cardiovascular-agents and Thrombosis

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

Thrombotic events act as a critical factor that interferes with Cardiovascular Diseases (CVDs), and antithrombotic herbal medicine is a long-standing controversial issue. Although a dispute is involved in their clinical application, all parties unanimously agree that herbal products have been widely used in folk medicine, and their interactions with conventional drugs are of high concern. This study aims to investigate how antithrombotic herbal medicines interact with Western cardiovascular drugs on the molecular level by taking an example of the most frequently used herbal pair, Danshen-Chuanxiong (DS-CX), and to discover more scientific evidence on their potential herb-drug interactions. Network pharmacology (NP), as an analytical approach of a complex system, is used to visualize and compare target profiles of DS-CX and Western cardiovascular drugs, which can be applied to predict common herb-drug targets and to construct a solid context for discussing herb-drug interactions. These interactions are further validated by in vitro assays, while in vivo zebrafish model employed for evaluating an overall pharmacological efficacy of herbal pairs in specific combination ratios. The study finds that DS could react directly to the Western cardiovascular drug targets relevant to antithrombotic pathways (i.e., thrombin, coagulation factor Xa and cyclooxygenase-1), whereas CX could not react directly and can synergistically affect antithrombotic effects with DS in specific combination ratios. Moreover, it is indicated that DS-CX may generate wide biological functions by a complicated mechanism of "neuro-immune-metabolism/endocrine" (NIM), which can further cause multiple direct and indirect interactions with Western cardiovascular drugs. From the clinical perspective, herb-drug interactions should be given high attention, especially when multiple herbs are used simultaneously.

Topics: Animals; Blood Coagulation; Cardiovascular Agents; Drug Synergism; Drugs, Chinese Herbal; Fibrinolytic Agents; Herb-Drug Interactions; Humans; Ligusticum; Medicine, Chinese Traditional; Salvia miltiorrhiza; Systems Biology; Thrombosis

Thrombotic disorders are characterized by an increase in the probability of the formation of unnecessary thrombi that might be due to the activation of the coagulation cascade or the circulating platelets. Platelets or thrombocytes play an essential role in hemostasis but abnormal platelet function leads to the development of a number of cardiovascular complications, including thrombotic disorders. Under pathological conditions, platelets are associated with the development of different thrombotic disorders, including atherosclerosis, arterial thrombosis and stroke, deep venous thrombosis and pulmonary embolism; therefore, platelets are the target of a number of anti-thrombotic strategies. Flavonoids, a large group of polyphenols ubiquitously expressed in fruits and vegetables that have attracted considerable attention because of their benefits in human health, including the reduction of the risk of cardiovascular disease. Flavonoids have been reported to reduce platelet activity by attenuating agonist-induced GPIIb/IIIa receptor activation, mobilization of intracellular free Ca2+, granule exocytosis, as well as activation of different signaling molecules such as mitogen- activated protein kinases or phospholipases. This review summarizes the current studies concerning the modulation of platelet activation by flavonoids, giving especial attention to those events associated to thrombotic disorders.

Topics: Animals; Cardiovascular Agents; Cardiovascular Diseases; Flavonoids; Humans; Platelet Activation; Thrombosis

Nanoparticles promise to advance strategies to treat vascular disease. Since being harnessed by the cancer field to deliver safer and more effective chemotherapeutics, nanoparticles have been translated into applications for cardiovascular disease. Systemic exposure and drug-drug interactions remain a concern for nearly all cardiovascular therapies, including statins, antithrombotic, and thrombolytic agents. Moreover, off-target effects and poor bioavailability have limited the development of completely new approaches to treat vascular disease. Through the rational design of nanoparticles, nano-based delivery systems enable more efficient delivery of a drug to its therapeutic target or even directly to the diseased site, overcoming biological barriers and enhancing a drug's therapeutic index. In addition, advances in molecular imaging have led to the development of theranostic nanoparticles that may simultaneously act as carriers of both therapeutic and imaging payloads. The following is a summary of nanoparticle therapy for atherosclerosis, thrombosis, and restenosis and an overview of recent major advances in the targeted treatment of vascular disease.

Topics: Animals; Cardiovascular Agents; Chemotaxis, Leukocyte; Cholesterol; Drug Carriers; Drug Evaluation, Preclinical; Forecasting; Humans; Inflammation; Macrophages; Mice; Nanoparticles; Neointima; Neovascularization, Pathologic; Plaque, Atherosclerotic; RNA Interference; RNA, Small Interfering; Thrombosis; Vascular Diseases

The advent of intracoronary stents has greatly increased the safety and applicability of percutaneous coronary interventions. One of the drawbacks of drug-eluting stents (DES) is the increased risk of late and very late stent thrombosis (ST). It was anticipated that the risks of ST after DES implantation would be solved with the advent of fully biodegradable scaffolds, which offer the possibility of transient scaffolding of the vessel to prevent acute vessel closure and recoil while also transiently eluting an antiproliferative drug to counteract constrictive remodelling and excessive neointimal hyperplasia. In spite of the enthusiasm for the concept of bioresorbable scaffolds, current clinical data on the Absorb bioresorbable vascular scaffold (BVS) have generated concerns about scaffold thrombosis (ScT) in both the early and late phases. However, the causes of ScT in both the early and late phases have yet to be fully elucidated. This article seeks to provide insights into the possible mechanical causes of ScT in the early and late phases with data stemming from intracoronary imaging (intravascular ultrasound and optical coherence tomography) of the currently published ScT cases following the implantation of BVS and reviews the practical recommendations for implantation of the BVS made by a group of experts.

Topics: Cardiovascular Agents; Coronary Vessels; Drug-Eluting Stents; Humans; Percutaneous Coronary Intervention; Thrombosis; Treatment Outcome

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

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

Acute inflammation is a host-protective response that is mounted in response to tissue injury and infection. Initiated and perpetuated by exogenous and endogenous mediators, acute inflammation must be resolved for tissue repair to proceed and for homeostasis to be restored. Resolution of inflammation is an actively regulated process governed by an array of mediators as diverse as those that initiate inflammation. Among these, resolvins have emerged as a genus of evolutionarily conserved proresolving mediators that act on specific cellular receptors to regulate leukocyte trafficking and blunt production of inflammatory mediators, while also promoting clearance of dead cells and tissue repair. Given that chronic unresolved inflammation is emerging as a central causative factor in the development of cardiovascular diseases, an understanding of the endogenous processes that govern normal resolution of acute inflammation is critical for determining why sterile maladaptive cardiovascular inflammation perpetuates. Here, we provide an overview of the process of resolution with a focus on the enzymatic biosynthesis and receptor-dependent actions of resolvins and related proresolving mediators in immunity, thrombosis, and vascular biology. We discuss how nutritional and current therapeutic approaches modulate resolution and propose that harnessing resolution concepts could potentially lead to the development of new approaches for treating chronic cardiovascular inflammation in a manner that is not host disruptive.

Topics: Animals; Anti-Inflammatory Agents; Cardiovascular Agents; Cardiovascular Diseases; Docosahexaenoic Acids; Humans; Lipid Metabolism; Thrombosis

Numerous epidemiological studies and clinical trials have reported the health benefits of omega-3 polyunsaturated fatty acids (PUFA), including a lower risk of coronary heart diseases. This review mainly focuses on the effects of alpha-linolenic (ALA), eicosapentaenoic (EPA) and docosahexaenoic (DHA) acids on some risk factors associated with atherothrombosis, including platelet activation, plasma lipid concentrations and oxidative modification of low-density lipoproteins (LDL). Special focus is given to the effects of marine PUFA on the formation of eicosanoids and docosanoids, and to the bioactive properties of some oxygenated metabolites of omega-3 PUFA produced by cyclooxygenases and lipoxygenases. The antioxidant effects of marine omega-3 PUFA at low concentrations and the pro-oxidant effects of DHA at high concentrations on the redox status of platelets and LDL are highlighted. Non enzymatic peroxidation end-products deriving from omega-3 PUFA such as hydroxy-hexenals, neuroketals and EPA-derived isoprostanes are also considered in relation to atherosclerosis. This article is part of a Special Issue entitled "Oxygenated metabolism of PUFA: analysis and biological relevance".

Topics: alpha-Linolenic Acid; Animals; Atherosclerosis; Cardiovascular Agents; Docosahexaenoic Acids; Dose-Response Relationship, Drug; Eicosapentaenoic Acid; Fatty Acids, Omega-3; Humans; Oxidation-Reduction; Risk Assessment; Risk Factors; Thrombosis; Treatment Outcome

Since the advent of percutaneous coronary intervention, enormous advances have been made in the treatment of coronary artery disease. Angioplasty and bare metal stents were plagued by high rates of restenosis leading to repeat revascularization procedures. Examination of the underlying pathophysiology of restenosis led to the development of drug-eluting stents to reduce neointimal hyperplasia. However, as restenosis rates declined, length of dual antiplatelet therapy use and risk of long-term stent thrombosis associated with drug-eluting stents increased. Subsequent generations have improved each facet of stent design. Novel alloys maintain durability and reduce strut thickness to increase deliverability, biocompatible polymers decrease the inflammatory response and improve drug elution kinetics, and new generations of drugs predictably inhibit restenosis. Developments on the horizon include stents with bioabsorbable polymers and platforms. The purpose of this review is to assess the evolution of stent design and the evidence behind each generation and to peer into the future of stent technology.

Topics: Angioplasty, Balloon, Coronary; Animals; Cardiovascular Agents; Coronary Artery Disease; Drug-Eluting Stents; Humans; Neointima; Thrombosis

Numerous naturalistic, experimental, and mechanistic studies strongly support the notion that-as part of fight-or-flight response-hemostatic responses to acute psychosocial stress result in net hypercoagulability, which would protect a healthy organism from bleeding in case of injury. Sociodemographic factors, mental states, and comorbidities are important modulators of the acute prothrombotic stress response. In patients with atherosclerosis, exaggerated and prolonged stress-hypercoagulability might accelerate coronary thrombus growth following plaque rupture. Against a background risk from acquired prothrombotic conditions and inherited thrombophilia, acute stress also might trigger venous thromboembolic events. Chronic stressors such as job strain, dementia caregiving, and posttraumatic stress disorder as well as psychological distress from depressive and anxiety symptoms elicit a chronic low-grade hypercoagulable state that is no longer viewed as physiological but might impair vascular health. Through activation of the sympathetic nervous system, higher order cognitive processes and corticolimbic brain areas shape the acute prothrombotic stress response. Hypothalamic-pituitary-adrenal axis and autonomic dysfunction, including vagal withdrawal, are important regulators of hemostatic activity with longer lasting stress. Randomized placebo-controlled trials suggest that several cardiovascular drugs attenuate the acute prothrombotic stress response. Behavioral interventions and psychotropic medications might mitigate chronic low-grade hypercoagulability in stressed individuals, but further studies are clearly needed. Restoring normal hemostatic function with biobehavioral interventions bears the potential to ultimately decrease the risk of thrombotic diseases.

Topics: Adaptation, Psychological; Blood Coagulation Factors; Cardiovascular Agents; Hemostasis; Humans; Hypothalamo-Hypophyseal System; Models, Biological; Pituitary-Adrenal System; Stress, Psychological; Thrombosis

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

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

Topics: Animals; Atherosclerosis; Biomarkers; Cardiovascular Agents; Diabetes Complications; Dyslipidemias; Early Diagnosis; Fibrinolytic Agents; Global Health; Health Behavior; Health Care Costs; Homocysteine; Humans; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Hyperhomocysteinemia; Hypertension; Magnetic Resonance Imaging; Medication Adherence; Plaque, Atherosclerotic; Risk Factors; Risk Reduction Behavior; Stents; Thrombosis; United States

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

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

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

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

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

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

IGF-1 (insulin-like growth factor-1) plays a unique role in the cell protection of multiple systems, where its fine-tuned signal transduction helps to preserve tissues from hypoxia, ischaemia and oxidative stress, thus mediating functional homoeostatic adjustments. In contrast, its deprivation results in apoptosis and dysfunction. Many prospective epidemiological surveys have associated low IGF-1 levels with late mortality, MI (myocardial infarction), HF (heart failure) and diabetes. Interventional studies suggest that IGF-1 has anti-atherogenic actions, owing to its multifaceted impact on cardiovascular risk factors and diseases. The metabolic ability of IGF-1 in coupling vasodilation with improved function plays a key role in these actions. The endothelial-protective, anti-platelet and anti-thrombotic activities of IGF-1 exert critical effects in preventing both vascular damage and mechanisms that lead to unstable coronary plaques and syndromes. The pro-survival and anti-inflammatory short-term properties of IGF-1 appear to reduce infarct size and improve LV (left ventricular) remodelling after MI. An immune-modulatory ability, which is able to suppress 'friendly fire' and autoreactivity, is a proposed important additional mechanism explaining the anti-thrombotic and anti-remodelling activities of IGF-1. The concern of cancer risk raised by long-term therapy with IGF-1, however, deserves further study. In the present review, we discuss the large body of published evidence and review data on rhIGF-1 (recombinant human IGF-1) administration in cardiovascular disease and diabetes, with a focus on dosage and safety issues. Perhaps the time has come for the regenerative properties of IGF-1 to be assessed as a new pharmacological tool in cardiovascular medicine.

Topics: Animals; Atherosclerosis; Cardiovascular Agents; Cardiovascular Diseases; Diabetes Mellitus; Humans; Insulin-Like Growth Factor I; Mice; Recombinant Proteins; Thrombosis

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

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

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

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

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

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

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

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

Although preventive pharmacological therapies effectually reduce the risk of cardiovascular events, acute coronary syndrome (ACS) remains a leading cause of morbidity and mortality in our country, Japan. Disruption of atherosclerotic vulnerable plaques and flow-limiting thrombus formation in non-stent segments of native coronary arteries are considered a main mechanism of ACS. In addition, stent thrombosis originating from implanted metallic coronary stents, so-called vulnerable stents, occasionally appears as ACS in the clinical settings. Coronary angioscopy is a unique imaging modality permitting direct visualization of luminal structures, such as atherosclerotic plaque, thrombus, stent struts, and proliferating neointima. On the basis of accumulated angioscopic findings, intense yellow plaques and stents without neointimal coverage are considered vulnerable plaques and vulnerable stents, respectively. In contrast, morphological disappearance of vulnerable plaques or vulnerable stents by pharmacological and trans-catheter therapies imply stabilization of the plaques or stents. Hence, angioscopic assessment for vulnerability (or stability) of atherosclerotic plaques and implanted stents might be useful for risk classification in the future events of ACS. To evaluate serial changes of coronary lumen after pharmacological and catheter interventions using angioscopy might also provide important information on potential benefits and surrogate endpoints of the therapies and on patients' management.

Topics: Acute Coronary Syndrome; Angioplasty, Balloon, Coronary; Angioscopy; Animals; Cardiovascular Agents; Coronary Artery Disease; Drug-Eluting Stents; Humans; Metals; Predictive Value of Tests; Prosthesis Design; Risk Assessment; Stents; Thrombosis; Time Factors; Treatment Outcome

Inflammation drives the formation, progression, and rupture of atherosclerotic plaques. Experimental studies have demonstrated that an inflammatory subset of monocytes/macrophages preferentially accumulate in atherosclerotic plaque and produce proinflammatory cytokines. T lymphocytes can contribute to inflammatory processes that promote thrombosis by stimulating production of collagen-degrading proteinases and the potent procoagulant tissue factor. Recent data link obesity, inflammation, and modifiers of atherosclerotic events, a nexus of growing clinical concern given the worldwide increase in the prevalence of obesity. Modulators of inflammation derived from visceral adipose tissue evoke production of acute phase reactants in the liver, implicated in thrombogenesis and clot stability. Additionally, C-reactive protein levels rise with increasing levels of visceral adipose tissue. Adipose tissue in obese mice contains increased numbers of macrophages and T lymphocytes, increased T lymphocyte activation, and increased interferon-gamma (IFN-gamma) expression. IFN-gamma deficiency in mice reduces production of inflammatory cytokines and inflammatory cell accumulation in adipose tissue. Another series of in vitro and in vivo mouse experiments affirmed that adiponectin, an adipocytokine, the plasma levels of which drop with obesity, acts as an endogenous antiinflammatory modulator of both innate and adaptive immunity in atherogenesis. Thus, accumulating experimental evidence supports a key role for inflammation as a link between risk factors for atherosclerosis and the biology that underlies the complications of this disease. The recent JUPITER trial supports the clinical utility of an assessment of inflammatory status in guiding intervention to limit cardiovascular events. Inflammation is thus moving from a theoretical concept to a tool that provides practical clinical utility in risk assessment and targeting of therapy.

Topics: Adaptive Immunity; Adiponectin; Adipose Tissue; Animals; Anti-Inflammatory Agents; Atherosclerosis; Cardiovascular Agents; Cardiovascular Diseases; Humans; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Immunity, Innate; Inflammation; Inflammation Mediators; Monocytes; Obesity; Risk Factors; Signal Transduction; Thrombosis; Translational Research, Biomedical

More than 1 in 1,000 patients in the U.S. has end-stage renal disease, and most patients who require renal-replacement therapy undergo hemodialysis. By the year 2020, more than 750,000 patients are expected to have end-stage renal disease, and over 500,000 will require hemodialysis. The greatest limitation of hemodialysis is the finite durability of hemodialysis accesses, which on average remain patent for <3 years but are the lifeline for hemodialysis patients. Catheter-based interventions are successful in restoring flow in more than 80% of hemodialysis accesses that undergo thrombosis and have replaced surgical revision as the treatment of choice for failing or thrombosed accesses. Catheter-based interventions have improved the quality of life for hemodialysis patients by reducing the need for temporary hemodialysis catheters and have prolonged total survival time by preserving existing access sites and by saving venous segments for future access creation. This review discusses the pathophysiology of dialysis access failure, presents the success rates of catheter-based treatments, and illustrates the interventional approaches for treating failing and thrombosed fistulas and grafts.

Topics: Angioplasty, Balloon; Arteriovenous Shunt, Surgical; Blood Vessel Prosthesis Implantation; Cardiovascular Agents; Graft Occlusion, Vascular; Humans; Kidney Failure, Chronic; Phlebography; Quality of Life; Radiography, Interventional; Renal Dialysis; Thrombectomy; Thrombosis; Time Factors; Treatment Outcome; Upper Extremity; Vascular Patency

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

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

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

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

Drug-eluting stents are considered to be superior to bare-metal stents in reducing restenosis rates at 6 months. However, drug-eluting stents appear to be subject to stent thrombosis, a concern that has been reported more frequently in recent times. In November 2003, a 64-year-old man with a medical history of hypertension, type 2 diabetes mellitus, and coronary artery disease underwent percutaneous coronary intervention for the deployment of a sirolimus-eluting stent in the left anterior descending coronary artery. He experienced no complications. More than 4 years later, at age 69, he underwent neurosurgical treatment for a subdural hematoma that resulted from a fall, and he was advised to stop taking aspirin and clopidogrel. Thirty-three days later--1,659 days after stent deployment--he presented with a clinical event that was associated with very late stent thrombosis. After undergoing emergent coronary angiography and the placement of 2 bare-metal stents, he resumed antiplatelet therapy, recovered uneventfully, and was discharged from the hospital in stable condition. To the best of our knowledge, 1,659 days is the longest reported interval between the deployment of a drug-eluting stent and the occurrence of a clinical event that was associated with very late stent thrombosis. Herein, we discuss the case of our patient, review the pertinent medical literature, reinforce the importance of continuous and uninterrupted antiplatelet therapy in drug-eluting stent recipients, and offer considerations regarding the use of drug-eluting stents.

Topics: Angioplasty, Balloon, Coronary; Aspirin; Cardiovascular Agents; Clopidogrel; Coronary Angiography; Drug Administration Schedule; Drug-Eluting Stents; Electrocardiography; Humans; Male; Middle Aged; Neurosurgical Procedures; Platelet Aggregation Inhibitors; Risk Assessment; Risk Factors; Sirolimus; Thrombosis; Ticlopidine; Time Factors; Treatment Outcome

Atherosclerosis and its clinical manifestations (i.e. myocardial infarction, stroke) are major causes of mortality and morbidity in Western countries. Endothelial dysfunction is considered the first step in the cascade leading up to coronary events. Increasing evidence suggests that direct inhibition of thromboxane A2/prostaglandin (TP)-receptors may not only have anti-platelet effects but also impact endothelial dysfunction as well as inflammatory component of atherosclerosis. While TP-receptor involvement in platelet function has received the greatest attention, more recent findings support the critical role of TP-receptor in other pathophysiological aspects of atherothrombosis. Prostanoids (i.e. TxA2, F2-isoprostanes, prostaglandins endoperoxides PGG2/PGH2) are known to promote the initiation and progression of atherosclerosis, not only via platelet activation, but through leukocyte-endothelial interactions and vasoconstriction. Dysfunctional endothelium, characterised by increased COX-activity, releases prostanoids that promote endothelial exposure to adhesion molecules and induce smooth muscle cell contraction. Plaque macrophages synthesise PGH2/PGG2 via COX-2; these potent prostanoids can trigger platelet activation and aggregation despite COX-1 inhibition by aspirin. TP-receptor inhibition has been reported to exert anti-atherosclerotic effects in pre-clinical model of disease. Reduction of plaque burden was associated with plaque stabilisation documented by the reduction in the content of macrophages, apoptotic cells, MMPs and endothelin-1, and the increase in smooth muscle cells content. TP-receptor blockade might have an anti-atherosclerotic and plaque stabilisation effect. The possibility of combining anti-platelet activity with an anti-atherosclerotic effect via selective TP-receptor inhibitors could have important implications especially in clinical conditions associated with increased production of prostanoids, such as diabetes.

Topics: Animals; Atherosclerosis; Cardiovascular Agents; Endothelial Cells; Humans; Muscle, Smooth, Vascular; Platelet Aggregation Inhibitors; Receptors, Prostaglandin; Receptors, Thromboxane A2, Prostaglandin H2; Signal Transduction; Thrombosis

First generation drug-eluting stents (DES) have significantly improved the treatment options for patients with symptomatic coronary artery disease by decreasing rates of acute vessel closure and restenosis after percutaneous coronary revascularization procedures. However, early enthusiasm was temperd by reports of late stent thrombosis (LST), which raised concerns about safety. Since millions of DES have been implanted in patients worldwide, it is imperative to understand the pathology of DES in man. Autopsy studies from the CVPath DES registry documented that delayed arterial healing is accompanied by poor endothelialization of stent struts which is the single best predictor of late stent thrombosis. Arterial healing of DES is highly heterogeneous and is dependent on underlying plaque morphology as well as on the stent location. We identified several anatomical and pathological changes in man, which were associated with LST; these include hypersensitivity reaction to polymer, plaque rupture, bifurcation sites, malapposition and stent fracture. DES was also associated with premature atherosclerotic changes versus BMS.

Topics: Cardiovascular Agents; Humans; Stents; Thrombosis

Since the first clinical angioplasty by Gruntzig in 1977, restenosis has been the primary drawback of percutaneous coronary intervention (PCI). In the balloon era. restenosis was correlated with elastic recoil and negative remodeling of the arterial wall. Later, introduction of stents proved to be a significant advance in reducing the elastic recoil and negative remodeling at the treatment site but stimulated proliferation, migration of smooth muscle cells, and neointimal hyperplasia, thereby generating a new type of restenosis, in-stent restenosis. Brachytherapy and drug-eluting stents (DES) may be considered the two breakthroughs against neointimal hyperplasia. However, concerns about stent thrombosis and incomplete elimination of in-stent restenosis with DES in complex lesions and patients justify the pursuit of research in this field. Non-stent based local drug delivery and particularly the use of paclitaxel-eluting balloons could be one of these strategies. We aimed to review the concept, preclinical-, and clinical data available with non-stent based local drug delivery and, in particular, with paclitaxel-eluting balloons.

Topics: Angioplasty, Balloon, Coronary; Animals; Cardiovascular Agents; Coronary Restenosis; Coronary Stenosis; Drug-Eluting Stents; Equipment Design; Humans; Hyperplasia; Paclitaxel; Prosthesis Design; Thrombosis; Treatment Outcome

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

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

The advent of drug-eluting stents (DES) has revolutionized the field of interventional cardiology. Their dramatic and persistent restenotic and target lesion revascularization advantages are unquestioned. However, concerns over the rare but potentially catastrophic risk of stent thrombosis (ST) have tempered universal acceptance of these devices. Although the precise mechanism of DES ST is undoubtedly multifactorial and as yet not fully elucidated, delayed or incomplete endothelial healing clearly plays a pivotal role. Detailed histopathological data have implicated a contributory allergic or hypersensitivity component, as verified by the Food and Drug Administration's Manufacturer and User Device Experience Center and the Research on Adverse Drug/device events And Reports (RADAR) project. These findings thus suggest a potential connection with the Kounis syndrome, the concurrence of acute coronary events with allergic, hypersensitivity, anaphylactic, or anaphylactoid reactions. Potential culprits responsible for this phenomenon include: arachidonic acid metabolites such as leukotrienes and thromboxane, proteolytic enzymes such as chymase and tryptase, histamine, cytokines, and chemokines. Additionally, inflammatory cells such as macrophages, T-lymphocytes, and mast cells are probably also contributory. Autopsy-confirmed infiltrates of various inflammatory cells including lymphocytes, plasma cells, macrophages, and eosinophils have been reported in all 3 vascular wall layers and are reminiscent of those associated with the Kounis syndrome. Although the concurrence of acute coronary syndromes with hypersensitivity reactions has been long established, the specific association with DES ST remains unproven. Potential incorporation of hypersensitivity suppressive agents might represent a promising paradigm shift from efficacy to safety in future DES designs.

Topics: Acute Coronary Syndrome; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Artery Disease; Drug Hypersensitivity; Drug-Eluting Stents; Humans; Hypersensitivity; Metals; Practice Guidelines as Topic; Prosthesis Design; Risk Assessment; Risk Factors; Thrombosis; Treatment Failure

Coronary stenting is routinely utilized to treat symptomatic obstructive coronary artery disease. However, the efficacy of bare metal coronary stents has been historically limited by restenosis, which is primarily due to excessive neointima formation. Drug-eluting stents (DES) are composed of a stainless steel backbone encompassed by a polymer in which a variety of drugs that inhibit smooth muscle cell proliferation and excessive neointima formation are incorporated. DES have significantly reduced the incidence of restenosis but are also associated with a small (approximately 0.5% per year) but significant risk of late stent thrombosis. In that regard, estrogen-eluting stents have also undergone clinical evaluation in reducing restenosis with the additional potential benefit of enhancing reendothelialization of the stent surface to reduce stent thrombosis. Estrogen directly promotes vasodilatation, enhances endothelial healing, and prevents smooth muscle cell migration and proliferation. Due to these mechanisms, estrogen has been postulated to reduce neointimal hyperplasia without delaying endothelial healing. In animal studies, estrogen treatment was effective in decreasing neointimal hyperplasia after both balloon angioplasty and stenting regardless of the method of drug delivery. The first uncontrolled human study using estrogen-coated stents demonstrated acceptable efficacy in reducing late lumen loss. However, subsequent randomized clinical trials did not show superiority of estrogen-eluting stents over bare metal stents or DES. Further studies are required to determine optimal dose and method of estrogen delivery with coronary stenting and whether this approach will be a viable alternative to the current DES armamentarium.

Topics: Angioplasty, Balloon, Coronary; Animals; Cardiovascular Agents; Clinical Trials as Topic; Coronary Artery Disease; Coronary Restenosis; Drug-Eluting Stents; Estrogens; Evidence-Based Medicine; Humans; Prosthesis Design; Thrombosis; Time Factors; Treatment Outcome

Topics: Absorbable Implants; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Drug-Eluting Stents; Everolimus; Humans; Lactic Acid; Magnesium; Polycarboxylate Cement; Polyesters; Polymers; Prosthesis Design; Sirolimus; Stents; Thrombosis; Time Factors; Treatment Outcome

With the availability of new data and the recent release of new European and US guidelines, contemporary care paradigms for the treatment of patients with non-ST-elevation acute coronary syndromes (NSTE ACS), including those undergoing percutaneous coronary intervention, are likely to undergo substantial changes. In recognition of this shifting landscape as well as the impact of new guidelines on care models for the treatment of patients with NSTE ACS, a roundtable was convened on October 25, 2007, to discuss the implications of these changes. The purpose of this review is to summarize the presentations and subsequent discussions from the roundtable, which examined the guidelines and evidence from a variety of perspectives, and to explore the best ways to incorporate new treatment paradigms into everyday clinical care. The multiple viewpoints expressed by the roundtable attendees illustrate the recognition that at this point, consensus has not been reached on the optimum algorithm for treatment of these patients. This article focuses on issues discussed during the roundtable from the perspective of the practicing cardiologist.

Topics: Acute Coronary Syndrome; Algorithms; Angioplasty, Balloon, Coronary; Anticoagulants; Aspirin; Cardiovascular Agents; Clinical Trials as Topic; Clopidogrel; Emergency Treatment; Evidence-Based Medicine; Fibrinolytic Agents; Hirudins; Humans; Peptide Fragments; Piperazines; Platelet Aggregation Inhibitors; Platelet Glycoprotein GPIIb-IIIa Complex; Postoperative Hemorrhage; Practice Guidelines as Topic; Prasugrel Hydrochloride; Recombinant Proteins; Risk Assessment; Stents; Thiophenes; Thrombosis; Ticlopidine

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

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

Peripheral arterial disease (PAD) is strongly associated with atherosclerosis in the coronary and carotid arteries, leading to a highly increased incidence of myocardial infarction, ischaemic stroke and cardiovascular death. Fortunately, pharmacological interventions in large clinical trials have been as effective in subgroups of patients with PAD as in subjects with other atherosclerotic disease. Antiplatelet treatment is indicated in virtually all patients with PAD. Aspirin 75-325 mg day(-1) is considered as first-line treatment, and clopidogrel 75 mg day(-1) is an effective alternative. Statin therapy is indicated to achieve a target low-density lipoprotein cholesterol level of < or = 2.5 mmol L(-1) in patients with PAD and there is emerging evidence that even lower levels are beneficial. Lowering of plasma homocysteine by supplementing folic acid, vitamin B(12) and vitamin B(6) is not recommended in patients with mild to moderate hyperhomocysteinaemia in the 12-25 micromol L(-1) range, since it does not reduce the incidence of cardiovascular events. Antihypertensive treatment is indicated to achieve a goal blood pressure of < or = 140/90 mmHg or < or = 130/80 mmHg in the presence of diabetes or chronic kidney disease. All classes of antihypertensive drugs are acceptable for treatment of hypertension in patients with PAD, but angiotensin-converting enzyme inhibitors ramipril or perindopril are especially appropriate because they reduce the incidence of cardiovascular events beyond their blood pressure-lowering effects. Beta-blockers should not be used as first-line antihypertensive treatment. Diabetic patients with PAD should reduce their glycosylated haemoglobin to < or = 7%. In conclusion, pharmacological secondary prevention of cardiovascular morbidity and mortality in patients with PAD should be as comprehensive as that in patients with established coronary or cerebrovascular disease.

Topics: Antihypertensive Agents; Aspirin; Cardiovascular Agents; Diabetic Angiopathies; Humans; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Hypercholesterolemia; Hyperhomocysteinemia; Hypertension; Peripheral Vascular Diseases; Platelet Aggregation Inhibitors; Risk Factors; Thrombosis

The excitement of drug-eluting stents and their promise for reduced restenosis rates have been tempered by recent reports of stent thrombosis. The mechanism of stent thrombosis is multifactorial but appears to be related to delayed endothelialization and healing, late stent malapposition, and antiplatelet resistance. The most important risk factor appears to be the discontinuation of dual antiplatelet therapy. The data from clinical trials suggest that drug-eluting stents are associated with increased incidence of death or myocardial infarction compared with bare metal stents at long-term follow-up, suggesting that the window of thrombotic risk with drug-eluting stents may extend far beyond that for bare metal stents. Measures to possibly decrease the incidence of stent thrombosis include improvements in antiplatelet regimens and newer generation of drug-eluting stents which have biodegradable polymers or are polymer-free. In addition, percutaneous coronary intervention with bare metal stents in patients may be helpful in those known to be intolerant or noncompliant to antiplatelet therapy, have planned procedures or surgeries, or have overwhelming risks which may require discontinuation of dual antiplatelet therapy.

Topics: Angioplasty, Balloon, Coronary; Cardiovascular Agents; Clinical Trials as Topic; Drug Administration Schedule; Humans; Incidence; Metals; Paclitaxel; Platelet Aggregation Inhibitors; Prosthesis Design; Research Design; Risk Assessment; Risk Factors; Sirolimus; Stents; Thrombosis; Time Factors

Caveolae are 50-100 nm cell surface plasma membrane invaginations that are highly enriched in cholesterol and sphingolipids and are characterized by the protein marker caveolin-1. Caveolin-1 is highly expressed in terminally differentiated cells. Among these cells, endothelial cells, smooth muscle cells, and macrophages have all been shown to play key roles in the development of vascular disease. Atherosclerosis and neointimal formation are two major processes that have been associated with arterial occlusion. In both cases, caveolin-1 has been shown to play an important role. However, depending on the cell type and the metabolic pathways regulated by this protein, caveolin-1 may positively or negatively influence the development of vascular disease. Both of these aspects will be discussed in this review.

Topics: Animals; Arteries; Atherosclerosis; Cardiovascular Agents; Caveolae; Caveolin 1; Endothelium, Vascular; Humans; Macrophages; Mice; Mice, Knockout; Muscle, Smooth, Vascular; Thrombosis

Anti-oxidised low-density lipoprotein (anti-oxLDL) antibodies are a heterogeneous group of autoantibodies including both pathogenic and protective subsets. Whereas in most studies the levels of anti-oxLDL antibodies were associated with enhanced atherosclerosis as evaluated by different methods, immunization with oxLDL leads to elevated levels of anti-oxLDL and protection against atherosclerosis. Anti-oxLDL can also be used for immunomodulation of atherosclerosis (i.e. possible therapeutic use of intravenous immunoglobulin, oral tolerance). More specific autoantibodies out of total anti-oxLDL should be selected, for instance, anti-oxLDL/beta-2-glycoprotein I complex, hence defining the fine-tuning of anti-oxLDL antibodies might detect which autoantibodies are pathogenic and which can be used therapeutically.

Topics: Animals; Atherosclerosis; Autoantibodies; Cardiovascular Agents; Epitope Mapping; Humans; Immune Tolerance; Immunoglobulins, Intravenous; Immunotherapy; Lipoproteins, LDL; Thrombosis

Thrombin converts fibrinogen to fibrin and is the most powerful activator of platelets thus playing a crucial role in arterial and venous thrombosis. The limitations of heparin, largely used in the therapy of arterial and venous thromboembolism, has prompted the development of new antithrombotic drugs, able to directly inhibit thrombin. They comprise hirudin, bivalirudin and argatroban, which are antithrombins for parenteral use, and the orally active ximelagatran which, once absorbed, is converted to the active compound melagatran. Hirudin is a polypeptide able to irreversibly block both the active site and the fibrin(ogen) binding site of thrombin; bivalirudin, a synthetic hirudin derivative, has the same binding sites of hirudin to thrombin but has a shorter pharmacological action and is safer for clinical use. Several clinical trials which tested these drugs in acute coronary syndromes, coronary angioplasty and venous thromboembolism. demonstrate that hirudin and bivalirudin are superior to heparin in significantly reducing cardiac major events. The advantage of hirudin and bivalirudin over heparin was also confirmed in adjuncts to thrombolytic therapy as well as in percutaneous angioplasty relating to thrombotic events but not to restenosis. Hirudin was also significantly better than both unfractionated heparin and low molecular weight heparin (LMWH) in the prophylaxis of venous thromboembolism in patients undergoing elective arthroplasty. Major bleeding associated to hirudin was not different from that observed with heparin. Preliminary data also indicate that melagatran/ximelagatran may be used in the prophylaxis of venous thromboembolism and in the prevention of arterial embolism in patients with non-valvular atrial fibrillation.

