularization; Narcotics; Oxygen Inhalation Therapy; Pulmonary Edema; Respiration, Artificial; Sepsis; Shock; Shock, Cardiogenic; Sodium Potassium Chloride Symporter Inhibitors; Vasoconstrictor Agents; Vasodilator Agents; Ventricular Dysfunction, Left

Matrix metalloproteinase (MMPs) are long understood to be involved in remodeling of the extracellular matrix. However, over the past decade, it has become clear that one of the most ubiquitous MMPs, MMP-2, has numerous intracellular targets in cardiac myocytes. Notably, MMP-2 proteolyzes components of the sarcomere, and its intracellular activity contributes to ischemia-reperfusion injury of the heart. Together with the well documented role played by MMPs in the myocardial remodeling that occurs following myocardial infarction, this has led to great interest in targeting MMPs to treat cardiac ischemic injury. In this review we will describe the expanding understanding of intracellular MMP-2 biology, and how this knowledge may lead to improved treatments for ischemic heart injury. We also critically review the numerous preclinical studies investigating the effects of MMP inhibition in animal models of myocardial infarction and ischemia-reperfusion injury, as well as the recent clinical trials that are part of the effort to translate these results into clinical practice. Acknowledging the disappointing results of past clinical trials of MMP inhibitors for other diseases, we discuss the need for carefully designed preclinical and clinical studies to avoid mistakes that have been previously made. We conclude that inhibition of MMPs, and in particular MMP-2, shows promise as a therapy to prevent the progression from ischemic injury to heart failure. However, it is critical that the full breadth of MMP-2 biology be taken into account as such therapies are developed.

Topics: Animals; Cardiovascular Agents; Disease Models, Animal; Humans; Matrix Metalloproteinase 2; Matrix Metalloproteinase Inhibitors; Molecular Targeted Therapy; Myocardial Infarction; Myocardial Reperfusion Injury; Myocardium; Signal Transduction; Ventricular Remodeling

Multiple, potentially practice-changing cardiology trials have been presented or published over the past year. In this paper, we summarize and place in clinical context, new data regarding management of acute coronary syndrome and ST-elevation myocardial infarction (copeptin assessment, otamixaban, cangrelor, prasugrel, sodium nitrite, inclacumab, ranolazine, preventive coronary intervention of non-culprit lesions, immediate thrombolytic therapy versus transfer for primary intervention), new coronary intervention data (thrombectomy, radial access, pressure wire fractional flow reserve, antiplatelet therapy duration and gene-guidance, permanent and biodegradable polymers, coronary bifurcation and strategies), and coronary artery bypass data (off pump vs. on pump). Latest trials in trans-aortic valve implantation, heart failure (eplerenone, aliskiren, spironolactone, sildenafil, dopamine, nesiritide, omecamtiv mecarbil, the algisyl left ventricular augmentation device, and echo-guided cardiac resynchronization), atrial fibrillation (edoxaban, dabigatran, and ablation), cardiac arrest (hypothermia, LUCAS™ mechanical chest compression), and cardiovascular prevention (vitamins, renal denervation for resistant hypertension, renal artery stenting, saxagliptin, alogliptin, and gastric banding) are also discussed.

Topics: Acute Coronary Syndrome; Cardiovascular Agents; Cardiovascular Diseases; Cardiovascular Surgical Procedures; Humans; Myocardial Infarction; Stents; Thrombolytic Therapy

Therapy with meldonium belongs to "metabolic direction" which is developing in cardiovascular medicine. Its purpose is restoration of impaired cellular metabolism.

Topics: Cardiotonic Agents; Cardiovascular Agents; Humans; Metabolism; Methylhydrazines; Myocardial Infarction; Randomized Controlled Trials as Topic; Treatment Outcome

Coronary artery disease (CAD) is the leading cause of death worldwide. There are several presenting clinical syndromes, including sudden cardiac death. Risk factor analysis can help the primary care provider identify patients who may need more extensive evaluation or treatment. Treatment may be medical or surgical and depends on the individual patient's comorbidities and preferences. In the future, growth of new blood vessels or cardiac cells may aid in the treatment of CAD.

Topics: Biomarkers; Cardiac Catheterization; Cardiovascular Agents; Coronary Artery Disease; Creatine Kinase, MB Form; Electrocardiography; Exercise Test; Humans; Myocardial Infarction; Myocardial Ischemia; Primary Health Care; Risk Assessment; Risk Factors; Stents; Troponin

No-reflow phenomenon is a consequence of percutaneous coronary intervention (PCI) which arises most of the time in the setting of myocardial infarction, but can be also the consequence of PCI in stable angina patients (rotatablator ablation technique or angioplasty in saphenous vein grafts). In this review, we summarize two ways of treating the no-reflow according to the current literature. First through the pharmacological approach where several compounds have been assessed like adenosine, nitroprusside, verapamil, nicorandil, dipyridamole, epinephrine or cyclosporine. Second through the mechanical approach where few strategies have been examined like intra-aortic balloon pumping or postconditioning. Finally, we provide an algorithm for treating a no-reflow even though no studies showed a beneficial effect in terms of clinical endpoints.

Topics: Animals; Cardiovascular Agents; Humans; Ischemic Postconditioning; Myocardial Infarction; No-Reflow Phenomenon; Treatment Outcome

Atherosclerosis of the coronary arteries is common, extensive, and more unstable among patients with chronic renal impairment or chronic kidney disease (CKD). The initial presentation of coronary disease is often acute coronary syndrome (ACS) that tends to be more complicated and has a higher risk of death in this population. Medical treatment of ACS includes antianginal agents, antiplatelet therapy, anticoagulants, and pharmacotherapies that modify the natural history of ventricular remodeling after injury. Revascularization, primarily with percutaneous coronary intervention and stenting, is critical for optimal outcomes in those at moderate and high risk for reinfarction, the development of heart failure, and death in predialysis patients with CKD. The benefit of revascularization in ACS may not extend to those with end-stage renal disease because of competing sources of all-cause mortality. In stable patients with CKD and multivessel coronary artery disease, observational studies have found that bypass surgery is associated with a reduced mortality as compared with percutaneous coronary intervention when patients are followed for several years. This article will review the guidelines-recommended therapeutic armamentarium for the treatment of stable coronary atherosclerosis and ACS and give specific guidance on benefits, hazards, dose adjustments, and caveats concerning patients with baseline CKD.

Topics: Acute Coronary Syndrome; Cardiovascular Agents; Coronary Artery Disease; Fibrinolytic Agents; Humans; Myocardial Infarction; Myocardial Revascularization; Practice Guidelines as Topic; Renal Insufficiency, Chronic; Risk Assessment

Topics: Cardiovascular Agents; Data Interpretation, Statistical; Erythropoietin; Evidence-Based Medicine; Humans; Myocardial Infarction; Stroke Volume; Treatment Outcome; Ventricular Function, Left

This study sought to investigate whether the everolimus-eluting stent (EES) is superior to the paclitaxel-eluting stent (PES) with respect to long-term individual clinical outcomes.. Individual studies have indicated a clinical advantage of coronary EES compared with PES with respect to restenosis and the composite endpoint of major adverse cardiac events. However, these trials were not powered for superiority in low-frequency event rates and have reported limited data beyond 1-year follow-up.. We conducted a meta-analysis of the final 3-year results from the international SPIRIT (Clinical Evaluation of the Xience V Everolimus Eluting Coronary Stent System in the Treatment of Patients With De Novo Native Coronary Artery Lesions) II, III, and IV clinical trials. Individual patient data from 4,989 patients who were prospectively randomized to treatment with EES (n = 3,350) or PES (n = 1,639) were pooled for analysis.. At 3-year follow-up, EES was superior to PES in reducing the following event rates: target lesion failure (8.9% vs. 12.5%, hazard ratio [HR]: 0.71, 95% confidence interval [CI]: 0.59 to 0.85; p = 0.0002), all-cause mortality (3.2% vs 5.1%, HR: 0.65, 95% CI: 0.49 to 0.86; p = 0.003), myocardial infarction (3.2% vs. 5.1%, HR: 0.64, 95% CI: 0.48 to 0.85; p = 0.002), cardiac death or myocardial infarction (4.4% vs. 6.3%, HR: 0.70, 95% CI: 0.54 to 0.90; p = 0.005), ischemia-driven target lesion revascularization (6.0% vs. 8.2%, HR: 0.72, 95% CI: 0.58 to 0.90; p = 0.004), stent thrombosis (0.7% vs. 1.7%, HR: 0.45, 95% CI: 0.26 to 0.78; p = 0.003), and major adverse cardiac events (9.4% vs. 13.0%, HR: 0.71, 95% CI: 0.60 to 0.85; p = 0.0002). No interaction was present between stent type and the 3-year relative rates of target lesion failure across a broad range of subgroups, with the exception of diabetes and vessel (left anterior descending vs. other).. In this large dataset with 3-year follow-up, coronary implantation of EES compared with PES resulted in reduced rates of all-cause mortality, myocardial infarction, ischemia-driven target lesion revascularization, stent thrombosis, and target lesion failure. Further research is warranted to characterize possible interactions between stent type, diabetes, and vessel.

Topics: Aged; Cardiovascular Agents; Coronary Artery Disease; Coronary Restenosis; Coronary Thrombosis; Drug-Eluting Stents; Everolimus; Female; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Multicenter Studies as Topic; Multivariate Analysis; Myocardial Infarction; Paclitaxel; Percutaneous Coronary Intervention; Proportional Hazards Models; Prosthesis Design; Randomized Controlled Trials as Topic; Risk Factors; Sirolimus; Time Factors; Treatment Outcome

One of the major dilemmas facing physicians is what diagnostic and therapeutic approaches should be recommended to those stable coronary artery disease patients whose symptoms are adequately controlled on medical therapy. This study sought to assess the evidence-based data relating to whether: 1) all patients with significant coronary lesions (i.e., ischemia-producing) should undergo percutaneous coronary intervention (PCI); 2) the best therapeutic approach is optimal medical therapy; or 3) PCI should be performed, but only in certain subsets of patients. We reviewed all recent meta-analyses of prospective randomized trials that compared the outcomes of medical therapy and PCI in stable, symptomatically controlled, coronary artery disease patients. To provide greater insights to the clinician, we then analyzed, in depth, 3 comprehensive and widely quoted randomized trials. Review of recently published (2012) meta-analyses, and the detailed analyses of 3 widely quoted individual studies, indicate no difference exists between PCI and medical therapy in nonfatal MI or in all-cause or cardiovascular mortality. Thus, clinical equipoise exists: in other words, there is no evidence-based justification for adopting 1 therapeutic strategy over the other. Therefore, it is not inappropriate, until additional evidence emerges, for the responsible, experienced physician to weigh several sources of information in formulating a recommendation to the patient, even though definitive evidence-based data are not as yet available. Such sources may include assessment of the individual patient's clinical presentation, assessment of the severity of ischemia, and the patient's precise coronary anatomy. Critical for more-reliable decision making will be future development of accurate measures of the individual patient's risk of MI and/or death, whether by biomarker, imaging, or ischemia assessments.

Topics: Cardiovascular Agents; Coronary Artery Disease; Evidence-Based Medicine; Humans; Myocardial Infarction; Patient Selection; Percutaneous Coronary Intervention; Risk Assessment; Risk Factors; Severity of Illness Index; Therapeutic Equipoise; Time Factors; Treatment Outcome

To compare by meta-analysis the efficacy and safety of sirolimus-eluting and bare-metal stents in coronary artery disease (CAD) patients with diabetes.. PubMed, MEDLINE and EMBASE were searched from 1971 to 2012. Data on the efficacy and safety of sirolimus-eluting and bare-metal stents in patients with diabetes were collected. A meta-analysis was then performed on a total of 1 259 CAD patients with diabetes from six studies. The odds ratio (OR) was used for comparison. Subgroup analysis was performed according to the sample size, year of study, subjects' geographic area and study method.. Compared with those in the bare-metal stent group (BMS), the subjects in the sirolimus-eluting stent (SES) group had a reduced risk for major cardiac events [OR 0.42, 95% confidence interval (CI): 024-0.74, p < 0.01] and target-lesion revascularisation (OR 0.26, 95% CI: 0.11 - 0.59, p < 0.01). There was no difference for myocardial infarction (OR 0.92, 95% CI: 0.61-1.40, p > 0.05) or mortality (OR 1.19, 95% CI: 0.74-1.92, p > 0.05). Subgroup analysis showed a significant difference for overall risk of major cardiac events between SES and BMS when the sample size was ≤ 90 (OR 0.28, 95% CI: 0.16-0.48, p < 0.01), when it was a randomised control trial (RCT) (OR 0.28, 95% CI: 0.19-0.42, p < 0.01), or when it was performed on European subjects (OR 0.45, 95% CI: 0.27-0.77, p < 0.01). The sensitivity was not different when one study was removed at a time.. Our study confirmed that SES are safer and more effective than BMS in CAD patients with diabetes, as far as major cardiac events are concerned.

Topics: Cardiovascular Agents; Chi-Square Distribution; Coronary Artery Disease; Diabetic Angiopathies; Drug-Eluting Stents; Humans; Metals; Myocardial Infarction; Odds Ratio; Patient Safety; Patient Selection; Percutaneous Coronary Intervention; Prosthesis Design; Risk Assessment; Risk Factors; Sirolimus; Stents; Treatment Outcome

Cardiovascular disease remains the leading cause of mortality worldwide. Many deaths are contributed to acute ST elevation myocardial infarction (STEMI). Recently, epidemiological studies have been shown reduction in STEMI related mortality over the last decade. This reduction has partially been attributed to new pharmacological and device advances that were utilized during STEMI treatment. The goal of this manuscript is to review new pharmacological and device approaches available in the treatment of STEMI patients.

Topics: Absorbable Implants; Cardiac Catheters; Cardiovascular Agents; Diffusion of Innovation; Drug-Eluting Stents; Humans; Myocardial Infarction; Percutaneous Coronary Intervention; Prosthesis Design; Stents; Thrombectomy; Treatment Outcome

In a variant proportion of patients presenting with chest pain and electrocardiographic changes characteristic for ST - elevation myocardial infarction, percutaneous coronary intervention achieves epicardial coronary artery reperfusion but not the myocardial reperfusion (ranging from 5% to 50%). Furthermore, prolonged myocardial ischemia often breaks down the coronary microvasculature and the flow to the infarct myocardium may seem to be markedly reduced. This condition is known as no reflow - phenomenon. The no reflow - phenomenon is associated with an increased incidence of malignant ventricular arrhythmias, heart failure and 30-days mortality. In the recent years in literature, several articles (subsequently discussed in the present review) have been published and made relevant to the study of the pathophysiology regarding no reflow - phenomenon. This knowledge has assisted in the development of new treatment strategies, such as prophylactic use of vasodilators, mechanical devices and drugs inhibiting platelet. The review has focused on the current literature about intra - coronary injection of drugs to treat no - reflow and microvascular dysfunction.

Topics: Cardiovascular Agents; Coronary Circulation; Humans; Injections; Microcirculation; Myocardial Infarction; No-Reflow Phenomenon

Non-adherence to evidence-based medications is a major public health problem. Less than 50 % of patients with coronary artery disease adhere to their prescribed therapies and this has important implications for morbidity, mortality, and health care spending. Like most complex behaviors, medication non-adherence is not solely the result of poor patient choices. Rather, there are myriad potential contributors attributable to patients, health care providers, and, more broadly, the health care system. Interventions including patient education and behavioral modification, improving patient-physician communication, and eliminating copayments for preventive pharmacotherapy have all been studied. Clinicians play a critical role in helping improve adherence and assessment of adherence must become a standard component of each clinical encounter. Ultimately, given the various etiologies that contribute to non-adherence, achieving meaningful gains will undoubtedly require payors, providers, and policymakers to develop, rigorously evaluate, and systematically deploy strategies that address key patient, clinician, and health system factors.

Topics: Attitude to Health; Cardiovascular Agents; Humans; Medication Adherence; Myocardial Infarction; Risk Factors

Recently, cardiac CTA has been proposed as a promising noninvasive tool for identification of rupture-prone plaques prior to a subsequent coronary event. This task is particularly challenging but the reward is high: identification of high-risk lesions could preclude plaque thrombosis and possibly prevent acute coronary syndromes. We present a case of a borderline mixed plaque with positive remodeling in the proximal left anterior descending artery (LAD). After 6 months and despite aggressive medical therapy, the patient developed acute ST-elevation myocardial infarction caused by a thrombotic lesion in the proximal LAD. We review the literature on CT characteristics of vulnerable plaque and discuss the possible preventive interventions.

Topics: Cardiovascular Agents; Coronary Angiography; Coronary Artery Disease; Coronary Thrombosis; Coronary Vessels; Disease Progression; Humans; Male; Middle Aged; Myocardial Infarction; Percutaneous Coronary Intervention; Plaque, Atherosclerotic; Predictive Value of Tests; Time Factors; Tomography, X-Ray Computed

The acute coronary syndrome is most often caused by plaque rupture and can result in a variety of clinical conditions. There are two general strategies (early invasive versus conservative) currently employed in the treatment of unstable angina or non-ST elevation myocardial infarction. Pooled data from recent clinical trials have demonstrated that high-risk patients benefit from a routine or early invasive approach while certain low-risk subgroups have similar outcomes with a conservative approach. Most patients in the USA are treated aggressively given advances in technology and the relative ease of interventional therapy. The routine invasive approach, however, remains controversial and has important limitations that are not well identified in trials. Furthermore, data from trials are difficult to interpret given their relevance to contemporary practice in today's cost conscious, health care environment. The decision to pursue an invasive or conservative approach should be based upon an individual patient's risk profile, and the level of medical therapy should be based on the underlying pathophysiology. The best strategy incorporates aggressive anti-atherosclerotic therapy with early risk stratification and invasive therapy when appropriate-the so-called hybrid approach. Identifying plaque rupture helps identify patients that would benefit from potent antiplatelet, antithrombotic, and anti-inflammatory therapies, and further insight into the natural history of coronary artery disease coupled with continued advances in diagnostic and interventional approaches will hopefully help guide long-term primary and secondary management.

Topics: Acute Coronary Syndrome; Cardiac Catheterization; Cardiovascular Agents; Combined Modality Therapy; Coronary Angiography; Coronary Artery Bypass; Evidence-Based Medicine; Humans; Myocardial Infarction; Patient Selection; Practice Guidelines as Topic; Predictive Value of Tests; Risk Assessment; Risk Factors; Time Factors; Treatment Outcome

We report the case of a 27-year-old woman with a rare presentation of right ventricular failure secondary to isolated right ventricular myocardial infarction, 3 weeks after an uncommon surgical procedure, the modified Cabrol operation. Her medical history also included a Ross procedure at the age of 12 years. On the basis of her subacute presentation and a consultation with cardiac surgeons, we decided on medical management. Follow-up echocardiography at 6 months revealed that the right ventricular systolic function remained severely impaired, but the patient was asymptomatic with excellent functional capacity.We review the surgical techniques of aortic graft replacement and their respective complications. We also discuss the impact of conservative and reperfusion strategies on prognosis and long-term outcomes in the setting of right ventricular infarction.

Topics: Adult; Aorta; Aortic Valve; Blood Vessel Prosthesis Implantation; Cardiovascular Agents; Echocardiography; Female; Graft Occlusion, Vascular; Heart Failure; Heart Valve Prosthesis Implantation; Humans; Myocardial Infarction; Recovery of Function; Thrombosis; Time Factors; Tomography, X-Ray Computed; Treatment Outcome; Ventricular Dysfunction, Right; Ventricular Function, Right

Refinement of interventional techniques, adjunctive pharmacological therapy, and the introduction of drug eluting stents have fostered new interest for the percutaneous treatment of unprotected left main coronary artery (ULMCA) stenosis. Several observational registries, some randomized controlled trials and several meta-analyses have consistently shown no difference in mortality and myocardial infarction between percutaneous coronary intervention (PCI) and coronary artery bypass graft (CABG) surgery in patients with ULMCA stenosis, but a higher rate of target vessel revascularization in patients treated with PCI. As a consequence, PCI of ULMCA stenosis has been upgraded to class IIa or IIb indication in the current European or American College of Cardiology/American Heart Association practice guidelines. Although these results are promising, they do not still represent enough evidence for extending PCI of ULMCA stenosis to current clinical practice. The EXCEL trial will address the value of PCI in relation to CABG for the treatment of ULMCA stenosis in more than 2000 patients. A major breakthrough of the SYNTAX trial has been the demonstration of an interaction between the coronary complexity and the revascularization strategy, suggesting that optimal risk stratification is a key element when deciding the best strategy of revascularization in this high-risk group of patients. Multidisciplinary team approach remains essential to provide a balanced information to the patient and to offer the beast treatment option.

Topics: Cardiovascular Agents; Coronary Artery Bypass; Coronary Stenosis; Evidence-Based Medicine; Humans; Myocardial Infarction; Patient Selection; Percutaneous Coronary Intervention; Practice Guidelines as Topic; Risk Assessment; Risk Factors; Treatment Outcome

The aim of this study was to perform a meta-analysis of randomized trials, evaluating the long-term outcomes of sirolimus-eluting stents (SES) versus bare-metal stents (BMS) in patients with ST-segment elevation myocardial infarction (STEMI).. Despite short-term outcomes of patients with STEMI undergoing primary percutaneous coronary intervention indicate a benefit of SES in terms of reintervention, several concerns remain on the long-term safety and efficacy of SES.. A systematic literature search of electronic resources, through October 2011, was performed using specific search terms. Included trials were randomized studies comparing SES to BMS in STEMI patients, with a follow-up ≥3 years.. Seven trials were included, with a total of 2,364 patients. At a median follow-up of 3 years, SES significantly reduced the risk of target-vessel revascularization when compared with BMS [odds ratio (OR), 0.44; 95 % confidence interval (CI), 0.34-0.57; p < 0.0001], without increasing the risk of mortality (OR 0.78; 95 % CI, 0.57-1.08; p = 0.14), reinfarction (OR 0.91; 95 % CI, 0.61-1.35, p = 0.64) and early to late stent thrombosis (OR 0.77; 95 % CI, 0.49-1.20; p = 0.25). However after the first year, SES did not further reduce target-vessel revascularization (OR 1.06; 95 % CI, 0.64-1.74; p = 0.83) and increased the risk of very late stent thrombosis (OR 2.81; 95 % CI, 1.33-5.92; p = 0.007).. At long-term follow-up, SES compared to BMS use in STEMI patients reduces the risk of target-vessel revascularization, without increasing the risk of death and reinfarction. However, the strong SES efficacy is counterbalanced by a significant risk of very late stent thrombosis.

Topics: Cardiovascular Agents; Chi-Square Distribution; Coronary Thrombosis; Drug-Eluting Stents; Humans; Middle Aged; Myocardial Infarction; Odds Ratio; Percutaneous Coronary Intervention; Prosthesis Design; Randomized Controlled Trials as Topic; Recurrence; Risk Assessment; Risk Factors; Sirolimus; Time Factors; Treatment Outcome

Disruption of intracoronary plaque with thrombus formation provides the pathophysiologic foundation for acute coronary syndromes, which comprise ST-segment myocardial infarction, non-ST-segment myocardial infarction, and unstable angina. Management differs depending on whether ST-segment elevation is present, but the general principles of timely restoration of coronary blood flow and initiation of secondary prevention strategies are applicable to all patients. The purpose of this review is to discuss first the epidemiology, pathophysiology, and diagnosis of acute myocardial infarction. Risk stratification and therapy for patients with ST-segment elevation myocardial infarction and non-ST-segment elevation acute coronary syndromes are then reviewed along with diagnosis and management of the complications of myocardial infarction.

Topics: Biomarkers; Cardiovascular Agents; Diagnosis, Differential; Electrocardiography; Humans; Myocardial Infarction; Myocardial Reperfusion; Risk Assessment

Some but not all studies have reported reduced rates of stent thrombosis (ST) with everolimus-eluting stents (EES) compared with other drug-eluting stents (DES). All of these studies were insufficiently powered to reliably detect differences in ST. We therefore performed a meta-analysis of randomized controlled trials comparing the risk of 2-year definite ST between EES and other DES.. Randomized controlled trials comparing EES versus other DES were searched through MEDLINE, EMBASE, Cochrane databases, and proceedings of international meetings. Information on study design, inclusion and exclusion criteria, sample characteristics, and clinical outcomes was extracted. Eleven randomized controlled trials (16,775 patients) were analyzed, including 5 trials (n=7113) of EES versus paclitaxel-eluting stents, 5 trials (n=7370) of EES versus sirolimus-eluting stents, and 1 trial (n=2292) of EES versus zotarolimus-eluting stents. By 2 years definite ST with EES compared with pooled DES occurred in 0.5% versus 1.3% patients, respectively (relative risk, 0.38; 95% CI, 0.24-0.59; P<0.0001). Similar results were observed when the broader definition of definite/probable ST was considered (relative risk, 0.46; 95% CI, 0.33-0.66; P<0.0001). EES compared with other DES reduced the relative risk of early ST (within 30 days), late ST (31 days to 1 year), cumulative 1-year ST, and very late ST (1-2 years). The reduced rate of definite ST observed with EES was consistent across all DES comparators with no interactions apparent during any time interval.. EES compared with a pooled group of paclitaxel-eluting stents, sirolimus-eluting stents, and zotarolimus-eluting stents is associated with a significant reduction of definite ST, an effect that appears early and increases in magnitude through at least 2 years.

Topics: Angioplasty, Balloon, Coronary; Cardiovascular Agents; Chi-Square Distribution; Coronary Thrombosis; Drug-Eluting Stents; Everolimus; Evidence-Based Medicine; Humans; Myocardial Infarction; Odds Ratio; Prosthesis Design; Randomized Controlled Trials as Topic; Risk Assessment; Risk Factors; Sirolimus; Time Factors; Treatment Outcome

Approximately one in four ischemic strokes is of cardioembolic origin. Non-valvular atrial fibrillation accounts for 50% of these cases, followed by myocardial infarction, intraventricular thrombus, valvular heart disease and a miscellany of causes. The incidence of embolic heart disease in the population could be about 30 cases per 100,000 inhabitants per year, and its prevalence between 5 and 10 cases per 1,000 persons aged 65 years or older. Hospital mortality is high, and 5-year survival is only one out of every five patients. The recurrence rate of this type of stroke is about 12% at 3 months, higher than that of non-cardioembolic stroke. The severity of cardioembolic strokes and the resulting disability are greater than with non-cardioembolic stroke. Age, a history of stroke or transient ischemic attack, hypertension, diabetes and heart failure play a role in stroke with atrial fibrillation as additional risk factors for future embolisms. Stroke rates can reach over 20% per year and therefore the prevention and treatment of these events are of paramount importance.

Topics: Age Distribution; Atrial Fibrillation; Brain Damage, Chronic; Brain Ischemia; Cardiovascular Agents; Comorbidity; Diabetes Mellitus; Female; Heart Valve Diseases; Humans; Hypertension; Intracranial Embolism; Male; Myocardial Infarction; Prevalence; Recurrence; Risk Factors; Sex Distribution; Survival Rate; Thrombophilia

Combination therapy, specifically with aspirin, cholesterol and blood pressure-lowering drugs, substantially reduces the risk of coronary heart disease, but the full preventive effect is only realized if treatment continues indefinitely. Our objective was to provide a summary estimate of adherence to drugs that prevent coronary heart disease, according to drug class and use in people who have had a myocardial infarction (secondary prevention) and people who have not (primary prevention).. A meta-analysis of data on 376,162 patients from 20 studies assessing adherence using prescription refill frequency for the following 7 drug classes was performed: aspirin, angiotensin-converting enzyme inhibitors, angiotensin receptor blockers, beta-blockers, calcium-channel blockers, thiazides, and statins. Meta-regression was used to examine the effects of age, payment, and treatment duration.. The summary estimate for adherence across all studies was 57% (95% confidence interval [CI], 50-64) after a median of 24 months. There were statistically significant differences in adherence between primary and secondary prevention: 50% (CI, 45-56) and 66% (CI, 56-75), respectively (P=.012). Adherence was lower for thiazides (42%) than for angiotensin receptor blockers (61%) in primary prevention (P=.02). There were no other statistically significant differences between any of the drug classes in primary or secondary prevention studies. Adherence decreased by 0.15% points/month (P=.07) and was unrelated to age or whether patients paid for their pills.. Adherence to preventive treatment is poor and little related to class of drug, suggesting that side effects are not the main cause. General, rather than class-specific, measures at improving adherence are needed.

Topics: Adrenergic beta-Antagonists; Age Factors; Angiotensin Receptor Antagonists; Angiotensin-Converting Enzyme Inhibitors; Anticholesteremic Agents; Antihypertensive Agents; Aspirin; Calcium Channel Blockers; Cardiovascular Agents; Cardiovascular Diseases; Drug Administration Schedule; Drug Costs; Drug Prescriptions; Humans; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Medication Adherence; Myocardial Infarction; Platelet Aggregation Inhibitors; Primary Prevention; Secondary Prevention; Self Administration; Sodium Chloride Symporter Inhibitors; Time Factors

Topics: Adult; Aged; Attitude of Health Personnel; Cardiovascular Agents; Coronary Artery Disease; Female; Health Knowledge, Attitudes, Practice; Humans; Male; Middle Aged; Myocardial Infarction; Patient Compliance; Predictive Value of Tests; Primary Prevention; Risk Assessment; Risk Factors; Risk Reduction Behavior; Treatment Outcome; Vascular Calcification

In experimental models of acute myocardial infarction (AMI), erythropoietin (EPO) reduces infarct size and improves left ventricular (LV) function. However, in the clinical setting, the effect of EPO in AMI was unclear. We conducted a systematic review and meta-analysis of randomized controlled trials (RCTs) of EPO to explore the safety and therapeutic effects of EPO in patients with AMI.. We identified reports of RCTs comparing EPO to placebo for AMI in adult humans in PubMed, Cochrane Central Register of Controlled Trials, and EMBASE. Outcomes included all-cause mortality, major cardiovascular events, cardiac function by LV ejection fraction and infarct size.. We included 13 articles of RCTs with data for 1,564 patients. Erythropoietin therapy did not improve LV ejection fraction (weighted mean difference [WMD] 0.33, 95% CI -1.90 to 1.24, P = .68) and had no effect on infarct size, as measured by cardiac magnetic resonance imaging (WMD -0.12, -2.16 to 1.91, P = .90) or serum peak value of creatine kinase-MB (WMD -2.01, -25.70 to 21.68, P = .87). Erythropoietin treatment did not decrease the risk of total adverse cardiac events (relative risk [RR] 1.02, 0.65-1.61, P = .92). Erythropoietin treatment also failed to decrease the risk of heart failure (RR, 0.69, 0.27-1.72, P = .42) and all-cause mortality (RR 0.55, 0.22-1.33, P = .18). Moreover, EPO had no effect on the risk of stent thrombosis (RR, 0.69, 0.29-1.64, P = .40).. Erythropoietin in patients with AMI seems to have no clinical benefit for heart function or reducing infarct size, cardiovascular events, and all-cause mortality. Erythropoietin may not be a choice for patients with AMI.

Topics: Adult; Aged; Cardiovascular Agents; Drug Administration Schedule; Erythropoietin; Female; Heart Failure; Humans; Magnetic Resonance Imaging; Male; Middle Aged; Myocardial Infarction; Randomized Controlled Trials as Topic; Risk; Stroke Volume; Survival Rate; Thrombosis; Treatment Failure; Ventricular Function, Left

In chronic stable angina of mild or moderate severity, there is an ongoing debate as to which treatment strategy should be offered to patients: intense medical drug therapy combined with revascularization if medical therapy fails, or direct coronary angiography in view of immediate revascularization in all patients if feasible, both combined with strict risk factor control and secondary prevention. Findings of two large randomized controlled trials, COURAGE and BARI 2D showed that in selected patients with mild to moderate angina and documented coronary disease by coronary angiography suitable for revascularization, there was no difference in death or myocardial infarction between the two strategies. It remains unclear, however, how these findings can be generalized to the broader spectrum of patients with unknown coronary anatomy. This review describes both treatment strategies, their strengths and limitations, and stresses the importance of the documentation of the extent of myocardial ischemia in risk stratifying such patients. Based on the available trial evidence, an algorithm is proposed how to tailor the management strategy to each patient's individual situation.

Topics: Angina Pectoris; Cardiovascular Agents; Chronic Disease; Coronary Artery Disease; Humans; Myocardial Infarction; Myocardial Revascularization; Patient Selection; Risk Assessment; Risk Factors; Treatment Outcome

To perform a systematic review and meta-analysis of studies reporting outcomes after drug-eluting stent (DES) implantation in chronic total occlusions (CTOs).. A review of publications and online databases in January 2010 retrieved 17 published studies that reported outcomes after DES implantation in CTOs: eight uncontrolled studies, seven nonrandomized comparative studies with bare-metal stents (BMS), one post-hoc analysis of a randomized trial, and one randomized trial. Data were pooled using random-effects meta-analysis models.. All published studies evaluated sirolimus- or paclitaxel-eluting stents. All studies reporting comparative angiographic outcomes revealed less binary angiographic restenosis with DES implantation compared to BMS (odds ratio: 0.15, 95% CI: 0.08, 0.26). Over a mean follow-up period of 18.9±16.5 months, the cumulative incidence of death, myocardial infarction, or stent thrombosis was similar between DES and BMS in all studies. Target lesion revascularization (odds ratio: 0.13, 95% CI: 0.06, 0.26) and target vessel revascularization (odds ratio 0.18, 95% CI: 0.11, 0.31) at 6-12 months were consistently lower among DES-treated patients. Similar patterns of safety and efficacy event rates were also observed in studies reporting>12 month outcomes.. Compared with BMS, treatment of chronic total coronary occlusions with DES is associated with significant reductions in angiographic and clinical restenosis with similar safety. The consistency and magnitude of treatment effect across both individual trials and the pooled analysis establish DES as the preferred therapy for percutaneous revascularization of CTOs.

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Chi-Square Distribution; Chronic Disease; Coronary Angiography; Coronary Occlusion; Coronary Restenosis; Drug-Eluting Stents; Female; Humans; Male; Middle Aged; Myocardial Infarction; Odds Ratio; Paclitaxel; Patient Selection; Prosthesis Design; Risk Assessment; Risk Factors; Sirolimus; Thrombosis; Time Factors; Treatment Outcome

First generation drug-eluting stents have shown differential efficacy in high-risk patient subsets at one year. It is unclear whether these differences endure over the medium- to long-term. We compared the five-year clinical efficacy and safety of sirolimus-eluting stents (SES) and paclitaxel-eluting stents (PES) in a population of high-risk patients.. The patient cohorts of the ISAR-DESIRE, ISAR-DIABETES, and ISAR-SMART-3 randomized trials were followed up for five years and data were pooled. The primary efficacy endpoint of the analysis was the need for target lesion revascularization (TLR) during a five-year follow-up period. The primary safety endpoint was the combination of death or myocardial infarction (MI) after five years.. A total of 810 patients (405 patients in the SES group and 405 patients in the PES group) was included. Over five years TLR was reduced by 39% with SES compared with PES stent (hazard ratio [HR] 0.61; 95% confidence interval [CI] 0.44-0.85; P = 0.004). No difference was observed according to death or MI rates between the two groups (HR 1.10; 95% CI 0.80-1.50; P = 0.57). Definite stent thrombosis occurred in 0.2% (n = 1) in the SES group and in 1.6% (n = 6) in the PES group (HR 0.16; 95% CI 0.02-1.34; P = 0.12).. In high-risk patient subsets the lower rate of 12-month TLR observed with SES in comparison PES is maintained out to five years. In terms of safety, although there was no difference in the overall incidence of death or MI, there was a trend towards more frequent stent thromboses with PES.

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Chi-Square Distribution; Coronary Angiography; Coronary Restenosis; Coronary Stenosis; Disease-Free Survival; Drug-Eluting Stents; Female; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Myocardial Infarction; Paclitaxel; Proportional Hazards Models; Randomized Controlled Trials as Topic; Risk Assessment; Risk Factors; Sirolimus; Thrombosis; Time Factors; Treatment Outcome

These studies sought to investigate the impact on mortality of coronary flow after passage of the wire through the culprit vessel in patients with ST-segment elevation myocardial infarction (STEMI) undergoing mechanical reperfusion.. Reduced spontaneous coronary flow before percutaneous coronary intervention influences mortality in patients with STEMI. Response to vessel wiring in patients with an occluded coronary artery before intervention might further discriminate outcomes irrespective of pre- and post-intervention coronary flow.. Data from the STRATEGY (Single High-Dose Bolus Tirofiban and Sirolimus-Eluting Stent Versus Abciximab and Bare-Metal Stent in Acute Myocardial Infarction) and MULTISTRATEGY (Multicenter Evaluation of Single High-Dose Bolus Tirofiban Versus Abciximab With Sirolimus-Eluting Stent or Bare-Metal Stent in Acute Myocardial Infarction Study) trials were pooled: of 919 index procedures, 902 films (98%) were technically adequate for core laboratory TIMI (Thrombolysis In Myocardial Infarction) flow determination.. TIMI flow grade 0 was present before percutaneous coronary intervention in 59% of infarct vessels, TIMI flow grade 1 to 2 was found in 21%, whereas the remainder of infarct arteries presented with TIMI flow grade 3. In 49% of patients who showed persistent TIMI flow grade 0 after wire insertion (AWI), mortality was higher at 30 days (5.3%) and 1 year (9.4%) compared with patients in whom TIMI flow grade before percutaneous coronary intervention was either >0 (0.8%; p < 0.003 and 3.6%, p < 0.008) or improved from 0 AWI (1.5%, p < 0.04 and 3.6%, p < 0.02). After correcting for multiple imbalances, including baseline and final flow, persistent TIMI flow grade 0 AWI remained associated at 30 days to 2-fold (risk ratio [RR]: 2.1, 95% confidence interval [CI]: 1.08 to 5.00; p = 0.038) and at 1 year to almost 3-fold increases of mortality (RR: 2.7, 95% CI: 1.3 to 5.6; p = 0.008).. STEMI patients displaying persistent no-flow AWI have a lower survival rate despite an apparently successful mechanical intervention. As an early marker for high residual mortality risk, persistent no-flow AWI may qualify STEMI patients for dedicated pharmacomechanical treatment strategies.

Topics: Abciximab; Aged; Analysis of Variance; Angioplasty, Balloon, Coronary; Antibodies, Monoclonal; Cardiovascular Agents; Coronary Angiography; Coronary Circulation; Drug-Eluting Stents; Evidence-Based Medicine; Female; Humans; Immunoglobulin Fab Fragments; Kaplan-Meier Estimate; Male; Metals; Middle Aged; Multicenter Studies as Topic; Myocardial Infarction; No-Reflow Phenomenon; Platelet Aggregation Inhibitors; Predictive Value of Tests; Proportional Hazards Models; Randomized Controlled Trials as Topic; Risk Assessment; Risk Factors; Sirolimus; Stents; Time Factors; Tirofiban; Treatment Outcome; Tyrosine

Stent fracture and subsequent stent thrombosis are known complications after stent implantation, especially in stents with closed cell design like the first generation sirolimus drug eluting stents (DES). Late stent thrombosis is very rarely encountered in our patient population, majority Chinese. We report a case of non-ST elevation myocardial infarction as a result of very late stent thrombosis (three years after implantation) due to stent fracture at the site of overlap of two first generation sirolimus DES. There were initial difficulties in restoring coronary flow by conventional reperfusion therapies but a successful outcome after implantation of an endothelial progenitor cell capture stent, with no further recurrence of ischemic event after 12 months. An attempt was made to analyze all existing factors present and contributing to the stent fracture and stent thrombosis in this case, as reported in the literature.

Topics: Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Angiography; Coronary Artery Disease; Drug-Eluting Stents; Humans; Male; Middle Aged; Myocardial Infarction; Prosthesis Design; Prosthesis Failure; Risk Factors; Sirolimus; Thrombosis; Time Factors; Treatment Outcome

Ischemic heart disease stands as the number one leading cause of death in the United States. Current interventions rely on the immediate restoration of blood flow to the ischemic area; however, this in turn may trigger a series of undesirable events that are further injurious to the myocardium, termed ischemia/reperfusion (I/R) injury. Therefore, there is a need for novel therapeutic strategies aimed at limiting the extent of myocardial injury. Yet, the molecular mechanisms responsible for I/R injury remain largely indefinable. Research efforts are currently investigating various signaling mechanisms to be used for potential targets limiting cardiac injury due to such cardiovascular events. In this review, we highlight two potential molecular targets, PPAR-γ and AMPK, which have been extensively reported to have various cardioprotective capabilities against I/R injury. Although functionally different, the pathways these proteins mediate seem to intersect and possibly act synergistically potentiating a cardioprotective response.

Topics: Adenylate Kinase; Cardiovascular Agents; Humans; Myocardial Infarction; Myocardial Reperfusion Injury; PPAR gamma

The lack of a mortality benefit of aspirin in prior meta-analyses of primary prevention trials of cardiovascular disease has contributed to uncertainty about the balance of benefits and risks of aspirin in primary prevention. We performed an updated meta-analysis of randomized controlled trials of aspirin to obtain best estimates of the effect of aspirin on mortality in primary prevention.. Eligible articles were identified by searches of electronic databases and reference lists. Outcomes of interest were all-cause mortality, cardiovascular mortality, myocardial infarction, stroke, and bleeding. Data were pooled from individual trials using the DerSimonian-Laird random-effects model, and results are presented as relative risk (RR) and 95% confidence intervals (CIs).. Nine randomized controlled trials enrolling 100,076 participants were included. Aspirin reduced all-cause mortality (RR 0.94; 95% CI, 0.88-1.00), myocardial infarction (RR 0.83; 95% CI, 0.69-1.00), ischemic stroke (RR 0.86; 95% CI, 0.75-0.98), and the composite of myocardial infarction, stroke, or cardiovascular death (RR 0.88; 95% CI, 0.83-0.94), but did not reduce cardiovascular mortality (RR 0.96; 95% CI, 0.84-1.09). Aspirin increased the risk of hemorrhagic stroke (RR 1.36; 95% CI, 1.01-1.82), major bleeding (RR 1.66; 95% CI, 1.41-1.95), and gastrointestinal bleeding (RR 1.37; 95% CI, 1.15-1.62). A lack of availability of patient-level data precluded exploration of benefits and risks of aspirin in key subgroups.. Aspirin prevents deaths, myocardial infarction, and ischemic stroke, and increases hemorrhagic stroke and major bleeding when used in the primary prevention of cardiovascular disease.

Topics: Adult; Aged; Aspirin; Cardiovascular Agents; Cause of Death; Female; Gastrointestinal Hemorrhage; Humans; Incidence; Male; Middle Aged; Myocardial Infarction; Primary Prevention; Randomized Controlled Trials as Topic; Risk Assessment; Stroke

Acute coronary syndrome is a common cause of morbidity and mortality, both in the United States and worldwide. The goal of this review is to familiarize clinicians with recent information regarding the diagnosis and treatment of acute coronary syndrome.. PubMed search and review of the relevant medical literature.. Acute coronary syndrome encompasses three clinical diagnoses: unstable angina, non-ST-segment elevation myocardial infarction), and ST-segment elevation myocardial infarction. The definition, pathophysiology, clinical presentation, diagnosis, and treatment of unstable angina/non-ST-segment elevation myocardial infarction are reviewed here. Diagnosing unstable angina/non-ST-segment elevation myocardial infarction is a significant challenge in critically ill patients not initially suspected of having acute coronary syndrome (i.e., noncardiac intensive care unit patients), and diagnostic and treatment strategies for these patients have not been clearly established.. Patients with acute coronary syndrome benefit from intensive medical therapy, including antianginal, antiplatelet, antithrombotic, and statin agents. Depending on their risk for future cardiovascular events as well as their risk of bleeding complications, patients may benefit from either an early invasive treatment strategy, in which routine coronary revascularization is performed, or a conservative strategy, in which revascularization is reserved for patients with recurrent or provocable cardiac ischemia.

Topics: Acute Coronary Syndrome; Angina, Unstable; Biomarkers; Cardiovascular Agents; Critical Illness; Diagnosis, Differential; Electrocardiography; Humans; Myocardial Infarction; Myocardial Revascularization; Thrombosis

Myocardial infarction is rarely caused by non-occlusive thrombus in angiographically normal coronary arteries. The cases reported in the literature are scarce and follow-up was usually short. The efficacy and tolerability of the exclusively medical treatment strategy used in most cases remain unknown.. To evaluate efficacy of medical treatment and long-term prognosis in these patients.. We retrospectively selected and analysed patients hospitalized in our centre between 1998 and 2008 for myocardial infarction caused by non-occlusive thrombus in angiographically normal coronary arteries (defined as stenosis<30%), who were exclusively medically treated. A long-term follow-up was performed. A review of the literature regarding such cases was carried out.. Sixteen patients were identified; apart from smoking, they had few conventional cardiovascular risk factors. Two patients died in hospital. The 14 survivors were followed up for an average of 4.9 years and only one death (non-cardiac cause) and one stroke (related to supraventricular arrhythmia) occurred in this period. Medical treatment included the use of glycoprotein IIb/IIIa inhibitors in 75% of cases. The literature review revealed 36 similar cases due to multiple aetiologies-particularly coronary artery spasm and prothrombotic coagulopathies.. Patients with myocardial infarction secondary to non-occlusive thrombus in angiographically normal coronary arteries seem to have a good long-term prognosis after the acute phase when treated with an exclusively medical strategy. However, initial clinical presentation was often severe, leading to early in-hospital death.

Topics: Adult; Cardiovascular Agents; Coronary Angiography; Coronary Stenosis; Coronary Thrombosis; Drug Therapy, Combination; Female; France; Hospital Mortality; Humans; Male; Middle Aged; Myocardial Infarction; Retrospective Studies; Severity of Illness Index; Time Factors; Treatment Outcome

Heart failure is a frequent complication of myocardial infarction. Several factors, such as recurrent myocardial ischemia, infarct size, ventricular remodeling, stunned myocardium, mechanical complications, and hibernating myocardium influence the appearance of left ventricular systolic dysfunction after myocardial infarction. Importantly, its presence increases the risk of death by at least 3- to 4-fold. The knowledge of the mechanisms and clinical features are essential for the diagnosis and treatment of left ventricular dysfunction and heart failure after myocardial infarction. Therefore, this review will focus on the clinical implications and treatment of heart failure after myocardial infarction. © 2011 Wiley Periodicals, Inc. The authors have no funding, financial relationships, or conflicts of interest to disclose.

Topics: Cardiovascular Agents; Heart Failure; Humans; Myocardial Infarction; Stem Cell Transplantation; Treatment Outcome; Ventricular Dysfunction, Left

In an aging population, major surgery is often performed in patients with complex co-morbidities. These patients present new risk constellations so that cardiac and respiratory complications mainly contribute to perioperative morbidity.. We composed a narrative review on pharmacological approaches to cardiovascular protection in the perioperative period including effects of central neuraxial blocks and hypothermia on cardiovascular outcome. The single chapters are structured as follows: pathophysiology-early studies-recent evidence-recommendations.. In coping with this challenge, innovative concepts like fast track surgery and pharmacological treatment are being utilized with increasing frequency including perioperative cardioprotection, novel strategies of anticoagulation or antiplatelet therapy, and protocols for postoperative pain therapy.. All the concepts described require an interdisciplinary approach in collaboration between operative physicians and physicians working in non-surgical disciplines like internal medicine, cardiology, and clinical pharmacology. The perioperative continuation of a pre-existing therapy with beta-blockers and other potentially cardioprotective agents like α(2)-agonists and statines is recommended. In the management of patients presenting for major surgery stratification of the perioperative risk is essential which considers both, invasiveness of the surgical procedure and conditions of the patient. Otherwise, side-effects might outweigh benefits of a potentially effective therapy as recently shown for the perioperative administration of beta-blockers that should be restricted to high-risk patients.

Topics: Cardiovascular Agents; Comorbidity; Cooperative Behavior; Coronary Thrombosis; Death, Sudden, Cardiac; Drug Therapy, Combination; Evidence-Based Medicine; Hospital Mortality; Humans; Interdisciplinary Communication; Length of Stay; Myocardial Infarction; Perioperative Care; Postoperative Complications; Risk Factors

Worldwide, the leading causes of death are ischemic heart disease and stroke. Moreover, patients with several risk factors or a history of ischemic heart disease are at a high risk of coronary event recurrence. There is evidence that primary cardiovascular disease prevention programs are effective when applied to the general population. However, therapeutic strategies designed to control several risk factors simultaneously in patients without evidence of cardiovascular disease are expensive and difficult to implement. In contrast, combination drug therapy is commonly used for secondary cardiovascular prevention and its beneficial effects on morbidity and mortality have been clearly demonstrated. Nevertheless, the actual impact of this approach is less than might be expected, partly because of poor adherence to drug regimens and the high cost of treatment in low- and middle-income countries. In patients who have had an acute myocardial infarction, the complexity of the regimen is inversely correlated ith compliance and is, in most cases, the reason for treatment discontinuation. Moreover, globally the ast majority of cardiovascular events take place in developing countries with limited health resources here access to treatment is poor. The development of fixed-dose combinations of drugs (i.e. polypills) designed for the treatment of myocardial infarction patients could help overcome these limitations, improve compliance and facilitate the distribution of and access to treatment in developing countries. We have begun a large clinical trial in five countries to investigate the beneficial effects of treatment using a polypill (i.e. aspirin, an angiotensin-converting enzyme inhibitor and a statin) on ischemic heart disease recurrence. The results of this study could provide the basis for a new therapeutic approach to the management of not only cardiovascular disease but also diabetes and stroke.

Topics: Cardiovascular Agents; Drug Combinations; Humans; Myocardial Infarction; Myocardial Ischemia; Secondary Prevention

Persons aged 65 years or older, often referred to as the elderly, are a rapidly increasing population in the United States. Cardiovascular disease is the most common cause of morbidity and death in this age group, and acute coronary syndrome accounts for a significant proportion of the deaths. Percutaneous coronary intervention is a well-established treatment for acute coronary syndrome and symptomatic coronary artery disease. However, community studies have shown that elderly patients are less likely to undergo revascularization, perhaps due to a "treatment-risk" paradox: elderly patients-at higher risk of morbidity and death from acute coronary syndrome-are denied revascularization even though they are likely to benefit from it. Age alone is one of the many reasons why percutaneous coronary intervention is avoided in elderly patients. This review examines past clinical trials and the existing evidence that supports performing percutaneous coronary intervention in elderly patients.

Topics: Acute Coronary Syndrome; Age Factors; Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Artery Disease; Evidence-Based Medicine; Heart Diseases; Humans; Myocardial Infarction; Patient Selection; Risk Assessment; Risk Factors; Treatment Outcome

The aim of this study was to investigate the impact of reference vessel diameter (RVD) and lesion length (LL) on the relative safety and efficacy of everolimus-eluting stents (EES) and paclitaxel-eluting stents (PES).. Lesion length and RVD are well-known predictors of adverse events after percutaneous coronary intervention.. Patient-level data were pooled from the randomized SPIRIT (Clinical Evaluation of the XIENCE V Everolimus Eluting Coronary Stent System) II, III, IV and COMPARE (Second-generation everolimus-eluting and paclitaxel-eluting stents in real-life practice) trials. Quantitative angiographic core laboratory data were available for 6,183 patients randomized to EES (n = 3,944) or PES (n = 2,239). Long lesions and small vessels were defined as LL >median (13.4 mm) and RVD ≤median (2.65 mm), respectively. Major adverse cardiac events (MACE) (consisting of cardiac death, myocardial infarction, or ischemia-driven target lesion revascularization) were assessed at 2 years, according to stent type in 3 groups: short lesions in large vessels (group A, n = 1,297); long lesions or small vessels but not both (group B, n = 2,981); and long lesions in small vessels (group C, n = 1,905).. The pooled 2-year MACE rates were 5.6%, 8.2%, and 10.4% in Groups A, B, and C, respectively (p < 0.0001). There was no significant interaction between lesion group and stent type (p = 0.64), indicating lower MACE with EES compared with PES regardless of LL and RVD. However, the absolute difference was largest in Groups B and C. In Group A, 2-year MACE rates were not significantly different between EES and PES (4.8% vs. 7.0%, respectively, p = 0.11). In contrast, EES was associated with lower 2-year rates of MACE in Group B (6.6% vs. 11.2%, p < 0.01) and in Group C (9.1% vs. 12.7%, p = 0.008) as well as lower rates of myocardial infarction, target lesion revascularization, and stent thrombosis. Multivariable analysis confirmed EES versus PES as an independent predictor of freedom from MACE in Groups B and C.. Patients with short lesions in large vessels have low rates of MACE at 2 years after treatment with either EES or PES. In higher-risk patients with long lesions and/or small vessels, EES results in significant improvements in both clinical safety and efficacy outcomes. (A Clinical Evaluation of the XIENCE V Everolimus Eluting Coronary Stent System in the Treatment of Patients With de Novo Native Coronary Artery Lesions; NCT00180310; SPIRIT III: A Clinical Evaluation of the Investigational Device XIENCE V Everolimus Eluting Coronary Stent System [EECSS] in the Treatment of Subjects With de Novo Native Coronary Artery Lesions; NCT00180479; SPIRIT IV Clinical Trial: Clinical Evaluation of the XIENCE V Everolimus Eluting Coronary Stent System in the Treatment of Subjects With de Novo Native Coronary Artery Lesions; NCT00307047; A Randomized Controlled Trial of Everolimus-eluting Stents and Paclitaxel-eluting Stents for Coronary Revascularization in Daily Practice: The COMPARE Trial; NCT01016041).

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Chi-Square Distribution; Coronary Angiography; Coronary Stenosis; Drug-Eluting Stents; Everolimus; Female; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Myocardial Infarction; Paclitaxel; Predictive Value of Tests; Proportional Hazards Models; Prosthesis Design; Randomized Controlled Trials as Topic; Risk Assessment; Risk Factors; Severity of Illness Index; Sirolimus; Thrombosis; Time Factors; Treatment Outcome

Successful revascularization of the epicardial coronary artery can be achieved in over 90% of percutaneous coronary intervention (PCI) procedures. However, postprocedural microvascular obstruction, despite the presence of normal epicardial flow, remains an important limitation which substantially reduces the beneficial effects of PCI. In this review article, a number of different methods available to diagnose microvascular obstruction after PCI are outlined. We also discussed the various pharmacological and mechanical strategies to reduce the occurrence of microvascular obstruction. In this regard, pretreatment with antiplatelet therapy remains crucial. In urgent PCI for acute myocardial infarction, available data suggest that manual thrombus aspiration device is beneficial in reducing the occurrence of procedure-related microvascular obstruction and possibly improve long-term clinical outcomes.

Topics: Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Artery Disease; Coronary Circulation; Coronary Occlusion; Embolism; Humans; Microcirculation; Myocardial Infarction; Prostheses and Implants; Thrombectomy

Although originally the practice of using balloon catheters proved successful in the short term, the long-term prognosis was less promising because of restenosis, which occurred in >or=30% of patients. This prompted the development of new techniques and mechanical adjuncts, or stents, to maintain lumen patency after balloon angioplasty. Bare metal stents (BMS), the first type of stent used in percutaneous coronary intervention, were designed to address the issues met by balloon angioplasty. BMS reduced the angiographic and clinical restenosis rates in de novo lesions compared to percutaneous transluminal coronary angioplasty alone and decreased the need for emergency coronary artery bypass graft surgery. BMS substantially reduced the incidence of abrupt artery closure, but restenosis still occurred after 6 months in about 20% of cases, necessitating repeat procedures. Drug-eluting stents (DES) improved on the principle of BMS by also delivering drugs locally to inhibit neointimal hyperplasia. DES greatly reduced the incidence of restenosis and resulted in a better safety profile as compared to radiation or systemic drug administration. These advantages and a lower cost compared to surgical interventions make DES an attractive option to treat coronary artery disease. Currently, five DES are available in the USA: the CYPHER sirolimus-eluting stent from Cordis (approved by FDA on 24 April 2003), the TAXUS Express(2) and Liberté paclitaxel-eluting stents from Boston Scientific (approved by FDA on 4 March 2004 and 10 October 2008, respectively) (hereafter TAXUS Express is referred to as TAXUS), the ENDEAVOR zotarolimus-eluting stent from Medtronic (approved by FDA on 1 February 2008), and the XIENCE V everolimus-eluting stent from Abbott Vascular (approved by FDA on 2 July 2008). Following the approval of CYPHER and TAXUS, the clinical data suggested a potential small increase in the rate of stent thrombosis (ST) in DES compared with BMS after implantation. To determine the differences in ST and other rare events between different stents, some modifications have been made to DES clinical trial design, and postmarket surveillance programs have been included to further evaluate the safety and efficacy of each DES. In this review, we will discuss the key clinical outcomes of DES clinical trials, design and key features of the current coronary stents, and major clinical development programs. Postmarket trials, designed to establish long-term safety around ST and o

Topics: Angioplasty, Balloon, Coronary; Cardiovascular Agents; Clinical Trials as Topic; Coronary Artery Disease; Coronary Restenosis; Drug-Eluting Stents; Everolimus; Evidence-Based Medicine; Humans; Metals; Myocardial Infarction; Prosthesis Design; Risk Assessment; Sirolimus; Stents; Thrombosis; Treatment Outcome

ST-elevation myocardial infarction (STEMI) interventions have significantly reduced mortality and morbidity from acute myocardial infarction. Compulsive management of thrombus is a fundamental requirement of these interventions. A pragmatic thrombus-guided management strategy is reviewed along with additional novel therapeutic adjuncts for STEMI interventions.

Topics: Angioplasty, Balloon, Coronary; Cardiac Catheterization; Cardiovascular Agents; Combined Modality Therapy; Coronary Thrombosis; Heart-Assist Devices; Hematologic Agents; Humans; Myocardial Infarction; Thrombectomy

Heart disease remains the leading cause of mortality in the United States despite recent reductions in the death rate. Complications of coronary artery disease and its sequelae are the most common mechanism of demise. There have been great advances in the prevention and treatment of acute myocardial infarction, and the literature is replete with articles on attempted localization of so-called vulnerable plaques and vulnerable or high-risk patients to find either that high-risk plaque or that individual before the event. Unfortunately, the search for the so-called vulnerable plaque is hampered by the lack of both natural history studies and proven local or regional therapies for these otherwise asymptomatic plaques. Although emphasis on the vulnerable or high-risk patient is appropriate, identifying these individuals in primary prevention is difficult. This article highlights insights into the pathophysiology of vulnerable plaque and presents a perspective on current treatments, improved risk stratification, and potential technologic advances that might affect future diagnosis and management.

Topics: Atherosclerosis; Cardiovascular Agents; Coronary Angiography; Coronary Artery Disease; Disease Progression; Drug Therapy, Combination; Female; Humans; Male; Myocardial Infarction; Prognosis; Risk Assessment; Severity of Illness Index; Survival Rate

To assess the safety and efficacy of the XIENCE V everolimus-eluting stent (EES) compared to the TAXUS paclitaxel-eluting stent (PES) in women at two years.. In this pooled analysis, a cohort of 395 women and 906 men was studied by using patient level and lesion level clinical data from SPIRIT II and SPIRIT III studies. Women enrolled in these two studies had higher demographic and lesion risk characteristics than their male counterparts. In-stent and in-segment late loss (LL) was significantly less in the women in the EES group compared to the women in the PES group (in-stent 0.15+/-0.44 mm vs. 0.45+/-0.51 mm; P<0.01, in-segment 0.09+/-0.46 mm vs. 0.29+/-0.40 mm; P<0.01). In women, EES compared to PES resulted in significant reductions in major adverse cardiac events (MACE) (8.5% vs 16.4%; p=0.02) and in target vessel failure (TVF) (11.2% vs 19.5%; p=0.02) at two years. In men, a significant difference was seen in in-stent LL and in-stent % diameter stenosis (DS) favouring EES (in-stent LL 0.14+/-0.33 mm vs. 0.28+/-0.47 mm; P<0.01, in-stent %DS 9.28+/-13.86 vs. 13.64+/-18.31; P<0.01). MACE rates at two years were lower in males treated with EES compared to PES (6.7% vs. 10.9%; p=0.03). The interaction between gender and stent type was not found to be significant for MACE at two years.. In this pooled analysis of two randomised trials, at two years, EES compared to PES resulted in reduced angiographic LL, fewer MACE and TVF events in women and reduced angiographic LL and %DS and fewer MACE events in men.

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Angiography; Coronary Restenosis; Coronary Stenosis; Drug-Eluting Stents; Everolimus; Female; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Multicenter Studies as Topic; Myocardial Infarction; Paclitaxel; Prosthesis Design; Randomized Controlled Trials as Topic; Retrospective Studies; Risk Assessment; Risk Factors; Sex Factors; Single-Blind Method; Sirolimus; Thrombosis; Time Factors; Treatment Outcome

The role of drug-eluting stent (DES) remains an unsettled issue in patients with ST-segment elevation myocardial infarction (STEMI). Therefore, we performed a meta-analysis of randomised trials to evaluate the clinical outcome of DES as compared with bare-metal stent (BMS) after percutaneous coronary intervention (PCI).. We undertook a literature search until July 2009. Thirteen clinical trials met inclusion criteria, with 7,244 patients enrolled. Up to 1-year, patients treated with DES as compared with BMS experienced less target-vessel revascularisation (TVR) (5.11% versus 11.19% respectively, p<0.00001) and recurrent myocardial infarction rates (3.03% versus 3.70% respectively, p=0.02). In addition, no significant differences were found in terms of cardiac death (2.80% versus 3.52%, p=0.21) and stent thrombosis (2.65% versus 2.76%, p=0.37). Using the adjusted indirect comparison, a significant difference between sirolimus- and paclitaxel-eluting stent was found when TVR was evaluated (OR [95% CI] =0.59 [0.40-0.89], p=0.01), without differences in other clinical outcomes.. In patients undergoing PCI for STEMI, treatment with DES is associated with decreased TVR and myocardial infarction rates, without increasing cardiac death or stent thrombosis occurrence. Sirolimus-eluting stent is associated with a greater TVR reduction as compared to paclitaxel-eluting stent.

Topics: Angioplasty, Balloon, Coronary; Cardiovascular Agents; Chi-Square Distribution; Drug-Eluting Stents; Evidence-Based Medicine; Humans; Least-Squares Analysis; Metals; Middle Aged; Myocardial Infarction; Odds Ratio; Paclitaxel; Prosthesis Design; Randomized Controlled Trials as Topic; Recurrence; Risk Assessment; Risk Factors; Sirolimus; Stents; Thrombosis; Time Factors; Treatment Outcome

Carotid endarterectomy (CEA) has been repeatedly described as a safe and efficacious procedure to provide a stroke-risk reduction benefit in both symptomatic and asymptomatic cases. Contemporary outcomes are acceptable using the large-scale randomized trials as a metric of success. Class I and II data can be applied to improve the care process of patients undergoing CEA. Myocardial infarction remains the most significant nonstroke complication; however, there is no significant benefit to noninvasive stress testing in patients with clinically stable disease. Perioperative beta-blockade may offer up to a 10-fold reduction in the rate of perioperative myocardial infarction, but deleterious effects are attributable to high-dose regimens. Angiotensin blockade has been shown to reduce cardiovascular mortality in patients with atherosclerosis by up to 25%, although few studies have examined these agents directly in carotid surgery patients. Statins are beneficial to patients undergoing CEA with trials demonstrating up to a 3% absolute reduction in the incidence of stroke following CEA. Aspirin therapy is associated with an up to 7% absolute reduction in early stroke following CEA; however, the efficacy of combination or high-dose antiplatelet therapy remains ill-defined. A treatment strategy that involves perioperative medical optimization is likely to improve surgical outcomes and long-term cardiovascular risk for patients undergoing CEA.

Topics: Adrenergic beta-Antagonists; Angiotensin-Converting Enzyme Inhibitors; Cardiovascular Agents; Carotid Artery Diseases; Endarterectomy, Carotid; Evidence-Based Medicine; Humans; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Myocardial Infarction; Perioperative Care; Platelet Aggregation Inhibitors; Risk Assessment; Risk Factors; Stroke; Time Factors; Treatment Outcome

Ischaemic postconditioning (brief periods of ischaemia alternating with brief periods of reflow applied at the onset of reperfusion following sustained ischaemia) effectively reduces myocardial infarct size in all species tested so far, including humans. Ischaemic postconditioning is a simple and safe manoeuvre, but because reperfusion injury is initiated within minutes of reflow, postconditioning must be applied at the onset of reperfusion. The mechanisms of protection by postconditioning include: formation and release of several autacoids and cytokines; maintained acidosis during early reperfusion; activation of protein kinases; preservation of mitochondrial function, most strikingly the attenuation of opening of the mitochondrial permeability transition pore (MPTP). Exogenous recruitment of some of the identified signalling steps can induce cardioprotection when applied at the time of reperfusion in animal experiments, but more recently cardioprotection was also observed in a proof-of-concept clinical trial. Indeed, studies in patients with an acute myocardial infarction showed a reduction of infarct size and improved left ventricular function when they underwent ischaemic postconditioning or pharmacological inhibition of MPTP opening during interventional reperfusion. Further animal studies and large-scale human studies are needed to determine whether patients with different co-morbidities and co-medications respond equally to protection by postconditioning. Also, our understanding of the underlying mechanisms must be improved to develop new therapeutic strategies to be applied at reperfusion with the ultimate aim of limiting the burden of ischaemic heart disease and potentially providing protection for other organs at risk of reperfusion injury, such as brain and kidney.

Topics: Algorithms; Animals; Cardiology; Cardiovascular Agents; Europe; Evidence-Based Medicine; Humans; Ischemic Preconditioning, Myocardial; Myocardial Infarction; Myocardial Reperfusion Injury; Myocardium; Risk Assessment; Risk Factors; Signal Transduction; Societies, Medical; Treatment Outcome

Although most medicines have historically been small molecules, many newly approved drugs are derived from proteins. Protein therapies have been developed for treatment of diseases in almost every organ system, including the heart. Great excitement has now arisen in the field of regenerative medicine, particularly for cardiac regeneration after myocardial infarction. Every year, millions of people suffer from acute myocardial infarction, but the adult mammalian myocardium has limited regeneration potential. Regeneration of the heart after myocardium infarction is therefore an exciting target for protein therapeutics. In this review, we discuss different classes of proteins that have therapeutic potential to regenerate the heart after myocardial infarction. Protein candidates have been described that induce angiogenesis, including fibroblast growth factors and vascular endothelial growth factors, although thus far clinical development has been disappointing. Chemotactic factors that attract stem cells, e.g., hepatocyte growth factor and stromal cell-derived factor-1, may also be useful. Finally, neuregulins and periostin are proteins that induce cell-cycle reentry of cardiomyocytes, and growth factors like IGF-1 can induce growth and differentiation of stem cells. As our knowledge of the biology of regenerative processes and the role of specific proteins in these processes increases, the use of proteins as regenerative drugs could develop as a cardiac therapy.

Topics: Angiogenic Proteins; Animals; Cardiovascular Agents; Cell Differentiation; Cell Movement; Cell Proliferation; Humans; Myocardial Infarction; Myocardium; Neovascularization, Physiologic; Proteins; Regeneration; Regenerative Medicine; Stem Cells; Translational Research, Biomedical

Topics: Arrhythmias, Cardiac; Cardiovascular Agents; Clinical Trials as Topic; Dietary Supplements; Evidence-Based Medicine; Fatty Acids, Omega-3; Humans; Myocardial Infarction; Treatment Outcome

Treatment of diabetic patients with multivessel coronary artery disease is controversial. This paper reviews pertinent literature on surgical revascularization with emphasis on which patients benefit from therapy. Recent studies of medical, percutaneous, and surgical therapies have added greatly to our understanding of the treatment of diabetic patients with coronary artery disease. Randomized trials show no advantage with prophylactic percutaneous coronary intervention over medical therapy. However, in patients with more severe three-vessel disease, coronary artery bypass graft surgery (CABG) improved outcomes with respect to reduced myocardial infarction events and cardiac death as compared with medical therapy. In addition, rates of late myocardial infarction and mortality were significantly lower in patients treated with CABG compared with those who received drug-eluting stents. Although the need for subsequent revascularization with drug-eluting stents is reduced compared with angioplasty and bare-metal stents, the rate is still higher than that associated with CABG. CABG reduces risks of myocardial infarction, cardiac death, and need for repeat revascularization in diabetic patients with severe, multivessel coronary artery disease.

Topics: Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Artery Bypass; Coronary Artery Disease; Diabetes Mellitus, Type 2; Drug-Eluting Stents; Humans; Myocardial Infarction; Randomized Controlled Trials as Topic; Risk Assessment; Severity of Illness Index; Treatment Outcome

Primary percutaneous coronary intervention (PCI) decreases myocardial damage and reduces the occurrence of mechanical complications and acute heart failure in patients with ST elevation myocardial infarction (STEMI). Nevertheless, left ventricular (LV) dysfunction remains the leading cause of in-hospital mortality in all subsets of patients and particularly for those in whom primary PCI fails to reopen the infarct-related artery. The clinical scenarios of acute LV failure are heart failure and cardiogenic shock, both conditions being associated with extremely poor outcomes. It has been estimated that LV failure accounts for >75% of the cases of shock complicating acute STEMI. As compared to similar situations, the decision-making process in these patients can potentially benefit from the known coronary anatomy and, in many instances, from the immediate implantation of an intraaortic balloon pump at the time of PCI in selected groups of patients. A thorough clinical and instrumental evaluation is mandatory to discriminate patients who will likely recover (either spontaneously or with further conventional procedures) from those who have irreversible myocardial injury and should be screened for LV assist devices and/or emergent heart transplantation. In this review, we provide a practical diagnostic and therapeutic algorithm that may be helpful for the clinical management of patients with acute LV failure after primary PCI.

Topics: Acute Disease; Algorithms; Angioplasty, Balloon, Coronary; Cardiac Surgical Procedures; Cardiovascular Agents; Heart Failure; Heart Transplantation; Heart-Assist Devices; Humans; Intra-Aortic Balloon Pumping; Myocardial Infarction; Prognosis; Time Factors; Ventricular Dysfunction, Left

Left ventricular (LV) remodelling remains an important treatment target in patients after myocardial infarction (MI) and chronic heart failure (CHF). Accumulating evidence has supported the concept that beneficial effects of current pharmacological treatment strategies to improve the prognosis in these patients, such as angiotensin-converting enzyme (ACE) inhibition, angiotensin type 1 receptor blocker therapy, and beta-blocker therapy, are related, at least in part, to their effects on LV remodelling and dysfunction. However, despite modern reperfusion therapy after MI and optimized treatment of patients with CHF, LV remodelling is observed in a substantial proportion of patients and is associated with an adverse clinical outcome. These observations call for novel therapeutic strategies to prevent or even reverse cardiac remodelling. Recent insights from experimental studies have provided new targets for interventions to prevent or reverse LV remodelling, i.e. reduced endothelial nitric oxide (NO) synthase-derived NO availability, activation of cardiac and leukocyte-dependent oxidant stress pathways, inflammatory pathway activation, matrix-metalloproteinase activation, or stem cell transfer and delivery of novel paracrine factors. An important challenge in translating these observations from preclinical studies into clinical treatment strategies relates to the fact that clinical studies are designed on top of established pharmacological therapy, whereas most experimental studies have tested novel interventions without concomitant drug regimens such as ACE inhibitors or beta-blockers. Therefore, animal studies may overestimate the effect of potential novel treatment strategies on LV remodelling and dysfunction, since established pharmacological therapies may act, in part, via identical or similar signalling pathways. Nevertheless, preclinical studies provide essential information for identifying potential novel targets, and their potential drawbacks, and are required for developing novel clinical treatment strategies to prevent or reverse LV remodelling and dysfunction.

Topics: Adrenergic beta-Antagonists; Angiogenesis Inducing Agents; Angiotensin II Type 1 Receptor Blockers; Angiotensin-Converting Enzyme Inhibitors; Animals; Anti-Inflammatory Agents; Antioxidants; Cardiovascular Agents; Cyclic GMP; Drugs, Investigational; Heart Failure; Humans; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Matrix Metalloproteinase Inhibitors; Mineralocorticoid Receptor Antagonists; Myocardial Infarction; Nitric Oxide; Protease Inhibitors; Signal Transduction; Stem Cell Transplantation; Treatment Outcome; Ventricular Remodeling

Coronary heart disease (CHD) is the leading cause of death world-wide. Its major pathophysiological manifestation is acute myocardial ischaemia-reperfusion injury. Innovative treatment strategies for protecting the myocardium against the detrimental effects of this form of injury are required in order to improve clinical outcomes in patients with CHD. In this regard, harnessing the endogenous protection elicited by the heart's ability to 'condition' itself, has recently emerged as a powerful new strategy for limiting myocardial injury, preserving left ventricular systolic function and potentially improving morbidity and mortality in patients with CHD. 'Conditioning' the heart to tolerate the effects of acute ischaemia-reperfusion injury can be initiated through the application of several different mechanical and pharmacological strategies. Inducing brief non-lethal episodes of ischaemia and reperfusion to the heart either prior to, during, or even after an episode of sustained lethal myocardial ischaemia has the capacity to dramatically reduce myocardial injury--a phenomenon termed ischaemic preconditioning (IPC), preconditioning or postconditioning, respectively. Intriguingly, similar levels of cardioprotection can be achieved by applying the brief episodes of non-lethal ischaemia and reperfusion to an organ or tissue remote from the heart, thereby obviating the need to 'condition' the heart directly. This phenomenon has been termed remote ischaemic 'conditioning', and it can offer widespread systemic protection to other organs which are susceptible to acute ischaemia-reperfusion injury such as the brain, liver, intestine or kidney. Furthermore, the identification of the signalling pathways which underlie the effects of 'conditioning', has provided novel targets for pharmacological agents allowing one to recapitulate the benefits of these cardioprotective phenomena--so-termed pharmacological preconditioning and postconditioning. Initial clinical studies, reporting beneficial effects of 'conditioning' the heart to tolerate acute ischaemia-reperfusion injury, have been encouraging. Larger multi-centred randomised studies are now required to determine whether these 'conditioning' strategies are able to impact on clinical outcomes. In this article, we provide an overview of 'conditioning' in all its various forms, describe the underlying mechanisms and review the recent clinical application of this emerging cardioprotective strategy.

Topics: Animals; Cardiac Surgical Procedures; Cardiovascular Agents; Humans; Ischemic Preconditioning, Myocardial; Myocardial Infarction; Myocardial Reperfusion Injury; Signal Transduction; Treatment Outcome; Ventricular Function, Left

Not only the prevalence, but also the mortality due to ischaemic cardiovascular disease is higher in older than in young humans, and the demographic shift towards an ageing population will further increase the prevalence of age-related cardiovascular disease. In order to develop strategies aimed to limit reversible and irreversible myocardial damage in older patients, there is a need to better understand age-induced alterations in protein expression and cell signalling. Cardioprotective phenomena such as ischaemic and pharmacological pre and postconditioning attenuate ischaemia/reperfusion injury in young hearts. Whether or not pre and postconditioning are still effective in aged organs, animals, or patients, i.e. under conditions where such cardioprotection is most relevant, is still a matter of debate; most studies suggest a loss of protection in aged hearts. The present review discusses changes in protein expression and cell signalling important to ischaemia/reperfusion injury with myocardial ageing. The efficacy of cardioprotective manoeuvres, e.g. ischaemic pre and postconditioning in aged organs and animals will be discussed, and the development of strategies aimed to antagonize the age-induced loss of protection will be addressed.

Topics: Age Factors; Aging; Animals; Cardiovascular Agents; Cytoprotection; Humans; Ischemic Preconditioning, Myocardial; Mitochondria, Heart; Myocardial Infarction; Myocardial Ischemia; Myocardial Reperfusion Injury; Myocardium; Signal Transduction; Treatment Outcome

Several physiological and pathophysiological stimuli or drugs modulate endothelial progenitor cell (EPC) mobilization. Moreover, levels of circulating EPCs predict cardiovascular risk and left ventricular remodelling after myocardial infarction. Nevertheless, our understanding in this field is complicated by lack of an unequivocal definition of EPCs, thus limiting their clinical applications. This review summarizes current knowledge and uncertainties on EPC characterization and mobilization in the attempt to define their role in the management of cardiovascular diseases.

Topics: Bone Marrow Cells; Cardiovascular Agents; Cells, Cultured; Cytokines; Endothelial Cells; Endothelium, Vascular; Humans; Myocardial Infarction; Stem Cells; Ventricular Remodeling

It is controversial as to whether nicorandil would have cardioprotective effects in patients with acute myocardial infarction (AMI) who are undergoing reperfusion therapy. A meta-analysis was performed to study the impacts of nicorandil on functional outcomes after AMI.. Randomized prospective cohort or retrospective cohort publications were identified up to October 2007 by means of a computer search of MEDLINE and Google Scholar databases. Two reviewers checked the quality of the studies and extracted data regarding patient and disease characteristics, study design, functional parameters such as Thrombolysis In Myocardial Infarction (TIMI) flow grade after reperfusion, left ventricular ejection fraction (LVEF) and left ventricular end-diastolic volume index (LVEDVI). Seventeen studies were included for the meta-analysis in this study. Nicorandil treatment reduced the incidence of TIMI flow grade < or =2 in 1,337 patients of 10 studies (risk ratio 0.63; 95% confidence interval (CI) 0.44 to 0.91). While no beneficial effect was observed on the peak creatine kinase value, nicorandil treatment was associated with greater LVEF (by 3.7%, 95%CI 1.8 to 5.7%), and lower LVEDVI (by 8.8 ml/kg, -14.4 to -3.3 ml/kg) in 905 patients of 11 studies.. The meta-analysis demonstrated that nicorandil treatment adjunctive to reperfusion therapy has beneficial effects on microvascular function and on functional recovery after AMI.

Topics: Aged; Cardiovascular Agents; Combined Modality Therapy; Coronary Circulation; Female; Humans; Male; Microcirculation; Middle Aged; Myocardial Infarction; Myocardial Reperfusion; Nicorandil; No-Reflow Phenomenon; Publication Bias; Recovery of Function; Stroke Volume; Treatment Outcome; Ventricular Function, Left

Reperfusion injury may cause myocardial cell death and limit the benefit achieved by restoration of coronary artery patency in patients with acute myocardial infarction. The mechanism includes altered Ca(2+) handling with cytosolic and mitochondrial Ca(2+) overload, Ca(2+)- and ATP-dependent hypercontraction, cytoskeletal fragility, mitochondrial permeability transition and gap junction-mediated propagation of cell death, as well as alterations in non-cardiomyocyte cells, in particular platelets and endothelial cells. cGMP modulates favorably all these mechanism, mainly through PKG-mediated actions, but cGMP synthesis is altered in reperfused cardiomyocytes and endothelial cells by mechanisms that are only partially understood. Stimulation of cGMP synthesis during initial reperfusion by means of natriuretic peptides has been found protective in different animal models and in patients. Moreover, increasing evidence indicates that cGMP is an important step in signal transduction of endogenous cardioprotection. Thus, the cGMP pathway appears as a key element in the pathophysiology of myocardial ischaemia-reperfusion and as a promising therapeutic target in patients with acute myocardial infarction.

Topics: Angioplasty, Balloon, Coronary; Animals; Cardiovascular Agents; Cyclic GMP; Cyclic GMP-Dependent Protein Kinases; Humans; Myocardial Infarction; Myocardial Reperfusion Injury; Myocardium; Necrosis; Second Messenger Systems; Time Factors

Cardiomyocyte death secondary to transient ischaemia occurs mainly during the first minutes of reperfusion in the form of contraction band necrosis. Research on the mechanisms leading to sarcolemmal rupture and necrosis during initial reperfusion identified several promising pharmacological targets directed either to correct the alterations in Ca(2+) handling occurring during this period (Na(+)/H(+)-exchanger, reverse mode of Na(+)/Ca(2+)-exchanger, sarcoplasmic reticulum) or to interfere with its consequences [hypercontracture, calpain activation, and mitochondrial permeability transition pore (mPTP) opening]. However, despite the fact that pharmacological tools against some of these targets have consistently demonstrated that it is possible to reduce infarct size in experimental studies by interventions applied at the time of reperfusion, the translation of these approaches to clinical practice has failed due in part to the lack of drugs able to be tested in humans. Recently, the benefits of both post-conditioning and inhibition of mPTP have been supported by proof-of-concept trials demonstrating the clinical applicability of strategies aimed at preventing lethal reperfusion injury. These promising results should stimulate efforts to develop drugs testable in humans against known, unexploited targets involved in reperfusion injury and to identify and validate additional ones.

Topics: Animals; Apoptosis; Calcium; Calcium Signaling; Cardiovascular Agents; Cytoprotection; Gap Junctions; Humans; Myocardial Infarction; Myocardial Reperfusion; Myocardial Reperfusion Injury; Myocardium; Necrosis; Time Factors; Treatment Outcome

Ventricular remodeling after myocardial infarction is defined as progressive chamber dilation and wall thinning, which leads to functional compromise. Remodeling is mediated by active processes of inflammation, fibrosis, and cardiomyocyte dropout over the weeks and months after infarction, and, therefore, provides a large temporal therapeutic window. In experimental models, interruption of molecular and physiological pathways that contribute to cardiomyocyte loss, and the resulting unfavorable ventricular geometry, can abrogate remodeling and prevent or improve heart failure. Remodeling is multifactorial and involves several parallel cellular pathways, which means many potential therapeutic targets exist. Of late, much attention has been given to the development of cell-based therapies; however, the abundant, promising pharmacotherapeutic developments should not be overlooked. This Review examines developments in pharmacological treatment of ventricular remodeling in preclinical models of myocardial infarction-specifically, disruption of the renin-angiotensin-aldosterone system through direct renin inhibition and blockade of aldosterone synthesis and/or uptake, enhancement of endothelial nitric oxide synthase synthesis, G-protein receptor kinase inhibition, administration of erythropoietin, and interruption of apoptosis-and highlights the challenge of translating these successes to treatment of human disease. Therapeutic targeting of multiple organ systems involved in recovery after myocardial infarction might prove to be the best approach to improve patients' cardiac outcome.

Topics: Animals; Apoptosis; Cardiovascular Agents; Disease Models, Animal; Drugs, Investigational; Erythropoiesis; Humans; Myocardial Infarction; Myocardium; Nitric Oxide Synthase Type III; Receptors, Adrenergic, beta; Recovery of Function; Renin-Angiotensin System; Signal Transduction; Treatment Outcome; Ventricular Remodeling

To evaluate outcome of patients undergoing sirolimus-eluting stent (SES) as compared to bare-metal stent (BMS) implantation during primary angioplasty for ST-segment elevation myocardial infarction (STEMI).. The role of SES in primary percutaneous coronary intervention setting is still debated.. We searched Medline, EMBASE, CENTRAL, scientific session abstracts, and relevant Websites for studies in any language, from the inception of each database until October 2008. Only randomized clinical trials with a mean follow-up period >6 months and sample size >100 patients were included. Primary endpoint for efficacy was target-vessel revascularization (TVR) and primary endpoint for safety was stent thrombosis. Secondary endpoints were cardiac death and recurrent myocardial infarction (MI).. Six trials were included in the meta-analysis, including 2,381 patients (1,192 randomized to SES and 1,189 to BMS). Up to 12-month follow-up, TVR was significantly lower in patients treated with SES as compared to patients treated with BMS (4.53% vs. 12.53%, respectively; odds ratio [OR] 0.33; 95% confidence interval [CI] 0.24-0.46; P < 0.00001). There were no significant differences in the incidence of stent thrombosis (3.02% vs. 3.70%, OR = 0.81 [95% CI, 0.52-1.27], P = 0.81), cardiac death (2.77% vs. 3.28%, OR = 0.84 [95% CI, 0.52-1.35], P = 0.47), and recurrent MI (2.94% vs. 4.04%, OR = 0.71 [95% CI, 0.45-1.11], P = 0.13) between the two groups.. SES significantly reduces TVR rates as compared to BMS in STEMI patients up to 1 year follow-up. Further studies with larger population and longer follow-up time are needed to confirm our findings.

Topics: Angioplasty, Balloon, Coronary; Cardiovascular Agents; Drug-Eluting Stents; Evidence-Based Medicine; Humans; Metals; Myocardial Infarction; Odds Ratio; Platelet Aggregation Inhibitors; Prosthesis Design; Randomized Controlled Trials as Topic; Recurrence; Risk Assessment; Risk Factors; Sirolimus; Stents; Thrombosis; Time Factors; Treatment Outcome

Infarct size can be limited by reducing the determinants of infarct size or increasing collateral blood flow by treatment initiated before the ischaemic event. Reperfusion is the definitive treatment for permanently reducing infarct size and restoring some degree of contractile function to the affected myocardium. Innate survival mechanisms in the heart can be stimulated by short, non-lethal periods of ischaemia and reperfusion, applied either before or after the ischaemic event. Preconditioning, a series of transient intervals of ischaemia and reperfusion applied before the lethal 'index' ischaemic event, sets in motion molecular and cellular mechanisms that increase cardiomyocyte survival to a degree that had not hitherto been seen before. The cardioprotective ischaemic-reperfusion protocol applied at onset of reperfusion, termed 'postconditioning' (Postcon), is also associated with significant cardioprotection that can be applied at the point of reperfusion treatment in the catheterization laboratory or operating room. Both preconditioning and Postcon have been successfully applied to the clinical setting and have been found to reduce infarct size and other attributes of post-ischaemic injury. This review will summarize the physiological preclinical data on preconditioning and Postcon that are relevant to their translation to clinical therapeutics and treatment.

Topics: Animals; Cardiovascular Agents; Cell Survival; Humans; Ischemic Preconditioning, Myocardial; Myocardial Infarction; Myocardial Ischemia; Myocardial Reperfusion Injury; Myocardium; Treatment Outcome

Coronary stent thrombosis is a serious problem in the drug-eluting stent era. Despite aggressive antiplatelet therapy during and after percutaneous coronary intervention (PCI), the incidence of sub-acute stent thrombosis remains approximately 0.5%-2%, which may represent a catastrophic clinical situation. Both procedural factors and discontinuation of antiplatelet therapy are normally associated with this event. We report on simultaneous stent thromboses of two drug-eluting stents implanted in two different vessels, which resulted in a life-threatening clinical condition. Possible contributing factors that led to synergistic thrombotic effects are discussed.

Topics: Angioplasty, Balloon, Coronary; Aspirin; Cardiovascular Agents; Clopidogrel; Coronary Angiography; Coronary Stenosis; Coronary Thrombosis; Diabetes Mellitus, Type 2; Drug-Eluting Stents; Female; Humans; Medication Adherence; Middle Aged; Myocardial Infarction; Platelet Aggregation Inhibitors; Risk Factors; Sirolimus; Ticlopidine; Treatment Outcome

Cocaine is a powerful stimulant that gives users a temporary sense of euphoria, mental alertness, talkativeness, and a decreased need for food and sleep. Cocaine intoxication is the most frequent cause of drug-related death reported by medical examiners in the US, and these events are most often related to the cardiovascular manifestations of the drug. Once playing a vital role in medicine as a local anesthetic, decades of research have established that cocaine has the ability to cause irreversible structural damage to the heart, greatly accelerate cardiovascular disease, and initiate sudden cardiac death. Although pathologic findings are often reported in the literature, few images are available to support these findings, and reviews of cocaine cardiopathology are rare. We describe the major pathologic findings linked to cocaine abuse in earlier research, their underlying mechanisms, and the treatment approaches currently being used in this patient population. A MEDLINE search was conducted to identify all English language articles from January 2000 to June 2008 with the subject headings and key words 'cocaine', 'heart', 'toxicity', and 'cardiotoxicity'. Epidemiologic, laboratory, and clinical studies on the pathology, pathophysiology, and pharmacology of the effects of cocaine on the heart were reviewed, along with relevant treatment options. Reference lists were used to identify earlier studies on these topics, and related articles from Google Scholar were also included. There is an established connection between cocaine use and myocardial infarction (MI), arrhythmia, heart failure, and sudden cardiac death. Numerous mechanisms have been postulated to explain how cocaine contributes to these conditions. Among these, cocaine may lead to MI by causing coronary artery vasoconstriction and accelerated atherosclerosis, and by initiating thrombus formation. Cocaine has also been shown to block K+ channels, increase L-type Ca2+ channel current, and inhibit Na+ influx during depolarization, all possible causes for arrhythmia. Additionally, cocaine use has been associated with left ventricular hypertrophy, myocarditis, and dilated cardiomyopathy, which can lead to heart failure if drug use is continued. Certain diagnostic tools, including ECG and serial cardiac markers, are not as accurate in identifying MI in cocaine users experiencing chest pain. As a result, clinicians should be suspicious of cocaine use in their differential diagnosis of chest pain, especia

Topics: Arrhythmias, Cardiac; Cardiovascular Agents; Cardiovascular Diseases; Clinical Trials as Topic; Cocaine; Death, Sudden, Cardiac; Heart; Heart Failure; Humans; Myocardial Infarction; Myocardium; Practice Guidelines as Topic

A growing body of animal studies provides evidence for potential cardioprotective effects of inhibitors of the enzyme phosphodiesterase isoform 5. Infarct size reduction by administration of phosphodiesterase 5 inhibitors was described in various experimental models of ischaemia and reperfusion. Furthermore, potential beneficial effects were demonstrated in experimental models of congestive heart failure and left ventricular hypertrophy. Some of the observed effects resemble the basic mechanisms of ischaemic pre-conditioning, mimicking both acute and delayed effects. Other effects may be due to action on systemic and cardiac haemodynamics. Mechanisms and signalling pathways, characterized in some of the experimental models, appear to be complex: for instance, the rate of cyclic guanosine monophosphate (cGMP) synthesis and the functional compartmentalization of intracellular cGMP metabolism as well as interaction with ss-adrenergic and nitric oxide signalling may influence effects in different experimental settings. In this review, we discuss mechanisms, signalling pathways, and experimental limitations and touch on considerations for translation into potentially useful applications in the clinical arena.

Topics: Animals; Cardiomegaly; Cardiovascular Agents; Cardiovascular Diseases; Cyclic GMP; Cyclic Nucleotide Phosphodiesterases, Type 5; Disease Models, Animal; Heart Failure; Humans; Myocardial Infarction; Myocardial Reperfusion Injury; Myocardium; Phosphodiesterase 5 Inhibitors; Phosphodiesterase Inhibitors; Signal Transduction

Topics: Acute Coronary Syndrome; Aged; Cardiovascular Agents; Humans; Hypertension; Intraoperative Period; Male; Myocardial Infarction; Tachycardia

Topics: Cardiovascular Agents; Clinical Protocols; Combined Modality Therapy; Evidence-Based Medicine; Humans; Myocardial Infarction; Myocardial Reperfusion; Patient Selection; Practice Guidelines as Topic; Quality Assurance, Health Care; Risk Assessment; Secondary Prevention; Time Factors; Treatment Outcome

Impaired renal function is a risk factor for cardiovascular disease and an adverse prognostic factor in patients with established cardiovascular disease. In addition, with current widespread use of invasive procedures in the treatment of acute myocardial infarction, contrast-induced nephropathy is a growing problem in this patient population. In acute myocardial infarction, impaired renal function may result from underlying kidney disease, acute renal failure, and the effect of drugs and contrast agents used during diagnostic procedures or treatment. These various causes may coexist, resulting in significantly worse outcomes. Prompt recognition of the degree of renal function impairment and institution of appropriate preventive and therapeutic measures are among major goals of in-hospital management of these patients. A commonly used method to evaluate renal function is the determination of glomerular filtration rate. Appropriate nephroprotective treatment should be used in patients at risk of contrast-induced nephropathy. The most commonly used methods include the use of iso-osmotic contrast agents and appropriate hydration in the periprocedural period. Studies are currently under way to evaluate nephroprotective properties of other drugs such as N-acetylcysteine, sodium chloride and sodium bicarbonate solutions, mannitol, and statins. Results of some studies suggest that these measures may effectively reduce the number of renal function deterioration events in patients with acute myocardial infarction. Regardless of the cause, impaired renal function in acute myocardial infarction is a significant adverse prognostic factor. Thus, despite some inconsistent views regarding the optimal management strategy, intensive diagnostic, preventive, and therapeutic measures are clearly necessary in patients with acute myocardial infarction and impaired renal function.

Topics: Acute Disease; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Chronic Disease; Contrast Media; Disease Progression; Glomerular Filtration Rate; Humans; Kidney; Kidney Diseases; Myocardial Infarction; Practice Guidelines as Topic; Renal Insufficiency; Risk Assessment; Risk Factors; Severity of Illness Index; Terminology as Topic; Treatment Outcome

Long-chain omega-3 polyunsaturated fatty acid (PUFA) supplementation has been used for the secondary prevention of fatal and nonfatal myocardial infarction (MI). However, the benefit of this therapy is frequently confused with other established treatments in the therapeutic strategy among such patients. We review the data on omega-3 PUFA use in secondary care and consider indications for its use which include post-MI and raised triglycerides. We suggest that the available evidence supports the use of omega-3 supplementation as part of the comprehensive secondary care package for post-MI patients.

Topics: Anti-Arrhythmia Agents; Biomarkers; Cardiovascular Agents; Drug Therapy, Combination; Evidence-Based Medicine; Fatty Acids, Omega-3; Fibrinolytic Agents; Humans; Hypolipidemic Agents; Myocardial Infarction; Secondary Prevention; Treatment Outcome; Triglycerides

Topics: Aged; Cardiovascular Agents; Female; Humans; Intraoperative Complications; Lung Neoplasms; Myocardial Infarction; Preoperative Care; Risk Assessment

The Clinical Outcomes Utilizing Revascularization and Aggressive Drug Evaluation (COURAGE) trial was designed to determine whether percutaneous coronary intervention (PCI) coupled with optimal medical therapy (OMT) reduced the risk of death or nonfatal myocardial infarction in patients with stable coronary artery disease as compared with OMT alone. COURAGE demonstrated that an initial strategy of PCI added to OMT in these patients relieved angina to a greater extent than an initial strategy of OMT alone for a period of approximately 24 months. The initial strategy of PCI (plus OMT) did not reduce death, myocardial infarction, or other major cardiovascular events compared with OMT alone. The important quality-of-life findings permit physicians to engage in an evidence-based discussion with patients about the expected clinical and health status benefits of initial versus deferred PCI when added to OMT.

Topics: Angina Pectoris; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Clinical Trials as Topic; Combined Modality Therapy; Coronary Artery Disease; Evidence-Based Medicine; Humans; Multicenter Studies as Topic; Myocardial Infarction; Patient Selection; Quality of Life; Risk Assessment; Time Factors; Treatment Outcome

Although advances in percutaneous catheter-based interventions (PCI) for coronary artery disease have been associated with reductions in angiographic as well as clinical restenosis, no consistent reduction in the occurrence of death or nonfatal myocardial infarction (MI) has been observed either between devices (balloon vs bare-metal stent vs drug-eluting stent [DES]) or between device and medically treated patients with chronic stable coronary disease. Objective evidence of myocardial ischemia--irrespective of the methodology used to demonstrate its presence--is qualitatively and quantitatively related to the occurrence of death and/or nonfatal MI. The magnitude of ischemia is directly proportional to the magnitude of revascularization benefit (reduction in death or MI). Revascularization by PCI is more effective in reducing ischemia than medical therapy alone. The evolution of both PCI technology (DES) and adjunctive pharmacology has improved the relative magnitude and durability of PCI benefit compared with medical therapy alone.

Topics: Angina Pectoris; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Clinical Trials as Topic; Combined Modality Therapy; Coronary Artery Disease; Evidence-Based Medicine; Humans; Multicenter Studies as Topic; Myocardial Infarction; Myocardial Ischemia; Patient Selection; Risk Assessment; Time Factors; Treatment Outcome

The spectrum of acute coronary syndrome (ACS) including unstable angina, non-ST-elevation myocardial infarction and ST-elevation myocardial infarction accounts for increasing numbers of deaths among persons age > or = 65 years in the US. This is important given demographic changes involving falling birth rates and increasing life expectancy. Elderly patients are likely to benefit the most from treatment of ACS, even though community practice still demonstrates less use of cardiac medications as an early-invasive approach among this population.

Topics: Acute Coronary Syndrome; Age Factors; Aged; Angina, Unstable; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Evidence-Based Medicine; Health Services for the Aged; Humans; Myocardial Infarction; Patient Selection; Practice Guidelines as Topic; Thrombolytic Therapy; Treatment Outcome

The objective was to analyze completed trials assessing the effect of oral L-arginine supplementation on clinical outcomes of patients with acute myocardial infarction (AMI).. Prior trials suggest that oral L-arginine administration improves endothelial function in patients with stable coronary artery disease (CAD). However, it is still unclear whether oral supplementation of L-arginine has any effect on clinical outcomes in patients with unstable CAD, such as AMI.. We systematically searched PubMed, Cochrane Library, Embase, reviews, and reference lists of relevant articles. The search strategy paired the term "arginine" with the following: "coronary heart disease," "myocardial infarction," "cardiovascular disease," "ischemia," and "trial." We conducted a meta-analysis of randomized, placebo-controlled L-arginine supplementation trials that evaluated clinical outcomes in AMI patients. Two reviewers independently assessed the trials. Differences were resolved by consensus.. Only 2 trials (927 participants) were included. None of the 2 studies showed a significant difference in event rate between the L-arginine and placebo groups. In an overall pooled estimate, there was a 7% reduction in mortality in the L-arginine treatment group (105/459, 22.9%) compared with the control group (111/455, 24.4%), which did not reach statistical significance (risk ratio [RR]: 0.93, 95% confidence interval [CI]: 0.74-1.17; P = 0.54).. Oral L-arginine supplementation has no effect on the clinical outcomes of patients with AMI.

Topics: Administration, Oral; Arginine; Cardiovascular Agents; Double-Blind Method; Humans; Middle Aged; Myocardial Infarction; Prospective Studies; Randomized Controlled Trials as Topic; Treatment Outcome

Billions of dollars are spent annually in the United States in the largely unregulated market of dietary supplements. Many of these supplements are marketed as weight-loss and athletic-performance-enhancement products. The association of various ephedra-containing products with adverse cardiovascular events has led to a ban on the sale of these products by the U.S. Food and Drug Administration. The result has been the emergence of new formulations marketed for weight loss and athletic-performance enhancement that are "ephedra-free" but contain other sympathomimetic substances, the safety of which has not been established. We present the case of a previously healthy 24-year-old man who presented with an ST-segment-elevation myocardial infarction (STEMI) within hours of taking the ephedra-free product Nutrex Lipo-6x. Emergent coronary angiography revealed the presence of extensive, diffuse thrombus in the left anterior descending coronary artery. The patient had no risk factors for coronary artery disease or myocardial infarction; this includes the absence of a hypercoagulable state and the absence of a history of illicit drug use. This case of STEMI--associated as it is with the use of a synephrine-containing product by a person without risk factors for coronary artery disease--is to our knowledge the 1st reported in the literature. We discuss the patient's evaluation and clinical course, and we review the literature with respect to synephrine-containing dietary supplements. On the basis of synephrine's chemical composition and mechanism of action, we propose a direct association between this patient's use of Nutrex Lipo-6x and his STEMI.

Topics: Adrenergic alpha-Agonists; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Angiography; Coronary Thrombosis; Dietary Supplements; Electrocardiography; Humans; Male; Myocardial Infarction; Synephrine; Treatment Outcome; Young Adult

Monoclonal antibodies are antibodies that are identical because they were produced by one type of immune cell, all clones of a single parent cell. This has become an important tool in biochemistry, molecular biology and medicine. The role of complement system in inflammation has been well established. Inflammation is a cornerstone of the post-myocardial infarction. Also, during a heart bypass procedure, the "complement activation" causes an inflammatory response that can lead to side effects such as chest pain, heart attack, stroke, heart failure, or death. One such agent which causes complement inhibition is pexelizumab. Pexelizumab (Alexion Pharmaceuticals), a recombinant humanized single chain monoclonal antibody to C5, blocks the conversion of C5 to C5a and C5b-9. Pexelizumab is an Alexion-engineered monoclonal antibody fragment designed to inhibit complement-mediated tissue damage associated with reperfusion injury and inflammation that occurs during open heart surgery. Recent Phase III trials have evaluated the role of pexelizumab in patients undergoing coronary artery bypass graft surgery and also in the treatment of acute myocardial infarction. In the ischemia/reperfusion setting of cardiopulmonary bypass surgery, pexelizumab appears to reduce cardiac enzyme release and possibly mortality. Pexelizumab can also be used as adjunctive therapy to fibrinolysis and primary percutaneous coronary intervention. If approved, pexelizumab would represent not only the first of a new class of therapeutics called terminal complement inhibitors for the reduction of death and peri-operative myocardial infarction in patients undergoing CABG-CPB surgery but also a new approach to improving outcomes for patients undergoing CABG surgery. Present article also includes relevant patents on the topic.

Topics: Anti-Inflammatory Agents; Antibodies, Monoclonal; Antibodies, Monoclonal, Humanized; Cardiopulmonary Bypass; Cardiovascular Agents; Clinical Trials as Topic; Complement Activation; Coronary Artery Bypass; Humans; Myocardial Infarction; Patents as Topic; Single-Chain Antibodies; Treatment Outcome

Acute myocardial infarction (AMI) during pregnancy or the early post-partum period is rare but has been shown to be associated with poor maternal as well as fetal outcome. Major changes in both diagnosis and treatment of AMI in the nonpregnant patient have lead to improved outcome which may also affect pregnant patients. The purpose of this paper is to review available information related to the pathophysiology and clinical profile and provide recommendations for the diagnosis and management of AMI occuring during pregnancy and the early post-partum period.

Topics: Adolescent; Adult; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Artery Bypass; Female; Humans; Incidence; Maternal Welfare; Myocardial Infarction; Obstetric Labor Complications; Pregnancy; Pregnancy Complications, Cardiovascular; Risk Factors; Thrombolytic Therapy; United States

'Translation' in medicine immediately suggests 'translational research', but there are many other varieties of 'translation'. I have selected 4 translations in the field of vascular neurology in which I have been involved in different respects: (1) the translation of results from men to women, taking the example of aspirin which, in primary prevention, decreases the risk of myocardial infarction in men and the risk of cerebral infarction in women, the reason for this sex difference being so far unknown; (2) the 'inverse translational research', from bedside to bench, taking the example of the disease we have identified--CADASIL--and showing how the study of one patient and his family led to the identification of a gene, Notch3, so far unknown in humans and to the discovery of its key role in the physiology of vascular smooth muscle cells; (3) the translation from individual case reports to multidisciplinary trials taking the example of hemicraniectomy in malignant cerebral infarction and emphasizing the interest in such rare and severe conditions of pooling and reporting the results of randomized clinical trials before the results of individual trials, and (4) the translation from research to practice, emphasizing not the well-known 'evidence to practice gap' but the slippery slope of 'lack of evidence to overpractice', taking the example of patent foramen ovale closure in migraine.

Topics: Aspirin; Awards and Prizes; Biomedical Research; CADASIL; Cardiovascular Agents; Cardiovascular Diseases; Cerebral Infarction; Craniotomy; Evidence-Based Medicine; Female; Foramen Ovale, Patent; Humans; Male; Medical Records; Migraine Disorders; Myocardial Infarction; Neurology; Randomized Controlled Trials as Topic; Receptor, Notch3; Receptors, Notch; Sex Factors; Treatment Outcome

"Metabolic treatment" involves the use of drugs to improve cardiomyocyte function. Trimetazidine is the most investigated drugs in this group. The ESC 2006 guidelines on the management of patients with stable angina mention the efficacy of metabolic treatment in improving physical efficiency and decreasing the recurrence of pain. The available data suggest that combined therapy of trimetazidine and haemodynamic drugs is an effective antianginal treatment that reduces the risk of pain recurrence (in as many as 64% of patients). The most recent studies also suggest that trimetazidine might be effective in patients with acute coronary syndromes, ischemic cardiomyopathy and heart failure. However, while trimetazidine has shown beneficial effects on surrogate endpoints in several small trials its effect on cardiovascular events is uncertain. Further large randomized studies are needed before its effects on cardiovascular events can be evaluated.

Topics: Acute Coronary Syndrome; Angina Pectoris; Cardiovascular Agents; Energy Metabolism; Humans; Myocardial Infarction; Myocardium; Practice Guidelines as Topic; Treatment Outcome; Trimetazidine

Topics: Animals; Cardiovascular Agents; Humans; Myocardial Infarction; Prognosis; Ventricular Remodeling

Trandolapril is a well known angiotensin converting enzyme (ACE) inhibitor with many cardiovascular (CV) indications. The objectives of this article are to review the pharmacokinetics and pharmacodynamics properties of trandolapril and to focus on its clinical relevance in cardiovascular medicine. Various populations have been studied in large clinical trials including patients with congestive heart failure (CHF) after an acute myocardial infarction (AMI), diabetics, patients with hypertension (HTN), stable coronary artery disease (CAD) and prevention of proteinuria. Long-term treatment with trandolapril in patients with reduced left ventricular function soon after AMI significantly reduced the risk of overall mortality, mortality from CV causes, sudden death, and the development of severe CHF. Treatment with trandolapril after AMI complicated by left ventricular dysfunction appears to be of considerable importance in patients with diabetes mellitus by saving lives and substantially reducing the risk of progression to severe CHF as well. Moreover, trandolapril reduces progression to proteinuria in high-risk patients. Some of the advantages of trandolapril over other ACE inhibitors are the wide spectrum of patient populations studied, the well established dosage and its proven trough-to-peak effect ratios permitting a safe once-a-day administration.

Topics: Angiotensin-Converting Enzyme Inhibitors; Cardiovascular Agents; Cardiovascular Diseases; Coronary Artery Disease; Diabetes Complications; Drug Administration Schedule; Heart Failure; Humans; Hypertension; Indoles; Myocardial Infarction; Proteinuria; Treatment Outcome; Ventricular Dysfunction, Left

Stable angina is usually caused by coronary atherosclerosis, and affects up to 16% of men and 10% of women aged 65-74 years in the UK. Risk factors include hypertension, elevated serum cholesterol levels, smoking, physical inactivity, and overweight. People with angina are at increased risk of other cardiovascular events and mortality compared with people without angina. Among people not thought to need coronary artery revascularisation, annual mortality is 1-2% and the annual non-fatal myocardial infarction (MI) rate is 2-3%.. We conducted a systematic review and aimed to answer the following clinical question: What are effects of long-term drug treatment for stable angina? We searched: Medline, Embase, The Cochrane Library, and other important databases up to June 2007 (BMJ Clinical Evidence reviews are updated periodically, please check our website for the most up-to-date version of this review). We included harms alerts from relevant organisations such as the US Food and Drug Administration (FDA) and the UK Medicines and Healthcare products Regulatory Agency (MHRA).. We found nine systematic reviews, RCTs, or observational studies that met our inclusion criteria. We performed a GRADE evaluation of the quality of evidence for interventions.. In this systematic review we present information relating to the long-term effectiveness and safety of the following interventions: beta-blockers, calcium channel blockers, long-acting nitrates, potassium channel openers, combinations of these anti-anginal drug treatments and the use of these anti-anginal drug treatment as an adjunct to existing therapies.

Topics: Adrenergic beta-Antagonists; Angina Pectoris; Calcium Channel Blockers; Cardiovascular Agents; Humans; Incidence; Myocardial Infarction; Prospective Studies; Risk Factors

In the past few years, the dogma that the heart is a terminally differentiated organ has been challenged. Evidence from preclinical investigations emerged that there are cells, even in the heart itself, that may be able to restore impaired cardiac function after myocardial infarction. Although the exact mechanisms by which the infarcted heart can be repaired by stem cells are not yet fully defined, there is a new optimism among cardiologists that this treatment will prove successful in addressing the cause of heart failure after myocardial infarction-myocyte loss. Despite the promising preliminary data of human myocardial stem cell trials, scientists have also focused on the possibility of enhancing the underlying mechanisms of stem cell repair to gain healthier myocardial tissue. Attempts to induce neo-angiogenesis by transfecting stem cells with signaling factors (such as VEGF), to raise the number of endothelial progenitor cells with medical treatments (such as statins), to transfect stem cells with heat shock protein 70 (as a cardioprotective agent against ischemia) and to enhance the healing process after myocardial infarction with the use of various forms of stimulating factors (G-CSF, SCF, GM-CSF) have been made with notable results. In this article, we summarize the evidence from preclinical and clinical myocardial stem cell studies that have addressed the possibility of enhancing the regenerative capacity of cells used after myocardial infarction.

Topics: Animals; Cardiovascular Agents; Gene Transfer Techniques; Heart Failure; Humans; Myocardial Infarction; Point-of-Care Systems; Stem Cell Transplantation; Treatment Outcome

ST-segment elevation myocardial infarction (STEMI) is associated with high morbidity and mortality, but timely reperfusion is known to result in dramatically improved patient outcomes. As many as 40% of patients with STEMI, however, present late after symptom onset, which reduces the likelihood of them receiving reperfusion therapy. The past two decades have been plagued with controversy regarding the relative benefits of reperfusion therapy after 12 h from symptom onset. Despite considerable data supporting late reperfusion and the 'late open-artery hypothesis', recent studies have demonstrated a lack of benefit with late reperfusion. Moreover, advances in the medical management of STEMI have dramatically reduced morbidity and mortality, further challenging the need for more-invasive techniques. Numerous questions have arisen regarding the appropriate management and risk stratification of asymptomatic post-STEMI patients who present late after symptom onset. In light of recent data, we present a Review of late reperfusion in STEMI, specifically highlighting the effects of current medical therapies, risk-stratification techniques, and indications for the use of late reperfusion over medical management.

Topics: Angioplasty, Balloon, Coronary; Biomarkers; Cardiovascular Agents; Cardiovascular Diseases; Exercise Test; Humans; Myocardial Infarction; Myocardial Reperfusion; Myocardium; Patient Selection; Practice Guidelines as Topic; Risk Assessment; Risk Factors; Stents; Stroke Volume; Thrombolytic Therapy; Time Factors; Treatment Outcome; Ventricular Function, Left

Topics: Cardiovascular Agents; Electrocardiography; Female; Humans; Male; Myocardial Infarction; Myocardial Revascularization; Practice Guidelines as Topic; Sensitivity and Specificity; United States

Healing after myocardial infarction (MI) is a well-orchestrated time-dependent process that involves inflammation, tissue repair with extracellular collagen matrix (ECCM) deposition and scar formation, and remodeling of myocardial structure, matrix, vasculature, and function. Rapid early ECCM degradation followed by slow ECCM replacement and maturation during post-MI healing results in a prolonged window of enhanced vulnerability to adverse remodeling. Decreased ECCM results in adverse ventricular remodeling, dysfunction, and rupture. Inflammation, a critical factor in normal healing, if impaired results in adverse remodeling and rupture. Several therapeutic drugs prescribed after MI exert pleiotropic effects that suppress ECCM and inflammation during healing and may have good, bad, or ugly consequences. This article reviews the potential impact of pleiotropic effects of some prototypic cardiac drugs such as renin-angiotensin-aldosterone system (RAAS) inhibitors, statins, and thrombolytics during healing post-ST-segment-elevation MI (STEMI), with special focus on inflammation, ECCM and remodeling, and implications in the elderly.

Topics: Aging; Animals; Cardiovascular Agents; Collagen; Extracellular Matrix; Humans; Inflammation; Myocardial Infarction; Ventricular Remodeling; Wound Healing

The author summarizes the evidences of angina pectoris' optimal treatment. The invasive treatment strategy became a frontrunner in this field as well. During the last years the number of percutaneous interventions became higher than bypass operations in many countries as well as in Hungary. The place of percutaneous interventions and bypass surgery in the treatment of angina pectoris is an important clinical problem. The author summarizes the data of three possible treatment options (medical therapy, percutaneous interventions and bypass surgery) of angina pectoris based on data of randomised trials. The evidences show that the first steps of therapy are - after the diagnosis - the influence of risk factors, life-style changes and optimal medical therapy. The optimal medical therapy consists of statin, aspirin and ACE inhibitor treatment besides antianginal therapy, where the beta blockers are regarded as first drugs of choice. Percutaneous interventions as initial treatment option are not recommended because we have no evidences that this intervention prolongs life and prevents myocardial infarction. If the patient remains symptomatic after medical treatment, it is necessary to perform revascularization. These procedures can improve the functional capacity more than medical treatment alone. The optimal treatment strategy of angina pectoris, based on evidence, is an important medical and economical problem.

Topics: Angina Pectoris; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Angiography; Coronary Artery Bypass; Coronary Stenosis; Evidence-Based Medicine; Exercise Test; Humans; Life Style; Myocardial Infarction; Predictive Value of Tests; Prognosis; Randomized Controlled Trials as Topic; Risk Assessment; Risk Factors

With the spread of invasive cardiology, and with the opening of new home centers today coronarography and the necessary coronary revascularization are accessible for everyone. The indication of invasive investigation of the acute coronary diseases (STEMI, NSTE-ACS) is crystallised by today. At the same time the indication that the invasive strategy of stable coronary disease depends on more factors, this is a complex exercise. This contains the clinical risk stratification (among the analysis of the classic risk factors), and measures the ejection fraction, and the result of the exercise test and the anatomically risk stratification - based on the coronarography. Authors summarised the clinical risk stratification and the indication of the invasive investigation of the stable coronary disease, based on the recent clinical trials and the guidelines.

Topics: Angina Pectoris; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Angiography; Coronary Artery Bypass; Coronary Stenosis; Decision Trees; Evidence-Based Medicine; Humans; International Cooperation; Life Style; Multicenter Studies as Topic; Myocardial Infarction; Randomized Controlled Trials as Topic; Risk Assessment; Risk Factors

Topics: Adolescent; Adult; Algorithms; Angioplasty, Balloon, Coronary; Benzodiazepines; Cardiovascular Agents; Chest Pain; Cocaine; Cocaine-Related Disorders; Combined Modality Therapy; Coronary Circulation; Diagnostic Imaging; Disease Management; Evidence-Based Medicine; Female; Humans; Male; Myocardial Infarction; Platelet Aggregation Inhibitors; Smoking; Sympathomimetics; Thrombophilia; Vasoconstrictor Agents

Late percutaneous coronary intervention (PCI) of a totally occluded infarct-related artery (IRA) in stable patients is currently not recommended based on the lack of clear clinical benefits in randomized controlled trials. We sought to perform a systematic review and meta-analysis of randomized controlled trials comparing PCI with optimal medical therapy in patients with IRA occlusion more than 12 hr after onset of acute myocardial infarction (AMI), focusing on left ventricular function and remodeling.. PubMed, CENTRAL, and mRCT were searched for eligible studies. Studies were included in the analysis if they were randomized controlled trials comparing conservative medical management with PCI performed at least 12 hr after the onset of symptoms of AMI, and data on left ventricular ejection fraction (LVEF) at baseline and follow-up were available. Studies were excluded if randomization occurred less than 12 hr after symptom onset, or if patients were hemodynamically unstable. Change in LVEF was the primary outcome of interest, with changes in left ventricular end-diastolic volume index (LVEDVI) and end-systolic volume index (LVESVI) analyzed as secondary endpoints. We retrieved five studies in which baseline and follow up LVEF data were available enrolling a total of 648 patients: 342 patients randomized to PCI and 306 to medical treatment. There was a statistically significant difference in LVEF changes over time favoring PCI (+3.1%, 95% CI +1.0 to +5.2, P = 0.0004). In addition, there were statistically significant differences changes in both LVEDVI (-5.1 ml in favor of PCI, 95% CI of -9.4 to -0.8, P = 0.020) and LVESVI (-5.3 ml in favor in PCI, 95% CI of -8.3 to -2.4, P = 0.0005).. This meta-analysis suggests that late revascularization of an occluded IRA may improve left ventricular systolic function and remodeling, supporting the "open artery hypothesis." The reason why these changes have not resulted in clinical benefits in large clinical trials is subject to debate.

Topics: Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Occlusion; Female; Humans; Male; Middle Aged; Myocardial Infarction; Patient Selection; Platelet Aggregation Inhibitors; Risk Assessment; Stents; Stroke Volume; Systole; Time Factors; Treatment Outcome; Ventricular Function, Left; Ventricular Remodeling

Cardiovascular disease is one of the major causes of early morbidity and death in the developed world, and is becoming a serious public health concern in many developing countries. Over the last 30 years, in the USA and France, coronary angioplasty has become a standard treatment for stable angina, and this despite the recommendations of Learned Societies concerning the treatment of this condition. Today, 85 % of angioplasty procedures are performed on patients with stable angina. This study presents meta-analyses that compare medical treatment with angioplasty, and examine the impact of these strategies on more specific populations such as the elderly and post-myocardial infarction patients. To our minds, this synthesis seems to be of particular importance as the COURAGE study has rekindled the debate by showing that improvements in medical treatment and way of life reduced mortality and the recurrence of MI at five years, whereas there was no positive impact of an invasive strategy in any of the subgroups. Nevertheless, as a whole, studies on this subject underscore the value of angioplasty in the medium term for symptom relief in the case of ineffective medical treatment, notably during an acute coronary syndrome both in patients under medical treatment and in those who underwent invasive therapy at the initial phase.

Topics: Angioplasty, Balloon, Coronary; Cardiovascular Agents; Clinical Trials as Topic; Coronary Disease; Humans; Meta-Analysis as Topic; Myocardial Infarction; Practice Guidelines as Topic

Bone marrow-derived mononuclear cells differentiate into endothelial cells in adult animals, including humans. These cells, endothelial progenitor cells (EPCs), play central roles in neovascularization in a variety of physiological and pathological processes. EPCs numbers are clinically relevant; in patients with vascular disease, EPC numbers are predictive of hard clinical endpoints and correlate with vascular health in patients without manifest atherosclerosis. EPCs express CXCR4 which allows homing to sites of neovascularization. The homing signal released by the target tissues is SDF-1 which is the ligand for CXCR4. With release of SDF-1 and reversal of the marrow/periphery gradient, EPCs are mobilized to the periphery where they are recruited to SDF-1 expressing tissues. The SDF-1/CXCR4 axis is the final common pathway for EPC mobilization by hypoxia, angiogenic peptides and G-CSF. Expression of SDF-1 in target tissues and CXCR4 in EPCs as well as angiogenic cytokines such as VEGF are regulated by hypoxia inducible factor-1 alpha (HIF-1 alpha). This paper discusses evidence suggesting that depressed HIF-1 alpha-mediated gene programming is the most fundamental of all cardiovascular risk factors and discusses the manipulation of this system with existing drugs such as cobalt or hydralazine. By stabilizing HIF-1 alpha protein, these compounds will enhance EPC mobilization and function, thereby improving cardiovascular health overall. This paper discusses why previous studies with EPC transplantation or mobilization with G-CSF have had negative results and proposes the use of Cobalt and Hydralazine to enhance EPC function to overcome the dysfunctional EPC phenotype that is seen in patients with vascular disease or cardiovascular risk factors.

Topics: Angiogenic Proteins; Animals; Cardiovascular Agents; Cardiovascular Diseases; Cell Hypoxia; Cell Movement; Chemokine CXCL12; Cobalt; Endothelial Cells; Gene Expression; Humans; Hydralazine; Hypoxia-Inducible Factor 1, alpha Subunit; Monocytes; Myocardial Infarction; Neovascularization, Physiologic; Oxygen; Receptors, CXCR4; Risk Factors; Signal Transduction; Stem Cell Transplantation; Stem Cells; Wound Healing

After a stroke or transient ischaemic attack (TIA) there is a high risk of stroke, particularly in the early days and weeks, and of other serious vascular events. Several preventive medical treatments can reduce these risks; starting them as early as possible will maximise the absolute risk reduction, as long as the diagnosis is secure, there is no known or suspected net harm from treatment, and they are acceptable to the patient. Medical treatments with clear evidence of benefit include: lowering blood pressure after all types of stroke or TIA; lowering blood cholesterol with a statin after ischaemic stroke or TIA; antiplatelet treatment after ischaemic stroke or TIA; and warfarin instead of antiplatelet treatment in patients with ischaemic stroke or TIA who have atrial fibrillation and no contraindications to anticoagulation. Lifestyle changes (for example, stopping smoking, reducing excess alcohol intake, adopting a healthy diet) and careful management of diabetes are also important.

Topics: Blood Pressure; Cardiovascular Agents; Cholesterol; Fibrinolytic Agents; Humans; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Ischemic Attack, Transient; Myocardial Infarction; Recurrence; Risk Factors; Stroke; Vascular Diseases

The mortality rate after myocardial infarction fell sharply with the advent of reperfusion methods and the use of efficient antithrombotic and antiischemic drugs. However, new infarcts, heart failure, arrythmias and sudden death remain frequent, especially in the first two years after the initial event. Large clinical studies have defined and validated therapies for secondary prevention, but the recommended measures are not always properly implemented. Patients with and without ST elevation after myocardial infarction share the same pathophysiologic mechanism, namely atherosclerotic plaque rupture or erosion, with different degrees of superimposed thrombosis and distal embolization. Secondary prevention is the same for these two patient categories. Acute coronary syndromes are associated with an increased risk of adverse cardiovascular outcomes (new myocardial ischemia, left ventricular dysfunction or sudden death) and require aggressive secondary prevention. However, risks factors such as smoking, hypertension, obesity, hypercholesterolemia and diabetes frequently persist. In addition, medical practice does not always respect consensus guidelines. Early risk stratification is necessary to detect residual myocardial ischemia in viable myocardium. After the acute phase, the prognosis depends on the degree of left ventricular dysfunction and the extent and severity of residual ischemia. Exercise and ambulatory electrocardiography, stress echocardiography, perfusion scintigraphy using vasodilator stress, magnetic resonance imaging and coronary angiography are all useful for identifying high-risk patients. Secondary prevention should include risk factor management with lifestyle modifications such as weight reduction, a reduction in saturated fats and an increase in monounsaturated fatty acids. Smoking cessation is crucial, and regular physical activity (30 min per day at least 5 days a week) is beneficial. Cardiac rehabilitation has been shown to improve exercise tolerance and cardiovascular outcome.

Topics: Cardiovascular Agents; Humans; Life Style; Myocardial Infarction; Prognosis; Risk Factors; Secondary Prevention

This article addresses issues related to acute myocardial infarction(MI) complicated by heart failure, particularly in elderly patients. Findings have shown that acute MI complicated by congestive heart failure (CHF) is associated with a high mortality, and that women with acute MI are more likely to be older and to develop CHF than men with acute MI. In general, management of CHF-complicating acute MI is similar in older and younger patients. Actions discussed include hemodynamic monitoring; the administration of oxygen; and the use of morphine, diuretics, nitroglycerin,angiotensin-converting enzyme inhibitors, angiotensin II receptor blockers, spironolactone, beta-blockers, calcium channel blockers, magnesium, digoxin, and positive inotropic drugs. The article also discusses measures for treating arrhythmias and for diagnosing mechanical complications.

Topics: Aged; Cardiovascular Agents; Clinical Trials as Topic; Heart Failure; Humans; Myocardial Infarction

The Losartan Intervention For Endpoint reduction in hypertension (LIFE) study is the first, and, so far, the only endpoint trial in patients with hypertension and left ventricular hypertrophy (LVH) to show a divergent therapeutic outcome of one treatment modality over another with equivalent blood pressure control. The purpose of this article is to review post hoc sub-analyses of LIFE study data and other clinical studies that offer some insight into possible treatment-related differences contributing to the superior stroke outcome of losartan versus atenolol beyond blood pressure reduction.. Relevant randomized clinical trials and review articles were identified through a MEDLINE search of English-language articles published between 1990 and 2006 using the search terms losartan, atenolol, LIFE, hypertension, and LVH. Articles describing major clinical studies, new data, or mechanisms pertinent to the LIFE study were selected for review.. Differences in blood pressure or in the distribution of add-on medications were not evident between study groups in the LIFE study. Thus, the observed outcomes benefits favoring losartan may involve other possible mechanisms, including differential effects of losartan and atenolol on LVH regression, left atrial diameter, atrial fibrillation, brain natriuretic peptide, vascular structure, thrombus formation/platelet aggregation, serum uric acid, albuminuria, new-onset diabetes, and lipid metabolism. Alternative explanations for the LIFE study findings have also been put forward, including the choice of atenolol as an appropriate active comparator and differential effects between treatment groups on central pulse pressure. Additional clinical trials are needed to determine if the beneficial effects of losartan seen in LIFE are shared by other inhibitors of the renin-angiotensin system.. Sub-analyses of the LIFE study data suggest that losartan's stroke benefit may arise from a mosaic of mechanisms rather than a single action. Further studies are expected to continue to delineate the mechanisms of differential responses to treatments in LIFE.

Topics: Adrenergic beta-Antagonists; Angiotensin II Type 1 Receptor Blockers; Antihypertensive Agents; Atenolol; Atrial Fibrillation; Atrial Natriuretic Factor; Biomarkers; Blood Pressure; Cardiovascular Agents; Cohort Studies; Drug Utilization; Endothelium, Vascular; Follow-Up Studies; Heart Atria; Humans; Hypertension; Hypertrophy, Left Ventricular; Losartan; Models, Biological; Myocardial Infarction; Natriuretic Peptide, Brain; Peptide Fragments; Platelet Aggregation; Platelet Aggregation Inhibitors; Protein Precursors; Randomized Controlled Trials as Topic; Research Design; Risk; Risk Factors; Stroke; Thrombosis; Treatment Outcome

Postinfarction management of patients must be individualized. The essential prognostic factor is the ejection fraction, measured at one month. The four basic drugs to be used in combination are antithrombotics, beta-blockers, converting enzyme inhibitors and statins. The objective of treatment is to reach the dose regimens used in clinical trials. Cardiovascular rehabilitation and treatment education must be proposed widely to improve control of risk factors, explain the role of each drug prescribed and teach the appropriate use of nitroglycerin and of emergency medical services. Indications for myocardial revascularization depend on the coronary anatomy. Indications for an implantable defibrillator and for cardiac replacement depend on the ejection fraction and on the existence of heart failure uncontrolled by drug treatment.

Topics: Cardiovascular Agents; Cell Transplantation; Defibrillators, Implantable; Heart Transplantation; Humans; Myocardial Infarction; Myocardial Revascularization

Acute coronary syndromes (ACS) present a major health challenge in modern medicine. With new clinical trials being conducted, our knowledge of latest therapies for ACS continually evolves. In this article, we review currently available medical therapies and provide evidence-based rationale for current pharmacologic therapies. Among the antiplatelet therapies, aspirin, clopidogrel, and glycoprotein IIb/IIIa inhibitors demonstrate significant efficacy in reducing morbidity and mortality. Among the anticoagulants, unfractionated heparin and low molecular weight heparin, particularly enoxaparin sodium, remain the hallmarks of therapy against which newer anticoagulants are often compared. Bivalirudin has recently showed significant efficacy in decreasing cardiovascular events and mortality, but with potentially less risk of bleeding than heparin. Results of trials evaluating warfarin remain inconsistent regarding potential benefits. Finally, fondaparinux sodium, recently tested, shows promise as a powerful yet safe anticoagulant. Fibrinolysis is an acceptable modality for reperfusion if facilities equipped for primary percutaneous revascularization are not available. Regarding anti-ischemic therapy, beta-adrenoceptor antagonists and nitrates remain critical in the early management of ACS. Inhibitors of the renin-angiotensin-aldosterone system have also shown significant reductions in the morbidity and mortality of patients presenting with ACS, particularly in patients with left ventricular dysfunction and clinical heart failure, with ACE inhibitors being first-line agents and angiotensin receptor antagonists being a reasonable substitute if ACE inhibitors are not tolerated. Among the lipid-lowering therapies, statins (HMG-CoA reductase inhibitors) have been documented as being the most well tolerated and most efficacious therapies for ACS patients and data exist that they should be administered early in ACS management. Studies evaluating combination therapy (antiplatelet drugs, beta-adrenoceptor antagonists, ACE inhibitors, and lipid-lowering agents) show a clear benefit in mortality in patients with known coronary artery disease. Efforts to improve these key evidence-based medical therapies are numerous and include such programs as the American College of Cardiology's Guidelines Applied in Practice, international patient registries such as the Global Registry of Acute Coronary Events, and studies such as CRUSADE. Finally, patients with diabetes mellitus pose

Topics: Acute Disease; Angina, Unstable; Anticoagulants; Cardiovascular Agents; Diabetes Mellitus, Type 2; Drug Therapy, Combination; Evidence-Based Medicine; Fibrinolytic Agents; Humans; Hypolipidemic Agents; Myocardial Infarction; Platelet Aggregation Inhibitors; Practice Guidelines as Topic

To increase awareness among nurse practitioners (NPs) of the American College of Cardiology (ACC)/American Heart Association (AHA) 2002 guideline update for the diagnosis and treatment of acute coronary syndrome, and for secondary prevention in patients with unstable angina (UA) and non-ST segment elevation myocardial infarction (NSTEMI).. ACC/AHA 2002 guideline update for the management of patients with UA and NSTEMI, ACC/AHA guidelines for patients with coronary and other atherosclerotic vascular disease, 2006 update, selected research and clinical articles.. Recent research has shown that patients with UA/NSTEMI benefit from the routine, long-term use of dual antiplatelet therapy with aspirin and clopidogrel. In suitable patients, outcome is also improved by adoption of an early invasive strategy combined with aggressive medical therapy.. Familiarity with the patient as well as current management recommendations can improve clinical outcomes for patients with UA/NSTEMI. Thus, NPs can play a pivotal role in the management of coronary disease, both during and following an acute ischemic event.

Topics: Aged; Aged, 80 and over; Angina, Unstable; Cardiovascular Agents; Electrocardiography; Female; Humans; Male; Middle Aged; Myocardial Infarction; Nurse Practitioners; Practice Guidelines as Topic; Risk Assessment; Thrombolytic Therapy

Acute coronary syndromes (ACSs), which include the clinical entities of unstable angina (UA), non-ST-segment elevation myocardial infarction (NSTEMI), and ST-segment elevation myocardial infarction (STEMI), account for more than 1.5 million hospital admissions annually in the United States alone. Approximately 1 million of these admissions are classified as UA/NSTEMI and approximately 500,000 are STEMI. Because of the overwhelming number of studies on ACSs over the past several years, this article focuses on new trials and therapies for treating patients diagnosed with STEMI.

Topics: Angioplasty, Balloon, Coronary; Anticoagulants; Cardiovascular Agents; Clinical Trials as Topic; Humans; Hypothermia, Induced; Myocardial Infarction; Oxygen; Platelet Aggregation Inhibitors; Platelet Glycoprotein GPIIb-IIIa Complex; Shock, Cardiogenic; Stents; Thrombectomy; Thrombolytic Therapy

Topics: Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Artery Bypass; Coronary Disease; Coronary Restenosis; Drug Implants; Humans; Myocardial Infarction; Paclitaxel; Randomized Controlled Trials as Topic; Saphenous Vein; Sirolimus; Stents; Treatment Outcome

Topics: Acute Coronary Syndrome; Cardiovascular Agents; Collateral Circulation; Coronary Stenosis; Coronary Vasospasm; Diagnosis, Differential; Electrocardiography; Fibrinolytic Agents; Humans; Myocardial Infarction; Prognosis

Topics: Angioplasty, Balloon, Coronary; Arteriosclerosis; Cardiovascular Agents; Contraindications; Coronary Thrombosis; Coronary Vasospasm; Ergonovine; Female; Humans; Myocardial Infarction; Oxytocics; Pregnancy; Pregnancy Complications, Cardiovascular; Prognosis; Risk Factors

Topics: Angioplasty, Balloon, Coronary; Biomarkers; Cardiovascular Agents; Coronary Artery Bypass; Coronary Artery Disease; Coronary Thrombosis; Creatine Kinase, MB Form; Defibrillators; Diagnostic Imaging; Electrocardiography; Emergencies; Extracorporeal Circulation; Humans; Myocardial Infarction

Topics: Angina Pectoris; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Artery Bypass; Diagnosis, Differential; Echocardiography; Electrocardiography; Humans; Myocardial Infarction; Prognosis

The elderly constitute an increasingly important sector of patients with acute coronary syndromes (ACS), although they have been under-represented in many therapeutic trials. Elderly patients with ACS usually have more complex co-morbidities and worse outcomes than their younger counterparts, and they are less likely to undergo revascularisation or to receive short- and long-term evidence-based medications. The most common ACS in the elderly is non-ST-segment elevation myocardial infarction (STEMI), which is associated with high mortality. For this reason, elderly patients with non-STEMI and unstable angina should be treated invasively early in the course of the episode. In elderly patients with STEMI, primary angioplasty seems to be more effective than fibrinolysis, and in patients aged >85 years a more conservative approach to fibrinolysis is also warranted because of the higher risk for cerebral haemorrhage. Therefore, angioplasty should be preferred when feasible, although more trials are needed before this strategy can definitely be documented as the preferred option. Drug-eluting stents afford greater benefit than bare metal stents in elderly patients and are more cost effective. After fibrinolysis, low-molecular-weight heparin appears to be superior to unfractionated heparin in elderly patients with STEMI but major bleeding and intracranial haemorrhages occur more frequently, especially in women aged >75 years. It is very important to understand that the elderly with ACS constitute a subgroup of atherosclerotic patients for whom decision making must be guided by the patients''physiological age' (determined by their physical condition and other co-morbidities) and not strictly by their 'chronological age'.

Topics: Acute Coronary Syndrome; Aged; Angina Pectoris; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Combined Modality Therapy; Drug-Eluting Stents; Fibrinolytic Agents; Humans; Middle Aged; Myocardial Infarction; Prognosis; Shock, Cardiogenic; Stents

Acute coronary syndrome is a major health problem affecting approximately 1.5 million individuals a year. Early diagnosis and appropriate evidence-based therapies improve clinical outcomes significantly. Current data suggest that an early invasive therapy may improve intermediate-term and long-term outcomes, particularly in high-risk individuals. The last few years also have seen significant advances in antiplatelet and antithrombotic therapies for the management of patients who have acute coronary syndrome.

Topics: Acute Coronary Syndrome; Angina, Unstable; Cardiovascular Agents; Clinical Protocols; Humans; Myocardial Infarction; Myocardial Revascularization; Risk Assessment

More than 1.2 million patients suffer from new or recurrent ischemic events occur annually. This includes an estimated 565,000 cases of first and 300,000 cases of recurrent myocardial infarction (MI). Although mortality from acute MI has declined in recent years, it still remains high at 25% to 30%. Despite its high mortality, prognosis can be improved with timely and effective use of evidence-based treatment in the acute setting. This review outlines the critical care management strategies for ST-segment MI (STEMI).

Topics: Algorithms; Cardiovascular Agents; Critical Care; Heart Conduction System; Humans; Myocardial Infarction; Myocardial Revascularization; Prognosis; Thrombolytic Therapy

Cardiovascular diseases, the clinical paradigm of atherosclerosis, are the primary cause of mortality in developed countries. The origin of the atheromatous lesion is multifactorial, as it is the therapeutic approach to its prevention and clinical complications. The initial symptoms of ischemia in a vascular bed are usually evident when the atherosclerotic process is very advanced, being indicative of a diffuse disease and of an elevated future risk for ischemic events in other vascular territories. We perform this review in this clinical scenario, highlighting the preventive and therapeutic aspects of demonstrated clinical efficacy, with no detail of those treatments with benefit insufficiently proven.

Topics: Angina Pectoris; Anticoagulants; Atherosclerosis; Brain Ischemia; Cardiovascular Agents; Combined Modality Therapy; Heart Failure; Humans; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Myocardial Infarction; Myocardial Ischemia; Peripheral Vascular Diseases; Platelet Aggregation Inhibitors; Risk Factors

Topics: Cardiac Pacing, Artificial; Cardiovascular Agents; Disease Progression; Electric Countershock; Heart Failure; Humans; Myocardial Infarction

Perioperative myocardial infarction (PMI) is a major cause of morbidity and mortality in patients undergoing noncardiac surgery. The incidence of PMI varies depending on the method used for diagnosis and is likely to increase as the population ages. Studies have examined different methods for prevention of myocardial infarction (MI), including the use of perioperative beta-blockers, alpha(2)-agonists, and statin therapy. However, few studies have focused on the treatment of PMI. Current therapy for acute MI generally involves anticoagulation and antiplatelet therapy, raising the potential for surgical site hemorrhage in this population. This article reviews the possible mechanisms, diagnosis, and treatment options for MI in the surgical setting. We also suggest algorithms for treatment.

Topics: Cardiovascular Agents; Diagnosis, Differential; Humans; Incidence; Myocardial Infarction; Perioperative Care; Prognosis; Risk Factors; Surgical Procedures, Operative

Although primary percutaneous coronary intervention has emerged as the preferred reperfusion strategy for patients with ST-segment elevation myocardial infarction (STEMI), it is available only in a minority of US hospitals. The fundamental problem is that there is presently no organized, uniform, national STEMI triage and treatment system that is comparable to the well-developed, highly successful system in the United States that directs major trauma victims to verified trauma centers. This article reviews prehospital and emergency department triage strategies, systems, and pharmacologic interventions for patients with STEMI that can help shorten the time to reperfusion in these patients.

Topics: Adrenergic beta-Antagonists; Angioplasty, Balloon, Coronary; Anticoagulants; Aspirin; Blood Platelets; Cardiovascular Agents; Clopidogrel; Community Health Services; Critical Pathways; Emergency Medical Services; Emergency Service, Hospital; Fibrinolytic Agents; Health Services Accessibility; Heparin; Humans; Myocardial Infarction; Patient Care Team; Platelet Aggregation Inhibitors; Platelet Glycoprotein GPIIb-IIIa Complex; Program Development; Ticlopidine; Time Factors; Treatment Outcome; Triage; United States

Patients with CKD and CAD have traditionally been a difficult population to diagnose and treat in the setting of ACS. In addition to having poorer outcomes post-ACS, data are lacking regarding best treatments available. Aggressive interventional and medical treatments in this group with already poor outcomes are not necessarily contraindicated and should always be considered. The appalling outcome for CKD patients post-ACS is improved by many therapies shown to benefit in the non-CKD patients. Data suggest that troponins are useful markers in CKD patients, that major bleeding is not increased with the use of GP IIb-IIIa antagonists, that thrombolytics have been used successfully in CKD patients, and that PCI electively and as a primary treatment for ACS is successful and probably more beneficial to treatment.

Topics: Angina, Unstable; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Humans; Kidney Failure, Chronic; Myocardial Infarction

Percutaneous coronary intervention (PCI) has been shown to improve symptoms compared with conservative medical treatment in patients with stable coronary artery disease (CAD); however, there is limited evidence on the effect of PCI on the risk of death, myocardial infarction, and subsequent revascularization. Therefore, we performed a meta-analysis of 11 randomized trials comparing PCI to conservative treatment in patients with stable CAD.. A total of 2950 patients were included in the meta-analysis (1476 received PCI, and 1474 received conservative treatment). There was no significant difference between the 2 treatment strategies with regard to mortality, cardiac death or myocardial infarction, nonfatal myocardial infarction, CABG, or PCI during follow-up. By random effects, the risk ratios (95% CIs) for the PCI versus conservative treatment arms were 0.94 (0.72 to 1.24), 1.17 (0.88 to 1.57), 1.28 (0.94 to 1.75), 1.03 (0.80 to 1.33), and 1.23 (0.80 to 1.90) for these 5 outcomes, respectively. A possible survival benefit was seen for PCI only in trials of patients who had a relatively recent myocardial infarction (risk ratio 0.40, 95% CI 0.17 to 0.95). Except for PCI during follow-up, there was no significant between-study heterogeneity for any outcome.. In patients with chronic stable CAD, in the absence of a recent myocardial infarction, PCI does not offer any benefit in terms of death, myocardial infarction, or the need for subsequent revascularization compared with conservative medical treatment.

Topics: Angina Pectoris; Angioplasty, Balloon, Coronary; Bayes Theorem; Cardiovascular Agents; Coronary Artery Disease; Coronary Disease; Coronary Stenosis; Death; Female; Humans; Male; Middle Aged; Myocardial Infarction; Myocardial Revascularization; Odds Ratio; Randomized Controlled Trials as Topic; Risk Assessment; Treatment Outcome

In the fibrinolytic era, several studies have suggested that the rate of atrioventricular block (AVB) in the setting of acute myocardial infarction (MI) is high and is associated with increased short-term mortality. We sought to delineate predictors of AVB and determine long-term mortality of patients developing AVB in the setting of ST-segment elevation MI (STEMI) treated with thrombolytic therapy.. We combined data on patients from 4 similar studies of STEMI. We identified independent predictors of AVB and compared the 6-month and 1-year mortality rates of patients with AVB (5251) to the rates of patients without AVB (70 742).. The incidence of AVB was 6.9%. Significant independent predictors of AVB included inferior MI, older age, worse Killip class at presentation, female sex, enrollment in the United States, current smoking, hypertension, and diabetes. Adjusted mortality was significantly higher in patients with AVB than in patients without AVB within 30 days (OR 3.2, 95% CI 2.7-3.7), 6 months (OR 1.6, 95% CI 1.5-1.8), and 1 year (OR 1.5, 95% CI 1.3-1.6). For patients with AVB and inferior MI, mortality odds ratios (ORs) were 2.2 (95% CI 1.7-2.7), 2.6 (95% CI 2.4-2.9), and 2.4 (95% CI 2.2-2.6) within 30 days, 6 months, and 1 year, respectively. For patients with AVB and anterior MI, mortality ORs were 3.0 (95% CI 2.2-4.1), 3.5 (95% CI 3.1-3.8), and 3.3 (95% CI 3.0-3.7) within 30 days, 6 months, and 1 year, respectively.. In the thrombolytic era, AVB in the setting of STEMI is common and associated with higher mortality. Future studies should focus on determining therapies that are effective at reducing mortality rates in such patients.

Topics: Aged; Cardiovascular Agents; Chest Pain; Comorbidity; Databases, Factual; Electrocardiography; Female; Fibrinolytic Agents; Follow-Up Studies; Heart Block; Humans; Incidence; Male; Middle Aged; Mortality; Myocardial Infarction; New Zealand; Odds Ratio; Randomized Controlled Trials as Topic; Recombinant Proteins; Risk Factors; Streptokinase; Survival Analysis; Tenecteplase; Thrombolytic Therapy; Tissue Plasminogen Activator; United States

Cardiovascular diseases are the number one cause of death in Germany. In 2002 about 70,000 people died of acute myocardial infarction (AMI) and of these 37% died before arrival at hospital which underlines the relevance of adequate prehospital care. The generic term acute coronary syndrome (ACS) was introduced because a single pathomechanism accounts for the different forms and comprises unstable angina pectoris (iAP), non-ST-elevation myocardial infarction (NSTEMI), ST-elevation myocardial infarction (STEMI) and sudden cardiac death (SCD). Characteristic features are retrosternal pain, vegetative symptoms and radiation of pain into the adjoining regions. Further differentiation can only be achieved by the 12-lead ECG, as cardiac-specific enzymes do not play a role in prehospital decisions. Prehospital delays should be avoided, history and physical examination should be brief but focused, vital parameters should be assessed and monitored. Basic treatment for ACS should comprise inhalative oxygen, nitrates, morphine, aspirin and beta-blockers. If STEMI is diagnosed, patients with symptoms <12 h should undergo fibrinolytic therapy unless there is primary percutaneous coronary intervention (PCI) available within 90 min or if contraindicated. Heparin should be given to patients with STEMI depending on the choice of fibrinolytic agent, it otherwise results in a higher risk of bleeding, but in patients with iAP or NSTEMI it reduces mortality. All patients must be accompanied by the emergency physician during transportation and should be brought to a hospital with primary PCI, especially those with complicated ACS. Treatment of complications depends largely on the type, persistence and severity.

Topics: Acute Disease; Angina Pectoris; Cardiovascular Agents; Coronary Disease; Electrocardiography; Emergency Medical Services; Germany; Humans; Myocardial Infarction

Emergency department (ED) management of patients who present with suspected unstable angina (UA) and non-ST elevation myocardial infarction (NSTEMI) is especially challenging. Therapies that demonstrate benefit in patients who experience proven disease may not be indicated in patients who present with suspected disease. The emergency practitioner must have a clear understanding of the benefit and harm of each therapy, allowing formulation of a simple approach to treatment selection based on disease presentation. This article reviews current literature and discusses the treatment recommendations from the American College of Cardiology (ACC) and American Heart Association (AHA) for patients who experience UA and ST elevation myocardial infarction (STEMI).

Topics: Angina, Unstable; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Decision Making; Electrocardiography; Humans; Myocardial Infarction; Treatment Outcome

NSTE-ACS is a complex clinical event characterized by a variable degree of myocardial ischemia and triggered, in most patients, by a rupture of a vulnerable plaque that leads to acute intraluminal nonocclusive thrombosis. Traditionally, acute management strategies for NSTE-ACS have been aimed at identification of vascular areas with discrete atheroma and revascularization of the affected myocardium. Studies that have evaluated invasive strategies in NSTE-ACS suggest that the rates of hard clinical events are similar for both intensive medical treatment and early invasive management strategies. As shown recently in the Cooperative Cardiovascular Project study, intensive therapy with beta-blockers appears to be a viable management option that has comparable outcomes in most patients with NSTE-ACS. Although several different treatment strategies have been advocated in the management of NSTE-ACS, the available evidence-based information does not fully support some of these traditional approaches. Future prospective, well-controlled trials are needed to fully ascertain the role of invasive and other medical management strategies in patients with NSTE-ACS. Long-term aggressive management of established risk factors for CAD is unquestionably the most prudent and cost-effective therapeutic approach in the long-term management in patients recovering from NSTE-ACS.

Topics: Algorithms; Angina, Unstable; Anticoagulants; Cardiovascular Agents; Humans; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Myocardial Infarction; Myocardial Revascularization; Platelet Aggregation Inhibitors

Topics: Analgesics, Opioid; Angina, Unstable; Biomarkers; Cardiovascular Agents; Electrocardiography; Europe; Humans; Morphine; Myocardial Infarction; Myocardial Reperfusion; Oxygen Inhalation Therapy; Shock, Cardiogenic

Current guidelines define the standard of care for patients after myocardial infarction (MI), with particular focus on patients with significant ventricular dysfunction. Inherent in these recommendations are assumptions about the relative risks and benefits, as well as the costs, of the available options. This review will consider strategies to prevent sudden death and heart failure post-MI by utilization of pharmacologic therapies--angiotensin-converting enzyme (ACE) inhibitors, angiotensin receptor blockers (ARB), aldosterone antagonists, statins, and beta-blockers--in parallel with the approaches reviewed elsewhere in this supplement. A patient-centric approach necessitates that drugs in each class be compared for efficacy within this patient population. Clinical trials have demonstrated the efficacy of several drugs, such as ACE inhibitors, beta-blockers, and aldosterone antagonists, in patients post-MI, yet these benefits do not seem to be reflected in the epidemiologic data. This may reflect underutilization of these therapies or, alternatively, support the notion that efficacy in clinical trials does not assure effectiveness in clinical practice. The latter point is a subject of ongoing investigation, while the former is being addressed through quality-of-care initiatives. In clinical practice, aggressiveness is key, starting with patient education. If patients understand their risks better, compliance and adoption of a more ideal lifestyle seem more likely. However, even with educational programs, human nature teaches us that marked change in behavior is difficult and therefore, to minimize risks, particularly of sudden death and heart failure post infarction, an optimized pharmacologic regimen serves as a powerful tool.

Topics: Adrenergic beta-Antagonists; Angiotensin II Type 1 Receptor Blockers; Angiotensin-Converting Enzyme Inhibitors; Cardiovascular Agents; Death, Sudden, Cardiac; Heart Failure; Humans; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Mineralocorticoid Receptor Antagonists; Myocardial Infarction; Risk Factors; Risk Reduction Behavior

The pharmacologic management of the patient post myocardial infarction (MI) aims to achieve several goals. Chief among these is to prevent subsequent events, which include death, reinfarction, and rehospitalization. Secondary goals include preventing arrhythmias, minimizing left ventricular (LV) remodeling, and preventing progression to heart failure. This review describes practical algorithms for use in the pharmacologic management of the patient post MI based on American Heart Association/American College of Cardiology guidelines. The intensity of drug treatment is determined guided by the degree of LV dysfunction and the presence or absence of ischemia and arrhythmic risk markers. All patients post MI require an angiotensin-converting enzyme (ACE) inhibitor and antiplatelet therapy, usually with aspirin. In individuals who cannot tolerate an ACE inhibitor, an angiotensin receptor blocker (ARB) is an adequate substitute. Numerous studies document the efficacy of ACE inhibitors, which decrease mortality and the risk of heart failure and stroke. Aldosterone blockade is recommended long-term for patients post MI with an LV ejection fraction < or = 40% and either symptomatic heart failure or diabetes. Use of a beta blocker is an important addition to most post-MI drug regimens. Beta blockers decrease mortality and are especially effective in patients with impaired LV function. Among the beta blockers, carvedilol, which also has alpha-adrenergic receptor blocking activity, was found to decrease mortality significantly in patients with low ejection fractions and heart failure. Another drug therapy of value in post-MI treatment is use of calcium-channel blockers. These are restricted to patients with conserved LV function in whom congestion is absent and in whom beta blockers are contraindicated. Current guidelines also recommend that patients post MI with elevated cholesterol levels should be prescribed lipid therapy with a statin at hospital discharge.

Topics: Adrenergic beta-Antagonists; Algorithms; Angiotensin II Type 1 Receptor Blockers; Angiotensin-Converting Enzyme Inhibitors; Calcium Channel Blockers; Cardiovascular Agents; Fish Oils; Heart Failure; Humans; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Mineralocorticoid Receptor Antagonists; Myocardial Infarction; Platelet Aggregation Inhibitors; Severity of Illness Index; Ventricular Dysfunction, Left; Ventricular Remodeling

Patients with left ventricular dysfunction (LVD) are at increased risk for dying suddenly of cardiac causes. The most common causes of LVD are coronary artery disease (CAD) and myocardial infarction (MI). Aggressive intervention following MI is essential for minimizing the myocardial damage that leads to LVD and the subsequent risk for heart failure and sudden cardiac death. This article describes practical algorithms for managing the patient post MI to minimize such risks. The degree of LVD is a key factor for determining clinical management strategies in the patient post MI. Risk factor reduction and selective neurohormonal blockade, especially with angiotensin-converting enzyme inhibitors, are usually recommended in the presence or absence of LVD, along with early use of a beta blocker. In patients with LVD, more aggressive intervention includes extended use of a beta blocker. In cases of LVD progressed to heart failure, the mixed beta and alpha blocker carvedilol has improved outcomes significantly. In clinical trials, carvedilol has been demonstrated to have antiarrhythmic activity, a property that offers protection against sudden arrhythmic death in high-risk patients with LVD. Addition of an aldosterone antagonist is also advised in patients with heart failure. In selected patients with reduced ejection fractions, use of surgical/catheter treatment and device therapy offers further benefits.

Topics: Adrenergic beta-Antagonists; Algorithms; Angiotensin-Converting Enzyme Inhibitors; Anti-Arrhythmia Agents; Cardiovascular Agents; Cardiovascular Surgical Procedures; Defibrillators, Implantable; Humans; Myocardial Infarction; Risk Factors; Risk Reduction Behavior; Ventricular Dysfunction, Left

Elderly patients are often excluded from therapeutic methods which have been shown to improve the prognosis of myocardial infarction (MI). The aim of this study was to describe the changes in management of MI in the elderly and to analyse the factors associated with hospital mortality due to MI during this period. All cases of acute MI in patients over 75 years of age from 1983 to 1999 and admitted to the Centre Hospitalier du Val d'Ariège were reviewed. The clinical features, the modalities of initial management and their treatment on discharge were compared by periods: 1983-88, 1989-93 and 1994-99. The changes in hospital mortality and the factors associated with this mortality were studied. Five hundred and forty-four cases of patients with an average age of 81 years were reviewed. The proportion of patients who were treated medically alone decreased over the 3 periods whereas treatment by angioplasty and thrombolysis increased (1.2% in 1983-88 versus 18.2% in 1994-99). Betablockers, ACE inhibitors and aspirin were much more prescribed on discharge from hospital. In parallel, the hospital mortality from MI decreased by half (50.8% in 1983-88 versus 24.9% in 1994-99). The independent factors associated with hospital mortality were age, anterior infarction (OR = 2.08 [1.39-3.13]), revascularisation of the culprit artery by thrombolysis or angioplasty (OR = 0.24 [0.09-0.61]) and the period of hospital stay (OR = 0.22 [0.12-0.38] in 1994-99 compared with 1983-88). The authors' experience reflects an improved prognosis of MI in the elderly partially due to the benefits of treatment by angioplasty and thrombolysis. Improvement of pre-hospital treatment, better diagnostic methods and more aggressive management of the elderly with MI also contribute to these results.

Topics: Aged; Aged, 80 and over; Angioplasty, Balloon, Coronary; Anticoagulants; Cardiovascular Agents; Comorbidity; Drug Therapy, Combination; Female; Fibrinolytic Agents; France; Hospital Mortality; Humans; Length of Stay; Male; Myocardial Infarction; Risk Factors; Thrombolytic Therapy

Topics: Aged; Angiotensin II; Angiotensin II Type 1 Receptor Blockers; Angiotensin-Converting Enzyme Inhibitors; Animals; Cardiovascular Agents; Diabetic Nephropathies; Disease Models, Animal; Drug Synergism; Drug Therapy, Combination; Female; Heart Failure; Humans; Hypertension; Kidney Diseases; Male; Middle Aged; Myocardial Infarction; Proteinuria; Rats; Renin-Angiotensin System; Ventricular Dysfunction, Left

Cardiovascular disease continues to be a major health problem. Tremendous efforts have been invested in clinical and laboratory research in the hopes of decreasing the risk of patients with cardiovascular disease undergoing cardiac and non-cardiac surgeries. A powerful endogenous mechanism of cardioprotection, termed ischemic preconditioning, was reported in a laboratory setting whereby the myocardium can be preconditioned by a brief ischemic episode and protected against a subsequent prolonged ischemic attack. Since this initial observation, several pharmacological agents have been demonstrated to mimic ischemic preconditioning. These include opioids, potassium channel openers such as pinacidil and diazoxide, and adenosine agonists. Recently, volatile anesthetics were found to be powerful cardiac preconditioning agents. Infarct size reduction as the result of anesthetic-induced preconditioning paralleled that of ischemic preconditioning. The use of volatile anesthetics as preconditioning agents in high-risk patients undergoing cardiac and non-cardiac surgeries can potentially result in the reduction of morbidity and disability in this class of patients. However, to fully realize the potential use of this novel property of volatile anesthetics, the underlying mechanism of anesthetic-induced preconditioning would need to be elucidated. This review highlights the major recent findings on the cardioprotective effects of volatile anesthetics.

Topics: Anesthetics, Inhalation; Cardiovascular Agents; Humans; Ischemic Preconditioning, Myocardial; Myocardial Infarction; Potassium Channels; Signal Transduction

Chronic heart failure is characterised by functional deficiencies of the myocardium. Structural abnormalities of the left ventricular wall occur in many cases as a consequence of myocardial infarction (MI). The overburdened postMI heart is characterised by an active reorganisation of the remaining myocardium. Increased expression and activity of matrix metalloproteinases lead to altered composition and arrangement of the extracellular matrix, which is accompanied by eccentric hypertrophy of cardiomyocytes. The altered geometry of the heart muscle fosters biomechanical stress, driving the heart into a dead-end situation. Clearly, novel therapeutic concepts must be developed to reverse this process. Part II of the current review will focus on emerging therapeutic targets for small molecule therapeutics in the fields of cardiac remodelling and impaired survival of cardiomyocytes in the diseased heart. Finally, innovative therapeutic concepts for heart gene therapy and replacement options for destroyed post-MI myocardium using embryonic and adult stem cells are described.

Topics: Apoptosis; Apoptosis Regulatory Proteins; Cardiovascular Agents; Cell- and Tissue-Based Therapy; Cytokines; Drug Design; Extracellular Matrix; Female; Genetic Therapy; Heart Failure; Humans; Male; Muscle Proteins; Myocardial Infarction; Signal Transduction; Ventricular Remodeling

Topics: Cardiac Surgical Procedures; Cardiovascular Agents; Disease Management; Humans; Myocardial Infarction; Risk Factors; United States

Topics: Animals; Cardiovascular Agents; Coronary Disease; Disease Models, Animal; Drug Evaluation, Preclinical; Female; Ligation; Mice; Models, Animal; Myocardial Infarction; Myocardial Reperfusion Injury; Rabbits; Rats; Rats, Wistar; Swine

Reviewing advances in cardiology and haematology together may appear at first sight to require some artificiality to make a satisfying fit. For two reasons, at least, this is not the case. Firstly, convergence in biology has become very clear over the past decade and this could not be better illustrated by the demonstration that the haemangioblast is the common progenitor of both haemapoietic stem cells and vascular endothelium. This opens the way to common (and differential) approaches to the manipulation of these cells, a field at present in its infancy. A second convergence is the common goal of understanding the processes resulting in haemostasis, thrombosis and vascular occlusion and the means for developing effective antithrombotics. This is exemplified by a number of agents either in use or in clinical trial as a result of haematological and cardiological collaboration. This collaboration is recognisable with the development, many years ago, of streptokinase and the use of aspirin in vascular disease and continues to this day with specific antiplatelet inhibitors and oral thrombin inhibitors as they become accepted into clinical use over the next few years. Here we review current advances in pharmacological treatments in cardiology and haematology, grouped primarily by disease process, focusing on novel and emerging therapies likely to be of importance in the future.

Topics: Angioplasty, Balloon, Coronary; Animals; Cardiovascular Agents; Coronary Disease; Heart Diseases; Hematologic Diseases; Hematologic Neoplasms; Humans; Myocardial Infarction; Stem Cell Transplantation; Thrombosis

Sudden cardiac death is an elusive process that claims a significant number of lives annually in the United States. It is often associated with increased mortality within the first year after myocardial infarction, with the highest frequency occurring among patients with left ventricular dysfunction. Therefore, increasing survival rates in patients with a history of both disorders is an important goal of therapy. Recent trials suggested that an implantable cardioverter-defibrillator (ICD) in these patients may be superior to medical intervention in reducing the high mortality rate. Four major trials measured the benefits of an ICD for patients at risk for life-threatening ventricular arrhythmias. We assessed whether patients in these trials received adequate drug therapy as directed by American College of Cardiology-American Heart Association guidelines. One aim was to determine if medicated patients who served as controls in the trials were fairly represented. Furthermore, the need for improved overall guideline adherence was apparent.

Topics: Adrenergic beta-Antagonists; Amiodarone; Angiotensin-Converting Enzyme Inhibitors; Cardiovascular Agents; Death, Sudden, Cardiac; Defibrillators, Implantable; Humans; Myocardial Infarction; Platelet Aggregation Inhibitors; Randomized Controlled Trials as Topic; Treatment Outcome; Ventricular Remodeling

Topics: Cardiovascular Agents; Evidence-Based Medicine; Humans; Myocardial Infarction; Randomized Controlled Trials as Topic; Thrombolytic Therapy

beta-Blocker therapy remains substantially underused in cardiac patients despite its proven mortality benefits. Reluctance to prescribe these agents may derive from concerns about their association with symptoms of depression, fatigue, and sexual dysfunction.. To determine the association of beta-blockers with depressive symptoms, fatigue, and sexual dysfunction by performing a quantitative review of randomized trials that tested beta-blockers in myocardial infarction, heart failure, and hypertension.. Randomized trials of beta-blockers used in the treatment of myocardial infarction, heart failure, or hypertension were identified by searching the MEDLINE database for English-language articles (1966-2001). In addition, we searched the reference lists of previously published trials and reviews of beta-blockers for additional studies.. Criteria for inclusion of trials in the review were: random allocation of study treatments, placebo control, noncrossover design, enrollment of at least 100 patients, and a minimum of 6 months of follow-up. The initial search produced 475 articles, 42 of which met these criteria. Fifteen of these trials reported on depressive symptoms, fatigue, or sexual dysfunction and were selected for inclusion.. For each trial, 1 author abstracted the frequency of adverse events in the beta-blocker and placebo groups and the numbers of patients randomized to the treatment groups. Two other authors verified the counts of events, and all authors adjudicated any discrepancies. Two different types of information on adverse events were abstracted: patient-reported symptoms and withdrawal of therapy due to a specified symptom. We categorized the tested beta-blockers by generation (early vs late) and lipid solubility (high vs low to moderate).. The 15 trials involved more than 35,000 subjects. beta-Blocker therapy was not associated with a significant absolute annual increase in risk of reported depressive symptoms (6 per 1000 patients; 95% confidence interval [CI], -7 to 19). beta-Blockers were associated with a small significant annual increase in risk of reported fatigue (18 per 1000 patients; 95% CI, 5-30), equivalent to 1 additional report of fatigue for every 57 patients treated per year with beta-blockers. beta-Blockers were also associated with a small, significant annual increase in risk of reported sexual dysfunction (5 per 1000 patients; 95% CI, 2-8), equivalent to one additional report for every 199 patients treated per year. None of the risks of adverse effects differed significantly by degree of beta-blocker lipid solubility. The risk associated with reported fatigue was significantly higher for early-generation than for late-generation beta-blockers (P =.04).. The conventional wisdom that beta-blocker therapy is associated with substantial risks of depressive symptoms, fatigue, and sexual dysfunction is not supported by data from clinical trials. There is no significant increased risk of depressive symptoms and only small increased risks of fatigue and sexual dysfunction. The risks of these adverse effects should be put in the context of the documented benefits of these medications.

Topics: Adrenergic beta-Antagonists; Cardiovascular Agents; Depression; Fatigue; Female; Heart Failure; Humans; Hypertension; Male; Myocardial Infarction; Randomized Controlled Trials as Topic; Risk; Sexual Dysfunction, Physiological

Many advances have been made in the treatment of acute coronary syndromes. Patients with intermediate-risk or high-risk features should receive treatment with the newer pharmacologic agents--enoxaparin, statins and, in selected cases, clopidogrel--in addition to established standard therapies (i.e., aspirin, beta-blockers, nitroglycerin, and oxygen). Use of GpIIb-IIIa inhibitors should also be strongly considered, especially in an early invasive approach. However, there is no substitute for a good physician who has the big picture and knows the individual patient in totality. This physician can best judge the dangers of the patient's acute cardiac condition against the comorbidities that may be exacerbated by revascularization procedures. The ability to weigh the risks of the patient's acute coronary syndrome against the risks of an aggressive invasive approach ultimately provides the best care for each patient.

Topics: Adrenergic beta-Antagonists; Angina, Unstable; Angiotensin-Converting Enzyme Inhibitors; Cardiovascular Agents; Chest Pain; Clinical Protocols; Hematologic Agents; Humans; Myocardial Infarction; Nitrates

Topics: Adolescent; Adult; Aged; Antihypertensive Agents; Arrhythmias, Cardiac; Blood Pressure; Blood Pressure Monitoring, Ambulatory; Calcium Channel Blockers; Cardiovascular Agents; Catecholamines; Chronotherapy; Circadian Rhythm; Clinical Trials as Topic; Cross-Over Studies; Delayed-Action Preparations; Diltiazem; Double-Blind Method; Electrocardiography, Ambulatory; Hemodynamics; Humans; Middle Aged; Multicenter Studies as Topic; Myocardial Infarction; Myocardial Ischemia; Sleep; Stroke; Verapamil

Thiazide diuretics, b-blockers, calcium channel blockers, and angiotensin converting enzyme (ACE) inhibitors are all superior to placebo for the primary prevention of coronary events in patients with hypertension. Recent studies have shown that ACE inhibitors are better than other antihypertensive agents in lowering overall cardiovascular morbidity and mortality, especially stroke. Blood pressure should be aggressively lowered (to < 140/90 mm Hg), especially in diabetic patients (to < 130/80 mm Hg), but care should be exercised in lowering the diastolic blood pressure below 65 mm Hg in patients with significant occlusive coronary artery disease. Hypertension in patients with stable angina should be treated with a b-blocker (alternatively a calcium channel blocker) together with an ACE inhibitor. Patients with hypertension and acute coronary syndrome (unstable angina or myocardial infarction) should be treated with a b-blocker, and with an ACE inhibitor if there is left ventricular dysfunction. A thiazide diuretic and/or a dihydropyridine calcium channel blocker could be added for blood pressure control. Calcium channel blockers should be avoided if there is significant left ventricular dysfunction.

