cardiovascular-agents and Hemorrhage

Since the outbreak of coronavirus disease 2019 (COVID-19) in 2019, it is gaining worldwide attention at the moment. Apart from respiratory manifestations, neurological dysfunction in COVID-19 patients, especially the occurrence of cerebrovascular diseases (CVD), has been intensively investigated. In this review, the effects of COVID-19 infection on CVD were summarized as follows: (I) angiotensin-converting enzyme 2 (ACE2) may be involved in the attack on vascular endothelial cells by severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2), leading to endothelial damage and increased subintimal inflammation, which are followed by hemorrhage or thrombosis; (II) SARS-CoV-2 could alter the expression/activity of ACE2, consequently resulting in the disruption of renin-angiotensin system which is associated with the occurrence and progression of atherosclerosis; (III) upregulation of neutrophil extracellular traps has been detected in COVID-19 patients, which is closely associated with immunothrombosis; (IV) the inflammatory cascade induced by SARS-CoV-2 often leads to hypercoagulability and promotes the formation and progress of atherosclerosis; (V) antiphospholipid antibodies are also detected in plasma of some severe cases, which aggravate the thrombosis through the formation of immune complexes; (VI) hyperglycemia in COVID-19 patients may trigger CVD by increasing oxidative stress and blood viscosity; (VII) the COVID-19 outbreak is a global emergency and causes psychological stress, which could be a potential risk factor of CVD as coagulation, and fibrinolysis may be affected. In this review, we aimed to further our understanding of CVD-associated COVID-19 infection, which could improve the therapeutic outcomes of patients. Personalized treatments should be offered to COVID-19 patients at greater risk for stroke in future clinical practice.

Topics: Anticoagulants; Antiviral Agents; Atherosclerosis; Cardiovascular Agents; COVID-19; COVID-19 Drug Treatment; Disseminated Intravascular Coagulation; Extracellular Traps; Hemorrhage; Humans; Hyperglycemia; Inflammation; Renin-Angiotensin System; SARS-CoV-2; Stroke; Thrombosis

To investigate the efficacy of drug-coated balloon (DCB) treatment for de novo coronary artery lesions in randomized controlled trials (RCTs).. DCB was an effective therapy for patients with in-stent restenosis. However, the efficacy of DCB in patients with de novo coronary artery lesions is still unknown.. Eligible studies were searched on PubMed, Web of Science, EMBASE, and Cochrane Library Database. Systematic review and meta-analyses of RCTs were performed comparing DCB with non-DCB devices (such as plain old balloon angioplasty (POBA), bare-metal stents (BMS), or drug-eluting stents (DES)) for the treatment of de novo lesions. Trial sequential meta-analysis (TSA) was performed to assess the false positive and false negative errors.. A total of 2,137 patients enrolled in 12 RCTs were analyzed. Overall, no significant difference in target lesion revascularization (TLR) was found, but there were numerically lower rates after DCB treatment at 6 to 12 months follow-up (RR: 0.69; 95% CI: 0.47 to 1.01;. DCB treatment was associated with a trend toward lower TLR when compared with controls. For patients at bleeding risk, DCB treatment was superior to BMS in TLR.

Topics: Aged; Aged, 80 and over; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coated Materials, Biocompatible; Coronary Artery Disease; Equipment Design; Female; Hemorrhage; Humans; Male; Middle Aged; Randomized Controlled Trials as Topic; Risk Factors; Time Factors; Treatment Outcome

Numerous studies have investigated use of acetylsalicylic acid (ASA) for prevention of cardiovascular deaths. The vast majority of the work in this area has focused on secondary prevention. However, underuse of ASA still remains a major issue. Fewer studies have investigated the impact of ASA on primary prevention of cardiovascular death. A meta-analysis of individual participant data from six randomized studies, published in 2009, showed decrease in serious vascular events but at the cost of causing increased bleeding and hemorrhagic stroke. Recent studies have raised a number of key questions regarding the benefits and risks of using ASA for primary prevention.

Topics: Aspirin; Cardiovascular Agents; Cardiovascular Diseases; Hemorrhage; Humans; Primary Prevention; Prognosis; Protective Factors; Randomized Controlled Trials as Topic; Risk Assessment; Risk Factors

The clinical benefit of aspirin for the primary prevention of cardiovascular disease (CVD) in diabetes remains uncertain. To evaluate the efficacy and safety of aspirin for the primary prevention of cardiovascular outcomes and all-cause mortality events in people with diabetes, we conducted an updated meta-analysis of published randomised controlled trials (RCTs) and a pooled analysis of individual participant data (IPD) from three trials.. Randomised controlled trials of aspirin compared with placebo (or no treatment) in participants with diabetes with no known CVD were identified from MEDLINE, Embase, Cochrane Library, and manual search of bibliographies to January 2019. Relative risks with 95% confidence intervals were used as the summary measures of associations.. We included 12 RCTs based on 34,227 participants with a median treatment duration of 5.0 years. Comparing aspirin use with no aspirin, there was a significant reduction in risk of major adverse cardiovascular events (MACE)0.89 (0.83-0.95), with a number needed to treat (NNT)of 95 (95% CI 61 to 208) to prevent one MACE over 5 years average follow-up. Evidence was lacking of heterogeneity and publication bias among contributing trials for MACE. Aspirin use had no effect on other endpoints including all-cause mortality; however, there was a significant reduction in stroke for aspirin dosage ≤ 100 mg/day 0.75 (0.59-0.95). There were no significant effects of aspirin use on major bleeding and other bleeding events, though some of the estimates were imprecise. Pooled IPD from the three trials (2306 participants) showed no significant evidence of an effect of aspirin on any of the outcomes evaluated; however, aspirin reduced the risk of MACE in non-smokers 0.70 (0.51-0.96) with a NNT of 33 (95% CI 20 to 246) to prevent one MACE.. Aspirin has potential benefits in cardiovascular primary prevention in diabetes. The use of low dose aspirin may need to be individualised and based on each individual's baseline CVD and bleeding risk. Systematic review registration PROSPERO: CRD42019122326.

Topics: Adolescent; Adult; Aged; Aged, 80 and over; Aspirin; Cardiovascular Agents; Cardiovascular Diseases; Diabetes Mellitus; Female; Hemorrhage; Humans; Male; Middle Aged; Primary Prevention; Randomized Controlled Trials as Topic; Risk Assessment; Risk Factors; Treatment Outcome; Young Adult

Topics: Aspirin; Atherosclerosis; Cardiovascular Agents; Cause of Death; Evidence-Based Medicine; Hemorrhage; Humans; Primary Prevention; Protective Factors; Randomized Controlled Trials as Topic; Risk Assessment; Risk Factors; Time Factors; Treatment Outcome

The role of aspirin as a means of primary prevention remains controversial.. We have conducted a meta-analysis of all randomized controlled trials (RCTs) to evaluate the role of aspirin in primary prevention.. Literature search was performed via PubMed, Embase, and the Cochrane Library for all related RCTs. All-cause mortality was the primary endpoint. Secondary endpoints included major adverse cardiovascular events (MACE), myocardial infarction (MI), cardiovascular mortality, cerebrovascular events, and bleeding events. We used a random effects model to report the risk ratios (RRs) with 95% confidence intervals (CIs).. Our analysis included 17 RCTs (164,862 patients; 83,309 received aspirin and 81,744 received placebo). Our study did not demonstrate any significant reduction in all-cause mortality for patients treated with aspirin when compared with placebo (RR 0.97; 95% CI 0.93-1.01; P = 0.13). Sensitivity analysis performed by excluding healthy elderly (≥ 65) showed significant reductions in all-cause mortality in the aspirin-treated patients (RR 0.94; 95% CI 0.90-0.99; P = 0.01). There were no significant differences between both groups regarding cardiovascular mortality and cerebrovascular events (P > 0.05). However, aspirin-treated patients significantly reduced MACE and MI events (RR 0.89; 95% CI 0.85-0.93; P < 0.001 and RR 0.88; 95% CI 0.78-0.98; P = 0.02, respectively), respectively. However, aspirin was associated with a significantly higher incidence of bleeding, including major bleeding and intracranial bleeding (P < 0.001).. Aspirin use in primary prevention has resulted in a lower incidence of MACE and MI without significantly effecting cerebrovascular events. However, aspirin was associated with a higher bleeding risk. Use of aspirin as a means of primary prevention should be thoroughly discussed with patients and pursued based on the risk of cardiovascular disease while also considering bleeding risk.

Topics: Aspirin; Cardiovascular Agents; Cardiovascular Diseases; Clinical Decision-Making; Hemorrhage; Humans; Incidence; Primary Prevention; Protective Factors; Randomized Controlled Trials as Topic; Risk Assessment; Risk Factors; Treatment Outcome

While the use of aspirin in the secondary prevention of cardiovascular (CVD) is well established, aspirin in primary prevention is not systematically recommended because the absolute CV event reduction is similar to the absolute excess in major bleedings. Recently, emerging evidence suggests the possibility that the assumption of aspirin, may also be effective in the prevention of cancer. By adding to the CV prevention benefits the potential beneficial effect of aspirin in reducing the incidence of mortality and cancer could tip the balance between risks and benefits of aspirin therapy in the primary prevention in favour of the latter and broaden the indication for treatment with in populations at average risk. While prospective and randomized study are currently investigating the effect of aspirin in prevention of both cancer and CVD, clinical efforts at the individual level to promote the use of aspirin in global (or total) primary prevention could be already based on a balanced evaluation of the benefit/risk ratio.

Topics: Aspirin; Cardiology; Cardiovascular Agents; Cardiovascular Diseases; Hemorrhage; Humans; Patient Selection; Primary Prevention; Risk Assessment; Risk Factors; Treatment Outcome

Whether revascularisation is superior to medical therapy in older populations presenting with non-ST-elevation acute coronary syndromes (NSTEACS) remains contentious, with inconclusive evidence from randomised trials. We aimed to compare routine invasive therapy with initial medical management in the elderly presenting with NSTEACS.. MEDLINE, EMBASE and Cochrane Controlled Trial Register were searched for studies comparing routine invasive therapy with initial medical management in patients ≥75 years old presenting with NSTEACS. Endpoints included long-term mortality, myocardial infarction (MI), revascularisation, rehospitalisation, stroke and major bleeding reported as ORs.. Four randomised trials and three observational studies met inclusion criteria, enrolling a total of 20 540 patients followed up from 6 months to 5 years. Routine invasive therapy reduced mortality (OR 0.67, CI 0.61 to 0.74), MI (OR 0.56, CI 0.45 to 0.70) and stroke (OR 0.53, CI 0.30 to 0.95). Analyses restricted to randomised controlled trials (RCTs) confirmed a reduction in MI (OR 0.51, CI 0.40 to 0.66), revascularisation (OR 0.27, CI 0.13 to 0.56) and a trend to reduced mortality (OR 0.84, CI 0.66 to 1.06) at the expense of major bleeding (OR 2.19, CI 1.12 to 4.28). Differences in major bleeding were unapparent in more recent studies.. Routine invasive therapy reduces MI and repeat revascularisation and may reduce mortality at the expense of major bleeding in elderly patients with NSTEACS. Our findings highlight the need for further RCTs to better determine the effect on mortality and contemporary bleeding risk.