Topics: Antithrombins; Cardiovascular Agents; Clinical Trials as Topic; Heparin; Hirudin Therapy; Humans; Thrombin; Thrombosis

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

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

Anticoagulants and antithrombotic drugs have played a key role in the prophylaxis, treatment and surgica/interventional management of thrombotic and cardiovascular disorders. There are several newer drugs which are currently developed for the anticoagulant management of cardiovascular diseases in both the medical and surgical indications. These include the low molecular weight heparins (LMWHs), antithrombin agents such as the Hirudin, Hirulog and Argatroban and indirect and direct anti-Xa drugs, represented by Pentasaccharide (Arixtra) and DX 9065a, respectively. Several other agents such as the natural and recombinant anti-Xa drugs and anti-tissue factor agents are also developed. The antiplatelet agents include Clopidogrel, Cilostazol, Anplag and GP IIb/IIIa inhibitors. For the subcutaneous indications, unfractionated heparin is gradually replaced by the low molecular weight heparins (LMWHs). LMWHs such as the Enoxaparin and Dalteparin are commonly used for the management of acute coronary syndrome. These drugs have been approved for the treatment of unstable angina and are currently undergoing rigorous trials for interventional indications. Arixtra is also developed for various subcutaneous indications. However, it exhibits lower anticoagulant effects and may not be optimal for intravenous and interventional purposes. At a higher dosage when administered intravenously the LMWHs produce varying degrees of anticoagulation at relatively lower activated clotting times (150-200). Several studies in vascular and cardiovascular interventions have shown that even at a relatively lower anticoagulant level the LMWHs are as effective as unfractionated heparin at the recommended dosages which produce a relatively higher level of anticoagulation (ACT > 200 secs.). Thus, these agents are currently developed for interventional and surgical indications. It should be emphasized that different LMWHs produce different degrees of anticoagulation and should therefore be individually optimized for a given interventional or surgical purposes. At a relatively high dosage the levels of LMWHs can be measured by using the ACT and APTT. When administered with such GP IIb/IIIa inhibitors as the Abciximab, Aggrastat or Eptifibratide, these drugs may require dosage adjustment However, since the introduction of the front loading of Clopidogrel, the unqualified use of GP IIb/IIIa is debated. LMWHs will find expanded indications in both the medical and surgical management of patients w

Topics: Anticoagulants; Cardiovascular Agents; Cardiovascular Diseases; Clinical Trials as Topic; Factor Xa Inhibitors; Fibrinolytic Agents; Forecasting; Heparin, Low-Molecular-Weight; Humans; Platelet Aggregation Inhibitors; Thrombin; Thrombosis

Drugs with the efficacy of modifying rheological properties of blood, blood vessels and their interactions are denoted by "hemorheologicals". Drugs of anti-hyperviscosemia, anti-coagulants, anti-platelet drugs, anti-thrombotics, vasodilators, endothelial cell protectors and anti-arthrosclerosis should be considered as hemorheologicals due to the actions in keeping blood fluidity and in maintaining normal vascular functions. The studies in hemorheology indicate that a tendency of hyperviscosity, hypercoagulation and being prone to thrombosis is prevalent in the elderly. Hemorheologicals are importance for and aging and life-threatening diseases. Blood stasis syndrome is a common pathological syndrome in the elderly. In traditional Chinese medicine, the treatment for the syndrome is by herbs which activates blood circulation to remove blood stasis. The herbs have the efficacy of improving hemorheological events. Therefore, the herbs are the source for developing hemorheologicals. Ligustrazine isolated from Chuangxiong is an example. It showed significant inhibition on shear induced platelet aggregation and on platelet intracellular calcium demonstrated by laser confocal microscope.

Topics: Aged; Animals; Anticoagulants; Blood Viscosity; Cardiovascular Agents; Coronary Disease; Drugs, Chinese Herbal; Fibrinolytic Agents; Hemodynamics; Hemorheology; Humans; Platelet Aggregation; Platelet Aggregation Inhibitors; Pyrazines; Rats; Rats, Wistar; Stroke; Thrombosis

Fibrinogen is a blood-borne glycoprotein comprised of three pairs of nonidentical polypeptide chains. Following vascular injury, fibrinogen is cleaved by thrombin to form fibrin which is the most abundant component of blood clots. As well as controlling blood loss at sites of tissue damage, other properties of fibrinogen have recently been discovered. For example, various cleavage products of fibrinogen and fibrin, released during coagulation and fibrinolysis, respectively, regulate cell adhesion and spreading, display vasoconstrictor and chemotactic activities, and are mitogens for several cell types including fibroblasts, endothelial and smooth muscle cells. Current research aims to define the bioactive fibrinogen molecule moieties and cellular receptors involved in these processes. Future studies may provide us with new opportunities to develop agents which are useful in promoting tissue repair or conversely in inhibiting fibrosis in inflammatory and fibroproliferative diseases where endothelial cell damage or chronic leakage of blood proteins is a feature.

Topics: Cardiovascular Agents; Cell Adhesion; Fibrinogen; Humans; Integrins; Mitogens; Models, Molecular; Platelet Glycoprotein GPIIb-IIIa Complex; Protein Conformation; Thrombosis

Topics: Cardiovascular Agents; Clinical Trials as Topic; Fatty Acids, Omega-3; Female; Humans; Male; Recurrence; Thrombosis; Vascular Diseases

The strategy of primary prevention of coronary heart disease (CHD) needs reconsideration. Recent results of trials of reducing the risk of CHD in those at moderate risk have been inconclusive and disappointing. More may be expected from intervention in those at high risk, and a selective policy is advocated. But, in those at high risk, it is usually necessary to give drugs in order to reduce the risk from hypertension and hypercholesterolaemia. Many currently used and popular drugs have never been submitted to rigourous long-term testing of their safety, although it was only through formal clinical trials that the adverse effects of clofibrate and of thiazides were identified. More, not fewer, clinical trials are needed if we are to avoid new tragedies. A plea is made for the urgent establishment of drug data banks to permit accurate monitoring of changes in the incidence of commonly occurring diseases in relation to the increasing use of drugs for primary prevention of vascular diseases and for social convenience.

Topics: Adrenergic beta-Antagonists; Cardiovascular Agents; Cerebrovascular Disorders; Cholesterol; Clofibrate; Coronary Disease; Diuretics; Humans; Hypertension; Information Systems; Lipids; Risk; Thrombosis

To investigate clinical outcomes of percutaneous coronary intervention using a sirolimus-eluting stent with bioresorbable polymer, Ultimaster (BP-SES) compared with a permanent polymer everolimus-eluting stent, Xience (PP-EES) in patients with high risk (ST-segment elevation and non-ST-segment elevation myocardial infarction) acute coronary syndromes (ACS) enrolled in the CENTURY II trial.. CENTURY II is a prospective, multicenter, randomized, single blind, controlled trial comparing BP-SES and PP-EES, with primary endpoint of target lesion failure (TLF) at 9month post-stent implantation. Out of 1123 patients enrolled in CENTURY II trial, 264 high risk ACS patients were included in this subgroup analysis, and the clinical outcomes including target lesion failure (TLF), target vessel failure (TVF), cardiac death, myocardial infarction, and stent thrombosis were evaluated at 24months.. The baseline clinical, angiographic and procedural characteristics were similar between two groups. At 24months, TLF occurred in 6.3% of patients receiving a BP-SES and 6.5% of patients receiving a PP-EES (P=0.95); TVF was 6.3% in patients receiving a BP-SES and 9.4% in patients receiving a PP-EES (P=0.36). There were no significant differences in cardiac death, myocardial infarction and stent thrombosis rate.. BP-SES achieved similar safety and efficacy outcomes as PP-EES in this ACS subgroup of CENTURY II study, at 24-month follow-up. This finding is hypothesis-generating and needs to be confirmed in larger trials with longer follow-up.

Topics: Absorbable Implants; Acute Coronary Syndrome; Aged; Cardiovascular Agents; Coronary Angiography; Coronary Restenosis; Drug-Eluting Stents; Europe; Everolimus; Female; Humans; Japan; Kaplan-Meier Estimate; Male; Middle Aged; Non-ST Elevated Myocardial Infarction; Percutaneous Coronary Intervention; Polymers; Prospective Studies; Prosthesis Design; Recurrence; Republic of Korea; Risk Factors; Single-Blind Method; ST Elevation Myocardial Infarction; Thrombosis; Time Factors; Treatment Outcome

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

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

The aim of the present paper was to make a report of the 12-month clinical outcomes of the DEBELLUM (Drug-Eluting-Balloon-Evaluation-for-Lower-Limb- mUltilevel-treatMent) randomized trial.. From September 2010 to March 2011, 50 patients were randomized between drug eluting balloon (DEB, N.=25) and conventional angioplasty balloon (PTA, N.=25). Patients were symptomatic for claudication and critical limb ischemia, with de novo stenosis or occlusion in the femoropopliteal (SFA) and infrapopliteal (BTK) region. Only in the SFA primary stenting was allowed and postdilatation performed with DEB or PTA depending on the assigned group.. One hundred and twenty-two lesions were treated: 92 (75.4%) SFA, 30 (24.6%) BTK. Twenty (40%) patients presented multilevel concomitant femoropopliteal and infra-popliteal lesions. Late lumen loss (LLL) was 0.64±0.9 mm in DEB group vs. 1.81±0.1 mm in the control group (P=0.01). In non-stented segment LLL was 0.63±0.9 mm (DEB) vs. 1.70±0.6 mm (PTA), P<0.01. In the stent subgroup was LLL 0.65±0.2 mm (DEB) vs. 1.91±0.3 mm (PTA), P<0.01. In the femoropopliteal region the overall LLL was 0.61±0.8 mm for DEB vs. 1.84±0.3 mm for PTA (P=0.02). BTK the overall LLL was 0.66±0.9 mm (DEB) vs. 1.69±0.5 mm (PTA) (P=0.03). The overall TLR was 12.2% for DEB and 35.3% for PTA (P<0.05). Amputation rate was 4% (DEB) vs. 12% (PTA), P=0.36. Thrombosis was 4% (DEB) vs. 8% (PTA), P≥0.05. Major adverse events 24% (DEB) vs. 60% (PTA), P<0.05. ABI improved more in the DEB group: 0.81±0.3 vs. 0.68±0.13 (P=0.02). Fontaine stage increased (from II b to I) 80% DEB vs. 56% PTA (P<0.05).. Results confirm and reinforce initial 6-month outcomes. In.Pact DEB balloons can be considered efficient to reduce restenosis rate.

Topics: Aged; Aged, 80 and over; Amputation, Surgical; Angioplasty, Balloon; Ankle Brachial Index; Cardiovascular Agents; Critical Illness; Drug Carriers; Equipment Design; Female; Femoral Artery; Hemodynamics; Humans; Intermittent Claudication; Ischemia; Kaplan-Meier Estimate; Limb Salvage; Lower Extremity; Male; Middle Aged; Peripheral Arterial Disease; Popliteal Artery; Risk Factors; Rome; Thrombosis; Time Factors; Treatment Outcome; Vascular Access Devices; Vascular Patency

The use of a drug-eluting balloon for the treatment of de novo coronary artery lesions remains to be evaluated. A previous trial in patients with stable and unstable angina comparing a bare metal stent mounted on a drug-eluting balloon with a sirolimus-eluting stent failed to meet the prespecified non-inferiority criteria versus the sirolimus-eluting stent. The stent struts of a bare metal stent pre-mounted on a drug-eluting balloon may prevent the appropriate delivery of drugs to the vessel wall and may result in reduced efficacy. In the present study we will therefore evaluate the efficacy of a drug-eluting balloon for treating de novo coronary artery lesions using a strategy designed to uniformly deliver drug to the vessel with a bare metal stent.. The Comparison of Drug-Eluting Balloon first study is a prospective, randomized, open-label trial designed to demonstrate the non-inferiority of first using a drug-eluting balloon (Sequent please; B. Braun, Melsungen, Germany) followed by a bare metal stent (Coroflex Blue; B. Braun) compared with using a drug-eluting stent (Resolute Integrity; Boston Scientific, Natick, MA, USA) for de novo coronary artery lesions. The primary endpoint of the study is in-segment late loss at 9 months measured by quantitative coronary angiography. Secondary endpoints include angiographic findings such as angiographic success, device success, binary angiographic restenosis, and clinical outcomes such as procedural success, all-cause death, myocardial infarction, target vessel revascularization, target lesion revascularization, and stent thrombosis. A total of 180 patients will be enrolled in the study.. The Comparison of Drug-Eluting Balloon first study will evaluate the clinical efficacy, angiographic outcomes and safety of a drug-eluting balloon first followed by a bare metal stent compared with a drug-eluting stent for the treatment of de novo coronary artery lesions.. Clinical Trials.gov: NCT01539603.

Topics: Angioplasty, Balloon, Coronary; Cardiovascular Agents; Clinical Protocols; Coronary Angiography; Coronary Artery Disease; Coronary Restenosis; Drug-Eluting Stents; Humans; Metals; Myocardial Infarction; Prospective Studies; Prosthesis Design; Republic of Korea; Research Design; Stents; Thrombosis; Time Factors; Treatment Outcome; Ultrasonography, Interventional

Limited data are available regarding the direct comparison of angiographic and clinical outcomes after percutaneous coronary intervention (PCI) with drug-eluting stents (DESs) for chronic total occlusion (CTO).. A prospective, randomized, multicenter trial was conducted to evaluate the non-inferiority of a zotarolimus-eluting stent (ZES; Endeavor Sprint®, n=80) to a sirolimus-eluting stent (SES; Cypher®, n=80) in patients with CTO lesion with a reference vessel diameter ≥ 2.5mm. The primary endpoint was in-segment binary restenosis rate at 9-month angiographic follow-up. Key secondary endpoints included target vessel failure (TVF; including cardiac death, myocardial infarction, and target vessel revascularization) and Academic Research Consortium-defined definite/probable stent thrombosis (ST) within 12 months. The ZES was non-inferior to the SES with respect to the primary endpoint, which occurred in 14.1% (95% confidence interval [CI]: 6.0-22.2) and in 13.7% (95%CI: 5.8-21.6) of patients, respectively (non-inferiority margin, 15.0%; P for non-inferiority <0.001). There were no significant between-group differences in the rate of TVF (10.0% vs. 17.5%; P=0.168) nor in the rate of ST (0.0% vs. 1.3%; P=0.316) during the 12-month clinical follow-up.. The effectiveness and safety of ZES are similar to those of SES and therefore it is a good treatment option in patients undergoing PCI for CTO with DESs.

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Chronic Disease; Coronary Angiography; Coronary Occlusion; Coronary Restenosis; Drug-Eluting Stents; Female; Humans; Male; Middle Aged; Myocardial Infarction; Prospective Studies; Prosthesis Design; Republic of Korea; Sirolimus; Thrombosis; Time Factors; Treatment Outcome; Ultrasonography, Interventional

 More widespread use of drug-eluting stents (DES) to treat coronary heart disease (CHD) has recently generated more attention to thrombosis, which was relative to the polymer. Polymer-free and biodegradable polymer-based stents are more frequently studied, but their efficacy on preventing detrimental clinical events is unclear.. To assess whether polymer-free paclitaxel-eluting stent (YINYI stent) was noninferior or equivalent to biodegradable polymer-based rapamycin-eluting stents (EXCEL stent) in preventing detrimental clinical cardiovascular events, a total of 167 consecutive CHD patients requiring DES implantation were randomly divided into the YINYI group (n = 82) and the EXCEL group (n = 85). The primary end-point was major adverse cardiac events (MACE). The secondary end-points included stent thrombosis events, all-cause mortality, and rehospitalization. The study was designed to test the noninferiority or equivalence of the YINYI stent compared with the EXCEL stent with respect to one-year MACE according to a noninferiority or equivalence margin of 0.1. One-year MACE was 6.10% in the YINYI group versus 5.88% in the EXCEL group. The lower limit of the one-sided 95% confidence interval was -0.0582 (P = 0.002 from the test for noninferiority). The 95% confidence interval for the equivalence test was [-0.0698, 0.0742] (P1 =0.004 and P2 =0.007 from 2 times the 1-sided test for equivalence). There was no statistically significant difference in thrombosis events, all-cause death, and rehospitalization (all P > 0.05).. In this small randomized trial, polymer-free paclitaxel-eluting stents appear to be noninferior or equivalent to biodegradable polymer-based rapamycin-eluting stents.

Topics: Absorbable Implants; Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Artery Disease; Drug-Eluting Stents; Female; Humans; Male; Middle Aged; Paclitaxel; Patient Readmission; Polymers; Sirolimus; Thrombosis

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

The impact of age on outcomes following everolimus-eluting stent (EES) or paclitaxel-eluting stent (PES) implantation was evaluated in a patient-level pooled analysis of the SPIRIT III (n=1,002) and SPIRIT IV (n=3,687) trials.. Clinical outcomes with EES compared to PES in elderly (≥ 65 years, n=2,071) and younger (<65 years, n=2,617) patients were evaluated at one year. At one year, elderly patients treated with EES rather than PES showed a significant reduction in target lesion failure (TLF) (3.9% EES vs. 6.8% PES, p=0.006), major adverse cardiac events (MACE) (4.0% EES vs. 7.1% PES, p=0.005), and ischaemia-driven target lesion revascularisation (ID-TLR) (2.0% EES vs. 4.0% PES, p=0.01). Younger patients treated with EES rather than PES also had significantly reduced one-year rates of TLF (4.9% EES vs. 7.9% PES, p=0.003), MACE (5.0% EES vs. 8.0% PES, p=0.004), target vessel myocardial infarction (MI) (2.0% EES vs. 3.4% PES, p=0.04), ID-TLR (3.3% EES vs. 5.5% PES, p=0.01) and stent thrombosis (0.5% EES vs. 1.6% PES, p=0.01).. In a pooled analysis from the SPIRIT III and IV trials, EES was safer and more effective than PES in both younger and older cohorts as evidenced by lower rates of TLR, TLF and MACE.

Topics: Age Factors; Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Drug-Eluting Stents; Everolimus; Female; Humans; Kaplan-Meier Estimate; Logistic Models; Male; Middle Aged; Multivariate Analysis; Myocardial Infarction; Paclitaxel; Prospective Studies; Prosthesis Design; Risk Assessment; Risk Factors; Single-Blind Method; Sirolimus; Thrombosis; Time Factors; Treatment Outcome

The long-term clinical performance of drug-eluting stents (DES) coated with biodegradable polymers is poorly known.. A total of 274 coronary patients were randomly allocated to paclitaxel-eluting stents, sirolimus-eluting stents, or bare metal stents (2:2:1 ratio). The two DES used the same biodegradable polymers and were identical except for the drug. At three years, the pooled DES population had similar rates of cardiac death or myocardial infarction (9.0% vs. 7.1; p=0.6), but lower risk of repeat interventions (10.0% vs. 29.9%; p<0.01) than controls with bare stents. The cumulative 3-year incidence of definite or probable stent thrombosis in the pooled DES group was 2.3% (first year: 1.8%; second year: 0.4%; third year: zero). There were no significant differences in outcomes between paclitaxel- and sirolimus-eluting stents.. The biodegradable-polymer coated DES releasing either paclitaxel or sirolimus were effective in reducing the 3-year rate of re-interventions.

Topics: Absorbable Implants; Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Artery Disease; Drug-Eluting Stents; Female; Follow-Up Studies; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Myocardial Infarction; Paclitaxel; Polymers; Proportional Hazards Models; Prosthesis Design; Risk Assessment; Risk Factors; Sirolimus; Thrombosis; Time Factors; Treatment Outcome

This 2-year follow-up of the XIENCE V USA study examines both the long-term safety and effectiveness of the everolimus-eluting coronary stent system (EECSS) in real-world patients.. The safety and effectiveness of EECSS at 1 year in real-world clinical settings have been demonstrated in XIENCE V USA trial with low rates of target lesion revascularization (TLR), cardiac death, myocardial infarction (MI), and stent thrombosis (ST). Data on whether efficacy is maintained after 1 year and the event rate of very late stent thrombosis (VLST) between 1 and 2 years have not yet been reported.. XIENCE V USA is a prospective, multicenter, single-arm, FDA required condition of approval study designed to examine the safety and effectiveness of EECSS in an all-inclusive, consecutively enrolled population from real-world clinical settings. Clinical end-point events, including ST, cardiac death, MI, and revascularization were adjudicated by an independent Clinical Events Committee..  Four thousand eight hundred and seventy-three (96.4%) out of 5,054 participants (1,875 standard-risk; 3,059 extended-risk) reached 2-year follow-up. The 2-year rate of Academic Research Consortium (ARC)-defined definite and probable ST was 0.96% (95% CI 0.70-1.28) in the overall population and 0.34% (95% CI 0.12-0.74) and 1.33% (95% CI 0.95-1.81) in the standard-risk and extended-risk cohorts, respectively. The rate of VLST was 0.06% in the overall population, 0.0% in the standard-risk, and 0.10% in the extended-risk cohorts. The 2-year composite rate of cardiac death and ARC-defined MI was 8.9% (95% CI 8.08-9.70) in the overall population and 5.6% (95% CI 4.61-6.78) and 10.8% (95% CI 9.71-11.94) in the standard-risk and extended-risk cohorts, respectively.. Low event rates observed at 1 year were maintained through 2 years. Despite the increased number of patients who discontinued dual antiplatelet therapy by 2 years, the ST rate remained consistently low, and <1% at 2 years due to low VLST occurrence. These results demonstrate continued safety and effectiveness of the XIENCE V everolimus-eluting stent in a highly complex, real-world patient population through 2 years.

Topics: Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Artery Disease; Drug-Eluting Stents; Everolimus; Female; Humans; Male; Middle Aged; Myocardial Infarction; Prospective Studies; Sirolimus; Thrombosis; United States

To report 6-month results of the DEBELLUM (Drug-Eluting Balloon Evaluation for Lower Limb MUltilevel TreatMent) randomized trial to evaluate the efficacy of a drug-eluting balloon (DEB) to reduce restenosis after treatment of multilevel lower limb occlusive disease vs. a conventional angioplasty balloon (AB).. Between September 2010 and March 2011, 50 consecutive patients (37 men; mean age 66±4 years) with 122 lesions (96 stenoses and 26 occlusions) of the femoropopliteal (92, 75.4%) or below-the-knee (BTK) arteries (30, 24.6%) were enrolled and randomly assigned to the DEB (25 patients with 57 lesions) or AB (25 patients with 65 lesions) group. Twenty patients presented multilevel lesions. Mean lesion length was 7.5±3.5 cm. Thirty-one (62%) of the patients were Fontaine stage IIb, while 19 (38%) were stage III or IV. DEBs or ABs were used for dilation of de novo lesions or for postdilation after primary stenting (superficial femoral artery only). Patients requiring provisional stenting after angioplasty secondary to flow-limiting dissection or residual stenosis >50% were ineligible. Primary endpoint was late lumen loss at 6 months. Secondary endpoints were target lesion revascularization (TLR), amputation, and thrombosis.. Late lumen loss was lower in the DEB group (0.5±1.4 vs. 1.6±1.7 mm, p<0.01). TLR was necessary in 6.1% of the DEB group vs. 23.6% of the AB group (p=0.02). Comparing the DEB to AB groups, the thrombosis rates were 3.0% vs. 5.2% (p=0.6), and the amputation rates were 3.0% vs. 7.9% (p=0.36). The binary restenosis rates were 9.1% (3/33 limbs) in the DEB group vs. 28.9% (11/38 limbs) in the control group (p=0.03). The ankle-brachial index improved to a greater degree in the DEB group: 0.87±0.22 vs. 0.70±0.13 (p<0.05). The Fontaine stage improved in both groups but more so in patients treated with DEBs (p=0.04).. The DEBELLUM trial confirmed the ability of paclitaxel-eluting balloons to reduce restenosis vs. conventional balloons at 6 months after treatment of multilevel (femoropopliteal and BTK) arterial disease in patients affected by claudication and CLI. A lower TLR rate and better clinical outcomes appear to be associated with the use of DEBs regardless of stent placement.

Topics: Aged; Aged, 80 and over; Amputation, Surgical; Angioplasty, Balloon; Arterial Occlusive Diseases; Cardiovascular Agents; Constriction, Pathologic; Drug Carriers; Equipment Design; Female; Femoral Artery; Humans; Limb Salvage; Lower Extremity; Male; Middle Aged; Paclitaxel; Popliteal Artery; Prospective Studies; Radiography; Recurrence; Rome; Severity of Illness Index; Stents; Thrombosis; Time Factors; Treatment Outcome; Vascular Access Devices

This was designed to assess the outcomes of side branch (SB) stenosis after implantation of three drug-eluting stents (DES). From 2,645 patients in the ZEST (Comparison of the Efficacy and Safety of Zotarolimus-Eluting Stent with Sirolimus-Eluting and PacliTaxel-Eluting Stent for Coronary Lesions) Trial, 788 patients had 923 bifurcation lesions with SB ≥ 1.5 mm were included. SB was treated in 150 lesions, including 35 (3.8%) receiving SB stenting. Of untreated SB with baseline stenosis < 50%, the incidences of periprocedural SB compromise was similar in the zotarolimus (15.8%), sirolimus (17.2%), and paclitaxel (16.6%) stent groups (P = 0.92). At follow-up angiography, delayed SB compromise occurred in 13.9%, 3.2%, and 9.4% (P = 0.010) of these groups. When classified into four groups (< 50%, 50%-70%, 70%-99%, and 100%), 9.0% of untreated SB were worsened, whereas improvement and stationary were observed in 9.6% and 81.4%. In a multivariable logistic regression model, main branch (MB) stenosis at follow-up (%) was the only independent predictor of SB stenosis worsening (odds ratio, 1.03; 95% confidence interval, 1.01-1.04; P < 0.001). After MB stenting in bifurcation lesions, a minority of SB appears to worsen. DES with strong anti-restenotic efficacy may help maintain SB patency.

Topics: Acute Disease; Aged; Blood Vessels; Cardiovascular Agents; Coronary Angiography; Coronary Stenosis; Drug-Eluting Stents; Female; Follow-Up Studies; Humans; Logistic Models; Male; Middle Aged; Myocardial Infarction; Myocardial Revascularization; Odds Ratio; Paclitaxel; Predictive Value of Tests; Sirolimus; Thrombosis; Treatment Outcome

This report describes the 4-year clinical outcomes of the SPIRIT II study, which randomized 300 patients to treatment with the XIENCE V everolimus-eluting stent (EES), or the TAXUS paclitaxel-eluting stent. At 4-year clinical follow-up, which was available in 256 (85.3%) patients, treatment with EES lead to a trend for lower rates of ischemia-driven major adverse cardiovascular events, a composite of cardiac death, myocardial infarction, and ischemia-driven target lesion revascularization (EES 7.7% vs. paclitaxel-eluting stent 16.4%, P = 0.056). Treatment with EES also resulted in a trend toward lower rates of cardiac death and numerically lower rates of myocardial infarction, ischemia-driven target lesion revascularization, and stent thrombosis. Overall, this study reports numerically fewer clinical events in patients treated with EES at 4-year follow-up, which is consistent with results from earlier follow-up.

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Artery Disease; Drug-Eluting Stents; Everolimus; Female; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Myocardial Infarction; Platelet Aggregation Inhibitors; Proportional Hazards Models; Prospective Studies; Prosthesis Design; Risk Assessment; Risk Factors; Single-Blind Method; Sirolimus; Thrombosis; Time Factors; Treatment Outcome

The aim of this study was the comparison of a new double-coated paclitaxel-eluting coronary stent with bare-metal stent (BMS) in patients undergoing percutaneous coronary intervention.. Stent coating with biodegradable polymers as a platform for elution of drugs has the potential for complete elution of drugs and for decreasing the risk of late complications.. Multicenter randomized trial comparing a paclitaxel-eluting stent (PES) coated with a biodegradable polymer and glycocalyx with the equivalent BMS. We randomly assigned 422 patients with de novo coronary lesions to PES (211 patients) or to BMS (211 patients). Primary end point was target vessel failure (TVF) defined as cardiac death, myocardial infarction, and target vessel revascularization. Clinical secondary end points were target vessel revascularization, target lesion revascularization, stent thrombosis (ST), and major adverse cardiovascular events (MACE). Angiographic secondary end points were late loss and binary restenosis.. At 1 year of follow-up, TVF rate was 9.5% in the PES group and 17.1% in the BMS group (P=0.02), and MACE rate was 10% in PES and 19% in BMS arm (P=0.009). All other secondary end points were reached but ST. ST rate was low and similar in both study arms.. The study shows that patients treated with PES with dual coating technology had significantly lower incidence of TVF and MACE than those treated with BMS design; however, longer follow-up should be necessary to assess true advantages of this technology compared with the previous one.

Topics: Aged; Angioplasty, Balloon, Coronary; Argentina; Cardiovascular Agents; Chi-Square Distribution; Coated Materials, Biocompatible; Coronary Angiography; Coronary Restenosis; Coronary Stenosis; Drug-Eluting Stents; Female; Glycocalyx; Humans; Kaplan-Meier Estimate; Lactic Acid; Logistic Models; Male; Metals; Middle Aged; Myocardial Infarction; Paclitaxel; Polyglycolic Acid; Polylactic Acid-Polyglycolic Acid Copolymer; Proportional Hazards Models; Prospective Studies; Prosthesis Design; Risk Assessment; Risk Factors; Severity of Illness Index; Stents; Thrombosis; Time Factors; Treatment Outcome

The aim of this study was to assess the long-term safety and efficacy of the CYPHER (Cordis, Johnson and Johnson, Bridgewater, New Jersey) sirolimus-eluting coronary stent (SES) in percutaneous coronary intervention (PCI) for ST-segment elevation myocardial infarction (STEMI).. Concern over the safety of drug-eluting stents implanted during PCI for STEMI remains, and long-term follow-up from randomized trials are necessary. TYPHOON (Trial to assess the use of the cYPHer sirolimus-eluting stent in acute myocardial infarction treated with ballOON angioplasty) randomized 712 patients with STEMI treated by primary PCI to receive either SES (n = 355) or bare-metal stents (BMS) (n = 357). The primary end point, target vessel failure at 1 year, was significantly lower in the SES group than in the BMS group (7.3% vs. 14.3%, p = 0.004) with no increase in adverse events.. A 4-year follow-up was performed. Complete data were available in 501 patients (70%), and the survival status is known in 580 patients (81%).. Freedom from target lesion revascularization (TLR) at 4 years was significantly better in the SES group (92.4% vs. 85.1%; p = 0.002); there were no significant differences in freedom from cardiac death (97.6% and 95.9%; p = 0.37) or freedom from repeat myocardial infarction (94.8% and 95.6%; p = 0.85) between the SES and BMS groups. No difference in definite/probable stent thrombosis was noted at 4 years (SES: 4.4%, BMS: 4.8%, p = 0.83). In the 580 patients with known survival status at 4 years, the all-cause death rate was 5.8% in the SES and 7.0% in the BMS group (p = 0.61).. In the 70% of patients with complete follow-up at 4 years, SES demonstrated sustained efficacy to reduce TLR with no difference in death, repeat myocardial infarction or stent thrombosis. (The Study to Assess AMI Treated With Balloon Angioplasty [TYPHOON]; NCT00232830).

Topics: Aged; Angioplasty, Balloon, Coronary; Australia; Cardiovascular Agents; Disease-Free Survival; Drug-Eluting Stents; Europe; Female; Follow-Up Studies; Humans; Kaplan-Meier Estimate; Male; Metals; Middle Aged; Myocardial Infarction; Proportional Hazards Models; Prosthesis Design; Recurrence; Risk Assessment; Risk Factors; Sirolimus; Stents; Survival Rate; Thrombosis; Time Factors; Treatment Outcome

The purpose of this study was to evaluate the long-term outcomes of the PASSION (Paclitaxel-Eluting Versus Conventional Stent in Myocardial Infarction with ST-Segment Elevation) trial.. In primary percutaneous coronary intervention for acute ST-segment elevation myocardial infarction (STEMI), the use of drug-eluting stents (DES) is still controversial. Several randomized controlled trials of DES, compared with bare-metal stents (BMS), with short-term follow-up showed a reduction in target lesion revascularization (TLR), but no differences in rates of cardiac death or recurrent myocardial infarction. Moreover, the occurrence of (very) late stent thrombosis (ST) continues to be of major concern, and, therefore, long-term follow-up results are needed.. We randomly assigned 619 patients presenting with STEMI to a paclitaxel-eluting stent (PES) or the similar BMS. The primary end point was the composite of cardiac death, recurrent myocardial infarction, or TLR. We performed clinical follow-up at 5 years.. At 5 years, the occurrence of the composite of cardiac death, recurrent myocardial infarction, or TLR was comparable at 18.6% versus 21.8% in PES and BMS, respectively (hazard ratio [HR]: 0.82, 95% confidence interval [CI]: 0.58 to 1.18, p = 0.28). The incidence of definite or probable ST was 12 (4.2%) in the PES group and 10 (3.4%) in the BMS group (HR: 1.19, 95% CI: 0.51 to 276, p = 0.68).. In the present analysis of PES compared with BMS in primary percutaneous coronary intervention for STEMI, no significant difference in major adverse cardiac events was observed. In addition, no difference in the incidence of definite or probable ST was seen, although very late ST was almost exclusively seen after the use of PES. (Paclitaxel-Eluting Versus Conventional Stent in Myocardial Infarction with ST-Segment Elevation [PASSION]; ISRCTN65027270).

Topics: Angioplasty, Balloon, Coronary; Cardiovascular Agents; Drug-Eluting Stents; Follow-Up Studies; Humans; Kaplan-Meier Estimate; Metals; Myocardial Infarction; Netherlands; Paclitaxel; Proportional Hazards Models; Prospective Studies; Recurrence; Risk Assessment; Risk Factors; Single-Blind Method; Stents; Thrombosis; Time Factors; Treatment Outcome

This study sought to report the long-term outcomes after drug-eluting stent (DES) implantation in saphenous vein graft (SVG) lesions in the SOS (Stenting of Saphenous Vein Grafts) trial.. The long-term outcomes after DES implantation in SVGs are poorly studied. Apart from the SOS trial, the only other randomized trial comparing DES with bare-metal stents (BMS) in SVGs reported higher mortality in the DES group at 32 months.. In the SOS trial, 80 patients with 112 lesions in 88 SVGs were randomized to a BMS or paclitaxel-eluting stent (PES) and demonstrated improved short-term angiographic and clinical outcomes with PES. Extended clinical follow-up was subsequently obtained.. Mean age was 67 ± 9 years, and all patients were men. The indications for stenting included acute coronary syndrome in 60% and stable angina in 31% of patients. The mean SVG age was 12 ± 6 years. The baseline characteristics of the patients in the 2 study groups were similar. Procedural success was achieved in 77 patients (96%). During a median follow-up of 35 months, compared with patients randomized to BMS, those receiving PES had a lower incidence of myocardial infarction (hazard ratio [HR]: 0.32, p = 0.01), target lesion revascularization (HR: 0.20, p = 0.004), target vessel revascularization (HR: 0.41, p = 0.03), and target vessel failure (HR: 0.34, p = 0.001) as well as a trend toward less definite or probable stent thrombosis (HR: 0.15, p = 0.08). All-cause mortality (HR: 2.04, p = 0.19) and cardiac mortality (HR: 0.62, p = 0.51) did not differ between groups.. During long-term follow-up, use of PES was associated with significantly better clinical outcomes than BMS in SVG lesions. (Stenting of Saphenous Vein Grafts Trial [SOS]; NCT00247208).

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Angiography; Coronary Artery Bypass; Drug-Eluting Stents; Female; Graft Occlusion, Vascular; Humans; Kaplan-Meier Estimate; Male; Metals; Middle Aged; Myocardial Infarction; Paclitaxel; Proportional Hazards Models; Prosthesis Design; Risk Assessment; Risk Factors; Saphenous Vein; Single-Blind Method; Stents; Thrombosis; Time Factors; Treatment Outcome; United States

We compared 4-year efficacy and safety of sirolimus-eluting stents (SES) and paclitaxel-eluting stents (PES) in patients with diabetes mellitus (DM).. Four-year comparison of SES with PES in diabetic patients has not been evaluated in a randomized manner.. This prospective, multicenter, randomized study compared SES (n = 200) and PES (n = 200) implantation in diabetic patients. We evaluated 4-year major adverse cardiac events (MACE) including death, myocardial infarction (MI), and target lesion revascularization (TLR).. The 2 groups had similar baseline characteristics. At 2 years, TLR (3.5% vs. 11.0%, log-rank, p < 0.01) and MACE (3.5% vs. 12.5%, log-rank, p < 0.01) were significantly lower in SES versus PES group with no difference of death or MI. At 4 years there were no differences in death (3.0% vs. 5.0%, p = 0.45) or MI (1.5% vs. 1.0%, p = 0.99) between SES and PES group. The TLR (7.5% vs. 12.0%, log-rank, p = 0.10) and MACE (11.0% vs. 16.0%, log-rank, p = 0.10) were statistically not different between SES and PES group. At multivariate Cox regression, post-procedural minimal lumen diameter (hazard ratio [HR]: 0.44, 95% confidence interval [CI]: 0.24 to 0.81, p < 0.01), hypercholesterolemia (HR: 2.21, 95% CI: 1.29 to 3.79, p < 0.01), and use of intravascular ultrasound (HR: 0.51, 95% CI: 0.26 to 0.99, p = 0.049) were independent predictors of 4-year MACE.. Superiority of SES over PES during 2 years was attenuated between 2 years and 4 years in diabetic patients. Use of intravascular ultrasound and larger post-procedural minimal lumen diameter were independent predictors of the improved long-term clinical outcomes.

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Chi-Square Distribution; Coronary Angiography; Coronary Stenosis; Diabetes Mellitus; Drug-Eluting Stents; Female; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Myocardial Infarction; Paclitaxel; Proportional Hazards Models; Prospective Studies; Prosthesis Design; Republic of Korea; Risk Assessment; Risk Factors; Severity of Illness Index; Sirolimus; Thrombosis; Time Factors; Treatment Outcome; Ultrasonography, Interventional

The objective of the study was to assess noninferiority of the polymer-free sirolimus-eluting Yukon Choice stent (Translumina GmbH, Hechingen, Germany) compared with the polymer-based Taxus Liberté stent (Boston Scientific, Natick, Massachusetts) with regard to the primary endpoint, in-stent late lumen loss, at 9 months in patients with diabetes mellitus.. The Yukon Choice stent has been evaluated in several randomized controlled trials before, albeit to date, there has been no trial that exclusively enrolled patients with diabetes mellitus.. Patients with diabetes mellitus undergoing percutaneous coronary intervention for clinically significant de novo coronary artery stenosis were randomized 1:1 to receive either the polymer-free sirolimus-eluting Yukon Choice stent or the polymer-based paclitaxel-eluting Taxus Liberté stent.. A total of 240 patients were randomized. Quantitative coronary angiography was available for 79% of patients. Mean in-stent late lumen loss was 0.63 ± 0.62 mm for the Yukon Choice stent and 0.45 ± 0.60 mm for the Taxus Liberté stent. Based on the pre-specified margin, the Yukon Choice stent failed to show noninferiority for the primary endpoint. During follow-up, there were no significant differences between groups regarding death, myocardial infarction, stent thrombosis, target lesion revascularization, target vessel revascularization, or nontarget vessel revascularization.. Compared with the Taxus Liberté stent, the polymer-free sirolimus-eluting Yukon Choice stent failed to show noninferiority with regard to the primary endpoint, in-stent late lumen loss, in patients with diabetes mellitus after 9-month follow-up. Both stents showed comparable clinical efficacy and safety. (Yukon Choice Versus Taxus Liberté in Diabetes Mellitus; NCT00368953).