Topics: Angina, Unstable; Blood Pressure; Cardiovascular Agents; Clinical Trials as Topic; Humans; Hypertension; Myocardial Infarction; Myocardial Ischemia

Topics: Angioplasty, Balloon, Coronary; Cardiopulmonary Bypass; Cardiovascular Agents; Humans; Myocardial Infarction; Prognosis; Randomized Controlled Trials as Topic; Shock, Cardiogenic; Survival Rate; Thrombolytic Therapy; Treatment Outcome

Topics: Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Artery Bypass; Dioxolanes; Feeding Behavior; Heptanoic Acids; Humans; Life Style; Myocardial Infarction; Myocardial Ischemia; Randomized Controlled Trials as Topic; Recurrence; Risk Factors; Stents; Survival Rate; Treatment Outcome

Omacor is a new omega-3 fatty acid product that is licensed for secondary prevention post-myocardial infarction. It confers an additional 20% reduction in all-cause mortality, based on the Gruppo Italiano per lo Studio della Sopravvivenza nell'Infarto miocardico prevenzione (GISSI-P) study data. The GISSI-P results are compared with other trials of secondary prevention.

Topics: Adult; Aged; Cardiovascular Agents; Docosahexaenoic Acids; Drug Combinations; Eicosapentaenoic Acid; Humans; Middle Aged; Myocardial Infarction; Randomized Controlled Trials as Topic; Survival Analysis; Treatment Outcome

The management of acute myocardial infarction has been revolutionized in the past decade. Advances in pharmacological and mechanical reperfusion therapy have improved the survival of patients who experience myocardial infarction. Although revascularisation techniques have been shown to reduce infarct size and in-hospital mortality, patients recovering from myocardial infarction are still at increased risk for reinfarction, congestive heart failure, and sudden death. Despite impressive technological advances, lifestyle modification and pharmacological interventions remain the key components of secondary prevention after myocardial infarction. Although the concept of secondary prevention of reinfarction and death has been investigated vigorously for several decades, preventive therapy has been seriously underused by physicians. The aim of this paper is to provide a comprehensive, evidence-based overview of secondary prevention postmyocardial infarction clinical trials, in the hope of improving the utilization of effective therapies in patients with coronary heart disease.

Topics: Adrenergic beta-Antagonists; Angiotensin-Converting Enzyme Inhibitors; Anti-Arrhythmia Agents; Anticoagulants; Aspirin; Calcium Channels; Cardiovascular Agents; Clinical Trials as Topic; Coronary Circulation; Death, Sudden, Cardiac; Diet; Exercise; Heart Failure; Humans; Hypolipidemic Agents; Life Style; Myocardial Infarction; Myocardial Revascularization; Nitric Oxide Donors; Risk Factors; Secondary Prevention; Smoking Cessation; Vasodilator Agents

Angiotensin-receptor blockers have been part of the antihypertensive treatment armamentarium since the mid-1990s. During this period, the number of agents has increased greatly, as has the number of indications for which these drugs are being tested in randomized controlled clinical trials. Beginning as efficacious and very well tolerated antihypertensives, angiotensin-receptor blockers have been shown to have benefits in patients with diabetes and heart failure that are not only attributable to the reduced blood pressure, as supported by recently concluded trials. The expanding treatment areas with these agents widen the interest in their applicability across the entire cardiovascular continuum. A number of large-scale studies set to report within the next few years will further determine the effects of angiotensin-receptor blockers in a range of cardiovascular indications beyond hypertension.

Topics: Angiotensin Receptor Antagonists; Angiotensin-Converting Enzyme Inhibitors; Animals; Antihypertensive Agents; Cardiovascular Agents; Cardiovascular Diseases; Diabetes Mellitus, Type 2; Heart Failure; Humans; Myocardial Infarction; Renin-Angiotensin System

This review analyzes important facets of contemporary percutaneous coronary interventions. The optimal strategy of acute myocardial infarction and shock is addressed, as is the role of angioplasty in multivessel coronary disease. Vascular Brachytherapy is essentially the sole available treatment modality for in-stent restenosis. The WRIST trials have provided the foundation for clinical experience and are discussed in detail. Finally, drug-eluting stents may become the next revolution in interventional cardiology and offer the hope of a "cure" for restenosis.

Topics: Angioplasty, Balloon; Animals; Brachytherapy; Cardiovascular Agents; Clinical Trials as Topic; Coronary Disease; Graft Occlusion, Vascular; Humans; Myocardial Infarction; Myocardial Revascularization; Shock, Cardiogenic; Stents

Topics: Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Artery Bypass; Dioxolanes; Feeding Behavior; Heptanoic Acids; Humans; Life Style; Myocardial Infarction; Myocardial Ischemia; Recurrence; Risk Factors; Stents

The clinical presentations of ischemic heart disease comprises the term of acute ischaemia syndromes, that include unstable angina pectoris, non-Q-wave myocardial infarction, Q-wave-myocardial infarction and sudden death. Among the different presentations of acute ischemic syndromes, the unstable angina and non-Q-wave myocardial infarction can be regarded together. In both pathologic entity, the plaque rupture, or erosion signifies the primary event, which is the source of the highly thrombogenic substances coming out from the core of the atherosclerotic plaque and entering to the coronary and systemic circulation. They cause a thrombocyte-rich "white" intracoronary thrombus, that is not fully obstructive, or there is adequate collateral circulation, being the pathogenetic substrate that prevents the development of transmural necrosis. The nosologically-bound two clinical entity can be called as "unstable coronary artery disease" (UCAD), since they have uniform etiologic, risk stratification and therapeutic backgrounds and also therapeutic targets that are basically distinct, they are admitted for transmural "ST-elevation" infarction. The review is discussing the therapy and the questions of follow-up of the disease according to the guidelines of the European Society of Cardiology and to the multicenter evidence based studies.

Topics: Angina, Unstable; Antithrombins; Cardiovascular Agents; Coronary Artery Bypass; Death, Sudden, Cardiac; Fibrinolytic Agents; Heart Conduction System; Heparin, Low-Molecular-Weight; Humans; Multicenter Studies as Topic; Myocardial Infarction; Platelet Aggregation Inhibitors; Platelet Glycoprotein GPIIb-IIIa Complex; Randomized Controlled Trials as Topic; Vasodilator Agents

Topics: Antihypertensive Agents; Blood Pressure; Cardiovascular Agents; Cardiovascular Diseases; Circadian Rhythm; Death, Sudden, Cardiac; Humans; Hypertension; Kidney Failure, Chronic; Myocardial Infarction

Patients with atherosclerotic renal artery stenosis may develop hypertension, recurrent pulmonary edema and chronic renal failure, but have a much higher risk of dying from stroke or myocardial infarction than of progressing to end-stage renal disease. Indeed, atherosclerotic renal artery stenosis typically occurs in high risk patients with coexistent vascular disease elsewhere. Recent controlled trials comparing medication to revascularization have shown that only a minority of such patients can expect hypertension cure, whereas the results of trials designed to document the ability of revascularization to prevent progressive renal failure are not yet available. Revascularization should be undertaken in patients with atherosclerotic renal artery stenosis and resistant hypertension or heart failure, and probably in those with rapidly deteriorating renal function or with an increase in plasma creatinine levels during angiotensin-converting enzyme inhibition, especially if their renal resistance--index before revascularization is less than 80. With or without revascularization, medical therapy using antihypertensive agents, statins and aspirin is necessary in almost all cases.

Topics: Angiotensin-Converting Enzyme Inhibitors; Arteriosclerosis; Aspirin; Cardiovascular Agents; Combined Modality Therapy; Creatinine; Diagnostic Imaging; Drug Therapy, Combination; Heart Failure; Humans; Hypertension, Renovascular; Hypolipidemic Agents; Myocardial Infarction; Platelet Aggregation Inhibitors; Pulmonary Edema; Radionuclide Imaging; Renal Artery; Renal Artery Obstruction; Risk Factors; Stroke

To review the trends in treatment and survival for patients with acute myocardial infarction over the last 20 years.. Studies were identified through MEDLINE searches and review of study bibliographies. Additional data were obtained from the Health Care Financing Administration including data from Medicare claims files (part A). Thirty-day mortality rates were calculated using Medicare data and case fatality rates from the National Hospital Discharge Survey. Published meta-analyses were used to determine treatment effects. Published studies were included if they reported the use of therapies for acute myocardial infarction at a population level. Trends in the demographic characteristics of the patients as well as infarct characteristics, medication use, and revascularization were recorded.. The use of acute treatments that are known to improve survival among patients with myocardial infarction has increased markedly during the last 20 years, leading to an estimated 9.6% reduction (from 27.0% to 17.4%) in 30-day mortality. After adjusting for potential interactions between therapies, the increase in use of aspirin, beta-blockers, angiotensin-converting enzyme (ACE) inhibitors, and reperfusion can explain 71% of the decrease in the 30-day age- and sex-adjusted mortality rate from 1975 to 1995. The greatest effect of a given therapy was that of aspirin, which accounted for 34% of the decrease in 30-day mortality, followed by thrombolysis (17%), primary angioplasty (10%), beta-blockers (7%), and ACE inhibitors (3%). If other treatments (such as heparin or nonprimary angioplasty), whose effects on mortality are less certain, are included, up to 90% of the decrease in 30-day mortality can be explained by changes in treatment.. The primary reason for the decrease in early mortality from myocardial infarction during the last 20 years appears to be increased use of effective treatments.

Topics: Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Artery Bypass; Humans; Incidence; Medicare; Mortality; Myocardial Infarction; Randomized Controlled Trials as Topic; Thrombolytic Therapy; Treatment Outcome; United States

Topics: Adrenergic beta-Antagonists; Angiotensin-Converting Enzyme Inhibitors; Arteriosclerosis; Aspirin; Calcium Channel Blockers; Cardiovascular Agents; Cost-Benefit Analysis; Germany; Humans; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Meta-Analysis as Topic; Myocardial Infarction; Randomized Controlled Trials as Topic; Secondary Prevention

Topics: Angina Pectoris; Cardiovascular Agents; Free Radical Scavengers; Heart Diseases; Humans; Myocardial Infarction; Nitric Oxide; Nitric Oxide Donors

The management of acute myocardial infarction (AMI) has changed dramatically over the last two decades, with the addition of fibrinolytic agents and primary coronary intervention (PCI). The more recent development of the glycoprotein (GP) IIb/IIIa antagonists, a new class of potent antiplatelet drugs, has the potential to considerably enhance the treatment of AMI patients. A number of recent studies have highlighted the potential incremental benefits with adjunctive IIb/IIIa-targeted therapy. In this review, we will discuss the pathophysiology of myocardial infarction (MI), the physiology and role of platelets in thrombosis and describe the currently available drugs. We will briefly summarise the results of recent clinical trials, discuss some key forthcoming trials and attempt to describe how GP IIb/IIIa antagonists may directly impact the immediate and near future day-to-day care of patients with AMI.

Topics: Acute Disease; Animals; Blood Platelets; Cardiovascular Agents; Humans; Myocardial Infarction; Myocardial Revascularization; Platelet Aggregation Inhibitors; Platelet Glycoprotein GPIIb-IIIa Complex

Acute myocardial infarction (MI) is the leading cause of death around the globe. Advances in the field of cardiology have identified several effective treatments that have lead to decrease in mortality from this cause over the past 3 decades. The purpose of this article is to review the existing literature in regards to secondary prevention after acute MI. A search of MEDLINE through August of 1999 was carried out to identify any available publications on secondary prevention after MI. Evidence on the use of both pharmacological and nonpharmacological interventions that was shown to be effective in improving morbidity and mortality was sought. Recommendations for the treatment of patients with acute MI are made based on existing evidence. Betablockers, aspirin and lipid-lowering agents for patients with low density lipoprotein-cholesterol > 130 mg% should be used for all patients following a MI. Angiotensin converting enzyme inhibitors are indicated for patients with congestive heart failure and/or reduced left ventricular ejection fraction and are likely protective in most patients. Calcium channel blockers (Verapamil and Diltiazem) are indicated as second-line therapy for patients who have contraindications or are intolerant to betablockers. The routine prophylactic use of antiarrhythmic drugs to suppress ventricular ectopic beats should be avoided. Recommendations regarding diet, smoking cessation and achievement of ideal body weight should be an integral part of patient management. Referral for outpatient rehabilitation should also be strongly encouraged. Finally, adequate control of blood pressure and diabetes cannot be overemphasized. Adherence to these goals in patients with acute MI will lead to better long-term outcomes and reduction in cardiac death, recurrent MI, stroke, and need for coronary revascularization.

Topics: Cardiovascular Agents; Humans; Life Style; Myocardial Infarction; Recurrence; Risk Factors; Survival Rate; Treatment Outcome

During the past 25 years, the cardiovascular effects of marine omega-3 (omega-3) fatty acids have been the subject of increasing investigation. In the late 1970s, epidemiological studies revealed that Greenland Inuits had substantially reduced rates of acute myocardial infarction compared with Western control subjects. These observations generated more than 4,500 studies to explore this and other effects of omega-3 fatty acids on human metabolism and health. From epidemiology to cell culture and animal studies to randomized controlled trials, the cardioprotective effects of omega-3 fatty acids are becoming recognized. These fatty acids, when incorporated into the diet at levels of about 1 g/d, seem to be able to stabilize myocardial membranes electrically, resulting in reduced susceptibility to ventricular dysrhythmias, thereby reducing the risk of sudden death. The recent GISSI (Gruppo Italiano per lo Studio della Sopravvivenza nell'Infarto miocardico)-Prevention study of 11,324 patients showed a 45% decrease in risk of sudden cardiac death and a 20% reduction in all-cause mortality in the group taking 850 mg/d of omega-3 fatty acids. These fatty acids have potent anti-inflammatory effects and may also be antiatherogenic. Higher doses of omega-3 fatty acids can lower elevated serum triglyceride levels; 3 to 5 g/ d can reduce triglyceride levels by 30% to 50%, minimizing the risk of both coronary heart disease and acute pancreatitis. This review summarizes the emerging evidence of the use of omega-3 fatty acids in the prevention of coronary heart disease.

Topics: alpha-Linolenic Acid; Cardiovascular Agents; Coronary Disease; Death, Sudden, Cardiac; Fatty Acids, Omega-3; Fish Oils; Greenland; Humans; Inuit; Myocardial Infarction; Randomized Controlled Trials as Topic

Cardiovascular death is the number one cause of death in the United States, with a rate that is more than double that for cancer. Over half of these cardiovascular deaths are due to acute myocardial infarction. Management of the patient with acute myocardial infarction during and after hospitalization is discussed with an emphasis on primary and secondary prevention, patient autonomy and decision making. There is also a review of the directions that treatment of acute myocardial infarction will take in the future.

Topics: Aged; Cardiovascular Agents; Critical Care; Female; Humans; Male; Myocardial Infarction; Myocardial Revascularization; Outpatient Clinics, Hospital

Diabetes mellitus as a disease of epidemiological impact leads to diabetic cardiopathy by modulation of myocardial, vascular and metabolic components. This includes the development of a coronary microangiopathy and a decrease of diastolic and systolic function of the left ventricle as well as the development of an autonomic diabetic neuropathy. Patients with diabetes show an increased mortality concerning cardiovascular events. They more often suffer from myocardial infarction as non-diabetics mostly with a more serious course. Moreover, the post-infarction course is affected with a worse prognosis as in non-diabetics. For diagnosis of cardial involvement in diabetes electrocardiographic and echocardiographic procedures are of use. Special tests of the autonomic function complete the diagnostic ensemble. An early therapy with ACE-inhibitors and beta blocking agents as well as a strong diabetes therapy, in particular with insulin, can influence the mortality favorably. Moreover, the diagnosis and therapy of additional cardiovascular risk factors (arterial hypertension, dyslipidemia) are very important, because these are correlated with a for diabetic patients markedly increased risk of mortality. The clinical relevance of the term diabetic cardiopathy is justified by the 6 factors: macroangiopathy, microangiopathy, disturbances of the myocardial metabolism, myocardial fibrosis, autonomic diabetic neuropathy and disturbances of the coagulability. Diagnostic and therapeutic goals are discussed.

Topics: Arteriosclerosis; Cardiovascular Agents; Coronary Disease; Diabetes Complications; Diabetes Mellitus; Diabetic Angiopathies; Diabetic Neuropathies; Diagnosis, Differential; Humans; Lipids; Myocardial Infarction; Risk Factors; Ventricular Dysfunction, Left

Management of acute coronary syndromes has been the focus of increased interest in recent years. This has come about with the recognition that the majority of patients who present to the hospital with chest pain have unstable angina or non-Q-wave myocardial infarction (MI). Further, sensitive biochemical markers of myocardial necrosis, such as troponin and creatine kinase, have improved early diagnosis. Markers of inflammation such as C-reactive protein (CRP), although not in wide clinical practice, may provide an early and important marker of prognosis. The current approach to management of acute coronary syndromes is careful risk stratification so as to select appropriate medical therapies and to guide the clinician to appropriate interventions such as angiography or percutaneous coronary intervention (PCI). Established therapies such as aspirin, heparin, intravenous nitrates, and, in selected patients, beta blockers or calcium antagonists, are being used concomitantly with, or are being supplanted by, newer therapies such as low-molecular-weight heparins and glycoprotein IIb/IIIa inhibitors. The role of hydroxymethyl glutaryl coenzyme A reductase inhibitors (statins) in patients with acute coronary syndromes is being investigated and shows promise.

Topics: Acute Disease; Adrenergic beta-Antagonists; Algorithms; Angina, Unstable; Biomarkers; Calcium Channel Blockers; Cardiovascular Agents; Coronary Disease; Heparin, Low-Molecular-Weight; Humans; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Myocardial Infarction; Nitroglycerin; Platelet Aggregation Inhibitors; Platelet Glycoprotein GPIIb-IIIa Complex; Randomized Controlled Trials as Topic; Risk; Risk Factors; Severity of Illness Index; Syndrome; Troponin I

During acute myocardial infarction (MI), aspirin, beta-adrenergic antagonists and oral angiotensin converting enzyme (ACE) inhibitors should be used as an adjunct to reperfusion therapy. Medications upon discharge from the hospital should include aspirin and a beta-blocker. An ACE inhibitor should also be prescribed unless the ejection fraction is > 45%. Particular indications for an ACE inhibitor are an anterior MI, congestive heart failure, ejection fraction < 45% and mitral regurgitation. beta-blockers, when given to patients treated with ACE inhibitors, appear to produce an additional benefit compared with an ACE inhibitor alone. Based on the Scandinavian Simvastatin Survival Study (4S), Cholesterol and Recurrent Events (CARE) and Long-Term Intervention with Pravastatin in Ischemic Disease (LIPID) trials, a statin should also be given to subjects with low density lipoprotein (LDL)-cholesterol levels above 125 mg/dl, independent of total cholesterol levels. Therapy should be administered in an attempt to reduce the LDL-cholesterol level to 90-100 mg/dl (2.3-2.6 mM/l). In patients with normal or low levels on initial evaluation, screening for lipid abnormalities should be deferred for 2 months since acute phase responses and passive hepatic congestion can cause spuriously normal levels. Calcium channel blockers, nitrates, lidocaine, anti-arrhythmic drugs and i.v. magnesium should not be administered routinely after acute MI and their use should be restricted to selected settings.

Topics: Adrenergic beta-Antagonists; Angiotensin-Converting Enzyme Inhibitors; Anti-Arrhythmia Agents; Calcium Channel Blockers; Cardiovascular Agents; Estrogen Replacement Therapy; Humans; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Magnesium; Myocardial Infarction; Nitrates; Platelet Aggregation Inhibitors

The coronary morbi-mortality is particularly high in type 2 diabetes, which represents the vast majority of all diabetes. Hyperglycemia is an independent vascular risk factor in the short and long-term. The relationship between the degree of hyperglycemia and vascular risk is linear with no threshold effect. The occurrence of a first coronary event is an occasion, though late, to review the management of all risk factors in diabetic patients. In these patients, intensive insulin therapy administered in the acute phase of infarction reduces cardiovascular mortality by 30% at 1 and 3 years. There are no specific studies of secondary prevention by optimal therapy of diabetes, but, in the UKPDS, the treatment of hyperglycemia with sulfonylurea or insulin only marginally reduced the number of cardiovascular events. On the other hand, treatment of obese patients with metformin significantly reduced the incidence of myocardial infarction and of mortality diabetes related. These results, though observed with the same level of glycemic control as in the other treatment groups, suggest a cardio-protective effect of metformin itself. These beneficial effects should be weighed up against the potential risk of lactic acidosis which still limits the widespread use of metformin in with coronary heart disease patients. Follow-up studies show that diabetic with coronary heart disease patients do not receive all effective therapeutic inventions in secondary prevention and that the treatment of hyperglycemia is often neglected. Close collaboration between cardiologists and diabetologists is necessary to improve the management of type 2 diabetes.

Topics: Acidosis, Lactic; Acute Disease; Adrenergic beta-Antagonists; Blood Glucose; Cardiovascular Agents; Case Management; Cohort Studies; Controlled Clinical Trials as Topic; Coronary Disease; Diabetes Complications; Diabetes Mellitus; Diabetes Mellitus, Type 2; Glyburide; Glycated Hemoglobin; Humans; Hypoglycemic Agents; Incidence; Insulin; Metformin; Myocardial Infarction; Obesity; Prospective Studies; Randomized Controlled Trials as Topic; Risk; Sulfonylurea Compounds; Treatment Outcome

The benefit of thrombolytic reperfusion has been demonstrated widely in patients who present with ST segment elevation and develop myocardial infarction. Instead, the role of thrombolytic therapy in patients who present with ST segment depression and develop myocardial infarction is still unresolved. The purpose of this paper is to review the literature on the subject and give rise to reconsideration of thrombolytic therapy in this subgroup of patients who are usually excluded from receiving thrombolytic agents because of the absence of indications and the presence of contraindications.

Topics: Angioplasty, Balloon, Coronary; Cardiovascular Agents; Combined Modality Therapy; Contraindications; Coronary Angiography; Drug Therapy, Combination; Electrocardiography; Humans; Male; Middle Aged; Myocardial Infarction; Thrombolytic Therapy

A variety of experimental studies have confirmed that preconditioning the myocardium by brief periods of ischemia represents a powerful cardioprotective effect resulting in a reduction of infarct size. After 15 years of research in the experimental laboratory, some evidence shows the existence of preconditioning in human patients with coronary artery disease: repeated balloon inflations before coronary angioplasty induce preconditioning-like effects; moreover, some studies demonstrate better clinical outcome in patients with angina before acute myocardial infarction, resembling a preconditioning effect. So far, a few drugs have been identified as potential mediators of preconditioning, e.g., adenosine, adenosine receptor agonists, and adenosine triphosphate-sensitive potassium channel openers. Before coronary angioplasty and heart surgery, these preconditioning mimetics might be used to protect myocardial tissue by means of preconditioning. Further research is required before preconditioning mimetics could be used for therapy in patients with chronic myocardial ischemia. Possible antipreconditioning effects of several drugs, e.g., sulfonylurea drugs have to be considered in the treatment of patients with coronary artery disease.

Topics: Cardiovascular Agents; Humans; Ischemic Preconditioning, Myocardial; Myocardial Infarction

This review article summarizes the long-term standard therapy for patients with myocardial infarction. The chronic therapy is able to significantly improve quality of life and survival of affected patients. Previous studies showed that in most western countries, the established standard therapy is not given to all patients who would benefit from chronic treatment. The essential parts of today's myocardial infarction treatment consists of effective beta-blockade, inhibition of the angiotensin-conversion enzyme, inhibition of platelet aggregation and lipid lowering agents. This article reviews the clinical benefits which may be expected from each of these therapeutic approaches. Newer, but not yet proven strategies, like blockade of the angiotensin receptor subtype 1 and treatment with antioxidative agents will be discussed.

Topics: Adrenergic beta-Antagonists; Angiotensin-Converting Enzyme Inhibitors; Aspirin; Cardiovascular Agents; Humans; Myocardial Infarction; Prognosis; Randomized Controlled Trials as Topic; Survival Rate

Topics: Cardiovascular Agents; Female; Humans; Life Style; Male; Myocardial Infarction; Risk Factors

Topics: Cardiovascular Agents; Diabetes Mellitus; Diet; Evidence-Based Medicine; Humans; Hyperlipidemias; Hypertension; Life Style; Myocardial Infarction; Recurrence; Risk Factors; Smoking Cessation

We report the case of a 63-year-old female patient with apical hypertrophic cardiomyopathy, diagnosed by the presence of localized apical hypertrophy in the echocardiogram and a typical "spade like" left ventricular angiographic image, but with unique electrocardiographic features, characterized by chronic ST segment elevation, and T wave inversion, in the anterolateral leads. These changes were initially interpreted as a manifestation of acute ischemic heart disease. Chronic ST segment elevation has been occasionally described in patients with hypertrophic cardiomyopathy complicated with apical necrosis and aneurysm formation, but not in uncomplicated cases of apical hypertrophic cardiomyopathy. Its knowledge by the physician could allow avoidance of problems of differential diagnosis with more frequent heart diseases, especially acute atherosclerotic ischaemic heart disease.

Topics: Cardiomyopathy, Hypertrophic; Cardiovascular Agents; Diagnosis, Differential; Diltiazem; Electrocardiography; Female; Humans; Middle Aged; Myocardial Infarction

Diabetes mellitus is a risk factor for coronarosclerosis and for high mortality after myocardial infarction (MI). The causes of this high mortality are: more extensive and premature coronarosclerosis, more frequent left ventricular dysfunction, worse glycemic control with increased myocardial oxygen consumption, sulfanylurea drugs before and during MI. The results of a multicenter study (DIGAMI) and other studies suggest that a better control of diabetes using intravenous infusion of insulin and glucose, followed by long-term (3 months) intensive insulin therapy subcutaneously, improves long-term prognosis after MI. The relative reduction of mortality at the end of follow-up (3.4 years) is 28%. Thrombolysis reduces mainly mortality in hospital,s period and does not provoke retinal haemorrhages. Aspirin lowers the relative risk of mortality to 0.72. The beta-blockers are less used in diabetic patients because they probably alter diabetic control, lipid profile and "mask" the hypoglycemic symptoms, but the results of the beta-blocker's effect concerning reduction of mortality are convincing. ACE inhibitors and statins also reduce mortality in diabetics with MI, via beneficial influence of endothelial dysfunction. The ATMA study registers reduction of rhythmogenic mortality by 29% with amiodarone in high risk of arrhythmia after MI. The invasive methods of treatment in diabetes are accompanied by higher risk of reobstruction. The attempt to reduce this tendency is realizable with intracoronary stents, glycoprotein IIb/IIIa inhibitors and aggressive early treatment of all other risk factors.

Topics: Cardiovascular Agents; Clinical Trials as Topic; Coronary Artery Disease; Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2; Humans; Hypoglycemic Agents; Myocardial Infarction; Risk Factors

Topics: Acute Disease; Angina, Unstable; Angioplasty, Balloon, Coronary; Angiotensin-Converting Enzyme Inhibitors; Cardiovascular Agents; Coronary Artery Bypass; Coronary Disease; Coronary Thrombosis; Humans; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Middle Aged; Myocardial Infarction; Syndrome

Neurohormonal activation is well studied in chronic heart failure, and covers aspects such as abnormalities of plasma catecholamines, particularly since plasma noradrenaline levels have been found to predict impaired prognosis in heart failure patients. This review will concentrate on the information available on circulating levels of adrenaline and noradrenaline. It will discuss how catecholamine levels change during different disease stages from myocardial infarction to severe chronic heart failure. It has been clearly shown that angiotensin converting enzyme (ACE) inhibitors exert particularly beneficial effects in heart failure patients with raised catecholamine levels. Nevertheless, reviewing how a variety of drug and non-drug interventions affect catecholamine levels and patients' survival, it is concluded that the effect on catecholamine levels does not directly correlate with a survival benefit of the respective intervention. Despite their prognostic significance, due to the development of new prognostic markers for patients with chronic heart failure, the overall clinical value of spot catecholamine levels remains limited.

Topics: Arousal; Cardiovascular Agents; Catecholamines; Clinical Trials as Topic; Heart Failure; Hemodynamics; Humans; Myocardial Infarction; Survival Rate

Topics: Arterial Occlusive Diseases; Arteriosclerosis; Cardiovascular Agents; Cerebral Infarction; Fibrinolytic Agents; Humans; Myocardial Infarction; Recurrence

Prevention and attenuation of ischemia and reperfusion injury in patients with acute coronary syndrome are critically important for cardiologists. To save these patients from deleterious ischemic insults, there are three different strategies. The first strategy is to increase ischemic tolerance before the onset of myocardial ischemia; the second is to attenuate the ischemia and reperfusion injury when an irreversible process of myocardial cellular injury occurs; the third is to treat the ischemic chronic heart failure that is caused by acute myocardial infarction. Adenosine, which is known to be cardioprotective against ischemia and reperfusion injury, may merit being used for these three cardioprotection strategies. First of all, adenosine induces collateral circulation via induction of growth factors, and triggers ischemic preconditioning, both of which induce ischemic tolerance in advance. Secondly, endogenous adenosine may mediate the infarct size-limiting effect of ischemic preconditioning, and exogenous adenosine is known to attenuate ischemia and reperfusion injury. Thirdly, we also revealed that adenosine metabolism is changed in patients with chronic heart failure, and increases in adenosine levels may attenuate the severity of ischemic heart failure. Therefore, adenosine therapy may improve the pathophysiology of ischemic chronic heart failure. Taking these factors together, we hereby propose potential tools for cardioprotection attributable to adenosine in ischemic hearts, and we postulate the use of adenosine therapy before, during, and after the onset of acute myocardial infarction.

Topics: 5'-Nucleotidase; Adenosine; Cardiovascular Agents; Collateral Circulation; Heart Failure; Humans; Ischemic Preconditioning, Myocardial; Myocardial Infarction; Myocardial Reperfusion Injury; Protein Kinase C

Current management of patients after an acute myocardial infarction (AMI) reflects a variety of approaches ranging from conservative to aggressive. Although each method is appropriate in certain subgroups, their application frequently lacks a scientific basis. Current, clinically relevant, evidence-based practice guidelines are needed for secondary prevention for survivors after an AMI. To meet this need, the California Cardiology Working Group was assembled to evaluate the available data from clinical trials and other published studies and develop evidence-based, cost-effective guidelines for clinicians to use as a basis for patient management after an AMI. The group consisted of 18 members, including cardiologists from academic institutions and physicians working in cardiac intensive care, private practices, and managed care settings, representing a broad spectrum of expertise pertaining to patients who have had an AMI. The members had expertise in cardiac intensive care, interventional cardiology, nuclear cardiology, lipid disorders, echocardiography, and cardiac rehabilitation. The intended audience for these practice guidelines includes all physicians who treat survivors of MI. A literature review of all relevant clinical trials and other published data about the natural history after AMI and the effects of current therapeutic modalities are discussed herein. Case histories served as models for application of the literature-based data. The recommendations for management were reached by consensus vote based on the scientific evidence. When more than 1 management option applied, this was recognized in the recommendations. The recommendations accompany the text.

Topics: Arrhythmias, Cardiac; Cardiovascular Agents; Cost-Benefit Analysis; Evidence-Based Medicine; Exercise; Humans; Hyperlipidemias; Hypertension; Myocardial Infarction; Myocardial Ischemia; Prognosis; Risk; Risk Factors; Smoking; Ventricular Function, Left

Patients with cardiovascular disease can derive significant benefit from the implementation of risk reduction therapies. Until recently, management of patients with coronary heart disease has centered on the use of angioplasty, bypass surgery and medical therapy for severe fixed obstructions. Several large randomized clinical trials now demonstrate the importance of medical risk reduction therapies in these patients. A consensus panel of the American Heart Association recommends that health care providers use a group of risk reduction therapies, which can significantly extend overall survival, improve quality of life, decrease the need for interventional procedures such as angioplasty and bypass grafting, and reduce the incidence of subsequent myocardial infarction. Since a minority of patients with cardiovascular disease now benefit from these strategies, changes in our health care delivery systems are recommended. Risk reduction case management by nursing staff can assist physicians and improve implementation of and patient adherence to these therapies. Programs are being discussed to develop support by third-party insurers for risk reduction therapies. Application of these therapies should be a routine part of care for patients with cardiovascular disease.

Topics: American Heart Association; Cardiovascular Agents; Case Management; Coronary Disease; Exercise; Humans; Hyperlipidemias; Hypertension; Myocardial Infarction; Nurses; Quality of Life; Randomized Controlled Trials as Topic; Risk; Risk Factors; Smoking; Smoking Cessation; Survival Rate; United States; Weight Loss

Although reperfusion therapy for acute myocardial infarction is known to reduce infarct size, improve left ventricular function, and reduce mortality, the full potential benefit may be limited by acceleration of damage resulting from reperfusion, or "reperfusion injury." Evidence of a variety of mechanisms of reperfusion injury has led to a wide range of proposed therapeutic interventions, including agents to prevent oxygen free radical damage, inhibit white blood cell function, reduce calcium influx, improve microvascular blood flow, inhibit sympathetic stimulation, and improve energy stores. A multitude of agents have been shown to limit infarct size in animals when administered before or during reperfusion. Unfortunately, most have been disappointing when tested clinically. Adenosine, a theoretically attractive agent for preventing reperfusion injury, has shown promise in small, clinical studies, and appears to be an endogenous substance involved in the protective effect of ischemic preconditioning. When studied in the setting of angioplasty for acute myocardial infarction, adenosine was associated with small infarct size and improved coronary flow. As myocardial preservation with reperfusion during bypass surgery shares pathophysiologic characteristics with the reperfused myocardium in acute infarction, early results of adenosine during bypass surgery presented at this symposium support the concept that adenosine may be beneficial. Two ongoing Phase II trials of adenosine in acute myocardial infarction-one with thrombolysis and one with direct angioplasty-will provide important information about the potential benefits of adenosine in the context of reperfusion.

Topics: Adenosine; Angioplasty, Balloon, Coronary; Animals; Cardiovascular Agents; Humans; Myocardial Infarction; Myocardial Reperfusion Injury; Randomized Controlled Trials as Topic; Thrombolytic Therapy; Vasodilator Agents

Since the results of studies done with angiotensin-converting-enzyme(ACE)-inhibitors, systemic thrombolysis and primary percutaneous transluminal angioplasty (PTCA) have been published, post-myocardial infarction therapy has changed dramatically. In most european countries systemic thrombolysis as early as possible is the standard therapy. Cardiologists prefer more and more immediate revascularisation if the technical standard of the hospital is allowing an acute intervention. Pharmacological therapy is done initially with beta-blockers and platelet aggregation inhibitors, if necessary intravenously, since the results of the e.g. GUSTO- and the AIRE-study are known. If left ventricular dysfunction exists or develops, ACE-inhibitors are given after the third day post myocardial infarction.

Topics: Adrenergic beta-Antagonists; Angioplasty, Balloon, Coronary; Angiotensin-Converting Enzyme Inhibitors; Cardiovascular Agents; Combined Modality Therapy; Drug Therapy, Combination; Fibrinolytic Agents; Humans; Myocardial Infarction; Platelet Aggregation Inhibitors; Randomized Controlled Trials as Topic; Risk Factors; Survival Rate; Thrombolytic Therapy

Topics: Cardiovascular Agents; Clinical Trials as Topic; Female; Hemodynamics; Humans; Male; Myocardial Infarction; Prognosis; Survival Rate

Based on results from a multitude of clinical trials of acute myocardial infarction, the beneficial role of a variety of pharmacologic agents, used in conjunction with thrombolytic therapy, has emerged. This is particularly true for aspirin, beta-blockers, heparin, and angiotensin-converting enzyme inhibitors. In addition, the dosage and timing of their administration have been shown to be crucial to their efficacy. The scientific and pathophysiologic basis as well as practical recommendations regarding their use are discussed. The exact role of nitrate therapy and potential for magnesium are presented in addition to data on agents that might be detrimental in the early stages of acute myocardial infarction.

Topics: Cardiovascular Agents; Combined Modality Therapy; Drug Administration Schedule; Drug Therapy, Combination; Humans; Myocardial Infarction; Randomized Controlled Trials as Topic; Recurrence; Survival Analysis; Thrombolytic Therapy; Treatment Outcome

The effective treatment of patients with acute myocardial infarction (AMI) and acute congestive heart failure (CHF) requires quick triage, accurate identification, and appropriate pharmacologic management. This article describes the initial assessment and management of adult patients with AMI and CHF, beginning with the first interaction of such patients with the emergency department staff.

Topics: Acute Disease; Cardiovascular Agents; Heart Failure; Humans; Myocardial Infarction; Shock, Cardiogenic; Thrombolytic Therapy

Acute myocardial infarction occurs with increasing frequency with advancing age, and older patients with acute MI are at increased risk of a variety of complications including congestive heart failure, arrhythmias and conduction disturbances, myocardial rupture, cardiogenic shock, and death. Older patients thus comprise a high-risk subgroup of the MI population who consequently may derive substantial benefit from appropriately selected therapeutic interventions. At the same time, many interventions are associated with increased risks in the elderly, so that individualization of treatment is essential in all patients. Optimal therapy is thus based on a careful risk-benefit assessment of the available treatment options in conjunction with information on patient preferences and other relevant factors. Though many therapeutic trials of patients with acute MI have either excluded elderly patients or enrolled too few older subjects to permit definitive conclusions, sufficient data are available to make specific recommendations in several areas. As shown in Table 6, therapies of proven value in the acute-phase treatment of elderly patients with MI include aspirin and thrombolysis. Intravenous beta blockers are likely to be of benefit as well, and long-term oral beta blockade after MI is clearly beneficial. ACE inhibitors are of proven value in the long-term management of patients with left ventricular dysfunction (ejection fraction less than 40%), but initiation of an ACE inhibitor should probably be delayed for 48 to 72 hours in most cases. The role of other agents including nitrates, magnesium, diltiazem, and verapamil requires further clarification, but anti-arrhythmic drugs and dihydropyridine calcium antagonists should generally be avoided in the absence of specific indications for their use. Finally, though the role of catheterization and revascularization in elderly patients with acute MI requires additional study, current data indicate that age alone should not be considered a contraindication to these procedures. As the age of the population continues to rise, the number of older patients at risk of acute MI also increases. Though progressively more sophisticated interventions may ultimately result in sizable reductions in post-MI morbidity and mortality, given the high risk of adverse outcomes in this population the best treatment is prevention. Thus, the greatest potential for the future, as well as the greatest challenge, is to develop more effective

Topics: Adrenergic beta-Antagonists; Aged; Angioplasty; Angiotensin-Converting Enzyme Inhibitors; Aspirin; Cardiovascular Agents; Female; Humans; Male; Myocardial Infarction; Thrombolytic Therapy

Elderly patients have a significantly higher mortality and morbidity compared with younger patients in the postmyocardial infarction period and thus, with the appropriate management have a greater potential for benefit compared with younger patients. It has been shown in the large randomized trials that elderly patients with acute myocardial infarction benefit significantly from administration of beta-blocking agents and angiotensin-converting enzyme inhibitors. Aspirin and warfarin sodium (Coumadin) have been shown to benefit patients of all age groups. Secondary prevention with cessation of smoking, use of lipid-lowering agents, treatment of hypertension, and estrogen therapy in the postmenopausal woman have been shown to be effective. Elderly patients, therefore, who are free of general noncardiac disability and who can be expected to live meaningful lives should be offered a comprehensive program to reduce their cardiac morbidity and mortality after discharge following acute myocardial infarction.

Topics: Adrenergic beta-Antagonists; Aged; Angiotensin-Converting Enzyme Inhibitors; Anticoagulants; Arrhythmias, Cardiac; Aspirin; Calcium Channel Blockers; Cardiovascular Agents; Estrogens; Female; Humans; Hyperlipidemias; Hypertension; Male; Myocardial Infarction; Risk Factors; Smoking

Myocardial infarction represents a crossroads in the natural history of coronary artery disease. The prognosis is determined by the severity of coronary artery disease, infarct size (and hence ejection fraction), and age of the patient. After infarction, patients may remain symptomless, or suffer angina, silent ischemia, reinfarction, heart failure or sudden death. Hence patient management after infarction includes (1) estimation of risk, (2) the use of stress tests to detect ischemia and rhythm disorders, (3) PTCA or bypass if required and (4) medical therapy. Cardiac catheterization is indicated in patients with angina or silent ischemia, non-Q wave infarction or large infarctus; its use is less well established in patients without ischemia and left ventricular dysfunction, but this indication is nevertheless increasingly accepted. PTCA is primarily utilized in patients with single or two vessel disease, while coronary bypass surgery is indicated in patients with left main or three vessel disease. All these measures are designed to improve symptoms and prognosis. For secondary prevention medical therapy should be used to treat cardiovascular risk factors (antihypertensive drugs, lipid-lowering drugs etc.), to inhibit platelets (aspirin, ticlopidine) or coagulation (coumarins), to block neurohumoral activation (betablocker, ACE-inhibitors), for vasoconstriction (calcium channel blockers, nitrates) and to suppress arrhythmias. The large number of drugs requires reasoned use depending on the risk profile of the individual patient. Cardiovascular risk factors should be treated appropriately. Platelet inhibitors should be given to all patients except those with atrial fibrillation or large ventricles (coumarins). Betablockers reduce mortality, reinfarction and sudden death after infarction and hence should be used if no contraindications exist. ACE-inhibitors are particularly effective in improving symptoms and prognosis in patients with impaired left ventricular function. Calcium antagonists should be used with caution and only in patients with normal left ventricular function. Nitrates are primarily effective in improving symptoms in patients with angina or heart failure. Antiarrhythmic drugs (amiodarone) are only useful in patients with complex arrhythmias. Digitalis has been shown to improve symptoms in patients with heart failure, while other inotropic drugs are virtually no longer used. These guidelines allow reasoned differential therapy after myocard

Topics: Adrenergic beta-Antagonists; Angioplasty, Balloon, Coronary; Angiotensin-Converting Enzyme Inhibitors; Anti-Arrhythmia Agents; Anticoagulants; Calcium Channel Blockers; Cardiovascular Agents; Coronary Angiography; Coronary Artery Bypass; Humans; Myocardial Infarction; Platelet Aggregation Inhibitors; Risk Factors

Topics: Cardiovascular Agents; Clinical Trials as Topic; Coronary Disease; Diabetes Mellitus, Type 1; Female; Humans; Male; Myocardial Infarction; Prognosis

Topics: Antidepressive Agents; Cardiovascular Agents; Depression; Humans; Myocardial Infarction; Myocardial Ischemia

While post-myocardial infarct patients with frequent ventricular premature contractions or nonsustained ventricular tachycardia (NSVT) are at an increased risk of sudden arrhythmic death, the empirical use of antiarrhythmic agents for such patients is no longer justified after the results of the Cardiac Arrhythmia Suppression Trial. A series of major breakthroughs in the design and clinical application of the implantable cardioverter defibrillator (ICD) have taken place over the past two decades since its invention by M Mirowski. Although there is a general consensus for the effectiveness of the ICD therapy in aborting sudden arrhythmic death, it is unknown whether the use of the ICD therapy results in prolonged survival. Three randomized clinical trials directed to the survivors of cardiac arrest due to ventricular tachycardia (VT) or ventricular fibrillation (VF) are currently in progress, comparing the ICD therapy with drug therapy (amiodarone, beta blockers, and sotalol). Already over seventeen hundred patients have been randomized and followed in these three clinical trials. All three trials continue currently indicating no emergence of statistically significant differences in total mortality between the two therapy groups. Prophylactic application of the ICD has been studied in the MADIT (Multicenter Automatic Defibrillator Implantation Trial)--the first randomized clinical trial dealing with implantable defibrillators. This study enrolled post-transmural infarct patients having documented NSVT, left ventricular dysfunction (ejection fraction 35% or lower) and inducible and nonsuppressible NSVT. The study was recently terminated because of an emergence of a highly significant lower mortality with the ICD therapy than with conventional drug therapy. The future for patients at an increased risk of sudden cardiac death is much brighter with future refinement of the ICD system and antiarrhythmic drug therapy, and with further improvement in the therapy directed at the underlying structural heart disease.

Topics: Arrhythmias, Cardiac; Cardiovascular Agents; Death, Sudden, Cardiac; Defibrillators, Implantable; Humans; Multicenter Studies as Topic; Myocardial Infarction; Randomized Controlled Trials as Topic

The currently available antianginal drugs act by reduction of myocardial O2 requirement and/or by coronary vasodilatation. The choice between beta blockers, nitrates, calcium antagonists or their combination depends on the clinical presentation, coexisting disorders and specific factors in individual patients. In addition to symptomatic treatment, secondary prophylactic measures, such as aspirin and reduction of serum cholesterol, are also necessary to prevent progression of the underlying coronary artery disease. In this paper the comparative efficacy and the indications of the various types of antianginal drugs are discussed.

Topics: Angina Pectoris; Angina, Unstable; Calcium Channel Blockers; Cardiovascular Agents; Coronary Vasospasm; Humans; Isosorbide Dinitrate; Myocardial Infarction; Nitroglycerin; Platelet Aggregation Inhibitors; Vasodilator Agents

Topics: Cardiovascular Agents; Clinical Trials as Topic; Contraindications; Decision Trees; Drug Therapy, Combination; Fibrinolytic Agents; Humans; Myocardial Infarction; Streptokinase; Thrombolytic Therapy; Tissue Plasminogen Activator

One of every four persons in the Western industrialised nations has cardiovascular disease. The perioperative setting in those patients is associated with the risk of myocardial ischaemia (PMI) and myocardial infarction, and also with the risk of perioperative stroke and dysfunction of the central nervous system (CNS). Perioperative cardiovascular morbidity represents a major healthcare challenge. The relevance of PMI is well documented. It has been demonstrated in early trials that both myocardial ischaemia and infarction are preventable in high-risk patients undergoing surgery, and that therapeutic agents such as adenosine-related agents, alpha 2-agonists, and other stress modulators can be safely administered to these patients. Regarding perioperative stroke, approximately 3 to 7% of patients undergoing cardiac surgery suffer stroke, with an additional 30% or more suffering in-hospital CNS dysfunction, and 10% suffering moderately severe long-term CNS dysfunction. Few data are available for noncardiac surgery. The number of outcome studies addressing prophylactic or therapeutic options in these patients is quite limited. In fact, only one recent study has established that perioperative stroke is preventable with the use of an adenosine-regulating agent. Thus, it appears that it may be possible to prevent stroke, even though these results require confirmation. Because of the aging of our population, and the medical, financial and social impact of cardiovascular disease, the development of anti-ischaemic therapy, particularly in the surgical patient, will be a critical area of medical research for the next several decades.

Topics: Anesthesia, General; Brain Damage, Chronic; Cardiovascular Agents; Cardiovascular Diseases; Cerebrovascular Disorders; Humans; Intraoperative Complications; Myocardial Infarction; Myocardial Ischemia; Postoperative Complications; Premedication; Risk Factors

Topics: Angioplasty, Balloon, Coronary; Cardiovascular Agents; Combined Modality Therapy; Coronary Disease; Hemodynamics; Humans; Myocardial Infarction; Myocardial Ischemia; Myocardial Revascularization; Postoperative Complications

Major cardiac events are inevitably followed with a pharmacologic plan of therapy for cardiac patients. Careful assessment of the patient's drug regimen is an important aspect of cardiovascular nursing practice. Such assessment will reveal implications for education, compliance counseling, and side effect evaluation. A thorough drug history should include information about both prescription and nonprescription drug use. Assessment for adherence is improved by using supportive, open-ended questions. Assessment for side effects that affect quality of life is important, particularly in the area of sexual dysfunction. Sexual function should be assessed before beginning cardiovascular drug therapy and monitored for changes during treatment. Using principles of chronopharmacology, or therapy based on the time-dependent effects of drugs, nurses can schedule cardiovascular medications and evaluate patient responses in relation to circadian variability in vulnerability and symptoms. Assessment for ease of self-management of the drug regimen should be a particular focus with non-English-speaking patients and those with complex or costly drug regimens.

Topics: Cardiovascular Agents; Dose-Response Relationship, Drug; Drug Administration Schedule; Drug Monitoring; Humans; Myocardial Infarction; Nursing Assessment; Patient Compliance; Patient Education as Topic; Treatment Outcome

Topics: Angina Pectoris; Cardiovascular Agents; Humans; Myocardial Infarction

Topics: Angina Pectoris; Cardiovascular Agents; Humans; Myocardial Infarction

The current treatment of survivors of acute myocardial infarction is now largely based on sound scientific principles, supported by the results of large and well-designed clinical trials. These have demonstrated that aspirin, anticoagulants, beta-blockers, angiotensin converting enzyme inhibitors, and lipid-lowering agents reduce mortality and reinfarction in selected groups of patients. It remains uncertain whether these different treatments are additive and whether there are beneficial or undesirable interactions. In addition to informing us about the effectiveness or otherwise of these and other drugs, we have learned much about the conduct, analysis, and limitations of clinical trials in this context. The selection of patients for the various treatments is a matter of opinion because the results of the trials are open to a variety of interpretations. In assessing trials, one must be sure that they have been conducted on the intention to treat principle and that surrogate and composite end points have not been inappropriately used. In applying the results of trials to one's own practice, one must take into account the problems of extrapolation and subgroup analysis.

Topics: Acute Disease; Cardiovascular Agents; Clinical Trials as Topic; Humans; Myocardial Infarction; Survivors

During the past 15 years, the in-hospital mortality of patients with acute myocardial infarction has considerably declined. The 2 main reasons for this decrease in mortality have been the introduction of intensive coronary care units, and reperfusion of myocardial infarction, either by coronary thrombolysis or percutaneous transluminal coronary angioplasty. However benefits of other therapies should not be overlooked. General care measures should include: close supervision, bed rest, liquid diet, analgesics, reduction of anxiety, oxygen therapy, intravenous heparin and aspirin, monitoring of blood pressure and heart rate. beta-blockers and angiotensin-converting enzyme inhibitors, combined or not with thrombolytic therapy, are also available to reduce the rate of mortality and morbidity. The benefits to be expected from these 2 medications combined have not yet been demonstrated, so that it appears reasonable in common practice to choose either drug according to the patient's functional state.

Topics: Cardiovascular Agents; Humans; Myocardial Infarction; Vascular Patency

Myocardial infarction (MI), myocardial ischemia, ventricular dysrhythmias, and sudden cardiac death (SCD) occur most frequently in the morning, especially in the first few hours after awakening. Among individual patients, however, this pattern may vary widely. Peaks in heart rate, blood pressure, and platelet aggregability and a trough in fibrinolytic activity are thought to influence the morning onset of events. beta-Blockers may blunt the peak occurrence of MI, SCD, and ischemia. Some calcium channel blockers may modify the pattern of ischemia. Alternate-day therapy with 325 mg of aspirin has been shown to blunt the morning onset of MI. The efficacy of thrombolytics may be affected by daily fluctuations in fibrinolytic activity.

Topics: Arrhythmias, Cardiac; Cardiovascular Agents; Circadian Rhythm; Death, Sudden, Cardiac; Heart Rate; Humans; Myocardial Infarction; Risk Factors

Topics: Aged; Cardiovascular Agents; Clinical Trials as Topic; Humans; Myocardial Infarction

Topics: Angioplasty, Balloon, Coronary; Cardiovascular Agents; Contraindications; Emergencies; First Aid; Humans; Monitoring, Physiologic; Myocardial Infarction; Thrombolytic Therapy; Time Factors

To discuss the important predictors of ventricular enlargement after myocardial infarction and the appropriate time frame for the initiation of medical and pharmacologic therapy.. A review of the important contributions relative to the process known as "postinfarction ventricular remodeling" is provided; current clinical implications and areas for future investigation are discussed.. Ventricular dilatation is an important factor in the prognosis after infarction. Stretching and thinning of the myocardium within the infarct region can be seen within hours after the acute event and may be accompanied by delayed but potentially progressive stretching and thinning in the noninfarct regions. Development of left ventricular hypertrophy in the nonischemic myocardium, in response to increased wall stress, can be observed but may be insufficient for proper compensation. This process is referred to as postinfarction remodeling and can result in progressive and long-term changes in ventricular architecture and function in the absence of additional ischemic injury.. The most effective way to limit the extent of postinfarction ventricular remodeling is to limit infarct size by prompt medical intervention within the first few hours. In addition to traditional post-infarction medications such as beta-blockers, nitrates, and aspirin, long-term benefit may be derived by use of adjunctive pharmacologic therapy such as angiotensin converting enzyme inhibitors, which have been shown to be valuable in limiting the extent of ventricular chamber dilatation after infarction. Studies in animal models and conclusions from clinical trials have shown that angiotensin converting enzyme inhibitors also decrease late mortality and cardiac morbidity after infarction, likely through favorable effects on both hemodynamic and neurohumoral factors specific to this class of medication.. These investigations notwithstanding, further studies are necessary for a complete understanding of the pathogenesis of postinfarction ventricular remodeling and the appropriate timing of specific pharmacologic therapy intended to limit ventricular dilatation. The hemodynamic and neurohumoral interactions on and within the heart must be thoroughly understood relative to microscopic and macroscopic changes in cardiac size, shape, and function after myocardial infarction.

Topics: Animals; Cardiomegaly; Cardiovascular Agents; Heart Ventricles; Hemodynamics; Humans; Myocardial Infarction

The early administration of nitrates in acute myocardial infarction (AMI) may lower myocardial oxygen demand and increase blood supply to the ischemic myocardium. Actually, nitrates are the drugs most largely used in AMI patients, but no definite proof of their clinical benefits had been reported before GISSI 3 and ISIS 4. Only a meta-analysis of several trials carried out before the thrombolytic era showed that intravenous nitrates and probably oral nitrates can reduce mortality when given early to patients with myocardial infarction. The adjunctive benefit of nitrates in AMI patients receiving the treatments recommended today (thrombolysis, aspirin, beta-blockade) remained undefined. Accordingly, two large controlled randomized studies--GISSI 3 and ISIS 4--were undertaken to verify benefits and risks of nitrate strategy vs ACE-inhibition strategy in AMI. Overall, about 80,000 patients were enrolled. In both studies a small, non significant decrease of mortality was observed in patients allocated to nitrate arms. In GISSI 3, the mortality reduction was greater in patients receiving both nitroglycerin and lisinopril. Either intravenous or by oral or transdermal route nitrates were well tolerated. In conclusion, the systematic administration of nitrates in acute myocardial infarction induces limited benefits in relation to the strategy based on the clinically indicated nitrate administration (applied in 60% of the control patients) but does not bring up risks.

Topics: Angiotensin-Converting Enzyme Inhibitors; Cardiovascular Agents; Humans; Myocardial Infarction; Nitrates; Randomized Controlled Trials as Topic; Research Design; Time Factors

Topics: Angiotensin-Converting Enzyme Inhibitors; Cardiovascular Agents; Digitalis Glycosides; Diuretics; Heart Failure; Humans; Hypertension; Myocardial Infarction; Prognosis

This overview summarizes the pathophysiology of acute myocardial infarction and reviews existing strategies for secondary prevention of myocardial infarction. The review also examines the complex interactions among lipids and the hemostatic/fibrinolytic systems to delineate the importance of lipid reduction as a secondary prevention measure.. Information gathered includes studies related to the pathogenesis of acute myocardial infarction, secondary prevention of myocardial infarction, hyperlipidemia and the hemostatic/fibrinolytic systems. All studies cited were published prior to 1993.. Atherosclerotic plaque rupture with occlusive thrombus formation is integral to the pathophysiology of acute myocardial infarction. Beta-blockers, acetylsalicylic acid, warfarin, and angiotensin-converting enzyme inhibitors are useful agents for secondary prevention. The myriad deleterious effects of hyperlipidemia that promote a prothrombotic and antifibrinolytic vascular milieu serve to elucidate the importance of lipid reduction as an additional secondary prevention measure.

Topics: Adrenergic beta-Antagonists; Angiotensin-Converting Enzyme Inhibitors; Aspirin; Cardiovascular Agents; Combined Modality Therapy; Coronary Artery Disease; Coronary Circulation; Humans; Hyperlipidemias; Hypolipidemic Agents; Myocardial Infarction; Thrombolytic Therapy; Warfarin

Treatment strategies in acute myocardial infarction are directed toward limitation of infarct size and reduction of frequency of complications. This goal is best achieved by early reperfusion of ischemic myocardium. All trials comparing thrombolytic treatment in acute myocardial infarction indicate that either streptokinase, APSAC, or rtPA reduce mortality significantly. Particularly patients at high risk (old patients, women) benefit most from thrombolytic treatment. Although, conservation of left ventricular function and risk reduction is best achieved by very early treatment, a reduction of mortality has even been shown if thrombolytic agents are if given before 12 hours after onset of symptoms. Primary PTCA is an attractive alternative to thrombolytic therapy particularly in patients with anterior wall myocardial infarction or cardiogenic shock. Routine PTCA early or late after thrombolytic treatment however does not alter the outcome of the patients. The value of rescue PTCA remains to be settled. Heparin as an adjunctive treatment of rtPA improves patency of the coronary arteries and reduces mortality. Newer anti-thrombotic agents like hirudin, argotraban, or monoclonal antibody 7E3 are even more promising for prevention of reocclusion after thrombolytic treatment. Of the conservative medical treatment aspirin, beta-blockade, nitrates, and magnesium all have been shown reduce mortality. Similar effects could not be proven for calcium antagonists or routine antiarrhythmic drugs. ACE-inhibitors are of value if given 3 days after onset of symptoms.

Topics: Aged; Angioplasty, Balloon, Coronary; Aspirin; Cardiovascular Agents; Combined Modality Therapy; Emergencies; Female; Humans; Male; Myocardial Infarction; Survival Rate; Thrombolytic Therapy

The diagnosis of coronary artery disease in the elderly is problematic because older patients often present atypical symptoms or are asymptomatic. Once coronary disease is diagnosed, the proper course of treatment is not always clear, since few studies have focused on patients older than 65 years. Moreover, older patients often have medical conditions that may aggravate coexisting cardiovascular problems or interfere with conventional pharmacotherapy. For these reasons many physicians who treat cardiovascular problems aggressively in younger patients are reluctant to do so in older individuals. There is considerable evidence, however, that older patients could benefit as much or more from aggressive therapy because of their greater risk of mortality from myocardial ischemia and infarction.

Topics: Age Factors; Aged; Cardiovascular Agents; Cause of Death; Comorbidity; Humans; Longitudinal Studies; Myocardial Infarction; Myocardial Ischemia; Randomized Controlled Trials as Topic; Risk Factors; Survival Rate; Treatment Outcome

Topics: Angioplasty, Balloon, Coronary; Angiotensin-Converting Enzyme Inhibitors; Cardiovascular Agents; Coronary Disease; Heart Failure; Heart Transplantation; Hemodynamics; Humans; Myocardial Contraction; Myocardial Infarction; Prognosis; Ventricular Function, Left

Topics: Animals; Cardiotonic Agents; Cardiovascular Agents; Drug Interactions; Drug Therapy, Combination; Heart Failure; Humans; In Vitro Techniques; Myocardial Contraction; Myocardial Infarction

Exercise testing remains an important non-invasive diagnostic test modality in patients with coronary artery disease. In recent years considerable advances have been achieved in the test methodology and in interpretation. The following points are important for the test methodology: (1.) The optimal exercise time is 8-12 minutes. (2.) The stepwise increases in work load should be as small as possible (ideally, according to the ramp protocol). (3.) Whenever possible patients should be tested on a symptom-limited basis. Submaximal ergometry is only indicated in the 2-3 weeks after acute myocardial infarction. (4.) The value of the exercise test depends mainly on the double product achieved (maximal systolic blood pressure x maximal heart rate). The interpretation of the exercise test should consider the clinical and hemodynamic responses and ST-segment changes. ST-segment depressions are the most important diagnostic parameter. The ECG localization (most frequently lateral wall) does not necessarily correspond to the anatomic localization. Exercise capacity and blood pressure response are important prognostic variables.

Topics: Cardiovascular Agents; Coronary Disease; Electrocardiography; Exercise Test; Hemodynamics; Humans; Myocardial Infarction; Physical Endurance; Prognosis; Time Factors

Topics: Angioplasty, Balloon, Coronary; Cardiovascular Agents; Combined Modality Therapy; Electrocardiography; Humans; Myocardial Infarction; Survival Rate; Thrombolytic Therapy

About 10% of survivors of an acute myocardial infarction will die in the following year. Thereafter the risk declines but reinfarction is still an important cause of mortality and morbidity. The post infarction trials have clearly shown that the best proven agents to mitigate this toll are aspirin, beta adrenoceptor blockers, and verapamil (but not other calcium blockers, except diltiazem for non Q wave infarction). In the context of hypertension treatment these post infarction trials may have important lessons for drug selection and ancillary treatment since the majority of subjects will ultimately die of ischaemic heart disease. Although the newer agents such as ACE and renin inhibitors, newer calcium channel blockers and alpha blockers have many promising properties in terms of risk factor reduction, no convincing mortality data exists; it is needed. This review will deal with the known effects (both good and bad) of antihypertensive agents and will also review other drug strategies relevant to the hypertensive patient. It will also point out large areas of ignorance.

Topics: Adrenergic beta-Antagonists; Antihypertensive Agents; Aspirin; Cardiovascular Agents; Humans; Hypertension; Myocardial Infarction; Recurrence

The pharmacologic approach to coronary protection, defined here as the prevention or delay of sudden death and myocardial infarction (without negatively affecting noncardiac mortality), is critically discussed. The value of pharmacologically treating mild hypertension and mild hypercholesterolemia is questioned, and the need for well-designed, randomized clinical trials with definitive endpoints to determine a drug's cardioprotective capability is emphasized. Based on such studies, it is concluded that some (but perhaps not all) beta-receptor antagonists as well as aspirin have been shown to protect against sudden cardiac death. Trials of thiazide diuretics, calcium antagonists, and angiotensin-converting enzyme inhibitors have not shown a reduction in sudden cardiac death, despite having individual benefits with respect to other aspects of cardiovascular disease. The demonstration that some beta blockers are cardioprotective is discussed in terms of the pathophysiology of sudden cardiac death, and differences in the pharmacokinetic profiles of individual agents.

Topics: Aged; Angiotensin-Converting Enzyme Inhibitors; Animals; Calcium Channel Blockers; Cardiovascular Agents; Death, Sudden, Cardiac; Europe; Humans; Hypercholesterolemia; Hypertension; Myocardial Infarction

Few areas of clinical medicine have undergone advancements in the last decade as dramatic as those in the management of acute myocardial infarction (AMI). Nursing care of the AMI patient should be based on a comprehensive knowledge of the pathophysiology involved in order to intervene appropriately, understand medical therapies utilized, and anticipate complications. This article offers an in-depth review and update of the pathophysiology of AMI, current recommendations regarding management of the patient with acute infarction, and an overview of complications that still pose a threat to recovery in some patients.

Topics: Cardiovascular Agents; Coronary Artery Bypass; Humans; Myocardial Infarction; Myocardial Reperfusion Injury; Oxygen Inhalation Therapy

In acute as well as in chronic ischemic heart disease, congestive heart failure indicates a poor prognosis. Treatment after acute myocardial infarction should differentiate between specific subsets. In cardiogenic shock due to extensive ischemic damage, acute revascularization by PTCA or CABG improves the otherwise poor outcome substantially. In congestive heart failure, pre- and afterload reduction by nitrates should be combined with dopamine if systolic blood pressure is below 100 mmHG or dobutamine if an inotropic substance is necessary despite systolic blood pressure greater than 100 mmHg. Amrinone is a potent alternative which combines positive inotropic and vasodilating properties. In chronic ischemic heart disease, congestive heart failure is a clearly defined indication for complete revascularization, if possible. As to drug treatment, progression of the disease characterized by a cardiomyopathy of overload as well as neurohormonal and peripheral maladaptation should be stopped in parallel with symptom relief. Therefore, ACE-Inhibitors are combined very early with diuretic treatment, and digitalis should be added in refractory patients.

Topics: Amrinone; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Artery Bypass; Coronary Disease; Digitalis Glycosides; Diuretics; Heart Failure; Humans; Myocardial Infarction; Shock, Cardiogenic; Vasodilator Agents

Topics: Cardiovascular Agents; Circadian Rhythm; Coronary Disease; Humans; Myocardial Infarction; Risk Factors; Sleep Stages

Topics: Cardiac Catheterization; Cardiovascular Agents; Cholesterol, Dietary; Combined Modality Therapy; Exercise Test; Humans; Myocardial Infarction; Myocardial Reperfusion; Prognosis; Recurrence

Myocardial infarction during pregnancy and puerperium is very rare. Increased awareness of its possible occurrence is important for diagnosis. We report on a 37-year-old woman without coronary risk factors who suffered an anterior septal infarction in the last trimester. Coronary angiography one month after normal delivery and two months after infarction revealed normal coronary arteries. Ventriculography showed anteroseptal akinesia. The assumed etiology of myocardial infarction appears to be coronary spasm. A history of vasospasm in other vascular beds, migraine and Raynaud's phenomenon support this hypothesis. The literature is reviewed with special emphasis on clinical picture, prognosis, etiology and management of myocardial infarction during pregnancy.

Topics: Adult; Cardiovascular Agents; Coronary Vasospasm; Female; Fetus; Heart Function Tests; Humans; Myocardial Infarction; Pregnancy; Pregnancy Complications, Cardiovascular; Risk Factors

Structural and biochemical modifications of the myocardium (remodeling) occur after acute myocardial infarction. An important part of this process of myocardial remodeling takes place in the interstitial compartment which is composed mainly of fibrillar collagen. These remodeling changes are associated with modifications in left ventricular geometry and function that could be deleterious and have significant clinical manifestations. Some salutary effects of the treatment are related to modifications of the process of interstitial remodeling. Clinical studies with calcium channel antagonists, nitrates and, specially converting enzyme inhibitors have shown significant improvement in the degree of ventricular dilation, hemodynamics and exercise tolerance as a compared to placebo treated patients. Ongoing clinical studies will provide us with more definite information on the effects of converting enzyme inhibitors on long term prognosis as well as on myocardial remodeling after acute myocardial infarction.

Topics: Animals; Cardiovascular Agents; Heart Aneurysm; Heart Failure; Heart Ventricles; Humans; Hypertrophy, Left Ventricular; Myocardial Infarction; Myocardium

Topics: Blood Volume; Cardiovascular Agents; Combined Modality Therapy; Heart; Heart Failure; Humans; Intra-Aortic Balloon Pumping; Myocardial Infarction; Oxygen Inhalation Therapy

Like all other scientific disciplines, preclinical pharmacological research is subject to permanent changes. New measuring devices and the possibility of continuous on line data acquisition have markedly influenced basic research in this field. Another aim of modern cardiovascular pharmacology is the testing of promising drugs in clinically relevant animal models of disease, particularly under conditions, referring to the everyday situation in patients, e.g. physical activity. Investigations carried out in this way allow an exact assessment of the clinical efficacy of new drugs, and are, thus, clearly indispensable, also from the ethical point of view, before primary evaluation of the drug in man.

Topics: Angina Pectoris; Animals; Arrhythmias, Cardiac; Austria; Cardiovascular Agents; Cats; Dogs; Drug Evaluation, Preclinical; Electric Countershock; Humans; Hypertension; Myocardial Infarction; Pharmacology; Rats; Research

Topics: Angioplasty, Balloon; Anticoagulants; Cardiovascular Agents; Combined Modality Therapy; Critical Care; Emergency Service, Hospital; Fibrinolytic Agents; Humans; Monitoring, Physiologic; Myocardial Infarction; Myocardial Revascularization

The treatment of pain in the acute phase of a suspected acute myocardial infarction is often insufficient and has remained unchanged during recent years. The introduction of substances with a potential to limit the infarct size, such as thrombolysis and beta-blockade, have, however, decreased the requirement for narcotic analgesics (which are still the drugs of choice in many hospitals). Knowledge is still lacking regarding the duration of pain relief, the time between drug administration and pain relief, and optimal doses for various analgesics. Future research should aim at the development of drugs with a more rapid onset of action, less side effects and more complete analgesia.

Topics: Analgesics; Analgesics, Opioid; Cardiovascular Agents; Humans; Myocardial Infarction; Pain

Topics: Cardiovascular Agents; Electric Countershock; Emergencies; Humans; Mobile Health Units; Myocardial Infarction; Resuscitation; Transportation of Patients

Beta blockers, glucose-insulin-potassium, nitrates, and thrombolytic interventions have been demonstrated to reduce the mortality of acute MI. Because of the number of interventions available, it will become progressively more difficult to isolate their additional benefits. The next challenge will be to determine the ideal combination of interventions to limit infarct size maximally in the context of early reperfusion, thereby limiting reperfusion injury and further improving salvage.

Topics: Arrhythmias, Cardiac; Cardiovascular Agents; Coronary Care Units; Humans; Monitoring, Physiologic; Myocardial Infarction

In medicine and in cardiology one must be aware that there is no "standard" management for any condition. However, some guidelines can be offered for the management of myocardial infarction in the early stages. The following can be considered an aggressive but stepwise approach to therapy of patients with suspected myocardial infarction using conventional drugs with or without thrombolytic therapy or coronary angioplasty. Any patient presenting with prolonged chest pain occurring at rest should have an electrocardiogram. If the ECG is abnormal, an evolving myocardial infarction can be suspected. In this setting, oxygen should be administered if the patient is dyspneic, cyanotic, or has rales in the chest, intravenous nitroglycerin should be given, and the patient's response should be assessed. Caution should be observed at this point if the patient is sweating or hypotensive. Administration of a vasodilator in a dehydrated patient may drop the blood pressure further. If pain is relieved and the ECG returns to normal, the working diagnosis is severe angina. However, acute myocardial infarction should not be dismissed. A strong case for the use of intravenous heparin can be made to prevent the redevelopment of intracoronary clot inasmuch as thrombosis probably occurs in most patients presenting with unstable and severe angina, as it most surely does in patients with an evolving acute myocardial infarction. If nitrates and oxygen relieve chest pain but the ECG remains abnormal, for example, ST segment elevation, the diagnosis of acute evolving myocardial infarction must be considered and intravenous nitrates should be continued. If the patient has no relief of pain from nitrates and oxygen and the ECG remains abnormal, morphine sulfate should be administered intravenously in sufficient dosage to relieve the chest pain but not produce hypotension or hypoventilation. Once the diagnosis of myocardial infarction has been made, some would begin administering intravenous lidocaine as prophylaxis against the ventricular arrhythmias commonly encountered in the earlier stages of myocardial infarction. It has not been my practice to use prophylactic lidocaine, but I believe it is prudent to have a low threshold for the use of this drug in patients with frequent PVCs, especially if they are multifocal. If the patient exhibits symptomatic bradycardia or heart block, a trial with intravenous atropine is warranted. Additionally, while all of this is going on, one should c

Topics: Cardiovascular Agents; Humans; Myocardial Infarction

In this article, data on mortality have been systematically reviewed from the randomized trials of intracoronary and intravenous (i.v.) thrombolytic therapy, hyaluronidase, i.v. nitrates, and calcium channel blockers in acute myocardial infarction (AMI). Such analyses confirm that i.v. streptokinase (SK) reduces short-term mortality by about 20%. Despite a higher incidence of reinfarction in the treated group, this early benefit is maintained long term. The excess reinfarction was observed whether or not SK was followed by anticoagulants or aspirin. The roles of pharmacologic interventions and percutaneous transluminal coronary angioplasty (PTCA) in preventing reinfarction and improving survival further are currently being evaluated. The pooled data from the existing trials of hyaluronidase and i.v. nitrates are consistent with a 20-30% reduction in mortality; ideally, these interventions should also be studied in future large randomized trials. Currently, there is no evidence either from individual studies or the aggregate of all the trials that calcium channel blockers reduce mortality. The collective experience from these trials conducted over the last two decades suggests that most interventions in AMI can at best have only moderate effects (10%, 20%, or at best 30%) on mortality. However, such modest effects produced by the widespread use of these agents could prevent several thousand premature deaths each years. Therefore, current and future trials that assess the effects of new or existing cardiovascular treatments on mortality should aim to randomize at least 10,000 average risk patients or a few thousand high risk patients.

Topics: Cardiovascular Agents; Humans; Myocardial Infarction

We have attempted to review the role of pharmacologic agents in the treatment of patients with acute myocardial infarction for the purposes of limiting infarct size. At this time, the beta-blocking agents and nitroglycerin have been the most extensively studied in clinical trials and should be part of our overall pharmacologic approach to patients with acute myocardial infarction. Treatment, however, needs to be individualized, depending on the resources available within one's hospital and community. The early treatment of patients with acute myocardial infarction is undergoing a revolution. Whereas a decade ago we were satisfied with simply monitoring patients for malignant arrhythmias, now we are aggressively attempting to limit infarct size and reperfuse myocardium. In all these proposed treatments for myocardial salvage, time is a crucial element. Therefore, emergency physicians and paramedics become a vital link to begin appropriate treatment leading to myocardial salvage and reperfusion. We must begin to think of all patients with symptoms of acute myocardial infarction as candidates for aggressive attempts at myocardial salvage. These attempts will only take place with well-coordinated, multidiscipline efforts involving cardiologists, cardiothoracic surgeons, emergency physicians, paramedics, and critical care teams. Our challenge over the next few years will be to develop efficient systems so that all patients with acute myocardial infarction can receive optimal care.

Topics: Adrenergic beta-Antagonists; Anti-Inflammatory Agents; Calcium Channel Blockers; Cardiovascular Agents; Humans; Hyaluronoglucosaminidase; Myocardial Infarction; Nitrates; Superoxide Dismutase

Atherosclerotic coronary artery disease is an important problem in the elderly and is the leading cause of death. It is a diagnosis that is often difficult to make; signs and symptoms of angina pectoris and myocardial infarction can be atypical in the elderly patient for a variety of reasons. The chest radiograph, electrocardiogram, and echocardiogram can provide diagnostic clues as to the presence of coronary artery disease. Exercise testing is foremost among the noninvasive diagnostic modalities, but it has significant limitations particular to the elderly patient. These include a decreased ability to exercise in the elderly, difficulty in interpretation because of an abnormal resting electrocardiogram, and the nature of an imperfect test that provides a statement of probability rather than an unequivocal diagnosis. Cardiac catheterization can be performed with minimal risk in selected, particularly unstable patients, in whom a surgical alternative is contemplated. The elderly patient can benefit as much from coronary artery bypass graft surgery as younger counterparts, albeit with a modestly increased risk. The medical therapy of coronary artery disease, stable and unstable angina, and myocardial infarction is not substantially different in the older patient. Nitrates, beta blockers, and calcium antagonists provide relief of anginal symptoms. The older patient stands to derive the same benefits from CCU monitoring as does the younger patient. An increased awareness of adverse drug reactions is necessary, however, and as for patients of any age, the particular goals of therapy may differ substantially and require an individualized approach.

Topics: Aged; Angina, Unstable; Arrhythmias, Cardiac; Cardiac Catheterization; Cardiovascular Agents; Coronary Artery Bypass; Coronary Disease; Echocardiography; Exercise Test; Humans; Myocardial Infarction

Topics: Acute Disease; Animals; Arrhythmias, Cardiac; Cardiovascular Agents; Coronary Disease; Coronary Vessels; Diastole; Dinoprostone; Dogs; Heart Arrest, Induced; Humans; Infusions, Parenteral; Myocardial Infarction; Perfusion; Prostaglandins E; Streptokinase; Time Factors

Topics: Animals; Arachidonic Acids; Cardiovascular Agents; Coronary Disease; Free Radicals; Humans; Leukocytes; Lysosomes; Myocardial Infarction; Myocarditis; Necrosis; Oxygen Consumption; Phospholipids

Topics: Adrenergic beta-Antagonists; Age Factors; Angioplasty, Balloon; Anti-Arrhythmia Agents; Anticoagulants; Cardiovascular Agents; Coronary Artery Bypass; Diabetes Mellitus; Humans; Hypercholesterolemia; Hyperlipoproteinemias; Hypertension; Myocardial Infarction; Physical Exertion; Platelet Aggregation; Risk; Smoking Prevention

Survivors of the acute phase of a myocardial infarction still have an increased risk of dying, primarily due to causes directly attributable to their coronary heart disease. This review of randomized clinical trials of various interventions with the potential to prolong life in these patients is an attempt to answer a vitally important question. What, if anything, can be done to improve the long-term prognosis in patients who have survived the initial one or two weeks after suffering an acute myocardial infarction? Seven classes of intervention are considered: anticoagulants, platelet-active drugs, lipid-lowering regimens, antiarrhythmic agents, physical exercise, calcium antagonists and beta-blockers. So far only beta-blockers have been shown to have a favorable effect on long-term survival. Many of the trials reviewed had design limitations; in particular, the sample size was often too small for the results to be conclusive.

Topics: Adrenergic beta-Antagonists; Anti-Arrhythmia Agents; Anticoagulants; Blood Platelets; Calcium Channel Blockers; Cardiovascular Agents; Clinical Trials as Topic; Exercise Therapy; Follow-Up Studies; Humans; Myocardial Infarction; Prognosis; Random Allocation

Topics: Acute Disease; Cardiac Catheterization; Cardiac Output; Cardiovascular Agents; Central Venous Pressure; Drug Therapy, Combination; Heart Failure; Heart Rate; Hemodynamics; Homeostasis; Humans; Myocardial Contraction; Myocardial Infarction; Respiration, Artificial

Topics: Angina Pectoris; Angina Pectoris, Variant; Cardiovascular Agents; Clinical Enzyme Tests; Coronary Angiography; Coronary Artery Bypass; Coronary Disease; Electrocardiography; Humans; Myocardial Infarction; Myocardial Revascularization; Prognosis

Topics: Assisted Circulation; Cardiovascular Agents; Heart; Hemodynamics; Humans; Intra-Aortic Balloon Pumping; Myocardial Infarction; Myocardial Revascularization; Shock, Cardiogenic

To compare the efficacy and safety of the dual-therapy CD34 antibody-covered sirolimus-eluting Combo stent (DTS) and the sirolimus-eluting Orsiro stent (O-SES) in patients with and without acute coronary syndrome (ACS) included in the SORT OUT X study.. The incidence of target lesion failure (TLF) after treatment with modern drug-eluting stents has been reported to be significantly higher in patients with ACS when compared to patients without ACS. Whether the results from the SORT OUT X study apply to patients with and without ACS remains unknown.. In total, 3146 patients were randomized to stent implantation with DTS (n = 1578; ACS: n = 856) or O-SES (n = 1568; ACS: n = 854). The primary end point, TLF, was a composite of cardiac death, target-lesion myocardial infarction (MI), or target lesion revascularization (TLR) within 1 year.. At 1 year, the rate of TLF was higher in the DTS group compared to the O-SES group, both among patients with ACS (6.7% vs. 4.1%; incidence rate ratio: 1.65 [95% confidence interval, CI: 1.08-2.52]) and without ACS (6.0% vs. 3.2%; incidence rate ratio: 1.88 [95% CI: 1.13-3.14]). The differences were mainly explained by higher rates of TLR, whereas rates of cardiac death and target lesion MI did not differ significantly between the two stent groups in patients with or without ACS CONCLUSION: Compared to the O-SES, the DTS was associated with a higher risk of TLF at 12 months in patients with and without ACS. The differences were mainly explained by higher rates of TLR.

Topics: Absorbable Implants; Acute Coronary Syndrome; Cardiovascular Agents; Coronary Artery Disease; Drug-Eluting Stents; Humans; Myocardial Infarction; Percutaneous Coronary Intervention; Prosthesis Design; Risk Factors; Sirolimus; Time Factors; Treatment Outcome

Drug eluting stents (DES) are associated with a 2% to 4% annual rate of target lesion failure through 5-to-10-year follow-up. The presence of a metallic protheses is a trigger for neo-atherosclerosis and very late stent thrombosis. A "leave nothing behind" strategy using Drug Coated Balloons has been suggested; however, paclitaxel coated balloons are only recommended in selected indications. Recently a novel sirolimus eluting balloon, the SELUTION SLR. A strategy of percutaneous coronary intervention (PCI) with SEB and provisional DES is non-inferior to a strategy of systematic DES on target vessel failure (TVF) at one and five years. If non-inferiority is met at 5 years, superiority will be tested.. SELUTION DeNovo is a multi-center international open-label randomized trial. Subjects meeting eligibility criteria are randomized 1:1 to treatment of all lesions with either SEB and provisional DES or systematic DES. Major inclusion criteria are PCI indicated for ≥1 lesion considered suitable for treatment by either SEB or DES and clinical presentation with chronic coronary syndrome, unstable angina or non-ST segment elevation myocardial infarction (NSTEMI). There is no limitation in the number of lesions to be treated. Target lesions diameters are between 2 and 5 mm. Major exclusion criteria are lesions in the left main artery, chronic total occlusions, ST segment elevation myocardial infarction and unstable non-ST segment elevation myocardial infarction. Three thousand three hundred twenty six patients will be included in 50 sites in Europe and Asia. TVF rates and their components will be determined at 30 days, 6 months and annually up to 5 years post-intervention. Among secondary endpoints, bleeding events, cost-effectiveness data and net clinical benefits will be assessed.. SELUTION DeNovo trial is an open-label, multi-center international randomized trial comparing a strategy of PCI with SEB and provisional DES to a strategy of PCI with systematic DES on TVF at one and five years. Non-inferiority will be tested at one and five years. If non-inferiority is met at five years, superiority will be tested.

Topics: Cardiovascular Agents; Drug-Eluting Stents; Humans; Myocardial Infarction; Non-ST Elevated Myocardial Infarction; Percutaneous Coronary Intervention; Prosthesis Design; Sirolimus; Treatment Outcome

To investigate whether supplementing older adults with monthly doses of vitamin D alters the incidence of major cardiovascular events.. Randomised, double blind, placebo controlled trial of monthly vitamin D (the D-Health Trial). Computer generated permuted block randomisation was used to allocate treatments.. Australia from 2014 to 2020.. 21 315 participants aged 60-84 years at enrolment. Exclusion criteria were self-reported hypercalcaemia, hyperparathyroidism, kidney stones, osteomalacia, sarcoidosis, taking >500 IU/day supplemental vitamin D, or unable to give consent because of language or cognitive impairment.. 60 000 IU/month vitamin D. The main outcome for this analysis was the occurrence of a major cardiovascular event, including myocardial infarction, stroke, and coronary revascularisation, determined through linkage with administrative datasets. Each event was analysed separately as secondary outcomes. Flexible parametric survival models were used to estimate hazard ratios and 95% confidence intervals.. 21 302 people were included in the analysis. The median intervention period was five years. 1336 participants experienced a major cardiovascular event (placebo 699 (6.6%); vitamin D 637 (6.0%)). The rate of major cardiovascular events was lower in the vitamin D group than in the placebo group (hazard ratio 0.91, 95% confidence interval 0.81 to 1.01), especially among those who were taking cardiovascular drugs at baseline (0.84, 0.74 to 0.97; P for interaction=0.12), although the P value for interaction was not significant (<0.05). Overall, the difference in standardised cause specific cumulative incidence at five years was -5.8 events per 1000 participants (95% confidence interval -12.2 to 0.5 per 1000 participants), resulting in a number needed to treat to avoid one major cardiovascular event of 172. The rate of myocardial infarction (hazard ratio 0.81, 95% confidence interval 0.67 to 0.98) and coronary revascularisation (0.89, 0.78 to 1.01) was lower in the vitamin D group, but there was no difference in the rate of stroke (0.99, 0.80 to 1.23).. Vitamin D supplementation might reduce the incidence of major cardiovascular events, although the absolute risk difference was small and the confidence interval was consistent with a null finding. These findings could prompt further evaluation of the role of vitamin D supplementation, particularly in people taking drugs for prevention or treatment of cardiovascular disease.. ACTRN12613000743763.

Topics: Aged; Cardiovascular Agents; Dietary Supplements; Humans; Myocardial Infarction; Vitamin D; Vitamins

Randomized trials have demonstrated the superiority of ultrathin strut drug-eluting stents compared with alternative stent designs. Whether these differences persist over late-term follow-up is uncertain.. This study sought to compare late-term (5-year) clinical outcomes among patients treated with ultrathin strut (60 µm) bioresorbable polymer sirolimus-eluting stents (BP SES) and thin strut (81 µm) durable polymer everolimus-eluting stents (DP EES).. BIOFLOW V (Biotronik Prospective Randomized Multicenter Study to Assess the Safety and Effectiveness of the Orsiro Sirolimus Eluting Coronary Stent System in the Treatment of Subjects with Up to Three De Novo or Restenotic Coronary Artery Lesions V) was an international, 2:1 randomized trial comparing percutaneous coronary intervention with ultrathin strut BP SES versus thin strut DP EES regarding the primary endpoint of 12-month target lesion failure (TLF). Prespecified outcomes through 5 years were assessed.. Among 1,334 patients randomized to treatment with BP SES (n = 884) or DP EES (n = 450), the 5-year rates of TLF were 12.3% for BP SES and 15.3% for DP EES (P = 0.108). Revascularization with BP SES was associated with a significantly lower target vessel-related myocardial infarction (6.6% vs 10.3%, P = 0.015) and late/very late definite/probable stent thrombosis (0.3% vs 1.6%, P = 0.021). Ischemia-driven target lesion revascularization was numerically but not significantly lower with BP SES (5.9% vs 7.7%, P = 0.202). Cardiac death rates were 2.6% versus 1.9% (P = 0.495) for BP SES and DP EES, respectively.. In a large, randomized trial, TLF and the individual outcomes of cardiac death and target lesion revascularization at 5 years were similar among patients treated with BP SES versus DP EES. Both target vessel-related myocardial infarction and late/very late definite/probable stent thrombosis were significantly lower with BP SES. These results confirm the durability of safety and the effectiveness of percutaneous coronary intervention with ultrathin BP SES.

Topics: Absorbable Implants; Cardiovascular Agents; Coronary Artery Disease; Death; Drug-Eluting Stents; Everolimus; Humans; Myocardial Infarction; Percutaneous Coronary Intervention; Polymers; Prospective Studies; Prosthesis Design; Sirolimus; Treatment Outcome

To explore (1) the extent to which a multicomponent intervention addressed determinants of the desired behaviours (ie, adherence to cardiac rehabilitation (CR) and cardiovascular medications), (2) the associated mechanism(s) of action and (3) how future interventions might be better designed to meet the needs of this patient population.. A qualitative evaluation embedded within a multicentre randomised trial, involving purposive semistructured interviews.. Nine cardiac centres in Ontario, Canada.. Potential participants were stratified according to the trial's primary outcomes of engagement and adherence, resulting in three groups: (1) engaged, adherence outcome positive, (2) engaged, adherence outcome negative and (3) did not engage, adherence outcome negative. Participants who did not engage but had positive adherence outcomes were excluded. Individual domains of the Theoretical Domains Framework were applied as deductive codes and findings were analysed using a framework approach.. Thirty-one participants were interviewed. Participants who were engaged with positive adherence outcomes attributed their success to the intervention's ability to activate determinants including behavioural regulation and knowledge, which encouraged an increase in self-monitoring behaviour and awareness of available supports, as well as reinforcement and social influences. The behaviour of those with negative adherence outcomes was driven by beliefs about consequences, emotions and identity. As currently designed, the intervention failed to target these determinants for this subset of participants, resulting in partial engagement and poor adherence outcomes.. The intervention facilitated CR adherence through reinforcement, behavioural regulation, the provision of knowledge and social influence. To reach a broader and more diverse population, future iterations of the intervention should target aberrant beliefs about consequences, memory and decision-making and emotion.. ClinicalTrials.gov registry; NCT02382731.

Topics: Cardiac Rehabilitation; Cardiovascular Agents; Humans; Myocardial Infarction; Ontario

Limited study has detailed the late-term safety and efficacy of chronic total coronary occlusion (CTO) revascularization among multiple centers applying modern techniques and with newer-generation drug-eluting stents.. Among 20 centers, 222 patients enrolled in the XIENCE coronary stent, performance, and technique (EXPERT) CTO trial underwent CTO percutaneous coronary intervention (PCI) with everolimus-eluting stents (EES). Through planned 4-year follow-up, the primary composite endpoint of major adverse cardiac events (MACE; death, myocardial infarction [MI] and target lesion revascularization) and rates of individual component endpoints and stent thrombosis were determined.. Demographic, lesion, and procedural characteristics included prior bypass surgery, 9.9%; diabetes, 40.1%; lesion length, 36.1 ± 18.5 mm; and stent length, 51.7 ± 27.2 mm. By 4 years, MACE rates were 31.6 and 22.4% by the pre-specified ARC and per-protocol definitions, respectively. Clinically-indicated target lesion revascularization at 4 years was 11.3%. In landmark analyses of events beyond the first year of revascularization, the annualized rates of target vessel-related MI and clinically-indicated target lesion revascularization were 0.53 and 1.3%, respectively. Through 4 years, the cumulative definite/probable stent thrombosis rate was 1.7% with no events occurring beyond the initial year of index revascularization.. In a multicenter registration trial representing contemporary technique and EES, these results demonstrate sustained long-term safety and effectiveness of EES in CTO percutaneous revascularization and can be used to inform shared decision making with patients being considered for CTO PCI relative to late safety and vessel patency.

Topics: Aged; Cardiovascular Agents; Chronic Disease; Coronary Occlusion; Coronary Thrombosis; Drug-Eluting Stents; Everolimus; Female; Humans; Male; Middle Aged; Myocardial Infarction; Percutaneous Coronary Intervention; Prospective Studies; Prosthesis Design; Risk Factors; Time Factors; Treatment Outcome; United States; Vascular Patency

The aim of this study was to examine the relationship of albuminuria to cardiovascular disease outcomes in diabetic patients undergoing treatment for stable coronary artery disease.. We analyzed data from 2176 participants of the Bypass Angioplasty Revascularization Investigation in type-2 diabetes (BARI-2D) trial, a randomized clinical trial comparing Percutaneous coronary intervention/Coronary artery bypass grafting (PCI/CABG) to medical therapy for people with diabetes. The population was stratified by baseline spot urine albumin-creatinine ratio (uACR) into normal (uACR <10 mg/g), mildly (uACR ≥10 mg/g < 30 mg/g), moderately (uACR ≥30 mg/g < 300 mg/g) and severely increased (uACR ≥300 mg/g) groups, and outcomes compared between groups. Death, myocardial infarction (MI) and/or stroke were experienced by 489 patients at a mean follow-up of 4.3 ± 1.5 years. Compared with normal uACR, mildly increased uACR was associated with a 1.4 times (P = 0.042) increase in all-cause mortality. Additionally, nonwhites with type-II diabetes and stable coronary artery disease who had mildly increased albuminuria had a Hazard ratio (HR) of 3.3 times (P = 0.028) for cardiovascular death, 3.1 times for (P = 0.002) all-cause mortality, and two times for (P = 0.015) MI during follow-up.. Mildly increased albuminuria is a significant predictor of all-cause mortality in those with type-II diabetes mellitus and stable coronary artery disease, as well as for cardiovascular events those who are nonwhites.

Topics: Aged; Albuminuria; Brazil; Cardiovascular Agents; Coronary Artery Bypass; Coronary Artery Disease; Diabetes Mellitus, Type 2; Diabetic Nephropathies; Europe; Female; Humans; Male; Middle Aged; Myocardial Infarction; North America; Percutaneous Coronary Intervention; Prospective Studies; Risk Assessment; Risk Factors; Stroke; Time Factors; Treatment Outcome

Polymer-free amphilimus-eluting stents (PF-AES) represent a novel elution technology in the current era of drug-eluting stents. The clinical safety and efficacy of PF-AES as compared with latest-generation permanent-polymer zotarolimus-eluting stents (PP-ZES) have not yet been investigated in a large randomized trial.. In this physician-initiated, prospective, multicenter, randomized, noninferiority trial, an all-comers population requiring percutaneous coronary intervention was enrolled across 3 European sites. Randomization (1:1 ratio) to PP-ZES or PF-AES was performed after stratification for troponin status and diabetes mellitus. In both treatment arms, troponin-positive patients were planned for 12-month dual antiplatelet therapy, whereas troponin-negative patients were planned for 1-month dual antiplatelet therapy. Outcome assessors were blinded to the allocated treatment. The device-oriented primary end point of target-lesion failure was defined as cardiac death, target-vessel myocardial infarction, or target-lesion revascularization at 12-months as analyzed by modified intention-to-treat (80% power, and a 3.5% noninferiority margin).. In total, 1502 patients were randomized and 1491 treated with the assigned stent and available for follow-up. The primary end point occurred in 42 (5.6%) of the 744 patients receiving PP-ZES versus 46 (6.2%) of the 747 patients receiving PF-AES. PF-AES were clinically noninferior to PP-ZES (risk difference, 0.5%; upper limit 1-sided 95% confidence interval, 2.6%; P. PF-AES were noninferior to PP-ZES regarding target-lesion failure at 12 months. Findings regarding the secondary end point and prespecified subgroups were generally consistent with that of the primary end point.. URL: https://www.clinicaltrials.gov . Unique identifier: NCT02328898.

Topics: Acute Coronary Syndrome; Aged; Angina, Stable; Angina, Unstable; Cardiovascular Agents; Coronary Artery Disease; Coronary Thrombosis; Drug-Eluting Stents; Europe; Female; Humans; Male; Middle Aged; Myocardial Infarction; Percutaneous Coronary Intervention; Polymers; Prospective Studies; Prosthesis Design; Risk Factors; Sirolimus; Time Factors; Treatment Outcome

New-generation drug-eluting stents offer the potential for enhanced late outcomes in comparison with early generation drug-eluting stents. However, assessment of extended long-term outcomes for these devices is lacking, especially regarding the comparison between new-generation drug-eluting stents with biodegradable or permanent polymers. The aim of this study is to compare the efficacy and safety of biodegradable polymer-based sirolimus-eluting stents (BP-SES; Yukon Choice PC) versus permanent polymer-based everolimus-eluting stents (PP-EES; Xience) versus early generation permanent polymer-based sirolimus-eluting stents (PP-SES; Cypher) at 10-year follow-up.. Overall, 2603 patients were randomized to treatment with BP-SES (n=1299), PP-EES (n=652), or PP-SES (n=652). The primary end point of this analysis was major adverse cardiac event, the composite of death, myocardial infarction, or target lesion revascularization. The main secondary end point of interest was definite/probable stent thrombosis. Follow-up at 10 years was available in 83% of the study patients.. The 10-year incidence of major adverse cardiac event (BP-SES 47.7% versus PP-EES 46.0% versus PP-SES 54.9%, P=0.003) and mortality (BP-SES 31.8% versus PP-EES 30.3% versus PP-SES 37.2%, P=0.02) was different among the groups. Definite/probable stent thrombosis was not significantly different among the groups (BP-SES 1.8% versus PP-EES 2.5% versus PP-SES 3.7%, P=0.09). Definite stent thrombosis was significantly different among the groups (BP-SES 1.1% versus PP-EES 0.8% versus PP-SES 2.4%, P=0.03). There were no significant differences between BP-SES and PP-EES.. In this unique long-term outcome analysis, BP-SES and PP-EES showed comparable clinical outcomes out to 10 years. PP-SES had higher rates of major adverse cardiac events and definite stent thrombosis.. URL: https://www.clinicaltrials.gov . Unique identifier: NCT00598676.

Topics: Absorbable Implants; Aged; Cardiovascular Agents; Coronary Angiography; Coronary Artery Disease; Coronary Stenosis; Coronary Thrombosis; Drug-Eluting Stents; Everolimus; Female; Humans; Male; Middle Aged; Myocardial Infarction; Percutaneous Coronary Intervention; Polymers; Prosthesis Design; Risk Assessment; Risk Factors; Sirolimus; Time Factors; Treatment Outcome

Polaprezinc is clinically used for the treatment of gastric ulcers. It induces the mobilization of mesenchymal stem cells and the mRNA expression of insulin-like growth factor-1 in vascular endothelial cells in order to protect injured gastric tissue or skin.. The current study population included 50 patients with primary acute myocardial infarction (AMI). After percutaneous coronary intervention, the subjects were randomly divided into 2 groups, namely, the nonpolaprezinc and polaprezinc groups. Peripheral blood and urinary samples were collected in a specific time to analyze zinc concentration, cardiac enzymes, and the levels of the inflammation marker interleukin-6. To evaluate the cardiac function, echocardiography was performed upon admission to the hospital and at 9 months post-AMI.. The urine and blood zinc levels of the polaprezinc group were higher compared with those of the non-polaprezinc group at 8 days after percutaneous coronary intervention. The mean interleukin-6/maximal creatine phosphokinase level was significantly reduced in the polaprezinc group (0.024 [0.003-0.066] vs. 0.076 [0.015-0.212], respectively; P = .045). In addition, echocardiography revealed that the ejection fraction of the nonpolaprezinc group was not significantly increased between day 3 and 9 months post-AMI (53 [49-60.8] vs. 59.5 [52-69.3], respectively; P = .015). However, a significant increase was detected in the ejection fraction of the polaprezinc group at the 2 time points (54 [51-57] vs. 62 [55-71], respectively; P < .01).. The results of the present study suggest that polaprezinc has an anti-inflammatory effect and improves cardiac function after AMI.

Topics: Aged; Anti-Inflammatory Agents; Biomarkers; Cardiovascular Agents; Carnosine; Electrocardiography; Female; Humans; Male; Middle Aged; Myocardial Infarction; Organometallic Compounds; Percutaneous Coronary Intervention; Treatment Outcome; Zinc; Zinc Compounds

Group-randomized trials of communities often rely on the convenience of pre-existing administrative divisions, such as school district boundaries or census entities, to divide the study area into intervention and control sites. However, these boundaries may include substantial heterogeneity between regions, introducing unmeasured confounding variables. This challenge can be addressed by the creation of exchangeable intervention and control territories that are equally weighted by pertinent socio-demographic characteristics. The present study used territory design software as a novel approach to partitioning study areas for The Minnesota Heart Health Program's "Ask about Aspirin" Initiative.. Twenty-four territories were created to be similar in terms of age, sex, and educational attainment, as factors known to modify aspirin use. To promote ease of intervention administration, the shape and spread of the territories were controlled. Means of the variables used in balancing the territories were assessed as well as other factors that were not used in the balancing process.. The analysis demonstrated that demographic characteristics did not differ significantly between the intervention and control territories created by the territory design software.. The creation of exchangeable territories diminishes geographically based impact on outcomes following community interventions in group-randomized trials. The method used to identify comparable geographical units may be applied to a wide range of population-based health intervention trials.. National Institutes of Health (Clinical Trials.gov), Identifier: NCT02607917 . Registered on 16 November 2015.

Topics: Aged; Aspirin; Cardiovascular Agents; Community Health Services; Cross-Over Studies; Female; Geographic Information Systems; Humans; Male; Middle Aged; Minnesota; Multicenter Studies as Topic; Myocardial Infarction; Patient Selection; Primary Prevention; Randomized Controlled Trials as Topic; Socioeconomic Factors; Software; Stroke

Endothelial progenitor cells (EPCs) have been characterized as one of the key effectors of endothelial healing. The effect of Danhong injection (DHI), the most widely prescribed Chinese medicine for coronary heart disease (CHD), on EPCs mobilization remains unclear.. We aimed to assess the effect of DHI on EPCs mobilization to repair percutaneous coronary intervention (PCI) induced vascular injury, and to investigate the characteristics and potential mechanism of DHI on EPCs mobilization.. Forty-two patients with CHD underwent PCI and received stent implantation were enrolled in a Phase II clinical trials. All patients received routine western medical treatment after PCI, patients of DHI group received DHI in addition. The levels of CECs, cytokines (vWF, IL-6, CRP) and EPCs were analyzed at baseline, post-PCI and after treatment. To investigate the characteristics of DHI on EPCs mobilization, 12 healthy volunteers received intravenous infusion of DHI once and the other 12 received for 7 days. EPCs enumeration were done at a series of time points. At last we tested the effect of DHI and three chemical constituents of DHI (danshensu; lithospermic acid, LA; salvianolic acid D, SaD) on EPCs level and expression of Akt, eNOS and MMP-9 in bone marrow cells of myocardial infarction (MI) mice.. In the DHI group the angina symptoms were improved, the levels of cytokines and CECs were reduced; while EPCs population was increased after treatment. In the phase I clinical trials, EPCs counts reached a plateau phase in 9 h and maintained for more than 10 h after a single dose. After continuous administration, EPCs levels plateaued on the 3rd or 4th day, and maintain till 1 day after the withdrawal, then its levels gradually declined. DHI treatment induced a timely dependent mobilization of EPCs. DHI promoted EPCs mobilization via upregulating the expression of Akt, eNOS and MMP-9 in BM. LA and SaD have played a valuable role in EPCs mobilization.. These initial results demonstrated that DHI is effective in alleviating endothelial injury and promoting endothelial repair through enhancing EPCs mobilization and revealed the effect feature and possible mechanisms of DHI in mobilizing EPCs.

Topics: Aged; Animals; Cardiovascular Agents; Coronary Disease; Drugs, Chinese Herbal; Endothelial Progenitor Cells; Endothelium, Vascular; Female; Humans; Injections; Male; Matrix Metalloproteinase 9; Mice, Inbred C57BL; Middle Aged; Myocardial Infarction; Nitric Oxide Synthase Type III; Percutaneous Coronary Intervention; Proto-Oncogene Proteins c-akt; Vascular System Injuries

Topics: Aged; Biomarkers; Blood Pressure; Cardiac Rehabilitation; Cardiovascular Agents; Cardiovascular Diseases; Cholesterol; Denmark; Female; Follow-Up Studies; Glycated Hemoglobin; Health Equity; Humans; Life Style; Male; Medication Adherence; Middle Aged; Myocardial Infarction; Prospective Studies; Risk Factors; Secondary Prevention; Smoking; Social Support; Socioeconomic Factors

We aimed to compare the long-term outcomes of the novel biodegradable polymer cobalt-chromium sirolimus-eluting stent (BP-SES) versus the durable polymer sirolimus-eluting stent (DP-SES) in the I-LOVE-IT2 trial.. Comparisons of the long-term safety and efficiency of the BP-DES versus the DP-DES are limited.. A total of 2,737 patients eligible for coronary stenting were randomized to the BP-SES or DP-SES group at a 2:1 ratio. The primary endpoint of target lesion failure (TLF) was defined as a composite of cardiac death, target vessel myocardial infarction (MI), or clinically indicated target lesion revascularization.. A three-year clinical follow-up period was available for 2,663 (97.3%) patients. There were no significant differences in TLF (8.9% vs. 8.6%, P = 0.81), patient-oriented composite endpoint (PoCE) (15.2% vs.14.5%, P = 0.63), or individual components between the BP-SES and DP-SES. Definite/probable stent thrombosis (ST) was low and similar at 3 years (0.8% vs. 1.0%, P = 0.64). Landmark analysis of 1-3 years showed that the TLF (2.7% vs. 2.6%, P = 0.81), PoCE (6.2% vs. 5.1%, P = 0.28), and definite/probable ST (0.4% vs. 0.4%, P = 1.00) were comparable between the 2 arms.. In this prospective randomized trial, the BP-SES showed similar clinical results versus the DP-SES in terms of safety and efficacy outcomes over a 3-year follow-up period.

Topics: Acute Coronary Syndrome; Aged; Cardiovascular Agents; China; Chromium Alloys; Coated Materials, Biocompatible; Coronary Artery Disease; Coronary Restenosis; Coronary Thrombosis; Drug-Eluting Stents; Female; Humans; Male; Middle Aged; Myocardial Infarction; Percutaneous Coronary Intervention; Polymers; Prospective Studies; Prosthesis Design; Recurrence; Risk Factors; Sirolimus; Time Factors; Treatment Outcome

This study sought to measure early strut coverage in patients receiving drug-eluting stents (DESs) and to explore the feasibility of short-term dual antiplatelet therapy (DAPT) based on the degree of early strut coverage.. Data for early strut coverage in patients receiving new-generation DESs, and its implications for DAPT continuation were limited.. A randomized, multicenter trial was conducted in 894 patients treated with DESs. Patients were randomly assigned to everolimus-eluting stent (EES) (n = 444) or biolimus-eluting stent (BES) (n = 450) groups and optical coherence tomography (OCT)-guided (n = 445) or angiography-guided (n = 449) implantation groups using a 2-by-2 factorial design. Early strut coverage was measured as the percentage of uncovered struts on 3-month follow-up OCT examination. The primary outcome was the difference in early strut coverage between EES and BES groups and between OCT- and angiography-guided implantation groups. The secondary outcome was a composite of cardiac death, myocardial infarction, stent thrombosis, and major bleeding during the first 12 months post-procedure in patients receiving 3-month DAPT based on the presence of early strut coverage (≤6% uncovered) on 3-month follow-up OCT.. Three-month follow-up OCT data were acquired for 779 patients (87.1%). The median percentage of uncovered struts at 3 months was 8.9% and 8.2% in the EES and BES groups, respectively (p = 0.69) and was lower in the OCT-guided group (7.5%) than in the angiography-guided group (9.9%; p = 0.009). Favorable early strut coverage (≤6% uncovered strut) was observed in 320 of 779 patients (41.1%). At 12 months, the composite event rarely occurred in the 3-month (0.3%) or 12-month (0.2%) DAPT groups (p = 0.80).. OCT-guided DES implantation improved early strut coverage compared with angiography-guided DES implantation, with no difference in strut coverage between EES and BES groups. Short-term DAPT may be feasible in selected patients with favorable early strut coverage (Determination of the Duration of the Dual Antiplatelet Therapy by the Degree of the Coverage of The Struts on Optical Coherence Tomography From the Randomized Comparison Between Everolimus-eluting Stents Versus Biolimus A9-eluting Stents [DETECT-OCT]; NCT01752894).

Topics: Aged; Cardiovascular Agents; Coronary Angiography; Coronary Artery Disease; Coronary Thrombosis; Drug Therapy, Combination; Drug-Eluting Stents; Everolimus; Feasibility Studies; Female; Humans; Male; Middle Aged; Myocardial Infarction; Percutaneous Coronary Intervention; Platelet Aggregation Inhibitors; Prosthesis Design; Republic of Korea; Risk Factors; Sirolimus; Stroke; Time Factors; Tomography, Optical Coherence; Treatment Outcome

The survival difference between adherers and non-adherers to placebo in the Coronary Drug Project has been used to support the thesis that adherence adjustment in randomized trials is not generally possible and, therefore, that only intention-to-treat analyses should be trusted. We previously demonstrated that adherence adjustment can be validly conducted in the Coronary Drug Project using a simplistic approach. Here, we re-analyze the data using an approach that takes full advantage of recent methodological developments.. We used inverse-probability weighted hazards models to estimate the 5-year survival and mortality risk when individuals in the placebo arm of the Coronary Drug Project adhere to at least 80% of the drug continuously or never during the 5-year follow-up period.. Adjustment for post-randomization covariates resulted in 5-year mortality risk difference estimates ranging from - 0.7 (95% confidence intervals (CI), - 12.2, 10.7) to 4.5 (95% CI, - 6.3, 15.3) percentage points.. Our analysis confirms that appropriate adjustment for post-randomization predictors of adherence largely removes the association between adherence to placebo and mortality originally described in this trial.. ClinicalTrials.gov, Identifier: NCT00000482 . Registered retrospectively on 27 October 1999.

Topics: Adult; Cardiovascular Agents; Humans; Male; Medication Adherence; Middle Aged; Myocardial Infarction; Patient Selection; Placebos; Time Factors; Treatment Outcome

The study sought to evaluate for the first time the 5-year outcomes after treating an all-comers population with newer-generation cobalt chromium-based Resolute Integrity zotarolimus-eluting stents (ZES) (Medtronic, Santa Rosa, California) versus platinum chromium-based PROMUS Element everolimus eluting stents (EES) (Boston Scientific, Natick, Massachusetts).. The DUTCH PEERS (TWENTE II) (DUrable polymer-based sTent CHallenge of Promus ElemEnt versus ReSolute integrity: TWENTE II) trial is a randomized, multicenter, single-blinded, investigator-initiated all-comers trial that found at its main analysis similar 1-year safety and efficacy for both drug-eluting stents. It is the first randomized trial ever to investigate the Resolute Integrity ZES and the first trial to compare both devices.. In total, 1,811 patients were 1:1 randomized to ZES versus EES. We performed a pre-specified assessment of the 5-year clinical outcomes in terms of safety and efficacy. The main endpoint target vessel failure (TVF) is a composite of cardiac death, target vessel-related myocardial infarction, or target vessel revascularization. Secondary endpoints included the individual components of TVF, and stent thrombosis. The study was independently monitored, and adverse clinical events were independently adjudicated.. Five-year clinical follow-up data was available in 1,798 (99.3%) patients. The ZES and EES groups showed favorable outcomes, with similar 5-year incidence of TVF (13.2% vs. 14.2%; p. At 5-year follow-up, the Resolute Integrity ZES and PROMUS Element EES showed similar and sustained results in terms of safety and efficacy for treating a broad population of all-comers.

Topics: Acute Coronary Syndrome; Aged; Cardiovascular Agents; Coronary Artery Disease; Coronary Restenosis; Coronary Thrombosis; Drug-Eluting Stents; Everolimus; Female; Humans; Male; Middle Aged; Myocardial Infarction; Netherlands; Percutaneous Coronary Intervention; Prosthesis Design; Risk Factors; Single-Blind Method; Sirolimus; Time Factors; Treatment Outcome

The authors sought to investigate the impact of diabetes mellitus (DM) on outcomes following contemporary drug-eluting stent (DES) implantation in the BIONICS (BioNIR Ridaforolimus Eluting Coronary Stent System in Coronary Stenosis) trial.. Patients with DM are at increased risk for adverse events following percutaneous coronary intervention (PCI).. A prospective, multicenter, 1:1 randomized trial was conducted to evaluate in a noninferiority design the safety and efficacy of ridaforolimus-eluting stents versus zotarolimus-eluting stents among 1,919 patients undergoing PCI. Randomization was stratified to the presence of medically treated DM, and a pre-specified analysis compared outcomes according to the presence or absence of DM up to 2 years.. The overall prevalence of DM was 29.1% (559 of 1,919). DM patients had higher body mass index, greater prevalence of hyperlipidemia and hypertension, and smaller reference vessel diameter. One-year target lesion failure (cardiac death, target vessel myocardial infarction, or ischemia-driven target lesion revascularization) was significantly higher among diabetic patients (7.8% vs. 4.2%; p = 0.002), mainly due to higher target lesion revascularization (4.5% vs. 2.0%; p = 0.002). Rates of cardiac death, myocardial infarction, and stent thrombosis did not statistically vary. Among 158 patients undergoing 13-month angiographic follow-up, restenosis rates were 3 times higher in diabetic patients compared with nondiabetic patients (15.2% vs. 4.7%; p = 0.01). Clinical and angiographic outcomes were similar between ridaforolimus-eluting stent- and zotarolimus-eluting stent-treated patients.. Despite advances in interventional therapies, and the implementation of new-generation DES, diabetic patients still have worse angiographic and clinical outcomes compared with nondiabetic patients undergoing PCI.

Topics: Aged; Cardiovascular Agents; Coronary Artery Disease; Coronary Restenosis; Coronary Stenosis; Coronary Thrombosis; Diabetes Mellitus; Drug-Eluting Stents; Female; Humans; Male; Middle Aged; Myocardial Infarction; Percutaneous Coronary Intervention; Prevalence; Prospective Studies; Prosthesis Design; Risk Factors; Single-Blind Method; Sirolimus; Time Factors; Treatment Outcome

This study sought to compare the clinical outcomes of 6-month versus 12-month dual antiplatelet therapy (DAPT) in patients receiving multiple biodegradable polymer-coated sirolimus-eluting stents (BP-SES) implants.. The clinical outcomes for patients who undergo multiple BP-SES implantation with different DAPT durations are uncertain.. In the I-LOVE-IT 2 trial, 907 patients treated with multiple BP-SES (total stent number ≥2) were assigned to receive 6-month (n = 440) or 12-month (n = 467) DAPT. The primary endpoint was 12-month target lesion failure (TLF), which is a composite of cardiac death, target vessel myocardial infarction (MI) or clinically indicated target lesion revascularization. The major secondary endpoints were 12-month net adverse clinical events, a composite of all causes of death, MI, stroke, any revascularization and bleeding.. The number of stents per patient between the 6-month and 12-month DAPT group was similar (2.4 ± 0.7 vs. 2.4 ± 0.7, P = 0.47). The incidence of 12-month TLF was comparable in the 6-month and 12-month DAPT groups (9.3% vs.7.5%, Log-rank P = 0.33). However, landmark analysis showed that 12-month DAPT, compared to 6-month DAPT, was associated with a significantly lower risk of TLF (4.8% vs. 2.4%, Log-rank P = 0.049) at a cost of a slightly increased risk of all bleeding events (0.5% vs. 1.7%, Log-rank P = 0.07) between 6 and 12 months.. In patients treated with multiple BP-SES, 6- and 12-month DAPT had similar impacts on 12-month clinical outcomes. Additionally, 12-month DAPT might reduce TLF between 6 and 12 months at the cost of a slightly increased risk of all bleeding events. © 2017 Wiley Periodicals, Inc.

Topics: Absorbable Implants; Acute Coronary Syndrome; Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; China; Coronary Angiography; Coronary Artery Disease; Drug Administration Schedule; Drug Therapy, Combination; Drug-Eluting Stents; Female; Hemorrhage; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Myocardial Infarction; Platelet Aggregation Inhibitors; Polymers; Prospective Studies; Risk Factors; Sirolimus; Stroke; Time Factors; Treatment Outcome

The MeRes-1 trial sought to study the safety and effectiveness of a novel sirolimus-eluting bioresorbable vascular scaffold (MeRes100 BRS) in treating de novo native coronary artery lesions by clinical evaluation and using multiple imaging modalities.. The MeRes-1 first-in-human trial was a single-arm, prospective, multicentre study, which enrolled 108 patients with de novo coronary artery lesions (116 scaffolds were deployed to treat 116 lesions in 108 patients). At six months, quantitative coronary angiography revealed in-scaffold late lumen loss of 0.15±0.23 mm with 0% binary restenosis. Optical coherence tomography demonstrated minimum scaffold area (6.86±1.73 mm2) and percentage neointimal strut coverage (99.30%). Quantitative intravascular ultrasound analysis confirmed a 0.14±0.16 mm2 neointimal hyperplasia area. At one year, major adverse cardiac events, a composite of cardiac death, any myocardial infarction and ischaemia-driven target lesion revascularisation, occurred in only one patient (0.93%) and there was no scaffold thrombosis reported. At one year, computed tomography angiography demonstrated that all scaffolds were patent and in-scaffold mean percentage area stenosis was 11.33±26.57%.. The MeRes-1 trial demonstrated the safety and effectiveness of MeRes100 BRS. The favourable clinical outcomes and effective vascular responses have provided the basis for further studies in a larger patient population. The MeRes-1 trial is registered at the Clinical Trials Registry-India.

Topics: Absorbable Implants; Aged; Cardiovascular Agents; Coronary Vessels; Everolimus; Female; Humans; Male; Middle Aged; Myocardial Infarction; Percutaneous Coronary Intervention; Polyesters; Prospective Studies; Sirolimus; Tomography, Optical Coherence; Treatment Outcome

This analysis investigates the 5-year outcomes of the biodegradable polymer biolimus-eluting stent (BP-BES) and durable polymer everolimus-eluting stent (DP-EES) in an all-comers population undergoing percutaneous coronary intervention.. Recent 1- and 3-year results from randomized trials have indicated similar safety and efficacy outcomes of BP-BES and DP-EES. Whether benefits of the biodegradable polymer device arise over longer follow-up is unknown. Moreover, in-depth, prospective, long-term follow-up data on metallic drug-eluting stents with durable or biodegradable polymers are scarce.. The COMPARE II trial (Abluminal Biodegradable Polymer Biolimus-Eluting Stent Versus Durable Polymer Everolimus-Eluting Stent) was a prospective, randomized, multicenter, all-comers trial in which 2,707 patients were randomly allocated (2:1) to BP-BES or DP-EES. The pre-specified endpoint at 5 years was major adverse cardiac events, a composite of cardiac death, nonfatal myocardial infarction, or target vessel revascularization.. Five-year follow-up was available in 2,657 patients (98%). At 5 years, major adverse cardiac events occurred in 310 patients (17.3%) in the BP-BES group and 142 patients (15.6%) in the DP-EES group (p = 0.26). The rate of the combined safety endpoint all-cause death or myocardial infarction was 15.0% in the BP-BES group versus 14.8% in the DP-EES group (p = 0.90), whereas the efficacy measure target vessel revascularization was 10.6% versus 9.0% (p = 0.18), respectively. Interestingly, definite stent thrombosis rates did not differ between groups (1.5% for BP-BES vs. 0.9% for DP-EES; p = 0.17).. The 5-year analysis comparing biodegradable polymer-coated BES and the durable polymer-coated EES confirms the initial early- and mid-term results regarding similar safety and efficacy outcomes in this all-comers percutaneous coronary intervention population.

Topics: Absorbable Implants; Aged; Cardiovascular Agents; Coronary Artery Disease; Coronary Thrombosis; Drug-Eluting Stents; Everolimus; Female; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Myocardial Infarction; Percutaneous Coronary Intervention; Polymers; Prospective Studies; Prosthesis Design; Risk Factors; Sirolimus; Time Factors; Treatment Outcome

The aim of this study was to compare neointimal modification with scoring balloon pre-dilation before drug-coated balloon (DCB) versus DCB standard therapy in patients presenting with drug-eluting stent (DES) restenosis.. DCB angioplasty for the treatment of coronary drug-eluting stent restenosis has demonstrated encouraging results. The efficacy of DCB treatment relies on rapid initial drug transfer and tissue retention of the antiproliferative drug. Neointimal modification with scoring balloon pre-dilation may enhance the efficacy of DCB therapy.. In this randomized, open-label, active-controlled trial, 252 patients with clinically significant DES restenosis were enrolled at 4 centers in Germany. Patients undergoing DCB angioplasty were randomly assigned to treatment with scoring balloon pre-dilation or standard therapy. The primary endpoint of the study was in-segment percentage diameter stenosis on 6- to 8-month follow-up angiography. The secondary endpoints included binary angiographic restenosis and late lumen loss on follow-up angiography, the combined incidence of death or myocardial infarction, target lesion revascularization, and target lesion thrombosis at 1 year.. Follow-up angiographic data at 6 to 8 months were available for 203 patients (80.6%). Scoring balloon pre-dilation compared with standard therapy showed significantly lower rates with respect to the primary endpoint (35.0 ± 16.8% vs. 40.4 ± 21.4%; p = 0.047) and binary angiographic restenosis (18.5% vs. 32.0%; p = 0.026). Late lumen loss was numerically lower after scoring balloon pre-dilation compared with standard therapy (0.31 ± 59 mm vs. 0.41 ± 0.74 mm; p = 0.27). There was no difference between the groups in the incidence of death or myocardial infarction (4.0% vs. 3.4%; p = 0.73). Scoring balloon versus standard therapy showed comparable rates of target lesion revascularization (16.2% vs. 21.8%; p = 0.26). No target lesion thrombosis occurred out to 1 year.. In patients presenting with drug-eluting stent restenosis, neointimal modification with scoring balloon improves the antirestenotic efficacy of DCB therapy. (Intracoronary Stenting and Angiographic Results: Optimizing Treatment of Drug Eluting Stent In-Stent Restenosis 4 [ISAR-DESIRE 4]; NCT01632371).

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiac Catheters; Cardiovascular Agents; Coated Materials, Biocompatible; Coronary Angiography; Coronary Restenosis; Coronary Thrombosis; Drug-Eluting Stents; Female; Germany; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Myocardial Infarction; Neointima; Percutaneous Coronary Intervention; Prosthesis Design; Therapeutics; Time Factors

The aim of this study was to compare the performance of drug-coated stents (DCS) versus bare-metal stents (BMS) in patients who are candidates for long-term oral anticoagulation (OAC) after percutaneous coronary interventions.. The randomized controlled LEADERS FREE (A Randomized Clinical Evaluation of the BioFreedom™ Stent) trial demonstrated the superior safety and efficacy of a polymer-free biolimus A9 DCS compared with a similar BMS used with 1 month of dual antiplatelet therapy in 2,466 patients at high bleeding risk.. The 2 stents were compared in a pre-specified analysis of the 879 LEADERS FREE patients (35.6%) scheduled to remain on OAC after percutaneous coronary intervention. The primary safety endpoint was a composite of cardiac death, myocardial infarction, and stent thrombosis. The primary efficacy endpoint was the incidence of clinically driven target lesion revascularization.. Baseline characteristics of 448 DCS and 431 BMS recipients were similar, 78.8% had histories of atrial fibrillation, and 21% presented with acute coronary syndromes. Four hundred patients in the DCS group and 376 in the BMS group were discharged on OAC after percutaneous coronary intervention. At 2 years, for the DCS and BMS recipients, respectively, the incidence of clinically driven target lesion revascularization was 7.5% versus 11.2% (hazard ratio: 0.63; 95% confidence interval: 0.40 to 1.01; p = 0.0514), the safety endpoint was reached by 14.4% and 15.0% (p = NS), and the rates of major bleeding events (Bleeding Academic Research Consortium 3 to 5) were 10.7% and 12.9% (p = NS).. The efficacy advantage of DCS over BMS up to 2 years appears confirmed in patients on long-term OAC. Despite the very short course of dual antiplatelet therapy, both the DCS and BMS groups experienced similarly high rates of major bleeding. (A Randomized Clinical Evaluation of the BioFreedom™ Stent [Leaders Free]; NCT01623180).

Topics: Acute Coronary Syndrome; Administration, Oral; Aged; Aged, 80 and over; Anticoagulants; Cardiovascular Agents; Coronary Artery Disease; Coronary Thrombosis; Double-Blind Method; Drug-Eluting Stents; Female; Hemorrhage; Humans; Kaplan-Meier Estimate; Male; Metals; Myocardial Infarction; Percutaneous Coronary Intervention; Platelet Aggregation Inhibitors; Proportional Hazards Models; Prosthesis Design; Risk Factors; Sirolimus; Stents; Time Factors; Treatment Outcome

The authors sought to evaluate the final 5-year safety and effectiveness of the platinum-chromium everolimus-eluting stent (PtCr-EES) in the randomized trial, as well as in 2 single-arm substudies that evaluated PtCr-EES in small vessels (diameter <2.5 mm; n = 94) and long lesions (24 to 34 mm; n = 102).. In the multicenter, randomized PLATINUM (PLATINUM Clinical Trial to Assess the PROMUS Element Stent System for Treatment of De Novo Coronary Artery Lesions), the PtCr-EES was noninferior to the cobalt-chromium everolimus-eluting stent (CoCr-EES) at 1 year in 1,530 patients undergoing percutaneous coronary intervention.. Patients with 1 or 2 de novo coronary artery lesions (reference vessel diameter 2.50 to 4.25 mm, length ≤24 mm) were randomized 1:1 to PtCr-EES versus CoCr-EES. All patients in the substudies received PtCr-EES. The primary endpoint was target lesion failure (TLF), a composite of target vessel-related cardiac death, target vessel-related myocardial infarction, or ischemia-driven target lesion revascularization.. In the randomized trial, the 5-year TLF rate was 9.1% for PtCr-EES and 9.3% for CoCr-EES (hazard ratio [HR]: 0.97; p = 0.87). Landmark analysis demonstrated similar TLF rates from discharge to 1 year (HR: 1.12; p = 0.70) and from 1 to 5 years (HR: 0.90; p = 0.63). There were no significant differences in the rates of cardiac death, myocardial infarction, target lesion or vessel revascularization, or stent thrombosis. PtCr-EES had 5-year TLF rates of 7.0% in small vessels and 13.6% in long lesions.. PtCr-EES demonstrated comparable safety and effectiveness to CoCr-EES through 5 years of follow-up, with low rates of stent thrombosis and other adverse events. The 5-year event rates were also acceptable in patients with small vessels and long lesions treated with PtCr-EES. (The PLATINUM Clinical Trial to Assess the PROMUS Element Stent System for Treatment of De Novo Coronary Artery Lesions [PLATINUM]; NCT00823212; The PLATINUM Clinical Trial to Assess the PROMUS Element Stent System for Treatment of De Novo Coronary Artery Lesions in Small Vessels [PLATINUM SV]; NCT01498692; The PLATINUM Clinical Trial to Assess the PROMUS Element Stent System for Treatment of Long De Novo Coronary Artery Lesions [PLATINUM LL]; NCT01500434).

Topics: Aged; Asia; Cardiovascular Agents; Chromium Alloys; Coronary Artery Disease; Coronary Thrombosis; Drug-Eluting Stents; Europe; Everolimus; Female; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Myocardial Infarction; Percutaneous Coronary Intervention; Platinum; Proportional Hazards Models; Prosthesis Design; Risk Factors; Time Factors; Treatment Outcome; United States

We sought to compare the procedural implications of using bioresorbable everolimus-eluting scaffolds (BVS) and Pt-Cr everolimus-eluting stent with abluminal bioabsorbable polymer (Synergy).. There are important differences in the respective platforms, which could impact on procedural performance, complications and outcomes.. A prospective, randomized single center study including consecutive patients in stable clinical condition and with lesions amenable to be treated with BVS according to predefined criteria. Patients were randomized to either treatment with BVS or Synergy. All procedural data were collected and 12 months clinical follow up conducted. Primary objectives were fluoroscopy time, median dose-area product, contras agent volumen, and peri-procedural troponin release.. A total of 200 patients were included, 100 in BVS group and 100 in Synergy group. No significant differences were observed in baseline clinical and angiographic characteristics. Predilatation (97.6 vs. 25.4%; P < 0.001), postdilatation (64.8 vs. 38.4%: P < 0.01), and use of 2 wires (20.8 vs. 10%; P = 0.02) were more frequent with BVS. The BVS group showed a significant increase in fluoroscopy time (18%), dose-area product (20%), and contrast volume (10%). Post-procedural increase of creatinine was similar and amount of TnI release was significantly higher with BVS but incidence of peri-procedural infarction was comparable. Clinical outcomes at 12 months were similar with definite thrombosis being 1% with BVS and 0% with Synergy.. The use of BVS in comparison with the Synergy stent in a similar lesional setting is associated with a higher use of resources in the procedure, more radiation, and higher TnI release. © 2016 Wiley Periodicals, Inc.

Topics: Absorbable Implants; Aged; Cardiovascular Agents; Coated Materials, Biocompatible; Contrast Media; Coronary Angiography; Coronary Artery Disease; Coronary Thrombosis; Drug-Eluting Stents; Everolimus; Female; Humans; Male; Middle Aged; Myocardial Infarction; Percutaneous Coronary Intervention; Polymers; Prospective Studies; Prosthesis Design; Radiation Dosage; Radiation Exposure; Radiography, Interventional; Risk Factors; Spain; Time Factors; Treatment Outcome

We aimed to investigate the impact of lesion calcification on angiographic outcomes after Absorb everolimus-eluting bioresorbable vascular scaffold (BVS) implantation in comparison with those after cobalt-chromium everolimus-eluting stent (CoCr-EES) implantation.. The present post hoc analysis of the ABSORB Japan randomised trial compared post-procedure and 13-month angiographic outcomes between patients implanted with BVS and CoCr-EES based on the presence or absence of calcification, excluding extremely heavily calcified lesions or lesions requiring rotational atherectomy. The study population comprised 384 patients with 384 lesions (including 114 lesions [29.7%] with moderate or severe calcification), classified into two subgroups: calcification, 114 (BVS: n=72 and CoCr-EES: n=42) and non-calcification, 270 (BVS: n=181 and CoCr-EES: n=89). Follow-up angiography was performed in 94.8% of patients. Both post-procedure and follow-up in-device minimal lumen diameters were comparable in both the BVS arm (calcification vs. non-calcification: 2.43±0.32 mm vs. 2.43±0.39 mm, p=0.91 and 2.17±0.49 mm vs. 2.27±0.47 mm, p=0.17) and in the CoCr-EES arm (2.68±0.34 mm vs. 2.65±0.42 mm, p=0.62 and 2.57±0.52 mm vs. 2.47±0.53 mm, p=0.36).. Moderate or severe lesion calcification (excluding patients with extremely heavily calcified lesions or lesions requiring rotational atherectomy) does not negatively affect angiographic outcomes at both post-procedure and 13-month follow-up after BVS implantation.

Topics: Absorbable Implants; Aged; Aged, 80 and over; Cardiovascular Agents; Coronary Artery Disease; Drug-Eluting Stents; Everolimus; Female; Humans; Japan; Male; Middle Aged; Myocardial Infarction; Percutaneous Coronary Intervention; Sirolimus; Treatment Outcome; Vascular Calcification

Implantation of early-generation metallic drug-eluting stents (DES) in patients with acute myocardial infarction (AMI) is associated with poor vessel wall healing. Use of biodegradable polymer (BP) DES might improve safety outcomes; however, the impact of varying drug elution and polymer absorption kinetics of BP-DES on clinical outcomes in the AMI population is unknown.. This subgroup analysis of the randomized PANDA III trial included 732 patients (366 in each group) presenting with recent (<1 month) AMI. Primary endpoint was 1-year target lesion failure (TLF), a composite of cardiac death, target vessel myocardial infarction (MI), or ischemia-driven target lesion revascularization. Secondary endpoints included a patient-oriented composite endpoint (PoCE) of all-cause death, all MI, or any revascularization; individual TLF and PoCE components; and definite/probable stent thrombosis (ST).. There were no significant differences between-groups in baseline clinical, angiographic, or procedural characteristics other than the proportion of post-dilatation, which was performed more frequently with the BuMA stent (53.9% vs. 44.5%; P = 0.004). After 1 year, compared to Excel SES implantation in patients with AMI, BuMA was associated with similar incidences of TLF and PoCE (5.5% vs. 8.3%, P = 0.14; 8.8% vs. 9.9%, P = 0.61, respectively) but lower incidences of MI (2.5% vs. 6.1%, P = 0.02), target vessel MI (2.2% vs. 5.8%, P = 0.01), and definite/probable ST (0.3% vs. 2.2%, P = 0.04).. BuMA SES, with faster drug elution rate and polymer absorption kinetics, might improve safety outcomes compared to Excel SES in the high-risk AMI population. © 2017 Wiley Periodicals, Inc.

Topics: Absorbable Implants; Adsorption; Aged; Cardiovascular Agents; China; Coronary Angiography; Coronary Thrombosis; Drug-Eluting Stents; Female; Humans; Kaplan-Meier Estimate; Kinetics; Lactic Acid; Male; Middle Aged; Myocardial Infarction; Percutaneous Coronary Intervention; Polyesters; Polyglycolic Acid; Polylactic Acid-Polyglycolic Acid Copolymer; Prospective Studies; Prosthesis Design; Recurrence; Risk Factors; Sirolimus; Treatment Outcome

The authors sought to compare the safety and efficacy of the biocompatible durable-polymer zotarolimus-eluting stent with the biodegradable-polymer biolimus-eluting stent in unselected coronary patients.. Biodegradable-polymer biolimus-eluting stents are superior to first-generation durable-polymer drug-eluting stents in long-term randomized all-comer trials. Long-term data comparing them to second-generation durable-polymer drug-eluting stents are lacking.. The study was a randomized, multicenter, all-comer, noninferiority trial in patients with chronic stable coronary artery disease or acute coronary syndromes and at least 1 coronary artery lesion requiring treatment with a drug-eluting stent. Endpoints included major adverse cardiac events (MACE), a composite of safety (cardiac death and myocardial infarction not clearly attributable to a non-target lesion) and efficacy (target lesion revascularization); the individual endpoints of MACE; all-cause mortality; any myocardial infarction; target vessel revascularization; and definite or probable stent thrombosis at 36 months.. From March 2011 to August 2012, 2,999 patients were randomly assigned (1:1) to receive either the zotarolimus-eluting (1,502 patients) or the biolimus-eluting (1,497 patients) stent. At 3-year follow-up, MACE occurred in 128 (8.6%) patients assigned to the durable-polymer zotarolimus-eluting stent and in 144 (9.6%) assigned to the biodegradable-polymer biolimus-eluting stent (p = 0.36). Occurrence of cardiac death (2.7% vs. 3.4%), myocardial infarction not clearly attributable to a non-target lesion (2.7% vs. 2.5%), and target lesion revascularization (5.4% vs. 5.5%) did not differ significantly between the 2 groups. Definite very late stent thrombosis occurred in 6 (0.4%) patients assigned to the durable-polymer zotarolimus-eluting stent and in 10 (0.7%) assigned to the biodegradable-polymer biolimus-eluting stent (p = 0.33).. At 3-year follow-up, the durable-polymer zotarolimus-eluting stent and the biodegradable-polymer biolimus-eluting stent were similar in clinical outcome, with no significant difference in safety and efficacy outcomes, including stent thrombosis.

Topics: Absorbable Implants; Aged; Cardiovascular Agents; Coronary Artery Disease; Coronary Thrombosis; Denmark; Drug-Eluting Stents; Female; Humans; Male; Middle Aged; Myocardial Infarction; Percutaneous Coronary Intervention; Polymers; Proportional Hazards Models; Prosthesis Design; Risk Factors; Sirolimus; Time Factors; Treatment Outcome

The optimal duration of dual antiplatelet therapy (DAPT) after drug-eluting stent (DES) implantation remains undetermined, especially for those at high risk of cardiac events postprocedure.. This study was aimed to investigate the impact of 6 versus 12 months of DAPT after DES implantation based on risk stratification with the residual SYNTAX score (rSS).. A total of 2737 patients in the I-LOVE-IT 2 trial were grouped according to rSS status (low rSS [rSS = 0, n = 1474] versus high rSS [rSS > 0, n = 1263]) and DAPT duration (6 months vs. 12 months). The primary endpoint was 12-month target lesion failure (TLF), and the major secondary endpoints were 12-month net adverse clinical events (NACE) and major bleeding.. Incidences of TLF (5.2 vs. 7.4%, P = 0.01) and NACE (9.2 vs. 13.4%, P < 0.001) at 12 months were significantly higher in patients with high rSSs compared with patients with low rSSs. Landmark analysis showed that, in patients with high rSS, 12-month DAPT was associated with slightly lower risks of TLF (3.0% vs. 1.6%, P = 0.08) and NACE (7.0 vs. 4.4%, P = 0.054) compared with 6-month DAPT within 6 to 12 months after PCI. Patients with different DAPT durations had similar risks of bleeding both in the low and high rSS groups.. Patients with high rSSs have an increased risk of TLF and NACE at 12 months after DES implantation. Twelve-month DAPT might be superior to 6-month DAPT in patients with high rSS for reducing adverse events within 6 to 12 months after PCI without excessive risk of bleeding. © 2017 Wiley Periodicals, Inc.

Topics: Acute Coronary Syndrome; Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; China; Coronary Angiography; Coronary Artery Disease; Decision Support Techniques; Drug Administration Schedule; Drug Therapy, Combination; Drug-Eluting Stents; Female; Hemorrhage; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Multivariate Analysis; Myocardial Infarction; Platelet Aggregation Inhibitors; Predictive Value of Tests; Proportional Hazards Models; Prospective Studies; Risk Factors; Sirolimus; Time Factors; Treatment Outcome

Percutaneous coronary intervention (PCI) in bifurcated lesions with second-generation drug-eluting stents (DES) was associated with increased myocardial infarction (MI) rates. Flexible stent designs that accommodate well to vessel tapering may be of benefit in challenging anatomies such as bifurcated target lesions, but so far data are scarce.. We analyzed the 2-year follow-up data of the DUTCH PEERS (TWENTE II) trial, which randomized 1811 all-comer patients to PCI with newer generation resolute integrity zotarolimus-eluting (Medtronic) or promus element everolimus-eluting stents (Boston Scientific). In bifurcated lesions, provisional stenting was generally performed. Target vessel failure is a composite endpoint, consisting of cardiac death, target vessel MI, or target vessel revascularization.. Patients with at least one bifurcated lesion (n = 465, 25.7 %) versus patients with non-bifurcated target lesions only (n = 1346, 74.3 %) showed similar rates of clinical endpoints including target vessel failure (9.2 versus 7.9 %, p = 0.36) and definite stent thrombosis (0.4 versus 1.0 %, p = 0.38). Target vessel MI was more common in patients with bifurcated lesions (3.4 versus 1.6 %, p = 0.02); but after multivariate analysis with propensity score adjustment, bifurcation treatment was found not to be an independent predictor of target vessel MI (HR 1.40, 95 % CI 0.71-2.76; p = 0.34). Among patients with bifurcated lesions, DES type and side-branch size did not affect outcome, but periprocedural MI occurred more often after two-stent approaches (9.0 versus 2.1 %; p = 0.002).. All-comer patients treated for bifurcated and non-bifurcated target lesions showed similar and low rates of clinical endpoints, suggesting that the DES used are efficacious and safe for treating bifurcated target lesions.

Topics: Aged; Cardiovascular Agents; Coronary Artery Disease; Coronary Thrombosis; Drug-Eluting Stents; Everolimus; Female; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Myocardial Infarction; Netherlands; Percutaneous Coronary Intervention; Proportional Hazards Models; Prosthesis Design; Risk Factors; Sirolimus; Time Factors; Treatment Outcome

The Absorb bioresorbable vascular scaffold (Absorb BVS) provides similar clinical outcomes compared with a durable polymer-based everolimus-eluting metallic stent (EES) in stable coronary artery disease patients. ST-elevation myocardial infarction (STEMI) lesions have been associated with delayed arterial healing and impaired stent-related outcomes. The purpose of the present study is to compare directly the arterial healing response, angiographic efficacy and clinical outcomes between the Absorb BVS and metallic EES.. A total of 191 patients with acute STEMI were randomly allocated to treatment with the Absorb BVS or a metallic EES 1:1. The primary endpoint is the neointimal healing (NIH) score, which is calculated based on a score taking into consideration the presence of uncovered and malapposed stent struts, intraluminal filling defects and excessive neointimal proliferation, as detected by optical frequency domain imaging (OFDI) six months after the index procedure. The study will provide 90% power to show non-inferiority of the Absorb BVS compared with the EES.. This will be the first randomised study investigating the arterial healing response following implantation of the Absorb BVS compared with the EES. The healing response assessed by a novel NIH score in conjunction with results on angiographic efficacy parameters and device-oriented events will elucidate disease-specific applications of bioresorbable scaffolds.

Topics: Absorbable Implants; Adolescent; Adult; Cardiovascular Agents; Coronary Artery Disease; Drug-Eluting Stents; Everolimus; Female; Humans; Immunosuppressive Agents; Male; Middle Aged; Myocardial Infarction; Percutaneous Coronary Intervention; Polymers; Sirolimus; Treatment Outcome; Young Adult

To compare the incidence and predictors of target lesion revascularisation (TLR) and non-TLR after percutaneous coronary intervention with drug-eluting stents (DES).. We pooled patient-level data on 6,137 patients (Resolute zotarolimus-eluting stent: 5,016, XIENCE everolimus-eluting stent: 1,121) in the RESOLUTE Global Program. At three years, clinically driven TLR, unplanned non-TLR, and no revascularisation occurred in 186, 618, and 5,333 patients, respectively. On multivariate analysis, predictors of both TLR and non-TLR were pre-procedure diameter stenosis (%) (odds ratio [OR] 1.01, 95% confidence interval [CI] [1.01-1.02], and OR 0.99 [0.99-1.00]), diabetes (OR 1.46 [1.07-1.99], and OR 1.37 [1.15-1.64]), and prior PCI (OR 1.42 [1.01-2.00], and OR 1.41 [1.18-1.68]). Baseline characteristics associated with TLR only were prior coronary artery bypass graft surgery (OR 2.85 [1.91-4.27]), in-stent restenosis (OR 2.35 [1.43-3.83]), age (OR 0.98 per year [0.97-1.00]), hypertension (OR 1.64 [1.10-2.44]), and pre-procedure reference vessel diameter (OR 0.74 per mm [0.55-0.99]). Baseline characteristics associated with non-TLR only were lesion location (left anterior descending vs. all others) (OR 0.70 [0.59-0.83]), and hyperlipidaemia (OR 1.42 [1.15-1.75]).. The cumulative incidence of non-TLR at three years in patients treated with current-generation DES was almost three times higher than TLR.

Topics: Adult; Aged; Aged, 80 and over; Cardiovascular Agents; Coronary Restenosis; Drug-Eluting Stents; Female; Humans; Incidence; Male; Middle Aged; Myocardial Infarction; Percutaneous Coronary Intervention; Risk Factors; Sirolimus; Time Factors; Treatment Outcome

In the randomized ROTAXUS trial, routine lesion preparation of complex calcified coronary lesions using rotational atherectomy (RA) prior to paclitaxel-eluting stent implantation did not reduce the primary endpoint of angiographic late lumen loss at 9 months compared to stenting without RA. So far, no long-term data of prospective head-to-head comparisons between both treatment strategies have been reported.. ROTAXUS randomly assigned patients with complex calcified coronary lesions to RA followed by stenting (n = 120) or stenting without RA (n = 120). The primary endpoint of the current analysis was the occurrence of major adverse cardiac events (MACE) at 2-year follow-up defined as the composite of death, myocardial infarction, and target vessel revascularization (TVR). At 2 years, MACE occurred in 32 patients in the RA group and 37 patients in the standard therapy group (29.4% vs. 34.3%, P = 0.47). The rates of death (8.3% vs. 7.4%, P = 1.00), myocardial infarction (8.3% vs. 6.5%, P = 0.80), target lesion revascularization (TLR, 13.8% vs. 16.7%, P = 0.58), and TVR (19.3% vs. 22.2%, P = 0.62) were similar in both groups.. Despite high rates of initial angiographic success, nearly one third of patients enrolled in ROTAXUS experienced MACE within 2-year follow-up, with no differences between patients treated with or without RA.

Topics: Aged; Atherectomy, Coronary; Cardiovascular Agents; Coronary Angiography; Coronary Artery Disease; Drug-Eluting Stents; Female; Germany; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Myocardial Infarction; Paclitaxel; Percutaneous Coronary Intervention; Prospective Studies; Prosthesis Design; Risk Factors; Time Factors; Treatment Outcome; Vascular Calcification

Historically, percutaneous coronary intervention (PCI) of bifurcation lesions was associated with worse procedural and clinical outcomes when compared with PCI of non-bifurcation lesions. Newer generation drug-eluting stents (DES) might improve long-term clinical outcomes after bifurcation PCI.. The LEADERS trial was a 10-center, assessor-blind, non-inferiority, all-comers trial, randomizing 1,707 patients to treatment with a biolimus A9(TM) -eluting stent (BES) with an abluminal biodegradable polymer or a sirolimus-eluting stent (SES) with a durable polymer (ClinicalTrials.gov Identifier: NCT00389220). Five-year clinical outcomes were compared between patients with and without bifurcation lesions and between BES and SES in the bifurcation lesion subgroup. There were 497 (29%) patients with at least 1 bifurcation lesion (BES = 258; SES = 239). At 5-year follow-up, the composite endpoint of cardiac death, myocardial infarction (MI) and clinically-indicated (CI) target vessel revascularization (TVR) was observed more frequently in the bifurcation group (26.6% vs. 22.4%, P = 0.049). Within the bifurcation lesion subgroup, no differences were observed in (cardiac) death or MI rates between BES and SES. However, CI target lesion revascularization (TLR) (10.1% vs. 15.9%, P = 0.0495), and CI TVR (12.0% vs. 19.2%, P = 0.023) rates were significantly lower in the BES group. Definite/probable stent thrombosis (ST) rate was numerically lower in the BES group (3.1% vs. 5.9%, P = 0.15). Very late (>1 year) definite/probable ST rates trended to be lower with BES (0.4% vs. 3.1%, P = 0.057).. In the treatment of bifurcation lesions, use of BES led to superior long-term efficacy compared with SES. Safety outcomes were comparable between BES and SES, with an observed trend toward a lower rate of very late definite/probable ST between 1 and 5 years with the BES. © 2015 Wiley Periodicals, Inc.

Topics: Aged; Cardiovascular Agents; Coronary Artery Disease; Coronary Thrombosis; Drug-Eluting Stents; Europe; Female; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Myocardial Infarction; Percutaneous Coronary Intervention; Prospective Studies; Prosthesis Design; Risk Factors; Sirolimus; Time Factors; Treatment Outcome

In percutaneous coronary intervention (PCI) patients new-generation drug-eluting stent (DES) has reduced adverse events in comparison to early-generation DES. The aim of the current study was to investigate the long-term clinical efficacy and safety of new-generation DES versus early-generation DES for PCI of unprotected left main coronary artery (uLMCA) disease.. The patient-level data from the ISAR-LEFT MAIN and ISAR-LEFT MAIN 2 randomized trials were pooled. The clinical outcomes of PCI patients assigned to new-generation DES (everolimus- or zotarolimus-eluting stent) versus early-generation DES (paclitaxel- or sirolimus-eluting stent) were studied. The primary endpoint was the composite of death, myocardial infarction (MI), target lesion revascularization and stroke (MACCE, major adverse cardiac and cerebrovascular event).. In total, 1257 patients were available. At 3 years, the risk of MACCE was comparable between patients assigned to new-generation DES or early-generation DES (28.2 versus 27.5 %, hazard ratio-HR 1.03, 95 % confidence intervals-CI 0.83-1.26; P = 0.86). Definite/probable stent thrombosis was low and comparable between new-generation DES and early-generation DES (0.8 versus 1.6 %, HR 0.52, 95 % CI 0.18-1.57; P = 0.25); in patients treated with new-generation DES no cases occurred beyond 30 days. Diabetes increased the risk of MACCE in patients treated with new-generation DES but not with early-generation DES (P interaction = 0.004).. At 3-year follow-up, a PCI with new-generation DES for uLMCA disease shows comparable efficacy to early-generation DES. Rates of stent thrombosis were low in both groups. Diabetes significantly impacts the risk of MACCE at 3 years in patients treated with new-generation DES for uLMCA disease. ClinicalTrials.gov Identifiers: NCT00133237; NCT00598637.

Topics: Aged; Cardiovascular Agents; Coronary Angiography; Coronary Artery Disease; Drug-Eluting Stents; Everolimus; Female; Germany; Humans; Italy; Kaplan-Meier Estimate; Male; Middle Aged; Myocardial Infarction; Percutaneous Coronary Intervention; Prosthesis Design; Risk Factors; Sirolimus; Stroke; Time Factors; Treatment Outcome

Our aim was to compare the safety and efficacy of a novel, ultrathin strut, biodegradable polymer sirolimus-eluting stent (BP-SES) with a thin strut, durable polymer everolimus-eluting stent (DP-EES) in a pre-specified subgroup of patients with acute ST-segment elevation myocardial infarction (STEMI) enrolled in the BIOSCIENCE trial.. The BIOSCIENCE trial is an investigator-initiated, single-blind, multicentre, randomised non-inferiority trial (NCT01443104). Randomisation was stratified according to the presence or absence of STEMI. The primary endpoint, target lesion failure (TLF), is a composite of cardiac death, target vessel myocardial infarction, and clinically indicated target lesion revascularisation within 12 months. Between February 2012 and May 2013, 407 STEMI patients were randomly assigned to treatment with BP-SES or DP-EES. At one year, TLF occurred in seven (3.4%) patients treated with BP-SES and 17 (8.8%) patients treated with DP-EES (RR 0.38, 95% CI: 0.16-0.91, p=0.024). Rates of cardiac death were 1.5% in the BP-SES group and 4.7% in the DP-EES group (RR 0.31, 95% CI: 0.08-1.14, p=0.062); rates of target vessel myocardial infarction were 0.5% and 2.6% (RR 0.18, 95% CI: 0.02-1.57, p=0.082), respectively, and rates of clinically indicated target lesion revascularisation were 1.5% in the BP-SES group versus 2.1% in the DP-EES group (RR 0.69, 95% CI: 0.16-3.10, p=0.631). There was no difference in the risk of definite stent thrombosis.. In this pre-specified subgroup analysis, BP-SES was associated with a lower rate of target lesion failure at one year compared to DP-EES in STEMI patients. These findings require confirmation in a dedicated STEMI trial.

Topics: Aged; Cardiovascular Agents; Coronary Thrombosis; Drug-Eluting Stents; Everolimus; Female; Humans; Male; Middle Aged; Myocardial Infarction; Percutaneous Coronary Intervention; Single-Blind Method; Sirolimus; Treatment Outcome

The objective of this study is to assess 3-year clinical outcome of patients with true bifurcation lesions (TBLs) versus non-true bifurcation lesions (non-TBLs) following treatment with second-generation drug-eluting stents (DES). TBLs are characterized by the obstruction of both main vessel and side-branch. Limited data are available on long-term clinical outcome following TBL treatment with newer-generation DES. We performed an explorative sub-study of the randomized TWENTE trial among 287 patients who had bifurcated target lesions with side-branches ≥2.0 mm. Patients were categorized into TBL (Medina classes: 1.1.1; 1.0.1; 0.1.1) versus non-TBL to compare long-term clinical outcome. A total of 116 (40.4 %) patients had TBL, while 171 (59.6 %) had non-TBL only. Target-lesion revascularization rates were similar (3.5 vs. 3.5 %; p = 1.0), and definite-or-probable stent thrombosis rates were low (both <1.0 %). The target-vessel myocardial infarction (MI) rate was 11.3 versus 5.3 % (p = 0.06), mostly driven by (periprocedural) MI ≤48 h from PCI. All-cause mortality and cardiac death rates were 8.7 versus 3.5 % (p = 0.06) and 3.5 versus 1.2 % (p = 0.22), respectively. The 3-year major adverse cardiac event rate for patients with TBL versus non-TBL was 20.0 versus 11.7 % (p = 0.05). At 1-, 2-, and 3-year follow-up, 6.5, 13.0, and 11.0 % of patients reported chest pain at less than or equal moderate physical effort, respectively, without any between-group difference. Patients treated with second-generation DES for TBL had somewhat higher adverse event rates than patients with non-TBL, but dissimilarities did not reach statistical significance. Up to 3-year follow-up, the vast majority of patients of both groups remained free from chest pain.

Topics: Aged; Angina Pectoris; Cardiovascular Agents; Coronary Angiography; Coronary Artery Disease; Coronary Thrombosis; Disease-Free Survival; Drug-Eluting Stents; Everolimus; Female; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Myocardial Infarction; Percutaneous Coronary Intervention; Prosthesis Design; Risk Factors; Sirolimus; Time Factors; Treatment Outcome

The PEPCAD China ISR trial investigated the safety and efficacy of paclitaxel-coated balloon (PCB) angioplasty in an Asian patient population with coronary drug-eluting stent in-stent restenosis (DES-ISR).. A total of 220 patients with coronary DES-ISR were treated with PCB angioplasty or with paclitaxel-eluting stents (PES). This randomized (1:1), single-blind prospective multicenter trial in a Chinese population used 9-month in-segment late lumen loss (LLL) as the primary endpoint. Secondary endpoints included the 24-month clinical event rates.. Both treatment groups were similar in terms of patient, lesion, or procedural characteristics. After the 12-month follow-up evaluation, additional clinical events only occurred in the PES study group. The combined rate of all-cause mortality and myocardial infarction (MI) in the PCB group was significantly lower than that in the PES group (3.7% vs. 11.8%, P = 0.03). Additional subgroup analyses of 9-month in-segment LLL and 2-year target lesion failure in patients with diabetes, small vessels, diffuse ISR, and stent margin restenosis did not show more favorable results for one specific treatment group.. The 2-year follow-up demonstrated sustained long-term clinical efficacy for both devices. PCB angioplasty was associated with significantly lower overall and cardiovascular mortality/MI rates in patients with DES-ISR lesions while avoiding the use of additional metal layers for drug release (ClinicalTrials.gov identifier: NCT 01622075).

Topics: Angioplasty, Balloon, Coronary; Cardiac Catheters; Cardiovascular Agents; China; Coated Materials, Biocompatible; Coronary Artery Disease; Coronary Restenosis; Drug-Eluting Stents; Humans; Myocardial Infarction; Paclitaxel; Percutaneous Coronary Intervention; Prospective Studies; Prosthesis Design; Risk Factors; Single-Blind Method; Time Factors; Treatment Outcome

The purpose of this study was to characterize outcomes for everolimus-eluting stent (EES)-treated subjects according to treatment with continued thienopyridine plus aspirin versus aspirin alone 12 to 30 months after stenting.. In the DAPT (Dual Antiplatelet Therapy) study, continued thienopyridine plus aspirin beyond 1 year after coronary stenting reduced ischemic events. Given low rates of stent thrombosis and myocardial infarction (MI) for current drug-eluting stents, we examined outcomes among EES-treated subjects in the DAPT study.. The DAPT study enrolled 25,682 subjects (11,308 EES-treated) after coronary stenting. Following 12 months of treatment with thienopyridine and aspirin, eligible subjects continued treatment with aspirin and 9,961 (4,703 with EES) were randomized to 18 months of continued thienopyridine or placebo. Stent type was not randomized, and the EES subset analysis was post hoc.. Among EES-treated patients, continued thienopyridine reduced stent thrombosis (0.3% vs. 0.7%, hazard ratio [HR]: 0.38, 95% confidence interval [CI]: 0.15 to 0.97; p = 0.04) and MI (2.1% vs. 3.2%, HR: 0.63, 95% CI: 0.44 to 0.91; p = 0.01) versus placebo but did not reduce a composite of death, MI, and stroke (4.3% vs. 4.5%, HR: 0.89, 95% CI: 0.67 to 1.18; p = 0.42), and increased moderate/severe bleeding (2.5% vs. 1.3%, HR: 1.79, 95% CI: 1.15 to 2.80; p = 0.01), and death (2.2% vs. 1.1%, HR: 1.80, 95% CI: 1.11 to 2.92; p = 0.02). Death due to cancer and not related to bleeding was increased (0.64% vs. 0.17%; p = 0.01).. In EES-treated subjects, significant reductions in stent thrombosis and MI and an increase in bleeding were observed with continued thienopyridine beyond 1 year compared with aspirin alone. (The Dual Antiplatelet Therapy Study [DAPT Study]); NCT00977938).

Topics: Aged; Aspirin; Cardiovascular Agents; Coronary Artery Disease; Coronary Thrombosis; Double-Blind Method; Drug Administration Schedule; Drug Therapy, Combination; Drug-Eluting Stents; Everolimus; Female; Hemorrhage; Humans; Male; Middle Aged; Myocardial Infarction; Percutaneous Coronary Intervention; Platelet Aggregation Inhibitors; Prosthesis Design; Pyridines; Risk Factors; Time Factors; Treatment Outcome

Non-ST-elevation myocardial infarction (NSTEMI) and unstable angina pectoris are frequent causes of hospital admission in the elderly. However, clinical trials targeting this population are scarce, and these patients are less likely to receive treatment according to guidelines. We aimed to investigate whether this population would benefit from an early invasive strategy versus a conservative strategy.. In this open-label randomised controlled multicentre trial, patients aged 80 years or older with NSTEMI or unstable angina admitted to 16 hospitals in the South-East Health Region of Norway were randomly assigned to an invasive strategy (including early coronary angiography with immediate assessment for percutaneous coronary intervention, coronary artery bypass graft, and optimum medical treatment) or to a conservative strategy (optimum medical treatment alone). A permuted block randomisation was generated by the Centre for Biostatistics and Epidemiology with stratification on the inclusion hospitals in opaque concealed envelopes, and sealed envelopes with consecutive inclusion numbers were made. The primary outcome was a composite of myocardial infarction, need for urgent revascularisation, stroke, and death and was assessed between Dec 10, 2010, and Nov 18, 2014. An intention-to-treat analysis was used. This study is registered with ClinicalTrials.gov, number NCT01255540.. During a median follow-up of 1·53 years of participants recruited between Dec 10, 2010, and Feb 21, 2014, the primary outcome occurred in 93 (40·6%) of 229 patients assigned to the invasive group and 140 (61·4%) of 228 patients assigned to the conservative group (hazard ratio [HR] 0·53 [95% CI 0·41-0·69], p=0·0001). Five patients dropped out of the invasive group and one from the conservative group. HRs for the four components of the primary composite endpoint were 0·52 (0·35-0·76; p=0·0010) for myocardial infarction, 0·19 (0·07-0·52; p=0·0010) for the need for urgent revascularisation, 0·60 (0·25-1·46; p=0·2650) for stroke, and 0·89 (0·62-1·28; p=0·5340) for death from any cause. The invasive group had four (1·7%) major and 23 (10·0%) minor bleeding complications whereas the conservative group had four (1·8%) major and 16 (7·0%) minor bleeding complications.. In patients aged 80 years or more with NSTEMI or unstable angina, an invasive strategy is superior to a conservative strategy in the reduction of composite events. Efficacy of the invasive strategy was diluted with increasing age (after adjustment for creatinine and effect modification). The two strategies did not differ in terms of bleeding complications.. Norwegian Health Association (ExtraStiftelsen) and Inger and John Fredriksen Heart Foundation.

Topics: Aged, 80 and over; Angina, Unstable; Cardiovascular Agents; Coronary Angiography; Coronary Artery Bypass; Female; Humans; Kaplan-Meier Estimate; Male; Myocardial Infarction; Myocardial Revascularization; Percutaneous Coronary Intervention; Postoperative Hemorrhage; Reoperation; Stroke; Time-to-Treatment; Treatment Outcome

This study has reported 10-year clinical follow-up of patients enrolled in the prospective, randomized LE MANS (Left Main Stenting) trial.. The very long-term outcome after left main stenting in comparison with surgical revascularization remains unknown.. In this prospective, multicenter trial, we randomly assigned 105 patients with unprotected left main coronary artery stenosis with low and medium complexity of coexisting coronary artery disease according to SYNTAX (Synergy Between Percutaneous Coronary Intervention With Taxus and Cardiac Surgery) score to percutaneous coronary intervention (PCI) with stenting (n = 52) or coronary artery bypass grafting (CABG) (n = 53). Drug-eluting stents were implanted in 35%, whereas arterial grafts to the left anterior descending artery were utilized in 81%. Currently, the mean long-term follow-up was collected at 9.8 ± 1.0 years. Follow up for all-cause mortality is complete, whereas the incidence of major adverse cardiovascular and cerebral events (MACCE) was reported from 90% of patients. Ambulatory follow-up was completed in 46 (43.9%) patients.. At 10 years, there was a trend toward higher ejection fraction in stenting when compared with surgery (54.9 ± 8.3% vs. 49.8 ± 10.3%; p = 0.07). The mortality (21.6% vs. 30.2%; p = 0.41) and MACCE (51.1% vs. 64.4%; p = 0.28) were statistically not different between groups; however, numerically the difference was in favor of stenting. Similarly, there was no difference in the occurrence of myocardial infarction (8.7 vs. 10.4%; p = 0.62), stroke (4.3 vs. 6.3%; p = 0.68), and repeated revascularization rates (26.1% vs. 31.3%; p = 0.64). The probability of very long-term survival up to 14 years was comparable between PCI and CABG (74.2% vs. 67.5%; p = 0.34; hazard ratio: 1.45, 95% confidence interval: 0.67 to 3.13); however, there was a trend toward higher MACCE-free survival in the PCI group (34.7% vs. 22.1%; p = 0.06; hazard ratio: 1.71, 95% confidence interval: 0.97 to 2.99).. In patients with unprotected left main coronary artery stenosis with low and medium complexity of coexisting coronary artery disease, stenting offers numerically, but statistically nonsignificant, favorable long-term outcome up to 10 years in terms of safety and efficacy outcome measures, therefore, constitutes an alternative therapy for CABG.

Topics: Aged; Cardiovascular Agents; Coronary Angiography; Coronary Artery Bypass; Coronary Artery Disease; Coronary Stenosis; Disease-Free Survival; Drug-Eluting Stents; Female; Humans; Male; Middle Aged; Myocardial Infarction; Percutaneous Coronary Intervention; Risk Factors; Stents; Stroke; Stroke Volume; Time Factors; Treatment Outcome; Ventricular Function, Left

This study sought to investigate the ischemic and bleeding outcomes of patients fulfilling high bleeding risk (HBR) criteria who were randomized to zotarolimus-eluting Endeavor Sprint stent (E-ZES) or bare-metal stent (BMS) implantation followed by an abbreviated dual antiplatelet therapy (DAPT) duration for stable or unstable coronary artery disease.. DES instead of BMS use remains controversial in HBR patients, in whom long-term DAPT poses safety concerns.. The ZEUS (Zotarolimus-Eluting Endeavor Sprint Stent in Uncertain DES Candidates) is a multinational, randomized single-blinded trial that randomized among others, in a stratified manner, 828 patients fulfilling pre-defined clinical or biochemical HBR criteria-including advanced age, indication to oral anticoagulants or other pro-hemorrhagic medications, history of bleeding and known anemia-to receive E-ZES or BMS followed by a protocol-mandated 30-day DAPT regimen. The primary endpoint of the study was the 12-month major adverse cardiovascular event rate, consisting of death, myocardial infarction, or target vessel revascularization.. Compared with patients without, those with 1 or more HBR criteria had worse outcomes, owing to higher ischemic and bleeding risks. Among HBR patients, major adverse cardiovascular events occurred in 22.6% of the E-ZES and 29% of the BMS patients (hazard ratio: 0.75; 95% confidence interval: 0.57 to 0.98; p = 0.033), driven by lower myocardial infarction (3.5% vs. 10.4%; p < 0.001) and target vessel revascularization (5.9% vs. 11.4%; p = 0.005) rates in the E-ZES arm. The composite of definite or probable stent thrombosis was significantly reduced in E-ZES recipients, whereas bleeding events did not differ between stent groups.. Among HBR patients with stable or unstable coronary artery disease, E-ZES implantation provides superior efficacy and safety as compared with conventional BMS. (Zotarolimus-Eluting Endeavor Sprint Stent in Uncertain DES Candidates [ZEUS]; NCT01385319).

Topics: Aged; Aged, 80 and over; Cardiovascular Agents; Coronary Artery Disease; Drug Therapy, Combination; Drug-Eluting Stents; Female; Hemorrhage; Humans; Male; Metals; Myocardial Infarction; Patient Selection; Percutaneous Coronary Intervention; Platelet Aggregation Inhibitors; Prosthesis Design; Risk Assessment; Risk Factors; Single-Blind Method; Sirolimus; Stents; Time Factors; Treatment Outcome

No data are available on the long-term performance of ultrathin strut biodegradable polymer sirolimus-eluting stents (BP-SES). We reported 2-year clinical outcomes of the BIOSCIENCE (Ultrathin Strut Biodegradable Polymer Sirolimus-Eluting Stent Versus Durable Polymer Everolimus-Eluting Stent for Percutaneous Coronary Revascularisation) trial, which compared BP-SES with durable-polymer everolimus-eluting stents (DP-EES) in patients undergoing percutaneous coronary intervention.. A total of 2119 patients with minimal exclusion criteria were assigned to treatment with BP-SES (n=1063) or DP-EES (n=1056). Follow-up at 2 years was available for 2048 patients (97%). The primary end point was target-lesion failure, a composite of cardiac death, target-vessel myocardial infarction, or clinically indicated target-lesion revascularization. At 2 years, target-lesion failure occurred in 107 patients (10.5%) in the BP-SES arm and 107 patients (10.4%) in the DP-EES arm (risk ratio [RR] 1.00, 95% CI 0.77-1.31, P=0.979). There were no significant differences between BP-SES and DP-EES with respect to cardiac death (RR 1.01, 95% CI 0.62-1.63, P=0.984), target-vessel myocardial infarction (RR 0.91, 95% CI 0.60-1.39, P=0.669), target-lesion revascularization (RR 1.17, 95% CI 0.81-1.71, P=0.403), and definite stent thrombosis (RR 1.38, 95% CI 0.56-3.44, P=0.485). There were 2 cases (0.2%) of definite very late stent thrombosis in the BP-SES arm and 4 cases (0.4%) in the DP-EES arm (P=0.423). In the prespecified subgroup of patients with ST-segment elevation myocardial infarction, BP-SES was associated with a lower risk of target-lesion failure compared with DP-EES (RR 0.48, 95% CI 0.23-0.99, P=0.043, Pinteraction=0.026).. Comparable safety and efficacy profiles of BP-SES and DP-EES were maintained throughout 2 years of follow-up.. URL: https://www.clinicaltrials.gov. Unique identifier: NCT01443104.