Topics: Age Factors; Aged; Aged, 80 and over; Cardiovascular Agents; Chi-Square Distribution; Coronary Artery Bypass; Female; Hemorrhage; Humans; Male; Non-ST Elevated Myocardial Infarction; Odds Ratio; Patient Readmission; Percutaneous Coronary Intervention; Recurrence; Risk Factors; Stroke; Time Factors; Treatment Outcome

Avoiding medications in which the risks outweigh the benefits in the elderly patient is a challenge for physicians, and different criteria to identify inappropriate prescription (IP) exist to aid prescribers. Definition of IP indicators in the Italian geriatric population affected by cardiovascular disease and chronic comorbidities could be extremely useful for prescribers and could offer advantages from a public health perspective. The purpose of the present study was to identify IP indicators by means of a systematic literature review coupled with consensus criteria. A systematic search of PubMed, EMBASE, and CENTRAL databases was conducted, with the search structured around four themes and combining each with the Boolean operator "and". The first regarded "prescriptions", the second "adverse events", the third "cardiovascular conditions", and the last was planned to identify studies on "older people". Two investigators independently reviewed titles, abstracts, full texts, and selected articles addressing IP in the elderly affected by cardiovascular condition using the following inclusion criteria: studies on people aged ≥65 years; studies on patients with no restriction on age but with data on subjects aged ≥65 years; and observational effectiveness studies. The database searches produced 5,742 citations. After removing duplicates, titles and abstracts of 3,880 records were reviewed, and 374 full texts were retrieved that met inclusion criteria. Thus, 49 studies reporting 32 potential IP indicators were included in the study. IP indicators regarded mainly drug-drug interactions, cardio- and cerebrovascular risk, bleeding risk, and gastrointestinal risk; among them, only 19 included at least one study that showed significant results, triggering a potential warning for a specific drug or class of drugs in a specific context. This systematic review demonstrates that both cardiovascular and non-cardiovascular drugs increase the risk of adverse drug reactions in older adults with cardiovascular diseases.

Topics: Aged; Cardiovascular Agents; Cardiovascular Diseases; Comorbidity; Drug Interactions; Hemorrhage; Humans; Inappropriate Prescribing; Stroke

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

Due to the high prevalence of cardiovascular diseases and the corresponding prescription of cardiac drugs, side effects and interactions may occur in a substantial number of patients. They can be explained by either pharmacokinetic or pharmaco-dynamic drug interactions which may be desired, but may also be life-threatening. Despite the fact that the novel oral anticoagulants are well tolerated, several factors restricting the use of these drugs, such as renal failure, have to be considered. The use of antihypertensive drugs may be limited by concomitant use of drugs that either induce of inhibit enzymatic metabolism, respectively inhibit renal drug, electrolyte, and/or water excretion. In this respect, the interaction between beta-blockers, ACE inhibitors, angiotensin receptor blockers and thiazide diuretics with non-steroidal antiinflammatory drugs is especially important. Muscle disorders are frequent side effects in patients undergoing statin therapy and affect up to 5% of patients. They may manifest as mild myalgia, but also as life-threatening rhabdomyolysis.

Topics: Cardiovascular Agents; Drug Interactions; Drug-Related Side Effects and Adverse Reactions; Germany; Hemorrhage; Humans; Kidney Diseases; Muscular Diseases

There are numerous national and international guidelines on the use of aspirin for the primary prevention of cardiovascular disease. Given the uncertainties about aspirin in primary prevention, our aim was to compare the recommendations and the reported evidence in guidelines for the treatment with aspirin of subjects free of cardiovascular disease with or without diabetes.. Guidelines were retrieved through Medline and other electronic databases and through a web-based search for guideline development organizations. The content of the recommendations and the underlying evidence were analysed with qualitative and bibliometric methods. In addition, we searched for recent studies to assess whether they underscore the current recommendations. We included 12 guidelines: six European, three North American, and one each from New Zealand, Australia, and the World Health Organization. Recommendations differ with regard to outcome (morbidity, mortality), time span (years of risk), cut-off percentage between high and low risk, and the dose of aspirin. Most guidelines are not in line with recent evidence, which show that aspirin is of uncertain net value as the reduction in absolute risk for occlusive CV events needs to be weighed against an increase in the risk of major bleeds.. We found conflicting recommendations in various guidelines about the use of aspirin for the primary prevention of cardiovascular events, which reflect differences in selection of the evidence and in the timing of publication. According to recent evidence, in general, the use of aspirin seems no longer justifiable in primary prevention in patients with or without diabetes.

Topics: Aspirin; Cardiology; Cardiovascular Agents; Cardiovascular Diseases; Diabetes Mellitus; Evidence-Based Medicine; Hemorrhage; Humans; Patient Selection; Practice Guidelines as Topic; Primary Prevention; Risk Assessment; Risk Factors; Treatment Outcome

Current acetylsalicylic acid (ASA) dosing algorithms for the prevention of secondary thrombotic events in acute coronary syndrome (ACS) patients are inconsistent and lack sufficient data support.. We performed a systematic review of the literature for studies that assessed clinical outcomes in patients with ACS following coronary stent insertion (SI) or medical treatment (MT). Acetylsalicylic acid dosing was stratified into low- (<160 mg) and high- (≥ 160 mg) dose categories. Outcomes were assessed at 1, 6, and 12 months and included major bleeding, myocardial infarction, and all-cause death. A random-effects meta-analysis was used to estimate the value of the mean for each outcome variable.. Of 12,472 publications identified, 136 studies with 289,330 patients were analyzed. In the 1-month SI analysis, proportions of patients (95% CI) in the low- and high-dose ASA categories experiencing major bleeding were 2.1% (1.5-2.6) and 1.9% (0.0-3.8); proportions with myocardial infarction were 2.1% (1.3-2.8) and 1.8% (0.9-2.6); and proportions of all-cause death were 2.8% (2.2-3.4) and 2.4% (1.3-3.5), respectively. Results were similar in the MT analysis, except that major bleeding rates for low and high doses were 1.7% (1.3-2.2) and 4.0% (2.2-5.8), respectively. Regression analyses suggested that the proportion of patients reporting each of the outcomes evaluated were not significantly different between the low- and high-dose categories, with the exception of the 1-month major bleeding following MT.. Our results suggest no improved clinical outcomes associated with higher ASA maintenance doses in ACS patients receiving SI or MT. In the MT analysis, there was more major bleeding in the first month after an ACS event with high-dose ASA.

Topics: Acute Coronary Syndrome; Aged; Aspirin; Cardiovascular Agents; Cardiovascular Diseases; Coronary Artery Bypass; Dose-Response Relationship, Drug; Female; Fibrinolytic Agents; Hemorrhage; Humans; Male; Middle Aged; Prosthesis Implantation; Stents

Aspirin has been recommended for the prevention of major adverse cardiovascular events (MACE, composite of non-fatal myocardial infarction, non-fatal stroke, and cardiovascular death) in diabetic patients without previous cardiovascular disease. However, recent meta-analyses have prompted re-evaluation of this practice. The study objective was to evaluate the relative and absolute benefits and harms of aspirin for the prevention of incident MACE in patients with diabetes.. We performed a systematic review and meta-analysis on seven studies (N=11,618) reporting on the use of aspirin for the primary prevention of MACE in patients with diabetes. Two reviewers conducted a systematic search of electronic databases (MEDLINE, EMBASE, the Cochrane Library, and BIOSIS) and hand searched bibliographies and clinical trial registries. Reviewers extracted data in duplicate, evaluated the quality of the trials, and calculated pooled estimates.. A total of 11,618 participants were included in the analysis. The overall risk ratio (RR) for MACE was 0.91 (95% confidence intervals, CI, 0.82-1.00) with little heterogeneity among trials (I2 0.0%). Secondary outcomes of interest included myocardial infarction (RR, 0.85; 95% CI, 0.66-1.10), stroke (RR, 0.84; 95% CI, 0.64-1.11), cardiovascular death (RR, 0.95; 95% CI, 0.71-1.27), and all-cause mortality (RR, 0.95; 95% CI, 0.85-1.06). There were higher rates of hemorrhagic and gastrointestinal events. In absolute terms, these relative risks indicate that for every 10,000 diabetic patients treated with aspirin, 109 MACE may be prevented at the expense of 19 major bleeding events (with the caveat that the relative risk for the latter is not statistically significant).. The studies reviewed suggest that aspirin reduces the risk of MACE in patients with diabetes without cardiovascular disease, while also causing a trend toward higher rates of bleeding and gastrointestinal complications. These findings and our absolute benefit and risk calculations suggest that those with diabetes but without cardiovascular disease lie somewhere between primary and secondary prevention patients on the spectrum of benefit and risk. This underscores the importance of considering individual risk in clinical decision making regarding aspirin in those with diabetes.

Topics: Aspirin; Cardiovascular Agents; Cardiovascular Diseases; Diabetes Complications; Evidence-Based Medicine; Female; Gastrointestinal Diseases; Hemorrhage; Humans; Incidence; Male; Patient Selection; Primary Prevention; Risk Assessment; Risk Factors; Time Factors; Treatment Outcome

Lung injury is an increasing cause of morbidity and mortality in patients treated with cytotoxic and noncytotoxic drugs. Prompt diagnosis is important because early drug-induced lung injury will often regress with the cessation of therapy. Diagnosis requires a high index of suspicion because infection, radiation pneumonitis, and recurrence of the underlying disease can manifest clinically and radiologically in a similar manner. Because the lungs have only a limited number of histopathologic responses to injury, including pulmonary edema/diffuse alveolar damage, NSIP, BOOP, EP, and pulmonary hemorrhage, knowledge of these manifestations and the corresponding radiologic manifestations can often be useful in suggesting a diagnosis of drug-induced lung injury. An understanding of the drugs most commonly associated with lung injury can also facilitate diagnosis.

Topics: Anti-Infective Agents; Antineoplastic Agents; Cardiovascular Agents; Cryptogenic Organizing Pneumonia; Diagnosis, Differential; Hemorrhage; Humans; Lung; Lung Diseases; Lung Diseases, Interstitial; Pulmonary Edema; Pulmonary Eosinophilia; Radiography

This study sought to compare next-generation cobalt-chromium-based titanium-nitride-oxide (TiNO)-coated stents with a platinum-chromium-based biodegradable polymer everolimus-eluting stent (EES) in patients with acute coronary syndrome (ACS).. Previous generation TiNO-coated stents showed acceptable performance in patients with ACS.. In a multicenter, randomized trial, we randomly assigned 1,491 ACS patients (2:1) to receive either a TiNO-coated stent (n = 989) or EES (n = 502). The primary endpoint was the rate of a composite of cardiac death, myocardial infarction (MI), or ischemia-driven target lesion revascularization at 12-month follow-up. The co-primary endpoint was a composite of cardiac death, MI, or major bleeding at 18 months.. A primary endpoint event occurred in 6.3% of patients in the TiNO-coated stent group versus in 7.0% in the EES group (hazard ratio: 0.93; 95% confidence interval: 0.71 to 1.22; p = 0.66 for superiority; p < 0.001 for noninferiority). A co-primary endpoint event occurred in 3.7% of the patients in the TiNO group and in 7.8% in the EES group (hazard ratio: 0.64; 95% confidence interval: 0.51 to 0.80; p = 0.001). TiNO-coated stents were associated with lower rates of cardiac death (0.6% vs. 2.6%; p = 0.002) and MI (2.2% vs. 5.0%; p = 0.007) at 18 months of follow-up. Rates of target lesion revascularization were not significantly different at 18 months (5.8% vs. 4.4%; p = 0.27).. In patients with ACS, cobalt-chromium-based TiNO-coated stents were noninferior to platinum-chromium-based biodegradable polymer EES for major cardiac events at 12 months, and were superior for the co-primary endpoint of cardiac death, MI, and bleeding at 18 months. (Comparison of Titanium-Nitride-Oxide-Coated Bio-Active-Stent (Optimax™) to the Drug (Everolimus) -Eluting Stent (Synergy™) in Acute Coronary Syndrome [TIDES-ACS]; NCT02049229).