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Chi-Square Distribution; Coronary Angiography; Coronary Restenosis; Coronary Stenosis; Diabetes Mellitus; Drug-Eluting Stents; Female; Germany; Humans; Male; Middle Aged; Myocardial Infarction; Paclitaxel; Polymers; Prospective Studies; Prosthesis Design; Risk Assessment; Risk Factors; Sirolimus; Thrombosis; Time Factors; Treatment Outcome

The aim of this study was to compare the 5-year outcomes of patients with multivessel disease (MVD) involving the proximal left anterior descending (LAD) artery who were treated with sirolimus drug-eluting stents (SES), bare metal stents (BMS) and coronary artery bypass surgery (CABG).. Clinical outcomes were compared between the 682 patients enrolled in the ARTS-I and ARTS-II study who had MVD involving the proximal LAD, and were treated with BMS (27.4%), CABG (30.2%), and SES (42.4%). At 5-year follow-up the primary endpoint of major adverse cardiovascular and cerebrovascular events (MACCE) occurred in 33.7%, 18.0% and 24.9% of patients treated with BMS, CABG and SES, respectively (BMS vs. SES p=0.04, CABG vs. SES p=0.07). Unadjusted and adjusted rates of mortality and death/stroke/myocardial infarction (safety) were comparable between all three treatments. Repeat revascularisation was significantly lower following CABG irrespective of adjustment. The absolute difference in MACCE between patients with a logistic EuroSCORE above and below the mean (i.e., 2.09%) was 18.8% (p=0.001), and 1.9% (p=0.28) for CABG and SES, respectively. In patients with a high EuroSCORE, SES was a significantly safer treatment (p=0.04) whilst repeat revascularisation remained lower with CABG irrespective of the EuroSCORE.. At 5-year follow-up CABG has comparable safety, and superior efficacy in terms of reducing repeat revascularisation compared to BMS and SES in the treatment of patients with MVD involving the proximal LAD however, appropriate patient selection remains imperative.

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Chi-Square Distribution; Coronary Angiography; Coronary Artery Bypass; Coronary Artery Disease; Drug-Eluting Stents; Female; Humans; Kaplan-Meier Estimate; Logistic Models; Male; Metals; Middle Aged; Myocardial Infarction; Netherlands; Patient Selection; Proportional Hazards Models; Prosthesis Design; Registries; Risk Assessment; Risk Factors; Sirolimus; Stents; Stroke; Thrombosis; Time Factors; Treatment Outcome

In the prospective randomized TRIAS pilot study, the bio-engineered Genous™ endothelial progenitor cell capturing stent was compared with the Taxus Liberté™ SR paclitaxel-eluting stent. At 1 yr, a statistically nonsignificant difference in the rates of target vessel failure (cardiac death, myocardial infarction, or target vessel revascularization) was observed. We have evaluated the safety and efficacy up to 2 yr.. A total of 193 patients with de novo coronary artery lesions carrying a high risk of restenosis were randomized to a Genous stent versus a Taxus stent. Dual antiplatelet therapy was prescribed for ≥1 month after Genous stent implantation and for ≥6 months after a Taxus stent.. Between 1 and 2 yr, patients treated with the Genous stent tended to have fewer episodes of target lesion revascularization (2.0% versus 5.3%), but nearly similar rates of cardiac death (1.0% versus 0%), myocardial infarction (0% versus 1.1%), and stent thrombosis (0% versus 1.1%) when compared with the Taxus stent. As a result, at 2-yr follow-up treatment with the Genous stent compared with the Taxus stent resulted in a nonsignificant difference in target vessel failure (TVR) (20.4% versus 15.8%; risk difference 4.6%, 95% CI -6.2-15.5%). No stent thrombosis was observed in the Genous group compared to five cases (in four patients) in the Taxus group, resulting in a difference as compared with the Taxus stent (risk difference -4.2%; 95%CI -8.2% to -0.2%).. In the TRIAS pilot study, treatment of coronary artery lesions carrying a high risk of restenosis with the Genous compared with the Taxus stent resulted in a nonsignificant difference of TVR at 2-yr follow-up, with convergence of the Kaplan-Meier curves between 1 and 2 yr. Stent thrombosis was only observed after Taxus stent implantation.

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Artery Disease; Coronary Restenosis; Drug Therapy, Combination; Drug-Eluting Stents; Endothelial Cells; Female; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Myocardial Infarction; Netherlands; Paclitaxel; Pilot Projects; Platelet Aggregation Inhibitors; Prospective Studies; Prosthesis Design; Risk Assessment; Risk Factors; Single-Blind Method; Stem Cells; Stents; Thrombosis; Time Factors; Treatment Outcome

These studies sought to evaluate the clinical outcomes of the slow-release Taxus paclitaxel-eluting stent (PES) versus an otherwise identical bare-metal stent (BMS).. Prior studies were not individually powered to generate reliable estimates of low-frequency safety endpoints or to characterize the long-term safety and efficacy profile of PES.. The completed 5-year databases from the prospective, randomized, double-blind TAXUS I, II, IV, and V trials were pooled for a patient-level analysis.. The study population comprised 2,797 randomized patients (1,400 PES and 1,397 BMS). At the end of the 5-year study period, PES compared with BMS significantly reduced the rate of ischemia-driven target lesion revascularization (12.3% vs. 21.0%, p < 0.0001), with consistent reductions across high-risk subgroups and in patients with and without routine angiographic follow-up. There were no significant differences between the stent types in the 1-year or cumulative 5-year rates of death or myocardial infarction (MI). However, cardiac death or MI between 1 and 5 years was increased with PES (6.7% vs. 4.5%, p = 0.01), as was stent thrombosis (protocol definition: 0.9% vs. 0.2%, p = 0.007; ARC definition: 1.4% vs. 0.9%, p = 0.18).. In this pooled patient-level analysis from the prospective, randomized, double-blind TAXUS trials, PES compared with BMS resulted in a durable 47% reduction in the 5-year rate of ischemia-driven target lesion revascularization in simple and complex lesions, with nonsignificant differences in the cumulative 5-year rates of death or MI. Between 1 and 5 years, however, the rates of cardiac death or MI and protocol-defined stent thrombosis were increased with PES.

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Chi-Square Distribution; Coronary Angiography; Coronary Artery Disease; Coronary Restenosis; Double-Blind Method; Drug-Eluting Stents; Europe; Female; Humans; Kaplan-Meier Estimate; Male; Metals; Middle Aged; Myocardial Infarction; Odds Ratio; Paclitaxel; Proportional Hazards Models; Prospective Studies; Prosthesis Design; Risk Assessment; Risk Factors; Severity of Illness Index; Stents; Thrombosis; Time Factors; Treatment Outcome; United States

This study sought to compare late safety and efficacy outcomes following percutaneous coronary revascularization with zotarolimus-eluting stents (ZES) and sirolimus-eluting stents (SES).. Despite higher late lumen loss and binary restenosis with ZES compared with SES, it is uncertain whether differences in early angiographic measures translate into more disparate late clinical events.. Clinical outcomes were prospectively evaluated through 5 years in the ENDEAVOR III (A Randomized Controlled Trial of the Medtronic Endeavor Drug [ABT-578] Eluting Coronary Stent System Versus the Cypher Sirolimus-Eluting Coronary Stent System in De Novo Native Coronary Artery Lesions) that randomized 436 patients of relatively low anatomic and clinical risk to treatment with ZES (n = 323) or SES (n = 113) and evaluated a primary endpoint of 8-month angiographic late lumen loss.. At 5 years (completeness of follow-up: 95.2%), pre-specified endpoints of all-cause mortality (5.2% vs. 13.0%, p = 0.02), myocardial infarction (1.0% vs. 4.6%, p = 0.03), and the composite event rates of cardiac death/myocardial infarction (1.3% vs. 6.5%, p = 0.009) and major adverse cardiac events (14.0% vs. 22.2%, p = 0.05) were significantly lower among patients treated with ZES. Rates of target lesion (8.1% ZES vs. 6.5% SES, p = 0.68) and target vessel revascularization were similar between treatment groups. Stent thrombosis was infrequent and similar in both groups (0.7% ZES vs. 0.9% SES, p = 1.0). Between 9 months and 5 years, progression of major adverse cardiac events was significantly more common with SES than with ZES (16.7% vs. 7.8%, p = 0.015).. Despite initially higher angiographic late lumen loss, rates of clinical restenosis beyond the protocol-specified angiographic follow-up period remain stable with ZES compared with the rates for SES, resulting in similar late-term efficacy. Over 5 years, significant differences in death, myocardial infarction, and composite endpoints favored treatment with ZES. (The Medtronic Endeavor III Drug Eluting Coronary Stent System Clinical Trial [ENDEAVOR III]; NCT00217256).

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Angiography; Coronary Artery Disease; Coronary Restenosis; Drug-Eluting Stents; Female; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Myocardial Infarction; Prospective Studies; Prosthesis Design; Risk Assessment; Risk Factors; Sirolimus; Thrombosis; Time Factors; Treatment Outcome

This study sought to investigate safety and efficacy of biolimus-eluting stents (BES) with biodegradable polymer as compared with sirolimus-eluting stents (SES) with durable polymer through 2 years of follow-up.. BES with a biodegradable polymer provide similar efficacy and safety as SES with a durable polymer at 9 months. Clinical outcomes beyond the period of biodegradation of the polymer used for drug release and after discontinuation of dual antiplatelet therapy are of particular interest.. A total of 1,707 patients were randomized to unrestricted use of BES (n = 857) or SES (n = 850) in an all-comers patient population.. At 2 years, BES remained noninferior compared with SES for the primary endpoint, which was a composite of cardiac death, myocardial infarction, or clinically indicated target vessel revascularization (BES 12.8% vs. SES 15.2%, hazard ratio [HR]: 0.84, 95% confidence interval [CI]: 0.65 to 1.08, p(noninferiority) < 0.0001, p(superiority) = 0.18). Rates of cardiac death (3.2% vs. 3.9%, HR: 0.81, 95% CI: 0.49 to 1.35, p = 0.42), myocardial infarction (6.3% vs. 5.6%, HR: 1.12, 95% CI: 0.76 to 1.65, p = 0.56), and clinically indicated target vessel revascularization (7.5% vs. 8.6%, HR: 0.86, 95% CI: 0.62 to 1.20, p = 0.38) were similar for BES and SES. The rate of definite stent thrombosis through 2 years was 2.2% for BES and 2.5% for SES (p = 0.73). For the period between 1 and 2 years, event rates for definite stent thrombosis were 0.2% for BES and 0.5% for SES (p = 0.42). After discontinuation of dual antiplatelet therapy, no very late definite stent thrombosis occurred in the BES group.. At 2 years of follow-up, the unrestricted use of BES with a biodegradable polymer maintained a similar safety and efficacy profile as SES with a durable polymer. (Limus Eluted From a Durable Versus Erodable Stent Coating [LEADERS]; NCT00389220).

Topics: Absorbable Implants; Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Chi-Square Distribution; Coronary Angiography; Coronary Artery Disease; Drug Therapy, Combination; Drug-Eluting Stents; Europe; Female; Follow-Up Studies; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Myocardial Infarction; Platelet Aggregation Inhibitors; Proportional Hazards Models; Prosthesis Design; Risk Assessment; Risk Factors; Sirolimus; Survival Rate; Thrombosis; Time Factors; Treatment Outcome

The SYNTAX score (SXscore) has been shown to be an effective predictor of clinical outcomes in patients undergoing percutaneous coronary intervention (PCI).. The SXscore was prospectively collected in 1,397 of the 1,707 patients enrolled in the "all-comers" LEADERS trial (patients post-surgical revascularisation were excluded). Post hoc analysis was performed by stratifying clinical outcomes at two-year follow-up, according to one of three SXscore tertiles: SXlow ≤8 (n=464), 816 (n=461). At two-year follow-up the rate of major adverse cardiovascular events was 18.4%, 12.0% and 9.4% in the SXhigh, SXmid, and SXlow tertile, respectively (HR 1.45; CI 1.21-1.74; p<0.01). There was a significantly higher rate of cardiac death in patients in the highest SXscore tertile (7% SXhigh versus 2.4% SXmid versus 1.8% SXlow; HR 2.22; CI 1.5-3.27; p<0.001). Within the SXhigh tertile the rate of cardiac death was significantly lower in patients treated with the biolimus-eluting stent compared with the sirolimus-eluting stent (4.7% versus 9.6%, HR 0.48; CI 0.23-0.99; p=0.046).. The SXscore when applied to an "all-comers" patient population allows for prospective risk stratification of patients undergoing PCI up to two years follow-up. In addition, the SXscore appears to separate the performance of devices in high risk patient groups.

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Angiography; Coronary Artery Disease; Coronary Restenosis; Drug-Eluting Stents; Female; Heart Diseases; Humans; Male; Middle Aged; Polymers; Proportional Hazards Models; Prospective Studies; Prosthesis Design; Risk Assessment; Risk Factors; Sirolimus; Thrombosis; Time Factors; Tomography, Optical Coherence; Treatment Outcome

The aim of this study is to assess the serial changes in strut apposition and coverage of the bioresorbable vascular scaffolds (BVS) and to relate this with the presence of intraluminal masses at 6 months with optical coherence tomography (OCT).. Incomplete strut/scaffold apposition (ISA) and uncovered struts are related to a higher risk of scaffold thrombosis. Bioresorbable vascular scaffolds can potentially avoid the risk of scaffold thrombosis because of its complete resorption. However, during the resorption period, the risk of scaffold thrombosis is unknown.. OCT was performed in 25 patients at baseline and 6 months. Struts were classified according to apposition, coverage, and presence of intraluminal masses. Persistent ISA was defined as malapposed struts present at baseline and follow-up, and late acquired ISA as ISA developing at follow-up, and scaffold pattern irregularities when the strut distribution suggested scaffold fracture.. At baseline, 3,686 struts were analyzed: 128 (4%) were ISA, and 53 (1%) were located over side-branches (SB). At 6 months, 3,905 struts were analyzed: 32 (1%) ISA, and 35 (1%) at the SB. Persistent ISA was observed more frequently than late acquired-ISA (81% vs. 16%, respectively; 3% were unmatchable). Late acquired ISA was associated with scaffold pattern irregularities, which were related to overstretching of the scaffold. Uncovered struts (63 struts, 2%) were more frequently observed in ISA and SB struts, compared with apposed struts (29% vs. 1%; p < 0.01). Intraluminal masses (14 cross-sections, 3%; in 6 patients, 24%) were more frequently located at the site of ISA and/or uncovered struts (39% vs. 2% and 13% vs. 2%, respectively; p < 0.01).. The lack of strut apposition at baseline is related to the presence of uncovered struts and intraluminal masses at 6 month. An appropriate balloon/artery ratio respecting the actual vessel size and avoiding the overstretching of the scaffold can potentially decrease the risk of scaffold thrombosis. (ABSORB Clinical Investigation, Cohort B [ABSORB B).

Topics: Aged; Angioplasty, Balloon, Coronary; Australia; Biocompatible Materials; Cardiovascular Agents; Drug-Eluting Stents; Europe; Everolimus; Female; Humans; Male; Middle Aged; New Zealand; Prosthesis Design; Sirolimus; Thrombosis; Time Factors; Tomography, Optical Coherence; Treatment Outcome; United States

The current study reports clinical outcomes at three year follow-up of the LEADERS clinical trial which was the first all-comers trial comparing a new generation biodegradable polymer biolimus drug-eluting stent (BES) with the first generation permanent polymer sirolimus-eluting stent (SES).. One thousand seven hundred and seven patients were randomised to unrestricted use of BES (n=857) or SES (n=850) in an all-comers population. Three year follow-up was available in 95% of the patients, 812 treated with BES and 809 treated with SES. At three years, BES remains non-inferior to SES for the primary endpoint of major adverse cardiac events (composite of cardiac death, myocardial infarction (MI), or clinically-indicated target vessel revascularisation (CI-TVR) (BES 15.7% versus SES 19%; HR 0.82 CI 0.65-1.03; p=0.09). The MACE Kaplan Meier event curves increasingly diverge with the difference in events increasing from 1.4% to 2.4% and 3.3% at 1, 2 and 3 years, respectively in favour of BES. The rate of cardiac death was non-significantly lower 4.2% versus 5.2% (HR=0.81 CI 0.52-1.26; p=0.34) and the rate of myocardial infarction was equivalent 7.2% versus 7.1% (HR 1.01 CI 0.70-1.44; p=0.97) for BES versus SES, respectively. Thus BES was non-inferior to SES in all the safety endpoints. Clinically-indicated TVR occurred in 9.4% of BES treated patients versus 11.1% of SES treated patients (HR 0.84 CI 0.62-1.13; p=0.25). Rates of definite stent thrombosis were 2.2% for BES and 2.9% for SES (HR 0.78 CI 0.43-1.43; p=0.43), with the event rate increase of 0.2% from one to three years for BES and 0.9% for SES. For patients presenting with ST-elevation myocardial infarction BES was superior to SES in reducing MACE.. The findings of the three year follow-up support the claim that the biodegradable polymer biolimus-eluting stent has equivalent safety and efficacy to permanent polymer sirolimus-eluting stent in an all-comers patient population. Its performance is superior in some subpopulations such as in ST-elevation MI patients and event rates for BES are overall lower than for SES with a trend toward increasing divergence of outcomes over three years.

Topics: Absorbable Implants; Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Chi-Square Distribution; Coronary Artery Disease; Drug Therapy, Combination; Drug-Eluting Stents; Europe; Female; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Myocardial Infarction; Platelet Aggregation Inhibitors; Polymers; Proportional Hazards Models; Prosthesis Design; Risk Assessment; Risk Factors; Sirolimus; Thrombosis; Time Factors; Treatment Outcome

Percutaneous coronary interventions for bifurcation lesions are often complex and associated with an unsatisfactory result. The aim of this first-in-man, observational study was to investigate the efficacy and safety of a paclitaxel-eluting balloon in these lesions.. Twenty-eight patients presenting significant coronary bifurcational lesions of the left coronary artery were studied. The main branch (MB) and the side branch (SB) were dilated with a drug-eluting balloon (DEB; SeQuent Please balloon catheter , 3 µg paclitaxel/mm2 balloon surface). An open-cell bare-metal stent (BMS; Coroflex) was then deployed in the MB. Only if the SB had a TIMI flow

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Catheters; Coated Materials, Biocompatible; Coronary Angiography; Coronary Artery Disease; Coronary Restenosis; Drug Delivery Systems; Equipment Design; Female; Germany; Humans; Male; Metals; Middle Aged; Paclitaxel; Pilot Projects; Prospective Studies; Prosthesis Design; Stents; Thrombosis; Time Factors; Treatment Outcome

This study evaluates the safety and efficacy of the XIENCE V 4.0 mm stent for the treatment of de novo native coronary artery lesions.. In the SPIRIT III trial, the XIENCE V everolimus-eluting stent (EES), compared with the TAXUS EXPRESS(2) paclitaxel-eluting stent (PES) in 2.5-3.75 mm diameter coronary arteries, resulted in reduced angiographic late loss (LL), noninferior rates of target vessel failure (TVF), and fewer major adverse cardiac events (MACE).. The SPIRIT III 4.0 mm registry was a concurrent arm of the SPIRIT III trial consisting of 69 nonrandomized patients with lesions

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Angiography; Coronary Stenosis; Drug-Eluting Stents; Everolimus; Female; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Myocardial Infarction; Paclitaxel; Predictive Value of Tests; Prospective Studies; Registries; Risk Assessment; Single-Blind Method; Sirolimus; Thrombosis; Time Factors; Treatment Outcome; United States

Drug-eluting stents (DES) have been designed to prevent restenosis, but long-term clinical outcome may be offset by an increased risk of stent thrombosis, which is associated with suboptimal stent implantation or delayed re-endothelialization. DES implantation has also been associated with local persistent endothelial dysfunction. Conversely, Trapidil is a potent anti-inflammatory, vasodilatator and antiproliferative drug and several studies have shown anti-restenotic effects, suggesting substantial clinical benefits through the use of Trapidil-eluting DES.. This is a longitudinal, single-blind, double-arm, randomized multicenter study. Forty patients with non-ST-elevation acute coronary syndromes who present at the index procedure with multivessel coronary disease in the major epicardial coronary arteries will be enrolled. Patients should present a culprit lesion with stenosis 70% or more associated with another stenosis 70% or more in another coronary artery. Patients will be randomized in a 1: 1 fashion to receive either an Intrepide trapidil-eluting stent or a Taxus paclitaxel-eluting stent on the culprit lesion. After 90 days, the nonculprit lesion will be treated with the stent of the opposite randomization arm and optical coherence tomography (OCT) analysis of the index stented segment will be performed. Follow-up angiography, combined with vasomotor analysis of endothelial function by rapid atrial pacing, will be done at 12 months after the index procedure on both stents. To further characterize the status of the endothelium, serum measurement of vascular endothelial growth factor gradient between the aorta and 15 mm distal to the implanted stent will be performed at 12 months. The primary endpoint of the study is to compare stent struts re-endothelialization at 90 days by OCT. The secondary endpoint is to compare angiographic outcome and coronary endothelial function 12 months after the index procedure and to compare clinical outcome at 1 and 2 years between trapidil-eluting DES versus paclitaxel-eluting DES.. We hypothesize that the utilization of trapidil-eluting DES in the setting of acute coronary syndromes will be characterized by a greater early re-endothelialization associated with an antiproliferative effect offering a similar efficacy with a better safety profile compared with first-generation DES.

Topics: Acute Coronary Syndrome; Angioplasty, Balloon, Coronary; Biomarkers; Cardiac Catheterization; Cardiovascular Agents; Cell Proliferation; Coronary Angiography; Coronary Restenosis; Coronary Vessels; Drug-Eluting Stents; Endothelium, Vascular; Humans; Italy; Longitudinal Studies; Paclitaxel; Prosthesis Design; Research Design; Single-Blind Method; Thrombosis; Time Factors; Tomography, Optical Coherence; Trapidil; Treatment Outcome; Vascular Endothelial Growth Factor A

The JACTAX HD trial ("JACTAX" Trial Drug Eluting Stent Trial) evaluated the safety and clinical performance of a novel JACTAX HD (Boston Scientific Corporation, Natick, Massachusetts) paclitaxel-eluting stent (PES) in de novo coronary lesions.. The JACTAX HD (Boston Scientific) stent consists of a pre-crimped bare-metal Liberté (Boston Scientific) stent coated on its abluminal aspect with an ultrathin (<1 microm) 1/1 mixture of biodegradable polylactide polymer and paclitaxel applied as discrete microdots (nominal totals of 9.2 microg each of polymer and paclitaxel per 16-mm stent).. In this prospective, single-arm, multicenter, first-human-use study (n = 103), the primary end point of 9-month major adverse cardiac events (MACE) (cardiac death, myocardial infarction, ischemia-related target vessel revascularization) was compared with an objective performance criterion (OPC) of 17% (11% MACE based on TAXUS ATLAS [TAXUS Liberté-SR Stent for the Treatment of de Novo Coronary Artery Lesions] trial results plus a pre-specified noninferiority margin of 6%).. The composite primary end point occurred in 7.8% of JACTAX HD patients with an upper 1-sided 95% confidence limit of 13.6%, thus meeting the pre-specified criteria for noninferiority. There was no death, Q-wave myocardial infarction, or stent thrombosis through 9 months. In-stent late loss was 0.33 +/- 0.45 mm, with an in-stent binary restenosis of 5.2% and net volume obstruction by intravascular ultrasound of 11.4 +/- 11.2%.. The JACTAX HD stent with an abluminal biodegradable polymer showed 9-month MACE, in-stent late loss, restenosis, and net volume obstruction comparable to that observed with the TAXUS Liberté (Boston Scientific) stent coated with a conformal durable polymer. Further studies are underway to better evaluate the potential of this new PES design, which might allow for more rapid endothelialization and improved vessel healing. ("JACTAX" Trial Drug Eluting Stent Trial; NCT00754728).

Topics: Absorbable Implants; Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coated Materials, Biocompatible; Coronary Angiography; Coronary Artery Disease; Coronary Restenosis; Drug-Eluting Stents; England; Female; Germany; Humans; Male; Middle Aged; Myocardial Infarction; Paclitaxel; Polymers; Prospective Studies; Prosthesis Design; Thrombosis; Time Factors; Treatment Outcome; Ultrasonography, Interventional

We sought to determine the 2-year impact of early and late-acquired incomplete stent apposition (ISA) on clinical events.. The late clinical impact of early or late-acquired ISA in bare-metal stents (BMS) and TAXUS stents (Boston Scientific, Natick, Massachusetts) is debatable.. We evaluated 1,580 patients enrolled in the intravascular ultrasound (IVUS) substudies of TAXUS IV, V, VI and TAXUS-ATLAS WH, LL, and DS trials.. There were 96 cases of early ISA in 26 (7.2%) BMS patients, 35 (9.7%) TAXUS Express patients (p = 0.28 vs. BMS), and 35 (7.3%) TAXUS Liberté patients (p = 0.21 vs. TAXUS Express, and p = 1.00 vs. BMS). Major adverse cardiovascular events were similar at 9 months in patients with early ISA versus control subjects with no ISA for BMS (3.8% vs. 15.2%, p = 0.13) and for TAXUS (11.6% vs. 8.8%, p = 0.45). There was no impact of early ISA on stent thrombosis. At 9-month follow-up, there were 36 cases of late-acquired ISA in 7 (2.7%) BMS patients, 17 (3.1%) patients with TAXUS slow-release (TAXUS Express or TAXUS Liberté), and 12 (15.4%) patients receiving TAXUS moderate-release. Over 2 ensuing years, major adverse cardiovascular events were similar in patients with late-acquired ISA versus control subjects with no ISA for BMS (14.3% vs. 7.9%, p = 0.54), TAXUS (overall, 8.3% vs. 8.1% p = 0.87), or TAXUS slow-release formulation (0% vs. 7.9%, p = 0.28). There was no impact of late-acquired ISA on stent thrombosis.. Neither routinely detected acute ISA nor routinely detected late-acquired ISA in BMS or TAXUS patients was associated with adverse clinical events over long-term follow-up.

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Cardiovascular Diseases; Coronary Angiography; Coronary Restenosis; Double-Blind Method; Drug-Eluting Stents; Female; Humans; Kaplan-Meier Estimate; Male; Metals; Middle Aged; Paclitaxel; Prospective Studies; Prosthesis Design; Stents; Thrombosis; Time Factors; Treatment Outcome; Ultrasonography, Interventional

Drug-eluting stents have shown to be superior over bare metal stents in clinical and angiographic outcomes after percutaneous treatment of coronary artery stenosis. However, long-term follow-up data are scarce and only available for sirolimus- and paclitaxel-eluting stents.. To assess the feasibility and performance of the XIENCE V everolimus-eluting stent (EES) versus an identical bare metal stent after a 5-year follow-up period.. SPIRIT FIRST was a First in Man, multicentre, prospective, single-blind, clinical trial, randomizing 60 patients with a single de novo coronary artery lesion in a ratio of 1:1 to either an everolimus eluting or a bare metal control stent.. At 5-year clinical follow-up, data were available in 89% and 86% of patients in the everolimus and control arm, respectively. In the everolimus arm, no additional death, myocardial infarction, clinically driven target lesion revascularization (TLR), or clinically driven target vessel revascularization (TVR) events were observed between 1- and 5-year follow-up. The 5-year hierarchical major adverse cardiac events (MACE) and target vessel failure (TVF) rates for the everolimus arm were 16.7% (4/24) for both endpoints. In the control group, no additional cardiac death, myocardial infarction, or clinically driven TLR events were observed between 2- and 5-year follow-up. No additional clinically driven TVR events were observed between 3- and 5-year follow-up. The 5-year hierarchical MACE and TVF rates for the control arm were 28.0% (7/25) and 36.0% (9/25), respectively. No stent thromboses were observed in either the everolimus arm or the control arm up to 5 years.. The favorable 5-year long term clinical outcome of the EES is consistent with the results from other studies of the EES with shorter follow-up.

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Angiography; Coronary Restenosis; Coronary Stenosis; Drug-Eluting Stents; Europe; Everolimus; Female; Follow-Up Studies; Humans; Kaplan-Meier Estimate; Male; Metals; Middle Aged; Myocardial Infarction; Prospective Studies; Prosthesis Design; Risk Assessment; Severity of Illness Index; Single-Blind Method; Sirolimus; Stents; Thrombosis; Time Factors; Treatment Outcome; Ultrasonography, Interventional

The optimal stenting strategy in true coronary artery bifurcation lesions has not been determined. In this study, a strategy of always stenting both the main vessel and the side branch (MV plus SB) was compared with a strategy of stenting the MV only with optional stenting of the SB. Stents used were sirolimus-eluting stents and paclitaxel-eluting stents.. A total of 108 patients with true coronary bifurcation lesions were randomly assigned to either routine stenting with drug-eluting stents (DES) in both the branches (group MV plus SB) or provisional stenting with DES placement in the main branch and DES placement in the SB only if MV stenting alone provided inadequate results (group MV). The primary end points were major adverse cardiac events (MACE) at 8 months, including myocardial infarction, cardiac death, and stent thrombosis or target vessel revascularization by either percutaneous coronary intervention or coronary artery bypass grafting.. Angiographic follow-up revealed 28.91+/-20.43% stenosis of the SB after provisional stenting and 18.93+/-15.34% (P<0.01) after routine stenting. The corresponding binary restenosis rates were 35.2 and 14.8% (P=0.015). SB stents were implanted in 16.7% of patients in the provisional stenting group and 94.4% of patients in the routine stenting group. In the main branch, binary restenosis rates prebifurcation were 11.1% after provisional and 7.4% after routine stenting (P=0.51), whereas binary restenosis rates postbifurcation were 14.8 and 9.3% (P=0.38), respectively. The overall 8-month incidence of target lesion reintervention was 31.5% after provisional and 7.4% after routine stenting (P<0.01), and cumulative MACE were 38.9 and 11.1% (P<0.01), respectively.. Routine stenting significantly improved the MACE outcome of percutaneous coronary intervention in true coronary bifurcation and bifurcation angle of 60 or less lesions as compared with provisional stenting.

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Chi-Square Distribution; China; Coronary Angiography; Coronary Artery Disease; Coronary Restenosis; Drug-Eluting Stents; Female; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Myocardial Infarction; Paclitaxel; Prosthesis Design; Risk Assessment; Risk Factors; Sirolimus; Thrombosis; Time Factors; Treatment Outcome

Three-year follow-up of major adverse cardiovascular event (MACE) (death, nonfatal myocardial infarction, target lesion revascularization) and the predictors of MACEs in diabetic patients after sirolimus-eluting stent (SES) or paclitaxel-eluting stent (PES) implantation have not been reported.. Diabetic patients with de novo coronary lesions (169 patients with 190 lesions) were randomly assigned prospectively to either SES or PES.. Baseline characteristics were similar between the two groups. The rates of MACEs [5.9% (n = 5) in the SES vs. 9.5% (n = 8) in the PES Group, P = 0.374] and definite stent thrombosis [1.2% (n = 1) in the SES vs. 3.6% (n = 3) in the PES Group, P = 0.368] were similar in the two groups during the three-year follow-up. Multivariate logistic analysis showed that insulin treatment was the only independent predictor of MACE [odds ratio (OR) 8.60, 95% confidence interval (CI) 3.25-22.76, P < 0.001] and target vessel revascularization (TVR) (OR 9.50, 95% CI 3.07-29.44, P < 0.001) during the three-year follow-up.. The rates of MACEs, TVR, and stent thrombosis during the three-year follow-up were similar in the SES and PES Groups. Insulin treatment was a main predictor of MACEs and TVR during the three-year follow-up after either SES or PES implantation.

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Chi-Square Distribution; Coronary Angiography; Coronary Stenosis; Diabetes Complications; Drug-Eluting Stents; Female; Humans; Hypoglycemic Agents; Insulin; Kaplan-Meier Estimate; Logistic Models; Male; Middle Aged; Myocardial Infarction; Odds Ratio; Paclitaxel; Prospective Studies; Prosthesis Design; Republic of Korea; Risk Assessment; Risk Factors; Severity of Illness Index; Sirolimus; Thrombosis; Time Factors; Treatment Outcome

The increased frequency of very late (>1 year) stent thrombosis (VLST) has raised concerns with regard to the safety of sirolimus-eluting stents and paclitaxel-eluting stents (PES).. Experimental and preliminary clinical findings with the zotarolimus-eluting stent (ZES) have suggested a favorable safety profile.. The ENDEAVOR IV (Randomized Comparison of Zotarolimus- and Paclitaxel-Eluting Stents in Patients With Coronary Artery Disease) trial is a single-blind randomized ZES versus PES clinical trial in 1,548 patients with de novo native coronary lesions; the primary end point-9-month target vessel failure-was previously reported, annual clinical follow-up is planned for 5 years, and this report describes the 3-year outcomes.. The ZES compared with PES reduced target vessel failure (12.3% vs. 15.9%, hazard ratio [HR]: 0.76, 95% confidence interval [CI]: 0.58 to 1.00, p = 0.049), myocardial infarctions (MI) (2.1% vs. 4.9%, HR: 0.44, 95% CI: 0.25 to 0.80, p = 0.005), and cardiac death plus MI (3.6% vs. 7.1%, HR: 0.52, 95% CI 0.32 to 0.82, p = 0.004). Although the overall 3-year rate of Academic Research Consortium definite/probable stent thrombosis did not differ significantly (1.1% vs. 1.7%, HR: 0.67, 95% CI 0.28 to 1.64, p = 0.380), VLST (between 1 and 3 years) was significantly reduced in ZES patients (1 event vs. 11 events; 0.1% vs. 1.6%, HR: 0.09, 95% CI: 0.01 to 0.71, p = 0.004). Ischemia-driven target lesion revascularization at 3 years was similar with ZES versus PES (6.5% vs. 6.1%, HR: 1.10, 95% CI: 0.73 to 1.65, p = 0.662).. Three-year follow-up results from the ENDEAVOR IV trial indicate similar antirestenosis efficacy but improved clinical safety associated with ZES compared with PES, due to significantly fewer peri-procedural and remote MIs associated with fewer VLST events. (A Randomized, Controlled Trial of the Medtronic Endeavor Drug [ABT-578] Eluting Coronary Stent System Versus the Taxus Paclitaxel-Eluting Coronary Stent System in De Novo Native Coronary Artery Lesions; NCT00217269).

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Restenosis; Coronary Stenosis; Drug-Eluting Stents; Female; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Myocardial Infarction; Paclitaxel; Platelet Aggregation Inhibitors; Proportional Hazards Models; Prospective Studies; Prosthesis Design; Risk Assessment; Risk Factors; Single-Blind Method; Sirolimus; Thrombosis; Time Factors; Treatment Outcome; United States

To assess the long-term safety and efficacy of the paclitaxel-eluting TAXUS moderate-release (MR) investigation-only stent for the treatment of long, complex coronary artery lesions.. TAXUS VI was a prospective, double-blind, multicentre trial wherein 446 patients were randomised between a TAXUS Express MR stent and an uncoated Express Control stent. At 5-years, the overall rate of major adverse cardiac events (MACE) was similar in the two groups at 27.8% in control and 31.3% in TAXUS (P = 0.61), including similar rates for stent thrombosis. The target vessel revascularisation (TVR) rate was 23.7% in control and 22.2% in TAXUS (P = 0.45) with a non-target lesion revascularisation (non-TLR) rate of 5.1% in control and 10.9% in TAXUS (P = 0.0274) and a TLR rate of 21.4% in control and 14.6% in TAXUS (relative reduction, 32%; P = 0.0325). Furthermore, subgroup analysis revealed that the TLR benefit of TAXUS was preserved among study groups including small vessels, long lesions and patients receiving multiple overlapping stents.. Treatment of complex coronary lesions with the TAXUS MR stent demonstrated similar MACE, similar TVR, and reduced TLR rates compared with control through five years. Based on these positive results, the aetiology of increased non-TLR TVR rate in TAXUS remains unclear.