Topics: Absorbable Implants; Aged; Cardiovascular Agents; Chi-Square Distribution; Coronary Angiography; Coronary Artery Disease; Coronary Thrombosis; Drug-Eluting Stents; Everolimus; Female; Humans; Kaplan-Meier Estimate; Linear Models; Male; Middle Aged; Myocardial Infarction; Odds Ratio; Percutaneous Coronary Intervention; Polymers; Proportional Hazards Models; Prosthesis Design; Risk Factors; Single-Blind Method; Sirolimus; Switzerland; Time Factors; Treatment Outcome

The aim of this study was to evaluate the late clinical performance of a polymer-free sirolimus- and probucol-eluting stent compared with a new-generation durable polymer-based zotarolimus-eluting stent.. It was previously shown that polymer-free sirolimus- and probucol-eluting stents were noninferior to zotarolimus-eluting stents at 12 months. However, long-term follow-up of these devices is critical to evaluate late comparative efficacy.. In a clinical trial with minimal exclusion criteria, 3,002 patients were randomly assigned to treatment with polymer-free sirolimus- and probucol-eluting stents versus zotarolimus-eluting stents. The primary endpoint was the combined incidence of cardiac death, target vessel-related myocardial infarction, or target lesion revascularization.. At 5 years, there was no difference in the incidence of the primary endpoint between sirolimus- and probucol-eluting stents and zotarolimus-eluting stents (23.8% vs. 24.2%, respectively; hazard ratio: 0.98; 95% confidence interval: 0.84 to 1.15; p = 0.80). The rates of the individual components of the primary endpoint were also comparable in both groups. The incidence of definite or probable stent thrombosis was low in both groups (1.3% vs. 1.6%, respectively; hazard ratio: 0.86; 95% confidence interval: 0.46 to 1.62; p = 0.64). The rates of any death, myocardial infarction, and revascularization were similar in both groups. Results were consistent across pre-specified subgroups of age, sex, diabetes, and vessel size.. Long-term outcomes of patients treated with polymer-free sirolimus- and probucol-eluting stents compared with a new-generation durable polymer-based zotarolimus-eluting stent were similar. Rates of stent thrombosis were low and comparable in both treatment groups, with few events beyond 12 months. (Efficacy Study of Rapamycin- vs. Zotarolimus-Eluting Stents to Reduce Coronary Restenosis [ISAR-TEST-5]; NCT00598533).

Topics: Aged; Cardiovascular Agents; Coronary Artery Disease; Coronary Thrombosis; Disease-Free Survival; Drug-Eluting Stents; Female; Germany; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Myocardial Infarction; Percutaneous Coronary Intervention; Polymers; Probucol; Proportional Hazards Models; Prosthesis Design; Risk Factors; Sirolimus; Time Factors; Treatment Outcome

Cardiac rehabilitation (CR) is the standard of care for patients with coronary heart disease. Despite considerable epidemiological evidence that high stress is associated with worse health outcomes, stress management training (SMT) is not included routinely as a component of CR.. One hundred fifty-one outpatients with coronary heart disease who were 36 to 84 years of age were randomized to 12 weeks of comprehensive CR or comprehensive CR combined with SMT (CR+SMT), with assessments of stress and coronary heart disease biomarkers obtained before and after treatment. A matched sample of CR-eligible patients who did not receive CR made up the no-CR comparison group. All participants were followed up for up to 5.3 years (median, 3.2 years) for clinical events. Patients randomized to CR+SMT exhibited greater reductions in composite stress levels compared with those randomized to CR alone (P=0.022), an effect that was driven primarily by improvements in anxiety, distress, and perceived stress. Both CR groups achieved significant, and comparable, improvements in coronary heart disease biomarkers. Participants in the CR+SMT group exhibited lower rates of clinical events compared with those in the CR-alone group (18% versus 33%; hazard ratio=0.49; 95% confidence interval, 0.25-0.95; P=0.035), and both CR groups had lower event rates compared with the no-CR group (47%; hazard ratio=0.44; 95% confidence interval, 0.27-0.71; P<0.001).. CR enhanced by SMT produced significant reductions in stress and greater improvements in medical outcomes compared with standard CR. Our findings indicate that SMT may provide incremental benefit when combined with comprehensive CR and suggest that SMT should be incorporated routinely into CR.. URL: http://www.clinicaltrials.gov. Unique identifier: NCT00981253.

Topics: Aged; Angina, Unstable; Baroreflex; C-Reactive Protein; Cardiovascular Agents; Cognitive Behavioral Therapy; Combined Modality Therapy; Coronary Disease; Counseling; Exercise Test; Female; Humans; Lipids; Male; Middle Aged; Myocardial Infarction; Proportional Hazards Models; Psychological Tests; Psychometrics; Psychotherapy, Group; Single-Blind Method; Social Support; Stress, Psychological; Stroke; Vascular Surgical Procedures

Blocking the renin-angiotensin-aldosterone system in ST-elevation myocardial infarction (STEMI) patients prevents heart failure and recurrent thrombosis. Our aim was to compare the effects of ramipril and losartan upon the markers of heart failure, endogenous fibrinolysis, and platelet aggregation in STEMI patients over the long term.. After primary percutaneous coronary intervention (PPCI), 28 STEMI patients were randomly assigned ramipril and 27 losartan, receiving therapy for six months with dual antiplatelet therapy (DAPT). We measured N-terminal proBNP (NT-proBNP), ejection fraction (EF), plasminogen-activator-inhibitor type 1 (PAI-1), and platelet aggregation by closure times (CT) at the baseline and after six months.. Baseline NT-proBNP ≥ 200 pmol/mL was observed in 48.1% of the patients, EF < 55% in 49.1%, and PAI-1 ≥ 3.5 U/mL in 32.7%. Six-month treatment with ramipril or losartan resulted in a similar effect upon PAI-1, NT-proBNP, EF, and CT levels in survivors of STEMI, but in comparison to control group, receiving DAPT alone, ramipril or losartan treatment with DAPT significantly increased mean CT (226.7 ± 80.3 sec versus 158.1 ± 80.3 sec, p < 0.05).. Ramipril and losartan exert a similar effect upon markers of heart failure and endogenous fibrinolysis, and, with DAPT, a more efficient antiplatelet effect in long term than DAPT alone.

Topics: Aged; Biomarkers; Cardiovascular Agents; Fibrinolysis; Heart Failure; Humans; Losartan; Middle Aged; Myocardial Infarction; Platelet Aggregation; Ramipril

This registry evaluated the safety and clinical outcomes of the Combo stent in an all-comers population in routine clinical practice. We report 1-year results.. Limitations of current generation drug-eluting stents (DES) are 3-fold: stent thrombosis, neoatherosclerosis related to impaired healing, and repeat revascularization due to (late-) in-stent restenosis. The Combo stent combines an abluminal biodegradable coating eluting sirolimus and a luminal anti-CD34(+) antibody layer to attract endothelial progenitor cells in order to promote vessel healing, thus preventing neointima formation and restenosis.. The REMEDEE (Randomized study to Evaluate the safety and effectiveness of an abluMinal sirolimus coatED bio-Engineered StEnt) post-market registry was an international, multicenter, prospective trial that evaluated clinical outcomes after deployment of the Combo stent, in an all-comers population of patients treated with a Combo stent in the setting of routine clinical care. Clinical endpoints were target lesion failure (TLF), defined as a composite of cardiac death, nonfatal myocardial infarction (MI), or target lesion revascularization (TLR).. Between June 2013 and March 2014, a total of 1,000 patients were included in the registry, 49.9% of whom presented with acute coronary syndrome. Mean age was 65 ± 11 years old (range: 34 to 94 years of age), and 74% of patients were male; 58.9% of 1,255 lesions were American Heart Association type B2 or C lesions. The primary endpoints were 5.7% TLF, 1.7% cardiac death, 0.7% target vessel MI, and 4.4% TLR. Definite stent thrombosis occurred in 0.5% of subjects; no thrombosis occurred after 9 days post-stenting.. This registry showed excellent 1-year results of novel Combo bioengineered stent technology in an all-comers patient population. (Prospective Registry to Assess the Long-term Safety and Performance of the Combo Stent [REMEDEE]; NCT01874002).

Topics: Acute Coronary Syndrome; Adult; Aged; Aged, 80 and over; Cardiovascular Agents; Coronary Angiography; Coronary Artery Disease; Coronary Restenosis; Coronary Thrombosis; Drug-Eluting Stents; Europe; Female; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Myocardial Infarction; Neointima; Percutaneous Coronary Intervention; Product Surveillance, Postmarketing; Prospective Studies; Prosthesis Design; Registries; Risk Factors; Sirolimus; Time Factors; Treatment Outcome; Wound Healing

The aim of this study was to investigate whether a 6-month dual-antiplatelet therapy (DAPT) duration was comparable with a 12-month duration in patients who underwent everolimus-eluting stent implantation.. Well-designed studies that determine optimal DAPT strategies after everolimus-eluting stent implantation are limited.. A total of 1,400 patients (implanted mean total stent length >45 mm) were randomly assigned to receive 6-month (n = 699) or 12-month (n = 701) DAPT between October 2010 and July 2014 at 20 centers in Korea. The primary endpoint was the composite of cardiac death, myocardial infarction, stroke, or TIMI (Thrombolysis in Myocardial Infarction) major bleeding at 1 year, analyzed using an intention-to-treat approach.. The primary endpoint occurred in 15 patients (2.2%) in the 6-month DAPT group and 14 patients (2.1%) in the 12-month DAPT group (hazard ratio [HR]: 1.07; p = 0.854). Definite or probable stent thrombosis occurred in 2 patients (0.3%) in the 6-month DAPT group and in 2 patients (0.3%) in the 12-month DAPT group (HR: 1.00; p = 0.999). There were no significant between-group differences in the primary endpoint in 686 patients with acute coronary syndrome (2.4% in both groups; HR: 1.00; p = 0.994) and in 506 patients with diabetes mellitus (2.2% [6-month] vs. 3.3% [12-month]; HR: 0.64; p = 0.428).. Compared with 12-month DAPT, 6-month DAPT did not increase the composite events of cardiac death, myocardial infarction, stroke, or TIMI major bleeding at 1 year in patients who underwent everolimus-eluting stent implantation. (Impact of Intravascular Ultrasound Guidance on Outcomes of XIENCE PRIME Stents in Long Lesions [IVUS-XPL Study]; NCT01308281).

Topics: Aspirin; Cardiovascular Agents; Clopidogrel; Coronary Thrombosis; Drug Administration Schedule; Drug Therapy, Combination; Drug-Eluting Stents; Everolimus; Hemorrhage; Humans; Intention to Treat Analysis; Myocardial Infarction; Percutaneous Coronary Intervention; Platelet Aggregation Inhibitors; Prosthesis Design; Republic of Korea; Risk Factors; Stroke; Ticlopidine; Time Factors; Treatment Outcome

CENTURY II is a prospective, multicentre, randomised, single-blind trial comparing the bioresorbable polymer sirolimus-eluting Ultimaster® stent (BP-SES) with the permanent polymer everolimus-eluting XIENCE stent (PP-EES). Here we present a pre-specified analysis of safety and efficacy outcomes in a subgroup of patients with small vessel coronary artery disease.. CENTURY II included 525 patients with lesions of reference diameter ≤2.5 mm. Treatment was randomly assigned: 277 patients received BP-SES (399 lesions) and 248 patients received PP-EES (377 lesions). The primary outcome was target lesion failure (TLF), which is a composite of cardiac death, target vessel-related myocardial infarction (MI) and target lesion revascularisation (TLR). There was no significant difference between treatment groups in baseline or procedural data. Mean pre-procedural reference diameter was similar (BP-SES 2.30±0.40 mm, PP-EES 2.31±0.42 mm, p=0.59). Stented length was 24.0±11.7 mm for BP-SES and 23.5±11.5 mm for PP-EES (p=0.45). At 12 months, there was no significant difference between the BP-SES and PP-EES groups in TLF (6.9% vs. 7.7%; p=0.72), cardiac death (1.1% vs. 1.2%; p=0.90), target vessel MI (1.8% vs. 3.2%; p=0.30), TLR (4.0% vs. 5.7%; p=0.37), or definite or probable stent thrombosis (0.7% vs. 1.2%; p=0.57).. In the large-scale, randomised CENTURY II trial, use of BP-SES and PP-EES for the treatment of small vessel coronary artery disease resulted in similar outcomes at 12 months.

Topics: Absorbable Implants; Aged; Aged, 80 and over; Cardiovascular Agents; Coronary Artery Disease; Coronary Thrombosis; Drug-Eluting Stents; Everolimus; Female; Humans; Immunosuppressive Agents; Male; Middle Aged; Myocardial Infarction; Percutaneous Coronary Intervention; Polymers; Sirolimus

Coronary drug-eluting stents with biodegradable polymers have been designed to improve safety and efficacy.. The Scandinavian Organization for Randomized Trials With Clinical Outcome (SORT OUT) VII trial-a large-scale registry-based randomized, multicenter, single-blind, 2-arm, noninferiority trial-compared 2 biodegradable polymer drug-eluting stents: the thin-strut cobalt-chromium sirolimus-eluting Orsiro stent and the stainless steel biolimus-eluting Nobori stent in an all-comer patient population. The primary end point target lesion failure was a composite of cardiac death, myocardial infarction (not related to other than index lesion), or target lesion revascularization within 1 year, analyzed by intention to treat (noninferiority margin of 3.0%). Clinically driven event detection based on Danish registries was used. A total of 1261 patients were assigned to receive the sirolimus-eluting stent (1590 lesions) and 1264 patients to the biolimus-eluting stent (1588 lesions). At 1 year, the composite end point target lesion failure occurred in 48 patients (3.8%) in the sirolimus-eluting group and in 58 patients (4.6%) in the biolimus-eluting group (absolute risk difference, -0.78% [upper limit of 1-sided 95% confidence interval, 0.61%]; P<0.0001). Rates of definite stent thrombosis occurred in 5 (0.4%) of the sirolimus-eluting group compared with 15 (1.2%) biolimus-eluting stent-treated patients (rate ratio, 0.33; 95% confidence interval, 0.12-0.92; P=0.034), which largely was attributable to a lower risk of subacute definite stent thrombosis: 0.1% versus 0.6% (rate ratio, 0.12; 95% confidence interval, 0.02-1.00; P=0.05).. The thin-strut sirolimus-eluting Orsiro stent was noninferior to the biolimus-eluting Nobori stent in unselected patients for target lesion failure at 1 year.. URL: http://www.clinicaltrials.gov. Unique identifier: NCT01879358.

Topics: Absorbable Implants; Aged; Cardiovascular Agents; Chromium Alloys; Coronary Artery Disease; Drug-Eluting Stents; Female; Humans; Intention to Treat Analysis; Male; Middle Aged; Myocardial Infarction; Percutaneous Coronary Intervention; Polymers; Prosthesis Design; Registries; Risk Factors; Scandinavian and Nordic Countries; Single-Blind Method; Sirolimus; Stainless Steel; Time Factors; Treatment Outcome

This study presents the two-year clinical outcomes of the Amsterdam ABSORB registry stratified by lesion and patient characteristics complexity (SYNTAX score and ABSORB II study enrolment criteria).. Patients treated with BVS were included in this prospective registry and stratified according to the ABSORB II trial inclusion and exclusion criteria and the SYNTAX score. The registry comprises 135 patients (59±11 years, 73% male, 18% diabetic) with 159 lesions. Median follow-up duration was 774 days (742-829). Median SYNTAX score was 11.5 (Q1-Q3: 6-17.5). Two-year event rates were cardiac death 0.7%, MI 5.3%, TVR 13.6%, TLR 11.4%, definite ST 3.0% and TVF 14.4%, respectively. Stratified analyses showed a significantly higher revascularisation rate in patients not meeting ABSORB II criteria (TVR: 2.3% vs. 19.2%, p=0.010, and TLR: 2.3% vs. 15.8%, p=0.025) and patients with SYNTAX score ≥11.5 (TVR: 4.8% vs. 21.8%, p=0.006, and TLR: 3.2% vs. 17.4%, p=0.007).. The use of Absorb BVS in patients meeting the ABSORB II trial inclusion criteria or those with low SYNTAX scores is associated with acceptable clinical outcomes at two-year follow-up. Patients with more complex characteristics have significantly higher revascularisation rates.

Topics: Absorbable Implants; Adult; Aged; Cardiovascular Agents; Coronary Angiography; Coronary Artery Disease; Drug-Eluting Stents; Female; Humans; Male; Middle Aged; Myocardial Infarction; Percutaneous Coronary Intervention; Prosthesis Design; Registries; Sirolimus; Treatment Outcome

Improved outcomes in patients with diabetes mellitus undergoing percutaneous coronary intervention remain an unmet clinical need. We assessed the long-term efficacy and safety of novel polymer-free sirolimus- and probucol-eluting stent in diabetic patients enrolled in intracoronary stenting and angiographic results: test efficacy of sirolimus- and probucol-eluting versus zotarolimus-eluting stents 5 trial.. In a pre-specified subgroup analysis, outcomes of diabetic patients treated with a sirolimus- and probucol-eluting stent or a second-generation zotarolimus-eluting stent were compared. The primary endpoint was a device-oriented composite outcome comprising cardiac death, target vessel-related myocardial infarction (MI), or target lesion revascularization (TLR) at 5-year follow-up. Event-free survival was assessed using the Kaplan-Meier method. Hazard ratios (HR) and 95 % confidence intervals (CI) were estimated from univariate Cox proportional hazards models.. A total of 870 patients with diabetes mellitus were treated with either a sirolimus- and probucol-eluting stent (n = 575) or a second-generation zotarolimus-eluting stent (n = 295). At 5 years, the rate of device-oriented composite endpoint was comparable between the sirolimus- and probucol-eluting stent and the second-generation zotarolimus-eluting stent (32.9 versus 33.4 %, HR 0.88, 95 % CI 0.76-1.26). No significant differences were observed between the sirolimus- and probucol-eluting stent and the second-generation zotarolimus-eluting stent groups in the incidence of cardiac death (15.6 versus 16.7 % HR 0.92, 95 % CI 0.63-1.32), target-vessel MI (4.6 versus 6.6 %, HR 0.73, 95 % CI 0.40-1.34), and TLR (18.6 versus 18.8 %, HR 1.00, 95 % CI, 0.72-1.41). The rate of definite or probable stent thrombosis was low and similar in both groups (2.5 versus 2.6 %, HR 1.02, 95 % CI, 0.41-2.52).. In patients with diabetes the long-term efficacy and safety of a polymer-free sirolimus- and probucol-eluting stent were comparable to a second-generation durable polymer zotarolimus-eluting stent. Trial registration ClinicalTrials.gov NCT00598533. Registered 10 January 2008.

Topics: Aged; Cardiovascular Agents; Cardiovascular Diseases; Coronary Angiography; Coronary Restenosis; Coronary Thrombosis; Diabetic Angiopathies; Disease-Free Survival; Drug-Eluting Stents; Female; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Myocardial Infarction; Percutaneous Coronary Intervention; Platelet Aggregation Inhibitors; Probucol; Proportional Hazards Models; Prosthesis Design; Retreatment; Risk Factors; Sirolimus; Time Factors; Treatment Outcome

Recurrent cardiovascular event remains high in stable coronary artery disease (SCAD), especially in patients with multiple risk factors, despite a high rate of use conventional treatment. Traditional Chinese Medicine (TCM) is a promising complementary and alternative medicine for treating SCAD, while evidence for its effect on long-term survival is limited. This study was designed to test if Chinese herbal medicine in addition to conventional treatment is more effective than conventional treatment alone in reducing major adverse cardiac event (MACE) for SCAD patients with multiple risk factors during a 1-year follow-up.. This is a multicenter, placebo-controlled, double-blinded, randomized controlled clinical trial. A total of 1500 patients are randomized in a 1:1 ratio to receive the Qing-Xin-Jie-Yu Granules (QXJYG) or the placebo granules, twice daily for 6 months. The primary outcome is the combined outcomes including cardiac death, nonfatal myocardial infarction and revascularization. The secondary outcome is the combined outcomes including all-cause mortality, re-admission for acute coronary syndrome (ACS), heart failure, malignant supraventricular and ventricular arrhythmia influencing hemodynamics, ischemic stroke, and other thromboembolic events during 1-year follow-up. The assessment is performed at baseline (before randomization), 1, 3, 6, 9, and 12 months after randomization.. This is the first multicenter trial sponsored by the national funding of China to evaluate TCM in combination with conventional treatment on 1-year survival in high-risk SCAD patients. If successful, it will provide an evidence-based complementary therapeutic approach for reducing MACE from SCAD.. The trial was registered in the Chinese Clinical Trial Registry on December 28, 2013. The registration number is ChiCTR-TRC-13004370 .

Topics: Cardiovascular Agents; China; Clinical Protocols; Coronary Artery Disease; Disease Progression; Double-Blind Method; Drug Therapy, Combination; Drugs, Chinese Herbal; Myocardial Infarction; Myocardial Revascularization; Patient Readmission; Research Design; Risk Factors; Time Factors; Treatment Outcome

Percutaneous coronary intervention (PCI) for stable coronary artery disease does not reduce the risk of death and myocardial infarction compared with optimal medical therapy (OMT), but many patients think otherwise. PCI Choice, a decision aid (DA), was designed for use during the clinical visit and includes information on quality of life and mortality outcomes for PCI with OMT versus OMT alone for stable coronary artery disease.. We conducted a randomized trial to assess the impact of the PCI Choice DA compared with usual care when there is a choice between PCI and optimal medical therapy. Primary outcomes were patient knowledge and decisional conflict, and the secondary outcome was an objective measure of shared decision making. A total of 124 patients were eligible for final analysis. Knowledge was higher among patients receiving the DA compared with usual care (60% DA; 40% usual care;. The PCI Choice DA improved patient knowledge but did not significantly impact decisional quality. Further work is needed to effectively address clinician knowledge gaps in shared decision-making skills, even in the context of carefully designed DAs.. URL: https://www.clinicaltrials.gov/. Unique identifier: NCT01771536.

Topics: Aged; Cardiovascular Agents; Choice Behavior; Clinical Decision-Making; Conflict, Psychological; Coronary Artery Disease; Decision Support Techniques; Female; Health Knowledge, Attitudes, Practice; Humans; Male; Middle Aged; Minnesota; Myocardial Infarction; Patient Education as Topic; Patient Participation; Patient Selection; Percutaneous Coronary Intervention; Predictive Value of Tests; Risk Assessment; Risk Factors; Treatment Outcome

The objective of this study was to assess the efficacy of sealing intermediate nonobstructive coronary saphenous vein graft (SVG) lesions with drug-eluting stents (DES; paclitaxel- or everolimus-eluting stents) for reducing major adverse cardiac events (MACE).. This was a randomized controlled multicenter clinical trial that enrolled patients with a previous coronary artery bypass graft who had developed at least 1 intermediate nonobstructive SVG lesion (30%-60% diameter stenosis by visual estimation). Patients were randomized (1:1) to DES implantation (SVG-DES) or medical treatment (SVG-MT) of the target SVG lesion. The primary efficacy outcome was the first occurrence of MACE defined as the composite of cardiac death, myocardial infarction, or coronary revascularization related to the target SVG during the duration of follow-up (minimum of 2 years). Secondary efficacy outcomes included MACE related to the target SVG lesion and overall MACE. A total of 125 patients (mean age 70±9 years, 87% men) were included, with a mean time from coronary artery bypass graft of 12±5 years. Sixty and 65 patients were allocated to the SVG-DES and SVG-MT groups, respectively. There were no events related to the target SVG at 30 days. After a median follow-up of 3.4 (interquartile range: 2.8-3.9) years, the MACE rate related to the target SVG was not significantly different in the 2 groups (SVG-DES: 15.0%, SVG-MT: 20.0%; hazard ratio, 0.65; 95% confidence interval, 0.23-1.53; P=0.33). There were no significant differences between groups in MACE related to the target SVG lesion (SVG-DES: 10.0%, SVG-MT: 16.9%; hazard ratio, 0.53; 95% confidence interval, 0.20-1.43; P=0.21) or global MACE (SVG-DES: 36.7%, SVG-MT: 44.6%; hazard ratio, 0.73; 95% confidence interval, 0.42-1.27; P=0.26).. Sealing intermediate nonobstructive SVG lesions with DES was safe but was not associated with a significant reduction of cardiac events at 3-year follow-up.. URL: http://www.clinicaltrials.gov. Unique identifier: NCT01223443.

Topics: Aged; Canada; Cardiovascular Agents; Constriction, Pathologic; Coronary Angiography; Coronary Artery Bypass; Drug-Eluting Stents; Female; Graft Occlusion, Vascular; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Myocardial Infarction; Paclitaxel; Percutaneous Coronary Intervention; Prosthesis Design; Risk Factors; Saphenous Vein; Severity of Illness Index; Time Factors; Treatment Outcome; Vascular Patency

We sought to compare the outcomes of low/moderate complexity patients treated with the Absorb BVS from the ABSORB EXTEND trial with patients treated with the XIENCE everolimus-eluting stent (EES), using propensity score (PS) matching of pooled data from the SPIRIT trials (SPIRIT II, SPIRIT III, SPIRIT IV) and the XIENCE V USA trial.. ABSORB EXTEND was a prospective, single-arm, open-label clinical study in which 812 patients were enrolled at 56 sites. This study allowed the treatment of lesions ≤28 mm in length and with a reference vessel diameter of 2.0-3.8 mm (as assessed by online QCA). The propensity score was obtained by fitting a logistic regression model with the cohort indicator as the binary outcome and other variables as the predictor variables. At one-year clinical follow-up, there was no statistical difference between groups with regard to MACE (5.0% vs. 4.8%, p=0.83), target lesion failure (5.0% vs. 4.7%, p=0.74), ischaemia-driven target vessel revascularisation (2.3% vs. 3.0%, p=0.38) and device thrombosis (1.0% vs. 0.3%, p=0.11). Myocardial infarction was higher with Absorb (3.3% vs. 1.5%, p=0.02), at the expense of periprocedural CK-MB elevation. Independent predictors of MACE among patients receiving Absorb BVS were treatment of multivessel disease, insulin-dependent diabetes and performance of post-dilation.. At one-year follow-up, propensity score-matched analysis demonstrated that the clinical safety and effectiveness of Absorb are comparable to those of XIENCE EES among non-complex patients treated with PCI.

Topics: Absorbable Implants; Adult; Aged; Aged, 80 and over; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Drug-Eluting Stents; Everolimus; Female; Humans; Immunosuppressive Agents; Male; Metals; Middle Aged; Myocardial Infarction; Propensity Score; Prospective Studies; Risk Factors; Time Factors; Treatment Outcome

The study sought to investigate clinical and multimodality imaging assessment of a bioresorbable sirolimus-eluting scaffold (NeoVas, Lepu Medical, Beijing, China) for patients with single de novo coronary artery lesions.. The NeoVas first-in-man study was a prospective, open-label study which enrolled 31 patients with single de novo lesions treated with a bioresorbable sirolimus-eluting scaffold. The primary endpoint was target lesion failure (TLF), a composite of cardiac death, target vessel myocardial infarction and clinically indicated target lesion revascularisation (TLR). Angiography, intravascular ultrasound (IVUS) and optical coherence tomography (OCT) imaging were performed at baseline and six months. Procedural success and device success were 100% (31/31 patients). At six months, the rate of TLF was 3.2%, with only one patient having clinically indicated TLR. No scaffold thrombosis was observed. The angiographic six-month in-scaffold late loss was 0.26±0.32 mm. The minimal scaffold area decreased from 7.11±1.56 mm2 post procedure to 6.74±1.38 mm2 at six months, as measured by IVUS. The OCT results showed that the neointimal hyperplasia area was low (1.56±0.46 mm2), with a high proportion of scaffold strut coverage (95.7%).. This first-in-man study shows feasibility, promising clinical and multimodality imaging results up to six months for the NeoVas bioresorbable sirolimus-eluting scaffold in the treatment of patients with simple de novo lesions, with an acceptable in-scaffold late loss, low neointimal hyperplasia, and a high percentage of scaffold strut coverage.

Topics: Absorbable Implants; Adult; Aged; Cardiovascular Agents; Coronary Artery Disease; Coronary Vessels; Drug-Eluting Stents; Female; Humans; Male; Middle Aged; Multimodal Imaging; Myocardial Infarction; Percutaneous Coronary Intervention; Prospective Studies; Sirolimus; Treatment Outcome

We conducted a pooled post hoc analysis (RESOLUTE All Comers and RESOLUTE International) of patients who had the Resolute® zotarolimus-eluting stent (R-ZES) implanted in revascularised total occlusions (TO) compared with patients treated with R-ZES for non-occluded lesions.. Patients were divided into three groups: chronic TO (CTO; n=256), non-chronic TO (n=292), and no occlusion (n=2,941). Clinical and safety outcomes assessed through two years included target lesion failure (TLF: cardiac death, target vessel myocardial infarction, and clinically driven target lesion revascularisation) and Academic Research Consortium definite or probable stent thrombosis. The rate of TLF at two years was not significantly different among patients in the CTO (9.1%), TO (9.8%), and no occlusion (10.4%) groups (log-rank p=0.800); neither were the components of TLF. Definite or probable stent thrombosis occurred more frequently in the TO group (2.8% vs. 1.2% in the CTO and 1.1% in the group with no occlusion, p=0.027). There were 10 late and six very late stent thrombosis events.. Apart from a higher rate of stent thrombosis in patients with TO, patients with totally occluded coronary arteries who receive revascularisation with an R-ZES have clinical outcomes comparable to those who receive a similar stent in non-occluded lesions.

Topics: Aged; Cardiovascular Agents; Chronic Disease; Coronary Occlusion; Coronary Thrombosis; Drug-Eluting Stents; Female; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Myocardial Infarction; Percutaneous Coronary Intervention; Prospective Studies; Prosthesis Design; Registries; Risk Factors; Sirolimus; Time Factors; Treatment Outcome

Treatment of bare metal in-stent restenosis with the paclitaxel-coated balloon catheter based on the PACCOCATH® technology has yielded superior six-month angiographic and one-year clinical results compared to a paclitaxel-eluting stent. The three-year clinical follow-up is presented.. One hundred and thirty-one patients with coronary bare metal in-stent restenosis (>70%, length: <22 mm, vessel diameter: 2.5-3.5 mm) were randomly treated with the paclitaxel-coated balloon (DCB) (3 µg/mm²) or a paclitaxel-eluting stent (DES). Clinical follow-up information was requested from the patients and from their physicians. Quantitative angiographic and demographic baseline data were statistically not different between the groups. Per intention-to-treat analysis at 12 months, the lesion-related rates of major adverse cardiac events were 7.6% and 16.9% (p=0.11) while at 36 months the respective numbers were 9.1% and 18.5% (p=0.14). These differences were primarily due to reduced target lesion revascularisation (TLR) in DCB 4/66 (6.2%) compared to DES patients 10/65 (15.4%) (p=0.10). From 12 to 36 months, 1/65 (1.5%) DCB patients experienced a myocardial infarction while neither TLR nor death occurred in any study patient in either group during that period.. The six-month superiority of the paclitaxel-coated balloon compared to the paclitaxel-eluting stent in the treatment of bare metal coronary in-stent restenosis persisted throughout the three-year clinical follow-up period indicating stability of the lesions treated. (ClinicalTrials.gov Identifier: NCT00393315).

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coated Materials, Biocompatible; Coronary Angiography; Coronary Artery Disease; Coronary Restenosis; Disease-Free Survival; Drug-Eluting Stents; Female; Germany; Humans; Intention to Treat Analysis; Kaplan-Meier Estimate; Male; Metals; Middle Aged; Myocardial Infarction; Paclitaxel; Percutaneous Coronary Intervention; Platelet Aggregation Inhibitors; Prosthesis Design; Retreatment; Stents; Time Factors; Treatment Outcome; Vascular Access Devices

The effect of long-term high-intensity statin therapy on coronary atherosclerosis among patients with acute ST-segment elevation myocardial infarction (STEMI) is unknown. The aim of this study was to quantify the impact of high-intensity statin therapy on plaque burden, composition, and phenotype in non-infarct-related arteries of STEMI patients undergoing primary percutaneous coronary intervention (PCI).. Between September 2009 and January 2011, 103 STEMI patients underwent intravascular ultrasonography (IVUS) and radiofrequency ultrasonography (RF-IVUS) of the two non-infarct-related epicardial coronary arteries (non-IRA) after successful primary PCI. Patients were treated with high-intensity rosuvastatin (40 mg/day) throughout 13 months and serial intracoronary imaging with the analysis of matched segments was available for 82 patients with 146 non-IRA. The primary IVUS end-point was the change in per cent atheroma volume (PAV). After 13 months, low-density lipoprotein cholesterol (LDL-C) had decreased from a median of 3.29 to 1.89 mmol/L (P < 0.001), and high-density lipoprotein cholesterol (HDL-C) levels had increased from 1.10 to 1.20 mmol/L (P < 0.001). PAV of the non-IRA decreased by -0.9% (95% CI: -1.56 to -0.25, P = 0.007). Patients with regression in at least one non-IRA were more common (74%) than those without (26%). Per cent necrotic core remained unchanged (-0.05%, 95% CI: -1.05 to 0.96%, P = 0.93) as did the number of RF-IVUS defined thin cap fibroatheromas (124 vs. 116, P = 0.15).. High-intensity rosuvastatin therapy over 13 months is associated with regression of coronary atherosclerosis in non-infarct-related arteries without changes in RF-IVUS defined necrotic core or plaque phenotype among STEMI patients.

Topics: Cardiovascular Agents; Cholesterol, HDL; Cholesterol, LDL; Coronary Artery Disease; Female; Humans; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Male; Middle Aged; Myocardial Infarction; Percutaneous Coronary Intervention; Plaque, Atherosclerotic; Prospective Studies; Rosuvastatin Calcium; Treatment Outcome; Ultrasonography, Interventional

To compare long-term outcome of patients treated for chronic total occlusion (CTO) lesions versus patients treated for non-CTO lesions only.. Percutaneous coronary interventions (PCI) for CTO lesions generally have a higher adverse event risk than PCI for non-CTO lesions. However, long-term outcome data from prospective studies with second-generation drug-eluting stent (DES) use in CTO lesions is scarce.. We analyzed in this substudy of the TWENTE trial the data of 674 patients, who had stable angina and were electively treated with second-generation DES (Resolute zotarolimus-eluting or Xience V everolimus-eluting stents). Main outcome parameter was target lesion failure (TLF), a composite of cardiac death, target vessel-related myocardial infarction (MI), or target lesion revascularization (TLR).. Patients with CTO lesions (n = 59, 8.8%) were more often treated for lesions in small vessels (94.9% vs. 63.1%, P < 0.001), long lesions (52.5% vs. 17.7%, P < 0.001) and multiple vessels (42.4% vs. 22.4%, P < 0.001), and were less often males (62.7% vs. 74.6%, P < 0.05) than patients with non-CTO lesions (n = 615, 91.2%). J-CTO scores ≥2 were present in 56% of CTO lesions. Despite significant differences in characteristics of patients, lesions, and interventional procedures, the TLF rate at 3-year follow-up was similar for both groups (13.6% vs. 12.9%, P = 0.89). In addition, a patient-oriented composite endpoint (any death, MI or revascularization) did not differ between groups (18.6% vs. 18.8%, P = 0.97).. Patients treated with second-generation DES for CTO lesions showed at 3-year follow-up an incidence of adverse clinical events that was low and similar to patients with non-CTO lesions only.

Topics: Aged; Cardiovascular Agents; Chronic Disease; Coronary Occlusion; Drug-Eluting Stents; Everolimus; Female; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Myocardial Infarction; Netherlands; Percutaneous Coronary Intervention; Prosthesis Design; Sirolimus; Time Factors; Treatment Outcome

Medication non-adherence is a major impediment to the management of cardiovascular disease risk factors. A better understanding of the modifying factors underlying medication non-adherence among individuals with known cardiovascular disease may inform approaches for addressing non-adherence.. The purpose of this study was to identify demographic and patient characteristics, medical comorbidities, psychosocial factors, and health belief-related factors associated with medication non-adherence among patients with known cardiovascular disease.. We performed secondary analysis of baseline data from a randomized trial.. The study included 405 patients with a diagnosis of hypertension and history of acute myocardial infarction that was diagnosed within a three-year period prior to enrollment.. Baseline demographics and patient characteristics, medical comorbidities, psychosocial factors, health belief-related factors, and patient-reported medication non-adherence were analyzed.. Of 405 patients, 173 (42.7 %) reported medication non-adherence. Factors associated with non-adherence in bivariate analysis included younger age, non-white race, having less than 12 years of education, smoking, financial insecurity, identifying as nervous or tense, higher life chaos score, greater worry about having a myocardial infarction, and greater worry about having a stroke. Using multivariable modeling, we determined that age (OR 0.97 per additional year, 95 % CI, 0.95-0.99), life chaos (OR 1.06 per additional point, 95 % CI, 1.00-1.11), and worry about stroke (OR 1.12 per additional point, 95 % CI, 1.01-1.25) remained significantly associated with self-reported medication non-adherence.. We found that worry about having a stroke, higher life chaos, and younger age were all significantly associated with self-reported medication non-adherence in patients with cardiovascular disease and a history of myocardial infarction. Further research exploring these factors as targets for intervention is needed, as is additional research examining modifiable causes of medication non-adherence among patients with cardiovascular disease.

Topics: Age Factors; Aged; Anxiety; Attitude to Health; Cardiovascular Agents; Comorbidity; Female; Humans; Hypertension; Life Style; Male; Medication Adherence; Middle Aged; Myocardial Infarction; Risk Factors; Self Administration; Self Report; Stroke

To investigate clinical outcomes of coronary intervention using a biolimus-eluting stent (BES) compared with a sirolimus-eluting stent (SES) in patients with acute myocardial infarction (AMI) in the Limus Eluted from A Durable versus ERodable Stent (LEADERS) coating trial at the final 5-year follow-up.. The LEADERS trial is a multicentre all-comer study, where patients (n=1707) were randomised to percutaneous intervention with either BES containing biodegradable polymer or SES containing durable polymer. Out of 1707 patients enrolled in this trial, 573 patients had percutaneous coronary intervention for AMI (BES=280, SES=293) and were included in the current analysis. Patient-oriented composite endpoint (POCE, including all death, all myocardial infarction (MI) and all revascularisations), major adverse cardiac events (MACE, including cardiac death, MI and clinically indicated target vessel revascularisation) and stent thrombosis were assessed at 5-year follow-up.. The baseline clinical, angiographic and procedural characteristics were well matched between BES and SES groups. In all patients with AMI, coronary intervention with a BES, compared with SES, significantly reduced POCE (28.9% vs 42.3%; relative risk (RR) 0.61, 95% CI 0.47 to 0.82, p=0.001) at 5-year follow-up. There was also a reduction in MACE rate in the BES group (18.2% vs 25.9%; RR 0.67, 95% CI 0.47 to 0.95, p=0.025); however, there was no difference in cardiac death and stent thrombosis. In patients with ST-elevation MI (STEMI), coronary intervention with BES significantly reduced POCE (24.4% vs 39.3%; RR 0.55, 95% CI 0.36 to 0.85, p=0.006), MACE (12.6% vs 25.0%; RR 0.47, 95% CI 0.26 to 0.83, p=0.008) and cardiac death (3.0% vs 11.4%; RR 0.25, 95% CI 0.08 to 0.75, p=0.007), along with a trend towards reduction in definite stent thrombosis (3.7% vs 8.6%; RR 0.41, 95% CI 0.15 to 1.18, p=0.088), compared with SES.. BES, compared with SES, significantly improved safety and efficacy outcomes in patients with AMI, especially those with STEMI, at 5-year follow-up.. NCT 00389220.

Topics: Absorbable Implants; Aged; Cardiovascular Agents; Coronary Angiography; Coronary Thrombosis; Drug-Eluting Stents; Female; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Myocardial Infarction; Odds Ratio; Percutaneous Coronary Intervention; Polymers; Predictive Value of Tests; Prosthesis Design; Recurrence; Risk Assessment; Risk Factors; Sirolimus; Time Factors; Treatment Outcome

The aim of this analysis was to assess the 7-year long-term safety and effectiveness of a randomized comparison of percutaneous coronary intervention (PCI) with sirolimus-eluting stents (SES) versus minimally invasive direct coronary artery bypass (MIDCAB) surgery for the treatment of isolated proximal left anterior descending lesions.. Long-term follow-up data comparing PCI by SES and MIDCAB surgery for isolated proximal left anterior descending lesions are sparse.. Patients were randomized either to PCI with SES (n = 65) or MIDCAB (n = 65). Follow-up data were obtained after 7 years with respect to the primary composite endpoint of death, myocardial infarction, and target vessel revascularization. Angina was assessed by the Canadian Cardiovascular Society classification and quality of life with Short Form 36 and MacNew quality of life questionnaires.. Follow-up was conducted in 129 patients at a median time of 7.3 years (interquartile range: 5.7, 8.3). There were no significant differences in the incidence of the primary composite endpoint between groups (22% PCI vs. 12% MIDCAB; p = 0.17) or the endpoints death (14% vs. 17%; p = 0.81) and myocardial infarction (6% vs. 9%, p = 0.74). However, the target vessel revascularization rate was higher in the PCI group (20% vs. 1.5%; p < 0.001). Clinical symptoms and quality of life improved significantly from baseline with both interventions and were similar in magnitude between groups.. At 7-year follow-up, PCI by SES and MIDCAB in isolated proximal left anterior descending lesions yielded similar long-term outcomes regarding the primary composite clinical endpoint and quality of life. Target vessel revascularization was more frequent in the PCI group. (MIDCAB Versus DES in Proximal LAD Lesions; NCT00299429).

Topics: Cardiovascular Agents; Coronary Angiography; Coronary Artery Bypass; Coronary Stenosis; Drug-Eluting Stents; Humans; Kaplan-Meier Estimate; Myocardial Infarction; Percutaneous Coronary Intervention; Prosthesis Design; Quality of Life; Risk Factors; Sirolimus; Surveys and Questionnaires; Time Factors; Treatment Outcome

Newer troponin assays offer the ability to quantify circulating troponin levels at an order of magnitude lower than contemporary assays, fueling continued debate over the prognostic implications of very low-level increases in concentration. We evaluated the prognostic implications of low-level increases in cardiac troponin I (cTnI) using an investigational single-molecule high-sensitivity assay in patients with acute coronary syndrome (ACS).. We measured cTnI using both a high-sensitivity troponin I (hsTnI) assay (Erenna, Singulex, 99(th) percentile 9 pg/ml) and a current generation sensitive assay (TnI-Ultra, Siemens, 99(th) percentile 40 pg/ml) at baseline in 1807 patients with non-ST elevation ACS and compared their prognostic ability for adverse cardiovascular events at 30 days and one year.. Among patients with TnI-Ultra<99(th) percentile, patients with elevated hsTnI (≥ 9 pg/ml) had a significantly higher risk than patients with hsTnI<9 pg/ml: cardiovascular death (CVD) or myocardial infarction (MI) at one year (7.0% vs 3.8%; p<0.001, hazard ratio (HR) 2.05, confidence interval (CI) 1.23-3.41); including a higher risk of CVD (3.5% vs 1.5%, p<0.001) and MI (5.0% vs 2.8%, p<0.001) individually. This higher risk of CVD/MI was independent of clinical risk stratification using the TIMI Risk Score (adj. HR 1.76, CI 1.05-2.90). Moreover, hsTnI showed a trend toward a gradient of risk even below the hsTnI 99 percentile.. Low-level cardiac troponin detected using a single-molecule technique, below the cutpoint of a contemporary sensitive assay, identified a significant gradient of risk. These findings support the prognostic relevance of low-level cardiac troponin elevation with increasingly sensitive assays in patients with ACS.

Topics: Acute Coronary Syndrome; Aged; Biomarkers; Cardiovascular Agents; Cohort Studies; Female; Humans; Male; Middle Aged; Myocardial Infarction; Prognosis; Proportional Hazards Models; Prospective Studies; Ranolazine; Risk Factors; Sensitivity and Specificity; Troponin I

We aimed to compare angiographic and clinical outcomes after the implantation of everolimus-eluting (EES) and sirolimus-eluting (SES) stents in patients with diabetes.. There are limited data on long-term outcome after EES vs SES implantation in diabetic patients.. We randomized 213 patients with diabetes and coronary artery disease to EES (n = 108) or SES (n = 105) implantation. Angiographic follow-up was performed 10 months after the index procedure and all patients were followed clinically for 4 years. The primary endpoint was angiographic in-stent late luminal loss at 10-month follow-up. Secondary endpoints included angiographic restenosis rate, the need for target lesion revascularization (TLR) and major adverse cardiac events (MACE; defined as cardiac death, myocardial infarction, definite stent thrombosis, or TLR) at 4-year follow-up.. At 10-month angiographic follow-up, in-stent late lumen loss was 0.20 ± 0.53 mm and 0.11 ± 0.49 mm (P = 0.28), and angiographic restenosis rate was 3.8% and 5.2% (P = 0.72) in the EES and SES groups, respectively. At 4-year clinical follow-up, MACE had occurred in 22 (20.4%) patients in the EES group and 25 (23.8%) patients in SES group (HR 0.84, 95% CI 0.47-1.49; P = 0.55), with TLR performed in 6 (5.6%) and 10 (9.5%) patients in the two groups (HR 0.57, 95% CI 0.21-1-58; P = 0.28).. EES and SES had comparable 10-month angiographic and 4-year clinical outcomes in patients with diabetes mellitus and coronary artery disease.

Topics: Aged; Cardiovascular Agents; Coronary Angiography; Coronary Artery Disease; Coronary Restenosis; Coronary Stenosis; Coronary Thrombosis; Denmark; Diabetic Angiopathies; Drug-Eluting Stents; Everolimus; Female; Humans; Male; Middle Aged; Myocardial Infarction; Percutaneous Coronary Intervention; Predictive Value of Tests; Prospective Studies; Prosthesis Design; Risk Factors; Sirolimus; Time Factors; Treatment Outcome

The aim of APPOSITION III was to evaluate the feasibility and performance of the STENTYS Self-Apposing¨ stent (STENTYS S.A., Paris, France) in the setting of primary percutaneous coronary intervention (PCI).. APPOSITION III was an international, prospective, multicentre registry. The study population consisted of 965 patients. The rate of the primary endpoint major adverse cardiac events (MACE), defined as the composite of cardiac death, recurrent target vessel myocardial infarction (TV-MI), and clinically driven target lesion revascularisation (CD-TLR), at one year was 9.3%. One-year cardiac death rate was 2.0%, TV-MI rate was 1.3%, CD-TLR rate was 7.4% and definite/probable stent thrombosis (ST) rate was 3.5% (definite ST 2.8%). An interim safety analysis of in-hospital outcomes in the first 400 patients showed higher event rates if post-dilation was not performed, and post-dilations became highly recommended in the remaining cohort. Patients undergoing post-dilation eventually showed a numerically lower one-year MACE rate (8.4% vs. 11.3%, p=0.137). One-year TV-MI (0.8% vs. 2.5%, p=0.027) and definite ST (1.9% vs. 5.0%, p=0.010) rates were significantly lower if post-dilation was performed, with the divergence occurring at <30 days.. The use of the STENTYS Self-Apposing¨ stent in the setting of primary PCI was feasible and associated with acceptable cardiovascular event rates which improved when post-dilation was performed.

Topics: Cardiovascular Agents; Coronary Restenosis; Humans; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Middle Aged; Myocardial Infarction; Percutaneous Coronary Intervention; Prospective Studies; Registries; Stents; Treatment Outcome

There is a paucity of data on the use of optimal medical therapy (OMT) in patients with complex coronary artery disease undergoing revascularization with percutaneous coronary intervention or coronary artery bypass grafting (CABG) and its long-term prognostic significance.. The Synergy Between Percutaneous Coronary Intervention With TAXUS and Cardiac Surgery (SYNTAX) trial is a multicenter, randomized, clinical trial of patients (n=1800) with complex coronary disease randomized to revascularization with percutaneous coronary intervention or CABG. Detailed drug history was collected for all patients at discharge and at the 1-month, 6-month, 1-year, 3-year, and 5-year follow-ups. OMT was defined as the combination of at least 1 antiplatelet drug, statin, β-blocker, and angiotensin-converting enzyme inhibitor/angiotensin receptor blocker. Five-year clinical outcomes were stratified by OMT and non-OMT. OMT was underused in patients treated with coronary revascularization, especially CABG. OMT was an independent predictor of survival. OMT was associated with a significant reduction in mortality (hazard ratio, 0.64; 95% confidence interval, 0.48-0.85; P=0.002) and composite end point of death/myocardial infarction/stroke (hazard ratio, 0.73; 95% confidence interval, 0.58-0.92; P=0.007) at the 5-year follow-up. The treatment effect with OMT (36% relative reduction in mortality over 5 years) was greater than the treatment effect of revascularization strategy (26% relative reduction in mortality with CABG versus percutaneous coronary intervention over 5 years). On stratified analysis, all the components of OMT were important for reducing adverse outcomes regardless of revascularization strategy.. The use of OMT remains low in patients with complex coronary disease requiring coronary intervention with percutaneous coronary intervention and even lower in patients treated with CABG. Lack of OMT is associated with adverse clinical outcomes. Targeted strategies to improve OMT use in postrevascularization patients are warranted.. URL: http://www.clinicaltrials.gov. Unique identifier: NCT00114972.

Topics: Aged; Biomarkers; Cardiovascular Agents; Combined Modality Therapy; Comorbidity; Coronary Artery Bypass; Coronary Disease; Drug Utilization; Drug-Eluting Stents; Female; Follow-Up Studies; Humans; Male; Middle Aged; Myocardial Infarction; Netherlands; Paclitaxel; Percutaneous Coronary Intervention; Prognosis; Proportional Hazards Models; Prospective Studies; Risk Factors; Stroke; Treatment Outcome

The aim of this study was to evaluate the pathophysiological features and response to primary percutaneous coronary intervention (PCI) of nonruptured/eroded plaque versus ruptured plaque as a cause of ST-segment elevation myocardial infarction (STEMI).. Autopsy series identified nonruptured/eroded plaque and ruptured plaque as the principal pathological substrates underlying coronary thrombosis in STEMI. The real incidence of different plaque morphologies, associated biological factors, superimposed thrombus, and their interaction with primary PCI remain largely unknown.. In a prospective study, 140 patients with STEMI underwent optical coherence tomography of the infarct-related artery (IRA) before PCI, after everolimus-eluting stent implantation and at 9-month follow-up. Histopathology and immunohistochemistry of thrombus aspirates and serum biomarkers were assessed at baseline.. Culprit plaque morphology was adjudicated in 97 patients: 32 plaques (33.0%) with an intact fibrous cap (IFC), 63 (64.9%) plaques with a ruptured fibrous cap (RFC), and 2 (2.1%) spontaneous dissections. Patients with an IFC and RFC had similar clinical characteristics, and serum inflammatory and platelets biomarkers. An IFC presented more frequently with a patent IRA (56.2% vs. 34.9%; p = 0.047), and had fewer lipid areas (lipid-rich areas: 75.0% vs. 100.0%; p < 0.001) and less residual thrombus before stenting (white thrombus: 0.41 mm(3) vs. 1.52 mm(3); p = 0.001; red thrombus: 0 mm(3) vs. 0.29 mm(3); p = 0.001) with a lower peak of creatine kinase-myocardial band (66.6 IU/l vs. 149.8 IU/l; p = 0.025). At the 9-month optical coherence tomography, IFC and RFC had similar high rates of stent strut coverage (92.5% vs. 91.2%; p = 0.15) and similar percentage of volume obstruction (12.6% vs. 10.2%; p = 0.27). No significant differences in clinical outcomes were observed up to 2 years.. In the present study, an IFC was observed at the culprit lesion site of one-third of STEMIs. IFC, compared with RFC, was associated with higher rates of patent IRA at first angiography, fewer lipid areas, and residual endoluminal thrombus. However, no difference in vascular response to everolimus-eluting stent was observed. (Optical Coherence Tomography Assessment of Gender Diversity in Primary Angioplasty [OCTAVIA]; NCT01377207).

Topics: Aged; Biomarkers; Cardiovascular Agents; Coronary Artery Disease; Coronary Thrombosis; Coronary Vessels; Drug-Eluting Stents; Everolimus; Female; Fibrosis; Humans; Immunohistochemistry; Inflammation Mediators; Italy; Male; Middle Aged; Myocardial Infarction; Percutaneous Coronary Intervention; Plaque, Atherosclerotic; Prospective Studies; Prosthesis Design; Rupture, Spontaneous; Thrombectomy; Time Factors; Tomography, Optical Coherence; Treatment Outcome

This study assessed clinical events and patient-reported chest pain 2 years after treatment of all-comers with Resolute Integrity zotarolimus-eluting stents (Medtronic Vascular, Santa Rosa, California) and Promus Element everolimus-eluting stents (Boston Scientific, Natick, Massachusetts).. For both drug-eluting stents (DES), no all-comer outcome data from >12 months of follow-up have been published. Although there is increasing interest in patient-reported chest pain following stenting, data with novel DES are scarce.. The DUTCH PEERS multicenter trial (TWENTE II) (DUrable Polymer-Based STent CHallenge of Promus ElemEnt Versus ReSolute Integrity) Randomized Trial [TWENTE II]) randomized 1,811 all-comer patients to treatment with 1 type of DES. Monitoring and event adjudication were performed by independent contract research organizations.. The 2-year follow-up of 1,810 patients (99.9%) was available. The primary composite endpoint target vessel failure occurred in 8.6% and 7.8% of patients treated with zotarolimus- and everolimus-eluting stents, respectively (p = 0.55). Rates of components of target vessel failure were: cardiac death (2.4% vs. 1.9%, p = 0.42); target vessel-related myocardial infarction (2.4% vs. 1.8%, p = 0.33); clinically-indicated target vessel revascularization (4.6% vs. 4.9%, p = 0.83). At 1- and 2-year follow-up, >80% of patients were free from chest pain (no between-stent difference). In addition, >87% of patients were either free from chest pain or experienced pain only at maximal physical exertion, but not during normal daily activities. Patients with chest pain after 12 months at no more than moderate physical effort had a higher risk of target vessel revascularization during the following year (hazard ratio: 1.89 [95% confidence interval: 1.05 to 3.39], p = 0.03).. During the second year of follow-up, the incidence of adverse clinical endpoints remained similar and low for both DES. The vast majority of patients were free from chest pain.

Topics: Aged; Angina Pectoris; Cardiovascular Agents; Coronary Artery Disease; Drug-Eluting Stents; Everolimus; Female; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Myocardial Infarction; Percutaneous Coronary Intervention; Polymers; Proportional Hazards Models; Prospective Studies; Prosthesis Design; Risk Factors; Single-Blind Method; Sirolimus; Time Factors; Treatment Outcome

This study sought to investigate the long-term comparative efficacy and safety of paclitaxel-eluting balloon (PEB), paclitaxel-eluting stent (PES), or balloon angioplasty (BA) for the treatment of drug-eluting stent restenosis.. The optimal treatment of drug-eluting stent restenosis remains unknown. Although PEB has shown encouraging results, the long-term clinical efficacy and safety of PEB remains poorly defined.. A total of 402 patients with clinically significant restenosis in limus-eluting stents were randomly assigned to receive PEB (n = 137), PES (n = 131), or BA (n = 134). For this analysis, PEB versus PES and PEB versus BA were compared. The primary efficacy and safety endpoints were target lesion revascularization and the composite of death or myocardial infarction.. At a median follow-up of 3 years, the risk of target lesion revascularization was comparable with PEB versus PES (hazard ratio [HR]: 1.46, 95% confidence interval [CI]: 0.91 to 2.33; p = 0.11) and lower with PEB versus BA (HR: 0.51, 95% CI: 0.34 to 0.74; p < 0.001). The risk of death/myocardial infarction tended to be lower with PEB versus PES (HR: 0.55, 95% CI: 0.28 to 1.07; p = 0.08), due to a lower risk of death (HR: 0.38, 95% CI: 0.17 to 0.87; p = 0.02). The risk of death/myocardial infarction was similar with PEB versus BA (HR: 0.96, 95% CI: 0.46 to 2.0; p = 0.91).. At 3 years, the use of PEB as compared with PES to treat patients with limus-eluting stent restenosis has similar efficacy and safety. PEB remains superior to BA. The sustained efficacy without trade-off in safety supports the role of PEB as treatment option for patients with drug-eluting stent restenosis. (Intracoronary Stenting and Angiographic Results: Drug Eluting Stent In-Stent Restenosis: 3 Treatment Approaches [ISAR-DESIRE 3]; NCT00987324).

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiac Catheterization; Cardiac Catheters; Cardiovascular Agents; Coated Materials, Biocompatible; Coronary Artery Disease; Coronary Restenosis; Drug-Eluting Stents; Female; Germany; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Myocardial Infarction; Odds Ratio; Paclitaxel; Percutaneous Coronary Intervention; Proportional Hazards Models; Prosthesis Design; Risk Factors; Time Factors; Treatment Outcome

Drug-eluting stent has been shown to reduce the risk of repeated revascularization. However, as shown for first-generation drug-eluting stent, they may be counterbalanced by a potential higher risk of stent thrombosis, especially among ST-segment elevation myocardial infarction patients. In addition, diabetes has been shown to be an independent predictor of poor survival and repeated target vessel revascularization. No data have been reported so far on the long-term benefits and safety of new-generation drug-eluting stent in ST-segment elevation myocardial infarction according to diabetes. Therefore, the aim of this study was to evaluate whether diabetes may impact on the benefits from everolimus-eluting stent versus first-generation drug-eluting stent in patients undergoing primary angioplasty.. We combined data from two randomized trials (PaclitAxel or Sirolimus-Eluting Stent vs Bare-Metal Stent in Primary Angioplasty and randomized comparison of everolimus-eluting stents and sirolimus-eluting stents in patients with ST elevation myocardial infarction) including consecutive ST-segment elevation myocardial infarction patients admitted within 12 h of symptom onset undergoing primary angioplasty and stent implantation at a tertiary centre with 24-h primary percutaneous coronary intervention capability. Primary endpoint of this study was major adverse cardiac events at 3-year follow-up. Secondary endpoints were as follows: (1) death, (2) reinfarction, (3) definite or probable ST and (4) target vessel revascularization at 3-year follow-up. No patient was lost to follow-up.. Our population is represented by 680 ST-segment elevation myocardial infarction patients treated with drug-eluting stent (180 enrolled in the PaclitAxel or Sirolimus-Eluting Stent vs Bare-Metal Stent in Primary Angioplasty trial, treated with first-generation drug-eluting stent, and 500 patients in the randomized comparison of everolimus-eluting stents and sirolimus-eluting stents in patients with ST elevation myocardial infarction, randomized to everolimus-eluting stent or sirolimus-eluting stent). Diabetes was observed in a total of 178 patients (26.1%) and associated with higher major adverse cardiac events, mortality, reinfarction, stent thrombosis and target vessel revascularization. Similar outcome was observed in terms of overall major adverse cardiac events, mortality, recurrent myocardial infarction, target vessel revascularization, with everolimus-eluting stent as compared to first-generation drug-eluting stent in both diabetic and non-diabetic patients, whereas everolimus-eluting stent was associated with a significantly lower rate of stent thrombosis only in diabetic patients (1.6% vs 9.6%, hazard ratio (95% confidence interval) = 0.15 (0.02-0.98), p = 0.04) whereas no difference was observed in non-diabetic patients.. This study shows that among ST-segment elevation myocardial infarction patients undergoing primary angioplasty, diabetes is associated with a significantly worse outcome at 3-year follow-up. A similar outcome was observed between everolimus-eluting stent and first-generation drug-eluting stent in non-diabetic patients, whereas among diabetic patients everolimus-eluting stent was associated with a significant reduction in stent thrombosis.

Topics: Cardiovascular Agents; Diabetes Mellitus; Drug-Eluting Stents; Everolimus; Humans; Myocardial Infarction; Paclitaxel; Percutaneous Coronary Intervention; Platelet Aggregation Inhibitors; Sirolimus; Treatment Outcome

This study sought to evaluate the mechanism of post-procedural cardiac biomarker (CB) rise following device implantation.. A fully bioresorbable Absorb scaffold, compared with everolimus-eluting metallic stents (EES), might be associated with a higher incidence of periprocedural myocardial injury.. In 501 patients with stable or unstable angina randomized to either Absorb (335 patients) or EES (n = 166) in the ABSORB II trial, 3 types of CB (creatine kinase, creatine kinase-myocardial band, and troponin) were obtained before and after procedure. Per protocol, periprocedural myocardial infarction (PMI) was defined as creatine kinase rise >2× the upper limit of normal with creatine kinase-myocardial band rise.. Incidence of side branch occlusion and any anatomic complications assessed by angiography was similar between the 2 treatment arms (side branch occlusion: Absorb: 5.3% vs. Xience: 7.6%, p = 0.07; any anatomic complication: Absorb: 16.4% vs. EES: 19.9%, p = 0.39). Fourteen patients who presented with recent myocardial infarction at entry with normalized creatine kinase-myocardial band according to the protocol were excluded for post-CB analysis. The overall compliance for CB was 97.8%. The CB rise subcategorized in 7 different ranges was comparable between the 2 treatment arms. PMI rate was numerically higher in the Absorb arm according to the per-protocol definitions, and treatment with overlapping devices was the only independent determinant of per-protocol PMI (odds ratio: 5.07, 95% confidence interval: 1.78 to 14.41, p = 0.002).. There were no differences in the incidence of CB rise and PMI between Absorb and EES. Device overlap might be a precipitating factor of myocardial injury. (ABSORB II Randomized Clinical Trial: A Clinical Evaluation to Compare the Safety, Efficacy, and Performance of Absorb Everolimus Eluting Bioresorbable Vascular Scaffold System Against Xience Everolimus Eluting Coronary Stent System in the Treatment of Subjects With Ischemic Heart Disease Caused by De Novo Native Coronary Artery Lesions [ABSORB II]; NCT01425281).

Topics: Absorbable Implants; Aged; Biomarkers; Cardiovascular Agents; Coronary Angiography; Coronary Artery Disease; Creatine Kinase, MB Form; Drug-Eluting Stents; Europe; Everolimus; Female; Humans; Incidence; Logistic Models; Male; Metals; Middle Aged; Multivariate Analysis; Myocardial Infarction; New Zealand; Odds Ratio; Percutaneous Coronary Intervention; Prospective Studies; Prosthesis Design; Risk Factors; Single-Blind Method; Time Factors; Treatment Outcome; Troponin; Up-Regulation

This study sought to report the 5-year outcomes of everolimus-eluting stents (EES) and paclitaxel-eluting stents (PES) in an all-comers population undergoing percutaneous coronary intervention (PCI).. The medium-term 1 and 2-year results of the prospective randomized COMPARE trial (A Trial of Everolimus-Eluting Stents and Paclitaxel-Eluting Stents for Coronary Revascularization in Daily Practice) showed superior clinical outcomes with EES compared with PES in an all-comers PCI population. Whether this benefit is sustained over longer-term follow-up is unknown. Furthermore, systematic long-term follow-up data on these metallic drug eluting stents with durable polymers are scarce.. We randomly assigned 1,800 patients undergoing PCI to EES or PES. The pre-specified composite primary endpoint was death, myocardial infarction (MI), or target vessel revascularization (TVR).. Follow-up at 5 years was completed in 1,791 (99.5%) patients. Treatment with EES compared with PES led to a relative risk reduction of the primary endpoint by 27% (18.4% vs. 25.1%, p = 0.0005), driven by lower rates of MI (7.0% vs. 11.5%, p = 0.001) and TVR (7.4% vs. 11.4%, p = 0.003), but not with mortality (9.0% vs. 10.3%, relative risk 0.88, p = 0.36). Moreover, patients treated with EES compared with PES had lower rates of definite/probable stent thrombosis at 5 years (3.1% vs. 5.9%, p = 0.005). The hazard curves for TVR, MI, and stent thrombosis diverge over the first 3 years and, subsequently, progress in parallel.. The early- and medium-term superiority of EES over PES measured both by safety and efficacy endpoints is sustained at 5 years in this all-comer population. (A Trial of Everolimus-Eluting Stents and Paclitaxel-Eluting Stents for Coronary Revascularization in Daily Practice [COMPARE]; NCT01016041).

Topics: Cardiovascular Agents; Coronary Artery Disease; Drug-Eluting Stents; Everolimus; Female; Humans; Kaplan-Meier Estimate; Male; Metals; Middle Aged; Myocardial Infarction; Netherlands; Paclitaxel; Percutaneous Coronary Intervention; Prospective Studies; Prosthesis Design; Risk Factors; Single-Blind Method; Thrombosis; Time Factors; Treatment Outcome

To evaluate the outcomes of patients treated with a new drug-eluting stent formulation with low doses of sirolimus, built in an ultra-thin-strut platform coated with biodegradable abluminal coating.. This study is a randomized trial that tested the main hypothesis that the angiographic late lumen loss of the novel sirolimus-eluting stent is noninferior compared with commercially available biolimus-eluting stent. A final study population comprising 170 patients with one or two de novo lesions was randomized in the ratio 2:1 for sirolimus-eluting stent or biolimus-eluting stent, respectively. The primary endpoint was 9-month angiographic in-stent late lumen loss. Adverse clinical events were prospectively collected for 1 year.. After 9 months, the novel sirolimus-eluting stent was shown noninferior compared with the biolimus stent for the primary endpoint (angiographic in-stent late lumen loss: 0.20 ± 0.29 mm vs. 0.15 ± 0.20 mm, respectively; P value for noninferiority <0.001). The 1-year incidence of death, myocardial infarction, repeat revascularization, and stent thrombosis remained low and not significantly different between the groups.. The present randomized trial demonstrates that the tested novel sirolimus-eluting stent was angiographically noninferior in comparison with a last-generation biolimus-eluting stent.

Topics: Absorbable Implants; Aged; Brazil; Cardiovascular Agents; Coated Materials, Biocompatible; Coronary Angiography; Coronary Artery Disease; Coronary Restenosis; Coronary Thrombosis; Coronary Vessels; Drug-Eluting Stents; Female; Humans; Male; Middle Aged; Myocardial Infarction; Percutaneous Coronary Intervention; Predictive Value of Tests; Prospective Studies; Prosthesis Design; Sirolimus; Time Factors; Treatment Outcome

Slow flow, no reflow and distal embolization often occur during primary angioplasty in ST segment elevation myocardial infarction (STEMI), compromising optimal myocardial reperfusion.. This study aimed at assessing the impact of deferred stenting (DS) on periprocedural events as compared to immediate stenting (IS). The second objective was to gather the reasons advocated by the physicians for deferring stenting.. All consecutive patients referred for primary angioplasty were included between September 2010 and November 2011. Physicians were free to choose the strategy between DS and IS but had to justify their choice. DS patients underwent a coronary angiogram control in a delay > 24h.. Ninety-eight patients were included. Forty patients underwent DS and 58 IS. DS strategy involved thrombus management by thromboaspiration (33 patients 82.5%) and by the use of AntiGpIIbIIIa (23 patients 62.2%). This strategy could be achieved with a low complication rate. In particular, one patient had a reocclusion leading to a rapid reintervention and one had a distal embolization. In comparison, 11 periprocedural events occurred in the IS subgroup. In addition, among DS patients, 7 were treated medically because of a non-significant stenosis. The major criteria considered by the operator to prefer DS in the presence of a TIMI 3 flow concerned thrombotic load.. This mono-centric experience confirmed the feasibility and the safety of DS. On top of reducing periprocedural events, it may allow for other treatment options in selected STEMI patients, e.g. surgery or medical treatment. The reasons leading physicians to choose DS were large thrombus burden on top of resolution of chest pain and normalization of the ECG. These criteria could help selecting situations in which DS may be of particular value as compared to IS.

Topics: Adult; Aged; Aged, 80 and over; Cardiac Catheterization; Cardiovascular Agents; Chest Pain; Comorbidity; Coronary Angiography; Coronary Thrombosis; Electrocardiography; Embolism; Feasibility Studies; Female; Heart Arrest; Hemorrhage; Hospital Mortality; Humans; Male; Middle Aged; Motivation; Myocardial Infarction; No-Reflow Phenomenon; Percutaneous Coronary Intervention; Physicians; Risk Factors; Shock, Cardiogenic; Stents; Thrombectomy; Time Factors

Incidence of chronic heart failure (HF) increases with age and cardiovascular (CV) morbidity. Co-morbidities increase hospitalization and mortality in HF, and non-CV co-morbidities may lead to preventable hospitalizations. We studied the impact of co-morbidities on mortality and morbidity in Systolic Heart Failure Treatment with the I(f) Inhibitor Ivabradine Trial, and investigated whether the impact of ivabradine was affected by co-morbidities. We analyzed the Systolic Heart Failure Treatment with the I(f) Inhibitor Ivabradine Trialpopulation, with moderate-to-severe HF and left ventricular dysfunction (in sinus rhythm with heart rate at rest ≥70 beats/min), according to co-morbidity: chronic obstructive pulmonary disease, diabetes mellitus, anemia, stroke, impaired renal function, myocardial infarction, hypertension, and peripheral artery disease. Co-morbidity load was classed as 0, 1, 2, 3, 4+ or 1 to 2 co-morbidities, or 3+ co-morbidities. Co-morbidities were evenly distributed between the placebo and ivabradine groups. Patients with more co-morbidities were likely to be older, women, had more advanced HF, were less likely to be on β blockers, with an even distribution on ivabradine 2.5, 5, or 7.5 mg bid and placebo at all co-morbidity loads. Number of co-morbidities was related to outcomes. Cardiovascular death or HF hospitalization events significantly increased (p <0.0001) with co-morbidity load, with the most events in patients with >3 co-morbidities for both, ivabradine and placebo. There was no interaction between co-morbidity load and the treatment effects of ivabradine. Hospitalization rate was lower at all co-morbidity loads for ivabradine. In conclusion, cardiac and noncardiac co-morbidities significantly affect CV outcomes, particularly if there are >3 co-morbidities. The effect of heart rate reduction with ivabradine is maintained at all co-morbidity loads.

Topics: Aged; Benzazepines; Cardiovascular Agents; Comorbidity; Cyclic Nucleotide-Gated Cation Channels; Double-Blind Method; Female; Follow-Up Studies; Global Health; Heart Failure, Systolic; Heart Rate; Humans; Incidence; Ivabradine; Male; Middle Aged; Myocardial Infarction; Pulmonary Disease, Chronic Obstructive; Survival Rate; Treatment Outcome

Discontinuation of guideline-recommended cardiac medications post-ST-elevation myocardial infarction (STEMI) is common and associated with increased mortality. DERLA-STEMI tested an intervention to improve long-term adherence to cardiac medications post-STEMI.. Between September 2011 and December 2012, STEMI patients from one health region in Ontario, who underwent an angiogram during their admission and survived to discharge, were cluster randomized (by primary care provider) to intervention or control. The intervention was an automated system of personalized, educational-reminders sent to the patient and their family physician, urging long-term use of secondary-prevention medications. Interventions were mailed at 1, 2, 5, 8, and 11 months after discharge. A total of 852 eligible participants were randomized to intervention (n = 424, 287 clusters) and control (n = 428, 295 clusters); 87% completed a 12-month follow-up. The primary outcome, defined as the proportion of participants taking (persistence) all 4-cardiovascular medication classes (acetylsalicylic acid, angiotensin blockers, statin, and β-blocker) at 12 months, was 58.4% (intervention) and 58.9% (control; adjusted odds ratio 1.03, 95% CI 0.77-1.36). Medication adherence, as assessed by the Morisky Medication Adherence Score, was statistically significantly better in the intervention group as compared with control (65.3% vs 58.0%, adjusted odds ratio 1.35, 95% CI 1.01-1.81).. The results suggest suboptimal use of 4 of 4 cardiac medication classes at 12 months. There was no significant difference compared with usual care in the persistence to guideline-recommended medications post-STEMI when participants (and their family physicians) receive repeated postal reminders.

Topics: Cardiovascular Agents; Cluster Analysis; Electrocardiography; Female; Follow-Up Studies; Humans; Male; Medication Adherence; Middle Aged; Myocardial Infarction; Patient Education as Topic; Registries; Time Factors

The aim of this study was to assess the safety and the efficacy of the novel sirolimus-eluting Prolim® stent with a biodegradable polymer in the all-comers population.. We prospectively enrolled all patients with stable coronary artery disease or acute coronary syndrome treated with Prolim® stent between January and December 2013 in two interventional cardiology centers in Poland. Angiographic control was planned at 12 months, in which 15 % of patients (randomly chosen) underwent optical coherence tomography imaging. The primary end-point was the cumulative rate of cardiac death, myocardial infarction, and target lesion revascularization at 12 months.. There were 204 patients enrolled, in whom 238 Prolim® stents were deployed (1.17 stent per patient). The mean age was 68 ± 10 years and 32.8 % were females. The examined stent was implanted in 5.9 % in STEMI patients, in 21.6 % - in NSTE-ACS and in 72.5 % - in patients with stable coronary artery disease. The Prolim® stent was most frequently implanted in right coronary artery (38.2 %) followed by left anterior descending artery (34.0 %). The cumulative major adverse cardiovascular events rate at 12 months was 6.9 %, and the clinically-driven target lesion revascularization rate - 5.4 %. At 12 months in quantitative coronary angiography the late lumen loss was 0.21 ± 0.18 mm, and in optical coherence tomography the mean neointima burden was 24.6 ± 8.6 %.. Sirolimus-eluting Prolim® stent with a biodegradable polymer is a feasible device with a very good safety profile and long-term clinical effectiveness.. ClinicalTrials.gov NCT02545985 .

Topics: Absorbable Implants; Acute Coronary Syndrome; Aged; Cardiovascular Agents; Coronary Angiography; Coronary Artery Disease; Coronary Vessels; Drug-Eluting Stents; Female; Humans; Male; Middle Aged; Myocardial Infarction; Neointima; Percutaneous Coronary Intervention; Poland; Polymers; Predictive Value of Tests; Prospective Studies; Prosthesis Design; Registries; Sirolimus; Time Factors; Tomography, Optical Coherence; Treatment Outcome

Previously, we reported that the nine-month angiographic result after treatment of coronary bifurcation lesions with provisional T-stenting was not significantly different from that with routine T-stenting. To compare long-term clinical outcomes of the two stenting strategies, we extended the follow-up of our study on bifurcation stenting.. One hundred and one patients with coronary bifurcation lesions had been randomly assigned to provisional T-stenting and 101 to routine T-stenting, using sirolimus-eluting stents. We performed complete five-year follow-up. The primary efficacy endpoint was the incidence of target lesion revascularisation (TLR), and the primary safety endpoint was the incidence of definite/probable stent thrombosis (ST). We also monitored death, myocardial infarction (MI) and MACE (composite of death, MI and TLR). The cumulative five-year incidence of TLR in the provisional T-stenting arm was not significantly different from that in the routine T-stenting arm (16.2% vs. 16.3%, p=0.97). The same was true for MACE (22.8% vs. 22.9%, p=0.91), the composite of death and MI (9.9% vs. 13.9%, p=0.40), and ST (2.0% vs. 5.1%; p=0.25).. During five-year follow-up, routine T-stenting offered no advantage over provisional T-stenting with respect to TLR or MACE. ClinicalTrials.gov Identifier: NCT00288535

Topics: Aged; Aged, 80 and over; Cardiovascular Agents; Coronary Angiography; Coronary Artery Disease; Coronary Restenosis; Coronary Thrombosis; Drug-Eluting Stents; Female; Germany; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Myocardial Infarction; Percutaneous Coronary Intervention; Prosthesis Design; Risk Factors; Sirolimus; Time Factors; Treatment Outcome

We aimed to evaluate the role of drug-eluting balloon SB inflation, using the novel DANUBIO balloon, after placement of a drug-eluting stent in the main branch in patients with bifurcation lesions.. Fifty-two patients with bifurcation lesions suitable for stenting were enrolled in the DEBSIDE trial at eight French centres between May 2012 and July 2013. Two patients were excluded from the trial because of significant protocol deviations. Systematic Nile PAX stent placement was followed by final drug-eluting balloon inflation, using the DANUBIO balloon, according to the size of the side branch. Clinical follow-up was scheduled at one, six, and twelve months and an angiographic control at six months. The primary endpoint was six-month late lumen loss (LLL) at the ostium of the side branch. Secondary endpoints were main branch (MB) LLL, binary restenosis of the SB and MB, and clinically driven revascularisation rates for both branches. The procedural success rate was 100%. Angiographic control at six months post-procedure was performed in 48 patients (96%). Two patients with no reported clinical events refused the angiographic control. At six-month follow-up the primary endpoint of side branch LLL was -0.04±0.34 mm and the secondary endpoint of MB LLL was 0.54±0.60 mm. There was only one myocardial infarction (2%) and no reported cardiac deaths. Only one patient (2%) had a non-clinically driven target lesion revascularisation (TLR) at the level of the side branch combined with a main branch revascularisation.. Systematic final inflation of a DANUBIO balloon in the side branch after placement of a Nile PAX stent in the main branch for the treatment of a bifurcation lesion is safe and effective and results in very low LLL and a low restenosis rate at the side branch ostium. The DEBSIDE clinical trial was registered at the United States National Institute of Health website (NCT01485081).

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiac Catheters; Cardiovascular Agents; Coated Materials, Biocompatible; Coronary Angiography; Coronary Artery Disease; Coronary Restenosis; Coronary Vessels; Drug-Eluting Stents; Female; France; Humans; Male; Middle Aged; Myocardial Infarction; Paclitaxel; Predictive Value of Tests; Prospective Studies; Prosthesis Design; Time Factors; Treatment Outcome

The aim of PMICS (Postmyocardial Infarction Cardiosclerosis) patients therapy within the dispensary supervision is CCI (Chronic Cardio Insufficiency) progression prevention, life quality improvement, hospitalization number decrease and life prognosis improvement. Despite the developed approaches to the given patients treatment, CCI progression prevention, the main disease treatment ensuring and prognosis assessment are not always as much as possible effective. The search of methods improving the given patients prognosis is highly actual.. To evaluate the meldonium clinical effectiveness in the early postmyocardial infarction period.. 67 patients were included in investigation, their age ranged from 40 to 70. They survived myocardial infarction (MI) and were discharged for further ambulatory supervision. The patients were randomized into two groups: the first one consisting of 32 patients got basic therapy for ischemic heart disease (IHD). The second group consisting of 35 patients besides basic therapy got mildronate during 12 weeks.. meldonium included in standard ischemic heart disease therapy in early postmyocardial infarction cardiosclerosis reduces the rate of angina pectoris attacks (p = 0.001), decreased the number of epiventricular extrasystoles (p = 0.002) and the number of paroxysmal rhythm disturbances (p = 0.001), decreased arterial blood pressure (middle SAP and DAP) p = 0.001, improves life quality and lowered the level of anxiety (p = 0.001).. The results received are likely to depend on the use of energetically advantageous pyruvate in glycolytic cycle due to restoration of equilibrium in processes of oxygen supply and its consumption, prevention of ATA (adenozine tryphosphoric acid) transport disturbances, elimination of toxic metabolic products accumulation. No side effects were registered during the course of mildronate treatment.

Topics: Adult; Aged; Cardiovascular Agents; Dose-Response Relationship, Drug; Electrocardiography; Female; Follow-Up Studies; Heart Rate; Humans; Male; Methylhydrazines; Middle Aged; Myocardial Infarction; Prognosis; Prospective Studies; Time Factors; Treatment Outcome

To assess the predictive value of C-reactive protein (CRP) on periprocedural myocardial injury (PMI), evaluated by creatine kinase-myocardial band isoform (CK-MB) elevation in patients undergoing percutaneous coronary intervention (PCI) with drug-eluting stent (DES) implantation for the treatment of coronary bifurcation lesions is actually unknown.. Systemic inflammation as assessed by CRP has been associated with averse events after DES implantation. After PCI, the occurrence of PMI is common and has also been associated with worse outcomes. Finally, bifurcations are frequently encountered anatomically complex lesions which the treatment is associated with higher complication rate compared with simple lesions.. A total of 96 patients (66 ± 10 years, 70 men) from the Coronary bifurcations: Application of the Crushing Technique Using Sirolimus-eluting stents (CACTUS) trial who had baseline CRP dosage and both baseline and postprocedural CK-MB measurement were included.. A complex bifurcation strategy was implemented in 53 (55%) patients, and angiographic success was achieved in all but two (2%) patients. Periprocedural myocardial necrosis (increase of CK-MB between one and three times the upper limit of normal [ULN]) was observed in 12 (13%) patients, and four (4%) patients had PCI-related myocardial infarction (increase of CK-MB more than three times ULN). Notably, progressively higher CRP levels were observed in patients with different increase in CK-MB (P = 0.041). Moreover, CRP >1 mg/L significantly predicted CK-MB rise (odds ratio 5.6, 95% confidence interval 1.5-4.3, P = 0.011).. In the setting of true coronary bifurcations treated by DES, baseline CRP levels were significantly associated with both the incidence and the extent of PMI.

Topics: Aged; Biomarkers; C-Reactive Protein; Cardiovascular Agents; Coronary Artery Disease; Creatine Kinase, MB Form; Drug-Eluting Stents; Female; Humans; Incidence; Male; Middle Aged; Myocardial Infarction; Myocardium; Necrosis; Percutaneous Coronary Intervention; Prospective Studies; Sirolimus; Treatment Outcome; Up-Regulation

The long-term performance of polymer-free stent systems in patients with diabetes mellitus has not been investigated extensively. This study reports long-term results of the LIPSIA Yukon trial which compared the polymer-free sirolimus-eluting Yukon Choice stent with the polymer-based paclitaxel-eluting Taxus Liberté stent in this subpopulation. At 9 months, the Yukon Choice stent failed to show non-inferiority in terms of the primary end point late lumen loss, while no significant difference in clinical outcome was detected.. The LIPSIA Yukon trial randomized 240 patients with diabetes mellitus to a polymer-free sirolimus eluting stent (Yukon Choice, Translumina) versus a polymer-based paclitaxel-eluting stent (Taxus Liberté, Boston Scientific). Clinical follow-up was conducted with a standardized telephone follow-up and all events were centrally adjudicated. Follow-up was available for 98.3% of patients after a median of 5.0 years. The incidence of all-cause death (16.9% versus 14.0%, P = 0.67), respectively definite or presumed cardiovascular death (7.6% versus 8.8%, P = 0.94) were similar in the Yukon Choice and the Taxus Liberté group. There were no significant differences in the rates of myocardial infarction (9.3% versus 7.9%, P = 0.88), definite stent thrombosis (0.8% versus 0.9%, P = 1.0), target lesion revascularization (15.3% versus 15.8%, P = 1.0), target vessel revascularization (18.6% versus 23.7%, P = 0.44), non-target vessel revascularization (18.6% versus 26.3%, P = 0.21), and stroke (3.4% versus 4.4%, P = 0.96) between patients assigned to the Yukon Choice and the Taxus Liberté stent.. At 5 years of follow-up, clinical outcome was similar between the polymer-free sirolimus-eluting Yukon Choice stent and the polymer-based paclitaxel-eluting Taxus Liberté stent.

Topics: Aged; Cardiovascular Agents; Coronary Artery Disease; Coronary Thrombosis; Diabetic Angiopathies; Drug-Eluting Stents; Female; Germany; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Myocardial Infarction; Paclitaxel; Percutaneous Coronary Intervention; Polymers; Prospective Studies; Prosthesis Design; Risk Factors; Sirolimus; Time Factors; Treatment Outcome

This study sought to perform clinical and imaging assessments of the DESolve Bioresorbable Coronary Scaffold (BCS).. BCS, which is drug eluting, may have potential advantages compared with conventional metallic drug-eluting stents. The DESolve system, designed to provide vessel support and neointimal suppression, combines a poly-l-lactic acid-based scaffold with the antiproliferative myolimus.. The DESolve First-in-Man (a non-randomized, consecutive enrollment evaluation of the DESolve myolimus eluting bioresorbable coronary stent in the treatment of patients with de novo native coronary artery lesions) trial was a prospective multicenter study enrolling 16 patients eligible for treatment. The principal safety endpoint was a composite of cardiac death, myocardial infarction, and clinically indicated target lesion revascularization. The principal imaging endpoint was in-scaffold late lumen loss (LLL) assessed by quantitative coronary angiography (QCA) at 6 months. Intravascular ultrasound (IVUS) and optical coherence tomography (OCT) imaging was performed at baseline and 6 months; multislice computed tomography (MSCT) was performed at 12 months.. Acute procedural success was achieved in 15 of 15 patients receiving a study scaffold. At 12 months, there was no scaffold thrombosis and no major adverse cardiac events directly attributable to the scaffold. At 6 months, in-scaffold LLL (by QCA) was 0.19 ± 0.19 mm; neointimal volume (by IVUS) was 7.19 ± 3.56%, with no evidence of scaffold recoil or late malapposition. Findings were confirmed with OCT and showed uniform, thin neointimal coverage (0.12 ± 0.04 mm). At 12 months, MSCT demonstrated excellent vessel patency.. This study demonstrated the feasibility and efficacy of the DESolve BCS. Results showing low in-scaffold LLL, low % neointimal volume at 6 months, no chronic recoil, and maintenance of lumen patency at 12 months prompt further study. (DESolve First-in-Man; EudraCT number 2011-000027-32).

Topics: Absorbable Implants; Aged; Aged, 80 and over; Belgium; Cardiovascular Agents; Coronary Angiography; Coronary Artery Disease; Coronary Restenosis; Drug-Eluting Stents; Female; Humans; Lactic Acid; Male; Materials Testing; Models, Cardiovascular; Multidetector Computed Tomography; Multimodal Imaging; Myocardial Infarction; Neointima; New Zealand; Percutaneous Coronary Intervention; Polyesters; Polymers; Predictive Value of Tests; Prospective Studies; Prosthesis Design; Time Factors; Tissue Scaffolds; Tomography, Optical Coherence; Treatment Outcome; Ultrasonography, Interventional; Vascular Patency

This study sought to assess the 2-year outcomes of the population included in the EXAMINATION (Everolimus-Eluting Stents Versus Bare-Metal Stents in ST-Segment Elevation Myocardial Infarction) trial beyond the 1-year prescription period of dual antiplatelet therapy.. The EXAMINATION trial compared the performance of everolimus-eluting stents (EES) versus bare-metal stents (BMS) in an all-comer ST-segment elevation myocardial infarction (STEMI) population.. This was a multicenter, multinational, prospective, randomized, single-blind, controlled trial in patients with STEMI. The primary endpoint, which was the combined endpoint of all-cause death, any recurrent myocardial infarction, and any revascularization, and the endpoints target lesion revascularization and stent thrombosis were assessed at 2 years.. Between December 31, 2008, and May 15, 2010, 1,498 patients were randomized to receive EES (n = 751) or BMS (n = 747). Compliance with dual antiplatelet regimen was reduced at 2 years to a similar degree (17.3% vs. 17.2%, p = 0.91). At 2 years, the primary endpoint occurred in 108 (14.4%) patients of the EES group and in 129 (17.3%) patients of the BMS group (p = 0.11). Rate of target lesion revascularization was significantly lower in the EES group than in the BMS group (2.9% vs. 5.6%; p = 0.009). Rates of definite and definite or probable stent thrombosis were also significantly reduced in the EES group (0.8% vs. 2.1%; p = 0.03, and 1.3% vs. 2.8%; p = 0.04, respectively).. The 2-year follow-up of the EXAMINATION trial confirms the safety and efficacy of the EES compared with BMS in the setting of STEMI. Specifically, both rates of target lesion revascularization and stent thrombosis were reduced in recipients of EES without any signs of late attrition for either of these endpoints. (A Clinical Evaluation of Everolimus Eluting Coronary Stents in the Treatment of Patients With ST-Segment Elevation Myocardial Infarction: EXAMINATION Study; NCT00828087).

Topics: Aged; Cardiovascular Agents; Coronary Thrombosis; Drug Administration Schedule; Drug Therapy, Combination; Drug-Eluting Stents; Europe; Everolimus; Female; Humans; Male; Middle Aged; Myocardial Infarction; Percutaneous Coronary Intervention; Platelet Aggregation Inhibitors; Prospective Studies; Prosthesis Design; Recurrence; Single-Blind Method; Sirolimus; Time Factors; Treatment Outcome

Second-generation everolimus-eluting stents (EES) and third generation biolimus-eluting stents (BES) have been shown to be superior to first-generation paclitaxel-eluting stents (PES) and second-generation sirolimus-eluting stents (SES). However, neointimal proliferation and very late stent thrombosis is still an unresolved issue of drug-eluting stent (DES) implantation overall. The Absorb™ (Abbott Vascular, Abbott Park, IL, USA) is the first CE approved DES with a bioresorbable vascular scaffold (BVS) thought to reduce long-term complication rates. The EVERBIO II trial was set up to compare the BVS safety and efficacy with both EES and BES in all patients viable for inclusion.. The EVERBIO II trial is a single-center, assessor-blinded, randomized trial. The study population consists of all patients aged≥18 years old undergoing percutaneous coronary intervention. Exclusion criterion is where the lesion cannot be treated with BVS (reference vessel diameter>4.0 mm). A total of 240 patients will be enrolled and randomly assigned into 3 groups of 80 with either BVS, EES or BES implantation. All patients will undergo a follow-up angiography study at 9 months. Clinical follow-up for up to 5 years will be conducted by telephone. The primary endpoint is in-segment late lumen loss at 9 months measured by quantitative coronary angiography. Secondary endpoints are patient-oriented major adverse cardiac event (MACE) (death, myocardial infarction and target-vessel revascularization), device-oriented MACE (cardiac death, myocardial infarction and target-lesion revascularization), stent thrombosis according to ARC and binary restenosis at follow-up 12 months angiography.. EVERBIO II is an independent, randomized study, aiming to compare the clinical efficacy, angiographic outcomes and safety of BVS, EES and BES in all comer patients.. The trial listed in clinicaltrials.gov as NCT01711931.

Topics: Absorbable Implants; Cardiovascular Agents; Clinical Protocols; Coronary Angiography; Coronary Artery Disease; Coronary Restenosis; Coronary Thrombosis; Drug-Eluting Stents; Everolimus; Humans; Myocardial Infarction; Percutaneous Coronary Intervention; Prosthesis Design; Research Design; Sirolimus; Switzerland; Time Factors; Tissue Scaffolds; Treatment Outcome

The aim of this study was to determine the relative utility of anatomic and ischemic burden of coronary artery disease for predicting outcomes.. Both anatomic burden and ischemic burden of coronary artery disease determine patient prognosis and influence myocardial revascularization decisions. When both measures are available, their relative utility for prognostication and management choice is controversial.. A total of 621 patients enrolled in the COURAGE (Clinical Outcomes Utilizing Revascularization and Aggressive Drug Evaluation) trial with baseline quantitative nuclear single-photon emission computed tomography (SPECT) and quantitative coronary angiography were studied. Several multiple regression models were constructed to determine independent predictors of the endpoint of death, myocardial infarction (MI) (excluding periprocedural MI) and non-ST-segment elevation acute coronary syndromes (NSTE-ACS). Ischemic burden during stress SPECT, anatomic burden derived from angiography, left ventricular ejection fraction, and assignment to either optimal medical therapy (OMT) + percutaneous coronary intervention (PCI) or OMT alone were analyzed.. In nonadjusted and adjusted regression models, anatomic burden and left ventricular ejection fraction were consistent predictors of death, MI, and NSTE-ACS, whereas ischemic burden and treatment assignment were not. There was a marginal (p = 0.03) effect of the interaction term of anatomic and ischemic burden for the prediction of clinical outcome, but separately or in combination, neither anatomy nor ischemia interacted with therapeutic strategy to predict outcome.. In a cohort of patients treated with OMT, anatomic burden was a consistent predictor of death, MI, and NSTE-ACS, whereas ischemic burden was not. Importantly, neither determination, even in combination, identified a patient profile benefiting preferentially from an invasive therapeutic strategy. (Clinical Outcomes Utilizing Revascularization and Aggressive Drug Evaluation [COURAGE]; NCT00007657).

Topics: Aged; Cardiovascular Agents; Coronary Angiography; Coronary Artery Disease; Coronary Circulation; Coronary Vessels; Female; Humans; Male; Middle Aged; Myocardial Infarction; Myocardial Perfusion Imaging; Percutaneous Coronary Intervention; Predictive Value of Tests; Risk Factors; Severity of Illness Index; Stroke Volume; Tomography, Emission-Computed, Single-Photon; Treatment Outcome; Ventricular Function, Left

Concern exists relating to potential attenuated efficacy of limus-eluting stents in patients with diabetes mellitus. In this respect diabetic patients with sirolimus-eluting stent (SES) failure requiring reintervention may be expected to derive particular benefit from a treatment-switch to paclitaxel-eluting stent (PES) implantation.. The aim of the current report was to investigate outcomes of patients with SES restenosis randomized to treatment with SES (same stent strategy) or PES (switch stent strategy) in the pre-specified subgroups of patients with and without diabetes mellitus.. In the setting of ISAR-DESIRE 2 trial, 450 patients with clinically significant SES restenosis were randomly assigned to receive either SES or PES. The primary end point was in-stent late loss at 6-8month follow-up angiography. Secondary endpoints were binary angiographic restenosis (diameter stenosis >50%) and target lesion revascularization (TLR), the composite of death or myocardial infarction (MI) and definite stent thrombosis at 12months.. Of 450 patients enrolled, 162 (36.0%) had a diagnosis of diabetes mellitus. In patients with diabetes 86 patients were randomly assigned to SES versus 76 to PES. In patients without diabetes 139 were assigned to SES versus 149 to PES. Late loss was comparable between SES and PES both in patients with diabetes (0.38±0.59mm vs. 0.37±0.59mm; p=0.97) and without (0.41±0.67mm vs. 0.38±0.6mm; p=0.98; pinteraction=0.89). Similarly binary restenosis was comparable between SES and PES in patients with diabetes (19.0% vs. 26.0%; p=0.32) or without (18.9% vs. 17.8%; p=0.98; pinteraction=0.36). TLR, death or MI and definite stent thrombosis were also similar in SES versus PES treatment groups regardless of diabetes status.. In cases of SES-restenosis, treatment with either repeat SES or switch to PES was associated with a comparable degree of efficacy, regardless of diabetic status.

Topics: Aged; Cardiovascular Agents; Coronary Angiography; Coronary Restenosis; Coronary Thrombosis; Diabetes Complications; Drug-Eluting Stents; Female; Germany; Humans; Male; Middle Aged; Myocardial Infarction; Paclitaxel; Patient Selection; Percutaneous Coronary Intervention; Risk Assessment; Risk Factors; Sirolimus; Time Factors; Treatment Outcome

We aimed to investigate, in patients with ST-segment elevation myocardial infarction (STEMI), whether the previously reported clinical benefits of sirolimus-eluting stent(s) (SES) in terms of reducing a major adverse cardiac and cerebrovascular event (MACCE) compared with bare-metal stent(s) (BMS) were maintained over a 5-year time period.. In the prospective single-centre randomized DEBATER trial, SES significantly reduced the rate of MACCE in STEMI patients within 1 year compared with BMS, mainly driven by a reduction of target lesion revascularization. Randomized data on the long-term safety and efficacy of SES in STEMI patients are conflicting and limited.. Between January 2006 and May 2008, a total of 907 STEMI patients were randomized to receive SES or BMS. The primary endpoint was MACCE defined as the composite of death, myocardial infarction, stroke, repeat revascularization and bleeding. Five-year follow-up data were collected by reviewing hospital records, telephone calls and a written questionnaire.. At 5 years, the rate of MACCE between the SES group and the BMS group was no longer significantly different (33.3 vs. 39.3%, P=0.12). The cumulative incidence of death and myocardial infarction was similar in both groups (11.0 vs. 9.7%, P=0.51). Repeat revascularization was performed in 21.1 and 25.8% of patients, respectively (P=0.12). The rate of very late stent thrombosis (1-5 years of follow-up) was very low in both groups (2.0 vs. 0.7%, P=0.12).. The benefits of SES in STEMI patients in terms of reducing MACCE faded over time. We found no safety concerns in terms of SES in the long term, with extremely low rates of very late stent thrombosis.

Topics: Cardiovascular Agents; Coronary Thrombosis; Drug-Eluting Stents; Humans; Kaplan-Meier Estimate; Metals; Myocardial Infarction; Netherlands; Percutaneous Coronary Intervention; Prospective Studies; Prosthesis Design; Recurrence; Risk Factors; Sirolimus; Stents; Time Factors; Treatment Outcome

To evaluate the anti-ischemic and anti-anginal efficacy of meldonium (Idrinol) in its short-term use as part of combination therapy in patients with chronic heart failure in the early post-infarction period.. The investigation enrolled 60 patients (men and women) aged 45 to 75 years at weeks 3-4 after postmyocardial infarction with symptoms of Functional Class II-III heart failure. All the patients underwent physical examination, 24-hour ECG monitoring, heart rate variability (HRV) study, and quality of life assessment using the Seattle questionnaire. After randomization of the patients into 2 groups, Group 1 (a study group) (n = 30) was given intravenous Idrinol 1000 mg/day in addition to the basic therapy of coronary heart disease. The study and control (Group 2; n = 30) groups were matched for age, gender, disease severity, and basic therapy pattern.. Following 10-14 days of treatment, both groups showed clinical improvement and the autonomically normalizing effect of meldonium (Idrinol), which were more pronounced in Group 1 patients.. Meldonium (Idrinol) was effective when parenterally administered in a dose of 1000 mg/day for 10-14 days as part of combination therapy in the early post-infarction period, which showed up as clinical improvement, a significant reduction in the frequency of angina attacks and in the need to use nitroglycerin, a decrease in the number of arrhythmia episodes, and its normalizing effect of HRV.

Topics: Administration, Oral; Aged; Cardiovascular Agents; Dose-Response Relationship, Drug; Electrocardiography; Exercise Tolerance; Female; Forkhead Transcription Factors; Humans; Male; Methylhydrazines; Middle Aged; Myocardial Infarction; Prospective Studies; Treatment Outcome

Substantial racial and ethnic disparities in cardiovascular care persist in the United States. For example, African Americans and Hispanics with cardiovascular disease are 10-40 percent less likely than whites to receive secondary prevention therapies, such as aspirin and beta-blockers. Lowering copayments for these therapies improves outcomes among all patients who have had a myocardial infarction, but the impact of lower copayments on health disparities is unknown. Using self-reported race and ethnicity for participants in the Post-Myocardial Infarction Free Rx Event and Economic Evaluation (MI FREEE) trial, we found that rates of medication adherence were significantly lower and rates of adverse clinical outcomes were significantly higher for nonwhite patients than for white patients. Providing full drug coverage increased medication adherence in both groups. Among nonwhite patients, it also reduced the rates of major vascular events or revascularization by 35 percent and reduced total health care spending by 70 percent. Providing full coverage had no effect on clinical outcomes and costs for white patients. We conclude that lowering copayments for medications after myocardial infarctions may reduce racial and ethnic disparities for cardiovascular disease.

Topics: Adult; Black or African American; Cardiovascular Agents; Cardiovascular Diseases; Female; Financing, Personal; Health Services Accessibility; Health Services Misuse; Healthcare Disparities; Hispanic or Latino; Humans; Insurance Coverage; Insurance, Pharmaceutical Services; Male; Medication Adherence; Middle Aged; Myocardial Infarction; Recurrence

Doxycycline has been demonstrated to reduced left ventricular (LV) remodeling, but its effect in patients with ST-elevation myocardial infarction (STEMI) and a baseline occluded [thrombolysis in myocardial infarction (TIMI) flow grade ≤1] infarct-related artery (IRA) is unknown. According to the baseline TIMI flow grade, 110 patients with a first STEMI were divided into 2 groups. Group 1: 77 patients with TIMI flow ≤1 (40 patients treated with doxycycline and 37 with standard therapy, respectively), and a Group 2: 33 patients with TIMI flow 2-3 (15 patients treated with doxycycline and 18 with standard therapy, respectively). The two randomized groups were well matched in baseline characteristics. A 2D-Echo was performed at baseline and at 6 months, together with a coronary angiography, for the remodeling and IRA patency assessment, respectively. The LV end-diastolic volume index (LVEDVi) decreased in Group 2 [-3 mL/m(2) (IQR: -12 to 4 mL/m(2))], and increased in Group 1 [6 mL/m(2) (IQR: -2 to 14 mL/m(2))], (p = 0.001). In Group 2, LVEDVi reduction was similar regardless of drug therapy, while in Group 1 the LVEDVi was smaller in patients treated with doxycycline as compared to control [3 mL/m(2) (IQR: -3 to 8 mL/m(2)) vs. 10 mL/m(2) (IQR: 1-27 mL/m(2)), p = 0.006]. A similar pattern was observed also for LV end-systolic volume and ejection fraction. In STEMI patients at higher risk, as those with a baseline TIMI flow grade ≤1, doxycycline reduces LV remodeling.

Topics: Aged; Aged, 80 and over; Cardiovascular Agents; Coronary Angiography; Coronary Circulation; Coronary Stenosis; Doxycycline; Drug Administration Schedule; Female; Humans; Italy; Male; Matrix Metalloproteinase Inhibitors; Middle Aged; Myocardial Infarction; Percutaneous Coronary Intervention; Prospective Studies; Risk Factors; Severity of Illness Index; Stroke Volume; Time Factors; Treatment Outcome; Vascular Patency; Ventricular Function, Left; Ventricular Remodeling

To evaluate the impact of 10-14-day intravenous administration of meldonium as part of combination therapy in patients with chronic heart failure in the early post-infarction period on the recovery period, structural and functional parameters, and heart rate variability (HRV).. The investigation enrolled 60 patients (men and women) aged 45 to 75 years at weeks 3-4 after post-myocardial infarction with symptoms of Functional Class II-III heart failure. All the patients underwent 24-hour electrochocardiography monitoring, cardiac echocardiography, and HRV study. After dividing the patients into 2 groups, Group 1 (a study group) (n = 30) was given intravenous meldonium (idrinol) 1000 mg/day in addition to the basic therapy of coronary heart disease. The patients in the study and control (Group 2; n = 30) groups were at baseline matched for age, gender, disease severity, and basic therapy pattern.. Following 10-14 days of treatment, both groups showed clinical improvement and the favorable changes in cardiac structural and functional parameters and HRV values, which were more pronounced in the patients receiving meldonium.. The patients with CHF using meldonium as part of combination therapy in the early post-infarction period were observed to have clinical improvement, a significant reduction in the rate of angina attacks and in the need for nitrates, a decrease in the number of arrhythmic and ischemic episodes, and favorable changes in cardiac structural and functional parameters and HRV values.

Topics: Aged; Cardiovascular Agents; Diastole; Drug Therapy, Combination; Female; Heart Failure; Heart Rate; Humans; Injections, Intravenous; Male; Methylhydrazines; Middle Aged; Myocardial Infarction; Systole; Treatment Outcome

We evaluated the prespecified endpoint, aborted myocardial infarction (AbMI), according to the use of a pharmacoinvasive (PI) strategy versus primary percutaneous coronary intervention (PCI) in 1754 patients randomised within 3 h of symptom onset in the STrategic Reperfusion Early After Myocardial infarction (STREAM) trial.. Based on sequential ECG's and biomarkers, AbMI was defined as ST-elevation resolution ≥50% (90 min posttenecteplase (TNK) in the PI arm or 30 min postprimary PCI) with minimal biomarker rise.. In the PI arm 11.1% (n=99) had AbMI versus 6.9% (n=59) in primary PCI arm (p<0.01). In a multivariable model, AbMI patients overall had less baseline ΣST-deviation, fewer baseline Q-waves and shorter total ischaemic times. PI AbMI patients had faster time to TNK (90 vs 100 min, p=0.015): total ischaemic time was 100 min longer in primary PCI AbMI patients and no difference in ischaemic time existed between AbMI and non-AbMI patients within this group. Although no significant interaction between treatment and AbMI on the composite endpoint of death/shock/congestive heart failure/recurrent MI occurred (p=0.292), PI AbMI patients had a lower incidence in this endpoint than non-AbMI patients (5.1 vs 12%, p=0.038); this was not evident in primary PCI patients. Forty-five patients (ie, 2.5%) had masquerading MI with minimal biomarker elevation and no evolution in baseline ST-elevation.. A PI strategy of early fibrinolysis more frequently aborts MI than primary PCI. Such PI patients had more favourable outcomes as compared with non-AbMIs. Diligent review of ECG evolution in STEMI distinguishes AbMI from infarct masquerade. ClinicalTrials.gov ID: NCT00623623.

Topics: Aged; Biomarkers; Cardiovascular Agents; Creatine Kinase, MB Form; Early Medical Intervention; Electrocardiography; Female; Fibrinolytic Agents; Humans; Male; Middle Aged; Myocardial Infarction; Percutaneous Coronary Intervention; Time-to-Treatment; Treatment Outcome; Troponin

Ischaemia in different arterial territories before acute myocardial infarction (AMI) may influence post-AMI outcomes. No studies have evaluated prospectively collected information on ischaemia and its effect on short- and long-term coronary mortality. The objective of this study was to compare patients with and without prospectively measured ischaemic presentations before AMI in terms of infarct characteristics and coronary mortality.. As part of the CALIBER programme, we linked data from primary care, hospital admissions, the national acute coronary syndrome registry and cause-specific mortality to identify patients with first AMI (n = 16,439). We analysed time from AMI to coronary mortality (n = 5283 deaths) using Cox regression (median 2.6 years follow-up), comparing patients with and without recent ischaemic presentations. Patients with ischaemic presentations in the 90 days before AMI experienced lower coronary mortality in the first 7 days after AMI compared with those with no prior ischaemic presentations, after adjusting for age, sex, smoking, diabetes, blood pressure and cardiovascular medications [HR: 0.64 (95% CI: 0.57-0.73) P < 0.001], but subsequent mortality was higher [HR: 1.42 (1.13-1.77) P = 0.001]. Patients with ischaemic presentations closer in time to AMI had the lowest seven day mortality (P-trend = 0.001).. In the first large prospective study of ischaemic presentations prior to AMI, we have shown that those occurring closest to AMI are associated with lower short-term coronary mortality following AMI, which could represent a natural ischaemic preconditioning effect, observed in a clinical setting.. Clinicaltrials.gov identifier NCT01604486.

Topics: Aged; Aged, 80 and over; Angina Pectoris; Atherosclerosis; Cardiovascular Agents; Cerebrovascular Disorders; Electronic Health Records; Female; Follow-Up Studies; Humans; Ischemia; Kaplan-Meier Estimate; Male; Middle Aged; Myocardial Infarction; Peripheral Arterial Disease; Prognosis; Prospective Studies; Risk Factors

The study sought to compare the risk of late outcome with a focus on very late definite stent thrombosis of the everolimus-eluting stent (EES) with that of the sirolimus-eluting stent (SES) at 3-year follow-up.. In the SORT OUT IV (SORT OUT IV Trial), comparing the EES with the SES in patients with coronary artery disease, the EES was noninferior to the SES at 9 months. The SORT OUT IV trial provides long-term head-to-head randomized comparison of the EES with the SES.. We prospectively randomized 2,774 patients in the SORT OUT IV trial. Follow-up through 3 years was complete in 2,771 patients (99.9%). The 3-year pre-specified endpoints were composites of safety and efficacy (major adverse cardiac events [MACE]: cardiac death, myocardial infarction, target vessel revascularization, and definite stent thrombosis).. At 3 years, the composite endpoint MACE occurred in 9.8% of the EES group and in 11.1% of the SES group (hazard ratio [HR]: 0.89, 95% confidence interval [CI]: 0.70 to 1.12). Overall rate of definite stent thrombosis was lower in the EES group (0.2% vs. 1.4%; HR: 0.15, 95% CI: 0.04 to 0.50), which was largely attributable to a lower risk of very late definite stent thrombosis: 0.1% versus 0.8% (HR: 0.09, 95% CI: 0.01 to 0.70).. At 3-year follow-up, the MACE rate did not differ significantly between EES- and SES-treated patients. A significant reduction of overall and very late definite stent thrombosis was found in the EES group. (The SORT OUT IV TRIAL [SORT OUT IV]; NCT00552877).

Topics: Aged; Cardiovascular Agents; Coronary Artery Disease; Coronary Thrombosis; Drug-Eluting Stents; Everolimus; Female; Humans; Male; Middle Aged; Myocardial Infarction; Percutaneous Coronary Intervention; Proportional Hazards Models; Prospective Studies; Prosthesis Design; Registries; Risk Factors; Scandinavian and Nordic Countries; Single-Blind Method; Time Factors; Treatment Outcome

This study sought to assess in vivo sex differences in the pathophysiology of ST-segment elevation myocardial infarction (STEMI) and vascular response to primary percutaneous coronary intervention (PCI).. There is no consensus on whether differences in the pathophysiology of STEMI and response to primary PCI between women and men reflect biological factors as opposed to differences in age.. In this prospective, multicenter study, 140 age-matched men and women with STEMI undergoing primary PCI with everolimus-eluting stent were investigated with intravascular optical coherence tomography, histopathology-immunohistochemistry of thrombus aspirates, and serum biomarkers. Primary endpoints were the percentages of culprit plaque rupture at baseline and everolimus-eluting stent strut coverage at 9-month follow-up as determined by optical coherence tomography.. Men and women had similar rates of plaque rupture (50.0% vs. 48.4%; risk ratio [RR]: 1.03; 95% confidence interval [CI]: 0.73 to 1.47; p = 0.56). Nonruptured/eroded plaques comprised 25% of all cases (p = 0.86 in men vs. women). There were no sex differences in composition of aspirated thrombus and immune and inflammatory serum biomarkers. At 9 months, women had similar strut coverage (90.9% vs. 92.5%; difference in medians: RR: 0.2%; 95% CI: -0.4% to 1.3%; p = 0.89) and amount of in-stent neointimal obstruction (10.3% vs. 10.6%; p = 0.76) as men did. There were no sex differences in clinical outcome either at 30-day or 1-year follow-up.. In patients presenting with STEMI undergoing primary PCI, no differences in culprit plaque morphology and factors associated with coronary thrombosis were observed between age-matched men and women. Women also showed similar vascular healing response to everolimus-eluting stents as men did. (Optical Coherence Tomography Assessment of Gender Diversity In Primary Angioplasty: The OCTAVIA Trial [OCTAVIA]; NCT01377207).

Topics: Aged; Aged, 80 and over; Biomarkers; Cardiovascular Agents; Chi-Square Distribution; Coronary Angiography; Coronary Artery Disease; Coronary Restenosis; Coronary Thrombosis; Drug-Eluting Stents; Everolimus; Female; Health Status Disparities; Humans; Male; Middle Aged; Myocardial Infarction; Neointima; Odds Ratio; Percutaneous Coronary Intervention; Prospective Studies; Risk Factors; Rupture, Spontaneous; Sex Factors; Sirolimus; Time Factors; Tomography, Optical Coherence; Treatment Outcome; Wound Healing

The aim of the current study was to compare everolimus-eluting stents (EES) with sirolimus-eluting stents (SES) in patients undergoing primary angioplasty.. Drug-eluting stents may offer benefits in terms of repeat revascularization. However, as shown for first-generation drug-eluting stents, they may be counterbalanced by a potential higher risk of stent thrombosis, especially among patients with ST-segment elevation myocardial infarction (STEMI). No data have been reported so far on the long-term benefits and safety of the new generation of drug-eluting stents in STEMI.. Consecutive STEMI patients admitted within 12 h of symptom onset and undergoing primary angioplasty and stent implantation at a tertiary center with 24-h primary percutaneous coronary intervention capability were randomly assigned to SES or EES. The primary endpoint was a major adverse cardiac event at 3-year follow-up. The secondary endpoints were death, reinfarction, definite or probable stent thrombosis, and target vessel revascularization at 3-year follow-up. No patient was lost to follow-up.. From April 2007 to May 2009, 500 patients with STEMI were randomized to EES (n = 250) or SES (n = 250). No difference was observed in terms of baseline demographic and clinical characteristics between the groups. No difference was observed between the groups in terms of number of implanted stents per patient or total stent length. However, a larger reference diameter was observed with SES (3.35 ± 0.51 mm vs. 3.25 ± 0.51 mm, p = 0.001), whereas patients randomized to EES more often received glycoprotein IIb/IIIa inhibitors (54.4% vs. 42.4%, p = 0.006). Follow-up data were available in all patients (1,095 ± 159 days). No significant difference was observed between EES and SES in major adverse cardiac events (16% vs. 20.8%, adjusted hazard ratio [HR]: 0.75 [95% confidence interval (CI): 0.5 to 1.13], p = 0.17), cardiac death (4.4% vs. 5.6%, adjusted HR: 0.77 [95% CI: 0.35 to 1.71], p = 0.53), recurrent MI (6.4% vs. 10%, adjusted HR: 0.62 [95% CI: 0.33 to 1.16], p = 0.13), and target vessel revascularization (4.8% vs. 4.8%, adjusted HR: 1.00 [95% CI: 0.45 to 2.32], p = 0.99). However, EES was associated with a significant reduction in stent thrombosis (1.6% vs. 5.2%, adjusted HR: 0.3 [95% CI: 0.1 to 0.92], p = 0.035).. This study shows that among STEMI patients undergoing primary angioplasty, EES has similar efficacy as SES, but is associated with a significant reduction in stent thrombosis. (Randomized Comparison of Everolimus Eluting Stents and Sirolimus Eluting Stent in Patients With ST Elevation Myocardial Infarction [RACES-MI]; NCT01684982).

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Thrombosis; Drug-Eluting Stents; Everolimus; Female; Humans; Italy; Kaplan-Meier Estimate; Male; Middle Aged; Myocardial Infarction; Platelet Aggregation Inhibitors; Proportional Hazards Models; Prospective Studies; Prosthesis Design; Recurrence; Risk Factors; Tertiary Care Centers; Time Factors; Treatment Outcome

Coronary artery disease is the leading cause of death in women. The proposed treatments for women are similar to those for men. However, in women with multivessel stable coronary artery disease and normal left ventricular function, the best treatment is unknown.. A post hoc analysis of the MASS II study with 10 years of follow-up, mean (standard deviation) 6.8 (3.7) years, enrolled between May 1995 and May 2000, evaluated 188 women with chronic stable multivessel coronary artery disease who underwent medical treatment, percutaneous coronary intervention or coronary artery bypass graft surgery. Primary end-points were incidence of total mortality, Q-wave myocardial infarction, or refractory angina. Data were analysed according to the intention-to-treat principle.. Women treated with percutaneous coronary intervention and medical treatment had more primary events than those treated with coronary artery bypass graft surgery, respectively, of 34, 44 and 22% (P = 0.003). Survival rates at 10 years were 72% for coronary artery bypass graft surgery, 72% for percutaneous coronary intervention and 56% for medical treatment (P = 0.156). For the composite end-point, Cox regression analysis adjusted for age, diabetes, hypertension, treatment allocation, prior myocardial infarction, smoking, number of vessels affected and total cholesterol, had a higher incidence of primary events with medical treatment than with coronary artery bypass graft surgery [hazard ratio (HR) = 2.38 (95% confidence interval (CI): 1.40-4.05); P = 0.001], a lower incidence with percutaneous coronary intervention than with medical treatment [HR = 0.60 (95% CI: 0.38-0.95); P = 0.031] but no differences between coronary artery bypass graft surgery and percutaneous coronary intervention. Regarding death, a protective effect was observed with percutaneous coronary intervention compared with medical treatment [HR = 0.44 (95% CI: 0.21-0.90); P = 0.025].. Percutaneous coronary intervention and coronary artery bypass graft surgery compared with medical treatment had better results after 10 years of follow-up.

Topics: Aged; Angina Pectoris; Cardiovascular Agents; Chi-Square Distribution; Chronic Disease; Coronary Artery Bypass; Coronary Artery Disease; Female; Humans; Kaplan-Meier Estimate; Middle Aged; Multivariate Analysis; Myocardial Infarction; Percutaneous Coronary Intervention; Proportional Hazards Models; Risk Factors; Sex Factors; Survival Rate; Time Factors; Treatment Outcome; Ventricular Function, Left

The aim of this study was to investigate the hypothesis that a novel biodegradable polymer-coated, cobalt-chromium (CoCr), sirolimus-eluting stent (BP-SES) is noninferior in safety and efficacy outcomes compared with a durable polymer (DP)-SES.. No randomized trials have the compared safety and efficacy of BP-SES versus DP-SES on similar CoCr platforms, thereby isolating the effect of the polymer type.. In this prospective, single-blind, randomized trial conducted at 32 Chinese sites, 2,737 patients eligible for coronary stenting were treated with BP- or DP-SES in a 2:1 ratio. The primary endpoint was 12-month target lesion failure (TLF), a composite of cardiac death, target vessel myocardial infarction, or clinically indicated target lesion revascularization. Secondary endpoints included TLF components, and definite/probable stent thrombosis.. At 12 months, the difference in the primary endpoint of TLF between BP-SES (6.3%) and DP-SES (6.1%) groups was 0.25% (95% confidence interval: -1.67% to 2.17%, p for noninferiority = 0.0002), demonstrating noninferiority of BP-SES to DP-SES. Individual TLF components of cardiac death (0.7% vs. 0.6%, p = 0.62), target vessel myocardial infarction (3.6% vs. 4.3%, p = 0.39), and clinically indicated target lesion revascularization (2.6% vs. 2.2%, p = 0.50) were similar, as were low definite/probable stent thrombosis rates (0.4% vs. 0.6%, p = 0.55).. In this large-scale real-world trial, BP-SES was noninferior to DP-SES for 1-year TLF. (Evaluate Safety and Effectiveness of the Tivoli ® DES and the Firebird ® DES for Treatment of Coronary Revascularization; NCT01681381).

Topics: Aged; Cardiovascular Agents; China; Chromium Alloys; Coronary Artery Disease; Coronary Thrombosis; Drug-Eluting Stents; Female; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Myocardial Infarction; Percutaneous Coronary Intervention; Polymers; Proportional Hazards Models; Prospective Studies; Prosthesis Design; Recurrence; Risk Factors; Single-Blind Method; Sirolimus; Time Factors; Treatment Outcome

The aim of this study was to evaluate the efficacy of a long-term secondary prevention programme following inpatient cardiovascular rehabilitation on cardiovascular risk and health-related quality of life in a cohort of middle-aged (≤58 years) coronary artery disease (CAD) patients of low educational level compared to usual care.. The study included 600 patients with CAD, with 271 in the intervention group (IG) and 329 in the control group (CG). The average age was nearly 50 years in both groups, nearly 90% were male, and 77% had less than 10 years of school education. No significant differences existed between the groups at baseline. Both groups had a 3-week comprehensive cardiovascular inpatient rehabilitation programme at the beginning, the intervention consisted of one further rehabilitation session in hospital after 6 months and regular telephone reminders over a period of 36 months. Analyses were conducted on an intention-to-treat basis. To evaluate the individual risk level, we used the PROCAM score and intima-media thickness (IMT) was measured at the common carotid artery on both sides following international standards. Health-related quality of life was assessed with the EUROQOL and HADS.. Patients in the IG showed better 3-year risk profile outcomes. The PROCAM score increased by 3.0 (IG) and by 3.7 (CG) from the beginning to after 3 years (p > 0.05 intention-to-treat). The average IMT increased by 0.04 mm in the CG and was reduced by 0.03 mm in the IG (p = 0.014 for the difference). The IG had a significant improvement in health-related quality of life. Mortality, myocardial infarction, and stroke were not different although 'other cardiac events' (cardiac surgery or intervention) were significantly lower in the IG than the CG patients (p < 0.05).. This long-term secondary prevention programme with inpatient rehabilitation at the beginning and telephone reminder for a 3-year period was successful. There were significant differences in health-related quality of life between the IG and CG, despite the relatively positive outcomes in the CG. In this low-education (predominantly male), middle-aged cohort, the positive impact on cardiovascular risk was pronounced in the high-risk subgroup (PROCAM 10-year risk 10-40%).

Topics: Adult; Cardiovascular Agents; Carotid Artery, Common; Carotid Intima-Media Thickness; Combined Modality Therapy; Coronary Artery Disease; Educational Status; Exercise Therapy; Female; Germany; Health Knowledge, Attitudes, Practice; Humans; Male; Middle Aged; Myocardial Infarction; Patient Education as Topic; Prospective Studies; Quality of Life; Reminder Systems; Risk Assessment; Risk Factors; Secondary Prevention; Stroke; Surveys and Questionnaires; Telephone; Time Factors; Treatment Outcome

We explored the impact of being hospitalized due to worsening heart failure (WHF) or a myocardial infarction (MI) on subsequent mortality in a large contemporary data set of patients with stable chronic systolic heart failure (HF).. A total of 6558 patients with stable systolic HF, 6505 with analysable data, with an EF of ≤35%, who were included in the Systolic Heart failure treatment with the If inhibitor ivabradine Trial (SHIFT), were followed for a median of 22.9 months with respect to hospitalizations and vital status. Among the 1288 patients who had at least one hospitalization due to WHF or MI, 455 (35.3%) died during follow-up compared with 600 (11.5%) among patients not hospitalized for these reasons. The risk for death was highest in the early phase after hospitalization. The risk declined rapidly during the first month but remained 3.5-fold (95% confidence interval 2.3-5.1) increased at 18 months after a first WHF hospitalization and 8.8-fold (95% confidence interval 3.6-21.6) increased at 18 months after a first MI hospitalization.. The present study confirms previous findings that in patients with stable chronic systolic HF, a hospitalization for WHF or MI is associated with substantially increased risk for subsequent death even with contemporary extensive background pharmacological therapy. The risk is most pronounced in the early phase of hospitalization but remains elevated even after 18 months. Preventing HF hospitalization appears as an important therapeutic objective in such patients, and a hospitalization for WHF or MI should lead to a careful therapeutic reassessment.

Topics: Aged; Aged, 80 and over; Benzazepines; Cardiovascular Agents; Chronic Disease; Disease Progression; Female; Follow-Up Studies; Heart Failure, Systolic; Hospitalization; Humans; Ivabradine; Male; Middle Aged; Myocardial Infarction; Prognosis; Risk Factors; Time Factors

Overlapping first generation sirolimus- and paclitaxel-eluting stents are associated with persistent inflammation, fibrin deposition and delayed endothelialisation in preclinical models, and adverse angiographic and clinical outcomes--including death and myocardial infarction (MI)--in clinical studies.. To establish as to whether there are any safety concerns with newer generation drug-eluting stents (DES).. Propensity score adjustment of baseline anatomical and clinical characteristics were used to compare clinical outcomes (Kaplan-Meier estimates) between patients implanted with overlapping DES (Resolute zotarolimus-eluting stent (R-ZES) or R-ZES/other DES) against no overlapping DES. Additionally, angiographic outcomes for overlapping R-ZES and everolimus-eluting stents were evaluated in the randomised RESOLUTE All-Comers Trial.. Patient level data from five controlled studies of the RESOLUTE Global Clinical Program evaluating the R-ZES were pooled. Enrollment criteria were generally unrestrictive.. 5130 patients.. 2-year clinical outcomes and 13-month angiographic outcomes.. 644 of 5130 patients (12.6%) in the RESOLUTE Global Clinical Program underwent overlapping DES implantation. Implantation of overlapping DES was associated with an increased frequency of MI and more complex/calcified lesion types at baseline. Adjusted in-hospital, 30-day and 2-year clinical outcomes indicated comparable cardiac death (2-year overlap vs non-overlap: 3.0% vs 2.1%, p=0.36), major adverse cardiac events (13.3% vs 10.7%, p=0.19), target-vessel MI (3.9% vs 3.4%, p=0.40), clinically driven target vessel revascularisation (7.7% vs 6.5%, p=0.32), and definite/probable stent thrombosis (1.4% vs 0.9%, p=0.28). 13-month adjusted angiographic outcomes were comparable between overlapping and non-overlapping DES.. Overlapping newer generation DES are safe and effective, with comparable angiographic and clinical outcomes--including repeat revascularisation--to non-overlapping DES.

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Angiography; Coronary Restenosis; Coronary Stenosis; Drug-Eluting Stents; Female; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Myocardial Infarction; Prosthesis Design; Risk Factors; Treatment Outcome

The aim of this study was to investigate the incidence and clinical sequelae of small side branch occlusion (SBO) after Absorb (Abbott Vascular, Santa Clara, California) bioresorbable vascular scaffold (BVS) implantation.. The thicker strut of metallic stents potentially contributes to a higher incidence of SBO.. We performed a post-hoc angiographic assessment of 1,209 side branches in 435 patients enrolled in the ABSORB-EXTEND single-arm trial (ABSORB EXTEND Clinical Investigation: A Continuation in the Clinical Evaluation of the ABSORB Bioresorbable Vascular Scaffold [BVS] System in the Treatment of Subjects With de Novo Native Coronary Artery Lesions), in comparison with 682 side branches in 237 patients treated with the everolimus-eluting metallic stent (EES) in the SPIRIT (A Clinical Evaluation of an Investigational Device. The Abbott XIENCE V Everolimus Eluting Coronary Stent System in the Treatment of Patients With de Novo Native Coronary Artery Lesions) first and II trials. Any visible side branches originating within the device implantation site or the 5-mm proximal and distal margins were included in the angiographic assessment. The SBO was defined as a reduction in Thrombolysis In Myocardial Infarction flow grade 0 or 1.. Post-procedural SBO was observed in 73 side branches (6.0%) in BVS group and 28 side branches (4.1%) in EES group (p = 0.09). Patients with post-procedural SBO were significantly associated with an increased incidence of in-hospital myocardial infarction (6.5% in SBO group vs. 0.5% in non-SBO group, p < 0.01). Multivariable analysis revealed that BVS was an independent predictor of post-procedural SBO (odds ratio: 2.09; 95% confidence interval: 1.18 to 3.68). By stratified analysis, BVS demonstrated a higher incidence of post-procedural SBO compared with EES only in small side branches with a reference vessel diameter ≤0.5 mm (10.5% vs. 3.9%, p = 0.03 between the groups, p for interaction = 0.08).. Bioresorbable vascular scaffold was associated with a higher incidence of post-procedural SBO compared with EES. This effect was more pronounced with small side branches with a reference vessel diameter ≤0.5 mm. (ABSORB EXTEND Clinical Investigation: A Continuation in the Clinical Evaluation of the ABSORB Bioresorbable Vascular Scaffold [BVS] System in the Treatment of Subjects With de Novo Native Coronary Artery Lesions: NCT01023789).

Topics: Absorbable Implants; Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Angiography; Coronary Occlusion; Drug-Eluting Stents; Everolimus; Female; Humans; Incidence; Logistic Models; Male; Metals; Middle Aged; Multivariate Analysis; Myocardial Infarction; Odds Ratio; Predictive Value of Tests; Prospective Studies; Prosthesis Design; Risk Assessment; Risk Factors; Sirolimus; Time Factors; Treatment Outcome

The DIABETES (DIABETes and sirolimus-Eluting Stent) trial is a prospective, multicentre, randomised, controlled trial aimed at demonstrating the efficacy of sirolimus-eluting stent (SES) as compared to bare metal stent (BMS) implantation in diabetic patients. The aim of the present analysis was to assess the five-year clinical follow-up of the patients included in this trial.. One hundred and sixty patients (222 lesions) were included: 80 patients were randomised to SES and 80 patients to BMS. Patients were eligible for the study if they were identified as non-insulin-dependent diabetics (NIDDM) or insulin-dependent diabetics (IDDM), with significant native coronary stenoses in ≥1 vessel. There was a sub-randomisation according to diabetes status. Clinical follow-up was extended up to five years. Five-year clinical follow-up was obtained in 96.2%. Overall, MACE at five years was significantly lower in the SES group as compared with the BMS arm, mainly due to a significant reduction in TLR. There were no significant differences in cardiac death or myocardial infarction (MI). This was also observed in both prespecified subgroups IDDM and NIDDM. In the SES group, the incidence density of definite/probable stent thrombosis was 0.53 per 100 person-years, whereas in the BMS group it was 0.8 per 100 person-years. Independent predictors of MACE were: SES implantation (p<0.001), multivessel stent implantation (p=0.04), and creatinine levels (p=0.001).. Five-year follow-up of the DIABETES trial suggests the effect of SES in reducing TLR is similar in both IDDM and NIDDM. No major safety concerns in terms of ST, MI or mortality were observed.

Topics: Aged; Cardiovascular Agents; Coronary Angiography; Coronary Stenosis; Coronary Thrombosis; Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2; Double-Blind Method; Drug-Eluting Stents; Female; Humans; Kaplan-Meier Estimate; Male; Metals; Middle Aged; Myocardial Infarction; Percutaneous Coronary Intervention; Proportional Hazards Models; Prospective Studies; Prosthesis Design; Risk Factors; Severity of Illness Index; Sirolimus; Spain; Stents; Time Factors; Treatment Outcome

This study sought to report the final 5-year outcomes of the ENDEAVOR IV (A Randomized, Controlled Trial of the Medtronic Endeavor Drug [ABT-578] Eluting Coronary Stent System Versus the Taxus Paclitaxel-Eluting Coronary Stent System in De Novo Native Coronary Artery Lesions) trial comparing the Endeavor zotarolimus-eluting stent (E-ZES) (Medtronic, Santa Rosa, California) with the Taxus paclitaxel-eluting stent (PES) (Boston Scientific, Natick, Massachusetts) in patients with single de novo coronary lesions.. Primary results of the ENDEAVOR IV trial demonstrated similar clinical outcomes with E-ZES and PES. Concerns with regard to late adverse clinical events with drug-eluting stents highlight the need for long-term follow-up with these devices.. Late outcomes after the use of E-ZES and PES were examined in the multicenter randomized ENDEAVOR IV trial in cumulative and landmark analyses. Assessed outcomes were related to device efficacy and patient safety.. At 5 years, clinical data were available for 722 (93.4%) E-ZES patients and 718 (92.6%) PES patients. Overall rates of target lesion revascularization (7.7% vs. 8.6%, p = 0.70) and target vessel failure were similar (17.2% vs. 21.1%, p = 0.061) with E-ZES compared with PES. The incidence of cardiac death or myocardial infarction (MI) was lower with E-ZES (6.4% vs. 9.1%, p = 0.048), primarily driven by a lower rate of target vessel MI with E-ZES (2.6% vs. 6.0%, p = 0.002). Although overall definite/probable stent thrombosis rates were similar between stents (1.3% vs. 2%, p = 0.42), rates of very late stent thrombosis (0.4% vs. 1.8%, p = 0.012) and late MI events (1.3% vs. 3.5%, p = 0.008) were significantly lower with E-ZES compared with PES.. These data demonstrate the durable efficacy and safety of E-ZES compared with PES for the treatment of de novo coronary lesions. Significant improvements in late safety outcomes were observed with E-ZES but should be considered hypothesis-generating, given the limited statistical power of the trial. (The ENDEAVOR IV Clinical Trial: A Trial of a Coronary Stent System in Coronary Artery Lesions; NCT00217269).

Topics: Aged; Cardiovascular Agents; Coronary Artery Disease; Coronary Thrombosis; Drug-Eluting Stents; Female; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Myocardial Infarction; Paclitaxel; Percutaneous Coronary Intervention; Proportional Hazards Models; Prospective Studies; Prosthesis Design; Risk Factors; Single-Blind Method; Sirolimus; Time Factors; Treatment Outcome; United States

This study sought to compare the efficacy and safety results after coronary implantation of a combined sirolimus-eluting CD34 antibody coated Combo stent (OrbusNeich Medical, Ft. Lauderdale, Florida) with the paclitaxel-eluting Taxus Liberté stent (PES) (Boston Scientific, Natick, Massachusetts). This report summarizes the first-in-man randomized, controlled multicenter REMEDEE trial (Randomized study to Evaluate the safety and effectiveness of an abluMinal sirolimus coatED bio-Engineered StEnt) angiographic, intravascular ultrasound, and clinical results up to 12 months.. Drug-eluting stents have limited restenosis and reintervention but are complicated by especially late and very late stent thrombosis and accelerated neoatherosclerosis. Alternative or adjunct technologies should address these limitations.. One hundred eighty-three patients with de novo native coronary artery stenoses were randomized 2:1 to Combo stent or PES implantation. The primary endpoint is the angiographic in-stent late lumen loss at 9 months, which was tested for noninferiority between the 2 stent groups. Secondary endpoints include the occurrence of major adverse cardiac events.. The Combo stent was found to be noninferior to the PES in 9-month angiographic in-stent late lumen loss with 0.39 ± 0.45 mm versus 0.44 ± 0.56 mm (pnoninferiority = 0.0012). At 12 months, the occurrence of major adverse cardiac events was 8.9% in the Combo group and 10.2% in the PES group (p = 0.80) with no difference in mortality, occurrence of myocardial infarction, or target lesion revascularization. No stent thrombosis was reported in either group.. In the REMEDEE trial the Combo stent has shown to be effective by meeting the primary noninferiority angiographic endpoint and safe, with an overall low rate of clinical events in both stent groups, including no stent thrombosis up to 12 months.

Topics: Aged; Antibodies; Antigens, CD34; Asia; Australia; Brazil; Cardiovascular Agents; Coated Materials, Biocompatible; Coronary Angiography; Coronary Restenosis; Coronary Stenosis; Coronary Thrombosis; Drug-Eluting Stents; Endothelial Cells; Europe; Female; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Myocardial Infarction; Paclitaxel; Percutaneous Coronary Intervention; Prosthesis Design; Risk Factors; Sirolimus; Stem Cells; Time Factors; Treatment Outcome; Ultrasonography, Interventional

Study aim - to elucidate possibilities of the use of precision administration of mononuclear bone marrow cells (MBMC) for the treatment of myocardial ischemia and heart failure. "Intramyocardial Multiple Precision Administration of Mononuclear Bone Marrow Cells in the Treatment of Myocardial Ischemia" was a double blind randomized placebo controlled study in which we included patients more or equal 6 months after Q-wave myocardial infarction with systolic myocardial dysfunction (ejection fraction <35%), not requiring myocardial revascularization, receiving stable optimal medical therapy for more or equal 8 weeks, and with implanted cardioverter-defibrillator. Transplantation of MBMC was guided by fluoroscopy and tridimensional NOGA XP Cardiac Navigation System. For assessment of efficacy of the method we used surrogate end points: decrease of number of fixed perfusion defects according to SPECT data and improvement of regional myocardial contractility according to data of echocardiography. Results of dynamic observation of the first experience of MBMC administration are presented in this paper.

Topics: Adult; Bone Marrow Transplantation; Cardiovascular Agents; Double-Blind Method; Female; Heart Failure; Heart Function Tests; Humans; Male; Middle Aged; Monitoring, Physiologic; Myocardial Contraction; Myocardial Infarction; Myocardial Ischemia; Radiography, Interventional; Therapy, Computer-Assisted; Tomography, Emission-Computed, Single-Photon; Treatment Outcome

The ZOMAXX I trial tested the noninferiority of a zotarolimus-eluting coronary stent (ZoMaxx(™) ) when compared with a paclitaxel-eluting coronary stent (Taxus(™) Express(2™) ) in a randomized trial of percutaneous intervention for de novo coronary artery stenosis. Angiographic analysis at the primary endpoint of 9 months has been reported previously. The purpose of this follow-on analysis was to describe the clinical results of the ZoMaxx and Taxus cohorts of the ZOMAXX I trial after 5 years.. In the ZOMAXX I trial, 199 patients received a ZoMaxx stent and 197 patients received a Taxus stent at 29 investigative sites in Europe, Australia, and New Zealand. The two groups were generally well matched with respect to both clinical and lesional characteristics, including the incidence of diabetes (ZoMaxx 22% vs. Taxus 26%; P = 0.29), reference vessel diameter (ZoMaxx 2.79 ± 0.43 mm vs. Taxus 2.81 ± 0.46 mm; P = 0.65), and lesion length (ZoMaxx 14.9 ± 5.7 mm vs. Taxus 14.6 ± 5.5; P = 0.61). Through 5 years of follow-up, a total of 21 patients had died, six patients had withdrawn, nine had been lost to follow-up, and 13 missed their 5-year visit, leaving a total of 347 patients for analysis (169 ZoMaxx and 178 Taxus). At the 5-year time point, there were no significant differences in any clinical metric including ischemia-driven target lesion revascularization (TLR; ZoMaxx 10.6% vs. Taxus 7.1%; P = 0.29), Q-wave myocardial infarction (ZoMaxx 1.5% vs. Taxus 1.0%; P = 0.99), definite/probable stent thrombosis (ZoMaxx 1.5% vs. Taxus 3.0%; P = 0.34), and cardiac death (ZoMaxx 3.0% vs. Taxus 1.0%; P = 0.28).. After 5 years, the differences in clinical outcome between patients treated with ZoMaxx vs. Taxus stents did not reach statistical significance. However, the nominally higher rate of ischemia-driven TLR (10.6 vs. 7.1%) and the previously reported higher rate of restenosis after 9 months suggest that the ZoMaxx stent afforded less neointimal inhibition when compared with Taxus. © 2013 Wiley Periodicals, Inc.

Topics: Aged; Australia; Cardiovascular Agents; Coronary Angiography; Coronary Restenosis; Coronary Stenosis; Coronary Thrombosis; Drug-Eluting Stents; Europe; Female; Humans; Male; Middle Aged; Myocardial Infarction; Neointima; New Zealand; Paclitaxel; Percutaneous Coronary Intervention; Prosthesis Design; Risk Factors; Severity of Illness Index; Sirolimus; Time Factors; Treatment Outcome

The aim of this study was to evaluate late safety and efficacy outcomes among patients enrolled in clinical trials comparing Endeavor zotarolimus-eluting stents (E-ZES) (Medtronic, Inc., Santa Rosa, California) with first-generation drug-eluting stents (DES) and bare-metal stents (BMS).. Despite demonstration of higher angiographic luminal loss and restenosis with E-ZES compared with alternative DES, whether differences in these early angiographic measures translate into more disparate late clinical events is uncertain.. Among 3,616 patients undergoing percutaneous coronary revascularization in 5 registration trials, late safety and efficacy events were compared between E-ZES (n = 2,132) versus sirolimus- or paclitaxel-eluting stents (n = 888) or BMS (n = 596).. Compared with a parallel cohort of patients treated with first-generation DES and BMS, 5-year rates of cardiac death/myocardial infarction (MI) (5.8% vs. 8.8% DES, p = 0.003; vs. 8.4% BMS, p = 0.02) and major adverse cardiac events (16.1% vs. 20.6% DES, p = 0.009; vs. 24.6% BMS, p < 0.001) were significantly lower with E-ZES. The E-ZES was associated with significantly lower target lesion revascularization (TLR) compared with BMS (7.4% vs. 16.3%, p < 0.001) but similar to comparator DES (7.4% vs. 8.1%, p = 0.63). Despite higher TLR in the first year with E-ZES compared with DES, between 1- and 5-year follow-up, rates of cardiac death/MI, TLR, and definite/probable stent thrombosis were significantly lower with E-ZES.. Over 5 years, significant differences in cardiac death/MI and composite endpoints favored treatment with E-ZES over comparator BMS and DES. Rates of clinical restenosis and safety events, including stent thrombosis beyond the first year of revascularization, remain stable with E-ZES, leading to significant differences compared with first-generation DES.

Topics: Aged; Cardiovascular Agents; Coronary Angiography; Coronary Restenosis; Coronary Stenosis; Coronary Thrombosis; Drug-Eluting Stents; Female; Humans; Kaplan-Meier Estimate; Male; Metals; Middle Aged; Myocardial Infarction; Paclitaxel; Percutaneous Coronary Intervention; Predictive Value of Tests; Prospective Studies; Prosthesis Design; Risk Factors; Sirolimus; Stents; Time Factors; Treatment Outcome

To investigate the predictive values of placental growth factor (PlGF) and its endogenous antagonist, soluble fms-like tyrosine kinase-1 (sFlt-1), for the long-term prognosis of patients with stable coronary artery disease (CAD). Both PlGF and sFlt-1 play important roles in the pathological mechanisms of atherosclerosis. We recently demonstrated that the plasma levels of these molecules are correlated with the severity of coronary atherosclerosis.. We enrolled 464 patients with stable CAD who consecutively underwent coronary angiography. Baseline blood samples were collected from the femoral artery immediately before coronary angiography (after the administration of 20 units of heparin), and the plasma levels of PlGF and sFlt-1 were measured. A Cox proportional hazard regression analysis was performed to evaluate the relationship between these parameters and the occurrence of all-cause death (ACD) and total cardiovascular events (TCVE) during a median follow-up of 3.3 years.. A total of 31 ACDs and 51 TCVEs occurred. Patients with higher PlGF/sFlt-1 ratios (>4.22×10(-2)) had a significantly higher risk of both ACD and TCVE than patients with lower ratios (<4.22×10(-2)) (hazard ratio [HR]: 3.32, 95% confidence interval [CI]: 1.43 to 7.72, p=0.005, and HR: 2.23, 95% CI: 1.23 to 4.03, p=0.008, respectively). A multivariate analysis showed the PlGF/sFlt-1 ratio to be an independent predictor for ACD, but not TCVE.. The baseline PlGF/sFlt-1 ratio is an independent predictor of long-term adverse outcomes in patients with stable CAD.

Topics: Aged; Biomarkers; Cardiovascular Agents; Cause of Death; Comorbidity; Coronary Angiography; Coronary Artery Disease; Female; Follow-Up Studies; Heart Failure; Humans; Kaplan-Meier Estimate; Kidney Failure, Chronic; Male; Middle Aged; Myocardial Infarction; Percutaneous Coronary Intervention; Placenta Growth Factor; Plasma; Pregnancy Proteins; Prognosis; Proportional Hazards Models; Risk Factors; Stroke; Treatment Outcome; Vascular Endothelial Growth Factor Receptor-1

Patients with diabetes mellitus remain at higher risk for adverse events following percutaneous coronary intervention and the identification of the optimum drug eluting stents (DES) in these patients is of high clinical relevance. We compared effectiveness of everolimus-eluting stents (EES; Xience) versus sirolimus-eluting stents (SES; Cypher) in patients with diabetes mellitus enrolled in the Intracoronary Stenting and Angiographic Results: Test Efficacy of 3 Limus-Eluting Stents (ISAR-TEST-4) trial.. In the setting of the ISAR-TEST-4 trial, 1304 patients with broad inclusion criteria were randomized to treatment with EES or SES. The focus of the present analysis is on a cohort of 377 patients with diabetes mellitus assigned to receive EES (n = 184) or SES (n = 193). The primary endpoint was the composite of cardiac death, myocardial infarction (MI) related to the target vessel, or target lesion revascularization (TLR) at 3-year follow-up. Secondary endpoints were parameters of angiographic and clinical restenosis (in-stent late lumen loss, binary restenosis, and TLR), all-cause mortality and definite/probable stent thrombosis.. EES was comparable to SES concerning the incidence of the primary endpoint (21% vs. 24%, respectively; relative risk = 0.87; 95% CI, 0.57-1.34; P = 0.53). Concerning the secondary endpoint, TLR at 3 years with EES versus SES stents was not statistically different (14.7% vs. 16.6%, respectively; relative risk = 0.85; 95% CI, 0.51-1.43; P = 0.55). In terms of angiographic outcomes patients treated with EES as compared to SES had significantly lower late lumen loss (0.22 ± 0.46 mm vs. 0.44 ± 0.66 mm, respectively; P < 0.001) and binary restenosis (8.4% vs. 17%, respectively; P = 0.02) at 6- to 8-month angiographic follow-up. EES was comparable to SES concerning the incidence of all-cause death (10% vs. 16%, respectively; relative risk = 0.66; 95% CI, 0.37-1.18; P = 0.16) and stent thrombosis (1.1% vs. 3.1%, respectively; P = 0.19).. In patients with diabetes mellitus enrolled in a real-world randomized control trial, EES is comparable to SES in terms of clinical efficacy and safety out to 3 years; angiographic markers of antirestenotic efficacy favored EES.

Topics: Aged; Cardiovascular Agents; Coronary Angiography; Coronary Artery Disease; Coronary Restenosis; Coronary Thrombosis; Diabetes Mellitus; Drug-Eluting Stents; Everolimus; Female; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Myocardial Infarction; Percutaneous Coronary Intervention; Prosthesis Design; Risk Factors; Time Factors; Treatment Outcome

Assuming that coronary interventions, both coronary bypass surgery (CABG) and percutaneous coronary intervention (PCI), are directed to preserve left ventricular function, it is not known whether medical therapy alone (MT) can achieve this protection. Thus, we evaluated the evolution of LV ejection fraction (LVEF) in patients with stable coronary artery disease (CAD) treated by CABG, PCI, or MT as a post hoc analysis of a randomized controlled trial with a follow-up of 10 years.. Left ventricle ejection fraction was assessed with transthoracic echocardiography in patients with multivessel CAD, participants of the MASS II trial before randomization to CABG, PCI, or MT, and re-evaluated after 10 years of follow-up.. Of the 611 patients, 422 were alive after 10.32 ± 1.43 years. Three hundred and fifty had LVEF reassessed: 108 patients from MT, 111 from CABG, and 131 from PCI. There was no difference in LVEF at the beginning (0.61 ± 0.07, 0.61 ± 0.08, 0.61 ± 0.09, respectively, for PCI, CABG, and MT, P = 0.675) or at the end of follow-up (0.56 ± 0.11, 0.55 ± 0.11, 0.55 ± 0.12, P = 0.675), or in the decline of LVEF (reduction delta of -7.2 ± 17.13, -9.08 ± 18.77, and -7.54 ± 22.74). Acute myocardial infarction (AMI) during the follow-up was associated with greater reduction in LVEF. The presence of previous AMI (OR: 2.50, 95% CI: 1.40-4.45; P = 0.0007) and during the follow-up (OR: 2.73, 95% CI: 1.25-5.92; P = 0.005) was associated with development of LVEF <45%.. Regardless of the therapeutic option applied, LVEF remains preserved in the absence of a major adverse cardiac event after 10 years of follow-up.. http://www.controlled-trials.com. Registration number ISRCTN66068876.

Topics: Aged; Analysis of Variance; Cardiovascular Agents; Coronary Artery Bypass; Coronary Stenosis; Echocardiography; Female; Follow-Up Studies; Humans; Male; Middle Aged; Myocardial Infarction; Myocardial Revascularization; Percutaneous Coronary Intervention; Stroke; Stroke Volume; Treatment Outcome; Ventricular Dysfunction, Left

The EVOLVE FHU trial demonstrated non-inferiority of six-month late loss with two dose formulations of SYNERGY, a novel bioabsorbable polymer everolimus-eluting stent (EES) compared with the durable polymer PROMUS Element (PE) EES. The current analysis describes the six-month IVUS and clinical results through two years from the EVOLVE FHU trial.. EVOLVE recruited 291 patients from 29 centres. At six months, IVUS-assessed in-stent net volume obstruction was 3.40 ± 5.06% for PROMUS Element (PE) vs. 2.68 ± 4.60% for SYNERGY (p=0.34) and 3.09 ± 4.29% for SYNERGY ½ dose (p=0.68 vs. PE). There were no significant differences between groups for any other measured IVUS parameter including resolved, persistent, and late-acquired incomplete stent apposition (ISA). At two years, target lesion failure (TLF) was 6.1% for PE vs. 5.5% for SYNERGY (p=0.87) and 5.2% for SYNERGY ½ dose (p=0.81). There were no significant differences between groups for cardiac death, repeat revascularisation, MI or stent thrombosis through two years.. At six months, everolimus delivered from an ultrathin bioabsorbable abluminal polymer resulted in equivalent net volume obstruction and ISA compared with a permanent polymer EES. There were no significant differences between PE and either SYNERGY stent for any major cardiac endpoint through two years. Clinical trials number: NCT01135225.

Topics: Australia; Cardiovascular Agents; Chi-Square Distribution; Coated Materials, Biocompatible; Coronary Angiography; Coronary Artery Disease; Coronary Restenosis; Coronary Thrombosis; Coronary Vessels; Drug-Eluting Stents; Europe; Everolimus; Humans; Kaplan-Meier Estimate; Myocardial Infarction; New Zealand; Percutaneous Coronary Intervention; Polymers; Predictive Value of Tests; Prosthesis Design; Risk Factors; Sirolimus; Time Factors; Treatment Outcome; Ultrasonography, Interventional

This study sought to report the final 5 years follow-up of the landmark LEADERS (Limus Eluted From A Durable Versus ERodable Stent Coating) trial.. The LEADERS trial is the first randomized study to evaluate biodegradable polymer-based drug-eluting stents (DES) against durable polymer DES.. The LEADERS trial was a 10-center, assessor-blind, noninferiority, "all-comers" trial (N = 1,707). All patients were centrally randomized to treatment with either biodegradable polymer biolimus-eluting stents (BES) (n = 857) or durable polymer sirolimus-eluting stents (SES) (n = 850). The primary endpoint was a composite of cardiac death, myocardial infarction (MI), or clinically indicated target vessel revascularization within 9 months. Secondary endpoints included extending the primary endpoint to 5 years and stent thrombosis (ST) (Academic Research Consortium definition). Analysis was by intention to treat.. At 5 years, the BES was noninferior to SES for the primary endpoint (186 [22.3%] vs. 216 [26.1%], rate ratio [RR]: 0.83 [95% confidence interval (CI): 0.68 to 1.02], p for noninferiority <0.0001, p for superiority = 0.069). The BES was associated with a significant reduction in the more comprehensive patient-orientated composite endpoint of all-cause death, any MI, and all-cause revascularization (297 [35.1%] vs. 339 [40.4%], RR: 0.84 [95% CI: 0.71 to 0.98], p for superiority = 0.023). A significant reduction in very late definite ST from 1 to 5 years was evident with the BES (n = 5 [0.7%] vs. n = 19 [2.5%], RR: 0.26 [95% CI: 0.10 to 0.68], p = 0.003), corresponding to a significant reduction in ST-associated clinical events (primary endpoint) over the same time period (n = 3 of 749 vs. n = 14 of 738, RR: 0.20 [95% CI: 0.06 to 0.71], p = 0.005).. The safety benefit of the biodegradable polymer BES, compared with the durable polymer SES, was related to a significant reduction in very late ST (>1 year) and associated composite clinical outcomes. (Limus Eluted From A Durable Versus ERodable Stent Coating [LEADERS] trial; NCT00389220).

Topics: Absorbable Implants; Aged; Cardiovascular Agents; Chi-Square Distribution; Coronary Artery Disease; Coronary Thrombosis; Drug-Eluting Stents; Europe; Female; Humans; Intention to Treat Analysis; Kaplan-Meier Estimate; Male; Middle Aged; Myocardial Infarction; Odds Ratio; Percutaneous Coronary Intervention; Polymers; Proportional Hazards Models; Prospective Studies; Prosthesis Design; Risk Factors; Sirolimus; Time Factors; Treatment Outcome

Methotrexate is a drug that has shown anti-ischemic effects in animal studies and positive results in heart failure clinical trials.. We will randomly assign 80 patients with acute myocardial infarction to receive methotrexate (0.05 mg/kg bolus followed by 0.05 mg/kg/h for 6 h) or matching placebo. The primary outcome will be the area under the curve (AUC) for creatine kinase (CK) release for 72 h. Secondary outcomes will be the peak levels of CK, CK-MB fraction and troponin I, AUC for CK-MB and troponin I, levels of B-type natriuretic peptide (BNP), high-sensitivity C-reactive protein (hsCRP) and erythrocyte sedimentation rate (ESR) at admission and at 30 days, left ventricular ejection fraction (LVEF) at baseline and at 30 days, death, TIMI (thrombolysis in myocardial infarction) frame count in the culprit artery, Killip score after 72 h and rate of reinfarction at 30 days.. We expect a reduction in the AUC for CK, CK-MB and troponin release in the methotrexate group compared to the placebo group. We also expect a reduction in the levels of BNP, hsCRP and ESR and an improvement of LVEF and TIMI frame count in the methotrexate group.. This trial may be the first to demonstrate the anti-inflammatory and anti-ischemic effects of methotrexate in patients with acute myocardial infarction.

Topics: Adult; Aged; Area Under Curve; Blood Sedimentation; C-Reactive Protein; Cardiovascular Agents; Creatine Kinase; Creatine Kinase, MB Form; Double-Blind Method; Humans; Methotrexate; Middle Aged; Myocardial Infarction; Natriuretic Peptide, Brain; Statistics as Topic; Treatment Outcome; Troponin; Young Adult

ACST-2 is currently the largest trial ever conducted to compare carotid artery stenting (CAS) with carotid endarterectomy (CEA) in patients with severe asymptomatic carotid stenosis requiring revascularization.. Patients are entered into ACST-2 when revascularization is felt to be clearly indicated, when CEA and CAS are both possible, but where there is substantial uncertainty as to which is most appropriate. Trial surgeons and interventionalists are expected to use their usual techniques and CE-approved devices. We report baseline characteristics and blinded combined interim results for 30-day mortality and major morbidity for 986 patients in the ongoing trial up to September 2012.. A total of 986 patients (687 men, 299 women), mean age 68.7 years (SD ± 8.1) were randomized equally to CEA or CAS. Most (96%) had ipsilateral stenosis of 70-99% (median 80%) with contralateral stenoses of 50-99% in 30% and contralateral occlusion in 8%. Patients were on appropriate medical treatment. For 691 patients undergoing intervention with at least 1-month follow-up and Rankin scoring at 6 months for any stroke, the overall serious cardiovascular event rate of periprocedural (within 30 days) disabling stroke, fatal myocardial infarction, and death at 30 days was 1.0%.. Early ACST-2 results suggest contemporary carotid intervention for asymptomatic stenosis has a low risk of serious morbidity and mortality, on par with other recent trials. The trial continues to recruit, to monitor periprocedural events and all types of stroke, aiming to randomize up to 5,000 patients to determine any differential outcomes between interventions.. ISRCTN21144362.

Topics: Aged; Angioplasty; Asymptomatic Diseases; Cardiovascular Agents; Carotid Stenosis; Endarterectomy, Carotid; Female; Humans; Male; Middle Aged; Myocardial Infarction; Patient Selection; Risk Assessment; Risk Factors; Severity of Illness Index; Stents; Stroke; Time Factors; Treatment Outcome

This first-in-human multicenter study sought to examine prospectively the safety and efficacy of a new, cobalt chromium thin-strut, coronary absorbable polymer-coated, sirolimus-eluting stent.. Bioabsorbable polymers on drug-eluting stents may lower the long-term risks of inflammation, delayed healing, and adverse events.. We enrolled patients with symptomatic coronary artery disease with stable or unstable angina pectoris and >50% diameter stenosis, amenable to coverage with a ≤23-mm long stent in a vessel 2.5 to 3.5 mm in diameter. All patients received dual antiplatelet therapy after implantation. Patients, in groups of 10, underwent repeat angiography, intravascular ultrasound, and optical coherence tomography at 4, 6, or 8 months, and all patients were seen or contacted at 18 months of follow-up.. The median (range) in-stent late lumen loss (LLL) was 0.03 mm (-0.22 to 0.21 mm), 0.10 mm (-0.03 to 1.2 mm), and 0.08 mm (-0.01 to 0.28 mm), at 4, 6, and 8 months, respectively. At 18 months, the median in-stent LLL was 0.08 mm (-0.30 to 0.46 mm). On optical coherence tomography, the proportion of uncovered stent struts decreased from a median of 7.3% (range 0.4% to 46.3%) at 4 months to 0% (range: 0% to 3.4%) at 18 months. The percentage of neointimal volume obstruction by intravascular ultrasound increased from a median of 5.3% to 9.1% between 4 and 6 months and remained nearly unchanged thereafter through 18 months of follow-up. The only recorded major adverse cardiac event was a myocardial infarction.. At 18 months of follow-up, this absorbable polymer-coated, cobalt chromium sirolimus-eluting stent was associated with a low and stable in-stent LLL, complete strut coverage, and no stent thrombosis. (First-In-Human Trial of the MiStent Drug-Eluting Stent [DES] in Coronary Artery Disease [DESSOLVE-I]; NCT01247428).

Topics: Absorbable Implants; Adult; Aged; Aged, 80 and over; Angina, Stable; Angina, Unstable; Australia; Belgium; Cardiovascular Agents; Chromium Alloys; Coronary Angiography; Coronary Artery Disease; Coronary Restenosis; Coronary Stenosis; Coronary Vessels; Drug Therapy, Combination; Drug-Eluting Stents; Female; Humans; Male; Middle Aged; Myocardial Infarction; Neointima; New Zealand; Percutaneous Coronary Intervention; Platelet Aggregation Inhibitors; Polymers; Prospective Studies; Prosthesis Design; Severity of Illness Index; Sirolimus; Time Factors; Tomography, Optical Coherence; Treatment Outcome; Ultrasonography, Interventional

This study sought to investigate the efficacy and performance of the XIENCE V everolimus-eluting stent (EES) (Abbott Vascular, Santa Clara, California) in the treatment of de novo coronary lesions in patients with 2- to 3-vessel multivessel coronary artery disease (MV-CAD).. Drug-eluting stents (DES) have emerged as an alternative to conventional coronary artery bypass surgery in patients with MV-CAD although first-generation DES yielded inferior efficacy and safety compared with surgery.. Prospective, randomized (1:1), multicenter feasibility trial was designed to assess angiographic efficacy of EES compared with the TAXUS paclitaxel-eluting stent (PES) in 200 patients, and a prospective, open-label, single-arm, controlled registry was designed to analyze the clinical outcome of EES at 1-year follow-up in 400 MV-CAD patients. For the randomized trial, the primary endpoint was in-stent late loss at 9 months. For the registry, the primary endpoint was a composite of all-cause death, myocardial infarction, and ischemia-driven target vessel revascularization at 12 months.. The primary endpoint per single lesion was significantly lower in the EES group compared with the PES group (-0.03 ± 0.49 mm vs. 0.23 ± 0.51 mm, p = 0.001). Similar results were observed when analyzing all lesions (0.05 ± 0.51 mm vs. 0.24 ± 0.50 mm, p < 0.001). Clinical outcome at 1 year yielded a composite of major adverse cardiac events of 9.2% in the single-arm registry, and 11.1% and 16.5% in the EES and PES randomized groups, respectively (p = 0.30).. The EXECUTIVE trial was a randomized pilot trial dedicated to the comparison of the efficacy of 2 different DES among patients with 2- to 3-vessel MV-CAD. The study shows lower in-stent late loss at 9 months with the EES XIENCE V compared with the PES TAXUS Libertè, and a low major adverse cardiac event rate at 1 year in patients with 2-to 3-vessel MV-CAD. (EXECUTIVE [EXecutive RCT: Evaluating XIENCE V in a Multi Vessel Disease]; NCT00531011).

Topics: Aged; Cardiovascular Agents; Coronary Angiography; Coronary Artery Disease; Coronary Restenosis; Coronary Vessels; Drug-Eluting Stents; Everolimus; Feasibility Studies; Female; Humans; Italy; Male; Middle Aged; Myocardial Infarction; Paclitaxel; Percutaneous Coronary Intervention; Predictive Value of Tests; Prospective Studies; Prosthesis Design; Registries; Sirolimus; Time Factors; Treatment Outcome

This study sought to evaluate the long-term safety and efficacy of everolimus-eluting stents (EES) and paclitaxel-eluting stents (PES) in patients with obstructive coronary artery disease.. The use of EES compared to PES has been shown to result in improved clinical outcomes in patients undergoing PCI. However, there have been concerns regarding the durability of these benefits over longer-term follow-up.. SPIRIT III was a prospective, multicenter trial in which 1,002 patients were randomized 2:1 to EES versus PES. Endpoints included ischemia-driven target vessel failure (TVF) (death, myocardial infarction (MI), or ischemia-driven target vessel revascularization [TVR]), the pre-specified primary endpoint), target lesion failure (TLF) (cardiac death, target-vessel MI, or ischemia-driven target lesion revascularization [TLR]), major adverse cardiac events (MACE) (cardiac death, MI, or ischemia-driven TLR), their individual components and stent thrombosis.. Five-year follow-up was available in 91.9% of patients. Treatment with EES versus PES resulted in lower 5-year Kaplan-Meier rates of TVF (19.3% vs. 24.5%, p = 0.05), TLF (12.7% vs. 19.0%, p = 0.008), and MACE (13.2% vs. 20.7%, p = 0.007). EES also resulted in reduced rates of all-cause death (5.9% vs. 10.1%, p = 0.02), with nonsignificantly different rates of MI, stent thrombosis, and TLR, and no evidence of late catch-up of TLR over time.. At 5 years after treatment, EES compared to PES resulted in durable benefits in composite safety and efficacy measures as well as all-cause mortality. Additionally, the absolute difference in TLR between devices remained stable over time without deterioration of effect during late follow-up.

Topics: Cardiovascular Agents; Coronary Artery Disease; Coronary Restenosis; Coronary Thrombosis; Drug-Eluting Stents; Everolimus; Humans; Kaplan-Meier Estimate; Myocardial Infarction; Paclitaxel; Percutaneous Coronary Intervention; Prospective Studies; Prosthesis Design; Risk Factors; Single-Blind Method; Sirolimus; Time Factors; Treatment Outcome; United States

The Orsiro Hybrid sirolimus-eluting stent is a newly developed third-generation drug-eluting stent, featuring a unique dual-polymer mix. An active bioabsorbable polymer delivers the anti-proliferative drug, sirolimus, via controlled release, while a passive biocompatible polymeric coating shields the metallic strut from surrounding tissue, preventing interaction. To date, the Orsiro Hybrid sirolimus-eluting stent has excelled in terms of late lumen loss at 9 months in a first-in-man single-arm trial. However, the efficacy and safety data for Orsiro Hybrid sirolimus-eluting stents in a broader population of all-comers are limited. The present study offers an angiographic and clinical comparison of the Orsiro Hybrid sirolimus-eluting stent and the Resolute Integrity zotarolimus-eluting stent in the treatment of patients with coronary artery disease.. The ORIENT trial is a multicenter, randomized, open-label, parallel-arm study designed to demonstrate the non-inferiority of the Orsiro Hybrid sirolimus-eluting stent relative to the Resolute Integrity zotarolimus-eluting stent. A total of 375 patients with a spectrum of coronary artery disease will undergo prospective, random assignment to a Orsiro Hybrid sirolimus-eluting stent or Resolute Integrity zotarolimus-eluting stent (2:1 ratio), for a primary endpoint of in-stent late lumen loss at 9 months by quantitative coronary angiography. Secondary 12-month clinical endpoints are death, target lesion revascularization, target vessel revascularization, myocardial infarction, stent thrombosis and target lesion failure (a composite of cardiac death, target lesion revascularization and target vessel-related myocardial infarction).. The ORIENT trial is the first study to date comparing the Orsiro Hybrid sirolimus-eluting stent with the Resolute Integrity zotarolimus-eluting stent for efficacy and safety in a population of all-comers with coronary artery disease.. Clinicaltrials.gov NCT01826552.

Topics: Cardiovascular Agents; Clinical Protocols; Coronary Angiography; Coronary Artery Disease; Coronary Restenosis; Coronary Thrombosis; Drug-Eluting Stents; Humans; Myocardial Infarction; Percutaneous Coronary Intervention; Prospective Studies; Prosthesis Design; Republic of Korea; Research Design; Sirolimus; Time Factors; Treatment Outcome

This study sought to investigate the impact of left main coronary artery (LMCA) 3-dimensional (3D) bifurcation angle (BA) parameters on 5-year clinical outcomes of patients randomized to LMCA percutaneous coronary intervention (PCI) in the SYNTAX (Synergy Between Percutaneous Coronary Intervention With Taxus and Cardiac Surgery) trial.. BA can affect outcome after bifurcation PCI; 3D angiographic analysis provides reliable BA measurements.. The diastolic distal BA (between left anterior descending and left circumflex) and its systolic-diastolic range were explored. A stratified post-hoc survival analysis was performed for 5-year major adverse cardiac and cardiovascular events (MACCE) (all-cause death, cerebrovascular accident, myocardial infarction, or repeat revascularization), a safety endpoint (all-cause death, cerebrovascular accident, or myocardial infarction), and repeat revascularization. Analysis was performed in patients where 3D BA was available pre- and post-PCI.. Of 266 patients eligible for analysis, 185 underwent bifurcation PCI (group B); 1 stent was used in 75 patients (group B1), whereas ≥2 stents were used in 110 patients (group B2). Stratification across pre-PCI diastolic distal BA tertiles (<82°, 82° to 106°, ≥107°) failed to show any difference in MACCE rates either in the entire study population (p = 0.99) or in group B patients (p = 0.78). Group B patients with post-PCI systolic-diastolic range <10° had significantly higher MACCE rates (50.8% vs. 22.7%, p < 0.001); repeat revascularization and safety endpoint rates were also higher (37.4% vs. 15.5%, p = 0.002, and 25.4% vs. 14.1%, p=0.055, respectively). Post-PCI systolic-diastolic range <10° was an independent predictor of MACCE (hazard ratio: 2.65; 95% confidence interval: 1.55 to 4.52; p < 0.001) in group B patients.. A restricted post-procedural systolic-diastolic distal BA range resulted in higher 5-year adverse event rates after LMCA bifurcation PCI. Pre-PCI BA value did not affect the clinical outcome.