Topics: Acute Coronary Syndrome; Aged; Cardiovascular Agents; Drug-Eluting Stents; Europe; Everolimus; Female; Hemorrhage; Humans; Male; Middle Aged; Percutaneous Coronary Intervention; Prosthesis Design; Time Factors; Titanium; Treatment Outcome

This study assessed baseline cardiovascular (CV) risk factors, concomitant CV medication use, risk of major adverse cardiac events-plus (MACE-plus), and bleeding adverse events (AEs) in patients with idiopathic pulmonary fibrosis (IPF) in three randomized, placebo-controlled phase III trials of pirfenidone.. Patients in the pirfenidone phase III trials were included. Patients with unstable or deteriorating cardiac disease within 6 months before enrollment were ineligible. Medical history at baseline and concomitant CV medication use during treatment were reported. A retrospective, blinded review of AE preferred terms was conducted to identify MACE-plus and bleeding events. Subgroup analyses examined the impact of concomitant CV medication use on how pirfenidone treatment affected clinical outcomes.. In total, 1247 patients were included [n = 623 pirfenidone (2403 mg/day) and n = 624 placebo]. The median age was 68 years, 74% were male, and 65% were current/former smokers. Commonly reported CV risk factors included hypertension (52%), obesity (44%), hypercholesterolemia (23%), and hyperlipidemia (23%). Pre-existing cardiac disorders included coronary artery disease (16%), myocardial infarction (5%), and atrial fibrillation (5%). Lipid-modifying agents (60%), antithrombotic agents (54%), and renin-angiotensin inhibitors (39%) were commonly used concomitant CV medications. The incidences of MACE-plus and bleeding events were similar between the pirfenidone and placebo groups (1.8% and 2.9% for MACE-plus events and 3.7% and 4.3% for bleeding events, respectively). Except for patients receiving heparin, pirfenidone had a beneficial effect compared with placebo on efficacy outcomes regardless of concomitant CV medications.. CV risk factors and comorbidities and use of concomitant CV medications are common in patients with IPF. Pirfenidone did not appear to increase the risk of CV or bleeding events. Use of several concomitant CV medications, including warfarin, did not appear to adversely impact pirfenidone's beneficial effect on efficacy outcomes.. NCT00287716, NCT00287729, and NCT01366209.. F. Hoffmann-La Roche Ltd. and Genentech, Inc.

Topics: Aged; Aged, 80 and over; Anti-Inflammatory Agents, Non-Steroidal; Atrial Fibrillation; Cardiovascular Agents; Cardiovascular Diseases; Coronary Artery Disease; Female; Hemorrhage; Humans; Idiopathic Pulmonary Fibrosis; Male; Middle Aged; Pyridones; Retrospective Studies; Risk Factors; Treatment Outcome; Warfarin

The safety and efficacy of antithrombotic regimens may differ between patients with atrial fibrillation who have acute coronary syndromes (ACS), treated medically or with percutaneous coronary intervention (PCI), and those undergoing elective PCI.. Using a 2×2 factorial design, we compared apixaban with vitamin K antagonists and aspirin with placebo in patients with atrial fibrillation who had ACS or were undergoing PCI and were receiving a P2Y. An antithrombotic regimen consisting of apixaban and a P2Y. URL: https://www.clinicaltrials.gov. Unique identifier: NCT02415400.

Topics: Acute Coronary Syndrome; Aged; Anticoagulants; Aspirin; Atrial Fibrillation; Cardiovascular Agents; Combined Modality Therapy; Disease Management; Drug Therapy, Combination; Elective Surgical Procedures; Female; Fibrinolytic Agents; Hemorrhage; Hospitalization; Humans; Male; Middle Aged; Percutaneous Coronary Intervention; Platelet Aggregation Inhibitors; Proportional Hazards Models; Prospective Studies; Purinergic P2Y Receptor Antagonists; Pyrazoles; Pyridones; Treatment Outcome; Vitamin K

In patients with high bleeding risk, percutaneous coronary intervention is still debated. This study compared 9-month angiographic and physiologic results in patients with high bleeding risk and de novo coronary lesions treated with either paclitaxel-coated balloon (PCB) or bare-metal stent (BMS).. A total of 40 patients (40 lesions) with high bleeding risk who underwent successful balloon angioplasty with fractional flow reserve (FFR) after balloon angioplasty more than 0.80 were randomized 1: 1 to treatment with PCB versus BMS. Dual antiplatelet therapy was limited to 1 month after the procedure.. Baseline clinical and lesional characteristics were well balanced between the two groups. There was no significant difference in the postprocedural FFR (0.87 ± 0.06 in PCB vs. 0.89 ± 0.06 in BMS, P = 0.254). At 9 months, late luminal loss was significantly lower in the PCB group (0.2 ± 0.3 vs. 1.2 ± 0.8 mm, P < 0.001). Restenosis only occurred in the BMS group (0 vs. 25.0%, P = 0.049).. In patients with high bleeding risk, FFR-guided PCB treatment showed superior efficacy in terms of angiographic and physiologic patency compared with BMS at mid-term follow-up with only 1 month of dual antiplatelet therapy (Clinicaltrials.gov identifier, NCT02456402).

Topics: Aged; Angioplasty, Balloon; Cardiac Catheters; Cardiovascular Agents; Clinical Decision-Making; Coated Materials, Biocompatible; Coronary Artery Disease; Dual Anti-Platelet Therapy; Female; Fractional Flow Reserve, Myocardial; Hemorrhage; Humans; Male; Metals; Middle Aged; Paclitaxel; Prospective Studies; Prosthesis Design; Republic of Korea; Risk Assessment; Risk Factors; Stents; Time Factors; Treatment Outcome; Vascular Patency

Topics: Acute Coronary Syndrome; Cardiovascular Agents; Double-Blind Method; Drug Administration Schedule; Drug Therapy, Combination; Drug-Eluting Stents; Hemorrhage; Humans; Percutaneous Coronary Intervention; Platelet Aggregation Inhibitors; Prosthesis Design; Risk Assessment; Risk Factors; Sirolimus; Time Factors; Treatment Outcome

Patients with chronic kidney disease (CKD) are at high risk for developing cardiovascular events. However, limited evidence is available regarding the use of aspirin in CKD patients to decrease cardiovascular risk and to slow renal disease progression.. Prospective, multicenter, open-label randomized controlled trial.. One hundred eleven patients with estimated glomerular filtration rate (eGFR) 15-60 ml/min/1.73 m. Aspirin treatment (100 mg/day) (n = 50) or usual therapy (n = 61). Mean follow-up time was 64.8 ± 16.4 months.. The primary endpoint was composed of cardiovascular death, acute coronary syndrome (nonfatal MI, coronary revascularization, or unstable angina pectoris), cerebrovascular disease, heart failure, or nonfatal peripheral arterial disease. Secondary endpoints were fatal and nonfatal coronary events, renal events (defined as doubling of serum creatinine, ≥ 50% decrease in eGFR, or renal replacement therapy), and bleeding episodes.. During follow-up, 17 and 5 participants suffered from a primary endpoint in the control and aspirin groups, respectively. Aspirin did not significantly reduce primary composite endpoint (HR, 0.396 (0.146-1.076), p = 0.069. Eight patients suffered from a fatal or nonfatal coronary event in the control group compared to no patients in the aspirin group. Aspirin significantly reduced the risk of coronary events (log-rank, 5.997; p = 0.014). Seventeen patients in the control group reached the renal outcome in comparison with 3 patients in the aspirin group. Aspirin treatment decreased renal disease progression in a model adjusted for age, baseline kidney function, and diabetes mellitus (HR, 0.272; 95% CI, 0.077-0.955; p = 0.043) but did not when adjusted for albuminuria. No differences were found in minor bleeding episodes between groups and no major bleeding was registered.. Small sample size and open-label trial.. Long-term treatment with low-dose aspirin did not reduce the composite primary endpoint; however, there were reductions in secondary endpoints with fewer coronary events and renal outcomes. ClinicalTrials.gov Identifier: NCT01709994.

Topics: Aged; Aspirin; Cardiovascular Agents; Cardiovascular Diseases; Disease Progression; Female; Glomerular Filtration Rate; Hemorrhage; Humans; Kidney; Male; Middle Aged; Primary Prevention; Prospective Studies; Renal Insufficiency, Chronic; Risk Factors; Spain; 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 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 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

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

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

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

Inclacumab, a novel monoclonal antibody against P-selectin in development for the treatment and prevention of atherosclerotic cardiovascular diseases, was administered in an ascending single-dose study as intravenous infusion to evaluate safety, pharmacokinetics, and pharmacodynamics. Fifty-six healthy subjects were enrolled in this randomized, double-blind placebo-controlled study. Each dose level (0.03-20 mg/kg) was investigated in separate groups of 8 subjects (6 on inclacumab, 2 on placebo). Platelet-leukocyte aggregates, free/total soluble P-selectin concentration ratio, drug concentrations, bleeding time, platelet aggregation, antibody formation, and routine laboratory parameters were measured frequently until 32 weeks. Pharmacokinetic profiles were indicative of target-mediated drug disposition. Platelet-leukocyte aggregate inhibition and soluble P-selectin occupancy showed dose dependency and were strongly correlated to inclacumab plasma concentrations, with IC50 of 740 and 4600 ng/mL, respectively. Inclacumab was well tolerated by the majority of subjects and did neither affect bleeding time nor platelet aggregation. These findings allowed the investigation of the potential beneficial therapeutic use of inclacumab in patient study.

Topics: Adult; Antibodies, Monoclonal; Bleeding Time; Cardiovascular Agents; Double-Blind Method; England; Female; Healthy Volunteers; Hemorrhage; Humans; Infusions, Intravenous; Male; Middle Aged; P-Selectin; Platelet Aggregation; Predictive Value of Tests; Risk Assessment; Young Adult

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

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 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

Left ventricular assist device (LVAD) failure and malfunction rates are critical gauges for establishing LVADs as a long-term therapy for end-stage heart failure patients. These device performance measures, however, have been inadequately characterized in the bridge-to-transplantation literature.. REMATCH is a randomized trial that compares optimal medical management with LVAD implantation for patients with end-stage heart failure. An independent committee adjudicated patient outcomes. The primary endpoint--survival--was analyzed by intention to treat using the log-rank statistic. Frequency of event occurrence was analyzed by Poisson regression. The time to first event was analyzed by the product limit method. Device performance was disaggregated into confirmed malfunctions and system failures. The latter were events in which patients could not be rescued with backup circulatory support measures.. The 1-year survival rate was 52% (95% confidence limit [CL]; 40%-63%) for LVAD patients versus 28% (95% CL; 17%-39%) for medical patients and the 2-year survival rate was 29% (95% CL; 19%-40%) for LVAD patients versus 13% (95% CL; 5%-22%) for medical patients. System failure was 0.13 per patient per year and the confirmed LVAD malfunction rate was 0.90. Freedom from device replacement was 87% at 1 year and 37% at 2 years.. Despite the observed rates of device malfunction and replacement, LVAD implantation confers clinically significant improvement with regard to survival as compared with medical management. Device modifications and innovations for infection management exhibit great promise of improving device performance in the near future.