Topics: Angioplasty, Balloon, Coronary; Cardiovascular Agents; Cardiovascular Diseases; Coated Materials, Biocompatible; Coronary Artery Disease; Double-Blind Method; Drug-Eluting Stents; Europe; Humans; Kaplan-Meier Estimate; Metals; Paclitaxel; Platelet Aggregation Inhibitors; Prospective Studies; Prosthesis Design; Severity of Illness Index; Stents; Thrombosis; Time Factors; Treatment Outcome

Our goal is to report the first large multicenter data for percutaneous coronary intervention (PCI) of bifurcation disease with drug-eluting stents (DES) in the United States.. Bifurcation PCI remains a challenge to this date. There are limited data on outcomes of patients treated with bifurcation DES implantation, particularly in the United States.. There were 161 patients with bifurcation disease [side branch (SB) >or=2-mm] treated with >or=1 sirolimus-eluting stents at 41 centers participating in the Stent deployment Techniques on cLinicaL outcomes of patients treated with the cypheRstent (STLLR) trial. There was no protocol mandated strategy for bifurcation PCI. One-year outcome data were collected. Angiographic and clinical data were adjudicated independently.. There were 147 patients (91.3%) treated with single stent strategy. Only 14 (8.7%) patients received sirolimus-eluting stents implantation in both branches. Among patients with single stent strategy, double wire strategy (DW) was selected in 27 (18.4%) patients whereas single wire strategy (SW) was selected in 120 (81.6%) patients. There were 48 (32.7%) Medina 1,1,1 bifurcations treated with SW (n = 34; 70.8%) and DW (n = 14; 29.2%). There were 26 procedures started with SW which had SB dilatation during the procedure, one as a bailout (TIMI-1 grade flow in the SB). Overall 1-year death, myocardial infarction, and target lesion revascularization occurred in 2.4, 4.0, and 5.6%, respectively. There was no significant difference in clinical outcomes between SW and DW. SB dilatation was associated with a high rate of stent thrombosis (8.6%).. Main branch stenting without SB protection is the most common approach utilized in the STLLR study, which may reflect contemporary DES bifurcation strategies in the Unite States. This strategy was associated with an acceptable low incidence of adverse outcomes at 1-year.

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

This study sought to evaluate the safety and efficacy of a biodegradable polymer-coated sirolimus-eluting stent (Excel, JW Medical System, Weihai, China) with 6-month dual antiplatelet therapy in daily practice.. It has been hypothesized that persistent presence of polymer may compromise the safety of drug-eluting stents, and that therefore biodegradable polymer coatings might reduce late adverse events.. Between June and November 2006, 2,077 patients, exclusively treated with Excel stents at 59 centers from 4 countries, were enrolled in this prospective, multicenter registry. Recommended antiplatelet regimen included clopidogrel and aspirin for 6 months followed by chronic aspirin therapy.. The average duration of clopidogrel treatment was 199.8 +/- 52.7 days and 80.5% of discharged patients discontinued clopidogrel at 6 months. The cumulative rates of major adverse cardiac events were 0.9% at 30 days, 2.7% at 1 year, and 3.1% at 18 months. Overall rate of stent thrombosis was 0.87% at 18 months. The rates of acute, subacute, late, and very late stent thrombosis were 0.1%, 0.38%, 0.34%, and 0.05%, respectively. Angiographic follow-up, performed in 974 (31.6%) lesions from 653 patients (31.7%), revealed a mean in-stent late lumen loss of 0.21 +/- 0.39 mm. Binary restenosis rates were 3.8% in-stent and 6.7% in-segment.. This multicenter registry documents satisfactory safety and efficacy profiles, as evidenced by low rates of major adverse cardiac events and stent thrombosis up to 18 months, for the Excel biodegradable polymer-based sirolimus-eluting stent when used with 6 months of dual antiplatelet therapy in a "real-world" setting. (Multi-Center Registry Trial of EXCEL Biodegradable Polymer Drug-Eluting Stent [CREATE]; NCT00331578).

Topics: Aged; Angioplasty, Balloon, Coronary; Asia; Aspirin; Cardiovascular Agents; Clopidogrel; Coated Materials, Biocompatible; Coronary Angiography; Coronary Artery Disease; Coronary Restenosis; Drug Administration Schedule; Drug Therapy, Combination; Drug-Eluting Stents; Female; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Platelet Aggregation Inhibitors; Polymers; Product Surveillance, Postmarketing; Prospective Studies; Prosthesis Design; Registries; Risk Assessment; Sirolimus; Thrombosis; Ticlopidine; Time Factors; Treatment Outcome

The aim of this multicentre, non-randomised trial was to evaluate the safety and efficacy at 180+/-14 days of a pimecrolimus eluting coronary stent based on a cobalt-chromium platform and a poly-L-lactic acid (PLLA) bioresorbable polymer.. Sixty-one patients, with single de novo coronary lesions <14 mm in length and a reference vessel diameter of 3.0 to 3.5 mm, were enrolled in five centres (Germany and Belgium). Angiography and IVUS were performed at baseline, post-procedure and 180+/-14 days later. The primary endpoint was a composite of major adverse cardiac events (MACE) at 180+/-14 days and expected to be below 20%. Patients had single vessel disease in 59%, 2-vessel disease in 28% and 3-vessel disease in 13% of cases. MACE rate at 180+/-14 days was 18.0%. Binary in-stent restenosis was 32.7% due to in-stent late lumen loss of 1.11+/-0.65 mm by QCA. Stent thrombosis rate at 30+/-7 and 180+/-14 days was 1.6% and 3.3%, respectively. Overall TLR rate at 30+/-7, 180+/-14 days and 12+/-1 months was 1.6%, 27.9% and 32.8% respectively.. The primary endpoint was met at 180+/-14 days. However, the anti-restenotic effect of the pimecrolimus eluting stent did not reach levels similar to clinically established DES.

Topics: Aged; Angioplasty, Balloon, Coronary; Belgium; Cardiovascular Agents; Chromium Alloys; Coronary Angiography; Coronary Restenosis; Coronary Stenosis; Drug-Eluting Stents; Female; Germany; Humans; Lactic Acid; Male; Middle Aged; Myocardial Infarction; Polyesters; Polymers; Prospective Studies; Prosthesis Design; Severity of Illness Index; Tacrolimus; Thrombosis; Time Factors; Treatment Outcome; Ultrasonography, Interventional

We evaluated the role of gender on clinical and angiographic results of the everolimus-eluting stent in the SPIRIT III trial.. The SPIRIT III trial demonstrated superior efficacy of the XIENCE V everolimus-eluting stent compared with the TAXUS paclitaxel-eluting stent. Whether these results are applicable to women is unknown.. A total of 1,002 patients with coronary artery lesions of 28 mm or less long in 2.5-3.75 mm diameter vessels were prospectively randomized to receive percutaneous coronary intervention with either XIENCE V stent or TAXUS stent placement. Post hoc gender subset analysis was performed.. A total of 669 patients (200 women) received the XIENCE V stent, and 332 patients (114 women) were assigned to the TAXUS stent. Women were older and had more hypertension and diabetes than men. At 1 year, rates of MACE (11.1% vs. 5.7%, P = 0.004), TVF (13.7% vs. 7.5%, P = 0.003), TVR (10.8% vs. 4.6%, P = 0.0007), and TLR (7.2% vs. 2.7%, P = 0.002) were higher in women compared with men. The difference in 1 year MACE and TVF rates between men and women remained after adjusting for baseline covariates. Although the angiographic characteristics at baseline were similar among the female cohort, women assigned to XIENCE V had lower in-stent late loss (0.19 vs. 0.42 mm, P = 0.01) compared with women treated with the TAXUS stent. Although 30-day clinical outcomes were similar for women treated with XIENCE V and TAXUS stents, at 1 year, women with XIENCE V stents had significantly lower MACE (8.2% vs. 16.1 %, P = 0.04) and TVR (3.1% vs. 8.9%, P = 0.03) compared with those treated with TAXUS stents. Stent thrombosis rates were similar between women receiving either XIENCE V or TAXUS stents.. Women in the SPIRIT III trial had inherently higher MACE and TVF rates than men. However, the angiographic and clinical benefits of using XIENCE V stents are generalizable to women.

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Cardiovascular Diseases; Coronary Angiography; Coronary Artery Disease; Coronary Restenosis; Drug-Eluting Stents; Everolimus; Female; Humans; Kaplan-Meier Estimate; Linear Models; Logistic Models; Male; Middle Aged; Myocardial Infarction; Paclitaxel; Prospective Studies; Prosthesis Design; Risk Assessment; Risk Factors; Sex Factors; Single-Blind Method; Sirolimus; Thrombosis; Time Factors; Treatment Outcome; Women's Health

The evaluation of drug-eluting devices in humans should include longterm follow-up owing to risk of late target vessel thrombosis with the possible fatal sequel.. Therefore, the three-year clinical outcome of the paclitaxel-eluting Corofiex Please stent in patients with de-novo coronary lesions was evaluated in the single-arm PECOPS I pilot study. The clinical data of 123/125 (98.4%) of all patients included were available 3.05 +/- 0.12 years following stent deployment. In the intention-to-treat analysis the incidence of cardiac death was 9/123 (7.3%), of myocardial infarction 4/123 (3.3%), and of in-segment target lesion revascularization 14/123 (11.4%). Target lesion revascularizations tended (p = 0.30) to occur less frequently (9/96 (16.6%)) in those patients in whom the stent length was longer than the lesion (4.80 +/- 2.71 mm) compared to 5/27 (18.5%) in those patients in whom the stent was shorter than the lesion (-3.0 +/- 2.43 mm). Stent thromboses occurred in 2/123 (1.6%) patients during the first 6 months, one of which two days after premature discontinuation of clopidogrel. The total 3-year MACE rate was 22/123 (17.9%).. The present study describes the paclitaxel-eluting Corotlex Please stent as a safe device with good long term performance when deployed in native coronary arteries. The occurrence of late major adverse events and late thromboses in particular seem to be very low.

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Angiography; Coronary Stenosis; Disease-Free Survival; Drug-Eluting Stents; Female; Follow-Up Studies; Germany; Humans; Male; Middle Aged; Myocardial Infarction; Paclitaxel; Pilot Projects; Platelet Aggregation Inhibitors; Prospective Studies; Prosthesis Design; Risk Assessment; Severity of Illness Index; Thrombosis; Time Factors; Treatment Outcome

We evaluated the relative contributions of drug-eluting stent-specific and background natural history-driven causes for adverse clinical events between 1 and 5 years, in the paclitaxel-eluting stent (PES) and bare-metal stent (BMS) cohorts of the TAXUS randomized clinical trial program.. Prior studies have demonstrated that clinical events in the first year after BMS are predominantly stent-related but thereafter tend to be driven more by atherosclerotic activity outside the stented segment. It is not known whether the same is true for PES.. Annualized hazard rates (HRs) were calculated for major adverse events in 1,400 TAXUS and 1,397 BMS patients from the randomized and blinded TAXUS I, II, IV, and V trials (median 4.8-year follow-up).. Although target vessel revascularization (TVR) during the first year was driven by target lesion revascularization (TLR), TVR after 1 year involved similar numbers of TLR and non-TLR events. Moreover, the annualized HR for non-target lesion TVR and other major adverse events (including death, myocardial infarction, and stent thrombosis) were relatively constant beyond 1 year and not significantly different between PES and BMS.. The low and similar late HR for many of the observed late events after BMS and PES suggests that many of the late events after PES reflect background disease activity outside the stented segment rather than stent-related events per se. Analyses of long-term drug-eluting stent outcomes should recognize and attempt to correct for this background event rate by using suitable BMS control subjects.

Topics: Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Artery Disease; Coronary Restenosis; Disease Progression; Double-Blind Method; Drug-Eluting Stents; Humans; Metals; Myocardial Infarction; Paclitaxel; Platelet Aggregation Inhibitors; Proportional Hazards Models; Prosthesis Design; Risk Assessment; Risk Factors; Stents; Thrombosis; Time Factors; Treatment Outcome

The aim of this study was to evaluate the benefits of sirolimus-eluting stents (SES) and paclitaxel-eluting stents (PES) as compared with bare-metal stents (BMS) in patients undergoing primary angioplasty.. Recent concerns have emerged on the potential higher risk of stent thrombosis after drug-eluting stent implantation, especially among ST-segment elevation myocardial infarction (STEMI) patients.. We randomly assigned STEMI patients admitted within 12 h of symptom onset undergoing primary angioplasty and stent implantation to BMS, PES, or SES. The primary study end point was target lesion revascularization at 1-year follow-up. All patients were reviewed at our outpatient clinic or by telephone interview at 6, 12, and 24 months.. From October 2003 to December 2005, 270 STEMI patients undergoing primary angioplasty were randomized to BMS (n = 90), PES (n = 90), or SES (n = 90). No patient was lost to follow-up. As compared with BMS (14.4%), both PES (4.4%, p = 0.023) and SES (3.3%, p = 0.016) were associated with a significant reduction in target lesion revascularization at 1-year follow-up. At 2-year follow-up no difference was observed in terms of death, reinfarction, and combined death and/or reinfarction, but as compared with BMS, both PES and SES were associated with significant benefits in major adverse cardiac events (PES: 16.7%, p = 0.015; SES: 15.6%, p = 0.009, respectively).. This study shows that among STEMI patients undergoing primary angioplasty, both SES and PES are safe and associated with significant benefits in terms of target lesion revascularization up to the 2-year follow-up. Thus, until the results of further large randomized trials with long-term follow-up become available, drug-eluting stents may be considered for STEMI patients undergoing primary angioplasty. (PaclitAxel or Sirolimus-Eluting Stent versus Bare Metal Stent in Primary Angioplasty [PASEO] Randomized Trial; NCT00759850).

Topics: Adult; Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Angiography; Drug-Eluting Stents; Female; Humans; Kaplan-Meier Estimate; Male; Metals; Middle Aged; Myocardial Infarction; Paclitaxel; Patient Selection; Platelet Aggregation Inhibitors; Prospective Studies; Prosthesis Design; Recurrence; Risk Assessment; Sirolimus; Stents; Thrombosis; Time Factors; Treatment Outcome

We tested two novel drug-eluting stents (DES), covered with a biodegradable-polymer carrier and releasing paclitaxel or sirolimus, which were compared against a bare metal stent (primary objective). The DES differed by the drug, but were identical otherwise, allowing to compare the anti-restenosis effects of sirolimus versus paclitaxel (secondary objective).. The efficacy of novel DES with biodegradable polymers should be tested in the context of randomized trials, even when using drugs known to be effective, such as sirolimus and paclitaxel.. Overall, 274 patients with de novo coronary lesions in native vessels scheduled for stent implantation were randomly assigned (2:2:1 ratio) for the paclitaxel (n = 111), sirolimus (n = 106), or bare metal stent (n = 57) groups. Angiographic follow-up was obtained at 9 months and major cardiac adverse events up to 12 months.. Both paclitaxel and sirolimus stents reduced the 9-month in-stent late loss (0.54-0.44 mm, 0.32-0.43 mm, vs. 0.90-0.45 mm respectively), and 1-year risk of target vessel revascularization and combined major adverse cardiac events (P < 0.05 for both, in all comparisons), compared with controls. Sirolimus stents had lower late loss than paclitaxel stents (P < 0.01), but similar 1-year clinical outcomes. There were no differences in the risk of death, infarction, or stent thrombosis among the study groups.. Both novel DES were effective in reducing neointimal hyperplasia and 1-year re-intervention, compared to bare metal stents. Our findings also suggest that sirolimus is more effective than paclitaxel in reducing angiographic neointima, although this effect was not associated with better clinical outcomes.

Topics: Aged; Angioplasty, Balloon, Coronary; Brazil; Cardiovascular Agents; Cardiovascular Diseases; Coated Materials, Biocompatible; Coronary Angiography; Coronary Restenosis; Coronary Stenosis; Drug-Eluting Stents; Female; Humans; Hyperplasia; Kaplan-Meier Estimate; Male; Metals; Middle Aged; Myocardial Infarction; Paclitaxel; Proportional Hazards Models; Prosthesis Design; Risk Assessment; Sirolimus; Stents; Thrombosis; Time Factors; Treatment Outcome

Lesion length remains a predictor of target lesion revascularisation and results of long lesion stenting remain poor. Sirolimus-eluting stents have been shown to perform better than paclitaxel eluting stents in long lesions. In this substudy of the LEADERS trial, we compared the performance of biolimus biodegradable polymer (BES) and sirolimus permanent polymer stents (SES) in long lesions.. A total of 1,707 'all-comer' patients were randomly allocated to treatment with BES and SES. A stratified analysis of angiographic and clinical outcomes at nine months and one year, respectively was performed for vessels with lesion length <20 mm versus >20 mm (as measured by quantitative angiography).Of 1,707 patients, 592 BES patients with 831 lesions and 619 SES patients with 876 lesions had only short lesions treated. One hundred and fifty-three BES patients with 166 lesions and 151 SES patients with 162 lesions had long lesions. There were no significant differences in baseline clinical characteristics, except for higher number of patients with long lesions presenting with acute myocardial infarction in both stent groups. Long lesions tended to have lower MLD and greater percent diameter stenosis at baseline than short lesions. Late loss was greater for long lesions than short lesions. There was no statistically significant difference in late loss between BES and SES stents (0.32+/-0.69 vs 0.24+/-0.57, p=0.59). Binary in-segment restenosis was present in 23.2% versus 13.1% of long lesions treated with BES and SES, respectively (p=0.042). In patients with long lesions, the overall MACE rate was similar for BES and SES (17% vs 14.6%; p=0.62). There was a trend towards higher overall TLR rate with BES (12.4 % vs 6.0%; HR=2.06; p=0.07) and clinically driven TLR (10.5% vs 5.3%: HR 1.94; p=0.13). Rates of definite stent thrombosis were 3.3% in the long lesion group and 1.3-1.7 % in the short lesion group.. BES and SES appear similar with respect to MACE in long lesions in this "all-comer" patient population. However, long lesions tended to have a higher rate of binary in-segment restenosis and TLR following BES than SES treatment.

Topics: Absorbable Implants; Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Angiography; Coronary Restenosis; Coronary Stenosis; Drug-Eluting Stents; Europe; Female; Humans; Male; Middle Aged; Myocardial Infarction; Polymers; Proportional Hazards Models; Prosthesis Design; Risk Assessment; Sirolimus; Thrombosis; Time Factors; Treatment Outcome

We sought to compare the clinical presentation and angiographic patterns of saphenous vein graft (SVG) failure after stenting with a paclitaxel-eluting stent (PES) versus a similar bare-metal stent (BMS).. The mode of SVG failure after stenting has been poorly characterized.. The SOS (Stenting Of Saphenous Vein Grafts) trial enrolled 80 patients with 112 lesions in 88 SVGs who were randomized to a BMS or PES. Angiographic follow-up at 12 months was available in 83% of the patients.. Binary angiographic restenosis occurred in 51% (24 of 47) of BMS-treated lesions versus 9% (4 of 43) of PES-treated lesions (p < 0.0001). Graft occlusion occurred in 9 of the 21 SVGs (43%) that failed in the BMS group and in 2 of 4 SVGs (50%) that failed in the PES group. SVG failure after stenting presented as an acute coronary syndrome in 10 of the 24 patients (42%) (7 of those 10 patients presented with non-ST-segment elevation acute myocardial infarction), stable angina in 9 (37%) patients, and without symptoms in 5 (21%) patients. Of the 19 patients (with 20 grafts) who developed symptomatic graft failure, repeat SVG revascularization was successfully performed in all 13 (100%) subtotally obstructed SVGs but was attempted (and successful) in only 1 of 7 (14%) occluded SVGs. Revascularization of a native coronary artery was performed in an additional 4 of 7 (57%) symptomatic patients with an occluded SVG.. SVG failure after stenting often presents as acute myocardial infarction and with SVG occlusion. Compared with BMS, PES reduce SVG failure.

Topics: Acute Coronary Syndrome; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Angiography; Coronary Artery Bypass; Coronary Restenosis; Drug-Eluting Stents; Graft Occlusion, Vascular; Greece; Humans; Metals; Myocardial Infarction; Paclitaxel; Prosthesis Design; Recurrence; Saphenous Vein; Single-Blind Method; Stents; Thrombosis; Time Factors; Treatment Outcome; United States

We assessed the impact of vessel size on outcomes of stenting with biolimus-eluting degradable polymer stent (BES) and sirolimus-eluting permanent polymer stent (SES) within a randomized multicenter trial (LEADERS).. Stenting of small vessels might be associated with higher rates of adverse events.. "All-comer" patients (n = 1,707) were randomized to BES and SES. Post-hoc-stratified analysis of angiographic and clinical outcomes at 9 months and 1 year, respectively, was performed for vessels with reference diameter 2.75 mm.. Of 1,707 patients, 429 patients in the BES group with 576 lesions and 434 patients in the SES group with 557 lesions had only small vessels treated (50.6% of the patient cohort). In patients with small vessels there was no significant difference in overall major adverse cardiac events (MACE) rate (12.1% vs. 11.8%; p = 0.89) or target lesion revascularization (TLR) rate (9.6% vs. 7.4%; p = 0.26) between BES and SES. The MACE and TLR rates in the small-vessel patient population were higher than in the large-vessel population. The TLR rate was 9.6% versus 2.6%, and MACE rate was 12.1% versus 7.1% for small versus large vessels in the BES arm (TLR: hazard ratio [HR] = 3.724, p = 0.0013; MACE: HR = 1.720, p = 0.0412). In the SES arm, TLR was 7.4% versus 5.1%, and MACE was 11.8% versus 10.3% in small versus large vessels (TLR: HR = 1.435, p = 0.2594; MACE: HR = 1.149, p = 0.5546).. Prevalence of small vessel disease is high in an "all-comer" population with higher TLR and MACE rates. The BES and SES seem equivalent in treatment outcomes of small vessels in this "all-comer" patient population.

Topics: Absorbable Implants; Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Angiography; Coronary Restenosis; Coronary Stenosis; Drug-Eluting Stents; Europe; Female; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Polymers; Proportional Hazards Models; Prosthesis Design; Risk Assessment; Severity of Illness Index; Sirolimus; Thrombosis; Time Factors; Treatment Outcome

The RESOLUTE trial examined the safety and efficacy of a next-generation zotarolimus-eluting coronary stent, Resolute (Medtronic CardioVascular Inc., Santa Rosa, California).. Revascularization benefits associated with current drug-eluting stents are often diminished in the presence of complex coronary lesions and in certain patient cohorts. Resolute uses a new proprietary polymer coating that extends the duration of drug delivery to match the longer healing duration often experienced in more complex cases.. The RESOLUTE trial was a prospective, nonrandomized, multicenter study of the Resolute stent in 139 patients with de novo coronary lesions with reference vessel diameters > or =2.5 and < or =3.5 mm and lesion length > or =14 and < or =27 mm. The primary end point was 9-month in-stent late lumen loss by quantitative coronary angiography. Secondary end points included major adverse cardiac events (MACE) at 30 days, 6, 9, and 12 months; acute device, lesion, and procedure success; and 9-month target vessel failure (TVF), target lesion revascularization (TLR), stent thrombosis, neointimal hyperplastic (NIH) volume, and percent NIH volume obstruction.. The 9-month in-stent late lumen loss was 0.22 +/- 0.27 mm. Cumulative MACE were 4.3%, 4.3%, 7.2%, and 8.7% at 30 days, 6, 9, and 12 months, respectively. Acute lesion, procedure, and device success rates were 100.0%, 95.7%, and 99.3%, respectively. At 9 months, TLR was 0.0%, TVF was 6.5%, stent thrombosis was 0.0%, NIH volume was 6.55 +/- 7.83 mm(3), and percent NIH volume obstruction was 3.73 +/- 4.05%.. In this feasibility study, the Resolute stent demonstrated low in-stent late lumen loss, minimal neointimal hyperplastic ingrowth, low TLR, no stent thrombosis, and acceptable TVF and MACE. (The RESOLUTE Clinical Trial; NCT00248079).

Topics: Aged; Angioplasty, Balloon, Coronary; Australia; Cardiovascular Agents; Coronary Angiography; Coronary Restenosis; Coronary Stenosis; Drug-Eluting Stents; Feasibility Studies; Female; Humans; Hyperplasia; Kaplan-Meier Estimate; Male; Middle Aged; Myocardial Infarction; New Zealand; Prospective Studies; Prosthesis Design; Sirolimus; Thrombosis; Time Factors; Treatment Outcome; Ultrasonography, Interventional; United States

To evaluate the 5-year clinical outcomes of patients treated with the Endeavor zotarolimus-eluting stent (ZES) in the ENDEAVOR I first-in-human study.. ENDEAVOR I was a prospective, nonrandomized, multicenter study of the Endeavor ZES in 100 consecutive patients with symptomatic coronary artery disease (CAD) due to de novo, stenotic lesions in native coronary arteries.. Patients with single or multivessel CAD were eligible to participate, but only one lesion per patient was treated. The lesion had to have > or = 50% stenosis, be < or = 15 mm in length, and located in a vessel with a reference diameter of 3.0-3.5 mm. Major adverse cardiac events (MACE), target lesion revascularization (TLR), target vessel failure (TVF), and stent thrombosis were evaluated 5 years after stent implantation.. The cumulative incidence of MACE was 2.0% at 1 year, 3.0% at 2 years, 6.1% at 3 years, 7.2% at 4 years, and 7.2% at 5 years. At 5 years, there were seven patients who had eight events; four noncardiac (cancer) deaths, three cases of TLR, of which one presented as a non-Q-wave MI because of a stent thrombosis at 10 days after the index procedure. There were no late or very late stent thromboses by any definition. TVF at 5 years was 5.2%.. Use of the Endeavor ZES to treat symptomatic CAD due to de novo lesions in native coronary arteries resulted in sustained clinical benefits to 5 years, with low rates of MACE, TLR, TVF, and stent thrombosis.

Topics: Adult; Aged; Angioplasty, Balloon, Coronary; Australia; Cardiovascular Agents; Coronary Angiography; Coronary Stenosis; Drug-Eluting Stents; Female; Humans; Male; Massachusetts; Middle Aged; Myocardial Infarction; New Zealand; Prospective Studies; Prosthesis Design; Severity of Illness Index; Sirolimus; Thrombosis; Time Factors; Treatment Outcome

In a number of coronary bifurcation lesions, both the main vessel and the side branch need stent coverage. Using sirolimus eluting stents, we compared 2 dedicated bifurcation stent techniques, the crush and the culotte techniques in a randomized trial with separate clinical and angiographic end-points.. A total of 424 patients with a bifurcation lesion were randomized to crush (n=209) and culotte (n=215) stenting. The primary end point was major adverse cardiac events; cardiac death, myocardial infarction, target vessel revascularization, or stent thrombosis after 6 months. At 6 months there were no significant differences in major adverse cardiac event rates between the groups; crush 4.3%, culotte 3.7% (P=0.87). Procedure and fluoroscopy times and contrast volumes were similar in the 2 groups. The rates of procedure-related increase in biomarkers of myocardial injury were 15.5% in crush versus 8.8% in culotte group (P=0.08). A total of 324 patients had a quantitative coronary assessment at the index procedure and after 8 months. The angiographic end-points of in-segment and in-stent restenosis of main vessel and/or side branch after 8 months were found in 12.1% versus 6.6% (P=0.10) and in 10.5% versus 4.5% (P=0.046) in the crush and culotte groups, respectively.. Both the crush and the culotte bifurcation stenting techniques were associated with similar and excellent clinical and angiographic results. Angiographically, there was a trend toward less in-segment restenosis and significantly reduced in-stent restenosis following culotte stenting.

Topics: Aged; Angioplasty, Balloon, Coronary; Biomarkers; Cardiovascular Agents; Coronary Angiography; Coronary Artery Disease; Coronary Restenosis; Denmark; Drug-Eluting Stents; Female; Finland; Humans; Kaplan-Meier Estimate; Latvia; Male; Middle Aged; Myocardial Infarction; Norway; Prosthesis Design; Sirolimus; Thrombosis; Time Factors; Treatment Outcome

The newly developed Nobori coronary stent coated with a bioresorbable polymer, polylactic acid, and the antiproliferative agent Biolimus A9 has the potential to reduce restenosis by suppressing neointima formation.. We conducted a randomized (2:1), controlled trial comparing the Biolimus A9-eluting stent Nobori and the paclitaxel-eluting stent Taxus Liberté, in 243 patients (153 Nobori and 90 Taxus) at 29 centers in Europe, Asia, and Australia. Patients with previously untreated lesions in up to 2 native coronary arteries were considered for enrollment. The primary end point was in-stent late loss at 9 months, whereas secondary end points included other quantitative coronary angiography parameters, such as in-segment late loss and the rate of restenosis as well as key intravascular ultrasound parameters. Clinical secondary end points were stent thrombosis and composite of major adverse cardiac events comprising death, myocardial infarction, and target vessel revascularization. At 9 months, the in-stent late loss was significantly lower in the Nobori group compared with the Taxus group (0.11+/-0.30 mm versus 0.32+/-0.50 mm) reaching both the primary hypothesis of noninferiority of Nobori stent versus Taxus Liberté stent (P<0.001) and the secondary hypothesis of superiority (P=0.001). This finding was confirmed by a significant reduction in binary restenosis from 6.2% in Taxus to 0.7% in Nobori (P=0.02) and neointimal volume obstruction, detected by intravascular ultrasound, from 5.5+/-7.2% in Taxus to 1.8+/-5.2% in Nobori (P=0.01). The major adverse cardiac events rate was 4.6% in the Nobori and 5.6% in the Taxus cohort of patients. The stent thrombosis rate was 0% in the Nobori arm and 4.4% in the Taxus arm.. The NOBORI 1 clinical trial confirmed its primary hypothesis--noninferiority of the Nobori Biolimus A9-eluting stent versus the Taxus Liberté stent in reducing neointimal proliferation. Both stents showed a low major adverse cardiac events rate in the studied population.

Topics: Angioplasty, Balloon, Coronary; Asia; Australia; Cardiovascular Agents; Cell Proliferation; Coronary Angiography; Coronary Restenosis; Coronary Stenosis; Coronary Vessels; Drug-Eluting Stents; Europe; Female; Humans; Hyperplasia; Male; Middle Aged; Myocardial Infarction; Paclitaxel; Prospective Studies; Risk Assessment; Sirolimus; Thrombosis; Time Factors; Treatment Outcome; Ultrasonography, Interventional

Stent thrombosis (ST) is an uncommon but serious complication of drug-eluting and bare metal stents. To assess drug-eluting stent ST in contemporary practice, we analyzed 2-year data from the 7492-patient ARRIVE registry.. Patients were enrolled at the initiation of percutaneous coronary intervention with no inclusion/exclusion criteria beyond use of the paclitaxel-eluting TAXUS stent. Two-year follow-up was 94% with independent adjudication of major cardiac events. A second, autonomous committee adjudicated Academic Research Consortium (ARC) definite/probable ST. Cumulative 2-year ARC-defined ST was 2.6% (1.0% early ST [<30 days], 0.7% late ST [31 to 365 days], and 0.8% very late ST [>1 year]). Simple-use (single-vessel and single-stent) cases had lower rates than expanded use (broader patient/lesion characteristics, 2-year cumulative: 1.4% versus 3.3%, P<0.001; early ST: 0.4% versus 1.4%, P<0.001; late ST: 0.5% versus 0.8%, P=0.14; very late ST: 0.4% versus 1.0%, P=0.008). Within 7 days of ST, 23% of patients died; 28% suffered Q-wave myocardial infarction. Mortality was higher with early ST (39%) than late ST (12%, P<0.001) or very late ST (13%, P<0.001). Multivariate analysis showed anatomic factors increased early ST (lesion >28 mm, lesion calcification) and late ST (vessel <3.0 mm); biological factors increased very late ST (renal disease, prior brachytherapy). Although early ST (71.4%) and very late ST (23.1%) patients had dual antiplatelet therapy at the time of ST, premature thienopyridine discontinuation was a strong independent predictor of both.. The relative risks of early and late ST differ. Knowledge of ST risk for specific subgroups may guide revascularization options until the completion of randomized trials in these broad populations.

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Artery Disease; Drug-Eluting Stents; Female; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Myocardial Infarction; Paclitaxel; Platelet Aggregation Inhibitors; Proportional Hazards Models; Registries; Risk Assessment; Risk Factors; Thrombosis; Time Factors; Treatment Outcome; United States

This article reports the 2-year clinical, angiographic, and intravascular ultrasound outcomes of the everolimus-eluting stent (EES) compared with the paclitaxel-eluting stent (PES) in the randomized SPIRIT II trial.. This was a prospective, single-blind clinical trial in which a total of 300 patients with de novo native coronary artery lesions were randomized to either EES or PES in a 3:1 fashion. Clinical follow-up was planned at 2 years in all patients. A subset of 152 patients underwent serial angiographic and intravascular ultrasound analyses at 6 months and 2 years. After 2 years, target lesion failure (cardiac death, myocardial infarction, and ischemia-driven target lesion revascularization) rates were 6.6% and 11% in EES and PES, respectively (P=0.31). At 6 months, a significant reduction in angiographic in-stent late loss and percentage volume obstruction measured by intravascular ultrasound was observed in the EES group. However, at 2-year follow-up, a late increased intimal hyperplasia growth after implantation of an EES was observed. There were no significant differences between EES and PES for in-stent late loss (EES, 0.33+/-0.37 mm versus PES, 0.34+/-0.34 mm; P=0.84) and percentage volume obstruction (EES, 5.18+/-6.22% versus PES, 5.80+/-6.31%; P=0.65) at 2 years. The incidence of stent thrombosis was low and comparable in both groups (EES, 0.9%; PES, 1.4%).. Although the previously reported angiographic and clinical superiority of the EES has vanished over time, this report confirms and extends the previously demonstrated noninferiority in terms of in-stent late loss of the EES when compared with the PES up to 2-year follow-up. There were no significant differences between EES and PES in clinical, angiographic and intravascular ultrasound outcomes at 2 years.

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Angiography; Coronary Artery Disease; Drug-Eluting Stents; Europe; Everolimus; Female; Humans; India; Kaplan-Meier Estimate; Male; Middle Aged; Myocardial Infarction; Myocardial Ischemia; New Zealand; Paclitaxel; Prospective Studies; Single-Blind Method; Sirolimus; Thrombosis; Time Factors; Treatment Outcome; Ultrasonography, Interventional

Treatment of bifurcations is a complex problem. The clinical value of treating side branches is an unsolved problem in the field of interventional cardiology.. We initiated a prospective randomized controlled trial. One hundred and ten patients with bifurcations were randomly assigned to 2 arms: Stenting of the main branch (MB, Taxus-stent, paclitaxel-eluting stents) and mandatory side branch (SB) percutaneous coronary intervention (PCI; kissing balloons) with provisional SB stenting (therapy A), or stenting of the MB (paclitaxel-eluting stents) with provisional SB-PCI only when the SB had a thrombolysis in myocardial infarction flow <2 (therapy B). The primary end point was target lesion revascularization. The mean ages were 66.8 years (A) versus 65.1 years (B, P=0.4), 71.4% (A) versus 77.8% were men (P=0.4), patients with diabetes were present in 25.0% versus 25.9% (P=0.9). The MB was left anterior descending artery in 80.4% versus 81.5% (A versus B, P=0.9). The SB-PCI and kissing balloon-PCI were performed according to the study protocol in 82.1%/73.2% versus 16.7%/13.0% (P<0.05 for both), while changing of the intended therapy was necessary in 17.9% versus 16.7% (A versus B, P=0.9). A final thrombolysis in myocardial infarction flow 3 (MB) was reached in all patients (groups A and B), final thrombolysis in myocardial infarction flow 3 (SB) was observed in 96.4% versus 88.9% (A versus B, P=0.3). Radiation time (min) and contrast medium (mL) were 14.2/210 (group A) versus 7.8/151.6 (group B; P for both <0.05). Six month - follow up: major adverse cardiac events was 23.2% (A) versus 24.1% (B, P=0.9), target lesion revascularization was 17.9% (A) versus 14.8% (B, P=0.7), and late lumen loss (MB) was 0.2 mm (A) versus 0.3 mm (B, P=0.5). In group B, no PCI of the SB was done during follow up.. A simple strategy using paclitaxel-eluting stents with only provisional SB-PCI may be of equal value to a more complex strategy with mandatory SB-PCI. Clinical Trial Registration- URL: http://www.controlled.trials.com. Unique identifier: ISRCTN22637771.

Topics: Adult; Aged; Aged, 80 and over; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Angiography; Coronary Artery Disease; Coronary Circulation; Coronary Restenosis; Drug-Eluting Stents; Female; Humans; Male; Middle Aged; Myocardial Infarction; Paclitaxel; Pilot Projects; Prospective Studies; Single-Blind Method; Thrombosis; Time Factors; Treatment Outcome

This paper reports the 3-year clinical outcomes of the XIENCE V (Abbott Vascular, Santa Clara, California) everolimus-eluting stent (EES) compared with the TAXUS (Boston Scientific, Natick, Massachusetts) paclitaxel-eluting stent (PES) in the randomized SPIRIT II (Clinical Evaluation of the Xience V Everolimus Eluting Coronary Stent System in the Treatment of Patients with de novo Native Coronary Artery Lesions) study.. The Xience V EES is a new-generation drug-eluting stent (DES) that might offer advantages over the first-generation DES in terms of improved clinical outcomes and a better safety profile.. The SPIRIT II trial was a multicenter, prospective, randomized, single-blind, clinical trial, randomizing 300 patients with de novo coronary artery lesions in a ratio of 3:1 to either EES or PES. The primary end point was in-stent late loss at 180 days.. At 3-year clinical follow-up cardiac death was numerically lower with EES than PES (0.5% vs. 4.3%, p = 0.056). The observed rate of myocardial infarction was 3.6% for EES and 7.2% for PES (p = 0.31). The rate of ischemia-driven target lesion revascularization was 4.6% and 10.1% for EES and PES, respectively (p = 0.14). Overall, there was a trend for lower major adverse cardiovascular events in the EES group compared with PES (7.2% vs. 15.9%, p = 0.053). The rate of stent thrombosis was low and comparable in both groups (EES 1.0% vs. PES 2.9%).. The present study reports the favorable 3-year clinical outcomes of the EES, which are consistent with the results from other studies of the EES with shorter follow-up.