Topics: Aged; Cardiovascular Agents; Chi-Square Distribution; Coronary Angiography; Coronary Artery Bypass; Coronary Artery Disease; Coronary Thrombosis; Coronary Vessels; Drug-Eluting Stents; Humans; Imaging, Three-Dimensional; Kaplan-Meier Estimate; Male; Middle Aged; Multivariate Analysis; Myocardial Infarction; Paclitaxel; Percutaneous Coronary Intervention; Predictive Value of Tests; Proportional Hazards Models; Prospective Studies; Radiographic Image Interpretation, Computer-Assisted; Risk Factors; Stroke; Time Factors; Treatment Outcome

We sought to evaluate the efficacy and safety of paclitaxel-coated balloon plus bare-metal stenting (BMS) in chronic total occlusions (CTOs).. Drug-eluting stent implantation after recanalization of CTOs is limited by the occurrence of restenosis and risk for late stent thromboses.. In this prospective, bicenter trial we treated 48 patients after successful chronic total occlusion (CTO) recanalization in a native coronary artery with paclitaxel-coated balloon plus BMS. Patients were matched according to stent length, reference diameter, and diabetes mellitus with 48 patients treated with Taxus stent implantation. Dual antiplatelet therapy was prescribed for 6 months. Angiographic (clinical) follow-up was obtained after 6 (12) months. Primary endpoint was in-stent late lumen loss.. There was no difference in patient baseline characteristics or procedural results. Stent length was 59.7 ± 32.4 mm (16-151 mm) for paclitaxel-coated balloon plus BMS versus 56.2 ± 25.9 mm (16-132 mm) for Taxus stent. Late loss was statistically not different within the stent with 0.64 ± 0.69 mm versus 0.43 ± 0.64 mm (difference 0.20 mm, 95% confidence interval -0.07 to 0.47, P = 0.14) and at the occlusion site with 0.33 ± 0.69 mm versus 0.26 ± 0.70 mm, respectively. Restenosis rate was 27.7% compared with 20.8% (P = 0.44) and the combined clinical endpoint (cardiac death, myocardial infarction attributed to the target vessel, target lesion revascularization) was 14.6% versus 18.8% (P = 0.58), respectively.. In conclusion, for patients with complex CTOs in native coronary arteries the use of paclitaxel-coated balloon after bare-metal stenting was associated with similar clinical results and a nonsignificantly higher in-stent late loss compared with a matched population with paclitaxel-eluting stent implantation.

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiac Catheters; Cardiovascular Agents; Chi-Square Distribution; Chronic Disease; Coated Materials, Biocompatible; Coronary Angiography; Coronary Occlusion; Coronary Restenosis; Drug Therapy, Combination; Drug-Eluting Stents; Equipment Design; Female; Germany; Humans; Male; Metals; Middle Aged; Myocardial Infarction; Paclitaxel; Platelet Aggregation Inhibitors; Prospective Studies; Prosthesis Design; Stents; Time Factors; Treatment Outcome

To evaluate the differential treatment effects of zotarolimus-eluting stents (ZES), sirolimus-eluting stents (SES), and paclitaxel-eluting stents (PES) according to diabetic status.. Diabetic patients have a higher risk of ischemic complications after stenting than nondiabetic patients.. Using data from the ZEST randomized trial, comparing ZES with SES and PES, we evaluated relative outcomes among stents in diabetic and nondiabetic patients. The primary outcome was a major adverse cardiac event (MACE), defined as a composite of death, myocardial infarction, or ischemia-driven target-vessel revascularization.. Of the 2,645 patients enrolled in the ZEST trial, 760 (29%) had diabetes mellitus. Baseline clinical and angiographic characteristics were similar in the three stent groups, regardless of diabetic status. In diabetic patients, ZES showed similar rates of MACE as compared to PES (13.8% vs. 15.3%, P = 0.58), but higher rates of MACE than SES (13.8% vs. 7.7%, P = 0.05). In nondiabetic patients, ZES showed similar rates of MACE as compared to SES (10.3% vs. 10.8%, P = 0.72), whereas significantly lower rates of MACE compared to PES (10.3% vs. 15.3%, P = 0.01). In comparing the ZES and SES groups, there was a substantial interaction between diabetic status and stent types on MACE occurrence (Interaction P = 0.07). However, in comparison of ZES and PES, there were no significant interactions between diabetes and stent type on MACE (Interaction P = 0.25).. In diabetic patients, SES showed the lowest rate of MACE compared with ZES and PES. But, in nondiabetic patients, SES and ZES showed significantly lower rates of MACE than PES. ZES shows a diabetes-related interaction on MACE compared with SES, but not with PES.

Topics: Aged; Cardiovascular Agents; Chi-Square Distribution; Coronary Angiography; Coronary Artery Disease; Coronary Thrombosis; Diabetes Mellitus; Drug-Eluting Stents; Female; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Myocardial Infarction; Paclitaxel; Percutaneous Coronary Intervention; Proportional Hazards Models; Prospective Studies; Prosthesis Design; Republic of Korea; Risk Assessment; Risk Factors; Sirolimus; Time Factors; Treatment Outcome

With progressive aging, coronary artery disease has been diagnosed at more advanced ages. Although patients aged 65 years or more have been referred to surgical or percutaneous coronary interventions, the best option for coronary artery disease treatment remains uncertain. The current study compared the 3 treatment options for coronary artery disease in patients aged 65 years or more and analyzed the impact of age in treatment options.. Patients were separated according to age: 65 years or more (n = 200) and less than 65 years (n = 411). All patients were followed for 10 years. The rates of overall mortality, acute myocardial infarction, and new revascularizations were analyzed.. Of 200 patients aged 65 years or more, 68 were randomized to medical therapy, 68 were randomized to percutaneous coronary intervention, and 64 were randomized to coronary artery bypass grafting. At 10 years, overall survival was 63% (medical therapy), 69% (percutaneous coronary intervention), and 66% (coronary artery bypass grafting) (P = .93). The survival free of combined events was 43% (medical therapy), 38% (percutaneous coronary intervention ), and 66% (coronary artery bypass grafting) (P = .007). The survival free of myocardial infarction was 82% (medical therapy), 77% (percutaneous coronary intervention), and 90% (coronary artery bypass grafting) (P = .17), and survival free of new revascularizations was 59% (medical therapy), 58% (percutaneous coronary intervention ), and 91% (coronary artery bypass grafting) (P = .0003). When the 2 age groups were compared, survival free of myocardial infarction for patients treated by percutaneous coronary intervention was 77% (older patients) and 92% (younger patients) (P = .004).. In this analysis, treatment options for patients aged 65 years or more who have coronary artery disease yield similar overall survival. However, coronary artery bypass grafting was associated with fewer coronary events, and percutaneous coronary intervention was associated with a higher incidence of myocardial infarction.

Topics: Age Factors; Aged; Angioplasty, Balloon, Coronary; Brazil; Cardiovascular Agents; Chi-Square Distribution; Coronary Artery Bypass; Coronary Artery Disease; Disease-Free Survival; Female; Humans; Kaplan-Meier Estimate; Male; Multivariate Analysis; Myocardial Infarction; Proportional Hazards Models; Prospective Studies; Risk Factors; Time Factors; Treatment Outcome

The objective of this analysis was to evaluate the safety and effectiveness of XIENCE V in acute myocardial infarction (AMI).. The XIENCE V(®) Everolimus-eluting coronary stent was superior to the TAXUS(®) paclitaxel-eluting stent in angiographic and clinical outcomes in the SPIRIT II, III, and IV randomized controlled trials, but patients with AMI were excluded.. XIENCE V USA is a large, prospective, multicenter, real-world single-arm postmarket surveillance trial. Consecutive patients undergoing PCI with XIENCE V were enrolled. For this analysis, clinical outcomes in 673 patients presenting with AMI (STEMI, n = 125) were as compared to patients without AMI (n = 3528) at 1 year.. At 1 year, ARC-defined stent thrombosis (ST) rates were 1.08% in AMI vs. 0.85% in the non-AMI group (P = 0.4987). The late ST (30 days-1 year) rates were 0.31% vs. 0.47% (AMI vs. non-AMI, P = 0.7551). Rates of target lesion revascularization (TLR) were 4.1% vs. 4.6% (P = 0.6104), and rates of target lesion failure (TLF) were 9.1% vs. 8.5%, (P = 0.5964). With the historical WHO definition of MI, 1 year TLF rates were 7.0% vs. 6.7% (P = 0.8001). Improvements in quality of life, angina frequency, angina stability, and physical limitations occurred at 6 months (each P < 0.0001) and were sustained at 1 year in both groups. There were no significant differences in clinical outcomes between STEMI and non-STEMI patients.. At 1 year, AMI patients treated with XIENCE V had low rates of ST, TLR, and TLF, similar to non-AMI patients. Marked improvements in patients' health status in this subgroup were also demonstrated.

Topics: Aged; Cardiovascular Agents; Coronary Thrombosis; Drug-Eluting Stents; Everolimus; Female; Humans; Male; Middle Aged; Myocardial Infarction; Percutaneous Coronary Intervention; Product Surveillance, Postmarketing; Prospective Studies; Risk Factors; Sirolimus; Time Factors; Treatment Outcome; United States

To report the final, cumulative, 5-year outcomes from the TAXUS ATLAS program, which studied the use of the TAXUS Liberté paclitaxel-eluting stent in de-novo coronary artery lesions.. TAXUS ATLAS Workhorse, Small Vessel, and Long Lesion are nonrandomized studies comparing TAXUS Liberté (N=871), TAXUS Liberté 2.25 mm (N=261), and TAXUS Liberté 38 mm (N=150) stents, respectively, with case-matched TAXUS Express historical controls.. In the unadjusted analysis, TAXUS Liberté showed comparable 5-year rates of major adverse cardiac events (27.1% TAXUS Express vs. 26.2% TAXUS Liberté, P=0.70) in workhorse lesions and greater 5-year cumulative freedom from target lesion revascularization (78.4 vs. 87.3%, P=0.03) in small vessels. In addition, a lower periprocedural myocardial infarction rate (MI, 4.1 vs. 0.0%; P=0.01) was observed in long lesions versus TAXUS Express. After propensity score adjustment, no statistically significant effect of TAXUS Liberté on the 5-year rates of TLR in small vessels (17.9 vs. 13.3%, P=0.36) or MI in long lesions (9.1 vs. 7.0%, P=0.53) was found, although the rates remained numerically lower with TAXUS Liberté.. Cumulative 5-year results of the TAXUS ATLAS studies suggest that the TAXUS Liberté stent provides similar safety and effectiveness in workhorse lesions, and may provide lower revascularization rates in small vessels and lower periprocedural MI rates in long lesions compared with the TAXUS Express stent, although no statistically significant differences were found following propensity adjustment.

Topics: Angioplasty, Balloon, Coronary; Asia; Cardiovascular Agents; Chi-Square Distribution; Coronary Artery Disease; Coronary Thrombosis; Drug-Eluting Stents; Humans; Kaplan-Meier Estimate; Logistic Models; Myocardial Infarction; New Zealand; Paclitaxel; Propensity Score; Prospective Studies; Prosthesis Design; Risk Assessment; Risk Factors; Time Factors; Treatment Outcome; United States

This study sought to determine the effect of rotational atherectomy (RA) on drug-eluting stent (DES) effectiveness.. DES are frequently used in complex lesions, including calcified stenoses, which may challenge DES delivery, expansion, and effectiveness. RA can adequately modify calcified plaques and facilitate stent delivery and expansion. Its impact on DES effectiveness is widely unknown.. The ROTAXUS (Rotational Atherectomy Prior to TAXUS Stent Treatment for Complex Native Coronary Artery Disease) study randomly assigned 240 patients with complex calcified native coronary lesions to RA followed by stenting (n = 120) or stenting without RA (n = 120, standard therapy group). Stenting was performed using a polymer-based slow-release paclitaxel-eluting stent. The primary endpoint was in-stent late lumen loss at 9 months. Secondary endpoints included angiographic and strategy success, binary restenosis, definite stent thrombosis, and major adverse cardiac events at 9 months.. Despite similar baseline characteristics, significantly more patients in the standard therapy group were crossed over (12.5% vs. 4.2%, p = 0.02), resulting in higher strategy success in the rotablation group (92.5% vs. 83.3%, p = 0.03). At 9 months, in-stent late lumen loss was higher in the rotablation group (0.44 ± 0.58 vs. 0.31 ± 0.52, p = 0.04), despite an initially higher acute lumen gain (1.56 ± 0.43 vs. 1.44 ± 0.49 mm, p = 0.01). In-stent binary restenosis (11.4% vs. 10.6%, p = 0.71), target lesion revascularization (11.7% vs. 12.5%, p = 0.84), definite stent thrombosis (0.8% vs. 0%, p = 1.0), and major adverse cardiac events (24.2% vs. 28.3%, p = 0.46) were similar in both groups.. Routine lesion preparation using RA did not reduce late lumen loss of DES at 9 months. Balloon dilation with only provisional rotablation remains the default strategy for complex calcified lesions before DES implantation.

Topics: Aged; Angioplasty, Balloon, Coronary; Atherectomy, Coronary; Cardiovascular Agents; Chi-Square Distribution; Coronary Angiography; Coronary Artery Disease; Coronary Restenosis; Coronary Thrombosis; Disease-Free Survival; Drug-Eluting Stents; Female; Germany; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Myocardial Infarction; Paclitaxel; Prospective Studies; Prosthesis Design; Time Factors; Treatment Outcome; Vascular Calcification

Women are underrepresented in clinical research, and few data are available from randomized head-to-head comparisons of second-generation drug-eluting stents (DES) in female patients. Aim of this study was to assess safety and efficacy of two second-generation DES in women. In TWENTE-a prospective, randomized, comparative DES trial-"real-world" patients were stratified for gender before randomization for Resolute or Xience V stents.. Target vessel failure (TVF; cardiac death, target vessel-related myocardial infarction, and clinically indicated target vessel revascularization) after 1 year was the predefined endpoint.. Among 1,391 patients, 382 (27.5%) women were randomized to Resolute (n = 192) and Xience V (n = 190). Baseline and procedural characteristics were similar for females in both study arms, except for smaller vessel and stent diameters in Resolute-treated lesions. After 1 year, TVF (8.9 vs. 8.4%; adjusted odds ratio [OR]: 0.95, 95% confidence interval [CI]: 0.41-2.20, P = 0.91) and a patient-oriented composite endpoint (13.0 vs. 12.1%, P = 0.79) did not differ significantly between women in both arms. Women were older than men (P < 0.01) and had more often diabetes mellitus (26.4 vs. 19.8%, P = 0.01) and hypertension (63.6 vs. 52.5%, P < 0.01), but there was no significant gender difference in TVF (adjusted OR: 1.18, 95% CI: 0.73-1.92, P = 0.50).. This gender-stratified TWENTE trial analysis resulted in no significant difference in safety and efficacy outcomes between Resolute- and Xience V-treated females.

Topics: Age Factors; Aged; Cardiovascular Agents; Chi-Square Distribution; Comorbidity; Coronary Angiography; Coronary Artery Disease; Drug-Eluting Stents; Everolimus; Female; Humans; Kaplan-Meier Estimate; Logistic Models; Male; Middle Aged; Myocardial Infarction; Netherlands; Odds Ratio; Percutaneous Coronary Intervention; Prospective Studies; Prosthesis Design; Risk Factors; Sex Factors; Sirolimus; Time Factors; Treatment Outcome

To assess the impact of age on safety and efficacy of paclitaxel-eluting stent (PES) implantation during primary percutaneous coronary intervention (PCI) in patients with ST-segment elevation myocardial infarction (STEMI).. The benefits of paclitaxel-eluting stent (PES) implantation during primary PCI were confirmed by the long-term results of the HORIZONS-AMI trial. Whether the effects of PES are independent of age has not been reported.. Data on 3,006 patients from the HORIZONS-AMI study randomized in a 3:1 ratio to PES or bare-metal stent (BMS) in whom at least one stent was implanted were assessed. There were 2,302 (76.6%) patients <70, and 704 patients ≥70 years of age.. At 3 years, among older patients a trend toward lower risk of major adverse cardiac events (MACE; death from any cause, stroke, reinfarction and unplanned revascularization for ischemia) related to PES use was observed (PES vs. BMS: 18.0% vs. 21.3%; P = 0.07). There was also a trend for reduction of MACE related to PES in older patients (26.4% vs. 33.1%; P = 0.09). Both, patients <70 and ≥70 years of age treated with PES were at lower risk for ischemic target vessel revascularization. However, a higher risk of major bleeding in elderly patients treated with PES was observed (P = 0.02 for interaction between age group and PES effects). No interaction between age and stent type in terms of the risk of other clinical end points, including all-cause death, was confirmed.. For STEMI patients undergoing primary PCI, the implantation of PES as compared with BMS reduced ischemic TVR, and this effect was independent of age.

Topics: Age Factors; Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Disease-Free Survival; Drug-Eluting Stents; Female; Hemorrhage; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Myocardial Infarction; Paclitaxel; Recurrence; Risk Factors; Stroke; Time Factors; Treatment Outcome

The use of a drug-eluting balloon for the treatment of de novo coronary artery lesions remains to be evaluated. A previous trial in patients with stable and unstable angina comparing a bare metal stent mounted on a drug-eluting balloon with a sirolimus-eluting stent failed to meet the prespecified non-inferiority criteria versus the sirolimus-eluting stent. The stent struts of a bare metal stent pre-mounted on a drug-eluting balloon may prevent the appropriate delivery of drugs to the vessel wall and may result in reduced efficacy. In the present study we will therefore evaluate the efficacy of a drug-eluting balloon for treating de novo coronary artery lesions using a strategy designed to uniformly deliver drug to the vessel with a bare metal stent.. The Comparison of Drug-Eluting Balloon first study is a prospective, randomized, open-label trial designed to demonstrate the non-inferiority of first using a drug-eluting balloon (Sequent please; B. Braun, Melsungen, Germany) followed by a bare metal stent (Coroflex Blue; B. Braun) compared with using a drug-eluting stent (Resolute Integrity; Boston Scientific, Natick, MA, USA) for de novo coronary artery lesions. The primary endpoint of the study is in-segment late loss at 9 months measured by quantitative coronary angiography. Secondary endpoints include angiographic findings such as angiographic success, device success, binary angiographic restenosis, and clinical outcomes such as procedural success, all-cause death, myocardial infarction, target vessel revascularization, target lesion revascularization, and stent thrombosis. A total of 180 patients will be enrolled in the study.. The Comparison of Drug-Eluting Balloon first study will evaluate the clinical efficacy, angiographic outcomes and safety of a drug-eluting balloon first followed by a bare metal stent compared with a drug-eluting stent for the treatment of de novo coronary artery lesions.. Clinical Trials.gov: NCT01539603.

Topics: Angioplasty, Balloon, Coronary; Cardiovascular Agents; Clinical Protocols; Coronary Angiography; Coronary Artery Disease; Coronary Restenosis; Drug-Eluting Stents; Humans; Metals; Myocardial Infarction; Prospective Studies; Prosthesis Design; Republic of Korea; Research Design; Stents; Thrombosis; Time Factors; Treatment Outcome; Ultrasonography, Interventional

Although current clinical guidelines recommend the use of thrombus aspiration (TA) during primary percutaneous coronary intervention (PPCI), previous studies evaluating TA demonstrated contradictory results. The aim of this study was to evaluate long-term clinical outcome after TA in adjunct to PPCI for acute ST-segment myocardial infarction (STEMI), as compared with conventional treatment, with the use of paclitaxel-eluting stents or bare-metal stents.. We analyzed data of the PASSION trial, in which 619 patients with STEMI were randomly assigned to a paclitaxel-eluting stent or a bare-metal stent. TA was performed in 311 patients (50.2%). Clinical endpoints at 2 years were compared between patients who received TA during PPCI with patients who underwent conventional PPCI. The primary outcome of interest was a composite of cardiac death, recurrent myocardial infarction (MI), or target-lesion revascularization (TLR). A propensity score model was made to account for baseline differences that could have affected the probability of performing TA.. Complete follow-up was available for 598 patients (96.6%). The cumulative incidence of the combined outcome measure of cardiac death, recurrent MI, or TLR was 40 (13.0%) in the TA group and 41 (13.5%) in the conventional PPCI group (HR 0.96; 95% CI 0.62-1.47; P = 0.84). Also after adjusting for propensity score, no significant difference in event rate was observed between both treatment groups.. In this post-hoc analysis of the PASSION trial, TA in adjunct to PPCI did not affect rates of major adverse cardiac events at 2 years follow-up, as compared with conventional PPCI.

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Chi-Square Distribution; Coronary Angiography; Drug-Eluting Stents; Female; Humans; Kaplan-Meier Estimate; Logistic Models; Male; Metals; Middle Aged; Myocardial Infarction; Netherlands; Odds Ratio; Paclitaxel; Propensity Score; Proportional Hazards Models; Prosthesis Design; Recurrence; Retrospective Studies; Risk Assessment; Risk Factors; Stents; Suction; Thrombectomy; Time Factors; Treatment Outcome

The aim of this randomized-controlled trial is to compare biolimus A9-eluting stent (Nobori) to sirolimus eluting stent (Cypher).. The Nobori coronary stent is coated only abluminally with a biodegradable polymer, poly-lactic acid, and the antiproliferative agent biolimus A9. This stent has been studied in randomized trials versus Taxus Express and Taxus Liberte and showed noninferiority and superiority for in-stent late loss. This is the first randomized trial of Nobori stent versus Cypher stent.. We conducted a randomized (3:2), controlled trial comparing Nobori and Cypher, in 335 patients (198 Nobori and 137 Cypher) at 15 centers in Japan. Patients with de-novo lesions in up to two native coronary arteries were considered for enrollment. The primary endpoint was freedom from target vessel failure (TVF), a composite of cardiac death, myocardial infarction, and target vessel revascularization at 9 months.. At 9 months, the primary endpoint of freedom from TVF was 92.6% in Nobori and 93.8% in Cypher arm (noninferiority test P < 0.001). As main secondary endpoints, the in-stent late loss was 0.12 ± 0.30 mm and 0.14 ± 0.34 mm in Nobori and Cypher stents, respectively. Target lesion revascularization was 0.5% in Nobori and 3.9% in Cypher treated patients (P = 0.04). Definite and probable stent thromboses were not recorded in any patient.. Despite the relatively small number of patients, this well controlled clinical trial confirmed the primary hypothesis of non-inferiority of the Nobori biolimus A9-eluting stent to the Cypher sirolimus-eluting stent for freedom from TVF. Both stents showed excellent midterm results.

Topics: Aged; Cardiovascular Agents; Coronary Angiography; Coronary Restenosis; Coronary Stenosis; Coronary Thrombosis; Drug-Eluting Stents; Female; Humans; Japan; Lactic Acid; Male; Middle Aged; Myocardial Infarction; Percutaneous Coronary Intervention; Polyesters; Polymers; Prosthesis Design; Sirolimus; Time Factors; Treatment Outcome

We assessed the relationship between diabetes and cardiac structure and function following myocardial infarction (MI) and whether diabetes influences the effect of direct renin inhibition on change in left ventricular (LV) size.. The ASPIRE trial enrolled 820 patients 2-8 weeks after MI with ejection fraction ≤ 45% and randomized them to the direct renin inhibitor aliskiren (n= 423) or placebo (n = 397) added to standard medical therapy. Echocardiography was performed at baseline and after 36 weeks in 672 patients with evaluable paired studies. Compared with non-diabetic patients, diabetic patients (n = 214) were at higher risk for a composite of cardiovascular (CV) death, heart failure hospitalization, recurrent MI, stroke, or aborted sudden death (14 vs. 7%; adjusted hazard ratio 1.63, 95% confidence interval 1.01-2.64, P= 0.045), despite similar left ventricular ejection fraction (37.9 ± 5.3 vs. 37.6 ± 5.2%, P= 0.48) and end-systolic volume (ESV) (84 ± 25 vs. 82 ± 28 mL, P= 0.46). Diabetic patients demonstrated greater concentric remodelling (relative wall thickness 0.38 ± 0.07 vs. 0.36 ± 0.07, P= 0.0002) and evidence of higher LV filling pressure (E/E' 11.1 ± 5.3 vs. 9.1 ± 4.3, P= 0.0011). At 36 weeks, diabetic patients experienced similar per cent reduction in ESV overall (-4.9 ± 17.9 vs. -5.5 ± 16.9, P= 0.67) but tended to experience greater reduction in ESV than non-diabetic patients when treated with aliskiren (interaction P = 0.08).. Compared with non-diabetic patients, diabetic patients are at increased risk of CV events post-MI despite no greater LV enlargement or reduction in systolic function. Diabetic patients demonstrate greater concentric remodelling and evidence of higher LV filling pressure, suggesting diastolic dysfunction as a potential mechanism for the higher risk observed among these patients.

Topics: Aged; Amides; Cardiovascular Agents; Diabetic Cardiomyopathies; Diastole; Double-Blind Method; Female; Fumarates; Humans; Male; Middle Aged; Myocardial Infarction; Renin; Systole; Treatment Outcome; Ventricular Dysfunction, Left; Ventricular Function, Left; Ventricular Remodeling

The Oral Rapamycin in ARgentina (ORAR) III trial is a randomized study comparing a strategy of oral rapamycin (OR) plus bare-metal stent (BMS) versus a strategy of drug-eluting stents (DES) in patients with de novo coronary lesions. The purpose of this study was to assess the 3 years cost-effectiveness outcome of each strategy.. OR after BMS has been associated with reduction of target vessel revascularization (TVR) although its value in long-term efficacy in comparison with DES is unknown.. In three hospitals in Buenos Aires, Argentina, 200 patients were randomized to OR plus BMS (n = 100) or DES (n = 100). Primary objectives were costs and effectiveness. Cost analysis included in-hospital and follow-up costs. Safety was defined as the composite of death, myocardial infarction (MI), and stroke. Efficacy was defined as TVR.. Baseline characteristics between groups were similar. The 3-year follow-up rate was 99%. Cardiac mortality was 2% and 5% in OR group and DES group, respectively (P = 0.44). The composite of death, MI and stroke rate was 11% in OR group and 20% in DES group (P = 0.078). TVR rate was 14.5% in OR group and 17.6% in DES group (P = 0.50), respectively. Three year cumulative costs were significantly lower in the OR arm as compared to the DES arm (P = 0.0001) and DES strategy did not result cost-effective according to the non-inferiority test.. At 3 years follow-up, there were no differences in effectiveness between the two strategies, and DES strategy was not more cost-effective as compared to OR plus BMS.

Topics: Administration, Oral; Aged; Argentina; Cardiovascular Agents; Chi-Square Distribution; Combined Modality Therapy; Coronary Artery Disease; Coronary Restenosis; Cost Savings; Cost-Benefit Analysis; Drug Costs; Drug-Eluting Stents; Female; Health Care Costs; Hospital Costs; Humans; Kaplan-Meier Estimate; Male; Metals; Middle Aged; Multivariate Analysis; Myocardial Infarction; Percutaneous Coronary Intervention; Proportional Hazards Models; Prosthesis Design; Risk Assessment; Risk Factors; Sirolimus; Stents; Stroke; Time Factors; Treatment Outcome

To compare the safety and efficacy of the new Coroflex™ Please stents with conventional Taxus™ Liberte stents in patients with coronary artery lesions.. The Coroflex™ Please stent is a new version of paclitaxel-eluting stent, and observational cohort studies have reported similar angiographic and clinical outcomes as with the first-generation stents. However, it has not been directly compared with the early generation paclitaxel-eluting stents in a multicenter, prospective, and randomized study.. We randomly assigned 319 patients to receive Coroflex™ Please stents (159 patients; 198 lesions) or Taxus™ Liberte stents (160 patients; 232 lesions). The primary end point was angiographic in-segment late luminal loss at 9 months.. Most baseline clinical and angiographic characteristics were similar between these two groups. The Coroflex™ Please and Taxus™ Liberte stents showed similar in-segment late loss (0.40 ± 0.53 mm vs. 0.39 ± 0.52 mm, P = 0.98) and rates of in-segment binary restenosis (22.2% vs. 18.8%, P = 0.48) at 9 months. After clinical follow-up for 12 months, the two groups had similar rates of death (1.3% vs. 1.3%, P > 0.99), myocardial infarction (3.8% vs. 7.5%, P = 0.22), stent thrombosis (2.5% vs. 1.9%, P = 0.72), and target-lesion revascularization (7.5% vs. 7.5%, P = 0.99).. The Coroflex™ Please stent resulted in similar angiographic and clinical outcomes as the Taxus™ Liberte stent in patients with coronary artery lesions.

Topics: Aged; Cardiovascular Agents; Chi-Square Distribution; Coronary Angiography; Coronary Artery Disease; Coronary Restenosis; Coronary Thrombosis; Disease-Free Survival; Drug-Eluting Stents; Female; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Myocardial Infarction; Paclitaxel; Percutaneous Coronary Intervention; Predictive Value of Tests; Prospective Studies; Prosthesis Design; Republic of Korea; Single-Blind Method; Time Factors; Treatment Outcome

The SPIRIT Small Vessel (SV) was designed to evaluate the safety and effectiveness of the 2.25-mm XIENCE V everolimus eluting coronary stent system (EECSS), known as the XIENCE nano EECSS, in subjects with SVs and ischemic heart disease.. The core sizes of XIENCE V EECSS are associated with low rates of restenosis and thrombosis in the general population, but the XIENCE nano EECSS has not been tested in the United States.. This prospective, single-arm, open-label study was conducted at 33 centers and in 150 patients in the United States. The primary endpoint was the target lesion failure (TLF) rate at 1 year, required to meet the prespecified performance goal (PG) of 20.4%, derived from historical data.. The mean patient age was 63 years, 38% were women, 39.2% were diabetic, 49.3% had multivessel disease, and the reference vessel diameter was 2.13 ± 0.23 mm. The 1-year TLF rate was 8.1% in with an upper limit of the one-sided 95% confidence interval of 13.0%, which met the PG of 20.4% (P < 0.0001). At 1 year, the rate of cardiac death was 1.5%, the target vessel myocardial infarction rate was 1.5%, and clinically indicated target lesion revascularization rate was 5.1%. The 8-month angiographic in-stent late loss was 0.2 ± 0.4 mm, respectively. The 1-year academic research consortium defined definite/probable stent thrombosis rate was 1.5%.. Based on the 1-year clinical and 8-month angiographic SPIRIT SV data, the XIENCE nano EECSS is considered safe and effective in the treatment of SVs.

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Angiography; Coronary Artery Disease; Coronary Restenosis; Coronary Thrombosis; Drug-Eluting Stents; Everolimus; Female; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Myocardial Infarction; Nanomedicine; Prospective Studies; Prosthesis Design; Sirolimus; Time Factors; Treatment Outcome; United States

It is widely believed that cardiac rehabilitation following acute myocardial infarction (MI) reduces mortality by approximately 20%. This belief is based on systematic reviews and meta-analyses of mostly small trials undertaken many years ago. Clinical management has been transformed in the past 30-40 years and the findings of historical trials may have little relevance now.. The principal objective was to determine the effect of cardiac rehabilitation, as currently provided, on mortality, morbidity and health-related quality of life in patients following MI. The secondary objectives included seeking programmes that may be more effective and characteristics of patients who may benefit more. DESIGN, SETTING, PATIENTS, OUTCOME MEASURES: A multi-centre randomised controlled trial in representative hospitals in England and Wales compared 1813 patients referred to comprehensive cardiac rehabilitation programmes or discharged to 'usual care' (without referral to rehabilitation). The primary outcome measure was all-cause mortality at 2 years. The secondary measures were morbidity, health service use, health-related quality of life, psychological general well-being and lifestyle cardiovascular risk factors at 1 year. Patient entry ran from 1997 to 2000, follow-up of secondary outcomes to 2001 and of vital status to 2006. A parallel study compared 331 patients in matched 'elective' rehabilitation and 'elective' usual care (without rehabilitation) hospitals.. There were no significant differences between patients referred to rehabilitation and controls in mortality at 2 years (RR 0.98, 95% CI 0.74 to 1.30) or after 7-9 years (0.99, 95% CI 0.85 to 1.15), cardiac events, seven of eight domains of the health-related quality of life scale ('Short Form 36', SF36) or the psychological general well-being scale. Rehabilitation patients reported slightly less physical activity. No differences between groups were reported in perceived overall quality of cardiac aftercare. Data from the 'elective' hospitals comparison concurred with these findings.. In this trial, comprehensive rehabilitation following MI had no important effect on mortality, cardiac or psychological morbidity, risk factors, health-related quality of life or activity. This finding is consistent with systematic reviews of all trials reported since 1983. The value of cardiac rehabilitation as practised in the UK is open to question.

Topics: Aged; Cardiovascular Agents; England; Exercise Therapy; Female; Health Services; Humans; Male; Middle Aged; Motor Activity; Myocardial Infarction; Psychometrics; Quality of Life; Risk Factors; Wales

Limited data are available regarding the direct comparison of angiographic and clinical outcomes after percutaneous coronary intervention (PCI) with drug-eluting stents (DESs) for chronic total occlusion (CTO).. A prospective, randomized, multicenter trial was conducted to evaluate the non-inferiority of a zotarolimus-eluting stent (ZES; Endeavor Sprint®, n=80) to a sirolimus-eluting stent (SES; Cypher®, n=80) in patients with CTO lesion with a reference vessel diameter ≥ 2.5mm. The primary endpoint was in-segment binary restenosis rate at 9-month angiographic follow-up. Key secondary endpoints included target vessel failure (TVF; including cardiac death, myocardial infarction, and target vessel revascularization) and Academic Research Consortium-defined definite/probable stent thrombosis (ST) within 12 months. The ZES was non-inferior to the SES with respect to the primary endpoint, which occurred in 14.1% (95% confidence interval [CI]: 6.0-22.2) and in 13.7% (95%CI: 5.8-21.6) of patients, respectively (non-inferiority margin, 15.0%; P for non-inferiority <0.001). There were no significant between-group differences in the rate of TVF (10.0% vs. 17.5%; P=0.168) nor in the rate of ST (0.0% vs. 1.3%; P=0.316) during the 12-month clinical follow-up.. The effectiveness and safety of ZES are similar to those of SES and therefore it is a good treatment option in patients undergoing PCI for CTO with DESs.

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Chronic Disease; Coronary Angiography; Coronary Occlusion; Coronary Restenosis; Drug-Eluting Stents; Female; Humans; Male; Middle Aged; Myocardial Infarction; Prospective Studies; Prosthesis Design; Republic of Korea; Sirolimus; Thrombosis; Time Factors; Treatment Outcome; Ultrasonography, Interventional

Recent secondary prevention trials have failed to demonstrate a beneficial effect of n-3 fatty acids on cardiovascular outcomes, which may be due to the growing use of statins since the mid-1990s. The aim of the present study was to assess whether statins modify the effects of n-3 fatty acids on major adverse cardiovascular events in patients with a history of myocardial infarction (MI).. Patients who participated in the Alpha Omega Trial were divided into consistent statin users (n = 3740) and consistent statin non-users (n = 413). In these two groups of patients, the effects of an additional daily amount of 400 mg eicosapentaenoic acid (EPA) plus docosahexaenoic acid (DHA), 2 g α-linolenic acid (ALA), or both on major cardiovascular events were evaluated. Multivariable Cox's proportional hazard models were used to calculate adjusted hazard rate ratios (HR(adj)). Among the statin users 495 (13%) and among the statin non-users 62 (15%) developed a major cardiovascular event. In statin users, an additional amount of n-3 fatty acids did not reduce cardiovascular events [HR(adj) 1.02; 95% confidence interval (CI): 0.80, 1.31; P = 0.88]. In statin non-users, however, only 9% of those who received EPA-DHA plus ALA experienced an event compared with 18% in the placebo group (HR(adj) 0.46; 95% CI: 0.21, 1.01; P= 0.051).. In patients with a history of MI who are not treated with statins, low-dose supplementation with n-3 fatty acids may reduce major cardiovascular events. This study suggests that statin treatment modifies the effects of n-3 fatty acids on the incidence of major cardiovascular events.

Topics: Aged; Aged, 80 and over; Cardiovascular Agents; Cardiovascular Diseases; Dietary Supplements; Double-Blind Method; Drug Interactions; Fatty Acids, Omega-3; Female; Heart Arrest; Humans; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Lipid Metabolism; Male; Margarine; Middle Aged; Myocardial Infarction; Stroke

To compare acute myocardial infarction patients with or without congestive heart failure in the French FAST-MI registry.. The French FAST-MI registry included 374 centers and 3059 patients over a 1-month period at the end of 2005, with 1-year follow-up. Among this population, patients with at least one congestive heart failure criterion constituted group 1 (n=1149; 37.5%) and were compared to patients without congestive heart failure (group 2, n=1910; 62.5%). The congestive heart failure patients were further divided according to presence of both beta-blockers and antagonists of the renin-angiotensin-aldosterone system at hospital discharge (n=511) or not (n=498), in order to assess the real-world clinical importance of recommended medications.. Overall in-hospital and 1-year mortality rates were 3.4% and 13.2%, respectively. In hospital survivors, presence of congestive heart failure was associated with increased mortality (adjusted hazard ratio: 1.55; 95% confidence interval, 1.10-2.17; P=.01). Survival was higher in patients without congestive heart failure, compared with congestive heart failure patients receiving or not recommended medications (P<.001). Congestive heart failure patients receiving neither renin-angiotensin-aldosterone system blockers nor beta-blockers (adjusted hazard ratio: 1.66; 95% confidence interval, 1.08-2.55; P=.02) had a significantly higher risk of death than patients receiving both classes of medications (adjusted hazard ratio: 1.16; 95% confidence interval, 0.82-1.64; not statistically significant). Patients receiving only one of the recommended classes had an intermediate risk (adjusted hazard ratio: 1.47; 95% confidence interval, 1.04-2.07; P=.03).. Patients admitted for acute myocardial infarction with congestive heart failure criteria are still at very high risk of mortality. When receiving major recommended medications, they presented with significantly reduced mortality rates. Additional efforts should therefore be made to encourage the prescription of recommended medications in acute myocardial infarction patients with congestive heart failure.

Topics: Adrenergic beta-Antagonists; Aged; Angiotensin II Type 1 Receptor Blockers; Cardiovascular Agents; Creatine Kinase; Electrocardiography; Female; Follow-Up Studies; France; Heart Failure; Heart Function Tests; Hospitals; Humans; Male; Middle Aged; Myocardial Infarction; Myocardial Reperfusion; Registries; Survival Analysis; Treatment Outcome

Drug-eluting stents (DES) have reduced the rate of restenosis but recent studies have raised concern over the risk of late stent thrombosis (LST). Incomplete stent endothelialization and delayed vascular healing have been associated with LST. The titanium-nitride-oxide coated bio-active stent (BAS) has shown promising results in patients with acute coronary syndromes, but there is little long-term optical coherence tomography (OCT) data comparing BAS with DES. The TITAX-AMI trial is a prospective, randomized, multicenter trial comparing BAS to paclitaxel-eluting stent (PES) in 425 patients with acute myocardial infarction. A total of 18 patients (9 per group) with no major cardiac events during follow-up, were enrolled in this substudy >36 months (mean 47 months) after stent implantation. Quantitative coronary angiography was performed and stent strut endothelialization and vascular healing were assessed with OCT. The binary stent strut coverage was significantly higher in the BAS group compared with the PES group (99.6 vs. 89.2%, p < 0.001) and there were less malapposed struts in the BAS group (0.2 vs. 13.8%, respectively, p < 0.001). The neointimal hyperplasia (NIH) thickness (266 ± 166 vs. 126 μm ± 126 μm, p < 0.001) and percentage of NIH area (26.2 vs. 7.6%, p < 0.001) were greater in the BAS group than in the PES group. Late incomplete endothelialization was not uncommon after PES implantation. Stents in the BAS group were completely endothelialized. This difference may contribute to the more common LST after PES implantation in the TITAX-AMI trial.

Topics: Aged; Cardiovascular Agents; Chi-Square Distribution; Coated Materials, Biocompatible; Coronary Angiography; Coronary Restenosis; Coronary Thrombosis; Coronary Vessels; Drug-Eluting Stents; Endothelial Cells; Female; Humans; Hyperplasia; Male; Middle Aged; Myocardial Infarction; Neointima; Paclitaxel; Percutaneous Coronary Intervention; Predictive Value of Tests; Prospective Studies; Prosthesis Design; Stents; Time Factors; Titanium; Tomography, Optical Coherence; Treatment Outcome

Percutaneous treatment of coronary bifurcation lesions remains hampered by suboptimal results, mainly in the side branch (SB), even with the use of drug-eluting stents (DES). Paclitaxel drug-eluting balloons (DEB) could provide an attractive alternative to treat bifurcations in combination with a provisional T-stenting technique in order to minimize SB restenosis. We compared angiographic and clinical outcomes of a provisional T-stenting technique with a DEB plus bare-metal stent (BMS) versus BMS versus paclitaxel DES.. In this randomized, international, multicenter, single-blinded 3-arm study, 117 patients with coronary bifurcation lesions underwent treatment with: (A) DEB in both main branch (MB) and SB and BMS in MB; (B) BMS in MB and regular balloon angioplasty in SB; or (C) paclitaxel DES in MB and regular balloon in SB. All patients underwent provisional T-stenting with an identical stent platform in the MB. Paclitaxel was the drug for elution in groups A and C. The primary endpoint was 6-month angiographic late luminal loss. Secondary end points were 6-month binary restenosis and 12-month major adverse cardiac events (MACE: death, myocardial infarction, target vessel revascularization).. The procedure was successful in all cases. Late luminal loss, measured respectively in the proximal MB, distal MB and SB was 0.58 ± 0.65, 0.41 ± 0.60, and 0.19 ± 0.66 mm in group A; 0.60 ± 0.65, 0.49 ± 0.85, and 0.21 ± 0.57 mm in group B; and 0.13 ± 0.45, 0.19 ± 0.64, and 0.11 ± 0.43 mm in group C (P = 0.001). Binary restenosis rates per bifurcation and MACE rates were 24.2%, 28.6%, and 15% (P = 0.45) and 20%, 29.7%, and 17.5% (P = 0.40) in groups A, B, and C, respectively.. Pretreatment of both MB and SB with DEB failed to show angiographic and clinical superiority over conventional BMS, using a provisional T-stenting technique. Moreover DES showed superior angiographic results than DEB and BMS.

Topics: Aged; Analysis of Variance; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Chi-Square Distribution; Coronary Angiography; Coronary Artery Disease; Coronary Restenosis; Coronary Vessels; Drug-Eluting Stents; Europe; Feasibility Studies; Female; Humans; Male; Metals; Middle Aged; Myocardial Infarction; Paclitaxel; Predictive Value of Tests; Prosthesis Design; Risk Factors; Single-Blind Method; Stents; Time Factors; Treatment Outcome

The aim of this study was to investigate the effect of different treatment interventions on plasma N-terminal fragment of the prohormone brain natriuretic peptide (NT-proBNP) levels and early exercise tolerance in patients with acute ST-segment elevation myocardial infarction.. 146 consecutive patients with ST-segment elevation myocardial infarction who received emergency percutaneous coronary intervention (PCI) (n = 55), elective PCI (n = 47), or drug treatment (n = 44) were included. Plasma NT-proBNP levels and left ventricular ejection fractions (LVEFs) were measured before the treatment intervention and at 1 week and 1 month afterward. An exercise stress test was performed 1 month after the intervention, and the occurrences of major adverse cardiac events (MACE) were recorded at the 1-month follow-up.. Compared with the elective PCI and drug treatment groups, at 1 week and 1 month after the intervention, the emergency PCI group's plasma NT-proBNP levels were significantly lower, and the group's LVEFs were significantly higher (all P < 0.05). There was a significantly negative correlation between plasma NT-proBNP levels and LVEFs in each group (all P < 0.05). The positive exercise stress testing rates were 13.0%, 32.6%, and 38.6% in the emergency PCI, elective PCI, and drug treatment groups, respectively (P < 0.05). The occurrences of MACE in the emergency PCI, elective PCI, and drug treatment groups were 34.5%, 59.5%, and 65.9%, respectively (P < 0.05).. Emergency PCI resulted in lower plasma NT-proBNP levels, lower MACE incidence, higher LVEFs, and better early exercise tolerance compared with elective PCI or drug treatment, indicating that lower plasma NT-proBNP levels predicted a better prognosis.

Topics: Adult; Aged; Angioplasty; Arrhythmias, Cardiac; Biomarkers; Cardiovascular Agents; Exercise Test; Exercise Tolerance; Female; Follow-Up Studies; Heart Failure; Humans; Male; Middle Aged; Myocardial Infarction; Natriuretic Peptide, Brain; Peptide Fragments; Treatment Outcome

The goal of this study was to demonstrate superiority of sirolimus-eluting stents (SES) over bare-metal stents (BMS) and of abciximab over no abciximab in primary percutaneous coronary intervention (PCI).. Drug-eluting stents (DES) are increasingly used in primary PCI, but the recommendations for use in primary PCI are based on a few randomized controlled trials with selected patients. The usefulness of abciximab in primary PCI is not established.. Nine hundred seven patients referred to the Catharina Hospital were randomized to SES or BMS, and to abciximab or no abciximab in a prospective, randomized, open 2 × 2 factorial trial with blinded evaluation. Primary endpoint was major adverse cardiac and cerebrovascular events (MACCE), defined as the composite of death, myocardial infarction (MI), stroke, repeat revascularization, and bleeding at 1 year (stent arm) and the composite of death, target vessel MI, target vessel revascularization (TVR), and bleeding at 30 days (abciximab arm).. At 1 year, the rate of MACCE was lower in the SES arm (16.5% vs. 25.8%, p = 0.001), mainly driven by less repeat revascularization (9.8% vs. 16.8%; p = 0.003) and without influencing the cumulative incidence of death and MI (5.2% vs. 5.8%; p = 0.68). At 30 days, the rate of the composite of death, target vessel MI, TVR, and bleeding was lower in the abciximab arm (8.2% vs. 12.4%, p = 0.04), mainly driven by less TVR due to less stent thrombosis (1.2% vs.7.4%, p < 0.001). However, bleeding complications occurred more frequently in the abciximab group (5.7% vs. 2.8%, p = 0.03).. Primary PCI with SES reduces adverse events at 1 year, mainly by reduction of repeat revascularization, whereas abciximab reduces early stent thrombosis, at the expense of more bleeding complications. (Comparison of Drug Eluting and Bare Metal Stents With or Without Abciximab in ST Elevation Myocardial Infarction [DEBATER]; NCT00986050).

Topics: Abciximab; Aged; Angioplasty, Balloon, Coronary; Antibodies, Monoclonal; Cardiovascular Agents; Cardiovascular Diseases; Chi-Square Distribution; Drug-Eluting Stents; Female; Hemorrhage; Humans; Immunoglobulin Fab Fragments; Kaplan-Meier Estimate; Male; Metals; Middle Aged; Myocardial Infarction; Netherlands; Platelet Aggregation Inhibitors; Prospective Studies; Prosthesis Design; Risk Assessment; Risk Factors; Sirolimus; Stents; Thrombosis; Time Factors; Treatment Outcome

To compare the efficacy of sirolimus- and everolimus-eluting stents in patients with bifurcation lesions treated with provisional side-branch stenting.. The efficacy of everolimus-eluting stents in bifurcation lesions has been poorly tested.. Patients with all types of Medina bifurcation lesions were randomly assigned to treatment with either a sirolimus- (n = 145) or everolimus-eluting stent (n = 148). We included patients with main vessel diameter over 2.5 mm and side branches over 2.25 mm. Patients with diffuse side-branch stenosis were excluded.. There were no significant differences between patients from the sirolimus and everolimus groups in terms of age, risk factors, clinical status, location of the bifurcation lesions or angiographic variables. Immediate results and in-hospital outcome were also similar in both groups of patients. In-hospital death occurred in two patients, one from each group. Target lesion revascularization was required in nine patients: four patients (2.7%) from the sirolimus group and five patients (3.4%) from the everolimus group. Late cardiac mortality occurred in two patients from the sirolimus group and in one patient from the everolimus group. Major cardiac event rates at 1 year were similar in both groups: nine patients (6.2%) in the sirolimus group and nine patients (6.1%) from the everolimus group (p: ns).. In patients with bifurcation lesions, no significant differences in clinical outcome at 1-year follow-up were observed between sirolimus- and everolimus-eluting stent groups.

Topics: Aged; Cardiovascular Agents; Chi-Square Distribution; Coronary Angiography; Coronary Artery Disease; Drug-Eluting Stents; Everolimus; Female; Humans; Male; Middle Aged; Myocardial Infarction; Percutaneous Coronary Intervention; Prospective Studies; Prosthesis Design; Sirolimus; Spain; Time Factors; Treatment Outcome; Ultrasonography, Interventional

The impact of age on outcomes following everolimus-eluting stent (EES) or paclitaxel-eluting stent (PES) implantation was evaluated in a patient-level pooled analysis of the SPIRIT III (n=1,002) and SPIRIT IV (n=3,687) trials.. Clinical outcomes with EES compared to PES in elderly (≥ 65 years, n=2,071) and younger (<65 years, n=2,617) patients were evaluated at one year. At one year, elderly patients treated with EES rather than PES showed a significant reduction in target lesion failure (TLF) (3.9% EES vs. 6.8% PES, p=0.006), major adverse cardiac events (MACE) (4.0% EES vs. 7.1% PES, p=0.005), and ischaemia-driven target lesion revascularisation (ID-TLR) (2.0% EES vs. 4.0% PES, p=0.01). Younger patients treated with EES rather than PES also had significantly reduced one-year rates of TLF (4.9% EES vs. 7.9% PES, p=0.003), MACE (5.0% EES vs. 8.0% PES, p=0.004), target vessel myocardial infarction (MI) (2.0% EES vs. 3.4% PES, p=0.04), ID-TLR (3.3% EES vs. 5.5% PES, p=0.01) and stent thrombosis (0.5% EES vs. 1.6% PES, p=0.01).. In a pooled analysis from the SPIRIT III and IV trials, EES was safer and more effective than PES in both younger and older cohorts as evidenced by lower rates of TLR, TLF and MACE.

Topics: Age Factors; Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Drug-Eluting Stents; Everolimus; Female; Humans; Kaplan-Meier Estimate; Logistic Models; Male; Middle Aged; Multivariate Analysis; Myocardial Infarction; Paclitaxel; Prospective Studies; Prosthesis Design; Risk Assessment; Risk Factors; Single-Blind Method; Sirolimus; Thrombosis; Time Factors; Treatment Outcome

The long-term clinical performance of drug-eluting stents (DES) coated with biodegradable polymers is poorly known.. A total of 274 coronary patients were randomly allocated to paclitaxel-eluting stents, sirolimus-eluting stents, or bare metal stents (2:2:1 ratio). The two DES used the same biodegradable polymers and were identical except for the drug. At three years, the pooled DES population had similar rates of cardiac death or myocardial infarction (9.0% vs. 7.1; p=0.6), but lower risk of repeat interventions (10.0% vs. 29.9%; p<0.01) than controls with bare stents. The cumulative 3-year incidence of definite or probable stent thrombosis in the pooled DES group was 2.3% (first year: 1.8%; second year: 0.4%; third year: zero). There were no significant differences in outcomes between paclitaxel- and sirolimus-eluting stents.. The biodegradable-polymer coated DES releasing either paclitaxel or sirolimus were effective in reducing the 3-year rate of re-interventions.

Topics: Absorbable Implants; Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Artery Disease; Drug-Eluting Stents; Female; Follow-Up Studies; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Myocardial Infarction; Paclitaxel; Polymers; Proportional Hazards Models; Prosthesis Design; Risk Assessment; Risk Factors; Sirolimus; Thrombosis; Time Factors; Treatment Outcome

The TWENTE trial recently enrolled more than 80% of all eligible patients, who were randomised to zotarolimus-eluting Resolute or everolimus-eluting XIENCE V stents. In the present study, we investigated whether eligible, non-enrolled patients differed from the randomised TWENTE trial population in baseline characteristics and one-year outcome.. Characteristics of 1,709 eligible patients were analysed. Independent external adjudication of clinical events was likewise performed for non-enrolled (n=318) and randomised patients (n=1,391). Non-enrolled and randomised patients did not differ in gender distribution, diabetes mellitus, and clinical presentation, but differed significantly in age and cardiovascular history. Nevertheless, clinical outcome after one year did not differ in the primary composite endpoint target-vessel failure (TVF; 9.8% vs. 8.1%; p=0.34), and its components cardiac death (1.6% vs. 1.2%; p=0.61), target vessel-related myocardial infarction (4.7% vs. 4.6%; p=0.92), and target-vessel revascularisation (3.8% vs. 3.0%; p=0.48). Previous bypass surgery predicted TVF in non-enrolled patients (p=0.001); removal of these patients resulted in identical TVF rates for non-enrolled and randomised patients (7.3% vs. 7.3%; p=0.99).. Despite some differences in baseline characteristics, non-enrolled and randomised patients did not differ in one-year outcome, which was favourable for both populations and may be related to the drug-eluting stents used.

Topics: Aged; Cardiovascular Agents; Chi-Square Distribution; Coronary Artery Disease; Drug-Eluting Stents; Eligibility Determination; Everolimus; Female; Humans; Kaplan-Meier Estimate; Logistic Models; Male; Middle Aged; Multivariate Analysis; Myocardial Infarction; Netherlands; Odds Ratio; Patient Selection; Percutaneous Coronary Intervention; Prospective Studies; Prosthesis Design; Risk Factors; Sirolimus; Time Factors; Treatment Outcome

Strict implementation of guidelines directed at multiple targets reduces vascular risk in diabetic patients. Whether this also applies to patients with chronic kidney disease (CKD) is uncertain. To evaluate this, the MASTERPLAN Study randomized 788 patients with CKD (estimated GFR 20-70 ml/min) to receive additional intensive nurse practitioner support (the intervention group) or nephrologist care (the control group). The primary end point was a composite of myocardial infarction, stroke, or cardiovascular death. During a mean follow-up of 4.62 years, modest but significant decreases were found for blood pressure, LDL cholesterol, anemia, proteinuria along with the increased use of active vitamin D or analogs, aspirin and statins in the intervention group compared to the controls. No differences were found in the rate of smoking cessation, weight reduction, sodium excretion, physical activity, or glycemic control. Intensive control did not reduce the rate of the composite end point (21.3/1000 person-years in the intervention group compared to 23.8/1000 person-years in the controls (hazard ratio 0.90)). No differences were found in the secondary outcomes of vascular interventions, all-cause mortality or end-stage renal disease. Thus, the addition of intensive support by nurse practitioner care in patients with CKD improved some risk factor levels, but did not significantly reduce the rate of the primary or secondary end points.

Topics: Aged; Cardiovascular Agents; Cardiovascular Diseases; Combined Modality Therapy; Disease Progression; Female; Glomerular Filtration Rate; Guideline Adherence; Humans; Kidney; Kidney Failure, Chronic; Linear Models; Male; Middle Aged; Motor Activity; Myocardial Infarction; Netherlands; Nurse Practitioners; Practice Guidelines as Topic; Preventive Health Services; Proportional Hazards Models; Renal Insufficiency, Chronic; Risk Assessment; Risk Factors; Risk Reduction Behavior; Severity of Illness Index; Smoking Cessation; Stroke; Time Factors; Treatment Outcome; Weight Loss

This study sought to determine the risk versus benefit ratio of an early aggressive (EA) approach in elderly patients with non-ST-segment elevation acute coronary syndromes (NSTEACS).. Elderly patients have been scarcely represented in trials comparing treatment strategies in NSTEACS.. A total of 313 patients ≥ 75 years of age (mean 82 years) with NSTEACS within 48 h from qualifying symptoms were randomly allocated to an EA strategy (coronary angiography and, when indicated, revascularization within 72 h) or an initially conservative (IC) strategy (angiography and revascularization only for recurrent ischemia). The primary endpoint was the composite of death, myocardial infarction, disabling stroke, and repeat hospital stay for cardiovascular causes or severe bleeding within 1 year.. During admission, 88% of the patients in the EA group underwent angiography (55% revascularization), compared with 29% (23% revascularization) in the IC group. The primary outcome occurred in 43 patients (27.9%) in the EA group and 55 (34.6%) in the IC group (hazard ratio [HR]: 0.80; 95% confidence interval [CI]: 0.53 to 1.19; p = 0.26). The rates of mortality (HR: 0.87; 95% CI: 0.49 to 1.56), myocardial infarction (HR: 0.67; 95% CI: 0.33 to 1.36), and repeat hospital stay (HR: 0.81; 95% CI: 0.45 to 1.46) did not differ between groups. The primary endpoint was significantly reduced in patients with elevated troponin on admission (HR: 0.43; 95% CI: 0.23 to 0.80), but not in those with normal troponin (HR: 1.67; 95% CI: 0.75 to 3.70; p for interaction = 0.03).. The present study does not allow a definite conclusion about the benefit of an EA approach when applied systematically among elderly patients with NSTEACS. The finding of a significant interaction for the treatment effect according to troponin status at baseline should be confirmed in a larger size trial. (Italian Elderly ACS Study; NCT00510185).

Topics: Acute Coronary Syndrome; Age Factors; Aged; Aged, 80 and over; Biomarkers; Cardiovascular Agents; Coronary Angiography; Coronary Artery Bypass; Female; Humans; Italy; Kaplan-Meier Estimate; Male; Myocardial Infarction; Patient Readmission; Percutaneous Coronary Intervention; Postoperative Hemorrhage; Proportional Hazards Models; Risk Assessment; Risk Factors; Stroke; Time Factors; Treatment Outcome; Troponin; Up-Regulation

This 2-year follow-up of the XIENCE V USA study examines both the long-term safety and effectiveness of the everolimus-eluting coronary stent system (EECSS) in real-world patients.. The safety and effectiveness of EECSS at 1 year in real-world clinical settings have been demonstrated in XIENCE V USA trial with low rates of target lesion revascularization (TLR), cardiac death, myocardial infarction (MI), and stent thrombosis (ST). Data on whether efficacy is maintained after 1 year and the event rate of very late stent thrombosis (VLST) between 1 and 2 years have not yet been reported.. XIENCE V USA is a prospective, multicenter, single-arm, FDA required condition of approval study designed to examine the safety and effectiveness of EECSS in an all-inclusive, consecutively enrolled population from real-world clinical settings. Clinical end-point events, including ST, cardiac death, MI, and revascularization were adjudicated by an independent Clinical Events Committee..  Four thousand eight hundred and seventy-three (96.4%) out of 5,054 participants (1,875 standard-risk; 3,059 extended-risk) reached 2-year follow-up. The 2-year rate of Academic Research Consortium (ARC)-defined definite and probable ST was 0.96% (95% CI 0.70-1.28) in the overall population and 0.34% (95% CI 0.12-0.74) and 1.33% (95% CI 0.95-1.81) in the standard-risk and extended-risk cohorts, respectively. The rate of VLST was 0.06% in the overall population, 0.0% in the standard-risk, and 0.10% in the extended-risk cohorts. The 2-year composite rate of cardiac death and ARC-defined MI was 8.9% (95% CI 8.08-9.70) in the overall population and 5.6% (95% CI 4.61-6.78) and 10.8% (95% CI 9.71-11.94) in the standard-risk and extended-risk cohorts, respectively.. Low event rates observed at 1 year were maintained through 2 years. Despite the increased number of patients who discontinued dual antiplatelet therapy by 2 years, the ST rate remained consistently low, and <1% at 2 years due to low VLST occurrence. These results demonstrate continued safety and effectiveness of the XIENCE V everolimus-eluting stent in a highly complex, real-world patient population through 2 years.

Topics: Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Artery Disease; Drug-Eluting Stents; Everolimus; Female; Humans; Male; Middle Aged; Myocardial Infarction; Prospective Studies; Sirolimus; Thrombosis; United States

Procedural and clinical outcomes still remain unfavorable for patients with long coronary lesions who undergo stent-based coronary interventions. Therefore, we compared the relative efficacy and safety of resolute zotarolimus-eluting stents (R-ZES) and sirolimus-eluting stents (SES) for patients with de novo long coronary lesions.. This randomized, multicenter, prospective trial, called the Percutaneous Treatment of LONG Native Coronary Lesions With Drug-Eluting Stent-IV (LONG-DES IV) trial, compared long R-ZES and SES in 500 patients with long (≥25 mm) native coronary lesions. The primary end point of the trial was in-segment late luminal loss at 9-month angiographic follow-up. The baseline characteristics were not different between R-ZES and SES groups, including lesion lengths (32.4±13.5 mm versus 31.0±13.5 mm, P=0.27). At 9-month angiographic follow-up, the R-ZES was noninferior to the SES with respect to in-segment late luminal loss, the primary study end point (0.14±0.38 mm versus 0.12±0.43 mm, P for noninferiority=0.03, P for superiority=0.68). In addition, in-stent late luminal loss (0.26±0.36 mm versus 0.24±0.42 mm, P=0.78) and the rates of in-segment (5.2% versus 7.2%, P=0.44) and in-stent (4.0% versus 6.0%, P=0.41) binary restenosis were not significantly different between the 2 groups. There were no significant between-group differences in the rate of adverse clinical events (death, myocardial infarction, stent thrombosis, target-lesion revascularization, and composite outcomes).. For patients with de novo long coronary artery disease, R-ZES implantation showed noninferior angiographic outcomes as compared with SES implantation.. URL: http://www.clinicaltrials.gov. Unique identifier: NCT01186094.

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Chi-Square Distribution; Coronary Angiography; Coronary Artery Disease; Coronary Restenosis; Coronary Thrombosis; Drug-Eluting Stents; Female; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Myocardial Infarction; Prospective Studies; Prosthesis Design; Republic of Korea; Risk Factors; Sirolimus; Time Factors; Treatment Outcome

This study sought to evaluate the safety and efficacy of the NOYA stent which is a cobalt chromium-based sirolimus-eluting stent (SES) with DL-polylactide biodegradable polymer (Medfavour Medical, Beijing, China) in treating de novo coronary artery lesions.. The NOYA I trial was designed to compare the NOYA stent with the FIREBIRD2™ stent, a durable polymer SES widely used in China (MicroPort Medical, Shanghai, China); the trial was a non-inferiority trial with a primary angiographic endpoint of the in-stent late lumen loss (LLL) at nine-month follow-up. The secondary endpoints were binary restenosis rates within nine months, major adverse cardiac events (MACE) defined as the composite of cardiac death, myocardial infarction (MI) or target lesion revascularisation (TLR), and definite/probable stent thrombosis (ST) at 24-month follow-up. A total of 300 patients (n=150 in each group) were enrolled in the study from 16 Chinese centres. The LLL in the NOYA group at nine-month follow-up was similar to the FIREBIRD2 group (0.11±0.18 mm vs. 0.14±0.23 mm, p=0.16; non-inferiority p<0.001). The rates of MACE, death, MI and TLR at 24-month follow-up were comparable between these two devices (p>0.05, respectively).. The biodegradable polymer NOYA stent was non-inferior to the FIREBIRD2 durable polymer stent with respect to the primary non-inferiority endpoint of in-stent LLL at nine-month follow-up. Clinical outcomes at 24-month follow-up were comparable between the two stents. (ClinicalTrials.gov number, NCT01226355).

Topics: Absorbable Implants; Aged; Analysis of Variance; Cardiovascular Agents; Chi-Square Distribution; China; Chromium Alloys; Coronary Angiography; Coronary Artery Disease; Coronary Restenosis; Coronary Vessels; Drug-Eluting Stents; Female; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Myocardial Infarction; Percutaneous Coronary Intervention; Polyesters; Predictive Value of Tests; Prosthesis Design; Single-Blind Method; Sirolimus; Time Factors; Treatment Outcome

This was designed to assess the outcomes of side branch (SB) stenosis after implantation of three drug-eluting stents (DES). From 2,645 patients in the ZEST (Comparison of the Efficacy and Safety of Zotarolimus-Eluting Stent with Sirolimus-Eluting and PacliTaxel-Eluting Stent for Coronary Lesions) Trial, 788 patients had 923 bifurcation lesions with SB ≥ 1.5 mm were included. SB was treated in 150 lesions, including 35 (3.8%) receiving SB stenting. Of untreated SB with baseline stenosis < 50%, the incidences of periprocedural SB compromise was similar in the zotarolimus (15.8%), sirolimus (17.2%), and paclitaxel (16.6%) stent groups (P = 0.92). At follow-up angiography, delayed SB compromise occurred in 13.9%, 3.2%, and 9.4% (P = 0.010) of these groups. When classified into four groups (< 50%, 50%-70%, 70%-99%, and 100%), 9.0% of untreated SB were worsened, whereas improvement and stationary were observed in 9.6% and 81.4%. In a multivariable logistic regression model, main branch (MB) stenosis at follow-up (%) was the only independent predictor of SB stenosis worsening (odds ratio, 1.03; 95% confidence interval, 1.01-1.04; P < 0.001). After MB stenting in bifurcation lesions, a minority of SB appears to worsen. DES with strong anti-restenotic efficacy may help maintain SB patency.

Topics: Acute Disease; Aged; Blood Vessels; Cardiovascular Agents; Coronary Angiography; Coronary Stenosis; Drug-Eluting Stents; Female; Follow-Up Studies; Humans; Logistic Models; Male; Middle Aged; Myocardial Infarction; Myocardial Revascularization; Odds Ratio; Paclitaxel; Predictive Value of Tests; Sirolimus; Thrombosis; Treatment Outcome

This report describes the 4-year clinical outcomes of the SPIRIT II study, which randomized 300 patients to treatment with the XIENCE V everolimus-eluting stent (EES), or the TAXUS paclitaxel-eluting stent. At 4-year clinical follow-up, which was available in 256 (85.3%) patients, treatment with EES lead to a trend for lower rates of ischemia-driven major adverse cardiovascular events, a composite of cardiac death, myocardial infarction, and ischemia-driven target lesion revascularization (EES 7.7% vs. paclitaxel-eluting stent 16.4%, P = 0.056). Treatment with EES also resulted in a trend toward lower rates of cardiac death and numerically lower rates of myocardial infarction, ischemia-driven target lesion revascularization, and stent thrombosis. Overall, this study reports numerically fewer clinical events in patients treated with EES at 4-year follow-up, which is consistent with results from earlier follow-up.

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Artery Disease; Drug-Eluting Stents; Everolimus; Female; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Myocardial Infarction; Platelet Aggregation Inhibitors; Proportional Hazards Models; Prospective Studies; Prosthesis Design; Risk Assessment; Risk Factors; Single-Blind Method; Sirolimus; Thrombosis; Time Factors; Treatment Outcome

The aim of this study was the comparison of a new double-coated paclitaxel-eluting coronary stent with bare-metal stent (BMS) in patients undergoing percutaneous coronary intervention.. Stent coating with biodegradable polymers as a platform for elution of drugs has the potential for complete elution of drugs and for decreasing the risk of late complications.. Multicenter randomized trial comparing a paclitaxel-eluting stent (PES) coated with a biodegradable polymer and glycocalyx with the equivalent BMS. We randomly assigned 422 patients with de novo coronary lesions to PES (211 patients) or to BMS (211 patients). Primary end point was target vessel failure (TVF) defined as cardiac death, myocardial infarction, and target vessel revascularization. Clinical secondary end points were target vessel revascularization, target lesion revascularization, stent thrombosis (ST), and major adverse cardiovascular events (MACE). Angiographic secondary end points were late loss and binary restenosis.. At 1 year of follow-up, TVF rate was 9.5% in the PES group and 17.1% in the BMS group (P=0.02), and MACE rate was 10% in PES and 19% in BMS arm (P=0.009). All other secondary end points were reached but ST. ST rate was low and similar in both study arms.. The study shows that patients treated with PES with dual coating technology had significantly lower incidence of TVF and MACE than those treated with BMS design; however, longer follow-up should be necessary to assess true advantages of this technology compared with the previous one.

Topics: Aged; Angioplasty, Balloon, Coronary; Argentina; Cardiovascular Agents; Chi-Square Distribution; Coated Materials, Biocompatible; Coronary Angiography; Coronary Restenosis; Coronary Stenosis; Drug-Eluting Stents; Female; Glycocalyx; Humans; Kaplan-Meier Estimate; Lactic Acid; Logistic Models; Male; Metals; Middle Aged; Myocardial Infarction; Paclitaxel; Polyglycolic Acid; Polylactic Acid-Polyglycolic Acid Copolymer; Proportional Hazards Models; Prospective Studies; Prosthesis Design; Risk Assessment; Risk Factors; Severity of Illness Index; Stents; Thrombosis; Time Factors; Treatment Outcome

Late-acquired stent malapposition (LASM) is a common finding after sirolimus-eluting stent (SES) implantation and may be the cause for late stent thrombosis. Inflammation may play a pivotal role in LASM just as it plays in stent restenosis. We have therefore investigated seven polymorphisms involved in inflammatory processes, related in previous reports to restenosis, on the risk of LASM in SES patients. Patients with ST-elevation myocardial infarction who underwent SES implantation and had intravascular ultrasonography (IVUS) data available for both immediate post-intervention and 9-month follow-up were included in the present study. In total, 104 patients from the MISSION! Intervention Study were genotyped for the caspase-1 5352 G/A, eotaxin 1382 A/G, CD14 260 A/G, colony stimulating factor 2 1943 C/T, IL10 -1117 C/T, IL10 4251 C/T, and the tumor necrosis factor alpha 1211 C/T polymorphisms. LASM occurred in 26/104 (25%) of patients. We found a significantly higher risk for LASM in patients carrying the caspase-1 (CASP1) 5352 A allele (RR = 2.32; 95% CI 1.22-4.42). In addition, mean neointimal growth was significantly lower in patients carrying this LASM risk allele (1.6 vs. 4.1%, p = 0.014). The other six polymorphisms related to inflammation were not significantly related to the risk of LASM. In conclusion, carriers of the 5352 A allele in the caspase-1 gene are at increased risk of developing LASM after SES implantation. If this is confirmed in larger studies, then screening for this polymorphism in patients undergoing percutaneous coronary interventions could eventually help cardiologists to better select between commercially available stents.

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Caspase 1; Chi-Square Distribution; Drug-Eluting Stents; Female; Gene Frequency; Genetic Predisposition to Disease; Humans; Inflammation; Inflammation Mediators; Male; Middle Aged; Myocardial Infarction; Netherlands; Prospective Studies; Risk Assessment; Risk Factors; Sirolimus; Time Factors; Treatment Outcome; Ultrasonography, Interventional

Independent adjudication of clinical trial events is traditionally performed by physicians on a clinical event classification (CEC) committee.. The experience of the centralized CEC group of the APEX-AMI trial is described. This group adjudicated key secondary pre-specified outcome measures of congestive heart failure (CHF) and cardiogenic shock through 90 days using an algorithmic approach for some events.. Data were collected via an electronic data capture (EDC) tool on all subjects, and additional information was provided via EDC for patients identified by site investigators with CHF or shock. Two strategies were used to adjudicate potential events: 1) a computer algorithm (followed by physician confirmation) analyzed data to determine whether events met trial end point definitions; or 2) physician review was used if EDC data were inadequate to allow classification by algorithm.. Of 5745 patients, 282 suspected cardiogenic shock and 465 suspected CHF events were identified. The computer algorithm or physicians confirmed 196/282 cardiogenic shock and 277/465 CHF end points. Overall, 242/742 (32.6%) of suspected events were classified by algorithm. Of the 500 events not resolved by computer algorithm, the CEC physicians agreed with site investigator assessments in 126/277 (45%) of CHF and 151/196 (77%) of cardiogenic shock events. The CEC committee completed adjudication of all suspected 30- and 90-day CHF and cardiogenic shock events within 7 days of the last patient 30-day follow-up visit and within 1 day of the last patient 90-day follow-up visit. Only 27% of patients required source document collection in addition to EDC-collected information.. A complementary approach of a computerized assessment and physician review was used in the CEC effort of the APEX-AMI trial. The algorithm categorized approximately one third of suspected CHF/cardiogenic shock events. The APEX-AMI CEC experience shows that an algorithmic approach may be a useful strategy for end point evaluation but requires validation.

Topics: Antibodies, Monoclonal; Antibodies, Monoclonal, Humanized; Bundle-Branch Block; Cardiovascular Agents; Diagnosis, Computer-Assisted; Double-Blind Method; Heart Failure; Humans; Kaplan-Meier Estimate; Myocardial Infarction; Observer Variation; Randomized Controlled Trials as Topic; Shock, Cardiogenic; Single-Chain Antibodies; Time Factors

The aim of this study was to assess the long-term safety and efficacy of the CYPHER (Cordis, Johnson and Johnson, Bridgewater, New Jersey) sirolimus-eluting coronary stent (SES) in percutaneous coronary intervention (PCI) for ST-segment elevation myocardial infarction (STEMI).. Concern over the safety of drug-eluting stents implanted during PCI for STEMI remains, and long-term follow-up from randomized trials are necessary. TYPHOON (Trial to assess the use of the cYPHer sirolimus-eluting stent in acute myocardial infarction treated with ballOON angioplasty) randomized 712 patients with STEMI treated by primary PCI to receive either SES (n = 355) or bare-metal stents (BMS) (n = 357). The primary end point, target vessel failure at 1 year, was significantly lower in the SES group than in the BMS group (7.3% vs. 14.3%, p = 0.004) with no increase in adverse events.. A 4-year follow-up was performed. Complete data were available in 501 patients (70%), and the survival status is known in 580 patients (81%).. Freedom from target lesion revascularization (TLR) at 4 years was significantly better in the SES group (92.4% vs. 85.1%; p = 0.002); there were no significant differences in freedom from cardiac death (97.6% and 95.9%; p = 0.37) or freedom from repeat myocardial infarction (94.8% and 95.6%; p = 0.85) between the SES and BMS groups. No difference in definite/probable stent thrombosis was noted at 4 years (SES: 4.4%, BMS: 4.8%, p = 0.83). In the 580 patients with known survival status at 4 years, the all-cause death rate was 5.8% in the SES and 7.0% in the BMS group (p = 0.61).. In the 70% of patients with complete follow-up at 4 years, SES demonstrated sustained efficacy to reduce TLR with no difference in death, repeat myocardial infarction or stent thrombosis. (The Study to Assess AMI Treated With Balloon Angioplasty [TYPHOON]; NCT00232830).

Topics: Aged; Angioplasty, Balloon, Coronary; Australia; Cardiovascular Agents; Disease-Free Survival; Drug-Eluting Stents; Europe; Female; Follow-Up Studies; Humans; Kaplan-Meier Estimate; Male; Metals; Middle Aged; Myocardial Infarction; Proportional Hazards Models; Prosthesis Design; Recurrence; Risk Assessment; Risk Factors; Sirolimus; Stents; Survival Rate; Thrombosis; Time Factors; Treatment Outcome

The purpose of this study was to evaluate the long-term outcomes of the PASSION (Paclitaxel-Eluting Versus Conventional Stent in Myocardial Infarction with ST-Segment Elevation) trial.. In primary percutaneous coronary intervention for acute ST-segment elevation myocardial infarction (STEMI), the use of drug-eluting stents (DES) is still controversial. Several randomized controlled trials of DES, compared with bare-metal stents (BMS), with short-term follow-up showed a reduction in target lesion revascularization (TLR), but no differences in rates of cardiac death or recurrent myocardial infarction. Moreover, the occurrence of (very) late stent thrombosis (ST) continues to be of major concern, and, therefore, long-term follow-up results are needed.. We randomly assigned 619 patients presenting with STEMI to a paclitaxel-eluting stent (PES) or the similar BMS. The primary end point was the composite of cardiac death, recurrent myocardial infarction, or TLR. We performed clinical follow-up at 5 years.. At 5 years, the occurrence of the composite of cardiac death, recurrent myocardial infarction, or TLR was comparable at 18.6% versus 21.8% in PES and BMS, respectively (hazard ratio [HR]: 0.82, 95% confidence interval [CI]: 0.58 to 1.18, p = 0.28). The incidence of definite or probable ST was 12 (4.2%) in the PES group and 10 (3.4%) in the BMS group (HR: 1.19, 95% CI: 0.51 to 276, p = 0.68).. In the present analysis of PES compared with BMS in primary percutaneous coronary intervention for STEMI, no significant difference in major adverse cardiac events was observed. In addition, no difference in the incidence of definite or probable ST was seen, although very late ST was almost exclusively seen after the use of PES. (Paclitaxel-Eluting Versus Conventional Stent in Myocardial Infarction with ST-Segment Elevation [PASSION]; ISRCTN65027270).

Topics: Angioplasty, Balloon, Coronary; Cardiovascular Agents; Drug-Eluting Stents; Follow-Up Studies; Humans; Kaplan-Meier Estimate; Metals; Myocardial Infarction; Netherlands; Paclitaxel; Proportional Hazards Models; Prospective Studies; Recurrence; Risk Assessment; Risk Factors; Single-Blind Method; Stents; Thrombosis; Time Factors; Treatment Outcome

This study sought to report the long-term outcomes after drug-eluting stent (DES) implantation in saphenous vein graft (SVG) lesions in the SOS (Stenting of Saphenous Vein Grafts) trial.. The long-term outcomes after DES implantation in SVGs are poorly studied. Apart from the SOS trial, the only other randomized trial comparing DES with bare-metal stents (BMS) in SVGs reported higher mortality in the DES group at 32 months.. In the SOS trial, 80 patients with 112 lesions in 88 SVGs were randomized to a BMS or paclitaxel-eluting stent (PES) and demonstrated improved short-term angiographic and clinical outcomes with PES. Extended clinical follow-up was subsequently obtained.. Mean age was 67 ± 9 years, and all patients were men. The indications for stenting included acute coronary syndrome in 60% and stable angina in 31% of patients. The mean SVG age was 12 ± 6 years. The baseline characteristics of the patients in the 2 study groups were similar. Procedural success was achieved in 77 patients (96%). During a median follow-up of 35 months, compared with patients randomized to BMS, those receiving PES had a lower incidence of myocardial infarction (hazard ratio [HR]: 0.32, p = 0.01), target lesion revascularization (HR: 0.20, p = 0.004), target vessel revascularization (HR: 0.41, p = 0.03), and target vessel failure (HR: 0.34, p = 0.001) as well as a trend toward less definite or probable stent thrombosis (HR: 0.15, p = 0.08). All-cause mortality (HR: 2.04, p = 0.19) and cardiac mortality (HR: 0.62, p = 0.51) did not differ between groups.. During long-term follow-up, use of PES was associated with significantly better clinical outcomes than BMS in SVG lesions. (Stenting of Saphenous Vein Grafts Trial [SOS]; NCT00247208).

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Angiography; Coronary Artery Bypass; Drug-Eluting Stents; Female; Graft Occlusion, Vascular; Humans; Kaplan-Meier Estimate; Male; Metals; Middle Aged; Myocardial Infarction; Paclitaxel; Proportional Hazards Models; Prosthesis Design; Risk Assessment; Risk Factors; Saphenous Vein; Single-Blind Method; Stents; Thrombosis; Time Factors; Treatment Outcome; United States

We compared 4-year efficacy and safety of sirolimus-eluting stents (SES) and paclitaxel-eluting stents (PES) in patients with diabetes mellitus (DM).. Four-year comparison of SES with PES in diabetic patients has not been evaluated in a randomized manner.. This prospective, multicenter, randomized study compared SES (n = 200) and PES (n = 200) implantation in diabetic patients. We evaluated 4-year major adverse cardiac events (MACE) including death, myocardial infarction (MI), and target lesion revascularization (TLR).. The 2 groups had similar baseline characteristics. At 2 years, TLR (3.5% vs. 11.0%, log-rank, p < 0.01) and MACE (3.5% vs. 12.5%, log-rank, p < 0.01) were significantly lower in SES versus PES group with no difference of death or MI. At 4 years there were no differences in death (3.0% vs. 5.0%, p = 0.45) or MI (1.5% vs. 1.0%, p = 0.99) between SES and PES group. The TLR (7.5% vs. 12.0%, log-rank, p = 0.10) and MACE (11.0% vs. 16.0%, log-rank, p = 0.10) were statistically not different between SES and PES group. At multivariate Cox regression, post-procedural minimal lumen diameter (hazard ratio [HR]: 0.44, 95% confidence interval [CI]: 0.24 to 0.81, p < 0.01), hypercholesterolemia (HR: 2.21, 95% CI: 1.29 to 3.79, p < 0.01), and use of intravascular ultrasound (HR: 0.51, 95% CI: 0.26 to 0.99, p = 0.049) were independent predictors of 4-year MACE.. Superiority of SES over PES during 2 years was attenuated between 2 years and 4 years in diabetic patients. Use of intravascular ultrasound and larger post-procedural minimal lumen diameter were independent predictors of the improved long-term clinical outcomes.

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Chi-Square Distribution; Coronary Angiography; Coronary Stenosis; Diabetes Mellitus; Drug-Eluting Stents; Female; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Myocardial Infarction; Paclitaxel; Proportional Hazards Models; Prospective Studies; Prosthesis Design; Republic of Korea; Risk Assessment; Risk Factors; Severity of Illness Index; Sirolimus; Thrombosis; Time Factors; Treatment Outcome; Ultrasonography, Interventional

The aim of this study was to evaluate a 3-week inpatient cardiac rehabilitation (Rehab) started early after the index event in patients with coronary heart disease and evidence-based secondary preventive medication.. All patients had acute coronary angiography, 679 were discharged from hospital receiving usual care (Hosp), 795 completed a comprehensive Rehab. Follow-up was 12 months.. Rehab patients were older (64 vs. 62 years; p < 0.001), had more multivessel disease (51 vs. 37%; p < 0.001), heart failure (64 vs. 40%, p < 0.001), ST-segment elevation myocardial infarction (59 vs. 52%, p = 0.014), and renal insufficiency (10 vs. 7%, p = 0.036). Gender, peripheral artery disease, diabetes, hypertension, and socioeconomic status were similar in groups. Rehab patients had more beta-blockers (88 vs. 75%, p < 0.001) and angiotensin-converting enzyme inhibitors (81 vs. 70%, p < 0.001), a lower low-density lipoprotein cholesterol (102 vs. 122 mg/dl, p < 0.001), and a higher proportion of non-smokers (44 vs. 39%, p = 0.024). Primary combined endpoint of mortality, myocardial infarction (MI), revascularization, and hospitalization occurred in 32.6% of Rehab patients and in 38.7% of Hosp patients [p = 0.014; absolute risk reduction 0.0615, relative risk reduction 16%, number needed to treat (NNT) 17]. Myocardial infarction (MI) (1.8 vs. 3.8%, p = 0.015; NNT 49) and hospitalization (31.8 vs. 38.0%, p = 0.013; NNT 17) were reduced. In multivariate analysis, primary endpoint was reduced significantly (OR 0.729; 95% CI 0.585-0.909; p = 0.005) giving a relative risk reduction of 27% in favour of Rehab.. Although Rehab patients were sicker at entry, their outcome was substantially improved within 12 months. With very low NNT, Rehab is highly effective and should be advised to all suitable patients with coronary heart disease.

Topics: Aged; Cardiology Service, Hospital; Cardiovascular Agents; Coronary Angiography; Coronary Disease; Female; Follow-Up Studies; Germany; Humans; Inpatients; Logistic Models; Male; Middle Aged; Myocardial Infarction; Myocardial Revascularization; Odds Ratio; Patient Readmission; Prospective Studies; Risk Assessment; Risk Factors; Secondary Prevention; Time Factors; Treatment Outcome

This study assessed the ability of the SYNTAX score (SXscore) to stratify risk in patients treated with percutaneous coronary intervention (PCI) using zotarolimus-eluting or everolimus-eluting stents.. The SXscore can identify patients treated with PCI who are at highest risk of adverse events.. The SXscore was calculated prospectively in 2,033 of the 2,292 patients enrolled in the RESOLUTE All Comers study (RESOLUTE III All Comers Trial: A Randomized Comparison of a Zotarolimus-Eluting Stent With an Everolimus-Eluting Stent for Percutaneous Coronary Intervention). Clinical outcomes in terms of a patient-oriented composite endpoint (POCE) of all-cause death, myocardial infarction (MI), and repeat revascularization; the individual components of POCE; target lesion failure (TLF) (a composite of cardiac death, target-vessel MI, and clinically driven target lesion revascularization); and stent thrombosis were subsequently stratified according to SXscore tertiles: SXscore(LOW) ≤ 9 (n = 698), 9 17 (n = 659).. At 12-month follow-up, rates of POCE, MI, repeat revascularization, TLF, and the composite of death/MI were all significantly higher in patients in the highest SXscore tercile. Rates of stent thrombosis were all highest in the SXscore(HIGH) tertile (p > 0.05). After multivariate adjustment, the SXscore was identified as an independent predictor of POCE, MI, repeat revascularization, and TLF (p < 0.05 for all). At 12-month follow-up, the SXscore, ACEF score, and Clinical SXscore had C-statistics of 0.57, 0.78, and 0.67, respectively, for mortality and of 0.62, 0.56, 0.63, respectively, for POCE. No significant between-stent differences were observed for TLF or POCE in any of the SXscore tertiles.. The SYNTAX score is able to stratify risk amongst an all-comers population treated with PCI with second-generation drug-eluting stents (DES); however, improvements can be made with the inclusion of clinical variables. (RESOLUTE III All Comers Trial: A Randomized Comparison of a Zotarolimus-Eluting Stent With an Everolimus-Eluting Stent for Percutaneous Coronary Intervention; NCT00617084).

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Artery Disease; Coronary Restenosis; Drug-Eluting Stents; Europe; Everolimus; Female; Health Status Indicators; Humans; Israel; Kaplan-Meier Estimate; Linear Models; Male; Middle Aged; Myocardial Infarction; Predictive Value of Tests; Proportional Hazards Models; Prospective Studies; Prosthesis Design; Risk Assessment; Risk Factors; Sirolimus; Survival Rate; Time Factors; Treatment Outcome

The objective of the study was to assess noninferiority of the polymer-free sirolimus-eluting Yukon Choice stent (Translumina GmbH, Hechingen, Germany) compared with the polymer-based Taxus Liberté stent (Boston Scientific, Natick, Massachusetts) with regard to the primary endpoint, in-stent late lumen loss, at 9 months in patients with diabetes mellitus.. The Yukon Choice stent has been evaluated in several randomized controlled trials before, albeit to date, there has been no trial that exclusively enrolled patients with diabetes mellitus.. Patients with diabetes mellitus undergoing percutaneous coronary intervention for clinically significant de novo coronary artery stenosis were randomized 1:1 to receive either the polymer-free sirolimus-eluting Yukon Choice stent or the polymer-based paclitaxel-eluting Taxus Liberté stent.. A total of 240 patients were randomized. Quantitative coronary angiography was available for 79% of patients. Mean in-stent late lumen loss was 0.63 ± 0.62 mm for the Yukon Choice stent and 0.45 ± 0.60 mm for the Taxus Liberté stent. Based on the pre-specified margin, the Yukon Choice stent failed to show noninferiority for the primary endpoint. During follow-up, there were no significant differences between groups regarding death, myocardial infarction, stent thrombosis, target lesion revascularization, target vessel revascularization, or nontarget vessel revascularization.. Compared with the Taxus Liberté stent, the polymer-free sirolimus-eluting Yukon Choice stent failed to show noninferiority with regard to the primary endpoint, in-stent late lumen loss, in patients with diabetes mellitus after 9-month follow-up. Both stents showed comparable clinical efficacy and safety. (Yukon Choice Versus Taxus Liberté in Diabetes Mellitus; NCT00368953).

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Chi-Square Distribution; Coronary Angiography; Coronary Restenosis; Coronary Stenosis; Diabetes Mellitus; Drug-Eluting Stents; Female; Germany; Humans; Male; Middle Aged; Myocardial Infarction; Paclitaxel; Polymers; Prospective Studies; Prosthesis Design; Risk Assessment; Risk Factors; Sirolimus; Thrombosis; Time Factors; Treatment Outcome

The aim of this study was to compare the 5-year outcomes of patients with multivessel disease (MVD) involving the proximal left anterior descending (LAD) artery who were treated with sirolimus drug-eluting stents (SES), bare metal stents (BMS) and coronary artery bypass surgery (CABG).. Clinical outcomes were compared between the 682 patients enrolled in the ARTS-I and ARTS-II study who had MVD involving the proximal LAD, and were treated with BMS (27.4%), CABG (30.2%), and SES (42.4%). At 5-year follow-up the primary endpoint of major adverse cardiovascular and cerebrovascular events (MACCE) occurred in 33.7%, 18.0% and 24.9% of patients treated with BMS, CABG and SES, respectively (BMS vs. SES p=0.04, CABG vs. SES p=0.07). Unadjusted and adjusted rates of mortality and death/stroke/myocardial infarction (safety) were comparable between all three treatments. Repeat revascularisation was significantly lower following CABG irrespective of adjustment. The absolute difference in MACCE between patients with a logistic EuroSCORE above and below the mean (i.e., 2.09%) was 18.8% (p=0.001), and 1.9% (p=0.28) for CABG and SES, respectively. In patients with a high EuroSCORE, SES was a significantly safer treatment (p=0.04) whilst repeat revascularisation remained lower with CABG irrespective of the EuroSCORE.. At 5-year follow-up CABG has comparable safety, and superior efficacy in terms of reducing repeat revascularisation compared to BMS and SES in the treatment of patients with MVD involving the proximal LAD however, appropriate patient selection remains imperative.

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Chi-Square Distribution; Coronary Angiography; Coronary Artery Bypass; Coronary Artery Disease; Drug-Eluting Stents; Female; Humans; Kaplan-Meier Estimate; Logistic Models; Male; Metals; Middle Aged; Myocardial Infarction; Netherlands; Patient Selection; Proportional Hazards Models; Prosthesis Design; Registries; Risk Assessment; Risk Factors; Sirolimus; Stents; Stroke; Thrombosis; Time Factors; Treatment Outcome

In the prospective randomized TRIAS pilot study, the bio-engineered Genous™ endothelial progenitor cell capturing stent was compared with the Taxus Liberté™ SR paclitaxel-eluting stent. At 1 yr, a statistically nonsignificant difference in the rates of target vessel failure (cardiac death, myocardial infarction, or target vessel revascularization) was observed. We have evaluated the safety and efficacy up to 2 yr.. A total of 193 patients with de novo coronary artery lesions carrying a high risk of restenosis were randomized to a Genous stent versus a Taxus stent. Dual antiplatelet therapy was prescribed for ≥1 month after Genous stent implantation and for ≥6 months after a Taxus stent.. Between 1 and 2 yr, patients treated with the Genous stent tended to have fewer episodes of target lesion revascularization (2.0% versus 5.3%), but nearly similar rates of cardiac death (1.0% versus 0%), myocardial infarction (0% versus 1.1%), and stent thrombosis (0% versus 1.1%) when compared with the Taxus stent. As a result, at 2-yr follow-up treatment with the Genous stent compared with the Taxus stent resulted in a nonsignificant difference in target vessel failure (TVR) (20.4% versus 15.8%; risk difference 4.6%, 95% CI -6.2-15.5%). No stent thrombosis was observed in the Genous group compared to five cases (in four patients) in the Taxus group, resulting in a difference as compared with the Taxus stent (risk difference -4.2%; 95%CI -8.2% to -0.2%).. In the TRIAS pilot study, treatment of coronary artery lesions carrying a high risk of restenosis with the Genous compared with the Taxus stent resulted in a nonsignificant difference of TVR at 2-yr follow-up, with convergence of the Kaplan-Meier curves between 1 and 2 yr. Stent thrombosis was only observed after Taxus stent implantation.

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Artery Disease; Coronary Restenosis; Drug Therapy, Combination; Drug-Eluting Stents; Endothelial Cells; Female; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Myocardial Infarction; Netherlands; Paclitaxel; Pilot Projects; Platelet Aggregation Inhibitors; Prospective Studies; Prosthesis Design; Risk Assessment; Risk Factors; Single-Blind Method; Stem Cells; Stents; Thrombosis; Time Factors; Treatment Outcome

These studies sought to evaluate the clinical outcomes of the slow-release Taxus paclitaxel-eluting stent (PES) versus an otherwise identical bare-metal stent (BMS).. Prior studies were not individually powered to generate reliable estimates of low-frequency safety endpoints or to characterize the long-term safety and efficacy profile of PES.. The completed 5-year databases from the prospective, randomized, double-blind TAXUS I, II, IV, and V trials were pooled for a patient-level analysis.. The study population comprised 2,797 randomized patients (1,400 PES and 1,397 BMS). At the end of the 5-year study period, PES compared with BMS significantly reduced the rate of ischemia-driven target lesion revascularization (12.3% vs. 21.0%, p < 0.0001), with consistent reductions across high-risk subgroups and in patients with and without routine angiographic follow-up. There were no significant differences between the stent types in the 1-year or cumulative 5-year rates of death or myocardial infarction (MI). However, cardiac death or MI between 1 and 5 years was increased with PES (6.7% vs. 4.5%, p = 0.01), as was stent thrombosis (protocol definition: 0.9% vs. 0.2%, p = 0.007; ARC definition: 1.4% vs. 0.9%, p = 0.18).. In this pooled patient-level analysis from the prospective, randomized, double-blind TAXUS trials, PES compared with BMS resulted in a durable 47% reduction in the 5-year rate of ischemia-driven target lesion revascularization in simple and complex lesions, with nonsignificant differences in the cumulative 5-year rates of death or MI. Between 1 and 5 years, however, the rates of cardiac death or MI and protocol-defined stent thrombosis were increased with PES.

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Chi-Square Distribution; Coronary Angiography; Coronary Artery Disease; Coronary Restenosis; Double-Blind Method; Drug-Eluting Stents; Europe; Female; Humans; Kaplan-Meier Estimate; Male; Metals; Middle Aged; Myocardial Infarction; Odds Ratio; Paclitaxel; Proportional Hazards Models; Prospective Studies; Prosthesis Design; Risk Assessment; Risk Factors; Severity of Illness Index; Stents; Thrombosis; Time Factors; Treatment Outcome; United States

This study sought to compare late safety and efficacy outcomes following percutaneous coronary revascularization with zotarolimus-eluting stents (ZES) and sirolimus-eluting stents (SES).. Despite higher late lumen loss and binary restenosis with ZES compared with SES, it is uncertain whether differences in early angiographic measures translate into more disparate late clinical events.. Clinical outcomes were prospectively evaluated through 5 years in the ENDEAVOR III (A Randomized Controlled Trial of the Medtronic Endeavor Drug [ABT-578] Eluting Coronary Stent System Versus the Cypher Sirolimus-Eluting Coronary Stent System in De Novo Native Coronary Artery Lesions) that randomized 436 patients of relatively low anatomic and clinical risk to treatment with ZES (n = 323) or SES (n = 113) and evaluated a primary endpoint of 8-month angiographic late lumen loss.. At 5 years (completeness of follow-up: 95.2%), pre-specified endpoints of all-cause mortality (5.2% vs. 13.0%, p = 0.02), myocardial infarction (1.0% vs. 4.6%, p = 0.03), and the composite event rates of cardiac death/myocardial infarction (1.3% vs. 6.5%, p = 0.009) and major adverse cardiac events (14.0% vs. 22.2%, p = 0.05) were significantly lower among patients treated with ZES. Rates of target lesion (8.1% ZES vs. 6.5% SES, p = 0.68) and target vessel revascularization were similar between treatment groups. Stent thrombosis was infrequent and similar in both groups (0.7% ZES vs. 0.9% SES, p = 1.0). Between 9 months and 5 years, progression of major adverse cardiac events was significantly more common with SES than with ZES (16.7% vs. 7.8%, p = 0.015).. Despite initially higher angiographic late lumen loss, rates of clinical restenosis beyond the protocol-specified angiographic follow-up period remain stable with ZES compared with the rates for SES, resulting in similar late-term efficacy. Over 5 years, significant differences in death, myocardial infarction, and composite endpoints favored treatment with ZES. (The Medtronic Endeavor III Drug Eluting Coronary Stent System Clinical Trial [ENDEAVOR III]; NCT00217256).

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Angiography; Coronary Artery Disease; Coronary Restenosis; Drug-Eluting Stents; Female; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Myocardial Infarction; Prospective Studies; Prosthesis Design; Risk Assessment; Risk Factors; Sirolimus; Thrombosis; Time Factors; Treatment Outcome

This study sought to investigate safety and efficacy of biolimus-eluting stents (BES) with biodegradable polymer as compared with sirolimus-eluting stents (SES) with durable polymer through 2 years of follow-up.. BES with a biodegradable polymer provide similar efficacy and safety as SES with a durable polymer at 9 months. Clinical outcomes beyond the period of biodegradation of the polymer used for drug release and after discontinuation of dual antiplatelet therapy are of particular interest.. A total of 1,707 patients were randomized to unrestricted use of BES (n = 857) or SES (n = 850) in an all-comers patient population.. At 2 years, BES remained noninferior compared with SES for the primary endpoint, which was a composite of cardiac death, myocardial infarction, or clinically indicated target vessel revascularization (BES 12.8% vs. SES 15.2%, hazard ratio [HR]: 0.84, 95% confidence interval [CI]: 0.65 to 1.08, p(noninferiority) < 0.0001, p(superiority) = 0.18). Rates of cardiac death (3.2% vs. 3.9%, HR: 0.81, 95% CI: 0.49 to 1.35, p = 0.42), myocardial infarction (6.3% vs. 5.6%, HR: 1.12, 95% CI: 0.76 to 1.65, p = 0.56), and clinically indicated target vessel revascularization (7.5% vs. 8.6%, HR: 0.86, 95% CI: 0.62 to 1.20, p = 0.38) were similar for BES and SES. The rate of definite stent thrombosis through 2 years was 2.2% for BES and 2.5% for SES (p = 0.73). For the period between 1 and 2 years, event rates for definite stent thrombosis were 0.2% for BES and 0.5% for SES (p = 0.42). After discontinuation of dual antiplatelet therapy, no very late definite stent thrombosis occurred in the BES group.. At 2 years of follow-up, the unrestricted use of BES with a biodegradable polymer maintained a similar safety and efficacy profile as SES with a durable polymer. (Limus Eluted From a Durable Versus Erodable Stent Coating [LEADERS]; NCT00389220).

Topics: Absorbable Implants; Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Chi-Square Distribution; Coronary Angiography; Coronary Artery Disease; Drug Therapy, Combination; Drug-Eluting Stents; Europe; Female; Follow-Up Studies; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Myocardial Infarction; Platelet Aggregation Inhibitors; Proportional Hazards Models; Prosthesis Design; Risk Assessment; Risk Factors; Sirolimus; Survival Rate; Thrombosis; Time Factors; Treatment Outcome

Despite the association of obesity with incident cardiovascular disease, obese patients with acute coronary syndrome (ACS) appear to have more favourable short-term outcomes. A study was undertaken to determine whether this 'obesity paradox' persists in the long term and to examine the specific relationship of central obesity with outcomes after ACS.. The relationship was investigated between two measures of obesity-body mass index (BMI) and waist circumference (WC)-and 30-day and 1-year outcomes after ACS. 6560 patients with non-ST elevation ACS in the MERLIN-TIMI 36 trial were followed for 1 year. Patients were stratified into three BMI groups (<25, 25-30, ≥30 kg/m2) and gender-specific tertiles of WC. The primary endpoint was cardiovascular death, myocardial infarction or recurrent ischaemia.. Patients with BMI ≥30 kg/m2 had a significantly lower risk of the primary endpoint than those with BMI <25 kg/m(2) (HR 0.64; 95% CI 0.51 to 0.81, p<0.0001) at 30 days. However, after the 30-day acute phase, landmark analysis from 30 days to 1 year showed no difference in risk between BMI groups (HR 1.09; 95% CI 0.92 to 1.29, p=0.34). WC tertiles demonstrated a similar relationship. When BMI groups were stratified by WC there was a trend towards more adverse outcomes in higher WC groups among those in lower BMI groups. The group with the lowest BMI and highest WC had the highest risk (HR 2.8; 95% CI 0.93 to 8.3; p=0.067).. Obesity is associated with more favourable short-term outcomes after ACS. However, in the longer term the obesity paradox is no longer present and may reverse. Those with WC out of proportion to BMI suggestive of significant central adiposity may be at highest risk following ACS.

Topics: Acute Coronary Syndrome; Aged; Anthropometry; Body Mass Index; Cardiovascular Agents; Female; Follow-Up Studies; Humans; Male; Middle Aged; Myocardial Infarction; Myocardial Revascularization; Obesity, Abdominal; Prognosis; Recurrence; Treatment Outcome; Waist Circumference

The aim was to study the effectiveness of prescription medication containing 90% omega-3 polyunsaturated fatty acids for 6 months on ventricular arrhythmias in patients with myocardial infarction less than a year ago. The study involved 56 patients with ventricular extrasystoles, from 500 to 1000 per day. Divided into two groups of patients we divided into I group - 30 people - received in addition to standard drug therapy of omega-3 PUFA 1 g daily, for 6 months; II group - 26 men were given only previously assigned therapies. The average age of patients in group I - 60,7+/-8,6, II group - 61+/-9,7 years (p> 0,05). ECG monitoring was performed at 3 and 6 months. Administration of highly concentration preparation of omega-3 PUFAs for 3 months reduced number of PVCs per day, frequencies of grades 2, 3, 4A, 4B, and high grade PVCs (grades 3 - 5) as a whole. These effects persisted after 6 months of treatment.

Topics: Aged; Cardiovascular Agents; Drug Monitoring; Drug Therapy, Combination; Electrocardiography; Fatty Acids, Omega-3; Female; Heart Rate; Humans; Male; Middle Aged; Myocardial Infarction; Severity of Illness Index; Time; Time Factors; Treatment Outcome; Ventricular Premature Complexes

The current study reports clinical outcomes at three year follow-up of the LEADERS clinical trial which was the first all-comers trial comparing a new generation biodegradable polymer biolimus drug-eluting stent (BES) with the first generation permanent polymer sirolimus-eluting stent (SES).. One thousand seven hundred and seven patients were randomised to unrestricted use of BES (n=857) or SES (n=850) in an all-comers population. Three year follow-up was available in 95% of the patients, 812 treated with BES and 809 treated with SES. At three years, BES remains non-inferior to SES for the primary endpoint of major adverse cardiac events (composite of cardiac death, myocardial infarction (MI), or clinically-indicated target vessel revascularisation (CI-TVR) (BES 15.7% versus SES 19%; HR 0.82 CI 0.65-1.03; p=0.09). The MACE Kaplan Meier event curves increasingly diverge with the difference in events increasing from 1.4% to 2.4% and 3.3% at 1, 2 and 3 years, respectively in favour of BES. The rate of cardiac death was non-significantly lower 4.2% versus 5.2% (HR=0.81 CI 0.52-1.26; p=0.34) and the rate of myocardial infarction was equivalent 7.2% versus 7.1% (HR 1.01 CI 0.70-1.44; p=0.97) for BES versus SES, respectively. Thus BES was non-inferior to SES in all the safety endpoints. Clinically-indicated TVR occurred in 9.4% of BES treated patients versus 11.1% of SES treated patients (HR 0.84 CI 0.62-1.13; p=0.25). Rates of definite stent thrombosis were 2.2% for BES and 2.9% for SES (HR 0.78 CI 0.43-1.43; p=0.43), with the event rate increase of 0.2% from one to three years for BES and 0.9% for SES. For patients presenting with ST-elevation myocardial infarction BES was superior to SES in reducing MACE.. The findings of the three year follow-up support the claim that the biodegradable polymer biolimus-eluting stent has equivalent safety and efficacy to permanent polymer sirolimus-eluting stent in an all-comers patient population. Its performance is superior in some subpopulations such as in ST-elevation MI patients and event rates for BES are overall lower than for SES with a trend toward increasing divergence of outcomes over three years.

Topics: Absorbable Implants; Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Chi-Square Distribution; Coronary Artery Disease; Drug Therapy, Combination; Drug-Eluting Stents; Europe; Female; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Myocardial Infarction; Platelet Aggregation Inhibitors; Polymers; Proportional Hazards Models; Prosthesis Design; Risk Assessment; Risk Factors; Sirolimus; Thrombosis; Time Factors; Treatment Outcome

Drug-eluting balloons (DEB) have recently emerged as a valuable treatment option for patients with coronary in-stent restenosis (ISR). However, little information exists on results of DEB therapy of in-stent restenosis from drug-eluting stents (DES).. The Pantera Lux balloon catheter, a novel DEB releasing paclitaxel with a BTHC matrix was studied in a prospective, multicentre first-in-man trial of patients with ISR either from bare metal stents (BMS) or drug-eluting stents (DES). Here we report on the clinical and angiographic follow-up of the first 45 Pantera Lux patients after six months. The mean age (± SD) of the studied ISR patients was 69 ± 9 years (82% males, 18% females). The distribution of BMS and DES in these patients was 53% and 47%, respectively. Success of deployment of the device was 100%. After six months, the major adverse cardiac event (MACE) rate was 7.7% including one post-procedural non-fatal myocardial infarction, one target lesion- and one target vessel- revascularisation (each clinically driven). Angiographic in-stent late lumen loss was 0.03 ± 0.35 mm (BMS: -0.08 ± 0.37 mm, DES: 0.15 ± 0.28 mm) as assessed by an independent angiographic core laboratory.. Treatment of coronary in-stent restenosis with the Pantera Lux paclitaxel-releasing balloon catheter shows very promising preliminary 6-month results, irrespective of whether the initially implanted stent was a bare metal- or a drug-eluting stent.

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coated Materials, Biocompatible; Coronary Angiography; Coronary Restenosis; Drug Delivery Systems; Drug-Eluting Stents; Equipment Design; Female; Germany; Humans; Male; Metals; Middle Aged; Myocardial Infarction; Paclitaxel; Predictive Value of Tests; Prospective Studies; Prosthesis Design; Stents; Time Factors; Treatment Outcome

After the excellent results of the PACCOCATH ISR and PEPCAD II trials in in-stent restenosis, paclitaxel-coated balloon (PCB) still has to prove its efficacy in native coronary disease.. In the PICCOLETO randomised trial, patients with stable or unstable angina undergoing PCI of small coronary vessels (≤ 2.75 mm) were randomised to the Dior PCB (28 patients) or the Taxus DES (29 patients). The primary study endpoint was percent diameter stenosis at 6-month angiographic follow-up (non-inferiority); secondary endpoints were angiographic binary restenosis and major adverse cardiac events (MACE: death, Q-wave myocardial infarction, TLR) at 9-month follow-up (non-inferiority). The two groups were not dissimilar for clinical and angiographic data. The study was interrupted after enrolment of two-thirds of the patients due to a clear superiority of one study group. The primary endpoint was not met: the PCB group had higher percent diameter stenosis (43.6% vs. 24.3%, p=0.029), angiographic restenosis (32.1 vs. 10.3%, p=0.043), and higher occurrence of MACE (35.7% vs. 13.8%, p=0.054).. Dior PCB failed to show equivalence to Taxus DES regarding angiographic endpoints during PCI of small coronary arteries. We hypothesise that it concerned the lack of efficacy of the device used (which has since been replaced by its second generation) rather than a class-effect in native coronary vessels.

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coated Materials, Biocompatible; Coronary Angiography; Coronary Artery Disease; Coronary Restenosis; Drug Delivery Systems; Drug-Eluting Stents; Equipment Design; Female; Humans; Male; Middle Aged; Myocardial Infarction; Paclitaxel; Prosthesis Design; Time Factors; Treatment Outcome

The extent to which recurrent events in patients with stable coronary artery disease is attributable to progression of an index lesion originally ≥50% diameter stenosis (DS) but not revascularized or originally <50% DS is unknown during optimal medical therapy (OMT).. In the COURAGE (Clinical Outcomes Utilizing Revascularization and Aggressive Drug Evaluation) trial, 205 patients assigned to OMT plus percutaneous coronary intervention (PCI) and 284 patients assigned to OMT only had symptom-driven angiograms suitable for analysis. Percentages of patients in the OMT+PCI and OMT-only cohorts with index lesions originally <50% DS were 30% and 32%, respectively; 20% and 68% had index lesions originally ≥50% DS. In both groups, index lesions originally <50% or ≥50% DS represented <4% and <25% of all such lesions, respectively. The only angiographic predictor of myocardial infarction or acute coronary syndrome was the number of lesions originally ≥50% DS that had not been revascularized (odds ratio, 1.15; confidence limits, 1.01-1.31; P<0.04).. Lesions originally <50% DS were index lesions in one third of patients referred for symptom-driven repeat angiography, but represented <4% of all such lesions. Nonrevascularized lesions originally ≥50% DS were more often index lesions in OMT-only patients, but still represented a minority (<25%) of all such lesions. These findings underscore the need for improved therapies to arrest plaque progression and reliable strategies for selecting stenoses warranting PCI.

Topics: Acute Coronary Syndrome; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Angiography; Coronary Artery Disease; Disease Progression; Female; Follow-Up Studies; Humans; Male; Middle Aged; Myocardial Infarction; Prognosis; Retrospective Studies; Risk Factors

Perhexiline improves functional capacity in heart failure, but the mechanisms are undefined. We sought its effects on myocardial deformation in patients with viable myocardium.. Thirty-six medically-treated patients, stable at least 6 months post-infarction with LV dysfunction and myocardial viability shown by dobutamine echo (DbE) were randomised to receive perhexiline or matching placebo for 1 year. Cardiopulmonary exercise testing and DbE were performed at baseline and follow-up. Peak-systolic strain (S) and strain rate (SR) were measured offline in 111 dysfunctional segments in the placebo and 88 in the treatment group at rest, low-dose (LDD) and peak-dose dobutamine (PDD).. The serum perhexiline level was 0.27+/-0.7 microg/l. There was no difference in the wall motion response to dobutamine at baseline and follow-up. Resting strain and SR were similar in the two groups at baseline and follow-up. However, SR at LDD and PDD increased in the placebo group and worsened during the same period in the perhexiline group. Patients on perhexiline and placebo had a similar rate-pressure product and exercise duration at baseline (7.9+/-2.7 vs 8.7+/-3.3 min, p=NS) and follow-up (9.6+/-4.6 vs 10.1+/-3.03 min, p=NS).. Perhexiline does not improve the deformation of abnormal myocardial segments in patients with ischaemic LV dysfunction.

Topics: Aged; Cardiotonic Agents; Cardiovascular Agents; Dobutamine; Echocardiography; Exercise Test; Female; Follow-Up Studies; Humans; Male; Middle Aged; Myocardial Infarction; Myocardial Ischemia; Perhexiline; Placebos; Treatment Failure; Ventricular Dysfunction, Left; Ventricular Function, Left

This study evaluates the safety and efficacy of the XIENCE V 4.0 mm stent for the treatment of de novo native coronary artery lesions.. In the SPIRIT III trial, the XIENCE V everolimus-eluting stent (EES), compared with the TAXUS EXPRESS(2) paclitaxel-eluting stent (PES) in 2.5-3.75 mm diameter coronary arteries, resulted in reduced angiographic late loss (LL), noninferior rates of target vessel failure (TVF), and fewer major adverse cardiac events (MACE).. The SPIRIT III 4.0 mm registry was a concurrent arm of the SPIRIT III trial consisting of 69 nonrandomized patients with lesions

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Angiography; Coronary Stenosis; Drug-Eluting Stents; Everolimus; Female; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Myocardial Infarction; Paclitaxel; Predictive Value of Tests; Prospective Studies; Registries; Risk Assessment; Single-Blind Method; Sirolimus; Thrombosis; Time Factors; Treatment Outcome; United States

The purpose of the study was to understand determinants of infarct size in a primary percutaneous intervention (PCI) population treated with pexelizumab compared with placebo.. In the multicenter APEX-AMI (Pexelizumab in Conjunction With Angioplasty in Acute Myocardial Infarction) trial, pexelizumab did not reduce 90-day mortality. Cardiac magnetic resonance (CMR) with delayed enhancement was used in a substudy evaluating infarct size and left ventricular ejection fraction (LVEF).. Consecutive patients undergoing primary PCI for first myocardial infarction (MI) as part of the APEX-AMI trial were enrolled in this substudy at 5 centers. The CMR was completed on days 3 to 5 (n=99) and day 90 (n=83) following PCI. Central core lab-masked analyses for quantified LVEF, volumes, and infarct size by planimetry were performed.. Patients were 60+/-12 years of age, male (n=83 [84%]), had similar time from symptom onset to presentation (median 2.6 h vs. 2.5 h; p=1.0), and similar baseline ST-segment deviation (13.5 mm vs. 14 mm; p=0.59) in both groups. Pexelizumab-treated patients had smaller infarct size (day 3 LV 10.5% vs. 16.2%, p=0.022; day 90 LV 5.9% vs. 12.4%, p=0.015) and higher LVEF (day 3 50.3% vs. 46.2%, p=0.073; day 90 53.9% vs. 49.3%, p=0.036) compared with placebo-treated patients. The median peak creatine kinase in the pexelizumab group was also significantly less than placebo (922 mg/dl vs. 1,973 mg/dl; p=0.03). Notably, the pexelizumab group had lower Thrombolysis In Myocardial Infarction (TIMI) flow grade pre-PCI (46.9% vs. 75.0%; p=0.018), a difference not seen in the overall APEX-AMI study. A multivariate model including baseline features and pexelizumab treatment found anterior MI location and pre-PCI TIMI flow to be significant independent predictors infarct size (p=0.001), whereas pexelizumab was not (p=0.29). No death, heart failure, or shock was noted in either substudy group at 90 days.. In a CMR substudy of pexelizumab in MI, baseline TIMI flow grade and anterior location were the only predictors of infarct size, with a reduction of pre-PCI TIMI flow grade 0 by 28%, leading to a 35% reduction in infarct size. (The APEX-AMI Trial; NCT00091637).

Topics: Aged; Angioplasty, Balloon, Coronary; Antibodies, Monoclonal; Antibodies, Monoclonal, Humanized; Australia; Cardiovascular Agents; Chi-Square Distribution; Coronary Circulation; Europe; Female; Humans; Linear Models; Magnetic Resonance Imaging, Cine; Male; Middle Aged; Myocardial Infarction; Myocardium; North America; Predictive Value of Tests; Risk Assessment; Risk Factors; Single-Chain Antibodies; Stroke Volume; Time Factors; Treatment Outcome; Ventricular Function, Left

This study was designed to investigate the effect of low-dose nesiritide on renal function and major cardiac events in patients with acute decompensated heart failure following acute myocardial infarction. Sixty patients were randomized into nesiritide (loading dose 0.5 microg/kg, maintenance dose 0.0075 microg/kg/min) and nitroprusside groups. Compared with the nitroprusside group, the nesiritide group had a greater heart rate reduction (P < 0.05), higher 24 h urine volume (P < 0.001), and more significant alleviation in dyspnea (P < 0.001). The prevalence of hypotension in the nesiritide group was lower than in the nitroprusside group (7.4% vs 28.5%, P < 0.05). The nesiritide group had a greater reduction in serum noradrenaline, angiotensin II, aldosterone, endothelin, and N-terminal prohormone brain natriuretic peptide (all P < 0.01). The mean serum creatinine in the nesiritide group was reduced (109.4 +/- 26.6 vs 102.8 +/- 21.6 micromol/l, P < 0.01), whereas it remained unchanged in the nitroprusside group (106.8 +/- 20 vs 106.0 +/- 19.2 micromol/l, P > 0.05). The rehospitalization or mortality rate was similar between the two groups 3 months after the therapy (P > 0.05). We conclude that low-dose nesiritide is more effective in suppressing the activation of the sympathetic and renin-angiotensin systems. It also improves the clinical symptoms and enhances renal function, but its effect on hospital readmission or mortality rate needs further investigation.

Topics: Aged; Biomarkers; Cardiovascular Agents; Chi-Square Distribution; Creatinine; Female; Heart Failure; Hemodynamics; Humans; Kidney; Kidney Diseases; Male; Middle Aged; Myocardial Infarction; Natriuretic Peptide, Brain; Nitroprusside; Patient Readmission; Peptide Fragments; Stroke Volume; Time Factors; Treatment Outcome; Ventricular Function, Left

The JACTAX HD trial ("JACTAX" Trial Drug Eluting Stent Trial) evaluated the safety and clinical performance of a novel JACTAX HD (Boston Scientific Corporation, Natick, Massachusetts) paclitaxel-eluting stent (PES) in de novo coronary lesions.. The JACTAX HD (Boston Scientific) stent consists of a pre-crimped bare-metal Liberté (Boston Scientific) stent coated on its abluminal aspect with an ultrathin (<1 microm) 1/1 mixture of biodegradable polylactide polymer and paclitaxel applied as discrete microdots (nominal totals of 9.2 microg each of polymer and paclitaxel per 16-mm stent).. In this prospective, single-arm, multicenter, first-human-use study (n = 103), the primary end point of 9-month major adverse cardiac events (MACE) (cardiac death, myocardial infarction, ischemia-related target vessel revascularization) was compared with an objective performance criterion (OPC) of 17% (11% MACE based on TAXUS ATLAS [TAXUS Liberté-SR Stent for the Treatment of de Novo Coronary Artery Lesions] trial results plus a pre-specified noninferiority margin of 6%).. The composite primary end point occurred in 7.8% of JACTAX HD patients with an upper 1-sided 95% confidence limit of 13.6%, thus meeting the pre-specified criteria for noninferiority. There was no death, Q-wave myocardial infarction, or stent thrombosis through 9 months. In-stent late loss was 0.33 +/- 0.45 mm, with an in-stent binary restenosis of 5.2% and net volume obstruction by intravascular ultrasound of 11.4 +/- 11.2%.. The JACTAX HD stent with an abluminal biodegradable polymer showed 9-month MACE, in-stent late loss, restenosis, and net volume obstruction comparable to that observed with the TAXUS Liberté (Boston Scientific) stent coated with a conformal durable polymer. Further studies are underway to better evaluate the potential of this new PES design, which might allow for more rapid endothelialization and improved vessel healing. ("JACTAX" Trial Drug Eluting Stent Trial; NCT00754728).

Topics: Absorbable Implants; Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coated Materials, Biocompatible; Coronary Angiography; Coronary Artery Disease; Coronary Restenosis; Drug-Eluting Stents; England; Female; Germany; Humans; Male; Middle Aged; Myocardial Infarction; Paclitaxel; Polymers; Prospective Studies; Prosthesis Design; Thrombosis; Time Factors; Treatment Outcome; Ultrasonography, Interventional

To evaluate whether an everolimus-eluting stent (EES) with thinner stent struts and polymer results in less periprocedural myonecrosis and adverse outcomes.. Higher periprocedural myocardial infarction (MI) rates have been reported with the TAXUS® EXPRESS(2) paclitaxel-eluting stent (PES) compared to the bare metal EXPRESS(2)® stent due to more frequent side branch compromise, presumably attributable to the thickness of the stent/polymer on the PES.. In the SPIRIT III trial, we identified 113 patients in the XIENCE V® EES group and 63 patients in the TAXUS EXPRESS(2) PES group who met the criteria of having a lesion with a jailed side branch (<2 mm diameter, and <50% stenosis). Two-year clinical outcomes were evaluated.. A periprocedural increase in Creatine Kinase-MB >1× upper normal level occurred in 9.0% of EES compared to 29.7% of PES patients with jailed side branches, P = 0.01. Through 2 years, major adverse cardiac events (MACE; cardiac death, MI, or target lesion revascularization [TLR]) occurred in 6.8% of EES and 19.0% of PES jailed side branch patients (P = 0.03), with numerically lower rates of MI (2.9% vs. 10.3%, P = 0.07) and TLR (3.9% vs. 10.3%, P = 0.17) in the EES group, with comparable rates of cardiac death (1.9% vs. 1.7%, P = 1.00).. In this post-hoc analysis of the SPIRIT III RCT, patients undergoing stenting of target lesions with jailed side branches with the thin strut and polymer XIENCE V EES compared to the thicker strut TAXUS PES had lower rates of MACE through 2 years due to fewer MIs and TLRs. © 2010 Wiley-Liss, Inc.

Topics: Aged; Angioplasty, Balloon, Coronary; Biomarkers; Cardiovascular Agents; Coronary Angiography; Coronary Artery Disease; Creatine Kinase, MB Form; Drug-Eluting Stents; Everolimus; Female; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Myocardial Infarction; Myocardium; Necrosis; Paclitaxel; Prospective Studies; Prosthesis Design; Risk Assessment; Risk Factors; Severity of Illness Index; Single-Blind Method; Sirolimus; Time Factors; Treatment Outcome; United States

This study evaluates cardiovascular risk factors associated with progression of coronary artery disease (CAD) in patients with silent ischemia following myocardial infarction.. Coronary artery disease only progresses slowly with comprehensive risk factor intervention.. A total of 104 of 201 patients (51.7%) of the Swiss Interventional Study on Silent Ischemia Type II (SWISSI II) with baseline and follow-up coronary angiography were included. All patients received comprehensive cardiovascular risk factor intervention according to study protocol. Logistic regression was used to evaluate associations between baseline cardiovascular risk factors and CAD progression.. The mean duration of follow-up was 10.3+/-2.4 years. At baseline, 77.9% of patients were smokers, 45.2% had hypertension, 73.1% had dyslipidemia, 7.7% had diabetes, and 48.1% had a family history of CAD. At last follow-up, only 27 patients of the initial 81 smokers still smoked, only 2.1% of the patients had uncontrolled hypertension, 10.6% of the patients had uncontrolled dyslipidemia, and 2.1% of the patients had uncontrolled diabetes. Coronary artery disease progression was found in up to 81 (77.9%) patients. Baseline diabetes and younger age were associated with increased odds of CAD progression. The time interval between baseline and follow-up angiography was also associated with CAD progression.. Coronary artery disease progression was highly prevalent in these patients despite comprehensive risk factor intervention. Further research is needed to optimize treatment of known risk factors and to identify other unknown and potentially modifiable risk factors.

Topics: Adult; Aged; Angioplasty, Balloon, Coronary; Antihypertensive Agents; Cardiovascular Agents; Chi-Square Distribution; Coronary Angiography; Coronary Stenosis; Disease Progression; Female; Humans; Hypoglycemic Agents; Hypolipidemic Agents; Logistic Models; Male; Middle Aged; Myocardial Infarction; Myocardial Ischemia; Odds Ratio; Risk Assessment; Risk Factors; Severity of Illness Index; Smoking Cessation; Switzerland; Time Factors

Drug-eluting stents have shown to be superior over bare metal stents in clinical and angiographic outcomes after percutaneous treatment of coronary artery stenosis. However, long-term follow-up data are scarce and only available for sirolimus- and paclitaxel-eluting stents.. To assess the feasibility and performance of the XIENCE V everolimus-eluting stent (EES) versus an identical bare metal stent after a 5-year follow-up period.. SPIRIT FIRST was a First in Man, multicentre, prospective, single-blind, clinical trial, randomizing 60 patients with a single de novo coronary artery lesion in a ratio of 1:1 to either an everolimus eluting or a bare metal control stent.. At 5-year clinical follow-up, data were available in 89% and 86% of patients in the everolimus and control arm, respectively. In the everolimus arm, no additional death, myocardial infarction, clinically driven target lesion revascularization (TLR), or clinically driven target vessel revascularization (TVR) events were observed between 1- and 5-year follow-up. The 5-year hierarchical major adverse cardiac events (MACE) and target vessel failure (TVF) rates for the everolimus arm were 16.7% (4/24) for both endpoints. In the control group, no additional cardiac death, myocardial infarction, or clinically driven TLR events were observed between 2- and 5-year follow-up. No additional clinically driven TVR events were observed between 3- and 5-year follow-up. The 5-year hierarchical MACE and TVF rates for the control arm were 28.0% (7/25) and 36.0% (9/25), respectively. No stent thromboses were observed in either the everolimus arm or the control arm up to 5 years.. The favorable 5-year long term clinical outcome of the EES is consistent with the results from other studies of the EES with shorter follow-up.

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Angiography; Coronary Restenosis; Coronary Stenosis; Drug-Eluting Stents; Europe; Everolimus; Female; Follow-Up Studies; Humans; Kaplan-Meier Estimate; Male; Metals; Middle Aged; Myocardial Infarction; Prospective Studies; Prosthesis Design; Risk Assessment; Severity of Illness Index; Single-Blind Method; Sirolimus; Stents; Thrombosis; Time Factors; Treatment Outcome; Ultrasonography, Interventional

To determine whether the efficacy of FX06 was dependent upon the timing of reperfusion therapy or the presence of collaterals in the Efficacy of FX06 in the prevention of myocardial reperfusion injury (F.I.R.E.) trial.. Two hundred and thirty-four (234) patients presenting with acute ST-segment elevation myocardial infarction were randomised to FX06 or matching placebo given as an intravenous bolus at reperfusion. Infarct size was assessed at 5-7 days and four months after myocardial infarction by cardiac magnetic resonance imaging determined total late enhancement and necrotic core zone. Patients were stratified according to presentation status (time-to-therapy <3 hours, n=108; time-to-therapy=3-6 hours, n=115) and presence of collaterals (yes, 46; no, 177). There were no statistically significant differences between groups at day 5-7. At four months, we observed statistically significant reductions of both measures of infarct size (0.3% vs. 2.4%, p=0.038; 8.0% vs. 16.0%, p=0.032) in the group given FX06 and presenting early. There was also a statistically significant reduction of total late enhancement zone among patients given FX06 with collaterals (7.3% vs. 15.2%, p=0.043). No differences were evident among late presenters or those without collaterals.. FX06 significantly reduced infarct size at four months in the early presenters and in those with collaterals.

Topics: Aged; Angioplasty, Balloon, Coronary; Biomarkers; Cardiovascular Agents; Collateral Circulation; Coronary Circulation; Double-Blind Method; Drug Administration Schedule; Female; Fibrin Fibrinogen Degradation Products; Humans; Injections, Intravenous; Magnetic Resonance Imaging; Male; Middle Aged; Myocardial Infarction; Myocardial Reperfusion Injury; Myocardium; Peptide Fragments; Stroke Volume; Time Factors; Treatment Outcome; Troponin I; Ventricular Function, Left

This first human use (FHU) study in bifurcation lesions evaluated safety and feasibility of the TAXUS Petal paclitaxel-eluting dedicated bifurcation stent.. This prospective, single-arm, multicentre study had a composite primary endpoint of 30-day death, myocardial infarction (MI), and target vessel revascularisation (TVR). Angiographic and intravascular ultrasound follow-up was at six months with clinical follow-up through five years. Mean age (N=28) was 60.9 + or - 9.3 years and 17.9% of patients had medically treated diabetes. Main branch (MB) lesion length was 13.8 + or - 5.9 mm with 4.4 + or - 2.5 mm in the side branch (SB). TAXUS Petal was successfully implanted in 89.3% of patients (25/28). On a per device basis, 73.5% (25/34) of Petal deployments were successful. The primary endpoint occurred in one patient (3.7%, in-hospital non-Q-wave MI). Through one year, TVR was 11.1%, target lesion revascularisation was 7.4%, and there were no deaths, Q-wave MIs, or stent thromboses. In-segment late loss (n=21) was 0.47 + or - 0.45 mm (proximal MB), 0.41 + or - 0.57 mm (distal MB), and 0.18 + or - 0.39 mm (SB).. The requirement for rotational alignment made delivery of this first generation TAXUS Petal stent challenging and accounted for the relatively low device delivery success. Clinical and angiographic outcomes were satisfactory when successful delivery was achieved.

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Angiography; Coronary Artery Disease; Drug-Eluting Stents; Europe; Feasibility Studies; Female; Humans; Male; Middle Aged; Myocardial Infarction; New Zealand; Paclitaxel; Prospective Studies; Prosthesis Design; Time Factors; Treatment Outcome; Ultrasonography, Interventional

The optimal stenting strategy in true coronary artery bifurcation lesions has not been determined. In this study, a strategy of always stenting both the main vessel and the side branch (MV plus SB) was compared with a strategy of stenting the MV only with optional stenting of the SB. Stents used were sirolimus-eluting stents and paclitaxel-eluting stents.. A total of 108 patients with true coronary bifurcation lesions were randomly assigned to either routine stenting with drug-eluting stents (DES) in both the branches (group MV plus SB) or provisional stenting with DES placement in the main branch and DES placement in the SB only if MV stenting alone provided inadequate results (group MV). The primary end points were major adverse cardiac events (MACE) at 8 months, including myocardial infarction, cardiac death, and stent thrombosis or target vessel revascularization by either percutaneous coronary intervention or coronary artery bypass grafting.. Angiographic follow-up revealed 28.91+/-20.43% stenosis of the SB after provisional stenting and 18.93+/-15.34% (P<0.01) after routine stenting. The corresponding binary restenosis rates were 35.2 and 14.8% (P=0.015). SB stents were implanted in 16.7% of patients in the provisional stenting group and 94.4% of patients in the routine stenting group. In the main branch, binary restenosis rates prebifurcation were 11.1% after provisional and 7.4% after routine stenting (P=0.51), whereas binary restenosis rates postbifurcation were 14.8 and 9.3% (P=0.38), respectively. The overall 8-month incidence of target lesion reintervention was 31.5% after provisional and 7.4% after routine stenting (P<0.01), and cumulative MACE were 38.9 and 11.1% (P<0.01), respectively.. Routine stenting significantly improved the MACE outcome of percutaneous coronary intervention in true coronary bifurcation and bifurcation angle of 60 or less lesions as compared with provisional stenting.

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Chi-Square Distribution; China; Coronary Angiography; Coronary Artery Disease; Coronary Restenosis; Drug-Eluting Stents; Female; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Myocardial Infarction; Paclitaxel; Prosthesis Design; Risk Assessment; Risk Factors; Sirolimus; Thrombosis; Time Factors; Treatment Outcome

Using optical coherence tomography, we assessed the proportion of uncovered struts at 6-month follow-up in zotarolimus-eluting stents (ZES), specifically Endeavor (Medtronic CardioVascular, Santa Rosa, California) stents, and identical bare-metal stents (BMS) implanted in patients with ST-segment elevation myocardial infarction (STEMI).. Sirolimus- and paclitaxel-eluting stents implanted in STEMI have been associated with delayed healing and incomplete strut coverage. ZES are associated with a more complete and uniform strut coverage in stable patients, but whether this holds true also after STEMI is unknown.. Forty-four patients with STEMI who underwent primary PCI were randomized to ZES or BMS (3:1 randomization). Angiographic, intravascular ultrasound, and optical coherence tomography follow-up was conducted at 6 months and clinical follow-up at 1 year. All images were analyzed by an independent core laboratory that was blind to stent assignments.. There were no differences between ZES and BMS in percentage of uncovered struts (median: 0.00% [interquartile range (IQR): 0.00% to 1.78%] vs. 1.98% [IQR: 0.21% to 7.33%], p = 0.13), maximum length of uncovered segments (0.00 [IQR: 0.00 to 1.19] mm vs. 1.38 [IQR: 0.65 to 3.30] mm, p = 0.10), percentage of malapposed struts (0.00% [IQR: 0.00% to 0.23%] vs. 0.15% [IQR: 0.00% to 5.81%], p = 0.16), and maximum length of malapposed segments (0.00 [IQR: 0.00 to 0.67] mm vs. 0.33 [IQR: 0.00 to 2.55] mm, p = 0.20). Neointimal response was similar between ZES and BMS (332 [IQR: 240 to 429] microm vs. 186 [IQR: 136 to 348] microm, p = 0.99) and evenly distributed. No late acquired malapposition was observed in both groups. There were no deaths, myocardial infarction, or stent thromboses at 1 year.. This optical coherence tomography study found no difference in strut coverage and similar vessel response to ZES, when compared with identical BMS, implanted during primary percutaneous coronary intervention in STEMI patients. (Six-Month Coverage and Vessel Wall Response of the Zotarolimus Drug-Eluting Stent Implanted in AMI Assessed by Optical Coherence Tomography [OCTAMI]; NCT00704561).

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Angiography; Coronary Vessels; Drug-Eluting Stents; Female; Humans; Male; Metals; Middle Aged; Myocardial Infarction; Predictive Value of Tests; Prospective Studies; Prosthesis Design; Sirolimus; Stents; Time Factors; Tomography, Optical Coherence; Treatment Outcome; Ultrasonography, Interventional

Three-year follow-up of major adverse cardiovascular event (MACE) (death, nonfatal myocardial infarction, target lesion revascularization) and the predictors of MACEs in diabetic patients after sirolimus-eluting stent (SES) or paclitaxel-eluting stent (PES) implantation have not been reported.. Diabetic patients with de novo coronary lesions (169 patients with 190 lesions) were randomly assigned prospectively to either SES or PES.. Baseline characteristics were similar between the two groups. The rates of MACEs [5.9% (n = 5) in the SES vs. 9.5% (n = 8) in the PES Group, P = 0.374] and definite stent thrombosis [1.2% (n = 1) in the SES vs. 3.6% (n = 3) in the PES Group, P = 0.368] were similar in the two groups during the three-year follow-up. Multivariate logistic analysis showed that insulin treatment was the only independent predictor of MACE [odds ratio (OR) 8.60, 95% confidence interval (CI) 3.25-22.76, P < 0.001] and target vessel revascularization (TVR) (OR 9.50, 95% CI 3.07-29.44, P < 0.001) during the three-year follow-up.. The rates of MACEs, TVR, and stent thrombosis during the three-year follow-up were similar in the SES and PES Groups. Insulin treatment was a main predictor of MACEs and TVR during the three-year follow-up after either SES or PES implantation.

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Chi-Square Distribution; Coronary Angiography; Coronary Stenosis; Diabetes Complications; Drug-Eluting Stents; Female; Humans; Hypoglycemic Agents; Insulin; Kaplan-Meier Estimate; Logistic Models; Male; Middle Aged; Myocardial Infarction; Odds Ratio; Paclitaxel; Prospective Studies; Prosthesis Design; Republic of Korea; Risk Assessment; Risk Factors; Severity of Illness Index; Sirolimus; Thrombosis; Time Factors; Treatment Outcome

Erythropoietin (EPO) enhances re-endothelialization and anti-apoptotic action. Larger clinical studies to examine the effects of high-dose EPO are in progress in patients with acute myocardial infarction (AMI).. The aim of this multi-center pilot study was to investigate the effect of `low-dose EPO' (6,000 IU during percutaneous coronary intervention (PCI), 24 h and 48 h) in 35 patients with a first ST-elevated AMI undergoing PCI who was randomly assigned to EPO or placebo (saline) treatment. Neointimal volume, cardiac function and infarct size were examined in the acute phase and 6 months later (ClinicalTrials.gov identifier: NCT00423020). No significant regression in in-stent neointimal volume was observed, whereas left ventricular (LV) ejection fraction was significantly improved (49.2% to 55.7%, P=0.003) and LV end-systolic volume was decreased in the EPO group (47.7 ml to 39.0 ml, P=0.036). LV end-diastolic volume tended to be reduced from 90.2% to 84.5% (P=0.159), whereas in the control group it was inversely increased (91.7% to 93.7%, P=0.385). Infarction sizes were significantly reduced by 38.5% (P=0.003) but not in the control group (23.7%, P=0.051). Hemoglobin, peak creatine kinase values, and CD34(+)/CD133(+)/CD45(dim) endothelial progenitors showed no significant changes. No adverse events were observed during study periods.. This is a first study demonstrating that short-term `low-dose' EPO to PCI-treated AMI patients did not prevent neointimal hyperplasia but rather improved cardiac function and infarct size without any clinical adverse effects.

Topics: Aged; Angioplasty, Balloon, Coronary; Biomarkers; Cardiovascular Agents; Chi-Square Distribution; Coronary Angiography; Coronary Restenosis; Creatine Kinase; Endothelial Cells; Erythropoietin; Female; Hemoglobins; Humans; Hyperplasia; Japan; Male; Middle Aged; Myocardial Infarction; Myocardium; Pilot Projects; Placebo Effect; Prospective Studies; Recombinant Proteins; Stem Cells; Stroke Volume; Time Factors; Treatment Outcome; Ultrasonography, Interventional; Ventricular Function, Left; Ventricular Remodeling

In the setting of primary percutaneous coronary intervention, patients with a chronic total occlusion in a non-infarct related artery were recently identified as a high-risk subgroup. It is unclear whether ST-elevation myocardial infarction patients with a chronic total occlusion in a non-infarct related artery should undergo additional percutaneous coronary intervention of the chronic total occlusion on top of optimal medical therapy shortly after primary percutaneous coronary intervention. Possible beneficial effects include reduction in adverse left ventricular remodeling and preservation of global left ventricular function and improved clinical outcome during future coronary events.. The Evaluating Xience V and left ventricular function in Percutaneous coronary intervention on occLusiOns afteR ST-Elevation myocardial infarction (EXPLORE) trial is a randomized, prospective, multicenter, two-arm trial with blinded evaluation of endpoints. Three hundred patients after primary percutaneous coronary intervention for ST-elevation myocardial infarction with a chronic total occlusion in a non-infarct related artery are randomized to either elective percutaneous coronary intervention of the chronic total occlusion within seven days or standard medical treatment. When assigned to the invasive arm, an everolimus-eluting coronary stent is used. Primary endpoints are left ventricular ejection fraction and left ventricular end-diastolic volume assessed by cardiac Magnetic Resonance Imaging at four months. Clinical follow-up will continue until five years.. The ongoing EXPLORE trial is the first randomized clinical trial powered to investigate whether recanalization of a chronic total occlusion in a non-infarct related artery after primary percutaneous coronary intervention for ST-elevation myocardial infarction results in a better preserved residual left ventricular ejection fraction, reduced end-diastolic volume and enhanced clinical outcome.. trialregister.nl NTR1108.

Topics: Angioplasty, Balloon, Coronary; Cardiovascular Agents; Chronic Disease; Clinical Protocols; Coronary Occlusion; Drug-Eluting Stents; Europe; Everolimus; Humans; Magnetic Resonance Imaging; Myocardial Contraction; Myocardial Infarction; Ontario; Prospective Studies; Prosthesis Design; Recovery of Function; Research Design; Sirolimus; Stroke Volume; Time Factors; Treatment Outcome; Ventricular Function, Left

The increased frequency of very late (>1 year) stent thrombosis (VLST) has raised concerns with regard to the safety of sirolimus-eluting stents and paclitaxel-eluting stents (PES).. Experimental and preliminary clinical findings with the zotarolimus-eluting stent (ZES) have suggested a favorable safety profile.. The ENDEAVOR IV (Randomized Comparison of Zotarolimus- and Paclitaxel-Eluting Stents in Patients With Coronary Artery Disease) trial is a single-blind randomized ZES versus PES clinical trial in 1,548 patients with de novo native coronary lesions; the primary end point-9-month target vessel failure-was previously reported, annual clinical follow-up is planned for 5 years, and this report describes the 3-year outcomes.. The ZES compared with PES reduced target vessel failure (12.3% vs. 15.9%, hazard ratio [HR]: 0.76, 95% confidence interval [CI]: 0.58 to 1.00, p = 0.049), myocardial infarctions (MI) (2.1% vs. 4.9%, HR: 0.44, 95% CI: 0.25 to 0.80, p = 0.005), and cardiac death plus MI (3.6% vs. 7.1%, HR: 0.52, 95% CI 0.32 to 0.82, p = 0.004). Although the overall 3-year rate of Academic Research Consortium definite/probable stent thrombosis did not differ significantly (1.1% vs. 1.7%, HR: 0.67, 95% CI 0.28 to 1.64, p = 0.380), VLST (between 1 and 3 years) was significantly reduced in ZES patients (1 event vs. 11 events; 0.1% vs. 1.6%, HR: 0.09, 95% CI: 0.01 to 0.71, p = 0.004). Ischemia-driven target lesion revascularization at 3 years was similar with ZES versus PES (6.5% vs. 6.1%, HR: 1.10, 95% CI: 0.73 to 1.65, p = 0.662).. Three-year follow-up results from the ENDEAVOR IV trial indicate similar antirestenosis efficacy but improved clinical safety associated with ZES compared with PES, due to significantly fewer peri-procedural and remote MIs associated with fewer VLST events. (A Randomized, Controlled Trial of the Medtronic Endeavor Drug [ABT-578] Eluting Coronary Stent System Versus the Taxus Paclitaxel-Eluting Coronary Stent System in De Novo Native Coronary Artery Lesions; NCT00217269).

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Restenosis; Coronary Stenosis; Drug-Eluting Stents; Female; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Myocardial Infarction; Paclitaxel; Platelet Aggregation Inhibitors; Proportional Hazards Models; Prospective Studies; Prosthesis Design; Risk Assessment; Risk Factors; Single-Blind Method; Sirolimus; Thrombosis; Time Factors; Treatment Outcome; United States

The rates of side branch occlusion and subsequent periprocedural MI during everolimus-eluting stent (EES) and paclitaxel-eluting stent (PES) placement were examined in the randomised SPIRIT III trial. Periprocedural myocardial infarction (MI) following drug-eluting stent placement is associated with long-term adverse outcomes. Occlusion of side branches may be an important factor contributing to periprocedural MIs. Consecutive procedural angiograms of patients randomly assigned to EES (n=669) or PES (n=333) were analysed by an independent angiographic core laboratory. Side branch occlusion was defined as Thrombolysis In Myocardial Infarction (TIMI) flow grade 0 or 1. Clinical outcomes through three years were compared by stent type and presence of side branch occlusion.. A total of 2,048 side branches were evaluated (EES N=1,345 side branches in 688 stented lesions, PES N=703 side branches in 346 stented lesions). Patients with compared to those without transient or final side branch occlusion had significantly higher non-Q-wave MI (NQMI) rates in-hospital (9.0% vs. 0.5%, p<0.0001). By multivariable analysis side branch occlusion was an independent predictor of NQMI (OR 4.45; 95% CI [1.82, 10.85]). Transient or final side branch occlusion occurred less frequently in patients receiving EES compared to PES (2.8% vs. 5.2%, p=0.009), contributing to the numerically lower rates of in-hospital NQMI with EES arm compared to PES (0.7% vs. 2.3%, p=0.05). Patients treated with EES rather than PES were less likely to develop side branch occlusion during stent placement, contributing to lower rates of periprocedural MI with EES compared to PES.

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Angiography; Coronary Artery Disease; Coronary Restenosis; Drug-Eluting Stents; Everolimus; Female; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Myocardial Infarction; Paclitaxel; Prospective Studies; Prosthesis Design; Risk Assessment; Risk Factors; Single-Blind Method; Sirolimus; Time Factors; Treatment Outcome; United States

Our goal is to report the first large multicenter data for percutaneous coronary intervention (PCI) of bifurcation disease with drug-eluting stents (DES) in the United States.. Bifurcation PCI remains a challenge to this date. There are limited data on outcomes of patients treated with bifurcation DES implantation, particularly in the United States.. There were 161 patients with bifurcation disease [side branch (SB) >or=2-mm] treated with >or=1 sirolimus-eluting stents at 41 centers participating in the Stent deployment Techniques on cLinicaL outcomes of patients treated with the cypheRstent (STLLR) trial. There was no protocol mandated strategy for bifurcation PCI. One-year outcome data were collected. Angiographic and clinical data were adjudicated independently.. There were 147 patients (91.3%) treated with single stent strategy. Only 14 (8.7%) patients received sirolimus-eluting stents implantation in both branches. Among patients with single stent strategy, double wire strategy (DW) was selected in 27 (18.4%) patients whereas single wire strategy (SW) was selected in 120 (81.6%) patients. There were 48 (32.7%) Medina 1,1,1 bifurcations treated with SW (n = 34; 70.8%) and DW (n = 14; 29.2%). There were 26 procedures started with SW which had SB dilatation during the procedure, one as a bailout (TIMI-1 grade flow in the SB). Overall 1-year death, myocardial infarction, and target lesion revascularization occurred in 2.4, 4.0, and 5.6%, respectively. There was no significant difference in clinical outcomes between SW and DW. SB dilatation was associated with a high rate of stent thrombosis (8.6%).. Main branch stenting without SB protection is the most common approach utilized in the STLLR study, which may reflect contemporary DES bifurcation strategies in the Unite States. This strategy was associated with an acceptable low incidence of adverse outcomes at 1-year.

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Angiography; Coronary Artery Disease; Drug-Eluting Stents; Female; Humans; Male; Middle Aged; Myocardial Infarction; Prospective Studies; Prosthesis Design; Risk Assessment; Sirolimus; Thrombosis; Time Factors; Treatment Outcome; United States

Stent length is a major predictor of restenosis in stable patients undergoing percutaneous coronary intervention (PCI) with bare metal stents (BMS). The effect of stent length is decreased by using drug eluting stents, however, this association had not been previously determined in patients with acute myocardial infarction (AMI). We sought to determine the impact of stent length on restenosis in patients who undergo primary PCI for AMI.. Three-hundred and fifty-seven and 355 patients with AMI were included respectively in the BMS and SES (sirolimus eluting stents) arms of the Trial to Assess the Use of the Cypher Stent in Acute Myocardial Infarction Treated with Balloon Angioplasty (TYPHOON). Patients were divided into four subgroups based on the total length of the culprit lesion stented segment (in mm) : <18, >or=18 and <23, >or=23 and < 28, and >or=28 (groups 1 - 4 respectively). Target lesion revascularisation (TLR) and angiographic late loss were used to assess the restenotic process. Despite similar lesion length, average stent length was longer in patients treated with SES as compared to BMS 22.1+/-8.6 and 20.3+/-8.2 mm respectively, p=0.005. The rate of 12m death and AMI was similar in SES and BMS. There was no significance influence of stent length on % TLR neither in BMS (12.6, 10.1, 17.4 and 12.3 - subgroups 1-4 respectively) nor in SES (3.9, 5, 2.2 and 2.7 respectively). There was also no significant impact of stent length on angiographic late loss (mm) neither in BMS (0.7, 0.87, 0.84 and 0.92 respectively) nor in SES (0.32, 0.0, 0.11 and 0.3 respectively).. Physicians tend to choose longer SES than BMS for a similar lesion length during primary PCI for AMI. Interestingly, stent length did not affect clinical or angiographic restenosis neither in BMS nor in SES in this group of patients who underwent primary PCI for acute MI. This data challenges current practice concerning the chosen stent length in patients with AMI.

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Angiography; Coronary Restenosis; Coronary Stenosis; Drug-Eluting Stents; Europe; Female; Humans; Israel; Male; Metals; Middle Aged; Myocardial Infarction; Prosthesis Design; Risk Assessment; Risk Factors; Severity of Illness Index; Single-Blind Method; Sirolimus; Stents; Time Factors; Treatment Outcome

The aim of this multicentre, non-randomised trial was to evaluate the safety and efficacy at 180+/-14 days of a pimecrolimus eluting coronary stent based on a cobalt-chromium platform and a poly-L-lactic acid (PLLA) bioresorbable polymer.. Sixty-one patients, with single de novo coronary lesions <14 mm in length and a reference vessel diameter of 3.0 to 3.5 mm, were enrolled in five centres (Germany and Belgium). Angiography and IVUS were performed at baseline, post-procedure and 180+/-14 days later. The primary endpoint was a composite of major adverse cardiac events (MACE) at 180+/-14 days and expected to be below 20%. Patients had single vessel disease in 59%, 2-vessel disease in 28% and 3-vessel disease in 13% of cases. MACE rate at 180+/-14 days was 18.0%. Binary in-stent restenosis was 32.7% due to in-stent late lumen loss of 1.11+/-0.65 mm by QCA. Stent thrombosis rate at 30+/-7 and 180+/-14 days was 1.6% and 3.3%, respectively. Overall TLR rate at 30+/-7, 180+/-14 days and 12+/-1 months was 1.6%, 27.9% and 32.8% respectively.. The primary endpoint was met at 180+/-14 days. However, the anti-restenotic effect of the pimecrolimus eluting stent did not reach levels similar to clinically established DES.

Topics: Aged; Angioplasty, Balloon, Coronary; Belgium; Cardiovascular Agents; Chromium Alloys; Coronary Angiography; Coronary Restenosis; Coronary Stenosis; Drug-Eluting Stents; Female; Germany; Humans; Lactic Acid; Male; Middle Aged; Myocardial Infarction; Polyesters; Polymers; Prospective Studies; Prosthesis Design; Severity of Illness Index; Tacrolimus; Thrombosis; Time Factors; Treatment Outcome; Ultrasonography, Interventional

We evaluated the role of gender on clinical and angiographic results of the everolimus-eluting stent in the SPIRIT III trial.. The SPIRIT III trial demonstrated superior efficacy of the XIENCE V everolimus-eluting stent compared with the TAXUS paclitaxel-eluting stent. Whether these results are applicable to women is unknown.. A total of 1,002 patients with coronary artery lesions of 28 mm or less long in 2.5-3.75 mm diameter vessels were prospectively randomized to receive percutaneous coronary intervention with either XIENCE V stent or TAXUS stent placement. Post hoc gender subset analysis was performed.. A total of 669 patients (200 women) received the XIENCE V stent, and 332 patients (114 women) were assigned to the TAXUS stent. Women were older and had more hypertension and diabetes than men. At 1 year, rates of MACE (11.1% vs. 5.7%, P = 0.004), TVF (13.7% vs. 7.5%, P = 0.003), TVR (10.8% vs. 4.6%, P = 0.0007), and TLR (7.2% vs. 2.7%, P = 0.002) were higher in women compared with men. The difference in 1 year MACE and TVF rates between men and women remained after adjusting for baseline covariates. Although the angiographic characteristics at baseline were similar among the female cohort, women assigned to XIENCE V had lower in-stent late loss (0.19 vs. 0.42 mm, P = 0.01) compared with women treated with the TAXUS stent. Although 30-day clinical outcomes were similar for women treated with XIENCE V and TAXUS stents, at 1 year, women with XIENCE V stents had significantly lower MACE (8.2% vs. 16.1 %, P = 0.04) and TVR (3.1% vs. 8.9%, P = 0.03) compared with those treated with TAXUS stents. Stent thrombosis rates were similar between women receiving either XIENCE V or TAXUS stents.. Women in the SPIRIT III trial had inherently higher MACE and TVF rates than men. However, the angiographic and clinical benefits of using XIENCE V stents are generalizable to women.

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Cardiovascular Diseases; Coronary Angiography; Coronary Artery Disease; Coronary Restenosis; Drug-Eluting Stents; Everolimus; Female; Humans; Kaplan-Meier Estimate; Linear Models; Logistic Models; Male; Middle Aged; Myocardial Infarction; Paclitaxel; Prospective Studies; Prosthesis Design; Risk Assessment; Risk Factors; Sex Factors; Single-Blind Method; Sirolimus; Thrombosis; Time Factors; Treatment Outcome; Women's Health

The evaluation of drug-eluting devices in humans should include longterm follow-up owing to risk of late target vessel thrombosis with the possible fatal sequel.. Therefore, the three-year clinical outcome of the paclitaxel-eluting Corofiex Please stent in patients with de-novo coronary lesions was evaluated in the single-arm PECOPS I pilot study. The clinical data of 123/125 (98.4%) of all patients included were available 3.05 +/- 0.12 years following stent deployment. In the intention-to-treat analysis the incidence of cardiac death was 9/123 (7.3%), of myocardial infarction 4/123 (3.3%), and of in-segment target lesion revascularization 14/123 (11.4%). Target lesion revascularizations tended (p = 0.30) to occur less frequently (9/96 (16.6%)) in those patients in whom the stent length was longer than the lesion (4.80 +/- 2.71 mm) compared to 5/27 (18.5%) in those patients in whom the stent was shorter than the lesion (-3.0 +/- 2.43 mm). Stent thromboses occurred in 2/123 (1.6%) patients during the first 6 months, one of which two days after premature discontinuation of clopidogrel. The total 3-year MACE rate was 22/123 (17.9%).. The present study describes the paclitaxel-eluting Corotlex Please stent as a safe device with good long term performance when deployed in native coronary arteries. The occurrence of late major adverse events and late thromboses in particular seem to be very low.

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Angiography; Coronary Stenosis; Disease-Free Survival; Drug-Eluting Stents; Female; Follow-Up Studies; Germany; Humans; Male; Middle Aged; Myocardial Infarction; Paclitaxel; Pilot Projects; Platelet Aggregation Inhibitors; Prospective Studies; Prosthesis Design; Risk Assessment; Severity of Illness Index; Thrombosis; Time Factors; Treatment Outcome

We sought to compare patient-oriented outcomes related to target vessel or nontarget vessel events for sirolimus-eluting stents (SES) versus bare-metal stents.. SES significantly reduce restenosis but the influence of reduced restenosis on overall patient-oriented outcome has not been reported.. The study population included 1,057 patients randomized in the SIRIUS (Sirolimus-Eluting Stent in De Novo Native Coronary Lesions) study and followed clinically for 5 years. The primary end point was a composite of all-cause mortality, any myocardial infarction, or any repeat revascularization. In secondary analyses, myocardial infarction and repeat revascularization events attributed to the target vessel or a nontarget vessel were compared by stent type.. Patients with an SES were more likely to be free from the primary composite end point at 5 years (60.4% vs. 47.8%, p < 0.001) chiefly due to a sustained reduction in target lesion revascularization for SES (cumulative incidence: 12.5% vs. 28.8%, p < 0.001). There was no difference in the cumulative incidence of myocardial infarction or revascularization attributed to remote segments of the target vessel. Events attributed to the nontarget vessel were frequent and not different for SES versus bare-metal stents (25.7% vs. 25.8%).. The benefit of SES over bare-metal stents for reduced target lesion revascularization is maintained for 5 years. Remote coronary segments of the target vessel and nontarget vessel remain an important cause of future adverse events despite sustained restenosis benefit.

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Artery Disease; Coronary Restenosis; Disease Progression; Double-Blind Method; Drug-Eluting Stents; Female; Humans; Kaplan-Meier Estimate; Male; Metals; Middle Aged; Myocardial Infarction; Platelet Aggregation Inhibitors; Proportional Hazards Models; Prosthesis Design; Risk Assessment; Risk Factors; Sirolimus; Stents; Time Factors; Treatment Outcome

We evaluated the relative contributions of drug-eluting stent-specific and background natural history-driven causes for adverse clinical events between 1 and 5 years, in the paclitaxel-eluting stent (PES) and bare-metal stent (BMS) cohorts of the TAXUS randomized clinical trial program.. Prior studies have demonstrated that clinical events in the first year after BMS are predominantly stent-related but thereafter tend to be driven more by atherosclerotic activity outside the stented segment. It is not known whether the same is true for PES.. Annualized hazard rates (HRs) were calculated for major adverse events in 1,400 TAXUS and 1,397 BMS patients from the randomized and blinded TAXUS I, II, IV, and V trials (median 4.8-year follow-up).. Although target vessel revascularization (TVR) during the first year was driven by target lesion revascularization (TLR), TVR after 1 year involved similar numbers of TLR and non-TLR events. Moreover, the annualized HR for non-target lesion TVR and other major adverse events (including death, myocardial infarction, and stent thrombosis) were relatively constant beyond 1 year and not significantly different between PES and BMS.. The low and similar late HR for many of the observed late events after BMS and PES suggests that many of the late events after PES reflect background disease activity outside the stented segment rather than stent-related events per se. Analyses of long-term drug-eluting stent outcomes should recognize and attempt to correct for this background event rate by using suitable BMS control subjects.

Topics: Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Artery Disease; Coronary Restenosis; Disease Progression; Double-Blind Method; Drug-Eluting Stents; Humans; Metals; Myocardial Infarction; Paclitaxel; Platelet Aggregation Inhibitors; Proportional Hazards Models; Prosthesis Design; Risk Assessment; Risk Factors; Stents; Thrombosis; Time Factors; Treatment Outcome

The aim of this study was to evaluate the benefits of sirolimus-eluting stents (SES) and paclitaxel-eluting stents (PES) as compared with bare-metal stents (BMS) in patients undergoing primary angioplasty.. Recent concerns have emerged on the potential higher risk of stent thrombosis after drug-eluting stent implantation, especially among ST-segment elevation myocardial infarction (STEMI) patients.. We randomly assigned STEMI patients admitted within 12 h of symptom onset undergoing primary angioplasty and stent implantation to BMS, PES, or SES. The primary study end point was target lesion revascularization at 1-year follow-up. All patients were reviewed at our outpatient clinic or by telephone interview at 6, 12, and 24 months.. From October 2003 to December 2005, 270 STEMI patients undergoing primary angioplasty were randomized to BMS (n = 90), PES (n = 90), or SES (n = 90). No patient was lost to follow-up. As compared with BMS (14.4%), both PES (4.4%, p = 0.023) and SES (3.3%, p = 0.016) were associated with a significant reduction in target lesion revascularization at 1-year follow-up. At 2-year follow-up no difference was observed in terms of death, reinfarction, and combined death and/or reinfarction, but as compared with BMS, both PES and SES were associated with significant benefits in major adverse cardiac events (PES: 16.7%, p = 0.015; SES: 15.6%, p = 0.009, respectively).. This study shows that among STEMI patients undergoing primary angioplasty, both SES and PES are safe and associated with significant benefits in terms of target lesion revascularization up to the 2-year follow-up. Thus, until the results of further large randomized trials with long-term follow-up become available, drug-eluting stents may be considered for STEMI patients undergoing primary angioplasty. (PaclitAxel or Sirolimus-Eluting Stent versus Bare Metal Stent in Primary Angioplasty [PASEO] Randomized Trial; NCT00759850).

Topics: Adult; Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Angiography; Drug-Eluting Stents; Female; Humans; Kaplan-Meier Estimate; Male; Metals; Middle Aged; Myocardial Infarction; Paclitaxel; Patient Selection; Platelet Aggregation Inhibitors; Prospective Studies; Prosthesis Design; Recurrence; Risk Assessment; Sirolimus; Stents; Thrombosis; Time Factors; Treatment Outcome

We report 2-year outcomes in a large unselected drug-eluting stent population (N=7,492) in the TAXUS Express2 ARRIVE post-market surveillance programme (101 U.S. sites).. No specific inclusion/exclusion criteria were mandated; patients enrolled at procedure initiation. Two-year follow-up was 94%, with independent adjudication of major cardiac events, monitoring of patients with cardiac events and an additional 10-20% sample by site. Most ARRIVE cases (64%, n=4,794) typified expanded use based on patient/lesion characteristics outside the simple use (single vessel/stent) pivotal trial populations. These expanded use patients had higher 2-year rates than simple use patients for mortality (7.8% vs. 4.2%, P<0.001), myocardial infarction (MI, 3.9% vs. 2.2%, P<0.001), target lesion revascularisation (TLR, 9.2% vs. 5.4%, P<0.001), and stent thrombosis (3.3% vs. 1.4%, P<0.001). Among subgroups with renal disease, chronic total occlusion (CTO), lesion >28 mm, reference vessel diameter (RVD) <2.5 mm, multivessel stenting, acute MI, bifurcation, vein graft, or in-stent restenosis, TLR ranged from 3.8% to 8.9% in year one, and from 1.3% to 6.0% during year two.. Mortality and stent-related events were higher in expanded use than simple use patients in the pivotal trials. ARRIVE provides a detailed estimate of procedural and 2-year outcomes in such real-world patients.

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Artery Disease; Coronary Restenosis; Coronary Thrombosis; Drug-Eluting Stents; Female; Heart Diseases; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Myocardial Infarction; Paclitaxel; Product Surveillance, Postmarketing; Proportional Hazards Models; Prosthesis Design; Registries; Risk Assessment; Time Factors; Treatment Outcome; United States

We tested two novel drug-eluting stents (DES), covered with a biodegradable-polymer carrier and releasing paclitaxel or sirolimus, which were compared against a bare metal stent (primary objective). The DES differed by the drug, but were identical otherwise, allowing to compare the anti-restenosis effects of sirolimus versus paclitaxel (secondary objective).. The efficacy of novel DES with biodegradable polymers should be tested in the context of randomized trials, even when using drugs known to be effective, such as sirolimus and paclitaxel.. Overall, 274 patients with de novo coronary lesions in native vessels scheduled for stent implantation were randomly assigned (2:2:1 ratio) for the paclitaxel (n = 111), sirolimus (n = 106), or bare metal stent (n = 57) groups. Angiographic follow-up was obtained at 9 months and major cardiac adverse events up to 12 months.. Both paclitaxel and sirolimus stents reduced the 9-month in-stent late loss (0.54-0.44 mm, 0.32-0.43 mm, vs. 0.90-0.45 mm respectively), and 1-year risk of target vessel revascularization and combined major adverse cardiac events (P < 0.05 for both, in all comparisons), compared with controls. Sirolimus stents had lower late loss than paclitaxel stents (P < 0.01), but similar 1-year clinical outcomes. There were no differences in the risk of death, infarction, or stent thrombosis among the study groups.. Both novel DES were effective in reducing neointimal hyperplasia and 1-year re-intervention, compared to bare metal stents. Our findings also suggest that sirolimus is more effective than paclitaxel in reducing angiographic neointima, although this effect was not associated with better clinical outcomes.

Topics: Aged; Angioplasty, Balloon, Coronary; Brazil; Cardiovascular Agents; Cardiovascular Diseases; Coated Materials, Biocompatible; Coronary Angiography; Coronary Restenosis; Coronary Stenosis; Drug-Eluting Stents; Female; Humans; Hyperplasia; Kaplan-Meier Estimate; Male; Metals; Middle Aged; Myocardial Infarction; Paclitaxel; Proportional Hazards Models; Prosthesis Design; Risk Assessment; Sirolimus; Stents; Thrombosis; Time Factors; Treatment Outcome

The Occluded Artery Trial (OAT) was a 2,201-patient randomized clinical trial comparing routine stent-based percutaneous coronary intervention (PCI) versus optimal medical therapy alone in stable myocardial infarction (MI) survivors with persistent infarct-related artery occlusion identified day 3 to 28 post MI. Intent-to-treat analysis showed no difference between strategies with respect to the incidence of new class IV congestive heart failure, MI, or death. The influence of PCI failure, procedural hazard, and crossover on trial results has not been reported.. Study angiograms were analyzed and adjudicated centrally. Factors associated with PCI failure were examined. Time-to-event analysis using the OAT primary outcome was performed by PCI success status. Landmark analysis (up to and beyond 30 days) partitioned early hazard versus late outcome according to treatment received.. Percutaneous coronary intervention was adjudicated successful in >87%. Percutaneous coronary intervention failure rates were similar in US and non-US sites, and did not significantly influence outcome at 60 months (hazard ratio for success vs fail 0.79, 99% CI 0.45-1.40, P = .29). Partitioning of early procedural hazard revealed no late benefit for PCI (hazard ratio for PCI success vs medical therapy alone 1.06, 99% CI 0.75-1.50, P = .66).. Percutaneous coronary intervention failure and complication rates in the OAT were low. Neither PCI failure nor early procedural hazard substantively influenced the primary trial results.