Topics: Aged; Cardiovascular Agents; Cause of Death; Female; Heart Failure; Heart-Assist Devices; Hemorrhage; Humans; Male; Middle Aged; Poisson Distribution; Prosthesis Failure; Sepsis; Stroke; Survival Rate

1. This study was carried out to assess the role of adenosine in the regulation of human erythropoietin (EPO) production. To this end we investigated in healthy volunteers whether the nonspecific adenosine antagonist theophylline increases and the adenosine uptake inhibitor dipyridamole decreases EPO production in response to an haemorrhage of 750 ml. 2. Healthy male nonsmokers received i.v. in a parallel, randomized, single-blind trial theophylline (loading dose 5 mg kg-1 over 20 min, followed by 0.5 mg kg-1 min-1), dipyridamole (0.21 mg kg-1 h-1) or placebo (0.9% NaCl) for 6 h following the phlebotomy. EPO concentrations were followed up to 72 h after phlebotomy. 3. Following blood loss EPO concentrations increased during all treatments. The AUCEPO (0,72 h) were not statistically significantly different (theophylline: 398 +/- 30, dipyridamole: 301 +/- 15, placebo: 332 +/- 57 [mu ml-1 h]). Creatinine clearance and urinary cAMP excretion were unaltered by any treatment. Urinary excretion of adenosine was significantly increased during infusion of dipyridamole. Plasma renin activity was significantly increased during theophylline infusion. 4. In our model of controlled, physiological stimulation of EPO production by haemorrhage, adenosine appears unlikely to play a major role as a mediator of renal EPO production.

Topics: Adenosine; Adult; Area Under Curve; Cardiovascular Agents; Creatinine; Dipyridamole; Erythropoietin; Hematocrit; Hemoglobins; Hemorrhage; Humans; Male; Phlebotomy; Phosphodiesterase Inhibitors; Single-Blind Method; Theophylline

The objective of this post hoc analysis was to analyze real-world dual antiplatelet therapy (DAPT) regimens following polymer-free sirolimus-eluting stent (PF-SES) implantations in an unselected patient population.. Patient-level data from two all-comers observational studies (ClinicalTrials.gov Identifiers: NCT02629575 and NCT02905214) were pooled and analyzed in terms of their primary endpoint. During the data verification process, we observed substantial deviations from DAPT guideline recommendations. To illuminate this gap between clinical practice and guideline recommendations, we conducted a post hoc analysis of DAPT regimens and clinical event rates for which we defined the net adverse event rate (NACE) consisting of target lesion revascularization (TLR, primary endpoint of all-comers observational studies) all-cause death, myocardial infarction (MI), stent thrombosis (ST), and bleeding events. A logistic regression was utilized to determine predictors why ticagrelor was used in stable coronary artery disease (CAD) patients instead of the guideline-recommended clopidogrel.. For stable CAD, the composite endpoint of clinical, bleeding, and stent thrombosis, i.e., NACE, between the clopidogrel and ticagrelor treatment groups was not different (5.4% vs. 5.1%, p = 0.745). Likewise, in the acute coronary syndrome (ACS) cohort, the NACE rates were not different between both DAPT strategies (9.2% vs. 9.3%, p = 0.927). There were also no differences in the accumulated rates for TLR, myocardial infarction ([MI], mortality, bleeding events, and stent thrombosis in elective and ACS patients. The main predictors for ticagrelor use in stable CAD patients were age < 65 years, smaller vessels, treatment of ostial and calcified lesions, and in-stent restenosis.. Within the framework of a post hoc analysis based on a real-world, large cohort study, there were no differences in the combined endpoint of major adverse cardiac events (MACE), bleeding and thrombotic events for clopidogrel and ticagrelor in stable CAD or ACS patients. Despite the recommendation for clopidogrel by the European Society of Cardiology (ESC), real-world ticagrelor use was observed in subgroups of stable CAD patients that ought to be explored in future trials.

Topics: Aged; Aged, 80 and over; Cardiovascular Agents; Coronary Artery Disease; Coronary Thrombosis; Drug-Eluting Stents; Dual Anti-Platelet Therapy; Female; Guideline Adherence; Hemorrhage; Humans; Male; Middle Aged; Multicenter Studies as Topic; Observational Studies as Topic; Percutaneous Coronary Intervention; Platelet Aggregation Inhibitors; Practice Guidelines as Topic; Practice Patterns, Physicians'; Prosthesis Design; Risk Assessment; Risk Factors; Sirolimus; Time Factors; Treatment Outcome

 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

Despite treatment guidance endorsing shortened dual antiplatelet therapy (DAPT) duration in high bleeding risk (HBR) patients after drug-eluting stents, limited evidence exists to support these recommendations. The present study was designed to examine the safety and effectiveness of 1-month DAPT duration following percutaneous coronary intervention with zotarolimus-eluting stents in HBR patients.. Onyx ONE Clear was a prospective, multicenter, nonrandomized study evaluating the safety and effectiveness of 1-month DAPT followed by single antiplatelet therapy in HBR patients undergoing percutaneous coronary intervention with Resolute Onyx drug-eluting stents. The primary analysis of cardiac death or myocardial infarction between 1 month and 1 year was performed in the prespecified one-month clear population of patients pooled from the Onyx ONE US/Japan study and Onyx ONE randomized controlled trial. One-month clear was defined as DAPT adherence and without major adverse events during the first month following percutaneous coronary intervention.. Among patients enrolled in Onyx ONE US/Japan (n=752) and Onyx ONE randomized controlled trial (n=1018), 1506 patients fulfilled one-month clear criteria. Mean HBR characteristics per patient was 1.6 with 44.7% having multiple risks. By 2 months and 1 year, respectively, 96.9% and 89.3% of patients were taking single antiplatelet therapy. Between 1 month and 1 year, the rate of the primary end point was 7.0%. The 1-sided upper 97.5% CI was 8.4%, less than the performance goal of 9.7% (. Among HBR patients who were event free before DAPT discontinuation at 1 month, favorable safety and effectiveness through 1 year support treatment with Resolute Onyx drug-eluting stents as part of an individualized strategy for shortened DAPT duration following percutaneous coronary intervention. Registration: URL: https://www.clinicaltrials.gov; Unique identifier NCT03647475.

Topics: Aged; Aged, 80 and over; Cardiovascular Agents; Coronary Artery Disease; Drug Administration Schedule; Drug-Eluting Stents; Dual Anti-Platelet Therapy; Female; Hemorrhage; Humans; Japan; Male; Middle Aged; Percutaneous Coronary Intervention; Platelet Aggregation Inhibitors; Prospective Studies; Prosthesis Design; Randomized Controlled Trials as Topic; Risk Assessment; Risk Factors; Sirolimus; Time Factors; Treatment Outcome; United States

Previous studies have shown that adherence to low-dose aspirin (LDA) is suboptimal. However, these studies were based on an average measure of adherence during follow-up, ignoring its dynamic process over time. We described the trajectories of adherence to LDA treatment among the French population over 3 years of follow-up.. We identified a cohort of 11 793 new LDA users, aged ≥50 years in 2010, by using the French national health-care database. Patients included had at least 3 years of history in the database before study entry to exclude prevalent aspirin users and to assess baseline comorbidities. They were followed from the first date of LDA supply (the index date) until the first date among death, exit from the database, or 3 years after the index date. Adherence to LDA was assessed every 3 months by using the proportion of days covered (PDC) and dichotomized with a cutoff of PDC of 0.8. We used group-based trajectory modeling to identify trajectories of LDA adherence. Predictors of LDA adherence trajectory membership were identified by multinomial logistics regression.. We identified 4 trajectories of adherence among new LDA users: the not-adherents (4737 [40.2%]), the delayed not-adherents (gradual decrease in adherence probability, 1601 [13.6%]), the delayed adherents (gradual increase in adherence probability, 1137 [9.6%]), and the persistent adherents (4318 [36.6%]). The probability of belonging to the not-adherent group was increased with female sex, low socioeconomic status, and polymedication and was reduced with a secondary indication for LDA use, such as diabetes, hypertension, and dementia, at least 4 consultations in the previous year, or 1 hospitalization or a cardiologist consultation in the 3 months before the index date.. This study provides a dynamic picture of adherence behaviors among new LDA users and underlines the presence of critical trajectories that intervention could target to improve adherence.

Topics: Aged; Aged, 80 and over; Aspirin; Cardiovascular Agents; Cardiovascular Diseases; Comorbidity; Databases, Factual; Female; France; Health Knowledge, Attitudes, Practice; Hemorrhage; Humans; Male; Medication Adherence; Middle Aged; Primary Prevention; Risk Factors; Secondary Prevention; Time Factors

To date, the long-term incidence and details of major bleeding (MB) and coronary thrombotic events (CTE) in patients with everolimus-eluting stent (EES) implantation have not been made clear.Methods and Results:The study population comprised 1,193 patients treated with EES without in-hospital events between 2010 and 2011. MB was defined as the occurrence of a Bleeding Academic Research Consortium type 3 or 5 bleeding event. The mean follow-up period was 2,996±433 days. Cumulative rate of MB was 7.4% and 10.8% at 5 and 8 years, respectively. Of 46 patients with intracranial bleeding, 20 had trauma-related intracranial bleeding. Cumulative rates of definite stent thrombosis and CTE at 8 years were 0.4% and 5.9%, respectively. Multivariate analysis revealed low body mass index (<23) (hazard ratio (HR), 1.57; 95% confidence interval (CI), 1.03-2.36; P=0.03) and concomitant use of oral anticoagulants (HR, 2.17; 95% CI, 1.30-3.50; P=0.004) as independent risk factors of MB and previous PCI (HR, 2.47; 95% CI, 1.29-1.00; P=0.006) as the factor for CTE.. MB is not uncommon and is a long-term hazard, but the occurrence of stent thrombosis is very low after EES implantation. Approximately half of the cases involving intracranial bleeding were associated with trauma.