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Angiography; Coronary Artery Disease; Coronary Restenosis; Drug-Eluting Stents; Europe; Everolimus; Female; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Myocardial Infarction; Paclitaxel; Prospective Studies; Prosthesis Design; Risk Assessment; Risk Factors; Single-Blind Method; Sirolimus; Thrombosis; Time Factors; Treatment Outcome; United States

The E-Five registry was designed to evaluate the safety and effectiveness of the Endeavor zotarolimus-eluting stent (ZES) (Medtronic CardioVascular, Santa Rosa, California) for the treatment of coronary artery stenosis across a wide range of patients treated in real-world clinical practice settings.. Early clinical trials with the Endeavor ZES have demonstrated low rates of target lesion revascularization with a favorable safety profile including low late stent thrombosis with up to 4 years of follow-up. A clinical registry was designed to complement controlled trial data by examining a large patient population, including high-risk patient subsets.. The E-Five registry is a prospective, nonrandomized, multicenter global registry conducted at 188 centers worldwide. Adult patients (n = 8,314) with coronary artery disease who underwent single-vessel or multivessel percutaneous coronary intervention were enrolled. The primary end point was the rate of major adverse cardiac events (MACE) at 12 months. A secondary analysis stratified patients by standard versus extended-use clinical and lesion characteristics.. Overall 12-month outcome rates were MACE 7.5%; cardiac death 1.7%; myocardial infarction (all) 1.6%; target lesion revascularization 4.5%; and stent thrombosis (Academic Research Consortium definite and probable) 1.1%. The 12-month MACE rates were 4.3% and 8.6% for standard- and extended-use patients, respectively (p < 0.001).. This large, international multicenter registry provides important information regarding the long-term safety and efficacy of the Endeavor ZES across standard and extended-use patients in the real-world setting. Rates of MACE and measures of safety including cardiac death, myocardial infarction, and stent thrombosis were low and consistent with pooled results of clinical trials. (E-Five Registry: A World-Wide Registry With The Endeavor Zotarolimus Eluting Coronary Stent [eFive Registry]; NCT00623441).

Topics: Aged; Angioplasty, Balloon, Coronary; Australia; Cardiovascular Agents; Coronary Stenosis; Europe; Female; Humans; Israel; Kaplan-Meier Estimate; Male; Middle Aged; Myocardial Infarction; Platelet Aggregation Inhibitors; Prospective Studies; Prosthesis Design; Registries; Risk Assessment; Sirolimus; South America; Thrombosis; Time Factors; Treatment Outcome; United States

We performed this study to investigate the vascular response in early period after zotarolimus-eluting stent (ZES) (Endeavor Sprint, Medtronic CardioVascular, Minneapolis, Minnesota) implantation.. The ZES has different characteristics, with biocompatible polymer and rapid drug-elution, compared with the first-generation drug-eluting stents (DES).. The ENDEAVOR OCT (Evaluation in 3 Months Duration of Neointimal Coverage after Zotarolimus-Eluting Stent Implantation by Optical Coherence Tomography) trial is a prospective, single-center study evaluating vascular healing patterns with optical coherence tomography (OCT) at 3 months after stent implantation. A total of 31 ZES in 30 patients underwent serial OCT at immediate post-intervention and 3 months. Neointimal growth and malapposition were analyzed at each stent strut of cross-sectional OCT images with 0.5-mm intervals.. The incidence of malapposition at post-intervention and 3 months was 6.0% and 0.2%, respectively. However, late acquired malapposition was not detected at 3 months. Of 31 stents, 27 stents (87.1%) were covered completely with neointima, but the remaining 4 stents had 2 (0.8%), 4 (0.9%), 4 (1.2%), and 6 (1.4%) uncovered struts. Overall mean percentage of covered stent struts was 99.9 +/- 0.4%. This finding was consistent among groups with acute coronary syndrome and stable angina pectoris (99.9 +/- 0.3% vs. 99.9 +/- 0.4%, p = 0.92). Intracoronary thrombus was documented in 1 stent (3.2%) among 31 stents.. Most of the stent struts were covered with neointima, and late acquired malapposition was not found at 3 months after ZES implantation. Therefore, the current study demonstrated that ZES might have a favorable in vivo vascular response at 3 months after stent implantation. (Evaluation of Zotarolimus Eluting Stent at 3 Months Using Optical Coherence Tomography [ENDEAVOR OCT]; NCT00815139).

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Angiography; Coronary Artery Disease; Coronary Vessels; Drug-Eluting Stents; Female; Humans; Male; Middle Aged; Predictive Value of Tests; Prospective Studies; Prosthesis Design; Sirolimus; Thrombosis; Time Factors; Tomography, Optical Coherence; Treatment Outcome; Tunica Intima; Ultrasonography, Interventional

The pivotal TAXUS IV (TAXUS IV-SR: Treatment of De Novo Coronary Disease Using a Single Paclitaxel-Eluting Stent) trial evaluated the long-term safety and effectiveness of the paclitaxel-eluting stent (PES) compared with an otherwise identical bare-metal stent (BMS) in a relatively uncomplicated population of patients with a single de novo lesion in a native coronary vessel, treated between March and July 2002.. Long-term follow-up is required to determine whether the early safety and efficacy of drug-eluting stents are maintained.. The primary end point of this prospective, randomized, double-blind trial was 9-month ischemia-driven target vessel revascularization (TVR) for PES versus the BMS control. Follow-up was complete in 1,230 (95.1%) of 1,294 randomized evaluable patients at 5 years.. Compared with BMS, PES significantly reduced TVR at 9 months (12.1% vs. 4.7%; p < 0.0001); this benefit was maintained through 5 years (27.4% vs. 16.9%; p < 0.0001), given comparable TVR rates for BMS and PES between years 1 and 5 (4.1%/year vs. 3.3%/year; respectively, p = 0.16). Similar patterns were observed for composite major adverse cardiac events (MACE) (32.8% BMS vs. 24.0% PES, p = 0.0001 at 5 years). Stent thrombosis was comparable for PES and BMS at 9 months (0.8% BMS vs. 0.8% PES; p = 0.98) and at 5 years (2.1% BMS vs. 2.2% PES, p = 0.87). The overall revascularization benefits of PES were consistent across multiple subgroups, including sex, diabetes, left anterior descending artery lesion location, reference vessel diameter, lesion length, and multiple stents.. These 5-year results demonstrate the long-term safety and sustained efficacy of PES compared with BMS in patients with noncomplex lesions. (TAXUS IV-SR: Treatment of De Novo Coronary Disease Using a Single Paclitaxel-Eluting Stent; NCT00292474).

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Chi-Square Distribution; Coronary Artery Disease; Diabetes Complications; Double-Blind Method; Drug-Eluting Stents; Female; Humans; Kaplan-Meier Estimate; Logistic Models; Male; Metals; Middle Aged; Myocardial Infarction; Paclitaxel; Platelet Aggregation Inhibitors; Prospective Studies; Prosthesis Design; Risk Assessment; Risk Factors; Stents; Thrombosis; Time Factors; Treatment Outcome

The long-term impact of treating bifurcation lesions on the overall outcome of patients with multivessel coronary disease treated percutaneously with drug-eluting stents is unknown. This analysis determined the influence of bifurcation treatment using sirolimus-eluting stents on 3-year clinical outcomes.. Of the 607 patients (2,160 lesions) in the ARTS II study, 324 patients underwent revascularisation procedures involving treatment of at least one bifurcation (465 lesions). Three-year outcomes were compared to those without bifurcations. Despite more diffuse and complex disease in the bifurcation group, survival free of adverse events was equivalent in the two groups. At 3-years, there was no difference in rate of overall MACCE (20.2% vs. 18.5%, p=NS) or any of the component events between the bifurcation and the non-bifurcation group. There was a trend for a higher rate of definite stent thrombosis in the bifurcation group (4.6 vs 2.1%, p=0.1), but in multivariate analysis the CK value post-procedure served as the only independent predictor of definite stent thrombosis (p=0.015), with the presence of a bifurcation lesion of borderline significance (p=0.056).. In multivessel disease treated by PCI with DES, the presence of bifurcation disease had no adverse influence on 3-year clinical outcomes.

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Cerebrovascular Disorders; Chi-Square Distribution; Coronary Angiography; Coronary Stenosis; Drug-Eluting Stents; Female; Humans; Kaplan-Meier Estimate; Logistic Models; Male; Middle Aged; Myocardial Infarction; Prosthesis Design; Risk Assessment; Risk Factors; Severity of Illness Index; Sirolimus; Thrombosis; Time Factors; Treatment Outcome

This study was conducted to determine whether direct stenting with TAXUS Liberté is noninferior to stenting after pre-dilation.. Direct stenting is performed in approximately 30% of patients, but data on clinical and angiographic outcomes with drug-eluting stents are limited.. The TAXUS ATLAS DIRECT STENT is a single-arm, multicenter study that enrolled patients with de novo coronary lesions visually estimated to be 10 to 28 mm in length in vessels 2.5 to 4.0 mm in diameter. The control group is the quantitative coronary angiography (QCA) subset of the TAXUS ATLAS trial, which used identical inclusion and exclusion criteria but mandated pre-dilation. The primary end point is 9-month analysis-segment percent diameter stenosis (%DS).. Baseline patient characteristics were similar between the groups. On QCA analysis, significantly shorter lesions with larger lumen diameter and less calcification were observed in the direct stent group. Direct stenting was successful in 97.6% of patients and was associated with a shorter procedure time and fewer complications. Follow-up %DS was noninferior for direct stent (26.41%) versus pre-dilation (29.14%) with a 1-sided 95% confidence interval of the difference between the groups (-0.34%) well below the pre-specified noninferiority margin (6.75%). Additionally, significantly lower restenosis (5.9% vs. 11.4%, p = 0.0229) and target lesion revascularization (TLR) 2.9% vs. 7.8%, p = 0.0087) rates were seen for direct stent versus pre-dilation.. Direct stenting of TAXUS Liberté is feasible and highly successful in carefully selected lesions. Direct stenting is noninferior to stenting after pre-dilation on the basis of %DS and can significantly reduce procedural time, procedural complications, and possibly angiographic restenosis and TLR.

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Angiography; Coronary Restenosis; Coronary Stenosis; Drug-Eluting Stents; Feasibility Studies; Female; Humans; Male; Middle Aged; New Zealand; Paclitaxel; Prospective Studies; Prosthesis Design; Severity of Illness Index; Singapore; Thrombosis; Time Factors; Treatment Outcome; United States

Acute and late stent malapposition (SM) after bare-metal stents (BMS) and sirolimus-eluting stents (SES) in ST-segment elevation myocardial infarction patients were studied.. Stent thrombosis may be caused by SM after primary percutaneous coronary intervention in ST-segment elevation myocardial infarction patients.. Post-procedure and follow-up intravascular ultrasound data were available in 184 out of 310 patients (60%; 104 SES, 80 BMS) included in the MISSION! Intervention Study. To determine the contribution of remodeling and changes in plaque burden to the change in lumen cross-sectional area (CSA) at SM sites, the change in lumen CSA (follow-up minus post-lumen CSA) was related to the change in external elastic membrane CSA (remodeling) and change in plaque and media CSA (plaque burden).. Acute SM was found in 38.5% SES patients and 33.8% BMS patients (p = 0.51), late SM in 37.5% SES patients and 12.5% BMS patients (p < 0.001). Acquired SM was found in 25.0% SES patients and 5.0% BMS patients (p < 0.001). Predictors of acute SM were reference diameter (SES: odds ratio [OR] 3.49, 95% confidence interval [CI] 1.29 to 9.43; BMS: OR 28.8, 95% CI 4.25 to 94.5) and balloon pressure (BMS: OR 0.74, 95% CI 0.58 to 0.94). Predictors of late SM were diabetes mellitus (SES: OR 0.16, 95% CI 0.02 to 1.35), reference diameter (BMS: OR 19.2, 95% CI 2.64 to 139.7), and maximum balloon pressure (BMS: OR 0.74, 95% CI 0.55 to 1.00). Change in lumen CSA was related to change in external elastic membrane CSA (R = 0.73, 95% CI 0.62 to 0.84) after SES implantation and to change in plaque and media CSA (R = -0.62, 95% CI -0.77 to -0.46) after BMS implantation. After SES implantation, acquired SM was caused by positive remodeling in 84% and plaque reduction in 16% of patients.. Acute SM was common after SES and BMS stent implantation in ST-segment elevation myocardial infarction patients. After SES implantation, late acquired SM is common and generally caused by positive remodeling.

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Angiography; Drug-Eluting Stents; Female; Humans; Male; Metals; Middle Aged; Myocardial Infarction; Odds Ratio; Risk Assessment; Risk Factors; Single-Blind Method; Sirolimus; Stents; Thrombosis; Time Factors; Treatment Outcome; Ultrasonography, Interventional

The aim of this study was to evaluate long-term outcome of patients treated for in-stent restenosis of bare-metal stents (BMS).. Treatment of restenosis of BMS is characterized by high recurrence rates. Vascular brachytherapy (VBT) improved outcome although late catch-up events were documented. Drug-eluting stents tested against VBT in this setting were found superior for at least the first year; superiority at longer follow-up is uncertain.. We evaluated 3-year outcome of the multicenter SISR (Sirolimus-Eluting Stents Versus Vascular Brachytherapy for In-Stent Restenosis) trial, which randomized patients with restenosis of BMS to either a sirolimus-eluting stents (SES) or VBT.. Target vessel failure (cardiac death, infarction, or target vessel revascularization [TVR]) at 9 months as previously reported was significantly improved with SES. Kaplan-Meier analysis at 3 years documented that survival free from target lesion revascularization (TLR) and TVR continues to be significantly improved with SES: freedom from TLR 81.0% versus 71.6% (log-rank p = 0.018), and TVR 78.2% versus 68.8% (log-rank p = 0.022), SES versus VBT. At 3 years, target vessel failure and major adverse cardiac events (death, infarction, emergency coronary artery bypass grafting, or repeat TLR) remained improved with SES, but did not reach statistical significance. There was no statistically significant difference in definite or probable stent thrombosis (3.5% for SES, 2.4% for VBT; p = 0.758).. At 3 years of follow-up, after treatment of in-stent restenosis of BMS, patients treated with SES have improved survival free of TLR and TVR compared with patients treated with VBT. Stent thrombosis rates are not different between the 2 groups but are higher than reported in trials of treatment of de novo lesions.

Topics: Angioplasty, Balloon, Coronary; Brachytherapy; Cardiovascular Agents; Coronary Artery Bypass; Coronary Restenosis; Drug-Eluting Stents; Humans; Kaplan-Meier Estimate; Metals; Myocardial Infarction; Platelet Aggregation Inhibitors; Prospective Studies; Prosthesis Design; Recurrence; Risk Assessment; Sirolimus; Stents; Thrombosis; Time Factors; Treatment Outcome; United States

A novel zotarolimus-eluting coronary stent system (ZoMaxx, Abbott Laboratories, Abbott Park, Illinois) was compared with a paclitaxel-eluting coronary stent (Taxus Express2) in a randomized trial of percutaneous intervention for de novo coronary artery stenosis. The primary end point was defined as noninferiority of in-segment late lumen loss after 9 months.. The ZoMaxx stent system elutes 10 microg/mm zotarolimus using a phosphorylcholine polymer loaded onto a novel stainless steel stent platform containing a 0.0007-inch inner layer of tantalum.. Twenty-nine investigative sites in Europe, Australia, and New Zealand enrolled 401 patients, 396 of whom received a study stent.. After 9 months, late lumen loss was significantly greater in the ZoMaxx group (in-stent 0.67 +/- 0.57 mm vs. 0.45 +/- 0.48 mm; p < 0.001; in-segment 0.43 +/- 0.60 mm vs. 0.25 +/- 0. 45 mm; p = 0.003), resulting in significantly higher rates of >50% angiographic restenosis (in-stent 12.9% vs. 5.7%; p = 0.03; in-segment 16.5% vs. 6.9%; p = 0.007). The upper bound of the 95% confidence interval on the difference in in-segment late lumen loss between the 2 treatment groups (0.27 mm) exceeded the 0.25 mm value pre-specified for noninferiority. There were no significant differences between ZoMaxx and Taxus-treated groups with respect to target lesion revascularization (8.0% vs. 4.1%; p = 0.14), major adverse cardiac events (12.6% vs. 9.6%; p = 0.43), or stent thrombosis (0.5% in both groups).. After 9 months, the ZoMaxx stent showed less neointimal inhibition than the Taxus stent, as shown by higher in-stent late loss and restenosis by qualitative coronary angiography.

Topics: Aged; Angioplasty, Balloon, Coronary; Australia; Cardiovascular Agents; Coronary Angiography; Coronary Restenosis; Coronary Stenosis; Drug-Eluting Stents; Europe; Female; Humans; Logistic Models; Male; Middle Aged; New Zealand; Paclitaxel; Prospective Studies; Prosthesis Design; Risk Assessment; Severity of Illness Index; Sirolimus; Thrombosis; Time Factors; Treatment Outcome; Ultrasonography, Interventional

Analysis of the 3-year outcome of the original population of the TAXi trial which compared the efficacy of the paclitaxel (PES) and the sirolimus (SES) stents in a randomized "real world" investigation.. The widespread use of drug-eluting stents strongly modified the world of interventional cardiology. The TAXi trial was a randomized comparison between PES and SES and showed similar efficacy between the two prostheses. Recently, emerging discussions raised questions about potential long-term risk with the use of DES. The present work attempts to describe the long-term outcome of the patients compared during the TAXi trial.. During April 2003 and January 2004, 202 patients were prospectively randomly assigned to the PES group (102 patients) and to the SES group (100 patients). The primary aim of the present investigation was the comparison of combined incidence of cardiac death, myocardial infarction, and target lesion revascularization within 36-months.. No difference in mortality of all causes was noted in the PES and the SES groups (3% vs. 7%, P=0.98) or in major adverse cardiac event free survival (89% vs. 83%, P=0.28). Four stent thromboses were observed, two in the PES group (205 and 788 days) and two in the SES group (210 and 772 days).. The long-term outcome analysis of the TAXi trial confirms available published data showing the equivalence of PES and SES on clinical basis.

Topics: Aged; Aged, 80 and over; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Cardiovascular Diseases; Female; Follow-Up Studies; Humans; Incidence; Kaplan-Meier Estimate; Male; Middle Aged; Myocardial Infarction; Myocardial Ischemia; Paclitaxel; Prospective Studies; Prosthesis Design; Research Design; Sirolimus; Stents; Thrombosis; Time Factors; Treatment Outcome

To assess the safety and efficacy of direct stenting using the sirolimus-eluting BX Velocitytrade mark stent in patients with coronary lesions.. Although direct coronary stenting has become a widespread practice, there have been no systematic assessments of direct stenting with drug-eluting stents.. Total of 225 patients with identical inclusion and exclusion criteria as the original SIRIUS trial were enrolled in this prospective single-arm study. They were compared in a no-inferiority design with 412 similar patients from the SIRIUS trial who had sirolimus-eluting stents deployed after predilatation and were preassigned to angiographic follow-up evaluation.. Direct stenting was successful in 85.8% of the patients. Compared with the predilatation group, direct stenting was associated with shorter median procedure duration (33 min vs. 45 min, P < 0.001). Angiographic follow-up at 8 months revealed similar late loss (in-stent-0.19 +/- 0.47 mm vs. 0.17 +/- 0.44 mm, and in-lesion-0.23 +/- 0.41 mm vs. 0.24 +/- 0.47 mm) and similar frequency of binary restenosis (in-stent-4.6% vs. 3.2% and in-lesion-6.1% vs. 8.9%) between the two treatment strategies. However, stent-edge restenosis was lower with direct stenting than in the predilatation control group (2.1% vs. 6.9%, P = 0.02). At 12-months, there were no significant differences in target lesion revascularization (3.7% vs. 5.1%, P = ns) or composite major adverse cardiac events (7.0% vs. 8.3%, P = ns).. In patients similar to those treated in the SIRIUS trial, direct stenting using sirolimus-eluting stents achieves excellent short- and long-term clinical and angiographic results with shorter procedure time and less frequent stent edge restenosis compared with predilation stent implantation techniques.

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Cardiovascular Diseases; Coronary Angiography; Coronary Restenosis; Coronary Stenosis; Drug-Eluting Stents; Feasibility Studies; Female; Humans; Male; Middle Aged; Prospective Studies; Research Design; Sirolimus; Thrombosis; Time Factors; Treatment Outcome; Ultrasonography, Interventional; United States

In 2 randomized, double-blind studies, 109 diabetic patients with trophic lesions and 101 non-diabetics suffering from peripheral vascular disease (PVD) stage IV (Fontaine) received daily 6-hour i.v. infusions of iloprost (less than or equal to 2ng/kg/min) or of placebo over 28 days. Iloprost treatment was superior to placebo, showing ulcer healing in more than 60% of patients compared to less than 25% in the control group. The beneficial effects were sustained during a 1 year follow-up period. Platelet activation, adhesion, aggregation and release reaction on atherosclerotic lesions, impaired microvascular perfusion, loss of microvascular barrier function, increased white blood cell - vessel wall interaction and hemorheological disturbances are all believed to play a role in PVD. Stable PGI2-mimetics inhibit platelet activation by all endogenous mediators as well as platelet release of mitogenic factors (PDGF).

Topics: Animals; Blood Platelets; Cardiovascular Agents; Clinical Trials as Topic; Diabetic Angiopathies; Disease Models, Animal; Double-Blind Method; Epoprostenol; Humans; Iloprost; Infusions, Intravenous; Microcirculation; Random Allocation; Rats; Thrombosis; Ulcer; Vascular Diseases

The HELIOS stent is a sirolimus-eluting stent with a biodegradable polymer and titanium oxide film as the tie-layer. The study aimed to evaluate the safety and efficacy of HELIOS stent in a real-world setting.. The HELIOS registry is a prospective, multicenter, cohort study conducted at 38 centers across China between November 2018 and December 2019. A total of 3060 consecutive patients were enrolled after application of minimal inclusion and exclusion criteria. The primary endpoint was target lesion failure (TLF), defined as a composite of cardiac death, non-fatal target vessel myocardial infarction (MI), and clinically indicated target lesion revascularization (TLR) at 1-year follow-up. Kaplan-Meier methods were used to estimate the cumulative incidence of clinical events and construct survival curves.. A total of 2998 (98.0%) patients completed the 1-year follow-up. The 1-year incidence of TLF was 3.10% (94/2998, 95% closed interval: 2.54-3.78%). The rates of cardiac death, non-fatal target vessel MI and clinically indicated TLR were 2.33% (70/2998), 0.20% (6/2998), and 0.70% (21/2998), respectively. The rate of stent thrombosis was 0.33% (10/2998). Age ≥60 years, diabetes mellitus, family history of coronary artery disease, acute myocardial infarction at admission, and device success were independent predictors of TLF at 1 year.. The 1-year incidence rates of TLF and stent thrombosis were 3.10% and 0.33%, respectively, in patients treated with HELIOS stents. Our results provide clinical evidence for interventional cardiologists and policymakers to evaluate HELIOS stent.. ClinicalTrials.gov, NCT03916432.

Topics: Cardiovascular Agents; Cohort Studies; Coronary Artery Disease; Drug-Eluting Stents; Humans; Middle Aged; Myocardial Infarction; Percutaneous Coronary Intervention; Polymers; Prospective Studies; Registries; Risk Factors; Sirolimus; Thrombosis; Time Factors; Treatment Outcome

To investigate the use of a sirolimus drug-coated balloon (DCB) in the management of a thrombosed arteriovenous graft (AVG).. A single-center prospective pilot study was conducted between October 2018 and October 2019. Twenty patients (age = 67.0 years ± 10; male = 35%; mean time on dialysis = 31 months) with thrombosed upper limb AVG were enrolled. After successful pharmacomechanical thrombectomy and adequate treatment of the graft vein junction, sirolimus DCB angioplasty was performed at the graft vein junction. The patients were followed-up for 6 months, and all adverse events occurring during the study period were recorded.. The primary circuit patency rates at 3 and 6 months were 76% and 65%, respectively, while the assisted-primary circuit patency rates at 3 and 6 months were 82% and 65%, respectively. The 3- and 6-month secondary circuit patency rates were 88% and 76%, respectively. Using Kaplan-Meier analyses, the estimated mean primary, assisted-primary, and secondary patencies were 285 days (95% confidence interval (CI) = 194-376 days), 319 days (95% CI = 221-416 days), and 409 days (95% CI = 333-485 days). No adverse event directly related to sirolimus DCB use was observed.. The results of this pilot study suggest that the application of sirolimus DCB at the graft vein junction after the successful thrombectomy of AVG may be a feasible option to improve patency outcomes.

Topics: Aged; Angioplasty, Balloon; Arteriovenous Shunt, Surgical; Blood Vessel Prosthesis Implantation; Cardiovascular Agents; Coated Materials, Biocompatible; Female; Graft Occlusion, Vascular; Humans; Male; Middle Aged; Pilot Projects; Prospective Studies; Recurrence; Renal Dialysis; Risk Factors; Sirolimus; Thrombectomy; Thrombosis; Time Factors; Treatment Outcome; Vascular Access Devices; Vascular Patency

Zilver PTX polymer-free, paclitaxel-coated stents and Viabahn stent grafts are effective for the treatment of femoropopliteal lesions. The aim of this study was to compare clinical outcomes between the two devices in patients with symptomatic peripheral arterial disease in real-world settings.. This multicenter, retrospective study concerned a clinical database of 445 patients with symptomatic peripheral arterial disease (Rutherford categories 1-6) who underwent either Zilver PTX or Viabahn implantation for a femoropopliteal lesion of 10 cm or longer with reference vessel diameters of 4.0 to 7.5 mm between 2012 and 2018 at five hospitals in Japan. Outcome measures were primary patency, freedom from stent thrombosis, freedom from any target lesion reintervention, limb salvage, and overall survival. After propensity score matching, these clinical outcomes were compared between patients treated with the Zilver PTX and those treated with the Viabahn. Also assessed were the interaction effects of baseline characteristics on the association of the Zilver PTX and Viabahn with restenosis and stent thrombosis.. In total, 271 patients were treated with the Zilver PTX, and 174 patients were treated with the Viabahn. Propensity score matching extracted 133 patient pairs with no major intergroup differences in baseline characteristics. The Zilver PTX group had a lower rate of 3-year primary patency (59.5%; [95% confidence interval (CI), 53.0%-66.2%] vs 69.6% [95% CI, 59.3%-79.4%]; P = .005), but a higher rate of 3-year freedom from stent thrombosis (93.6% [95% CI, 90.0%-96.3%] vs 82.4% [95% CI, 74.5%-89.0%], P = .038). There was no significant difference in overall survival, limb salvage, or freedom from reintervention (all P > .05). An interaction analysis showed that the restenosis risk of the Zilver PTX was significantly higher vs the Viabahn in patients with no or one below-the-knee runoff vessel and in those with intravascular ultrasound use than in patients with two or three below-the-knee runoff vessels and in those without intravascular ultrasound use, respectively (P for interaction = .046 and .010, respectively), whereas the stent thrombosis risk of the Zilver PTX was significantly smaller vs the Viabahn in patients not on dialysis than in those on dialysis (P for interaction = .034).. Compared with Viabahn stent grafts, Zilver PTX stents have a lower rate of primary patency but a higher rate of freedom from stent thrombosis.

Topics: Aged, 80 and over; Blood Vessel Prosthesis; Blood Vessel Prosthesis Implantation; Cardiovascular Agents; Databases, Factual; Drug-Eluting Stents; Endovascular Procedures; Female; Femoral Artery; Graft Occlusion, Vascular; Humans; Japan; Limb Salvage; Male; Middle Aged; Paclitaxel; Peripheral Arterial Disease; Popliteal Artery; Prosthesis Design; Reoperation; Retrospective Studies; Risk Assessment; Risk Factors; Thrombosis; Time Factors; Treatment Outcome; Vascular Patency

There has been great interest in phospholipids (PLs) from marine by-products due to their long-chain polyunsaturated fatty acids with unique health and functional properties. Here, marine PLs from squid viscera and gonads were comprehensively characterized and compared by UPLC-Q-Exactive Orbitrap/MS-based lipidomics analysis. A total of thirteen phospholipid classes including 1223 molecular species were identified and quantified in both resources. PC, PE and SM were further isolated from the total PLs of squid viscera and gonads, respectively. All isolated squid PL components were first evaluated for anti-inflammatory, antioxidant and cardiovascular effects using in vivo zebrafish models. Our results showed the diversity, content and physiological functions of PLs from squid by-products, which provided a basis for their future application in the nutritional and pharmaceutical industry.

Topics: Animals; Anti-Inflammatory Agents; Antioxidants; Arrhythmias, Cardiac; Cardiovascular Agents; Chromatography, High Pressure Liquid; Decapodiformes; Fibrinolytic Agents; Gonads; Humans; Lipidomics; Mass Spectrometry; Phospholipids; Thrombosis; Viscera; Zebrafish

Topics: Adrenal Cortex Hormones; Anticoagulants; Arthritis, Rheumatoid; Cardiovascular Agents; Echocardiography, Doppler; Female; Heart Failure; Humans; Immunosuppressive Agents; Middle Aged; Predictive Value of Tests; Recovery of Function; Stroke Volume; Thrombosis; Time Factors; Treatment Outcome; Ventricular Function, Left

This study sought to compare clinical outcomes between bioresorbable scaffolds (BRS) and durable polymer everolimus-eluting metallic stents (DP-EES) in patients with acute myocardial infarction (AMI) undergoing successful percutaneous coronary intervention (PCI).. From March 2016 to October 2017, 952 patients with AMI without cardiogenic shock undergoing successful PCI with BRS (n = 136) or DP-EES (n = 816) were enrolled from a multicenter, observational Korea Acute Myocardial Infarction Registry.. In the crude population, there was no significant difference in the 1-year rate of device-oriented composite endpoint (DOCE) and device thrombosis between the BRS and DP-EES groups (2.2% vs. 4.8%, hazard ratio [HR] 0.43, 95% confidence interval [CI] 0.13-1.41, p = 0.163; 0.7% vs. 0.5%, HR 1.49, 95% CI 0.16-13.4, p = 0.719, respectively). BRS implantation was opted in younger patients (53.7 vs. 62.6 years, p < 0.001) with low-risk profiles, and intravascular image-guided PCI was more preferred in the BRS group (60.3% vs. 27.2%, p < 0.001).. At 1-year follow-up, no differences in the rate of DOCE and device thrombosis were observed between patients with AMI treated with BRS and those treated with DP-EES. Our data suggest that imaging-guided BRS implantation in young patients with low risk profiles could be a reasonable strategy in the setting of AMI.

Topics: Absorbable Implants; Acute Disease; Adult; Aged; Cardiovascular Agents; Drug-Eluting Stents; Endpoint Determination; Everolimus; Female; Humans; Male; Middle Aged; Myocardial Infarction; Percutaneous Coronary Intervention; Proportional Hazards Models; Republic of Korea; Thrombosis; Tissue Scaffolds; Treatment Outcome

Current drug-eluting stents have abluminal polymer coating; however, thrombus formation in these compared with that in uniformly coated stents remains controversial. We evaluated thrombus formation and early endothelialization after using abluminal biodegradable polymer-coated sirolimus- (BP-SES), and everolimus-eluting stents (BP-EES) versus a durable polymer-coated everolimus-eluting stent (DP-EES) in an in vivo setting. BP-SES, BP-EES, and DP-EES (n = 6 each) were implanted in coronary arteries of 12 mini-pigs that were then sacrificed after 7 and 10 days. Stents were stained with hematoxylin and eosin, and a combined Verhoeff and Masson trichrome stain. Areas of fibrin deposition were digitally detected and measured with off-line morphometric software. Stents were investigated for re-endothelialization by transmission electron microscopy. At 7 days, histological analysis revealed the lowest area of fibrin deposition in BP-SES (BP-SES vs. BP-EES vs. DP-EES; 0.10 ± 0.06 mm2 vs. 0.15 ± 0.07 mm2 vs. 0.19 ± 0.06 mm2, p = 0.0004). At 10 days, the area of fibrin deposition was significantly greater in DP-EES (0.13 ± 0.04 mm2 vs. 0.14 ± 0.05 mm2 vs. 0.19 ± 0.08 mm2, p = 0.007). Endothelial cells in BP-SES demonstrated a significantly greater number of tight junctions than those in DP-EES according to by transmission electron microscopy for both days (p<0.05). Various parameters, including an inflammatory reaction and neointimal formation, were comparable among the groups at 7 and 10 days. An abluminal biodegradable polymer-coated SES showed the least fibrin deposition and greatest endothelial cell recovery at an early stage following implantation in the coronary arteries of mini-pigs.

Topics: Absorbable Implants; Animals; Cardiovascular Agents; Coated Materials, Biocompatible; Coronary Angiography; Coronary Artery Disease; Coronary Vessels; Drug-Eluting Stents; Endothelial Cells; Everolimus; Fibrin; Models, Animal; Percutaneous Coronary Intervention; Polymers; Prosthesis Design; Sirolimus; Swine; Swine, Miniature; Thrombosis; Treatment Outcome

The objective of this study was to assess the feasibility, safety and initial efficacy of paclitaxel administration using a novel drug delivery catheter for the prevention of restenosis in infrapopliteal de novo and restenotic lesions.. Restenosis continues to be a great challenge after percutaneous revascularization procedures for peripheral arterial disease, particularly for below-the-knee applications.. A prospective, multicenter first-in-human registry of a novel delivery catheter delivering liquid paclitaxel was conducted in 10 patients. The primary efficacy endpoint at 6 months was freedom from clinically driven target lesion revascularization (CD-TLR) and the primary safety endpoint at 1, 3, and 6 months were thrombosis, major amputation in the target limb and target limb related death.. All patients tolerated the procedure well with no reports of adverse procedural events. Twelve (n = 12) lesions in ten patients were treated with a mean lesion length of 83.3 ± 49.2 mm, with the lesion length range of 30mm to 182 mm. At 6-month follow-up, the rate of CD-TLR was 30% (3 of 10 patients). Zero patients (0 out of 10) demonstrated thrombosis, major amputation in the target limb and target limb related death at the 1, 3, and 6 month follow-up intervals.. This first in-human experience obtained in a multicenter study of real-world de novo and restenotic lesions demonstrates a favorable safety and efficacy profile at 6 months. Randomized comparison to current drug coated balloons should be performed to further validate this approach and positive experience.

Topics: Amputation, Surgical; Angioplasty, Balloon; Cardiovascular Agents; Catheterization, Peripheral; Constriction, Pathologic; Feasibility Studies; Female; Humans; Limb Salvage; Lower Extremity; Male; Paclitaxel; Peripheral Arterial Disease; Prospective Studies; Recurrence; Registries; Risk Factors; Thrombosis; Time Factors; Treatment Outcome; United States; Vascular Access Devices; Vascular Patency

Aortic mural thrombi in a normal (non-aneurysmal or minimally atherosclerotic) vessel are an uncommon condition. They are usually located in the descending aorta and, less frequently, in the aortic arch or in the abdominal aorta. The typical clinical presentation is the appearance of symptoms/signs of peripheral arterial embolization, such as lower limb or visceral ischaemia, but these can also be accidentally found in asymptomatic patients. We report the case of a 40-year old man with untreated hypertension and dyslipidaemia admitted to hospital for atypical chest pain associated with an elevation in high-sensitivity troponin T with normal creatine kinase isoenzime MB creatine kinase isoenzyme. Elektrocardiogram (EKG) and transthoracic echocardiography were non-diagnostic; in order to exclude an aortic dissection, a gated chest computed tomography was performed and showed an aortic thrombus on a minimally atherosclerotic wall. Then, a transoesophageal echocardiography confirmed an aortic floating thrombus (7 × 4 mm). Cardiac surgeons advised against surgery and therapy with antiplatelet, low molecular weight heparin, β-blocker, antihypertensive and lipid-lowering drugs was initiated. A complete resolution of the thrombus was observed at the 12-day tomographic control.

Topics: Adult; Aorta, Thoracic; Aortic Diseases; Aortography; Asymptomatic Diseases; Atherosclerosis; Cardiovascular Agents; Echocardiography, Transesophageal; Humans; Male; Plaque, Atherosclerotic; Thrombosis; Tomography, X-Ray Computed; Treatment Outcome

Drug-eluting coronary stents reduce restenosis rate and late lumen loss compared with bare-metal stents; however, drug-eluting coronary stents may delay vascular healing and increase late stent thrombosis. The peroxisome proliferator-activated receptor-delta (PPARδ) exhibits actions that could favorably influence outcomes after drug-eluting coronary stents placement.. Here, we report that PPARδ ligand-coated stents strongly reduce the development of neointima and luminal narrowing in a rabbit model of experimental atherosclerosis. Inhibition of inflammatory gene expression and vascular smooth muscle cell (VSMC) proliferation and migration, prevention of thrombocyte activation and aggregation, and proproliferative effects on endothelial cells were identified as key mechanisms for the prevention of restenosis. Using normal and PPARδ-depleted VSMCs, we show that the observed effects of PPARδ ligand GW0742 on VSMCs and thrombocytes are PPARδ receptor dependent. PPARδ ligand treatment induces expression of pyruvate dehydrogenase kinase isozyme 4 and downregulates the glucose transporter 1 in VSMCs, thus impairing the ability of VSMCs to provide the increased energy demands required for growth factor-stimulated proliferation and migration.. In contrast to commonly used drugs for stent coating, PPARδ ligands not only inhibit inflammatory response and proliferation of VSMCs but also prevent thrombocyte activation and support vessel re-endothelialization. Thus, pharmacological PPARδ activation could be a promising novel strategy to improve drug-eluting coronary stents outcomes.