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Clinical Protocols; Cohort Studies; Coronary Angiography; Coronary Occlusion; Female; Humans; Male; Middle Aged; Myocardial Infarction; Treatment Outcome

Lesion length remains a predictor of target lesion revascularisation and results of long lesion stenting remain poor. Sirolimus-eluting stents have been shown to perform better than paclitaxel eluting stents in long lesions. In this substudy of the LEADERS trial, we compared the performance of biolimus biodegradable polymer (BES) and sirolimus permanent polymer stents (SES) in long lesions.. A total of 1,707 'all-comer' patients were randomly allocated to treatment with BES and SES. A stratified analysis of angiographic and clinical outcomes at nine months and one year, respectively was performed for vessels with lesion length <20 mm versus >20 mm (as measured by quantitative angiography).Of 1,707 patients, 592 BES patients with 831 lesions and 619 SES patients with 876 lesions had only short lesions treated. One hundred and fifty-three BES patients with 166 lesions and 151 SES patients with 162 lesions had long lesions. There were no significant differences in baseline clinical characteristics, except for higher number of patients with long lesions presenting with acute myocardial infarction in both stent groups. Long lesions tended to have lower MLD and greater percent diameter stenosis at baseline than short lesions. Late loss was greater for long lesions than short lesions. There was no statistically significant difference in late loss between BES and SES stents (0.32+/-0.69 vs 0.24+/-0.57, p=0.59). Binary in-segment restenosis was present in 23.2% versus 13.1% of long lesions treated with BES and SES, respectively (p=0.042). In patients with long lesions, the overall MACE rate was similar for BES and SES (17% vs 14.6%; p=0.62). There was a trend towards higher overall TLR rate with BES (12.4 % vs 6.0%; HR=2.06; p=0.07) and clinically driven TLR (10.5% vs 5.3%: HR 1.94; p=0.13). Rates of definite stent thrombosis were 3.3% in the long lesion group and 1.3-1.7 % in the short lesion group.. BES and SES appear similar with respect to MACE in long lesions in this "all-comer" patient population. However, long lesions tended to have a higher rate of binary in-segment restenosis and TLR following BES than SES treatment.

Topics: Absorbable Implants; Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Angiography; Coronary Restenosis; Coronary Stenosis; Drug-Eluting Stents; Europe; Female; Humans; Male; Middle Aged; Myocardial Infarction; Polymers; Proportional Hazards Models; Prosthesis Design; Risk Assessment; Sirolimus; Thrombosis; Time Factors; Treatment Outcome

Our aim was to access clinical effectiveness of percutaneous coronary intervention (PCI) when added to optimal medical therapy (OMT) in older patients with stable coronary artery disease (CAD).. While older patients with CAD are at increased risk for cardiac events compared with younger patients, it is unclear whether PCI may mitigate this risk more effectively than OMT alone or, alternatively, may be associated with more complications.. We conducted a pre-specified analysis of outcomes in stable CAD patients stratified by age and randomized to PCI+OMT or OMT alone in the COURAGE (Clinical Outcomes Utilizing Revascularization and Aggressive druG Evaluation) trial.. A total of 1,381 patients (60%) were <65 years of age (mean 56+/-6 years) and 904 patients (40%) were >or=65 years of age (mean 72+/-5 years). Achieved treatment targets for blood pressure, low-density lipoprotein cholesterol, adherence to diet and exercise, and angina-free status did not differ by age or treatment assignment. Among older patients, there was a 2- to 3-fold higher death rate, but similar rates of myocardial infarction, stroke, and major cardiac events compared with younger patients. The addition of PCI to OMT did not improve or worsen clinical outcomes in patients>or=65 years of age during a median 4.6 year follow-up.. These data support adherence to American College of Cardiology/American Heart Association clinical practice guidelines that advocate OMT as an appropriate initial management strategy, regardless of age. (Clinical Outcomes Utilizing Revascularization and Aggressive Drug Evaluation [COURAGE]; NCT00007657).

Topics: Aged; Angina, Unstable; Angioplasty, Balloon, Coronary; Blood Pressure; Body Mass Index; Cardiovascular Agents; Combined Modality Therapy; Coronary Artery Disease; Diet; Exercise; Female; Follow-Up Studies; Hospitalization; Humans; Lipoproteins, LDL; Male; Myocardial Infarction; Outcome Assessment, Health Care; Smoking Cessation; Stroke

We sought to compare the clinical presentation and angiographic patterns of saphenous vein graft (SVG) failure after stenting with a paclitaxel-eluting stent (PES) versus a similar bare-metal stent (BMS).. The mode of SVG failure after stenting has been poorly characterized.. The SOS (Stenting Of Saphenous Vein Grafts) trial enrolled 80 patients with 112 lesions in 88 SVGs who were randomized to a BMS or PES. Angiographic follow-up at 12 months was available in 83% of the patients.. Binary angiographic restenosis occurred in 51% (24 of 47) of BMS-treated lesions versus 9% (4 of 43) of PES-treated lesions (p < 0.0001). Graft occlusion occurred in 9 of the 21 SVGs (43%) that failed in the BMS group and in 2 of 4 SVGs (50%) that failed in the PES group. SVG failure after stenting presented as an acute coronary syndrome in 10 of the 24 patients (42%) (7 of those 10 patients presented with non-ST-segment elevation acute myocardial infarction), stable angina in 9 (37%) patients, and without symptoms in 5 (21%) patients. Of the 19 patients (with 20 grafts) who developed symptomatic graft failure, repeat SVG revascularization was successfully performed in all 13 (100%) subtotally obstructed SVGs but was attempted (and successful) in only 1 of 7 (14%) occluded SVGs. Revascularization of a native coronary artery was performed in an additional 4 of 7 (57%) symptomatic patients with an occluded SVG.. SVG failure after stenting often presents as acute myocardial infarction and with SVG occlusion. Compared with BMS, PES reduce SVG failure.

Topics: Acute Coronary Syndrome; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Angiography; Coronary Artery Bypass; Coronary Restenosis; Drug-Eluting Stents; Graft Occlusion, Vascular; Greece; Humans; Metals; Myocardial Infarction; Paclitaxel; Prosthesis Design; Recurrence; Saphenous Vein; Single-Blind Method; Stents; Thrombosis; Time Factors; Treatment Outcome; United States

The RESOLUTE trial examined the safety and efficacy of a next-generation zotarolimus-eluting coronary stent, Resolute (Medtronic CardioVascular Inc., Santa Rosa, California).. Revascularization benefits associated with current drug-eluting stents are often diminished in the presence of complex coronary lesions and in certain patient cohorts. Resolute uses a new proprietary polymer coating that extends the duration of drug delivery to match the longer healing duration often experienced in more complex cases.. The RESOLUTE trial was a prospective, nonrandomized, multicenter study of the Resolute stent in 139 patients with de novo coronary lesions with reference vessel diameters > or =2.5 and < or =3.5 mm and lesion length > or =14 and < or =27 mm. The primary end point was 9-month in-stent late lumen loss by quantitative coronary angiography. Secondary end points included major adverse cardiac events (MACE) at 30 days, 6, 9, and 12 months; acute device, lesion, and procedure success; and 9-month target vessel failure (TVF), target lesion revascularization (TLR), stent thrombosis, neointimal hyperplastic (NIH) volume, and percent NIH volume obstruction.. The 9-month in-stent late lumen loss was 0.22 +/- 0.27 mm. Cumulative MACE were 4.3%, 4.3%, 7.2%, and 8.7% at 30 days, 6, 9, and 12 months, respectively. Acute lesion, procedure, and device success rates were 100.0%, 95.7%, and 99.3%, respectively. At 9 months, TLR was 0.0%, TVF was 6.5%, stent thrombosis was 0.0%, NIH volume was 6.55 +/- 7.83 mm(3), and percent NIH volume obstruction was 3.73 +/- 4.05%.. In this feasibility study, the Resolute stent demonstrated low in-stent late lumen loss, minimal neointimal hyperplastic ingrowth, low TLR, no stent thrombosis, and acceptable TVF and MACE. (The RESOLUTE Clinical Trial; NCT00248079).

Topics: Aged; Angioplasty, Balloon, Coronary; Australia; Cardiovascular Agents; Coronary Angiography; Coronary Restenosis; Coronary Stenosis; Drug-Eluting Stents; Feasibility Studies; Female; Humans; Hyperplasia; Kaplan-Meier Estimate; Male; Middle Aged; Myocardial Infarction; New Zealand; Prospective Studies; Prosthesis Design; Sirolimus; Thrombosis; Time Factors; Treatment Outcome; Ultrasonography, Interventional; United States

To evaluate the 5-year clinical outcomes of patients treated with the Endeavor zotarolimus-eluting stent (ZES) in the ENDEAVOR I first-in-human study.. ENDEAVOR I was a prospective, nonrandomized, multicenter study of the Endeavor ZES in 100 consecutive patients with symptomatic coronary artery disease (CAD) due to de novo, stenotic lesions in native coronary arteries.. Patients with single or multivessel CAD were eligible to participate, but only one lesion per patient was treated. The lesion had to have > or = 50% stenosis, be < or = 15 mm in length, and located in a vessel with a reference diameter of 3.0-3.5 mm. Major adverse cardiac events (MACE), target lesion revascularization (TLR), target vessel failure (TVF), and stent thrombosis were evaluated 5 years after stent implantation.. The cumulative incidence of MACE was 2.0% at 1 year, 3.0% at 2 years, 6.1% at 3 years, 7.2% at 4 years, and 7.2% at 5 years. At 5 years, there were seven patients who had eight events; four noncardiac (cancer) deaths, three cases of TLR, of which one presented as a non-Q-wave MI because of a stent thrombosis at 10 days after the index procedure. There were no late or very late stent thromboses by any definition. TVF at 5 years was 5.2%.. Use of the Endeavor ZES to treat symptomatic CAD due to de novo lesions in native coronary arteries resulted in sustained clinical benefits to 5 years, with low rates of MACE, TLR, TVF, and stent thrombosis.

Topics: Adult; Aged; Angioplasty, Balloon, Coronary; Australia; Cardiovascular Agents; Coronary Angiography; Coronary Stenosis; Drug-Eluting Stents; Female; Humans; Male; Massachusetts; Middle Aged; Myocardial Infarction; New Zealand; Prospective Studies; Prosthesis Design; Severity of Illness Index; Sirolimus; Thrombosis; Time Factors; Treatment Outcome

Drug-eluting stents (DESs) are increasingly used for treatment of acute ST-segment elevation myocardial infarction (STEMI), but there are few comparisons of outcomes of various types of DES. We compared the efficacy and safety of zotarolimus-eluting stents (ZESs), sirolimus-eluting stents (SESs), and paclitaxel-eluting stents (PESs) in primary intervention for STEMI. This multicenter, prospectively randomized ZEST-AMI trial included 328 patients at 12 medical centers who were randomly assigned to ZES (n = 108), SES (n = 110), or PES (n = 110) deployment. The primary end point was major adverse cardiac events (death, MI, and ischemia-driven target vessel revascularization) at 12 months. Secondary end points included the individual components of the primary end point, late loss, angiographic restenosis, and stent thrombosis. Baseline clinical and angiographic characteristics were well matched. In-segment late loss (0.28 +/- 0.42 vs 0.46 +/- 0.48 vs 0.47 +/- 0.50 mm, respectively, p = 0.029) and restenosis rate (2.7% vs 15.9% vs 12.3%, respectively, p = 0.027) at 8 months were lowest in the SES group compared to the ZES and PES groups. At 12 months, cumulative incidence rates of primary end points in the ZES, SES, and PES groups were 11.3%, 8.2%, and 8.2%, respectively (p = 0.834). There were 2 acute (in the SES group) and 5 subacute (2 in the SES group and 3 in the PES group) stent thromboses. Incidence of death, recurrent MI, or ischemia-driven target vessel revascularization did not differ among the 3 groups. In conclusion, despite the difference in restenosis rate, the efficacy and safety of the 3 different DESs showed similar, acceptable results in the treatment of STEMI.

Topics: Angioplasty, Balloon, Coronary; Aspirin; Cardiovascular Agents; Clopidogrel; Coronary Angiography; Coronary Restenosis; Coronary Thrombosis; Drug-Eluting Stents; Female; Humans; Male; Middle Aged; Myocardial Infarction; Myocardial Revascularization; Paclitaxel; Platelet Aggregation Inhibitors; Prospective Studies; Recurrence; Sirolimus; Ticlopidine

We sought to investigate the long-term efficacy of oral sirolimus therapy and its impact on the incidence of de novo malignancies in the OSIRIS (Oral Sirolimus to Inhibit Recurrent In-Stent Stenosis) trial population.. The OSIRIS trial showed a significant reduction of angiographic restenosis with an oral adjunctive sirolimus treatment for in-stent restenosis. The long-term efficacy of oral sirolimus therapy is unknown.. Three hundred patients with in-stent restenosis were randomly assigned to receive placebo, a cumulative loading dose of 8 mg (usual-dose), or 24 mg (high-dose) of sirolimus over 3 days (2 days before and the day of intervention) followed by maintenance therapy of 2 mg/day for 7 days. The primary outcome of this analysis was the incidence of composite of death, myocardial infarction, and target vessel revascularization at 4-year follow-up. Secondary outcome was the incidence of newly diagnosed malignancies.. No significant differences were observed between placebo, usual-, and high-dose sirolimus treatment groups regarding primary outcome (33.3%, 39.4%, and 31.3%, respectively; p = 0.46), death (5.9%, 9.1%, and 11.1%, respectively; p = 0.41), target vessel revascularization (30.4%, 30.3%, and 22.2%, respectively; p = 0.33), and rate of newly diagnosed malignancies (7.8%, 3.0%, and 11.1%, respectively; p = 0.09).. The benefit in the reduced need for repeat intervention observed at 1 year with high-dose oral sirolimus therapy was attenuated over 4 years. Moreover, this regimen was associated with numerical yet not a significant increase in newly diagnosed malignancies without augmenting the malignancy-induced risk of death. (Oral Sirolimus for In-Stent Restenosis [OSIRUS] trial; NCT00859183).

Topics: Administration, Oral; Aged; Aged, 80 and over; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Angiography; Coronary Restenosis; Double-Blind Method; Humans; Immunosuppressive Agents; Kaplan-Meier Estimate; Middle Aged; Myocardial Infarction; Neoplasms; Risk Assessment; Sirolimus; Time Factors

In a number of coronary bifurcation lesions, both the main vessel and the side branch need stent coverage. Using sirolimus eluting stents, we compared 2 dedicated bifurcation stent techniques, the crush and the culotte techniques in a randomized trial with separate clinical and angiographic end-points.. A total of 424 patients with a bifurcation lesion were randomized to crush (n=209) and culotte (n=215) stenting. The primary end point was major adverse cardiac events; cardiac death, myocardial infarction, target vessel revascularization, or stent thrombosis after 6 months. At 6 months there were no significant differences in major adverse cardiac event rates between the groups; crush 4.3%, culotte 3.7% (P=0.87). Procedure and fluoroscopy times and contrast volumes were similar in the 2 groups. The rates of procedure-related increase in biomarkers of myocardial injury were 15.5% in crush versus 8.8% in culotte group (P=0.08). A total of 324 patients had a quantitative coronary assessment at the index procedure and after 8 months. The angiographic end-points of in-segment and in-stent restenosis of main vessel and/or side branch after 8 months were found in 12.1% versus 6.6% (P=0.10) and in 10.5% versus 4.5% (P=0.046) in the crush and culotte groups, respectively.. Both the crush and the culotte bifurcation stenting techniques were associated with similar and excellent clinical and angiographic results. Angiographically, there was a trend toward less in-segment restenosis and significantly reduced in-stent restenosis following culotte stenting.

Topics: Aged; Angioplasty, Balloon, Coronary; Biomarkers; Cardiovascular Agents; Coronary Angiography; Coronary Artery Disease; Coronary Restenosis; Denmark; Drug-Eluting Stents; Female; Finland; Humans; Kaplan-Meier Estimate; Latvia; Male; Middle Aged; Myocardial Infarction; Norway; Prosthesis Design; Sirolimus; Thrombosis; Time Factors; Treatment Outcome

The newly developed Nobori coronary stent coated with a bioresorbable polymer, polylactic acid, and the antiproliferative agent Biolimus A9 has the potential to reduce restenosis by suppressing neointima formation.. We conducted a randomized (2:1), controlled trial comparing the Biolimus A9-eluting stent Nobori and the paclitaxel-eluting stent Taxus Liberté, in 243 patients (153 Nobori and 90 Taxus) at 29 centers in Europe, Asia, and Australia. Patients with previously untreated lesions in up to 2 native coronary arteries were considered for enrollment. The primary end point was in-stent late loss at 9 months, whereas secondary end points included other quantitative coronary angiography parameters, such as in-segment late loss and the rate of restenosis as well as key intravascular ultrasound parameters. Clinical secondary end points were stent thrombosis and composite of major adverse cardiac events comprising death, myocardial infarction, and target vessel revascularization. At 9 months, the in-stent late loss was significantly lower in the Nobori group compared with the Taxus group (0.11+/-0.30 mm versus 0.32+/-0.50 mm) reaching both the primary hypothesis of noninferiority of Nobori stent versus Taxus Liberté stent (P<0.001) and the secondary hypothesis of superiority (P=0.001). This finding was confirmed by a significant reduction in binary restenosis from 6.2% in Taxus to 0.7% in Nobori (P=0.02) and neointimal volume obstruction, detected by intravascular ultrasound, from 5.5+/-7.2% in Taxus to 1.8+/-5.2% in Nobori (P=0.01). The major adverse cardiac events rate was 4.6% in the Nobori and 5.6% in the Taxus cohort of patients. The stent thrombosis rate was 0% in the Nobori arm and 4.4% in the Taxus arm.. The NOBORI 1 clinical trial confirmed its primary hypothesis--noninferiority of the Nobori Biolimus A9-eluting stent versus the Taxus Liberté stent in reducing neointimal proliferation. Both stents showed a low major adverse cardiac events rate in the studied population.

Topics: Angioplasty, Balloon, Coronary; Asia; Australia; Cardiovascular Agents; Cell Proliferation; Coronary Angiography; Coronary Restenosis; Coronary Stenosis; Coronary Vessels; Drug-Eluting Stents; Europe; Female; Humans; Hyperplasia; Male; Middle Aged; Myocardial Infarction; Paclitaxel; Prospective Studies; Risk Assessment; Sirolimus; Thrombosis; Time Factors; Treatment Outcome; Ultrasonography, Interventional

Stent thrombosis (ST) is an uncommon but serious complication of drug-eluting and bare metal stents. To assess drug-eluting stent ST in contemporary practice, we analyzed 2-year data from the 7492-patient ARRIVE registry.. Patients were enrolled at the initiation of percutaneous coronary intervention with no inclusion/exclusion criteria beyond use of the paclitaxel-eluting TAXUS stent. Two-year follow-up was 94% with independent adjudication of major cardiac events. A second, autonomous committee adjudicated Academic Research Consortium (ARC) definite/probable ST. Cumulative 2-year ARC-defined ST was 2.6% (1.0% early ST [<30 days], 0.7% late ST [31 to 365 days], and 0.8% very late ST [>1 year]). Simple-use (single-vessel and single-stent) cases had lower rates than expanded use (broader patient/lesion characteristics, 2-year cumulative: 1.4% versus 3.3%, P<0.001; early ST: 0.4% versus 1.4%, P<0.001; late ST: 0.5% versus 0.8%, P=0.14; very late ST: 0.4% versus 1.0%, P=0.008). Within 7 days of ST, 23% of patients died; 28% suffered Q-wave myocardial infarction. Mortality was higher with early ST (39%) than late ST (12%, P<0.001) or very late ST (13%, P<0.001). Multivariate analysis showed anatomic factors increased early ST (lesion >28 mm, lesion calcification) and late ST (vessel <3.0 mm); biological factors increased very late ST (renal disease, prior brachytherapy). Although early ST (71.4%) and very late ST (23.1%) patients had dual antiplatelet therapy at the time of ST, premature thienopyridine discontinuation was a strong independent predictor of both.. The relative risks of early and late ST differ. Knowledge of ST risk for specific subgroups may guide revascularization options until the completion of randomized trials in these broad populations.

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Artery Disease; Drug-Eluting Stents; Female; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Myocardial Infarction; Paclitaxel; Platelet Aggregation Inhibitors; Proportional Hazards Models; Registries; Risk Assessment; Risk Factors; Thrombosis; Time Factors; Treatment Outcome; United States

Stents eluting antiproliferative drugs reduce the incidence of restenosis but delay healing of the vascular wall. We assessed the safety and efficacy of catheter-based local delivery of fluid paclitaxel in patients with coronary de novo stenoses after implantation of a bare metal stent.. We conducted a prospective, randomized trial comparing the local delivery of fluid paclitaxel after bare metal stent implantation (group I) with the implantation of a bare metal stent (group II) and the implantation of a paclitaxel-eluting stent (group III) in 204 patients. The primary end point was in-stent late lumen loss. Secondary end points included binary restenosis rate >50%, minimal lumen diameter, diameter stenosis, and a composite clinical end point (major adverse cardiac events and revascularization of the target lesion) 6 months after intervention. At 6 months, angiography showed an in-stent late lumen loss of 0.61+/-0.44 mm in group I versus 0.99+/-0.72 mm in group II (I versus II, P=0.0006) and 0.44+/-0.48 mm in group III (noninferiority of I versus III, P=0.023). The 1-sided 95% CI for the true difference of the means of in-stent late lumen loss in groups I and III was -infinity to 0.3174188. The cumulative overall rate of major cardiac events was 13.4% in group I, 26.8% in group II, and 14.9% in group III. Target lesion revascularization rate was 13.4% (group I), 22.1% (group II), and 13.4% (group III).. Additional antiproliferative treatment of de novo lesions in native coronary arteries with catheter-based delivery of fluid paclitaxel after bare metal stenting was safe and significantly reduced neointimal proliferation, restenosis, and clinical events compared with bare metal stent implantation alone.

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiac Catheterization; Cardiovascular Agents; Cell Proliferation; Coronary Angiography; Coronary Restenosis; Coronary Stenosis; Drug-Eluting Stents; Female; Humans; Male; Metals; Middle Aged; Myocardial Infarction; Paclitaxel; Prospective Studies; Prosthesis Design; Single-Blind Method; Stents; Time Factors; Treatment Outcome; Tunica Intima

This article reports the 2-year clinical, angiographic, and intravascular ultrasound outcomes of the everolimus-eluting stent (EES) compared with the paclitaxel-eluting stent (PES) in the randomized SPIRIT II trial.. This was a prospective, single-blind clinical trial in which a total of 300 patients with de novo native coronary artery lesions were randomized to either EES or PES in a 3:1 fashion. Clinical follow-up was planned at 2 years in all patients. A subset of 152 patients underwent serial angiographic and intravascular ultrasound analyses at 6 months and 2 years. After 2 years, target lesion failure (cardiac death, myocardial infarction, and ischemia-driven target lesion revascularization) rates were 6.6% and 11% in EES and PES, respectively (P=0.31). At 6 months, a significant reduction in angiographic in-stent late loss and percentage volume obstruction measured by intravascular ultrasound was observed in the EES group. However, at 2-year follow-up, a late increased intimal hyperplasia growth after implantation of an EES was observed. There were no significant differences between EES and PES for in-stent late loss (EES, 0.33+/-0.37 mm versus PES, 0.34+/-0.34 mm; P=0.84) and percentage volume obstruction (EES, 5.18+/-6.22% versus PES, 5.80+/-6.31%; P=0.65) at 2 years. The incidence of stent thrombosis was low and comparable in both groups (EES, 0.9%; PES, 1.4%).. Although the previously reported angiographic and clinical superiority of the EES has vanished over time, this report confirms and extends the previously demonstrated noninferiority in terms of in-stent late loss of the EES when compared with the PES up to 2-year follow-up. There were no significant differences between EES and PES in clinical, angiographic and intravascular ultrasound outcomes at 2 years.

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Angiography; Coronary Artery Disease; Drug-Eluting Stents; Europe; Everolimus; Female; Humans; India; Kaplan-Meier Estimate; Male; Middle Aged; Myocardial Infarction; Myocardial Ischemia; New Zealand; Paclitaxel; Prospective Studies; Single-Blind Method; Sirolimus; Thrombosis; Time Factors; Treatment Outcome; Ultrasonography, Interventional

Treatment of bifurcations is a complex problem. The clinical value of treating side branches is an unsolved problem in the field of interventional cardiology.. We initiated a prospective randomized controlled trial. One hundred and ten patients with bifurcations were randomly assigned to 2 arms: Stenting of the main branch (MB, Taxus-stent, paclitaxel-eluting stents) and mandatory side branch (SB) percutaneous coronary intervention (PCI; kissing balloons) with provisional SB stenting (therapy A), or stenting of the MB (paclitaxel-eluting stents) with provisional SB-PCI only when the SB had a thrombolysis in myocardial infarction flow <2 (therapy B). The primary end point was target lesion revascularization. The mean ages were 66.8 years (A) versus 65.1 years (B, P=0.4), 71.4% (A) versus 77.8% were men (P=0.4), patients with diabetes were present in 25.0% versus 25.9% (P=0.9). The MB was left anterior descending artery in 80.4% versus 81.5% (A versus B, P=0.9). The SB-PCI and kissing balloon-PCI were performed according to the study protocol in 82.1%/73.2% versus 16.7%/13.0% (P<0.05 for both), while changing of the intended therapy was necessary in 17.9% versus 16.7% (A versus B, P=0.9). A final thrombolysis in myocardial infarction flow 3 (MB) was reached in all patients (groups A and B), final thrombolysis in myocardial infarction flow 3 (SB) was observed in 96.4% versus 88.9% (A versus B, P=0.3). Radiation time (min) and contrast medium (mL) were 14.2/210 (group A) versus 7.8/151.6 (group B; P for both <0.05). Six month - follow up: major adverse cardiac events was 23.2% (A) versus 24.1% (B, P=0.9), target lesion revascularization was 17.9% (A) versus 14.8% (B, P=0.7), and late lumen loss (MB) was 0.2 mm (A) versus 0.3 mm (B, P=0.5). In group B, no PCI of the SB was done during follow up.. A simple strategy using paclitaxel-eluting stents with only provisional SB-PCI may be of equal value to a more complex strategy with mandatory SB-PCI. Clinical Trial Registration- URL: http://www.controlled.trials.com. Unique identifier: ISRCTN22637771.

Topics: Adult; Aged; Aged, 80 and over; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Angiography; Coronary Artery Disease; Coronary Circulation; Coronary Restenosis; Drug-Eluting Stents; Female; Humans; Male; Middle Aged; Myocardial Infarction; Paclitaxel; Pilot Projects; Prospective Studies; Single-Blind Method; Thrombosis; Time Factors; Treatment Outcome

COURAGE compared outcomes in stable coronary patients randomized to optimal medical therapy plus percutaneous coronary intervention (PCI) versus optimal medical therapy alone.. Angiographic data were analyzed by treatment arm, health care system (Veterans Administration, US non-Veterans Administration, Canada), and gender. Veterans Administration patients had higher prevalence of coronary artery bypass graft surgery and left ventricular ejection fraction < or =50%. Men had worse diameter stenosis of the most severe lesion, higher prevalence of prior coronary artery bypass graft surgery, lower left ventricular ejection fraction, and more 3-vessel disease that included a proximal left anterior descending lesion (P<0.0001 for all comparisons versus women). Failure to cross rate (3%) and visual angiographic success of stent procedures (97%) were similar to contemporary practice in the National Cardiovascular Data Registry. Quantitative angiographic PCI success was 93% (residual lesion <50% in-segment) and 82% (<20% in-stent), with only minor nonsignificant differences among health care systems and genders. Event rates were higher in patients with higher jeopardy scores and more severe vessel disease, but rates were similar irrespective of treatment strategy. Within the PCI plus optimal medical therapy arm, complete revascularization was associated with a trend toward lower rate of death or nonfatal myocardial infarction. Complete revascularization was similar between genders and among health care systems.. PCI success and completeness of revascularization did not differ significantly by health care system or gender and were similar to contemporary practice. Angiographic burden of disease affected overall event rates but not response to an initial strategy of PCI plus optimal medical therapy or optimal medical therapy alone.

Topics: Angina Pectoris; Angioplasty, Balloon, Coronary; Canada; Cardiovascular Agents; Coronary Angiography; Coronary Stenosis; Female; Humans; Male; Morbidity; Myocardial Infarction; Outcome Assessment, Health Care; Prevalence; Severity of Illness Index; Sex Distribution; Stents; United States

This paper reports the 3-year clinical outcomes of the XIENCE V (Abbott Vascular, Santa Clara, California) everolimus-eluting stent (EES) compared with the TAXUS (Boston Scientific, Natick, Massachusetts) paclitaxel-eluting stent (PES) in the randomized SPIRIT II (Clinical Evaluation of the Xience V Everolimus Eluting Coronary Stent System in the Treatment of Patients with de novo Native Coronary Artery Lesions) study.. The Xience V EES is a new-generation drug-eluting stent (DES) that might offer advantages over the first-generation DES in terms of improved clinical outcomes and a better safety profile.. The SPIRIT II trial was a multicenter, prospective, randomized, single-blind, clinical trial, randomizing 300 patients with de novo coronary artery lesions in a ratio of 3:1 to either EES or PES. The primary end point was in-stent late loss at 180 days.. At 3-year clinical follow-up cardiac death was numerically lower with EES than PES (0.5% vs. 4.3%, p = 0.056). The observed rate of myocardial infarction was 3.6% for EES and 7.2% for PES (p = 0.31). The rate of ischemia-driven target lesion revascularization was 4.6% and 10.1% for EES and PES, respectively (p = 0.14). Overall, there was a trend for lower major adverse cardiovascular events in the EES group compared with PES (7.2% vs. 15.9%, p = 0.053). The rate of stent thrombosis was low and comparable in both groups (EES 1.0% vs. PES 2.9%).. The present study reports the favorable 3-year clinical outcomes of the EES, which are consistent with the results from other studies of the EES with shorter follow-up.

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Angiography; Coronary Artery Disease; Coronary Restenosis; Drug-Eluting Stents; Europe; Everolimus; Female; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Myocardial Infarction; Paclitaxel; Prospective Studies; Prosthesis Design; Risk Assessment; Risk Factors; Single-Blind Method; Sirolimus; Thrombosis; Time Factors; Treatment Outcome; United States

The aim of this study was to evaluate clinical and economic outcomes for subjects receiving zotarolimus-eluting (ZES) (n = 323) versus sirolimus-eluting stents (SES) (n = 113) in the ENDEAVOR III (Randomized Controlled Trial of the Medtronic Endeavor Drug [ABT-578] Eluting Coronary Stent System Versus the Cypher Sirolimus-Eluting Coronary Stent System in De Novo Native Coronary Artery Lesions) clinical trial.. Although previous clinical trials have evaluated long-term clinical outcome for drug-eluting stents, none considered their economic implications.. We analyzed case report form information with quality-of-life adjustment and Medicare cost weights applied from secondary sources; compared differences in clinical outcomes, quality-adjusted survival, medical resource use, and medical costs; and evaluated cost-effectiveness through 3-year follow-up.. The use of ZES versus SES reduced the 3-year rates/100 subjects of death or myocardial infarction (3.9 vs. 10.8; difference, -6.9; 95% confidence interval [CI]: -13.0 to 0.8; p = 0.028), with no difference in target vessel revascularization rates (17.9 vs. 12.2; difference, 5.7; 95% CI: -3.7 to 15.1; p = 0.23) but greater use of coronary artery bypass graft (CABG) surgery (3.5 vs. 0.0; difference 3.5; 95% CI: 1.3 to 5.7; p = 0.002). After discounting at 3% per annum, total medical costs for ZES versus SES were similar ($23,353 vs. $21,657; difference, $1,696; 95% CI: -$1,089 to $4,482, p = 0.23), and the 3-year cost-effectiveness ratio was $57,002/quality-adjusted life year.. Despite a reduction in death or myocardial infarction and no difference in total revascularizations, medical costs were not decreased due to increased CABG repeat revascularization procedures for subjects receiving ZES versus SES. If future trials observe similar differences, improved safety with no difference in medical costs, the use of ZES versus SES will be a clinically and economically attractive treatment strategy. (The Medtronic Endeavor III Drug Eluting Coronary Stent System Clinical Trial [ENDEAVOR III]; NCT00217256).

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Artery Bypass; Coronary Artery Disease; Cost-Benefit Analysis; Drug-Eluting Stents; Female; Health Care Costs; Humans; Male; Medicare; Middle Aged; Models, Economic; Myocardial Infarction; Prosthesis Design; Quality of Life; Quality-Adjusted Life Years; Risk Assessment; Sirolimus; Time Factors; Treatment Outcome; United States

The aim of this study was to assess, after 2 years of follow-up, the safety, efficacy, and cost-effectiveness of a zotarolimus-eluting stent (ZES) compared with a paclitaxel-eluting stent (PES) in patients with native coronary lesions.. Early drug-eluting stents were associated with a small but significant incidence of very late stent thrombosis (VLST), occurring >1 year after the index procedure. The ZES has shown encouraging results in clinical trials.. The ENDEAVOR IV trial (Randomized, Controlled Trial of the Medtronic Endeavor Drug [ABT-578] Eluting Coronary Stent System Versus the Taxus Paclitaxel-Eluting Coronary Stent System in De Novo Native Coronary Artery Lesions), a randomized (1:1), single-blind, controlled trial (n = 1,548) compared ZES versus PES in patients with single de novo coronary lesions. Two-year follow-up was obtained in 96.0% of ZES and 95.4% of PES patients. The primary end point was target vessel failure (TVF), and safety end points included Academic Research Consortium-defined stent thrombosis. Economic end points analyzed included quality-adjusted survival, medical costs, and relative cost-effectiveness of ZES and PES.. The TVF at 2 years was similar in ZES and PES patients (11.1% vs. 13.1%, p = 0.232). There were fewer myocardial infarctions (MIs) in ZES patients (p = 0.022), due to fewer periprocedural non-Q-wave MIs and fewer late MIs between 1 and 2 years. Late MIs were associated with increased VLST (PES: 6 vs. ZES: 1; p = 0.069). Target lesion revascularization was similar comparing ZES with PES (5.9% vs. 4.6%; p = 0.295), especially in patients without planned angiographic follow-up (5.2% vs. 4.9%; p = 0.896). The cost-effectiveness of ZES and PES was similar.. After 2 years of follow-up, ZES demonstrated efficacy and cost-effectiveness comparable to PES, with fewer MIs and a trend toward less VLST. (The ENDEAVOR IV Clinical Trial: A Trial of a Coronary Stent System in Coronary Artery Lesions; NCT00217269).

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Constriction, Pathologic; Coronary Angiography; Coronary Artery Disease; Cost-Benefit Analysis; Drug-Eluting Stents; Female; Health Care Costs; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Models, Economic; Myocardial Infarction; Paclitaxel; Prospective Studies; Prosthesis Design; Quality of Life; Quality-Adjusted Life Years; Risk Assessment; Single-Blind Method; Sirolimus; Time Factors; Treatment Outcome; United States

The E-Five registry was designed to evaluate the safety and effectiveness of the Endeavor zotarolimus-eluting stent (ZES) (Medtronic CardioVascular, Santa Rosa, California) for the treatment of coronary artery stenosis across a wide range of patients treated in real-world clinical practice settings.. Early clinical trials with the Endeavor ZES have demonstrated low rates of target lesion revascularization with a favorable safety profile including low late stent thrombosis with up to 4 years of follow-up. A clinical registry was designed to complement controlled trial data by examining a large patient population, including high-risk patient subsets.. The E-Five registry is a prospective, nonrandomized, multicenter global registry conducted at 188 centers worldwide. Adult patients (n = 8,314) with coronary artery disease who underwent single-vessel or multivessel percutaneous coronary intervention were enrolled. The primary end point was the rate of major adverse cardiac events (MACE) at 12 months. A secondary analysis stratified patients by standard versus extended-use clinical and lesion characteristics.. Overall 12-month outcome rates were MACE 7.5%; cardiac death 1.7%; myocardial infarction (all) 1.6%; target lesion revascularization 4.5%; and stent thrombosis (Academic Research Consortium definite and probable) 1.1%. The 12-month MACE rates were 4.3% and 8.6% for standard- and extended-use patients, respectively (p < 0.001).. This large, international multicenter registry provides important information regarding the long-term safety and efficacy of the Endeavor ZES across standard and extended-use patients in the real-world setting. Rates of MACE and measures of safety including cardiac death, myocardial infarction, and stent thrombosis were low and consistent with pooled results of clinical trials. (E-Five Registry: A World-Wide Registry With The Endeavor Zotarolimus Eluting Coronary Stent [eFive Registry]; NCT00623441).

Topics: Aged; Angioplasty, Balloon, Coronary; Australia; Cardiovascular Agents; Coronary Stenosis; Europe; Female; Humans; Israel; Kaplan-Meier Estimate; Male; Middle Aged; Myocardial Infarction; Platelet Aggregation Inhibitors; Prospective Studies; Prosthesis Design; Registries; Risk Assessment; Sirolimus; South America; Thrombosis; Time Factors; Treatment Outcome; United States

The pivotal TAXUS IV (TAXUS IV-SR: Treatment of De Novo Coronary Disease Using a Single Paclitaxel-Eluting Stent) trial evaluated the long-term safety and effectiveness of the paclitaxel-eluting stent (PES) compared with an otherwise identical bare-metal stent (BMS) in a relatively uncomplicated population of patients with a single de novo lesion in a native coronary vessel, treated between March and July 2002.. Long-term follow-up is required to determine whether the early safety and efficacy of drug-eluting stents are maintained.. The primary end point of this prospective, randomized, double-blind trial was 9-month ischemia-driven target vessel revascularization (TVR) for PES versus the BMS control. Follow-up was complete in 1,230 (95.1%) of 1,294 randomized evaluable patients at 5 years.. Compared with BMS, PES significantly reduced TVR at 9 months (12.1% vs. 4.7%; p < 0.0001); this benefit was maintained through 5 years (27.4% vs. 16.9%; p < 0.0001), given comparable TVR rates for BMS and PES between years 1 and 5 (4.1%/year vs. 3.3%/year; respectively, p = 0.16). Similar patterns were observed for composite major adverse cardiac events (MACE) (32.8% BMS vs. 24.0% PES, p = 0.0001 at 5 years). Stent thrombosis was comparable for PES and BMS at 9 months (0.8% BMS vs. 0.8% PES; p = 0.98) and at 5 years (2.1% BMS vs. 2.2% PES, p = 0.87). The overall revascularization benefits of PES were consistent across multiple subgroups, including sex, diabetes, left anterior descending artery lesion location, reference vessel diameter, lesion length, and multiple stents.. These 5-year results demonstrate the long-term safety and sustained efficacy of PES compared with BMS in patients with noncomplex lesions. (TAXUS IV-SR: Treatment of De Novo Coronary Disease Using a Single Paclitaxel-Eluting Stent; NCT00292474).

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Chi-Square Distribution; Coronary Artery Disease; Diabetes Complications; Double-Blind Method; Drug-Eluting Stents; Female; Humans; Kaplan-Meier Estimate; Logistic Models; Male; Metals; Middle Aged; Myocardial Infarction; Paclitaxel; Platelet Aggregation Inhibitors; Prospective Studies; Prosthesis Design; Risk Assessment; Risk Factors; Stents; Thrombosis; Time Factors; Treatment Outcome

To evaluate effects of sirolimus-eluting stents (SES) compared to bare-metal stents (BMS) at stent edges in patients with acute myocardial infarction (AMI).. Clinical, angiographic, intravascular ultrasound (lVUS) and virtual histology (VH)-IVUS results were obtained and analysed in 20 SES and 20 BMS AMI patients at the index procedure and at nine months follow-up. Quantitative angiography and IVUS showed a trend toward decreases in mean lumen diameter, vessel volume, minimum lumen area and mean lumen area at both stent edges of BMS, and at the proximal edge of SES. At the distal stent edge, a significant difference between BMS and SES treated patients in mean lumen area was found (D-0.8+/-1.6 mm2 versus D0.2+/-0.8 mm2 respectively, p=0.04). Furthermore, in-stent SES had a larger lumen volume (SES: 167.7+/-59.2 mm3 versus BMS: 125.1+/-43.8 mm3; p=0.02) and less neointima volume (7.3+/-9.1 mm3 versus 53.2+/-35.1 mm3; p<0.001). Neither SES nor BMS demonstrated a significant effect on plaque composition at follow-up VH-IVUS analysis.. A significant difference between SES and BMS treated patients was observed with respect to mean lumen diameter distal to the stented segment which suggests a downstream effect of sirolimus elution.

Topics: Adult; Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Angiography; Coronary Artery Disease; Drug-Eluting Stents; Female; Humans; Hyperplasia; Male; Metals; Middle Aged; Myocardial Infarction; Prosthesis Design; Sirolimus; Stents; Time Factors; Treatment Outcome; Ultrasonography, Interventional

The long-term impact of treating bifurcation lesions on the overall outcome of patients with multivessel coronary disease treated percutaneously with drug-eluting stents is unknown. This analysis determined the influence of bifurcation treatment using sirolimus-eluting stents on 3-year clinical outcomes.. Of the 607 patients (2,160 lesions) in the ARTS II study, 324 patients underwent revascularisation procedures involving treatment of at least one bifurcation (465 lesions). Three-year outcomes were compared to those without bifurcations. Despite more diffuse and complex disease in the bifurcation group, survival free of adverse events was equivalent in the two groups. At 3-years, there was no difference in rate of overall MACCE (20.2% vs. 18.5%, p=NS) or any of the component events between the bifurcation and the non-bifurcation group. There was a trend for a higher rate of definite stent thrombosis in the bifurcation group (4.6 vs 2.1%, p=0.1), but in multivariate analysis the CK value post-procedure served as the only independent predictor of definite stent thrombosis (p=0.015), with the presence of a bifurcation lesion of borderline significance (p=0.056).. In multivessel disease treated by PCI with DES, the presence of bifurcation disease had no adverse influence on 3-year clinical outcomes.

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Cerebrovascular Disorders; Chi-Square Distribution; Coronary Angiography; Coronary Stenosis; Drug-Eluting Stents; Female; Humans; Kaplan-Meier Estimate; Logistic Models; Male; Middle Aged; Myocardial Infarction; Prosthesis Design; Risk Assessment; Risk Factors; Severity of Illness Index; Sirolimus; Thrombosis; Time Factors; Treatment Outcome

Previous randomised studies have shown a significant reduction in restenosis when oral rapamycin (OR) is administered to patients undergoing bare metal stent (BMS) implantation. How this regimen compares to drug eluting stents (DES) is unknown.. Two-hundred patients with de novo coronary lesions were randomised to treatment with OR plus BMS (100 pts) or with DES (100 pts). OR was given as a bolus of 10 mg per day before PCI followed by daily doses of 3 mg during following 13 days. Primary endpoints were to compare hospital, follow-up and overall cost at one, two, three and five years of follow-up. The secondary endpoints included death, myocardial infarction (MI) and stroke and were analysed as major adverse cardiovascular events (MACCE). Target vessel (TVR) and target lesion revascularisation (TLR) were independently analysed. Costs included procedural resources, hospitalisation, medications, repeat revascularisation procedures and professional fees. Baseline demographic, clinical and angiographic characteristics were similar. At 18.3 +/- 7 months of follow-up, the initial strategy of OR plus BMS resulted in significant cost saving when compared to DES (p=0.0001). TLR rate was 8.2% with DES and 7.0% with OR plus BMS (p=0.84), similarly no differences in TVR rate in both groups was seen (10.6% and 10.5% in OR and DES group respectively, p=0.86). Non-inferiority testing, determined that DES therapy failed to be cost saving compared to OR in all possible cost scenarios.. A strategy of OR plus BMS is cost saving compared to DES in patients undergoing PCI for de novo coronary lesions.

Topics: Administration, Oral; Aged; Angioplasty, Balloon, Coronary; Argentina; Cardiovascular Agents; Coronary Angiography; Coronary Artery Disease; Coronary Restenosis; Cost Savings; Drug-Eluting Stents; Female; Health Care Costs; Hospital Mortality; Humans; Kaplan-Meier Estimate; Logistic Models; Male; Metals; Middle Aged; Myocardial Infarction; Proportional Hazards Models; Prospective Studies; Prosthesis Design; Risk Assessment; Sirolimus; Stents; Stroke; Time Factors; Treatment Outcome

Medication nonadherence is a major public health problem, especially for patients with coronary artery disease. The cost of prescription drugs is a central reason for nonadherence, even for patients with drug insurance. Removing patient out-of-pocket drug costs may increase adherence, improve clinical outcomes, and even reduce overall health costs for high-risk patients. The existing data are inadequate to assess whether this strategy is effective.. The Post-Myocardial Infarction Free Rx and Economic Evaluation (Post-MI FREEE) trial aims to evaluate the effect of providing full prescription drug coverage (ie, no copays, coinsurance, or deductibles) for statins, beta-blockers, angiotensin-converting enzyme inhibitors, and angiotensin II receptor blockers to patients after being recently discharged from the hospital. Potentially eligible patients will be those individuals who receive their health and pharmacy benefits through Aetna, Inc. Patients enrolled in a Health Savings Account plan, who are > or =65 years of age, whose plan sponsor (ie, the employer, union, government, or association that sponsors the particular benefits package) has opted out of participating in the study, and who do not receive both medical services and pharmacy coverage through Aetna will be excluded. The plan sponsor of each eligible patient will be block randomized to either full drug coverage or current levels of pharmacy benefit, and all subsequently eligible patients of that same plan sponsor will be assigned to the same benefits group. The primary outcome of the trial is a composite clinical outcome of readmission for acute MI, unstable angina, stroke, congestive heart failure, revascularization, or inhospital cardiovascular death. Secondary outcomes include medication adherence and health care costs. All patients will be followed up for a minimum of 1 year.. The Post-MI FREEE trial will be the first randomized study to evaluate the impact of reducing cost-sharing for essential cardiac medications in high-risk patients on clinical and economic outcomes.

Topics: Adrenergic beta-Antagonists; Aged; Angiotensin-Converting Enzyme Inhibitors; Cardiovascular Agents; Continuity of Patient Care; Cost Sharing; Drug Costs; Evaluation Studies as Topic; Female; Humans; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Insurance, Pharmaceutical Services; Male; Middle Aged; Myocardial Infarction; Patient Compliance; Patient Selection; Risk Assessment; Secondary Prevention; Sensitivity and Specificity

Ivabradine is a selective heart rate-lowering agent that acts by inhibiting the pacemaker current If in sinoatrial node cells. Patients with coronary artery disease and left ventricular dysfunction are at high risk of death and cardiac events, and the BEAUTIFUL study was designed to evaluate the effects of ivabradine on outcome in such patients receiving optimal medical therapy. This report describes the study population at baseline.. BEAUTIFUL is an international, multicentre, randomized, double-blind trial to compare ivabradine with placebo in reducing mortality and cardiovascular events in patients with stable coronary artery disease and left ventricular systolic dysfunction (ejection fraction <40%).. A total of 10,917 patients were randomized. At baseline, their mean age was 65 years, 83% were male, 98% Caucasian, 88% had previous myocardial infarction, 37% had diabetes, and 40% had metabolic syndrome. Mean ejection fraction was 32% and resting heart rate was 71.6 bpm. Concomitant medications included beta-blockers (87%), renin-angiotensin system agents (89%), antithrombotic agents (94%), and lipid-lowering agents (76%).. Main results from BEAUTIFUL are expected in 2008, and should show whether ivabradine, on top of optimal medical treatment, reduces mortality and cardiovascular events in this population of high-risk patients.

Topics: Aged; Benzazepines; Cardiovascular Agents; Coronary Artery Disease; Diabetes Complications; Double-Blind Method; Drug Therapy, Combination; Female; Heart Failure; Humans; Ivabradine; Male; Metabolic Syndrome; Middle Aged; Myocardial Infarction; Ventricular Dysfunction, Left

We assessed whether a novel programme to evaluate/communicate predicted coronary heart disease (CHD) risk could lower patients' predicted Framingham CHD risk vs. usual care.. The Risk Evaluation and Communication Health Outcomes and Utilization Trial was a prospective, controlled, cluster-randomised trial in nine European countries, among patients at moderate cardiovascular risk. Following baseline assessments, physicians in the intervention group calculated patients' predicted CHD risk and were instructed to advise patients according to a risk evaluation/communication programme. Usual care physicians did not calculate patients' risk and provided usual care only. The primary end-point was Framingham 10-year CHD risk at 6 months with intervention vs. usual care.. Of 1103 patients across 100 sites, 524 patients receiving intervention, and 461 receiving usual care, were analysed for efficacy. After 6 months, mean predicted risks were 12.5% with intervention, and 13.7% with usual care [odds ratio = 0.896; p = 0.001, adjusted for risk at baseline (17.2% intervention; 16.9% usual care) and other covariates]. The proportion of patients achieving both blood pressure and low-density lipoprotein cholesterol targets was significantly higher with intervention (25.4%) than usual care (14.1%; p < 0.001), and 29.3% of smokers in the intervention group quit smoking vs. 21.4% of those receiving usual care (p = 0.04).. A physician-implemented CHD risk evaluation/communication programme improved patients' modifiable risk factor profile, and lowered predicted CHD risk compared with usual care. By combining this strategy with more intensive treatment to reduce residual modifiable risk, we believe that substantial improvements in cardiovascular disease prevention could be achieved in clinical practice.

Topics: Cardiovascular Agents; Clinical Protocols; Cluster Analysis; Communication; Coronary Disease; Death, Sudden, Cardiac; Female; Humans; Male; Middle Aged; Myocardial Infarction; Prognosis; Prospective Studies; Risk Assessment; Risk Factors; Weight Loss

This study sought to determine predictors of outcome and examine the influence of baseline risk on therapeutic impact of late mechanical opening of a persistently occluded infarct related artery after myocardial infarction in stable patients.. Previous studies in patients with acute coronary syndromes suggest that the impact of infarct-related artery recanalization on clinical outcome is greatest in patients at highest risk.. Of 2,201 patients (age 58.6 +/- 11.0 years) with infarct-related artery occlusion on days 3 to 28 after myocardial infarction in the OAT (Occluded Artery Trial) study, 1,101 were assigned to percutaneous coronary intervention (PCI) and 1,100 to medical therapy alone and followed for a mean of 3.2 years. The primary end point was a composite of death, reinfarction, or New York Heart Association functional class IV heart failure. Interaction of treatment effect with tertiles of predicted survival were examined using the Cox survival model.. The 5-year rate for the primary end point was 18.9% versus 16.1% for patients assigned to PCI and medical treatment alone, respectively (hazard ratio [HR]: 1.14, 95% confidence interval [CI]: 0.92 to 1.43, p 0.23). Lack of benefit of PCI was consistent across the risk spectrum for both the primary end point and total mortality, including for the highest tertile (33.9% PCI vs. 27.3% medical treatment alone, HR: 1.27, 99% CI: 0.87 to 1.85 primary end point and 23.5% PCI vs. 21.7% medical treatment alone, HR: 1.16, 99% CI: 0.73 to 1.85 mortality). The independent predictors of the composite outcome were history of heart failure (HR: 2.06, p < 0.001), peripheral vascular disease (HR: 1.93, p 0.001), diabetes (HR: 1.49, p 0.002), rales (HR: 1.88, p < 0.001), decreasing ejection fraction (HR: 1.48 per 10%, p < 0.001), decreasing days from myocardial infarction to randomization (HR: 1.04 per day, p < 0.001), and decreasing glomerular filtration rate (HR: 1.11 per 10 ml/min/1.73 m(2), p < 0.001).. In the OAT study, there was no variation in the effect of PCI on clinical outcomes at different levels of patient risk, including the subset with very high event rates. (Occluded Artery Trial [OAT]; NCT00004562)

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Occlusion; Female; Heart Failure; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Multivariate Analysis; Myocardial Infarction; Patient Selection; Proportional Hazards Models; Recurrence; Risk Assessment; Risk Factors; Time Factors; Treatment Outcome

Acute and late stent malapposition (SM) after bare-metal stents (BMS) and sirolimus-eluting stents (SES) in ST-segment elevation myocardial infarction patients were studied.. Stent thrombosis may be caused by SM after primary percutaneous coronary intervention in ST-segment elevation myocardial infarction patients.. Post-procedure and follow-up intravascular ultrasound data were available in 184 out of 310 patients (60%; 104 SES, 80 BMS) included in the MISSION! Intervention Study. To determine the contribution of remodeling and changes in plaque burden to the change in lumen cross-sectional area (CSA) at SM sites, the change in lumen CSA (follow-up minus post-lumen CSA) was related to the change in external elastic membrane CSA (remodeling) and change in plaque and media CSA (plaque burden).. Acute SM was found in 38.5% SES patients and 33.8% BMS patients (p = 0.51), late SM in 37.5% SES patients and 12.5% BMS patients (p < 0.001). Acquired SM was found in 25.0% SES patients and 5.0% BMS patients (p < 0.001). Predictors of acute SM were reference diameter (SES: odds ratio [OR] 3.49, 95% confidence interval [CI] 1.29 to 9.43; BMS: OR 28.8, 95% CI 4.25 to 94.5) and balloon pressure (BMS: OR 0.74, 95% CI 0.58 to 0.94). Predictors of late SM were diabetes mellitus (SES: OR 0.16, 95% CI 0.02 to 1.35), reference diameter (BMS: OR 19.2, 95% CI 2.64 to 139.7), and maximum balloon pressure (BMS: OR 0.74, 95% CI 0.55 to 1.00). Change in lumen CSA was related to change in external elastic membrane CSA (R = 0.73, 95% CI 0.62 to 0.84) after SES implantation and to change in plaque and media CSA (R = -0.62, 95% CI -0.77 to -0.46) after BMS implantation. After SES implantation, acquired SM was caused by positive remodeling in 84% and plaque reduction in 16% of patients.. Acute SM was common after SES and BMS stent implantation in ST-segment elevation myocardial infarction patients. After SES implantation, late acquired SM is common and generally caused by positive remodeling.

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Angiography; Drug-Eluting Stents; Female; Humans; Male; Metals; Middle Aged; Myocardial Infarction; Odds Ratio; Risk Assessment; Risk Factors; Single-Blind Method; Sirolimus; Stents; Thrombosis; Time Factors; Treatment Outcome; Ultrasonography, Interventional

We sought to determine the best cardiac biomarker to predict infarct size, left ventricular ejection fraction (LVEF), and clinical outcome in patients undergoing primary percutaneous coronary intervention (PCI) for ST-segment elevation myocardial infarction (STEMI).. The cardiac biomarkers, creatine kinase (CK), CK-MB, and troponins T and I are routinely measured after myocardial infarction. However, their correlation with functional and clinical outcomes after PCI for STEMI is not well established.. In the EVOLVE (EValuation Of MCC-135 for Left VEntricular Salvage in Acute Myocardial Infarction) trial, patients were randomized to receive intracellular calcium modulator as adjunct to primary PCI for first large STEMI. Cardiac biomarker levels were determined in 378 patients before PCI and serially up to 72 h. Single-photon emission computed tomography was performed after 5 and 30 days, and patients were monitored up to 180 days.. All single time-point, peak, and area under time-concentration curve of CK, CK-MB, and troponins T and I after PCI significantly correlated with infarct size and LVEF. In particular, 72-h troponin I (TnI72h) correlated strongly with 5-day and 30-day infarct size (r > 0.70; p < 0.001). A TnI72h threshold >55 ng/ml was 90% sensitive for large infarct size (> or =10%) and low LVEF (< or =40%) with specificities of 70% and 52%, respectively (c = 0.88, 0.81; p < 0.001). The highest TnI72h tertile was associated with increased 180-day composite clinical events (23% vs. 23% vs. 42%; p = 0.001) and independently predicted adverse events (hazard ratio = 2.3; p = 0.01).. Assessing TnI72h after primary PCI is a simple, effective method to estimate infarct size, LVEF, and potentially useful for risk stratification.

Topics: Aged; Angioplasty, Balloon, Coronary; Benzenesulfonates; Biomarkers; Cardiovascular Agents; Coronary Angiography; Creatine Kinase, MB Form; Disease-Free Survival; Female; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Myocardial Infarction; Myocardium; Piperazines; Predictive Value of Tests; Proportional Hazards Models; Prospective Studies; Risk Assessment; Stroke Volume; Time Factors; Tomography, Emission-Computed, Single-Photon; Treatment Outcome; Troponin I; Troponin T; United States; Ventricular Function, Left

The aim of this study was to evaluate long-term outcome of patients treated for in-stent restenosis of bare-metal stents (BMS).. Treatment of restenosis of BMS is characterized by high recurrence rates. Vascular brachytherapy (VBT) improved outcome although late catch-up events were documented. Drug-eluting stents tested against VBT in this setting were found superior for at least the first year; superiority at longer follow-up is uncertain.. We evaluated 3-year outcome of the multicenter SISR (Sirolimus-Eluting Stents Versus Vascular Brachytherapy for In-Stent Restenosis) trial, which randomized patients with restenosis of BMS to either a sirolimus-eluting stents (SES) or VBT.. Target vessel failure (cardiac death, infarction, or target vessel revascularization [TVR]) at 9 months as previously reported was significantly improved with SES. Kaplan-Meier analysis at 3 years documented that survival free from target lesion revascularization (TLR) and TVR continues to be significantly improved with SES: freedom from TLR 81.0% versus 71.6% (log-rank p = 0.018), and TVR 78.2% versus 68.8% (log-rank p = 0.022), SES versus VBT. At 3 years, target vessel failure and major adverse cardiac events (death, infarction, emergency coronary artery bypass grafting, or repeat TLR) remained improved with SES, but did not reach statistical significance. There was no statistically significant difference in definite or probable stent thrombosis (3.5% for SES, 2.4% for VBT; p = 0.758).. At 3 years of follow-up, after treatment of in-stent restenosis of BMS, patients treated with SES have improved survival free of TLR and TVR compared with patients treated with VBT. Stent thrombosis rates are not different between the 2 groups but are higher than reported in trials of treatment of de novo lesions.

Topics: Angioplasty, Balloon, Coronary; Brachytherapy; Cardiovascular Agents; Coronary Artery Bypass; Coronary Restenosis; Drug-Eluting Stents; Humans; Kaplan-Meier Estimate; Metals; Myocardial Infarction; Platelet Aggregation Inhibitors; Prospective Studies; Prosthesis Design; Recurrence; Risk Assessment; Sirolimus; Stents; Thrombosis; Time Factors; Treatment Outcome; United States

The TAXUS ATLAS Small Vessel (SV) and Long Lesion (LL) multicenter studies compared the performance of the thin-strut (0.0038 inch) TAXUS Liberté 2.25-mm stent (Boston Scientific; Natick, Massachusetts) and the TAXUS Liberté 38-mm long stent (Boston Scientific; Natick, Massachusetts) with the earlier paclitaxel-eluting TAXUS Express (Boston Scientific) stent that has identical polymer, drug dosage, and release kinetics but different stent geometry and thicker struts (0.0052 inch).. The TAXUS Liberté stent was designed with thinner and more even strut spacing to provide more uniform drug distribution, as well as increased flexibility and conformability. Clinical benefits of the new stent design have not been evaluated.. The TAXUS ATLAS SV and LL studies are nonrandomized studies comparing outcomes of the TAXUS Liberté 2.25 mm (N = 261) and TAXUS Liberté 38 mm (N = 150) stents to TAXUS Express historical control groups derived from the TAXUS IV and V trials. Inclusion/exclusion criteria for TAXUS Express and Liberté groups were similar in both studies.. Each study met its primary end point of noninferiority of 9-month in-segment diameter stenosis. Furthermore, TAXUS Liberté 2.25 mm, when compared with TAXUS Express, significantly reduced the rate of both 9-month angiographic restenosis (18.5% vs. 32.7%, p = 0.0219) and 12-month target lesion revascularization (6.1% vs. 16.9%, p = 0.0039). In addition, TAXUS Liberté 38 mm significantly reduced the risk of 12-month myocardial infarction compared with TAXUS Express (1.4% vs. 6.5%, p = 0.0246).. The thinner-strut TAXUS Liberté stent improved outcomes compared with the earlier TAXUS Express stent in both SVs and LLs (A Study of the TAXUS Liberté Stent for the Treatment of de Novo Coronary Artery Lesions in Small Vessels; NCT00371748; A Study of the TAXUS Liberté Stent for the Treatment of Long De Novo Coronary Artery Lesions; NCT00371475).

Topics: Aged; Angioplasty, Balloon, Coronary; Asia; Cardiovascular Agents; Coronary Angiography; Coronary Restenosis; Drug-Eluting Stents; Female; Humans; Linear Models; Logistic Models; Male; Middle Aged; Myocardial Infarction; North America; Paclitaxel; Platelet Aggregation Inhibitors; Proportional Hazards Models; Prosthesis Design; Risk Assessment; Time Factors; Treatment Outcome

To evaluate the safety and effectiveness of the Zilver vascular stent in the treatment of de novo or restenotic lesions in the external and common iliac arteries.. Regardless of the results of an initial percutaneous transluminal angioplasty (PTA), 151 consecutive patients were implanted with Zilver vascular stents (Cook, Bloomington, Ind) in up to two stenotic (< or =10 cm) or occluded (< or =5 cm) atherosclerotic lesions of the external or common iliac arteries. The primary endpoint was the rate of major adverse events within 9 months after the procedure. Major adverse events were defined as death, myocardial infarction, target lesion revascularization, and limb loss. Secondary endpoints included acute procedural success, 30-day clinical success, 9-month patency rate, 9-month functional status (on the basis of the validated Walking Impairment Questionnaire), and ankle-brachial index (ABI).. of 1-, 6-, and 9-month follow-up are reported. Results The 9-month device and/or procedural-related major adverse event rate (adjudicated by an independent clinical events committee) was 2.7%. The all-cause major adverse event rate was 7.5%. Both rates were substantially below the prespecified objective performance criterion of 16%. The acute procedure success rate and 30-day clinical success rate were 98.0% and 94.0%, respectively. The 9-month patency rate, measured with duplex ultrasonography, was 92.9%. Significant improvement in the ABI and walking distance and walking speed scores, relative to preprocedural values, was seen at 1 month and was maintained through 9-month follow-up.. The Zilver vascular stent is safe and effective as an adjunct to PTA in the treatment of symptomatic disease of the iliac arteries.

Topics: Aged; Amputation, Surgical; Angioplasty, Balloon; Ankle; Arterial Occlusive Diseases; Atherosclerosis; Blood Pressure; Brachial Artery; Cardiovascular Agents; Female; Humans; Iliac Artery; Male; Middle Aged; Myocardial Infarction; Prospective Studies; Prosthesis Design; Radiography; Recovery of Function; Recurrence; Risk Assessment; Stents; Surveys and Questionnaires; Time Factors; Treatment Outcome; United States; Vascular Patency; Walking

KAI-9803, a delta-protein kinase C inhibitor, has been shown to ameliorate injury associated with ischemia and reperfusion in animal models of acute myocardial infarction (MI).. Direct Inhibition of delta-Protein Kinase C Enzyme to Limit Total Infarct Size in Acute Myocardial Infarction (DELTA MI) was a "first-in-human," dose-escalation study that evaluated the safety, tolerability, and activity of KAI-9803 for patients with acute anterior ST-segment elevation MI undergoing primary percutaneous coronary intervention. Patients who presented within 6 hours of symptom onset and had an occluded left anterior descending infarct artery on angiography were randomized in a 2:1 fashion to receive 1 of 4 doses of KAI-9803 (cohort 1, 0.05 mg; cohort 2, 0.5 mg; cohort 3, 1.25 mg; cohort 4, 5.0 mg) versus blinded concurrent placebo delivered in 2 divided doses via intracoronary injection before and after reestablishment of antegrade epicardial flow with percutaneous coronary intervention. Safety and biomarker end points were assessed. Overall, 154 patients were randomized and treated with study drug (37 in cohort 1, 38 in cohort 2, 38 in cohort 3, 41 in cohort 4). The incidence of serious adverse events was similar between patients treated with KAI-9803 versus placebo. Other safety end points, including changes in QT intervals and standard laboratory values after study drug administration, were similar between treatment groups. Although the study was not powered to demonstrate efficacy with the biomarker end points assessed, signs of drug activity with KAI-9803 were suggested by trends for consistent, nonsignificant reductions in creatine kinase-MB area under the curve and ST-recovery area under the curve values across all dosing cohorts with KAI-9803 compared with concurrent placebo, and similar trends were demonstrated for improvements in (99m)technetium sestamibi infarct size values with active study drug in cohorts 1, 2, and 3.. KAI-9803 had an acceptable safety and tolerability profile when delivered via intracoronary injection during primary percutaneous coronary intervention for ST-segment elevation MI. Signs of potential drug activity were demonstrated with biomarker end points in this small exploratory study, indicating that further testing of KAI-9803 as an adjunctive therapy for ST-segment elevation MI is warranted.

Topics: Angioplasty, Balloon, Coronary; Biomarkers; Cardiovascular Agents; Chemotherapy, Adjuvant; Cohort Studies; Combined Modality Therapy; Coronary Angiography; Coronary Vessels; Dose-Response Relationship, Drug; Double-Blind Method; Electrocardiography; Female; Humans; Injections, Intra-Arterial; Male; Middle Aged; Myocardial Infarction; Myocardial Reperfusion; Peptides; Protein Kinase C-delta; Protein Kinase Inhibitors

(1) To evaluate the clinical outcomes of patients with moderate coronary lesions and borderline fractional flow reserve (FFR) measurements (between 0.75 and 0.80), comparing those who underwent coronary revascularization (CR) to those who had medical treatment (MT), and (2) to determine the predictive factors of major adverse cardiac events (MACE) at follow-up.. A total of 107 consecutive patients (mean age 62 +/- 10 years) with at least one moderate coronary lesion (mean percent diameter stenosis 47 +/- 12%) evaluated by coronary pressure wire with FFR measurement between 0.75 and 0.80 (mean 0.77 +/- 0.02) were included in the study. MACE [CR, myocardial infarction (MI), cardiac death) and the presence of angina were evaluated at follow-up.. Sixty-three patients (59%) underwent CR and 44 patients (41%) had MT, with no clinical differences between groups. At a mean follow-up of 13 +/- 7 months, MACE related to the coronary lesion evaluated by FFR were higher in the MT group compared with CR group (23% vs. 5%, P = 0.005). Most MACE consisted of CRs, with no differences between groups in MI and cardiac death rate at follow-up. Both MT and FFR measurements in an artery supplying a territory with previous MI were independent predictive factors of MACE at follow-up, respectively (hazard ratio 5.2, 95% CI 1.4-18.9, P = 0.01; hazard ratio 4.1, 95% CI 1.1-15.3, P = 0.03). The presence of angina at follow-up was more frequent in the MT group compared with the CR group (41% vs. 9%, P = 0.002).. In patients with moderate coronary lesions and borderline FFR measurements deferral of revascularization was associated with a higher rate of MACE (CR) and a higher prevalence of angina at follow-up, especially in those with previous MI in the territory evaluated by FFR. Further prospective randomized studies should confirm whether or not an FFR cut-off point of 0.80 instead of 0.75 would be more appropriate for deferring CR in these cases.

Topics: Aged; Angina Pectoris; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Angiography; Coronary Artery Bypass; Coronary Stenosis; Female; Follow-Up Studies; Fractional Flow Reserve, Myocardial; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Myocardial Infarction; Patient Selection; Proportional Hazards Models; Risk Assessment; Risk Factors; Severity of Illness Index; Time Factors; Treatment Outcome

Despite routine use of coronary artery bypass graft (CABG) and percutaneous coronary intervention (PCI), no conclusive evidence exists that either modality is superior to medical therapy (MT) alone for treating multivessel coronary artery disease with stable angina and preserved ventricular function.. The primary end points were total mortality, Q-wave myocardial infarction, or refractory angina requiring revascularization. The study comprised 611 patients randomly assigned to undergo CABG (n=203), PCI (n=205), or MT (n=203). At the 5-year follow-up, the primary end points occurred in 21.2% of patients who underwent CABG compared with 32.7% treated with PCI and 36% receiving MT alone (P=0.0026). No statistical differences were observed in overall mortality among the 3 groups. In addition, 9.4% of MT and 11.2% of PCI patients underwent repeat revascularization procedures compared with 3.9% of CABG patients (P=0.021). Moreover, 15.3%, 11.2%, and 8.3% of patients experienced nonfatal myocardial infarction in the MT, PCI, and CABG groups, respectively (P<0.001). The pairwise treatment comparisons of the primary end points showed no difference between PCI and MT (relative risk, 0.93; 95% confidence interval, 0.67 to 1.30) and a significant protective effect of CABG compared with MT (relative risk, 0.53; 95% confidence interval, 0.36 to 0.77).. All 3 treatment regimens yielded comparable, relatively low rates of death. MT was associated with an incidence of long-term events and rate of additional revascularization similar to those for PCI. CABG was superior to MT in terms of the primary end points, reaching a significant 44% reduction in primary end points at the 5-year follow-up of patients with stable multivessel coronary artery disease.

Topics: Adrenergic beta-Antagonists; Aged; Angina Pectoris; Angioplasty, Balloon, Coronary; Angiotensin-Converting Enzyme Inhibitors; Calcium Channel Blockers; Cardiovascular Agents; Coronary Artery Bypass; Coronary Disease; Coronary Restenosis; Diet, Fat-Restricted; Disease-Free Survival; Drug Therapy, Combination; Electrocardiography; Endpoint Determination; Female; Follow-Up Studies; Humans; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Male; Middle Aged; Myocardial Infarction; Nitrates; Prognosis; Reoperation; Stents; Survival Analysis; Treatment Outcome

High-density lipoprotein (HDL) cholesterol is an inverse predictor of coronary atherosclerotic disease. Preliminary data have suggested that HDL infusions can induce atherosclerosis regression.. To investigate the effects of reconstituted HDL on plaque burden as assessed by intravascular ultrasound (IVUS).. A randomized placebo-controlled trial was conducted at 17 centers in Canada. Intravascular ultrasound was performed to assess coronary atheroma at baseline and 2 to 3 weeks after the last study infusion.. Between July 2005 and October 2006, 183 patients had a baseline IVUS examination and of those, 145 had evaluable serial IVUS examinations after 6 weeks.. Sixty patients were randomly assigned to receive 4 weekly infusions of placebo (saline), 111 to receive 40 mg/kg of reconstituted HDL (CSL-111); and 12 to receive 80 mg/kg of CSL-111.. The primary efficacy parameter was the percentage change in atheroma volume. Nominal changes in plaque volume and plaque characterization index on IVUS and coronary score on quantitative coronary angiography were also prespecified end points.. The higher-dosage CSL-111 treatment group was discontinued early because of liver function test abnormalities. The percentage change in atheroma volume was -3.4% with CSL-111 and -1.6% for placebo (P = .48 between groups, P<.001 vs baseline for CSL-111). The nominal change in plaque volume was -5.3 mm3 with CSL-111 and -2.3 mm3 with placebo (P = .39 between groups, P<.001 vs baseline for CSL-111). The mean changes in plaque characterization index on IVUS (-0.0097 for CSL-111 and 0.0128 with placebo) and mean changes in coronary score (-0.039 mm for CSL-111 and -0.071 mm with placebo) on quantitative coronary angiography were significantly different between groups (P = .01 and P =.03, respectively). Administration of CSL-111 40 mg/kg was associated with mild, self-limiting transaminase elevation but was clinically well tolerated.. Short-term infusions of reconstituted HDL resulted in no significant reductions in percentage change in atheroma volume or nominal change in plaque volume compared with placebo but did result in statistically significant improvement in the plaque characterization index and coronary score on quantitative coronary angiography. Elevation of HDL remains a valid target in vascular disease and further studies of HDL infusions, including trials with clinical end points, appear warranted.. clinicaltrials.gov Identifier: NCT00225719

Topics: Aged; Angina, Unstable; Apolipoprotein A-I; Cardiovascular Agents; Cholesterol, HDL; Coronary Angiography; Coronary Artery Disease; Female; Humans; Infusions, Intravenous; Male; Middle Aged; Myocardial Infarction; Phosphatidylcholines; Ultrasonography, Interventional

Ranolazine is a novel antianginal agent that reduces ischemia in patients with chronic angina but has not been studied in patients with acute coronary syndromes (ACS).. To determine the efficacy and safety of ranolazine during long-term treatment of patients with non-ST-elevation ACS.. A randomized, double-blind, placebo-controlled, multinational clinical trial of 6560 patients within 48 hours of ischemic symptoms who were treated with ranolazine (initiated intravenously and followed by oral ranolazine extended-release 1000 mg twice daily, n = 3279) or matching placebo (n = 3281), and followed up for a median of 348 days in the Metabolic Efficiency With Ranolazine for Less Ischemia in Non-ST-Elevation Acute Coronary Syndromes (MERLIN)-TIMI 36 trial between October 8, 2004, and February 14, 2007.. The primary efficacy end point was a composite of cardiovascular death, myocardial infarction (MI), or recurrent ischemia through the end of study. The major safety end points were death from any cause and symptomatic documented arrhythmia.. The primary end point occurred in 696 patients (21.8%) in the ranolazine group and 753 patients (23.5%) in the placebo group (hazard ratio [HR], 0.92; 95% confidence interval [CI], 0.83-1.02; P = .11). The major secondary end point (cardiovascular death, MI, or severe recurrent ischemia) occurred in 602 patients (18.7%) in the ranolazine group and 625 (19.2%) in the placebo group (HR, 0.96; 95% CI, 0.86-1.08; P = .50). Cardiovascular death or MI occurred in 338 patients (10.4%) allocated to ranolazine and 343 patients (10.5%) allocated to placebo (HR, 0.99; 95% CI, 0.85-1.15; P = .87). Recurrent ischemia was reduced in the ranolazine group (430 [13.9%]) compared with the placebo group (494 [16.1%]; HR, 0.87; 95% CI, 0.76-0.99; P = .03). QTc prolongation requiring a reduction in the dose of intravenous drug occurred in 31 patients (0.9%) receiving ranolazine compared with 10 patients (0.3%) receiving placebo. Symptomatic documented arrhythmias did not differ between the ranolazine (99 [3.0%]) and placebo (102 [3.1%]) groups (P = .84). No difference in total mortality was observed with ranolazine compared with placebo (172 vs 175; HR, 0.99; 95% CI, 0.80-1.22; P = .91).. The addition of ranolazine to standard treatment for ACS was not effective in reducing major cardiovascular events. Ranolazine did not adversely affect the risk of all-cause death or symptomatic documented arrhythmia. Our findings provide support for the safety and efficacy of ranolazine as antianginal therapy.. clinicaltrials.gov Identifier: NCT00099788.

Topics: Acetanilides; Aged; Angina Pectoris; Cardiovascular Agents; Double-Blind Method; Enzyme Inhibitors; Female; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Myocardial Infarction; Myocardial Ischemia; Piperazines; Proportional Hazards Models; Ranolazine; Recurrence

Analysis of the 3-year outcome of the original population of the TAXi trial which compared the efficacy of the paclitaxel (PES) and the sirolimus (SES) stents in a randomized "real world" investigation.. The widespread use of drug-eluting stents strongly modified the world of interventional cardiology. The TAXi trial was a randomized comparison between PES and SES and showed similar efficacy between the two prostheses. Recently, emerging discussions raised questions about potential long-term risk with the use of DES. The present work attempts to describe the long-term outcome of the patients compared during the TAXi trial.. During April 2003 and January 2004, 202 patients were prospectively randomly assigned to the PES group (102 patients) and to the SES group (100 patients). The primary aim of the present investigation was the comparison of combined incidence of cardiac death, myocardial infarction, and target lesion revascularization within 36-months.. No difference in mortality of all causes was noted in the PES and the SES groups (3% vs. 7%, P=0.98) or in major adverse cardiac event free survival (89% vs. 83%, P=0.28). Four stent thromboses were observed, two in the PES group (205 and 788 days) and two in the SES group (210 and 772 days).. The long-term outcome analysis of the TAXi trial confirms available published data showing the equivalence of PES and SES on clinical basis.

Topics: Aged; Aged, 80 and over; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Cardiovascular Diseases; Female; Follow-Up Studies; Humans; Incidence; Kaplan-Meier Estimate; Male; Middle Aged; Myocardial Infarction; Myocardial Ischemia; Paclitaxel; Prospective Studies; Prosthesis Design; Research Design; Sirolimus; Stents; Thrombosis; Time Factors; Treatment Outcome

Evidence-based medications (EBM) are underused in older patients despite potentially larger absolute benefits. Little is known about factors influencing prescribing in the elderly with acute coronary syndromes.. Among the 15,904 patients from the Sibrafiban vs aspirin to Yield Maximum Protection from ischemic Heart events postacute cOroNary sYndromes (SYMPHONY) and second SYMPHONY trials, we examined the rates of use of EBM according to age (< 75 or > or = 75 years, and 3 subgroups of 5 year increments among patients > or = 75 years).. Ninety-day mortality increased with age (< 75 years, 1.3%; > or = 75 to < 80 years, 4.4%; > or = 80 to < 85 years, 6.0%; > or = 85 years, 9.6%). Compared with subjects < 75 years (n = 14,043), acute EBM use was lower among patients > or = 75 years (n = 1794): aspirin (83% vs 85%), heparin (73% vs 78%), and beta-blockers (70% vs 76%). Similarly, discharge use of beta-blockers (69% vs 76%) and statins (28% vs 40%) was lower, although this was not the case for angiotensin-converting enzyme inhibitors (44% vs 41%). These patterns persisted among eligible patients. Beyond the age of 75 years, EBM use was not further influenced by age except for statins and angiotensin-converting enzyme inhibitors, which were used less frequently in those > or = 85 years. Among patients aged > or = 75 years, prediction for use of each EBM in multivariable modeling was modest (C indices, approximately 0.7); except for statins, increasing age did not predict lower EBM use.. Despite higher mortality risk, EBM use was lower among older patients even considering eligibility. Among those aged > or = 75 years, age was no longer the major factor predicting EBM use. The modest C indices suggest other factors are associated with prescribing, underscoring the need for treatment algorithms and quality assurance measures in older patients.

Topics: Aged; Aged, 80 and over; Angina, Unstable; Aspirin; Cardiovascular Agents; Evidence-Based Medicine; Female; Humans; Male; Myocardial Infarction; Oximes; Piperidines; Platelet Aggregation Inhibitors

The aim of this open randomized study was to compare the clinical efficacy of mildronate in complex therapy of chronic heart failure (CHF) and basic therapy in patients with CHF and type 2 diabetes mellitus (DM2) during the postinfarction period. The subjects were 60 II to III NYHA CHF patients aged 43 to 70 yo also suffering from DM2; the patients were observed during the early postinfarction period (weeks 3 to 4 from the onset of myocardial infarction). The patients were randomized into two groups: the 30 patients of the main group received basic therapy plus mildronate in a dose of 1 g a day, while the 30 patients of the control group received basic therapy only. The observation lasted 16 weeks. The following parameters were measured dynamically: NYHA functional class (FC), 6-min walking test results, left ventricular ejection fraction (LVEF), LV isovolumic relaxation time, microalbuminuria, glomerular filtration speed (GFS), functional renal reserve (FRR), carbohydrate and lipid exchange, cardiac rhythm variability parameters, and the quality of life. The use of mildronate in addition to basic therapy was associated with a more evident decrease in CHF FC, (by 19% vs. 14%), increase in 6-min walking test distance (25.5% vs. 18%), as well as a tendency to normalization of diastolic heart function and an increase in LVEF (by 12% vs. 7%). By comparison with basic therapy, the patients in the mildronate group displayed a statistically significant improvement in renal functioning: GFS increased by 20% vs. 2% (p < 0.05), the proportion of patients with an exhausted FRR decreased (p < 0.05), the average level of MAU decreased significantly (24% vs. 9%, p < 0.05). In the main group, a significant decrease in blood triglyceride level (by 33%, p < 0.05) and total cholesterol level (by 28%, p < 0.1) was noted. A hypoglycemizing ability of mildronate was noted. The use of mildronate in the basic therapy favors the normalization of vegetative homeostasis and improves the quality of life.

Topics: Cardiovascular Agents; Chronic Disease; Diabetes Mellitus, Type 2; Female; Heart Failure; Humans; Male; Methylhydrazines; Middle Aged; Myocardial Infarction; Prospective Studies

Insulin has a free fatty acid (FFA)-suppressive effect, vascular endothelial growth factor (VEGF)- and matrix metalloproteinase (MMP)-lowering effect, and a potential myocardial-protective effect. Whether low-dose insulin exerts these effects in patients with acute myocardial infarction (MI) was investigated. Thirty-two patients administered thrombolytics and heparin were randomly assigned to a modified glucose-insulin-potassium (GIK) regimen (insulin 2.5 U/hour, dextrose and potassium titrated to prevent hyperglycemia) or normal saline solution and potassium (controls) for 48 hours. Plasma FFA, serum VEGF, pro-MMP-1, and myoglobin were measured at baseline and sequentially for 48 hours. FFA concentrations were increased at baseline; increased further in the first 4 hours in controls (p

Topics: Cardiovascular Agents; Electrocardiography; Fatty Acids, Nonesterified; Female; Glucose; Humans; Insulin; Male; Matrix Metalloproteinase 1; Middle Aged; Myocardial Infarction; Myocytes, Cardiac; Myoglobin; Potassium; Vascular Endothelial Growth Factor A

The aim of the work was to study the effect of metabolic triad with different mechanisms of acting--high-dose Glucose-Insulin-Potassium--25% polarizing solution (25% glucose, 50 IU soluble insulin and 4% 144 ml KCL-GIK), mildronat, preductal MR on the functional condition of heart during the acute myocardial infarction. 20 patients from the main group and 20 from the control one have been under the study. Patients with diabetes and heavy forms of heart failure (killip class>2) were not included in the study. Evaluation of the functional condition of heart was based on ECG and echocardiography data received before and after the treatment. It was determined that the frequency of the rhythm disorder decreases in the conditions of metabolic triad as well as during the thrombolitic reperfusion. Average period of time for normalization of S-T segment elevation made up 5.4+/-1.8 days and 7.3+/-1.2 days in case of the control group. The received data make it relevant to include the complex metabolic triad for preventive purpose during the complications followed after the acute myocardial infarction.

Topics: Adult; Aged; Cardiovascular Agents; Drug Therapy, Combination; Female; Glucose; Humans; Insulin; Male; Methylhydrazines; Middle Aged; Myocardial Infarction; Potassium; Trimetazidine; Vasodilator Agents

Myocardial injury during coronary intervention occurs in 10-40% of cases and is often characterized by a slight increase of markers of myocardial necrosis, without symptoms, electrocardiographic changes or impairment of cardiac function. However, even small increases of creatine kinase-MB levels are expression of a true and detectable infarction, and may be associated with higher follow-up mortality. The cause of CK-MB elevation in case of procedural complications (dissection, transient vessel closure, no reflow, side branch occlusion etc.) is obvious; however, most cases of minor CK-MB elevation occur in patients with uncomplicated procedure with excellent final angiographic results. It has been suggested that the main mechanism explaining occurrence of myocardial necrosis during otherwise successful coronary interventions may be distal microembolization of plaque components, an enhanced inflammatory state or due to total plaque burden and/or to plaque instability. Different treatments have been proposed to prevent myocardial injury during coronary intervention, including nitrate infusion, intracoronary beta-blockers, adenosine, clopidogrel and IIb/IIIa inhibitors, but none of those (apart from the use of IIb/IIIa inhibitors) has been routinely introduced in clinical practice. We performed the ARMYDA (Atorvastatin for Reduction of MYocardial Damage during Angioplasty) trial, i.e. the first prospective, randomised, placebo controlled study to evaluate effects of 7 days of pre-treatment with a fixed dose of atorvastatin (40 mg/day) on post-procedural release of markers of myocardial damage in patients with stable angina undergoing percutaneous intervention. In this study therapy with atorvastatin has been associated with 80% risk reduction on the occurrence of peri-procedural myocardial infarction, as well as with significant reduction of post-intervention peak levels of all markers of myocardial damage. The mechanisms underlying the beneficial effects of atorvastatin may be an inflammatory action reducing myocardial necrosis due to microembolization, an improvement of endothelial function on microcirculation, and direct protection of myocardium.

Topics: Aged; Angioplasty, Balloon, Coronary; Atorvastatin; Biomarkers; Cardiovascular Agents; Double-Blind Method; Drug Administration Schedule; Female; Heptanoic Acids; Humans; Male; Middle Aged; Myocardial Infarction; Prospective Studies; Pyrroles; Treatment Outcome

To study the 5-year outcome of patients treated with gold-coated stent placement.. We have previously shown in the setting of a randomized trial that gold-coated stents are associated with worse mid-term outcome, mainly because of an increased risk of restenosis, compared to uncoated stents. The long-term outcome and, in particular, mortality risk after implantation of gold-coated stents are not known.. A total of 731 patients with symptoms or signs of ischemia received randomly either a gold-coated (n = 367) or an uncoated steel stent (n = 364) of identical design. Patients were clinically followed-up at 1 and 5 years. The primary endpoint of the study was the composite of major cardiac events (death, myocardial infarction, or target vessel revascularization (TVR)). The incidence of death was a secondary endpoint.. Five-year follow-up was available in 97.5% of the patients. The composite of death, myocardial infarction, or TVR occurred in 51% of the patients treated with gold-coated stents and 40% of the patients treated with uncoated stents (P = 0.005). Of note, there was a marked increase in the absolute difference in mortality between patients in the gold-coated and uncoated stent groups, from 1.6% at 1 year to 4.9% after 5-year follow-up (P = 0.09). A multivariate analysis showed that gold-coated stent implantation was independently associated with 5-year mortality (hazard ratio, 1.46; 95% confidence interval, 1.02-2.09; P = 0.04).. Gold-coated stents are associated with a sustained increased overall risk for major cardiac events, and notably, they may increase the long-term mortality risk.

Topics: Aged; Blood Vessel Prosthesis Implantation; Cardiovascular Agents; Coated Materials, Biocompatible; Coronary Angiography; Coronary Restenosis; Coronary Stenosis; Female; Follow-Up Studies; Germany; Gold; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Multivariate Analysis; Myocardial Infarction; Predictive Value of Tests; Risk Factors; Stents; Survival Analysis; Time Factors; Treatment Outcome

To determine the effects of n3-PUFA supplementation, in the dose used in the GISSI-Prevenzione study, on indices of heart rate variability (HRV) in patients following myocardial infarction (AMI).. Open label randomised single blind controlled trial. Thirty eight patients post AMI, stable on standard secondary prevention drug therapy were single blind randomised to receive either Omacor 1 g/day (n = 21) or usual care (n = 17). HRV indices (time and frequency-domain) were measured at baseline and following 3 months of treatment.. At baseline there were no significant differences in clinical, biochemical or HRV indices between patient groups. After 3 months therapy there were no observed changes in measured HRV indices in either the Omacor supplemented or 'usual care' groups.. Three month supplementation of omega 3 PUFA (Omacor) 1 g/day has no effect on HRV is patients post AMI.

Topics: Cardiovascular Agents; Docosahexaenoic Acids; Drug Combinations; Eicosapentaenoic Acid; Female; Heart Rate; Humans; Male; Middle Aged; Myocardial Infarction

Pretreatment is not the most common strategy practiced for clopidogrel administration in elective coronary stenting. Moreover, limited information is available on the antiplatelet pharmacodynamics of a 300-mg versus a 600-mg clopidogrel loading dose, and the comparative effect of eptifibatide with these regimens is unknown.. Patients undergoing elective stenting (n=120) were enrolled in a 2x2 factorial study (300 mg clopidogrel with or without eptifibatide; 600 mg clopidogrel with or without eptifibatide) (Clopidogrel Loading With Eptifibatide to Arrest the Reactivity of Platelets [CLEAR PLATELETS] Study). Clopidogrel was administered immediately after stenting. Aggregometry and flow cytometry were used to assess platelet reactivity. Eptifibatide added a > or =2-fold increase in platelet inhibition to 600 mg clopidogrel alone at 3, 8, and 18 to 24 hours after stenting as measured by 5 micromol/L ADP-induced aggregation (P<0.001). Without eptifibatide, 600 mg clopidogrel produced better inhibition than 300 mg clopidogrel at all time points (P<0.001). Glycoprotein IIb/IIIa (GPIIb/IIIa) blockade was associated with lower cardiac marker release. Active GPIIb/IIIa expression was inhibited most in the groups treated with eptifibatide (P<0.05).. In elective stenting without clopidogrel pretreatment, use of a GPIIb/IIIa inhibitor produces superior platelet inhibition and lower myocardial necrosis compared with high-dose (600 mg) or standard-dose (300 mg) clopidogrel loading alone. In the absence of a GPIIb/IIIa inhibitor, 600 mg clopidogrel provides better platelet inhibition than the standard 300-mg dose. These results require confirmation in a large-scale clinical trial.

Topics: Adult; Aged; Aged, 80 and over; Angina Pectoris; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Clopidogrel; Coronary Stenosis; Coronary Thrombosis; Dose-Response Relationship, Drug; Drug Synergism; Drug Therapy, Combination; Eptifibatide; Female; Humans; Male; Middle Aged; Myocardial Infarction; Myocardium; Necrosis; Peptides; Platelet Aggregation; Platelet Aggregation Inhibitors; Platelet Glycoprotein GPIIb-IIIa Complex; Premedication; Risk Factors; Stents; Ticlopidine

The combination of reperfusion therapy and high-dose glucose-insulin-potassium (GIK) infusion seems beneficial in acute myocardial infarction (MI). Current evidence, however, is not considered conclusive.. The Glucose-Insulin-Potassium Study-2 (GIPS-2) will investigate whether GIK, in adjunction to reperfusion therapy, is beneficial in MI patients without signs of heart failure at admission. A total of at least 1044 patients with an acute MI treated with either thrombolysis or primary percutaneous coronary intervention will be randomized to an infusion of high-dose GIK or no infusion. The primary end point of the study is 30-day mortality. Secondary end points are mortality at 1 year, recurrence of MI, repeat intervention, and infarct size.. If high-dose GIK significantly reduces mortality at 30 days in all patients, the adjunction of this treatment to reperfusion therapy may become part of standard regimen for patients with acute MI without heart failure.

Topics: Algorithms; Angioplasty, Balloon, Coronary; Apoptosis; Cardiovascular Agents; Combined Modality Therapy; Electrocardiography; Endpoint Determination; Energy Metabolism; Fatty Acids, Nonesterified; Glucose; Humans; Informed Consent; Infusions, Intravenous; Insulin; Myocardial Infarction; Myocardial Reperfusion Injury; Myocardium; Netherlands; Patient Selection; Potassium; Research Design; Sample Size; Thrombolytic Therapy

Experimental and clinical evidence has recently shown that pluripotent stem cells can be mobilized by granulocyte colony-stimulating factor (G-CSF) and may enhance myocardial regeneration early after primary percutaneous coronary intervention (PCI) management of acute myocardial infarction. Sustained or long-term effects of mobilized CD34-positive mononuclear stem cells, however, are unknown.. Thirty consecutive patients with ST-elevation myocardial infarction undergoing primary PCI with stenting and abciximab were selected for the study 85+/-30 minutes after PCI; 15 patients were randomly assigned to receive subcutaneous G-CSF at 10 microg/kg body weight for 6 days in addition to standard care including aspirin, clopidogrel, an angiotensin-converting enzyme inhibitor, beta-blocking agents, and statins. In patients with comparable demographics and clinical and infarct-related characteristics, G-CSF stimulation led to sustained mobilization of CD34 positive mononuclear cells (MNC(CD34+)), with a 20-fold increase (from 3+/-2 at baseline to 66+/-54 MNC(CD34+)/microL on day 6; P<0.001); there was no evidence of leukocytoclastic effects, accelerated restenosis rate, or any late adverse events. Within 4 months, G-CSF-induced MNC(CD34+) mobilization led to enhanced resting wall thickening in the infarct zone of 1.16+/-0.29 mm (P<0.05 versus control), which was sustained at 1.20+/-0.28 after 12 months (P<0.001 versus control). Similarly, left ventricular ejection fraction improved from 48+/-4% at baseline to 54+/-8% at 4 months (P<0.005 versus control) and 56+/-9% at 12 months (P<0.003 versus control and paralleled by sustained improvement of wall-motion score index from 1.70+/-0.22 to 1.42+/-0.26 and 1.33+/-0.21 at 4 and 12 months, respectively), after G-CSF (P<0.05 versus baseline and P<0.03 versus controls). Accordingly, left ventricular end-diastolic diameter showed no remodeling and stable left ventricular dimensions after G-CSF stimulation, whereas left ventricular end-diastolic diameter in controls revealed enlargement from 55+/-4 mm at baseline to 58+/-4 mm (P<0.05 versus baseline) at 12 months after infarction and no improvement in diastolic function.. Mobilization of MNC(CD34+) by G-CSF after primary PCI may offer a pragmatic strategy for improvement in ventricular function and prevention of left ventricular remodeling 1 year after acute myocardial infarction.

Topics: Abciximab; Adult; Angioplasty, Balloon, Coronary; Antibodies, Monoclonal; Anticoagulants; Blood Cell Count; Cardiovascular Agents; Combined Modality Therapy; Coronary Angiography; Drug Therapy, Combination; Female; Follow-Up Studies; Granulocyte Colony-Stimulating Factor; Hematopoietic Stem Cell Mobilization; Hematopoietic Stem Cells; Humans; Immunoglobulin Fab Fragments; Male; Middle Aged; Myocardial Infarction; Postoperative Care; Prospective Studies; Stents; Treatment Outcome; Ventricular Function, Left; Ventricular Remodeling

Stent implantation for isolated stenosis of the proximal left anterior descending coronary artery (LAD) with preserved left ventricular function has been found to have a better clinical and angiographic outcome at one year than balloon angioplasty (PTCA).. To establish whether those results are maintained at five year follow up.. Patients were followed at least every six months. For those who died during follow up, data were obtained from medical records.. Freedom from death, non-fatal myocardial infarction, cerebrovascular accident, and repeated target lesion revascularisation. Secondary end points were revascularisation in a remote region and freedom from angina.. Follow up was complete in all patients. At five years, the primary end point was reached more often by patients randomised to stent implantation than to PTCA (80% v 53%; odds ratio (OR) 0.29 (95% confidence interval (CI) 0.13 to 0.69); p = 0.0034). In the PTCA group, 35% of patients underwent target lesion revascularisation v 15% in the stent group (OR 0.33, 95% CI 0.13 to 0.80; p = 0.014). There was a trend towards increased mortality in the PTCA group than in the stent group (17% v 7%; OR 0.36, 95% CI 0.10 to 1.21; p = 0.098). No significant differences were found between PTCA and stent groups for non-fatal myocardial infarction (8% v 5%; OR 0.58, 95% CI 0.13 to 2.54; p = 0.46) or cerebrovascular accident (2% v 0%).. In patients with isolated stenosis of the proximal LAD, a five year clinical follow up confirmed a better outcome in those treated with stenting than with PTCA.

Topics: Acute Disease; Angina Pectoris; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Angiography; Coronary Stenosis; Follow-Up Studies; Humans; Myocardial Infarction; Myocardial Ischemia; Myocardial Revascularization; Stents; Treatment Outcome

Implantation of bone-marrow stem cells in the heart might be a new method to restore tissue viability after myocardial infarction. We injected up to 1.5x10(6) autologous AC133+ bone-marrow cells into the infarct border zone in six patients who had had a myocardial infarction and undergone coronary artery bypass grafting. 3-9 months after surgery, all patients were alive and well, global left-ventricular function was enhanced in four patients, and infarct tissue perfusion had improved strikingly in five patients. We believe that implantation of AC133+ stem cells to the heart is safe and might induce angiogenesis, thus improving perfusion of the infarcted myocardium. See Commentary page 11

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Artery Bypass; Hematopoietic Stem Cell Transplantation; Humans; Male; Middle Aged; Myocardial Infarction

This study was designed to compare the long-term consequences of percutaneous transluminal coronary angioplasty (PTCA) and continued medical treatment.. The long-term effects of percutaneous coronary intervention need evaluating, especially in comparison with an alternative policy of continued medical treatment.. The Second Randomized Intervention Treatment of Angina (RITA-2) is a randomized trial of PTCA versus conservative (medical) care in 1,018 patients considered suitable for either treatment option. Information on clinical events, interventions, and symptoms is available for a median seven years follow-up.. Death or myocardial infarction (MI) occurred in 73 (14.5%) PTCA patients and 63 (12.3%) medical patients (difference +2.2%, 95% confidence interval -2.0% to +6.4%, p = 0.21). There were 43 deaths in both groups, of which 41% were cardiac-related. Among patients assigned PTCA 12.7% subsequently had coronary artery bypass grafts, and 14.5% required additional non-randomized PTCA. Most of these re-interventions occurred within a year of randomization, and after two years the re-intervention rate was 2.3% per annum. In the medical group, 35.4% required myocardial revascularization: 15.0% in the first year and an annual rate of 3.6% after two years. An initial policy of PTCA was associated with improved anginal symptoms and exercise times. These treatment differences narrowed over time, mainly because of coronary interventions in medical patients with severe symptoms.. In RITA-2 an initial strategy of PTCA did not influence the risk of death or MI, but it improved angina and exercise tolerance. Patients considered suitable for PTCA or medical therapy can be safely managed with continued medical therapy, but percutaneous intervention is appropriate if symptoms are not controlled.

Topics: Angina Pectoris; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Artery Bypass; Exercise Test; Female; Humans; Longitudinal Studies; Male; Middle Aged; Myocardial Infarction; Severity of Illness Index; Treatment Outcome; United Kingdom

To assess antiischemic efficacy, safety and effect on myocardial perfusion of a course treatment with mildronate (as monotherapy and in combination with atenolol) in patients with postinfarction left ventricular dysfunction associated with moderate heart failure.. Patients (n=47) with postinfarction cardiosclerosis, angina, and decreased tolerance to physical exertion were divided into 2 groups. Patients of group 1 had functional class II angina and NYHA class I-II heart failure, patients of group 2 had functional class II-III angina and severe heart failure. Mildronate (0.75-1.0 g/day) was used as monotherapy in group 1 and in combination with atenolol (25-50 mg/day) in group 2. Duration of therapy was 3 weeks.. The use of mildronate was associated with marked antiischemic effect. Combined administration of mildronate and atenolol resulted in additional antiischemic effect without impairment of hemodynamics in patients with severe heart failure. Course use of mildronate was well tolerated. Adverse effects were registered in 4,2% of cases.

Topics: Adrenergic beta-Antagonists; Atenolol; Cardiovascular Agents; Drug Therapy, Combination; Humans; Male; Methylhydrazines; Middle Aged; Mitochondrial Trifunctional Protein; Multienzyme Complexes; Myocardial Infarction; Ventricular Dysfunction, Left

Restenosis after percutaneous coronary intervention (PCI) is a major problem affecting 15% to 30% of patients after stent placement. No oral agent has shown a beneficial effect on restenosis or on associated major adverse cardiovascular events. In limited trials, the oral agent tranilast has been shown to decrease the frequency of angiographic restenosis after PCI.. In this double-blind, randomized, placebo-controlled trial of tranilast (300 and 450 mg BID for 1 or 3 months), 11 484 patients were enrolled. Enrollment and drug were initiated within 4 hours after successful PCI of at least 1 vessel. The primary end point was the first occurrence of death, myocardial infarction, or ischemia-driven target vessel revascularization within 9 months and was 15.8% in the placebo group and 15.5% to 16.1% in the tranilast groups (P=0.77 to 0.81). Myocardial infarction was the only component of major adverse cardiovascular events to show some evidence of a reduction with tranilast (450 mg BID for 3 months): 1.1% versus 1.8% with placebo (P=0.061 for intent-to-treat population). The primary reason for not completing treatment was > or =1 hepatic laboratory test abnormality (11.4% versus 0.2% with placebo, P<0.01). In the angiographic substudy composed of 2018 patients, minimal lumen diameter (MLD) was measured by quantitative coronary angiography. At follow-up, MLD was 1.76+/-0.77 mm in the placebo group, which was not different from MLD in the tranilast groups (1.72 to 1.78+/-0.76 to 80 mm, P=0.49 to 0.89). In a subset of these patients (n=1107), intravascular ultrasound was performed at follow-up. Plaque volume was not different between the placebo and tranilast groups (39.3 versus 37.5 to 46.1 mm(3), respectively; P=0.16 to 0.72).. Tranilast does not improve the quantitative measures of restenosis (angiographic and intravascular ultrasound) or its clinical sequelae.

Topics: Administration, Oral; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Angiography; Coronary Restenosis; Double-Blind Method; Female; Follow-Up Studies; Humans; Male; Middle Aged; Myocardial Infarction; ortho-Aminobenzoates; Treatment Outcome; Ultrasonography

Topics: Aged; Angina, Unstable; Anticholesteremic Agents; Atorvastatin; Cardiovascular Agents; Drug Therapy, Combination; Female; Follow-Up Studies; Heptanoic Acids; Humans; Hypercholesterolemia; Male; Middle Aged; Myocardial Infarction; Pyrroles; Recurrence; Survival Rate

25 survivors of primary macrofocal myocardial infarction (MI) were treated for a year with children. The response in 9(36%) patients was achieved with a single dose 180 mg, in 16(64%) patients with concomitant arterial hypertension the dose was raised to 300 mg. No fatal outcomes were registered. Repeated IM developed in 4(16%) patients. 15(60%) patients improved, deterioration was seen in 4(16%) patients. Dilren-induced complications occurred in 3(12%) patients.

Topics: Adult; Cardiovascular Agents; Diltiazem; Humans; Male; Middle Aged; Myocardial Infarction; Treatment Outcome

The performance of the cardiovascular system depends on the interaction of the left ventricle and arterial system. An appropriate coupling of these two components is important to quantify the efficiency of myocardium, determined by Ea/Ees. The end-systolic elastance of the left ventricle (Ees) is an index of contractility which is independent of loading conditions, while the arterial end-systolic elastance (Ea) represents the properties of the arterial system. The aim of our study is to investigate the effects of a bolus of remifentanil (R) on myocardial efficiency.. In a period of 3 months we examined prospectively the effects of R in a group of 12 patients, ASA IV, 49-75 years old, submitted intraoperatively to cardiac anesthesia for revascularization of myocardium. After induction of anesthesia and before the beginning of surgery, a bolus of R (1 mg/kg/min) was administered and with the use of trans-esophageal echocardiography we determined both the left ventricle end-systolic volume and end-diastolic volume to assess, with different end-systolic arterial pressures, the ventricle elastance (Ees) and arterial elastance (Ea) before and after administration of R.. The present findings indicate that R decreases the ventricular elastance from 6.07 mmHg/ml/m2 to 4.8, with a less decrease of arterial elastance from 3.69 mmHg/ml/m2 to 3.07.. The results suggest that R preserves a good left ventricular-arterial coupling and mechanical efficiency, despite a little increase of coupling, probably because ventricular and arterial properties are so matched as to minimize the systolic work of the left ventricle.

Topics: Aged; Anesthetics, Intravenous; Aorta; Cardiovascular Agents; Combined Modality Therapy; Coronary Artery Bypass; Coronary Disease; Echocardiography, Transesophageal; Electric Impedance; Female; Heart Failure; Heart Rate; Hemorheology; Humans; Injections, Intravenous; Male; Middle Aged; Myocardial Contraction; Myocardial Infarction; Oxygen Consumption; Piperidines; Propofol; Prospective Studies; Remifentanil; Stroke Volume; Thiopental; Vascular Resistance; Vecuronium Bromide; Ventricular Function, Left

Recent clinical trials have demonstrated a better ability of low-molecular-weight heparin, compared to unfractionated heparin, in reducing ischemic cardiac events in patients with acute coronary syndromes without ST-segment elevation. No data are available concerning the in-vivo comparison of enoxaparin and unfractionated heparin on thrombin generation in patients with unstable angina or non-Q-wave myocardial infarction. We measured the plasma levels of prothrombin fragment 1+2 (a marker of prothrombin activation) and thrombin/antithrombin complex (a marker of thrombin generation) in 45 patients with non ST-elevation acute coronary syndromes who were randomized to receive enoxaparin, 3000 IU anti-Xa as an i. v. bolus, followed by 70 IU anti-Xa/Kg every 8 h for 3 days (23 pts. Group 1) or a bolus of 100 IU/kg of unfractionated heparin followed by infusion for 3 days titrated to maintain the aPTT between 70 and 90 s (22 pts, Group 2). Plasma levels of prothrombin fragment 1+2 reduced significantly at 3rd h of treatment in both groups (-42% in Group 1 and -45% in Group 2), reached the lowest plasma concentration at the 24th h and exhibited a slight increase at the 72nd h; no differences were observed between the two groups at any time points. Plasma thrombin/antithrombin complex levels had a similar behaviour: reduced markedly in both groups at the 3rd h (-52% in Group 1 and -46% in Group 2), remained lower during the first two days and slightly rose at 72nd h. No differences between the two groups in plasma levels of this marker were apparent during drug infusion. In Group 1 the aPTT did not show significant changes: in Group 2 the mean value of aPTT doubled the basal value at any time point of determination. Both enoxaparin and unfractionated heparin produced a marked and similar reduction of thrombin generation. Other unknown mechanisms might explain the different clinical effects of the two heparins.

Topics: Acute Disease; Aged; Angina, Unstable; Anticoagulants; Antithrombin III; Biomarkers; Cardiovascular Agents; Comorbidity; Coronary Thrombosis; Drug Therapy, Combination; Electrocardiography; Enoxaparin; Female; Heparin; Humans; Male; Middle Aged; Myocardial Infarction; Partial Thromboplastin Time; Peptide Fragments; Peptide Hydrolases; Prothrombin; Risk Factors; Thrombin; Treatment Outcome

The purpose of this study was to examine the effect of diltiazem on cardiac function and neurohumoral factors (BNP, epinephrine, norepinephrine) after reperfused myocardial infarction without congestive heart failure (Killip class I). On the first day after myocardial infarction following reperfusion therapy patients were randomly assigned to diltiazem treatment (group 1, n=33) or no treatment (group 2, n=39). We then performed echocardiographic examinations on the patients and measured heart rate, mean blood pressure and neurohormones (BNP, epinephrine and norepinephrine). Follow-up evaluations of echocardiography were performed at 4 and 12 weeks and of neurohormones at 1 and 4 weeks after acute myocardial infarction. The highest peaks of plasma BNP, epinephrine, and norepinephrine levels were observed before treatment and decreased with time in both groups. After 4 weeks the level of plasma BNP in the diltiazem treatment group was lower than in the no treatment group [55+/-3 pg/mL vs 85+/-5 pg/mL (P < 0.05)]. Other neurohormones did not differ between groups. Fractional shortening (FS) and ejection fraction (EF)improved after myocardial infarction in both groups, but significantly more in the diltiazem group (P < 0.05) after 12 weeks of treatment. Changes in BNP correlated significantly with changes in left ventricular end systolic volumes, FS and EF. In this study, diltiazem significantly improved systolic function and reduced the level of plasma BNP after myocardial infarction, which suggest that diltiazem may have a beneficial effect on myocardial infarction without congestive heart failure.

Topics: Aged; Blood Pressure; Cardiovascular Agents; Diltiazem; Echocardiography; Epinephrine; Female; Heart; Heart Failure; Heart Function Tests; Heart Rate; Humans; Male; Middle Aged; Myocardial Infarction; Myocardial Reperfusion Injury; Natriuretic Peptide, Brain; Neurotransmitter Agents; Norepinephrine; Prospective Studies; Time Factors; Ventricular Function, Left

Previous studies have suggested suboptimal use of cardiac medications for secondary prevention after myocardial infarction (MI) and atrial fibrillation (AF), especially among older people.. To determine whether patients older than 75 years are less likely than those aged 65 to 74 to be prescribed medications with evidence-based indications, including angiotensin-converting enzyme (ACE) inhibitors for left ventricular dysfunction (LVD) and/or diabetes mellitus (DM), aspirin and/or beta-blockers for those with a history of MI, and warfarin for chronic AF.. A retrospective cohort study.. Twenty-nine hospitals, predominantly tertiary-care institutions.. A total of 407 patients randomized to ventricular or dual-chamber pacing from February 26, 1993, to September 30, 1994, in the Pacemaker Selection in the Elderly (PASE) trial.. A review of the patient's medical history and a physical exam at study enrollment, three follow-up timepoints, and a study closeout.. Patients older than 75 years with LVD and/or DM were less likely to be prescribed ACE inhibitors (OR = .56 (0.31-1.00)); patients older than 75 with a history of MI were less likely to be taking aspirin (OR = .43 (0.19-.95)), and patients older than 75 with AF were less likely to be prescribed warfarin (OR = .18 (0.05-.61)). Patients older than 75 years of age with any or all of the conditions studied were less likely to be prescribed indicated medications than those ages 65 to 74 (OR = .35 (0.18-.70)), after controlling for between-group differences in comorbidity, gender, and number of noncardiac medications.. Older age is a significant independent negative correlate of evidence-based cardiac medication use in this cohort. Causes for this finding need to be explored.

Topics: Aged; Aged, 80 and over; Atrial Fibrillation; Cardiovascular Agents; Combined Modality Therapy; Comorbidity; Diabetes Mellitus; Drug Therapy, Combination; Drug Utilization; Female; Frail Elderly; Humans; Male; Myocardial Infarction; Pacemaker, Artificial; Retrospective Studies; Single-Blind Method; Ventricular Dysfunction, Left

To assess the impact of fee-for-service (FFS) versus HMO medical insurance coverage on receipt of aspirin, beta-blockers, and calcium channel blockers at the time of hospital discharge following an acute myocardial infarction.. Prospective, population-based study.. All 16 community and tertiary care hospitals in the metropolitan area of Worcester, Massachusetts.. The study population consisted of patients under 65 years of age hospitalized with a validated acute myocardial infarction in all hospitals in the Worcester (Massachusetts) Standard Metropolitan Statistical Area (1990 census estimate, 437,000) during 1986, 1988, 1990, 1991, and 1993.. After adjustment for demographic and clinical variables as well as study year, the odds ratios for receipt of each medication for patients with HMO insurance compared with FFS were 1.05 (95% confidence interval [CI] 0.77, 1.44) for aspirin, 1.32 (95% CI 0.98, 1.76) for beta-blockers, and 0.72 (95% CI 0.54, 0.96) for calcium channel blockers. Examination of temporal trends in utilization of these agents suggests that observed decreases in use of calcium channel blockers and increases in use of beta-blockers over the period under study occurred more rapidly for HMO than for FFS patients.. Overall, use of aspirin and beta-blockers was comparable among HMO and FFS patients and use of calcium channel blockers (deemed less effective or ineffective for secondary prevention) was lower among HMO patients. Differential adoption, over time, of evidence-based prescribing practices for medications between HMO and FFS patients who have had a myocardial infarction warrants further study.

Topics: Adrenergic beta-Antagonists; Adult; Aspirin; Calcium Channel Blockers; Cardiovascular Agents; Confidence Intervals; Drug Utilization; Fee-for-Service Plans; Female; Health Maintenance Organizations; Humans; Male; Massachusetts; Middle Aged; Multivariate Analysis; Myocardial Infarction; Odds Ratio; Patient Discharge; Population Surveillance; Prospective Studies

Oxidized low-density lipoprotein is involved in the pathogenesis of atherosclerosis. In epidemiological studies antioxidants have been inversely related with coronary heart disease. Findings from controlled trials are inconclusive.. We studied the primary preventive effect of vitamin E (alpha tocopherol) and beta carotene supplementation on major coronary events in the Alpha-Tocopherol, Beta-Carotene Cancer Prevention Study, a controlled trial undertaken primarily to examine the effects of these agents on cancer. A total of 27 271 Finnish male smokers aged 50 to 69 years with no history of myocardial infarction were randomly assigned to receive vitamin E (50 mg), beta carotene (20 mg), both agents, or placebo daily for 5 to 8 years (median, 6.1 years). The end point was the first major coronary event, either nonfatal myocardial infarction (surviving at least 28 days; n = 1204) or fatal coronary heart disease (n = 907).. The incidence of primary major coronary events decreased 4% (95% confidence interval, -12% to 4%) among recipients of vitamin E and increased 1% (95% confidence interval, -7% to 10%) among recipients of beta carotene compared with the respective nonrecipients. Neither agent affected the incidence of nonfatal myocardial infarction. Supplementation with vitamin E decreased the incidence of fatal coronary heart disease by 8% (95% confidence interval, -19% to 5%), but beta carotene had no effect on this end point.. Supplementation with a small dose of vitamin E has only marginal effect on the incidence of fatal coronary heart disease in male smokers with no history of myocardial infarction, but no influence on nonfatal myocardial infarction. Supplementation with beta carotene has no primary preventive effect on major coronary events.

Topics: Aged; beta Carotene; Cardiovascular Agents; Coronary Disease; Dietary Supplements; Female; Humans; Incidence; Male; Middle Aged; Myocardial Infarction; Risk; Treatment Outcome; Vitamin E

The impairment of intracellular calcium homeostasis is an important biochemical alteration in stunned and hibernating myocardium. These different forms of viable myocardium frequently occur after myocardial infarction and their recognition may modify the therapeutic program and prognosis. Experimental studies and experiences on male subjects have demonstrated that calcium-channel blockers exert a protective action on myocardial reperfusion injury and reduce infarct size.. The aim of the present study was to evaluate the efficacy of i.v. diltiazem (i.e. a calcium-channel blocker with negative inotropic effect) in enhancing the contractility of viable akinetic myocardium in patients after myocardial infarction.. Sixty patients (52 males and 8 females, age 57 +/- 10 years) with the first acute myocardial infarction were evaluated with dobutamine-echocardiography 9 +/- 2 days after admission and on the following day with diltiazem-echocardiography. Diltiazem was administered i.v. using repeated boluses of 0.25 mg/kg up to the maximum dose of 1 mg/kg. Before and during the infusion, left ventricular regional function was scored and the Wall Motion Score Index (WMSI) was calculated; ECG and arterial blood pressure were also monitored. Results were compared with low-dose dobutamine-echocardiography. In a subset of 13 patients who underwent myocardial revascularization (7 coronary artery by-pass graftings and 6 percutaneous transluminal angioplasties), post-procedure echocardiograms were performed to evaluate whether regional left ventricular function had improved.. Low-dose dobutamine and diltiazem enhanced regional left ventricular contractility in 28 and 31 patients, respectively; both tests were positive in 26 cases. Conversely, dobutamine-test was negative in 32 patients and diltiazem in 29, with concordance in 27. A good correlation was found between diltiazem and dobutamine WMSI at the basal evaluation (r = 0.91; p < 0.000) as well as during the pharmacological test (r = 0.86; p < 0.000). In patients who underwent myocardial revascularization, the same good correlation was found between diltiazem-WMSI and WMSI evaluated after the procedure (r = 0.91; p < 0.000).. Acute i.v. administration of diltiazem about ten days after myocardial infarction may enhance the contractility of viable akinetic ventricular wall segments, as evaluated with echocardiography. The results of this study may have some physiopathological and therapeutical implications that could lead to reconsidering the use of calcium-channel blockers, particularly diltiazem, in selected patients after myocardial infarction.

Topics: Adult; Calcium Channel Blockers; Cardiovascular Agents; Diltiazem; Dobutamine; Echocardiography; Female; Humans; Injections, Intravenous; Male; Middle Aged; Myocardial Contraction; Myocardial Infarction; Ventricular Function, Left

To compare clinical and functional status in patients who had similar 5-year survival after coronary artery bypass grafting (CABG) and percutaneous transluminal coronary angioplasty (PTCA).. Randomized trial of 1829 patients followed for an average 5.4 years.. Patients with multivessel coronary artery disease suitable for both CABG and PTCA and not previously revascularized.. Coronary artery bypass grafting or PTCA within 2 weeks after randomization.. Symptoms, exercise test results, medication use, and quality-of-life measures collected at 4 to 14 weeks, and at 1, 3, and 5 years after randomization.. Intention to treat.. Differences in angina-free rates between patients assigned to PTCA and CABG decreased from 73% vs 95% at 4 to 14 weeks (P<.001) to 79% vs 85% at 5 years (P=.007). Similar patterns were observed for exercise-induced angina and ischemia, except 5-year differences were not significant. At follow-up of 1 year and later, quality of life, return to work, modification of smoking and exercise behaviors, and cholesterol levels were similar for the 2 treatments. Compared with patients assigned to CABG, use of anti-ischemic medication was higher in patients assigned to PTCA, while smaller differences were observed for other medications. Among patients angina-free at 5 years, 52% of patients who had PTCA required revascularization after the initial procedure vs 6% of patients who had CABG.. The narrowing of treatment differences in angina and exercise-induced ischemia rates can be attributed to a return of symptoms among patients assigned to CABG and incremental surgical procedures among patients assigned to PTCA. Patients assigned to PTCA apparently were able to tolerate higher rates of residual ischemia as evidenced by comparable quality of life and 5-year survival.

Topics: Aged; Angina Pectoris; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Artery Bypass; Coronary Disease; Exercise Test; Female; Heart Function Tests; Humans; Male; Middle Aged; Myocardial Infarction; Outcome and Process Assessment, Health Care; Quality of Life; Risk Factors; Survival Rate; United States

We hypothesized that among the patients enrolled in the Asymptomatic Cardiac Ischemia Pilot (ACIP) trial, those who reported angina either within the previous 6 weeks or experienced angina during ambulatory electrocardiographic (ECG) monitoring during activities of daily life or during stress testing would be more likely to experience an adverse cardiac event within a year than those who did not experience angina. Of the 558 patients enrolled in ACIP, 325 (58.2%) reported angina in the previous 6 weeks, 300 (53.8%) had stress-induced angina, and 63 (11.3%) reported angina during activities of daily life associated with ST-segment changes on the 48-hour ambulatory electrocardiogram. Some patients had > 1 of these angina symptoms and thus 8 angina status categories were identified. Adverse cardiac events were defined as death, nonfatal myocardial infarction (MI), or hospitalization for ischemic events, which included revascularization not specified by the ACIP protocol. One hundred and sixty-seven patients (29.9%) were asymptomatic (i.e., they never had angina) by our defined criteria. Three hundred ninety-one patients (70.1%) were symptomatic. Symptomatic patients had a higher incidence of death, MI, or hospitalization for ischemic events (15.3% symptomatic vs 7.8% asymptomatic, p = 0.016). History of angina within 6 weeks before randomization was predictive of death, MI, or hospitalization for ischemic event (p = 0.007). This finding was due to a large difference in the need for hospitalizations which would be expected to be driven by the presence of angina. By contrast, angina during ambulatory electrocardiogram or stress test was not predictive of an adverse cardiac event. The asymptomatic status of coronary disease patients who have objective documentation of ischemia is not uniformly defined and many different categories can be identified. In this population of patients with proven coronary artery disease and myocardial ischemia, a history of angina in the previous 6 weeks was a good predictor of an adverse event occurring in the next year.

Topics: Angina Pectoris; Cardiovascular Agents; Death, Sudden, Cardiac; Electrocardiography, Ambulatory; Follow-Up Studies; Hospitalization; Humans; Incidence; Life Tables; Myocardial Infarction; Myocardial Ischemia; Myocardial Revascularization; Pilot Projects; Predictive Value of Tests; Prognosis; Proportional Hazards Models; Time Factors

The role of percutaneous transluminal coronary angioplasty (PTCA) in the management of patients with angina remains controversial, particularly in patients whose symptoms are adequately controlled by medical treatment.. RITA-2 is a randomised trial comparing the long-term effects of PTCA and conservative (medical) care in patients with coronary artery disease considered suitable for either treatment option. 1018 patients were recruited from 20 cardiology centres in UK and Ireland. The 504 randomised to PTCA were intended to have dilatation within 3 months. The 514 assigned to medical treatment received antianginal drugs; those whose symptoms were not controlled by optimum medical therapy could cross-over to myocardial revascularisation. The primary endpoint was the combined frequency of death from all causes and definite non-fatal myocardial infarction.. This report covers a median 2-7 years' follow-up. At randomisation 53% of patients had grade 2 or worse angina, and 40% had two or more diseased coronary arteries. 93% of patients randomised to PTCA had this procedure carried out, within a median of 5 weeks. Death or definite myocardial infarction occurred in 32 patients (6.3%) treated with PTCA and in 17 patients (3.3%) with medical care (absolute difference 3.0% [95% CI 0.4-5.7%]. p = 0.02). This difference was mainly due to one death and seven non-fatal myocardial infarctions related to the randomised procedures. There were 18 deaths (11 PTCA, seven medical) of which ten were not due to heart disease. Of the patients in the PTCA group, 40 (7.9%) required coronary artery bypass grafting (CABG), including nine instead of PTCA and seven emergencies following unsuccessful PTCA. 56 other PTCA patients (11.1%) required further non-randomised PTCA. In the medical group 118 patients (23.0%) underwent a revascularisation procedure during follow-up, mostly because of worsening symptoms. Angina improved in both groups, but more so in the PTCA group. There was a 16.5% absolute excess of grade 2 or worse angina in the medical group 3 months after randomisation (p < 0.001), which attenuated to 7.6% after 2 years. Total exercise time (Bruce protocol) also improved in both groups, again with a treatment difference in favour of PTCA: mean advantage of 35 s at 3 months (p < 0.001). These benefits of PTCA were greater in patients with more severe angina at baseline, judged by high initial grade of angina and short initial exercise-time.. In patients with coronary artery disease considered suitable for either PTCA or medical care, early intervention with PTCA was associated with greater symptomatic improvement, especially in patients with more severe angina. When managing individuals with angina, clinicians must balance these benefits against the small excess hazard associated with PTCA due to procedure-related complications.

Topics: Aged; Angina Pectoris; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Cause of Death; Coronary Artery Bypass; Exercise Test; Female; Follow-Up Studies; Humans; Male; Middle Aged; Myocardial Infarction; Severity of Illness Index; Treatment Outcome

Despite growing interest concerning the prescription of different drugs in different clinical settings, no explanatory variables have been determined. The aim of this study was to verify if there are any differences in drug prescription at the time of hospital release following myocardial infarction and if any of these differences can be explained by scientific evidence concerning treatment efficacy.. All drugs prescribed to 430 patients discharged from three different cardiology departments after acute myocardial infarction were analyzed. Based on current scientific evidence, it has been, ascertained that aspirin, beta-blockers and ACE-inhibitors can be prescribed unless contraindicate whereas anticoagulants, nitrates and calcium antagonists should be prescribed only in specific clinical conditions. The odd ratio of prescription of each drug among the three cardiology departments was calculated and adjusted for any clinical and test result variables that can specifically affect drug prescription.. Different clinical characteristics of the patients discharged from the three cardiology departments are the following: mean age ranges from 60 to 66 years (p < 0.001), the incidence of non-Q myocardial infarction ranges from 23 to 45% (p < 0.001), post infarction angina ranges from 6 to 15% (p = 0.016), left ventricular failure ranges from 6 to 13% (p = 0.003) and arrhythmia ranges from 5 to 18% (p = 0.007). The adjusted odd ratio for clinical and test results variables showed that prescriptions were similar for ACE-inhibitors (odd ratio 1.3; 95% confidence interval from 0.6 to 3.2), aspirin (OR 2.2; 95% confidence interval from 0.8 to 5.5), beta-blockers (OR 2.2, 95% confidence interval from 0.9 to 5.5) and oral anticoagulants (1.6; 95% confidence interval from 0.6 to 4.5). Instead, there is a statistically significant difference in the prescription of nitrates (OR 4.4; 95% confidence interval from 1.6 to 12.3) and of calcium antagonists (OR 5.4%, 95% confidence interval from 1.0 to 12.5).. Evidence based drug efficacy after acute myocardial infarction seems to establish a uniform pattern of drug prescription in different cardiology departments.

Topics: Acute Disease; Aged; Cardiovascular Agents; Drug Prescriptions; Electrocardiography; Female; Humans; Male; Middle Aged; Myocardial Infarction; Time Factors; Ventricular Function, Left

The aim of this study was to document changes in drug prescription after myocardial infarction. One hundred and seventy four men with typical myocardial infarction recensed by the Toulouse MONICA centre between 1989 and 1990 were followed up for 4.5 years. A copy of their drug prescription was obtained during the acute phase of infarction, at the time of discharge from hospital or clinic, after 6 months, and finally, after 4.5 years after infarction. During the acute phase, the majority of patients received nitrate derivatives, platelet antiaggregants, calcium antagonists, betablockers and antiarrhythmics. Between hospital discharge and the sixth month, the prescription of lipid lowering drugs quadrupled (from 8 to 33%; p < 0.00001) and those of platelet anti-aggregants decreased (from 82 to 70%; p < 0.01). The prescriptions of other drugs remained relatively stable. Between the 6th month and the 4th year of follow-up the only prescription to increase significantly was that of ACE inhibitors (from 14 to 23%; p < 0.03). The other prescriptions were maintained: platelet anti-aggregants (70% at 6 months vs 75% at 4.5 years), nitrate derivatives (59 vs 51%), betablockers (51 vs 52%), calcium antagonists (51 vs 48%), lipid lowering drugs (33 vs 42%), diuretics (3 vs 6%) and inotropic agents (2 vs 2%). Overall analysis showed an increase in the prescriptions of lipid-lowering agents (p < 0.00001) and ACE inhibitors (p < 0.002). On the other hand, the prescriptions of calcium antagonists and nitrate derivatives tended to decrease. These results show that the treatment of patients with coronary artery disease is based on drugs of proven efficacy, reflecting the impact of large scale therapeutic trials on everyday medical practice.

Topics: Adult; Cardiovascular Agents; Cohort Studies; Dose-Response Relationship, Drug; Drug Therapy, Combination; Drug Utilization; Humans; Longitudinal Studies; Male; Middle Aged; Myocardial Infarction

On the basis of the signal averaged ECG (SA ECG) principle the authors analyse the gradually filtered ECG signal (in ranges of 0-120 Hz with increments of 10 Hz). The voltage sums are determined in eight segments of the QRS complex. The described VSF-ECG method (Voltage Sum of Filtered ECG) was applied in a group of healthy probands and in groups of selected patients. The measurements in healthy probands were used to determine the value of standard in healthy subjects. Repeated measurements confirmed a good reproducibility of the VSF-ECG method. The method enables a precise quantification of heart activation progression. VSF-ECG is a method revealing the changes of heart activation progression being not reflected as late potentials. Parameters of the method are indicators of activation splitting upon the infarction area and also an indicator of the electric milieu of the entire heart.

Topics: Action Potentials; Cardiovascular Agents; Electrocardiography; Heart Conduction System; Humans; Male; Myocardial Infarction; Reproducibility of Results; Sensitivity and Specificity; Signal Processing, Computer-Assisted; Ventricular Function

Topics: Aged; Cardiovascular Agents; Cross-Sectional Studies; Drug Therapy, Combination; Female; Humans; Male; Middle Aged; Myocardial Infarction; Patient Discharge; Prospective Studies; Risk Factors; Spain

Sixty-one patients admitted with acute myocardial infarction, and a symptom's duration of less than 6 hr were randomized into two groups. Immediately after hospitalisation, members of the verum group (n = 32) received 500 mcg of selenium (as sodium selenite). Thereafter they received a daily dosage of 100 mg coenzyme Q10 (Bio-Quinone) and 100 mcg selenium (Bio-Selenium in the form of 1-seleno-methionine) for a period of one year. The control group (n = 29) were given matching placebo preparations. The groups were comparable as with respect to age, sex and medical treatment. Biochemical parameters showed a reduced concentration of CPK- and ASAT-level in the verum group during the acute phase (although not statistically significant). None of the patients in the verum group (i.e. on antioxidative treatment) showed prolongation of the frequency corrected QT-interval. In the control group, 40% revealed a prolongation of the QT-interval by more than 440 msec (p < 0.001). There were no significant differences, with respect to early complications. During the one-year follow-up period after myocardial infarction, six patients (20%) from the control group died from re-infarction whereas one patient from the verum group suffered a non-cardiac death.

Topics: Antioxidants; Cardiovascular Agents; Coenzymes; Creatine Kinase; Electrocardiography; Female; Free Radical Scavengers; Humans; Male; Middle Aged; Myocardial Infarction; Oxidative Stress; Selenomethionine; Sodium Selenite; Ubiquinone

This study was conducted to explore mechanisms that could explain the possible clinical benefit of early administration of a beta 1-selective adrenoreceptor blocking agent or a bradycardiac drug as adjunct to thrombolysis in acute myocardial infarction.. The effects of beta-blockers given concomitantly with thrombolytic therapy in patients with acute myocardial infarction have not been fully examined. The potential role of specific bradycardiac agents lacking negative inotropism as an alternative to beta-blockers in this setting has never been studied in humans.. In a double-blind study, we examined the effects of early intravenous and continued oral administration of a beta-blocker (atenolol), a specific bradycardiac agent (alinidine) or placebo on left ventricular function, late coronary artery patency, infarct size, exercise capacity and incidence of arrhythmias.. A total of 292 patients with acute myocardial infarction of < or = 5 h duration and without contraindications to thrombolytic or beta-blocker therapy were studied. Of these, 100 were allocated to treatment with atenolol (5 to 10 mg intravenously followed by 25 to 50 mg orally every 12 h), 98 to alinidine (20 to 40 mg intravenously followed by 20 to 40 mg orally every 8 h) and 94 to placebo. All patients received 100 mg of alteplase over 3 h and full intravenous heparinization. No significant differences in coronary artery patency, global ejection fraction or regional wall motion were observed at 10 to 14 days among the three groups. Likewise, enzymatic and scintigraphic infarct size were also very similar. Neither atenolol nor alinidine was associated with a significant reduction in the incidence of arrhythmias during the 1st 24 h. No significant differences in clinical events were observed, with the exception of a greater incidence of nonfatal pulmonary edema in the atenolol group (6% vs. 1% in the alinidine group and 0% in the placebo group, p = 0.021).. In the absence of contraindications, the administration of a beta-blocker or a specific bradycardiac agent together with thrombolytic therapy was safe. In this limited number of patients, these agents did not appear to enhance myocardial salvage or preservation of left ventricular function or to reduce the incidence of major arrhythmias in the early phase of infarction.

Topics: Adult; Aged; Arrhythmias, Cardiac; Atenolol; Cardiovascular Agents; Clonidine; Double-Blind Method; Drug Administration Schedule; Drug Therapy, Combination; Exercise Test; Female; Humans; Infusions, Intravenous; Male; Middle Aged; Myocardial Infarction; Thrombolytic Therapy; Tissue Plasminogen Activator; Treatment Outcome; Vascular Patency; Ventricular Function, Left

Taprostene is a prostacyclin analogue that inhibits platelet aggregation and thus might be a useful adjuvant to thrombolytic agents in acute myocardial infarction. In a placebo-controlled dose rising study, taprostene or placebo was intravenously infused in 80 patients treated with the thrombolytic agent saruplase (rscu-PA) for acute myocardial infarction. Three doses of taprostene were used: 6.25; 12.5; or 25.0 ng.kg-1 x min-1. Taprostene or placebo was infused for 48 h, followed by a 24 h tapering period. All 80 patients had short symptom-to-treatment delay and marked ST segment elevation. Patency at 90 min was documented in 58/78 patients (two patients had no angiography). Success rate varied from 67-82% in the four treatment arms (P = 0.33). Patency after rescue PTCA was seen in 10 out of 13 patients. Of the 58 patients having a patent artery at 90 min, none of the 43 taprostene patients and one of the 15 placebo patients had a re-occluded artery at the second angiography at 32-48 h (5/58 patients had no recatheterization). Conversely, of nine patients who had successful rescue PTCA, three of four placebo patients had a re-occluded artery at the second angiography compared to one of five taprostene patients (one placebo patient had no recatheterization) (P = 0.33). Safety evaluation revealed no major difference between the placebo plus saruplase and the taprostene plus saruplase groups. Taprostene was well tolerated up to 25 ng.kg-1 x min-1. Although taprostene did not affect 90 min patency, there was a trend to better maintenance of patency after rescue PTCA.

Topics: Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Angiography; Double-Blind Method; Drug Therapy, Combination; Epoprostenol; Hemodynamics; Humans; Infusions, Intravenous; Myocardial Infarction; Pilot Projects; Recombinant Proteins; Survival Rate; Thrombolytic Therapy; Urokinase-Type Plasminogen Activator

The pharmacologic approach to coronary protection, defined here as the prevention or delay of sudden death and myocardial infarction (without negatively affecting noncardiac mortality), is critically discussed. The value of pharmacologically treating mild hypertension and mild hypercholesterolemia is questioned, and the need for well-designed, randomized clinical trials with definitive endpoints to determine a drug's cardioprotective capability is emphasized. Based on such studies, it is concluded that some (but perhaps not all) beta-receptor antagonists as well as aspirin have been shown to protect against sudden cardiac death. Trials of thiazide diuretics, calcium antagonists, and angiotensin-converting enzyme inhibitors have not shown a reduction in sudden cardiac death, despite having individual benefits with respect to other aspects of cardiovascular disease. The demonstration that some beta blockers are cardioprotective is discussed in terms of the pathophysiology of sudden cardiac death, and differences in the pharmacokinetic profiles of individual agents.

Topics: Aged; Angiotensin-Converting Enzyme Inhibitors; Animals; Calcium Channel Blockers; Cardiovascular Agents; Death, Sudden, Cardiac; Europe; Humans; Hypercholesterolemia; Hypertension; Myocardial Infarction

Medical practice patterns change in response to a variety of stimuli, one of which may be the publication of the results of randomized clinical trials. We assessed the temporal association between the publication of clinical trials on myocardial infarction and changes in treatment practices for this disorder.. We analyzed the use of aspirin before and after myocardial infarction and that of calcium antagonists after myocardial infarction in 2231 survivors of myocardial infarction enrolled in the Survival and Ventricular Enlargement (SAVE) study over a three-year period (from January 1987 through January 1990). The proportion of patients using these treatments was analyzed before and after the publication dates of three clinical trials: the Physicians' Health Study, published in January 1988, which supported the use of aspirin to prevent a first myocardial infarction; the Second International Study of Infarct Survival (ISIS-2), published in August 1988, which supported the use of aspirin after myocardial infarction; and the Multicenter Diltiazem Postinfarction Trial, published in August 1988, which reported a deleterious effect of diltiazem in some patients after myocardial infarction.. The use of aspirin before myocardial infarction increased from 16.2 percent to 23.9 percent between January 1987 and January 1990 (P less than 0.001). Enrollment in the study after the publication of the Physicians' Health Study independently predicted aspirin use before myocardial infarction (odds ratio, 1.43; 95 percent confidence interval, 1.11 to 1.85). The use of aspirin after myocardial infarction increased from 38.8 percent to 71.9 percent (P less than 0.001) during the three-year study period. Enrollment in the study after the publication of ISIS-2 independently predicted the use of aspirin after myocardial infarction (odds ratio, 2.28; 95 percent confidence interval, 1.89 to 2.76). The use of calcium antagonists after myocardial infarction decreased from 57.1 percent to 33.1 percent (P less than 0.001) during the study period. Enrollment in the study after the publication of the Multicenter Diltiazem Postinfarction Trial independently predicted the use of calcium antagonists after myocardial infarction (odds ratio, 0.47; 95 percent confidence interval, 0.39 to 0.57).. These observations suggest that randomized clinical trials have a measurable influence on medical practice patterns.

Topics: Adult; Aged; Aspirin; Calcium Channel Blockers; Captopril; Cardiomegaly; Cardiovascular Agents; Diltiazem; Drug Utilization; Female; Humans; Male; Middle Aged; Myocardial Infarction; Practice Patterns, Physicians'; Randomized Controlled Trials as Topic; Survival Rate; Time Factors; United States

To assess the effect of CLS 2210 (a new formulation of calcium dobesilate) on the evolution of acute myocardial infarction, 100 patients presenting their first infarct were distributed, according to their sequential admissions to the hospital, into CLS 2210-treated group (50 patients) or a comparison group (50 patients not receiving CLS 2210). The two groups were similar in age, sex, predisposing factors, and site of infarction. Intravenous infusion of CLS 2210 was begun within six hours of onset of chest pain and continued for seventy-two hours. Thereafter, it was given, as oral capsules, in a dose of 1,000 mg every eight hours throughout the hospitalization. Before and during the trial, blood samples were drawn for the measurements of serum concentrations of creatine kinase (CK), and twelve-lead electrocardiograms (ECGs) were obtained serially in each patient. All objective data were analyzed on a coded basis without reference to the treatment. In the comparison group, thirty-six to forty-eight hours was required for CK to fall to 50% of the baseline value, whereas in the CLS 2210-treated group it reached 50% of the baseline in eighteen to twenty-four hours. For each infarction site, a statistically significant fall was reached earlier in the CLS 2210 group. CK, the ECG index, and the sum of the ST segments showed earlier and more rapid improvement in the CLS 2210 group than in the comparison group. The consumption of narcotic analgesic agents and nitroglycerin was substantially less in the CLS 2210 group than in the comparison group.(ABSTRACT TRUNCATED AT 250 WORDS)

Topics: Benzenesulfonates; Calcium Dobesilate; Cardiovascular Agents; Drug Evaluation; Electrocardiography; Humans; Myocardial Infarction; Pilot Projects; Random Allocation

An enquiry into the prescribing behaviour in patients discharged from hospital after myocardial infarction was performed in 36 hospital departments in France and included 528 patients. Each patient was prescribed an average of 3.6 drugs. The most commonly prescribed drug was Aspirin (63.3%) followed by the calcium antagonists (61.7%) long acting nitrate derivatives (49.5%) and betablockers (41.5%). These results suggest that many post-infarction prescriptions disregard recently acquired scientific knowledge.

Topics: Adrenergic beta-Antagonists; Adult; Aged; Aged, 80 and over; Aspirin; Calcium Channel Blockers; Cardiovascular Agents; Drug Prescriptions; France; Health Surveys; Humans; Middle Aged; Myocardial Infarction; Surveys and Questionnaires; Vasodilator Agents

In an unblinded trial of intravenous streptokinase (SK) in early acute myocardial infarction, 11 806 patients in one hundred and seventy-six coronary care units were enrolled over 17 months. Patients admitted within 12 h after the onset of symptoms and with no contraindications to SK were randomised to receive SK in addition to usual treatment and complete data were obtained in 11 712. At 21 days overall hospital mortality was 10.7% in SK recipients versus 13% in controls, an 18% reduction (p = 0.0002, relative risk 0.81). The extent of the beneficial effect appears to be a function of time from onset of pain to SK infusion (relative risks 0.74, 0.80, 0.87, and 1.19 for the 0-3, 3-6, 6-9, and 9-12 h subgroups). SK seems to be a safe drug for routine administration in acute myocardial infarction.

Topics: Aged; Cardiovascular Agents; Clinical Trials as Topic; Female; Follow-Up Studies; Humans; Infusions, Parenteral; Male; Myocardial Infarction; Prospective Studies; Random Allocation; Streptokinase; Time Factors

In a controlled, randomised, double-blind study to see whether knowledge of left-ventricular ejection fraction (LVEF) could reduce the frequency of left-sided heart failure after acute myocardial infarction, LVEF was determined a few days before hospital discharge in a consecutive series of 60 patients. Subsequently, the patients were randomly assigned to two groups. The cardiologist responsible for their treatment was aware of the LVEF result in group I but not in group II. A month after hospital discharge there was no significant difference in the LVEF between the groups. 2 months after discharge there were no significant differences between the groups in clinical and radiological signs of left-ventricular heart failure or the use of drugs. The cardiologist's clinical estimate of the LVEF and the result of the radionuclide determination were significantly correlated. Thus, the use of LVEF did not change the clinical outcome. The need for randomised controlled studies in the evaluation of diagnostic methods is emphasised.

Topics: Adult; Aged; Cardiovascular Agents; Double-Blind Method; Female; Humans; Middle Aged; Myocardial Infarction; Prospective Studies; Radionuclide Imaging; Random Allocation; Stroke Volume; Technetium; Time Factors

Survivors of the acute phase of a myocardial infarction still have an increased risk of dying, primarily due to causes directly attributable to their coronary heart disease. This review of randomized clinical trials of various interventions with the potential to prolong life in these patients is an attempt to answer a vitally important question. What, if anything, can be done to improve the long-term prognosis in patients who have survived the initial one or two weeks after suffering an acute myocardial infarction? Seven classes of intervention are considered: anticoagulants, platelet-active drugs, lipid-lowering regimens, antiarrhythmic agents, physical exercise, calcium antagonists and beta-blockers. So far only beta-blockers have been shown to have a favorable effect on long-term survival. Many of the trials reviewed had design limitations; in particular, the sample size was often too small for the results to be conclusive.

Topics: Adrenergic beta-Antagonists; Anti-Arrhythmia Agents; Anticoagulants; Blood Platelets; Calcium Channel Blockers; Cardiovascular Agents; Clinical Trials as Topic; Exercise Therapy; Follow-Up Studies; Humans; Myocardial Infarction; Prognosis; Random Allocation

We aimed to evaluate the long-term outcomes of the novel NeoVas sirolimus-eluting bioresorbable scaffold (BRS) for the treatment of de novo coronary artery disease.. The long-term safety and efficacy of the novel NeoVas BRS are still needed to be elucidated.. A total of 1103 patients with de novo native coronary lesions for coronary stenting were enrolled. The primary endpoint of target lesion failure (TLF) was defined as a composite of cardiac death (CD), target vessel myocardial infarction (TV-MI), or ischemia-driven-target lesion revascularization (ID-TLR).. A three-year clinical follow-up period was available for 1,091 (98.9%) patients. The cumulative TLF rate was 7.2% with 0.8% for CD, 2.6% for TV-MI, and 5.1% for ID-TLR. Additionally, 128 (11.8%) patient-oriented composite endpoint and 11 definite/probable stent thromboses (1.0%) were recorded.. The extended outcomes of the NeoVas objective performance criterion trial demonstrated a promising 3-year efficacy and safety of the NeoVas BRS in low-risk patients with low complexity in terms of lesions and comorbidities.

Topics: Absorbable Implants; Cardiovascular Agents; Coronary Artery Disease; Drug-Eluting Stents; Humans; Myocardial Infarction; Percutaneous Coronary Intervention; Prospective Studies; Sirolimus; Treatment Outcome

The HELIOS stent is a sirolimus-eluting stent with a biodegradable polymer and titanium oxide film as the tie-layer. The study aimed to evaluate the safety and efficacy of HELIOS stent in a real-world setting.. The HELIOS registry is a prospective, multicenter, cohort study conducted at 38 centers across China between November 2018 and December 2019. A total of 3060 consecutive patients were enrolled after application of minimal inclusion and exclusion criteria. The primary endpoint was target lesion failure (TLF), defined as a composite of cardiac death, non-fatal target vessel myocardial infarction (MI), and clinically indicated target lesion revascularization (TLR) at 1-year follow-up. Kaplan-Meier methods were used to estimate the cumulative incidence of clinical events and construct survival curves.. A total of 2998 (98.0%) patients completed the 1-year follow-up. The 1-year incidence of TLF was 3.10% (94/2998, 95% closed interval: 2.54-3.78%). The rates of cardiac death, non-fatal target vessel MI and clinically indicated TLR were 2.33% (70/2998), 0.20% (6/2998), and 0.70% (21/2998), respectively. The rate of stent thrombosis was 0.33% (10/2998). Age ≥60 years, diabetes mellitus, family history of coronary artery disease, acute myocardial infarction at admission, and device success were independent predictors of TLF at 1 year.. The 1-year incidence rates of TLF and stent thrombosis were 3.10% and 0.33%, respectively, in patients treated with HELIOS stents. Our results provide clinical evidence for interventional cardiologists and policymakers to evaluate HELIOS stent.. ClinicalTrials.gov, NCT03916432.

Topics: Cardiovascular Agents; Cohort Studies; Coronary Artery Disease; Drug-Eluting Stents; Humans; Middle Aged; Myocardial Infarction; Percutaneous Coronary Intervention; Polymers; Prospective Studies; Registries; Risk Factors; Sirolimus; Thrombosis; Time Factors; Treatment Outcome

Despite decreasing mortality from cardiovascular disease (CVD), there are persistent inequities in mortality between socioeconomic groups. Primary preventative medications reduce mortality in CVD; thus, inequitable treatments will contribute to unequal outcomes. Physicians might contribute to inequality by prescribing preventative medication for CVD to themselves in a biased manner.. To determine whether primary medications for preventing CVD were prescribed inequitably between physicians and non-physicians.. This retrospective study retrieved registry data on prescribed medications for all physicians in Sweden aged 45-74 years, during 2013, and for reference non-physician individuals, matched by sex, age, residence, and level of education. The outcome was any medication for preventing CVD, received at least once during 2013.. Age and the sex-specific prevalence of myocardial infarction (MI) among physicians and non-physicians were used as a proxy for the need for medication. Thereafter, to limit the analysis to preventative medication, we excluded individuals that were diagnosed with CVD or diabetes. To analyse differences in medication usage between physicians and matched non-physicians, we estimated odds ratios (ORs) with conditional logistic regression and adjusted for need and household income.. MI prevalences were 5.7% for men and 2.3% for women, among physicians, and 5.4% for men and 1.8% for women, among non-physicians. We included 25,105 physicians and 44,366 non-physicians. The OR for physicians receiving any CVD preventative medication, compared to non-physicians, was 1.65 (95% confidence interval 1.59-1.72).. We found an inequity in prescribed preventative CVD medications, which favoured physicians over non-physicians.. KEYPOINTSGroups with low socioeconomic status have lower rates of using medication that prevents cardiovascular disease, compared to groups with high socioeconomic status.Physicians are responsible for prescribing all medicines to prevent cardiovascular disease; thus, biased prescriptions could have effects on the equality of care in the population.Compared to individuals with equivalent education, physicians had higher rates of using medication that prevents cardiovascular disease.This study highlights the need for systematic population-based evaluation of CVD risk in order to promote equitable CVD outcomes.

Topics: Cardiovascular Agents; Cardiovascular Diseases; Cross-Sectional Studies; Diabetes Mellitus; Female; Humans; Male; Myocardial Infarction; Retrospective Studies; Risk Factors; Sweden

Long drug-eluting stents may limit the issue of overlapping multiple stents when treating long coronary lesions.. The aim of the study was to assess the safety and efficacy of the 48 mm Xience Xpedition everolimus-eluting stent (48mm-EES) for the treatment of long coronary lesions, in an all-comer population.. Patients receiving at least one 48mm-EES were prospectively included from March 2014 to December 2018. The primary endpoint was target lesion failure (TLF), defined as a composite of cardiac death, target vessel myocardial infarction, and clinically driven target lesion revascularization (TLR) at 1 year. The main secondary endpoint was the patient-oriented composite endpoint (POCE) defined as a composite of death, stroke, myocardial infarction, and reintervention.. A total of 268 patients with 276 long coronary lesions, including 94 chronic total occlusions (CTO), were successfully treated using at least one 48mm-EES. The total stent length per lesion was 66 ± 22 mm. A single 48mm-EES was suitable to successfully treat the target lesion in 48% of cases (60% for non-CTO lesions). One-year follow-up rate was 96.3%. TLF occurred in 13 patients (5.3%), mainly driven by TLR (4.1%). Two cardiac death occurred (0.7%). POCE occurred in 30 patients (11.6%) mainly driven by repeat revascularization (9.7%). Definite stent thrombosis was observed in two patients (0.7%). No difference was observed in one-year outcomes between single 48mm-EES and multiple stents implantation as well as between CTO and non-CTO lesions.. The 48mm-EES is safe and effective to treat long coronary lesions, including CTOs, and provides attractive cost-effectiveness by limiting multiple stenting.

Topics: Cardiovascular Agents; Death; Drug-Eluting Stents; Everolimus; Humans; Kaplan-Meier Estimate; Myocardial Infarction; Percutaneous Coronary Intervention; Prosthesis Design; Risk Factors; Sirolimus; Time Factors; Treatment Outcome

Myocardial ischemia-reperfusion injury leads to aggravated cardiac remodeling and heart failure. After myocardial infarction (MI), angiogenesis plays a vital role in the repair and regeneration of tissue. The purpose of the current study was to determine the effect of Tanshinone IIA (Tan IIA) on angiogenesis and elucidate its related mechanism.. The C57BL/6 mice MI model was established to evaluate the therapeutic effect of Tan IIA in vivo. MicroRNA (miRNA) microarray and bioinformatics analysis were performed to determine the differential expressions of miRNAs after Tan IIA administration. Cell proliferation, migration, and angiogenesis capacity were detected by EdU, Transwell, and Tube formation assay in vitro, respectively. The relationship between miR-499-5p (miR-499) and paired phosphate and tension homolog deleted on chromosome ten (PTEN) was confirmed by using a Dual-luciferase reporter assay.. Our results showed that Tan IIA administration improved cardiac function after MI by activating angiogenesis. Further miRNA microarray and bioinformatics analysis revealed that miR-499 was significantly down-regulated, while PTEN was remarkably upregulated after Tan IIA administration post-MI. In addition, we found that miR-499 knock-down effectively promotes cell proliferation, migration, and tube formation ability of HUVECs. Dual-luciferase reporter assay demonstrated that PTEN contains a direct binding site for miR-499-5p.. Tan IIA improves cardiac function post-MI by inducing angiogenesis. In terms of the mechanism, Tan IIA promotes therapeutic angiogenesis by regulating miR-499-5p/PTEN signaling pathway.

Topics: Abietanes; Animals; Cardiovascular Agents; Disease Models, Animal; Mice; Mice, Inbred C57BL; MicroRNAs; Myocardial Infarction; Myocardial Ischemia; Myocardial Reperfusion Injury; Neovascularization, Pathologic; Neovascularization, Physiologic; PTEN Phosphohydrolase

Non-human primate monkey model of myocardial ischemic infarction is precious for translational medicine research. Ligation of the left anterior descending (LAD) artery is a common procedure to induce myocardial ischemic infarction. However, the consistency of the myocardial infarction thus generated remains problematic. The present study was undertaken to critically evaluate the monkey model of myocardial ischemic infarction to develop a procedure for a consistent cross-study comparison. Forty male Rhesus monkeys were divided into 4 groups and subjected to LAD artery ligation at different levels along the artery. In addition, the major diagonal branch was selectively ligated parallel to the ligation site of the LAD artery according to the diagonal branch distribution. Analyses of MRI, echocardiography, cardiac hemodynamics, electrocardiography, histopathology, and cardiac injury biomarkers were undertaken to characterize the monkeys with myocardial infarction. Ligation at 40% of the total length of the artery, measured from the apex end, produced variable infarct areas with inconsistent functional alterations. Ligation at 60% or above coupled with selective ligation of diagonal branches produced a consistent myocardial infarction with uniform dysfunction. However, ligation at 70% caused a lethal threat. After a thorough analysis, it is concluded that ligation at 60% of the total length coupled with selective ligation of diagonal branches, enables standardization of the location of occlusion and the subsequent ischemic area, as well as avoids the influence of the diagonal branches, are ideal to produce a consistent monkey model of myocardial ischemic infarction.

Topics: Animals; Cardiovascular Agents; Coronary Vessels; Heart; Male; Myocardial Infarction; Myocardium

Myocardial free wall rupture is a rare, but serious complication of acute myocardial infarction with high mortality. We present a case of a 64-year-old patient with this devastating complication of an anterior ST segment elevation myocardial infarction (STEMI) with a prolonged time delay. Cardiac surgery was not performed due to prohibitive surgical risk and predicted poor prognosis. We describe our successful therapeutic intervention consisting of immediate pericardial drainage, vasoactive and inotropic support, intraaortic balloon pump placement and continuous veno-venous hemodialysis. This combined therapy led to patient stabilization and after incremental clinical improvement the patient was able to return to a normal life. After several months a long-term mechanical circulatory support was implanted as a bridge to heart transplant.

Topics: Cardiac Surgical Procedures; Cardiovascular Agents; Humans; Middle Aged; Myocardial Infarction; ST Elevation Myocardial Infarction

To explore the clinical characteristics of acute myocardial infarction (AMI) with ventricular septal perforation (VSR), the prognosis comparison of different treatment methods, and analysis of related risk factors.. From January 2006 to February 2020, 29 patients with AMI and VSR diagnosed in the People's Hospital of Peking University were selected as the study group. Among them, 16 cases were male (55.2%), 13 cases were female (44.8%), and the average age was 64.69 ± 10.32 years old. They were divided into two groups: the survival group (N = 16) and non-survival group (N = 13), according to whether they survived within 30 days of surgical or drug conservative treatment. The clinical characteristics, coronary angiography, and treatment of the two groups were summarized, and the prognosis and related risk factors were analyzed.. There was no significant difference in the basic clinical characteristics between the two groups (P > 0.05). Compared with the results of coronary angiography in the two groups, the proportion of the culprit vessel, which was a simple anterior descending branch in the non-survival group, was higher than that in the survival group. There was a statistical difference between the two groups (P < 0.05). The perioperative data of the two groups showed that the proportion of patients with complete revascularization, simultaneous bypass, and recanalization of culprit vessels in the survival group was significantly higher than that in the non-survival group (P < 0.05). However, the incidence of postoperative low cardiac output and mortality during hospitalization in the survival group were significantly lower than those in the non-survival group (P < 0.05). Logistic regression analysis showed that complete revascularization (OR = 0.021, 95% CI 0.001-0.374, P = 0.009) and recanalization of culprit vessels (OR = 0.045, 95% CI 0.004-0.548, P = 0.015) were independent risk factors for 30-day mortality. Kaplan-Meier survival curve showed that during the follow-up period, the long-term survival rate of patients with operation and complete revascularization was significantly higher than that of patients with drug conservative treatment and incomplete revascularization. There was a statistical difference between the two groups (P < 0.05).. Complete revascularization and recanalization of culprit vessels are independent risk factors for 30-day mortality in patients with AMI and VSR. The long-term survival rate of patients after surgery and complete revascularization is significantly higher than that of patients with conservative medical treatment and incomplete revascularization. Surgery and complete revascularization are important factors affecting the long-term prognosis of patients with AMI and VSR.

Topics: Aged; Cardiovascular Agents; Coronary Angiography; Coronary Artery Bypass; Female; Hospital Mortality; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Myocardial Infarction; Myocardial Revascularization; Prognosis; Risk Factors; Ventricular Septal Rupture

Medication adherence is a recognized key factor of secondary cardiovascular disease prevention. Cardiac rehabilitation increases medication adherence and adherence to lifestyle changes. This study aimed to evaluate the impact of in-hospital cardiac rehabilitation (IH-CR) on medication adherence as well as other cardiovascular outcomes, following an acute myocardial infarction (AMI).. This is a population-based study. Data were obtained from the Health Information Systems of the Lazio Region, Italy (5 million inhabitants). Hospitalized patients aged ≥ 18 years with an incident AMI in 2013-2015 were investigated. We divided the whole cohort into 4 groups of patients: ST-elevation AMI (STEMI) and non-ST-elevation AMI (NSTEMI) who underwent or not percutaneous coronary intervention (PCI) during the hospitalization. Primary outcome was medication adherence. Adherence to chronic poly-therapy, based on prescription claims for both 6- and 12-month follow-up, was defined as Medication Possession Ratio (MPR) ≥ 75% to at least 3 of the following medications: antiplatelets, β-blockers, ACEI/ARBs, statins. Secondary outcomes were all-cause mortality, hospital readmission for cardiovascular and cerebrovascular event (MACCE), and admission to the emergency department (ED) occurring within a 3-year follow-up period.. A total of 13.540 patients were enrolled. The median age was 67 years, 4.552 (34%) patients were female. Among the entire cohort, 1.101 (8%) patients attended IH-CR at 33 regional sites. Relevant differences were observed among the 4 groups previously identified (from 3 to 17%). A strong association between the IH-CR participation and medication adherence was observed among AMI patients who did not undergo PCI, for both 6- and 12-month follow-up. Moreover, NSTEMI-NO-PCI participants had lower risk of all-cause mortality (adjusted IRR 0.76; 95% CI 0.60-0.95), hospital readmission due to MACCE (IRR 0.78; 95% CI 0.65-0.94) and admission to the ED (IRR 0.80; 95% CI 0.70-0.91).. Our findings highlight the benefits of IH-CR and support clinical guidelines that consider CR an integral part in the treatment of coronary artery disease. However, IH-CR participation was extremely low, suggesting the need to identify and correct the barriers to CR participation for this higher-risk group of patients.

Topics: Adrenergic beta-Antagonists; Aged; Aged, 80 and over; Angiotensin Receptor Antagonists; Angiotensin-Converting Enzyme Inhibitors; Cardiac Rehabilitation; Cardiovascular Agents; Cause of Death; Databases, Factual; Female; Heart Disease Risk Factors; Hospitalization; Humans; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Incidence; Italy; Male; Medication Adherence; Middle Aged; Myocardial Infarction; Patient Readmission; Platelet Aggregation Inhibitors; Polypharmacy; Retrospective Studies; Risk Assessment; Secondary Prevention; Time Factors; Treatment Outcome

The "no reflow" phenomenon, where the coronary artery is patent after treatment of acute myocardial infarction (AMI) but tissue perfusion is not restored, is associated with worse outcome. The mechanism of no reflow is unknown. We hypothesized that pericytes contraction, in an attempt to maintain a constant capillary hydrostatic pressure during reduced coronary perfusion pressure, causes capillary constriction leading to no reflow and that this effect is mediated through the orphan receptor, GPR39, present in pericytes. We created AMI (coronary occlusion followed by reperfusion) in GPR39 knock out mice and littermate controls. In a separate set of experiments, we treated wild-type mice undergoing coronary occlusion with vehicle or VC43, a specific inhibitor of GPR39, before reperfusion. We found that no reflow zones were significantly smaller in the GPR39 knockouts compared with controls. Both no reflow and infarct size were also markedly smaller in animals treated with VC43 compared with vehicle. Immunohistochemistry revealed greater capillary density and larger capillary diameter at pericyte locations in the GPR39-knockout and VC43-treated mice compared with controls. We conclude that GPR39-mediated pericyte contraction during reduced coronary perfusion pressure causes capillary constriction resulting in no reflow during AMI and that smaller no reflow zones in GPR39-knockout and VC43-treated animals are associated with smaller infarct sizes. These results elucidate the mechanism of no reflow in AMI, as well as providing a therapeutic pathway for the condition.

Topics: Animals; Calcium Signaling; Cardiovascular Agents; Cells, Cultured; Coronary Circulation; Coronary Vessels; Disease Models, Animal; Female; Male; Mice, Inbred C57BL; Mice, Knockout; Myocardial Infarction; No-Reflow Phenomenon; Pericytes; Receptors, G-Protein-Coupled; Vasoconstriction

Relatively high rates of adherence to myocardial infarction (MI) secondary prevention medications have been reported, but register-based, objective real-world data is scarce. We aimed to analyse adherence to guideline-recommended medications for secondary prevention of MI in 2017 to 2018 (period II) and compare the results with data from 2004 to 2005 (period I) in Estonia.. Study populations were formed based on data from the Estonian Health Insurance Fund's database and on Estonian Myocardial Infarction Register. By linking to the Estonian Medical Prescription Centre database adherence to guideline-recommended medications for MI secondary prevention was assessed for 1 year follow-up period from the first hospitalization due to MI. Data was analysed using the defined daily dosages methodology.. Total of 6694 and 6060 cases of MI were reported in periods I and II, respectively. At least one prescription during the follow up period was found for beta-blockers in 81.0% and 83.5% (p = 0.001), for angiotensin converting enzyme inhibitor/angiotensin II receptor blocker (ACEi/ARB) in 76.9% and 66.0% (p < 0.001), and for statins in 44.0% and 67.0% (p < 0.001) of patients in period I and II, respectively. P2Y12 inhibitors were used by 76.4% of patients in period II. The logistic regression analysis adjusted to gender and age revealed that some drugs and drug combinations were not allocated similarly in different age and gender groups.. In Estonia, adherence to MI secondary prevention guideline-recommended medications has improved. But as adherence is still not ideal more attention should be drawn to MI secondary prevention through systematic guideline implementation.

Topics: Adult; Aged; Aged, 80 and over; Cardiovascular Agents; Drug Utilization; Estonia; Female; Guideline Adherence; Healthcare Disparities; Humans; Male; Middle Aged; Myocardial Infarction; Practice Guidelines as Topic; Practice Patterns, Physicians'; Registries; Secondary Prevention; Time Factors; Treatment Outcome; Young Adult

Depressive disorders induced by acute myocardial infarction (AMI) play a pivotal role in the deterioration of cardiac function, and Shuangxinfang (Psycho-cardiology Formula, PCF) was reported to alleviate heart function damage and improve depression-like behavior, but the complex mechanism in such process has not been clarified.. AMI models were established and PCF was administered in rats. Subjects were then assessed in open field test (OFT) and forced swimming test (FST) recapitulating symptoms of depressive disorder. Afterward, pharmacoproteomic profiling of the hippocampus and peri-infarct border zone (BZ) was performed using a label-free liquid chromatography-tandem mass spectrometry (LC-MS/MS) technique, to identify contributing proteins and pathways responsible for myocardial ischemia and behavioral allostasis. Bioinformatics analysis was processed for further investigation, while western blotting was employed for testing dominating proteins to validate proteomic results.. Rats in the AMI group showed depression-like behavior in OFT and FST, which was improved by PCF. There were 131 differentially expressed proteins (DEPs) in BZ and 64 proteins in the hippocampus being detected and quantified shared by the sham group, the AMI group, and the PCF group. Subsequently, pertinent pathways and molecular functions were further identified. Altered molecules were discovered to be enriched in the apoptotic process, innate immune response, and NF-κB transcription factor activity in BZ, as well as chemical synaptic transmission, axon, collagen binding, cell adhesion, response to carbohydrate, laminin binding, and cellular response to nitric oxide in the hippocampus. Groups of signal transducers were also able to select multiple pathways, including innate immunity and arginine biosynthesis in the heart, also integrin signaling in the brain. DEPs were intersected from the myocardium and hippocampus to screen out the protein S100A9, which was up-regulated in the AMI group compared with the sham, and showed a down-regulation trend after treatment with PCF.. Taken together, we present a comprehensive proteomics analysis of rat models with depression post-AMI. Reviewing the literatures concerned, it's hypothesized that macrophage/microglia inflammation mediated by S100A9 might be the pivotal pathogenic process of psycho-cardiology disease, as well as potential mechanisms for the treatment of PCF.

Topics: Animals; Antidepressive Agents; Behavior, Animal; Calgranulin B; Cardiovascular Agents; Chromatography, High Pressure Liquid; Chromatography, Reverse-Phase; Depression; Disease Models, Animal; Drugs, Chinese Herbal; Hippocampus; Macrophages; Male; Microglia; Motor Activity; Myocardial Infarction; Myocardium; Open Field Test; Protein Interaction Maps; Proteome; Proteomics; Rats, Sprague-Dawley; Tandem Mass Spectrometry; Ventricular Function, Left

This study aimed to investigate the effect of the therapy of amiodarone combined with atorvastatin on cardiac function of patients with acute myocardial infarction after percutaneous coronary intervention (PCI). A total of 90 patients with acute myocardial infarction who underwent PCI in the tertiary care hospital from January 2019 to January 2020 were selected as the subjects and randomly assigned into the control group and the study group, with 45 cases in each group. All the subjects had undergone PCI. The control group received amiodarone while those the study group received atorvastatin additionally. Comparison was done on the clinical efficacy, cardiac function, myocardial injury indicator and inflammatory factor between the two groups. The overall response rate (ORR) in the study group was significantly higher than that in the control group (P<0.05); patients in the study group had markedly better cardiac function compared with those in the control group (P<0.001); patients in the study group had considerably lower creatine kinase (CK) index, creatine kinase-MB (CK-MB) index, tumor necrosis factor (TNF-α) and interleukin-6 (IL-6) as opposed to those in the control group (P<0.001). It was observed that the therapy of amiodarone combined with atorvastatin could effectively improve the clinical indicators and cardiac function of patients with acute myocardial infarction after PCI. It is effective and worthy of wide promotion and application.

Topics: Amiodarone; Atorvastatin; Cardiovascular Agents; Case-Control Studies; China; Creatine Kinase, MB Form; Drug Therapy, Combination; Female; Humans; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Inflammation Mediators; Interleukin-6; Male; Middle Aged; Myocardial Infarction; Percutaneous Coronary Intervention; Random Allocation; Time Factors; Treatment Outcome; Tumor Necrosis Factor-alpha

Patients and medical professionals have a common misconception that cardiovascular diseases (CVD) predominantly affect men, which can lead to less prescribing of cardiovascular drugs to women. This study examined whether there were sex differences in the administration of cardiovascular (CV) drugs in patients admitted to the intensive care unit of the Internal Medicine Clinic of Foča University Hospital (ICFUH).. The study comprised 332 patients hospitalized at the ICFUH from January 1st to June 30th, 2019. The following data on leading CVD and risks related to CV drug administration were collected: age, hyperlipidemia (HLD), diabetes mellitus (DM), chronic kidney disease (CKD), liver disease (LD), heart failure (HF), hypertension (HTN), myocardial infarction (MI), and stroke (S). The amount of the CV drugs of interest (statins, antiplatelet drugs, calcium channel blockers, ACE inhibitors, beta blockers, diuretics) administered during hospitalization was expressed as the Defined Daily Dose (DDD)/100 bed-days (BD) for patients of both sexes separately.. During hospitalization in the intensive care unit of ICFUH, female patients were less likely to be treated with statins than male patients (30.1 vs. 57.5 DDD/100 BD, P<0.05). There was no difference between sexes regarding the use of antihypertensive drugs. Women were less likely to be treated by antiplatelet therapy, more precisely by acetylsalicylic acid (30.4 vs. 36.9 DDD/100 BD, P<0.05).. Our study indicates that there were sex differences in CV drug administration in ICFUH. Presuming that drugs used during hospitalization were at least partially a continuation of the previous therapy prescribed by the family doctor, it is possible that such differences exist in primary care.