Topics: Aged; Aged, 80 and over; Cardiovascular Agents; Coronary Thrombosis; Drug-Eluting Stents; Dual Anti-Platelet Therapy; Everolimus; Female; Hemorrhage; Humans; Incidence; Japan; Male; Middle Aged; Percutaneous Coronary Intervention; Prosthesis Design; Retrospective Studies; Risk Assessment; Risk Factors; Time Factors; Treatment Outcome

Topics: Acute Coronary Syndrome; Aged; Anticoagulants; Aspirin; Atrial Fibrillation; Cardiovascular Agents; Combined Modality Therapy; Drug Therapy, Combination; Elective Surgical Procedures; Female; Fibrinolytic Agents; Hemorrhage; Hospitalization; Humans; Length of Stay; Male; Middle Aged; Multicenter Studies as Topic; Percutaneous Coronary Intervention; Platelet Aggregation Inhibitors; Proportional Hazards Models; Prospective Studies; Purinergic P2Y Receptor Antagonists; Pyrazoles; Pyridones; Randomized Controlled Trials as Topic; Survival Analysis; Treatment Outcome; Vitamin K

The aim of this single center all-comers retrospective registry study was to assess the efficacy and safety of percutaneous coronary intervention (PCI) using drug-coated balloon (DCB) in de novo lesions including large proximal coronary arteries.. A total of 487 PCIs were performed using paclitaxel-coated DCB in 562 de novo lesions with the possibility for bailout stenting in a patient population presenting with stable coronary artery disease (CAD) or acute coronary syndrome (ACS). Half of the patients had at least one risk factor for bleeding. All of the treated lesions were de novo and 60% of DCBs used were ≥ 3.0 mm in diameter. The median follow-up time was 18 months for MACE and 60 months for survival.. The total mortality after DBC only strategy was 2.3 and 9.3% at 12 months in stable CAD and ACS, respectively. The 12-month MACE rate was 7.1 and 12% in stable CAD and ACS. The rate of ischemia-driven target lesion revascularization was only 1.4% in stable CAD and 2.8% after ACS at 12 months. Median duration of DAPT was one month. The 12 month rate of significant bleeding (Bleeding Academic Research Consortium types 2-5) was 5.9%. Acute vessel closure occurred only in one case (0.2%) after DCB treatment. Bailout stenting was used in 12% of lesions.. PCI using DCB-only strategy with the possibility for provisional stenting is a safe and efficient in de novo coronary artery lesions in both stable CAD and ACS. This strategy may be useful especially in patients with high bleeding risk.

Topics: Acute Coronary Syndrome; Aged; Aged, 80 and over; Angina, Unstable; Angioplasty, Balloon, Coronary; Cardiac Catheters; Cardiovascular Agents; Coated Materials, Biocompatible; Coronary Artery Disease; Female; Hemorrhage; Humans; Male; Middle Aged; Non-ST Elevated Myocardial Infarction; Paclitaxel; Registries; Retrospective Studies; Risk Factors; ST Elevation Myocardial Infarction; Time Factors; Treatment Outcome

Topics: Aspirin; Cardiovascular Agents; Cardiovascular Diseases; Clinical Decision-Making; Diabetes Mellitus; Hemorrhage; Humans; Patient Selection; Primary Prevention; Protective Factors; Randomized Controlled Trials as Topic; Risk Assessment; Risk Factors; Treatment Outcome

In patients ≥80 years of age, the use of second-generation cobalt-chromium everolimus-eluting stents (CoCr-EES) versus bare-metal stents has been shown to reduce myocardial infarction (MI) and target vessel revascularization (TVR) rates, without an increase in bleeding. However, safety and efficacy of CoCr-EES in octogenarians compared to younger populations are less certain. We aimed to compare the clinical outcomes between octogenarian and non-octogenarian patients undergoing percutaneous coronary intervention (PCI) with CoCr-EES.. We retrospectively analyzed 186 patients treated with CoCr-EES; 54 octogenarians (63 lesions) and 132 non-octogenarians (152 lesions). The primary endpoint was a 1-year composite of all-cause death, MI, TVR, cerebrovascular accident (CVA), or major bleeding. Stent thrombosis (ST) was also evaluated.. Radial approach was used in 70.4% of octogenarians versus 80.3% of non-octogenarians (p = 0.18). Rates of dual antiplatelet therapy at 1 year were 90.7% for octogenarians and 90.9% for non-octogenarians (p = 1.00). The primary endpoint occurred in 14.8% of octogenarians and 11.4% of non-octogenarians (p = 0.52). There were no significant differences with respect to the rates of 1-year all-cause death (7.4% vs. 3.8%, p = 0.30), MI (1.9% vs. 1.5%, p = 1.00), TVR (3.7% vs. 5.3%, p = 0.65), CVA (1.9% vs. 2.3%, p = 1.00), and definite/probable ST (1.9% vs. 1.5%, p = 1.00) between the 2 groups. Major bleeding was observed in only 1 of octogenarians. Multivariate analysis demonstrated that chronic kidney disease and intravascular ultrasound use were the only independent predictors of the primary endpoint.. According to our series, 1-year safety and efficacy outcomes of CoCr-EES PCI in octogenarians were comparable to those in non-octogenarians.. We compared the clinical outcomes between octogenarian and non-octogenarian patients treated with second-generation cobalt-chromium everolimus-eluting stents (CoCr-EES). In our series, 1-year safety and efficacy outcomes of CoCr-EES percutaneous coronary intervention in octogenarians were similar to those in younger counterparts.

Topics: Adult; Age Factors; Aged; Aged, 80 and over; Cardiovascular Agents; Chromium Alloys; Coronary Artery Disease; Coronary Vessels; Drug-Eluting Stents; Everolimus; Female; Hemorrhage; Humans; Male; Middle Aged; Percutaneous Coronary Intervention; Prosthesis Design; Retrospective Studies; Risk Assessment; Risk Factors; Time Factors; Treatment Outcome

Cilostazol has been associated with spontaneous reports of cardiovascular adverse events and serious bleeding. The objective of this study is to determine the relative risk of cardiovascular adverse events or haemorrhages in patients with peripheral artery disease treated with cilostazol in comparison to pentoxifylline users.. Population-based cohort study including all individuals older than 40 who initiated cilostazol or pentoxifylline during 2009-2011 in SIDIAP database. The two treatment groups were matched through propensity score (PS).. Nine thousand one hundred twenty-nine patients met inclusion criteria and after PS matching, there were 2905 patients in each group. 76% of patients were men, with similar mean ages in both groups (68.8 for cilostazol and 69.4 for pentoxifylline). There were no differences in bleeding, cerebrovascular and cardiovascular events between both groups.. Patients treated with cilostazol were different from those treated with pentoxifylline at baseline, so they were matched through PS. We did not find differences between treatment groups in the incidence of bleeding or cardiovascular and cerebrovascular events. Cilostazol should be used with precaution in elderly polymedicated patients.

Topics: Age Factors; Aged; Aged, 80 and over; Cardiovascular Agents; Cerebrovascular Disorders; Cilostazol; Databases, Factual; Drug Interactions; Electronic Health Records; Female; Hemorrhage; Humans; Incidence; Male; Middle Aged; Patient Safety; Pentoxifylline; Peripheral Arterial Disease; Phosphodiesterase 3 Inhibitors; Polypharmacy; Primary Health Care; Retrospective Studies; Risk Assessment; Risk Factors; Spain; Time Factors; Treatment Outcome

Prolonged dual anti-platelet therapy (DAPT) is undesirable in certain patients. The biolimus-A9 drug-coated stent (BA9-DCS) has a rapid drug-elution profile allowing shortened DAPT.. The demographics, procedural data, and clinical outcomes for 505 patients presenting with an ACS to three UK centres and treated with a BA9-DCS stent (PCI-DCS) were collected, and compared to a consecutive ACS cohort of unselected patients treated in the same period with drug-eluting stents (PCI-DES).. PCI-DCS patients were older, more often female with hypertension, chronic kidney disease, severe LV dysfunction, and peripheral vascular disease more frequent than the PCI-DES cohort. PCI-DCS patients had a much higher Mehran bleed risk score (21.5 ± 7.7 vs. 15.9 ± 7.7, P < 0.0001). Baseline disease burden was greater in the PCI-DCS cohort with more left main and three vessel disease. During PCI, more stents (1.91 ± 1.1 vs. 1.57 ± 0.94, P < 0.0001), total stent length (38.2 ± 20.8 vs. 31.4 ± 20.3, P < 0.0001) and longer stents (38.2 ± 20.8 vs. 31.4 ± 20.3 mm, P < 0.0001) were used in the PCI-DCS cohort with rotational atherectomy also used more frequently. Physician-recommended DAPT duration was 2.9 ± 3.9 months for PCI-DCS patients and 11.3 ± 2.4 months for PCI-DES patients (P < 0.0001). At 12-month follow-up, definite stent thrombosis (0.6% vs. 1.1%) and TLR (3.2% vs. 2.7%) rates were similar between the two groups. After adjustment for baseline differences, there were no statistically significant differences in death and combined MACE rates at 12 months.. The outcomes of patients treated with polymer-free BA9 drug-coated stent who present with an ACS and who were deemed unsuitable for prolonged DAPT are encouraging. Further studies are warranted.

Topics: Acute Coronary Syndrome; Aged; Aged, 80 and over; Cardiovascular Agents; Coronary Artery Disease; Drug Administration Schedule; Drug Therapy, Combination; Drug-Eluting Stents; Female; Hemorrhage; Humans; Male; Middle Aged; Percutaneous Coronary Intervention; Platelet Aggregation Inhibitors; Preliminary Data; Prosthesis Design; Retrospective Studies; Risk Assessment; Risk Factors; Sirolimus; Time Factors; Treatment Outcome; United Kingdom

To date there is no validated evidence for standardized treatment of patients with Takotsubo syndrome (TTS). Medication therapy after final TTS diagnosis remains unclear. Previous data on patient outcome is ambivalent. Aim of this study was to evaluate medication therapy in TTS and to analyze patient outcome.. Within an observational retrospective cohort study we analyzed our medical records and included 72 patients with TTS that underwent cardiovascular magnetic resonance imaging (CMR) after a median of 2 days interquartile range (IQR 1-3.5). We investigated medication therapy at discharge. Medication implementation and major adverse clinical events (MACE) were prospectively evaluated after a median follow-up of 24 months (IQR 6-43). Left ventricular function, myocardial oedema and late gadolinium enhancement were analyzed in a CMR follow-up if available.. Antithrombotic therapy was recommended in 69 (96%) patients including different combinations. Antiplatelet monotherapy was prescribed in 28 (39%) patients. Dual antiplatelet therapy was recommended in 29 (40%) patients. Length of therapy duration varied from one to twelve months. Only in one case oral anticoagulation was prescribed due to apical ballooning with a left ventricular ejection fraction <30%. In all other cases oral anticoagulation was recommended due to other indications. ß-adrenoceptor antagonists and ACE inhibitors were recommended in 63 (88%), mineralocorticoid receptor antagonists were prescribed in 31 (43%) patients. After a median of 2 months (IQR 1.3-2.9) left ventricular function significantly recovered (49.1% ± 10.1 vs. 64.1% ± 5.7, P < 0.001) and myocardial oedema significantly decreased (13.5 ± 11.3 vs. 0.6% ± 2.4, P = <0.001) in the CMR follow-up. The 30-day mortality was 1%. MACE rate after 24 months was 12%.. Although therapy guidelines for TTS currently do not exist, we found that the majority of patients were treated with antithrombotic and heart failure therapy for up to twelve months. Left ventricular function and myocardial oedema recovered rapidly within the first two months. Outcome analysis showed a low bleeding rate and a high short-term survival. Therefore, TTS patients might benefit from antithrombotic and heart failure therapy at least for the first two months.