Topics: Angioplasty, Balloon; Animals; Aorta; Aortic Diseases; Atherosclerosis; Blood Platelets; Cardiovascular Agents; Carotid Artery Injuries; Cell Movement; Cell Proliferation; Cells, Cultured; Coronary Artery Disease; Disease Models, Animal; Dose-Response Relationship, Drug; Drug-Eluting Stents; Energy Metabolism; Glucose Transporter Type 1; Human Umbilical Vein Endothelial Cells; Humans; Mice, Knockout; Muscle, Smooth, Vascular; Myocytes, Smooth Muscle; Neointima; Platelet Activation; PPAR delta; Protein Serine-Threonine Kinases; Pyruvate Dehydrogenase Acetyl-Transferring Kinase; Rats; Rats, Sprague-Dawley; Re-Epithelialization; Recurrence; Signal Transduction; Steroids; Thrombosis; Time Factors; Transfection

The effectiveness of drug remaxol inclusion in the scheme of treatment of patients with myocardial infarction on the background of degree III - III acute cardiac insufficiency was evaluated by the analysis of clinical and laboratory data of 126 patients with newly diagnosed acute myocardial infarction including ST-segment elevation on the background of acute cardiac insufficiency. Depending on the regimen, patients were divided into two groups. The first (control) group included 60 patients who received conventional thrombolytic therapy; the second (main) group included 66 patients which, after thrombolytic therapy, received remaxol (single daily intravenous administration, 400 mL at 3 - 4 mL/min rate) with controlled central venous pressure, arterial pressure, and diuresis. The course lasted for 3 - 5 days, depending on the severity of condition. A high efficiency of the treatment regimen including remaxol was established as characterized by more rapid (in comparison to conventional therapy) stabilization of disturbed systemic hemodynamics and recovery of weakened myocardial contractility, decreased risk of cardiac arrhythmias, and relieved hyperhomocysteinemia that, in turn, reduced the risk of complications such as thrombosis and thromboembolism.

Topics: Aged; Arrhythmias, Cardiac; Blood Pressure; Cardiovascular Agents; Case-Control Studies; Drug Administration Schedule; Female; Fibrinolytic Agents; Heart Rate; Humans; Hyperhomocysteinemia; Injections, Intravenous; Male; Middle Aged; Shock, Cardiogenic; Succinates; Thromboembolism; Thrombolytic Therapy; Thrombosis; Treatment Outcome

The difference between left atrial (LA) and systemic coagulation activity in paroxysmal atrial fibrillation (PAF) is unclear.. We enrolled 100 patients with PAF who underwent AF ablation. Warfarin was stopped 1 day before the procedure. LA volume index and LA emptying fraction were measured by 64-slice multidetector computed tomography. Immediately after transseptal puncture, blood samples were simultaneously collected from the LA and systemic circulation (SC). In addition, to evaluate the effect of warfarin on D-dimer levels we recruited an additional 27 PAF patients on continuous warfarin. Even in patients with low CHADS2 scores (mean 0.59 ± 0.68) and during sinus rhythm, the prevalence of positive LA-D-dimer (≥ 0.5 µg/ml) was greater than that of SC-D-dimer (23% vs. 10%, P<0.01). The LA-D-dimer-positive patients had a larger mean LA volume index and reduced LA emptying fraction than the LA-D-dimer-negative patients. Multiple logistic regression analysis revealed that LA volume index was independently correlated with positive LA-D-dimer (odds ratio 2.245, 95% confidence interval 1.194-4.626, P=0.0112). The prevalence of positive LA-D-dimer was significantly lower in patients taking continuous warfarin, than in those on discontinuous warfarin (3.7% vs. 23%, P=0.025).. An enlarged LA volume index was associated with high LA coagulation status in patients with paroxysmal AF. Adequate warfarin control during AF catheter ablation may reduce the prevalence of positive LA-D-dimer.

Topics: Adult; Aged; Anticoagulants; Atrial Fibrillation; Blood Coagulation; Cardiovascular Agents; Catheter Ablation; Combined Modality Therapy; Comorbidity; Diabetes Mellitus; Female; Fibrin Fibrinogen Degradation Products; Heart Atria; Humans; Hypertension; International Normalized Ratio; Male; Middle Aged; Multidetector Computed Tomography; Predictive Value of Tests; Prognosis; Proportional Hazards Models; Prospective Studies; Prothrombin Time; Severity of Illness Index; Stroke; Thrombophilia; Thrombosis; Ultrasonography; Warfarin

This study sought to assess the rate and predictors of 1-year restenosis after drug-eluting stent implantation for femoropopliteal (FP) lesions in patients with peripheral arterial disease.. Zilver PTX, a paclitaxel-eluting stent for FP lesions, provides superior outcomes to angioplasty and bare-metal stents in clinical trials. However, its real-world outcomes and the associated features remain unclear.. This was a prospective multicenter study enrolling 831 FP lesions (797 limbs, 690 patients) treated by Zilver PTX implantation. The primary endpoint was 1-year restenosis. Secondary endpoints included major adverse limb event and stent thrombosis.. Mean lesion length was 17 ± 10 cm. One-year restenosis, major adverse limb event, and stent thrombosis rates were 37%, 22%, and 2%, respectively. The generalized linear mixed model showed that lesion length ≥16 cm assessed by angiography and distal external elastic membrane area ≤27 mm(2) and minimum stent area ≤12 mm(2) assessed by intravascular ultrasound were independent risk factors for restenosis. One-year restenosis rates were 15% in cases with none of these risk factors and 50% in those with ≥2 risk factors.. The current study demonstrated 1-year real-world outcomes after drug-eluting stent treatment for FP lesions, including challenging ones in clinical practice. Lesion length, external elastic membrane area, and minimum stent area were independent predictors for restenosis. (Zilver PTX for the Femoral Artery and Proximal Popliteal Artery-Prospective Multicenter Registry [ZEPHYR]; UMIN000008433).

Topics: Aged; Aged, 80 and over; Cardiovascular Agents; Drug-Eluting Stents; Endovascular Procedures; Female; Femoral Artery; Humans; Japan; Kaplan-Meier Estimate; Linear Models; Male; Multivariate Analysis; Odds Ratio; Paclitaxel; Peripheral Arterial Disease; Popliteal Artery; Proportional Hazards Models; Prospective Studies; Prosthesis Design; Radiography; Recurrence; Risk Factors; Thrombosis; Time Factors; Treatment Outcome; Ultrasonography, Interventional; Vascular Patency

Explore the relation between body mass index (BMI) and cardiovascular disease, and the influence of optimal medical therapy (OMT) on this relationship.. Patients from the REACH cohort, an international, prospective cohort of patients with or at high risk of atherosclerosis with documentation of potential confounders, including treatments and risk factors, were followed up to 4 years (n = 54 285). Patients were categorized according to baseline BMI (ranging from underweight to Grade III obesity). Optimal medical therapy was defined as the use of the four cardioprotective medication classes (statins, ACE inhibitors/angiotensin II receptor blockers, β-blockers, and antiplatelet agents). The main outcomes were all-cause mortality, cardiovascular (CV) mortality, and CV events. In primary and secondary prevention, a reverse J-shaped curve best described the relationship between BMI categories and the incidence of the various outcomes. In secondary prevention, the highest adjusted risks were observed for underweight patients (1.97, P < 0.01, and 1.29, P = 0.03, for CV mortality and CV events) and the lowest HRs were observed, respectively, in Grade II and Grade III obese patients (0.73, P < 0.01 and 0.80, P < 0.01). The proportion of patients on OMT increased with BMI from 10.1 to 36% (P < 0.001). The apparent CV protection conferred by obesity persisted in patients receiving OMT.. An obesity paradox was observed in both primary and secondary CV prevention patients. The intensity of use of evidence-based preventive medications does not account for the paradoxical CV protection associated with obesity. At extremes of BMI, further interventions beyond OMT may be needed to reduce CV risk.

Topics: Age Distribution; Aged; Atherosclerosis; Body Mass Index; Cardiovascular Agents; Cardiovascular Diseases; Evidence-Based Medicine; Female; Global Health; Humans; Male; Middle Aged; Obesity, Metabolically Benign; Prospective Studies; Risk Factors; Thrombosis; Treatment Outcome

This study sought to evaluate whether the permanent fluoropolymer-coated Xience Xpedition everolimus-eluting stent (Xience-EES) exhibits lower acute thrombogenicity compared with contemporary drug-eluting stents (DES) with biodegradable polymer coatings in an acute swine shunt model.. Previous pre-clinical and clinical experience suggests that several factors may influence the predisposition for acute thrombus formation of polymer-coated DES, including stent design and the polymer coating technology. It remains unclear whether relevant differences exist with respect to acute thrombogenicity, particularly between current commercial stent designs using permanent polymers and those using biodegradable polymers.. An ex vivo carotid to jugular arteriovenous porcine shunt model involving a test circuit of 3 in-line stents, was used to test acute thrombogenicity, where Xience-EES (n = 24) was compared with 4 CE-marked DES with biodegradable polymer coatings (BioMatrix Flex, Synergy, Nobori, and Orsiro [n = 6 each]). After 1 h of circulation, platelet aggregation in whole mount stents was evaluated by confocal microscopy with immunofluorescent staining against dual platelet markers (CD61/CD42b) along with scanning electron microscopy.. Xience-EES showed the least percentage of thrombus-occupied area as compared with the biodegradable polymer-coated DES, with a significant difference compared with BioMatrix Flex and Synergy (mean differences: [BioMatrix Flex: 15.54, 95% confidence interval [CI]: 11.34 to 19.75, p < 0.001; Synergy: 8.64, 95% CI: 4.43 to 12.84, p < 0.001; Nobori: 4.22, 95% CI: -0.06 to 8.49, p = 0.055; Orsiro: 2.95, 95% CI: -1.26 to 7.15, p = 0.286). The number of cell nuclei on strut surfaces was also the least in Xience-EES, with a significant difference relative to BioMatrix Flex, Nobori, and Orsiro (mean ratios: BioMatrix Flex: 4.73, 95% CI: 2.46 to 9.08, p < 0.001; Synergy: 1.44, 95% CI: 0.75 to 2.76, p = 0.51; Nobori: 5.97, 95% CI: 3.11 to 11.44, p < 0.001; Orsiro: 5.16, 95% CI: 2.69 to 9.91, p < 0.001).. Xience-EES's overall design confers acute thromboresistance relative to contemporary DES with biodegradable coatings, with less platelet aggregation versus BioMatrix Flex and Synergy, and less inflammatory cell attachment versus BioMatrix Flex, Nobori, and Orsiro, in an ex vivo swine shunt model, which lends support to reported clinical findings of lower early stent thrombosis.

Topics: Acute Disease; Animals; Blood Coagulation; Cardiovascular Agents; Coated Materials, Biocompatible; Drug-Eluting Stents; Endovascular Procedures; Everolimus; Inflammation; Materials Testing; Microscopy, Confocal; Microscopy, Electron, Scanning; Models, Animal; Platelet Aggregation; Polymers; Prosthesis Design; Swine; Thrombosis; Time Factors

Acute peripheral arterial thrombosis can be threatening to life and limb. Dissolution of the thrombus local catheter-directed intra-arterial infusion of fibrinolytic agents such as urokinase is the standard therapy for thrombosis; however, this method is time-intensive, and amputation of the affected limb is still needed in 10-30% of cases. Furthermore, thrombolytic therapy carries the risk of bleeding complications. The use of small gas-filled bubbles, or ultrasound contrast agents (UCAs), in combination with ultrasound has been investigated as an improved thrombolytic therapy in acute coronary and cerebral arterial thrombosis. The authors describe a porcine model of acute peripheral arterial occlusion to test contrast-enhanced sonothrombolysis approaches that combine ultrasound, UCAs and fibrinolytic agents and recommend a strategy for preventing severe allergic reactions to UCAs in the pigs.

Topics: Anaphylaxis; Animals; Cardiovascular Agents; Contrast Media; Female; Indomethacin; Lipids; Mechanical Thrombolysis; Microbubbles; Peripheral Arterial Disease; Premedication; Swine; Thrombosis

Topics: Absorbable Implants; Adult; Cardiovascular Agents; Coated Materials, Biocompatible; Coronary Angiography; Coronary Vessels; Everolimus; Humans; Male; Myocardial Infarction; Percutaneous Coronary Intervention; Predictive Value of Tests; Prosthesis Design; Sirolimus; Thrombosis; Time Factors; Tomography, Optical Coherence; Treatment Outcome

To assess long-term outcome after rotational atherectomy (RA) is followed by drug-eluting stent (DES) implantation in complex calcified coronary lesions.. RA can favorably modify heavily calcified coronary lesions, but long-term outcome is poor when it is used as a stand-alone therapy or combined with bare-metal stents. DES have reduced rates of restenosis in a wide range of patient and lesion subsets, but little information is available on long-term clinical outcome when RA is followed by DES implantation (Rota-DES) in complex calcified lesions.. Two hundred and five patients with de novo complex calcified coronary lesions treated with Rota-DES were analyzed. Mean age was 69.7 ± 9.3 years, 63 patients (31%) had diabetes mellitus and 21 patients (10%) had chronic renal failure. Total stent length/patient was 32 mm. The majority of patients were treated with paclitaxel-eluting stents (64%) or sirolimus-eluting stents (30%). Angiographic success rate was 98%. The incidence of in-hospital major adverse cardiac events (MACE), defined as death, myocardial infarction (MI), and target vessel revascularization (TVR), was 4.4%. Long-term follow-up was available for 188 patients (92%). At a median follow-up period of 15 months (range, 1-84), the cumulative incidence of MACE (Kaplan-Meier estimate) was 17.7%. Death occurred in 4.4%, MI in 3.4%, TVR in 9.9%, and target lesion revascularization (TLR) in 6.8%. One definite (0.5%) and one probable (0.5%) stent thrombosis were observed. In a multivariate analysis, low ejection fraction (<40%) was the only independent predictor of MACE, and both age and diabetes were independent predictors of TLR.. This study represents the largest European data set of patients treated with RA in the DES era. RA followed by DES implantation in calcified coronary lesions appears to be feasible and effective, with a high rate of procedural success and low incidence of TLR and MACE at long term considering this complex patient and lesion subset.

Topics: Aged; Aged, 80 and over; Atherectomy, Coronary; Cardiovascular Agents; Comorbidity; Coronary Angiography; Coronary Artery Disease; Diabetes Mellitus; Drug-Eluting Stents; Female; Hospital Mortality; Humans; Incidence; Kaplan-Meier Estimate; Kidney Failure, Chronic; Male; Middle Aged; Multivariate Analysis; Myocardial Infarction; Paclitaxel; Percutaneous Coronary Intervention; Proportional Hazards Models; Prosthesis Design; Registries; Retrospective Studies; Risk Factors; Sirolimus; Stroke; Thrombosis; Time Factors; Treatment Outcome; Vascular Calcification

This study aimed to analyze the use of everolimus-eluting stents (EES) and paclitaxel-eluting stents (PES) in an unrestricted diabetic population and to compare the performance of these two drug-eluting stents.. EES have demonstrated superiority in efficacy when compared to PES in a general population. However, it is controversial whether this superiority holds true in a diabetic population.. From March 2004 to May 2010, 968 patients with consecutive diabetes who underwent percutaneous coronary intervention and implantation of an EES (n = 388) or PES (n = 580) at our institution. In-hospital, 1-month, 6-month, and 1-year clinical outcomes were analyzed and compared. Correlates of major adverse cardiac events (MACE) were identified.. Baseline clinical characteristics were similar between stent types except for more family history of coronary artery disease in the PES group and more insulin-dependent diabetes and unstable angina at initial diagnosis in the EES group. The PES group had higher number of lesions treated, longer stents used, and a higher proportion of intravascular ultrasound and glycoprotein IIb/IIIa inhibitor use. The EES group had more type C and distal lesions. There was higher target lesion revascularization (TLR)-MACE in the PES group (3.3% vs. 1.0%, P = 0.03) as well as a higher rate of stent thrombosis (ST) (8 patients vs. 0 in the EES group, P = 0.03). ST continued to be higher in the PES group at 6 and 12 months and mortality was higher at 12 months in the PES group (9.4% vs. 5.2%, P = 0.02). After adjustment, no significant differences were found between stent types on Cox regression analysis for hazard ratios at 1-year follow-up of TLR-MACE.. In a diabetic population undergoing PCI, the use of an EES compared to PES was associated with lower rates of stent thrombosis; but after adjustment the composite TLR-MACE at 1 year was similar between both stents.

Topics: Aged; Cardiovascular Agents; Chi-Square Distribution; Coronary Angiography; Coronary Artery Disease; Diabetic Angiopathies; Disease-Free Survival; District of Columbia; Drug-Eluting Stents; Everolimus; Female; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Multivariate Analysis; Myocardial Infarction; Paclitaxel; Percutaneous Coronary Intervention; Platelet Aggregation Inhibitors; Predictive Value of Tests; Proportional Hazards Models; Prosthesis Design; Registries; Retrospective Studies; Risk Assessment; Risk Factors; Sirolimus; Thrombosis; Time Factors; Treatment Outcome; Ultrasonography, Interventional

Polymer-coating represents a key component of drug-eluting stent (DES) technology and its possible impact on vessel-wall healing is a matter of debate. The clinical impact of different polymer-coating may be assessed by comparing the outcome of patients treated by DES having the same stent platform and drug, and differing in the polymer. Thus, we compared the clinical outcome of patients treated by Endeavor Zotarolimus-eluting stent (E-ZES) and Resolute Zotarolimus-eluting stent (R-ZES) as they differ in the polymer-coating only.. At our Institution, E-ZES was available during a first period and then it was substituted by the R-ZES during a second period. Clinical, angiographic, and procedural data were prospectively collected. Clinical follow-up was prospectively obtained up to 1-year. Primary endpoint was the occurrence of major adverse cardiac events (MACE) at 12-month.. A total of 467 patients undergoing percutaneous coronary intervention were enrolled: 233 patients treated with E-ZES and 234 with R-ZES. Patients treated by R-ZES had similar clinical characteristics and worse angiographic characteristics compared with those treated by E-ZES. At 12-month follow-up, MACE rate was significantly lower in the R-ZES group compared with E-ZES group (4.2% vs. 14.6%; P < 0.01). This difference was due to nonsignificantly lower rates of death and myocardial infarction and to significant lower rate of target-lesion-revascularization (R-ZES 3.4% vs. E-ZES 10.3%, P < 0.01).. The results of this study suggest that the clinical outcome of patients treated by DES differing for the polymer coating only may be different. Polymer coating is a pivotal, probably underrated, component of DES technology which may influence the clinical performance of DES.

Topics: Aged; Cardiovascular Agents; Coated Materials, Biocompatible; Coronary Angiography; Drug-Eluting Stents; Female; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Myocardial Infarction; Percutaneous Coronary Intervention; Polymers; Proportional Hazards Models; Prospective Studies; Prosthesis Design; Rome; Sirolimus; Thrombosis; Time Factors; Treatment Outcome

Partial thrombosis of the false lumen has been reported as a significant predictor of mortality during follow-up in patients with acute type B aortic dissection. The purpose of this study was to investigate the correlation of false lumen thrombosis and aortic expansion during follow-up in patients with acute type B aortic dissection.. All medically treated patients with acute type B aortic dissection observed in 4 cardiovascular referral centers between 1998 and 2011, with admission and follow-up computed tomography or magnetic resonance imaging scans, were included. Aortic diameters of the dissected aortas were measured at 4 levels on the baseline and follow-up scans, and annual growth rates were calculated. Univariate and multivariate regression analyses were used to investigate the effect of false lumen thrombosis on aortic growth rate.. A total of 84 patients were included, of whom 40 (47.6%) had a partially thrombosed false lumen, 7 (8.3%) had a completely thrombosed false lumen, and 37 (44.0%) had a patent false lumen. A total of 273 of the 336 (81.3%) evaluated aortic levels were dissected segments. Overall, the mean aortic diameter increased significantly at all evaluated levels (P < .001). Univariate analysis showed that annual aortic growth rates were significantly higher in those segments having a false lumen with partial thrombosis (mean, 4.25 ± 10.2) when compared with the patent group (mean, 2.10 ± 5.56; P = .035). In multivariate analysis, partial lumen thrombosis was an independent predictor of higher aortic growth (adjusted mean difference, 2.05 mm/year; 95% confidence interval, 0.10-4.01; P = .040).. In patients with acute type B aortic dissection, aortic segments with a partially thrombosed false lumen have a significantly higher annual aortic growth rate when compared with those presenting with patent or complete thrombosis of the false lumen. Therefore, patients with partial thrombosis require more intensive follow-up and may benefit from prophylactic intervention.

Topics: Aortic Aneurysm; Aortic Dissection; Aortography; Cardiovascular Agents; Connecticut; Disease Progression; Female; Humans; Italy; Linear Models; Magnetic Resonance Angiography; Male; Multivariate Analysis; Netherlands; Predictive Value of Tests; Risk Factors; Thrombosis; Time Factors; Tomography, X-Ray Computed; Treatment Outcome

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

A 73-year-old woman was admitted to our hospital with anterior acute myocardial infarction due to subacute thrombosis after coronary stenting with a zotarolimus-eluting stent (ZES), which is a newly developed drug-eluting stent that has been widely used since May 2009 in Japan. Five days before, she underwent implantation with a ZES in the left anterior descending artery due to stable angina pectoris. After stenting, the intravascular ultrasonography showed no malapposition from the proximal to the distal edge of the stent. She received aspirin 100 mg/day and clopidogrel 75 mg/day from 2 weeks before the stent was implanted. When we investigated the single nucleotide polymorphisms of CYP2C19 in this patient, both CYP2C19*2 and CYP2C19*3 were detected, and she was classified as a poor metabolizer. This report is the first to describe subacute stent thrombosis following the implantation of a newly developed ZES in a Japanese patient, which may be related to clopidogrel resistance.

Topics: Aged; Angioplasty, Balloon, Coronary; Anterior Wall Myocardial Infarction; Aryl Hydrocarbon Hydroxylases; Aspirin; Cardiovascular Agents; Clopidogrel; Coronary Angiography; Coronary Artery Disease; Cytochrome P-450 CYP2C19; Drug Resistance; Drug-Eluting Stents; Female; Genotype; Humans; Phenotype; Platelet Aggregation Inhibitors; Polymorphism, Single Nucleotide; Prosthesis Design; Sirolimus; Thrombectomy; Thrombosis; Ticlopidine; Treatment Outcome; Ultrasonography, Interventional

To assess clinical performance of the second-generation Endeavor Resolute(®) drug-eluting stents (DES) in an unrestricted high-risk cohort of patients.. New-generation DESs aim to further increase its clinical safety and efficacy by means of more biocompatible components limiting inflammatory response, assuring strut coverage and preserving endothelial vascular function.. Between January 2008 and April 2009 820 unselected consecutive high-risk patients (1,352 lesions) treated with the Endeavor Resolute(®) stent were enrolled in an independent multicenter registry. Primary end-points of this registry were immediate procedural outcome, incidence of target lesion failure (TLF, defined as composite of cardiac death, myocardial infarction, and target lesion revascularization) and rate of ARC stent thrombosis at 12-months follow-up.. High-risk patient/lesion profile included acute coronary syndrome diagnosis in 57% of patients, diabetes mellitus in 23% and ACC/AHA type B2/C lesion in 74%. Endeavor Resolute(®) stent was used in an off-label indication in 52% of cases with stent/patient ratio of 1.93 and average stented segment of 39.8±26.6 mm. Immediate procedural success was accomplished in 96.0% of cases and at median 12-month follow-up TLF rate was 7.1% with 4.0% of clinically driven repeat revascularizations and 1.1% of definite/probable stent thrombosis incidence. At multivariable analysis, nor off-label Endeavor Resolute(®) stent use or multiple stent implantations were associated to an increased risk of adverse events.. Extensive use of the new Endeavor Resolute(®) stent was associated with favorable procedural and 12-month outcomes despite the treatment of unselected complex clinical and anatomical presentation. Endeavor Resolute(®) stent showed excellent safety and efficacy profile also in off-label indications.

Topics: Adult; Aged; Aged, 80 and over; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Chi-Square Distribution; Coronary Artery Disease; Drug-Eluting Stents; Female; Hospital Mortality; Humans; Italy; Kaplan-Meier Estimate; Logistic Models; Male; Middle Aged; Multivariate Analysis; Myocardial Infarction; Product Labeling; Prospective Studies; Prosthesis Design; Registries; Risk Assessment; Risk Factors; Sirolimus; Thrombosis; Time Factors; Treatment Outcome

Stent fracture has emerged as a complication of drug-eluting stent and is now recognized as contributing to in-stent restenosis and possibly stent thrombosis. Although optical coherence tomography (OCT) can detect stent fractures in the absence of circumference struts, it is challenging to visualize stent fractures with only cross-sectional OCT images. We describe two cases of restenosis with stent fracture detected by a novel three-dimensional OCT image reconstruction technique. This technique allows identification of a single stent fracture even in the absence of angiographic signs.

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Angiography; Coronary Restenosis; Coronary Stenosis; Coronary Vessels; Drug-Eluting Stents; Humans; Imaging, Three-Dimensional; Male; Prosthesis Design; Prosthesis Failure; Sirolimus; Thrombosis; Time Factors; Tomography, Optical Coherence; Treatment Outcome

Although drug-eluting stents (DESs) can decrease the risk of restenosis, this benefit is tempered by a possible increased risk of in-stent thrombosis. We assessed the effects of rapamycin on human umbilical vein endothelial cells (HUVECs) to identify the alterations in gene expression associated with thrombosis. Expression of tissue plasminogen activator (t-PA) and plasminogen activator inhibitor 1 (PAI-1) was assessed in HUVECs treated with rapamycin (final concentrations: 1, 10, 100, and 1000 ng/mL) for 24 and 48 hours. Incubation of HUVECs with rapamycin strongly reduced the expression of t-PA in a concentration-dependant manner (P < .05 to < .01). However, the expression of PAI-1 was induced by rapamycin (P < .05 to < .01). The increase in PAI-1 induction was up to 3.3-fold. In conclusion, rapamycin inhibited t-PA and induced PAI-1 expression in HUVECs. This effect may contribute to in-stent thrombosis associated with DESs.

Topics: Cardiovascular Agents; Cells, Cultured; Dose-Response Relationship, Drug; Down-Regulation; Drug-Eluting Stents; Human Umbilical Vein Endothelial Cells; Humans; Plasminogen Activator Inhibitor 1; Prosthesis Design; RNA, Messenger; Sirolimus; Thrombosis; Time Factors; Tissue Plasminogen Activator; Up-Regulation

Previous studies for approved indications (on-label) have shown the good safety and efficacy profiles of the Nobori DES. We conducted a prospective, multicentre study to validate the clinical performance of this stent in a real-world setting.. A total of 3,067 consecutive patients undergoing a percutaneous coronary intervention with the Nobori DES were enrolled in the NOBORI 2 registry. At one and two years, 97% and 95% of patients, respectively, were available for follow-up. The rates of target lesion failure (TLF), cardiac death, myocardial infarction and target lesion revascularisations were: 3.9%, 1.2%, 1.9% and 2.2% at one year and 5.1%, 1.6%, 2.4% and 3.0% at two years. Overall, 2,242 patients (73%) were treated for at least one off-label indication. When comparing off-label and on-label groups, the results were: TLF 4.5% vs. 2.2%, p=0.003 at one year and 5.9% vs. 2.8%, p=0.001 at two years. The rate of stent thrombosis was 0.68%, and 0.80% at one and two years, respectively with no difference between the off-label and on-label groups (0.76% vs. 0.48%, p=0.6 and 0.89% vs. 0.61%, p=0.5).. The promising results previously observed in lower risk patients can be replicated in daily practice. As expected, in off-label indications, rates of adverse events were higher. Nevertheless, our results suggest the good and sustained performance of this stent system in high-risk patients with significant comorbidities and/or complex lesions.

Topics: Absorbable Implants; Aged; Analysis of Variance; Angioplasty, Balloon, Coronary; Asia; Cardiovascular Agents; Coronary Artery Disease; Drug-Eluting Stents; Europe; Female; Guideline Adherence; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Myocardial Infarction; Polymers; Practice Guidelines as Topic; Product Labeling; Prospective Studies; Prosthesis Design; Registries; Sirolimus; Thrombosis; Time Factors; Treatment Outcome

In this retrospective study, we compared the in-hospital and long-term outcomes of the on-label and off-label uses of drug-eluting stents.From April 2003 through June 2007, 1,538 patients underwent percutaneous coronary intervention with a drug-eluting stent (sirolimus or paclitaxel) at Tehran Heart Center. Off-label implantation of the drug-eluting stent was as implemented on the basis of specific clinical and procedural characteristics set forth in our text. There were 708 patients in the on-label group and 830 in the off-label group.Baseline characteristics were not significantly different between the groups. Histories of non-ST-segment-elevation myocardial infarction, percutaneous coronary intervention, and coronary artery bypass grafting were more prevalent in the off-label group. Both groups had similar procedural and in-hospital complications. The follow-up rate at 1 year was 93.1% in the on-label group and 93.3% in the off-label group. During that period, the occurrence of major adverse cardiac events was not significantly different between the groups. After 1 year between the respective on- and off-label uses of the sirolimus-eluting and paclitaxel-eluting stents, and after adjustment for diabetes mellitus, myocardial infarction, percutaneous coronary intervention, and coronary artery bypass grafting, there was no remarkable difference in the occurrence of major adverse cardiac events (hazard ratio, 0.688; 95% confidence interval, 0.365-1.295; P=0.2463) or target-vessel revascularization (hazard ratio, 0.69; 95% confidence interval, 0.291-1.636; P=0.3993).We found that off-label use of drug-eluting stents was safe after 1 year and that such use was not associated with increased in-hospital myocardial infarction or death.

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Chi-Square Distribution; Coronary Artery Disease; Drug-Eluting Stents; Female; Guideline Adherence; Hospital Mortality; Humans; Iran; Kaplan-Meier Estimate; Male; Middle Aged; Multivariate Analysis; Myocardial Infarction; Paclitaxel; Practice Guidelines as Topic; Product Labeling; Proportional Hazards Models; Prosthesis Design; Registries; Retrospective Studies; Risk Assessment; Risk Factors; Sirolimus; Thrombosis; Time Factors; Treatment Outcome

In this study we compared the outcomes of the everolimus-eluting stent (EES) versus the zotarolimus-eluting stent (ZES) in patients treated at a tertiary medical center, with up to one year of follow-up.. Unselected consecutive patients were retrospectively recruited following stenting with the ZES (n = 197) or EES (n = 190). The first 100 consecutive patients in each cohort underwent syntax scoring. The primary endpoint of the study was target vessel failure, defined as the combined endpoint of cardiac death, non-fatal myocardial infarction, or target vessel revascularization. Secondary endpoints included target lesion revascularization, target lesion failure, acute stent thrombosis, total death, cardiac death, and non-fatal myocardial infarction.. The two groups were similar, including for Syntax scores (19.6 ± 12.8 versus 20.6 ± 13.6), number of stents per patient (2.9 ± 1.9 versus 2.9 ± 2.1), and cardiovascular risk factors. By one year, the primary outcome occurred in 20.8% EES versus 26.7% ZES (P = 0.19) patients. The secondary endpoints were as follows: target lesion revascularization (8.9% versus 20.6%, P = 0.003), target vessel revascularization (18.9% versus 25.6%, P = 0.142), definite and probable stent thrombosis (0% versus 2.5%), non-fatal myocardial infarction (2.7% versus 3.6%), and mortality (3.2% versus 5.1%) for the EES versus the ZES, respectively.. EES had similar target vessel failure to ZES, but superior target lesion revascularization and target lesion failure at one year of follow-up in an unselected cohort of patients.

Topics: Aged; Aged, 80 and over; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Chi-Square Distribution; Coronary Restenosis; Coronary Stenosis; Drug-Eluting Stents; Everolimus; Female; Humans; Iowa; Kaplan-Meier Estimate; Male; Middle Aged; Myocardial Infarction; Retrospective Studies; Sirolimus; Thrombosis; Time Factors; Treatment Outcome

Topics: Cardiovascular Agents; Drug-Eluting Stents; Human Umbilical Vein Endothelial Cells; Humans; Plasminogen Activator Inhibitor 1; Sirolimus; Thrombosis; Tissue Plasminogen Activator

Atrial fibrillation (AF) is the most common chronic pathologic arrhythmia in dogs, and whereas thromboembolism is a common complication of AF in humans, this complication has not been previously reported in dogs. This report describes thrombotic complications associated with AF in three dogs. A spherical left atrial mass consistent with a thrombus was identified in two dogs during echocardiographic examination. A third dog experienced arterial thromboembolism confirmed with ultrasound and postmortem examination. These cases provide a unique antemortem description of intra-atrial thrombus formation and cardioembolic disease associated with AF in dogs, and raise awareness of the importance of thorough echocardiographic evaluation of the atria for thrombus prior to pharmacologic cardioversion or direct current cardioversion.

Topics: Animals; Anticoagulants; Atrial Fibrillation; Cardiovascular Agents; Dog Diseases; Dogs; Fatal Outcome; Female; Male; Thrombosis; Warfarin

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

At present, percutaneous coronary intervention with drug-eluting stent (DES) implantation represents the default strategy to treat coronary artery disease in many institutions around the world. However, concerns regarding long-term safety of first-generation DES have prompted the development of novel DES systems such as the NEVO (Cordis Corporation, Johnson & Johnson, Warren, NJ) sirolimus-eluting stent with biodegradable polymer and reservoir technology. In the current report, we present, for the first time, a complete midterm invasive assessment of a patient treated with this novel device in the Res-Elution I study.

Topics: Angioplasty, Balloon, Coronary; Biocompatible Materials; Cardiovascular Agents; Coronary Angiography; Coronary Artery Disease; Coronary Restenosis; Drug-Eluting Stents; Humans; Male; Middle Aged; Prosthesis Design; Sirolimus; Thrombosis; Time Factors; Tomography, Optical Coherence; Treatment Outcome; Ultrasonography, Interventional

We aimed at comparing the long term clinical outcome of SES and PES in routine clinical practice.. Although sirolimus-eluting stents (SES) more effectively reduce neointimal hyperplasia than paclitaxel-eluting stents (PES), uncertainty prevails whether this difference translates into differences in clinical outcomes outside randomized controlled trials with selected patient populations and protocol-mandated angiographic follow-up.. Nine hundred and four consecutive patients who underwent implantation of a drug-eluting stent between May 2004 and February 2005: 467 patients with 646 lesions received SES, 437 patients with 600 lesions received PES. Clinical follow-up was obtained at 2 years without intervening routine angiographic follow-up. The primary endpoint was a composite of death, myocardial infarction (MI), or target vessel revascularization (TVR).. At 2 years, the primary endpoint was less frequent with SES (12.9%) than PES (17.6%, HR = 0.70, 95% CI 0.50-0.98, P = 0.04). The difference in favor of SES was largely driven by a lower rate of target lesion revascularisation (TLR; 4.1% vs. 6.9%, P = 0.05), whereas rates of death (6.4% vs. 7.6%, P = 0.49), MI (1.9% vs. 3.2%, P = 0.21), or definite stent thrombosis (0.6% vs. 1.4%, P = 0.27) were similar for both stent types. The benefit regarding reduced rates of TLR was significant in nondiabetic (3.6% vs. 7.1%, P = 0.04) but not in diabetic patients (5.6% vs. 6.1%, P = 0.80).. SES more effectively reduced the need for repeat revascularization procedures than PES when used in routine clinical practice. The beneficial effect is maintained up to 2 years and may be less pronounced in diabetic patients.

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Chi-Square Distribution; Coronary Angiography; Coronary Stenosis; Diabetes Mellitus; Drug-Eluting Stents; Female; Humans; Male; Middle Aged; Myocardial Infarction; Paclitaxel; Proportional Hazards Models; Prospective Studies; Prosthesis Design; Registries; Risk Assessment; Risk Factors; Severity of Illness Index; Sirolimus; Switzerland; Thrombosis; Time Factors; Treatment Outcome

Topics: Adult; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Angiography; Drug-Eluting Stents; Fibrinolytic Agents; Humans; Male; Middle Aged; Myocardial Infarction; Paclitaxel; Prosthesis Design; Thrombolytic Therapy; Thrombosis; Time Factors; Treatment Outcome

To present data from the cohort of patients in the all-comers Endeavor zotarolimus-eluting stent (ZES) registry (E-Five) who underwent 2-year follow-up.. The Endeavor ZES has been shown to be safe and efficacious for treatment of single, de novo lesions in patients with stable coronary artery disease. E-Five evaluated the ZES in over 8,000 real-world patients, at 188 sites followed to 1 year. A subset of sites continued follow-up through 2 years to evaluate late-term safety and effectiveness of the ZES in this population with diverse clinical and lesion characteristics.. E-Five, a prospective, multicenter, nonrandomized global registry, collected 2-year outcomes for 2,116 patients from 26 centers. Sites were selected for participation based on patient accrual rates and the ability to continue follow-up activities for an additional year. Complete data was available for 2,054 patients. To observe whether or not a sustained benefit was achieved, data for all patients from the selected sites were included in the analysis.. The outcomes in the 2-year cohort tracked with the results of randomized controlled trials using the Endeavor ZES. One year results were MACE 7.5%, TLR 4.5%, and ARC definite/probable stent thrombosis 0.6%. Outcomes at 2 years for MACE, TLR, and ARC definite/probable stent thrombosis were 8.5, 5.1, and 0.7%, respectively.. Long-term efficacy and safety outcomes were maintained between 1 and 2 years for the 2-year patient cohort, with only a small number of additional MACE, TLR, and very late stent thrombosis events.