Topics: Angiotensin-Converting Enzyme Inhibitors; Antihypertensive Agents; Cardiovascular Agents; Female; Humans; Hypertension; Male; Myocardial Infarction; Sex Characteristics

Reports of long-term outcomes of patients treated with drug-eluting stents in total coronary occlusions are limited. We analysed clinical outcomes of patients treated with the zotarolimus-eluting Resolute stent (R-ZES) implanted in coronary total occlusions versus non-occluded lesions.. Patients treated with R-ZES and included in four trials (RESOLUTE All Comers, RESOLUTE International, RESOLUTE China RCT, and RESOLUTE China Registry) were pooled and divided into three groups - patients with chronic total occlusions (CTO), patients with total occlusions that had occurred recently (rec-TO), and patients without total occlusions (non-TO). Clinical outcomes at five years were analysed. Of 5,487 patients treated with R-ZES in these trials, 8.0% had CTOs, 8.5% rec-TOs and 83.5% non-TOs. Patients had a mean age of 62.8 years, approximately 25% were female and 30% were diabetics. TLF was similar in the three groups at five years (TLF was 13.2%, 12.5% and 13.3% in the CTO, rec-TO and non-TO groups, respectively, p=0.96). Stent thrombosis tended to occur more frequently for rec-TO compared to CTO and non-TO patients (2.6% vs 1.2% and 1.3%, respectively, p=0.11).. In this large population of patients who had R-ZES implanted, five-year clinical outcomes were similar whether or not the stents were implanted in total occlusions.

Topics: Cardiovascular Agents; China; Coronary Artery Disease; Coronary Occlusion; Drug-Eluting Stents; Female; Humans; Male; Middle Aged; Myocardial Infarction; Percutaneous Coronary Intervention; Prosthesis Design; Sirolimus; Time Factors; Treatment Outcome

Background There is no clinical guidance on treatment in patients with non-ischemic myocardial injury and type 2 myocardial infarction (T2MI). Methods and Results In a cohort of 22 589 patients in the emergency department at Karolinska University Hospital in Sweden during 2011 to 2014 we identified 3853 patients who were categorized into either type 1 myocardial infarction, T2MI, non-ischemic acute and chronic myocardial injury. Data from all dispensed prescriptions within 180 days of the visit to the emergency department were obtained concerning β-blockers, angiotensin-converting enzyme inhibitors/angiotensin II receptor blockers, statins, and platelet inhibitors. We estimated adjusted hazard ratios (HR) with 95% CI for all-cause mortality in relationship to the number of medications (categorized into 0-1 [referent], 2-3 and 4 medications) in the groups of myocardial injury. In patients with T2MI, treatment with 2 to 3 and 4 medications was associated with a 50% and 56% lower mortality, respectively (adjusted HR [95% CI], 0.50 [0.25-1.01], and 0.43 [0.19-0.96]), while corresponding associations in patients with acute myocardial injury were 24% and 29%, respectively (adjusted HR [95% CI], 0.76 [0.59-0.99] and 0.71 [0.5-1.02]), and in patients with chronic myocardial injury 27% and 37%, respectively (adjusted HR [95% CI], 0.73 [0.58-0.92] and 0.63 [0.46-0.87]). Conclusions Patients with T2MI and non-ischemic acute or chronic myocardial injury are infrequently prescribed common cardiovascular medications compared with patients with type 1 myocardial infarction. However, treatment with guideline recommended drugs in patients with T2MI and acute or chronic myocardial injury is associated with a lower risk of death after adjustment for confounders.

Topics: Aged; Cardiovascular Agents; Cohort Studies; Emergency Service, Hospital; Female; Guideline Adherence; Heart Diseases; Humans; Male; Mortality; Myocardial Infarction; Outcome Assessment, Health Care; Practice Guidelines as Topic; Practice Patterns, Physicians'; Sweden

Topics: Acute Coronary Syndrome; Cardiovascular Agents; Heart; Humans; Myocardial Infarction

Topics: Angioedema; Angiotensin-Converting Enzyme Inhibitors; Cardiovascular Agents; Coronary Angiography; COVID-19; COVID-19 Nucleic Acid Testing; Drug Substitution; Humans; Male; Middle Aged; Myocardial Infarction; Patient Care Management; Platelet Aggregation Inhibitors; Ramipril; SARS-CoV-2; Treatment Outcome

US and European guidelines diverge on whether to vaccinate adults who are not at high risk for cardiovascular events against influenza. Here, we investigated the associations between influenza vaccination and risk for acute myocardial infarction, stroke and pulmonary embolism during the 2009 pandemic in Norway, when vaccination was recommended to all adults.. Using national registers, we studied all vaccinated Norwegian individuals who suffered AMI, stroke, or pulmonary embolism from May 1, 2009 through September 30, 2010. We defined higher-risk individuals as those using anti-diabetic, anti-obesity, anti-thrombotic, pulmonary or cardiovascular medications (i.e. individuals to whom vaccination was routinely recommended); all other individuals were regarded as having lower-risk. We estimated incidence rate ratios with 95% CI using conditional Poisson regression in the pre-defined risk periods up to 180 days following vaccination compared to an unexposed time-period, with adjustment for season or daily temperature.. Overall, we observed lower risk for cardiovascular events following influenza vaccination. When stratified by baseline risk, we observed lower risk across all three outcomes in association with vaccination among higher-risk individuals. In this subgroup, relative risks were 0.72 (0.59-0.88) for AMI, 0.77 (0.59-0.99) for stroke, and 0.73 (0.45-1.19) for pulmonary embolism in the period 1-14 days following vaccination when compared to the background period. These associations remained essentially the same up to 180 days after vaccination. In contrast, the corresponding relative risks among subjects not using medications were 4.19 (2.69-6.52), 1.73 (0.91-3.31) and 2.35 (0.78-7.06).. In this nationwide study, influenza vaccination was associated with overall cardiovascular benefit. This benefit was concentrated among those at higher cardiovascular risk as defined by medication use. In contrast, our results demonstrate no comparable inverse association with thrombosis-related cardiovascular events following vaccination among those free of cardiovascular medications at baseline. These results may inform the risk-benefit balance for universal influenza vaccination.

Topics: Aged; Aged, 80 and over; Cardiovascular Agents; Cardiovascular Diseases; Female; Heart Disease Risk Factors; Humans; Incidence; Influenza Vaccines; Influenza, Human; Male; Mass Vaccination; Middle Aged; Myocardial Infarction; Norway; Prognosis; Pulmonary Embolism; Registries; Risk Assessment; Stroke; Time Factors

Use of statin has been associated with reduced risk of cardiovascular diseases events and mortality. However, in patients with end-stage renal disease (ESRD), the protective effects of statin are controversial. To evaluate the impact of chronic statin use on clinical outcomes of patients with acute myocardial infarction (AMI) with ESRD.. We enrolled 8056 patients with ESRD who were initially diagnosed and admitted for first AMI from Taiwan's National Health Insurance Research Database. Of which, 2134 patients underwent statin therapy. We randomly selected and use age, sex, hypertension, diabetes mellitus (DM), peripheral vascular diseases (PVD), heart failure (HF), cerebrovascular accidents (CVA), chronic obstructive pulmonary disease, matched with the study group as controls (non-stain user). We compared the effects of statin use in term of all-cause death among patients with AMI with ESRD.. Statin use resulted in a significantly higher survival rate in patients ith AMI with ESRD compared with non-statin users. After adjusted the comorbidities the male patients and patients with DM, PVD, HF and CVA had lower long-term survival rate (all p<0.001). Patients who underwent percutaneous coronary intervention (p<0.001), ACE inhibitors/angiotensin II receptor blockers (p<0.001), β receptor blockers (p<0.001) and statin therapy (p=0.007) had better long-term survival rate. Patients with AMI with ESRD on statin therapy exhibited a significantly lower risk of mortality compared with non-statin users (p<0.0001).. Among patients with ESRD with AMI, statin therapy was associated with reduced all-cause mortality.

Topics: Cardiovascular Agents; Cardiovascular Diseases; Case-Control Studies; Cause of Death; Comorbidity; Female; Humans; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Kidney Failure, Chronic; Male; Middle Aged; Mortality; Myocardial Infarction; Protective Agents; Sex Factors; Survival Rate; Taiwan; Time

Morbidity and mortality from acute myocardial infarction (AMI) remains substantial although interventional coronary reperfusion strategies are widely use and successful. MI remains the most common cause of heart failure (HF) worldwide. Here we demonstrated that Panax Notoginseng saponins (PNS), the extract of Panax notoginseng, exerts cardioprotective effect in AMI and the underlying mechanism refers to inducing cardiomyocyte autophagy, antiplatelet aggregation, enhancing endothelial migration and angiogenesis. PNS was initially tested to rescue the myocardial infarct size and cardiac function in left anterior descending (LAD) ligation-operated mice to mimic AMI. RNA-seq to profile transcriptome changes in the heart by treatment with PNS were then conducted. PNS and its main constituents Rg1 and Rd directly inhibited platelet aggregation of healthy subjects with VerifyNow Aspirin and P2Y12 assays but less affecting on coagulation compared with dual-antiplatelet (DAPT). In addition, wound healing scratch assay and heart staining demonstrated that PNS and its main constituents Rg1 and R1 significant enhanced the migration of endothelial cells and angiogenesis in response to MI injury. Interestingly, PNS rather than its constituents enhanced glucose deprivation (GD)-induced autophagy through phosphorylation of AMPK Thr172 and CaMKII Thr287 in cardiomyocytes. These findings provide new insights for drug development from natural products like PNS against ischemia heart diseases and HF post MI.

Topics: AMP-Activated Protein Kinases; Animals; Autophagy; Calcium-Calmodulin-Dependent Protein Kinase Type 2; Cardiovascular Agents; Cell Line; Disease Models, Animal; Heart Failure; Human Umbilical Vein Endothelial Cells; Humans; Mice, Inbred C57BL; Myocardial Infarction; Myocytes, Cardiac; Neovascularization, Physiologic; Panax notoginseng; Phosphorylation; Platelet Aggregation; Rats; Saponins; Signal Transduction

Cardiac patches are an effective way to deliver therapeutics to the heart. However, such procedures are normally invasive and difficult to perform. Here, we develop and test a method to utilize the pericardial cavity as a natural "mold" for in situ cardiac patch formation after intrapericardial injection of therapeutics in biocompatible hydrogels. In rodent models of myocardial infarction, we demonstrate that intrapericardial injection is an effective and safe method to deliver hydrogels containing induced pluripotent stem cells-derived cardiac progenitor cells or mesenchymal stem cells-derived exosomes. After injection, the hydrogels form a cardiac patch-like structure in the pericardial cavity, mitigating immune response and increasing the cardiac retention of the therapeutics. With robust cardiovascular repair and stimulation of epicardium-derived cells, the delivered therapeutics mitigate cardiac remodeling and improve cardiac functions post myocardial infarction. Furthermore, we demonstrate the feasibility of minimally-invasive intrapericardial injection in a clinically-relevant porcine model. Collectively, our study establishes intrapericardial injection as a safe and effective method to deliver therapeutic-bearing hydrogels to the heart for cardiac repair.

Topics: Animals; Cardiac Surgical Procedures; Cardiovascular Agents; Cell Differentiation; Drug Delivery Systems; Exosomes; Extracellular Matrix; Hydrogels; Induced Pluripotent Stem Cells; Male; Materials Testing; Mesenchymal Stem Cells; Mice; Minimally Invasive Surgical Procedures; Myocardial Infarction; Myocytes, Cardiac; Pericardium; Rats; Swine

In the Netherlands, the burden of coronary artery disease is higher than that of any other disease. The healthcare costs amount to approximately 2.3 billion per year. Cardiovascular risk management (CVRM) reduces mortality and prevents myocardial infarction in patients with stable angina pectoris (AP). In patients with stable AP without a left main coronary artery stenosis or heart failure, percutaneous coronary intervention (PCI) does not reduce mortality, nor does it prevent myocardial infarction. The effect on AP is questionable. Improvement of treatment of stable AP can be achieved using intensive CVRM and targeted anti-anginal medication and only if optimal medical therapy (OMT) is not sufficient, a PCI. Clear communication and sharing of tasks between general practitioners and cardiologists in the form of network medicine is necessary, making use of multidisciplinary guidelines and unambiguous, jointly applied quality indicators. Financing of the treatment trajectory for stable AP should promote this integral approach.

Topics: Angina, Stable; Cardiovascular Agents; Coronary Artery Disease; Disease Management; Female; Humans; Male; Myocardial Infarction; Netherlands; Percutaneous Coronary Intervention; Treatment Outcome

The benefits of chronic polytherapy in reducing readmissions and death after myocardial infarction (MI) have been clearly shown. However, real-world evidence shows poor medication adherence and large geographic variation, suggesting critical issues in access to optimal care. Our objectives were to measure adherence to polytherapy, to compare the amount of variation attributable to hospitals of discharge and to community-based providers, and to identify determinants of adherence to medications.. This is a population-based study. Data were obtained from the information systems of the Lazio and Tuscany Regions, Italy (9.5 million inhabitants). Patients hospitalized with incident MI in 2010-2014 were analyzed. The outcome measure was medication adherence, defined as a Medication Possession Ratio (MPR) ≥ 0.75 for at least 3 of the following drugs: antiplatelets, β-blockers, ACEI/ARBs, statins. A 2-year cohort-study was performed. Cross-classified multilevel models were applied to analyze geographic variation. The variance components attributable to hospitals of discharge and community-based providers were expressed as Median Odds Ratio (MOR).. A total of 32,962 patients were enrolled. About 63% of patients in the Lazio cohort and 59% of the Tuscan cohort were adherent to chronic polytherapy. Women and patients aged 85 years and over were most at risk of non-adherence. In both regions, adherence was higher for patients discharged from cardiology wards (Lazio: OR = 1.58, p < 0.001, Tuscany: OR = 1.59, p < 0.001) and for patients with a percutaneous coronary intervention during the index admission. Relevant variation between community-based providers was observed, though when the hospital of discharge was included as a cross-classified level, in both Lazio and Tuscany regions the variation attributable to hospitals of discharge was the only significant component (Lazio: MOR = 1.30, p = 0.001; Tuscany: MOR = 1.31, p = 0.001).. Adherence to best practice treatments after MI is not consistent with clinical guidelines, and varies between patient groups as well as within and between regions. The variation attributable to providers is affected by the hospital of discharge, up to two years from the acute episode. This variation is likely to be attributable to hospital discharge processes, and could be reduced through appropriate policy levers.

Topics: Adrenergic beta-Antagonists; Adult; Aged; Aged, 80 and over; Angiotensin Receptor Antagonists; Angiotensin-Converting Enzyme Inhibitors; Cardiovascular Agents; Community Health Services; Databases, Factual; Female; Guideline Adherence; Healthcare Disparities; Humans; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Italy; Male; Medication Adherence; Middle Aged; Myocardial Infarction; Patient Discharge; Platelet Aggregation Inhibitors; Polypharmacy; Practice Guidelines as Topic; Practice Patterns, Physicians'; Recurrence; Retrospective Studies; Secondary Prevention; Time Factors; Treatment Outcome

Topics: Angina Pectoris; Blood Vessel Prosthesis; Blood Vessel Prosthesis Implantation; Cardiac Rehabilitation; Cardiovascular Agents; Cardiovascular Diseases; Combined Modality Therapy; Complementary Therapies; Coronary Angiography; Coronary Artery Disease; Coronary Stenosis; Drugs, Chinese Herbal; Humans; Male; Medicine, Chinese Traditional; Middle Aged; Myocardial Infarction; Myocardial Revascularization; Stents; Stroke Volume; Syndrome; Tai Ji

How renal function influences post-acute myocardial infarction (AMI) cardiac remodeling and outcomes remains unclear. This study evaluated the impact of levels of renal impairment on drug therapy, echocardiographic parameters, and outcomes in patients with AMI undergoing percutaneous coronary intervention (PCI). A total of 611 patients diagnosed with AMI underwent successful PCI, and two echocardiographic examinations were performed within 1 year after AMI. Patients were categorized according to Group 1: severely impaired estimated glomerular filtration rate (eGFR)<30, Group 2: mildly impaired 30≤eGFR<60, Group 3: potentially at risk 60≤eGFR<90 and normal eGFR≥90 ml/min/1.73 m2. During the 5-year follow-up period, the primary endpoints were cardiovascular mortality and outcomes. Patients with worse renal function (eGFR<30) were older and had a higher prevalence of hypertension and diabetes, but relatively few were smokers or had hyperlipidemia. Despite more patients with lesions of the left anterior descending artery, those with worse renal function received suboptimal guideline-directed medical therapy (GDMT). Notably, patients with worse renal function presented with worse left ventricular function at baseline and subsequent follow-up. Kaplan-Meier analysis revealed increased cardiovascular death, development of heart failure, recurrent AMI and revascularization in patients with worse renal function. Notably, as focusing on patients with ST elevation MI, the similar findings were observed. In multivariable Cox regression, impaired renal function showed the most significant hazard ratio in cardiovascular death. Collectively, in AMI patients receiving PCI, outcome differences are renal function dependent. We found that patients with worse renal function received less GDMT and presented with worse cardiovascular outcomes. These patients require more attention.

Topics: Adult; Age Factors; Aged; Aged, 80 and over; Cardiovascular Agents; Combined Modality Therapy; Female; Follow-Up Studies; Glomerular Filtration Rate; Heart Failure; Humans; Kaplan-Meier Estimate; Longitudinal Studies; Male; Middle Aged; Myocardial Infarction; Percutaneous Coronary Intervention; Postoperative Period; Prevalence; Renal Insufficiency; Risk Factors; Treatment Outcome; Ventricular Remodeling

Khat (Catha edulis) chewing is linked to several social, psychological, and health-related problems. Studies show that khat is associated with gastrointestinal and nervous system diseases. However, little is known about khat's effect on the cardiovascular system. This case report describes acute myocardial infarction (AMI) among two young adults who chew khat frequently, but who do not have underlying cardiovascular disease (CVD) risk factors. Case 1 is a 29-year-old apparently healthy man who presented with severe, squeezing, left-side chest pain after consumption of khat. Most of the laboratory results were within the normal range except for his serum troponin level, which was 400 times more than the normal limit. The patient was diagnosed with Killip class IV, ST-segment elevation, anteroseptal AMI. Case 2 is a 25-year-old man who is a frequent khat chewer. He presented with sudden-onset, severe, squeezing, retrosternal chest pain after khat chewing and vigorous activity. The patient was diagnosed with (Killip class III) acute ST-elevation myocardial infarction with cardiogenic pulmonary edema. These case reports describe two young adult male patients who were confirmed of having AMI with no known risk factors. Both cases had a similar history of frequent khat chewing and the onset of AMI after it, implying that khat could be an important CVD risk factor among young adults. Hence, it is essential to explore further the epidemiology and association between khat use and AMI. Both molecular and population-level studies could help to establish the causal relationship of khat and CVD.

Topics: Adult; Cardiovascular Agents; Catha; Humans; Male; Myocardial Infarction

Infarct size is a major determinant of outcomes after acute myocardial infarction (AMI). Carbon monoxide-releasing molecules (CORMs), which deliver nanomolar concentrations of carbon monoxide to tissues, have been shown to reduce infarct size in rodents. We evaluated efficacy and safety of CORM-A1 to reduce infarct size in a clinically relevant porcine model of AMI. We induced AMI in Yorkshire White pigs by inflating a coronary angioplasty balloon to completely occlude the left anterior descending artery for 60 minutes, followed by deflation of the balloon to mimic reperfusion. Fifteen minutes after balloon occlusion, animals were given an infusion of 4.27 mM CORM-A1 (n = 7) or sodium borate control (n = 6) over 60 minutes. Infarct size, cardiac biomarkers, ejection fraction, and hepatic and renal function were compared amongst the groups. Immunohistochemical analyses were performed to compare inflammation, cell proliferation, and apoptosis between the groups. CORM-A1-treated animals had significant reduction in absolute infarct area (158 ± 16 vs. 510 ± 91 mm2, P < 0.001) and infarct area corrected for area at risk (24.8% ± 2.6% vs. 45.2% ± 4.0%, P < 0.0001). Biochemical markers of myocardial injury also tended to be lower and left ventricular function tended to recover better in the CORM-A1 treated group. There was no evidence of hepatic or renal toxicity with the doses used. The cardioprotective effects of CORM-A1 were associated with a significant reduction in cell proliferation and inflammation. CORM-A1 reduces infarct size and improves left ventricular remodeling and function in a porcine model of reperfused MI by a reduction in inflammation. These potential cardioprotective effects of CORMs warrant further translational investigations.

Topics: Animals; Apoptosis; Biomarkers; Boranes; Carbon Monoxide; Carbonates; Cardiovascular Agents; Caspase 3; Cell Proliferation; Disease Models, Animal; Interleukin-1beta; Ki-67 Antigen; Myocardial Infarction; Myocardial Reperfusion Injury; Myocytes, Cardiac; Sus scrofa; Ventricular Function, Left; Ventricular Remodeling

Ginsenoside Re, an herbal ingredient from ginseng, has been demonstrated to protect the heart from various cardiovascular diseases. In this study, we investigated the protective effects and mechanisms of ginsenoside Re (Gin-Re) on cardiac function and left ventricular remodeling in a rat model of myocardial infarction (MI). After ligating the left anterior descending coronary artery, Wistar rats were treated with Gin-Re (135 mg/kg) by gavage everyday for 4 weeks. Serological detection showed that Gin-Re significantly inhibited myocardial injury and attenuated oxidative stress in MI rats. Echocardiographic observation showed that Gin-Re significantly improved cardiac function and prevented left ventricular dilatation induced by MI. Pathological observation found that Gin-Re significantly decreased interstitial fibrosis in the left ventricle of MI rats. Compared with the MI group, Gin-Re treatment promoted AMPKα phosphorylation, decreased TGF-β1 expression, and attenuated Smad2/3 activation. After Gin-Re treatment, the phosphorylation of FAK, PI3K p110α, and Akt was enhanced in MI rats, while PI3K p110β showed no difference compared with the MI group. These results indicate that Gin-Re may improve MI-induced cardiac dysfunction and mitigate ventricular remodeling through regulation of the AMPK/TGF-β1/Smad2/3 and FAK/PI3K p110α/Akt signaling pathways.

Topics: AMP-Activated Protein Kinases; Animals; Cardiovascular Agents; Disease Models, Animal; Fibrosis; Focal Adhesion Kinase 1; Ginsenosides; Male; Myocardial Infarction; Myocardium; Oxidative Stress; Phosphatidylinositol 3-Kinase; Phosphorylation; Proto-Oncogene Proteins c-akt; Rats, Wistar; Signal Transduction; Smad Proteins, Receptor-Regulated; Transforming Growth Factor beta1; Ventricular Function, Left; Ventricular Remodeling

Interleukin-15 is a pleotropic factor, capable of modulating metabolism, survival, proliferation, and differentiation in many different cell types. The rationale behind this study relates to previous work demonstrating that IL-15 is a major factor present in stem cell extracts, which protects cardiomyocytes subjected to hypoxic stress in vitro. The objective of this current study was to assess whether administration of IL-15 peptide will also show protective effects in vivo. The data indicate that administration of IL-15 reduces cell death, increases vascularity, decreases scar size, and significantly improves left ventricular ejection fraction in a mouse model of myocardial infarction.

Topics: Animals; Cardiovascular Agents; Cell Death; Cells, Cultured; Disease Models, Animal; Human Umbilical Vein Endothelial Cells; Humans; Interleukin-15; Male; Mice, Inbred C57BL; Myocardial Infarction; Myocytes, Cardiac; Neovascularization, Physiologic; Recovery of Function; Stroke Volume; Ventricular Function, Left

The aim of this study was to compare five-year clinical outcomes between an everolimus-eluting bioresorbable scaffold (BRS) and an everolimus-eluting metallic stent (EES) in STEMI patients.. This observational and retrospective study included 235 consecutive STEMI patients treated with BRS, compared with 235 STEMI patients treated with EES from the EXAMINATION trial, by applying propensity score matching. The primary endpoint was a device-oriented endpoint (DOCE), including cardiac death, target vessel myocardial infarction and target lesion revascularisation at five-year follow-up. Device thrombosis, according to the ARC criteria, was also evaluated. Optical coherence tomography (OCT) analysis was also performed at five years in event-free BRS patients. The cumulative incidence of five-year DOCE was higher in the BRS group as compared to the EES group (13.2% vs 7.6%, HR 1.87, 95% CI: 0.94-3.44, p=0.071), mainly driven by a higher rate of TLR (7.6% vs 1.7%, HR 1.15, 95% CI: 0.44-2.30, p=0.004). The five-year definite BRS thrombosis rate was also higher as compared to EES (4.2% vs 1.2%, HR 3.49, 95% CI: 0.95-12.82, p=0.054). OCT analysis showed a high incidence of neoatherosclerosis in the BRS group.. The five-year event risk was higher with BRS versus EES in STEMI. This suggests that the probability of obtaining favourable results at very long-term follow-up is low. Whether better results will be obtained with new-generation BVS remains to be determined.

Topics: Absorbable Implants; Aged; Aged, 80 and over; Cardiovascular Agents; Drug-Eluting Stents; Everolimus; Female; Humans; Male; Metals; Myocardial Infarction; Percutaneous Coronary Intervention; Prosthesis Design; Retrospective Studies; Sirolimus; ST Elevation Myocardial Infarction; Stents; Time Factors; Tissue Scaffolds; Treatment Outcome

Recently, 12 randomized clinical trials (RCTs) have demonstrated the efficacy of novel therapies for mainly secondary prevention of atherosclerotic cardiovascular disease. However, given the potential overlapping eligibility of the RCTs, along with the cost of the new therapies, there are uncertainty and questions about implementing these RCT findings in real-world clinical practice.. To determine the eligibility and preventive potential for these new preventive therapies in a contemporary population.. This population-based contemporary cohort study included 6292 patients with known ischemic heart disease (IHD) and 2277 with a previous myocardial infarction (MI) enrolled between November 2003 and February 2015. Analyses were performed in the Copenhagen General Population Study with a mean (SD) of 7.7 (3.5) years of follow-up. The data were analyzed between January and October 2019.. We determined the drug eligibility and evidence-based potential for preventing major cardiovascular events of the 12 cardiovascular drugs tested in the following recent RCTs: IMPROVE-IT, PEGASUS, EMPA-REG, LEADER, SUSTAIN-6, FOURIER, CANVAS, REVEAL, CANTOS, COMPASS, ODYSSEY-OUTCOMES, and REDUCE-IT. The analyses were performed in patients with known IHD or with a previous MI at baseline.. Of 6292 participants, 3861 (61%) were men and the mean (interquartile range) age was 69 (62-76) years. In patients with IHD or MI at baseline, eligibility for 1 or more new medications was 80% (n = 5036) and 99% (n = 2273), respectively, by meeting RCT enrollment criteria. Dividing the new therapies into 4 drug classes (lipid-modifying, antithrombotic, anti-inflammatory, and antidiabetic drugs), 2594 and 1834 patients with IHD or MI (41% and 81%, respectively) were eligible for 2 or more drug classes simultaneously. The 5-year estimated percentage of major cardiovascular events that could be prevented for each new therapy was 1% to 20% in patients with IHD or MI at baseline.. Most patients with known IHD or previous MI are eligible for additional new secondary prevention therapies. This raises questions for the cardiovascular community and health care authorities about access to these potentially expensive therapies, including strategies for prioritizing their use.

Topics: Aged; Atherosclerosis; Cardiovascular Agents; Cohort Studies; Evidence-Based Pharmacy Practice; Female; Humans; Male; Middle Aged; Myocardial Infarction; Myocardial Ischemia; Secondary Prevention

Approximately one-third of patients considered for coronary revascularization have diabetes, which is a major determinant of clinical outcomes, often influencing the choice of the revascularization strategy. The usefulness of fractional flow reserve (FFR) to guide treatment in this population is understudied and has been questioned.. To evaluate the usefulness and rate of major adverse cardiovascular events (MACE) of integrating FFR in management decisions for patients with diabetes who undergo coronary angiography.. This cross-sectional study used data from the PRIME-FFR study derived from the merger of the POST-IT study (Portuguese Study on the Evaluation of FFR-Guided Treatment of Coronary Disease [March 2012-November 2013]) and R3F study (French Study of FFR Integrated Multicenter Registries Implementation of FFR in Routine Practice [October 2008-June 2010]), 2 prospective multicenter registries that shared a common design. A population of all-comers for whom angiography disclosed ambiguous lesions was analyzed for rates, patterns, and outcomes associated with management reclassification, including revascularization deferral, in patients with vs without diabetes. Data analysis was performed from June to August 2018.. Death from any cause, myocardial infarction, or unplanned revascularization (MACE) at 1 year.. Among 1983 patients (1503 [77%] male; mean [SD] age, 65 [10] years), 701 had diabetes, and FFR was performed for 1.4 lesions per patient (58.2% of lesions in the left anterior descending artery; mean [SD] stenosis, 56% [11%]; mean [SD] FFR, 0.81 [0.01]). Reclassification by FFR was high and similar in patients with and without diabetes (41.2% vs 37.5%, P = .13), but reclassification from medical treatment to revascularization was more frequent in the former (142 of 342 [41.5%] vs 230 of 730 [31.5%], P = .001). There was no statistical difference between the 1-year rates of MACE in reclassified (9.7%) and nonreclassified patients (12.0%) (P = .37). Among patients with diabetes, FFR-based deferral identified patients with a lower risk of MACE at 12 months (25 of 296 [8.4%]) compared with those undergoing revascularization (47 of 257 [13.1%]) (P = .04), and the rate was of the same magnitude of the observed rate among deferred patients without diabetes (7.9%, P = .87). Status of insulin treatment had no association with outcomes. Patients (6.6% of the population) in whom FFR was disregarded had the highest MACE rates regardless of diabetes status.. Routine integration of FFR for the management of coronary artery disease in patients with diabetes may be associated with a high rate of treatment reclassification. Management strategies guided by FFR, including revascularization deferral, may be useful for patients with diabetes.

Topics: Aged; Cardiovascular Agents; Clinical Decision-Making; Coronary Angiography; Coronary Artery Bypass; Coronary Artery Disease; Coronary Stenosis; Cross-Sectional Studies; Diabetes Mellitus; Female; Fractional Flow Reserve, Myocardial; Humans; Male; Myocardial Infarction; Percutaneous Coronary Intervention; Prospective Studies

This study sought to determine clinical outcomes between treatment groups over long-term follow-up.. The safety and efficacy of a ridaforolimus-eluting stent (RES) was evaluated in the BIONICS (BioNIR Ridaforolimus-Eluting Coronary Stent System in Coronary Stenosis) and NIREUS (BioNIR Ridaforolimus Eluting Coronary Stent System [BioNIR] European Angiography Study) trials, demonstrating noninferiority of RES in comparison with a zotarolimus-eluting stent (ZES) regarding 1-year target lesion failure (TLF) and 6-month angiographic late lumen loss, respectively.. Patient-level data from the BIONICS (N = 1,919) and NIREUS (N = 302) randomized trials were pooled, and outcomes in patients implanted with RES and ZES compared. Broad inclusion criteria allowed enrollment of patients with acute coronary syndromes and complex lesions. The primary endpoint was the 2-year rate of TLF or clinically driven target lesion revascularization.. A total of 2,221 patients (age 63.2 ± 10.3 years; 79.7% men) undergoing percutaneous coronary intervention with RES (n = 1,159) or ZES (n = 1,062) were included. Clinical and angiographic characteristics were similar between groups. At 2 years, the primary endpoint of TLF was similar among patients implanted with RES and ZES (7.0% vs. 7.2%; p = 0.94). Rates of target lesion revascularization (4.8% RES vs. 4.1% ZES; p = 0.41) and target vessel-related myocardial infarction (3.1% RES vs. 3.8% ZES; p = 0.52) did not differ between groups. The overall rate of stent thrombosis was also similar (0.5% RES vs. 0.9% ZES; p = 0.39).. In a pooled analysis of 2 randomized trials, 2-year clinical outcomes were similar between patients undergoing percutaneous coronary intervention with RES and ZES. These results support the long-term safety and efficacy of RES for the treatment of a broad population of patients with coronary artery disease.

Topics: Aged; Cardiovascular Agents; Coronary Angiography; Coronary Artery Disease; Coronary Thrombosis; Drug-Eluting Stents; Female; Humans; Male; Middle Aged; Myocardial Infarction; Percutaneous Coronary Intervention; Prosthesis Design; Randomized Controlled Trials as Topic; Risk Factors; Sirolimus; Time Factors; Treatment Outcome

The 'My Experience of Taking Medicines' (MYMEDS) questionnaire is a self-reporting tool for identifying modifiable adherence barriers among individuals prescribed post-myocardial infarction (MI) secondary prevention medicines (SPM) in clinical practice. It was found to be a useful tool to support the conduction of patient-centred consultation in cardiology outpatient leading to improved outcomes including better adherence to SPM and patient satisfaction. This study describes the rationale and development of the MYMEDS tool, its performance and usefulness in identifying modifiable barriers to adherence in cardiology medical practice including user feedback of 204 consecutive post-MI patients who completed an evaluation based on MYMEDS.. Modifiable non-adherence factors were initially identified based on literature review and stakeholder feedback. A draft MYMEDS questionnaire was piloted in 10 patients and adapted accordingly. The final version comprises six sections, covering current medicines, understanding and satisfaction with medicines, concerns about medicines, practical adherence barriers, fitting medicines into daily routine, and adherence to individual SPMs. The questionnaire was mailed to post-MI patients who then attended an outpatient medicines optimisation clinic.. Mean age was 70.5 years and 67.6% were male. The tool was effective in revealing modifiable adherence barriers that could be addressed during the consultation. There were high rates of concern that SPMs could be harmful (33.2%) or overprescribed (43.2%), practical issues with swallowing medicines (8.2%), opening packaging (7.3%) or accessing repeat prescriptions (5.2%), forgetfulness (19.7%), and concerns about inconvenience (13.5%). Mean number of barriers per patient was 1.8 ± 1.5. The medications most commonly associated with non-adherence were statins (21.5%), angiotensin II receptor blockers (21.1%), and antiplatelet agents (18.5%). In total, 42.5% of patients acknowledged non-adherence behaviour. Patient feedback on MYMEDS was positive, with near-unanimous agreement that it was simple, clear and not too long, and that it enabled them to raise any concerns they had about their medicines. Patients reported that their individual medicines related needs were better addressed.. MYMEDS is a practical tool that can successfully identify modifiable barriers to SPM adherence which can be addressed in a clinical setting. It can be easily rolled out in daily clinical practice to enable individualised person-centred medicines optimisation consultation.

Topics: Administration, Oral; Aged; Aged, 80 and over; Biofeedback, Psychology; Cardiovascular Agents; Decision Making, Shared; Deglutition; Drug Packaging; Drug-Related Side Effects and Adverse Reactions; Female; Health Knowledge, Attitudes, Practice; Humans; Inappropriate Prescribing; Male; Medication Adherence; Middle Aged; Myocardial Infarction; Patient Satisfaction; Predictive Value of Tests; Secondary Prevention; Self Report; Surveys and Questionnaires

Background The survival benefit associated with cumulative adherence to multiple clinical and lifestyle-related guideline recommendations for secondary prevention after acute myocardial infarction (AMI) is not well established. Methods and Results We examined adults with AMI (mean age 68 years; 64% men) surviving at least 30 (N=25 778) or 90  (N=24 200) days after discharge in a large integrated healthcare system in Northern California from 2008 to 2014. The association between all-cause death and adherence to 6 or 7 secondary prevention guideline recommendations including medical treatment (prescriptions for β-blockers, renin-angiotensin-aldosterone system inhibitors, lipid medications, and antiplatelet medications), risk factor control (blood pressure <140/90 mm Hg and low-density lipoprotein cholesterol <100 mg/dL), and lifestyle approaches (not smoking) at 30 or 90 days after AMI was evaluated with Cox proportional hazard models. To allow patients time to achieve low-density lipoprotein cholesterol <100 mg/dL, this metric was examined only among those alive 90 days after AMI. Overall guideline adherence was high (35% and 34% met 5 or 6 guidelines at 30 days; and 31% and 23% met 6 or 7 at 90 days, respectively). Greater guideline adherence was independently associated with lower mortality (hazard ratio, 0.57 [95% CI, 0.49-0.66] for those meeting 7 and hazard ratio, 0.69 [95% CI, 0.61-0.78] for those meeting 6 guidelines versus 0 to 3 guidelines in 90-day models, with similar results in the 30-day models), with significantly lower mortality per each additional guideline recommendation achieved. Conclusions In a large community-based population, cumulative adherence to guideline-recommended medical therapy, risk factor control, and lifestyle changes after AMI was associated with improved long-term survival. Full adherence was associated with the greatest survival benefit.

Topics: Aged; Aged, 80 and over; California; Cardiovascular Agents; Cigarette Smoking; Female; Humans; Hypolipidemic Agents; Male; Medication Adherence; Middle Aged; Myocardial Infarction; Patient Compliance; Protective Factors; Recurrence; Risk Assessment; Risk Factors; Risk Reduction Behavior; Secondary Prevention; Smoking Cessation; Time Factors; Treatment Outcome

To test the long-term efficacy of a sirolimus-coated balloon (SCB).. Nanoluté was a prospective registry to evaluate the clinical performance of a novel SCB (Concept Medical Research Private Limited, India) for the treatment of de novo coronary lesions and in-stent restenosis (ISR). We here present the 24 months clinical data.. All patients treated with SCB for any type of coronary indication between July 2012 and September 2015 were enrolled at Indian centers and clinically followed up to 24 months. Primary endpoints were major adverse cardiovascular events (MACE) defined as a composite of cardiac death, target lesion revascularization (TLR), and target vessel-myocardial infarction (MI).. A total of 484 SCBs were used in 408 patients to treat 435 lesions. In detail, the SCB was used for 183 patients with ISR, 185 with de novo small vessel disease, and 40 with de novo large vessel disease. Mean balloon length and diameter (average ± SD) were 22.3 ± 7.1 mm and 2.7 ± 0.40 mm, respectively. All patients with 24 months follow-up were included. Overall MACE rate was 4.2% (n = 17) with three cardiac deaths (0.7%), 13 TLR (3.2%), and one MI (0.2%).. The Nanoluté prospective registry is the first long-term clinical evidence of the safety and feasibility of this type of SCB, both in patients with ISR or de novo lesions.

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coated Materials, Biocompatible; Coronary Artery Disease; Coronary Restenosis; Equipment Design; Female; Humans; India; Male; Middle Aged; Myocardial Infarction; Prospective Studies; Registries; Risk Factors; Sirolimus; Time Factors; Treatment Outcome

The melatonin receptor (MT) agonist ramelteon has a higher affinity to MT1 than for MT2 receptors and induces cardioprotection by involvement of mitochondrial potassium channels. Activation of mitochondrial potassium channels leads to release of free radicals. We investigated whether (1) ramelteon-induced cardioprotection is MT2 receptor specific and (2) if free radicals are involved in ramelteon-induced cardioprotection.. Hearts of male Wistar rats were randomized, placed on a Langendorff system, and perfused with Krebs-Henseleit buffer at a constant pressure of 80 mmHg. All hearts were subjected to 33 min of global ischemia and 60 min of reperfusion. Before ischemia hearts were perfused with ramelteon (Ram) with or without the MT2 receptor inhibitor 4-phenyl-2-propionamidotetralin (4P-PDOT+Ram, 4P-PDOT). In subsequent experiments, ramelteon was administered together with the radical oxygen species (ROS) scavenger N-2-mercaptopropionylglycine (MPG+Ram). To determine whether the blockade of ramelteon-induced cardioprotection can be restored, we combined ramelteon and MPG with mitochondrial permeability transition pore (mPTP) inhibitor cyclosporine A (CsA) at different time points. Infarct size was determined by triphenyltetrazolium chloride (TTC) staining.. Ramelteon-induced infarct size reduction was completely blocked by 4P-PDOT and MPG. Ramelteon and MPG combined with CsA before ischemia were not cardioprotective but CsA at the onset of reperfusion could restore infarct size reduction.. This study shows for the first time that despite the higher affinity to MT1 receptors, (1) ramelteon-induced cardioprotection involves MT2 receptors, (2) cardioprotection requires ROS release, and (3) inhibition of the mPTP can restore infarct size reduction.

Topics: Animals; Cardiovascular Agents; Disease Models, Animal; Indenes; Isolated Heart Preparation; Male; Mitochondria, Heart; Mitochondrial Membrane Transport Proteins; Mitochondrial Permeability Transition Pore; Myocardial Infarction; Myocardial Reperfusion Injury; Myocytes, Cardiac; Rats, Wistar; Reactive Oxygen Species; Receptor, Melatonin, MT2; Signal Transduction; Ventricular Function, Left

Topics: Animals; Cardiovascular Agents; Cells, Cultured; Disease Models, Animal; Endoplasmic Reticulum Chaperone BiP; Extracellular Signal-Regulated MAP Kinases; Heat-Shock Proteins; Isolated Heart Preparation; Male; Mice; Myocardial Infarction; Myocardial Reperfusion Injury; Myocytes, Cardiac; Peptide Fragments; Receptors, G-Protein-Coupled; Relaxin; Signal Transduction; Unfolded Protein Response; Ventricular Function, Left; Ventricular Remodeling

The plant Anchusa italica Retz. (Anchusa azurea Mill.) has been traditionally used in Uygur medicine for the treatment of cardiovascular and cerebrovascular diseases in China. Our previous study showed that total flavonoids from Anchusa italica Retz. (TFAI) exhibited potent cardioprotection in acute ischemia/reperfusion injured rats.. This study was undertaken to investigate the effects of TFAI on chronic myocardial infarction (MI) in mice and the underlying mechanism.. Total flavonoids were extracted from the whole herb of Anchusa italica Retz. and were characterized using HPLC-MS analysis. The left anterior descending branch of the coronary artery was ligated to simulate MI injury in mice. After surgery, mice were orally fed with TFAI at the doses of 10, 30 and 50 mg/kg body weight/day for a total of four weeks. Cardiac function and infarct size were measured, and inflammatory mediators were detected. Hematoxylin and eosin (H&E) staining and Masson's trichrome staining were performed on heart sections. The apoptotic factors, such as Bax, Bcl-2 and cleaved caspase 3, as well as the key proteins in the PI3K/Akt/mTOR signaling pathway were examined by Western blot.. The content of total flavonoids in TFAI was 56.2%. Four weeks following the MI surgery, TFAI enhanced the survival rate in post-MI mice. TFAI treatment at the doses of 30 and 50 mg/kg remarkably reduced infarct size and improved cardiac function as indicated by elevated EF and FS. Assay of the inflammatory factors showed that sera levels of TNF-α, IL-1β and IL-6 were markedly decreased by TFAI treatment compared to the MI group. H&E staining and Masson's trichrome staining demonstrated that TFAI suppressed myocyte hypertrophy and cardiac fibrosis as indicated by the decreased cross-section area and collagen volume. Western blot analysis showed that cleaved caspase 3 and Bax/Bcl-2 were significantly downregulated following TFAI treatment. Furthermore, TFAI treatment significantly suppressed the activation of the PI3K/Akt/mTOR signaling pathway.. Our data suggest that TFAI exerts a potent protective effect against chronic MI injury, and its beneficial effects on cardiac function and cardiac remodeling might be attributable, at least in part, to anti-inflammation and inhibition of the PI3K/Akt/mTOR signaling pathway.

Topics: Animals; Anti-Inflammatory Agents; Apoptosis; Apoptosis Regulatory Proteins; Boraginaceae; Cardiovascular Agents; Disease Models, Animal; Fibrosis; Flavonoids; Inflammation Mediators; Male; Mice, Inbred C57BL; Myocardial Infarction; Myocardium; Phosphatidylinositol 3-Kinase; Plant Extracts; Proto-Oncogene Proteins c-akt; Signal Transduction; TOR Serine-Threonine Kinases; Ventricular Function, Left; Ventricular Remodeling

The study aimed to investigate the effects of the sodium-glucose co-transporter 2 (SGLT2) inhibitor empagliflozin on chronic heart failure (HF) in normoglycemic rats. The effects of empagliflozin were compared with the standard medications for HF, e.g., angiotensin-converting enzyme (ACE) inhibitor fosinopril, beta-blocker bisoprolol, and aldosterone antagonist spironolactone. Myocardial infarction (MI) was induced in male Wistar rats via permanent ligation of the left descending coronary artery. One-month post MI, 50 animals were randomized into 5 groups (n = 10): vehicle-treated, empagliflozin (1.0 mg/kg), fosinopril (10 mg/kg), bisoprolol (10 mg/kg), and spironolactone (20 mg/kg). All medications except empagliflozin were titrated within a month and administered per os daily for 3 months. Echocardiography, 24-hour urine volume test, and treadmill exercise tests were performed at the beginning and at the end of the study. Treatment with empagliflozin slowed the progression of left ventricular dysfunction: LV sizes and ejection fraction were not changed and the minute volume was significantly increased (from 52.0 ± 15.5 to 61.2 ± 21.2 ml/min) as compared with baseline. No deaths occurred in empagliflozin group. The 24-hour urine volume tends to be higher in empagliflozin and spironolactone groups than in vehicle and fosinopril group. Moreover, empagliflozin exhibited maximal physical exercise tolerance in comparison with all investigated groups (289 ± 27 s versus 183 ± 61 s in fosinopril group, 197 ± 95 s in bisoprolol group, and 47 ± 46 s in spironolactone group, p = 0.0035 for multiple comparisons). Sodium-glucose co-transporter 2 inhibitor empagliflozin reduced progression of left ventricular dysfunction and improved tolerance of physical exercise in normoglycemic rats with HF. Empagliflozin treatment was superior with respect to physical tolerance compared with fosinopril, bisoprolol, and spironolactone.

Topics: Animals; Benzhydryl Compounds; Bisoprolol; Cardiovascular Agents; Chronic Disease; Disease Models, Animal; Exercise Tolerance; Fosinopril; Glucosides; Heart Failure; Male; Myocardial Infarction; Rats, Wistar; Sodium-Glucose Transporter 2 Inhibitors; Spironolactone; Ventricular Dysfunction, Left; Ventricular Function, Left

To explore the mechanism of Shengmai Yin (SMY) for coronary heart disease (CHD) by systemic pharmacology and chemoinformatics.. Traditional Chinese Medicine Systems Pharmacology Database (TCMSP), traditional Chinese medicine integrative database (TCMID) and the traditional Chinese medicine (TCM) Database@Taiwan were used to screen and predict the bioactive components of SMY. Pharmmapper were utilized to predict the potential targets of SMY, the TCMSP was utilized to obtain the known targets of SMY. The Genecards and OMIM database were utilized to collect CHD genes. Cytoscape was then used for network construction and analysis, and DAVID was used for Gene Ontology (GO) and pathway enrichment analysis. After that, animal experiments were then performed to further validate the results of systemic pharmacology and chemoinformatics.. Three major networks were constructed: (1) CHD genes' protein-protein interaction (PPI) network; (2) SMY-CHD PPI network; (3) SMY known target-CHD PPI network. The other networks are minor networks generated by analyzing the three major networks. Experimental results showed that compared with the model group, the Shengmai injection (SMI) can reduce the myocardial injury score and the activities of serum aspartate aminoconvertase (AST), CK and lactate dehydrogenase (LDH) in rats (P<0.05), and reduce serum lipid peroxide (LPO) content and increase serum superoxide dismutase (SOD) and glutathione peroxidase (GSH-Px) activities in myocardial infarction rats (P<0.05). SMI can also decrease the expression of MMP-9 mRNA and increase that of TIMP-1 mRNA (P<0.01).. SMY may regulate the signaling pathways (such as PPAR, FoxO, VEGF signaling), biological processes (such as angiogenesis, blood pressure formation, inflammatory response) and targets (such as AKT1, EGFR, MAPK1) so as to play a therapeutic role in CHD.

Topics: Animals; Cardiovascular Agents; Coronary Disease; Databases, Factual; Disease Models, Animal; Drug Combinations; Drugs, Chinese Herbal; Female; Gene Regulatory Networks; Humans; Male; Matrix Metalloproteinase 9; Myocardial Infarction; Myocytes, Cardiac; Protein Interaction Maps; Rats, Sprague-Dawley; Signal Transduction; Tissue Inhibitor of Metalloproteinase-1

Shexiang Baoxin Pill (SBP) is a commercial Chinese medicine included in the Chinese Pharmacopoeia with well-established cardiovascular protect effect in clinic. However, the mechanism of SBP underlying protective effect on cardiovascular disease has not been clearly elucidated yet.. We aimed to investigate the underlying protective mechanisms of SBP on an acute myocardial infarction (AMI) rat model by using comprehensive metabolomics.. The rat model of AMI was generated by ligating the left anterior descending coronary artery. After two weeks of treatment with SBP, comprehensive metabolomics and echocardiography index was performed for a therapeutic evaluation. The wiff data were processed using Progenesis QI and metabolites were identified based on the database of HMDB and LIPIDMAPS. Meanwhile, the untargeted metabolomics data from LC-MS combined with correlation analysis to characterize the metabolic alterations.. The metabolomics profiles of different groups in different biological samples (heart, serum, urine and feces) were significantly different, in which a total of 217 metabolites were identified. AMI caused comprehensive metabolic changes in amino acid metabolism, glycerophospholipid metabolism and pyrimidine metabolism, while SBP reversed more than half of the differential metabolic changes, mainly affecting amino acid metabolism, butanoate metabolism and glycerophospholipid metabolism. Correlation analysis found that SBP could significantly alter the metabolic activity of six key metabolites (5-hydroxyindoleacetic acid, glycerophosphocholine, PS (20:4/0:0), xanthosine, adenosine and L-phenylalanine) related to AMI. The key role of these metabolites was further validated with correlation analysis with echocardiography indexes.. This study demonstrated that SBP was effective for protecting cardiac dysfunction by regulating amino acid, lipid and energy metabolisms. The results also suggested that the modulation on gut microbiota might be involved the cardioprotective effect of SBP.

Topics: Animals; Cardiovascular Agents; Disease Models, Animal; Drugs, Chinese Herbal; Energy Metabolism; Male; Metabolome; Metabolomics; Myocardial Infarction; Myocardium; Rats, Sprague-Dawley; Recovery of Function; Ventricular Function, Left

 The ABC (age, biomarkers, and clinical history)-stroke and ABC-bleeding are biomarker-based scores proposed to predict stroke and bleeding, but non-specificity of biomarkers is common, predicting different clinical events at the same time. We assessed the predictive performance of the ABC-stroke and ABC-bleeding scores, for outcomes beyond ischemic stroke and major bleeding, in a cohort of atrial fibrillation (AF) patients..  We included AF patients stable on vitamin K antagonists for 6 months. The ABC-stroke and ABC-bleeding were calculated and the predictive values for myocardial infarction (MI), acute heart failure (HF), a composite of cardiovascular events, and all-cause deaths were compared..  We included 1,044 patients (49.2% male; median age 76 [71-81] years). During 6.5 (4.3-7.9) years, there were 58 (5.6%) MIs, 98 (9.4%) acute HFs, 167 (16%) cardiovascular events, and 418 (40%) all-cause deaths. There were no differences in mean ABC-stroke and ABC-bleeding scores in patients with/without MI (.  In AF patients, the ABC-stroke and ABC-bleeding scores demonstrated similar predictive ability for outcomes beyond stroke and bleeding, including MI, acute HF, a composite of cardiovascular events, and all-cause deaths. This is consistent with nonspecificity of biomarkers that predict "sick" patients or poor prognosis overall.

Topics: Age Factors; Aged; Aged, 80 and over; Anticoagulants; Area Under Curve; Atrial Fibrillation; Biomarkers; Cardiovascular Agents; Cause of Death; Comorbidity; Death, Sudden, Cardiac; Decision Support Techniques; Female; Heart Failure; Hemorrhage; Humans; Male; Mortality; Myocardial Infarction; Platelet Aggregation Inhibitors; Prognosis; ROC Curve; Severity of Illness Index; Stroke; Vitamin K

Ranolazine is approved for patients with chronic stable angina but has not been formally studied in patients with refractory angina pectoris (RAP). Patients with RAP have limited therapeutic options and significant limitations in their quality of life. The Ranolazine Refractory Angina Registry was designed to evaluate the safety, tolerability, and effectiveness of ranolazine in RAP patients in order to expand treatment options for this challenging patient population. Using an extensive prospective database, we enrolled 158 consecutive patients evaluated in a dedicated RAP clinic. Angina class, medications, major adverse cardiac events including death, myocardial infarction, and revascularization were obtained at 12, 24, and 36 months. At 3 years, 95 (60%) patients remained on ranolazine. A ≥2 class improvement in angina was seen in 48% (38 of 80 patients with known Canadian Cardiovascular Society class) of those who remained on ranolazine. Discontinuation due to side effects, ineffectiveness, cost, and progression of disease were the principle reasons for discontinuation, but primarily occurred within the first year. In conclusion, ranolazine is an effective antianginal therapy at 3-year follow-up in patients with RAP and may reduce cardiac readmission.

Topics: Aged; Angina Pectoris; Cardiovascular Agents; Constipation; Deprescriptions; Diabetes Mellitus; Disease Progression; Dizziness; Drug Costs; Dyslipidemias; Edema; Female; Humans; Hypertension; Male; Medication Adherence; Middle Aged; Mortality; Myocardial Infarction; Myocardial Revascularization; Nausea; Ranolazine; Registries; Smoking; Treatment Failure; Treatment Outcome

Diosmetin has shown great potential in the control of several diseases. The aim of the present study was to evaluate the role of diosmetin as a candidate agent for the treatment of myocardial infarction which was mainly caused by hypoxia. The model of hypoxia‑injured myocardial cells was established using the H9c2 cell line. Cell viability was determined using Cell Counting Kit‑8, cell apoptosis was determined by Annexin V‑FITC Apoptosis Detection Kit and cleaved caspase‑3 level was assessed by western blot analysis. Autophagy was monitored using a commercial kit, and a well‑established reporter system was used to confirm the role of diosmetin in autophagy. The activity of adenosine 5'‑monophosphate‑activated protein kinase (AMPK) signaling was detected by western blot analysis. Cell viability assay indicated that diosmetin alleviated hypoxia‑induced cell death of H9c2 cells in a dose‑dependent manner. Data of the apoptosis assay revealed that diosmetin reduced the proportion of apoptotic cells in the hypoxia‑injured H9c2 cells. It was also found that the occurrence of autophagy was promoted when hypoxia‑injured cells were treated with diosmetin alone, and results of the western blot analysis revealed that AMPK signaling was activated by diosmetin. Administration of diosmetin together with an inhibitor of autophagy (3‑methyladenine, 3‑MA) or AMPK (Compound C) was able to decrease the diosmetin‑induced autophagy as well as the cytoprotective effects in the hypoxia‑injured cells. Our study concluded that diosmetin exhibits a cytoprotective effect on hypoxia‑injured myocardial cells by inducing autophagy and alleviating apoptosis. AMPK was demonstrated to regulate the observed effects caused by diosmetin. This investigation confirmed diosmetin as a promising drug candidate for myocardial infarction treatment. The present findings regarding the inherent molecular mechanisms involved in the protective effects of diosmetin promote the clinical application of diosmetin.

Topics: Adenine; Animals; Apoptosis; Autophagy; Cardiovascular Agents; Cell Hypoxia; Cell Line; Cytoprotection; Flavonoids; Mice; Myocardial Infarction; Myocardium; Myocytes, Cardiac; Pyrazoles; Pyrimidines

This study sought to compare clinical outcomes between bioresorbable scaffolds (BRS) and durable polymer everolimus-eluting metallic stents (DP-EES) in patients with acute myocardial infarction (AMI) undergoing successful percutaneous coronary intervention (PCI).. From March 2016 to October 2017, 952 patients with AMI without cardiogenic shock undergoing successful PCI with BRS (n = 136) or DP-EES (n = 816) were enrolled from a multicenter, observational Korea Acute Myocardial Infarction Registry.. In the crude population, there was no significant difference in the 1-year rate of device-oriented composite endpoint (DOCE) and device thrombosis between the BRS and DP-EES groups (2.2% vs. 4.8%, hazard ratio [HR] 0.43, 95% confidence interval [CI] 0.13-1.41, p = 0.163; 0.7% vs. 0.5%, HR 1.49, 95% CI 0.16-13.4, p = 0.719, respectively). BRS implantation was opted in younger patients (53.7 vs. 62.6 years, p < 0.001) with low-risk profiles, and intravascular image-guided PCI was more preferred in the BRS group (60.3% vs. 27.2%, p < 0.001).. At 1-year follow-up, no differences in the rate of DOCE and device thrombosis were observed between patients with AMI treated with BRS and those treated with DP-EES. Our data suggest that imaging-guided BRS implantation in young patients with low risk profiles could be a reasonable strategy in the setting of AMI.

Topics: Absorbable Implants; Acute Disease; Adult; Aged; Cardiovascular Agents; Drug-Eluting Stents; Endpoint Determination; Everolimus; Female; Humans; Male; Middle Aged; Myocardial Infarction; Percutaneous Coronary Intervention; Proportional Hazards Models; Republic of Korea; Thrombosis; Tissue Scaffolds; Treatment Outcome

Pharmacological strategies aimed at co-activating peroxisome proliferator-activated receptor-gamma (PPAR-γ)/nuclear factor erythroid 2-related factor 2 (Nrf2) pathway have shown promising results in alleviating myocardial injury. The aim of the study was to evaluate the role of chrysin, a PPAR-γ agonist, in ischemia-reperfusion (IR)-induced myocardial infarction (MI) in rats and to explore the molecular mechanism driving this activity. To evaluate this hypothesis, chrysin (60 mg/kg, orally), PPAR-γ antagonist (GW9662, 1 mg/kg, intraperitoneally), or both were administered to rats for 28 days. On the 29th day, one-stage ligation of left anterior descending coronary artery for 45 min followed by 60 min of reperfusion was performed. Chrysin significantly decreased infarct size and improved cardiac functions following IR-induced MI. This improvement was corroborated by augmented PPAR-γ/Nrf2 expression as confirmed by immunohistochemistry and western blotting analysis. Chrysin exhibited strong anti-oxidant property as demonstrated by increased GSH and CAT levels and decreased 8-OHdG and TBARS levels. Our findings also imply that chrysin significantly inhibited inflammatory response as validated by decreased NF-κB, IKK-β, CRP, TNF-α and MPO levels. In addition, chrysin decreased TUNEL/DAPI positivity, a marker of apoptotic response and normalized cardiac injury markers. The histopathological and ultrastructural analysis further supported the functional and biochemical outcomes, showing preserved myocardial architecture. Intriguingly, co-administration with GW9662 significantly diminished the cardioprotective effect of chrysin as demonstrated by depressed myocardial function, decreased PPAR-γ/Nrf2 expression and increased oxidative stress. In conclusion, the present study demonstrates that co-activation of PPAR-γ/Nrf2 by chrysin may be crucial for its cardioprotective effect.

Topics: Animals; Anti-Inflammatory Agents; Antioxidants; Apoptosis; Cardiovascular Agents; Disease Models, Animal; Flavonoids; Hemodynamics; Inflammation Mediators; Male; Myocardial Infarction; Myocardial Reperfusion Injury; Myocytes, Cardiac; NF-E2-Related Factor 2; Oxidative Stress; PPAR gamma; Rats, Wistar; Signal Transduction; Ventricular Function, Left

To ascertain the most appropriate treatment for chronic, stable, coronary artery disease (CAD) in patients submitted to elective coronary angiography.. A total of 814 patients included in the prospective cohort study were referred for elective coronary angiography and were followed up on average for 6±1.9 years. Main outcomes were all-cause death, cardiovascular death, non-fatal myocardial infarction (MI) and stroke and late revascularization and their combinations as major adverse cardiac and cerebral events (MACCE): MACCE-1 included cardiovascular death, nonfatal MI, and stroke; MACCE-2 was MACCE-1 plus late revascularization. Survival curves and adjusted Cox proportional hazard models were used to explore the association between the type of treatment and outcomes.. All-cause death was lower in participants submitted to percutaneous coronary intervention (PCI) (0.41, 0.16-1.03, P=0.057) compared to medical treatment (MT). Coronary-artery bypass grafting (CABG) had an overall trend for poorer outcomes: cardiovascular death 2.53 (0.42-15.10), combined cardiovascular death, nonfatal MI, and stroke 2.15 (0.73-6.31) and these events plus late revascularization (2.17, 0.86-5.49). The corresponding numbers for PCI were 0.27 (0.05-1.43) for cardiovascular death, 0.77 (0.32-1.84) for combined cardiovascular death, nonfatal MI, and stroke and 2.35 (1.16-4.77) with the addition of late revascularization. These trends were not influenced by baseline blood pressure, left ventricular ejection fraction and previous MI. Patients with diabetes mellitus had a significantly higher risk of recurrent revascularization when submitted to PCI than CABG.. Patients with confirmed CAD in elective coronary angiography do not have a better prognosis when submitted to CABG comparatively to medical treatment. Patients treated with PCI had a trend for the lower incidence of combined cardiovascular events, at the expense of additional revascularization procedures. Patients without significant CAD had a similar prognosis than CAD patients treated with medical therapy.

Topics: Aged; Cardiovascular Agents; Cause of Death; Chronic Disease; Coronary Angiography; Coronary Artery Disease; Endovascular Procedures; Female; Humans; Male; Middle Aged; Myocardial Infarction; Percutaneous Coronary Intervention; Predictive Value of Tests; Prospective Studies; Referral and Consultation; Risk Assessment; Risk Factors; Stroke; Time Factors; Treatment Outcome

The coronavirus disease 2019 (COVID-19) pandemic has changed health care delivery worldwide. Although decreases in hospitalization for acute myocardial infarction (AMI) have been reported during the pandemic, the implication for in-hospital outcomes is not well understood.. To define changes in AMI case rates, patient demographics, cardiovascular comorbidities, treatment approaches, and in-hospital outcomes during the pandemic.. This cross-sectional study retrospectively analyzed AMI hospitalizations that occurred between December 30, 2018, and May 16, 2020, in 1 of the 49 hospitals in the Providence St Joseph Health system located in 6 states (Alaska, Washington, Montana, Oregon, California, and Texas). The cohort included patients aged 18 years or older who had a principal discharge diagnosis of AMI (ST-segment elevation myocardial infarction [STEMI] or non-ST-segment elevation myocardial infarction [NSTEMI]). Segmented regression analysis was performed to assess changes in weekly case volumes. Cases were grouped into 1 of 3 periods: before COVID-19 (December 30, 2018, to February 22, 2020), early COVID-19 (February 23, 2020, to March 28, 2020), and later COVID-19 (March 29, 2020, to May 16, 2020). In-hospital mortality was risk-adjusted using an observed to expected (O/E) ratio and covariate-adjusted multivariable model.. Date of hospitalization.. The primary outcome was the weekly rate of AMI (STEMI or NSTEMI) hospitalizations. The secondary outcomes were patient characteristics, treatment approaches, and in-hospital outcomes of this patient population.. The cohort included 15 244 AMI hospitalizations (of which 4955 were for STEMI [33%] and 10 289 for NSTEMI [67%]) involving 14 724 patients (mean [SD] age of 68 [13] years and 10 019 men [66%]). Beginning February 23, 2020, AMI-associated hospitalizations decreased at a rate of -19.0 (95% CI, -29.0 to -9.0) cases per week for 5 weeks (early COVID-19 period). Thereafter, AMI-associated hospitalizations increased at a rate of +10.5 (95% CI, +4.6 to +16.5) cases per week (later COVID-19 period). No appreciable differences in patient demographics, cardiovascular comorbidities, and treatment approaches were observed across periods. The O/E mortality ratio for AMI increased during the early period (1.27; 95% CI, 1.07-1.48), which was disproportionately associated with patients with STEMI (1.96; 95% CI, 1.22-2.70). Although the O/E mortality ratio for AMI was not statistically different during the later period (1.23; 95% CI, 0.98-1.47), increases in the O/E mortality ratio were noted for patients with STEMI (2.40; 95% CI, 1.65-3.16) and after risk adjustment (odds ratio, 1.52; 95% CI, 1.02-2.26).. This cross-sectional study found important changes in AMI hospitalization rates and worse outcomes during the early and later COVID-19 periods. Future studies are needed to identify contributors to the increased mortality rate among patients with STEMI.

Topics: Aged; Cardiovascular Agents; Coronary Artery Bypass; COVID-19; Cross-Sectional Studies; Female; Hospital Mortality; Hospitalization; Humans; Length of Stay; Male; Myocardial Infarction; Pandemics; Percutaneous Coronary Intervention; Retrospective Studies; United States

Dissection after plain balloon angioplasty is required to achieve adequate luminal area; however, it is associated with a high risk of vascular events. This study aimed to examine the relationship between non-flow limiting coronary dissections and subsequent lumen loss and long-term clinical outcomes following successful drug-coated balloon (DCB) treatment of de novo coronary lesions.. A total of 227 patients with good distal flow (Thrombolysis in Myocardial Infarction flow grade 3) following DCB treatment were retrospectively enrolled and stratified according to the presence or absence of a non-flow limiting dissection. The primary endpoint was late lumen loss (LLL) at 6-month angiography, and the secondary endpoint was target vessel failure (TVF, a composite of cardiac death, target vessel myocardial infarction, target vessel revascularization, and target vessel thrombosis).. The cohort consisted of 95 patients with and 132 patients without a dissection. There were no between-group differences in LLL (90.8%) returning for angiography at 6 months (0.05±0.19 mm in non-dissection and 0.05±0.30 mm in dissection group,. The presence of a dissection following successful DCB treatment of a de novo coronary lesion may not be associated with an increased risk of LLL or TVF (Impact of Drug-coated Balloon Treatment in de Novo Coronary Lesion; NCT04619277).

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Angiography; Coronary Artery Disease; Dissection; Drug-Eluting Stents; Female; Humans; Male; Middle Aged; Myocardial Infarction; Paclitaxel; Postoperative Complications; Retrospective Studies; Treatment Outcome

Calycosin (CC) is a phytoestrogen, isolated from Radix astragali a well-known Chinese herb and used for treating various pathological conditions. The current study was projected to elucidate the cardio-preservative property of CC in isoproterenol (ISO) induced cardiac injury model (MI) in rats. Male SD rats (n=48) were equally divided into 4 groups which include normal rats (Control; n=12), ISO-MI rats (n=12) which were injected with 85 mg/kg of ISO for 2 days. ISO+CC rats (n=12) were pre and post-treated with CC (30 mg/kg). CC alone rats (n=12) were injected with only CC (30 mg/kg). Pre and post-treatment with CC after and before ISO exposure showed strong cardioprotective property through significant reduction (p<0.05) in the mean values of cardiac infarct size, serum cardiac markers, inflammatory markers, apoptotic markers, lipid peroxidation (oxidative stress) by improving antioxidant status as well as reversing all those histopathological changes. Based on the results, we suggest that CC might be useful against MI if consumed along with standard MI medication to lower cardiac dysfunction and its related complications. However, further studies are needed to justify the above statement.

Topics: Animals; Antioxidants; Apoptosis; Apoptosis Regulatory Proteins; Cardiovascular Agents; Disease Models, Animal; Inflammation Mediators; Isoflavones; Isoproterenol; Lipid Peroxidation; Male; Myocardial Infarction; Myocytes, Cardiac; Oxidative Stress; Rats, Sprague-Dawley; Ventricular Function

Acute heart failure patients could benefit from heart rate reduction, as myocardial consumption and oxidative stress are related to tachycardia. Ivabradine could have a clinical role attenuating catecholamine-induced tachycardia. The aim of this study was to evaluate hemodynamic effects of ivabradine in a swine model of acute heart failure.. Myocardial infarction was induced by 45 min left anterior descending artery balloon occlusion in 18 anesthetized pigs. An infusion of dobutamine and noradrenaline was maintained aiming to preserve adequate hemodynamic support, accompanied by fluid administration to obtain a pulmonary wedged pressure ≥ 18 mmHg. After reperfusion, rhythm and hemodynamic stabilization, the animals were randomized to 0.3 mg/kg ivabradine intravenously (n = 9) or placebo (n = 9). Hemodynamic parameters were observed over a 60 min period.. Ivabradine was associated with a significant reduction in heart rate (88.4 ± 12.0 bpm vs. 122.7 ± 17.3 bpm after 15 min of ivabradine/placebo infusion, p < 0.01) and an increase in stroke volume (68.8 ± 13.7 mL vs. 52.4 ± 11.5 mL after 15 min, p = 0.01). There were no significant differences in systemic or pulmonary arterial pressure, or significant changes in pulmonary capillary pressure. However, after 15 min, cardiac output was significantly reduced with ivabradine (-5.2% vs. +15.0% variation in ivabradine/placebo group, p = 0.03), and central venous pressure increased (+4.2% vs. -19.7% variation, p < 0.01).. Ivabradine reduces heart rate and increases stroke volume without modifying systemic or left filling pressures in a swine model of acute heart failure. However, an excessive heart rate reduction could lead to a decrease in cardiac output and an increase in right filling pressures. Future studies with specific heart rate targets are needed.

Topics: Acute Disease; Animals; Arterial Pressure; Cardiac Output; Cardiovascular Agents; Disease Models, Animal; Female; Heart Failure; Heart Rate; Ivabradine; Myocardial Infarction; Sus scrofa; Time Factors

Bioresorbable scaffolds (BRS) were conceived to ensure transient coronary artery support during antiproliferative drug delivery. However, the Absorb everolimus-eluting bioresorbable scaffold was found to be inferior to everolimus-eluting metallic stents (EES) in moderately complex coronary anatomies. We sought to investigate whether the Absorb represents a valuable option for the percutaneous treatment of patients with ST-elevation myocardial infarction (STEMI).. We pooled the individual patient data of two randomised trials specifically designed to investigate the performance of Absorb versus EES in patients with acute myocardial infarction (MI). The primary outcome was lesion (in-segment) diameter stenosis at angiographic follow-up. The main secondary outcome was the device-oriented composite endpoint (DOCE) of cardiac death, target vessel MI and target lesion revascularisation at one year. A total of 388 patients with STEMI were allocated to Absorb (n=227) or EES (n=161). Angiographic follow-up at one year was available for 332 (85.6%) patients. Lesion diameter stenosis was comparable between Absorb and EES (22.8±9.8% versus 23.6±11.2%; mean difference -0.8%, 95% confidence interval [CI]: -3.18-1.48, p=0.47). DOCE occurred in 21 patients at one year, with similar distribution between the Absorb and EES groups (5.3% versus 5.6%; hazard ratio 0.95, 95% CI: 0.40-2.26, p=0.91).. This pooled analysis provides evidence for a comparable angiographic performance and suggests similar clinical performance of Absorb and EES in STEMI patients undergoing percutaneous revascularisation. The long-term durability of Absorb and the extent to which newer BRS platforms might have a potential role in STEMI deserve further investigation. Both trials were registered at www.clinicaltrials.gov (NCT01942070 and NCT01986803).

Topics: Absorbable Implants; Cardiovascular Agents; Drug-Eluting Stents; Everolimus; Humans; Myocardial Infarction; Percutaneous Coronary Intervention; Prosthesis Design; Randomized Controlled Trials as Topic; Sirolimus; ST Elevation Myocardial Infarction; Stents; Time Factors; Treatment Outcome

We aimed to assess long-term safety and performance of the Orsiro sirolimus-eluting coronary stent with biodegradable polymer in a large unselected population and in pre-specified subgroups.. BIOFLOW-III is a prospective, multicenter, international, observational registry with follow-up visits scheduled at 6 and 12 months, and at 3 and 5 years (NCT01553526).. 1356 patients with 1738 lesions were enrolled. Of those, 392 (28.9%) declined to participate in the study extension from 18 months to 5 years, 37 (2.7%) withdrew consent, and 89 (6.6%) were lost to follow-up. At 5-years, Kaplan-Meier estimates of target lesion failure, defined as a composite of cardiac death, target-vessel myocardial infarction, coronary artery bypass grafting and clinically driven target lesion revascularization was 10.0% [95% confidence interval (CI): 8.4; 12.0] in the overall population, and 14.0% [95% CI: 10.5; 18.6], 10.3% [95% CI: 7.8; 13.5], 1.8% [95% CI: 0.3; 12.0], and 11.3% [95% CI: 8.5; 15.1] in the pre-defined risk groups of patients with diabetes mellitus, small vessels ≤2.75 mm, chronic total occlusion, and acute myocardial infarction. Definite stent thrombosis was observed in 0.3% [95% CI: 0.1; 0.9] of patients.. These long-term outcomes provide further evidence on the safety and performance of a sirolimus-eluting biodegradable polymer stent within daily clinical practice. The very low definite stent thrombosis rate affirms biodegradable polymer safety and performance.

Topics: Absorbable Implants; Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Chronic Disease; Coronary Artery Disease; Coronary Occlusion; Coronary Thrombosis; Drug-Eluting Stents; Female; Humans; Male; Middle Aged; Myocardial Infarction; Polyesters; Prospective Studies; Prosthesis Design; Recurrence; Registries; Risk Factors; Sirolimus; Time Factors; Treatment Outcome

American and European associations of cardiology published specific guidelines about recommended drugs for secondary prevention in ST-segment elevation myocardial infarction (STEMI) patients. Our aim was to assess whether drug prescription for STEMI patients was in accordance with the guidelines at discharge and after 1 year.. We used data of 361 patients admitted for STEMI in a tertiary hospital in Switzerland from 2014 to 2016. We assessed the adequacy of prescription of recommended drugs at two time points: discharge and after 1 year. Medications assessed were aspirin, P2Y12 inhibitors, statin, angiotensin-converting enzyme inhibitors (ACEIs)/angiotensin receptor blockers (ARBs) and β-blockers. We took into account several criteria like statin dosage (low versus high intensity) and presence of contraindication for consideration of optimal therapy. Predictors of incomplete prescription of guideline medications were then assessed with multivariate logistic regression models.. From discharge (n = 358) to 1-year follow-up (n = 303), rate of optimal prescription was reduced from 98.6 to 91.7% for aspirin, from 93.9 to 79.1% for P2Y12 inhibitors, from 83.8 to 65.7% for statins, from 98.6 to 95.6% for ACEIs/ARBs, and from 97.1 to 96.9% for β-blockers. Predictors of incomplete prescription of guideline medications at discharge were female sex (odds ratio [OR] 2.54, p = 0.007), active or former smoker status (OR 2.29, p = 0.017), multivessel disease (OR 2.07, p = 0.022), left ventricular ejection fraction < 40% (OR 2.49, p = 0.008), and transfer to cardiac surgery (OR 9.66, p = 0.018). At 1 year, age > 65 (OR 1.92, p = 0.036) remained the only significant predictor.. The present study showed a high prescription rate of guideline-recommended medications in a referral center for primary percutaneous coronary intervention. At discharge, women and co-morbid patients were at the highest risk of incomplete prescription of guideline medications, whereas long-term prescription was suboptimal for elderly. A drug lacking at time of discharge was rarely introduced within the year, which underscores the paramount importance of optimal prescription at time of discharge. Strategies like implementing a standardized prescription could reduce the proportion of suboptimal prescription. It could therefore be one way to improve the long-term quality of care of our patients to the highest level. This study used local data from AMIS Plus-National Registry of Acute Myocardial Infarction in Switzerland (NCT01305785).

Topics: Adrenergic beta-Antagonists; Aged; Angiotensin Receptor Antagonists; Angiotensin-Converting Enzyme Inhibitors; Aspirin; Cardiovascular Agents; Drug Prescriptions; Female; Follow-Up Studies; Guideline Adherence; Humans; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Middle Aged; Myocardial Infarction; Prescription Drugs; Prospective Studies; Registries; Secondary Prevention; ST Elevation Myocardial Infarction; Switzerland

After myocardial infarction, guidelines recommend pharmaceutical treatment with a combination of five different types of drugs for prevention in patients. However, studies from different countries have shown that this goal is not achieved in many patients. The aim of this study was to assess both healthcare and prescribed pharmaceutical treatment in the fourth quarter after index myocardial infarction.. We conducted a claims data analysis with the data of patients who had had a myocardial infarction in the years 2013 or 2014, using information from the largest German health insurance fund ('AOK'). We analysed contact with physicians, hospital care and actual prescriptions for medication recommended in international guidelines, referring to beta-blockers, ACE inhibitors or angiotensin II receptor blockers, P2Y12-antiplatelet agents, acetylsalicylic acid and statins, one year after myocardial infarction. Analysis was stratified by age and sex, compared between patient groups and over time.. We identified 2352 patients who had survived myocardial infarction. Some 96.9% of these participants had at least one contact with their general practitioner (GP) one year after myocardial infarction, 22.8% contacted a cardiologist and 19.7% were hospitalised. Prescription rates range from 37.8% for acetylsalicylic acid to 70.4% for ACE inhibitors. However, only 24.1% received statins, beta-blockers, ACE inhibitors and an antiplatelet drug simultaneously. Prescription of recommended drugs after myocardial infarction decreased steadily over time.. Long-term medical prevention after myocardial infarction is improvable. GPs should take care of the pharmaceutical prevention after myocardial infarction as they are the physicians seen most intensively in this period.

Topics: Aged; Aged, 80 and over; Cardiovascular Agents; Female; Germany; Humans; Insurance Claim Review; Male; Medication Adherence; Middle Aged; Myocardial Infarction; Patient Acceptance of Health Care; Time Factors

Current study was to evaluate the prevalence of guideline recommended medications adherence in myocardial infarction (MI) patients postpercutaneous coronary intervention (PCI) and the association of medication nonadherence and major adverse cardiovascular events (MACEs).MI patients who underwent PCI in the last 12 months were enrolled. Demographic and clinical characteristics were collected and guideline recommended medications were evaluated. Patients were divided into with and without MACEs groups.Compared to patients without MACEs, those with MACEs were older (54.8 ± 16.4 vs 51.1 ± 15.2 years), more likely to be smoker (40.2% vs 31.9%), have higher body mass index (BMI; 25.0 ± 6.1 vs 23.8 ± 5.7 kg/m), diabetes (47.5% vs 37.8%), ischemic stroke (34.4% vs 25.6%), and estimated lower glomerular filtration rate (85.4 ± 9.6 vs 92.6 ± 10.7 mL/minute/1.73 m). Patients with MACEs were also more likely to present with ST-elevation MI (STEMI; 54.1% vs 48.4%) and to undergo urgent PCI (62.3% vs 56.3%). Furthermore, patients with MACEs were less likely to adhere to dual antiplatelet therapy (77.9% vs 85.9%), renin-angiotensin system inhibitor (62.3% vs 69.7%), and beta-blocker (69.7% vs 72.8%) treatment. In unadjusted model, medication nonadherence was associated with 2-fold higher odds of MACEs. After adjustment for demographics, risk factors, comorbidities, and peri-PCI characteristics, medications nonadherence remained independently associated with MACEs, with odds ratio of 1.40 (95% confidence interval: 1.29-1.87).Medications adherence rate among MI patients post-PCI is suboptimal in China, which is independently associated with MACEs.

Topics: Adult; Aged; Cardiovascular Agents; Cardiovascular Diseases; China; Female; Humans; Male; Medication Adherence; Middle Aged; Myocardial Infarction; Percutaneous Coronary Intervention; Prevalence

Small and big conductance Ca. In a prospective blinded experimental laboratory investigation, hearts of male Wistar rats were randomized and placed on a Langendorff system, perfused with Krebs-Henseleit buffer at a constant pressure of 80 mmHg. All hearts were subjected to 33 min of global ischemia and 60 min of reperfusion. At the onset of reperfusion, hearts were perfused with various concentrations of levosimendan (0.03-1 μM) in order to determine a concentration-response relationship. To elucidate the involvement of K. Infarct size in controls was 60 ± 7% and 59 ± 6% respectively. Levosimendan at a concentration of 0.3 μM reduced infarct size to 30 ± 5% (P < 0.0001 vs. control). Higher concentrations of levosimendan did not induce a stronger effect. Paxilline but not NS8593 completely abolished levosimendan-induced cardioprotection while both substances alone had no effect on infarct size.. Cardioprotection by levosimendan-induced postconditioning shows a binary phenomenon, either ineffective or with maximal effect. The cardioprotective effect requires activation of big but not small K

Topics: Animals; Cardiovascular Agents; Disease Models, Animal; Dose-Response Relationship, Drug; Ischemic Preconditioning, Myocardial; Isolated Heart Preparation; Large-Conductance Calcium-Activated Potassium Channels; Male; Myocardial Infarction; Myocardial Reperfusion Injury; Myocardium; Rats, Wistar; Simendan; Small-Conductance Calcium-Activated Potassium Channels

Lesion length is a major predictor of adverse outcomes after percutaneous coronary intervention. Long lesions often require multiple stents with variable overlap, which increases the probability of geographical miss and the incidence of mechanical complications, such as side-branch occlusion, restenosis, and stent thrombosis. These pitfalls may be avoided by use of an ultra-long device.. We retrospectively assessed the performance of the 48-mm Xience Xpedition everolimus-eluting stent (EES) at our institution.. A total of 123 patients (mean age: 60.94 years, n = 93 [76%] male) with 129 lesions were identified. Lesions (n = 69, 53.5%) were located in the left anterior descending artery, the right coronary artery (n = 47, 36.4%), and the circumflex artery (n = 8, 6.2%); 83 lesions involved a major side branch. The majority were treated with a provisional single-stent strategy. Other characteristics included significant tortuosity in 15 lesions (11.6%) and moderate-to-heavy calcification in 46 lesions (35.7%). In all cases, balloon pre-dilatation was performed before stent insertion. Successful delivery and deployment of the 48-mm EES device was achieved in 100% of the patients. The mean number of stents per lesion was 1.4, while the mean total stent length was 58 ± 17.3 mm and mean stent diameter, 3.00 ± 0.67 mm. The procedural success rate was 99.2%. The 30-day major cardiac adverse event (MACE) rate was 0.8%, while the 12-month MACE was 3.3%.. The Xience 48-mm EES device appears to be safe and efficacious with a low clinical event rate at the 12-month follow-up. Where feasible, this would support the use of the ultra-long 48-mm platform in lieu of multiple overlapping shorter devices.

Topics: Cardiovascular Agents; Coronary Artery Disease; Drug-Eluting Stents; Everolimus; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Myocardial Infarction; Paclitaxel; Percutaneous Coronary Intervention; Prosthesis Design; Retrospective Studies; Sirolimus; Treatment Outcome

We assessed the effect of a pre-discharge medication checklist on discharge prescription rates of guideline recommended medications following myocardial infarction. In addition, we assessed what proportion of the residual prescribing gap following implementation of the checklist was due to the presence of contraindications.. We examined baseline prescription rates of guideline recommended medications in 100 patients discharged from our institution following acute myocardial infarction. We then introduced a pre-discharge checklist and reassessed discharge medications and reasons for non-prescription of guideline recommended medications in 447 patients with acute myocardial infarction.. We demonstrated a significant gap in the prescription of guideline recommended secondary prevention medications at the time of discharge in our pre-intervention cohort. Introduction of a pre-discharge checklist resulted in a significant improvement in the prescription rates of all guideline recommended secondary prevention medications, with aspirin increasing from 90% to 97% (p=0.004), Adenosine diphosphate (ADP) receptor antagonist from 84% to 96% (p=0.0001), B-blocker from 79% to 87% (p=0.03), statin from 88% to 96% (p=0.002) and angiotensin converting enzyme (ACE) inhibitor from 58% to 70% (p=0.03). The residual gap in prescribing was largely explained by the presence of contraindications or absence of an indication in the case of ACE-inhibitors. Once these were taken into account there was a residual gap of 0-4% which represents genuine non-adherence to the guidelines.. Introduction of a pre-discharge checklist led to significant improvement in prescription rates of all five guideline recommended secondary prevention medications. The residual gap in medication prescription following introduction of the checklist was largely due to the presence of contraindications rather than non-adherence.

Topics: Acute Coronary Syndrome; Cardiovascular Agents; Drug Prescriptions; Female; Follow-Up Studies; Guideline Adherence; Humans; Male; Middle Aged; Myocardial Infarction; Patient Discharge; Prospective Studies; Secondary Prevention

The oxygen supply-demand imbalance is the fundamental pathophysiology of myocardial infarction (MI). Reducing myocardial oxygen consumption (MVO

Topics: Animals; Cardiovascular Agents; Combined Modality Therapy; Disease Models, Animal; Dogs; Heart Rate; Heart-Assist Devices; Ivabradine; Myocardial Infarction; Myocardium; Oxygen Consumption; Prosthesis Design; Prosthesis Implantation; Recovery of Function; Ventricular Function, Left

There are few studies which compare the efficacy and safety of the Resolute Onyx zotarolimus-eluting stent (O-ZES) and everolimus-eluting stent (EES) in patients with acute myocardial infarction (AMI). Therefore, the present study aimed to compare clinical outcomes of O-ZES and EES in patients with AMI undergoing successful percutaneous coronary intervention (PCI).. From January 2016 to December 2016, the Korea Acute Myocardial Infarction Registry (KAMIR) enrolled 3,364 consecutive patients. Among them, O-ZES was used in 402 patients and EES was used in 1,084 patients. The primary endpoint was target lesion failure (TLF), as defined by composite of cardiac death, target vessel myocardial infarction (TV-MI), and ischemic driven-target lesion revascularization (ID-TLR) at 6 month clinical follow-up.. At 6 months, the incidence of TLF was not significantly different between O-ZES and EES group (4.0% vs. 3.9%, adjusted hazard ratio [HR] 1.17, 95% confidential interval [CI] 0.58-2.35, p = 0.665). O-ZES also showed similar results of cardiac death (3.7% vs. 3.4%, adjusted HR 1.25, 95% CI 0.59-2.63, p = 0.560), TV-MI (0.2% vs. 0.6%, adjusted HR 0.56, 95% CI 0.07-4.85, p = 0.600), ID-TLR (0.0% vs. 0.3%, p = 0.524), and definite or probable stent thrombosis (0.2% vs. 0.3%, adjusted HR 0.63, 95% CI 0.06-6.41, p = 0.696) when compared with EES.. The present study shows that implantation of O-ZES or EES provided similar clinical outcomes with similar risk at 6-month of TLF and definite/probable ST in patients with AMI undergoing successful PCI.

Topics: Aged; Cardiovascular Agents; Drug-Eluting Stents; Everolimus; Female; Humans; Male; Middle Aged; Myocardial Infarction; Percutaneous Coronary Intervention; Prosthesis Design; Registries; Republic of Korea; Retrospective Studies; Risk Factors; Sirolimus; Time Factors; Treatment Outcome

Long-term clinical outcomes of permanent polymer everolimus-eluting stent (PP-EES) implantation after rotational atherectomy (RA) have not been fully evaluated. We sought to investigate the long-term clinical outcomes of PP-EES implantation after RA and assess the impact of hemodialysis on this treatment strategy.. Patients who underwent percutaneous coronary intervention (PCI) with PP-EES at 22 institutions between January 2010 and December 2011 were enrolled in this multicenter, observational trial. From a total of 1918 registered patients, 113 patients with 115 de-novo lesions who underwent PCI with PP-EES following RA were retrospectively analyzed. The primary endpoint was a major adverse cardiac event (MACE) defined as the composite of cardiac death, non-fatal myocardial infarction (MI), and clinically driven target lesion revascularization (TLR).. Long-term follow-up was available for 112 patients (99.1%). The median follow-up period was 2.9 (interquartile range 1.9-3.6) years. The mean age of the patients was 72.3 ± 8.8 years and 64 patients (56.6%) had chronic kidney disease (≥stage 3, 42 on hemodialysis). The cumulative incidences of MACE, non-fatal MI, and TLR were 22.1%, 5.3%, and 10.6%, respectively. Cox's proportional hazards analysis showed that the independent predictors of TLR were hemodialysis and chronic total occlusion. (HR, 14.1; 95% CI, 1.74-155.5; p = 0.01, HR, 9.01; 95% CI, 1.34-62.5; p = 0.02).. PP-EES implantation after lesion modification by RA is considered to be a feasible treatment strategy for heavily calcified lesions. Hemodialysis and chronic total occlusion appeared to be associated with TLR.

Topics: Aged; Aged, 80 and over; Atherectomy, Coronary; Cardiovascular Agents; Coronary Artery Disease; Drug-Eluting Stents; Everolimus; Female; Humans; Incidence; Male; Middle Aged; Myocardial Infarction; Percutaneous Coronary Intervention; Polymers; Prosthesis Design; Renal Dialysis; Retrospective Studies; Risk Assessment; Risk Factors; Severity of Illness Index; Time Factors; Tokyo; Treatment Outcome; Vascular Calcification

Heart failure-associated morbidity and mortality is largely attributable to extensive and unregulated cardiac remodelling. Roselle (Hibiscus sabdariffa) calyces are enriched with natural polyphenols known for antioxidant and anti-hypertensive effects, yet its effects on early cardiac remodelling in post myocardial infarction (MI) setting are still unclear. Thus, the aim of this study was to investigate the actions of roselle extract on cardiac remodelling in rat model of MI. Male Wistar rats (200-300 g) were randomly allotted into three groups: Control, MI, and MI + Roselle. MI was induced with isoprenaline (ISO) (85 mg/kg, s.c) for two consecutive days followed by roselle treatment (100 mg/kg, orally) for 7 days. Isoprenaline administration showed changes in heart weight to body weight (HW/BW) ratio. MI was especially evident by the elevated cardiac injury marker, troponin-T, and histological observation. Upregulation of plasma levels and cardiac gene expression levels of inflammatory cytokines such as interleukin (IL)-6 and IL-10 was seen in MI rats. A relatively high percentage of fibrosis was observed in rat heart tissues with over-expression of collagen (Col)-1 and Col-3 genes following isoprenaline-induced MI. On top of that, cardiomyocyte areas were larger in heart tissues of MI rats with upregulation of atrial natriuretic peptide (ANP) and brain natriuretic peptide (BNP) gene expression, indicating cardiac hypertrophy. Interestingly, roselle supplementation attenuated elevation of plasma troponin-T, IL-6, IL10, and gene expression level of IL-10. Furthermore, reduction of cardiac fibrosis and hypertrophy were observed. In conclusion, roselle treatment was able to limit early cardiac remodelling in MI rat model by alleviating inflammation, fibrosis, and hypertrophy; hence, the potential application of roselle in early adjunctive treatment to prevent heart failure.

Topics: Animals; Atrial Natriuretic Factor; Cardiovascular Agents; Collagen Type I; Collagen Type III; Disease Models, Animal; Fibrosis; Heart Ventricles; Hibiscus; Hypertrophy, Left Ventricular; Inflammation Mediators; Interleukin-10; Interleukin-6; Isoproterenol; Male; Myocardial Infarction; Myocytes, Cardiac; Natriuretic Peptide, Brain; Rats, Wistar; Troponin T; Ventricular Function, Left; Ventricular Remodeling

The aim of the Nanoluté registry was to observe the clinical performance of a novel sirolimus coated balloon (SCB) (Concept Medical Research Private Limited, India) for the treatment of coronary de-novo and restenotic lesions.. All patients treated with SCB between July 2012 and September 2015 were enrolled at Indian centres and clinically followed for 1, 3, 6 and 12 months post-procedure. Primary endpoints were procedural success and device-oriented adverse cardiac events (DOCE) at 12 months. DOCE were defined as a composite of cardiac death, target lesion revascularization (TLR) and target vessel-myocardial infarction.. A total of 394 SCB were used in 332 patients to treat 356 lesions. In-stent restenosis and small coronary vessel disease occurred in 46% and 43% of the patients respectively. Mean balloon length and diameter (average ± SD) were 21.83 ± 6.70 mm and 2.69 ± 0.45 mm respectively. All patients with 1 year follow-up were included. Overall DOCE rate was 4.2% (n = 14) which included death 0.3% (n = 1), TLR 3.6% (n = 12) and myocardial infarction 0.3% (n = 1).. The Nanoluté prospective registry, is the first clinical evidence of the safety and feasibility of this type of SCB, both in patients with in-stent restenosis or de novo lesions.

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiac Catheters; Cardiovascular Agents; Coated Materials, Biocompatible; Coronary Artery Disease; Equipment Design; Feasibility Studies; Female; Humans; India; Male; Middle Aged; Myocardial Infarction; Prospective Studies; Registries; Retreatment; Risk Factors; Sirolimus; Time Factors; Treatment Outcome

To evaluate long-term clinical outcomes of the Absorb bioresorbable vascular scaffold (BVS) system (Abbott Vascular) in an all-comers Middle East population.. This prospective registry study included an initial set of patients with coronary lesions treated using Absorb BVS. Patients were followed for target vessel failure (TVF) including cardiac death, target vessel myocardial infarction (MI), and target lesion revascularization.. A total of 217 patients (age, 55 ± 11 years; male, 169) with 300 treated lesions were included (median follow-up, 36 months [range, 26-41 months]; complete follow-up, 201 patients). Diabetes mellitus and acute coronary syndrome were present in 50% and 57% of patients, respectively. TVF rate was 32/201 (15.9%), including cardiac death in 10 (5%), target vessel MI in 13 (6.5%), and target lesion revascularization in 22 patients (10.9%). Definite or probable device thrombosis occurred in 11/201 patients (5.5%). TVF was associated with heart failure, worse ejection fraction, multi-vessel BVS, multi BVS in lesion, and total BVS length >50 mm.. Long-term outcome following Absorb BVS implantation in a population with high prevalence of high-risk and complex patients is acceptable, but heart failure, worse ejection fraction, and multi-vessel or long BVS implantation were associated with worse outcomes.

Topics: Absorbable Implants; Acute Coronary Syndrome; Adult; Aged; Cardiovascular Agents; Coronary Artery Disease; Coronary Thrombosis; Diabetes Mellitus; Drug-Eluting Stents; Everolimus; Female; Heart Failure; Humans; Male; Middle Aged; Myocardial Infarction; Prospective Studies; Registries; Stroke Volume; Treatment Outcome; United Arab Emirates

The goal of this analysis was to evaluate the final 5-year safety and effectiveness of the PROMUS Element platinum-chromium everolimus-eluting stent in unselected patients treated in routine clinical practice.. The prospective, open-label PROMUS Element™ European Post-Approval Surveillance Study (PE-PROVE) enrolled 1,010 "real-world" patients who received the PROMUS Element stent. Adverse event rates were low at 1-year, and the incidence of stent thrombosis was 0.6%.. The primary endpoint was target vessel failure (TVF; overall and PE stent-related), a composite of cardiac death, myocardial infarction (MI) related to the target vessel, or target vessel revascularization (TVR) at 1-year post-implantation. Five-year clinical outcomes were evaluated in overall as well as high-risk patient subgroups.. The overall 5-year TVF rate was 14.9%, with 7.0% being related to the study stent. Cardiac death, MI and TVR related to the study stent occurred in 0.5%, 3.2%, and 5.7%, respectively. Stent thrombosis through 5-year follow-up was 1.0%. The rates of overall and study stent related TVF were numerically higher in patients with medically treated diabetes, long lesions (≥28 mm), and small diameter vessels (≤2.5 mm) compared to the overall study population. Additionally, favorable stent thrombosis rates through 5 years were reported for the PROMUS Element stent in these high-risk subgroups.. The final 5-year data from the PE-PROVE study demonstrate favorable outcomes and low rates of adverse events with the PE stent when used in "real-world" patients with coronary artery disease.

Topics: Cardiovascular Agents; Chromium; Coronary Artery Disease; Coronary Thrombosis; Drug-Eluting Stents; Europe; Everolimus; Female; Humans; Male; Myocardial Infarction; Percutaneous Coronary Intervention; Platinum; Prospective Studies; Prosthesis Design; Registries; Risk Factors; Time Factors; Treatment Outcome

To investigate the prevalence, predictors and associations between guideline-directed medical therapy (GDMT) and clinical outcomes in acute myocardial infarction (AMI) patients undergoing percutaneous coronary intervention (PCI) from eight academic centers in the United States.. Evidence for GDMT in patients with AMI comes from randomized controlled trials. The use of GDMT in clinical practice is unknown in this setting.. PROMETHEUS is a multicenter observational registry comprising 19,914 patients with acute coronary syndrome (ACS) undergoing PCI. Patients with AMI were divided into two groups based on the prescription of GDMT or not (non-GDMT) at discharge. GDMT was defined according to American College of Cardiology/American Heart Association (ACC/AHA) class I recommendations, specifically, dual antiplatelet therapy, statin and beta-blocker for all AMI patients, and additional ACEI/ARB in patients with left ventricular ejection fraction (LVEF) less than 40%, hypertension, diabetes mellitus (DM) or chronic kidney disease (CKD). The primary endpoint was major adverse cardiovascular events (MACE) defined as a composite of all-cause death, MI, stroke or unplanned target vessel revascularization (TVR) at 1 year.. Out of 4,834 patients with AMI, 3,356 (69.4%) patients were discharged on GDMT. Patients receiving GDMT were more often younger and male. Compared with non-GDMT patients, GDMT patients had a significantly lower frequency of comorbidities. Predictors of greater GDMT prescription at discharge were ST-segment elevation myocardial infarction (STEMI), and increased body mass index (BMI), whereas hypertension, prior PCI, anemia and CKD were associated with less GDMT prescription. At 1 year, the use of GDMT was associated with a significantly lower incidence of MACE (13.7% vs. 22.5%; adjusted HR 0.68; 95%CI 0.58-0.80; P < 0.001), death (3.7% vs. 9.4%; adjusted HR 0.61; 95%CI 0.46-0.80; P < 0.001), and unplanned TVR (8.4% vs. 11.3%; adjusted HR 0.76; 95%CI 0.61-0.96; P = 0.020). However, there were no significant differences in the incidence of MI (4.3% vs. 7.0%; adjusted HR 0.75; 95%CI 0.56-1.01; P = 0.056), stroke (1.5% vs. 2.0%; adjusted HR 0.79; 95%CI 0.47-1.34; P = 0.384) between the two groups.. In a contemporary practice setting in the United States, GDMT was utilized in just over two-thirds of AMI patients undergoing PCI. Predictors of GDMT prescription at discharge included STEMI, BMI and absence of hypertension, CKD, anemia or prior PCI. Use of GDMT was associated with significantly lower risk of 1-year MACE and mortality.

Topics: Acute Coronary Syndrome; Aged; Cardiovascular Agents; Comorbidity; Drug Prescriptions; Drug Utilization; Female; Guideline Adherence; Humans; Incidence; Male; Middle Aged; Myocardial Infarction; Patient Discharge; Percutaneous Coronary Intervention; Polypharmacy; Practice Guidelines as Topic; Practice Patterns, Physicians'; Registries; Risk Factors; Time Factors; Treatment Outcome; United States

In this paper, we look at the case of a 79 years old male who received a Wiktor stent (WS) implantation for myocardial infarction in proximal left anterior descending artery 18 years ago. Eleven years later, an Everolimus eluting stent (EES; Xience V™) was implanted for the proximal edge restenosis of WS from mid left main trunk to the middle part of WS. Seven years after EES implantation, the angiography and optical coherence tomography revealed in-stent restenosis with severe stent recoil just distal to the overlapping zone of WS. In the present case, stent recoil seems to have occurred due to different radial stiffness and flexibility between the two stents.

Topics: Aged; Cardiovascular Agents; Coronary Angiography; Coronary Vessels; Drug-Eluting Stents; Humans; Male; Myocardial Infarction; Prosthesis Design; Prosthesis Failure; Tomography, Optical Coherence; Treatment Outcome

Panax Notoginseng Saponins (PNS) is a formula of Chinese medicine commonly used for treating ischemia myocardial in China. However, its mechanism of action is yet unclear. This study investigated the effect and the mechanism of PNS on myocardial ischemia-reperfusion injury (MIRI) through the hypoxia-inducible factor 1α (HIF-1α)/bcl-2/adenovirus E1B19kDa-interacting protein3 (BNIP3) pathway of autophagy.. We constructed a rat model of myocardial injury and compared among 4 groups (n = 10, each): the sham-operated group (Sham), the ischemia-reperfusion group (IR), the PNS low-dose group, and the PNS high-dose group were pretreated with PNS (30 and 60 mg/kg, respectively). Serum creatine kinase, malonaldehyde (MDA), lactate dehydrogenase, myocardial tissue superoxide dismutase, and reactive oxygen species were detected in rats with myocardial ischemia-reperfusion after the intervention of PNS. The rat myocardial tissue was examined using hematoxylin and eosin (H&E) staining, and the mitochondria of myocardial cells were observed using transmission electron microscopy. The expressions of microtubule-associated protein light chain 3 (LC3), HIF-1α, BNIP3, Beclin-1, and autophagy-related gene-5 (Atg5) in rat myocardial tissue were detected using Western blotting.. The results showed that PNS was significantly protected against MIRI, as evidenced by the decreasing in the concentration of serum CK, MDA, lactate dehydrogenase, and myocardial tissue superoxide dismutase, reactive oxygen species, the attenuation of myocardial tissue histopathological changes and the mitochondrial damages of myocardial cells, and the increase of mitochondria autophagosome in myocardial cells. In addition, PNS significantly increased the expression of LC3 and the ratio of LC3II/LC3I in rat myocardial tissue. Moreover, PNS significantly increased the expression of HIF-1α, BNIP3, Atg5, and Beclin-1 in rat myocardial tissue.. The protective effect of PNS on MIRI was mainly due to its ability to enhance the mitochondrial autophagy of myocardial tissue through the HIF-1α/BNIP3 pathway.

Topics: Animals; Autophagy; Autophagy-Related Protein 5; Beclin-1; Cardiovascular Agents; Disease Models, Animal; Hypoxia-Inducible Factor 1, alpha Subunit; Male; Membrane Proteins; Microtubule-Associated Proteins; Mitochondrial Proteins; Myocardial Infarction; Myocardial Reperfusion Injury; Myocytes, Cardiac; Panax; Rats, Sprague-Dawley; Saponins; Signal Transduction

The use of vascular endothelial growth factor inhibitors such as sorafenib is limited by a risk of severe cardiovascular toxicity. A 28-year-old man with acute myeloid leukemia treated with prednisone, tacrolimus, and sorafenib following stem cell transplantation presented with severe bilateral lower extremity claudication. The patient was discharged against medical advice prior to finalizing a cardiovascular evaluation, but returned 1 week later with signs suggestive of septic shock. Laboratory tests revealed troponin I of 12.63 ng/mL, BNP of 1690 pg/mL, and negative infectious workup. Electrocardiogram showed sinus tachycardia and new pathologic Q waves in the anterior leads. Coronary angiography revealed severe multivessel coronary artery disease. Peripheral angiography revealed severely diseased left anterior and posterior tibial arteries, tibioperoneal trunk, and peroneal artery, and subtotal occlusion of the right posterior tibial artery. Multiple coronary and peripheral drug-eluting stents were implanted. An intra-aortic balloon pump was placed. Cardiac magnetic resonance imaging revealed chronic left ventricular infarction with some viability, 17% ejection fraction, and left ventricular mural thrombi. The patient opted for medical management. Persistent symptoms 9 months later led to repeat angiography, showing total occlusion of the second obtuse marginal artery due to in-stent restenosis with proximal stent fracture, and chronic total occlusion of the right internal iliac artery extending to the pudendal branch. Cardiac positron emission tomography/computed tomography viability study demonstrated viable myocardium, deeming revascularization appropriate. Symptom resolution was obtained with no recurrences. Sorafenib-associated vasculopathy may follow a fulminant course. Multimodality cardiovascular imaging is essential for optimal management.

Topics: Adult; Antineoplastic Agents; Cardiotoxicity; Cardiovascular Agents; Coronary Artery Disease; Coronary Restenosis; Defibrillators; Defibrillators, Implantable; Drug-Eluting Stents; Electric Countershock; Endovascular Procedures; Humans; Intra-Aortic Balloon Pumping; Leukemia, Myeloid, Acute; Male; Myocardial Infarction; Peripheral Arterial Disease; Protein Kinase Inhibitors; Sorafenib; Treatment Outcome

The study reports the final 5-year safety and effectiveness outcomes of the novel abluminal groove-filled biodegradable polymer-coated FIREHAWK sirolimus-eluting stent in a large patient cohort.. The TARGET clinical program was conducted to evaluate the performance of the FIREHAWK stent, and this objective performance criterion study pooled long-term safety and efficacy data from three TARGET trials for greater statistical power to analyze low-frequency events.. Patient-level pooled data from 1,007 individuals in the TARGET I randomized controlled trial (n = 227), TARGET I long lesion cohort (n = 50), and TARGET II registry (n = 730) were prospectively collected and analyzed. The primary endpoint, target lesion failure (TLF), was defined as a composite of cardiac death, target vessel myocardial infarction (TV-MI), and ischemia-driven indicated target lesion revascularization (ID-TLR) at 5 years. All patients were exclusively treated with the FIREHAWK stent and had annual follow-up visits for up to 5 years.. Among 947 patients (94.0%) who completed the 5-year clinical follow-up, the 5-year TLF event rate was 8.1%; the events included 18 cardiac deaths, 36 TV-MIs, and 33 ID-TLRs. Only four (0.4%) very late probable or definite stent thrombosis events were observed beyond 1 year after stent implantation. In the subgroup analysis, lesion length ≥ 30 mm was associated with higher long-term TLF incidence, while the use of a predilation-sizing-postdilation technique showed no significant effect on long-term outcomes.. Five-year results demonstrate the continuing safety and efficacy of the FIREHAWK Stent, with relatively lower incidence of thrombotic events.

Topics: Absorbable Implants; Aged; Cardiovascular Agents; China; Coronary Artery Disease; Coronary Thrombosis; Drug-Eluting Stents; Female; Humans; Incidence; Male; Middle Aged; Myocardial Infarction; Percutaneous Coronary Intervention; Prospective Studies; Prosthesis Design; Randomized Controlled Trials as Topic; Registries; Risk Factors; Sirolimus; Time Factors; Treatment Outcome

Percutaneous mechanical circulatory support devices are increasingly used in acute myocardial infarction complicated by cardiogenic shock (AMI-CS), despite limited evidence for their effectiveness. The aim of this study was to evaluate outcomes associated with use of the Impella device compared with intra-aortic balloon pump (IABP) and medical treatment in patients with AMI-CS.. Data of patients with AMI-CS treated with the Impella device at European tertiary care hospitals were collected retrospectively. All patients underwent early revascularization and received optimal medical treatment. Using IABP-SHOCK II (Intraaortic Balloon Pump in Cardiogenic Shock II) trial inclusion and exclusion criteria, 372 patients were identified and included in this analysis. These patients were matched to 600 patients from the IABP-SHOCK II trial. The following baseline criteria were used as matching parameters: age, sex, mechanical ventilation, ejection fraction, prior cardiopulmonary resuscitation, and lactate. Primary end point was 30-day all-cause mortality.. In total, 237 patients treated with an Impella could be matched to 237 patients from the IABP-SHOCK II trial. Baseline parameters were similarly distributed after matching. There was no significant difference in 30-day all-cause mortality (48.5% versus 46.4%, P=0.64). Severe or life-threatening bleeding (8.5% versus 3.0%, P<0.01) and peripheral vascular complications (9.8% versus 3.8%, P=0.01) occurred significantly more often in the Impella group. Limiting the analysis to IABP-treated patients as a control group did not change the results.. In this retrospective analysis of patients with AMI-CS, the use of an Impella device was not associated with lower 30-day mortality compared with matched patients from the IABP-SHOCK II trial treated with an IABP or medical therapy. To further evaluate this, a large randomized trial is warranted to determine the effect of the Impella device on outcome in patients with AMI-CS.. URL: https://www.clinicaltrials.gov . Unique identifier: NCT03313687.

Topics: Aged; Cardiovascular Agents; Europe; Female; Heart-Assist Devices; Humans; Intra-Aortic Balloon Pumping; Male; Middle Aged; Myocardial Infarction; Myocardial Revascularization; Prosthesis Design; Recovery of Function; Registries; Retrospective Studies; Risk Factors; Shock, Cardiogenic; Time Factors; Treatment Outcome

Data on bioresorbable vascular scaffolds (BVS) for the treatment of long lesions are limited. We studied the use of BVS-Absorb in routine clinical practice and compared the outcome of long lesions with short lesions. Implantation of drug-eluting scaffolds without PSP-technique (predilation, proper sizing and postdilation) is associated with an increased thrombotic risk. We compared the long-term outcome up to 36 months of patients with short (< 20 mm) and long (≥20 mm) coronary artery lesions after implantation of bioresorbable vascular scaffolds (BVS) via PSP-technique.. Three hundred twenty-six patients with 424 lesions were enrolled in this prospective study and underwent percutaneous coronary intervention with the Absorb BVS. Clinical follow-up was scheduled after 12, 24 and 36 months. In all lesions the PSP-technique was used. The device oriented composite endpoint (DOCE) was defined as cardiac death, myocardial infarction (MI) not clearly related to a non-target vessel and target lesion revascularization (TLR).. Kaplan-Meier estimates for DOCE after 12 months were 2.63% for short lesions and 8.09% for long lesions (p = 0.0131), 5.51% vs. 11.35% (p = 0.0503) after 24 months and 8.00% vs. 18.00% (p = 0.0264) after 36 months of clinical follow-up. Kaplan-Meier estimates for TLR after 12 months were 1.46% for short and 7.69% for long lesions (p = 0.0012), 2.06% vs. 8.75% after 24 months (p = 0.0027) and 4.96% vs. 9.59% after 36 months of follow-up (p = 0.0109). Scaffold thrombosis rates were low.. In long lesions compared to short ones the bioresorbable scaffold Absorb implanted with the proper PSP technique Absorb has significant higher rates of DOCE.. Is 3 (non-random sample).

Topics: Absorbable Implants; Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coated Materials, Biocompatible; Coronary Artery Disease; Coronary Thrombosis; Everolimus; Female; Humans; Male; Middle Aged; Myocardial Infarction; Prosthesis Design; Risk Assessment; Risk Factors; Time Factors; Treatment Outcome

The aims of this study were to assess variation in revascularization of asymptomatic patients with stable ischemic heart disease, identify the predictors of variation, and determine if it was associated with clinical outcomes.. Management of stable ischemic heart disease in asymptomatic patients with obstructive coronary artery disease is controversial, potentially leading to practice variation.. A retrospective observational cohort study was performed using population-based data from Ontario, Canada, in patients with asymptomatic stable ischemic heart disease and obstructive coronary artery disease. The cohort was divided on the basis of treatment strategy: revascularization or medical therapy. Hospitals were allocated into tertiles of their revascularization ratio. Outcomes included death and nonfatal myocardial infarction. Hierarchical logistic regression was used to assess the predictors of revascularization, with median odds ratios used to quantify variation. Proportional hazards models were used to determine the association between management strategy and outcomes.. The cohort included 9,897 patients, 47% treated with medical therapy and 53% with revascularization. Between hospitals, 2-fold variation existed in the ratio of revascularized to medically treated patients. However, the variation across hospitals was not explained by patient, physician, or hospital factors (median odds ratio in null model: 1.25; median odds ratio in full model: 1.31). Revascularization was associated with a hazard ratio of 0.81 (95% confidence interval: 0.69 to 0.96) for death and a hazard ratio of 0.58 (95% confidence interval: 0.46 to 0.73) for myocardial infarction, with this benefit consistent across tertiles of revascularization ratio.. Wide variation was observed in revascularization practice that was not explained by known factors. Despite this variation, a clinical benefit was observed with revascularization that was consistent across hospitals.

Topics: Aged; Asymptomatic Diseases; Cardiovascular Agents; Coronary Artery Bypass; Coronary Artery Disease; Female; Healthcare Disparities; Humans; Male; Middle Aged; Myocardial Infarction; Ontario; Percutaneous Coronary Intervention; Practice Patterns, Physicians'; Retrospective Studies; Risk Factors; Time Factors; Treatment Outcome

We evaluated 1-year outcomes after platinum chromium everolimus-eluting stents (PtCr-EES) in small versus non-small coronary arteries within a large, diverse sample of men, women, and minorities.. There exists limited outcomes data on the use of second-generation drug-eluting stent to treat small diameter coronary arteries.. We pooled patients from the PLATINUM Diversity and PROMUS Element Plus stent registries. Small-vessel percutaneous coronary intervention (SV-PCI) was defined as ≥1 target lesion with reference vessel diameter (RVD) ≤2.5 mm. Endpoints included major adverse cardiac event (MACE; death, myocardial infarction [MI] or target vessel revascularization [TVR]), target vessel failure (TVF; death related to the target vessel, target vessel MI or TVR) and definite/probable stent thrombosis (ST). Multivariable Cox regression was used to risk-adjust outcomes.. We included 4,155/4,182 (99%) patients with available RVD, of which 1,607 (39%) underwent small-vessel PCI. SV-PCI was not associated with increased MACE (adjHR 1.02; 95%CI 0.81-1.30) or TVF (adjHR 1.07; 95%CI 0.82-1.39). MI risk was lower in white men compared to women and minorities, both in the setting of SV-PCI (adjHR 0.41; 95%CI 0.23-0.74 and adjHR 0.39; 95%CI 0.20-0.75, respectively) and for non-SV-PCI (adjHR 0.61; 95%CI 0.38-0.99 and adjHR 0.45; 95%CI 0.27-0.74, respectively). There was no significant interaction between RVD and sex or minority status for any endpoint.. In a large diverse contemporary PCI outcomes database, SV-PCI with PtCr-EES was not associated with increased MACE or TVR and did not account for the increased MI risk noted in women and minorities compared to white men.

Topics: Aged; Cardiovascular Agents; Chromium; Coronary Artery Disease; Coronary Thrombosis; Drug-Eluting Stents; Everolimus; Female; Health Status Disparities; Humans; Male; Middle Aged; Minority Health; Myocardial Infarction; Observational Studies as Topic; Percutaneous Coronary Intervention; Platinum; Prosthesis Design; Race Factors; Registries; Retrospective Studies; Risk Factors; Sex Factors; Time Factors; Treatment Outcome; United States

Percutaneous coronary intervention (PCI) in patients with diabetes mellitus (DM) remains challenging even with modern drug-eluting stents (DES) due to high rates of repeat revascularization. Everolimus-eluting bioresorbable scaffolds (EE-BRS) might allow for repeat intervention prolonging the time interval of percutaneous treatment options.. The ABSORB DM Benelux Study is a dedicated prospective, international study to evaluate the midterm safety and efficacy of EE-BRS in DM patients. All DM patients that received ≥ 1 EE-BRS for any indication were enrolled and prospectively followed. Study endpoints were major adverse cardiac events (MACE): a composite of all-cause death, any myocardial infarction (MI) and ischemic-driven target vessel revascularization (TVR); target lesion failure (TLF): a composite of cardiac death (CD), target vessel MI, and ischemic-driven target lesion revascularization (TLR), as well as definite or probable scaffold thrombosis (ScT).. Between April 2015 till March 2017, 150 DM patients and 188 lesions were treated and followed up to 3 years. Device implantation success was 100%. MACE occurred in 15.2% (event rate of 8.8 per 100 PY). TLF was reported in 11.7% (7.0 events per 100 PY). CD, target vessel MI, ischemic-driven TLR occurred in 3.4%, 3.6% and 5.5% respectively, while ScT was observed in 1.4%. There were no occurrences of late or very late ScT.. EE-BRS treatment in DM patients shows comparable midterm safety and efficacy outcomes when historically compared with modern DES. New-generation EE-BRS might offer an attractive alternative to metallic DES in treatment of fast progressing atherosclerosis population as in DM patients. Trial registration NTR5447. Registered 05 October 2015, retrospectively registered.

Topics: Absorbable Implants; Aged; Cardiovascular Agents; Coated Materials, Biocompatible; Coronary Artery Disease; Coronary Thrombosis; Diabetes Mellitus; Europe; Everolimus; Female; Follow-Up Studies; Humans; Male; Middle Aged; Myocardial Infarction; Percutaneous Coronary Intervention; Prospective Studies; Prosthesis Design; Registries; Risk Factors; Time Factors; Treatment Outcome

Topics: Animals; Cardiovascular Agents; Extracellular Vesicles; Humans; Ischemic Preconditioning; Myocardial Infarction; Myocardial Reperfusion Injury; Myocytes, Cardiac; Paracrine Communication; Platelet Activation; Signal Transduction; Treatment Outcome; Ventricular Function, Left; Ventricular Remodeling

Recent studies reported that cAMP-binding protein Epac1-deficient mice were protected against various forms of cardiac stress, suggesting that pharmacological inhibition of Epac1 could be beneficial for the treatment of cardiac diseases. To test this assumption, we characterized an Epac1-selective inhibitory compound and investigated its potential cardioprotective properties.. We used the Epac1-BRET (bioluminescence resonance energy transfer) for searching for non-cyclic nucleotide Epac1 modulators. A thieno[2,3-b]pyridine derivative, designated as AM-001 was identified as a non-competitive inhibitor of Epac1. AM-001 has no antagonist effect on Epac2 or protein kinase A activity. This small molecule prevents the activation of the Epac1 downstream effector Rap1 in cultured cells, in response to the Epac1 preferential agonist, 8-CPT-AM. In addition, we found that AM-001 inhibited Epac1-dependent deleterious effects such as cardiomyocyte hypertrophy and death. Importantly, AM-001-mediated inhibition of Epac1 reduces infarct size after mouse myocardial ischaemia/reperfusion injury. Finally, AM-001 attenuates cardiac hypertrophy, inflammation and fibrosis, and improves cardiac function during chronic β-adrenergic receptor activation with isoprenaline (ISO) in mice. At the molecular level, ISO increased Epac1-G protein-coupled receptor kinase 5 (GRK5) interaction and induced GRK5 nuclear import and histone deacetylase type 5 (HDAC5) nuclear export to promote the activity of the prohypertrophic transcription factor, myocyte enhancer factor 2 (MEF2). Inversely, AM-001 prevented the non-canonical action of GRK5 on HDAC5 cytoplasmic shuttle to down-regulate MEF2 transcriptional activity.. Our study represents a 'proof-of-concept' for the therapeutic effectiveness of inhibiting Epac1 activity in cardiac disease using small-molecule pharmacotherapy.

Topics: Animals; Cardiovascular Agents; Cell Death; Chronic Disease; Disease Models, Animal; Fibrosis; G-Protein-Coupled Receptor Kinase 5; Guanine Nucleotide Exchange Factors; HEK293 Cells; Histone Deacetylases; Humans; MEF2 Transcription Factors; Mice; Mice, 129 Strain; Mice, Inbred C57BL; Mice, Knockout; Myocardial Infarction; Myocardial Reperfusion Injury; Myocytes, Cardiac; Rats; Signal Transduction; Ventricular Dysfunction, Left; Ventricular Function, Left; Ventricular Remodeling

This prospective, patient-level analysis assessed the safety and efficacy of NeoVas sirolimus-eluting bioresorbable scaffold (BRS) in patients with coronary lesions. Furthermore, to meet China Food and Drug Administration requirements, we conducted an objective performance criterion study by pooling all patients implanted with the NeoVas BRS in a previous randomized controlled trial (RCT) and registry trial.. Drug-eluting stent-related permanent vessel caging by metallic struts may lead to several complications associated with percutaneous coronary intervention. BRSs reportedly result in more stent thromboses (ST) in comparison to everolimus-eluting stents. The NeoVas (Lepu Medical, Beijing, China) is a novel sirolimus-eluting poly-l-lactic acid (PLLA)-based BRS whose safety and efficacy remains to be fully elucidated.. Patient-level data derived from 1,103 patients with de novo native coronary lesions in the NeoVas RCT (n = 278) and NeoVas registry (n = 825) were prospectively collected, pooled, and analyzed. The primary outcome was 12-month target lesion failure (TLF), a composite of cardiac death, target vessel myocardial infarction, or ischemia-driven-target lesion revascularization. The patient-oriented composite endpoint (PoCE) of all-cause death, all MI, or any revascularization was also analyzed.. The 12-month rate of TLF in 1,103 patients (follow-up rate, 99.8%) was 3.0%, significantly lower than the performance goal of 8.5% (P < 0.0001). Furthermore, 50 (5.4%) PoCEs and five definite/probable ST (0.5%) were recorded.. This pooled, patient-level analysis indicates that the NeoVas BRS has promising 1-year efficacy and safety profiles.

Topics: Absorbable Implants; Acute Coronary Syndrome; Adolescent; Adult; Aged; Cardiovascular Agents; China; Coated Materials, Biocompatible; Coronary Artery Disease; Female; Humans; Male; Middle Aged; Myocardial Infarction; Percutaneous Coronary Intervention; Prospective Studies; Prosthesis Design; Randomized Controlled Trials as Topic; Registries; Risk Factors; Sirolimus; Time Factors; Treatment Outcome; Young Adult

Patients with established coronary artery disease (CAD) have an increased risk of new cardiovascular events. An underuse of secondary preventive drugs has been observed, and many patients may not attain the treatment goals for secondary prevention. The aims of the present nationwide register-based cohort study were to assess the degree of risk factor control and long-term outcomes in patients < 80 years with Type 1 myocardial infarction (MI) with and without prior CAD.. Data concerning all patients with MI admitted to hospitals in Norway from 2013 to 2016 were retrieved from the Norwegian Myocardial Infarction Register (NORMI). Long-term mortality was obtained through linkage with the Norwegian Cause of Death Registry.. In total, 47,204 patients were registered in the NORMI from 2013 to 2016. Prior CAD was recorded in 7219 (25.2%) of the 28,607 patients < 80 years old with Type 1 MIs. On average, 3 of the 6 defined treatment targets for secondary preventive therapy were attained, and only 1% of the patients achieved all targets. Patients with MI and prior CAD had increased risk of death or new MI compared to patients without prior CAD during long-term follow-up (adjusted HR 1.6, 95% CI 1.5-1.7).. Prior CAD was frequent in patients with acute MI. The attainment of secondary preventive treatment targets in patients with MI and prior CAD was not optimal, and the long-term outcomes were reduced compared to patients without prior CAD. Increased efforts to improve risk factor control are needed.

Topics: Aged; Cardiovascular Agents; Coronary Artery Disease; Female; Guideline Adherence; Health Status; Humans; Male; Middle Aged; Myocardial Infarction; Norway; Practice Guidelines as Topic; Practice Patterns, Physicians'; Recurrence; Registries; Risk Assessment; Risk Factors; Risk Reduction Behavior; Secondary Prevention; Time Factors; Treatment Outcome

Background Secondary prevention medications are often not prescribed to frail, older adults following acute myocardial infarction, potentially because of the absence of data to support use, perceived lack of benefit, and concern over possible harms. We examined the effect of using more guideline-recommended medications after myocardial infarction on mortality, rehospitalization, and functional decline in the frailest and oldest segment of the US population-long-stay nursing home residents. Methods and Results We conducted a retrospective cohort study of nursing home residents aged ≥65 years using 2007 to 2010 national US Minimum Data Set clinical assessment data and Medicare claims. Exposure was the number of secondary prevention medications (antiplatelets, β-blockers, statins, and renin-angiotensin-aldosterone system inhibitors) initiated after myocardial infarction. Outcomes were 90-day death, rehospitalization, and functional decline. We compared outcomes for new users of 2 versus 1 and 3 or 4 versus 1 medications using the inverse probability of treatment-weighted odds ratios with 95% CI. The cohort comprised 4787 residents, with a total of 509 death, 820 functional decline, and 1226 rehospitalization events. Compared with individuals who initiated 1 medication, mortality odds ratios were 0.98 (95% CI, 0.79-1.22) and 0.74 (95% CI, 0.57-0.97) for users of 2 and 3 or 4 medications, respectively. Rehospitalization odds ratios were 1.00 (95% CI, 0.85-1.17) for 2 and 0.97 (95% CI, 0.8-1.17) for 3 or 4 medications. Functional decline odds ratios were 1.04 (95% CI, 0.85-1.28) for 2 and 1.12 (95% CI, 0.89-1.40) for 3 or 4 medications. In a stability analysis excluding antiplatelet drugs from the exposure definition, more medication use was associated with functional decline. Conclusions Use of more guideline-recommended medications after myocardial infarction was associated with decreased mortality in older, predominantly frail adults, but no difference in rehospitalization. Results for functional decline from the main and stability analyses were discordant and did not rule out an increased risk associated with more medication use.

Topics: Age Factors; Aged; Aged, 80 and over; Cardiovascular Agents; Databases, Factual; Drug Utilization; Female; Frail Elderly; Frailty; Geriatric Assessment; Homes for the Aged; Humans; Male; Medicare; Myocardial Infarction; Nursing Homes; Protective Factors; Recurrence; Retrospective Studies; Risk Assessment; Risk Factors; Secondary Prevention; Time Factors; Treatment Outcome; United States

Topics: Age Factors; Aged; Aged, 80 and over; Cardiovascular Agents; Comorbidity; Databases, Factual; Female; Health Status; Hospital Mortality; Humans; Male; Myocardial Infarction; Percutaneous Coronary Intervention; Retrospective Studies; Risk Assessment; Risk Factors; Time Factors; Treatment Outcome; United States

The ULISSE registry has demonstrated the real-world performance of the Ultimaster biodegradable polymer sirolimus-eluting stent (BP-SES) in a large cohort of patients undergoing percutaneous coronary intervention, including a large proportion of patients presenting with acute myocardial infarction (AMI).. We performed a subgroup analysis of the ULISSE registry in AMI patients and compared the outcomes of this vulnerable cohort with that of patients presenting without AMI (non-AMI). The primary end point was the incidence of 1-year target lesion failure (TLF), a composite of cardiac death, target vessel myocardial infarction (TV-MI), and clinically indicated target lesion revascularization (TLR).. Of 1,660 patients included in the ULISSE registry, 381(23%) presented with AMI, 207(54.3%) non-ST elevation myocardial infarction, and 174(45.7%) ST-elevation myocardial infarction. Compared with non-AMI patients, those with AMI were more frequently female and smokers, with lower left ventricular ejection fraction (LVEF) and chronic kidney disease requiring dialysis. At 1 year, TLF rate was significantly higher in AMI than non-AMI patients (7.9 vs. 4.1%; HR 1.98, CI 95% 1.22-3.23; p = .005) driven by higher rate of cardiac death (4.0 vs. 1.1%; HR 3.59, CI 95% 1.64-7.88; p = .01) and TV-MI (2.8 vs 0.9%; HR 2.99,CI 95% 1.22-7.37; p = .01), without differences in TLR rate (4.3 vs. 2.9%,HR 0.66, CI95% 0.35-1.25; p = .2). At multivariate Cox regression analysis, eGFR <40 mL/min (HR: 2.868) and LVEF <40% (HR: 2.394) were the only independent predictors of TLF.. In AMI patients, Ultimaster BP-SES implantation was associated with higher rate of TLF and definite stent thrombosis compared with non-AMI patients. The high incidence of adverse events was mainly driven by the unfavorable baseline risk profile.

Topics: Absorbable Implants; Aged; Cardiovascular Agents; Coronary Artery Disease; Coronary Thrombosis; Drug-Eluting Stents; Female; Humans; Italy; Male; Middle Aged; Myocardial Infarction; Percutaneous Coronary Intervention; Polymers; Progression-Free Survival; Prosthesis Design; Recurrence; Registries; Retrospective Studies; Risk Factors; Sirolimus; Time Factors

Background Secondary prevention after acute myocardial infarction ( AMI ) requires long-term guideline-directed medical therapy. However, the level of medication adherence, factors associated with poor adherence, and extent to which good adherence can reduce adverse events after AMI in China remain uncertain. Methods and Results In 2013 to 2014, 4001 AMI patients aged ≥18 years were discharged alive from 53 hospitals across China (mean age 60.5±11.7 years; 22.7% female). Good adherence was defined as taking medications (aspirin, β-blockers, statins, clopidogrel, or angiotensin-converting enzyme inhibitors/angiotensin-receptor blockers) ≥90% of the time as prescribed. Cox models assessed the association between good adherence (a time-varying covariate) and 1-year cardiovascular events after AMI . The most common medications were aspirin (82.2%) and statins (80.5%). There were 243 patients who were not prescribed any medications during follow-up; 1-year event rates were higher for these patients (25.1%, 95% CI 19.7-30.6%) versus those taking ≥1 medications (6.6%, 95% CI 5.76-7.34%). The overall rate of good adherence was 52.9%. Good adherence was associated with lower risk of 1-year events (adjusted hazard ratio 0.61, 95% CI 0.49-0.77). The most common reason for poor adherence was belief that one's condition had improved/no longer required medication. More comorbidities and lower education level were associated with poor adherence. Conclusions Good adherence reduced 1-year cardiovascular event risk after AMI . About half of our cohort did not have good adherence. National efforts to improve AMI outcomes in China should focus on medication adherence and educating patients on the importance of cardiovascular medications for reducing risk of recurrent events. Clinical Trial Registration URL : http://www.clinicaltrials.gov . Unique identifier: NCT01624909.

Topics: Aged; Cardiovascular Agents; China; Female; Humans; Longitudinal Studies; Male; Medication Adherence; Middle Aged; Myocardial Infarction; Patient Reported Outcome Measures; Prospective Studies; Protective Factors; Recurrence; Risk Assessment; Risk Factors; Secondary Prevention; Time Factors; Treatment Outcome

Neutrophils have both detrimental and beneficial effects in myocardial infarction (MI), but little is known about the underlying pathways. S100A8/A9 is a pro-inflammatory alarmin abundantly expressed in neutrophils that is rapidly released in the myocardium and circulation after myocardial ischaemia. We investigated the role of S100A8/A9 in the innate immune response to MI.. In 524 patients with acute coronary syndrome (ACS), we found that high plasma S100A8/A9 at the time of the acute event was associated with lower left ventricular ejection fraction (EF) at 1-year and increased hospitalization for heart failure (HF) during follow-up. In wild-type C57BL/6 mice with MI induced by permanent coronary artery ligation, treatment with the S100A9 blocker ABR-238901 during the inflammatory phase of the immune response inhibited haematopoietic stem cell proliferation and myeloid cell egression from the bone marrow. The treatment reduced the numbers of neutrophils and monocytes/macrophages in the myocardium, promoted an anti-inflammatory environment, and significantly improved cardiac function compared with MI controls. To mimic the clinical scenario, we further confirmed the effects of the treatment in a mouse model of ischaemia/reperfusion. Compared with untreated mice, 3-day ABR-238901 treatment significantly improved left ventricular EF (48% vs. 35%, P = 0.002) and cardiac output (15.7 vs. 11.1 mL/min, P = 0.002) by Day 21 post-MI.. Short-term S100A9 blockade inhibits inflammation and improves cardiac function in murine models of MI. As an excessive S100A8/A9 release is linked to incident HF, S100A9 blockade might represent a feasible strategy to improve prognosis in ACS patients.

Topics: Animals; Calgranulin A; Calgranulin B; Cardiovascular Agents; Disease Models, Animal; Inflammation; Mice; Mice, Inbred C57BL; Myeloid Cells; Myocardial Infarction; Myocardium

Recent advances in best medical therapy (BMT) has been associated with reduced risk of stroke similar to that observed following surgical carotid revascularization (CR). Thus, it remains uncertain which subset(s) of patients would benefit from prophylactic CR+BMT for asymptomatic carotid stenosis (ACS) over BMT alone. The purpose of this study was to analyze the contemporary experience in the management of >70% ACS in an academic institution, to compare the short- and long-term outcomes of BMT alone against CR+BMT, and to identify risk factors for the development of future cerebrovascular events.. A retrospective review of all patients with severe ACS between January 2005 and December 2012 at Loyola University Medical Center and its affiliated Edward Hines Jr. Veterans Administration Hospital was conducted. Baseline patient characteristics, medications, and follow-up data were collected from electronic medical records, and treatment outcomes were compared. The random forest method was performed to select potential important variables for the development of late stroke. The recursive partitioning regression analysis (RPRA) was performed to identify the patient subgroup at increased risk of future stroke.. Of 409 patients identified; 247 were treated with CR and 162 with BMT. Between these groups with CR+BMT and BMT alone, the mean age was 69.1±8.2 versus 75.5±9.0, respectively (P<0.01). Mean follow-up was 60.7±37.5 months. Early (30-day) outcomes of stroke, acute myocardial infarction or mortality did not differ between the treatment modalities (2.0% CR vs. 0.6% BMT, P=0.41). Probability of freedom from ipsilateral stroke, and any stroke at 1- and 5-year follow-up were also comparable between CR+BMT and BMT alone. However, random forest method and RPRA demonstrated that patients with history of diabetes and remote stroke treated with BMT alone were at a high risk for future stroke (36.4% in total, 7.2% per year). The diabetics with contralateral carotid stenosis >50% who are active smokers are at the highest risk for stroke after CR (20.0% in total, 4.0% per year).. Prophylactic CR+BMT does not provide overall late stroke prevention compared with BMT alone. Diabetics with a history of stroke, in particular, are at an increased risk of stroke despite BMT. Timely CR+BMT for high-risk patients is still indicated.

Topics: Aged; Aged, 80 and over; Asymptomatic Diseases; Cardiovascular Agents; Carotid Stenosis; Endarterectomy, Carotid; Female; Humans; Illinois; Male; Middle Aged; Myocardial Infarction; Regression Analysis; Retrospective Studies; Risk Assessment; Risk Factors; Severity of Illness Index; Stroke; Time Factors; Treatment Outcome

Extracellular matrix (ECM) remodeling is a major pathophysiological process during post-myocardial infarction (MI). The activation, differentiation, and proliferation of cardiac fibroblasts to myofibroblasts regulate the expression of ECM proteins. The signaling by bone morphogenetic protein (BMP-4), an extracellular ligand of the TGF-β family, has recently been identified as an essential pathway in regulating cardiovascular dysfunctions including myocardial fibrosis. Oligomeric proanthocyanidins (OPC) are well known for their cardioprotective activity. The primary aim of the study was to investigate BMP-4-mediated ECM turnover in cardiac fibrosis during isoproterenol-induced post-MI and its downregulation by OPC. Myocardial injury was evaluated by assaying serum markers LDH and CK. Oxidative stress and the enzymatic and nonenzymatic antioxidant levels were assessed to support the cardioprotective nature of OPC. The total collagen level was analyzed by measuring hydroxyproline levels. The ISO-induced group showed a significant decrease in the levels of antioxidants due to severe oxidative stress and increased expression of BMP-4 which reflects the increased expression of MMP 2 and 9 with a concomitant increase and deposition of fibrillary collagens type I and III responsible for the fibrotic scar formation as evidenced in the histological analysis.BMP-4 activation, thus, is strongly associated with cardiac fibrosis which was downregulated upon OPC supplementation. This study provides an evidence supporting the antifibrotic effect of OPC via regulation of BMP-4-mediated ECM turnover and also substantiates the remarkable antioxidant efficacy of OPC against isoproterenol induced severe oxidative stress and subsequent post-MI cardiac fibrosis.

Topics: Animals; Antioxidants; Bone Morphogenetic Protein 4; Cardiovascular Agents; Collagen; Disease Models, Animal; Fibrosis; Isoproterenol; Lipid Peroxidation; Male; Matrix Metalloproteinase 2; Matrix Metalloproteinase 9; Myocardial Infarction; Myocardium; Oxidative Stress; Proanthocyanidins; Rats, Wistar; Ventricular Function, Left; Ventricular Remodeling

There is a paucity of information about treatment and mortality trends after acute myocardial infarction (AMI) for cancer survivors (CS).. In this population-based study, the authors compared temporal trends of treatments and outcomes (mortality, nonfatal cardiovascular outcomes), among CS and patients without cancer (the noncancer patient [NCP] group) with AMI in Ontario (Canada) using inverse probability treatment weight (IPTW)-adjusted modeling.. Among CS and NCP with AMI in Ontario, similar improvements in mortality and receipt of treatments were observed between 1995 and 2013. However, compared with NCP, CS had a higher risk of mortality and heart failure. Cancer 2018;124:1269-78. © 2017 American Cancer Society.

Topics: Acute Disease; Adrenergic beta-Antagonists; Aged; Angiotensin-Converting Enzyme Inhibitors; Cancer Survivors; Cardiovascular Agents; Case-Control Studies; Female; Follow-Up Studies; Humans; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Male; Middle Aged; Myocardial Infarction; Neoplasms; Survival Rate; Time Factors; Treatment Outcome

The molecular mechanisms through which ghrelin exerts its cardioprotective effects during cardiac remodeling post-myocardial infarction (MI) are poorly understood. The aim of this study was to investigate whether the cardioprotection mechanisms are mediated by modulation of JAK/STAT signaling and what triggers this modulation. Rats were divided into six groups (n = 12/group): control, sham, sham + ghrelin (100 µg/kg, s.c., daily, starting 1 day post-MI), MI, MI+ ghrelin, and MI+ ghrelin+ AG490, a potent JAK2 inhibitor (5 mg/kg, i.p., daily). All treatments were administered for 3 weeks. Administration of ghrelin to MI rats improved left ventricle (LV) architecture and restored cardiac contraction. In remote non-infarcted areas of MI rats, ghrelin reduced cardiac inflammation and lipid peroxidation and enhanced antioxidant enzymatic activity. In addition, independent of the growth factor/insulin growth factor-1 (GF/IGF-1) axis, ghrelin significantly increased the phosphorylation of JAK2 and Tyr702 and Ser727 residues of STAT3 and inhibited the phosphorylation of JAK1 and Tyr701 and Ser727 residues of STAT1, simultaneously increasing the expression of BCL-2 and decreasing in the expression of BAX, cleaved CASP3, and FAS. This effect coincided with decreased expression of SOCS3. All these beneficial effects of ghrelin, except its inhibitory action on IL-6 expression, were partially and significantly abolished by the co-administration of AG490. In conclusion, the cardioprotective effect of ghrelin against MI-induced LV injury is exerted via activation of JAK2/STAT3 signaling and inhibition of STAT1 signaling. These effects were independent of the GF/IGF-1 axis and could be partially mediated via inhibition of cardiac IL-6.

Topics: Animals; Apoptosis; Cardiovascular Agents; Disease Models, Animal; Ghrelin; Heart Ventricles; Interleukin-6; Janus Kinase 2; Male; Myocardial Infarction; Myocytes, Cardiac; Oxidative Stress; Rats, Sprague-Dawley; Signal Transduction; STAT1 Transcription Factor; STAT3 Transcription Factor; Suppressor of Cytokine Signaling 3 Protein; Ventricular Dysfunction, Left; Ventricular Function, Left; Ventricular Remodeling

To date, experience with bioresorbable scaffolds (BRS) that elute agents other than everolimus is limited. Thus, a post-marketing clinical follow-up study was conducted to evaluate the continued safety and effectiveness of the DESolve® NOVOLIMUS™ Eluting BRS as treatment for patients with stable coronary artery disease.. The DESolve BRS combines a poly-l-lactide-based backbone with a biodegradable polylactide-based polymer and Novolimus, a macrocyclic lactone mTOR inhibitor.. One hundred and two patients (mean age 62 years, 77.5% male) were enrolled at 10 European sites. Comparison of baseline and post-procedural angiographic assessment was performed, and a device-oriented composite endpoint (comprising cardiac death, target vessel myocardial infarction, and clinically driven target lesion revascularization) and rate of scaffold thrombosis at 12 months were examined.. The device was successfully delivered and deployed in 98.2% (107/109) of the lesions, with two failures to cross the lesion. A total of 100 patients (109 lesions) were treated with a DESolve BRS. Post-procedural angiographic assessment indicated an in-scaffold acute gain of 1.54 ± 0.44 mm, with a reduction in % diameter stenosis from 61.00 ± 11.29 to 12.69 ± 0.44. At 12 months, the device-oriented composite endpoint had occurred in 3.0% (3/100) of patients, with 1.0% (1/100) experiencing scaffold thrombosis and myocardial infarction and 3.0% (3/100) undergoing target lesion revascularization. There were no cardiac deaths.. Results through 12 months indicate that the DESolve BRS is a safe and effective treatment for coronary lesions, though larger, long-term prospective studies are needed.

Topics: Absorbable Implants; Adult; Aged; Aged, 80 and over; Cardiovascular Agents; Coronary Angiography; Coronary Artery Disease; Coronary Thrombosis; Female; Germany; Humans; Italy; Macrolides; Male; Middle Aged; Myocardial Infarction; Percutaneous Coronary Intervention; Product Surveillance, Postmarketing; Prospective Studies; Prosthesis Design; Risk Factors; Time Factors; Treatment Outcome; Young Adult

To evaluate the target lesion failure (TLF) rate of the SYNERGY stent in all-comers, multiethnic Asian population.. Currently, most drug eluting stents deliver anti-proliferative drugs from a durable polymer which is associated with a risk of late stent thrombosis. The novel everolimus-eluting, platinum chromium SYNERGY stent is coated with a bioabsorbable abluminal polymer that resolves within 4 months.. This was a prospective, single center registry of consecutive patients treated with the SYNERGY stent between December 2012 and April 2015. The primary outcome was the incidence of TLF, defined as the combination of cardiac death, target vessel myocardial infarction, or clinically driven target lesion revascularization (TLR) at 1 year.. A total of 807 patients received the SYNERGY stent during the study period. One-year clinical outcome data was available for 765 patients (94.8%) and were considered for statistical analysis. The mean age was 60.7 ± 10.8 years, and 83.4% were males. Patients with acute myocardial infarction consisted of 50.3% (ST-segment elevation myocardial infarction: 23.0%, Non-ST-segment elevation myocardial infarction: 27.3%) of the study population. The treated lesions were complex (ACC/AHA type B2/C: 72.7%). The primary end point of TLF at 1 year was 5.8%. Rates of cardiac mortality, target vessel myocardial infarction, and TLR were 4.2, 1.0, and 1.3%, respectively, at 1 year. Predictors of the incidence and time to early TLF were female gender, Malay ethnicity, diabetes mellitus, acute myocardial infarction at presentation, a prior history of coronary artery bypass surgery and the presence of lesion calcification. The incidence of definite stent thrombosis was 0.4% at 1 year.. In this registry, the use of the SYNERGY stent was associated with low rates of TLF at 1 year.

Topics: Absorbable Implants; Aged; Angioplasty, Balloon, Coronary; Asian People; Cardiovascular Agents; Coronary Artery Disease; Drug-Eluting Stents; Everolimus; Female; Humans; Incidence; Male; Middle Aged; Myocardial Infarction; Prospective Studies; Prosthesis Design; Registries; Risk Factors; Singapore; Time Factors; Treatment Failure

Puerarin is an active ingredient of pueraria, which has been developed for puerarin injections, used in the treatment of cardiovascular diseases including arrhythmia, myocardial ischemia and hypertension. However, the molecular mechanisms of puerarin on ischemia/reperfusion (I/R)‑induced myocardial apoptosis in diabetic rats are not fully understood. The present study aimed to investigate whether puerarin can attenuate I/R‑induced myocardial apoptosis in diabetic rats, and to investigate the underlying mechanism. A hemodynamic analyzing system was employed to analyze the left ventricular developed pressure (LVDP), the left ventricular end‑systolic interior dimension (LVIDs) and the left ventricular end diastolic interior dimension (LVIDd). ELISA kits were used to analyze malondialdehyde (MDA), superoxide dismutase (SOD), tumor necrosis factor‑α (TNF‑α) and interleukin (IL)‑6 levels, NO production and caspase‑3 activity. Nuclear factor (NF)‑κB, ascular endothelial growth factor A (VEGFA), angiotensin (Ang)‑I, phosphorylated (p)‑endothelial nitric oxide synthase protein expression was analyzed using western blot analysis. Puerarin significantly reduced the myocardial infarct area, and increased left ventricular developed pressure in diabetic rats with myocardial I/R. Oxidative stress, inflammation and nuclear factor‑κB protein expression were significantly reduced by puerarin. Furthermore, puerarin activated the protein expression levels of VEGFA and Ang‑I, and increased nitric oxide production, phosphorylated‑endothelial nitric oxide synthase protein expression and caspase‑3 activity. These results demonstrated that the myocardial protective effect of puerarin serves to reduce myocardial I/R injury, via upregulation of VEGFA/Ang‑1 and suppression of apoptosis, in diabetic rats with myocardial I/R.

Topics: Angiotensin I; Animals; Anti-Inflammatory Agents; Antioxidants; Apoptosis; Cardiovascular Agents; Diabetes Mellitus, Experimental; Isoflavones; Male; Myocardial Infarction; Myocardial Reperfusion Injury; Oxidative Stress; Rats; Rats, Sprague-Dawley; Up-Regulation; Vascular Endothelial Growth Factor A; Vasodilator Agents

Information is lacking on prescribing of preventative cardiovascular pharmacotherapies for patients with non-ST elevation myocardial infarction (NSTEMI) in the Asian region. This study examined the prescribing rate of these pharmacotherapies, comparing NSTEMI to STEMI, and variations across demographics and clinical factors within the NSTEMI group in the multi-ethnic Malaysian population.. This is a retrospective analysis of the Malaysian National Cardiovascular Disease Database-Acute Coronary Syndrome registry from year 2006 to 2013 (n = 30,873). On-discharge pharmacotherapies examined were aspirin, ADP-antagonists, statins, ACE-inhibitors, angiotensin-II-receptor blockers, and beta-blockers. Multivariate logistic regression was used to calculate adjusted odds ratio of receiving individual pharmacotherapies according to patients' characteristics in NSTEMI patients (n = 11,390).. Prescribing rates for cardiovascular pharmacotherapies had significantly increased especially for ADP-antagonists (76%) in NSTEMI patients. More than 85% were prescribed statins and antiplatelets but rates remained significantly lower compared to STEMI. Women and those over 65 years old were less likely to be prescribed these pharmacotherapies compared to men and younger NSTEMI patients. Chinese and Indians were more likely to receive selected pharmacotherapies compared to Malays (main ethnicity). Geographical variations were observed; East Malaysian (Malaysian Borneo) patients were less likely to receive these compared to Western region of Malaysian Peninsular. Underprescribing in patients with risk factors such as diabetes were observed with other co-morbidities influencing prescribing selectively.. This study uncovers demographic and clinical variations in cardiovascular pharmacotherapies prescribing for NSTEMI. Concerted efforts by policy makers, specialty societies, and physicians are required focusing on elderly, women, Malays, East Malaysians, and high-risk patients.

Topics: Aged; Cardiovascular Agents; Drug Utilization; Female; Humans; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Malaysia; Male; Myocardial Infarction; Practice Patterns, Physicians'; Registries; Secondary Prevention

Periprocedural myocardial infarction (PMI) is reported to be associated with adverse long-term clinical outcomes. This study compared the rates of PMI following treatment of de novo coronary lesions using either a paclitaxel-coated balloon (PCB) or a newer-generation drug-eluting stent (DES).. We compared the incidence of PMI in propensity-matched patients with stable angina pectoris and single-vessel de novo coronary lesions who underwent treatment with a PCB or newer-generation DES. Propensity score matching was performed to adjust for differences in baseline clinical and angiographic characteristics.. After propensity matching, the study cohort included 108 patients (PCB: n=54 and DES: n=54). The peak mean values of creatine kinase-myocardial band (13.3±26.3 vs. 2.2±2.8 ng/ml, P=0.003) and high-sensitive troponin T (0.62±1.38 vs. 0.09±0.19 ng/ml, P=0.007) were significantly higher in the DES group compared with the PCB group. The incidence of PMI was significantly higher in the DES group [DES: 11 (20.4%) vs. PCB: one (1.9%); P=0.002]. Total occlusion of the side-branch occurred in two patients treated with DES, but no patients treated with PCB. Treatment with a newer-generation DES was found to be an independent predictor of PMI on multivariable analyses.. In patients with stable angina using a PCB, compared with deployment of a newer-generation DES, is associated with a significant reduction in the risk of PMI.

Topics: Aged; Angina, Stable; Angioplasty, Balloon, Coronary; Biomarkers; Cardiac Catheters; Cardiovascular Agents; Coated Materials, Biocompatible; Coronary Angiography; Creatine Kinase, MB Form; Databases, Factual; Drug-Eluting Stents; Female; Humans; Incidence; Male; Middle Aged; Myocardial Infarction; Paclitaxel; Propensity Score; Prosthesis Design; Republic of Korea; Risk Assessment; Risk Factors; Time Factors; Treatment Outcome; Troponin T

Nonhuman primate (NHP) models are more predictive than rodent models for developing induced pluripotent stem cell (iPSC)-based cell therapy, but robust and reproducible NHP iPSC-cardiomyocyte differentiation protocols are lacking for cardiomyopathies research. We developed a method to differentiate integration-free rhesus macaque iPSCs (RhiPSCs) into cardiomyocytes with >85% purity in 10 days, using fully chemically defined conditions. To enable visualization of intracellular calcium flux in beating cardiomyocytes, we used CRISPR/Cas9 to stably knock-in genetically encoded calcium indicators at the rhesus AAVS1 safe harbor locus. Rhesus cardiomyocytes derived by our stepwise differentiation method express signature cardiac markers and show normal electrochemical coupling. They are responsive to cardiorelevant drugs and can be successfully engrafted in a mouse myocardial infarction model. Our approach provides a powerful tool for generation of NHP iPSC-derived cardiomyocytes amenable to utilization in basic research and preclinical studies, including in vivo tissue regeneration models and drug screening.

Topics: Animals; Biomarkers; Calcium; Cardiovascular Agents; Cell Differentiation; Cell Line; CRISPR-Cas Systems; Dependovirus; Disease Models, Animal; Fluorescence; Founder Effect; Gene Expression; Gene Knock-In Techniques; Genes, Reporter; Genetic Loci; Genetic Vectors; Induced Pluripotent Stem Cells; Macaca mulatta; Mice; Myocardial Infarction; Myocytes, Cardiac; Nanog Homeobox Protein; Octamer Transcription Factor-3; Stage-Specific Embryonic Antigens; Transplantation, Heterologous

Activation of melatonin receptors induces cardioprotection. Mitochondrial potassium channels (mKCa and mKATP) are involved in the signaling cascade of preconditioning. The melatonin receptor agonist ramelteon is an approved oral medication for treatment of insomnia, but nothing is known about possible cardioprotective properties. We investigated whether (1) ramelteon induces cardioprotection mediated by the melatonin receptor; (2) this effect is concentration-dependent; and (3) mKCa and/or mKATP channels are critically involved in ramelteon-induced cardioprotection. Hearts of male Wistar rats were randomized and placed on a Langendorff system, perfused with Krebs-Henseleit buffer at a constant pressure of 80 mm Hg. All hearts were subjected to 33 minutes of global ischemia and 60 minutes of reperfusion. Before, ischemic hearts were perfused with different concentrations of ramelteon (0.01-5 μM) for determination of a concentration-effect curve. In subsequent experiments, the lowest protective concentration of ramelteon was administered together with paxilline (mKCa channel inhibitor) and 5-hydroxydecanoate (mKATP channel inhibitor). To determine whether the reduction of ischemia and reperfusion injury by ramelteon is mediated by melatonin receptor, we combined ramelteon with luzindole, a melatonin receptor antagonist. Infarct size was determined by triphenyltetrazolium chloride staining. In control animals, infarct size was 58% ± 6%. Ramelteon in a concentration of 0.03 µM reduced infarct size to 28% ± 4% (P < 0.0001 vs. Con). A lower concentration of ramelteon did not initiate cardioprotection, and higher concentrations did not further decrease infarct size. Paxilline, 5-hydroxydecanoate, and luzindole completely blocked the ramelteon-induced cardioprotection. This study shows for the first time that (1) ramelteon induces cardioprotection through melatonin receptor; (2) the effect is not concentration-dependent; and (3) activation of mKCa and mKATP channels is involved.

Topics: Animals; Cardiovascular Agents; Hemodynamics; Indenes; Isolated Heart Preparation; Male; Mitochondria, Heart; Myocardial Infarction; Myocardial Reperfusion Injury; Myocytes, Cardiac; Potassium Channels; Potassium Channels, Calcium-Activated; Rats, Wistar; Receptors, Melatonin; Signal Transduction; Ventricular Function, Left

The study sought to compare the vasomotor and microcirculatory function of the infarct-related artery (IRA) between bioresorbable vascular scaffolds (BVS) and everolimus-eluting stents (EES) at 3 years.. The ABSORB STEMI TROFI II study showed similar outcomes between BVS and EES in the context of ST-segment elevation myocardial infarction at 3 years.. Sixty-three consecutive event-free patients of the randomized TROFI II study were screened to undergo coronary angiography with vasomotor, microcirculatory, and optical coherence tomography (OCT) examination at 3 years. Vasomotion was defined as >4% change in mean lumen diameter to acetylcholine (ACH) and nitroglycerin as assessed by quantitative angiography. Microcirculatory examination was performed with pressure or thermodilution techniques.. A total of 38 patients (20 BVS and 18 EES) were included. At 3 years, ≥60% of patients exhibited paradoxical vasoconstriction to ACH in the periscaffold or stent segments. Vasoconstriction to ACH and vasodilatation to nitroglycerin were more often observed in the scaffold or stent segment with BVS than with EES (77.8% vs. 25.0%; p = 0.008 and 61.1% vs. 18.8%; p = 0.018). The IRA-depending microcirculation showed similar index of resistance (23.8 vs. 22.4; p = 0.781), coronary flow reserve (2.4 vs. 1.9; p = 0.523), fractional flow reserve (0.91 vs. 0.93; p = 0.317), and absolute flow (135.5 ml/min vs. 147.3 ml/min; p = 0.791). OCT showed remaining strut footprints and larger number of intraluminal scaffold dismantling (26.3% vs. 0%; p = 0.049) in the BVS group.. Both endothelium-dependent and -independent vasomotion of the IRA were more evident with BVS, as compared with EES, at 3 years. Functional microcirculatory parameters were mostly adequate and similar between BVS and EES. Clinical implications of these findings warrant further investigations.

Topics: Aged; Cardiovascular Agents; Coated Materials, Biocompatible; Coronary Artery Disease; Coronary Circulation; Drug-Eluting Stents; Everolimus; Female; Humans; Male; Microcirculation; Middle Aged; Myocardial Infarction; Percutaneous Coronary Intervention; Prosthesis Design; Randomized Controlled Trials as Topic; Time Factors; Treatment Outcome; Vasoconstriction; Vasodilation

The impact of treatment strategies on outcomes in patients with stable coronary artery disease (CAD) and type 2 diabetes mellitus (T2DM) according to presenting angina has not been rigorously assessed.. We performed a patient-level pooled-analysis (n = 5027) of patients with stable CAD and T2DM randomized to optimal medical therapy [OMT], percutaneous coronary intervention [PCI] + OMT, or coronary artery bypass grafting [CABG] + OMT. Endpoints were death/myocardial infarction (MI)/stroke, post-randomization revascularization (both over 5 years), and angina control at 1 year.. Increasing severity of baseline angina was associated with higher rates of death/MI/stroke (p = 0.009) and increased need for post-randomization revascularization (p = 0.001); after multivariable adjustment, only association with post-randomization revascularization remained significant. Baseline angina severity did not influence the superiority of CABG + OMT to reduce the rate of death/MI/stroke and post-randomization revascularization compared to other strategies. CABG + OMT was superior for angina control at 1 year compared to both PCI + OMT and OMT alone but only in patients with ≥ Class II severity at baseline. Comparisons between PCI + OMT and OMT were neutral except that PCI + OMT was superior to OMT for reducing the rate of post-randomization revascularization irrespective of presenting angina severity.. Presenting angina severity did not influence the superiority of CABG + OMT with respect to 5-year rates of death/MI/stroke and need for post-randomization revascularization. Presenting angina severity minimally influenced relative benefits for angina control at 1 year.

Topics: Aged; Angina Pectoris; Cardiovascular Agents; Coronary Artery Bypass; Coronary Artery Disease; Diabetes Mellitus, Type 2; Female; Humans; Male; Middle Aged; Myocardial Infarction; Percutaneous Coronary Intervention; Randomized Controlled Trials as Topic; Retreatment; Risk Assessment; Risk Factors; Severity of Illness Index; Stroke; Time Factors; Treatment Outcome

NLRP3 inflammasome plays critical roles in a variety of human diseases and represents a promising drug target. In this study, we established the in vivo functional activities of JC124, a previously identified NLRP3 inflammasome inhibitor from our group, in mouse models of Alzheimer's disease and acute myocardial infarction. To understand the chemical space of this lead structure, a series of analogues were designed, synthesized, and biologically characterized. The results revealed the critical roles of the two substituents on the benzamide moiety of JC124. On the other hand, modifications on the sulfonamide moiety of JC124 are well tolerated. Two new lead compounds, 14 and 17, were identified with improved inhibitory potency (IC

Topics: Alzheimer Disease; Animals; Benzenesulfonamides; Cardiovascular Agents; Cognition; Disease Models, Animal; Drug Design; Drug Evaluation, Preclinical; Female; Inflammasomes; Interleukin-1beta; Macrophages; Mice, Inbred C57BL; Mice, Inbred ICR; Mice, Transgenic; Myocardial Infarction; NLR Family, Pyrin Domain-Containing 3 Protein; Structure-Activity Relationship; Sulfonamides

Although improvements in timing and approach for early reperfusion with acute coronary syndromes have occurred, myocardial injury culminating in a myocardial infarction (MI) remains a common event. Although a multifactorial process, an imbalance between the induction of proteolytic pathways, such as matrix metalloproteinases (MMPs) and endogenous tissue inhibitors of metalloproteinase (TIMPs), has been shown to contribute to this process. In the present study, a full-length TIMP-3 recombinant protein (rTIMP-3) was encapsulated in a specifically formulated hyaluronic acid (HA)-based hydrogel that contained MMP-cleavable peptide cross-links, which influenced the rate of rTIMP-3 release from the HA gel. The effects of localized delivery of this MMP-sensitive HA gel (HAMMPS) alone and containing rTIMP-3 (HAMMPS/rTIMP-3) were examined in terms of the natural history of post-MI remodeling. Pigs were randomized to one of the following three different groups: MI and saline injection (MI/saline group, 100-μl injection at nine injection sites, n = 7), MI and HAMMPS injection (MI/HAMMPS group; 100-μl injection at nine injection sites, n = 7), and MI and HAMMPS/rTIMP-3 injection (MI/HAMMPS/rTIMP-3 group; 20-μg/100-μl injection at nine injection sites, n = 7). Left ventricular (LV) echocardiography was serially performed up to 28 days post-MI. LV dilation, as measured by end-diastolic volume, and the degree of MI wall thinning were reduced by ~50% in the HAMMPS/rTIMP-3 group ( P < 0.05). Furthermore, indexes of heart failure progression post-MI, such as LV filling pressures and left atrial size, were also attenuated to the greatest degree in the HAMMPS/rTIMP-3 group. At 28 days post-MI, HAMMPS/rTIMP-3 caused a relative reduction in the transcriptional profile for myofibroblasts as well as profibrotic pathways, which was confirmed by subsequent histochemistry. In conclusion, these findings suggest that localized delivery of a MMP-sensitive biomaterial that releases a recombinant TIMP holds promise as a means to interrupt adverse post-MI remodeling. NEW & NOTEWORTHY The present study targeted a myocardial matrix proteolytic system, matrix metalloproteinases (MMPs), through the use of a recombinant tissue inhibitor of MMPs incorporated into a MMP-sensitive hydrogel, which was regionally injected using a large animal model of myocardial infarction. Left ventricular geometry and function and indexes of myocardial remodeling were improved with this approach and support the

Topics: Animals; Cardiovascular Agents; Delayed-Action Preparations; Dextran Sulfate; Disease Models, Animal; Drug Carriers; Drug Compounding; Extracellular Matrix; Gene Expression Profiling; Heart Ventricles; Hyaluronic Acid; Hydrogels; Male; Myocardial Infarction; Myofibroblasts; Recombinant Proteins; Tissue Inhibitor of Metalloproteinase-3; Transcription, Genetic; Transcriptome; Ventricular Function, Left; Ventricular Remodeling

Dronedarone improves microvascular flow during atrial fibrillation and reduces the infarct size in acute models of myocardial infarction. However, dronedarone might be harmful in patients with recent decompensated heart failure and increases mortality in patients with permanent atrial fibrillation. A pathophysiological explanation for these discrepant data is lacking. This study investigated the effects of dronedarone on gene and protein expression in the infarcted area and border zone in pigs subjected to anterior ischemia/reperfusion myocardial infarction. The ischemia/reperfusion myocardial infarction was induced in 16 pigs. Eight pigs were treated with dronedarone for 28 days after myocardial infarction, the remaining pigs served as control. Microarray-based transcriptome profiling and 2D-DIGE-based proteome analysis were used to assess the effects of dronedarone on left ventricular gene expression in healthy (LV), infarcted (MI), and border zone tissue. Selected targets were validated by RT-qPCR or immunoblot analyses, with special emphasize given to the transcriptome/proteome overlap. Combined "omics" analysis was performed to identify most significant disease and function charts affected by dronedarone and to establish an integrated network. The levels of 879 (BZ) or 7 (MI) transcripts and 51 (LV) or 15 (BZ) proteins were significantly altered by dronedarone, pointing to a substantial efficacy of dronedarone in the border zone. Transcriptome and proteome data indicate that dronedarone influences post-infarction remodeling processes and identify matricellular proteins as major targets of dronedarone in this setting. This finding is fully supported by the disease and function charts as well as by the integrated network established by combined "omics". Dronedarone therapy alters myocardial gene expression after acute myocardial infarction with pronounced effects in the border zone. Dronedarone promotes infarct healing via regulation of periostin and might contribute to the limitation of its expansion as well as cardiac rupture. Thus, there are no experimental hints that dronedarone per se has direct harmful effects after MI in ventricular tissue. Impact statement Dronedarone reduced the infarct size in models of acute myocardial infarction (MI). Here, we show that dronedarone attenuates many of the substantial changes in gene expression that are provoked by acute myocardial infarction (AMI) in pigs. Dronedarone modifies the expression of gene panels r

Topics: Animals; Cardiovascular Agents; Disease Models, Animal; Dronedarone; Gene Expression Profiling; Immunoblotting; Microarray Analysis; Myocardial Infarction; Proteome; Real-Time Polymerase Chain Reaction; Reverse Transcriptase Polymerase Chain Reaction; Swine; Treatment Outcome; Two-Dimensional Difference Gel Electrophoresis; Ventricular Remodeling

Treatment of in-stent restenosis (ISR) is still a clinical challenge in interventional cardiology. Paclitaxel-coated balloons (PCBs) are an attractive therapeutic option for ISR. There are several different types of PCBs available for percutaneous coronary intervention, but to date, comparative data between different types of PCBs for the treatment of ISR are scarce.. This single centre, nonrandomized, retrospective study under real-world condition included 194 patients with 194 ISR treated by repeat percutaneous coronary intervention with PCBs. The primary end point was major adverse cardiac events (MACEs), defined as cardiac death, myocardial infarction and need for target lesion revascularization (TLR) at 1 year. Secondary end points were MACE and TLR at long-term follow-up.. Baseline clinical and angiographic parameters were comparable between the two groups. Patients in the iopromide-based PCB and butyryl-tri-hexyl citrate (BTHC)-PCB groups were followed up for 32.2±20.5 and 24.2±13.3 months, respectively (P=0.001). MACEs at 1-year follow-up were 15.0 and 15.8% (P=0.879) for the BTHC-PCB and iopromide-based PCB groups, respectively. TLR, myocardial infarction and cardiac death for BTHC-PCB versus iopromide-based PCB at 1-year follow-up were 9.6 versus 11.8%, P=0.622; 5.3 versus 3.9%, P=0.640; and 5.3 versus 3.9%, P=0.640, respectively. If complete follow-up periods were included in the analysis, BTHC-PCB and iopromide-based PCB had comparable rates of MACE (P=0.835) and TLR (P=0.792).. BTHC-PCB and iopromide-based PCB had comparable rates of MACE and TLR for the treatment of ISR at 1-year and long-term follow-up.