Topics: Aged; Aged, 80 and over; Cardiovascular Agents; Drug Therapy, Combination; Edema, Cardiac; Female; Hemorrhage; Humans; Kaplan-Meier Estimate; Magnetic Resonance Imaging; Male; Medical Records; Middle Aged; Patient Discharge; Recovery of Function; Retrospective Studies; Risk Factors; Stroke Volume; Takotsubo Cardiomyopathy; Time Factors; Treatment Outcome; Ventricular Function, Left

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

Aspirin is known to reduce mortality and recurrent vascular events. However, there are no reports about the dose-response of loading aspirin in treating acute ischemic stroke. The objective of this study was to compare the effectiveness of different loading doses of aspirin in acute ischemic stroke presenting within 48 hours of symptom onset.. This was a retrospective, hospital-based cohort study. Patients were classified as high dose (160-325 mg) or low dose (<160 mg) based on the initial loading dose of aspirin at the emergency department. The primary outcome measure was a favorable modified Rankin Scale (mRS) score of 1 or lower on discharge. Secondary outcomes included in-hospital mortality, stroke progression during admission, and bleeding events. A propensity score with 1:3 matching was used to balance baseline characteristics, and stepwise multiple logistic regression was performed for variable adjustment.. From a total of 7738 available patients, 3802 patients were included. Among them, 750 patients were in the high-dose group. Multiple logistic regression after matching revealed that the high-dose group was significantly associated with a favorable clinical outcome on discharge (odds ratio: 1.49, 95% confidence interval: 1.17-1.89, P <.01), but not mortality or stroke progression. The high-dose group also experienced more minor bleeding events.. A higher loading dose of aspirin (160-325 mg) can be beneficial in treating acute ischemic stroke, although there is an increased risk of minor bleeding.

Topics: Aged; Aged, 80 and over; Aspirin; Brain Ischemia; Cardiovascular Agents; Disability Evaluation; Disease Progression; Female; Hemorrhage; Hospital Mortality; Humans; Logistic Models; Male; Middle Aged; Multivariate Analysis; Odds Ratio; Predictive Value of Tests; Propensity Score; Registries; Remission Induction; Retrospective Studies; Risk Factors; Stroke; Time Factors; Treatment Outcome

Topics: Aged; Aspirin; Cardiovascular Agents; Cardiovascular Diseases; Female; Hemorrhage; Humans; Male; Middle Aged; Primary Prevention; Recurrence; Risk Assessment; Risk Factors; Secondary Prevention; Treatment Outcome

Aortic occlusion is accompanied by a hyperdynamic cardiovascular response secondary to increased systemic vascular resistance and increased cardiac output. This study was designed primarily to determine the safety and cardiovascular response to hydrogen sulfide (H2S; HS) administration with supraceliac aortic cross-clamp and, secondarily, on short-duration resuscitation.. A validated porcine model (five sham swine compared with five controls) demonstrated a significant hyperdynamic cardiovascular response to 35% blood volume hemorrhage, 50-minute suprarenal aortic cross-clamping, and 6-hour resuscitation. Eight additional experimental swine were administered HS at 4 mg/min during aortic cross-clamping.. During the cross-clamp period, hemodynamic curves of mean arterial pressure and heart rate demonstrated a blunting effect with HS administration, with a significant decrease being seen with mean arterial pressure at the end of the cross-clamp period (120 vs 149 mm Hg; P = .04). Resuscitation requirements were significantly reduced at 6 hours because the HS cohort received 8 L less crystalloid (P = .001) and 10.4 mg less epinephrine (P < .001). There was not a significant change in cardiac output, systemic vascular resistance, pulmonary vascular resistance, or pathologic liver analysis.. The administration of HS during the 50 minutes of supraceliac aortic cross-clamp significantly reduced stress of the left heart. On clamp release, HS significantly reduced the need for volume and pressors. HS has positive benefits during cross-clamp and subsequent resuscitation, demonstrating that targeted pharmacologic therapy is possible to minimize adverse physiologic changes with aortic occlusion.

Topics: Animals; Aorta; Arterial Pressure; Cardiac Output; Cardiopulmonary Resuscitation; Cardiotonic Agents; Cardiovascular Agents; Constriction; Crystalloid Solutions; Disease Models, Animal; Epinephrine; Fluid Therapy; Heart Rate; Hemodynamics; Hemorrhage; Hydrogen Sulfide; Isotonic Solutions; Myocardial Reperfusion Injury; Swine; Time Factors

Topics: Acute Coronary Syndrome; Cardiovascular Agents; Guideline Adherence; Hemorrhage; Heparin; Hospital Mortality; Humans; Platelet Aggregation Inhibitors; Practice Guidelines as Topic

Performance metrics currently focus on the measurement of the application of guideline-indicated medications without considering the appropriate dosing of these drugs.. We studied 39 291 patients from the Can Rapid Risk Stratification of Unstable Angina Patients Suppress Adverse Outcomes with Early Implementation of the ACC/AHA Guidelines (CRUSADE) registry with non-ST-segment elevation acute coronary syndromes. We evaluated hospital variability in the composite use of American College of Cardiology/American Heart Association guideline-recommended therapies (adherence) and the proportion of treated patients with the recommended dose of heparins or a glycoprotein IIb/IIIa antagonist (safety), and its association with risk-adjusted in-hospital mortality and bleeding. The rates of composite guideline adherence (median, 85%; 25th, 75th percentile, 82, 88) and antithrombotic dosing safety (median, 53%; 25th, 75th percentile, 45%, 60%) varied among hospitals. Correlation between hospital composite adherence and safety metrics was significant but low (r=0.16, P=0.008). Risk-adjusted in-hospital mortality was inversely related to both guideline adherence (odds ratio-10% increment, 0.80; 95% confidence interval, 0.67-0.94) and safety metrics (odds ratio-10% increment, 0.90; 95% confidence interval, 0.83-0.98). Safety was inversely related to major bleeding (adjusted odds ratio-10% increment, 0.93; 95% confidence interval, 0.87-0.98). In comparison with hospitals with low adherence and safety (≤median performance) metrics, those with mixed performance metrics (high adherence and low safety, low adherence and high safety) had intermediate risk-adjusted mortality rates, whereas hospitals with above-average performance on both metrics (>median performance) had a trend for lowest risk adjusted mortality rates (odds ratio 0.83; 95% confidence interval, 0.68-1.01). Hospitals with high safety had lower bleeding rates in comparison to those with low safety.. Guideline adherence and dosing safety appeared to provide independent and complementary information on hospital bleeding and mortality, supporting the need for broader metrics of quality that should include measures of both guideline-based care and safety.

Topics: Acute Coronary Syndrome; American Heart Association; Cardiovascular Agents; Dose-Response Relationship, Drug; Guideline Adherence; Hemorrhage; Heparin; Hospital Mortality; Hospitals; Humans; Inpatients; Odds Ratio; Patient Safety; Platelet Aggregation Inhibitors; Platelet Glycoprotein GPIIb-IIIa Complex; Practice Guidelines as Topic; Treatment Outcome; United States

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

Topics: Anticoagulants; Arrhythmogenic Right Ventricular Dysplasia; Atrial Fibrillation; Benzazepines; Bradycardia; Cardiovascular Agents; Heart Diseases; Hemorrhage; Humans; Ivabradine; Point-of-Care Systems

Topics: Autopsy; Cardiovascular Agents; Coronary Artery Disease; Coronary Vessels; Drug-Eluting Stents; Fatal Outcome; Hemorrhage; Humans; Male; Middle Aged; Neointima; Paclitaxel; Percutaneous Coronary Intervention; Plaque, Atherosclerotic; Prosthesis Design; Tomography, Optical Coherence; Treatment Outcome; Ultrasonography, Interventional

It is a case report of bleeding when using dabigatran in patient with renal failure caused by the concurrent use of spironolactone and angiotensin-converting enzyme (ACE) inhibitors. The patient (75 years old) at the decompensation of chronic heart failure in the background of persistent atrial fibrillation was appointed the combination of ACE inhibitors, spironolactone, and dabigatran. 10 days after the start of using spironolactone and dabigatran bleeding was marked with decrease in hemoglobin levels to 69 g/l, creatinine level increases to 3.6 mg/dL (glomerular filtration rate by MDRD 18 ml/min/1,73 m2), and potassium to 5.5 mEq/ l. Against the background of the abolition of drugs normalization of renal function was marked. The question of an increased risk of nephrotoxicity with concurrent use of ACE inhibitors and spironolactone is discussed.

Topics: Aged; Angiotensin-Converting Enzyme Inhibitors; Atrial Fibrillation; Benzimidazoles; beta-Alanine; Cardiovascular Agents; Dabigatran; Drug Interactions; Drug Therapy, Combination; Heart Failure; Hemorrhage; Humans; Male; Renal Insufficiency, Chronic; Spironolactone; Treatment Outcome; Withholding Treatment

To describe the characteristics, treatment, and mortality in patients with ST-elevation myocardial infarction (STEMI) by use of chronic oral anticoagulant (OAC) therapy.. Using data from the Global Registry of Acute Coronary Syndromes (GRACE), patient characteristics, treatment, and reperfusion strategies of STEMI patients on chronic OAC are described, and relevant variables compared with patients not on chronic OAC. Six-month post-discharge mortality rates were evaluated by Cox proportional hazard models.. Of 19,094 patients with STEMI, 574 (3.0%) were on chronic OAC at admission. Compared with OAC non-users, OAC users were older (mean age 73 vs. 65 years), more likely to be female (37 vs. 29%), were more likely to have a history of atrial fibrillation, prosthetic heart valve, venous thromboembolism, or stroke/transient ischaemic attack, had a higher mean GRACE risk score (166 vs. 145), were less likely to be Killip class I (68 vs. 82%), and were less likely to undergo catheterization/percutaneous coronary intervention (52 vs. 66%, respectively). Of the patients who underwent catheterization, fewer OAC users had the procedure done within 24 h of admission (56.5 vs. 64.5% of OAC non-users). In propensity-matched analyses (n=606), rates of in-hospital major bleeding and in-hospital and 6-month post-discharge mortality were similar for OAC users and OAC non-users (2.7 and 3.7%, p=0.64; 15 and 13%, p=0.56; 15 and 12%, p=0.47, respectively), rates of in-hospital recurrent myocardial infarction (8.6 and 2.0%, p<0.001) and atrial fibrillation (32 and 22%, p=0.004) were higher in OAC patients, and rates of 6-month stroke were lower (0.6 and 4.3%, p=0.038). Patients in both groups who underwent catheterization had lower mortality than those who did not undergo catheterization.. This is the largest study to describe the characteristics and treatment of STEMI patients on chronic OAC. The findings suggest that patients on chronic OAC are less likely to receive guideline-indicated management, but have similar adjusted rates of in-hospital and 6-month mortality.

Topics: Administration, Oral; Aged; Aged, 80 and over; Anticoagulants; Cardiovascular Agents; Female; Hemorrhage; Hospital Mortality; Humans; Male; Middle Aged; Myocardial Infarction; Myocardial Revascularization; Percutaneous Coronary Intervention; Propensity Score; Prospective Studies

Second-generation drug-eluting stents (DES) have provided better results over both bare-metal stents and first-generation DES. However, comparative data of different first- and second-generation DES in a clinical setting of all-comers have not been well studied.. Baseline clinical and angiographic characteristics and in-hospital and follow-up events were recorded for enrolled patients. The composite of death, myocardial infarction, and stroke, defined as major adverse cardiac and cerebrovascular events (MACCE), as well as target vessel revascularization (TVR) was used as the primary end point. Between May 2007 and May 2009, 10,852 patients subjected to drug-eluting stent implantation were enrolled at 74 sites. 3,032 patients (27.9 %) were treated with Taxus™, 4,382 (40.4 %) with Cypher™, 1,012 (9.3 %) with Endeavor™, 1,693 (15.6 %) with Xience V™ and 733 (6.8 %) with Promus™ during this period. At 1-year follow-up, the comparison between groups revealed no significant differences with respect to overall death, MACCE, definite stent thrombosis, TVR, stroke and major bleeding. After adjustment for risk factors in final regression models, a modestly significant association of DES type to MACCE was observed (p = 0.046); however, this association could not be attributed to one particular DES. An impact of DES type on TVR was not seen after risk adjustment.. Data generated from the prospective German drug-eluting stent (DES.DE) registry confirm that safety and efficacy of different first- and second-generation DES are clinically equivalent in the first year of follow-up, even in a more complex setting.