Topics: Aged; Angioplasty, Balloon, Coronary; Asia; Cardiovascular Agents; Coronary Artery Disease; Drug Therapy, Combination; Drug-Eluting Stents; Europe; Female; Follow-Up Studies; Humans; Latin America; Male; Middle Aged; Platelet Aggregation Inhibitors; Prospective Studies; Prosthesis Design; Registries; Risk Assessment; Risk Factors; Sirolimus; Thrombosis; Time Factors; Treatment Outcome

The TAXUS OLYMPIA registry is a prospective, global, post-approval program designed to collect clinical outcome data through 1 year from patients receiving the TAXUS Liberté paclitaxel-eluting stent in routine interventional cardiology practice.. The thin-strut TAXUS Liberté stent has been studied in ongoing clinical trials with specific inclusion/exclusion criteria.. Between September 2005 and April 2007, a total of 21,954 patients from 365 sites in 57 countries eligible to receive a TAXUS Liberté stent were enrolled in the TAXUS OLYMPIA registry. Baseline characteristics and procedure patterns were collected and clinical follow-up is available for 1 year. The primary endpoint was the composite cardiac event (cardiac death, MI, and reintervention of the target vessel) rate related to the TAXUS Liberté stent at 1 year. All cardiac events were monitored and all endpoints were independently adjudicated.. Complex patients and lesions were prevalent, including: 27% medically-treated diabetes, 58% ACC/AHA type B2/C lesions, 32% multiple stenting, 13% long lesions (>28 mm), and 10% small vessels (<2.5 mm). At 1 year, the composite cardiac event rate was 4.4%, including 1.4% cardiac death, 1.0% MI, and 3.2% TVR. Stent thrombosis (ST, angiographically confirmed) occurred in 0.8% of patients, with 0.4% ST occurring >30 days postprocedure. The composite cardiac event rate related to the TAXUS Liberté stent was 3.8% at 1 year.. Low 1-year cardiac event rates were reported with TAXUS Liberté in a broad spectrum of patients, thereby confirming the technical and clinical performance of this stent in a "real-world" setting.

Topics: Africa, Northern; Aged; Angioplasty, Balloon, Coronary; Asia; Cardiovascular Agents; Diabetes Mellitus; Drug-Eluting Stents; Europe; Female; Humans; Male; Middle Aged; Myocardial Infarction; Paclitaxel; Practice Patterns, Physicians'; Proportional Hazards Models; Prospective Studies; Prosthesis Design; Registries; Regression Analysis; Risk Assessment; Risk Factors; South America; Thrombosis; Time Factors; Treatment Outcome

Late stent thrombosis (LST) after drug-eluting stent (DES) implantation is a major clinical problem that has not been fully explained. Incomplete neointimal coverage of stent struts is an important morphometric predictor of LST, which may be associated with impaired healing and the absence of full coverage of struts at branch-point ostia. Optical coherence tomography (OCT) was performed to compare 3 types of stents placed across side branches.. At 9-month follow-up, the neointimal coverage of the struts of 58 stents across a side branch was measured by OCT (bare metal (BMS), n = 20; sirolimus-eluting (SES), n = 23; paclitaxel-eluting (PES), n = 15). According to the diameter ratio of side branch to main vessel, the side branches were classified as either large (ratio > 0.33) or small (ratio ≤ 0.33). BMS had the lowest frequency of uncovered struts (29.4%) and the greatest neointimal thickness on the struts (123 ± 33 µm). Neointimal thickness on the struts was less for SES than for PES (72 ± 16 vs. 91 ± 22 µm, P = 0.009), but there was no difference in the frequency of uncovered struts (66.1% vs. 58.6%, P=0.493). For large side branches, the frequency of uncovered struts was greater than in the small group for SES (87.5% vs. 40.7%, P = 0.0002) and PES (83.3% vs. 18.2%; P = 0.0013); there was no significant difference for BMS (43.8% vs. 16.7%, P = 0.138).. Neointimal coverage on struts across a side branch was less frequently observed in DES than in BMS, particularly in large side branches.

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Chi-Square Distribution; Coronary Vessels; Drug-Eluting Stents; Female; Humans; Japan; Male; Metals; Middle Aged; Paclitaxel; Prosthesis Design; Risk Assessment; Risk Factors; Sirolimus; Stents; Thrombosis; Time Factors; Tomography, Optical Coherence; Treatment Outcome; Tunica Intima

 The cytochrome P450 (CYP) 2C19*2 polymorphism is associated with reduced responsiveness to clopidogrel and poor clinical outcome after stent implantation. Despite the high frequency of this polymorphism in Japanese patients, its contribution to cardiac events and stent thrombi after drug-eluting stent (DES) implantation is not clear in this population..  One hundred Japanese patients received clopidogrel and underwent follow-up optical coherence tomography (OCT) after DES implantation. The patients were divided into 2 groups: those with at least one CYP2C19*2 allele (*2 carriers) and non-carriers. The incidence of stent thrombosis and major adverse cardiac events (MACE; ie, death, myocardial infarction, and target vessel revascularization) was compared between the 2 groups. In addition, OCT was used to evaluate the incidence of intra-stent thrombus, defined as a mass protruding into the lumen with significant attenuation. Of the 100 patients, 42 were *2 carriers. No remarkable differences in the baseline characteristics were noted. Although MACE did not differ significantly between the 2 groups, a subclinical intra-stent thrombus was detected more frequently in *2 carriers than in non-carriers (52.3% vs. 15.5%, P=0.0002). Multivariate logistic regression analysis showed that the presence of the CYP2C19*2 polymorphism was the only independent predictive factor for intra-stent thrombus (P=0.00006)..  From these results it is suggested that CYP2C19*2 polymorphism is associated with subclinical thrombus formation among Japanese patients receiving clopidogrel. (Circ J 2011; 75: 99-105).

Topics: Aged; Angioplasty, Balloon, Coronary; Aryl Hydrocarbon Hydroxylases; Asian People; Cardiovascular Agents; Chi-Square Distribution; Cineangiography; Clopidogrel; Cytochrome P-450 CYP2C19; Drug-Eluting Stents; Female; Gene Frequency; Genetic Predisposition to Disease; Humans; Japan; Logistic Models; Male; Middle Aged; Myocardial Infarction; Paclitaxel; Phenotype; Platelet Aggregation Inhibitors; Polymorphism, Genetic; Prosthesis Design; Risk Assessment; Risk Factors; Sirolimus; Thrombosis; Ticlopidine; Time Factors; Tomography, Optical Coherence; Treatment Outcome

Topics: Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Vessels; Drug-Eluting Stents; Humans; Metals; Paclitaxel; Prosthesis Design; Risk Assessment; Risk Factors; Sirolimus; Stents; Thrombosis; Time Factors; Tomography, Optical Coherence; Treatment Outcome; Tunica Intima

Topics: Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Stenosis; Diabetes Mellitus; Drug-Eluting Stents; Humans; Myocardial Infarction; Paclitaxel; Prosthesis Design; Risk Assessment; Risk Factors; Sirolimus; Thrombosis; Time Factors; Treatment Outcome

Topics: Angioplasty, Balloon, Coronary; Biocompatible Materials; Cardiovascular Agents; Coronary Angiography; Coronary Artery Disease; Coronary Restenosis; Drug-Eluting Stents; Humans; Prosthesis Design; Sirolimus; Thrombosis; Time Factors; Tomography, Optical Coherence; Treatment Outcome; Ultrasonography, Interventional

To investigate the clinical outcomes of paclitaxel-eluting stents (PES) and sirolimus-eluting stents (SES) in patients on dialysis.. Between May 2004 and December 2008, 95 patients on dialysis with 124 lesions were treated with PES alone, and were compared to 184 patients on dialysis with 244 lesions treated with SES alone, retrospectively. One-year major adverse cardiac event (MACE) including stent thrombosis, target lesion revascularisation (TLR), myocardial infarction (MI) and cardiac death were compared. Baseline characteristics were similar except for previous CABG (p = 0.02) and reference vessel diameter (p = 0.04). During hospitalisation, all cause death was more frequently observed in the PES group (p = 0.004). In-hospital MACE was not significantly different (p = 0.8). The incidence of 1-year MACE in the PES group was lower than that in the SES group (14.7%, 28.3%, p = 0.04), mainly due to the reduction of TLR (11.6%, 25.0%, p = 0.03). Rates of stent thrombosis (0%, 2.7%, p = 0.1), MI (1.1%, 3.8%, p = 0.2), and cardiac death (3.2%, 4.4%, p = 0.6) were not significantly different.. PES appears to be more efficient in reducing angiographic and clinical restenosis in dialysis patients compared with SES.

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Chi-Square Distribution; Coronary Angiography; Coronary Artery Disease; Coronary Restenosis; Drug-Eluting Stents; Female; Hospital Mortality; Humans; Japan; Kaplan-Meier Estimate; Male; Middle Aged; Myocardial Infarction; Paclitaxel; Proportional Hazards Models; Prosthesis Design; Renal Dialysis; Renal Insufficiency; Retrospective Studies; Risk Assessment; Risk Factors; Sirolimus; Thrombosis; Time Factors; Treatment Outcome

Our purpose was to investigate the clinical outcomes of Zotarolimus- and Paclitaxel-eluting stents in Turkish patients with coronary artery disease (CAD). In general, the outcome of drug-eluting stent (DES) placement has a proven efficacy in randomized trials. However, the difference in efficacy between the Zotarolimus and Paclitaxel-eluting stents in unselected Turkish patients is controversial. Therefore, we investigated the clinical outcomes of these two drug-eluting stents in the real-world.. We created a registry and prospectively analyzed data on a consecutive series of all patients who presented to our institution with symptomatic coronary artery disease between February 2005 and March 2007 and who were treated with the zotarolimus- or the paclitaxel-eluting stent. The follow-up period was approximately two years. The primary end-point was major cardiac events, and the secondary end-point was definite stent thrombosis. Informed consent was obtained from all subjects, and the study protocol was approved by the local ethical committee.. In total, 217 patients were treated with either the zotarolimus-eluting stent (n = 116) or the paclitaxel-eluting stent (n = 101). The lesions in the 2 arms of the study were treated similarly by conventional technique. At 24-month follow-up the paclitaxel-eluting stent group showed significantly higher non-Q wave myocardial infarction (2.6% vs 5.9%, p: 0.02), Q wave myocardial infarction (1.7% vs 5.9%, p: 0.049), coronary artery binding graft surgery (2.6% vs 6.9%, p: 0.002), and late stent thrombosis (1.7% vs 3.9%, p: 0.046).. Zotarolimus-eluting stents demonstrated better clinical outcomes than Paclitaxel-eluting stents in a daily routine practice of coronary intervention in an unselected Turkish population.

Topics: Aged; Cardiovascular Agents; Coronary Artery Disease; Drug-Eluting Stents; Follow-Up Studies; Humans; Middle Aged; Paclitaxel; Patient Selection; Postoperative Complications; Prospective Studies; Random Allocation; Registries; Retrospective Studies; Sirolimus; Thrombosis; Time Factors; Treatment Outcome; Turkey

Topics: Angioplasty, Balloon, Coronary; Cardiovascular Agents; Drug-Eluting Stents; Evidence-Based Medicine; Humans; Metals; Myocardial Infarction; Paclitaxel; Prosthesis Design; Recurrence; Risk Assessment; Risk Factors; Sirolimus; Stents; Thrombosis; Time Factors; Treatment Outcome

The purpose of this study was to assess the frequency of very late stent thrombosis (VLST) after stenting with bare-metal stents (BMS) and drug-eluting stents (DES) for ST-segment elevation myocardial infarction (STEMI).. Stent thrombosis occurs more frequently after stenting for STEMI than after elective stenting, but there are little data regarding VLST.. Consecutive patients (n = 1,463) who underwent stenting for STEMI were prospectively enrolled in our database. BMS were implanted exclusively from 1995 to 2002, and DES and BMS were implanted from 2003 to 2009. Follow-up was obtained at 1 to 15 years.. BMS patients (n = 1,095) were older and had more shock, whereas DES patients (n = 368) had more diabetes and smaller vessels. Stent thrombosis occurred in 107 patients, of which 42 were VLST (>1 year). Stent thrombosis continued to increase to at least 11 years with BMS and to at least 4.5 years with DES. Stent thrombosis rates with BMS versus DES were similar at 1 year (5.1% and 4.0%, respectively) but increased more with DES after the first year (1.9%/year vs. 0.6%/year, respectively). Landmark analysis (>1 year) found DES had a higher frequency of VLST (p < 0.001) and reinfarction (p = 0.003). DES was the only significant independent predictor of VLST (hazard ratio: 3.79, 95% confidence interval: 1.64 to 8.79, p = 0.002).. VLST after primary PCI for STEMI occurs with relatively high frequency to at least 11 years with BMS and to at least 4.5 years with DES. Very late stent thrombosis and reinfarction (>1 year) were more frequent with DES. New strategies are needed to manage this problem.

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Chi-Square Distribution; Drug-Eluting Stents; Female; Follow-Up Studies; Humans; Kaplan-Meier Estimate; Logistic Models; Male; Metals; Myocardial Infarction; North Carolina; Paclitaxel; Propensity Score; Proportional Hazards Models; Prospective Studies; Prosthesis Design; Recurrence; Registries; Risk Assessment; Risk Factors; Sirolimus; Stents; Thrombosis; Time Factors; Treatment Outcome

This study sought to evaluate the impact of SYNTAX score (SXscore), and compare its performance in isolation and combination with the PAMI (The Primary Angioplasty in Myocardial Infarction Study) score, for the prediction of 1-year clinical outcomes in patients with ST-segment elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention.. Patients with STEMI were excluded from the original SYNTAX score (SXscore) algorithm. Therefore, the utility of using the SXscore in this patient group remains undefined.. SXscore was calculated retrospectively in 807 patients with STEMI enrolled in the randomized STRATEGY (Single High-Dose Bolus Tirofiban and Sirolimus-Eluting Stent Versus Abciximab and Bare-Metal Stent in Acute Myocardial Infarction) and MULTISTRATEGY (Multicenter Evaluation of Single High-Dose Bolus Tirofiban Versus Abciximab With Sirolimus-Eluting Stent or Bare-Metal Stent in Acute Myocardial Infarction Study) clinical trials. Clinical outcomes of all-cause death, reinfarction, and clinically driven target vessel revascularization were subsequently stratified according to SXscore tertiles: SX(LOW) ≤ 9 (n = 311), 9 < SX(MID) ≤ 16 (n = 234), SX(HIGH) >16 (n = 262).. At 1-year follow-up, all clinical outcomes including mortality, mortality/reinfarction, major adverse cardiac events (MACE) (a composite of all-cause death, reinfarction and target vessel revascularization), and definite, definite/probable, and any stent thrombosis were all significantly higher in patients in the highest SXscore tertile. SXscore was identified as an independent predictor of mortality, MACE, and stent thrombosis out to 1-year follow-up. The combination SYNTAX-PAMI score led to a net reclassification improvement of 15.7% and 4.6% for mortality and MACE, respectively. The C-statistics for the SXscore, PAMI score, and the combined SYNTAX-PAMI score were 0.65, 0.81, and 0.73 for 1-year mortality, and 0.68, 0.64, and 0.69 for 1-year MACE, respectively.. SXscore does have a role in the risk stratification of patients with STEMI having primary percutaneous coronary intervention; however, this ability can be improved through a combination with clinical variables. (Multicentre 2×2 Factorial Randomised Study Comparing Tirofiban Versus Abciximab and SES Versus BMS in AMI; NCT00229515).

Topics: Abciximab; Aged; Angioplasty, Balloon, Coronary; Antibodies, Monoclonal; Cardiovascular Agents; Coronary Angiography; Disease-Free Survival; Drug-Eluting Stents; Female; Humans; Immunoglobulin Fab Fragments; Kaplan-Meier Estimate; Male; Metals; Middle Aged; Multicenter Studies as Topic; Myocardial Infarction; Platelet Aggregation Inhibitors; Predictive Value of Tests; Proportional Hazards Models; Randomized Controlled Trials as Topic; Recurrence; Retrospective Studies; Risk Assessment; Risk Factors; ROC Curve; Severity of Illness Index; Sirolimus; Stents; Thrombosis; Time Factors; Tirofiban; Treatment Outcome; Tyrosine

This serial angiographic study evaluated the incidence and predictors of late restenosis after sirolimus-eluting stent (SES) implantation.. Previous studies showed late restenosis (i.e., late catch-up phenomenon) after implantation of 7-hexanoyltaxol-eluting stents and nonpolymeric, paclitaxel-eluting stents.. Between August 2004 and December 2006, SES implantation was performed in 1,393 patients with 2,008 lesions, in whom 8-month and 2-year follow-up coronary angiography were planned.. Of 2,008 lesions, 1,659 (83%) underwent 8-month follow-up angiography (8.3 ± 2.2 months). Restenosis was observed in 122 lesions (7.4%). Coronary angiography 2 years (1.9 ± 0.4 years) after SES deployment was performed in 1,168 lesions (74% of lesions without restenosis at 8-month follow-up angiography). Late restenosis was observed in 83 lesions (7.1%). There was significant decrease in minimum luminal diameter (MLD) between 8-month and 2-year follow-up (2.56 ± 0.56 mm vs. 2.35 ± 0.71 mm, p < 0.001). Multivariate analysis showed in-stent restenosis before SES implantation and MLD at 8-month follow-up as independent predictors of late restenosis.. Between 8-month and 2-year follow-up after SES implantation, MLD decreases, which results in late restenosis in some lesions. In-stent restenosis before SES implantation and MLD at 8-month follow-up are independent predictors of late restenosis.

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Chi-Square Distribution; Coronary Angiography; Coronary Restenosis; Coronary Stenosis; Drug-Eluting Stents; Female; Humans; Incidence; Japan; Logistic Models; Male; Middle Aged; Myocardial Infarction; Prosthesis Design; Registries; Risk Assessment; Risk Factors; Sirolimus; Thrombosis; Time Factors; Treatment Outcome

Topics: Adult; Anticoagulants; Antiphospholipid Syndrome; Biomarkers; Blood Chemical Analysis; Blood Coagulation; Blood Coagulation Tests; Cardiovascular Agents; Catastrophic Illness; Diagnosis, Differential; Electrocardiography; Humans; Immunosuppressive Agents; Ischemia; Lupus Erythematosus, Systemic; Male; Predictive Value of Tests; Severity of Illness Index; Thrombosis; Tomography, X-Ray Computed; Treatment Outcome; Vasculitis

Percutaneous intervention carries a higher risk of distal embolization and poorer outcome in saphenous vein grafts (SVG) than in native coronary vessels. Embolic protection devices (EPD) have demonstrated value in decreasing the risk of embolization and post-procedural enzymes elevation after SVG intervention. Although there is ample evidence to support the routine use of EPD for SVG interventions, frequently those devices are not utilized or cannot be used because of technical reasons. As we previously reported, the "undersized stenting" approach seems to be an attractive strategy when EPD cannot be used. We present a case with severe SVG degeneration that illustrates the feasibility of this strategy.

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Angiography; Coronary Artery Bypass; Drug-Eluting Stents; Embolism; Everolimus; Graft Occlusion, Vascular; Humans; Male; Prosthesis Design; Saphenous Vein; Sirolimus; Thrombosis; Tomography, Optical Coherence; Treatment Outcome; Ultrasonography, Interventional

The SPIRIT V (A Clinical Evaluation of the XIENCE V Everolimus-Eluting Coronary Stent System in the Treatment of Patients With De Novo Coronary Artery Lesions) study is a post-market surveillance experience of the XIENCE V (Abbott Vascular, Santa Clara, California) everolimus-eluting stent (EES) in patients with higher-risk coronary anatomy.. Previous pre-approval studies have shown the safety and efficacy of EES in highly selected groups of patients.. The SPIRIT V trial is a prospective, open label, single arm, multicenter study. Two thousand seven hundred patients with multiple de novo coronary artery lesions suitable for treatment with a planned maximum of 4 EES were enrolled at 93 centers in Europe, Asia Pacific, Canada, and South Africa. Lesions had a reference vessel diameter between 2.25 and 4.0 mm and a length of ≤ 28 mm by visual estimation. An independent clinical events committee adjudicated all end point-related events. The primary end point was the composite rate of all death, myocardial infarction (MI), and target vessel revascularization at 30 days. Secondary end points included stent thrombosis and acute success (clinical device and procedure success).. At 30 days, the primary composite end point of all death, MI, and target vessel revascularization was 2.7%. At 1 year, rates of cardiac death, overall MI, and target lesion revascularization were 1.1%, 3.5%, and 1.8%, respectively. The cumulative rate of definite and probable stent thrombosis was low at 0.66% at 1 year.. Use of EES in patients with multiple, complex de novo lesions yielded 1-year major adverse cardiac events, stent thrombosis, and target lesion revascularization rates that are comparable to those of the more controlled SPIRIT II and SPIRIT III trials-which included patients with restricted inclusion/exclusion criteria-and other all-comer population, physician-initiated studies like the X-SEARCH (Xience Stent Evaluated At Rotterdam Cardiology Hospital) and COMPARE (A Randomized Controlled Trial of Everolimus-eluting Stents and Paclitaxel-eluting Stents for Coronary Revascularization in Daily Practice) trials.

Topics: Aged; Angioplasty, Balloon, Coronary; Asia; Canada; Cardiovascular Agents; Coronary Artery Disease; Disease-Free Survival; Drug-Eluting Stents; Europe; Everolimus; Female; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Myocardial Infarction; Product Surveillance, Postmarketing; Prospective Studies; Prosthesis Design; Registries; Risk Assessment; Risk Factors; Sirolimus; South Africa; Thrombosis; Time Factors; Treatment Outcome

Topics: Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Restenosis; Coronary Stenosis; Drug-Eluting Stents; Evidence-Based Medicine; Humans; Myocardial Infarction; Paclitaxel; Patient Selection; Risk Assessment; Risk Factors; Sirolimus; Thrombosis; Time Factors; Treatment Outcome

The treatment of unprotected left main coronary artery (uLMCA) bifurcation lesions remains challenging.. We hypothesized that the type of drug-eluting stent would correlate with clinical outcomes for the treatment of uLMCA bifurcation lesions.. One hundred fifteen patients who underwent stent implantation using a provisional T-stenting technique with sirolimus-eluting stents (SES) or paclitaxel-eluting stents (PES) for uLMCA bifurcation lesions were enrolled. A major adverse cardiac event (MACE) was defined as a composite of cardiac death, myocardial infarction, or target lesion revascularization.. Ninety-four patients were treated with SES and 21 patients with PES. Baseline characteristics were similar between the 2 groups. Angiographic follow-up was performed in 99 (86%) patients. Late loss in the LMCA to the left anterior descending coronary artery was significantly lower in the SES group than in the PES group (0.28 ± 0.54 mm vs 1.03 ± 0.45 mm, P<0.001). One case of stent thrombosis occurred in the SES group. During follow-up with a median of 712 days, the SES group had a lower MACE compared with the PES group (10.6% vs. 28.6%, P = 0.032). Cox proportional hazards models including age, sex, diabetes, acute coronary syndrome, true bifurcation, stenting strategy, and type of drug-eluting stent used (SES vs. PES) demonstrated that stent type was the only predictor of MACE (hazard ratio of PES vs SES: 3.88, 95% confidence interval: 1.29-11.67, P = 0.016).. According to the results of the present study, SES may be associated with more favorable outcomes than PES for stenting of uLMCA bifurcation, which should be further studied by larger trials.

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Angiography; Coronary Artery Disease; Coronary Restenosis; Drug-Eluting Stents; Female; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Myocardial Infarction; Paclitaxel; Proportional Hazards Models; Prospective Studies; Prosthesis Design; Registries; Republic of Korea; Risk Assessment; Risk Factors; Sirolimus; Thrombosis; Time Factors; Treatment Outcome

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

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

Topics: Angioplasty, Balloon, Coronary; Cardiovascular Agents; Drug-Eluting Stents; Fibrinolytic Agents; Hirudins; Humans; Myocardial Infarction; Paclitaxel; Peptide Fragments; Prosthesis Design; Randomized Controlled Trials as Topic; Recombinant Proteins; Thrombosis; Time Factors; Treatment Outcome

Topics: Acute Coronary Syndrome; Angina Pectoris; Angioplasty, Balloon, Coronary; Angioscopy; Animals; Biomedical Research; Cardiac Imaging Techniques; Cardiovascular Agents; Career Choice; Coronary Artery Disease; Coronary Restenosis; Coronary Vessels; Diagnostic Imaging; Drug-Eluting Stents; Female; Humans; Male; Sirolimus; Thrombosis; Tunica Intima; Ultrasonography, Interventional

To explore optimal management strategies for bifurcation lesions with sirolimus-eluting stents (SES).. Among 12,824 patients enrolled in the j-Cypher Registry, we identified 2,122 patients with 2,250 non-left main bifurcation lesions (average age: 69 years; diabetes: 39%; acute coronary syndrome: 24%; lesion length ≥30 mm: 17%; true bifurcation: 53%) treated exclusively with SES. The majority of lesions (1,978 lesions, 88%) were treated by provisional side branch stenting approach with a 4.5% crossover rate, while the elective two-stent approach (stenting both main and side branches) was adopted in 272 lesions. The 3-year incidence of target-lesion revascularisation (TLR) was significantly higher in the elective two-stent group than in the provisional group (18.5% vs. 9.8%, p<0.0001). The incidence of definite stent thrombosis was not different between the two groups (1.3% vs. 0.61%, p=0.21). Among 1,871 lesions with main branch stenting alone, final kissing balloon dilatation (FKB) was performed in 938 lesions (50%). The incidence of TLR was not different between the two groups with or without FKB (9.9% vs. 9.2%, p=0.98).. The provisional approach provided a good long-term outcome in the majority of lesions with low crossover rate to the two-stent approach. Lesions treated with FKB had similar TLR outcome to those without FKB after main branch stenting alone.

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Chi-Square Distribution; Coronary Artery Disease; Coronary Restenosis; Drug-Eluting Stents; Female; Humans; Japan; Kaplan-Meier Estimate; Logistic Models; Male; Middle Aged; Odds Ratio; Proportional Hazards Models; Registries; Risk Assessment; Risk Factors; Sirolimus; Thrombosis; Time Factors; Treatment Outcome

This study sought to assess the impact of intravascular ultrasound (IVUS)-guided versus angiography-guided drug-eluting stent (DES) implantation.. There are limited data on IVUS guidance in the DES era. Therefore, we investigated the impact of IVUS guidance on clinical outcomes in the MATRIX (Comprehensive Assessment of Sirolimus-Eluting Stents in Complex Lesions) registry.. The MATRIX registry prospectively enrolled consecutive, unselected patients treated with sirolimus-eluting stents (SES) (n = 1,504); 631 patients (42%) underwent IVUS-guided stenting, and 873 (58%) had only angiographic guidance. We assessed 30-day, 1-year, and 2-year rates of death/myocardial infarction (MI), major adverse cardiac events (cardiac death, MI, or target vessel revascularization), and definite/probable stent thrombosis in 548 propensity-score matched patient pairs.. After matching, baseline and angiographic characteristics were similar in IVUS and no-IVUS groups. Patients in the IVUS group had significantly less death/MI at 30 days (1.5% vs. 4.6%, p < 0.01), 1 year (3.3% vs. 6.5%, p < 0.01), and 2 years (5.0% vs. 8.8%, p < 0.01). Patients in the IVUS group had significantly less major adverse cardiac events at 30 days (2.2% vs. 4.8%, p = 0.04) and numerically less major adverse cardiac events at 1 year (9.1% vs. 13.5%, p = 0.07) and 2 years (12.9% vs. 16.7%, p = 0.18). Rates of MI were significantly lower in the IVUS group at 30 days (1.5% vs. 4.0%, p < 0.01), 1 year (1.8% vs. 4.8%, p < 0.01), and 2 years (2.1% vs. 5.7%, p < 0.01).. IVUS-guided stent implantation appears to be associated with a reduction in both early and long-term clinical events. Further investigation in randomized controlled trials is warranted.

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Angiography; Coronary Artery Disease; Drug-Eluting Stents; Female; Humans; Kaplan-Meier Estimate; Logistic Models; Male; Middle Aged; Myocardial Infarction; New York City; Propensity Score; Proportional Hazards Models; Prospective Studies; Prosthesis Design; Radiography, Interventional; Registries; Risk Assessment; Risk Factors; Sirolimus; Thrombosis; Time Factors; Treatment Outcome; Ultrasonography, Interventional

The aim of this study was to identify the worldwide practice of Cypher Select (Cordis Corporation, Bridgewater, New Jersey) or Cypher Select Plus sirolimus-eluting stent (SES) in patients 80 years of age (octogenarian) and to identify clinical outcomes in this patient population.. The use of drug-eluting stents in elderly patients may have different features compared with younger patients.. Between 2006 and 2008, 15,147 patients from 320 hospitals in 56 countries were enrolled in a registry. Initial implantation and follow-up outcome information obtained at 1-year follow-up in 675 octogenarian patients were compared with those in 14,472 nonoctogenarian patients.. Octogenarians had significantly more comorbidities and had higher Charlson comorbidity index scores (1.5 ± 1.6 vs. 1.0 ± 1.3, p < 0.001). Rates of cardiac death (3.3% vs. 0.9%, p < 0.001), myocardial infarction (2.3% vs. 1.9%, p = 0.021), and definite or probable stent thrombosis (2.3% vs. 0.9%, p = 0.0002), and major bleeding (2.0% vs. 0.9%, p = 0.015) were significantly higher in octogenarians at 1 year; however, there was no significant difference in the rate of target lesion revascularization between the 2 groups (3.2% vs. 2.2%, p = 0.12). In octogenarians, a high Charlson comorbidity index was an independent predictor of death and stent thrombosis up to 360 days from the index procedure (hazard ratio: 1.3, 95% confidence interval: 1.1 to 1.5, p < 0.001, and hazard ratio: 1.5, 95% confidence interval: 1.3 to 1.8, p < 0.001, respectively).. Stenting with SES may be an effective therapeutic option in elderly patients, with acceptable rates of complications and a very low rate of repeat revascularization as demonstrated by this e-SELECT (A Multi-Center Post-Market Surveillance Registry) subgroup analysis.

Topics: Age Factors; Aged; Aged, 80 and over; Angioplasty, Balloon, Coronary; Australia; Cardiovascular Agents; Drug-Eluting Stents; Europe; Female; Fibrinolytic Agents; Humans; Internet; Kaplan-Meier Estimate; Male; Middle Aged; Myocardial Infarction; North America; Patient Selection; Platelet Aggregation Inhibitors; Product Surveillance, Postmarketing; Proportional Hazards Models; Prospective Studies; Prosthesis Design; Registries; Republic of Korea; Risk Assessment; Risk Factors; Sirolimus; South America; Thrombosis; Time Factors; Treatment Outcome

To assess the safety and efficacy of the second generation DIOR paclitaxel drug-eluting balloon (DEB) for in-stent restenosis in a real world setting in a prospective single-arm registry with 8-month clinical outcomes.. In this "real world", international prospective registry, patients with in-stent restenosis (bare-metal stent and drug-eluting stent) were enrolled- in a unique study design- with a one week enrolment period, spread over 104 centres worldwide. Patients underwent predilatation with a regular balloon, with subsequent DEB inflation in the target lesion. Additional stenting of the target lesion was left to the operators discretion in case of suboptimal angiographic success (TIMI flow <3 and/or residual stenosis >30%). The primary endpoint was 6-9-month major adverse cardiac events (MACE: all cause death, myocardial infarction, and target vessel revascularisation). A total of 250 evaluable patients were enrolled in a large web-based clinical research form and treated with the second generation DIOR DEB. Of these, 244 had 6-9 month clinical follow-up, with a mean follow-up time of 7.5 months. The cumulative MACE rate at follow-up was 11.1%, with 3 (1.2%) cardiac deaths, 1 (0.4%) non-cardiac death, 5 (2.0%) myocardial infarctions of which 2 (0.8%) periprocedural, 21 (8.6%) target vessel revascularisations, of which 18 (7.4%) target lesion revascularisations.. In-stent restenosis treatment with the second generation DIOR DEB is safe and feasible, with high angiographic success and low target lesion revascularisation and overall MACE rates. Moreover this new and unique method of high speed and short duration multicentre study enrolment was very successful.

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Angiography; Coronary Restenosis; Drug-Eluting Stents; Female; Humans; Male; Middle Aged; Myocardial Infarction; Paclitaxel; Patient Selection; Prospective Studies; Prosthesis Design; Registries; Risk Assessment; Risk Factors; Thrombosis; Time Factors; Treatment Outcome

We sought to assess the efficacy and safety of everolimus-eluting stents for unprotected left main disease.. A total of 173 consecutive patients with de novo significant unprotected left main stenosis received an everolimus-eluting stent in four French centres. Among them, 140 (81 %) had involvement of the distal portion of left main, and 129/140 (92%) were treated with provisional side branch T-stenting, with a side branch stenting rate of 20%. Angiographic success was achieved in all cases. At 12 months, the cumulative rate of major adverse cardiac or cerebrovascular events (MACCE) was 26/173 (15%) including death from any cause (N=5, 2.9%), stroke (N=4, 2.3%), Q-wave myocardial infarction (MI) (N=2, 1.2%), non-Q-wave MI (N=6, 3.5%) and any repeat revascularisation (N=16, 9.3%). At one year, the rate of target-lesion revascularisation (TLR) was 5/173 (2.9%), target-vessel revascularisation was 12/173 (7 %) and the rate of definite or probable left main stent thrombosis 1/173 (0.6 %).. Unprotected left main stenting using everolimus-eluting stents and a strategy of provisional side branch T-stenting for distal lesions, is safe and effective in the midterm, with a relatively low rate of events and reintervention at one year.

Topics: Aged; Aged, 80 and over; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Angiography; Coronary Restenosis; Coronary Stenosis; Drug-Eluting Stents; Everolimus; Female; Hospital Mortality; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Myocardial Infarction; Pilot Projects; Proportional Hazards Models; Prospective Studies; Prosthesis Design; Registries; Risk Assessment; Risk Factors; Sirolimus; Stroke; Thrombosis; Time Factors; Treatment Outcome

Topics: Aged; Angioplasty, Balloon, Coronary; Angioscopy; Cardiovascular Agents; Coronary Artery Disease; Drug-Eluting Stents; Humans; Male; Predictive Value of Tests; Prosthesis Design; Sirolimus; Thrombosis; Time Factors; Tomography, Optical Coherence; Treatment Outcome

Conflicting patient outcomes have been reported after the use of sirolimus-eluting stents or bare-metal stents. In this nonrandomized study, we examine the outcomes after placement of sirolimus-eluting versus bare-metal stents in an unselected population of patients who underwent percutaneous coronary revascularization.We used THIRD-base, a longitudinal data registry of patients who underwent revascularization at our institution, to compare demographics and outcomes in patients treated with a sirolimus-eluting or bare-metal stent from January 2001 through June 2006. Outcome measures included major acute coronary and cerebral events at 30 days, target-vessel failure at 9 months and at 3 years, and stent thrombosis. Target-vessel failure was defined as the composite of all-cause death, recurrent myocardial infarction in the treated vessel distribution, and target-vessel revascularization. Logistic regression and Cox proportional regression models were used to determine the predictors of outcome.Of the 6,425 patients analyzed, 2,581 patients (40.2%) received only sirolimus-eluting stents, and 3,844 patients (59.8%) received only bare-metal stents. Early major acute coronary and cerebral events and stent thrombosis at 30 days and 9 months were similar in both groups. Target-vessel failure was less frequent in sirolimus-eluting stent patients than in bare-metal stent patients at 9 months (4.84% vs 11.81%, P < 0.0001) and at 3 years (29% vs 32%, P < 0.0001).Use of sirolimus-eluting stents improved target-vessel failure survival at 9 months and at 3 years. Late adverse events were determined by known risk factors for atherosclerosis, not by stent type.