Topics: Aged; Aged, 80 and over; Angioplasty, Balloon, Coronary; Butyrates; Cardiac Catheters; Cardiovascular Agents; Coated Materials, Biocompatible; Coronary Angiography; Coronary Artery Disease; Coronary Restenosis; Drug-Eluting Stents; Equipment Design; Excipients; Female; Humans; Iohexol; Male; Middle Aged; Myocardial Infarction; Paclitaxel; Percutaneous Coronary Intervention; Retrospective Studies; Risk Factors; Time Factors; Treatment Outcome

Few studies have suggested that patients with myocardial infarction (MI) may be at increased risk of cancer, but further large register-based studies are needed to evaluate this subject. The aim of this study was to assess the incident rates of cancer and death by history of MI, and whether an MI is independently associated with cancer in a large cohort study.. All Danish residents aged 30-99 in 1996 without prior cancer or MI were included and were followed until 2012. Patients were grouped according to incident MI during follow-up. Incidence rates (IR) of cancer and death in individuals with and without MI and incidence rate ratios (IRR, using multivariable Poisson regression analyses) of cancer associated with an MI were calculated.. Of 2,871,168 individuals, 122,275 developed an MI during follow-up, 11,375 subsequently developed cancer (9.3%, IR 19.1/1000 person-years) and 65,225 died (53.3%, IR 106.0/1000 person-years). In the reference population, 372,397 developed cancer (13.0%, IR 9.3/1000 person-years) and 753,767 died (26.3%, IR 18.2/1000 person-years). Compared to the reference population, higher IRs of cancer and death were observed in all age groups (30-54, 55-69 and 70-99 years) and time since an MI (0-1, 1-5 and 5-17 years) in the MI population. MI was associated with an increased risk of overall cancer (IRR 1.14, 95% CI 1.10-1.19) after adjusting for age, sex and calendar year, also when additionally adjusting for chronic obstructive pulmonary disease, hypertension, dyslipidemia, diabetes and socioeconomic status (IRR 1.08, 95% CI 1.03-1.13), but not after further adjustment for the first 6 months post-MI (IRR 1.00, 95% CI 0.96-1.05).. Patients after an MI have increased incidence of cancer, which may be explained by mutual risk, occult cancers and increased surveillance. Focus on risk factor management to reduce cancer and MI is warranted.

Topics: Adult; Aged; Aged, 80 and over; Cardiovascular Agents; Comorbidity; Denmark; Female; Humans; Incidence; Male; Middle Aged; Myocardial Infarction; Neoplasms; Prognosis; Registries; Risk Assessment; Risk Factors; Time Factors

Biodegradable polymer sirolimus-eluting stents (BP-SESs) have been reported to be noninferior compared with durable polymer everolimus-eluting stents (DP-EES) in a randomized clinical trial. We sought to compare the efficacy and safety of an ultrathin strut BP-SES with a DP-EES in an all-comers population.. Among 7640 consecutive patients who underwent percutaneous coronary intervention between March 2011 and June 2015, 4638 patients were exclusively treated with BP-SES (N=1896; 3137 lesions) or DP-EES (N=2742; 4468 lesions). After propensity score matching within strata of clinical indications, the final study population consisted of 2902 matched patients (BP-SES 2406 lesions and DP-EES 2368 lesions). The primary device-oriented composite end point (DOCE) included cardiac death, target vessel myocardial infarction, and target lesion revascularization at 1 year. BP-SES (6.9%) was noninferior to DP-EES (8.0%) with respect to device-oriented composite end point (hazard ratio [HR], 0.85; 95% CI, 0.65-1.11; P for noninferiority <0.001; P for superiority=0.24). No differences in cardiac death (BP-SES, 2.3% versus DP-EES, 3.0%; HR, 0.76; 95% CI, 0.49-1.20; P=0.25), myocardial infarction (BP-SES, 4.6% versus DP-EES, 4.6%; HR, 1.00; 95% CI, 0.71-1.40; P=0.99), or target lesion revascularization (BP-SES, 2.8% versus DP-EES, 2.5%; HR, 1.11; 95% CI, 0.71-1.74; P=0.65) were observed. The rate of periprocedural myocardial infarction was comparable between the 2 groups (2.1% versus 2.2%; HR, 0.97; 95% CI, 0.59-1.58; P=0.89). The rate of definite stent thrombosis was similarly low throughout 1 year (BP-SES, 0.8% versus DP-EES, 0.8%; HR, 1.00; 95% CI, 0.45-2.22; P=1.00).. In a consecutively enrolled percutaneous coronary intervention population reflecting routine clinical practice, BP-SES was noninferior to DP-EES for device-oriented composite end point at 1 year.. URL: https://www.clinicaltrials.gov . Unique identifier: NCT02241291.

Topics: Absorbable Implants; Aged; Cardiovascular Agents; Coronary Artery Disease; Coronary Thrombosis; Drug-Eluting Stents; Everolimus; Female; Humans; Male; Middle Aged; Myocardial Infarction; Percutaneous Coronary Intervention; Polymers; Propensity Score; Prospective Studies; Prosthesis Design; Registries; Risk Assessment; Risk Factors; Sirolimus; Switzerland; Time Factors; Treatment Outcome

Metformin has been demonstrated to decrease infarct size (IS) and prevent postinfarction left ventricular (LV) remodeling in rodents when given intravenously at the time of reperfusion. It remains unclear whether similar cardioprotection can be achieved in a large animal model.. The objective of this study was to determine whether intravascular infusion of metformin at the time of reperfusion reduces myocardial IS in a porcine model of acute myocardial infarction.. In a blinded and randomized preclinical study, closed-chest swine (n=20) were subjected to a 60-minute left anterior descending coronary artery occlusion to produce myocardial infarction. Contrast-enhanced computed tomography was performed during left anterior descending coronary artery occlusion to assess the ischemic area-at-risk. Animals were randomized to receive either metformin or vehicle as an initial intravenous bolus (5 mg/kg) 8 minutes before reperfusion, followed by a 15-minute left coronary artery infusion (1 mg/kg per minute) commencing with the onset of reperfusion. Echocardiography and computed tomographic imaging of LV function were performed 1 week later, at which time the heart was removed for postmortem pathological analysis of area-at-risk and IS (triphenyltetrazolium chloride). Baseline variables including hemodynamics and LV function were similar between groups. Peak circulating metformin concentrations of 374±35 µmol/L were achieved 15 minutes after reperfusion. There was no difference between the area-at-risk as a percent of LV mass by computed tomography (vehicle: 20.7%±1.1% versus metformin: 19.7%±1.3%; P=0.59) or postmortem pathology (22.4%±1.2% versus 20.2%±1.2%; P=0.21). IS relative to area-at-risk averaged 44.5%±5.0% in vehicle-treated versus 38.2%±6.8% in metformin-treated animals ( P=0.46). There was no difference in global function 7 days after myocardial infarction as assessed by echocardiography or computed tomographic ejection fraction (56.2%±2.6% versus 56.3%±2.4%; P=0.98).. In contrast to rodent hearts, postconditioning with high-dose metformin administered immediately before reperfusion does not reduce IS or improve LV function 7 days after myocardial infarction in swine. These results reinforce the importance of rigorously testing therapies in large animal models to facilitate clinical translation of novel cardioprotective therapies.

Topics: Animals; Cardiovascular Agents; Disease Models, Animal; Drug Administration Schedule; Echocardiography; Infusions, Intra-Arterial; Injections, Intravenous; Metformin; Multidetector Computed Tomography; Myocardial Infarction; Myocardium; Species Specificity; Stroke Volume; Sus scrofa; Time Factors; Ventricular Function, Left; Ventricular Remodeling

We investigated the underlying mechanism of ivabradine (IVA) in promoting angiogenesis and reducing cardiac hypertrophy in mice with myocardial infarction (MI).. Nineteen mice were randomly assigned into three groups as follows: sham group (10 ml/kg/day phosphate buffer saline (PBS), n=6), model group (MI and 10 ml/kg/day PBS, n=6) and IVA group (MI and 10 mg/kg/day IVA, n=7). All groups received an intragastric gavage for four weeks. Heart and body mass were measured. Cardiac function and heart rate were assessed by echocardiography and electrocardiography, respectively. The collagen deposition, area of cardiomyocytes, and number of capillaries were evaluated using Masson's staining, anti-wheat germ agglutinin (WGA) staining, and platelet endothelial cell adhesion molecule-1 (CD31) staining, respectively. The protein kinase B (Akt)- endothelial nitric oxide synthase (eNOS) signaling and p-38 mitogen-activated protein kinase (MAPK) family in myocardium were determined by western blot.. IVA treatment greatly improved cardiac dysfunction and suppressed cardiac hypertrophy at 4 weeks after MI (p<0.05). Heart rate and fibrotic area of IVA group declined notably compared to those of the model group (p<0.05). IVA administration substantially reduced cardiomyocyte size and increased capillary formation (p<0.05). Besides, IVA medication can enhance Akt-eNOS signaling and inhibit p38 MAPK phosphorylation in the heart of mice with MI (p<0.05).. IVA can perform two functions, the promotion of angiogenesis and the reduction of cardiac hypertrophy, both of which were closely associated with Akt-eNOS signaling activation and p38 MAPK inhibition.

Topics: Administration, Oral; Angiogenesis Inducing Agents; Animals; Cardiomegaly; Cardiovascular Agents; Disease Models, Animal; Echocardiography; Electrocardiography; Heart Rate; Ivabradine; Male; Mice; Mice, Inbred C57BL; Myocardial Infarction; Myocardium; Nitric Oxide Synthase Type III; Random Allocation

Coronary artery spasm (CAS) is known to be a risk factor for cardiovascular events. However, there is limited data whether the multi-vessel and diffuse spasm (MVDS) is related to more adverse clinical outcomes compared to the Non-MVDS. The aim of this study is to evaluate the impact of the MVDS on clinical outcomes during a 3-year clinical follow-up period.A total 2797 patients underwent coronary angiography (CAG) with acetylcholine (ACH) provocation test from Nov 2004 to Oct 2010 were enrolled. It is a single-center, observational, prospective, all-comers registry designed to reflect the "real world" practic. The patients were divided into the 3 groups; the negative spasm (NS) group (n = 1188), the Non-MVDS group (n = 1081), and the MVDS group (n = 528). The incidence of major adverse cardiac events (MACE) and recurrent angina was evaluated up to 3 years. To minimize confounding factors, multivariable Cox-proportional hazards regression analysis was performed.In the 3-year clinical follow-up, the incidence of total death, myocardial infarction, de novo percutaneous coronary intervention (PCI), cerebrovascular accident and MACE were similar among the 3 groups. However, recurrent angina occurred more frequently in the MVDS group than in the NS group (hazard ratio [HR], 1.96; 95% confidence interval [CI], 1.27-3.02; P = .002). Recurrence angina between the MVDS group and the Non-MVDS group was not statistically significant (HR, 1.36; 95% CI, 0.91-2.03; P = .129).In this study, although the incidence of major adverse cardiovascular events were not different regardless of spasm type, the MVDS was associated with higher incidence of recurrent chest pain requiring repeat CAG during the 3-year follow-up period, suggesting more intensive optimal medical therapy with close clinical follow up would be necessary for this particular subset of patients.

Topics: Acetylcholine; Aged; Angina Pectoris; Cardiovascular Agents; Coronary Angiography; Coronary Vasospasm; Female; Humans; Incidence; Male; Middle Aged; Myocardial Infarction; Prognosis; Registries; Republic of Korea; Risk Factors; Time

To evaluate long-term outcomes in patients undergoing either paclitaxel-eluting stents (PES) or endeavor zotarolimus-eluting stents (E-ZES) placement and to assess comparative effectiveness of PES vs. E-ZES in different "off-label" and "high-risk" patient subgroups.. PES and E-ZES are frequently used in percutaneous coronary interventions (PCIs). However, the long-term comparative effectiveness of PES vs. E-ZES in real practice is unknown.. We created a longitudinal database by linking the New York State (NYS) cardiac registries, the NYS hospital discharge file, the National Death Index, and the U.S. Census file for patients undergoing either PES or E-ZES placement from July 2008 through December 2009. All-cause mortality, acute myocardial infarction (AMI), target lesion PCI (TLPCI), and target vessel coronary artery bypass graft (TVCABG) surgery were compared for 9,264 propensity score matched patients for a 5-year follow-up period using the Kaplan-Meier method with further adjustment using Cox proportional hazards regression.. We did not detect significant differences between E-ZES and PES (reference) in 5-year mortality (adjusted hazard ratio : 1.02, 95% confidence interval : 0.91-1.14), AMI (AHR: 1.05, 95% CI: 0.90-1.22), TLPCI (AHR: 0.99, 95% CI: 0.86-1.13), and TVCABG (AHR, 1.07, 95% CI: 0.84-1.36). For six "off-label" and two "high-risk" subpopulations, we had similar findings for the two stent groups.. NYS observational data suggest that 5-year outcomes are comparable in patients receiving either PES or E-ZES placement, mirroring the findings of recent clinical trials. © 2017 Wiley Periodicals, Inc.

Topics: Aged; Aged, 80 and over; Cardiovascular Agents; Comparative Effectiveness Research; Coronary Artery Disease; Databases, Factual; Drug-Eluting Stents; Female; Humans; Male; Middle Aged; Myocardial Infarction; New York; Paclitaxel; Percutaneous Coronary Intervention; Prosthesis Design; Registries; Risk Factors; Sirolimus; Time Factors; Treatment Outcome

Kawasaki disease (KD) is the most common cause of acquired heart disease in children in Japan, North America and Europe. Undiagnosed and untreated KD can have clinically significant consequences later in life. The clinical spectrum of missed childhood KD is frequently being recognized during adulthood. We report four adult cases of acute coronary events, in which coronary angiography was suggestive of sequelae of KD.. Four adults who presented with acute coronary events, had coronary angiography for evaluation. Indoor-admission files were analyzed for the clinical details of individual cases.. Two cases were below 40 years of age. None of the patients had any known conventional risk factors for atherosclerosis. Case 4 had a clinical history of childhood KD. Coronary angiography revealed ectasia of multiple coronary arteries and stenosis in distal segments in the first three cases and large thrombosed aneurysm with calcified walls in the fourth case.. We hereby report four adult cases with acute coronary events, who had markedly dilated coronary artery segments suggestive of possible sequelae of childhood KD.

Topics: Adult; Aged; Anterior Wall Myocardial Infarction; Cardiovascular Agents; Coronary Aneurysm; Coronary Angiography; Coronary Artery Bypass; Coronary Artery Disease; Coronary Stenosis; Coronary Thrombosis; Delayed Diagnosis; Humans; India; Male; Mucocutaneous Lymph Node Syndrome; Myocardial Infarction; Predictive Value of Tests; Tertiary Care Centers; Treatment Outcome; Vascular Calcification

The Nobori biolimus-eluting stent (BES) is a biodegradable polymer drug-eluting stent (DES). Several studies have shown its noninferiority in comparison with durable polymer DES.. We sought to investigate the efficacy and the safety of Nobori BES in an all-comer population undergoing a percutaneous coronary intervention.. A total of 12 912 patients with 19 947 coronary lesions, undergoing percutaneous coronary intervention with Nobori BES implantation at 200 centres around the world between August 2010 and December 2015, were included in this prospective registry. Patients were stratified into four groups according to the total stent length, with cutoffs at 18, 24 and 28 mm. The primary endpoint was the occurrence of major adverse cardiac events defined as the composite of cardiac death, target vessel myocardial infarction and clinically driven target lesion revascularization at 1 year.. At 1 year, the major adverse cardiac events rate was the highest (4.6%) in the fourth quartile of stent length (>28 mm), whereas the overall rate of the primary endpoint in the all cohort was 3.5%. Both target lesion revascularization and target vessel revascularization rates were significantly higher in patients with longer stent length was implanted (all P<0.05). The incidence of definite and probable stent thrombosis at 1 year was 0.5% in all cohort and similar across the four groups (varying from 0.4 to 0.7%, all P=NS).. Our data confirmed the efficacy and the safety of the Nobori BES in routine clinical practice. Longer stent length is associated with a higher risk of adverse cardiac events, and yet, this risk is comparable with that of other DES.

Topics: Absorbable Implants; Aged; Cardiovascular Agents; Coronary Artery Disease; Drug-Eluting Stents; Female; Humans; Male; Middle Aged; Myocardial Infarction; Percutaneous Coronary Intervention; Polymers; Prospective Studies; Prosthesis Design; Registries; Risk Factors; Sirolimus; Time Factors; Treatment Outcome

Long-term progression of peripheral arterial disease (PAD) as initial manifestation of atherosclerotic arterial disease is not well described. Cardiovascular (CV) risk was examined in different PAD populations diagnosed in a hospital setting in Sweden.. Data for this retrospective cohort study were retrieved by linking data on morbidity, medication use, and mortality from Swedish national registries. Primary CV outcome was a composite of myocardial infarction, ischemic stroke (IS), and CV death. Kaplan-Meier analysis and Cox proportional hazards modeling was used for describing risk and relative risk.. Of 66,189 patients with an incident PAD diagnosis (2006-2013), 40,136 had primary PAD, 16,786 had PAD + coronary heart disease (CHD), 5803 had PAD + IS, and 3464 had PAD + IS + CHD. One-year cumulative incidence rates of major CV events for the groups were 12%, 21%, 29%, and 34%, respectively. Corresponding numbers for 1-year all-cause death were 16%, 22%, 33%, and 35%. Compared with the primary PAD population, the relative risk increase for CV events was highest in patients with PAD + IS + CHD (hazard ratio [HR], 2.01), followed by PAD + IS (HR, 1.87) and PAD + CHD (HR, 1.42). Despite being younger, the primary PAD population was less intensively treated with secondary preventive drug therapy.. PAD as initial manifestation of atherosclerotic disease diagnosed in a hospital-based setting conferred a high risk: one in eight patients experienced a major CV event and one in six patients died within 1 year. Despite younger age and substantial risk of future major CV events, patients with primary PAD received less intensive secondary preventive drug therapy.

Topics: Age Factors; Aged; Aged, 80 and over; Ambulatory Care; Brain Ischemia; Cardiovascular Agents; Cause of Death; Comorbidity; Disease Progression; Female; Humans; Incidence; Kaplan-Meier Estimate; Male; Middle Aged; Myocardial Infarction; Peripheral Arterial Disease; Prevalence; Prognosis; Proportional Hazards Models; Registries; Retrospective Studies; Risk Assessment; Risk Factors; Secondary Prevention; Stroke; Sweden; Time Factors

Topics: Aged; Aged, 80 and over; Cardiovascular Agents; Drug Prescriptions; Female; Humans; Incidence; Male; Myocardial Infarction; Norway; Secondary Prevention

Following myocardial infarction (MI), peri-infarct myocardial edema formation further impairs cardiac function. Extracellular RNA (eRNA) released from injured cells strongly increases vascular permeability. This study aimed to assess the role of eRNA in MI-induced cardiac edema formation, infarct size, cardiac function, and survival after acute MI and to evaluate the therapeutic potential of ribonuclease 1 (RNase-1) treatment as an eRNA-degrading intervention.. C57BL/6J mice were subjected to MI by permanent ligation of the left anterior descending coronary artery. Plasma eRNA levels were significantly increased compared with those in controls starting from 30 minutes after ligation. Systemic application of RNase-1, but not DNase, significantly reduced myocardial edema formation 24 hours after ligation compared with controls. Consequently, eRNA degradation by RNase-1 significantly improved the perfusion of collateral arteries in the border zone of the infarcted myocardium 24 hours after ligation of the left anterior descending coronary artery, as detected by micro-computed tomography imaging. Although there was no significant difference in the area at risk, the area of vital myocardium was markedly larger in mice treated with RNase-1 compared with controls, as detected by Evans blue and 2,3,5-triphenyltetrazolium chloride staining. The increase in viable myocardium was associated with significantly preserved left ventricular function, as assessed by echocardiography. Moreover, RNase-1 significantly improved 8-week survival following MI.. eRNA is an unrecognized permeability factor in vivo, associated with myocardial edema formation after acute MI. RNase-1 counteracts eRNA-induced edema formation and preserves perfusion of the infarction border zone, reducing infarct size and protecting cardiac function after MI.

Topics: Animals; Apoptosis; Cardiovascular Agents; Coronary Circulation; Disease Models, Animal; Edema, Cardiac; Male; Mice, Inbred C57BL; Myocardial Infarction; Myocardium; Ribonuclease, Pancreatic; RNA; RNA Stability; Time Factors; Tissue Survival; Ventricular Function, Left

Adult heart has limited potential for regeneration after pathological injury due to the limited cell proliferation of cardiomyocytes and the quiescent status of progenitor cells. As such, induction of cell-cycle reentry of cardiomyocytes is one of the key strategies for regeneration of damaged heart. In this study, a subset of miRNAs including miR-708 were identified to be much more abundant in the embryonic and neonatal cardiomyocytes than that in adult rodents. Overexpression of miR-708 promoted cellular proliferation of H9C2 cells or primary cardiomyocytes from neonatal rats or mice

Topics: Animals; Cardiovascular Agents; Cell Proliferation; Cells, Cultured; Heart; Mice; MicroRNAs; Mitogen-Activated Protein Kinase 14; Myocardial Infarction; Myocytes, Cardiac; Rats; Stress, Physiological; Treatment Outcome

The aim of this study was to report clinical outcomes in patients treated in routine practice 2 years after everolimus-eluting bioresorbable stent (BRS) implantation.. Long-term results in patients undergoing BRS implantation in routine clinical practice are sparse, and existing evidence from randomized trials considers mostly selected patients.. The ISAR-ABSORB registry enrolled consecutive patients undergoing BRS implantation in routine clinical practice at 2 high-volume centers in Germany. Angiographic follow-up was scheduled after 6 to 8 months and clinical follow-up to 24 months. The primary endpoint was the composite of death, myocardial infarction, or target lesion revascularization, and secondary endpoints included individual components of the primary endpoint and definite stent thrombosis. Event rates were calculated using the Kaplan-Meier method.. A total of 419 patients were included. The mean age was 66.6 ± 10.9 years, 31.5% had diabetes, and 39.0% presented with acute coronary syndrome. Forty-nine percent of lesions were considered complex (American College of Cardiology/American Heart Association type B2 or C), and 13.1% were bifurcation lesions. The mean reference vessel diameter was 2.89 ± 0.46 mm. At 2 years, the primary endpoint had occurred in 21.6% of patients: death in 6.3%, myocardial infarction in 3.9%, target lesion revascularization in 16.0%, and definite stent thrombosis in 3.8%.. Long-term follow-up of patients treated with BRS in routine practice showed higher event rates than expected. Future studies are required to determine the impact of changes in implantation technique and to define the optimal duration of dual antiplatelet therapy in these patients.

Topics: Absorbable Implants; Acute Coronary Syndrome; Aged; Cardiovascular Agents; Coronary Angiography; Coronary Stenosis; Coronary Thrombosis; Drug Administration Schedule; Drug Therapy, Combination; Drug-Eluting Stents; Everolimus; Female; Germany; Hospitals, High-Volume; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Myocardial Infarction; Percutaneous Coronary Intervention; Platelet Aggregation Inhibitors; Proportional Hazards Models; Prosthesis Design; Registries; Risk Factors; Time Factors; Treatment Outcome

The aim of this study was to assess clinical restenosis and its predictors after implantation of bioresorbable vascular scaffolds (BVS) in everyday practice in the large-scale German-Austrian ABSORB Registry (GABI-R).. Between November 2013 and January 2016, 3,264 patients underwent BVS implantation in the 93 centres of GABI-R. At six-month follow-up, 24 patients experienced clinically indicated target lesion revascularisation (cTLR) unrelated to BVS thrombosis (cumulative incidence 0.76%; angiographically, 58.3% of in-BVS restenosis of focal pattern). Compared to patients without cTLR, patients with cTLR had more lesions per patient (1.83±1.0 vs. 1.36±0.7), complex (52.3% vs. 36.2%) and mild-to-moderately calcified lesions (65.9% vs. 60.5%) treated, and more frequently had overlapping BVS (22.2% vs. 10.8%), all p<0.05. Implanted BVS length was 40.0 mm (28.0, 46.9) vs. 23.0 mm (18.0, 30.0), p<0.001, remaining in the multivariable analysis the only independent predictor of cTLR (hazard ratio 1.02, 95% CI: 1.01-1.04, p<0.001). The myocardial infarction rate was also significantly higher among patients with cTLR, 29.2% vs. 1.7%, p<0.0001.. cTLR related to BVS restenosis at six months after BVS implantation is a rare event depending on implanted BVS length. Whether cTLR increases the myocardial infarction risk needs to be evaluated at longer-term follow-up and within the setting of adequately powered randomised trials.

Topics: Absorbable Implants; Aged; Angioplasty, Balloon, Coronary; Austria; Cardiovascular Agents; Coated Materials, Biocompatible; Coronary Angiography; Coronary Artery Disease; Coronary Restenosis; Coronary Thrombosis; Everolimus; Female; Germany; Humans; Male; Middle Aged; Multivariate Analysis; Myocardial Infarction; Odds Ratio; Proportional Hazards Models; Prospective Studies; Prosthesis Design; Registries; Risk Factors; Time Factors; Treatment Outcome

Diabetes mellitus (DM), low ejection fraction (EF), and the extent of coronary artery disease (CAD) have all been identified as predictors of cardiovascular events in multivessel disease, but their comparative contributions to future risk remain unclear in patients with unprotected left main coronary artery (ULMCA) disease. Through this study we aimed to categorize the risk for cardiovascular events in patients with ULMCA disease using simple clinical descriptors.. Our study included a total of 5975 patients with ULMCA disease from the Interventional Research Incorporation Society-Left MAIN Revascularization registry who were treated with percutaneous coronary intervention (n=2850), coronary artery bypass grafting (n=2337), or medical therapy alone (n=608). We categorized the risk for cardiovascular events using simple clinical descriptors (DM, low EF, and the extent of CAD). The primary outcome was a major adverse cardiac or cerebrovascular event (MACCE) (i.e. death from any cause, stroke, myocardial infarction, or repeat revascularization).. Overall, the 5-year rate of MACCE was highest in the medical group, lower in the percutaneous coronary intervention group, and lowest in the coronary artery bypass grafting group (42.5, 25.7, and 19.9%, respectively; P<0.001). In multivariable modeling, the presence of DM [hazard ratio (HR): 1.25; 95% confidence interval (CI): 1.12-1.40; P<0.001], low EF of 40% or less (HR: 1.83; 95% CI: 1.56-2.15; P<0.001), and the extent of CAD (HR: 1.14; 95% CI: 1.08-1.21; P<0.001) were independent predictors of MACCE; in addition, these factors were consistently associated with a significantly higher risk for MACCE, regardless of index treatment strategies.. Simple clinical descriptors can assist clinicians in identifying high-risk patients and in predicting future cardiovascular events within the broad range of risk factors for ULMCA disease.

Topics: Aged; Asia; Cardiovascular Agents; Chi-Square Distribution; Coronary Artery Bypass; Coronary Artery Disease; Coronary Stenosis; Female; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Multivariate Analysis; Myocardial Infarction; Percutaneous Coronary Intervention; Proportional Hazards Models; Registries; Retreatment; Risk Assessment; Risk Factors; Stroke; Time Factors; Treatment Outcome

Identifying predictive factors for major cardiovascular events and death in patients with unprotected left main coronary artery disease is of great clinical value for risk stratification and possible guidance for tailored preventive strategies.. The Interventional Research Incorporation Society-Left MAIN Revascularization registry included 5795 patients with unprotected left main coronary artery disease (percutaneous coronary intervention, n=2850; coronary-artery bypass grafting, n=2337; medication alone, n=608). We analyzed the incidence and independent predictors of major adverse cardiac and cerebrovascular events (MACCE; a composite of death, MI, stroke, or repeat revascularization) and all-cause mortality in each treatment stratum. During follow-up (median, 4.3 years), the rates of MACCE and death were substantially higher in the medical group than in the percutaneous coronary intervention and coronary-artery bypass grafting groups (. Among patients with unprotected left main coronary artery disease, the key clinical predictors for MACCE and death were generally similar regardless of index treatment. This study provides effect estimates for clinically relevant predictors of long-term clinical outcomes in real-world left main coronary artery patients, providing possible guidance for tailored preventive strategies.. URL: https://clinicaltrials.gov. Unique identifier: NCT01341327.

Topics: Aged; Asia; Cardiovascular Agents; Cause of Death; Comorbidity; Coronary Artery Bypass; Coronary Artery Disease; Female; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Myocardial Infarction; Percutaneous Coronary Intervention; Proportional Hazards Models; Registries; Risk Assessment; Risk Factors; Stents; Stroke; Time Factors; Treatment Outcome

Topics: Bed Rest; Cardiology; Cardiovascular Agents; Heart Diseases; History, 20th Century; History, 21st Century; Humans; Length of Stay; Myocardial Infarction

The aim of this study was to analyse the procedural results and midterm safety of everolimus-eluting bioresorbable vascular scaffolds (BVS) used for percutaneous coronary intervention in a large all-comers cohort from the German-Austrian ABSORB RegIstRy (GABI-R).. A total of 3,231 patients were included in this prospective, observational, multicentre study (ClinicalTrials.gov NCT02066623) of consecutive patients undergoing BVS implantation between November 2013 and January 2016. Endpoints were major adverse cardiac events (MACE; a composite endpoint of death, target vessel revascularisation, and myocardial infarction), and target lesion failure (TLF; a composite endpoint of cardiac death, target vessel myocardial infarction, and target lesion revascularisation). Scaffold thrombosis was a further endpoint. Of all patients, 51.5% presented with acute coronary syndrome. Predilatation and post-dilatation were performed in 91.5% and 71.9% of patients, respectively. Procedural success was 98.9%. After six months, the incidence of MACE was 4.1% and of TLF 2.4%. The rate of target vessel MI was 1.5%, and target lesion revascularisation was performed in 1.8%. Definite/ probable scaffold thrombosis was documented in 1.4% of patients.. GABI-R, the largest registry to provide data regarding safety after BVS implantation in a real-world setting, reveals high procedural success and low six-month event rates.

Topics: Absorbable Implants; Aged; Angioplasty, Balloon, Coronary; Austria; Cardiovascular Agents; Coated Materials, Biocompatible; Coronary Artery Disease; Coronary Stenosis; Coronary Thrombosis; Everolimus; Female; Germany; Humans; Incidence; Kaplan-Meier Estimate; Male; Middle Aged; Myocardial Infarction; Prospective Studies; Prosthesis Design; Registries; Risk Factors; Time Factors; Treatment Outcome

The COMBO stent combines sirolimus elution with an endothelial progenitor cell-capturing layer to promote early endothelialisation. There has not been a head-to-head comparison of this novel device with any other currently used drug-eluting stent (DES). We sought to compare clinical outcome at two years after COMBO stent placement with the Resolute Integrity or PROMUS Element stent in an all-comers cohort.. Patients from the REMEDEE registry (COMBO, n=1,000) were matched with patients from the DUTCH PEERS trial (PROMUS Element/Resolute Integrity, n=1,811). Propensity score matching on 13 baseline characteristics was applied to create two balanced cohorts of patients treated with COMBO versus PROMUS Element/Resolute Integrity. Propensity score matching yielded 771 patient pairs, representing all-comers patients, with a median age of 65 years, 27% female and more than 50% of patients presenting with acute coronary syndrome. Target lesion failure (TLF), a composite of cardiac death, target vessel MI and any target lesion revascularisation, at two-year follow-up was 7.9% in COMBO and 6.4% in PROMUS Element/Resolute Integrity, HR 1.24 (95% CI: 0.85-1.81), p=0.26. Definite stent thrombosis (ST) was not significantly different between groups (0.8% vs. 0.9%, p=0.79).. In a propensity-matched analysis, the COMBO stent showed similar rates of TLF and ST at two-year follow-up compared to Resolute Integrity and PROMUS Element.

Topics: Adult; Aged; Cardiovascular Agents; Coronary Artery Disease; Drug-Eluting Stents; Everolimus; Female; Humans; Male; Middle Aged; Myocardial Infarction; Percutaneous Coronary Intervention; Registries; Risk Factors; Sirolimus; Treatment Outcome

The impact of percutaneous coronary intervention (PCI) on chronic total occlusion in patients with well-developed collaterals is not clear.. A total of 640 chronic total occlusion patients with collateral flow grade ≥2 were divided into 2 groups; chronic total occlusion patients either treated with PCI (the PCI group; n=305) or optimal medical therapy (the optimal medical therapy group; n=335). To adjust for potential confounders, a propensity score matching analysis was performed. Major clinical outcomes were compared between the 2 groups up to 5 years. In the entire population, the PCI group had a lower hazard of myocardial infarction (hazard ratio [HR], 0.177;. In our study, successful revascularization by PCI for chronic total occlusion lesions with well-developed collaterals was associated with lower incidence of death and myocardial infarction, improved left ventricular function, but increased repeat revascularization rate.

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Chi-Square Distribution; Chronic Disease; Collateral Circulation; Coronary Circulation; Coronary Occlusion; Coronary Vessels; Databases, Factual; Drug-Eluting Stents; Female; Humans; Kaplan-Meier Estimate; Logistic Models; Male; Middle Aged; Myocardial Infarction; Propensity Score; Proportional Hazards Models; Recovery of Function; Registries; Risk Factors; Stroke Volume; Time Factors; Treatment Outcome; Ventricular Function, Left

The purpose of this study was to evaluate the outcomes of the novel Fantom coronary bioresorbable scaffold at 6 months.. The Fantom sirolimus-eluting bioresorbable scaffold incorporates a unique proprietary iodinated, polycarbonate copolymer of tyrosine analogs that is radiopaque, with thin struts (125 μm) that facilitate device delivery and precise target lesion treatment.. The 6-month outcomes and performance of the Fantom scaffold were evaluated in 117 patients with single de novo native coronary artery lesions of length ≤20 mm and reference vessel diameter 2.5 to 3.5 mm. The primary angiographic endpoint was mean late lumen loss at 6 months measured by quantitative coronary angiography. Procedural outcomes were categorized as short-term technical success, short-term procedural success, and clinical procedural success. The primary clinical endpoint was major adverse cardiac events at 6 months, the composite of cardiac death, myocardial infarction (MI), or clinically driven target lesion revascularization (TLR).. Short-term technical success, short-term procedural success, and clinical procedural success were achieved in 96.6%, 99.1%, and 99.1% of patients, respectively. Mean 6-month in-stent late lumen loss was 0.25 ± 0.40 mm (n = 100). Binary restenosis was present in 2 patients (2.0%). Major adverse cardiac events within 6 months occurred in 3 patients (2.6%), including no deaths, 2 MIs, and 2 TLRs (1 patient had both an MI and TLR). Scaffold thrombosis occurred in 1 patient (0.9%).. The clinical results from 117 patients enrolled in cohort A of the multicenter FANTOM II (Safety & Performance Study of the FANTOM Sirolimus-Eluting Bioresorbable Coronary Scaffold) study demonstrate favorable 6-month outcomes of this novel device in the treatment of noncomplex coronary artery disease.

Topics: Absorbable Implants; Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coated Materials, Biocompatible; Coronary Angiography; Coronary Artery Disease; Coronary Restenosis; Coronary Stenosis; Female; Humans; Male; Middle Aged; Myocardial Infarction; Predictive Value of Tests; Prosthesis Design; Risk Factors; Sirolimus; Time Factors; Treatment Outcome

Fibroblast growth factor 1 (FGF1), a heparin/heparan sulfate-binding growth factor, is a potent cardioprotective agent against myocardial infarction (MI). The impact of heparin, the standard of care for MI patients entering the emergency room, on cardioprotective effects of FGF1 is unknown, however.. To address this, a rat model of MI was employed to compare cardioprotective potentials (lower infarct size and improve post-ischemic function) of native FGF1 and an engineered FGF1 (FGF1ΔHBS) with reduced heparin-binding affinity when given at the onset of reperfusion in the absence or presence of heparin. FGF1 and FGF1ΔHBS did not alter heparin's anticoagulant properties. Treatment with heparin alone or native FGF1 significantly reduced infarct size compared to saline (P < 0.05). Surprisingly, treatment with FGF1ΔHBS markedly lowered infarct size compared to FGF1 (P < 0.05). Both native and modified FGF1 restored contractile and relaxation function (P < 0.05 versus saline or heparin). Furthermore, FGF1ΔHBS had greater improvement in cardiac function compared to FGF1 (P < 0.05). Heparin negatively impacted the cardioprotective effects (infarct size, post-ischemic recovery of function) of FGF1 (P < 0.05) but not of FGF1ΔHBS. Heparin also reduced the biodistribution of FGF1, but not FGF1ΔHBS, to the left ventricle. FGF1 and FGF1ΔHBS bound and triggered FGFR1-induced downstream activation of ERK1/2 (P < 0.05); yet, heparin co-treatment decreased FGF1-produced ERK1/2 activation, but not that activated by FGF1ΔHBS.. These findings demonstrate that modification of the heparin-binding region of FGF1 significantly improves the cardioprotective efficacy, even in the presence of heparin, identifying a novel FGF ligand available for therapeutic use in ischemic heart disease.

Topics: Animals; Cardiovascular Agents; Disease Models, Animal; Extracellular Signal-Regulated MAP Kinases; Fibroblast Growth Factor 1; Heparin; Humans; Ligands; Male; Mutation; Myocardial Contraction; Myocardial Infarction; Myocardial Reperfusion Injury; Myocardium; Protein Binding; Rats, Sprague-Dawley; Receptor, Fibroblast Growth Factor, Type 1; Recovery of Function; Tissue Distribution; Ventricular Function, Left

The objective was to assess whether total stent length (TSL) after cobalt-chromium everolimus-eluting stent (CoCr-EES) implantation was associated with long-term clinical outcomes.. The impact of TSL after CoCr-EES implantation on long-term clinical outcomes remained unclear.. A total of 1,007 consecutive patients with 1,382 lesions treated only with CoCr-EES were analyzed. Patients and lesions were divided into tertile group: TSL per patient (TSL-P) (PA [8-23 mm], n = 382; PB [23-46 mm], n = 312; and PC [46-204 mm], n = 313), and TSL per lesion (TSL-L) (LA [8-18 mm], n = 486; LB [18-28 mm], n = 475; and LC [28-140 mm], n = 421). The cumulative 3-year incidence of clinically driven target-lesion revascularization (CD-TLR) and definite stent thrombosis (ST) based on TSL-P and TSL-L groupings were accessed.. After inverse probability of weighted adjustment, the cumulative 3-year incidence of CD-TLR for the TSL-P and TSL-L were higher in the PC and LC groups than in the other groups (hazard ratio [HR] 2.92, 95% confidence intervals [CI] 1.66-5.15, P < 0.001 vs. PA; HR 2.49, 95% CI 1.47-4.20, P < 0.001 vs. PB; HR 1.94, 95% CI 1.15-3.28, P = 0.01 vs. LA; HR 2.80, 95% CI 1.73-4.54, P < 0.001 vs. LB, respectively). No significant differences in the cumulative 3-year incidence of definite ST were observed in both TSL-P and TSL-L groups.. TSL after CoCr-EES implantation has significantly impact on CD-TLR rate through 3 years, but it is not associated with an increased incidence of definite ST. © 2016 Wiley Periodicals, Inc.

Topics: Aged; Aged, 80 and over; Cardiovascular Agents; Chromium Alloys; Coronary Artery Disease; Coronary Thrombosis; Drug-Eluting Stents; Everolimus; Female; Humans; Incidence; Japan; Kaplan-Meier Estimate; Male; Middle Aged; Myocardial Infarction; Percutaneous Coronary Intervention; Proportional Hazards Models; Prosthesis Design; Retrospective Studies; Risk Factors; Time Factors; Treatment Outcome

Objective Age screening and preventive medication for future myocardial infarction and stroke has been previously described. We aimed to ascertain whether different age cut-offs are needed for males and females. Methods We determined five parameters for each sex according to age cut-off: detection rate (sensitivity), false-positive rate, proportion of the population eligible for treatment with a polypill, proportion who benefit from taking a polypill (simvastatin 20 mg, losartan 25 mg, hydrochlorothiazide 12.5 mg, amlodipine 2.5 mg), and among these, years of life gained without a first myocardial infarction or stroke. Results Approximately one-third benefit, regardless of the age cut-off. For males and females combined, using ages 40 and 80, the detection rates are 98% and 52%, false-positive rates are 51% and 7%, population percentages eligible for treatment are 52% and 7%, and years of life gained without a first myocardial infarction or stroke are 8.4 and 3.6. Using age 50, detection rates are 93% (males) 98% (females), false-positive rates 37% (males) 40% (females), percentage of the population eligible for treatment 38% (males) 41% (females), percentage who benefit 35% (males) 33% (females), and years of life gained without an event 8.5 (males) 7.0 (females). At a given age cut-off, the sex differences are relatively small. Conclusion A single age cut-off can be used for both sexes.

Topics: Adult; Age Factors; Aged; Cardiovascular Agents; Drug Combinations; Female; Humans; Hydrochlorothiazide; Losartan; Male; Middle Aged; Myocardial Infarction; Preventive Health Services; Simvastatin; State Medicine; Stroke; United Kingdom

The aims of this study were to evaluate clinical outcomes following PCI using SeQuent Please paclitaxel-coated balloons (PCB) of ISR and denovo lesions (DNL), in all-comer patients at Liverpool Hospital, Sydney, Australia.. There have been promising results for PCI using drug-coated balloons; however, long-term data for clinical outcomes are lacking.. Baseline patient demographics, PCI procedural details, and clinical outcomes were collected. The primary endpoint was the incidence of MACE, a composite of cardiac death, myocardial infarction (MI), and clinical-driven target lesion restenosis (TLR). The median follow-up for clinical events was 1.3 [0.6-1.9] years.. A total of 188 lesions (n = 147 patients) were treated with PCB, comprising 118 (63%) ISR lesions and 70 (38%) DNL. Patient mean age was 67 ± 11years, 79% were male, and 54% had type 2 diabetes mellitus (DM). MACE was recorded in 17 patients (12%), with cardiac death confirmed in 1 patient (0.7%). MACE was significantly lower for DNL than ISR (1% vs. 15%, P = 0.03), and PCB had favourable TLR for DNL. Cox regression demonstrated that DM (HR 7.17, 0.92-55.6, P = 0.05) and prior CABG (HR 3.22, 1.17-8.83, P = 0.02) were independent predictors of MACE for ISR lesions.. MACE rates were acceptable, with overall low incidence of cardiac death, MI, and TLR, for PCB treatment of ISR and DNL. Independent predictors of poor outcome in the ISR group were DM and prior CABG. The particularly low MACE for the DNL group supports direct PCB as a viable stent-sparing PCI strategy in challenging patients and lesion subsets. © 2016 Wiley Periodicals, Inc.

Topics: Aged; Aged, 80 and over; Angioplasty, Balloon, Coronary; Cardiac Catheters; Cardiovascular Agents; Chi-Square Distribution; Coated Materials, Biocompatible; Coronary Angiography; Coronary Restenosis; Female; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Myocardial Infarction; New South Wales; Paclitaxel; Percutaneous Coronary Intervention; Proportional Hazards Models; Registries; Retreatment; Retrospective Studies; Risk Factors; Stents; Time Factors; Treatment Outcome

It has become apparent that, in comparison to metallic stents, bioresorbable vascular scaffolds (BVS) require specific implantation techniques. The aim of this study was to investigate outcomes following BVS implantation using a dedicated strategy for optimal deployment.. Four hundred consecutive lesions (264 patients) treated with the Absorb BVS were analysed. All procedures were performed based on the following principles: 1) aggressive lesion preparation; 2) high-pressure post-dilation; and 3) a low threshold for intravascular imaging. The majority of target lesions (74.8%) were type B2 or C lesions. Predilation (97.3%) and post-dilation (99.8%) were performed in almost all cases. The mean post-dilation pressure was 21±5 atm, and the total scaffold length per patient was 53.2±32.5 mm. Intravascular imaging was performed in the majority of cases (85.8%) and, when utilised after post-dilatation, a further intervention was required in 24.5% of lesions. The cumulative target lesion failure rates were 7.9% at one year and 11.6% at two years. Definite/probable scaffold thrombosis occurred in three patients (1.2% at one and two years).. Clinical outcomes following implantation of current-generation BVS, in a real-world population with a high prevalence of complex lesions, were acceptable when utilising our optimised implantation strategy.

Topics: Absorbable Implants; Adult; Aged; Aged, 80 and over; Cardiovascular Agents; Cohort Studies; Coronary Artery Disease; Drug-Eluting Stents; Female; Humans; Male; Middle Aged; Myocardial Infarction; Percutaneous Coronary Intervention; Prosthesis Design; Sirolimus; Treatment Outcome

Topics: Cardiovascular Agents; Coronary Disease; Humans; Myocardial Infarction; Prognosis

Calcium channel blockers diltiazem and nitrate have been used as selective coronary vasodilators for patients with significant coronary artery spasm (CAS). However, no study has compared the efficacy of diltiazem alone versus diltiazem with nitrate for long-term clinical outcomes in patients with CAS.. A total of 2741 consecutive patients without significant coronary artery disease with positive CAS by acetylcholine (Ach) provocation test between November 2004 and May 2014 were enrolled. Significant CAS was defined as a narrowing of >70% by incremental intracoronary injection of 20, 50, and 100 μg of Ach into the left coronary artery. Patients were assigned to either the diltiazem group (n=842) or the dual group (diltiazem with nitrate, n=1899) at physician discretion. To adjust for potential confounders, a propensity score matching (PSM) analysis was performed using the logistic regression model. After PSM analysis, two well-balanced groups (811 pairs, n=1622, C-statistic=0.708) were generated.. At 5 years, there were similar incidences in primary endpoints, including mortality, myocardial infarction, revascularization, and recurrent angina requiring repeat coronary angiography between the two groups. Diltiazem alone was not an independent predictor for major adverse cardiovascular events or recurrent angina requiring repeat coronary angiography.. Despite the expected improvement of endothelial function and the relief of CAS, the combination of diltiazem and nitrate treatment was not superior to diltiazem alone in reducing mortality and cardiovascular events up to 5 years in patients with significant CAS.

Topics: Acetylcholine; Aged; Angina Pectoris; Calcium Channel Blockers; Cardiovascular Agents; Coronary Angiography; Coronary Artery Disease; Coronary Vasospasm; Diltiazem; Drug Therapy, Combination; Female; Humans; Incidence; Male; Middle Aged; Myocardial Infarction; Nitrates; Propensity Score; Time Factors; Vasodilator Agents

The preconditioning-like infarct-sparing and anti-inflammatory effects of the peptide hormone relaxin following ischemic injury have been studied in the heart. Whether reperfusion therapy with recombinant human relaxin-2, serelaxin, reduces myocardial infarct size and attenuates the subsequent NLRP3 inflammasome activation leading to further loss of functional myocardium following ischemia/reperfusion (I/R) injury is unknown.. After baseline echocardiography, adult male wild-type C57BL or eNOS knockout mice underwent myocardial infarction (MI) by coronary artery ligation for 30 min followed by 24 h reperfusion. Mice were treated with either serelaxin (10 µg/kg; sc) or saline 1 h prior to ischemia or 5 min before reperfusion. In both pre-treatment and reperfusion therapy arms, serelaxin improved survival at 24 h post MI in wild-type mice (79% and 82%) as compared with controls (46% and 50%, P = 0.01), whereas there was no difference in survival between serelaxin- and saline-treated eNOS knockout mice. Moreover, serelaxin significantly reduced infarct size (64% and 67% reduction, P < 0.05), measured with TTC staining, and preserved LV fractional shortening (FS) and end-systolic diameter (LVESD) in wild-type mice as compared with controls (P < 0.05). Interestingly, caspase-1 activity in the heart tissue, a measure of inflammasome formation, was markedly reduced in serelaxin-treated wild-type mice compared with controls at 24 h post-MI in both treatment modalities (P < 0.05). Genetic deletion of eNOS abolished the infarct-sparing and anti-inflammatory effects of serelaxin as well as functional preservation. Serelaxin plasma levels assessed at 5 min and 1 h after treatment, using ELISA, approximated physiologic relaxin levels during pregnancy in mice and parallels that in humans.. Serelaxin attenuates myocardial I/R injury and the subsequent caspase-1 activation via eNOS-dependent mechanism.

Topics: Animals; Cardiovascular Agents; Caspase 1; Cells, Cultured; Disease Models, Animal; Inflammasomes; Male; Mice, Inbred C57BL; Mice, Knockout; Myocardial Infarction; Myocardial Reperfusion; Myocardial Reperfusion Injury; Myocardium; Nitric Oxide Synthase Type III; Nitrites; NLR Family, Pyrin Domain-Containing 3 Protein; Rats; Receptors, G-Protein-Coupled; Recombinant Proteins; Relaxin; Signal Transduction; Time Factors; Ventricular Function, Left

The present study was aimed to determine the efficacy of nicorandil in treating cardiac reperfusion injury with an underlying co-morbidity of vascular calcification (VC). Adenine diet was used to induce VC in Wistar rat and the heart was isolated to induce global ischemia reperfusion (IR) by Langendorff method, with and without the nicorandil (7.5mg/kg) pre-treatment and compared with those fed on normal diet. The adenine-treated rats displayed abnormal ECG changes and altered mitochondrial integrity compared to a normal rat heart. These hearts, when subjected to IR increased the infarct size, cardiac injury (measured by lactate dehydrogenase and creatine kinase activity in the coronary perfusate) and significantly altered the hemodynamics compared to the normal perfused heart. Nicorandil pretreatment in rat fed on normal diet enhanced the hemodynamics significantly (P<0.05) along with a substantial reduction in the mitochondrial dysfunction (measured by high ADP to oxygen consumption ratio, respiratory control ratio, enzyme activities and less swelling behavior) when subjected to IR. However, this cardio-protective effect of nicorandil was absent in rat heart with underlying calcification. Our results suggest that, the protective effect of nicorandil, a known mitochondrial ATP linked K

Topics: Animals; Biomarkers; Cardiovascular Agents; Cytoprotection; Disease Models, Animal; Energy Metabolism; Hemodynamics; Isolated Heart Preparation; Lipid Peroxidation; Male; Mitochondria, Heart; Myocardial Infarction; Myocardial Reperfusion Injury; Myocytes, Cardiac; Nicorandil; Oxidative Stress; Potassium Channels; Rats, Wistar; Vascular Calcification

The authors evaluated the 5-year cumulative incidence of cardiovascular events following Resolute zotarolimus-eluting stent (R-ZES) implantation.. Individual trials are often underpowered to show differences for low-frequency adverse events. The R-ZES was studied in 10 prospective clinical trials, designed with identical adverse event definitions, ascertainment, and adjudication.. The RESOLUTE Global Clinical Trial Program includes 7,618 patients treated with R-ZES: RESOLUTE first-in-human study (N = 139), RESOLUTE All Comers (N = 1,140), RESOLUTE International (N = 2,349), RESOLUTE US (N = 1,402), RESOLUTE US 38 mm (N = 114), RESOLUTE Japan (N = 100), RESOLUTE Japan Small Vessel Study (N = 65), RESOLUTE Asia (N = 311), RESOLUTE China Randomized Controlled Trial (N = 198), and RESOLUTE China Registry (N = 1,800). The 5-year cumulative incidence of events was calculated.. The 5-year cumulative incidence of cardiac events was 13.4% for target lesion failure and included 5.0% cardiac death, 4.4% target vessel myocardial infarction, and 6.3% clinically driven target lesion revascularization. Dual-antiplatelet therapy at 1, 3, and 5 years was 91%, 37%, and 32%, respectively. The 5-year cumulative incidence of definite or probable stent thrombosis was 1.2%, which comprised 0.7% at 1 year and an annualized rate of 0.1% thereafter. Five-year use of dual-antiplatelet therapy varied geographically from 63% in Japan to 11% in Europe.. In the largest group of R-ZES patients examined to date, the majority of stent-related events, including target vessel myocardial infarction and stent thrombosis, occurred within the first year of implantation with much lower risks of these events out to 5 years.

Topics: Aged; Asia; Australia; Cardiovascular Agents; Clinical Trials as Topic; Coronary Artery Disease; Coronary Thrombosis; Drug Therapy, Combination; Drug-Eluting Stents; Europe; Evidence-Based Medicine; Female; Humans; Incidence; Kaplan-Meier Estimate; Male; Middle Aged; Myocardial Infarction; North America; Percutaneous Coronary Intervention; Platelet Aggregation Inhibitors; Prosthesis Design; Risk Factors; Sirolimus; South America; Time Factors; Treatment Outcome

The safety and efficacy of the second-generation biodegradable polymer Cobalt-Chromium sirolimus-eluting stent (EXCEL2) in daily clinical practice remains unknown. Additionally, to meet the China Food and Drug Administration requirements, we conducted an objective performance criterion study from the CREDIT II and CREDIT III trials.. CREDIT II was a randomized trial comparing the EXCEL2 versus EXCEL stent in patients with up to 2 de novo coronary lesions. CREDIT III was a prospective, single-arm study evaluating the efficacy and safety of EXCEL2 in broad types of de novo coronary artery lesions. This pooled analysis included patients in the CREDIT III and EXCEL2 arm of the CREDIT II trial. The primary outcome was 12-month target lesion failure (TLF), a composite of cardiac death, target vessel myocardial infarction (TV-MI), and clinical indicated target lesion revascularization (CI-TLR). The patient-oriented composite endpoint (PoCE) of all-cause death, all MI, or any revascularization was also analyzed.. A total of 833 patients were included, consisting of 625 in the CREDIT III trial and 208 in the EXCEL2 arm of the CREDIT II trial. Twelve-month TLF occurred in 6.1% patients, cardiac death in 0.4%, TV-MI in 5%, and CI-TLR in 1.1%. Additionally, 64 (7.7%) PoCE and 3 probable late stent thromboses (0.4%) were recorded.. EXCEL2 stent met the objective performance criterion on efficacy and safety with a low level of 12-month TLF as well as stent thrombosis when treating patients with de novo coronary lesions. © 2017 Wiley Periodicals, Inc.

Topics: Absorbable Implants; Adult; Aged; Cardiovascular Agents; China; Chromium Alloys; Coronary Artery Disease; Coronary Thrombosis; Drug-Eluting Stents; Female; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Myocardial Infarction; Percutaneous Coronary Intervention; Polymers; Proportional Hazards Models; Prosthesis Design; Randomized Controlled Trials as Topic; Registries; Risk Factors; Sirolimus; Time Factors; Treatment Outcome

To compare the 1-year outcomes of a durable polymer Zotarolimus-eluting stent (ZES) versus a biodegradable polymer Biolimus-eluting stent (BES) in patients undergoing percutaneous coronary intervention.. A total of 2083 patients from 2 different registries, 1125 treated with BES in NOBORI registry and 858 received ZES in CONSTANT registry were included in this study. Clinical outcomes were compared with the use of propensity score matching (PSM). The primary endpoint was a composite of major adverse cardiovascular and cerebrovascular events (MACCEs) including cardiac death, myocardial infarction, clinically driven target lesion revascularization and stroke. Secondary end points were individual components of MACCEs as well as the incidence of stent thrombosis at 1-year follow-up.. After PSM, 699 matched pairs of patients (n=1398) showed no significant difference between BES and ZES in the risk of composite MACCEs at 1 year (2.6% vs. 1.7%; p=0.36). Cardiac death was not statistically different between groups (0.7% vs. 0.4%, p=0.73). Target lesion revascularization rate was also similar between BES and ZES (1.1% vs. 0.7%, p=0.579). Non-Q wave myocardial infarction, as well as target-vessel revascularization rate, was similar between the two groups (0.14% for BES and 0.72% for ZES). Both stent types were excellent with no cases of stent thrombosis and rate of Q wave myocardial infarction reported during the follow-up period.. In this cohort of patients treated with BES or ZES, the rate of MACCEs at 1 year was low and significantly not different between both groups.

Topics: Absorbable Implants; Aged; Cardiovascular Agents; Coronary Artery Disease; Drug-Eluting Stents; Female; Humans; Middle Aged; Myocardial Infarction; Percutaneous Coronary Intervention; Polymers; Propensity Score; Registries; Sirolimus; Time Factors; Treatment Outcome

The success of drug-coated balloon therapy might be compromised by intraprocedural particulate embolisation of matrix coating, which may cause downstream microvascular obstruction. We aimed to investigate whether drug-coated balloon therapy was associated with an increase in markers of myocardial necrosis compared with drug-eluting stents or plain balloon angioplasty.. In the ISAR-DESIRE-3 trial, patients with limus-eluting stent restenosis were randomised to treatment with a paclitaxel-coated balloon (PCB), paclitaxel-eluting stent (PES) or balloon angioplasty. We included enrolled patients who had pre- and post-intervention high-sensitivity troponin (hs-TnT) levels available. The delta (peak post-procedure minus baseline) troponin was compared between treatment arms. The association between delta troponin tertiles and three-year mortality was also evaluated. Three hundred and forty-three (343) patients were included, comprising patients treated with PCB (n=115), PES (n=112) and balloon angioplasty (n=116). Groups were well matched in terms of baseline characteristics. There was no difference in delta troponin in patients treated with PCB, PES and balloon angioplasty (36±65, 70±183, and 51±124 ng/L, respectively, p=0.16). Three-year mortality was 7.7%, 8.8% and 14.3% for the 1st, 2nd and 3rd tertiles of delta troponin, respectively, p=0.23.. In patients with drug-eluting stent restenosis, there was no difference in subclinical myocardial necrosis among patients treated with PCB, PES, and balloon angioplasty.

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Angiography; Coronary Restenosis; Drug-Eluting Stents; Female; Humans; Male; Middle Aged; Myocardial Infarction; Percutaneous Coronary Intervention; Treatment Outcome

Many cardioprotective pharmacological agents failed to exert their protective effects in diabetic hearts subjected to myocardial ischemia/reperfusion (MI/R). Identify the molecular basis linking diabetes with MI/R injury is scientifically important and may provide effective therapeutic approaches. Dynamin-related protein 1 (Drp1)-mediated mitochondrial fission plays an important role in MI/R injury under non-diabetic conditions. Importantly, recent studies indicated that Drp1-mediated mitochondrial fission is enhanced in the myocardium of diabetic mice. The above evidences suggested that Drp1 may be one critical molecule linking diabetes with MI/R injury. We hypothesized that inhibition of Drp1 may be effective to reduce MI/R injury in diabetic hearts.. High-fat diet and streptozotocin-induced diabetic mice were subjected to MI/R or sham operation. Mdivi-1 (1.2 mg/kg), a small molecule inhibitor of Drp1 or vehicle was administrated 15 min before the onset of reperfusion. Outcome measures included mitochondrial morphology, mitochondrial function, myocardial injury, cardiac function and oxidative stress.. Mitochondrial fission was significantly increased following MI/R as evidenced by enhanced translocation of Drp1 to mitochondria and decreased mitochondrial size. Delivery of Mdivi-1 into diabetic mice markedly inhibited Drp1 translocation to the mitochondria and reduced mitochondrial fission following MI/R. Inhibition of Drp1 in diabetic hearts improved mitochondrial function and cardiac function following MI/R. Moreover, inhibition of Drp1 reduced myocardial infarct size and serum cardiac troponin I and lactate dehydrogenase activities. These cardioprotective effects were associated with decreased cardiomyocyte apoptosis and malondialdehyde production and increased activities of antioxidant enzyme manganese superoxide dismutase.. Pharmacological inhibition of Drp1 prevents mitochondrial fission and reduces MI/R injury in diabetic mice. The findings suggest Drp1 may be a potential novel therapeutic target for diabetic cardiac complications.

Topics: Animals; Apoptosis; Cardiovascular Agents; Diabetes Mellitus, Experimental; Diet, High-Fat; Dynamins; L-Lactate Dehydrogenase; Male; Malondialdehyde; Mice, Inbred C57BL; Mitochondria, Heart; Mitochondrial Dynamics; Myocardial Infarction; Myocardial Reperfusion Injury; Myocytes, Cardiac; Oxidative Stress; Quinazolinones; Signal Transduction; Streptozocin; Superoxide Dismutase; Troponin I

The area of myocardial infarction continues to expand for hours after reperfusion. The injured but viable myocardium may be salvaged if the signals leading to cell death are interrupted. Activation of the caspase-1 inflammasome in the heart shortly after ischemia-reperfusion contributes to the final infarct size. Plasma-derived α-1 anti-trypsin (AAT) has shown to inhibit inflammasome formation in vitro and in vivo. To explore the potential translational clinical value of AAT as a therapeutic, we conducted a series of preclinical experiments designed to simulate clinically relevant scenarios.. Adult male CD1 mice were used. The left anterior descending coronary artery was ligated for 30 or 75 minutes followed by reperfusion, to explore different severity of ischemic injury. Plasma-derived AAT (Prolastin C) was administered intraperitoneally after reperfusion, without pretreatment, exploring 3 different doses (60, 120, and 180 mg/kg). In a subgroup of mice, we administered Prolastin C with a delay of 30 minutes after reperfusion to simulate the clinical context of delayed administration, and we also used a model of permanent coronary artery ligation without reperfusion. Finally, we tested whether a single dose at reperfusion was sufficient to maintain a benefit in the longer term (7 days). Infarct size was measured by 3 different and independent methodologies: pathology, plasma levels of troponin I, and wall motion abnormalities at echocardiography.. Prolastin C given at reperfusion after 30 minutes of ischemia provided a powerful reduction in infarct size (>50% reduction in all methodology used, all P < 0.01) without a clear dose-dependent response. Prolongation of ischemia to 75 minutes nor a delay in treatment by 30 minutes after reperfusion had any negative impact on Prolastin C effects. A single dose given at reperfusion was as effective as multiple daily doses. When given to the mouse without reperfusion, Prolastin C failed to reduce infarct size.. Plasma-derived AAT (Prolastin C) given as an adjunct to reperfusion powerfully limits the final infarct size across a wide range of experiments in the mouse reproducing clinically relevant scenarios, such as variable duration of ischemia, delay in administration in the drug, and a large therapeutic index.

Topics: alpha 1-Antitrypsin; Animals; Cardiovascular Agents; Cytoprotection; Disease Models, Animal; Drug Administration Schedule; Male; Mice; Myocardial Infarction; Myocardial Reperfusion Injury; Myocardium; Time Factors; Tissue Survival; Troponin I; Ventricular Function, Left

The purpose of this study was to compare the 1-year outcome of everolimus-eluting bioresorbable scaffolds (eBRS) and Novolimus-eluting bioresorbable scaffolds (nBRS) in patients undergoing percutaneous coronary intervention in a real-life clinical practice scenario.. eBRS and nBRS are available and have been proved safe for coronary artery stenting in well-selected patients.. Consecutive patients who underwent bioresorbable scaffold implantation were evaluated retrospectively via 2:1 propensity matching. Target lesion failure comprising cardiac death, target vessel myocardial infarction, and target lesion revascularization was examined after 12 months, along with its individual components as well as scaffold thrombosis.. A total 506 patients were available for matching. Of these, 212 eBRS patients (mean age = 62.9 years) and 106 nBRS patients (mean age = 63.1 years) were analyzed after matching. Baseline characteristics and clinical presentation were comparable in both groups. Acute coronary syndromes were present in 53.3% of the eBRS group and in 48.1% of the nBRS group (p = 0.383). Lesion characteristics were also similar. Pre-dilation (99.5% vs. 98.1%; p = 0.218) and post-dilation (84.4% vs. 86.8%; p = 0.576) were performed in the same proportion of matched eBRS and nBRS patients, respectively. The 1-year rates of target lesion failure (4.7% vs. 4.5%; p = 0.851), target lesion revascularization (2.6% vs. 3.5%; p = 0.768), cardiac death (1.5% vs. 2.0%; p = 0.752), and definite scaffold thrombosis (2.0% vs. 1.0%; p = 0.529) did not differ significantly between the eBRS and nBRS groups.. The present study reveals comparable clinical results for the 2 types of bioresorbable scaffolds when used during routine practice, but further evidence from randomized controlled trials is needed.

Topics: Absorbable Implants; Acute Coronary Syndrome; Aged; Cardiovascular Agents; Coated Materials, Biocompatible; Coronary Artery Disease; Coronary Thrombosis; Everolimus; Female; Humans; Kaplan-Meier Estimate; Macrolides; Male; Matched-Pair Analysis; Middle Aged; Myocardial Infarction; Percutaneous Coronary Intervention; Prosthesis Design; Registries; Risk Factors; Time Factors; Treatment Outcome

This study explored Bacopa monnieri, a medicinal Ayurvedic herb, as a cardioprotectant against ischemia/reperfusion injury using cardiac function and coronary flow as end-points.. In normal isolated rat hearts, coronary flow, left ventricular developed pressure, heart rate, and functional recovery were measured using the Langendorff preparation. Hearts were perfused with either (i) Krebs-Henseleit (normal) solution, (control), or with 30, 100 μg/ml B. monnieri ethanolic extract (30 min), or (ii) with normal solution or extract for 10 min preceding no-perfusion ischemia (30 min) followed by reperfusion (30 min) with normal solution. Infarct volumes were measured by triphenyltetrazolium staining. L-type Ca. B. monnieri improves myocardial function following ischemia/reperfusion injury through recovery of coronary blood flow, contractile force and decrease in infarct size. Thus this may lead to a novel cardioprotectant strategy.

Topics: Animals; Bacopa; Cardiovascular Agents; Coronary Vessels; Heart; Heart Rate; Heart Ventricles; In Vitro Techniques; Male; Myocardial Infarction; Myocardial Reperfusion Injury; Myocardium; Phytotherapy; Plant Extracts; Protective Agents; Rats, Wistar; Regional Blood Flow; Ventricular Pressure

The authors sought to investigate 1-year outcomes in patients treated with bioresorbable everolimus-eluting vascular scaffolds (BVS) for "long coronary lesions.". The present substudy derived from the GHOST-EU registry included 1,722 lesions in 1,468 consecutive patients, enrolled between November 2011 and September 2014 at 11 European centers.. The lesions were divided into 3 groups according to continuous BVS length: 1) shorter than 30 mm; 2) between 30 and 60 mm; and 3) longer than 60 mm. Primary device-oriented endpoint (target lesion failure [TLF]) was defined as a combination of cardiovascular death, target vessel myocardial infarction, or clinically driven target lesion revascularization.. Patients with lesions ≥60 mm had more comorbidities and more complex lesion characteristics, including chronic total occlusions (37%), bifurcation lesions (40.3%), higher Syntax score (16.4 ± 7.8), and higher number of scaffolds implanted per lesion (3.3 ± 0.9 mm). The main target vessel was the left anterior coronary artery in all groups. Median follow-up was 384 (interquartile range: 359 to 459) days. One-year follow-up was completed in 70.3% of patients. TLF at 1 year was significantly higher in group C (group A 4.8%, group B 4.5%, group C 14.3%; overall p = 0.001), whereas there were no significant differences between groups A and B. Finally, a numerically higher (but not statistically significant) number of scaffold thromboses were observed in group C when compared with shorter lesions (group A 2.1%, group B 1.1%, group C 3.8%; overall p = 0.29).. In a real-world setting, treatment of long coronary lesions with BVS ≥60 mm was associated with a higher TLF rate, driven by myocardial infarction and clinically driven target lesion revascularization.

Topics: Absorbable Implants; Aged; Cardiovascular Agents; Coated Materials, Biocompatible; Coronary Angiography; Coronary Artery Disease; Coronary Thrombosis; Europe; Everolimus; Female; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Myocardial Infarction; Percutaneous Coronary Intervention; Proportional Hazards Models; Prosthesis Design; Registries; Retrospective Studies; Risk Factors; Time Factors; Treatment Outcome

Immediately after stent/scaffold implantation, quantitative coronary angiography (QCA) in comparison to optical coherence tomography (OCT) more severely underestimates the lumen diameter (LD) in Absorb than in XIENCE. This OCT-QCA discrepancy has not been evaluated at long-term follow-up. The present study aimed to assess the accuracy of QCA with reference to OCT in Absorb as compared to XIENCE.. We assessed two-year QCA and OCT in the ABSORB Japan randomised trial (Absorb n=87, XIENCE n=44). The accuracy of QCA parameters was assessed with reference to OCT measurements. OCT-QCA luminal dimensions were compared in matched cross-sections at both edges of the scaffolds (n=127) and stents (n=78). OCT-QCA late lumen loss (LLL) was also assessed using the Bland-Altman method. The systematic error of LD on QCA in Absorb was -0.092 mm (relative difference -3.3%) with a random error of 0.473 mm, whereas in XIENCE the systematic error was -0.018 mm (-0.5%) with a random error of 0.477 mm. These OCT-QCA discrepancies did not differ between Absorb and XIENCE (p=0.275) at two-year follow-up. QCA tended to underestimate LLL more in Absorb than in XIENCE (QCA-LLL minus OCT-LLL: -0.180±0.308 mm vs. -0.058±0.322 mm, p=0.058) at two-year follow-up, although this comparison was not statistically powered.. The two-year dimensional measurements on QCA had minor and insignificant systematic errors between both devices. A discrepancy between QCA-LLL and OCT-LLL would raise a question as to whether this parameter is appropriate for the comparative assessment of device performance.

Topics: Absorbable Implants; Cardiovascular Agents; Chromium; Cobalt; Coronary Angiography; Coronary Artery Disease; Drug-Eluting Stents; Everolimus; Female; Humans; Middle Aged; Myocardial Infarction; Percutaneous Coronary Intervention; Sirolimus

Previous studies have indicated that the Ilex genus exhibits antioxidant, neuroprotective, hepatoprotective, and anti-inflammatory activities. However, the pharmacologic action and mechanisms of Ilex cornuta against cardiac diseases have not yet been explored. The present study was designed to investigate the antioxidant and cardioprotective effects of Ilex cornuta root with in vitro and in vivo models. The anti-oxidative effects of the extract of Ilex cornuta root (ICR) were measured by 2, 2-diphenyl-1-picrylhydrazyl (DPPH) free-radical scavenging and MTT assays as well as immunoassay. Furthermore, a rat model of myocardial ischemia was established to investigate the cardioprotective effect of ICR in vivo. Eight compounds were isolated and identified from ICR and exhibited DPPH free-radical scavenging activities. They also could increase cell viability and inhibit morphological changes induced by H

Topics: Animals; Antioxidants; Apoptosis; Cardiovascular Agents; Cell Survival; Hydrogen Peroxide; Ilex; Malondialdehyde; Myocardial Infarction; Myocardial Ischemia; Myocardium; Myocytes, Cardiac; Oxidative Stress; Phytotherapy; Plant Extracts; Plant Roots; Rats, Sprague-Dawley; Reactive Oxygen Species; Superoxide Dismutase

The objective of this study was to clarify the incidence and predictors of early and late target lesion revascularization (TLR) after everolimus-eluting stent (EES) implantation in actual clinical practice.. Several clinical studies have reported the incidence and predictors of TLR after EES implantation. However, detailed features of early and late TLR are unknown.. We analyzed the clinical data of patients who underwent EES implantation between January 2010 and December 2011 at 22 institutions in Japan (Tokyo-MD PCI study). Patients who underwent ischemia-driven TLR (ID-TLR) were grouped according to the number of years elapsed since stent placement, and incidence and correlations between clinical factors were analyzed.. Statistical analysis was performed for 1,899 patients and 2,305 lesions. The mean age was 70.0 ± 9.9 years, and the median follow-up period was 1,281 days (IQR: 762-1,440 days). The incidence of ID-TLR was 2.7% at 1 year and 5.4% at 4 years. After 2 years, the ID-TLR rates plateaued. The independent predictors of ID-TLR occurring within 2 years were hemodialysis, triple vessel disease, restenotic lesion, and ostial lesions. The independent predictors of ID-TLR between 2 and 4 years were diabetes mellitus and peripheral artery disease.. The ID-TLR rates leveled off after 2 years. Furthermore, the predictors of ID-TLR that occurred within 2 years of EES implantation differed from those that occurred later than 2 years. © 2017 Wiley Periodicals, Inc.

Topics: Aged; Cardiovascular Agents; Coronary Artery Disease; Coronary Restenosis; Drug-Eluting Stents; Everolimus; Female; Humans; Incidence; Kaplan-Meier Estimate; Male; Middle Aged; Myocardial Infarction; Percutaneous Coronary Intervention; Proportional Hazards Models; Prosthesis Design; Retrospective Studies; Risk Factors; Time Factors; Tokyo; Treatment Outcome

Interruption of blood supply to the heart results in acute myocardial infarction (AMI), and further damages the heart muscles. Available drugs for the treatment MI have one or other side effects, and there is a need for development of better alternative drugs from herbal sources. Here, we evaluated cardioprotective effect of Cyperus rotundus on isoprenaline- induced myocardial infarction. Thirty five Wistar rats, aged 60-100 days with body wt. 150-200 g, pretreated with ethanolic extract of Cyperus rotundus L. (@ 250 and 500 mg/kg body wt.) orally before induction of myocardial necrosis by administrating isoprenaline (85 mg/kg, s.c.) on 19th and 20th day of the pretreatment period. The treated rats were examined for gross functioning of heart, heart weight/body wt. Ratio, and also observed histopathologically. Further, activities of various cardiac enzymes such as aspartate transaminase, alanine transaminase, creatinine kinase-myoglobulin, lactate dehydrogenase, and the gold marker troponin-I were also determined. The levels altered by isoproterenol were found to be restored significantly by the test extracts especially at higher dose. Biochemical observations viz., serum ALT (P <0.0001), AST (P <0.0001), creatine kinase-myoglobulin (CK-MB) (P <0.0001), LDH (P <0.0001) demonstrated significant cardioprotective activity of the ethanolic extract of C. rotundus (500 mg/kg body wt.), against isoprenaline induced myocardial infarction. These results were also substantiated by physical parameters and histopathological observations. All these results were comparable with that of two standard drugs metoprolol (10 mg/kg/day), ramipril (3 mg/kg/day) as well as polyherbal formulation Abana (50 mg/kg/day).

Topics: Adrenergic beta-1 Receptor Antagonists; Angiotensin-Converting Enzyme Inhibitors; Animals; Biomarkers; Cardiotoxicity; Cardiovascular Agents; Cyperus; Cytoprotection; Disease Models, Animal; Ethanol; Isoproterenol; Male; Metoprolol; Myocardial Infarction; Myocardium; Necrosis; Phytotherapy; Plant Extracts; Plants, Medicinal; Ramipril; Rats, Wistar; Rhizome; Solvents

To evaluate the rate of clinical events and bleeding risk according to age in patients undergoing percutaneous coronary intervention (PCI) with a new-generation drug-eluting stent (DES) enrolled in the RESOLUTE Global Clinical Program.. This study represents a pooled analysis of five trials included in the RESOLUTE program including 5,130 patients, of whom 1,675 (32.6%) were ≥70 years old (elderly patients).. After adjusting for confounders, age ≥70 years was a significant predictor of high mortality at 30 days (0.6 vs. 0.1%, P = 0.017) and 2 years (7.2 vs. 2%, P < 0.001). No differences were seen with respect to acute myocardial infarction (MI) or target lesion and vessel revascularization rates between young and elderly patients. Bleeding rates were higher in the elderly throughout follow-up. In the elderly, 7 of the 27 (26%) patients with bleeding episodes died, with a median time between bleeding episode to death of 21 days. In the younger population, 1 patient of 17 with a bleeding episode died (400 days later).. Elderly patients undergoing PCI with a new-generation DES have increased mortality and bleeding risk, with similar rates of acute MI and repeat revascularization. Bleeding risk was higher in the elderly and strongly related to death. Target lesion failure rates were not significantly different between the two age groups, suggesting that the Resolute zotarolimus-eluting stent (R-ZES) is effective for patients younger and older than 70 years of age. R-ZES may be recommended for elderly patients when PCI with a DES is identified as a suitable option.

Topics: Age Factors; Aged; Aged, 80 and over; Cardiovascular Agents; Coronary Artery Disease; Drug-Eluting Stents; Female; Hemorrhage; Humans; Kaplan-Meier Estimate; Logistic Models; Male; Middle Aged; Multivariate Analysis; Myocardial Infarction; Observational Studies as Topic; Percutaneous Coronary Intervention; Prosthesis Design; Randomized Controlled Trials as Topic; Risk Factors; Sirolimus; Time Factors; Treatment Outcome

To report clinical outcomes in patients treated with drug-eluting balloon (DEB) versus second-generation drug-eluting stent (DES) for in-stent restenosis (ISR) involving a bifurcation lesion.. Between February 2007 and November 2012, 167 bifurcation restenoses in 158 patients were treated with either DEB (n=73) or second-generation DES (n=85). The EuroSCORE was significantly higher in the DEB group (4.2±3.8 vs. 2.8±2.1, p=0.004). Regarding restenosed stent type, second-generation DES was more frequently seen in the DEB group (26.9% vs. 6.7%, p<0.001). In this group, there was also a trend towards more frequent stenting for a previous ISR (stent-in-stent) as compared with the DES group (25.6% vs. 15.6%, p=0.074). Over a median follow-up period of 701 days, there was no significant difference in major adverse cardiac events (MACE), defined as cardiac death, myocardial infarction including periprocedural myocardial infarction, target vessel revascularisation, between the two groups (p=0.585). Independent predictors of MACE on multivariate Cox regression analysis included stent-in-stent (HR: 2.16; 95% CI: 1.11 to 4.20; p=0.023) and true bifurcation lesions (HR: 2.98; 95% CI: 1.45 to 6.14; p=0.001).. DEB for bifurcation restenosis may be an acceptable treatment option, especially in cases where repeat stenting has not already been performed for the treatment of a previous restenosis.

Topics: Aged; Cardiovascular Agents; Chi-Square Distribution; Coated Materials, Biocompatible; Coronary Angiography; Coronary Artery Disease; Coronary Restenosis; Drug-Eluting Stents; Female; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Multivariate Analysis; Myocardial Infarction; Percutaneous Coronary Intervention; Proportional Hazards Models; Retreatment; Retrospective Studies; Risk Factors; Time Factors; Treatment Outcome; Vascular Access Devices

We aimed to assess the safety and performance of a novel sirolimus-eluting stent with biodegradable polymer under real-world conditions.. This prospective, multicentre, observational, all-comers registry enrolled 1,356 patients. The primary endpoint was target lesion failure at 12 months: it occurred in 5.1% (95% CI: 4.0-6.4) of patients in the overall population and in 7.7% (95% CI: 5.5-10.9), 5.8% (95% CI: 4.2-8.1), 1.8% (95% CI: 0.2-11.8) and 7.2% (95% CI: 5.1-10.0) of patients with diabetes mellitus, small vessels, chronic total occlusion and acute myocardial infarction, respectively.. This novel stent platform demonstrated good clinical outcomes in an all-comers population, even in predefined high-risk groups. ClinialTrials.gov identifier: NCT01553526

Topics: Absorbable Implants; Adult; Aged; Cardiovascular Agents; Coronary Artery Disease; Drug-Eluting Stents; Everolimus; Female; Humans; Male; Middle Aged; Myocardial Infarction; Percutaneous Coronary Intervention; Prospective Studies; Prosthesis Design; Registries; Sirolimus; Treatment Outcome

While secondary prevention improves prognosis after acute myocardial infarction (AMI), previous studies have suggested suboptimal guideline adherence, lack of improvement over time and gender differences. This study contributes contemporary data from a large national cohort.. We identified 51,620 patients <75 years examined at two and/or twelve months post AMI in the Swedish Web-system for Enhancement and Development of Evidence-based care in Heart disease Evaluated According to Recommended Therapies (SWEDEHEART). Risk factor control and readmissions at one year were compared between the 2005 and 2012 cohorts, and between genders.. Lipid control (LDL-cholesterol <2.5 mmol/L) improved from 67.9% to 71.1% (p = 0.016) over time, achieved by 67.9% vs 63.3%, p < 0.001 of men vs women. Blood pressure control (<140 mmHg systolic) increased over time (59.1% vs 69.5%, p < 0.001 in 2005 and 2012 cohorts) and was better in men (66.4% vs 61.9%, p < 0.001). Smoking cessation rate was 55.6% without differences between genders or over time. Cardiac readmissions occurred in 18.2% of women and 15.5% of men, decreasing from 2005 to 2012 (20.8% vs 14.9%). Adjusted odds ratio was 1.22 (95% CI 1.14-1.32) for women vs men and 0.94 (95% CI 0.92-0.96) for the 2012 vs the 2005 cohort.. Although this study compares favourably to previous studies of risk factor control post AMI, improvement over time was mainly seen regarding blood pressure, revealing substantial remaining preventive potential. The reasons for gender differences seen in risk factor control and readmissions require further analysis.

Topics: Aged; Cardiovascular Agents; Cholesterol, LDL; Female; Guideline Adherence; Health Behavior; Humans; Hypertension; Male; Medication Adherence; Middle Aged; Myocardial Infarction; Patient Readmission; Practice Guidelines as Topic; Registries; Secondary Prevention; Sex Distribution; Sex Factors; Smoking Cessation; Sweden

The extent to which drug adherence may be affected by patient characteristics remains unclear. This study investigated potential determinants of adherence to evidence-based cardioprotective medications in patients with acute myocardial infarction.. Patient-based retrospective cohort study of 4655 elderly one-year survivors of acute myocardial infarction, members of a health organization in Israel, between 2005 and 2010.. All patients filled at least one prescription for any key medication. Adherence was measured using the proportion-of-days-covered (PDC) metric and defined as PDC ≥ 80%.. Nonadherence to aspirin, β-blockers, angiotensin converting enzyme inhibitors/angiotensin receptor blockers or statins approximated 50%, and 80% for combined therapy of all medications. In multivariable analyses, compared with nonadherents to all medications, adherers to at least one medication were more likely to be of Jewish origin (adjusted odds ratio (AOR), 2.11; 95% confidence interval (CI), 1.60-2.78), inhabitants of the central or northern districts, and attending a cardiologist at least once during the first year of follow-up (AOR, 1.26; 95% CI, 1.05-1.51). Increasing number of outpatient visits was associated with improved adherence and followed a significant dose-response gradient. Factors significantly associated with reduced adherence were presence of comorbid conditions, particularly chronic ischemic heart disease (AOR 0.69; 95% CI, 0.57-0.83) and readmissions (AOR, 0.65; 95% CI, 0.55-0.78). Results were consistent when evaluating adherence to each medication separately.. Outpatient adherence to recommended therapy in patients with acute myocardial infarction is suboptimal and is related to health services utilization. Further research is needed to investigate patient subjective behavioral-related drivers for medication therapy discontinuation after myocardial infarction in the absence of a clinical reason.

Topics: Age Factors; Aged; Ambulatory Care; Cardiovascular Agents; Chi-Square Distribution; Comorbidity; Evidence-Based Medicine; Female; Health Knowledge, Attitudes, Practice; Humans; Israel; Logistic Models; Male; Medication Adherence; Middle Aged; Multivariate Analysis; Myocardial Infarction; Odds Ratio; Retrospective Studies; Risk Factors; Secondary Prevention; Time Factors; Treatment Outcome

There is increasing evidence that various types of drug-eluting stents (DES) may differ regarding the long-term safety and efficacy, particularly in complex lesion subsets.. In a cohort of consecutive patients undergoing bifurcation stenting, we sought to compare the 1-year efficacy and safety of the first-generation paclitaxel-eluting stents (PES), the first-generation sirolimus-eluting (SES) and the second-generation everolimus- or zotarolimus-eluting stents (EES/ZES).. We treated 2197 patients (mean age 67.5 years, 75.4 % male) with provisional T-stenting for de novo coronary bifurcation lesions using PES, SES or EES/ZES. Primary endpoint (MACE) was the composite of death from any cause, myocardial infarction (MI) and target lesion revascularisation (TLR).. Side branch stenting was found to be clinically indicated in 793 patients (36.1 %). The cumulative 1-year incidence of MACE was 18.8 % after PES, 13.1 % after PCI with SES and 12.2 % after EES/ZES (p = 0.003), the combined endpoint death and MI occurred in 6.6, 5.6 and 8.3 % (p = 0.253) and death in 4.3, 5.2 and 5.3 % (p = 0.581), respectively. After adjustment for co-variables the type of DES was a significant (p = 0.008) predictor of MACE [HR (95 % confidence interval) PES vs SES 1.34 (1.04-1.71), PES vs. EES/ZES 1.75 (1.19-2.57), EES/ZES vs. SES 0.762 (0.531-1.095)], but not of death (p = 0.581), death and MI (p = 0.077) or stent thrombosis (ST) (p = 0.925).. In de novo coronary bifurcation lesions treated with provisional T-stenting, SES and EES/ZES achieved better outcomes than PES by reducing the need for reintervention.

Topics: Aged; Cardiovascular Agents; Coronary Artery Disease; Coronary Restenosis; Coronary Thrombosis; Drug-Eluting Stents; Female; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Myocardial Infarction; Percutaneous Coronary Intervention; Prosthesis Design; Registries; Retreatment; Risk Factors; Time Factors; Treatment Outcome

Even though drug-coated balloon (DCB) angioplasty has emerged as a treatment option for drug-eluting stent in-stent restenosis (DES-ISR), the most effective treatment strategy for DES-ISR is still under debate. Therefore, we compared long-term clinical outcomes following DCB treatment of DES-ISR with those following 2nd-generation drug-eluting stent (DES) treatment. We identified 248 DES-ISR lesions in 238 patients that were treated with either 2nd-generation DES implantation (n = 56) or DCB angioplasty (n = 192). We compared the incidences of major adverse cardiac events (MACEs) in the two groups during the 2-year period following treatment. MACE was defined as cardiac death, non-fatal myocardial infarction, or target-vessel revascularization. The percentage of patients with diabetes and the mean age of patients in the DCB group were greater than in the DES group. The DCB group also had a smaller reference vessel diameter. The DES group had a larger post-intervention minimal luminal diameter. We found no significant difference in the MACE rate between the two groups during the 2 years following treatment (11.0 % in the DCB group vs. 8.9 % in the DES group, p = 0.660). Reference segment diameter was the only independent predictive factor for MACE in the post-treatment period (hazard ratio 0.35, 95 % confidence interval: 0.15-0.82, p = 0.016). Clinical efficacy of DCB angioplasty for treatment of DES-ISR was comparable to that of 2nd-generation DES implantation as measured by the rate of MACEs in the two groups. Reference segment diameter was the only statistically significant independent predictor for MACE in the 2-year period following treatment.

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiac Catheters; Cardiovascular Agents; Coated Materials, Biocompatible; Coronary Angiography; Coronary Artery Disease; Coronary Restenosis; Drug-Eluting Stents; Female; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Myocardial Infarction; Percutaneous Coronary Intervention; Proportional Hazards Models; Prosthesis Design; Republic of Korea; Retrospective Studies; Risk Factors; Time Factors; Treatment Outcome

The Xience V USA Study demonstrated safety and efficacy of the XIENCE V(®) everolimus-eluting stent (EES) in a large, prospective study of a real-world, unselected patient population. There is limited long-term data regarding EES performance in high risk patients with bifurcation lesions (BIF). The objective of this analysis was to evaluate the long-term safety and effectiveness of EES in patients with BIF from the XIENCE V USA study.. The Xience V USA Study was a single arm, prospective, multicenter, real-world study (n = 5,054) undergoing PCI with EES. Baseline data and clinical outcomes at 4 years were evaluated in the subgroup of patients with ≥ 1 BIF who did not undergo a staged procedure. Co-primary endpoints were ARC definite/probable stent thrombosis and a composite of cardiac death and ARC-defined myocardial infarction (MI). Endpoints were adjudicated by an independent CEC.. Of 4,768 patients who did not undergo a staged procedure, there were 511 (10.7%) patients with BIF and 4,257 (89.3%) patients without BIF. Follow-up data was available in 4,459 patients (466 BIF, 3,993 non-BIF). Through binary outcome analysis, at 1 year the overall definite/probable stent thrombosis rates were higher in the BIF group (1.84% vs. 0.76%, P = 0.03). However, at 4 years, the difference in cumulative rates of ARC definite/probable stent thrombosis (BIF 2.3% vs. non-BIF 1.4%, P = 0.13) remained the same as that at 1 year, with no incremental definite/probable stent thrombosis in BIF patients from 2-4 years. The 4-year rates of composite cardiac death and MI were 13.5% for BIF vs. 14.1% for non-BIF (P = 0.78). At 4 years, target lesion failure (19.1% vs. 18.3%, P = 0.66) and ischemia driven-target lesion revascularization (10.2% vs. 10.1%, P = 0.89) were comparable between the two groups.. This subgroup analysis of BIF lesions in a real world population receiving EES demonstrates continued low rates of clinical outcomes in the BIF subgroup at 4 years with no incremental stent thrombosis increase in BIF patients from 2 to 4 years. © 2015 Wiley Periodicals, Inc.

Topics: Aged; Cardiovascular Agents; Coronary Artery Disease; Coronary Thrombosis; Drug-Eluting Stents; Everolimus; Female; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Myocardial Infarction; Percutaneous Coronary Intervention; Product Surveillance, Postmarketing; Prospective Studies; Prosthesis Design; Risk Factors; Time Factors; Treatment Outcome; United States

To assess the safety and efficacy of fractional flow reserve (FFR) guided paclitaxel-coated balloon (PCB) treatment for de novo coronary artery lesions.. There is limited data on PCB treatment for de novo lesions especially of major epicardial coronary arteries.. Sixty-six patients with 67 de novo lesions who underwent successful plain old balloon angioplasty (POBA) were included. If POBA-FFR was favorable (≥ 0.85), PCB was applied and if POBA-FFR was <0.85, stent implantation was preferred over PCB.. Forty-five lesions were treated with PCB (67.2%) and 22 lesions with stents (32.8%). Dual antiplatelet therapy duration was 6 weeks. Late luminal loss with PCB was significantly less than stent (0.05 ± 0.27 mm vs. 0.40 ± 0.54 mm, P = 0.022). The baseline FFR of target lesions was 0.69 ± 0.16 in PCB and 0.60 ± 0.11 in stent group (P = 0.015), however, the FFR at 9 months was not different between groups (0.85 ± 0.08 in PCB vs. 0.85 ± 0.05 in stent group, P = 0.973). At 1 year, one myocardial infarction and one target lesion revascularization related to in-stent restenosis were detected, both in the stent group.. POBA-FFR-guided PCB treatment is safe and effective for de novo coronary lesions with good anatomical and physiological patency at mid-term follow-up. © 2015 Wiley Periodicals, Inc.

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiac Catheters; Cardiovascular Agents; Coated Materials, Biocompatible; Coronary Angiography; Coronary Artery Disease; Coronary Restenosis; Coronary Vessels; Drug Therapy, Combination; Drug-Eluting Stents; Equipment Design; Female; Fractional Flow Reserve, Myocardial; Humans; Male; Middle Aged; Myocardial Infarction; Paclitaxel; Platelet Aggregation Inhibitors; Predictive Value of Tests; Prospective Studies; Registries; Republic of Korea; Time Factors; Treatment Outcome; Vascular Patency

Coronary inflammation and healing influence outcomes of diabetic patients treated with Percutaneous coronary revascularization (PCI). Stents covered with biodegradable polymers (bp) may offer advantages over nonerodible polymer ones, because polymer reabsorption extinguish coronary inflammation and favours healing. Aim of our study was to assess the safety and efficacy of bp-biolimus-eluting stent (bp-BES) in a large series of consecutive diabetic patients.. From 2009 to 2013 we retrospectively enrolled consecutive diabetic patients treated with PCI and bp-BES implantation. Primary end points were target lesion revascularization (TLR) and stent thrombosis rates.. Study cohort counted 747 patients. Multivessel disease was present in 48.2% with a mean stent/patient ratio of 1.860.78. During the hospital stay no stent thrombosis occurred. At 3-year follow-up we observed a 1.5% cumulative incidence of cardiac death, 1.1% of myocardial infarction and 6.3% of TLR. Stent thrombosis occurred in 1.1% of patients, all in the first 2 years of follow-up. Kaplan-Meier analysis showed a TLR-free survival at 1 and 3 years of 97.2 and 96.1%, respectively.. PCI with bp-BES seems to be well tolerated and effective in a large unselected population of diabetic patients. The good results observed were maintained at 3 years of follow-up.

Topics: Aged; Cardiovascular Agents; Coronary Artery Disease; Coronary Thrombosis; Diabetes Complications; Drug-Eluting Stents; Europe; Female; Follow-Up Studies; Humans; Kaplan-Meier Estimate; Male; Mexico; Middle Aged; Multivariate Analysis; Myocardial Infarction; Percutaneous Coronary Intervention; Proportional Hazards Models; Prosthesis Design; Registries; Retrospective Studies; Risk Factors; Tertiary Care Centers; Time Factors; Treatment Outcome

observational studies suggest that older patients are less likely to receive secondary prevention medicines following acute coronary syndrome (ACS).. to examine the association of increasing age with receipt of specialist care and influence of specialist care on long-term mortality in patients with non-ST elevation myocardial infarction (NSTEMI).. a cohort study.. National ACS registry of England and Wales.. a total of 85,183 patients admitted with NSTEMI between 2006 and 2010.. logistic regression analyses to assess receipt of secondary prevention medicines (ACE inhibitor, β-blocker, statin, aspirin) by age group; multivariate Cox regression models to examine longitudinal effect of cardiologist care on all-cause mortality by age group.. mean age 72.0 years (SD 13.0 years), mean follow-up was 2.13 years. Older patients received less cardiologist care (70.2% of NSTEMI patients ≥85 years compared with 94.7% of patients <65) years and had more co-morbidity. Cardiologists prescribed more secondary prevention in all age groups than generalists, but this was mostly explained away by co-morbidity (receipt of statin crude OR 1.51 (1.27,1.80), fully adjusted OR 1.11 (0.92,1.33) in patients ≥85 years). Receiving cardiologist care compared with generalist care was associated with a decreased risk of death in all even after adjustment for co-morbidity, disease severity and secondary prevention; this benefit reduced incrementally with older age group (adjusted hazard ratio (HR) 0.58 (0.49,0.68) aged <65; 0.87 (0.82,0.92) aged ≥85).. older patients with NSTEMI were less likely to see a cardiologist, but reduced treatment by generalists was explained away by co-morbidity. Cardiologist care was associated with lower mortality in all age groups than a generalist, but this survival benefit was less pronounced in older patients.

Topics: Adrenergic beta-Antagonists; Age Factors; Aged; Aged, 80 and over; Angiotensin-Converting Enzyme Inhibitors; Aspirin; Cardiology; Cardiovascular Agents; Comorbidity; Delivery of Health Care; England; Female; General Practice; Humans; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Logistic Models; Longitudinal Studies; Male; Middle Aged; Multivariate Analysis; Myocardial Infarction; Odds Ratio; Proportional Hazards Models; Referral and Consultation; Registries; Risk Factors; Secondary Prevention; Specialization; Time Factors; Treatment Outcome; Wales

The internal mammary artery (IMA) is the preferred conduit for bypassing the left anterior descending (LAD) artery in patients undergoing coronary artery bypass grafting. Systematic evaluation of the frequency and predictors of IMA failure and long-term outcomes is lacking.. The Project of Ex-vivo Vein Graft Engineering via Transfection (PREVENT) IV trial participants who underwent IMA-LAD revascularization and had 12- to 18-month angiographic follow-up (n=1539) were included. Logistic regression with fast false selection rate methods was used to identify characteristics associated with IMA failure (≥75% stenosis). The relationship between IMA failure and long-term outcomes, including death, myocardial infarction, and repeat revascularization, was assessed with Cox regression. IMA failure occurred in 132 participants (8.6%). Predictors of IMA graft failure were LAD stenosis <75% (odds ratio, 1.76; 95% confidence interval, 1.19-2.59), additional bypass graft to diagonal branch (odds ratio, 1.92; 95% confidence interval, 1.33-2.76), and not having diabetes mellitus (odds ratio, 1.82; 95% confidence interval, 1.20-2.78). LAD stenosis and additional diagonal graft remained predictive of IMA failure in an alternative model that included angiographic failure or death before angiography as the outcome. IMA failure was associated with a significantly higher incidence of subsequent acute (<14 days of angiography) clinical events, mostly as a result of a higher rate of repeat revascularization.. IMA failure was common and associated with higher rates of repeat revascularization, and patients with intermediate LAD stenosis or with an additional bypass graft to the diagonal branch had increased risk for IMA failure. These findings raise concerns about competitive flow and the benefit of coronary artery bypass grafting in intermediate LAD stenosis without functional evidence of ischemia.. URL: http:/www.clinicaltrials.gov. Unique identifier: NCT00042081.

Topics: Aged; Cardiac Catheterization; Cardiovascular Agents; Combined Modality Therapy; Comorbidity; Coronary Angiography; Coronary Disease; Coronary Restenosis; Diabetes Complications; Double-Blind Method; Female; Graft Occlusion, Vascular; Humans; Internal Mammary-Coronary Artery Anastomosis; Kaplan-Meier Estimate; Male; Middle Aged; Multicenter Studies as Topic; Myocardial Infarction; Postoperative Complications; Proportional Hazards Models; Randomized Controlled Trials as Topic; Reoperation; Treatment Failure

We aimed to analyze angiographic and clinical results of patients undergoing BRS implantation in a real-world setting.. Angiographic and clinical outcome data from patients undergoing implantation of drug-eluting bioresorbable stents (BRS) in routine clinical practice is scant.. Consecutive patients undergoing implantation of everolimus-eluting BRS at two high-volume centers in Munich, Germany were enrolled. Data were collected prospectively. All patients were scheduled for angiographic surveillance 6-8 months after stent implantation. Quantitative coronary angiographic analysis was performed in a core laboratory. Clinical follow-up was performed to 12 months and events were adjudicated by independent assessors.. A total of 419 patients were studied. Mean age was 66.6 ± 10.9 years, 31.5% had diabetes mellitus, 76.1% had multivessel disease, and 39.0% presented with acute coronary syndrome; 49.0% of lesions were AHA/ACC type B2/C, 13.1% had treatment of bifurcation lesions. Mean reference vessel diameter was 2.89 ± 0.46 mm. At angiographic follow-up in-stent late loss was 0.26 ± 0.51 mm, in-segment diameter stenosis was 27.5 ± 16.1, and binary angiographic restenosis was 7.5%. At 12 months, the rate of death, myocardial infarction, or target lesion revascularization was 13.1%. Definite stent thrombosis occurred in 2.6%.. The use of everolimus-eluting BRS in routine clinical practice is associated with high antirestenotic efficacy in patients undergoing angiographic surveillance. Overall clinical outcomes at 12 months are satisfactory though stent thrombosis rates are not insignificant. Further study with longer term follow-up and larger numbers of treated patients is required before we can be sure of the role of these devices in clinical practice.

Topics: Absorbable Implants; Acute Coronary Syndrome; Aged; Cardiovascular Agents; Coronary Angiography; Coronary Artery Disease; Coronary Restenosis; Coronary Thrombosis; Coronary Vessels; Drug-Eluting Stents; Everolimus; Female; Germany; Hospitals, High-Volume; Humans; Male; Middle Aged; Myocardial Infarction; Percutaneous Coronary Intervention; Predictive Value of Tests; Prosthesis Design; Registries; Risk Factors; Time Factors; Treatment Outcome

Topics: Angina, Unstable; Cardiovascular Agents; Coronary Artery Bypass; Female; Humans; Male; Myocardial Infarction; Percutaneous Coronary Intervention

Little is known about Emergency Medical Services (EMS) use and pre-hospital triage of patients with acute ST-elevation myocardial infarction (STEMI) in Arabian Gulf countries.. Clinical arrival and acute care within 24 h of STEMI symptom onset were compared between patients transferred by EMS (Red Crescent and Inter-Hospital) and those transferred by non-EMS means. Data were retrieved from a prospective registry of 36 hospitals in 6 Arabian Gulf countries, from January 2014 to January 2015.. We enrolled 2,928 patients; mean age, 52.7 (SD ±11.8) years; 90% men; and 61.7% non-Arabian Gulf citizens. Only 753 patients (25.7%) used EMS; which was mostly via Inter-Hospital EMS (22%) rather than direct transfer from the scene to the hospital by the Red Crescent (3.7%). Compared to the non-EMS group, the EMS group was more likely to arrive initially at a primary or secondary health care facility; thus, they had longer median symptom-onset-to-emergency department arrival times (218 vs. 158 min; p˂.001); they were more likely to receive primary percutaneous coronary interventions (62% vs. 40.5%, p = 0.02); they had shorter door-to-needle times (38 vs. 42 min; p = .04); and shorter door-to-balloon times (47 vs. 83 min; p˂.001). High EMS use was independently predicted mostly by primary/secondary school educational levels and low or moderate socioeconomic status. Low EMS use was predicted by a history of angina and history of percutaneous coronary intervention. The groups had similar in-hospital deaths and outcomes.. Most acute STEMI patients in the Arabian Gulf region did not use EMS services. Improving Red Crescent infrastructure, establishing integrated STEMI networks, and launching educational public campaigns are top health care system priorities.

Topics: Adult; Aged; Angina Pectoris; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Educational Status; Electrocardiography; Emergency Medical Services; Emergency Service, Hospital; Emigrants and Immigrants; Female; Hospital Mortality; Humans; Male; Middle Aged; Middle East; Myocardial Infarction; Percutaneous Coronary Intervention; Prospective Studies; Registries; Socioeconomic Factors; Time Factors; Treatment Outcome; Triage

Preclinical and clinical studies have demonstrated that berberine (BBR) improves diabetic complications and reduces mortality of patients with congestive heart failure. The therapeutic effects of BBR have been reported to be mediated by its regulation of adenosine monophosphate (AMP)-activated protein kinase (AMPK). We previously reported that BBR protects against ischemia-reperfusion injury via regulating AMPK activity in both ischemic and nonischemic areas of the rat heart. Since diabetic hearts are more sensitive to ischemia-reperfusion injury, we examined whether BBR treatment exhibited cardioprotective effects in the diabetic heart. Type 2 diabetic rats were pretreated plus or minus BBR for 7 days and subjected to 30-minute ischemia followed by 120-minute reperfusion. Pretreatment of type 2 diabetic rats with BBR reduced ischemia-reperfusion injury infarct size and attenuated arrhythmia compared to untreated diabetic controls. Subsequent to ischemia-reperfusion, serum triglyceride, total cholesterol, and malondialdehyde levels were reduced by pretreatment of type 2 diabetic rats with BBR compared to untreated diabetic controls. In contrast, serum glucose and superoxide dismutase levels were unaltered. The mechanism for the BBR-mediated cardioprotective effect was examined. Pretreatment with BBR did not alter AMPK activity in ischemic areas at risk but increased AMPK activity in nonischemic areas compared to untreated diabetic controls. The increased AMPK activity in nonischemic areas was due an elevated ratio of AMP to adenosine triphosphate (ATP) and adenosine diphosphate to ATP. In addition, pretreatment with BBR increased protein kinase B (AKT) phosphorylation and reduced glycogen synthase kinase 3β (GSK3β) activity in nonischemic areas compared to untreated diabetic controls. These findings indicate that BBR protects the diabetic heart from ischemia-reperfusion injury. In addition, BBR may mediate this cardioprotective effect through AMPK activation, AKT phosphorylation, and GSK3β inhibition in the nonischemic areas of the diabetic heart.

Topics: AMP-Activated Protein Kinases; Animals; Arrhythmias, Cardiac; Berberine; Biomarkers; Blood Glucose; Cardiovascular Agents; Diabetes Mellitus, Experimental; Diabetes Mellitus, Type 2; Diabetic Cardiomyopathies; Energy Metabolism; Enzyme Activation; Glycogen Synthase Kinase 3 beta; Lipids; Male; Myocardial Infarction; Myocardial Reperfusion Injury; Myocardium; Phosphorylation; Proto-Oncogene Proteins c-akt; Rats, Wistar; Signal Transduction

To evaluate whether aleglitazar (Ale), a dual PPARα/γ agonist, has additive effects on myocardial protection against ischemia-reperfusion injury.. Human cardiomyocytes (HCMs), cardiomyocytes from cardiac-specific PPARγ knockout (MCM-PPARγ (CKO) ) or wild type (MCM-WT) mice were incubated with different concentrations of Ale, and subjected to simulated ischemia-reperfusion (SIR) or normoxic conditions (NSIR). Cell viability, apoptosis and caspase-3 activity were determined. HCMs were transfected with siRNA against PPARα (siPPARα) or PPARγ (siPPARγ) followed by incubation with Ale. PPARα/γ DNA binding capacity was measured. Cell viability, apoptosis and levels of P-AKT and P-eNOS were assessed. Infarct size following 30 min coronary artery occlusion and 24 h reperfusion were assessed in WT and db/db diabetic mice following 3-day pretreatment with vehicle, Ale or glimeperide.. Ale (at concentrations of 150-600 nM) increased cell viability and reduced apoptosis in HCMs, MCM-WT and MCM-PPAR (CKO) exposed to SIR. In HCM, the protective effect was partially blocked by siPPARα alone or siPPARγ alone, and completely blocked by siPPARα+siPPARγ. Ale increased P-Akt/P-eNOS in HCMs. P-Akt or P-eNOS levels were decreased when PPARα alone, PPARγ alone and especially when both were knocked down. Peritoneal GTTs revealed that db/db mice had developed impaired glucose tolerance and insulin sensitivity, which were normalized by Ale or glimepiride treatment. Ale, but not glimepiride, limited infarct size in both WT and diabetic mice after ischemia-reperfusion.. Ale protects against myocardial apoptosis caused by hypoxia-reoxygenation in vitro and reduces infarct size in vivo.

Topics: Animals; Apoptosis; Cardiotonic Agents; Cardiovascular Agents; Cell Survival; Diabetes Mellitus, Experimental; Heart; Humans; Male; Mice; Myocardial Infarction; Myocardial Reperfusion Injury; Myocardium; Myocytes, Cardiac; Oxazoles; PPAR alpha; PPAR gamma; Protective Agents; Signal Transduction; Thiophenes

The behaviour of side branches (SBs) covered by a bioresorbable vascular scaffold (BVS) is not well known. This study analysed the rate of side branch occlusion (SBO) immediately after BVS implantation, its clinical impact, predictors of SBO and the fate of such SBs at follow-up.. We assessed 140 patients with 346 jeopardised SBs divided into three groups: small (<1 mm, n=181), intermediate (1-2 mm, n=102) and large (>2 mm, n=63). SBO was defined as a TIMI flow 0 or 1. Computed tomography was scheduled at six months for patients with jailed SBs >1 mm. Immediate occlusion occurred in 31 (9%) SBs: 22 (12%) small, 8 (8%) intermediate and one (1.6%) large, while post-procedural SBO was 5.5%. In-hospital events included one thrombosis (0.7%) and eight non-Q-wave myocardial infarctions (6%). After 17±3 months, one patient died (0.7%) and six patients needed repeat revascularisation (4%). Re-evaluation showed no late SBO at 7±3 months. Predictors of SBO were: small SBs (OR 2.06, 95% CI: 1.08-4.63; p<0.05) and stenosis >50% at the origin (OR 17.22, 95% CI: 7.79-38.10; p<0.01).. The incidence of SBO and its clinical impact were low when SBs >1 mm were covered. These favourable results were maintained at midterm.

Topics: Absorbable Implants; Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Angiography; Coronary Artery Disease; Drug-Eluting Stents; Everolimus; Female; Follow-Up Studies; Humans; Male; Middle Aged; Myocardial Infarction; Tomography, X-Ray Computed; Treatment Outcome

The purpose of this study was to compare the 1-year outcomes of the ABSORB everolimus-eluting bioresorbable scaffold (BRS) (Abbott Vascular, Santa Clara, California) and the XIENCE everolimus-eluting stent (EES) (Abbott Vascular) in patients undergoing percutaneous coronary intervention.. Randomized studies of the ABSORB BRS have been performed in selected patient and lesion scenarios. The available registries of the ABSORB BRS reflect real-world practice more closely compared with randomized studies, but most of them are limited by the small sample size and the lack of comparative outcomes versus second-generation drug-eluting stents.. A total of 1,189 consecutive patients treated with ABSORB BRS from the GHOST-EU (Gauging coronary Healing with bioresorbable Scaffolding plaTforms in EUrope) registry and 5,034 patients treated with XIENCE EES from the XIENCE V USA registry were analyzed. Clinical outcomes were compared with the use of propensity-score matching techniques and reported as Kaplan-Meier estimates and absolute risk difference (D) with 95% confidence intervals (CIs). The primary endpoint was a device-oriented composite endpoint, including cardiac death, target vessel myocardial infarction, and ischemia-driven target lesion revascularization at 1-year follow-up.. After propensity score matching was performed for the entire population (N = 6,223), there were 905 matched pairs of patients. In the matched cohort (N = 1,810), there was no significant difference between ABSORB BRS and XIENCE EES in the risk of device-oriented composite endpoint at 1 year (5.8% vs. 7.6%, D = -1.8 [95% CI: -4.1 to 0.5]; p = 0.12). Cardiac death was less likely to occur in the ABSORB BRS group (0.7% vs. 1.9%, D = -1.2 [95% CI: -2.2 to 0.2]; p = 0.03), and a trend toward a reduction in myocardial infarction was noted with ABSORB BRS compared with XIENCE EES (2.4% vs. 4.0%, D = -1.6 [95% CI: -3.2 to 0.0]; p = 0.07). Conversely, no differences in ischemia-driven target lesion revascularization (4.6% vs. 3.5%, D = 1.1 [95% CI: -0.7 to 2.9]; p = 0.22) and definite or probable device thrombosis (1.8% vs. 1.1%, D = 0.7 [95% CI: -0.4 to 1.8]; p = 0.23) were detected between ABSORB BRS and XIENCE EES.. In a contemporary large cohort of patients undergoing percutaneous coronary intervention with ABSORB BRS, the combined rate of ischemic events at 1 year was low and nonsignificantly different compared with matched patients treated with XIENCE EES.

Topics: Absorbable Implants; Aged; Cardiovascular Agents; Chi-Square Distribution; Coronary Artery Disease; Coronary Thrombosis; Drug-Eluting Stents; Europe; Everolimus; Female; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Multivariate Analysis; Myocardial Infarction; Percutaneous Coronary Intervention; Product Surveillance, Postmarketing; Propensity Score; Proportional Hazards Models; Prosthesis Design; Registries; Risk Assessment; Risk Factors; Time Factors; Treatment Outcome; United States

China is experiencing a marked increase in ST-segment elevation myocardial infarction hospitalizations, with 30% occurring among women and higher risk of in-hospital death in relatively younger age groups (<70). Yet, little is known about sex differences in ST-segment elevation myocardial infarction presentation and management.. In a nationally representative sample of patients with ST-segment elevation myocardial infarction admitted to 162 Chinese hospitals in 2001, 2006, and 2011, we examined sex differences in hospitalization rates, clinical profiles, and quality of care. Among 11 986 patients, the proportion of women was unchanged between 2001 and 2011. The estimated national rates of hospital admission per 100 000 people increased from 4.6 in 2001 to 18.0 in 2011 among men (3.9-fold increase) and from 1.9 to 8.0 among women (4.2-fold increase) (Ptrend<0.0001). The median age of women increased from 68 years in 2001 to 72 years in 2011 (Ptrend<0.001); however, there was no age change in men (63 years in 2011) (Ptrend=0.48). After accounting for age, women had a higher frequency of comorbidities. Although there were significant sex differences in the time interval of >12 hours between symptom onset and admission time in 2001, since 2006 delays in presentation were comparable between women and men. Fewer women without contraindications received evidence-based therapies than men, including reperfusion (57.5% versus 44.2%), early aspirin (88.8% versus 85.9%), and clopidogrel (56.9% versus 52.5%, P<0.001 for all) and the differences were largely unchanged over time.. Women experienced a higher increase in hospitalization rates for ST-segment elevation myocardial infarction in China between 2001 and 2011 and were less likely to receive evidence-based therapies, especially reperfusion. In addition to efforts to improve quality of care generally, understanding the reasons for this sex disparity and addressing these differences in care should be a priority.. URL: https://www.clinicaltrials.gov. Unique identifier: NCT01624883.

Topics: Age Factors; Aged; Cardiovascular Agents; China; Comorbidity; Female; Health Status Disparities; Healthcare Disparities; Hospital Mortality; Hospitalization; Humans; Male; Middle Aged; Myocardial Infarction; Myocardial Reperfusion; Retrospective Studies; Risk Factors; Sex Factors; Time Factors; Treatment Outcome

Alpha-1-antitrypsin (AAT) is an abundant plasma protein with neutrophil elastase-inhibiting activity, and AAT is available as a plasma-derived therapeutic (pAAT). In experimental myocardial infarction, pAAT reduced acute inflammatory injury because of ischemia-reperfusion. The aim of the present study was to assess the properties of a recombinant protein composed of human AAT fused to the human immunoglobulin (Ig) G1 Fc fragment (rhAAT-Fc) in experimental myocardial infarction.. Ten-week-old CD1 male mice underwent transient occlusion (30 minutes) of the left anterior coronary artery. rhAAT-Fc (2 mg/kg) or pAAT (60 mg/kg) were administered upon reperfusion. We used human plasma-derived Ig (2 mg/kg) or a matching volume of NaCl 0.9% as control solutions. After 24 hours, infarct size and caspase-1 activity were quantified. The left ventricular ejection fraction (LVEF) was measured by echocardiography at 24 hours and 7 days. A variant of rhAAT-Fc lacking elastase inhibition activity, rhAAT-Fc, was also tested.. The rhAAT-Fc induced a significant reduction in infarct size (P < 0.01 vs. all controls, P > 0.05 vs. pAAT). Caspase-1 activity was reduced to the same degree with rhAAT-Fc and pAAT (-70%; P < 0.05; P > 0.05 rhAAT-Fc vs. pAAT). The effects on infarct size after a single administration were reflected by preservation of LVEF at 24 hours and 7 days (all P < 0.05). rhAAT-Fc without elastase inhibiting activity, rhAAT-Fc, conferred comparable effects on infarct size, caspase-1 activity, and LVEF (P > 0.2 vs. rhAAT-Fc).. The pAAT and recombinant human AAT-Fc reduce the acute myocardial inflammatory injury after ischemia-reperfusion in the mouse leading to preservation of viable myocardium and systolic function, independent on the effects on neutrophil elastase.

Topics: alpha 1-Antitrypsin; Animals; Cardiovascular Agents; Caspase 1; Disease Models, Animal; Humans; Immunoglobulin Fc Fragments; Leukocyte Elastase; Male; Mice; Myocardial Infarction; Myocardial Reperfusion Injury; Myocarditis; Myocardium; Recombinant Fusion Proteins; Stroke Volume; Time Factors; Tissue Survival; Ventricular Function, Left

To evaluate angiographic and clinical results of ZES compared with EES after recanalization of CTOs.. ZES and EES showed similar clinical results in non-CTO lesions. Whether ZES and EES are also comparable in true CTO lesions (TIMI 0 flow, duration of occlusion of more than 3 months) with a higher risk of restenosis has not been addressed so far.. 125 patients with successful CTO recanalization via antegrade or retrograde approach were included. EES were implanted in 68 patients and ZES in 57 patients. Dual antiplatelet therapy was prescribed for 12 months. Follow-up angiography was scheduled at 9 months and clinical follow-up at 12 months. The primary angiographic outcome measure was in-stent late lumen loss. Primary clinical outcome measures were target lesion revascularization rate (TLR) and major adverse cardiac events (MACE) as a composite of cardiac death, TLR and myocardial infarction not clearly attributable to a non-target vessel.. Baseline characteristics were similar in both groups. Mean stent length was 72.8 ± 33.0mm with EES and 70.8 ± 31.5 mm with ZES (P = 0.72). In-stent late lumen loss was 0.50 ± 0.71 mm for EES compared with 0.59 ± 0.72 (P = 0.52) for ZES. There were similar rates for TLR (EES 10.3% versus ZES 10.5%, P = 0.97) and MACE (EES 10.3% versus ZES 12.3%). No definite or probable stent thrombosis occurred. Stent length but not type of stent was predictive for in-stent late loss and TLR.. ZES and EES showed similar angiographic and clinical outcomes for treatment of CTOs. © 2016 Wiley Periodicals, Inc.

Topics: Aged; Cardiovascular Agents; Chronic Disease; Coronary Angiography; Coronary Occlusion; Coronary Restenosis; Drug Therapy, Combination; Drug-Eluting Stents; Everolimus; Female; Humans; Male; Middle Aged; Myocardial Infarction; Percutaneous Coronary Intervention; Platelet Aggregation Inhibitors; Predictive Value of Tests; Prosthesis Design; Risk Factors; Sirolimus; Time Factors; Treatment Outcome

The primary prevention of cardiovascular disease is a public health priority. To assess the costs and benefits of a Polypill Prevention Programme using a daily 4-component polypill from age 50 in the UK, we determined the life years gained without a first myocardial infarction (MI) or stroke, together with the total service cost (or saving) and the net cost (or saving) per year of life gained without a first MI or stroke. This was estimated on the basis of a 50 % uptake and a previously published 83 % treatment adherence. The total years of life gained without a first MI or stroke in a mature programme is 990,000 each year in the UK. If the cost of the Polypill Prevention Programme were £1 per person per day, the total cost would be £4.76 bn and, given the savings (at 2014 prices) of £2.65 bn arising from the disease prevented, there would be a net cost of £2.11 bn representing a net cost per year of life gained without a first MI or stroke of £2120. The results are robust to sensitivity analyses. A national Polypill Prevention Programme would have a substantial effect in preventing MIs and strokes and be cost-effective.

Topics: Aged; Aged, 80 and over; Amlodipine; Aspirin; Cardiovascular Agents; Case-Control Studies; Cohort Studies; Cost-Benefit Analysis; Humans; Hydrochlorothiazide; Losartan; Markov Chains; Middle Aged; Myocardial Infarction; Polypharmacy; Primary Prevention; Quality-Adjusted Life Years; Simvastatin; Stroke; United Kingdom

Treatment of coronary in-stent restenosis (ISR) is still associated with a high incidence of recurrence. We aimed to compare the efficacy and safety of drug-eluting balloons (DEB) for the treatment of ISR as compared with conventional balloon angioplasty (BA) and drug-eluting stents (DES).. Between January 2006 and May 2012 a total of 177 patients (188 lesions, 64.1 ± 11.7 years old) who underwent percutaneous coronary intervention for ISR were retrospectively enrolled. Clinical outcomes were compared between patients treated with DEB (n = 58, 32.8%), conventional BA (n = 65, 36.7%), or DES (n = 54, 30.5%). The primary end point was a major adverse cardiac event (MACE), defined as a composite of cardiac death, myocardial infarction, and target lesion revascularization(TLR).. Baseline characteristics were not different except for a history of previous MI, which was more frequent in patients treated by conventional BA or DES than in patients treated by DEB (40.0% vs. 48.1% vs. 17.2%, respectively, p = 0.002). The total incidences of MACEs were 10.7%, 7.4%, and 15.4% in patients treated by DEB, DES, or conventional BA, respectively (p > 0.05). TLR was more frequent in patients treated by conventional BA than in patients treated by DEB or DES, but this was not statistically significant (10.8% vs. 6.9% vs. 3.7%, p > 0.05 between all group pairs, respectively).. This study showed that percutaneous coronary intervention using DEB might be a feasible alternative to conventional BA or DES implantation for treatment of coronary ISR. Further large-scaled, randomized study assessing long-term clinical and angiographic outcomes will be needed.

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiac Catheters; Cardiovascular Agents; Cause of Death; Coated Materials, Biocompatible; Coronary Angiography; Coronary Artery Disease; Coronary Restenosis; Drug-Eluting Stents; Feasibility Studies; Female; Humans; Male; Middle Aged; Myocardial Infarction; Prosthesis Design; Retreatment; Retrospective Studies; Risk Factors; Time Factors; Treatment Outcome

Coronary artery disease (CAD) is a life-threatening medical emergency which needs urgent medical attention. Percutaneous coronary intervention (PCI) is common and necessary for patients with CAD, but it has not completely evaluated in cases with repeated PCI. Therefore, the aim of this study was to examine the risk factors and prognosis in patients with CAD requiring repeated PCI. This is a prospective observational study. A total of 1126 patients with CAD requiring PCI took part in this study. Clinical parameters including baseline characteristics, hemodynamic data, location of vascular lesions, SYNTAX score, left ventricular ejection fraction, central pulse pressure (CPP), central aortic systolic pressure (CSP), risk factors, and invasive strategies were analyzed to identify the risk factors for patients requiring repeated PCI. We further analyzed the prognosis, including risk for myocardial infarction (MI), cardiovascular (CV) mortality, and all-cause mortality, in patients with repeated PCI. Among patients with PCI, 276 received repeated PCI. Patients in the repeated PCI group had a higher CPP (66.7 vs 62.5 mm Hg; P = 0.006), CSP (139.9 vs 135.9 mm Hg; P = 0.017), and male preponderance (P = 0.012). Drugs including diuretics, beta-blockers (BBs), angiotensin-converting enzyme inhibitors (ACEIs), and aspirin were all used more frequently in the repeated PCI group (all P < 0.05). Freedom from MI was lower in the repeated PCI group than in the single PCI group (P < 0.001). Logistic regression revealed that CPP, CSP, number of diseased vessels, male sex, usage of diuretics, BBs, ACEIs, and MI were all predictors for requiring repeated PCI (all P < 0.05). In addition, CPP was a predictor for MI attack, CV mortality, and all-cause mortality in the repeated PCI group (P = 0.010, P = 0.041, P = 0.004, respectively). Elevated CPP, CSP, male sex, multiple diseased vessels, and the usage of diuretics, BBs, ACEIs, and MI were predictors for repeated PCI. Most importantly, CPP was strongly associated with MI attack, CV mortality, and all-cause mortality, and could serve as a prognostic parameter for mortality in patients with CAD after performing repeated PCI.

Topics: Aged; Blood Glucose; Blood Pressure; Cardiovascular Agents; Coronary Artery Disease; Female; Humans; Kaplan-Meier Estimate; Lipids; Logistic Models; Male; Middle Aged; Myocardial Infarction; Percutaneous Coronary Intervention; Prognosis; Prospective Studies; Risk Factors; Severity of Illness Index; Sex Factors

To measure the adherence to polytherapy after myocardial infarction (MI), to compare the proportions of variation attributable to hospitals of discharge and to primary care providers, and to identify determinants of adherence to medications.. This is a population-based study. Data were obtained from the Information Systems of the Lazio Region, Italy (5 million inhabitants).. Patients hospitalised with incident MI in 2007-2010.. The outcome was chronic polytherapy after MI. Adherence was defined as a medication possession ratio ≥0.75 for at least three of the following drugs: antiplatelets, β-blockers, ACEI angiotensin receptor blockers, statins.. A 2-year cohort study was performed. Cross-classified multilevel models were applied to analyse geographic variation and compare proportions of variability attributable to hospitals of discharge and primary care providers. The variance components were expressed as median ORs MORs. If the MOR is 1.00, there is no variation between clusters. If there is considerable between-cluster variation, the MOR will be large.. A total of 9606 patients were enrolled. About 63% were adherent to chronic polytherapy. Adherence was higher for patients discharged from cardiology wards (OR=1.56 vs other wards, p<0.001) and for patients with general practitioners working in group practice (OR=1.14 vs single-handed, p=0.042). A relevant variation in adherence was detected between local health districts (MOR=1.24, p<0.001). When introducing the hospital of discharge as a cross-classified level, the variation between local health districts decreased (MOR=1.13, p=0.020) and the variability attributable to hospitals of discharge was significantly higher (MOR=1.37, p<0.001).. Secondary prevention pharmacotherapy after MI is not consistent with clinical guidelines. The relevant geographic variation raises equity issues in access to optimal care. Adherence was influenced more by the hospital that discharged the patient than by the primary care providers. Cross-classified models proved to be a useful tool for defining priority areas for more targeted interventions.

Topics: Adult; Aged; Aged, 80 and over; Cardiology Service, Hospital; Cardiovascular Agents; Chronic Disease; Cohort Studies; Drug Therapy, Combination; Evidence-Based Medicine; Female; General Practitioners; Health Services Accessibility; Hospitals; Humans; Italy; Male; Medication Adherence; Middle Aged; Myocardial Infarction; Patient Discharge; Primary Health Care; Secondary Prevention

Ivabradine selectively inhibits the pacemaker current of the sinoatrial node, slowing heart rate. Few studies have examined the effects of ivabradine on the mechanical properties of the heart after reperfused myocardial infarction (MI). Advances in ultrasound speckle-tracking allow strain analyses to be performed in small-animal models, enabling the assessment of regional mechanical function.. After 1 hour of coronary occlusion followed by reperfusion, mice received 10 mg/kg per day of ivabradine dissolved in drinking water (n=10), or were treated as infarcted controls (n=9). Three-dimensional high-frequency echocardiography was performed at baseline and at days 2, 7, 14, and 28 post-MI. Speckle-tracking software was used to calculate intramural longitudinal myocardial strain (Ell) and strain rate. Standard deviation time to peak radial strain (SD Tpeak Err) and temporal uniformity of strain were calculated from short-axis cines acquired in the left ventricular remote zone. Ivabradine reduced heart rate by 8% to 16% over the course of 28 days compared to controls (P<0.001). On day 28 post-MI, the ivabradine group was found to have significantly smaller end-systolic volumes, greater ejection fraction, reduced wall thinning, and greater peak Ell and Ell rate in the remote zone, as well as globally. Temporal uniformity of strain and SD Tpeak Err were significantly smaller in the ivabradine-treated group by day 28 (P<0.05).. High-frequency ultrasound speckle-tracking demonstrated decreased left ventricular remodeling and dyssynchrony, as well as improved mechanical performance in remote myocardium after heart rate reduction with ivabradine.

Topics: Animals; Benzazepines; Cardiovascular Agents; Disease Models, Animal; Echocardiography; Heart Rate; Heart Ventricles; Ivabradine; Magnetic Resonance Imaging, Cine; Male; Mice; Mice, Inbred C57BL; Myocardial Contraction; Myocardial Infarction; Myocardial Reperfusion Injury; Ventricular Function, Left; Ventricular Remodeling

The treatment of in-stent restenosis (ISR) remains challenging. Small case series have described successful utilisation of bioresorbable vascular scaffolds (BVS) (Absorb; Abbott Vascular, Santa Clara, CA, USA) to treat ISR. We report our experience with this novel approach.. Patients with ISR in native coronary arteries undergoing percutaneous coronary intervention (PCI) for ISR were treated using BVS. A total of 84 ISR lesions were treated in 65 patients. The mean age was 66±11 years, 28% had acute coronary syndrome (ACS) and 28% were diabetic. PCI was successful in all patients and all scaffolds were delivered and deployed successfully in the target lesion. All 65 patients had six-month follow-up and 49 patients had 12-month clinical follow-up. The target lesion revascularisation (TLR) rate was 3.1% at six months and 12.2% at 12 months. The mean duration from PCI to TLR was 301±148 days. No scaffold thrombosis occurred during the study period.. This proof of concept study demonstrates that ISR treatment utilising BVS is feasible and appears to have acceptable target lesion failure rates. Prospective randomised trials are necessary to assess whether BVS are more effective than drug-eluting stents or drug-eluting balloons to treat ISR.

Topics: Absorbable Implants; Adult; Aged; Aged, 80 and over; Cardiovascular Agents; Coronary Artery Disease; Coronary Restenosis; Drug-Eluting Stents; Everolimus; Female; Humans; Male; Middle Aged; Myocardial Infarction; Percutaneous Coronary Intervention; Prospective Studies; Time Factors

α-Lipoic acid (LA) has been shown to offer protection against ischemia-reperfusion injury (IRI) in multiple organ systems. N-[(R)-1,2-dithiolane-3-pentanoyl]-L-glutamyl-L-alanine (CMX-2043), a novel analogue of LA, was studied as part of a preclinical development program intended to identify safe and efficacious drug candidates for prevention or reduction in myocardial IRI. This study was designed to evaluate the efficacy of CMX-2043 in an animal model of myocardial IRI and to establish effective dosing conditions. CMX-2043 or placebo was administered at different doses, routes, and times in male Sprague-Dawley rats subjected to 30-minute left coronary artery ligation. Fluorescent microsphere injection defined the area at risk (AR). Animals were euthanized 24 hours after reperfusion, and the hearts were excised, sectioned, and stained with triphenyltetrazolium. Cytoprotective effectiveness was determined by comparing the unstained myocardial infarction zone (MI) to the ischemic AR. The reduction in the MI-AR ratio was used as the primary measure of drug efficacy relative to placebo injections. Treatment with CMX-2043 reduced myocardial IRI as measured by the MI-AR ratio and the incidence of arrhythmia. The compound was effective when administered by injection, both before and during the ischemic injury and at reperfusion. The most efficacious dose was that administered 15 minutes prior to the ischemic event and resulted in a 36% (P < .001) reduction in MI-AR ratio compared to vehicle control.

Topics: Administration, Oral; Animals; Arrhythmias, Cardiac; Cardiovascular Agents; Cytoprotection; Dipeptides; Disease Models, Animal; Dose-Response Relationship, Drug; Drug Administration Schedule; Injections, Intravenous; Male; Myocardial Infarction; Myocardial Reperfusion Injury; Myocardium; Rats, Sprague-Dawley; Thioctic Acid

The long-term clinical impact of polymer-free sirolimus-eluting stents (PF-SES) in unselected patients undergoing percutaneous coronary intervention (PCI) still remains poorly investigated. We studied the long-term clinical impact of PF-SES in a large cohort of unselected patients receiving PCI therapy at two tertiary care centers in India.. A total of 3213 patients received PCI with drug-eluting stents during the period from December 2004 to September 2011. Among these, those receiving PF-SES implantation were retrospectively included in this registry. The primary endpoint in our study was the occurrence of major adverse cardiac events (MACE), defined as the composite of death/myocardial infarction (MI) and target lesion revascularization, whereas the main secondary endpoints were cardiac death/MI and definite/probable stent thrombosis.. A total of 1213 patients (83.8% men, 31.8% diabetics) with 1658 lesions (52.5% B2/C, according to the American College of Cardiology/American Heart Association classification) were studied. After a median follow-up of 1160 days, MACE occurred in 10.0% of patients, whereas the rates of cardiac death/MI and definite/probable ST were found to be 5.4 and 1.9%, respectively. The incidence of MACE was more common in patients aged at least 65 years [hazard ratio (HR)=1.69, 95% confidence interval (CI)=1.13-2.52, P=0.01] and diabetics (HR=1.71, 95% CI=1.18-2.47, P=0.004). The incidence of cardiac death/MI was more common in patients aged at least 65 years (HR=2.21, 95% CI=1.32-3.70, P=0.003). The baseline risk profile did not impact the occurrence of target lesion revascularization.. In this large cohort of unselected PCI patients treated in India, PF-SES shows a sustained safety and efficacy at long-term follow-up.

Topics: Aged; Cardiovascular Agents; Coronary Angiography; Coronary Artery Disease; Coronary Thrombosis; Drug-Eluting Stents; Female; Humans; Incidence; India; Kaplan-Meier Estimate; Male; Middle Aged; Myocardial Infarction; Percutaneous Coronary Intervention; Proportional Hazards Models; Prosthesis Design; Registries; Retrospective Studies; Risk Factors; Sirolimus; Tertiary Care Centers; Time Factors; Treatment Outcome

Acute Coronary Treatment and Intervention Outcomes Network Registry-Get With The Guidelines (ACTION Registry-GWTG) was designed to measure and improve the treatment and outcomes of patients with acute myocardial infarction (AMI), yet it is unknown whether performance of Medicare Hospital Compare metrics and outcomes differ between hospitals participating versus those not participating in the registry.. Using 2007 to 2010 Hospital Compare data, we matched participating to nonparticipating hospitals based on teaching status, size, percutaneous coronary intervention capability, and baseline (2007) Hospital Compare AMI process measure performance. We used linear mixed modeling to compare 2010 Hospital Compare process measure adherence, 30-day risk-adjusted mortality, and readmission rates. We repeated these analyses after stratification according to baseline performance level.. Compared with nonparticipating hospitals, those participating were larger (median 288 vs 139 beds, P < .0001), more often teaching hospitals (18.8% vs 6.3%, P < .0001), and more likely had interventional catheterization lab capabilities (85.7% vs 34.0%, P < .0001). Among 502 matched pairs of participating and nonparticipating hospitals, we found high levels of process measure adherence in both 2007 and 2010, with minimal differences between them. Rates of 30-day mortality and readmission in 2010 were also similar between both groups. Results were consistent across strata of baseline performance level.. In this observational analysis, there were no significant differences in the performance of Hospital Compare process measures or outcomes between hospitals in Acute Coronary Treatment and Intervention Outcomes Network Registry-Get With The Guidelines and other hospitals not in the registry. However, baseline performance on the Hospital Compare process measures was very high in both groups, suggesting the need for new quality improvement foci to further improve patient outcomes.

Topics: Adult; Aged; Cardiovascular Agents; Disease Management; Female; Guideline Adherence; Hospitals; Humans; Male; Middle Aged; Myocardial Infarction; Outcome and Process Assessment, Health Care; Percutaneous Coronary Intervention; Quality Indicators, Health Care; Registries; United States

Data on multiple bioresorbable vascular scaffolds (BVS) for the treatment of coronary lesions are limited. We compared clinical results after implantation of single or multiple BVS for the treatment of de-novo coronary artery disease.. We enrolled 236 patients with 311 lesions treated with Absorb BVS. Quantitative coronary angiography before and after scaffold implantation was performed. All lesions were predilated. Absorb was implanted with slow inflation and 81% were postdilated with a high-pressure balloon. Patients received dual antiplatelet therapy for 6 months for stable angina pectoris and for 12 months for acute coronary syndrome. Patients were clinically followed for 12 months. Acute gain was 1.39±0.47 mm. Multiple scaffolds per lesion were implanted in 23.8% (N=74/311 lesions). The mean scaffold length was 21 mm for single and 48 mm (range 28-112 mm) for multiple BVS. Periprocedural myocardial infarction (13.5 vs. 4.6%, P<0.013) and target lesion revascularization (6.8 vs. 0.8%; P=0.003) were significantly higher in the multiple-scaffold group compared with the single-scaffold group. There was no definite scaffold thrombosis. (http://www.clinicaltrials.gov, NCT02162056).. Target lesion revascularization within 12 months and periprocedural myocardial infarction were higher for lesions treated with multiple scaffolds compared with lesions treated with single BVS.

Topics: Absorbable Implants; Acute Coronary Syndrome; Aged; Angina, Stable; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coated Materials, Biocompatible; Coronary Angiography; Coronary Artery Disease; Drug Administration Schedule; Drug Therapy, Combination; Female; Germany; Humans; Male; Middle Aged; Myocardial Infarction; Platelet Aggregation Inhibitors; Prospective Studies; Prosthesis Design; Registries; Risk Factors; Time Factors; Treatment Outcome

Secondary preventive drug therapy following acute myocardial infarction (AMI) is recommended to reduce the risk of new cardiovascular events. The aim of this nationwide cohort study was to examine the initiation and long-term use of secondary preventive drugs after AMI.. The prescription of drugs in 42,707 patients < 85 years discharged alive from hospital after AMI in 2009-2013 was retrieved by linkage of the Norwegian Patient Register, the Norwegian Prescription Database, and the Norwegian Cause of Death Registry. Patients were followed for up to 24 months.. The majority of patients were discharged on single or dual antiplatelet therapy (91 %), statins (90 %), beta-blockers (82 %), and angiotensin-converting enzyme inhibitors (ACEI)/angiotensin receptor II blockers (ARB) (60 %). Patients not undergoing percutaneous coronary intervention (PCI) (42 %) were less likely to be prescribed secondary preventive drugs compared with patients undergoing PCI. This was particular the case for dual antiplatelet therapy (43 % vs. 87 %). The adherence to prescribed drugs was high: 12 months after index AMI, 84 % of patients were still on aspirin, 84 % on statins, 77 % on beta-blockers and 57 % on ACEI/ARB. Few drug and dose adjustments were made during follow-up.. Guideline-recommended secondary preventive drugs were prescribed to most patients discharged from hospital after AMI, but the percentage receiving such therapy was significantly lower in non-PCI patients. The long-time adherence was high, but few drug adjustments were performed during follow-up. More attention is needed to secondary preventive drug therapy in AMI patients not undergoing PCI.

Topics: Adrenergic beta-Antagonists; Aged; Aged, 80 and over; Angiotensin II Type 1 Receptor Blockers; Angiotensin-Converting Enzyme Inhibitors; Cardiovascular Agents; Drug Prescriptions; Drug Therapy, Combination; Female; Guideline Adherence; Humans; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Male; Medication Adherence; Middle Aged; Myocardial Infarction; Norway; Platelet Aggregation Inhibitors; Practice Guidelines as Topic; Registries; Secondary Prevention; Time Factors; Treatment Outcome

Topics: Angina, Unstable; Cardiovascular Agents; Coronary Artery Bypass; Female; Humans; Male; Myocardial Infarction; Percutaneous Coronary Intervention

Topics: Angina, Unstable; Cardiovascular Agents; Coronary Artery Bypass; Female; Humans; Male; Myocardial Infarction; Percutaneous Coronary Intervention

Topics: Angina, Unstable; Cardiovascular Agents; Coronary Artery Bypass; Female; Humans; Male; Myocardial Infarction; Percutaneous Coronary Intervention

Topics: Angina, Unstable; Cardiovascular Agents; Coronary Artery Bypass; Female; Humans; Male; Myocardial Infarction; Percutaneous Coronary Intervention

To the best of the authors' knowledge, very few publications are available which report on the prognostic significance of the culprit vessel in patients with ST elevation myocardial infarction treated with successful primary percutaneous coronary intervention.. The aim of the authors was to obtain data on the significance of the culprit vessel in patients with ST elevation myocardial infarction treated successfully by primary percutaneous coronary intervention.. The authors performed a retrospective study in 10,763 patients with ST elevation myocardial infarction who underwent successful primary percutaneous coronary intervention. The culprit vessels were the left main artery, left anterior descendent artery, left circumflex artery, and right coronary artery. The authors constructed univariate survival curves for different culprit vessels and also performed multivariate modelling of time-to-death, controlling for age, sex, and comorbidities.. The majority of the culprit lesions were found in the left anterior descendent artery (44.3%), the right coronary artery (40.9%), and the left circumflex artery (13.7%). The culprit vessel was overall a highly significant (p<0.0001) factor of survival, with right coronary artery exhibiting a highly significantly better prognosis (hazard ratio 0.69, 95% CI 0.61-0.79, p<0.0001) and left main artery exhibiting a significantly worse prognosis (hazard ratio 1.56, 95% CI 1.04-2.35, p = 0.0321) than the reference vessel (left anterior descendent artery).. These data demonstrate that the culprit vessel has independent prognostic significance. Orv. Hetil., 2016, 157(32), 1282-1288.

Topics: Adult; Aged; Cardiovascular Agents; Coronary Angiography; Coronary Disease; Coronary Vessels; Female; Heart Conduction System; Humans; Male; Middle Aged; Myocardial Infarction; Patient Discharge; Percutaneous Coronary Intervention; Predictive Value of Tests; Prognosis; Retrospective Studies; Secondary Prevention

The aim of the study was to evaluate the efficiency of invasive strategies for the treatment of 306 patients with recurrent myocardial infarction (IM) admitted to our clinic in 2003-2007. We compared the results of three approaches: various forms of transdermal coronary interventions (TDI) including delayed (24-72 hr) ones (n = 30), surgical myocardial revascularization within 8-12 weeks after the onset of recurrent myocardial infarction (n = 25), and conservative therapy (n = 251). Overall cardiovascular lethality was estimated during 5 years in 101 patients. It was shown that recurrent myocardial infarction is a predictor of high risk of death associated, in the absence of reperfusion therapy, with high intra-hospital and long-term lethality. TD1 soon after recurrent IM does not exclude possibility of its application in a later period. Various interventions including delayed ones markedly decrease the frequency of complications and lethal outcome that remains high in their absence. At the same time, severe lesions of the coronary bed in many patients with recurrent MI limit the possibility of using TDI and should be regarded as indications for planned surgical myocardial revascularization. Coronary bypass surgery after myocardial scarring prevents progress of left ventricle dysfunction, improves its contractility and increases life expectancy. Enhanced availability of reperfusion strategies in the form of TDI and/or delayed surgical myocardial revascularization opens up new possibilities for effective treatment of recurrent Ml.

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Artery Bypass; Female; Hospital Mortality; Humans; Long Term Adverse Effects; Male; Middle Aged; Myocardial Infarction; Recurrence; Retrospective Studies; Russia; Survival Analysis; Thrombolytic Therapy; Time-to-Treatment; Treatment Outcome

The HOPE-3-Trial investigated the effect of primary prevention on cardio- and neurovascular events in patients without known atherosclerotic disease, but with intermediate risk. In a factorial design Rosuvastatin 10 mg, Candesartan 16 mg/HCT 12.5 mg or both were compared with placebo. Rosuvastatin effectively lowered LDL-cholesterol and the rate of cardio- and neurovascular complications with a NNT of approximately 500/year without detectable effect on mortalitiy. Candesartan 16 mg/HCT 12.5 mg did not influence any endpoint, however, the predefined subgroup of patients with hypertension level I had a benefit. Patients with systolic pressure <131 mmHg even trended towards a higher risk if treated. The combination of statin and blood pressure-lowering agents showed no additive effects. The benefit was solely the result of statin therapy alone. Primary prevention with Rosuvastatin can be recommended if the cardio- and neurovascular risk is 1-2%/year, independent of the initial LDL, although the NNT of 500-1400/year is high and mortalitiy is not decreased. Possibly there will be future studies with longer term follow up to verify a reduction in mortality. Therapy with Candesartan 16 mg/HCT 12,5 mg has a beneficial effect only in patients with hypertension. Further studies with different antihypertensives and more intensive blood pressure lowering are desirable. The approach of combining all three drugs within a poly-pill for primary prevention in an intermediate risk population without elevated blood pressure is not recommended.

Topics: Cardiovascular Agents; Humans; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Hypertension; Myocardial Infarction; Stroke

Cardiovascular disease is one of the most common causes of death worldwide, with many individuals having experienced acute coronary syndrome (ACS). How patients with a history of ACS value aspects of their medical treatment have been evaluated rarely. The aim of this study was to determine patient priorities for long-term drug therapy after experiencing ACS.. To identify patient-relevant treatment characteristics, a systematic literature review and qualitative patient interviews were conducted. A questionnaire was developed to elicit patient's priorities for different characteristics of ACS treatment using Analytic Hierarchy Process (AHP). To evaluate the patient-relevant outcomes, the eigenvector method was applied.. Six-hundred twenty-three patients participated in the computer-assisted personal interviews and were included in the final analysis. Patients showed a clear priority for the attribute "reduction of mortality risk" (weight: 0.402). The second most preferred attribute was the "prevention of a new myocardial infarction" (weight: 0.272), followed by "side effect: dyspnea" (weight: 0.165) and "side effect: bleeding" (weight: 0.117). The "frequency of intake" was the least important attribute (weight: 0.044).. In conclusion, this study shows that patients strongly value a reduction of the mortality risk in post-ACS treatment. Formal consideration of patient preferences and priorities can help to inform a patient-centered approach, clinical practice, development of future effective therapies, and health policy for decision makers that best represents the needs and goals of the patient.

Topics: Acute Coronary Syndrome; Adult; Aged; Aged, 80 and over; Body Mass Index; Cardiovascular Agents; Decision Support Techniques; Female; Humans; Male; Middle Aged; Myocardial Infarction; Patient Acceptance of Health Care; Patient Preference; Risk Factors; Socioeconomic Factors

There is little evidence regarding the efficacy and safety of bioresorbable scaffolds (BRS) for the percutaneous treatment of chronic total occlusions.. We performed a multicenter registry of consecutive chronic total occlusion patients treated with BRS (Absorb; Abbott Vascular) and second-generation drug-eluting stents (DES) at 5 institutions. Long-term target-vessel failure (a composite of cardiac death, target-vessel myocardial infarction, and ischemia-driven target-lesion revascularization) was the primary end point. Inverse probability of treatment weight-adjusted Cox regression was used to account for pretreatment differences between the 2 groups. A total of 537 patients (n=153 BRS; n=384 DES) were included. BRS patients were younger and had lower prevalence of comorbidities. Overall mean Japan-Chronic Total Occlusion (J-CTO) score was 1.43±1.16, with no differences between groups. Procedural success was achieved in 99.3% and 96.6% of BRS- and DES-treated patients, respectively (P=0.07). At a median follow-up of 703 days, there were no differences in target-vessel failure between BRS and DES (4.6% versus 7.7%; P=0.21). By adjusted Cox regression analysis, there were still no significant differences between BRS and DES (hazard ratio, 1.54; 95% confidence interval, 0.69-3.72; P=0.34). However, secondary analyses suggested a signal toward higher ischemia-driven target-lesion revascularization with BRS.. Implantation of BRS versus second-generation DES in chronic total occlusion was associated with similar risk of target-vessel failure at long-term follow-up. However, a signal toward increased ischemia-driven target-lesion revascularization with BRS was observed. Large randomized studies should confirm these findings.

Topics: Absorbable Implants; Aged; Cardiovascular Agents; Chi-Square Distribution; Chronic Disease; Coated Materials, Biocompatible; Comorbidity; Coronary Angiography; Coronary Occlusion; Drug-Eluting Stents; Female; Humans; Kaplan-Meier Estimate; Logistic Models; Male; Middle Aged; Multivariate Analysis; Myocardial Infarction; Percutaneous Coronary Intervention; Propensity Score; Proportional Hazards Models; Prosthesis Design; Registries; Risk Factors; Time Factors; Treatment Outcome

Topics: Adrenergic beta-Antagonists; Cardiovascular Agents; Humans; Myocardial Infarction; Treatment Outcome

Plasma norepinephrine (NE) and brain natriuretic peptide (BNP, termed BNP-45 in rats) are considered as essential neurohormones indicating heart failure progression. The purposes of this study were to examine the effects of ivabradine (IBD) on cardiac function and plasma NE and BNP-45 after chronic ischemic heart failure (CHF) in non-diabetic rats and diabetic rats. We further determined if sympathetic NE uptake-1 (a major pathway to metabolize NE) mechanism is responsible for the role played by IBD.. We ligated rat's coronary artery to induce CHF; and injected streptozotocin (STZ) to induce diabetic hyperglycemia. Echocardiography was employed to determine cardiac function. We used ELISA to examine plasma NE and BNP-45; and Western Blot analysis to examine the protein levels of NE uptake-1 in sympathetic nerves.. CHF increased the levels of NE and BNP-45 in non-STZ rats and STZ rats. Systemic injection of IBD significantly attenuated the augmented NE and BNP-45 and impaired left ventricular function induced by CHF in those rats. This effect appeared to be less in STZ rats. A liner relation was observed between the NE/BNP-45 levels and left ventricular function after administration of IBD. Also, IBD was observed to have a recovery effect on the downregulated NE uptake-1 evoked by CHF, but to a smaller degree in STZ rats.. Our data revealed specific signaling mechanisms by which IBD improves the cardiac function as IBD alleviates impaired NE uptake-1and thereby decreases heightened NE and BNP-45 induced by CHF. Our data also demonstrated that the effects of IBD are weakened after diabetic hyperglycemia likely due to worsen NE uptake-1 pathway. Thus, targeting sympathetic NE uptake-1 signaling molecules has clinical implications for treatment and management of CHF in diabetes. Our data were also to shed light on strategies for application of this drug because NE and BNP play an important role in regulation of progression and prognosis of CHF, and in particular, because IBD affects NE uptake-1 pathway in hyperglycemic animals to a less degree.

Topics: Animals; Benzazepines; Cardiovascular Agents; Coronary Vessels; Diabetes Mellitus, Experimental; Disease Models, Animal; Echocardiography; Heart Failure; Heart Function Tests; Hyperglycemia; Ivabradine; Ligation; Male; Myocardial Infarction; Nerve Tissue Proteins; Norepinephrine; Rats; Rats, Sprague-Dawley; Signal Transduction; Streptozocin

A number of registry studies have reported suboptimal adherence to guidelines for cardiovascular prevention during the first year after acute myocardial infarction (AMI). However, only a few studies have addressed long-term secondary prevention after AMI. This study evaluates prevention guideline adherence and outcome of guideline-directed secondary prevention in patients surviving 2 years after AMI.. Patients aged 18-85 years at the time of their index AMI were consecutively identified from hospital discharge records between July 2010 and December 2011 in Gothenburg, Sweden. All patients who agreed to participate in the study (16.2%) were invited for a structured interview, physical examinations and laboratory analysis 2 years after AMI. Guideline-directed secondary preventive goals were defined as optimally controlled blood pressure, serum cholesterol, glucose, regular physical activity, smoking cessation and pharmacological treatment.. The mean age of the study cohort (n = 200) at the index AMI was 63.0 ± 9.7 years, 79% were men. Only 3.5% of the cohort achieved all six guideline-directed secondary preventive goals 2 years after infarction. LDL < 1.8 mmol/L was achieved in 18.5% of the cohort, regular exercise in 45.5% and systolic blood pressure <140 mmHg in 57.0%. Anti-platelet therapy was used by 97% of the patients, beta-blockers by 83.0%, angiotensin-converting enzyme inhibitors/angiotensin receptor blockers by 76.5% and statins by 88.5%. During follow-up, non-fatal adverse cardiovascular events (cardiac hospitalization, recurrent acute coronary syndrome, angina pectoris, new percutaneous coronary intervention, new onset of atrial fibrillation, post-infarct heart failure, pacemaker implantation, stroke/transient ischemic attack (TIA), cardiac surgery and cardiac arrest) occurred in 47% of the cohort and readmission due to cardiac causes in 30%.. Our data showed the failure of secondary prevention in our daily clinical practice and high rate of non-fatal adverse cardiovascular events 2 years after AMI.

Topics: Adolescent; Adult; Aged; Aged, 80 and over; Cardiovascular Agents; Female; Guideline Adherence; Health Status; Humans; Life Style; Male; Mental Health; Middle Aged; Myocardial Infarction; Patient Compliance; Patient Discharge Summaries; Practice Guidelines as Topic; Practice Patterns, Physicians'; Process Assessment, Health Care; Risk Assessment; Risk Factors; Risk Reduction Behavior; Secondary Prevention; Sweden; Time Factors; Treatment Outcome; Young Adult

We assessed long-term outcomes in patients with extra-small (XS) (≤2.25 mm) and small vessels (SV) (>2.25-2.75 mm) treated with the Resolute zotarolimus-eluting stent (R-ZES).. Data from eight studies including patients with XS or SV were pooled for this analysis. Among 2,141 patients (837 XS, 1,304 SV), three-year cumulative major adverse cardiac events (15.4% vs. 11.5%; adj. HR [95% CI]: 1.3 [1.0, 1.7], p=0.12), target lesion failure (12.4% vs. 9.3%, adj. HR: 1.1 [0.8, 1.5], p=0.56), and target lesion revascularisation (TLR: 6.9% vs. 4.5%, adj. HR 1.4 [0.9, 2.1], p=0.17) were greater in the XS cohort but were not significantly different after propensity adjustment. Target vessel revascularisation occurred more frequently in XS patients in both unadjusted and adjusted analyses (11.2% vs. 7.6%, adj. HR: 1.5 [1.1, 2.1], p=0.02). Stent thrombosis was low in both cohorts (1.2% vs. 0.6%, p=0.09). In the XS cohort, insulin-dependent diabetics had over twofold higher rates of TLR than non-diabetics (13.6% vs. 6.0%, p=0.02).. Long-term lesion-specific results among patients with XS vessels treated with the R-ZES were not significantly different from those among patients with SV, but specific patients with XS vessels (e.g., insulin-dependent diabetics) may remain at high risk for TLR.

Topics: Adult; Aged; Aged, 80 and over; Cardiovascular Agents; Coronary Restenosis; Coronary Thrombosis; Drug-Eluting Stents; Female; Humans; Male; Middle Aged; Myocardial Infarction; Percutaneous Coronary Intervention; Sirolimus; Treatment Outcome

to analyze causes of attacks of angina pectoris and assess impact of optimization of antianginal therapy on frequency of attacks provoked by various factors.. We analyzed diaries of 1226 survivors of myocardial infarction (MI) which occurred within 12months before inclusion in the LINKOR program. Causes of pain and their changes with correction of antianginal therapy were registered during 16 weeks of follow-up.. Participants of the study indicated the following factors as causes of pain: physical exertion (74.9%), psycho-emotional stress (52.6%), meteorological factors (25.9%), elevation of arterial pressure(AP) (18.8%), meals (12.1%), alcohol intake (4.7%), sexual activity (4.4%). Attacks at rest in wakeful state and during sleep were reported by 4.5 and 4.5% of patients, respectively. Prescription of ivabradine and in some cases correction of antihypertensive therapy led to double reduction of the number of patients who indicated physical exertion as a cause of angina. Numbers of patients with attacks caused by meals, AP elevation, psycho-emotional stress, alcohol intake, unfavorable meteorological conditions, and sexual activity decreased by 83.2, 75, 63.3, 63.6, 61.3, and 60.9%, respectively. Numbers of patients with attacks at rest in wakeful state, and at night decreased by 79.8 and 69%, respectively. More than two thirds of patients achieved class I of angina.. Optimization of antianginal therapy directed to lowering or myocardial oxygen consumption leads to reduction of frequency of attacks of pain caused by various triggers. This improves quality of life, increases everyday activity, secures independence, and loweres risk of depression and anxiety.

Topics: Aged; Angina Pectoris; Benzazepines; Cardiovascular Agents; Female; Humans; Ivabradine; Male; Middle Aged; Myocardial Infarction; Physical Exertion; Quality of Life; Risk Factors

While patients with diabetes mellitus (DM) have more extensive coronary disease and worse survival after acute myocardial infarction (AMI) than patients without DM, data on whether they experience more angina are conflicting.. We examined angina prevalence over the year following AMI among 3367 patients, including 1080 (32%) with DM, from 24 US hospitals enrolled in the TRIUMPH registry from 2005 to 2008.. Patients with vs. without DM were more likely to be treated with antianginal medications both at discharge and over follow up. Despite more aggressive angina therapy, patients with vs. without DM had higher prevalence and severity of angina prior to AMI (49 vs. 43%, p = 0.001) and at each follow-up assessment, although rates of angina declined in both groups over time. In a hierarchical, multivariable, repeated-measures model that adjusted for multiple demographic and clinical factors including severity of coronary disease and in-hospital revascularization, DM was associated with a greater odds of angina over the 12 months of follow up; this association increased in magnitude over time (12-month OR 1.18, 95% CI 1.01-1.37; DM*time pinteraction = 0.008).. Contrary to conventional wisdom, angina is more prevalent and more severe among patients with DM, both prior to and following AMI. This effect is amplified over time and independent of patient and treatment factors, including the presence of multivessel disease and coronary revascularization. This increased burden of angina may be due to more diffuse nature of coronary disease, more rapid progression of coronary disease over time, or greater myocardial demand among DM patients.

Topics: Aged; Angina Pectoris; Cardiovascular Agents; Coronary Artery Disease; Diabetes Mellitus; Female; Health Status; Humans; Hypoglycemic Agents; Male; Middle Aged; Multivariate Analysis; Myocardial Infarction; Odds Ratio; Prevalence; Prognosis; Prospective Studies; Registries; Risk Factors; Severity of Illness Index; Surveys and Questionnaires; Time Factors; United States

To assess the clinical outcome at 1-year follow-up of real-world patients with long coronary lesions treated with the 38 mm Xience Prime (Abbott Vascular) everolimus-eluting stent (EES).. Long-lesions present special challenges to the interventional cardiologists, including increased risk of restenosis, periprocedural injury, geographical miss, and stent deliverability. Indeed, results obtained with shorter stent in the treatment of simpler lesions are of limited applicability to longer stents.. Consecutive patients presenting with a long coronary lesion treated by percutaneous coronary intervention with at least one implanted 38 mm EES were enrolled in the study. Their clinical data were prospectively registered. Major adverse cardiac events (MACE) were defined as a composite of cardiac death, nonfatal myocardial infarction (according to the Universal Definition) and target vessel revascularization. Stent thrombosis was defined according to the Academic Research Consortium criteria.. Overall, 203 real-world patients (152 men, 68 ± 9 years) were enrolled in the P38 Study. At 1-year follow-up, 6 (3.0%) patients had died from cardiac causes, 7 (3.4%) had a nonfatal myocardial infarction and 8 (3.9%) underwent target vessel revascularization, yielding a 10.3% cumulative rate of MACE. Two patients had a stent thrombosis (one definite and one probable). No significant differences in event rates were found between patients with and without an additional stent implanted overlapping the 38 mm one.. The use of a new-generation polymer-based 38 mm EES in a real-world population with unselected long lesions is associated with excellent procedural results and good clinical outcomes at 12-month follow-up.

Topics: Aged; Cardiovascular Agents; Coronary Artery Disease; Coronary Thrombosis; Drug-Eluting Stents; Everolimus; Female; Follow-Up Studies; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Myocardial Infarction; Percutaneous Coronary Intervention; Polymers; Prospective Studies; Prosthesis Design; Registries; Risk Factors; Sirolimus; Time Factors; Treatment Outcome

To compare the early clinical outcomes between ABSORB bioresorbable vascular scaffold (BVS) (Abbott Vascular, Santa Clara, CA) and cobalt chromium everolimus-eluting stents in real-world patients with mostly complex disease.. BVS represents the most interesting development in the drug-eluting stent field over recent years with promising results emerging from clinical trials. Available data however on the use of the ABSORB in real-world patients is limited.. All patients (n = 92) treated with BVS and 1296 patients treated with EES were included in this study. Propensity score matching was performed to adjust for differences in baseline clinical characteristics, yielding 92 patient pairs (BVS = 92 patients with 137 lesions and EES = 92 patients with 124 lesions). Clinical outcomes were examined between the 2 groups at 6-months.. In both groups, most lesions were classified as either B2 or C (83.9% vs. 77.4%, P = 0.19). Predilatation (97.8% vs. 75.8%, P < 0.01) as well as postdilation (99.3% vs. 77.4%, P < 0.01) was more common in the BVS group. Clinical outcomes at 6-months were similar between the two groups with respect to both target lesion revascularization (3.3% vs. 5.4%, P = 0.41) and major adverse cardiac events (defined as the composite of target vessel revascularization, follow-up myocardial infraction and all-cause death) (3.3% vs. 7.6%, P = 0.19).. ABSORB BVS for the treatment of complex lesions appears to be associated with good procedural and early clinical outcomes similar to those observed with conventional drug-eluting stents. Larger studies with long-term follow-up are required in order to fully assess the role of BVS in the treatment of such lesions and how this compares with that of conventional stents. © 2014 Wiley Periodicals, Inc.

Topics: Absorbable Implants; Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Chi-Square Distribution; Chromium Alloys; Coronary Angiography; Coronary Artery Disease; Drug-Eluting Stents; Everolimus; Female; Humans; Italy; Logistic Models; Male; Middle Aged; Myocardial Infarction; Propensity Score; Prosthesis Design; Retrospective Studies; Risk Factors; Sirolimus; Stents; Time Factors; Tomography, Optical Coherence; Treatment Outcome; Ultrasonography, Interventional

Besides early percutaneous coronary intervention (PCI) long-term medical treatment is crucial for outcomes after ST-elevation myocardial infarction (STEMI). The present study aimed to identify predictors of adherence to evidence-based medication in this high risk population.. A total of 1025 consecutive patients with adjudicated STEMI treated by primary PCI in a single centre as part of the Cologne Infarction Model (KIM) were prospectively analysed. Gender-specific multivariate predictors of long-term medication adherence were identified. Follow-up with available information on drug use was completed for 610 of 738 (82.7%) patients confirmed to be alive after a median period of 36 months. Adherence was persistently high for evidence-based medication with 90.8% for acetylsalicylic acid (ASA), 88.2% for statins, 87.5% for beta-blockers and 79.2% for ACE-inhibitors or angiotensin-receptor blockers (ARBs). Patients with a history of heart failure had a higher medication adherence to beta-blockers, ACE-inhibitors/ARBs and diuretics, whereas long-term prescription rates for calcium channel blockers (CCBs) were lower in patients with reduced versus preserved ejection fraction. Patients with a history of hypertension presented higher medication adherence to CCBs, ACE-inhibitors/ARBs and diuretics but not to beta-blockers. On multivariate analysis, age, body mass index (BMI), hypertension, chronic kidney disease and lack of PCI were independently associated with prescription of diuretics at follow-up. In women, adherence was lower to beta-blockers and higher to CCBs compared to men.. In the high risk population of STEMI patients long-term adherence to evidence-based medication is high. The lower adherence to beta-blockers and higher prescription rate for CCBs in women needs particular attention.

Topics: Aged; Aged, 80 and over; Cardiovascular Agents; Chi-Square Distribution; Drug Prescriptions; Female; Germany; Humans; Logistic Models; Male; Medication Adherence; Middle Aged; Multivariate Analysis; Myocardial Infarction; Percutaneous Coronary Intervention; Prospective Studies; Registries; Risk Factors; Sex Factors; Time Factors; Treatment Outcome

Topics: Cardiovascular Agents; Coronary Aneurysm; Coronary Angiography; Coronary Thrombosis; Drug Therapy, Combination; Echocardiography; Electrocardiography; Female; Humans; Middle Aged; Myocardial Infarction; Tomography, X-Ray Computed; Treatment Outcome

To evaluate the performance of biolimus-eluting stent (BES) in patients with ST-elevation myocardial infarction (STEMI) undergoing percutaneous coronary intervention (PCI) in a real world clinical scenario.. Randomized studies suggest that the BES with biodegradable polymer is more effective and safe than early generation coronary stents in patients with STEMI.. We included all consecutive STEMI patients undergoing PCI in this prospective, multicenter registry. The primary endpoint of the study was the rate of major adverse cardiac events (MACE), a composite of cardiac death, recurrent myocardial infarction and ischemia-driven target vessel revascularization at 1-year follow-up.. Between June and December 2012 we enrolled 311 STEMI patients. The primary endpoint occurred in 3.2% (95% confidence interval: 1.6-5.8) of patients: cardiac death, re-infarction, and ischemia-driven TVR occurred in 2.3%, 1.3%, and 0.6% of patients, respectively. One-year MACE-free survival was 96.8% ± 1.0%.. In a real-world cohort of STEMI patients undergoing PCI, the use of BES is associated with good 1-year clinical outcome. These results confirm and expand previous findings showing the efficacy and safety of BES in the setting of randomized trials.

Topics: Aged; Cardiovascular Agents; Disease-Free Survival; Drug-Eluting Stents; Female; Humans; Italy; Kaplan-Meier Estimate; Male; Middle Aged; Myocardial Infarction; Percutaneous Coronary Intervention; Prospective Studies; Prosthesis Design; Recurrence; Registries; Risk Factors; Sirolimus; Time Factors; Treatment Outcome

Bioresorbable vascular scaffold (BVS) implantation is a new, promising treatment method of coronary artery disease. Preliminary data in patients with stable angina are encouraging. However, the utility of BVS was not sufficiently evaluated in the setting of acute thrombotic lesions. The aim of this study was an optical coherence tomography (OCT) assessment of acute procedural result of the everolimus-eluting BVS implantation in patients with ST segment elevation myocardial infarction (STEMI) and evaluation of mid-term clinical outcomes.. OCT examination was conducted in 23 STEMI patients who underwent primary angioplasty with BVS implantation. Off-line qualitative and quantitative coronary angiography and OCT analyses were performed by an independent core laboratory.. Successful procedural and clinical results were achieved in 95.7% of patients, and device success was observed in all patients. In OCT evaluation, most of the struts (95.4 ± 7.96%) were well apposed, 4.6 ± 5.71% were classified as malapposed. The final minimum lumen diameter was 2.6 ± 0.35 mm, minimum scaffold area was 6.9 ± 1.54 mm² and final residual stenosis was 8.8 ± 24.37%. Edge dissections were found in 3 (7.7%) lesions. Median follow-up period was 229 (interquartile range 199-248) days. One myocardial infarction, due to sub-acute stent thrombosis, occurred in a patient who discontinued pharmacotherapy.. The study shows that everolimus-eluting BVS implantation in STEMI is safe and feasible. The OCT evaluation confirmed excellent acute performance with appropriate scaffold expansion and low rate of malapposition.