Topics: Aged; Cardiovascular Agents; Chi-Square Distribution; Coronary Angiography; Drug-Eluting Stents; Female; Germany; Hemorrhage; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Myocardial Infarction; Percutaneous Coronary Intervention; Proportional Hazards Models; Prospective Studies; Prosthesis Design; Registries; Risk Assessment; Risk Factors; Stroke; Thrombosis; Time Factors; Treatment Outcome

Bleeding events are common after percutaneous coronary intervention (PCI) and have been shown to increase mortality in studies of acute coronary syndrome (ACS) and anti-thrombotic therapy. Despite this evidence, bleeding has not been included as a traditional major endpoint in clinical trials of low-risk populations enrolled in PCI clinical trials. Thus, the impact of specific bleeding definitions has not been evaluated fully among these patients.. Using patient-level pooled data from sirolimus and zotarolimus drug-eluting stent clinical trials, we identified bleeding events using three common definitions of bleeding, ACUITY, TIMI, and GUSTO, and assessed the impact on mortality and MI at 12 months after PCI. The GUSTO, ACUITY, and TIMI classifications identified bleeding rates of 2.3%, 1.9%, and 2.1%, respectively. The GUSTO criteria classified all 118 suspected bleeding events. There were 22 (18.6%) and 8 (6.8%) suspected bleeding events that did not meet ACUITY and TIMI criteria, respectively. The combined endpoint of all-cause death or myocardial infarction (MI) at 12 months was significantly higher for patients with a bleeding event compared with those who did not bleed [hazard ratio 1.95 (95% CI 1.06-3.60)].. There is a substantial variability in the utility and inclusiveness of three widely used bleeding definitions in identifying clinically significant bleeding events in clinical trials of low risk patients undergoing PCI with DES. Patients with bleeding after elective PCI have an increased one-year risk of death or MI compared to those patients who do not bleed.

Topics: Aged; Cardiovascular Agents; Chi-Square Distribution; Clinical Trials as Topic; Drug-Eluting Stents; Endpoint Determination; Female; Hemorrhage; Humans; Kaplan-Meier Estimate; Logistic Models; Male; Middle Aged; Multivariate Analysis; Myocardial Infarction; Percutaneous Coronary Intervention; Proportional Hazards Models; Prosthesis Design; Risk Assessment; Risk Factors; Sirolimus; Terminology as Topic; Time Factors; Treatment Outcome

Measurement of hospital quality has traditionally focused on processes of care and postprocedure outcomes. Appropriateness measures for percutaneous coronary intervention (PCI) assess quality as it relates to patient selection and the decision to perform PCI. The association between patient selection for PCI and processes of care and postprocedural outcomes is unknown.. We included 203 531 patients undergoing nonacute (elective) PCI from 779 hospitals participating in the National Cardiovascular Data Registry (NCDR) CathPCI Registry between July 2009 and April 2011. We examined the association between a hospital's proportion of nonacute PCIs categorized as inappropriate by the 2009 Appropriate Use Criteria (AUC) for Coronary Revascularization and in-hospital mortality, bleeding complications, and use of optimal guideline-directed medical therapy at discharge (ie, aspirin, thienopyridines, and statins). When categorized as hospital tertiles, the range of inappropriate PCI was 0.0% to 8.1% in the lowest tertile, 8.1% to 15.2% in the middle tertile, and 15.2% to 58.6% in the highest tertile. Compared with lowest-tertile hospitals, mortality was not significantly different at middle-tertile (adjusted odds ratio [OR], 0.93; 95% confidence interval [CI], 0.73-1.19) or highest-tertile hospitals (OR, 1.12; 95% CI, 0.88-1.43; P=0.35 for differences between tertiles). Similarly, risk-adjusted bleeding did not vary significantly (middle-tertile OR, 1.13; 95% CI, 1.02-1.16; highest-tertile OR, 1.02; 95% CI, 0.91-1.16; P=0.07 for differences between tertiles) nor did use of optimal medical therapy at discharge (85.3% versus 85.7% versus 85.2%; P=0.58).. In a national cohort of nonacute PCIs, a hospital's proportion of inappropriate PCIs was not associated with in-hospital mortality, bleeding, or medical therapy at discharge. This suggests PCI appropriateness measures aspects of hospital PCI quality that are independent of how well the procedure is performed. Therefore, PCI appropriateness and postprocedural outcomes are both important metrics to inform PCI quality.

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Chi-Square Distribution; Female; Health Services Research; Hemorrhage; Hospital Mortality; Hospitals; Humans; Linear Models; Male; Middle Aged; Odds Ratio; Outcome and Process Assessment, Health Care; Patient Discharge; Patient Selection; Quality Indicators, Health Care; Registries; Risk Assessment; Risk Factors; Time Factors; Treatment Outcome; United States

Topics: Anticoagulants; Antidiuretic Hormone Receptor Antagonists; Aspirin; Benzazepines; Cardiovascular Agents; Drug Combinations; Embolism; Gastrointestinal Hemorrhage; Hemorrhage; Humans; Hypernatremia; Japan; Platelet Aggregation Inhibitors; Substance Withdrawal Syndrome; Tolvaptan

Stent thrombosis is a rare but potentially fatal complication of percutaneous treatment of coronary disease. Its occurrence after placement of drug eluting stents (DES) has raised concerns, as this event may occur very late after stent implantation. Here, we report a case of very late stent thrombosis (VLST) experienced 1462 days after DES deployment in a patient with challenging clinical status, requiring counterbalancing hemorrhagic and thrombotic risk factors.

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Angiography; Drug Administration Schedule; Drug-Eluting Stents; Electrocardiography; Female; Hemorrhage; Humans; Paclitaxel; Platelet Aggregation Inhibitors; Thrombosis; Time Factors

Topics: Blood Transfusion; Cardiopulmonary Resuscitation; Cardiovascular Agents; Fluid Therapy; Hemorrhage; Humans; United States; Wounds and Injuries

Decision Aids (DA) are well established in various fields of medicine. It can improve the quality of decision-making and reduce decisional conflict. In neonatal care, and due to scientific equipoise, neonatologists caring for extreme low birth weight (ELBW) infants are in need to elicit parents' preferences with regard to the use of indomethacin therapy in ELBW infants. We aimed to develop a DA that elicits parents' preferences with regard to indomethacin therapy in ELBW infants.. We developed a DA for the use of the indomethacin therapy in ELBW infants according to the Ottawa Decision Support Framework. The development process involved parents, neonatologists, DA developers and decision making experts. A pilot testing with healthy volunteers was conducted through an evaluation questionnaire, a knowledge scale, and a validated decisional conflict scale.. The DA is a computer-based interactive tool. In the first part, the DA provides information about patent ductus arteriosus (PDA) as a disease, the different treatment options, and the benefits and downsides of using indomethacin therapy in preterm infants. In the second part, it coaches the parent in the decision making process through clarifying values and preferences. Volunteers rated 10 out of 13 items of the DA positively and showed significant improvement on both the knowledge scale (p = 0.008) and the decisional conflict scale (p = 0.008).. We have developed a computer based DA to assess parental preferences with regard to indomethacin therapy in preterm infants. Future research will involve measurement of parental preferences to guide and augment the clinical decisions in current neonatal practice.

Topics: Adult; Bronchopulmonary Dysplasia; Cardiovascular Agents; Decision Support Techniques; Ductus Arteriosus, Patent; Female; Hemorrhage; Humans; Indomethacin; Infant, Extremely Low Birth Weight; Infant, Newborn; Infant, Premature; Intracranial Hemorrhages; Lung Diseases; Parents; Pilot Projects; Severity of Illness Index

Topics: Aged; Ankle Brachial Index; Aspirin; Atherosclerosis; Cardiovascular Agents; Cardiovascular Diseases; Evidence-Based Medicine; Female; Hemorrhage; Humans; Male; Middle Aged; Primary Prevention; Randomized Controlled Trials as Topic; Research Design; Risk Assessment; Scotland; Time Factors; Treatment Outcome

To assess the short-term prognosis of patients with recent symptomatic intracranial atherosclerotic disease in the posterior circulation and evaluate differences in the outcome of patients receiving medical or endovascular treatment.. The records of 50 consecutive patients with symptomatic intracranial atherosclerotic disease in the posterior circulation were reviewed to record the occurrence of transient ischemic attack, stroke, major bleeding, and/or death during the 12-month period following a neurological event. Twenty-five patients received medical treatment alone, 13 initially received medical treatment and subsequently were treated with angioplasty/stenting due to recurrent events (analyzed in both groups), and 12 patients received endovascular treatment initially. The crossover patients were considered as 1 treated patient in each group; thus, there were 38 subjects (33 men; mean age 68+/-9 years) receiving medical therapy compared with 25 patients (21 men; mean age 63+/-13 years) who underwent endovascular procedures.. During the 12-month period, subjects in the medically-treated group had a higher rate of events (37%, 14/38) than patients who received angioplasty/stenting (12%, 3/25; p = 0.042). Notably, there were 7 (18%) TIAs and 6 (16%) strokes in medically-treated patients versus no TIAs (0%, p = 0.035) and only 2 (8%, p = NS) strokes in the endovascular group, both of which occurred within 48 hours of the procedure. There were no deaths and only a single major bleeding event in each group.. Endovascular treatment of patients with symptomatic intracranial disease of the posterior territory appears to be associated with a substantially better outcome.

Topics: Aged; Angioplasty; Argentina; Cardiovascular Agents; Cerebrovascular Circulation; Chi-Square Distribution; Female; Hemorrhage; Humans; Intracranial Arteriosclerosis; Ischemic Attack, Transient; Male; Middle Aged; Retrospective Studies; Risk Assessment; Risk Factors; Stents; Stroke; Time Factors; Treatment Outcome

Atrial fibrillation (AF) has been established as an independent predictor of long-term mortality after acute myocardial infarction. However, this is less well defined across the whole spectrum of acute coronary syndromes (ACSs). The Acute Coronary Syndrome Prospective Audit is a prospective multicenter registry with 12-month outcome data for 3,393 patients (755 with ST-segment elevation myocardial infarction, 1942 with high-risk non-ST-segment elevation ACS [NSTE-ACS], and 696 with intermediate-risk NSTE-ACS). A total of 149 patients (4.4%) had new-onset AF and 387 (11.4%) had previous AF. New-onset AF was more, and previous AF was less frequent in those with ST-segment elevation myocardial infarction than in those with high-risk NSTE-ACS or intermediate-risk NSTE-ACS (p <0.001). Compared to patients without arrhythmia, patients with new-onset AF and previous AF were significantly older and had more high-risk features at presentation (p <0.004). Patients with new-onset AF more often had left main coronary artery disease, resulting in a greater rate of surgical revascularization (p <0.001). Only new-onset AF resulted in adverse in-hospital outcomes (p <0.001). Only patients with previous AF had greater long-term mortality (hazard ratio 1.42, p <0.05). New-onset AF was only associated with a worse long-term composite outcome (hazard ratio 1.66, p = 0.004). However, the odds ratio for the composite outcome was greatest for patients with new-onset AF with intermediate-risk NSTE-ACS (odds ratio 3.9, p = 0.02) than for those with high-risk NSTE-ACS (odds ratio 2.0, p = 0.01) or ST-segment elevation myocardial infarction (odds ratio 1.4, p = 0.4). In conclusion, new-onset AF was associated with worse short-term outcomes and previous AF was associated with greater mortality even at long-term follow-up. The prognostic burden of new-onset AF differed with the type of ACS presentation.

Topics: Acute Coronary Syndrome; Acute Kidney Injury; Age Factors; Aged; Atrial Fibrillation; Australia; Cardiovascular Agents; Coronary Artery Bypass; Coronary Artery Disease; Creatine Kinase; Drug Utilization; Electrocardiography; Female; Heart Failure; Heart Rate; Hemorrhage; Hospital Mortality; Humans; Length of Stay; Male; Middle Aged; Myocardial Infarction; Prospective Studies; Recurrence; Registries; Risk Factors; Severity of Illness Index; Stroke

Topics: Acute Disease; Benzenesulfonates; Brain Ischemia; Cardiovascular Agents; Data Interpretation, Statistical; Hemorrhage; Humans; Nitrogen Oxides; Stroke

Patients with kidney disease and acute myocardial infarction (AMI) receive standard therapy, including thrombolytic medication, less frequently than patients with normal kidney function. Our goal is to identify potential differences in thrombolytic medication delays and thrombolytic-associated bleeding events by severity of kidney disease.. This is a retrospective cohort analysis of Cooperative Cardiovascular Project data for all Medicare patients with AMI from 4,601 hospitals. Outcome measures included time to administration of thrombolytic medication censored at 6 hours and bleeding events.. Of 109,169 patients (mean age, 77.4 years; 50.6% women), 13.9% received thrombolysis therapy. Average time to thrombolytic therapy was longer in patients with worse kidney function. Adjusted hazard ratios for minutes to thrombolytic therapy were 0.83 (95% confidence interval [CI], 0.79 to 0.87) for patients with a serum creatinine level of 1.6 to 2.0 mg/dL (141 to 177 micromol/L) and 0.58 (95% CI, 0.53 to 0.63) for patients with a creatinine level greater than 2.0 mg/dL (>177 micromol/L) or on dialysis therapy compared with those with normal kidney function. Odds ratios for bleeding events in patients administered thrombolytics versus those who were not decreased with worse kidney function: adjusted odds ratios, 2.28 (95% CI, 2.16 to 2.42) in patients with normal kidney function and 1.84 (95% CI, 1.09 to 3.10) in dialysis patients.. Patients with worse kidney function experienced treatment delays, but were not at greater risk for thrombolysis-associated excess bleeding events. Physician concerns of thrombolytic-associated bleeding may not be sufficient reason to delay the administration of thrombolytic medication.

Topics: Aged; Aged, 80 and over; Cardiovascular Agents; Cohort Studies; Comorbidity; Creatinine; Databases, Factual; Diabetes Mellitus; Female; Fibrinolytic Agents; Heart Diseases; Hemorrhage; Humans; Hypertension; Kidney Diseases; Life Tables; Male; Medicare; Myocardial Infarction; Peptic Ulcer; Proportional Hazards Models; Retrospective Studies; Sampling Studies; Thrombolytic Therapy; Time Factors; United States

Oral antiplatelet agents (OAAs) can prevent further vascular events in cardiovascular disease. How prior use or recent discontinuation of OAA affects clinical presentation of acute coronary syndromes (ACS) and clinical outcomes (death, myocardial infarction [MI]) is unclear.. We studied and followed up for up to 30 days a cohort of 1358 consecutive patients admitted for a suspected ACS; of these, 930 were nonusers, 355 were prior users of OAA, and 73 had recently withdrawn OAA. Nonusers were at lower risk, more frequently presented with ST-elevation MI on admission, and more frequently had Q-wave MI at discharge than prior users (36.6% versus 17.5%, P<0.001; and 47.8% versus 28.2%, P<0.001, respectively). However, there was no difference regarding the incidence of death or MI at 30 days between nonusers and prior users (10.3% versus 12.4%, P=NS). In addition, prior users experienced more major bleeds within 30 days compared with nonusers (3.4% versus 1.4%, respectively; P=0.04). Recent withdrawers were admitted on average 11.9+/-0.8 days after OAA withdrawal. Interruption was primarily a physician decision for scheduled surgery (n=47 of 73). Despite a similar cardiovascular risk profile, recent withdrawers had higher 30-day rates of death or MI (21.9% versus 12.4%, P=0.04) and bleedings (13.7% versus 5.9%, P=0.03) than prior users. After multivariate analysis, OAA withdrawal was found to be an independent predictor of both mortality and bleedings at 30 days.. Among ACS patients, prior users represent a higher-risk population and present more frequently with non-ST-elevation ACS than nonusers. Although patients with a recent interruption of OAA resemble those chronically treated by OAA, they display worse clinical outcomes.

Topics: Acute Disease; Administration, Oral; Aged; Aspirin; Cardiovascular Agents; Cohort Studies; Drug Therapy, Combination; Electrocardiography; Female; Follow-Up Studies; Hemorrhage; Humans; Incidence; Male; Middle Aged; Myocardial Infarction; Myocardial Ischemia; Paris; Platelet Aggregation Inhibitors; Prospective Studies; Risk Factors; Syndrome; Thrombosis; Treatment Outcome; Withholding Treatment

Drug-induced pulmonary toxicity is increasing and early diagnosis is important because of the associated morbidity and mortality. Diagnosis is often difficult and is usually based on a history of drug therapy and exclusion of infection, radiation pneumonitis, and recurrence of the underlying disease. Although HRCT findings are frequently nonspecific, diagnosis can be facilitated by an understanding of the most common histopathologic and radiologic manifestations of drug-induced lung injury and knowledge of the drugs usually involved.

Topics: Adult; Aged; Anti-Bacterial Agents; Antineoplastic Agents; Cardiovascular Agents; Cryptogenic Organizing Pneumonia; Female; Hemorrhage; Humans; Lung; Lung Diseases; Lung Diseases, Interstitial; Male; Middle Aged; Pulmonary Eosinophilia; Radiography, Thoracic; Tomography, X-Ray Computed

This study was designed to investigate whether reperfusion with adenosine had an effect on myocardial high energy phosphate levels and cardiac function in hearts extracted from acutely hemorrhaged rats. Rats were bled to a mean arterial pressure of 0 mmHg for 5, 10 or 15 minutes and hearts were removed and assigned to one of three groups: 1) Hearts freeze clamped for measuring high energy phosphates; 2) Hearts perfused by Langendorff method at a constant perfusion pressure of 90 mmHg for 30 minutes followed by freeze clamping and determining high energy phosphates and; 3) Hearts perfused with adenosine (20 microM) and treated in the same way as in group 2. In group 1 myocardial ATP was significantly reduced as compared with control. When reperfusion started within 10 min, ATP contents recovered to the levels of control, and there were no significant changes between groups 2 and 3. LVP and LV dp/dt in group 3 were significantly higher than those in group 2. When reperfusion started after 15 min, ATP remained at a low level and few hearts could be resuscitated. These findings suggest that early resuscitation with adenosine might facilitate cardiac recovery following acute hemorrhage.

Topics: Adenosine; Adenosine Triphosphate; Animals; Cardiovascular Agents; Heart Rate; Hemorrhage; In Vitro Techniques; Male; Myocardial Reperfusion; Myocardium; Rats; Rats, Wistar; Time Factors; Ventricular Function, Left

Topics: Cardiovascular Agents; Ergot Alkaloids; Female; Hemorrhage; Humans; Oxytocics; Postpartum Hemorrhage; Postpartum Period; Pregnancy

Topics: Cardiovascular Agents; Ergot Alkaloids; Female; Hemorrhage; Humans; Hyaluronoglucosaminidase; Labor, Obstetric; Postpartum Hemorrhage; Postpartum Period; Pregnancy

Topics: Brain; Cardiovascular Agents; Ergot Alkaloids; Hemorrhage; Humans; Oxytocics; Reserpine

Topics: Cardiovascular Agents; Ergot Alkaloids; Female; Hemorrhage; Humans; Hyaluronoglucosaminidase; Labor, Obstetric; Oxytocics; Pregnancy

Topics: Cardiovascular Agents; Ergot Alkaloids; Female; Hemorrhage; Humans; Labor, Obstetric; Placenta; Pregnancy

Topics: Cardiovascular Agents; Ergot Alkaloids; Female; Hemorrhage; Humans; Labor, Obstetric; Oxytocics; Pregnancy

Topics: Cardiovascular Agents; Ergot Alkaloids; Female; Hemorrhage; Humans; Labor, Obstetric; Methylergonovine; Oxytocics; Postpartum Hemorrhage; Pregnancy

Topics: Cardiovascular Agents; Ergot Alkaloids; Gastrointestinal Tract; Hemorrhage; Humans

Topics: Cardiovascular Agents; Ergot Alkaloids; Female; Hemorrhage; Humans; Labor, Obstetric; Methylergonovine; Midwifery; Oxytocics; Pregnancy

Topics: Cardiovascular Agents; Ergot Alkaloids; Female; Hemorrhage; Humans; Labor, Obstetric; Methylergonovine; Oxytocics; Pregnancy

Topics: Cardiovascular Agents; Ergonovine; Ergot Alkaloids; Female; Hemorrhage; Humans; Hyaluronoglucosaminidase; Labor, Obstetric; Oxytocics; Pregnancy

Topics: Cardiovascular Agents; Ergot Alkaloids; Female; Fetal Development; Hemorrhage; Humans; Labor, Obstetric; Oxytocics; Oxytocin; Pregnancy

Topics: Cardiovascular Agents; Ergot Alkaloids; Female; Hemorrhage; Humans; Labor, Obstetric; Methylergonovine; Oxytocics; Pregnancy

Topics: Cardiovascular Agents; Ergot Alkaloids; Female; Hemorrhage; Humans; Labor, Obstetric; Methylergonovine; Postpartum Period; Pregnancy

Topics: Cardiovascular Agents; Ergonovine; Ergot Alkaloids; Female; Hemorrhage; Humans; Labor, Obstetric; Pregnancy; Work

Topics: Cardiovascular Agents; Ergonovine; Ergot Alkaloids; Female; Hemorrhage; Humans; Oxytocics; Postpartum Hemorrhage; Postpartum Period; Pregnancy

Topics: Cardiovascular Agents; Disease Management; Ergot Alkaloids; Female; Hemorrhage; Humans; Oxytocics; Oxytocin; Postpartum Hemorrhage; Postpartum Period; Pregnancy

Topics: Cardiovascular Agents; Hemorrhage; Hypotension; Hypotension, Controlled; Muscle Relaxants, Central