Topics: Absorbable Implants; Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coated Materials, Biocompatible; Coronary Angiography; Coronary Vessels; Everolimus; Female; Humans; Male; Middle Aged; Myocardial Infarction; Pilot Projects; Poland; Predictive Value of Tests; Prospective Studies; Prosthesis Design; Registries; Time Factors; Tomography, Optical Coherence; Treatment Outcome

To describe drug adherence and treatment goals, and to identify the independent predictors of smoking persistence and unsatisfactory lifestyle habits six months after an acute myocardial infarction (AMI).. 11,706 patients with AMI (30% female, mean age 68 years) were enrolled in 163 large-volume coronary care units (CCUs). At six months, drug adherence was ≥90%, while blood pressure (BP) <140/90 mmHg, low density lipoprotein (LDL) <100 mg/dl (in patients on statins), HbA1c <7% (in treated diabetics), and smoking persistence were observed in 74%, 76%, 45%, and 27% of patients, respectively. Inadequate fish intake decreased from 73% to 55%, inadequate intake of fruit and vegetables from 32% to 23%, and insufficient exercise in eligible patients from 74% to 59% (p < 0.0001). At multivariable analysis, a post-discharge cardiac visit and referral to cardiac rehabilitation at follow-up were independently associated with a lower risk of insufficient physical exercise (odds ratio (OR) 0.71 and 0.70, respectively) and persistent smoking (OR 0.68 and 0.60), whereas only referral to cardiac rehabilitation was associated with a lower risk of inadequate fish and fruit/vegetable intake (OR 0.70 and 0.65).. Six months after an AMI, despite a high adherence to drug treatments, BP, LDL, and diabetic goals are inadequately achieved. Subjects with healthy lifestyles improved after discharge, but the rate of those with regular exercise habits and adequate fish intake could be further improved. Access to post-discharge cardiac visit and referral to cardiac rehabilitation were associated with better adherence to healthy lifestyles. Knowledge of the variables associated with specific lifestyle changes may help in tailoring secondary prevention programmes.

Topics: Aged; Aged, 80 and over; Antihypertensive Agents; Cardiovascular Agents; Chi-Square Distribution; Diet; Exercise; Female; Habits; Health Knowledge, Attitudes, Practice; Health Services Accessibility; Humans; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Hypoglycemic Agents; Italy; Logistic Models; Male; Medication Adherence; Middle Aged; Multivariate Analysis; Myocardial Infarction; Odds Ratio; Practice Guidelines as Topic; Referral and Consultation; Registries; Risk Assessment; Risk Factors; Risk Reduction Behavior; Secondary Prevention; Smoking; Smoking Cessation; Smoking Prevention; Time Factors; Treatment Outcome

Few data exist on the recent trends in the outcome of women hospitalized with acute coronary syndrome. We examined temporal trends in the hospital management and outcomes of women hospitalized with acute coronary syndrome in a real-world setting.. We evaluated time-dependent changes in the clinical characteristics, management strategies, and outcomes of women enrolled in the Acute Coronary Syndrome Israeli Surveys (ACSIS) between 2000 and 2010. Periods were categorized as early (2000-2004) and late (2006-2010).. Among 11,536 patients enrolled in ACSIS, 2710 (24%) were women. Frequency of women presenting with acute coronary syndrome had declined from 25% in 2000 to 22% in 2010 (P for trend = .002). Women presented less frequently with ST-elevation myocardial infarction and more frequently with associated comorbidities (P < .001 for both). There was no significant reduction in the time delay from symptom onset to emergency department between early and late periods (median: 128 vs 125 minutes; P = .86). This was further reflected in no increase in the frequency of women meeting the goal of door-to-balloon time of ≤90 minutes. The utilization of evidence-based cardiovascular therapies had increased significantly over the past decade (P < .001 for all). After multivariate adjustment, admission in the late surveys was associated with a significant reduction in 30-day major adverse cardiac events and 1-year mortality (hazard ratio 0.76; 95% confidence interval, 0.65-0.9, and 0.73; 0.59-0.89, respectively).. Despite increased frequency of comorbidities and lack of change in time to admission among women hospitalized with acute coronary syndrome, temporal change in management strategies over the last decade may have contributed to improved outcomes in this population.

Topics: Acute Coronary Syndrome; Aged; Aged, 80 and over; Cardiovascular Agents; Comorbidity; Coronary Care Units; Diabetes Mellitus; Disease Management; Female; Hospital Mortality; Humans; Hypertension; Israel; Middle Aged; Myocardial Infarction; Odds Ratio; Patient Admission; Registries; Time-to-Treatment; Treatment Outcome

Despite 4 decades of intense effort and substantial financial investment, the cardioprotection field has failed to deliver a single drug that effectively reduces myocardial infarct size in patients. A major reason is insufficient rigor and reproducibility in preclinical studies.. To develop a multicenter, randomized, controlled, clinical trial-like infrastructure to conduct rigorous and reproducible preclinical evaluation of cardioprotective therapies.. With support from the National Heart, Lung, and Blood Institute, we established the Consortium for preclinicAl assESsment of cARdioprotective therapies (CAESAR), based on the principles of randomization, investigator blinding, a priori sample size determination and exclusion criteria, appropriate statistical analyses, and assessment of reproducibility. To validate CAESAR, we tested the ability of ischemic preconditioning to reduce infarct size in 3 species (at 2 sites/species): mice (n=22-25 per group), rabbits (n=11-12 per group), and pigs (n=13 per group). During this validation phase, (1) we established protocols that gave similar results between centers and confirmed that ischemic preconditioning significantly reduced infarct size in all species and (2) we successfully established a multicenter structure to support CAESAR's operations, including 2 surgical centers for each species, a Pathology Core (to assess infarct size), a Biomarker Core (to measure plasma cardiac troponin levels), and a Data Coordinating Center-all with the oversight of an external Protocol Review and Monitoring Committee.. CAESAR is operational, generates reproducible results, can detect cardioprotection, and provides a mechanism for assessing potential infarct-sparing therapies with a level of rigor analogous to multicenter, randomized, controlled clinical trials. This is a revolutionary new approach to cardioprotection. Importantly, we provide state-of-the-art, detailed protocols ("CAESAR protocols") for measuring infarct size in mice, rabbits, and pigs in a manner that is rigorous, accurate, and reproducible.

Topics: Animals; Biomarkers; Cardiovascular Agents; Cooperative Behavior; Disease Models, Animal; Drug Evaluation, Preclinical; Female; Guidelines as Topic; Humans; Ischemic Preconditioning, Myocardial; Male; Mice; Myocardial Infarction; Myocardium; National Heart, Lung, and Blood Institute (U.S.); Predictive Value of Tests; Rabbits; Reproducibility of Results; Research Design; Species Specificity; Swine; Time Factors; Troponin I; United States

A Site-specifically PEGylated exendin-4 (denoted as PEG-Ex4) is an exendin-4 (denoted as Ex4) analog we developed by site-specific PEGylation of exendin-4 with a high molecular weight trimeric poly(ethylene glycol) (tPEG). It has been shown to possess prolonged half-life in vivo with similar receptor binding affinity compared to unmodified exendin-4 by our previous work. This study is sought to test whether PEG-Ex4 is suitable for treating myocardial infarction (MI). In the MI model, PEG-Ex4 was administered every 3 days while equivalent amount of Ex4 was administered every 3 days or twice daily. Animal survival rate, heart function, remodeling and neoangiogenesis were evaluated and compared. Tube formation was examined in endothelial cells. In addition, Western blotting and histology were performed to determine the markers of cardiac hypertrophy and angiogenesis and to explore the possible molecular mechanism involved. PEG-Ex4 and Ex4 showed comparable binding affinity to GLP-1 receptor. In MI mice, PEG-Ex4 given at 3 days interval achieved similar extent of protection as Ex4 given twice daily, while Ex4 given at 3 days interval failed to produce protection. PEG-Ex4 elevated endothelial tube formation in vitro and capillary density in the border area of MI. PEG-Ex4 increased Akt activity and VEGF production in a GLP-1R dependent manner in endothelial cells and antagonism of GLP-1R, Akt or VEGF abolished the protection of PEG-Ex4 in the MI model. PEG-Ex4 is a potent long-acting GLP-1 receptor agonist for the treatment of chronic heart disease. Its protection might be attributed to enhanced angiogenesis mediated by the activation of Akt and VEGF.

Topics: Aminophylline; Animals; Atropine; Blotting, Western; Cardiovascular Agents; Disease Models, Animal; Drug Combinations; Exenatide; Glucagon-Like Peptide 1; Heart; Heart Function Tests; Histocytochemistry; Male; Mice, Inbred C57BL; Myocardial Infarction; Myocardium; Neovascularization, Physiologic; Nitroglycerin; Papaverine; Peptides; Phenobarbital; Survival Analysis; Treatment Outcome; Venoms

The purpose of this study was to compare the 1-year outcome between bioresorbable vascular scaffold (BVS) and everolimus-eluting metallic stent (EES) in ST-segment elevation myocardial infarction (STEMI) patients.. The Absorb BVS (Abbott Vascular, Santa Clara, California) is a polymeric scaffold approved for treatment of stable coronary lesions. Limited and not randomized data are available on its use in ST-segment elevation myocardial infarction (STEMI) patients.. This study included 290 consecutive STEMI patients treated by BVS, compared with either 290 STEMI patients treated with EES or 290 STEMI patients treated with bare-metal stents (BMS) from the EXAMINATION (A Clinical Evaluation of Everolimus Eluting Coronary Stents in the Treatment of Patients With ST-segment Elevation Myocardial Infarction) trial, by applying propensity score matching. The primary endpoint was a device-oriented endpoint (DOCE), including cardiac death, target vessel myocardial infarction, and target lesion revascularization, at 1-year follow-up. Device thrombosis, according to the Academic Research Consortium criteria, was also evaluated.. The cumulative incidence of DOCE did not differ between the BVS and EES or BMS groups either at 30 days (3.1% vs. 2.4%, hazard ratio [HR]: 1.31 [95% confidence interval (CI): 0.48 to 3.52], p = 0.593; vs. 2.8%, HR: 1.15 [95% CI: 0.44 to 2.30], p = 0.776, respectively) or at 1 year (4.1% vs. 4.1%, HR: 0.99 [95% CI: 0.23 to 4.32], p = 0.994; vs. 5.9%, HR: 0.50 [95% CI: 0.13 to 1.88], p = 0.306, respectively). Definite/probable BVS thrombosis rate was numerically higher either at 30 days (2.1% vs. 0.3%, p = 0.059; vs. 1.0%, p = 0.324, respectively) or at 1 year (2.4% vs. 1.4%, p = 0.948; vs. 1.7%, p = 0.825, respectively), as compared with EES or BMS.. At 1-year follow-up, STEMI patients treated with BVS showed similar rates of DOCE compared with STEMI patients treated with EES or BMS, although rate of scaffolds thrombosis, mostly clustered in the early phase, was not negligible. Larger studies with longer follow-up are needed to confirm our findings.

Topics: Absorbable Implants; Adult; Aged; Cardiovascular Agents; Coronary Thrombosis; Databases, Factual; Drug-Eluting Stents; Everolimus; Female; Humans; Kaplan-Meier Estimate; Logistic Models; Male; Metals; Middle Aged; Myocardial Infarction; Percutaneous Coronary Intervention; Propensity Score; Proportional Hazards Models; Prosthesis Design; Recurrence; Retrospective Studies; Risk Factors; Sirolimus; Time Factors; Treatment Outcome

Topics: Absorbable Implants; Cardiovascular Agents; Drug-Eluting Stents; Female; Humans; Male; Metals; Myocardial Infarction; Percutaneous Coronary Intervention; Sirolimus

Topics: Angina, Unstable; Cardiovascular Agents; Communication Barriers; Early Medical Intervention; Humans; Myocardial Infarction; Translational Research, Biomedical

The use of evidence-based therapies has improved the outcome of patients with acute coronary syndrome (ACS), but there is a time lag between the generation of clinical evidence and its application in routine clinical practice. We sought to quantify temporal lags in the lifecycle of American College of Cardiology (ACC)/American Heart Association (AHA) class IA ACS therapies.. Using current and historical ACC/AHA guideline publications, we retrieved publication dates of pivotal clinical trials (PCTs) and class IA guideline-recommended therapies for patients with ST-elevation myocardial infarction (STEMI) and unstable angina (UA)/non-STEMI (NSTEMI). Clinical practice uptake data for each therapy were retrieved from the National Registry for Myocardial Infarction, Can Rapid Risk Stratification of Unstable Angina Patients Suppress Adverse Outcomes with Early Implementation of the ACC/AHA Guidelines, and Acute Coronary Treatment and Intervention Outcomes Network Registry-Get with the Guidelines, which are registries containing publicly available peer-reviewed data. Descriptive data were calculated and compared for each phase of the evidence lifecycle for both STEMI and UA/NSTEMI drug classifications.. We identified 11 class IA- and 4 class IB/IC-recommended therapies for acute, inhospital, and discharge use for patients with STEMI or UA/NSTEMI. The median time lags were 2 years (interquartile range [IQR], 1-4 years) from PCT to practice guideline recommendation, 14 years (IQR, 11-15 years) from guideline recommendation to 90% practice uptake, and overall, a 16-year median (IQR, 13-19 years) from PCT to 90% practice uptake.. The time of PCT publication to meaningful uptake of class IA ACS therapies into clinical practice took a median of 16 years. This significant time lag indicates systemic barriers to the translation of therapeutics into routine clinical practice.

Topics: Angina, Unstable; Cardiovascular Agents; Communication Barriers; Early Medical Intervention; Evidence-Based Practice; Guideline Adherence; Humans; Meaningful Use; Myocardial Infarction; Needs Assessment; Practice Guidelines as Topic; Randomized Controlled Trials as Topic; Registries; Risk Assessment; Translational Research, Biomedical

Topics: Animals; Cardiovascular Agents; Drug Evaluation, Preclinical; Female; Humans; Ischemic Preconditioning, Myocardial; Male; Myocardial Infarction; National Heart, Lung, and Blood Institute (U.S.); Research Design

Topics: Aged; Aged, 80 and over; Cardiovascular Agents; Female; Humans; Male; Myocardial Infarction; Prognosis; Spain; Survival Rate

To assess the safety and efficacy of Biolimus A9-eluting stents (BES, BioMatrix™ and BioMatrix Flex™) in routine clinical practice.. The LEADERS randomized trial has documented equivalent efficacy and superior safety of the BES when compared to a first generation Sirolimus-eluting Cypher(TM) stent.. 5,472 patients from 57 centers, treated with BES, were enrolled in an international multicenter registry and followed clinically up to 2 years.. Mean patient age was 63.2 ± 11 years, 24% of patients had diabetes, and 49.8% presented with an acute coronary syndrome. 99.3% of patients were discharged on dual antiplatelet therapy (DAPT), 83.3% remained on DAPT at 1 year and 30.6% at 2 years. The incidence of the composite primary end point [major adverse cardiac events (MACE) at 12 months] was 4.5% [cardiac death 0.9%, myocardial infarction 1.7%, clinically indicated target vessel revascularization (ci-TVR) 2.8%]. MACE incidence was 6.8% at 24 months (cardiac death 1.5%, myocardial infarction 2.4%, ci-TVR 4.3%). At 12 months, 32 patients (0.6%) had suffered at least one definite or probable stent thrombosis (ST), and 91 patients (1.7%) a major bleed (MB). Nine patients with ST (27.3%) and 7 patients with a MB (7.7%) died during the first year after the index procedure. Between 12 and 24 months after implantation, there were 18 (0.4%) additional MB and 8 (0.2%) additional ST.. This large international cohort documents a low 12 and 24 months MACE incidence and a very low ST incidence in an unselected patient population undergoing BES implantation. The results are in keeping with those of the randomized controlled LEADERS trial. Even though ST with this stent was a rare event, it was still associated with significant mortality. MB remains a problem, and warrants improved tailoring of DAPT in recipients of drug eluting stents.

Topics: Aged; Cardiovascular Agents; Comorbidity; Coronary Artery Disease; Coronary Thrombosis; Drug Therapy, Combination; Drug-Eluting Stents; Female; Humans; Incidence; Kaplan-Meier Estimate; Male; Middle Aged; Myocardial Infarction; Percutaneous Coronary Intervention; Platelet Aggregation Inhibitors; Proportional Hazards Models; Registries; Risk Factors; Sirolimus; Time Factors; Treatment Outcome

This study sought to assess the frequency and clinical impact of dual antiplatelet therapy (DAPT) nonadherence.. There are limited data on the impact of DAPT nonadherence during the first year after a second-generation drug-eluting stent placement.. After successful Endeavor zotarolimus-eluting stent implantation, 2,265 patients were enrolled in a registry with limited exclusions and monitored during 12 months of prescribed DAPT. Predictors of any nonadherence (ANA) at 6 months were analyzed by multivariable analysis, and the association between ANA at 6 or 12 months with the endpoints of death, myocardial infarction, and stent thrombosis was assessed.. The study population included 30% female patients, 34% with diabetes and 36% with acute coronary syndromes. ANA occurred in 208 patients (9.6%) before 6 months and 378 patients (18.5%) before 1 year. Major bleeding (odds ratio [OR]: 12.83, 95% confidence interval [CI]: 7.55 to 21.80, p < 0.001) was the only predictor of ANA at 6 months. In time-dependent analyses, ANA before 6 months was associated with an increased risk of death or myocardial infarction (7.6% vs. 3.0%, p < 0.001) and a numerical increase in stent thrombosis (2.0% vs. 0.9%, p = 0.12). After adjustment for baseline differences, ANA within 6 months remained associated with death or MI (OR: 1.95, 95% CI: 1.02 to 3.75). ANA occurring after 6 months did not increase the risk of subsequent ischemic events.. DAPT ANA occurs frequently and is associated with increased risk for thrombotic complications if it occurs within the first 6 months. Major bleeding was a significant correlate of DAPT ANA within 6 months. (EDUCATE: The MEDTRONIC Endeavor Drug Eluting Stenting: Understanding Care, Antiplatelet Agents and Thrombotic Events; NCT01069003).

Topics: Aged; Aspirin; Cardiovascular Agents; Clopidogrel; Coronary Thrombosis; Drug Therapy, Combination; Drug-Eluting Stents; Female; Hemorrhage; Humans; Kaplan-Meier Estimate; Logistic Models; Male; Medication Adherence; Middle Aged; Multivariate Analysis; Myocardial Infarction; Odds Ratio; Percutaneous Coronary Intervention; Platelet Aggregation Inhibitors; Prasugrel Hydrochloride; Prospective Studies; Prosthesis Design; Registries; Risk Factors; Sirolimus; Ticlopidine; Time Factors; Treatment Outcome

The purpose of this study is to investigate the association between migration status and education level and the use of recommended drugs after first acute myocardial infarction (MI).. A nationwide cohort study performed in Sweden from January 1, 2006 to August 1, 2008. The cohort consisted of 49,037 incident cases of first acute MI. In total, 37,570 individuals survived 180 days after MI, of whom 4782 (12.7%) were foreign-born. We used logistic regression to estimate the odds ratio (OR) with 95% confidence interval (CI) of the association between migration status and education level and prescribed drugs after MI.. One third of the patients who were not on any recommended cardiovascular drugs before MI continued to be without recommended cardiovascular drugs after MI. Among those with no cardiovascular drugs before MI, we found no difference in recommended drug use after MI by migration status (OR 1.00, 95% CI 0.89-1.12). Among those with some but not all recommended cardiovascular drugs before MI, foreign-born cases had a slightly non-significant lower use of recommended drugs (OR 0.92, 95% CI 0.83-1.03). Foreign-born patients with low education had a slightly lower use of recommended drug compared to Sweden-born. Women with low education had a lower use of drugs after MI (Sweden born, OR 0.85; 95% CI 0.74-0.96 and foreign born OR 0.51; 95% CI 0.34-0.77).. There is no apparent difference between foreign-born and Sweden-born in recommended drug use after MI. However, our study reveals an inequity in secondary prevention therapy after myocardial infarction by education level.

Topics: Acute Disease; Aged; Aged, 80 and over; Cardiovascular Agents; Cohort Studies; Educational Status; Emigrants and Immigrants; Female; Humans; Logistic Models; Male; Middle Aged; Myocardial Infarction; Odds Ratio; Prescription Drugs; Secondary Prevention; Sex Factors; Social Class; Sweden

We assessed the feasibility and the procedural and long-term safety of intracoronary (i.c) imaging for documentary purposes with optical coherence tomography (OCT) and intravascular ultrasound (IVUS) in patients with acute ST-elevation myocardial infarction (STEMI) undergoing primary PCI in the setting of IBIS-4 study. IBIS4 (NCT00962416) is a prospective cohort study conducted at five European centers including 103 STEMI patients who underwent serial three-vessel coronary imaging during primary PCI and at 13 months. The feasibility parameter was successful imaging, defined as the number of pullbacks suitable for analysis. Safety parameters included the frequency of peri-procedural complications, and major adverse cardiac events (MACE), a composite of cardiac death, myocardial infarction (MI) and any clinically-indicated revascularization at 2 years. Clinical outcomes were compared with the results from a cohort of 485 STEMI patients undergoing primary PCI without additional imaging. Imaging of the infarct-related artery at baseline (and follow-up) was successful in 92.2% (96.6%) of patients using OCT and in 93.2% (95.5%) using IVUS. Imaging of the non-infarct-related vessels was successful in 88.7% (95.6%) using OCT and in 90.5% (93.3%) using IVUS. Periprocedural complications occurred <2.0% of OCT and none during IVUS. There were no differences throughout 2 years between the imaging and control group in terms of MACE (16.7 vs. 13.3%, adjusted HR1.40, 95% CI 0.77-2.52, p = 0.27). Multi-modality three-vessel i.c. imaging in STEMI patients undergoing primary PCI is consistent a high degree of success and can be performed safely without impact on cardiovascular events at long-term follow-up.

Topics: Aged; Cardiovascular Agents; Coronary Vessels; Drug-Eluting Stents; Europe; Feasibility Studies; Female; Humans; Male; Metals; Middle Aged; Multimodal Imaging; Myocardial Infarction; Percutaneous Coronary Intervention; Predictive Value of Tests; Prospective Studies; Prosthesis Design; Risk Factors; Sirolimus; Time Factors; Tomography, Optical Coherence; Treatment Outcome; Ultrasonography, Interventional

Topics: Cardiovascular Agents; Cardiovascular Diseases; Drug Combinations; Humans; Male; Medication Adherence; Middle Aged; Myocardial Infarction; Randomized Controlled Trials as Topic; Treatment Outcome

To develop an economic model to estimate the change in the number of events and costs of non-fatal myocardial infarction (MI) and non-fatal ischemic stroke (IS) as a result of implementing routine risk-stratification with a multiple inflammatory biomarker approach.. Reductions in the numbers of non-fatal MI and non-fatal IS events and in related per-member-per-month (PMPM) and 5-year costs (excluding test costs) due to biomarker testing were modeled for a US health plan with one million beneficiaries. Inputs for the model included literature-based MI and IS incidence rates, healthcare costs associated with MI and IS, laboratory results of biomarker testing, MI and IS hazard ratios related to biomarker levels, patient monitoring and intervention costs and use/costs of preventative pharmacotherapy. Preventative pharmacotherapy inputs were based on an analysis of pharmacy claims data. Costs savings (2013 USD) were assessed for patients undergoing biomarker testing compared to the standard of care. Data from MDVIP and Cleveland Heart Lab supported two critical inputs: (1) treatment success rates and (2) the population distribution of biomarker testing. Incidence rates, hazard ratios, and other healthcare costs were obtained from the literature.. For a health plan with one million members, an estimated 21,104 MI and 22,589 IS events occurred in a 5-year period. Routine biomarker testing among a sub-group of beneficiaries ≥35 years old reduced non-fatal MI and IS events by 2039 and 1869, respectively, yielding cost savings of over $187 million over 5 years ($3.13 PMPM), excluding test costs. Results were sensitive to changes in treatment response rates. Nonetheless, cost savings were observed for all input values.. This study suggests that health plans can realize substantial cost savings by preventing non-fatal MI and IS events after implementation of routine biomarker testing. Five-year cost savings before test costs could exceed $3.13 PMPM.

Topics: 1-Alkyl-2-acetylglycerophosphocholine Esterase; Adult; Age Factors; Aged; Aged, 80 and over; Biomarkers; C-Reactive Protein; Cardiovascular Agents; Cardiovascular Diseases; Costs and Cost Analysis; Female; Hematologic Tests; Humans; Insurance Claim Review; Male; Middle Aged; Models, Econometric; Myocardial Infarction; Peroxidase; Risk Assessment; Risk Factors; Stroke; United States

Patients with chronic obstructive pulmonary disease (COPD) have increased mortality following myocardial infarction (MI) compared with patients without COPD. We investigated the extent to which differences in recognition and management after MI could explain the mortality difference.. 300 161 patients with a first MI between 2003 and 2013 were identified in the UK Myocardial Ischaemia National Audit Project database. Logistic regression was used to compare mortality in hospital and at 180 days postdischarge between patients with and without COPD. Variables relating to inhospital factors (delay in diagnosis, use of reperfusion and time to reperfusion/use of angiography) and use of secondary prevention were sequentially added to models.. Mortality was higher for patients with COPD both inhospital (4.6% vs 3.2%) and at 180 days (12.8% vs 7.7%). After adjusting for inhospital factors, the effect of COPD on inhospital mortality after MI was reduced for both ST-elevation myocardial infarctions (STEMIs) and non-STEMIs (STEMIs OR 1.24 (95% CI 1.10 to 1.41) to 1.13 (95% CI 0.99 to 1.29); non-STEMIs OR 1.34 (95% CI 1.24 to 1.45) to 1.16 (95% CI 1.07 to 1.26)). Adjusting for inhospital factors reduced the effect of COPD on mortality after non-STEMI at 180 days (OR 1.56 (95% CI 1.47 to 1.65) to 1.37 (95% CI 1.31 to 1.44)). Adjusting for use of secondary prevention also reduced the effect of COPD on mortality at 180 days for STEMIs and non-STEMIs (STEMIs OR 1.45 (95% CI 1.31 to 1.61) to 1.25 (95% CI 1.11 to 1.41); non-STEMIs OR 1.37 (95% CI 1.31 to 1.44) to 1.26 (95% CI 1.17 to 1.35).. Delayed diagnosis, timing and use of reperfusion of a STEMI, use of angiography after a non-STEMI and use of secondary prevention medicines are all potential explanations for the mortality gap after MI in people with COPD.

Topics: Aged; Aged, 80 and over; Cardiovascular Agents; Comorbidity; Coronary Angiography; Delayed Diagnosis; Female; Healthcare Disparities; Hospital Mortality; Humans; Logistic Models; Male; Medical Audit; Middle Aged; Myocardial Infarction; Myocardial Reperfusion; Odds Ratio; Predictive Value of Tests; Pulmonary Disease, Chronic Obstructive; Registries; Risk Assessment; Risk Factors; Secondary Prevention; Time Factors; Treatment Outcome; United Kingdom

Prior studies have demonstrated that patients with high-risk acute myocardial infarction (AMI) are less likely to receive guideline-directed medications during hospitalisation. It is unknown if this paradox persists following discharge. We aimed to assess if persistence with guideline-directed medications post discharge varies by patients' risk following AMI.. Data were analysed from two prospective, multicentre US AMI registries. The primary outcome was persistence with all prescribed guideline-directed medications (aspirin, β-blockers, statins, angiotensin-antagonists) at 1, 6 and 12 months post discharge. The association between risk and medication persistence post discharge was assessed using multivariable mixed-effect models.. Among 6434 patients with AMI discharged home, 2824 were considered low-risk, 2014 intermediate-risk and 1596 high-risk for death based upon their Global Registry of Acute Coronary Event (GRACE) 6-month risk score. High-risk was associated with a lower likelihood of receiving all appropriate therapies at discharge compared with low-risk patients (relative risk (RR) 0.90; 95% CI 0.87 to 0.94). At 12 months, the rate of persistence with all prescribed therapies was 61.5%, 57.9% and 45.9% among low-risk, intermediate-risk and high-risk patients, respectively. After multivariable adjustment, high-risk was associated with lower persistence with all prescribed medications (RR 0.87; 95% CI 0.82 to 0.92) over follow-up. Similar associations were seen for individual medications. Over the 5 years of the study, persistence with prescribed therapies post discharge improved modestly among high-risk patients (RR 1.05; 95% CI 1.03 to 1.08 per year).. High-risk patients with AMI have a lower likelihood of persistently taking prescribed medications post discharge as compared with low-risk patients. Continued efforts are needed to improve the use of guideline-directed medications in high-risk patients.

Topics: Adrenergic beta-Antagonists; Adult; Aged; Aged, 80 and over; Angiotensin II Type 1 Receptor Blockers; Angiotensin-Converting Enzyme Inhibitors; Aspirin; Cardiovascular Agents; Chi-Square Distribution; Female; Guideline Adherence; Humans; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Linear Models; Logistic Models; Male; Medication Adherence; Middle Aged; Multivariate Analysis; Myocardial Infarction; Odds Ratio; Platelet Aggregation Inhibitors; Practice Guidelines as Topic; Practice Patterns, Physicians'; Recurrence; Registries; Retrospective Studies; Risk Assessment; Risk Factors; Secondary Prevention; Time Factors; Treatment Outcome; United States

Studies evaluating long-term (≥5 years) outcome of percutaneous coronary intervention (PCI) compared with coronary artery bypass grafting (CABG) in patients with unprotected left main coronary artery disease (ULMCAD) are still limited, despite concerns for late adverse events after drug-eluting stents implantation.. We identified 1,004 patients with ULMCAD (PCI: n=364, CABG: n=640) among 15,939 patients with first coronary revascularization enrolled in the CREDO-Kyoto PCI/CABG registry cohort-2. The primary outcome measure in the current analysis was a composite of death, myocardial infarction, and stroke (death/MI/stroke). The cumulative 5-year incidence of and the adjusted risk for death/MI/stroke were significantly higher in the PCI group than in the CABG group (34.5% vs. 24.1%, log-rank P<0.001, adjusted hazard ratio (HR): 1.48 [95% confidence interval (CI): 1.07-2.05, P=0.02]). The adjusted risks for all-cause death was not significantly different between the 2 groups. Regarding the stratified analysis by the SYNTAX score, the adjusted risk for death/MI/stroke was not significantly different between the 2 groups in patients with low (<23) or intermediate (23-33) SYNTAX score, whereas it was significantly higher in the PCI group than in the CABG group in patients with high (≤33) SYNTAX score.. CABG as compared with PCI was associated with better long-term outcome in patients with ULMCAD, especially those with high anatomical complexity.

Topics: Cardiovascular Agents; Cause of Death; Combined Modality Therapy; Comorbidity; Coronary Artery Bypass; Coronary Disease; Death, Sudden, Cardiac; Follow-Up Studies; Humans; Japan; Kaplan-Meier Estimate; Mortality; Myocardial Infarction; Percutaneous Coronary Intervention; Platelet Aggregation Inhibitors; Proportional Hazards Models; Registries; Risk; Severity of Illness Index; Stents; Stroke; Treatment Outcome

This study sought to evaluate procedural and clinical outcomes among patients undergoing chronic total occlusion (CTO) percutaneous coronary intervention (PCI) using contemporary methods and everolimus-eluting stents (EES).. Limited studies have detailed the procedural and late-term safety and efficacy of CTO revascularization among multiple centers applying modern techniques and with newer-generation drug-eluting stents.. Among 20 centers, 250 consecutive patients were enrolled for attempted CTO PCI. Procedural and in-hospital clinical outcomes were examined in addition to the 1-year primary endpoint of death, myocardial infarction, and target lesion revascularization (major adverse cardiac events [MACE]).. Demographic, lesion, and procedural characteristics included prior bypass surgery: 9.9%; diabetes: 40.1%; lesion length: 36.1 ± 18.5 mm; and stent length: 51.7 ± 27.2 mm. Procedural success, defined as guidewire recanalization with no in-hospital MACE, was 96.4%. Success with antegrade-only methods was 97.9% and 86.2% by retrograde/combined methods, respectively. Compared with a pre-specified performance goal derived from 6 prior CTO drug-eluting stent trials (1-year MACE: 24.4%), treatment with EES was associated with significantly lower composite adverse events for both intent-to-treat (18.5%, 1-sided upper confidence interval: 23.4%, p = 0.025) and per-protocol populations (8.2%, 1-sided upper confidence interval: 12.3%, p < 0.0001). Target lesion revascularization at 1 year was 6.3%. Dual antiplatelet therapy adherence was 53.9% at 1 year, yet subacute definite stent thrombosis occurred in only 2 patients (0.9%), and late probable stent thrombosis occurred in 1 patient (0.5%).. In a multicenter registration trial representing contemporary technique and EES, favorable procedural success and late-term clinical outcomes support CTO PCI in a patient population with high lesion complexity. (EXPERT CTO: Evaluation of the XIENCE PRIME LL and XIENCE Nano Everolimus Eluting Coronary Stent Coronary Stents, Performance, and Technique in Chronic Total Occlusions; NCT01435031).

Topics: Aged; Cardiovascular Agents; Chronic Disease; Coronary Occlusion; Coronary Thrombosis; Drug-Eluting Stents; Everolimus; Female; Humans; Male; Middle Aged; Myocardial Infarction; Percutaneous Coronary Intervention; Prospective Studies; Prosthesis Design; Risk Factors; Time Factors; Treatment Outcome; United States

Topics: Cardiovascular Agents; Humans; Myocardial Infarction; Secondary Prevention

Adherence to drugs that are prescribed after myocardial infarction remains suboptimal. Although eliminating patient cost sharing for secondary prevention increases adherence and reduces rates of major cardiovascular events, the long-term clinical and economic implications of this approach have not been adequately evaluated.. We developed a Markov model simulating a hypothetical cohort of commercially insured patients who were discharged from the hospital after myocardial infarction. Patients received β-blockers, renin-angiotensin system antagonists, and statins without cost sharing (full coverage) or at the current level of insurance coverage (usual coverage). Model inputs were extracted from the Post Myocardial Infarction Free Rx Event and Economic Evaluation trial and other published literature. The main outcome was an incremental cost-effectiveness ratio as measured by cost per quality-adjusted life year gained. Patients receiving usual coverage lived an average of 9.46 quality-adjusted life years after their event and incurred costs of $171,412. Patients receiving full coverage lived an average of 9.60 quality-adjusted life years and incurred costs of $167,401. Compared with usual coverage, full coverage would result in greater quality-adjusted survival (0.14 quality-adjusted life years) and less resource use ($4011) per patient. Our results were sensitive to alterations in the risk reduction for post-myocardial infarction events from full coverage.. Providing full prescription drug coverage for evidence-based pharmacotherapy to commercially insured post-myocardial infarction patients has the potential to improve health outcomes and save money from the societal perspective over the long-term.. https://www.clinicaltrials.gov. Unique identifier: NCT00566774.

Topics: Aged; Aged, 80 and over; Cardiovascular Agents; Cost-Benefit Analysis; Humans; Markov Chains; Middle Aged; Models, Economic; Myocardial Infarction; Secondary Prevention

This study aimed to assess the clinical impact of strut width (evaluated by abluminal strut surface area [ASSA]) on periprocedural myocardial infarction (PMI) and clinical outcomes in patients treated with bioresorbable scaffolds (BRS) versus first-generation sirolimus-eluting stents (SES).. To date, there are no reports on the impact of ASSA on PMI and clinical outcomes.. We compared the impact of ASSA on outcomes and PMI in propensity-matched patients treated with BRS and SES. The primary outcome was the incidence of major adverse cardiac events (MACE), defined as the combination of all-cause mortality, follow-up myocardial infarction, and target vessel revascularization, at 30-days and 1-year follow-ups. The secondary endpoint was the incidence of PMI.. After propensity-matched analysis, 499 patients (147 BRS patients vs. 352 SES patients) were evaluated. Mean ASSA was higher in patients treated with BRS versus SES (BRS: 132.3 ± 76.7 mm(2) vs. SES: 67.6 ± 48.4 mm(2), p < 0.001). MACE was not significantly different between groups (30-days MACE: BRS: 0% vs. SES: 1.4%, p = 0.16, and 1-year MACE: BRS: 15.7% vs. SES: 11.4%, p = 0.67). The incidence of PMI was significantly higher in the BRS group (BRS: 13.1% vs. SES: 7.5%, p = 0.05). Multivariable analyses indicated that treatment of left anterior descending artery and ASSA were independent predictors of PMI.. BRS implantation, compared with SES implantation, was associated with a higher incidence of PMI. MACE at 30 days and 1 year were not significantly different. Left anterior descending artery percutaneous coronary intervention and ASSA were independent predictors of PMI.

Topics: Absorbable Implants; Aged; Cardiovascular Agents; Chi-Square Distribution; Coronary Artery Disease; Drug-Eluting Stents; Everolimus; Female; Humans; Incidence; Italy; Kaplan-Meier Estimate; Logistic Models; Male; Middle Aged; Multivariate Analysis; Myocardial Infarction; Odds Ratio; Percutaneous Coronary Intervention; Propensity Score; Prosthesis Design; Retrospective Studies; Risk Factors; Treatment Outcome

In order to assess the effect of a vascular event on adherence to treatment we examined a total of 68 patients presenting with coronary atherosclerosis. The patients' age varied from 31 to 84 years (mean 57.1±8.7). There were 55 (81.1%) men and 13 (18.9%) women. Drug regimen compliance was evaluated by means of the Morisky-Green Medication Adherence Questionnaire before and after the vascular event. Of the 68 examined patients, 15 (22.1%) had not taken any therapeutic agents before the vascular event occurred, despite existing arterial hypertension. Drug regimen compliance prior to the vascular event was low in 82.4% of cases. The number of patients with coronary atherosclerosis and low compliance to treatment before the vascular event decreased significantly thereafter (p=0.0012). After the vascular event, the number of patients adhering to the doctor's recommendations on medicamentous therapy increases considerably. At the same time, a sufficiently great number of patients [about 30% of patients after endured myocardial infarction (MI) and 18% after transcutaneous coronary intervention (TCI)] still remain in the category of those "having low drug regimen compliance" and, accordingly, have high risk for the development of recurrent vascular events. Endured TCI increases patient compliance more significantly than MI, which requires additional study of a psychological component of the given fact.

Topics: Cardiovascular Agents; Coronary Artery Disease; Female; Humans; Hypertension; Male; Middle Aged; Myocardial Infarction; Needs Assessment; Patient Compliance; Percutaneous Coronary Intervention; Platelet Aggregation Inhibitors; Russia; Secondary Prevention; Surveys and Questionnaires

Topics: Absorbable Implants; Cardiovascular Agents; Coronary Artery Disease; Drug-Eluting Stents; Everolimus; Female; Humans; Male; Myocardial Infarction; Percutaneous Coronary Intervention

Although reperfusion is essential in restoring circulation to ischemic myocardium, it also leads to irreversible events including reperfusion injury, decreased cardiac function and ultimately scar formation. Various cell types are involved in the multi-phase repair process including inflammatory cells, vascular cells and cardiac fibroblasts. Therapies targeting these cell types in the infarct border zone can improve cardiac function but are limited by systemic side effects. The aim of this work was to develop liposomes with surface modifications to include peptides with affinity for cell types present in the post-infarct myocardium. To identify peptides specific for the infarct/border zone, we used in vivo phage display methods and an optical imaging approach: fluorescence molecular tomography (FMT). We identified peptides specific for cardiomyocytes, endothelial cells, myofibroblasts, and c-Kit + cells present in the border zone of the remodeling infarct. These peptides were then conjugated to liposomes and in vivo specificity and pharmacokinetics were determined. As a proof of concept, cardiomyocyte specific (I-1) liposomes were used to deliver a PARP-1 (poly [ADP-ribose] polymerase 1) inhibitor: AZ7379. Using a targeted liposomal approach, we were able to increase AZ7379 availability in the infarct/border zone at 24h post-injection as compared with free AZ7379. We observed ~3-fold higher efficiency of PARP-1 inhibition when all cell types were assessed using I-1 liposomes as compared with negative control peptide liposomes (NCP). When analyzed further, I-1 liposomes had 9-fold and 1.5-fold higher efficiencies in cardiomyocytes and macrophages, respectively, as compared with NCP liposomes. In conclusion, we have developed a modular drug delivery system that can be targeted to cell types of therapeutic interest in the infarct border zone.

Topics: Animals; Biological Availability; Cardiovascular Agents; Cell Surface Display Techniques; Disease Models, Animal; Drug Compounding; Endothelial Cells; Lipids; Liposomes; Macrophages; Male; Mice, Inbred C57BL; Myocardial Infarction; Myocardial Reperfusion Injury; Myocardium; Myocytes, Cardiac; Myofibroblasts; Peptide Library; Peptides; Poly (ADP-Ribose) Polymerase-1; Poly(ADP-ribose) Polymerase Inhibitors; Solubility

Critical limb ischemia (CLI), a frequently encountered disorder, is associated with a high rate of limb amputation and mortality. To identify patients at high risk for CLI, we developed a simple risk score for peripheral arterial occlusive disease (PAOD).In our cross-sectional study, we first evaluated 1000 consecutive PAOD patients treated at our institution from 2005 to 2007, documenting clinical symptoms, comorbidities, and concomitant medication. We calculated odds ratios (OR) in a binary logistic regression model to find possible risk factors for CLI. We then verified the score in a second step that included the 1124 PAOD patients we treated between 2007 and 2011.In the first patient group, the greatest risk factors for CLI were age ≥75 years (OR 2.0), type 2 diabetes (OR 3.1), prior myocardial infarction (OR 2.5), and therapy with low molecular weight heparins (2.8). We scored 1 point for each of those conditions. One point was given for age between 65 and 75 years (OR 1.6) as well as for therapy with cardiac glycosides (OR 1.9) or loop diuretic therapy (OR 1.5). As statin therapy was protective for CLI with an OR of 0.5, we subtracted 1 point for those patients.In the second group, we could prove that frequency of CLI was significantly higher in patients with a high CLI score. The score correlated well with inflammatory parameters (c-reactive protein and fibrinogen). We were also able to define 3 different risk groups for low (score -1 to 1), intermediate (score 2-4), and high CLI risk (score >4).We developed a simple risk stratification scheme that is based on conditions that can be easily assessed from the medical history, without any laboratory parameters. This score should help to identify PAOD patients at high risk for CLI.

Topics: Age Factors; Aged; Aged, 80 and over; Arterial Occlusive Diseases; Cardiovascular Agents; Comorbidity; Cross-Sectional Studies; Diabetes Mellitus, Type 2; Extremities; Female; Humans; Hypoglycemic Agents; Ischemia; Male; Microcirculation; Middle Aged; Myocardial Infarction; Odds Ratio; Peripheral Arterial Disease; Risk Assessment; Risk Factors

Topics: Aged; Cardiovascular Agents; Coronary Angiography; Coronary Artery Disease; Coronary Restenosis; Drug-Eluting Stents; Guidelines as Topic; Hospitalization; Humans; Male; Myocardial Infarction; Sirolimus; Tomography, Optical Coherence

To compare the 1-year clinical outcomes after implantation of the amphilimus, polymer-free stent (Cre8) versus new generation everolimus-eluting stents (EESs) in a real-world patient registry.. A total of 187 consecutive patients treated with Cre8 between January 2011 and August 2013 in four Italian centers were included. These were propensity matched with 150 patients treated with new generation EES during the same period. Primary outcome was 1-year major adverse cardiovascular events (MACE), defined as all-cause death, myocardial infarction, and target vessel revascularization.. Both groups had similar baseline characteristics, including diabetes (28% Cre8 vs. 27.3% EES, P = 0.972) and previous percutaneous coronary intervention (56% Cre8 vs. 58% EES, P = 0.726). There was a higher prevalence of B2/C lesions in the EES group (70.1% vs. 83.8%, P < 0.001). Total stent length per patient was similar. There were no significant differences in 1-year estimated MACE (7.4% Cre8 vs. 10.2% EES, P = 0.261), all-cause mortality (1.3% Cre8 vs. 1.4% EES, P = 0.823), target vessel revascularization (5.2% Cre8 vs. 8.8% EES, P = 0.169), and target lesion revascularization (3% Cre8 vs. 7.4% EES, P = 0.108) between the two groups. When adjusting for differences in baseline lesion characteristics, hazard ratio(Cre8/EES) for MACE was not significantly different between the two groups (0.75, 95% confidence interval 0.37-1.53, P(noninferiority) = 0.001, P(superiority) = 0.432). In patients with diabetes (Cre8, n = 42; EEE, n = 41), 1-year target lesion revascularization was 2.5% in the Cre8 group versus 14.6% in the EES group (P = 0.056).. In a "real-world" patient registry, the Cre8 stent is associated with noninferior 1-year MACE rates compared with that of new generation EES. Trends of superior efficacy in patients with diabetes treated with Cre8 require further investigation.

Topics: Aged; Cardiovascular Agents; Coronary Artery Disease; Drug-Eluting Stents; Everolimus; Female; Humans; Italy; Kaplan-Meier Estimate; Logistic Models; Male; Middle Aged; Multivariate Analysis; Myocardial Infarction; Odds Ratio; Percutaneous Coronary Intervention; Polymers; Prevalence; Propensity Score; Prosthesis Design; Registries; Risk Factors; Time Factors; Treatment Outcome

Topics: Absorbable Implants; Angioplasty, Balloon, Coronary; Cardiac Catheters; Cardiovascular Agents; Coated Materials, Biocompatible; Coronary Angiography; Coronary Thrombosis; Equipment Design; Everolimus; Humans; Male; Middle Aged; Myocardial Infarction; Platelet Aggregation Inhibitors; Recurrence; Time Factors; Tomography, Optical Coherence; Treatment Outcome

to assess the clinical and cost-effectiveness of the addition to the treatment of patients with coronary artery disease, myocardial infarction (MI). If current blocker ivabradine.. as a basis for pharmacoeconomic research results of the program are taken battleships, in which 1226 patients with MI less than 12 months ago, for 16 weeks received ivabradine in addition to standard therapy. When conducting pharmacoeconomic calculations take into account the direct medical and non-medical costs of treating patients with drugs; the call ambulance crews (CAC); on the patients stay in the hospital at admission. To determine the cost of use of ivabradine used data on daily dosages of the drug presented in the program battleships. In this case, using the retail price of drugs taken from the resource pharmindex.ru (date accessed 6/23/14). When calculating the cost of hospitalization and emergency calls using the values specified in the decree of october 18, 2013 No932 "About the state guarantees the free provision of medical care to citizens for 2014 and the planning period of 2015 and 2016.".. according to a study LINCOR adding ivabradine to standard therapy resulted in a significant reduction in the frequency of angina attacks, the need for treatment for CACs and hospitalization. Average total cost of a full 16-week course of therapy with a patient ivabradine 1.87 times lower than with the standard therapy alone. The most obvious benefits to health care institutions: the total cost of emergency calls and hospitalization when added to treatment with ivabradine reduced 20,027.79 to 1,630.45 rubles, le 12.3 times.. despite the increase in direct costs due to the cost of the drug, the addition to the standard therapy of ivabradine in patients with myocardial infarction, pharmaco is more effective than using only standard therapy, due to a significant reduction in the need for emergency calls and hospitalization.

Topics: Benzazepines; Cardiovascular Agents; Cost-Benefit Analysis; Costs and Cost Analysis; Cyclic Nucleotide-Gated Cation Channels; Drug Costs; Humans; Ivabradine; Myocardial Infarction; Retrospective Studies

The cardiovascular burden and consequences of peripheral atherosclerosis appear to differ between men and women. Data regarding long-term outcomes, including the impact of medical prophylactic treatment, are insufficient. This study examined long-term outcomes according to sex following primary vascular surgery, adjusted for multiple variables as well as recommended medical prophylaxis.. All Danish patients who underwent peripheral vascular surgery from January 2000 to December 2007 were stratified into five procedural groups: (a) aorto-iliac bypass or thromboendarterectomy, (b) femoro-femoral crossover, (c) thromboendarterectomy of the femoral arteries, (d) infrainguinal bypass, or (e) axillo- uni-, and bifemoral bypass. Data were analyzed according to sex for differences in myocardial infarction, stroke, and death, individually and combined, after surgery.. A total of 11,234 patients were included: 6,289 males and 4,945 females. The overall adjusted hazard ratio for male patients compared with female patients for death was 1.11 (95% CI 1.06-1.17), for MI was 1.16 (95% CI 1.04-1.29), for stroke was 0.99 (95% CI 0.89-1.11), and for any major adverse cardiovascular event was 1.10 (95% CI 1.05-1.16).. These findings show that, despite indication, severity, and concomitant medical treatment of peripheral artery disease, men have a higher risk of mortality and adverse cardiovascular events following surgery for peripheral arterial disease.

Topics: Aged; Aged, 80 and over; Cardiovascular Agents; Cause of Death; Comorbidity; Denmark; Female; Health Status Disparities; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Myocardial Infarction; Peripheral Arterial Disease; Registries; Retrospective Studies; Risk Factors; Severity of Illness Index; Sex Factors; Stroke; Time Factors; Treatment Outcome; Vascular Surgical Procedures

Since 2009, the United Kingdom diving incident data show an increasing number of fatalities in the over-50s age group. Previous studies also suggest some divers take cardiac medications. Since 2001, diving medicals have not been mandatory for UK sport divers. Instead, an annual medical self-certification form, submitted to their club/school or training establishment, is required. We documented in a survey of UK sport divers the prevalence of cardiac events and medications and the frequency of medical certifications.. An anonymous on-line questionnaire was publicised. Measures included diver and diving demographics, prescribed medications, diagnosed hypertension, cardiac issues, events and procedures, other health issues, year of last diving medical, diagnosed persistent foramen ovale (PFO), smoking and alcohol habits, exercise and body mass index.. Of 672 completed surveys, hypertension was reported by 119 (18%) with 25 of these (21%) having not had a diving medical. Myocardial infarction 6 (1%), coronary artery bypass grafting 3 (< 1%), atrial fibrillation 19 (3%) and angina 12 (2%) were also reported. PFOs were reported by 28 (4%), with 20 of these opting for a closure procedure. From 83 treated incidences of decompression illness (DCI), 19 divers reported that a PFO was diagnosed.. Divers inevitably develop health problems. Some continue to dive with cardiac issues, failing to seek specialised diving advice or fully understand the role of the diving medical. Physicians without appropriate training in diving medicine may inform a diver they are safe to continue diving with their condition without appreciating the potential risks. The current procedure for medical screening for fitness to dive may not be adequate for all divers.

Topics: Adolescent; Adult; Age Distribution; Aged; Alcohol Drinking; Angina Pectoris; Atrial Fibrillation; Body Mass Index; Cardiovascular Agents; Cardiovascular Diseases; Certification; Coronary Artery Bypass; Decompression Sickness; Diving; Exercise; Female; Foramen Ovale, Patent; Health Status; Humans; Hypertension; Male; Middle Aged; Myocardial Infarction; Recreation; Smoking; Surveys and Questionnaires; Time Factors; United Kingdom

Topics: Cardiovascular Agents; Female; Health Status Disparities; Humans; Male; Myocardial Infarction; Peripheral Arterial Disease; Stroke; Vascular Surgical Procedures

The prevalence of the use of secondary prevention cardiovascular medications is lower among women than men, but it is unclear if this is a result of lower treatment initiation among women or lower treatment adherence. We aimed to map the treatment pathway for survivors of acute myocardial infarction (AMI) by sex and age.. This retrospective population-based cohort study used linked administrative data sets in British Columbia (2004-2011), which include health care, prescription drugs, sociodemographic, and mortality information. The study cohort included all individuals admitted to hospital for AMI in 2007-2009 and survived for 1 year after hospital discharge. Patients were evaluated for whether they initiated and then subsequently filled prescriptions angiotensin-converting enzyme inhibitors, β-blockers, and statins. More than two thirds of AMI survivors initiated treatment on all appropriate medications, given their contraindications, within 2 months of discharge. Younger men were significantly more likely than younger women to initiate appropriate treatment (adjusted odds ratio, 1.38; 95% confidence interval, 1.10-1.75). By the end of 1 year after discharge, only one third of all AMI survivors filled all appropriate prescriptions for at least 80% of the year. There was no significant difference in adherence to medication therapy between women and men.. The majority of AMI survivors either discontinue treatment or do not refill their prescriptions consistently. Women <55 years are significantly less likely to be on optimal therapy by the end of 1 year after discharge, which is driven by a sex disparity in treatment initiation and not treatment adherence.

Topics: Adult; Age Factors; Aged; Aged, 80 and over; Cardiovascular Agents; Chi-Square Distribution; Drug Prescriptions; Drug Utilization Review; Female; Health Knowledge, Attitudes, Practice; Healthcare Disparities; Humans; Logistic Models; Male; Medication Adherence; Middle Aged; Myocardial Infarction; Odds Ratio; Retrospective Studies; Risk Factors; Secondary Prevention; Sex Factors; Time Factors; Treatment Outcome; Young Adult

Little is known about whether enrollment versus nonenrollment in Medicare's prescription drug plan (Part D) is associated with better outcomes after acute myocardial infarction (AMI).. Using Medicare records linked to Acute Coronary Treatment and Intervention Outcomes Network Registry-Get With The Guidelines, we identified 59 149 Medicare beneficiaries (age ≥65 years) discharged after AMI between January 2007 and December 2010. We described trends in Medicare Part D enrollment, and compared the following 30-day and 1-year outcomes: all-cause death, all-cause readmissions, and major adverse cardiac events (a composite of all-cause death or readmission for AMI or stroke) between Part D enrollees and nonenrollees, after adjustment for patient and hospital factors. From 2007 to 2010, 29 264 (49.5%) patients with AMI enrolled in Medicare were also participating in Part D by hospital discharge. All-cause 30-day death was more common among enrollees versus nonenrollees (4.0% versus 3.3%), but this difference was not statistically significant after multivariable adjustment (adjusted hazard ratio, 1.06 [95% confidence interval, 0.97-1.17]). Enrollees also had higher unadjusted risks of 30-day all-cause readmissions or major adverse cardiac events, and 1-year mortality, all-cause readmissions, or major adverse cardiac events, but these were attenuated after multivariable adjustment. Adherence to key secondary prevention medications (statins, β-blockers, angiotensin-converting enzyme inhibitors or angiotensin receptor blockers, and P2Y12 antagonists) remained low (range, 55%-64%) at 1 year post discharge among Part D enrollees.. Only half of Medicare-insured patients with AMI were enrolled in Part D by hospital discharge, and their 30-day and 1-year adjusted outcomes did not differ substantially from nonenrollees. There remain opportunities for improvement in medication adherence among patients with prescription drug coverage.

Topics: Aged; Aged, 80 and over; Cardiovascular Agents; Electronic Health Records; Female; Humans; Insurance Benefits; Male; Medical Record Linkage; Medicare Part D; Medication Adherence; Myocardial Infarction; Patient Discharge; Patient Readmission; Recurrence; Registries; Risk Assessment; Risk Factors; Stroke; Time Factors; Treatment Outcome; United States

The growth factor neuregulin (NRG) is one of the most promising candidates in protein therapy as potential treatment for myocardial infarction (MI). In the last few years, biomaterial based delivery systems, such as polymeric microparticles (MPs) made of poly(lactic co glycolic acid) and polyethylene glycol (PLGA and PEG-PLGA MPs), have improved the efficacy of protein therapy in preclinical studies. However, no cardiac treatment based on MPs has yet been commercialized since this is a relatively new field and total characterization of polymeric MPs remains mandatory before they reach the clinical arena. Therefore, the objective of this study was to characterize the in vivo release, bioactivity and biodegradation of PLGA and PEG-PLGA MPs loaded with biotinylated NRG in a rat model of MI. The effect of PEGylation in the clearance of the particles from the cardiac tissue was also evaluated. Interestingly, MPs were detected in the cardiac tissue for up to 12 weeks after administration. In vivo release analysis showed that bNRG was released in a controlled manner throughout the twelve week study. Moreover, the biological cardiomyocyte receptor (ErbB4) for NRG was detected in its activated form only in those animals treated with bNRG loaded MPs. On the other hand, the PEGylation strategy was effective in diminishing phagocytosis of these MPs compared to noncoated MPs in the long term (12 weeks after injection). Taking all this together, we report new evidence in favor of the use of polymeric PLGA and PEG-PLGA MPs as delivery systems for treating MI, which could be soon included in clinical trials.

Topics: Animals; Biological Availability; Biotinylation; Cardiovascular Agents; Delayed-Action Preparations; Disease Models, Animal; Drug Carriers; Drug Compounding; Drug Stability; Female; Humans; Lactic Acid; Macrophages; Myocardial Infarction; Myocardium; Neuregulin-1; Particle Size; Phagocytosis; Polyesters; Polyethylene Glycols; Polyglycolic Acid; Polylactic Acid-Polyglycolic Acid Copolymer; Rats, Sprague-Dawley; Receptor, ErbB-4; Recombinant Proteins

Methods of estimating race/ethnicity using administrative data are increasingly used to examine and target disparities; however, there has been no validation of these methods using clinically relevant outcomes.. To evaluate the validity of the indirect method of race/ethnicity identification based on place of residence and surname for assessing clinically relevant outcomes.. A total of 2387 participants in the Post-MI Free Rx Event and Economic Evaluation (MI FREEE) trial who had both self-reported and Bayesian Improved Surname Geocoding method (BISG)-estimated race/ethnicity information available.. We used tests of interaction to compare differences in the effect of providing full drug coverage for post-MI medications on adherence and rates of major vascular events or revascularization for white and nonwhite patients based upon self-reported and indirect racial/ethnic assignment.. The impact of full coverage on clinical events differed substantially when based upon self-identified race (HR=0.97 for whites, HR=0.65 for nonwhites; interaction P-value=0.05); however, it did not differ among race/ethnicity groups classified using indirect methods (HR=0.87 for white and nonwhites; interaction P-value=0.83). The impact on adherence was the same for self-reported and BISG-estimated race/ethnicity for 2 of the 3 medication classes studied.. Quantitatively and qualitatively different results were obtained when indirectly estimated race/ethnicity was used, suggesting that these techniques may not accurately describe aspects of race/ethnicity related to actual health behaviors.

Topics: Adult; Bayes Theorem; Black or African American; Cardiovascular Agents; Data Collection; Ethnicity; Female; Geographic Mapping; Healthcare Disparities; Hispanic or Latino; Humans; Male; Medication Adherence; Middle Aged; Myocardial Infarction; Names; Racial Groups; Residence Characteristics; Self Report; Socioeconomic Factors; Treatment Outcome; White People

To determine the clinical profile, burden of risk factors, and quality of care among patients hospitalized for an acute myocardial infarction (AMI) with special focus on gender differences.. The study included 256 AMI patients admitted to the Coronary Care Unit of "Mother Teresa" hospital in Tirana during 2013-2014. We obtained information on patients' demographic data, AMI characteristics, complications (heart failure [HF] and ventricular fibrillation [VF]), risk factors and medication use prior and during the AMI hospitalization. Age-adjusted Poisson regression analyses were applied to explore gender differences (women vs men) with regard to clinical profile and quality of care and results are expressed as incidence rate ratios (IRR).. 55.4% of patients had ≥3 risk factors, 44.5% developed HF, and 5.7% developed VF. Only 40.4% of patients received all 4 medication classes (beta-blockers, angiotensin-converting-enzyme inhibitor/angiotensin receptor blockers, statins, and aspirin) and 46.4% had revascularization. Significantly more women than men were obese, (P=0.042) had diabetes, (P=0.001) developed HF (P<0.001) or experienced a VF episode (P<0.001). After adjusting for age, differences with regard to obesity (IRR=.17; 95% confidence interval [CI] 1.15-4.09), diabetes (IRR=1.35; 95% CI 1.07-1.71), HF (IRR=1.32; 95% CI 1.02-1.74) and VF (IRR=2.82; 95% CI 1.07-7.43) remained significant. There were no differences with regard to individual drug classes taken. However, women had fewer revascularization procedures than men (IRR=0.65; 95% CI 0.43-0.98).. Women were found to have more unfavorable clinical profile, higher complication rates, and underutilization of therapy, which may be influenced by socioeconomic differences between genders and lead to a differential prognosis.

Topics: Acute Disease; Aged; Aged, 80 and over; Albania; Cardiovascular Agents; Diabetes Mellitus; Female; Humans; Male; Middle Aged; Myocardial Infarction; Myocardial Revascularization; Obesity; Prognosis; Quality of Health Care; Risk Factors; Sex Factors

Topics: Aged; Analgesics, Opioid; Antidepressive Agents; Biosimilar Pharmaceuticals; Black or African American; Cardiovascular Agents; Centers for Medicare and Medicaid Services, U.S.; Cost Savings; Drug Costs; Dual MEDICAID MEDICARE Eligibility; Economics, Pharmaceutical; Fraud; Humans; Legislation, Drug; Medicaid; Medicare Part C; Medicare Part D; Medication Therapy Management; Myocardial Infarction; Outcome Assessment, Health Care; Pharmacies; Prescription Drugs; United States; United States Dept. of Health and Human Services

We sought to evaluate the prognosis of different treatment strategies on patients with multivessel coronary disease and high SYNTAX score. 171 patients with multivessel coronary disease and SYNTAX score ε33, who underwent coronary angiography between July 2009 and July 2010 at our hospital were retrospectively selected and divided into incomplete and complete revascularization intervention groups (IR), a coronary artery bypass surgery group (CABG), a conservative drug therapy group according to treatment strategies chosen and agreed by the patients. These patients were followed up for 19.44 ± 5.73 months by telephone or outpatient service. We found the medical treatment group has a lower overall survival than the IR, CR group, and CABG group (P log-rank values are 0.03, 0.03, and 0.02, respectively). The medical treatment group also has a lower survival than the IR group, CR group, and CABG group in cerebral stroke and recurrent myocardial infarction (MI) (P log-rank values are 0.004, 0.03, and 0.001, respectively) and MACE events (P log-rank values are 0.003, 0.001 and P < 0.001, respectively). The medical treatment group and IR group have lower survival in recurrent angina pectoris than the CR group and CABG group (P log-rank values are 0.02, 0.02 and 0.03, 0.008, respectively). There are no significant differences between the CR group and the CABG group in number of deaths, strokes and recurrent MIs, MACE events, angina pectoris (P log-rank values are 0.69, 0.53, and 0.86, respectively). The IR group shows a lower survival than the CR group and CABG group only in angina pectoris (P log-rank values are 0.03 and 0.008, respectively). For the patients with a high SYNTAX score, medical treatment is still inferior to revascularization therapy (interventional therapy or coronary artery bypass surgery). It appears that the CABG is not obviously superior to the coronary intervention therapy. Complete revascularization and coronary artery bypass grafting treatments simply have better survival in angina pectoris compared to the incomplete revascularization. Therefore, individual treatment strategies are recommended and more trials are required to study these effects.

Topics: Adult; Aged; Angina Pectoris; Cardiovascular Agents; Coronary Artery Bypass; Coronary Disease; Female; Humans; Male; Middle Aged; Myocardial Infarction; Postoperative Complications; Stroke; Survival Analysis

The role of the second-generation zotarolimus-eluting stent RESOLUTE in small-vessel coronary artery disease is unclear. The aim of this study was examine the angiographic results of RESOLUTE in de novo coronary lesions of ≥50 % diameter stenosis in target vessels ≤2.5 mm. From August 2008 to April 2010, 142 symptomatic patients with 159 lesions who fitted the inclusion criteria were treated with RESOLUTE. The mean age of patients was 66 ± 10 years, with male predominance (66 %). Diabetes mellitus was found in 62 (43.7 %) patients, whereas multivessel disease was observed in 105 (73.9 %). The mean stent size and length used were 2.33 ± 0.13 and 22 ± 8 mm, respectively. Follow-up angiography was performed on 143 (89.9 %) lesions in 127 (89.4 %) patients at a mean of 10.3 ± 3.6 months. Angiographic restenosis was found in 9 (6.3 %) lesions; the late loss was 0.26 ± 0.34 mm. At 1-year follow-up there were four cardiovascular deaths, two nonfatal myocardial infarctions, and six repeated revascularizations. The resultant major adverse cardiac event rate was 8.5 %. The use of RESOLUTE to treat small-vessel disease is associated with good clinical and angiographic outcomes at 1 year.

Topics: Aged; Cardiovascular Agents; Coronary Angiography; Coronary Restenosis; Coronary Stenosis; Drug-Eluting Stents; Female; Humans; Male; Middle Aged; Myocardial Infarction; Percutaneous Coronary Intervention; Prosthesis Design; Retrospective Studies; Sirolimus; Time Factors; Treatment Outcome

Drug-eluting stent (DES) implantation is a very effective treatment of bare-metal stent-in-stent restenosis (BMS-ISR). Therapeutic options for drug-eluting stent-in-stent restenosis (DES-ISR) are less well defined, as there are only few data on safety and effectiveness of interventional modalities. This study compared the 1-year clinical outcome after the use of drug-eluting balloon (DEB) to second-generation everolimus-eluting stent (EES) for treatment of DES-ISR.. This observational study included 86 patients with 86 DES-ISR. Forty patients were treated by repeat percutaneous coronary intervention (PCI) using an EES. Forty-six patients were treated by repeat PCI using a DEB. Follow-up periods were 22 ± 11 and 25 ± 19 months, respectively. The primary endpoint of the study was survival free of major adverse cardiac events (MACEs) at 1 year. Secondary endpoints were needed for target lesion revascularization (TLR), definite stent thrombosis (ST) at 1 year, and MACE rate during total follow-up period.. Baseline clinical and angiographic parameters were comparable between the two groups. EES were associated with a higher MACE rate at 1 year compared to DEB (27.5 vs. 8.6%, respectively; P = 0.046). TLR rates for EES and DEB were 22.5% versus 4.3%, respectively, P = 0.029, while rates of definite ST at 1 year follow-up were comparable (2.5% vs. 0%, respectively; P = 0.945). There were no differences in myocardial infarction rates between the two groups (5% vs. 2%, respectively; P = 0.595) and in mortality. Considering the complete follow-up periods, DEB were associated with significantly less MACE compared to EES (log-rank test, P = 0.045). Furthermore, comparison of TLR rates showed a strong trend in favor of DEB compared to EES (P = 0.074).. Treatment of DES-ISR using a DEB is associated with favorable rates of MACE and TLR at 1-year follow-up compared to the implantation of an EES.

Topics: Aged; Cardiac Catheters; Cardiovascular Agents; Coated Materials, Biocompatible; Coronary Angiography; Coronary Restenosis; Coronary Thrombosis; Disease-Free Survival; Drug-Eluting Stents; Everolimus; Female; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Myocardial Infarction; Paclitaxel; Percutaneous Coronary Intervention; Prosthesis Design; Risk Factors; Sirolimus; Time Factors; Treatment Outcome

To assess the proportion of patients receiving pharmacological therapy for secondary prevention after an acute coronary syndrome (ACS) in Portugal and to identify age and sex inequalities.. Retrospective cohort study.. We studied 747 episodes of ST-segment elevation myocardial infarction (STEMI) and 1364 of non-ST-segment elevation ACS (NSTE-ACS), within a sample of ACS cases consecutively discharged from 10 Portuguese hospitals, in 2008-2009. We estimated adjusted odds ratios (OR) for the association of age and sex with the use of each pharmacological treatment.. In STEMI and NSTE-ACS patients, the proportion of patients discharged with aspirin was 96 and 88%, clopidogrel 91 and 78%, aspirin+clopidogrel 88 and 71%, beta-blockers 80 and 76%, angiotensin-converting enzyme (ACE) inhibitors/ARB 82 and 80%, statins 93 and 90%, 3-drug (aspirin/clopidogrel+beta-blocker+statin) 76 and 69%, and 5-drug treatment (aspirin+clopidogrel+beta-blocker+ACE inhibitor/ARB+statin) 61 and 48%, respectively. Among STEMI patients, those aged ≥80 years were substantially less often discharged with clopidogrel (OR 0.22, 95% confidence interval, CI, 0.08-0.56), aspirin+clopidogrel (OR 0.34, 95% CI 0.15-0.76), beta-blockers (OR 0.39, 95% CI 0.18-0.82), 3-drug (OR 0.41, 95% CI 0.21-0.83), and 5-drug treatments (OR 0.44, 95% CI 0.23-0.83) than those <60 years; women were less likely to be discharged with aspirin+clopidogrel (OR 0.52, 95% CI 0.29-0.91). Among NSTE-ACS patients, those aged ≥80 years were much less likely to be discharged with beta-blockers (OR 0.58, 95% CI 0.36-0.93), statins (OR 0.35, 95% CI 0.19-0.64), and 3-drug treatment (OR 0.47, 95% CI 0.30-0.75); sex had no significant effect on treatment prescription.. The vast majority of younger patients were discharged on evidence-based secondary preventive medications, but only half received the 5-drug combination. Recommended therapies were substantially underprescribed in older patients.

Topics: Acute Coronary Syndrome; Adult; Age Factors; Aged; Aged, 80 and over; Cardiovascular Agents; Drug Prescriptions; Drug Therapy, Combination; Drug Utilization Review; Evidence-Based Medicine; Female; Guideline Adherence; Health Care Surveys; Healthcare Disparities; Humans; Logistic Models; Male; Middle Aged; Myocardial Infarction; Odds Ratio; Patient Discharge; Portugal; Practice Guidelines as Topic; Practice Patterns, Physicians'; Retrospective Studies; Risk Factors; Secondary Prevention; Sex Factors; Time Factors; Young Adult

To compare biodegradable polymer biolimus-eluting (BES) with abluminal drug elution and durable polymer everolimus-eluting (EES) stents in the treatment of bifurcation lesions.. The persistence of a polymer in drug-eluting stents (DES) following drug elution has been viewed as a possible culprit for restenosis. DES with biodegradable polymer may thus be associated with improved clinical outcomes, especially in high-risk lesions such as those at bifurcation sites.. We performed a retrospective study of consecutive de novo bifurcation lesions treated with EES between October 2006 and October 2011 and BES between February 2008 and March 2012. Study endpoints included major adverse cardiac events (MACE) defined as all-cause death, myocardial infarction (MI), including peri-procedural MI, and target vessel revascularization (TVR) as well as target lesion revascularization (TLR) separately.. We analyzed 236 bifurcation lesions treated with either BES (79 lesions in 69 patients) or EES (157 lesions in 154 patients). Patient and procedural characteristics were broadly similar between the two groups. Estimated MACE and TVR rates at 2-year follow-up were similar between the BES and EES groups (MACE = 13.6 ± 4.6% vs. 14.6 ± 3.2% (P = 0.871); TVR = 6.9 ± 3.5% vs. 8.0 ± 2.7% (P = 0.889). No significant differences were noted between the two groups following propensity-score matched analysis. There was no probable or definite stent thrombosis.. BES use in the treatment of bifurcation lesions appears to be associated with good clinical outcomes, comparable to those seen with EES, at long-term follow-up. These results are hypothesis-generating and need to be validated with larger studies.

Topics: Absorbable Implants; Aged; Cardiovascular Agents; Coronary Artery Disease; Coronary Thrombosis; Drug-Eluting Stents; Everolimus; Female; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Myocardial Infarction; Percutaneous Coronary Intervention; Polymers; Prosthesis Design; Retrospective Studies; Risk Factors; Sirolimus; Time Factors; Treatment Outcome

We report the case of a 77-year-old male patient who was admitted to our institution for non-ST segment elevation myocardial infarction. Coronary angiography showed a sub-occlusive lesion of the distal left anterior descending artery (LAD) in the context of a diffuse atherosclerotic disease involving a very long segment of the vessel (about 80mm in length by visual estimation). Pre-dilatation was performed in the mid calcified segment of the LAD with a non-compliant balloon inducing vessel dissection. An everolimus-eluting bioresorbable vascular scaffold (EEBVS) was then advanced in the LAD but the first delivery attempt at the distal site failed because of friction between the EEBVS struts and the calcified vessel wall. In order to facilitate EEBVS delivery, a 5Fr catheter system (Heart Rail II, Terumo, Tokyo, Japan) was advanced in the mid LAD within a standard 6Fr guiding catheter facilitating a non-traumatic deep intubation up to the mid LAD. This strategy increased back-up support facilitating the delivery, beyond the site of resistance, of four EEBVS implanted in overlap. This case demonstrated the successful use of a guide catheter extension system to deliver multiple EEBVS in a patient with a long, calcified LAD lesion.

Topics: Absorbable Implants; Aged; Angioplasty, Balloon, Coronary; Cardiac Catheterization; Cardiac Catheters; Cardiovascular Agents; Coronary Angiography; Coronary Artery Disease; Drug-Eluting Stents; Everolimus; Humans; Male; Myocardial Infarction; Prosthesis Design; Tissue Scaffolds; Treatment Outcome; Vascular Calcification

Newer-generation everolimus-eluting stents (EES) have been shown to improve clinical outcomes compared with early-generation sirolimus-eluting (SES) and paclitaxel-eluting stents (PES) in patients undergoing percutaneous coronary intervention (PCI). Whether this benefit is maintained among patients with saphenous vein graft (SVG) disease remains controversial.. We assessed cumulative incidence rates (CIR) per 100 patient years after inverse probability of treatment weighting to compare clinical outcomes. The pre-specified primary endpoint was the composite of cardiac death, myocardial infarction (MI), and target vessel revascularisation (TVR). Out of 12,339 consecutively treated patients, 288 patients (5.7%) underwent PCI of at least one SVG lesion with EES (n=127), SES (n=103) or PES (n=58). Up to four years, CIR of the primary endpoint were 58.7 for EES, 45.2 for SES and 45.6 for PES with similar adjusted risks between groups (EES vs. SES; HR 0.94, 95% CI: 0.55-1.60, EES vs. PES; HR 1.07, 95% CI: 0.60-1.91). Adjusted risks showed no significant differences between stent types for cardiac death, MI and TVR.. Among patients undergoing PCI for SVG lesions, newer-generation EES have similar safety and efficacy to early-generation SES and PES during long-term follow-up to four years.

Topics: Aged; Cardiovascular Agents; Coronary Artery Bypass; Drug-Eluting Stents; Everolimus; Female; Graft Occlusion, Vascular; Humans; Male; Middle Aged; Myocardial Infarction; Netherlands; Paclitaxel; Percutaneous Coronary Intervention; Prosthesis Design; Registries; Risk Factors; Saphenous Vein; Sirolimus; Switzerland; Time Factors; Treatment Outcome

To evaluate safety and efficacy of the everolimus-eluting bioresorbable scaffold (BVS) in patients with ST-segment elevation myocardial infarction (STEMI).. According to the current guidelines, drug-eluting stents are the treatment of choice in patients with STEMI. BVS represents a new technology capable to restore the native vessel vasomotion and potentially avoiding long-term limitations such as stent thrombosis.. From October 2012 to May 2013, patients with evidence of STEMI eligible for BVS implantation were included in this study. Exclusion criteria were not defined.. A total of 25 patients, respectively 31 lesions, were treated. Procedural success was achieved in 97%. Two major adverse cardiac events occurred during hospitalization and follow-up: one patient with cardiogenic shock at the index procedure subsequently died. One patient suffered from instable angina with need for interventional revascularization of a previously untreated vessel. One target vessel failure as a consequence of an intra-procedural dissection was seen. However, no target lesion failure was noted. During 132.7 ± 68.7 days of follow-up none of the patients died.. Our findings suggest that implantation of BVS in STEMI patients is feasible in this small cohort of highly selected patients. Further evaluation in randomized-controlled trials is needed.

Topics: Absorbable Implants; Aged; Cardiovascular Agents; Coated Materials, Biocompatible; Coronary Angiography; Everolimus; Feasibility Studies; Female; Humans; Male; Middle Aged; Myocardial Infarction; Percutaneous Coronary Intervention; Prosthesis Design; Sirolimus; Time Factors; Tissue Scaffolds; Tomography, Optical Coherence; Treatment Outcome

Eicosapentaenoic acid (EPA) has antiarrhythmic effects. The J-wave on an electrocardiogram is associated with a high incidence of ventricular tachycardia/fibrillation (VT/VF). We evaluated relationships between EPA and J-waves, and their involvement in the occurrence of VT/VF in acute myocardial infarction (AMI). Two hundred consecutive patients undergoing successful percutaneous coronary intervention within 12 h after AMI onset were enrolled. Serum EPA level and J-waves at admission were evaluated. The patients were divided into two groups according to the optimal cutoff value (2.94) of serum EPA level (% of total fatty acids): LOW (<2.94, 61 ± 11 years, n = 103) and HIGH groups (≥2.94, 70 ± 13 years, n = 81). J-waves were observed more frequently in the LOW (36/103, 35 %) than in HIGH group (16/81, 20 %) (P = 0.020). The 30-day incidence of VT/VF including those occurring before admission was higher in the LOW (19.5 %) than in HIGH group (6.2 %) (P = 0.009). The patients with J-waves showed a higher incidence of VT/VF (23.1 %) than those without J-waves (9.9 %) (P = 0.019). Kaplan-Meier analysis showed that the highest incidence of VT/VF was observed in the LOW with J-wave group (27.8 %), followed by the LOW without J-wave (15.0 %), HIGH with J-wave (12.5 %), and HIGH without J-wave (4.6 %) (P = 0.013). Cox proportional hazard analysis revealed that Killip grade and low serum EPA level or presence of J-waves were significantly associated with the incidence of VT/VF. Low serum EPA level is a risk for incidence of VT/VF in the acute phase of myocardial infarction. Involvement of the J-wave and its possible link with EPA in the pathogenesis of ischemia-induced VT/VF are suggested.

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Eicosapentaenoic Acid; Electrocardiography; Female; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Myocardial Infarction; Risk Factors; Tachycardia, Ventricular; Treatment Outcome; Ventricular Fibrillation

Professor Keith AA Fox speaks to Caroline Telfer, Commissioning Editor. Professor Keith AA Fox is the British Heart Foundation and the Duke of Edinburgh Professor of Cardiology at the University of Edinburgh (UK). He is a founding fellow of the European Society of Cardiology and is currently Chair of the Programme of the European Society of Cardiology. In addition, he was President of the British Cardiovascular Society from 2009 to 2012. Professor Fox gave the State-of-the-Art lecture on acute coronary syndromes at the American Heart Association, as well as the 2009 Plenary lecture at the European Society of Cardiology-American College of Cardiology Symposium, the Lord Rayner lecture of the Royal College of Physicians (London, UK) and the Sir Stanley Davidson Lecture of the Royal College (Edinburgh, UK). He was awarded the Silver Medal of the European Society of Cardiology in 2010. Professor Fox's major research interest lies in the mechanisms and manifestations of acute coronary arterial disease; his work extends from underlying biological mechanisms to in vitro and in vivo studies and clinical trials. He is the author of more than 587 scientific papers (H-index Web of Science 73, Citations: 30,261 to March 2013). Professor Fox is chairman of the RITA program, co-chairman of ROCKET-AF and OASIS program, and chair of the GRACE program (the largest multinational study in acute coronary syndromes), and a lead investigator for studies on novel antithrombins, anticoagulants and antiplatelets. He is an International Associate Editor of the European Heart Journal and a member of the editorial boards of a number of journals. His current areas of research include the inhibition of coronary thrombosis and the role of platelets and inflammation in acute coronary syndromes.

Topics: Biomedical Research; Cardiovascular Agents; Mobile Applications; Myocardial Infarction; Registries; Risk Assessment

Patient long-term adherence to β-blockers, HMG-CoA reductase inhibitors (statins), and angiotensin-converting enzyme inhibitors (ACEIs)/angiotensin receptor blockers (ARBs) after acute myocardial infarction (AMI) is alarmingly low. It is unclear how prevalent patient adherence may be across small geographic areas and whether this geographic prevalence may vary.. This is a retrospective cohort study using Medicare service claims files from 2007 to 2009 with Medicare beneficiaries 65 years and above who were alive 30 days after the index AMI hospitalization between January 1, 2008 and December 31, 2008 (N=85,017). The adjusted proportions of patients adherent to β-blockers, statins, and ACEIs/ARBs, respectively, in the 12 months after discharge across the 306 Hospital Referral Regions (HRRs) were measured and compared by control chart. The intracluster correlation coefficient (ICC) and the additional prediction power from this small-area variation on individual patient adherence were assessed.. The adjusted proportion of patients adherent across HRRs ranged from 58% to 74% (median, 66%) for β-blockers, from 57% to 67% (median, 63%) for ACEIs/ARBs, and from 58% to 73% (median, 66%) for statins. The ICC was 0.053 (95% CI, 0.043-0.064) for β-blockers, 0.050 (95% CI, 0.039-0.061) for ACEIs/ARBs, and 0.041 (95% CI, 0.031-0.052) for statins. The adjusted proportion of patients adherent across HRRs increased the c-statistic by 0.01-0.02 (P < 0.0001).. Nonadherence to evidence-based preventive therapies post-AMI among older adults was prevalent across small geographic regions. Moderate small-area variation in patient adherence exists.

Topics: Age Factors; Aged; Aged, 80 and over; Cardiovascular Agents; Comorbidity; Evidence-Based Medicine; Female; Humans; Insurance Claim Review; Male; Medicare; Medication Adherence; Myocardial Infarction; Residence Characteristics; Retrospective Studies; Risk Factors; Sex Factors; Small-Area Analysis; Socioeconomic Factors; United States

Despite recommended pharmacotherapies the use of secondary prevention therapy after myocardial infarction (MI) remains suboptimal. Patients with diabetes mellitus (DM) have worse prognosis after MI compared to patients without DM and aggressive secondary prevention pharmacotherapy in this population is therefore warranted. We examined the changes in use of evidence-based secondary prevention pharmacotherapy in patients with and without DM discharged after first MI.. All patients aged 30 years or older admitted with first MI in Denmark during 1997-2006 were identified by individual-level linkage of nationwide registries of hospitalizations. Univariate and multivariate logistic regression models were used to identify patient characteristics associated with initiation of acetylsalicylic acid, angiotensin-converting enzyme inhibitors or angiotensin receptor blockers, β-blockers, and clopidogrel within 90 days, and statins within 180 days of discharge, respectively.. A total of 78,230 patients were included, the mean age was 68.3 years (SD 13.0), 63.5% were men and 9,797 (12.5%) had diabetes. Comparison of claimed prescriptions in the period 1997-2002 and 2003-2006 showed significant (p < 0.001) increases in claims for acetylsalicylic acid (38.9% vs. 69.7%), angiotensin-converting enzyme inhibitors or angiotensin receptor blockers (38.7% vs. 50.4%), β-blockers (69.2% vs. 77.9%), clopidogrel (16.7% vs. 66.3%), and statins (41.3% vs. 77.3%). During 2003-2006, patients with DM claimed significantly less acetylsalicylic acid (odds ratio [OR] 0.81 [95% confidence interval [CI] 0.74-0.88) and clopidogrel (OR 0.91 [95% CI 0.83-1.00]) than patients without DM.. Despite sizeable increase in use of evidence-based secondary prevention pharmacotherapy after MI from 1997 to 2006, these drugs are not used in a substantial proportion of subjects and patients with DM received significantly less antiplatelet therapy than patients without DM. Increased focus on initiation of secondary prevention pharmacotherapy after MI is warranted, especially in patients with DM.

Topics: Adult; Aged; Aged, 80 and over; Cardiovascular Agents; Chi-Square Distribution; Denmark; Diabetes Complications; Drug Prescriptions; Drug Utilization Review; Female; Humans; Logistic Models; Male; Middle Aged; Multivariate Analysis; Myocardial Infarction; Odds Ratio; Patient Discharge; Practice Patterns, Physicians'; Registries; Secondary Prevention; Time Factors; Treatment Outcome

The aim of this study was to compare the 2-year clinical outcomes of overlapping second-generation everolimus-eluting stents (EES) with those of overlapping resolute zotarolimus-eluting stents (R-ZES) in the treatment of long coronary artery lesions.. This retrospective analysis included 256 patients treated with overlapping EES (n=121) and R-ZES (n=135) for long coronary artery lesions (total stent length per lesion ≥34 mm). Study endpoints included major adverse cardiac events (MACE) defined as the composite of cardiac death, myocardial infarction, and target-vessel revascularization (TVR), as well as target-lesion revascularization and definite stent thrombosis separately at 2 years.. In the two groups, the mean age was older and the average number of disease vessel was higher in the R-ZES group. The mean lesion length and total stent length per lesion were longer in the R-ZES group. EES were more frequently implanted in the left anterior descending coronary artery. No significant differences in the estimated MACE (5.8% for EES vs. 8.1% for R-ZES; P=0.548) or TVR (3.4% for EES vs. 4.0% for R-ZES; P=0.806) rates were noted between the two groups at 2-year follow-up. The incidence of definite stent thrombosis was low and similar in both groups (0.83% for EES vs. 0% for R-ZES; P=0.473). No significant differences were noted with respect to MACE or TVR between the two groups following propensity score matching.. Stent overlap with second-generation EES or R-ZES was associated with low rates of MACE, TVR, and stent thrombosis at 2-year follow-up. Our results suggest that the use of overlapping EES or R-ZES in long coronary lesions is associated with good long-term clinical outcomes. These results need to be validated with randomized controlled trials.

Topics: Aged; Cardiovascular Agents; Chi-Square Distribution; Coronary Artery Disease; Coronary Thrombosis; Drug-Eluting Stents; Everolimus; Female; Humans; Kaplan-Meier Estimate; Logistic Models; Male; Middle Aged; Myocardial Infarction; Percutaneous Coronary Intervention; Propensity Score; Proportional Hazards Models; Prosthesis Design; Retrospective Studies; Risk Factors; Sirolimus; Time Factors; Treatment Outcome

Differential outcomes in patients with acute systolic heart failure (HF) complicating acute myocardial infarction (AMI) and the efficacy of mineralocorticoid receptor antagonists according to non-ST-segment and ST-segment elevation myocardial infarction (NSTEMI, STEMI) status has not been specifically investigated.. In the EPHESUS study, 6632 patients with acute HF and left ventricular ejection fraction<40% were randomized 3-14 days post-AMI (median 7.3 ± 3.0 days) to receive eplerenone (n=3319) or placebo (n=3313). Among them, 6392 patients with available data on baseline ST-segment status (4634 STEMI; 1758 NSTEMI) were compared using a Cox model analysis stratified according to quintiles of propensity score (PS), taking into account major baseline risk factors, including revascularization.. STEMI and NSTEMI patients differed significantly across a large variety of baseline characteristics. During 30 months of follow-up, all-cause death occurred in 19% and 13% (P<0.0001), cardiovascular death in 16% and 12% (P<0.0001), cardiovascular death and hospitalization in 33% and 26% (P<0.0001) and death from progression of HF in 5% and 3% (P<0.0001) of unadjusted NSTEMI and STEMI patients, respectively. After Cox model PS adjustment without revascularization, NSTEMI status still proved to be a risk factor for all-cause death, cardiovascular death and death from progression of HF. After Cox model PS adjustment including revascularization, none of the outcomes differed between STEMI and NSTEMI patients. Eplerenone morbidity and mortality benefits were consistent in the STEMI and NSTEMI subgroups.. In patients with acute systolic HF complicating AMI, eplerenone improves outcomes equally in STEMI and NSTEMI patients. Worse outcomes associated with NSTEMI could be explained by more co-morbidities, less aggressive therapies and, mainly, less frequent revascularization.

Topics: Aged; Cardiovascular Agents; Cardiovascular Diseases; Cause of Death; Comorbidity; Coronary Thrombosis; Disease Progression; Electrocardiography; Eplerenone; Female; Heart Failure; Humans; Male; Middle Aged; Mineralocorticoid Receptor Antagonists; Multicenter Studies as Topic; Myocardial Infarction; Myocardial Revascularization; Prognosis; Proportional Hazards Models; Randomized Controlled Trials as Topic; Retrospective Studies; Spironolactone; Treatment Outcome

There are few studies comparing the long-term efficacy and safety of the zotarolimus-eluting stent (ZES) with sirolimus- (SES) and paclitaxel-eluting stents (PES) in the unselected cohorts that were subject to real life clinical practice.. Total 2,769 patient who underwent successful percutaneous coronary intervention (PCI) with the three drug-eluting stents (DES) between April 2006 and July 2008 were analyzed retrospectively. A total of 1,152 patients were treated with SES, 810 with PES, and 807 with ZES. The primary analysis endpoint was cumulative rate of target-lesion failure (TLF) at 24 months, defined as the composite of cardiac death, target-vessel-related myocardial infarction (MI), and target-lesion revascularization (TLR).. At 24 months, the incidence of TLF was significantly lower in the SES group compared with the ZES (7.6% vs. 11.3%, HR = 0.66, CI = 0.49–0.88, P = 0.005) or the PES group (7.6% vs. 10.2%, HR = 0.74, CI = 0.55–0.99, P = 0.048), while similar between the PES and the ZES groups (HR = 0.89, CI = 0.66–1.20, P = 0.443). The difference was mostly driven by higher rate of TLR in the ZES and PES groups compared with the SES group, mostly within the first year post-PCI. However, the rate of hard endpoints (cardiac death or nonfatal MI) was similar among the three groups. These results were reproduced in the propensity score-matched cohort.. This observational study shows that the use of SES is superior to PES or ZES for the TLF in the overall and matched analysis.

Topics: Aged; Cardiovascular Agents; Coronary Angiography; Coronary Artery Disease; Drug-Eluting Stents; Female; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Myocardial Infarction; Paclitaxel; Percutaneous Coronary Intervention; Proportional Hazards Models; Prosthesis Design; Republic of Korea; Retrospective Studies; Risk Assessment; Risk Factors; Sirolimus; Time Factors; Treatment Outcome

Patients requiring chronic hemodialysis (HD) are at high risk for restenosis after percutaneous coronary intervention (PCI) with bare metal stents. Outcome data on drug-eluting stent (DES) implantation in HD patients are limited and suggest superiority of paclitaxel-eluting stents (PES) over limus-eluting stents (LES).. In total, 218 consecutive patients were prospectively enrolled. A comparison of post-PCI outcomes up to 2 years was carried out between patients receiving PES (n=62) and LES (n=156; SES n=112, EES n=44). The primary end point was 2-year major adverse cardiac events [MACE; death, Q-wave myocardial infarction and target lesion revascularization (TLR)].. Baseline characteristics were comparable. The overall prevalence of diabetes mellitus was 71%. On clinical follow-up to 2 years, MACE rates were similar [PES 32/51 (62.7%) vs. LES 77/132 (58.3%), p=0.59]; however, clinically-driven revascularization occurred more than twice as frequently in LES patients: TLR [PES 4/36 (11.1%) vs. LES 24/93 (25.8%), p=0.07] and target vessel revascularization [5/37 (13.5%) vs. 33/96 (34.4%), p=0.02]. Given that overall mortality was nominally higher for PES patients [31/50 (62.0%) vs. 61/127 (48.0%), p=0.09], a competing outcome analysis was implemented for TLR against mortality, which demonstrated that the trend for increased TLR with LES was no longer apparent (p=0.282). On multivariable adjustment, only diabetes mellitus was independently associated with TLR (use of PES was not).. Patients on chronic HD experience high rates of clinically driven TLR despite DES implantation. Use of PES does not demonstrate a significant advantage over LES in this population.

Topics: Aged; Cardiovascular Agents; Chi-Square Distribution; Coronary Artery Disease; Coronary Restenosis; Diabetes Mellitus; District of Columbia; Drug-Eluting Stents; Everolimus; Female; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Multivariate Analysis; Myocardial Infarction; Paclitaxel; Percutaneous Coronary Intervention; Prevalence; Proportional Hazards Models; Prospective Studies; Prosthesis Design; Renal Dialysis; Renal Insufficiency, Chronic; Risk Factors; Time Factors; Treatment Outcome

We evaluated the clinical value of a single measurement of high-sensitivity C-reactive protein (hs- CRP) in patients presenting to the emergency department with chest pain. We screened 408 consecutive patients of whom 292 comprised the final cohort for this study. Hs-CRP measured in the emergency department (ED) in patients presenting with chest pain and admitted for evaluation of acute myocardial infarction was neither sensitive nor specific in predicting acute myocardial infarction, myocardial ischemia on SPECT imaging, need for coronary revascularization, or cardiovascular or all-cause rehospitalization at 30 days. In addition, use of a specific CRP cut off >1 was not associated with an increase in all-cause rehospitalization at 30 days.

Topics: Acute Disease; Aged; C-Reactive Protein; Cardiovascular Agents; Chest Pain; Comorbidity; Emergency Service, Hospital; Female; Humans; Male; Middle Aged; Myocardial Infarction; Myocardial Ischemia; Patient Readmission; Percutaneous Coronary Intervention; Sensitivity and Specificity; Severity of Illness Index

To report a single-center experience of drug-eluting balloons (DEB) in the treatment of in-stent restenosis (ISR) and de novo coronary artery disease.. DEB are emerging as an alternative treatment for coronary stenosis especially when metal scaffolding is undesirable (in-stent restenosis and small-vessel de novo disease). Although there are various randomized trials and registry studies, the data from real-world cohorts are lacking.. Consecutive patients treated with the In.Pact Falcon™ (Medtronic Inc., Minneapolis, MN, USA) paclitaxel-eluting balloon between January 2009 and December 2011 were retrospectively studied. The measured end-points were cardiac death, myocardial infarction (MI), target lesion revascularization (TLR), target vessel revascularization (TVR), and major adverse cardiac events (MACE) defined as combination of cardiac death, MI, and TVR.. A total of 275 lesions were successfully treated in 184 patients. The mean age was 66.2 ± 9.6 years, and 87% were males. The predominant indication for DEB use was ISR (62%), with de novo lesions accounting for the remainder (38%). A mean of 1.48 ± 0.9 DEB were used per patient. Bailout stenting was required in 24% of lesions. The median clinical follow-up was 14.6 months (IQR 12-23). The overall rates of cardiac death, MI, TLR, TVR, and MACE were 3.8%, 1.6%, 16.8%, 17.9%, and 21.7%, respectively. The overall rate of stent thrombosis was 0.5% (n = 1).. Our results suggests that DEB can be considered in lesions where the use of stents is not desirable, especially restenotic lesions. Further long-term follow-up of these patients will provide us more insights on the long-term outcomes.

Topics: Adult; Aged; Aged, 80 and over; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Artery Disease; Coronary Restenosis; Female; Humans; Male; Middle Aged; Myocardial Infarction; Paclitaxel; Patient Outcome Assessment; Registries; Retrospective Studies; Stents

This study sought to compare everolimus-eluting stents (EES) versus Resolute zotarolimus-eluting stents (ZES) in terms of patient- or stent-related clinical outcomes in an "all-comer" group of patients with diabetes mellitus (DM) who underwent percutaneous coronary intervention.. DM significantly increases the risk of adverse events after percutaneous coronary intervention. The efficacy and safety of second-generation drug-eluting stents, in particular EES versus ZES, in patients with DM have not been extensively evaluated.. Patients with DM (1,855 of 5,054 patients, 36.7%) from 2 prospective registries (the EXCELLENT [Efficacy of Xience/Promus Versus Cypher in Reducing Late Loss After Stenting] registry and RESOLUTE-Korea [Registry to Evaluate the Efficacy of Zotarolimus-Eluting Stent]) who were treated with EES (n = 1,149) or ZES (n = 706) were compared. Stent-related outcome was target lesion failure (TLF), and patient-oriented composite events were a composite of all-cause mortality, any myocardial infarction, and any revascularization.. Despite a higher risk patient profile in the ZES group, both TLF (43 of 1,149 [3.7%] vs. 25 of 706 [3.5%], p = 0.899) and patient-oriented composite events (104 of 1,149 [9.1%] vs. 72 of 706 [10.2%], p = 0.416) were similar between the EES and ZES in patients with DM at 1 year. In those without DM, EES and ZES also showed comparable incidence of TLF (39 of 1,882 [2.1%] vs. 33 of 1,292 [2.6%], p = 0.370) and patient-oriented composite events (119 of 1,882 [6.3%] vs. 81 of 1,292 [6.3%], p = 0.951), which were all significantly lower than in the DM patients. These results were corroborated by similar findings from the propensity score-matched cohort. Upon multivariate analysis, chronic renal failure was the most powerful predictor of TLF in DM patients (hazard ratio: 4.39, 95% confidence interval: 1.91 to 10.09, p < 0.001).. After unrestricted use of second-generation drug-eluting stents in all-comers receiving percutaneous coronary intervention, both EES and ZES showed comparable clinical outcomes in the patients with DM up to 1 year of follow-up. DM compared with non-DM patients showed significantly worse patient- and stent-related outcomes. Nonetheless, overall incidences of TLF were low, even in the patients with DM, suggesting excellent safety and efficacy of both types of second-generation drug-eluting stents in this high-risk subgroup of patients.

Topics: Aged; Cardiovascular Agents; Chi-Square Distribution; Coronary Angiography; Coronary Artery Disease; Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2; Diabetic Angiopathies; Drug-Eluting Stents; Everolimus; Female; Humans; Kaplan-Meier Estimate; Kidney Failure, Chronic; Logistic Models; Male; Middle Aged; Multivariate Analysis; Myocardial Infarction; Patient Selection; Percutaneous Coronary Intervention; Propensity Score; Proportional Hazards Models; Prosthesis Design; Registries; Republic of Korea; Risk Factors; Sirolimus; Time Factors; Treatment Outcome

We examined 416 patients with acute myocardial infarction. 249 patients had STEMI and 167 NSTEMI. 227 were men and 189 women. 142 men had STEMI and 85 men had NSTEMI. 107 women were diagnosed with STEMI and 82 with NSTEMI. 22.5% of patient with STEMI and 20.2% of patients with NSTEMI died (p = 0.58). We compared the effect of anticoagulant treatment, clopidogrel, salicylate, nitrate, beta-blocker, angiotensin-converting enzyme inhibitor, statin and trimetazidine therapy on mortality in function of the type of myocardial infarction. There were no differences between mortality of patients with STEMI and NSTEMI with respect of use of heparine, salicylate, nitrate, beta-blocker, ACE inhibitor, statin and trimetazidine. While examining the effect of clopidogrel, we observed a significantly lower mortality rate in patients with NSTEMI compared to the STEMI group (p = 0.005). These differences are due to the known variability in clopidogrel absorption and metabolism, which could be influenced by the type of myocardial infarction.

Topics: Acute Disease; Aged; Anticoagulants; Cardiovascular Agents; Cardiovascular Diseases; Drug Therapy; Female; Humans; Male; Middle Aged; Myocardial Infarction; Risk Factors

Generic prescription drugs made by different manufacturers may vary in color or shape, and switching among these drug products may interrupt medication use.. To determine whether nonpersistent use of generic drugs among patients with cardiovascular disease after myocardial infarction (MI) is associated with inconsistent appearance of their medications.. Cohort and nested case-control studies.. Claims from a commercial health insurance database in the United States.. Patients discharged after hospitalization for MI between 2006 and 2011 who initiated treatment with a generic β-blocker, angiotensin-converting enzyme inhibitor, angiotensin II-receptor blocker, or statin. Case patients discontinued their index medication for at least 1 month; control patients continued treatment. Control patients were matched to case patients on therapeutic class, number of dispensings before nonpersistence, sex, and age.. Rates of changes in pill color and shape during the year after MI were calculated. Next, 2 refills preceding nonpersistence were evaluated to determine whether pill color or shape had changed. Odds of discordance among case and control patients were compared using conditional logistic regression.. A total of 29% of patients (3286 of 11,513) had a change in pill shape or color during the study. Statins had the most changes in appearance, whereas β-blockers had the fewest. A total of 4573 episodes of nonpersistence was matched to 19,881 control episodes. The odds of nonpersistence in case patients increased by 34% after a change in pill color (adjusted odds ratio, 1.34 [95% CI, 1.12 to 1.59]) and 66% after a change in pill shape (adjusted odds ratio, 1.66 [CI, 1.43 to 1.94]).. Only 3 categories of drugs indicated after MI were evaluated, and clinical outcomes were not addressed.. Variation in the appearance of generic pills is associated with nonpersistent use of these essential drugs after MI among patients with cardiovascular disease.. Agency for Healthcare Research and Quality and the Harvard Program in Therapeutic Science.

Topics: Adrenergic beta-Antagonists; Angiotensin II Type 1 Receptor Blockers; Angiotensin-Converting Enzyme Inhibitors; Cardiovascular Agents; Case-Control Studies; Cohort Studies; Drugs, Generic; Female; Humans; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Male; Medication Adherence; Myocardial Infarction

Eosinophils have been involved in a wide spectrum of pro-inflammatory and pro-thrombotic conditions, with the development of cardiovascular complications in a significant proportion of hypereosinophilic patients. However, no study has so far evaluated the impact of eosinophils levels on periprocedural myocardial infarction (PMI) in patients undergoing non-urgent percutaneous coronary interventions (PCI), that was, then, aim of current study.. In a consecutive cohort of patients, myonecrosis biomarkers were dosed at intervals from 6 to 48 h after PCI. Periprocedural myonecrosis was defined as troponin I increase by 3 times the ULN or by 50% of an elevated baseline value, whereas PMI as CKMB increase by 3 times the ULN or 50% of baseline.. Our population is represented by 1543 patients who were divided according to tertiles of absolute eosinophils count (AEC ≤ 0.1; 0.1-0.2; >0.2 × 10ˆ3/ml). Higher AEC was related to male gender (p = 0.002), arterial hypertension (p = 0.02), diabetes (p = 0.001), previous coronary revascularization (p = 0.003 for PCI, p = 0.03 for CABG), treatment with ARBs, beta-blockers, diuretics and ASA (p < 0.001), statins (p = 0.02), calcium antagonists (p = 0.05), glycosylated hemoglobin (p < 0001), creatinine levels (p = 0.001) and platelet count (p = 0.01), while inversely with acute presentation (p < 0.001), glycemia (p = 0.03), HDL-cholesterol and C-reactive protein (p = 0.02). AEC related with multivessel coronary artery disease (p = 0.05), lesion length (p = 0.01), drug eluting stents implantation (p = 0.001) and use of kissing balloon technique (p = 0.05), while inversely to intracoronary thrombus (p < 0.001) and thrombectomy (p = 0.04). AEC did not influence the occurrence of PMI (p = 0.06, adjusted OR [95% CI] = 1.06 [0.86-1.31], p = 0.57) or myonecrosis (p = 0.15, adjusted OR [95% CI] = 1.06 [0.88-1.27], p = 0.53). Results were confirmed at subgroup analysis in higher-risk subsets of patients.. In patients undergoing non-urgent PCI, eosinophils levels are not associated with the occurrence of periprocedural myocardial infarction or myonecrosis.

Topics: Aged; Biomarkers; C-Reactive Protein; Cardiovascular Agents; Cholesterol, HDL; Comorbidity; Coronary Thrombosis; Creatinine; Diabetes Mellitus; Eosinophils; Female; Glycated Hemoglobin; Humans; Hypertension; Leukocyte Count; Male; Middle Aged; Myocardial Infarction; Myocardium; Necrosis; Percutaneous Coronary Intervention; Platelet Count; Recurrence; Renal Insufficiency; Retrospective Studies; Smoking; Stents; Thrombectomy

Elderly patients are at high risk of mortality when they present with ST-elevation myocardial infarction (STEMI). However, few data exist about prognostic factors in this sub-group when treated with primary percutaneous coronary intervention (pPCI).. To assess outcome and predictors of mortality among patients aged >80 years treated with pPCI.. We evaluated 139 consecutive patients (age 85.1 ± 3.9 years, 43.2% males) who underwent pPCI for STEMI.. Male patients were younger and were more likely to have a history of coronary artery disease. Overall 30-day and 1-year mortality rates were 20.9% and 28.1%, respectively. Thrombolysis in Myocardial Infarction (TIMI) flow 3 was achieved in 82% of patients. There was a pPCI success rate in male patients. At univariable analysis, older age, diabetes mellitus, Killip class >III, left ventricular ejection fraction (LVEF) <40%, no use of stent, failure of pPCI, systolic blood pressure (SBP) <100 mm Hg, and infarct-related artery (left anterior descending vs others) were associated with higher 1-year mortality. Multivariate analysis identified LVEF <40% (hazard ratio: [HR] = 3.70; 95% confidence interval [CI]: 1.30-7.87; P = 0.0001), age (1-year step, HR: 1.13; 95% CI: 1.04-1.23; P = 0.007), failure of pPCI (HR: 2.93; 95% CI: 1.44-5.98; P = 0.0001), Killip class ≥III (HR: 2.29; 95% CI: 1.03-5.4; P = 0.04) and SBP <100 mm Hg (HR: 2.64; 95% CI: 1.22-5.19; P = 0.01) to be independently associated with increased 1-year mortality.. Our data show that elderly patients with STEMI have a high risk of mortality, which is particularly high in the first 30 days. Older age, LVEF <40% at admission, hemodynamic instability (higher Killip class or low SBP), and postinterventional TIMI flow <3 were independent predictors of mortality in our population.

Topics: Age Factors; Aged, 80 and over; Blood Pressure; Cardiovascular Agents; Chi-Square Distribution; Coronary Circulation; Databases, Factual; Female; Humans; Italy; Kaplan-Meier Estimate; Male; Multivariate Analysis; Myocardial Infarction; Percutaneous Coronary Intervention; Proportional Hazards Models; Retrospective Studies; Risk Factors; Sex Factors; Stroke Volume; Time Factors; Treatment Outcome; Ventricular Function, Left

This study investigates the therapeutic potential of intracoronary tacrolimus against acute myocardial infarction (AMI) in minipigs with serial cardiac magnetic resonance (CMR) and changes at histological and protein levels. Twelve minipigs subjected to permanent left anterior descending artery ligation were randomized as tac-treated group (n=6, with intracoronary tacrolimus treatment) and controls (n=6). CMR with cine and late gadolinium enhancement (LGE) studies were performed on postoperative days 2, 5, and 21. There were no significant differences in left ventricular function (LVF), contractility, and LGE between the two groups on day 2. On day 5, the tac-treated group showed a significantly higher ejection fraction, smaller infarct, and lower day-5/day-2 infarct ratio than controls. On day 21, the controls demonstrated further deterioration of LVF and infarct. Contrastingly, the tac-treated animals demonstrated preservation of LVF, contractility, significantly smaller infarct, and lower day-21/day-2 infarct ratios compared with those on day 5 and controls. The in vivo CMR results were correlated with in vitro findings on histology, immunostaining, and Western blotting which revealed significantly less fibrosis, higher vascularities, less CD68+ and CD40+ inflammatory cells, lower expressions of inflammatory (MMP-9, NF-κB, and TNF-α), and apoptotic (Bax, Caspase-3, c-PARP) biomarkers, respectively, in tac-treated AMI minipigs than controls.

Topics: Animals; Apoptosis; Biomarkers; Cardiac Imaging Techniques; Cardiovascular Agents; Heart Ventricles; Immunohistochemistry; Inflammation; Magnetic Resonance Imaging, Cine; Male; Myocardial Infarction; Swine; Swine, Miniature; Tacrolimus; Ventricular Function, Left

An 82-year old woman presented with chest pain and was diagnosed as having acute myocardial infarction. Coronary angiography (CAG) showed 90% stenosis in the proximal left anterior descending artery (LAD). The patient underwent percutaneous coronary intervention using a sirolimus-eluting stent (SES). A repeat CAG performed 6 months after SES implantation revealed no problems. Eight years later, the patient presented with recurrent angina. CAG showed severe stenosis of the SES with a large aneurysm. We performed off-pump coronary artery bypass grafting without ligation or plication of the LAD, but with the application of fibrin glue to the coronary artery aneurysm. The postoperative course was uneventful. The mechanism responsible for the occurrence of coronary artery aneurysms occurring late after drug-eluting stent implantation remains unclear, and the treatment strategy remains controversial. Herein, we discuss a surgical treatment for this rare entity.

Topics: Aged, 80 and over; Angina Pectoris; Cardiovascular Agents; Coronary Aneurysm; Coronary Angiography; Coronary Artery Bypass, Off-Pump; Drug-Eluting Stents; Female; Fibrin Tissue Adhesive; Humans; Myocardial Infarction; Percutaneous Coronary Intervention; Prosthesis Design; Sirolimus; Time Factors; Tomography, X-Ray Computed; Treatment Outcome

Limited data exist on contemporary sex-related differences in long-term outcomes of coronary patients receiving drug-eluting stents. In this study we evaluate differences for males (M) and females (F) in 2-year target lesion failure (TLF) in an unselected consecutive series of patients treated with everolimus-eluting stents (EES) and paclitaxel-eluting stents (PES) at a tertiary medical center.. Data on 348 consecutive patients (M 221, F 127) stented with EES and PES were retrospectively analyzed. The primary end point of the study was to compare sex-related outcomes in TLF, defined as the combined end point of cardiac death, nonfatal myocardial infarction, and target lesion revascularization (TLR). Secondary end points included TLR, target vessel failure, target vessel revascularization, acute stent thrombosis as defined by the Academic Research Consortium, and cardiac death. The cineangiograms of the first consecutive 162 patients (M 105, F 57) were independently reviewed by a cardiologist blinded to clinical outcome, and SYNTAX scoring was performed. Follow-up was achieved using medical records and/or phone calls and was censored at 2 years. Descriptive analysis was performed on all variables. Univariate analysis compared the M and F cohorts. Multivariate analysis using Cox regression was performed to determine independent predictors of TLF with time, including sex as an independent variable in the model.. M had more prior percutaneous coronary interventions and restenotic lesions and a higher prevalence of smoking. They also had longer length of disease and received more stents than F. F were older and had a higher prevalence of prior stroke. Angiographic complexity was not statistically different between the two groups, as judged by SYNTAX scoring (M 20.8±13.8, F 19.7±13.9, P=0.650). At 2-year follow-up, TLF was 27.4% and 24.8% (P=0.614) with no statistical difference between TLR (23.3% versus [vs] 21.6%), cardiac death (2.8% vs 3.2%), and definite and probable stent thrombosis (2.3% vs 0.0%) in M and F, respectively. Cox regression analysis using backward elimination showed that the number of stents per patient was the only independent predictor of TLF with time (hazard ratio 1.201, 95% confidence interval 1.126-1.280, P=0.001).. In this cohort of patients receiving EES and PES, M and F did not have statistically different outcomes at 2-year follow-up, consistent with recent reports in the current era of percutaneous coronary interventions.

Topics: Aged; Aged, 80 and over; Cardiovascular Agents; Coronary Angiography; Coronary Restenosis; Coronary Stenosis; Coronary Thrombosis; Drug-Eluting Stents; Everolimus; Female; Humans; Iowa; Kaplan-Meier Estimate; Male; Middle Aged; Multivariate Analysis; Myocardial Infarction; Paclitaxel; Percutaneous Coronary Intervention; Proportional Hazards Models; Prosthesis Design; Retrospective Studies; Risk Factors; Sex Factors; Sirolimus; Tertiary Care Centers; Time Factors; Treatment Outcome

Topics: Cardiovascular Agents; Coronary Aneurysm; Drug-Eluting Stents; Female; Humans; Myocardial Infarction; Percutaneous Coronary Intervention; Sirolimus

Topics: Cardiovascular Agents; Drugs, Generic; Female; Humans; Male; Medication Adherence; Myocardial Infarction

Topics: Cardiovascular Agents; Drugs, Generic; Female; Humans; Male; Medication Adherence; Myocardial Infarction

Topics: Cardiovascular Agents; Drugs, Generic; Female; Humans; Male; Medication Adherence; Myocardial Infarction

There is increasing emphasis on optimizing evidence-based medication (EBM) persistence as a means to improve longitudinal patient outcomes after acute myocardial infarction (MI); yet it is unknown whether differences in medication persistence exist between patients discharged from academic versus nonacademic hospitals. We linked Medicare pharmacy claims data with 3,184 patients with non-ST-segment elevation MI >65 years of age who were treated in 2006 at 253 hospitals participating in the Can Rapid Risk Stratification of Unstable Angina Patients Suppress Adverse Outcomes with Early Implementation of the American College of Cardiology and American Heart Association guidelines registry. Using multivariate regression, we compared persistent filling of β blockers, angiotensin-converting enzyme inhibitors and/or angiotensin receptor blockers, clopidogrel, and statins at 90 days and 1 year postdischarge between patients discharged from academic and nonacademic hospitals. Patients treated at academic hospitals were more frequently nonwhite (19% vs 8%, p <0.001) and had a greater co-morbidity burden (Charlson score ≥4 in 36% vs 30%, p = 0.001) than patients treated at nonacademic hospitals. Composite persistence to all EBMs prescribed at discharge was low and not significantly different between academic and nonacademic hospitals at 90 days (46% vs 45%, adjusted incidence rate ratio = 0.99, 95% confidence interval 0.95 to 1.04) and at 1 year (39% vs 39%, adjusted incidence rate ratio = 1.02, 95% confidence interval 0.98 to 1.07). Rates of persistence to EBMs were similar between patients with MI >65 years old treated at academic versus nonacademic hospitals; however, persistence rates are low both early and late postdischarge, highlighting a continued need for quality improvement efforts to optimize post-MI management.

Topics: Aged; Aged, 80 and over; Cardiovascular Agents; Female; Follow-Up Studies; Guideline Adherence; Hospital Mortality; Hospitals, General; Humans; Male; Myocardial Infarction; Patient Discharge; Registries; Retrospective Studies; Risk Assessment; Risk Factors; United States

Topics: Absorbable Implants; Adult; Cardiovascular Agents; Coated Materials, Biocompatible; Coronary Angiography; Coronary Vessels; Everolimus; Humans; Male; Myocardial Infarction; Percutaneous Coronary Intervention; Predictive Value of Tests; Prosthesis Design; Sirolimus; Thrombosis; Time Factors; Tomography, Optical Coherence; Treatment Outcome

Topics: Aged; Angioplasty, Balloon, Coronary; Angioscopy; Biopsy; Cardiovascular Agents; Coronary Aneurysm; Coronary Angiography; Coronary Artery Disease; Coronary Thrombosis; Drug-Eluting Stents; Female; Humans; Myocardial Infarction; Neointima; Percutaneous Coronary Intervention; Predictive Value of Tests; Prosthesis Design; Risk Factors; Sirolimus; Syndrome; Thrombectomy; Tomography, Optical Coherence; Treatment Outcome; Ultrasonography, Interventional

Improved early outcome in non-ST elevation myocardial infarction (NSTEMI) patients has been mainly attributed to a broader use of invasive strategies. Little is known about the impact of other changes in early management.. We aimed to assess 15-year trends in one-year mortality and their determinants in NSTEMI patients. We used data from 4 one-month French registries, conducted 5 years apart from 1995 to 2010 including 3903 NSTEMI patients admitted to intensive care units.. From 1995 to 2010, no major change was observed in patient characteristics, while therapeutic management evolved considerably. Early use of antiplatelet agents, β-blockers, ACE-inhibitors and statins increased over time (P < 0.001); use of newer anticoagulants (low-molecular-weight heparin, bivalirudin or fondaparinux) increased from 40.8% in 2000 to 78.9% in 2010 (P < 0.001); percutaneous coronary intervention (PCI)≤ 3 days of admission rose from 7.6% to 48.1% (P < 0.001). One-year death decreased from 20% to 9.8% (HR adjusted for baseline parameters, 2010 vs. 1995 = 0.47, 95% CI: 0.35-0.62). Early PCI (HR = 0.67; 95% CI: 0.49-0.90), use of newer anticoagulants (HR = 0.62; 95% CI: 0.48-0.78) and early use of evidence based medical therapy (HR = 0.54; 95% CI: 0.40-0.72) were predictors of improved one year-survival.. One-year mortality of NSTEMI patients decreased by 50% in the past 15years. Our data support current guidelines recommending early invasive strategies and use of newer anticoagulants for NSTEMI, and also show a strong positive association between early use of appropriate medical therapies and one-year survival, suggesting that these medications should be used from the start.

Topics: Aged; Cardiovascular Agents; Electrocardiography; Female; Follow-Up Studies; Forecasting; France; Humans; Male; Myocardial Infarction; Percutaneous Coronary Intervention; Prognosis; Registries; Retrospective Studies; Survival Rate

Topics: Cardiovascular Agents; Drugs, Generic; Female; Humans; Male; Medication Adherence; Myocardial Infarction

Topics: Cardiovascular Agents; Chromium Alloys; Coronary Artery Disease; Drug-Eluting Stents; Female; Humans; Male; Myocardial Infarction; Percutaneous Coronary Intervention; Polymers; Sirolimus

To assess the role of percutaneous coronary intervention (PCI) for in-hospital and one-year prognosis of ST elevation (STE) myocardial infarction (MI) patients with impaired glucose tolerance (IGT) or type 2 diabetes mellitus (T2DM).. This registry study included 601 STEMI patients admitted to hospital within 24 hours after STEMI onset during one year. According to medical history, dynamics of glycemia and results of oral glucose tolerance test patients were divided into 3 groups: (1) without disturbances of carbohydrate metabolism (DCM), (2) with IGT and (3) with T2DM. Primary PCI was performed in 373 (62.06%) patients while 228 (37.94%) received pharmacological treatment only. The following events were registered during one year after PCI: recurrent MI, stroke, admission for decompensated chronic heart failure (CHF), repeat emergency PCI.. Patients with IGT and DM compared with those without DCM had similarly more severe course of the index MI and worse one-year prognosis. PCI significantly improved one-year prognosis in patients with and without DCM.. Use of urgent PCI in STEMI patients with both DM and IGT is prognostically more beneficial in terms of lowering rate of adverse events during one year after MI.

Topics: Carbohydrate Metabolism; Cardiovascular Agents; Diabetes Mellitus, Type 2; Electrocardiography; Female; Follow-Up Studies; Glucose Intolerance; Humans; Male; Middle Aged; Myocardial Infarction; Percutaneous Coronary Intervention; Postoperative Complications; Prognosis; Registries; Risk Factors; Russia; Severity of Illness Index; Treatment Outcome

Mortality due to coronary heart disease has been declining as a result of better clinical patient management, including secondary prevention with the aid of effective drugs. The clinical challenge remains how to improve adherence to evidence-based cardiac care for all patients who can benefit from it. The present study aimed to assess the effectiveness of drug use after acute myocardial infarction (AMI) in reducing total medium-term mortality and to establish whether there are disparities in prescribing all therapies of demonstrated effectiveness.. We conducted a retrospective cohort study between 2002 and 2009 using a record linkage database, considering 1327 patients discharged after AMI.. Cox's regression models were used for the survival analysis with time-dependent variables. Logistic regression analyses were performed to investigate the inequalities in the actual use of therapies found significantly associated with a lower mortality in the survival analyses.. Therapies independently associated with a lower all-cause mortality risk were antiplatelet drugs, beta-blockers, angiotensin-converting enzyme inhibitors, and statins. Gender-related differences in prescriptions were seen for statins and antiplatelet drugs; age-related differences emerged for all drugs. Associated chronic obstructive pulmonary disease reduced the likelihood of patients taking the effective treatments.. The present study revealed disparities in the use of treatments for the secondary prevention of coronary heart disease unjustifiable on the strength of clinical evidence.

Topics: Adolescent; Adult; Aged; Aged, 80 and over; Cardiovascular Agents; Chi-Square Distribution; Child; Child, Preschool; Comorbidity; Drug Prescriptions; Drug Therapy, Combination; Drug Utilization Review; Female; Guideline Adherence; Health Services Accessibility; Healthcare Disparities; Humans; Infant; Infant, Newborn; Italy; Logistic Models; Male; Medical Record Linkage; Middle Aged; Myocardial Infarction; Practice Guidelines as Topic; Practice Patterns, Physicians'; Propensity Score; Proportional Hazards Models; Retrospective Studies; Risk Factors; Secondary Prevention; Sex Factors; Time Factors; Treatment Outcome; Young Adult

International guidelines recommend referral for cardiac rehabilitation (CR) after acute myocardial infarction (AMI). However, the impact on long-term survival after CR referral has not been adjusted by time-variance. We compared the effects of CR referral after hospitalization for AMI in two consecutive decades.. A total of 2196 and 2055 patients were recruited in the prospective observational studies of the Evaluation of the Methods and Management of Acute Coronary Events (EMMACE) -1 and 2 in 1995 and 2003, (1995: median age 72 years, 39% women, 74% referred vs 2003: median age 71 years, 36% women, 64% referred) and followed up through September 2010. Survival functions showed CR referral to be an independent predictor for survival in 2003, but not in 1995 (hazard ratio (HR), 0.90; 95% confidence interval [CI]; 0.70 to 1.17, p = 0.44 in 1995 vs HR, 0.80; 95% CI, 0.66 to 0.96, p = 0.02 in 2003) when patients entered the model at three months after discharge and had a common exit at 90 months. Significant positive and negative predictors for CR referral were beta-blocker prescription (+), reperfusion (+) and age (-) in 1995, and reperfusion (+), revascularization (+), heart failure (HF) (+), antiplatelets (+), angiotensin-converting-enzyme inhibitor (ACE-I) (+), statins (+), diabetes (-), and the modified Global Registry of Acute Cardiac Events (GRACE) risk score (-) in 2003.. CR referral was associated with improved survival in 2003, but not in 1995 in patients admitted with acute MI.

Topics: Age Factors; Aged; Aged, 80 and over; Cardiovascular Agents; Comorbidity; England; Female; Hospitalization; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Myocardial Infarction; Myocardial Revascularization; Outcome and Process Assessment, Health Care; Proportional Hazards Models; Prospective Studies; Referral and Consultation; Risk Assessment; Risk Factors; Time Factors; Treatment Outcome

Individuals with unrecognized myocardial infarction (UMI) have similar risks for cardiovascular events and mortality as those with recognized myocardial infarction (RMI). The prevalence of cardioprotective medication use and blood pressure and low-density lipoprotein cholesterol control among individuals with UMI is unknown.. Participants from the REasons for Geographic And Racial Differences in Stroke (REGARDS) study who were recruited between May 2004 and October 2007 received baseline twelve-lead electrocardiograms (n = 21,036). Myocardial infarction (MI) status was characterized as no MI, UMI (electrocardiogram abnormalities consistent with MI without self-reported history; n = 949; 4.5%), and RMI (self-reported history of MI; n = 1574; 7.5%).. For participants with no MI, UMI, and RMI, prevalence of use was 38.4%, 44.4%, and 75.7% for aspirin; 18.0%, 25.8%, and 57.2% for beta blockers; 31.7%, 38.7%, and 55.0% for angiotensin converting enzyme inhibitors or angiotensin receptor blockers; and 28.1%, 33.9%, and 64.1% for statins, respectively. Participants with RMI were 35% more likely to have low-density lipoprotein cholesterol < 100 mg/dL than participants with UMI (prevalence ratio = 1.35, 95% confidence interval 1.19-1.52). Blood pressure control (,140/90 mmHg) was similar between RMI and UMI groups (prevalence ratio = 1.03, 95% confidence interval 0.93-1.13).. Although participants with UMI were somewhat more likely to use cardioprotective medications than those with no MI, they were less likely to use cardioprotective medications and to have controlled low-density lipoprotein cholesterol than participants with RMI. Increasing appropriate treatment and risk factor control among individuals with UMI may reduce risk of mortality and future cardiovascular events.

Topics: Aged; Black or African American; Cardiovascular Agents; Cross-Sectional Studies; Drug Utilization; Drug Utilization Review; Electrocardiography; Female; Humans; Male; Middle Aged; Myocardial Infarction; Practice Patterns, Physicians'; Residence Characteristics; Risk Assessment; Risk Factors; Secondary Prevention; Stroke; Treatment Outcome; United States; White People

This study was carried out to determine the effect of the use of dual antiplatelet therapy (DAPT) for more than 12 months on long-term clinical outcomes in patients who had undergone a percutaneous coronary intervention with the first and second generations of drug-eluting stents (DES).. The potential benefits of the use of DAPT beyond a 12-month period in patients receiving DES have not been established clearly. Moreover, it is also unclear whether the optimal duration of DAPT is similar for all DES types.. A total of 2141 patients with coronary artery disease treated exclusively with Cypher sirolimus-eluting stents (SES) or Endeavor zotarolimus-eluting stents (ZES) were considered for retrospective analysis. The primary endpoint [a composite of all-cause mortality, nonfatal myocardial infarction (MI), and stroke] was compared between the 12-month DAPT and the >12-month DAPT group.. A total of 1870 event-free patients on DAPT at 12 months were identified. The average follow-up was 28.2±7.4 months. The primary outcomes were similar between the two groups (4.1% 12-month DAPT vs. 1.9% >12-month DAPT; P=0.090). Incidences of death, MI, stroke, and target vessel revascularization did not differ significantly between the two groups. Subgroup analysis showed that in the patients with hypertension, >12-month DAPT significantly reduced the occurrence of death/MI/stroke compared with that in the 12-month DAPT group (P=0.04). In patients implanted with SES, the primary outcome was significantly lower with the >12-month DAPT group (5.2% 12-month DAPT vs. 1.6% >12-month DAPT; P=0.016), whereas in patients with ZES, the primary outcome was comparable between the two groups (2.3% 12-month DAPT vs. 2.0% >12-month DAPT; P=0.99).. In our study, for all patients, >12-month DAPT in patients who had received DES was not significantly more effective than 12-month DAPT in reducing the rate of death/MI/stroke. Our findings, that patients who received SES benefit from >12-month DAPT whereas extended use of DAPT was not significantly more effective in those implanted with ZES, implied that the optimal duration of DAPT was different depending on different types of DES.

Topics: Aged; Aspirin; Cardiovascular Agents; Chi-Square Distribution; Clopidogrel; Coronary Artery Disease; Disease-Free Survival; Drug Administration Schedule; Drug Therapy, Combination; Drug-Eluting Stents; Female; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Multivariate Analysis; Myocardial Infarction; Percutaneous Coronary Intervention; Platelet Aggregation Inhibitors; Proportional Hazards Models; Prosthesis Design; Retrospective Studies; Risk Assessment; Risk Factors; Sirolimus; Stroke; Ticlopidine; Time Factors; Treatment Outcome

Social gradients in cardiovascular mortality across the United Kingdom may reflect differences in incidence, disease severity, or treatment. It is unknown whether a universal healthcare system delivers equitable lifesaving medical therapy for coronary heart disease. We therefore examined secular trends in the use of key medical therapies stratified by socioeconomic circumstances across a broad spectrum of coronary disease presentations, including acute coronary syndromes, secondary prevention, and clinical angina.. This was a cross-sectional observational analysis of nationally representative primary and secondary care data from the United Kingdom. Data on treatments for all myocardial infarction patients in 2003 and 2007 were derived from the Myocardial Ischemia National Audit Project (n=51 755). Data on treatments for patients with chronic angina (n=33 211) or requiring secondary prevention (n=32 976) in 1999 and 2007 were extracted from the General Practice Research Database. Socioeconomic circumstances were defined using a weighted composite of 7 area-level deprivation domains. Treatment estimates were age-standardized. Use of all therapies increased in all patient groups, both men and women. Improvements were most marked in primary care, where use of β-blockers, statins, and angiotensin-converting enzyme inhibitors or angiotensin receptor blockers for secondary prevention and treatment of angina doubled, from ≈30% to >60%. Small age gradients persisted for some therapies. No consistent socioeconomic gradients or sex differences were observed for myocardial infarction and postrevascularization (hard diagnoses). However, some sex inequality was apparent in the treatment of younger women with angina.. Cardiovascular treatment is generally equitable and independent of socioeconomic circumstances. Future strategies should aim to further increase overall treatment levels and to eradicate remaining age and sex inequalities.

Topics: Adrenergic beta-Antagonists; Age Factors; Aged; Angina Pectoris; Angiotensin II Type 1 Receptor Blockers; Angiotensin-Converting Enzyme Inhibitors; Cardiovascular Agents; Coronary Disease; Cross-Sectional Studies; Delivery of Health Care; Female; Health Care Surveys; Healthcare Disparities; Humans; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Male; Middle Aged; Myocardial Infarction; Outcome and Process Assessment, Health Care; Platelet Aggregation Inhibitors; Practice Patterns, Physicians'; Primary Health Care; Secondary Care; Secondary Prevention; Sex Factors; Socioeconomic Factors; State Medicine; Treatment Outcome; United Kingdom

Second-generation everolimus-eluting stents (EES) are safer and more efficient than first-generation paclitaxel-eluting stents (PES). Third-generation biolimus-eluting stents (BES) have been found to be non-inferior to PES. To date, there is no available comparative study between EES and BES. We aimed to investigate the safety and efficacy of BES with biodegradable polymer compared to EES with durable polymer at a follow-up of two years in an unselected population of consecutively enrolled patients.. A group of 814 consecutive patients undergoing percutaneous coronary intervention (PCI) was enrolled between 2007 and 2010, of which 527 were treated with EES and 287 with BES implantation. Clinical outcome was compared in 200 pairs using propensity score matching. The primary endpoint was a composite of death, myocardial infarction (MI) and target vessel revascularisation (TVR) at two-year follow-up. Median follow-up was 22 months. The primary outcome occurred in 11.5% of EES and 10.5% of BES patients (HR 1.11, 95% CI: 0.61-2.00, p=0.74). At two years, there was no significant difference with regard to death (HR 0.49, 95% CI: 0.18-1.34, p=0.17), cardiac death (HR 0.14, 95% CI: 0.02-1.14, p=0.66) or MI (HR 6.10, 95% CI: 0.73-50.9, p=0.10). Stent thrombosis (ST) incidence was evenly distributed between EES (n=2) and BES (n=2) (p-value=1.0).. This first clinical study failed to demonstrate any significant difference regarding safety or efficacy between these two types and generations of drug-eluting stents (DES).

Topics: Aged; Cardiovascular Agents; Chi-Square Distribution; Coronary Artery Disease; Coronary Thrombosis; Drug-Eluting Stents; Everolimus; Female; Follow-Up Studies; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Multivariate Analysis; Myocardial Infarction; Percutaneous Coronary Intervention; Propensity Score; Proportional Hazards Models; Prosthesis Design; Risk Factors; Sirolimus; Time Factors; Treatment Outcome

L5 is the most negatively charged subfraction of human low-density lipoprotein (LDL) and is the only subfraction of LDL capable of inducing apoptosis in cultured vascular endothelial cells (ECs) by inhibiting fibroblast growth factor-2 (FGF2) transcription. We examined whether plasma L5 levels are elevated in patients with ST-segment elevation myocardial infarction (STEMI) and whether aspirin provides epigenetic protection of human coronary artery ECs (HCAECs) exposed to L5.. Plasma L5 levels were compared between patients with STEMI (n = 10) and control subjects with chest pain syndrome but a normal coronary arteriogram (n = 5). L5 was isolated from the plasma of STEMI patients and control subjects, and apoptosis, FGF2 expression, and FGF2 promoter methylation were examined in HCAECs treated with L5 and aspirin. Plasma L5 levels were significantly higher in STEMI patients than in control subjects (P < 0.001). Treatment of HCAECs with L5 resulted in reduced survival and FGF2 expression and increased CpG methylation of the FGF2 promoter. Co-treatment of HCAECs with L5 and a physiologically relevant, low concentration of aspirin (0.2 mM) attenuated the adverse effects of L5 on HCAEC survival, FGF2 expression, and FGF2 promoter methylation. In contrast, high concentrations of aspirin (≥1.0 mM) accentuated the effects of L5.. Our results show that L5 levels are significantly increased in STEMI patients. Furthermore, L5 impairs HCAEC function through CpG methylation of the FGF2 promoter, which is suppressed in the presence of low-concentration aspirin. Our results provide evidence of a novel mechanism of aspirin in the prevention of MI.

Topics: Aged; Apoptosis; Aspirin; Base Sequence; Cardiovascular Agents; Case-Control Studies; Cell Survival; Cells, Cultured; Coronary Artery Disease; Coronary Vessels; CpG Islands; Cytoprotection; DNA Methylation; Dose-Response Relationship, Drug; Endocytosis; Endothelial Cells; Epigenesis, Genetic; Female; Fibroblast Growth Factor 2; Humans; Lipoproteins, LDL; Male; Middle Aged; Molecular Sequence Data; Myocardial Infarction; Promoter Regions, Genetic; Proto-Oncogene Proteins c-akt; Scavenger Receptors, Class E; Transfection; Up-Regulation

Autophagy is a biological process during which cells digest organelles in their cytoplasm and recycle the constituents. The impact of autophagy in the heart, however, remains unclear in part because of the inability to noninvasively image this process in living animals.. Here, we report the use of fluorescence molecular tomography and a cathepsin-activatable fluorochrome to image autophagy in the heart in vivo after ischemia/reperfusion and rapamycin (RAP) therapy. We show that cathepsin-B activity in the lysosome is upregulated by RAP and that this allows the expanded lysosomal compartment in autophagy to be imaged in vivo with fluorescence molecular tomography. We further demonstrate that the delivery of diagnostic nanoparticles to the lysosome by endocytosis is enhanced during autophagy. The upregulation of autophagy by RAP was associated with a 23% reduction (P<0.05) of apoptosis in the area at risk and a 45% reduction in final infarct size (19.6±5.6% of area at risk with RAP versus 35.9±9.1% of area at risk without RAP; P<0.05).. The ability to perform noninvasive tomographic imaging of autophagy in the heart has the potential to provide valuable insights into the pathophysiology of autophagy, particularly its role in cardiomyocyte salvage. Although additional data are needed, our study supports the investigation of RAP therapy in patients with acute coronary syndromes.

Topics: Animals; Apoptosis; Autophagy; Cardiovascular Agents; Cathepsin B; Disease Models, Animal; Enzyme Activation; Female; Fluorescent Dyes; Ischemic Postconditioning; Lysosomes; Mice; Mice, Inbred C57BL; Microscopy, Confocal; Microspheres; Myocardial Infarction; Myocardial Reperfusion Injury; Myocardium; Optical Imaging; Radionuclide Imaging; Sirolimus; Time Factors; Tomography; X-Ray Microtomography

Tryton side branch (SB) reverse culotte stenting has been employed for the treatment of left main (LM) stem bifurcations in patients at high risk for bypass surgery. The aim of this study was to assess acute angiographic results and six-month clinical outcome after implantation of the Tryton stent in the LM.. We studied 52 consecutive patients with LM disease treated in nine European centres. Angiographic and clinical data analysis was performed centrally. Fifty-one of 52 patients (age 68±11 yrs, 75% male, 42% unstable angina, SYNTAX score 20±8) were successfully treated with the Tryton stent. Medina class was 1,1,1 in 33 (63%), 1,0,1 in 7 (13%), 1,1,0 in 3 (6%), 0,1,1 in 8 (4%) and 0,0,1 in 1 (2%). The Tryton stent on a stepped balloon (diameter 3.5-2.5 mm) was used in 41/51 (80%) of cases. The mean main vessel stent diameter was 3.4±0.4 mm with an everolimus-eluting stent employed in 30/51 (59%) of cases. Final kissing balloon dilatation was performed in 48/51 (94%). Acute gain was 1.52±0.86 mm in the LM and 0.92±0.47 mm in the SB. The angiographic success rate was 100%; the procedural success rate reached 94%. Periprocedural MI occurred in three patients. At six-month follow-up, the TLR rate was 12%, MI 10% and cardiac death 2%. The hierarchical MACE rate at six months was 22%. No cases of definite stent thrombosis occurred.. The use of the Tryton stent for treatment of LM bifurcation disease in combination with a conventional drug-eluting stent is feasible and achieves an optimal angiographic result. Safety of the procedure and six-month outcome are acceptable in this high-risk lesion PCI. Further safety and efficacy studies with long-term outcome assessment of this strategy are warranted.

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Angiography; Coronary Artery Disease; Drug-Eluting Stents; Europe; Everolimus; Female; Humans; Male; Middle Aged; Myocardial Infarction; Predictive Value of Tests; Prosthesis Design; Registries; Retrospective Studies; Sirolimus; Stents; Time Factors; Treatment Outcome

The aim of this study is to evaluate the acute and long-term outcomes of ostial stentings among bare-metal stents (BMS), sirolimus-eluting stents, and paclitaxel-eluting stents.. According to the CAPTAIN (Cardiovascular Atherosclerosis and Percutaneous TrAnsluminal INterventions) registry, from November 1995 to June 2011, 420 patients with ostial lesions were treated using BMS implantations (243 patients with 247 lesions), CYPHER implantations (77 patients with 77 lesions), or TAXUS implantations (100 patients with 104 lesions).. Compared with the CYPHER and TAXUS groups, the BMS group had larger late loss (0.29±0.53, 0.64±0.78, and 1.30±0.79 mm, respectively, P=0.006) and restenosis rate (6, 8, and 33%, respectively, P<0.001). During the long-term follow-up, the BMS group had higher target lesion revascularization than the CYPHER and TAXUS groups (17, 4, and 6%, respectively, P=0.002). The cardiac event-free survival rate, as determined by the Kaplan-Meier analysis, was also lower in the BMS group than in the CYPHER and TAXUS groups (55, 86, and 76%, respectively, P<0.001).. Intracoronary stenting with drug-eluting stent for ostial lesions was associated with lower angiographic restenosis and late loss, and a more favorable long-term clinical outcome than BMS.

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Chi-Square Distribution; Coronary Angiography; Coronary Artery Disease; Coronary Restenosis; Coronary Thrombosis; Disease-Free Survival; Drug-Eluting Stents; Female; Humans; Kaplan-Meier Estimate; Male; Metals; Middle Aged; Myocardial Infarction; Paclitaxel; Predictive Value of Tests; Prospective Studies; Prosthesis Design; Registries; Risk Factors; Sirolimus; Stents; Time Factors; Treatment Outcome

Flavonoids are important components of 'functional foods', with beneficial effects on the cardiovascular function, mainly due to their antioxidant activity. Many flavonoids exert antihypertensive, anti-atherosclerotic and antiplatelet activity and positive effects against endothelial dysfunction. Recent evidence indicates that they exert cardioprotective effects against myocardial ischaemia/reperfusion (I/R) injury. The aim of this work was to investigate these properties for flavonoids with different structural characteristics.. In this work, the cardioprotective effects of eight flavonoids endowed with different structural characteristics were tested on Langendorff-perfused rat hearts submitted to 30 min of global ischaemia followed by 120 min of reperfusion (I/R).. Only the 5-hydroxy-substituted derivatives, such as 5-hydroxy flavone, apigenin, chrysin and naringenin, conferred on the hearts an improved post-ischaemic functional recovery associated with lower extension of tissue injury. A similar pharmacological profile was exhibited by 5-methoxy flavone. In contrast, 6-hydroxy flavone, 7-hydroxy flavone and 4'-hydroxy flavanone did not confer significant protection against the injury induced by I/R.. Some flavonoids exhibit direct cardioprotective effects against the injury induced by drastic I/R and this pharmacological property seems to be related to their structural characteristics. Such an influence of structural requirements seems to indicate that the cardioprotective effects may be due to the interaction with specific pharmacological targets.

Topics: Animals; Cardiovascular Agents; Flavones; Flavonoids; Heart; Male; Myocardial Contraction; Myocardial Infarction; Myocardial Reperfusion Injury; Myocardium; Phytotherapy; Plant Extracts; Rats; Rats, Wistar

Topics: Adult; Aftercare; Aged; Angina, Unstable; Biomarkers; Cardiovascular Agents; Comorbidity; Diagnostic Techniques, Cardiovascular; Disease Management; Female; Humans; Inpatients; Male; Middle Aged; Myocardial Infarction; Myocardial Revascularization; Risk Assessment

Drug-eluting stents are more effective in reducing restenosis than bare-metal stents. Paclitaxel-eluting stents (PES) and sirolimus-eluting stents (SES) are the most widely used first-generation drug-eluting stents, but long-term comparative data on these are scant. The aim of the present report is to investigate the 6-year clinical outcomes of PES versus SES in a matched cohort of single-center registry patients.. Data were obtained from the observational, monocentric registry of 632 consecutive patients who underwent percutaneous coronary intervention between September 2002 and September 2005 with PES or SES. We assessed the composite and separate occurrence of the major adverse cardiac events (MACE), including death, nonfatal myocardial infarction, and target lesion revascularization (TLR).. After a propensity 1 : 1 matching analysis, baseline clinical, procedural, and angiographic characteristics were well balanced between the two groups. Throughout the 6 years of follow-up, there were no significant differences between PES and SES in terms of MACE (P=0.52), all-cause death (P=0.24), myocardial infarction (P=0.25), stent thrombosis (P=0.38), and TLR (P=0.68). The sensitivity analysis on the total unmatched population confirmed this result, the stent type not being predictive of MACE (PES vs. SES group, hazard ratio 0.97, 95% confidence interval 0.66-1.41, P=0.87) or TLR (PES vs. the SES group, hazard ratio 1.35, 95% confidence interval 0.69-2.64, P=0.38).. In this 'real-life' registry, PES and SES showed a comparable safety and efficacy profile throughout the 6 years of follow-up. The increase in the rate of TLR was slow and comparable between the two groups, even though the 'late catch-up' phenomenon showed a different temporal pattern between PES and SES.

Topics: Aged; Cardiovascular Agents; Chi-Square Distribution; Coronary Angiography; Coronary Artery Disease; Coronary Thrombosis; Disease-Free Survival; Drug-Eluting Stents; Female; Hospitals, High-Volume; Humans; Kaplan-Meier Estimate; Logistic Models; Male; Middle Aged; Myocardial Infarction; Paclitaxel; Percutaneous Coronary Intervention; Propensity Score; Prospective Studies; Prosthesis Design; Registries; Risk Factors; Sirolimus; Time Factors; Treatment Outcome

Topics: Cardiovascular Agents; Coronary Angiography; Coronary Vessels; Drug-Eluting Stents; Humans; Male; Middle Aged; Myocardial Infarction; Percutaneous Coronary Intervention; Platelet Aggregation Inhibitors; Predictive Value of Tests; Prosthesis Design; Sirolimus; Treatment Outcome

Predictors of long-term mortality after discharge after acute myocardial infarction (AMI) are well characterized. However, these established risk factors are based on data almost exclusively derived from older studies without consistent use of revascularization therapy and adjunctive therapy with statins, platelet inhibitors, beta-blockers and ACE inhibitors/ARBs. We therefore sought to investigate predictors of 1-year mortality in survivors of AMI treated with contemporary guideline-adherent therapy.. We performed a retrospective analysis of 3,782 patients surviving acute ST-elevation and non ST-elevation myocardial infarction who were enrolled in the prospective, randomized, double-blind, controlled OMEGA trial with 104 German centers. The primary objective of the OMEGA study was to determine the effect of highly purified omega-3 fatty acid ethyl esters-90 on the rate of sudden cardiac death in patients surviving AMI and receiving current guideline-adherent treatment within the 1-year of follow-up. 80.8 % of the patients received early revascularization therapy. At discharge, 94.2 % of the patients received beta-blocker, 90.4 % ACE inhibitor/angiotensin receptor blocker, 94.3 % statin, 95.4 % aspirin and 88.4 % clopidogrel. During the 1-year follow-up 139 patients (3.7 %) died. Multivariate logistic regression analysis revealed the following independent predictors of 1-year mortality in decreasing order of importance: ejection fraction <45 % [odds ratio (OR) 2.28, 95 % confidence interval (CI) 1.53-3.41], age ≥70 years (OR 2.17, 95 % CI 1.42-3.32), no acute revascularization (OR 2.02, 95 % CI 1.33-3.08), prior stroke/transient ischemic attack (OR 1.90, 95 % CI 1.09-3.30), peripheral arterial disease (OR 1.86, 95 % CI 1.12-3.10), heart rate >85/min (OR 1.82, 95 % CI 1.23-2.71), chronic obstructive lung disease (OR 1.77, 95 % CI 1.01-3.10) and HDL cholesterol <40 mg/dl (OR 1.75, 95 % CI 1.15-2.67).. In patients surviving AMI and treated with contemporary guideline-adherent therapy, 1-year mortality was low. Nevertheless, traditional risk factors such as ejection fraction <45 %, older age, no acute revascularization and comorbidities were the strongest predictors of long-term mortality supporting the findings from previous studies.

Topics: Aged; Aged, 80 and over; Cardiovascular Agents; Chi-Square Distribution; Drug Therapy, Combination; Female; Germany; Guideline Adherence; Humans; Logistic Models; Male; Middle Aged; Multicenter Studies as Topic; Multivariate Analysis; Myocardial Infarction; Odds Ratio; Patient Discharge; Practice Guidelines as Topic; Practice Patterns, Physicians'; Randomized Controlled Trials as Topic; Retrospective Studies; Risk Factors; Time Factors; Treatment Outcome

Assess impact of Medicare Part D benefit phases on adherence with evidence-based medications after hospitalization for an acute myocardial infarction.. Random 5 percent sample of Medicare beneficiaries.. Difference-in-difference analysis of drug adherence by AMI patients stratified by low-income subsidy (LIS) status and benefit phase.. Subjects were identified with an AMI diagnosis in Medicare Part A files between April 2006 and December 2007 and followed until December 2008 or death (N = 8,900). Adherence was measured as percent of days covered (PDC) per month with four drug classes used in AMI treatment: angiotensin-converting enzyme (ACE) inhibitors/angiotensin II receptor blockers (ARBs), beta-blockers, statins, and clopidogrel. Monthly exposure to Part D benefit phases was calculated from flags on each Part D claim.. For non-LIS enrollees, transitioning from the initial coverage phase into the Part D coverage gap was associated with statistically significant reductions in mean PDC for all four drug classes: statins (-7.8 percent), clopidogrel (-7.0 percent), beta-blockers (-5.9 percent), and ACE inhibitor/ARBs (-5.1 percent). There were no significant changes in adherence associated with transitioning from the gap to the catastrophic coverage phase.. As the Part D doughnut hole is gradually filled in by 2020, Medicare Part D enrollees with critical diseases such as AMI who rely heavily on brand name drugs are likely to exhibit modest increases in adherence. Those reliant on generic drugs are less likely to be affected.

Topics: Acute Disease; Age Factors; Aged; Aged, 80 and over; Cardiovascular Agents; Drug Utilization; Evidence-Based Practice; Female; Humans; Insurance Claim Review; Male; Medicare Part D; Medication Adherence; Myocardial Infarction; Residence Characteristics; Sex Factors; Socioeconomic Factors; United States

Sheng-Mai-San (SMS) has been used for the treatment of cardiovascular disease for many years in China.. This study investigated the protective effects and active ingredients of SMS on myocardial injury (MI) in mice.. SMS and n-butanol extraction of SMS (SMS-Bu) were prepared and administered to ISO-treated mice once a day for 7 consecutive days. The doses were equivalent to the raw medicinal herbs of SMS 5.72, 2.86 and 1.43 g/kg/d, respectively. Propranolol was used as positive control. Serum biomarkers, histopathological and electrocardiographic were evaluated.. Serum lactate dehydrogenase, creatine kinase and myeloperoxidase increased to 4473.6 ± 322.5, 950.0 ± 35.0 and 90.4 ± 12.2 U/L in the model group. SMS and SMS-Bu groups showed a decrease from 10 to 29% for lactate dehydrogenase and from 17 to 42% for creatine kinase, respectively. Both SMS and SMS-Bu significantly attenuated the myeloperoxidase activities (from 42 to 56%) and malondialdehyde levels (from 25 to 45%) compared with the model group. Decreased superoxide dismutase activities in ISO-treated mice were elevated from 19 to 59% when treated with SMS and SMS-Bu. These biochemical results were supported by electrocardiogram (ECG) and histopathological observations. Furthermore, 8 ginsenosides and 16 lignans were identified in SMS-Bu.. These findings suggested that SMS-Bu was the mainly active fraction of SMS which exerted its beneficial effects on MI mainly through protecting myocardial tissue and reducing oxidative damage, and the ginsenosides and lignans may serve as active ingredients of SMS for the treatment of MI.

Topics: Animals; Biomarkers; Cardiovascular Agents; Chromatography, Liquid; Creatine Kinase; Cytoprotection; Disease Models, Animal; Drug Combinations; Drugs, Chinese Herbal; Isoproterenol; L-Lactate Dehydrogenase; Malondialdehyde; Mice; Mice, Inbred ICR; Myocardial Infarction; Myocardium; Peroxidase; Phytotherapy; Plants, Medicinal; Superoxide Dismutase; Tandem Mass Spectrometry

The determination of inflammation markers in circulation has enabled an important improvement in the study of cardiovascular diseases. It was tested the hypothesis that non-specific markers such as erythrocyte sedimentation rate (ESR), C-reactive protein (CRP) and fibrinogen may provide prognostic information in patients with acute myocardial infarction with persistent ST-segment elevation (STEMI) undergoing primary angioplasty (PCI).. A cohort of 197 consecutive patients with STEMI undergoing primary PCI was enrolled, evaluating during hospitalization, the peak values of the following markers of inflammation: ESR, CRP and fibrinogen. A telephone follow-up has been made in order to investigate any possible new cardiovascular events after hospital discharge and the procedure performed.. Higher values of CRP were statistically associated with adverse future events as composite endpoint and with the single endpoint of death. Furthermore, higher age, presence of hypertension, history of previous cardiovascular events, were statistically significantly associated with cardiac events at follow up. In this group were also overrepresented subjects with anterior myocardial infarction in the anterior localization and with an EF ? 35% at discharge.. CRP appears to be a predictor of future cardiovascular events, confirming that a pro-inflammatory state promotes the progression of atherosclerotic disease and its complications.

Topics: Acute Disease; Age Factors; Angioplasty; Biomarkers; Blood Sedimentation; C-Reactive Protein; Cardiovascular Agents; Cardiovascular Diseases; Electrocardiography; Fibrinogen; Humans; Inflammation Mediators; Myocardial Infarction; Socioeconomic Factors

International studies provide an opportunity to compare treatment approaches and outcomes. The present study compares elderly hospitalized acute myocardial infarction (AMI) patients in Minneapolis/St. Paul, USA (MSP) and Göteborg, Sweden (GB).. A population-based sample of hospitalized AMI (ICD-9 410) patients aged ≥75 in MSP and GB in 2001-02 was abstracted by trained nurses. Mortality was ascertained from medical records and death certificates. Demographics, cardiovascular procedures, and prescription medications were compared using sex-specific generalized linear models. Adjusted hazard ratios (HR) were calculated with Cox regression. In MSP 839 (387 men, 452 women) and in GB 564 (275 men, 289 women) patients were identified. Age was similar (men: MSP 83 ± 7, GB 82 ± 5; women: MSP 84 ± 6, GB 84 ± 6) yet MSP patients had more previous cardiovascular comorbidities and procedures (PCI/CABG). Guideline-based medication use was high in both locations. MSP patients were significantly more likely to undergo PCI (men: MSP 33%, GB 7%; women: MSP 30%, GB 7%). Survival at 7.5 years was 27.8% among MSP patients (men: 26.6%, women: 28.8%) and 17.2% among GB patients (men: 17.5%, women: 17.0%). After adjustment for baseline characteristics and guideline-based therapies, survival was higher among MSP men [HR: 0.66, 95% confidence interval (CI): 0.50-0.88] and women (HR: 0.49, 95% CI: 0.36-0.67) compared with GB.. In MSP and GB, guideline-based therapy use was high. However, PCI use was markedly higher in MSP. Long-term survival was better among elderly men and women in MSP compared with GB possibly related to greater utilization of PCI.

Topics: Aged, 80 and over; Cardiovascular Agents; Coronary Angiography; Female; Hospitalization; Humans; Male; Minnesota; Myocardial Infarction; Percutaneous Coronary Intervention; Prescription Drugs; Sex Distribution; Sweden; Treatment Outcome

Topics: Angioplasty, Balloon, Coronary; Cardiomyopathy, Dilated; Cardiovascular Agents; Coronary Angiography; Coronary Artery Disease; Diabetes Mellitus, Type 2; False Negative Reactions; Follow-Up Studies; Humans; Hypertension; Internal Mammary-Coronary Artery Anastomosis; Magnetic Resonance Imaging; Male; Middle Aged; Myocardial Infarction; Myocardial Perfusion Imaging; Myocardial Stunning; Overweight; Reoperation; Stents; Stroke Volume

Topics: Arteriovenous Fistula; Cardiac Catheterization; Cardiovascular Agents; Female; Hand; Humans; Middle Aged; Myocardial Infarction; Platelet Aggregation Inhibitors; Postoperative Complications; Radial Artery; Regional Blood Flow; Treatment Outcome; Ultrasonography, Doppler; Vascular Surgical Procedures; Veins

Dietary intake of naturally occurring plant sterols is inversely related to serum cholesterol concentrations. Elevated serum cholesterol increases the risk of myocardial infarction (MI), but it is unknown if this can be reduced by dietary intake of naturally occurring plant sterols. Our aim was to investigate if a high intake of naturally occurring plant sterols is related to a lower risk of contracting a first MI. The analysis included 1005 prospective cases (219 women, 786 men) and 3148 matched referents (723 women, 2425 men), aged 29-73 y at baseline, from the population-based Northern Sweden Health and Disease Study. A food frequency questionnaire (FFQ) was completed at baseline. Absolute plant sterol intake was inversely related to the risk of a first MI in men (OR highest vs. lowest quartile = 0.70; 95% CI: 0.53, 0.85; P-trend = 0.006) but not in women. After adjustment for confounders, the estimated risk was somewhat attenuated (OR highest vs. lowest quartile = 0.71; 95% CI: 0.55, 0.92; P-trend = 0.067), suggesting that increasing sterol intake from 150 to 340 mg/d reduces the risk of a first MI by 29%. Energy-adjusted plant sterol intake was not related to the risk of a first MI in either men or women. In conclusion, the findings of this observational study show that a high absolute intake of naturally occurring plant sterols is significantly related to a lower risk of a first MI in men in northern Sweden, whereas no significant relation was seen for energy-adjusted plant sterol intake. In women, no significant associations were found. The results from this study show that intake of plant sterols may be important in prevention of MI.

Topics: Adult; Aged; Cardiovascular Agents; Diet; Diet Surveys; Energy Intake; Female; Humans; Male; Middle Aged; Myocardial Infarction; Phytosterols; Phytotherapy; Plant Extracts; Prospective Studies; Risk Factors; Sex Factors; Surveys and Questionnaires; Sweden

The present study is aimed to investigate the effect of Gualou Xiebai Decoction (GXD) ethanol extract on myocardial fibrosis and clarify the possible mechanism.. Rats with ligated left anterior descending coronary artery were treated with GXD ethanol extract (1.14 g/kg, 2.27 g/kg, 4.53 g/kg) daily via gavage for 4 weeks. Histopathological changes and collagen distribution were evaluated by haematoxylin and eosin and Masson staining. The mRNA levels of Collagen I and Collagen III were detected by real-time PCR. The expressions of TGF-β1, TGFβ receptor (TGFβR)I, TGFβRII, P-Smad2/3 and Smad7 were determined by Western blot.. GXD treatment was significantly reduced the heart weight/body weight ratio (P < 0.05) as well as the left ventricle weight/body weight ratio (P < 0.05). It also significantly alleviated the degree of inflammation, decreased myocardial collagen volume fraction (P < 0.05 ∼ 0.01), together with markedly prevented the upregulations of Collagen I and Collagen III (P < 0.05 ∼ 0.01). Moreover, GXD downregulated expressions of TGF-β1, TGFβRI, TGFβRII, Smad2/3 whereas improved Smad7 expression in the myocardial fibrosis rats.. GXD ameliorates myocardial fibrosis induced by cardiac infarction with ligated left anterior descending coronary artery, the mechanism maybe involve in inhibiting the TGF-β1 signalling pathway.

Topics: Allium; Animals; Cardiovascular Agents; Collagen; Drugs, Chinese Herbal; Fibrosis; Heart Ventricles; Inflammation; Male; Myocardial Infarction; Myocardium; Organ Size; Phytotherapy; Rats; Rats, Wistar; Signal Transduction; Smad Proteins; Smad2 Protein; Smad3 Protein; Smad7 Protein; Transforming Growth Factor beta1; Trichosanthes

The treatment of acute myocardial infarction (AMI), both with ST-segment elevation [ST-elevation myocardial infarction (STEMI)] and non-ST-segment elevation [non-ST-elevation myocardial infarction (NSTEMI)], is evolving in Piedmont, with an increase in interventional procedures and hub-and-spoke networks. This new region-wide survey provides updated assessment of the management of STEMI and unprecedented data on NSTEMI.. In 30 coronary care units in Piedmont, all patients with AMI symptoms of duration less than 48 h, between January and March 2007, were included.. Of 921 patients, 447 had STEMI and 474 NSTEMI. Diabetes was present in 35% and chronic kidney disease in 38%. Hospital mortality was 4.7% [95% confidence interval (CI) 3.3-6.1]: age 75 years or older, Killip class higher than 1 and known diabetes or abnormal blood glucose on admission were multivariate predictors. Thrombolysis and primary percutaneous transluminal coronary angioplasty (pPTCA) were performed in 17.6 and 53.1% of 391 patients, respectively, with STEMI of 12 h or less, and 29.3% had no reperfusion therapy, notably 52% of patients aged 75 years or older and 51% of those reaching non-24/24 h interventional centres. Mortality after pPTCA was 2.5% and onsite door-to-balloon time was less than 90 min in 67.5%. Overall mortality after STEMI was 5.4% (95% CI 3.2-7.6). In NSTEMI, use of antithrombotic treatments was extensive, but invasive treatment within 72 h was limited to 8% of patients in centres without interventional facilities and independent of patient's risk profile. Mortality after NSTEMI was 4.0% (95% CI 2.2-5.8) and was predicted by both the Global Registry of Acute Coronary Events risk score and diabetes.. There is room for improvement in the treatment of AMI in our region, with more extensive use of reperfusion therapy in STEMI, especially in the elderly, and early revascularization and optimal medical treatment in higher-risk NSTEMI.

Topics: Aged; Aged, 80 and over; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Comorbidity; Coronary Care Units; Delivery of Health Care; Female; Fibrinolytic Agents; Health Care Surveys; Health Services Accessibility; Hospital Mortality; Humans; Italy; Length of Stay; Male; Middle Aged; Multivariate Analysis; Myocardial Infarction; Patient Admission; Residence Characteristics; Risk Factors; Thrombolytic Therapy; Time Factors; Time-to-Treatment; Treatment Outcome

This study sought to assess the clinical safety and effectiveness of the Resolute zotarolimus-eluting stent (R-ZES) in patients with in-stent restenosis (ISR) from 2 large trials.. ISR treatment is associated with higher rates of subsequent cardiac events compared with treatment of de novo lesions. Although drug-eluting stents (DES) are an option, second-generation DES are largely untested in the treatment of ISR.. A total of 3,489 patients were pooled from the RAC (RESOLUTE All Comers) trial and the RESOLUTE International (RINT) registry. Two-year clinical endpoints included clinically driven target lesion revascularization (TLR), target lesion failure (TLF), cardiac death (CD), target vessel myocardial infarction (TVMI), combined CD or TVMI (CD/TVMI), and Academic Research Consortium definite and probable stent thrombosis (ST).. Overall, 281 patients (8.1%) received an R-ZES for ISR. Two-year TLR and TLF rates were significantly higher in ISR patients than in non-ISR patients (TLR: 12.7% vs. 4.3%, p = 0.003; TLF: 17.4% vs. 9.4%, p = 0.007); however, the CD/TVMI rate was not (6.9% vs. 6.1%, p = 0.711). Seven ISR patients had ST. Two-year outcomes by ISR stent type were similar: bare-metal stent (BMS)-ISR TLR was 12.5% and TLF was 17.2%; DES-ISR TLR was 13.0% and TLF was 18.8%. CD/TVMI was 7.3% and 7.2% for BMS-ISR and DES-ISR, respectively.. Using R-ZES to treat ISR appears equally safe in BMS-ISR and DES-ISR, with CD/TVMI rates comparable to 2-year outcomes in other clinical trials. Although revascularization rates are still higher in ISR lesions, the R-ZES offers an effective alternative for treatment of BMS-ISR and DES-ISR. (Randomized, Two-Arm, Non-inferiority Study Comparing Endeavor-Resolute Stent With Abbot Xience-V Stent [RESOLUTE-AC]; NCT00617084; and RESOLUTE International Registry: Evaluation of the Resolute Zotarolimus-Eluting Stent System in a 'Real-World' Patient Population [RINT]; NCT00752128).

Topics: Aged; Cardiovascular Agents; Coronary Restenosis; Coronary Thrombosis; Drug-Eluting Stents; Female; Humans; Logistic Models; Male; Middle Aged; Multivariate Analysis; Myocardial Infarction; Odds Ratio; Percutaneous Coronary Intervention; Propensity Score; Prosthesis Design; Randomized Controlled Trials as Topic; Registries; Risk Factors; Sirolimus; Time Factors; Treatment Outcome

Cardiovascular diseases are the first cause of death in elderly patients. So it seems important to estimate the adequacy of the medical prescriptions to the guidelines in this population and for these diseases. A retrospective analysis was performed in nine hospitals on 736 patients aged 65 years old and over hospitalized in the acute care geriatric unit. Cardiovascular prescribing were analyzed for each patient according to STOPP and START. The population (n=736) has a mean age of 86.7 years and belongs in 45.0% of the cases to the group of dependence GIR3-4. According to STOPP, two inappropriate prescriptions are noticed: calcium channel blockers with chronic constipation concerning 9% of the included population and aspirin at dose > 150 mg/day representing 8.4% of this population. According to START, angiotensin converting enzyme inhibitor are under-prescribed in elderly patients with heart failure (140 patients = 19.0% of the population) and following acute myocardial infarction (116 patients = 15.8%). Anticoagulation in patients with atrial fibrillation is also under-prescribed: 82 patients are concerned (11.0% of the population). The prescription of ACE inhibitor is influenced by renal insufficency in patients with heart failure. The anticoagulation in atrial fibrillation is age and dependence-related. This analysis demonstrates an inadequacy between the clinical practice and guidelines for two major cardiovascular diseases: the heart failure and the atrial fibrillation. The importance of the inadequacy was suspected of opportunities for improvement, in particular in the presence of their risk factors: very elderly patients, loss of autonomy and renal insufficiency.

Topics: Aged; Aged, 80 and over; Angiotensin-Converting Enzyme Inhibitors; Anticoagulants; Atrial Fibrillation; Calcium Channel Blockers; Cardiovascular Agents; Cardiovascular Diseases; Comorbidity; Constipation; Drug Utilization; Female; France; Guideline Adherence; Heart Failure; Humans; Hypertension; Inappropriate Prescribing; Male; Myocardial Infarction; Retrospective Studies

Topics: Angina Pectoris; Blood Flow Velocity; Cardiovascular Agents; Combined Modality Therapy; Coronary Circulation; Coronary Restenosis; Coronary Stenosis; Hemodynamics; Humans; Multicenter Studies as Topic; Myocardial Infarction; Patient Selection; Percutaneous Coronary Intervention; Randomized Controlled Trials as Topic; Severity of Illness Index; Treatment Outcome

There are extremely limited data on minority populations, especially Hispanics, describing the clinical epidemiology of acute coronary disease. The aim of this study is to examine the incidence rate of acute myocardial infarction (AMI), in-hospital case-fatality rate (CFR), and management practices among residents of greater San Juan (Puerto Rico) who were hospitalized with an initial AMI.. Our trained study staff reviewed and independently validated the medical records of patients who had been hospitalized with possible AMI at any of the twelve hospitals located in greater San Juan during calendar year 2007.. The incidence rate (# per 100,000 population) of 1,415 patients hospitalized with AMI increased with advancing age and were significantly higher for older patients for men (198) than they were for women (134). The average age of the study population was 64 years, and women comprised 45% of the study sample. Evidence-based cardiac therapies, e.g., aspirin, beta blockers, ACE inhibitors/angiotensin receptor blockers, and statins, were used with 60% of the hospitalized patients, and women were less likely than men to have received these therapies (59% vs. 65%) or to have undergone interventional cardiac procedures (47% vs. 59%) (p<0.05). The in-hospital CFR increased with advancing age and were higher for women (8.6%) than they were for men (6.0%) (p<0.05).. Efforts are needed to reduce the magnitude of AMI, enhance the use of evidence-based cardiac therapies, reduce possible gender disparities, and improve the short-term prognoses of Puerto Rican patients hospitalized with an initial AMI.

Topics: Adult; Age Distribution; Aged; Aged, 80 and over; Cardiac Catheterization; Cardiovascular Agents; Comorbidity; Disease Management; Drug Utilization; Female; Hospital Mortality; Humans; Incidence; Male; Middle Aged; Myocardial Infarction; Myocardial Revascularization; Risk Factors; Sex Distribution; Sexism; Socioeconomic Factors; Urban Population