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Cerebrovascular Disorders; Chi-Square Distribution; Coronary Artery Disease; Drug-Eluting Stents; Female; Humans; Kaplan-Meier Estimate; Logistic Models; Male; Metals; Middle Aged; Myocardial Infarction; Patient Selection; Propensity Score; Proportional Hazards Models; Prosthesis Design; Registries; Retrospective Studies; Risk Assessment; Risk Factors; Sirolimus; Stents; Texas; Thrombosis; Time Factors; Treatment Outcome

The XIENCE V USA (XIENCE V Everolimus Eluting Coronary Stent System Condition-of-Approval Post-Market study) sought to: 1) evaluate the safety of everolimus-eluting coronary stent systems (EECSS) in a contemporary cohort of real-world subjects; and 2) prospectively test the quality of event reporting with analysis of matched patients from the randomized SPIRIT IV (Clinical Evaluation of the XIENCE V Everolimus Eluting Coronary Stent System in the Treatment of Subjects With de Novo Native Coronary Artery Lesions) trial.. Randomized trials have demonstrated the safety and efficacy of EECSS in selected "standard-risk" patients.. The XIENCE V USA trial was a prospective, multicenter, single-arm study in unselected patients. The primary endpoint was Academic Research Consortium (ARC)-defined definite and probable stent thrombosis (ST); the co-primary endpoint was the composite of cardiac death and myocardial infarction at 1 year. Secondary analyses included: 1) stratification by standard-risk and extended-risk cohorts; and 2) late ST after dual antiplatelet therapy interruption.. Of 5,054 participants (1,875 standard-risk; 3,179 extended-risk), 4,958 (98.1%) reached 1-year follow-up. The rate of ARC-defined definite and probable ST was 0.84% (95% confidence interval [CI]: 0.60% to 1.14%) in the overall population and 0.33% (95% CI: 0.12% to 10.72%) and 1.14% (95% CI: 0.80% to 11.58%) in the standard-risk and extended-risk cohorts, respectively. No late ST was observed after dual antiplatelet therapy interruption in either cohort after 6 months. The composite rate of cardiac death and ARC-defined myocardial infarction was 6.5% (95% CI: 5.79% to 17.17%) in the overall population, 3.8% (95% CI: 2.98% to 14.78%) in the standard-risk cohort, and 8.0% (95% CI: 7.09% to 19.02%) in the extended-risk cohort.. This study comprehensively reports ST rates for EECSS in a contemporary real-world population. The absence of ST after dual antiplatelet therapy interruption beyond 6 months in standard-risk and high-risk patients is notable. Consistent safety outcomes between matched standard-risk cohorts from the XIENCE V USA study and the SPIRIT IV randomized trial suggest that this study affords a reliable benchmark for understanding the safety of EECSS in the context of real-world clinical practice. (XIENCE V Everolimus Eluting Coronary Stent System [EECSS] USA Post-Approval Study; NCT00676520).

Topics: Aged; Angioplasty, Balloon, Coronary; Benchmarking; Cardiovascular Agents; Coronary Artery Disease; Device Approval; Drug-Eluting Stents; Everolimus; Female; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Myocardial Infarction; Platelet Aggregation Inhibitors; Product Surveillance, Postmarketing; Prospective Studies; Prosthesis Design; Risk Assessment; Risk Factors; Sirolimus; Thrombosis; Time Factors; Treatment Outcome; United States

Management of acute mesenteric ischemia is still a matter of concern for physicians. This disorder has been associated to an increased mortality mainly because of a late diagnosis and controversial treatment options.. We describe the case of a multidisciplinary approach to a cardiogenic thrombotic occlusion of superior mesenteric artery resulting in acute mesenteric ischemia. After rapid diagnosis with Duplex scan, we brought the patient to our catheterization laboratory and managed it with the common tools used for primary percutaneous coronary intervention. Among the specific issues of this case report, we observed some of the common complications of the acute myocardial infarction managed in the catheterization laboratory and treated them with the same tools used in the "myocardial area.". We showed how an "interventional cardiologist's" approach to acute mesenteric ischemia was effective in restoring superior mesenteric artery patency and in aborting a mesenteric infarction.

Topics: Acute Disease; Atrial Fibrillation; Cardiovascular Agents; Combined Modality Therapy; Female; Humans; Ischemia; Mesenteric Artery, Superior; Mesenteric Vascular Occlusion; Middle Aged; Patient Care Team; Radiography; Stents; Thrombolytic Therapy; Thrombosis; Treatment Outcome; Ultrasonography, Doppler, Duplex; Vascular Patency

Calcified coronary lesions have commonly been considered as a challenge for interventional cardiologists, and few previous studies of sirolimus-eluting stent (SES) for calcified lesion have been limited by small sample size. Therefore, we evaluated the effectiveness of SES implantation for the treatment of calcified lesions in a large Chinese cohort of real world practice.. A total of 956 consecutive patients who successfully received SES placement were enrolled in this study, and were divided into the two groups according to whether the mild-moderate calcified lesion treated with SES exists or not: noncalcified group (n = 637) and calcified group (n = 319). Lesions treated with SES were subjected to quantitative coronary angiography immediately and 8 months after stenting.. Baseline characteristics including clinical, demographic or angiographic data were well balanced between the noncalcified and calcified groups. In the angiographic follow-up at 8 months, the in-stent restenosis and in-segment restenosis rates were similar in both the groups (in-stent restenosis: 3.8 vs. 4.0%, P>0.05; in-segment restenosis: 8.5 vs. 9.7%, P>0.05). The target lesion revascularization was not different between the two groups (5.2 vs. 6.8%; P>0.05). In addition, the in-stent late loss and overall thrombosis rate were also similar in both the groups (0.17+/-0.41 vs. 0.18+/-0.35 mm and 1.8 vs. 1.8%, P>0.05, respectively).. Although stenting of the calcified lesion was hard, successful treatment with SES for mild-moderate calcified lesions was conferred to similar favorable results compared with noncalcified lesions in patients with coronary artery disease.

Topics: Aged; Angioplasty, Balloon, Coronary; Calcinosis; Cardiovascular Agents; China; Coronary Angiography; Coronary Artery Disease; Coronary Restenosis; Drug-Eluting Stents; Female; Humans; Male; Middle Aged; Prospective Studies; Severity of Illness Index; Sirolimus; Thrombosis; Time Factors; Treatment Outcome

The differences between using sirolimus-eluting stents (SESs) and paclitaxel-eluting stents (PESs) in the vascular response at 9 months after implantation were examined with optical coherence tomography (OCT).. OCT was carried out in 33 SESs [33 patients, 19 with acute coronary syndrome (ACS) and 14 with stable angina pectoris (SAP)] and 27 PESs (27 patients, 15 with ACS and 12 with SAP) at 9 months after stent implantation. Stent strut coverage and apposition at each strut were evaluated. The frequency of uncovered struts was significantly higher in SES (12.5+/-15.2 vs 4.9+/-7.9 %, P=0.01). The incidence of complete covered stents with neointima was 9.1% (3/33) in SES and 29.6% (8/27) in PES (P=0.05). The pattern of neointima in PES was more heterogeneous than that in SES (1.3+/-0.5 for SES vs 2.0+/-0.6 for PES, P<0.001). The intracoronary thrombus was frequently detected in SES [10 (30.3%) in SES vs 5 (18.5%) in PES, P=0.29].. Uncovered struts were frequently observed in SES, but the pattern of neointima was more heterogeneous in PES at 9 months. In addition, stent coverage was incomplete in both stent groups at 9 months after stent implantation.

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Angiography; Coronary Artery Disease; Coronary Vessels; Drug-Eluting Stents; Female; Humans; Male; Middle Aged; Paclitaxel; Prosthesis Design; Registries; Sirolimus; Thrombosis; Time Factors; Tomography, Optical Coherence; Treatment Outcome; Tunica Intima

To determine the 3 year safety and efficacy of crush-stenting with paclitaxel-eluting stents.. The optimum two-stent strategy for treatment of coronary bifurcation lesions is undetermined. Crush-stenting is advocated to minimize restenosis through complete circumferential stent coverage; long-term follow-up data are lacking.. In a single center prospective registry, 100 consecutive patients with bifurcation lesions were treated with the Crush technique. The vast majority (93%) were true bifurcations, predominantly involving the left anterior descending and diagonal arteries. Technical success was 98%. Final kissing balloon dilatation, which became standard practice during the study, was attempted in 68 patients and successful in 51. Abciximab was used in all cases. There were no peri-procedural stent thromboses. Follow-up was 100% at 3 years. Symptom-driven target lesion revascularisation was 8% at 3 years. Cumulative 3-year major adverse cardiac events was 28% (7 cardiac deaths, 15 myocardial infarctions, 11 target vessel revascularisations). Absence of a final kissing inflation predicted repeat revascularisation but not death, infarction or stent thrombosis. Three probable stent thromboses occurred, of which two were very late.. Where a two-stent bifurcation strategy is required, Crush-stenting with paclitaxel-eluting stents is safe and effective in the long-term. Failure to perform a final kissing dilatation increases the likelihood of revascularisation but not other adverse events.

Topics: Abciximab; Adult; Aged; Aged, 80 and over; Angioplasty, Balloon, Coronary; Antibodies, Monoclonal; Cardiovascular Agents; Chi-Square Distribution; Coronary Artery Disease; Disease-Free Survival; Drug-Eluting Stents; England; Female; Follow-Up Studies; Humans; Immunoglobulin Fab Fragments; Kaplan-Meier Estimate; Male; Middle Aged; Myocardial Infarction; Paclitaxel; Patient Selection; Platelet Aggregation Inhibitors; Prospective Studies; Prosthesis Design; Registries; Risk Assessment; Thrombosis; Time Factors; Treatment Outcome

Our aim was to access the incidence of late major adverse cardiac events (MACE) and stent thrombosis (ST) in nonselected, complex patients followed for a period >/=4 years.. Despite the efficacy of drug-eluting stents (DES) in reducing repeated target lesion revascularization, concerns regarding the occurrence of late and very late ST have partially obscured the benefits of this novel technology.. All consecutive patients treated solely with DES between May 2002 and January 2005 were enrolled into this prospective, nonrandomized, single-center registry. The primary end point was long-term occurrence of MACE up to 7 years. Independent predictors of MACE, cardiac death, target lesion revascularization, and ST were obtained by a multivariate Cox proportional hazards regression model.. A total of 1,010 patients were enrolled. Most of them were men (77%) with a mean age of 63.7 years. Stent/patient rate was 1.4. Patients were kept in dual antiplatelet therapy for 3 and 6 months after Cypher (Cordis, Johnson & Johnson, Miami Lakes, Florida) and Taxus (Boston Scientific Corp., Natick, Massachusetts) stent implantation, respectively. Follow-up was obtained in 98.2% of the cohort (median 5.01 years). Survival free of MACE and cumulative incidence of definite/probable ST were 84.6% and 1.7%, respectively. Independent predictors of ST were percutaneous coronary intervention in the setting of acute myocardial infarction, DES overlapping, treatment of multivessel disease, presence of moderate-to-severe calcification at lesion site, and in-stent residual stenosis.. The deployment of DES in complex, real-world patients resulted in a low rate of very long-term MACE and ST. However, ST still occurs very long after the index procedure.

Topics: Aged; Angioplasty, Balloon, Coronary; Brazil; Calcinosis; Cardiovascular Agents; Coronary Restenosis; Disease-Free Survival; Drug Therapy, Combination; Drug-Eluting Stents; Female; Heart Diseases; Humans; Incidence; Kaplan-Meier Estimate; Male; Middle Aged; Myocardial Infarction; Paclitaxel; Platelet Aggregation Inhibitors; Proportional Hazards Models; Prospective Studies; Registries; Risk Assessment; Risk Factors; Sirolimus; Thrombosis; Time Factors; Treatment Outcome

The Endeavor zotarolimus-eluting coronary stent has been shown to reduce the restenosis rate compared to bare metal stents and has impacted other clinical measures such as mortality, acute myocardial infarctions (AMI) and target vessel revascularisation (TVR).. Using pooled efficacy data from the Endeavor clinical trial programme, a model was developed to compare the cost effectiveness of the Endeavor drug eluting stent (DES) with the Driver bare meal stent (BMS) over a four year time period. Endeavor was more costly but had an improved clinical outcome compared to Driver BMS over four years with a 4% reduction in deaths, 33% reduction in AMI and a 45% reduction in TVR. Late stent thrombosis was the only event showing an increased incidence for Endeavor of 0.2% compared to 0% for Driver. The incremental cost effectiveness ratio was pound3,757/quality adjusted life years (QALY).. Although much controversy has surrounded the appropriate way to assess the cost effectiveness of DES technology, a comprehensive analysis is presented and this suggests that by using extended clinical trial data out to four years, the Endeavor DES in particular, but DES technologies in general, are cost-effective approaches to percutaneous coronary intervention.

Topics: Angioplasty, Balloon, Coronary; Cardiovascular Agents; Clinical Trials as Topic; Coronary Artery Disease; Cost-Benefit Analysis; Drug Costs; Drug-Eluting Stents; Health Care Costs; Humans; Markov Chains; Metals; Models, Economic; Myocardial Infarction; National Health Programs; Prosthesis Design; Quality-Adjusted Life Years; Sirolimus; Stents; Thrombosis; Time Factors; Treatment Outcome; United Kingdom

Topics: Angioplasty, Balloon, Coronary; Cardiovascular Agents; Clinical Trials as Topic; Coronary Artery Disease; Drug-Eluting Stents; Humans; Platelet Aggregation Inhibitors; Research Design; Risk Assessment; Sirolimus; Thrombosis; Time Factors; Treatment Outcome

Percutaneous treatment of old, degenerated saphenous vein grafts (SVG) is associated with a high likelihood of major adverse cardiac events. When an acute coronary syndrome (ACS) develops in a patient with old SVG, fresh thrombus may superimpose on an old, degenerative atheroma: a sudden increase in the athero-thrombotic burden ensues with consequent, frequent total occlusion of the lumen. In this scenario, transluminal recanalization of the graft is usually associated with the highest chance of distal embolization and no-reflow and positioning of an embolic protection device (EPD) is almost mandatory. However, distal EPD are difficult to place when the vessel is totally occluded and do not completely avoid distal embolization. We report two cases of totally occluded SVG in patients admitted for ACS that were recanalized with the aid of a proximal EPD system with angiographic and clinical success.

Topics: Acute Coronary Syndrome; Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Angiography; Coronary Artery Bypass; Drug-Eluting Stents; Embolism; Equipment Design; Everolimus; Female; Filtration; Graft Occlusion, Vascular; Humans; Male; Metals; Middle Aged; Prosthesis Design; Saphenous Vein; Sirolimus; Stents; Thrombectomy; Thrombosis; Treatment Outcome; Vascular Patency

There are limited data on the long-term safety and efficacy profile of coronary stent implantation in patients with stable coronary artery disease (CAD) undergoing percutaneous coronary intervention (PCI).. We aimed to assess the 4-year clinical outcome in patients who received a bare-metal stent (BMS), sirolimus-eluting stent (SES), or a paclitaxel-eluting stent (PES) for the percutaneous treatment of stable angina in our center during 2000-2005.. In the study period, a total of 2,449 consecutive patients (BMS = 1,005; SES = 373; and PES = 1071) underwent a PCI as part of three historical PCI-cohorts for stable angina and were routinely followed for the occurrence of major adverse cardiac events (MACE).. At 4 years follow-up, 264 BMS patients (26.8%) had a MACE, compared to 75 SES patients (20.9%) and 199 PES patients (23.9%). Multivariate analysis showed that SES and PES were superior to BMS with respect to MACE [hazard ratio (HR) = 0.62, 95% confidence interval (CI): 0.47-0.81; HR = 0.67, 95% CI: 0.55-0.82, respectively]. The occurrence of MACE was significantly lower in the SES and PES population, primarily due to less target-vessel revascularization (TVR) procedures (HR = 0.53, 95% CI: 0.37-0.75; HR = 0.71, 95% CI: 0.62-0.81, respectively). The occurrence of early, late, and very late stent thrombosis was equally rare with each stent type. There were no significant differences between SES and PES on death, myocardial infarction, TVR, and MACE.. These findings suggest that SES and PES result in decreased TVR procedures and MACE compared to BMS at 4 years follow-up. SES or PES implantation should be the preferred choice over BMS for patients with stable CAD undergoing PCI.

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Artery Disease; Drug-Eluting Stents; Female; Humans; Kaplan-Meier Estimate; Male; Metals; Middle Aged; Myocardial Infarction; Netherlands; Paclitaxel; Platelet Aggregation Inhibitors; Proportional Hazards Models; Prosthesis Design; Registries; Risk Assessment; Risk Factors; Sirolimus; Stents; Thrombosis; Time Factors; Treatment Outcome

Topics: Abciximab; Angioplasty, Balloon, Coronary; Antibodies, Monoclonal; Cardiovascular Agents; Coronary Artery Disease; Disease-Free Survival; Drug-Eluting Stents; Humans; Immunoglobulin Fab Fragments; Myocardial Infarction; Paclitaxel; Patient Selection; Platelet Aggregation Inhibitors; Prosthesis Design; Risk Assessment; Thrombosis; Time Factors; Treatment Outcome

The aim of this study was to compare outcomes after percutaneous coronary intervention (PCI) with sirolimus-eluting stents (SES) and paclitaxel-eluting stents (PES) in the treatment of cardiac allograft vasculopathy (CAV).. PCI in patients with CAV is associated with increased rates of restenosis compared with PCI in patients without CAV. There are no dedicated studies on the influence of different drug-eluting stents (DES) on the outcomes of patients with CAV.. This is a retrospective observational study of 108 consecutive patients with CAV who underwent PCI with SES and PES at UCLA Medical Center and University of Padova Medical Center between 2002 and 2008.. Baseline characteristics were similar among SES (n = 68) and PES (n = 40) patients with the exception of older patients, larger minimal lumen diameter, and smaller diameter stenosis in the SES-treated patients. Angiographic follow-up at 1 year was high in the SES and PES groups (74% vs. 76%, p = 0.8). The SES and PES groups had similar binary restenosis rates (10% vs. 9%, p = 0.7), percent diameter stenosis (24 +/- 24% vs. 24 +/- 18%, p = 0.94), and late lumen loss (0.67 +/- 1.03 mm vs. 0.68 +/- 1.11 mm, p > 0.9). One-year clinical outcomes were not significantly different among CAV patients treated with either SES or PES (major adverse cardiac events: 10% vs. 15%, p = 0.5; death: 3% vs. 5%, p = 0.4; myocardial infarction: 3% vs. 5%, p = 0.4; target vessel revascularization: 4% vs. 8%, p = 0.3).. In patients who underwent PCI for CAV, both SES and PES were safe and effective with no significant differences in clinical and angiographic outcomes. Randomized clinical trials comparing different DES with longer follow-up are necessary to identify the optimal treatment strategy for patients with CAV.

Topics: Adult; Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Chi-Square Distribution; Coronary Angiography; Coronary Restenosis; Coronary Stenosis; Drug-Eluting Stents; Female; Heart Transplantation; Humans; Italy; Los Angeles; Male; Middle Aged; Myocardial Infarction; Paclitaxel; Prosthesis Design; Retrospective Studies; Severity of Illness Index; Sirolimus; Thrombosis; Time Factors; Transplantation, Homologous; Treatment Outcome

Topics: Angioplasty, Balloon, Coronary; Cardiovascular Agents; Cardiovascular Diseases; Coronary Angiography; Coronary Restenosis; Drug-Eluting Stents; Humans; Metals; Paclitaxel; Prosthesis Design; Stents; Thrombosis; Time Factors; Treatment Outcome; Ultrasonography, Interventional

This study sought to examine whether circulatory levels of endothelial dysfunction biomarkers [vascular cell adhesion molecule (sVCAM-1), intercellular adhesion molecule (sICAM-1), sE-selectin, von Willebrand factor (vWF), tissue plasminogen activator (t-PA) and plasminogen activator inhibitor (PAI-1)] are associated with occurrence of late or very late stent thrombosis (ST) after percutaneous coronary intervention with sirolimus-eluting stent implantation, and to assess the possible influence of genetic variants of these proteins on ST.. Serum levels of sVCAM-1, sICAM-1, sE-selectin, vWF, t-PA and PAI-1 were measured, and polymorphisms of vWF (-1234C/T, -1185A/G and -1051G/A), t-PA (insertion/deletion) and PAI-1 genes (4G/5G) were determined in 41 patients who experienced at least one episode of late or very late ST. Eighty-two patients without ST randomly selected from the same study period served as controls.. Serum levels of vWF, sVCAM-1 and sICAM-1 were significantly increased in patients with ST than in controls (all P<0.01). No significant difference was observed in the genotype and allele distribution of the vWF, t-PA and PAI-1 gene polymorphisms. Multivariable logistic regression analysis showed that vWF, sVCAM-1, discontinuation of clopidogrel therapy and left ventricular ejection fraction of less than 50% were independent determinants of late ST.. Increased serum vWF and sVCAM-1 levels are associated with late ST, suggesting that endothelial dysfunction contributes to the development of late or very late ST.

Topics: Aged; Angioplasty, Balloon, Coronary; Biomarkers; Cardiovascular Agents; Case-Control Studies; Chi-Square Distribution; China; Coronary Angiography; Drug-Eluting Stents; E-Selectin; Female; Gene Frequency; Humans; Intercellular Adhesion Molecule-1; Logistic Models; Male; Middle Aged; Plasminogen Activator Inhibitor 1; Platelet Aggregation Inhibitors; Polymorphism, Genetic; Risk Assessment; Risk Factors; Sirolimus; Stroke Volume; Thrombosis; Time Factors; Tissue Plasminogen Activator; Treatment Outcome; Vascular Cell Adhesion Molecule-1; Ventricular Function, Left; von Willebrand Factor

Topics: Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Restenosis; Coronary Stenosis; Drug-Eluting Stents; Everolimus; Humans; Metals; Myocardial Infarction; Patient Selection; Prosthesis Design; Risk Assessment; Severity of Illness Index; Sirolimus; Stents; Thrombosis; Time Factors; Treatment Outcome

Stent thrombosis is a serious complication of percutaneous coronary intervention (PCI). We examined the incidence of stent thrombosis and other outcomes in patients treated with PCI and paclitaxeleluting stents (PES), sirolimus-eluting stents (SES) or bare-metal stents (BMS).. All patients who underwent PES, SES or BMS implantation from January 2002 to June 2005 were identified in the population-based Western Denmark Heart Registry. All were followed for 36 months. Cox regression analysis was used to estimate relative risk (RR), controlling for covariates. A total of 12,374 patients were treated with stents: 1,298 with PES, 2,202 with SES and 8,847 with BMS. The three-year incidence of definite stent thrombosis was similar in the DES group (1.1%) and in the BMS group (0.7%) (adjusted relative risk [RR]: 1.24; 95% confidence interval [CI]: 0.85-1.81). Very late definite stent thrombosis occurred more frequently in DES-treated patients (adjusted RR: 2.89, 95% CI: 1.48- 5.65). The three-year mortality rate did not differ significantly between the two groups. Target lesion revascularisation (TLR) was lower in DES-treated patients than in BMS-treated patients (adjusted RR: 0.71, 95% CI: 0.63-0.81).. An increased risk of very late definite stent thrombosis was observed in DES-treated patients compared with BMS-treated patients, but a similar mortality was detected. TLR continued to be lower among patients receiving DES.

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Chi-Square Distribution; Coronary Artery Disease; Denmark; Drug-Eluting Stents; Female; Follow-Up Studies; Humans; Incidence; Kaplan-Meier Estimate; Male; Metals; Middle Aged; Myocardial Infarction; Paclitaxel; Platelet Aggregation Inhibitors; Proportional Hazards Models; Prosthesis Design; Registries; Risk Assessment; Risk Factors; Sirolimus; Stents; Thrombosis; Time Factors; Treatment Outcome

Limited data are available on the long-term outcome following PCI with paclitaxel-eluting stent (PES) implantation in patients with unprotected left main coronary artery (LMCA). The objective of this study was to evaluate "real world" long-term outcome following paclitaxel-eluting stent (PES) implantation for unprotected LMCA disease in patients enrolled in the TRUE registry.. From March 2003 to October 2004, 93 consecutive patients (81.7% male) underwent PCI for unprotected LMCA disease. Surveillance angiography was performed at 6.8+/-3.3 months follow-up. The target lesion involved the distal LMCA in 68 (73.1%) patients. Double stenting techniques were performed in 46 (67.6%) distal LMCA, of these 50% were stented using the Crush technique. Clinical follow-up was complete in all patients with 85.8% angiographic follow-up rate. In-segment restenosis occurred in 16 (20.3%) patients and was focal in 72.4% of cases and significantly higher in patients with distal LMCA (36.8% vs. 13.6%, p<0.04). At a median follow-up of 1,450 days (IQR 1281-1595), the overall incidence of MACE was 35.5% and the TLR rate was 25.8% and significantly higher in patients with bifurcation stenting (32.3% vs. 8%, p<0.02). The estimated cardiac survival rate at one and four years was 96.7% and 93.3%, respectively. Total mortality rate was 14.1% and cardiac was 6.5%. There was one (1.1%) definite stent thrombosis (ST) and one (1.1%) probable ST.. Treatment of unprotected LMCA disease with PES, after four years follow-up, appears to be safe and effective with a low rate of cardiac mortality and overall risk of ST. The need for target lesion revascularisation in 25.8% of patients highlights the need for more effective PCI especially in patients with distal LMCA disease.

Topics: Adult; Aged; Aged, 80 and over; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Chi-Square Distribution; Coronary Angiography; Coronary Artery Disease; Coronary Restenosis; Disease-Free Survival; Drug-Eluting Stents; Europe; Female; Follow-Up Studies; Hospital Mortality; Humans; Kaplan-Meier Estimate; Logistic Models; Male; Middle Aged; Myocardial Infarction; Paclitaxel; Prosthesis Design; Registries; Risk Assessment; Risk Factors; Severity of Illness Index; Thrombosis; Time Factors; Treatment Outcome

The aim of this study was to evaluate and compare the clinical and angiographic outcomes of 3 drug-eluting stents (DES) in patients with large vessel diameter and single coronary artery lesions.. The efficacy of 3 DESs may be similar.. A total of 411 consecutive patients who visited 3 university hospitals from June 2004 to December 2007 and had a single coronary lesion which was treated with the use of a DES that was 3.5 mm in diameter were enrolled in this study. Patients were divided into 3 stent groups: Paclitaxel-eluting stent (PES, n = 105), Sirolimus-eluting stent (SES, n = 259), and Zotarolimus-eluting stent (ZES, n = 47). The study end point was a composite of major adverse cardiac events (MACE) including cardiac death, myocardial infarction (MI), and ischemia-driven target-vessel revascularization (TVR) for 12 months.. Baseline characteristics were not different. Late loss was higher in the ZES group than the other stents (0.5 +/- 0.4 mm in SES vs 0.3 +/- 0.5 mm in PES, 0.7 +/- 0.5 mm in ZES, P = 0.001). The total MACE-free survival rate was not significantly different between the SES group and the PES group (98.8% in SES vs 97.1% in PES, P = 0.252) or the PES group and the ZES group (97.1% in PES vs 93.6% in ZES, P = 0.301). However, the SES group showed a significantly better MACE-free survival rate compared with the ZES group (98.8% in SES vs 93.6% in ZES, P = 0.018).. Clinical and angiographic outcomes of DES in a large vessel diameter and single coronary artery is excellent and SES appears to show better angiographic and clinical outcomes than ZES.

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Chi-Square Distribution; Coronary Angiography; Coronary Artery Disease; Coronary Restenosis; Disease-Free Survival; Drug-Eluting Stents; Female; Hospital Mortality; Hospitals, University; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Myocardial Infarction; Paclitaxel; Prosthesis Design; Republic of Korea; Risk Assessment; Risk Factors; Severity of Illness Index; Sirolimus; Thrombosis; Time Factors; Treatment Outcome

The prospective multicenter German DES.DE registry provides real world data to evaluate the therapeutic principle of two different drug-eluting stents (DES) [Sirolimus- (SES) and Paclitaxel-eluting stent (PES)] in the context of the German Health System.. Differential DES have been effective in randomized trials, but their difference in safety and efficacy in diabetic patients has not been well studied.. Baseline, predefined procedural as well as clinical in-hospital and follow-up events were recorded for all 1,526 diabetic patients. The composite of death, myocardial infarction (MI), and stroke defined as major adverse cardiac and cerebrovascular events (MACCE) and target vessel revascularization (TVR) were defined as primary endpoints.. Between October 2005 and October 2006, 1,526 diabetic patients, 34.2% of them being insulin-dependent, were enrolled (SES: n = 612; PES: n = 914) at 98 DES.DE sites. Overall, one third of patients were admitted with acute coronary syndrome (ACS) and 70% had multivessel-disease reflecting a real world scenario. With similar baseline clinical and descriptive morphology of coronary artery disease (CAD) in both DES groups, there were no statistical differences in 1-year follow-up with respect to rates of overall mortality (5.8% vs. 5.4%), TVR (12.0% vs. 11.3%), overall stent thrombosis (5.6% vs. 4.6%) and MACCE (11.4% vs. 10.3%) between both DES.. The data collected in DES.DE revealed no differences in clinical outcomes within 1 year between SES and PES in diabetic patients in a "real-world" setting.

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Chi-Square Distribution; Coronary Artery Disease; Diabetes Complications; Drug-Eluting Stents; Female; Germany; Humans; Kaplan-Meier Estimate; Logistic Models; Male; Middle Aged; Myocardial Infarction; Odds Ratio; Paclitaxel; Prospective Studies; Registries; Risk Assessment; Risk Factors; Severity of Illness Index; Sirolimus; Stroke; Thrombosis; Time Factors; Treatment Outcome

Topics: Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Artery Disease; Diabetes Complications; Drug-Eluting Stents; Everolimus; Humans; Myocardial Infarction; Paclitaxel; Patient Selection; Risk Assessment; Risk Factors; Severity of Illness Index; Sirolimus; Stroke; Thrombosis; Time Factors; Treatment Outcome

Studies in the primary care setting are of high interest for assessing the management situation of patients with manifestations of atherothrombosis.. Therefore, we documented diagnostic procedures, characteristics, and management of patients with symptomatic and asymptomatic peripheral arterial disease (PAD).. Prospective cross-sectional study in primary care practices throughout Germany.. A total of 671 patients with newly diagnosed PAD were included (mean age 69.1 years; 62.1% men). Cardiovascular risk factors were highly prevalent in the total PAD group: arterial hypertension in 84.2%, hyperlipidaemia in 75.5%, present smoking in 45.0% and diabetes mellitus in 47.3%. Atherothrombotic comorbidities were also frequent: coronary artery disease in 44.9% and cerebrovascular disease in 28.1%. For confirmation of diagnosis, patients were referred to specialists in 66.9% of cases. Overall, ankle brachial index was measured in 89.0%, and a clinical PAD score assessed in 66.6% (agreement of both measures with Cohen's kappa only, kappa = 0.039; p = 0.209). Drug treatment of risk factors (as secondary prophylaxis) in line with current guidelines was reported in a high percentage of patients: 88.6% with any antiplatelet drug, 69.3% with statins, 62.4% with angiotensin converting enzyme inhibitors, 23.5% with AT(1) receptor blockers and 43.9% with beta-blockers. Between asymptomatic and symptomatic PAD, differences in the risk factor/comorbidity profiles were small; however, the latter group received intensified treatment.. Our findings confirm that patients with PAD pose a substantial challenge to physicians because of their high number of comorbidities. Compared with previous studies, management of such patients appears to have improved.

Topics: Adult; Aged; Aged, 80 and over; Arteriosclerosis; Cardiovascular Agents; Cross-Sectional Studies; Female; Humans; Male; Middle Aged; Peripheral Arterial Disease; Platelet Aggregation Inhibitors; Prospective Studies; Risk Factors; Thrombosis

This study aimed to compare the NERS (New Risk Stratification) and SYNTAX (Synergy between Percutaneous Coronary Intervention with Taxus and Cardiac Surgery) scores for prognostication after stenting of unprotected left main stenosis in a "real-world" setting.. In contrast to existing systems, the NERS score encompasses clinical, procedural, and angiographic characteristics.. The NERS score was derived from 260 patients with unprotected left main stenosis who underwent percutaneous coronary intervention and tested in 337 patients in a consecutive left main registry (66.55 +/- 10.49 years, 78.9% men) undergoing percutaneous coronary intervention in a prospective, multicenter trial. Six-month clinical and angiographic follow-up was obtained in 100% and 88.9% of patients, respectively. The primary end point was major adverse cardiac events (MACE), encompassing myocardial infarction, all-cause death, and target vessel revascularization. Receiver-operator characteristic (ROC) curve was generated for the comparison of NERS versus SYNTAX scores.. The NERS score consisted of 54 variables (17 clinical, 4 procedural, and 33 angiographic). A NERS score > or =25 demonstrated a sensitivity and specificity of 92.0% and 74.1% (MACE as state variable), respectively, significantly higher than SYNTAX intermediate risk (20.5% and 25.4%) or SYNTAX higher risk (70.5% and 35.2%, p for all <0.001). At follow-up, myocardial infarction, cardiac death, and target vessel revascularization occurred in 3.0%, 5.6%, and 13.1% of patients, respectively, for a composite MACE of 26.0%. A NERS score > or =25 (hazard ratio: 1.13; 95% confidence interval [CI]: 1.11 to 1.16; p < 0.001) was the only independent predictor of cumulative MACE and stent thrombosis at follow-up (odds ratio: 31.04; 95% CI: 19.36 to 67.07; p < 0.001).. The NERS score was more predictive of MACE than the SYNTAX score was. Further study is needed to address their relative roles in assessment for appropriateness of coronary artery bypass graft versus percutaneous coronary intervention for unprotected left main coronary artery stenosis.

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Chi-Square Distribution; China; Coronary Angiography; Coronary Artery Bypass; Coronary Stenosis; Drug-Eluting Stents; Female; Health Status Indicators; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Myocardial Infarction; Odds Ratio; Paclitaxel; Predictive Value of Tests; Proportional Hazards Models; Prospective Studies; Prosthesis Design; Registries; Risk Assessment; Risk Factors; ROC Curve; Thrombosis; Time Factors; Treatment Outcome

The aim of this study was to examine the incidence of clinical events after implantation of the TAXUS Express (Boston Scientific Corporation, Natick, Massachusetts) paclitaxel-eluting stent in saphenous vein graft (SVG) lesions in an unselected patient population.. Saphenous vein grafts have 1-year occlusion rates of 12% to 20%, with >50% failure by 7 to 10 years. Many diseased SVGs are treated by percutaneous coronary intervention to avoid higher-risk reoperation, but bare-metal stents have 35% to 40% historical SVG restenosis rates by 18 months. Reported outcomes of drug-eluting stents in SVG lesions are limited and mainly retrospective.. The ARRIVE (TAXUS Peri-Approval Registry: A Multicenter Safety Surveillance) program compiled data on 7,492 patients receiving > or =1 TAXUS Express (Boston Scientific) stent, including 474 patients with SVG. All cardiac events were monitored with independent adjudication of end points. Patients enrolled at procedure start with no mandated inclusion/exclusion criteria.. The ARRIVE SVG patient 2-year follow-up was 96% complete (457 of 474). The SVG patients had significantly more baseline comorbidities/complex disease than simple-use patients (n = 2,698) undergoing native coronary intervention or other expanded-use patients (n = 4,320 without SVG patients). They had higher 2-year rates of mortality (10.9% vs. 4.2%, p < 0.001), myocardial infarction (5.3% vs. 2.2%, p < 0.001), and Academic Research Consortium definite/probable stent thrombosis (4.7% vs. 1.4%, p < 0.001) than the simple-use group. They also had higher 2-year adverse event rates, including significantly more mortality (10.9% vs. 7.5%, p = 0.008) than other expanded-use patients.. The ARRIVE SVG patients have significantly different baseline risk and higher clinical risk through 2 years than simple-use and other expanded-use patients. Nonetheless, compared with historical SVG revascularization rates, treatment with paclitaxel-eluting stent seems to offer a reasonable therapeutic option in this high-risk group. (TAXUS ARRIVE: TAXUS Peri-Approval Registry: A Multicenter Safety Surveillance Program; NCT00569491) and (TAXUS ARRIVE 2: A Multicenter Safety Surveillance Program; NCT00569751).

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Chi-Square Distribution; Coronary Artery Bypass; Coronary Restenosis; Drug-Eluting Stents; Female; Graft Occlusion, Vascular; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Paclitaxel; Proportional Hazards Models; Prosthesis Design; Registries; Risk Assessment; Risk Factors; Saphenous Vein; Thrombosis; Time Factors; Treatment Outcome; United States

In-stent restenosis (ISR) remains a persistent, unresolved issue even in the era of percutaneous coronary intervention (PCI) using drug-eluting stents. The present study compares the clinical and angiographic outcomes of using sirolimus-eluting stents (SES) for re-intervention against ISR that was originally treated with sirolimus-eluting or bare-metal (BMS) stents.. This prospective single-center registry investigated 179 ISR lesions in 158 consecutive patients (53 lesions in 49, and 126 in 109 patients originally treated with SES and BMS, respectively), who had undergone re-intervention with SES. The patients were clinically and angiographically followed up at 8 months after re-PCI. The incidence of re-restenosis (29 vs 12%, P<0.01), ischemia-driven target lesion revascularization (TLR; 21 vs 8%, P<0.05) and major adverse cardiac events (MACE; 21 vs 9%, P<0.05) were significantly greater in ISR lesions originally treated with SES than in those originally treated with BMS at 8 months after re-PCI. Moreover, late luminal loss was significantly greater in the group with post-SES restenosis (P<0.05). Even after adjustment, post-SES restenosis was the only independent predictor of re-restenosis and MACE (P<0.05, each).. Although the re-restenosis rate is acceptable, the incidence rates of late restenosis, ischemia-driven TLR and MACE are higher after repeated SES implantation to treat SES, than BMS restenosis. These results might affect the mid-term clinical outcomes of re-intervention with SES.

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Angiography; Coronary Restenosis; Drug-Eluting Stents; Female; Humans; Japan; Logistic Models; Male; Metals; Middle Aged; Myocardial Infarction; Odds Ratio; Prospective Studies; Prosthesis Design; Registries; Risk Assessment; Risk Factors; Sirolimus; Stents; Thrombosis; Time Factors; Treatment Outcome

The optimal duration of dual antiplatelet therapy remains controversial.. Between December 2006 and March 2008, 823 patients were enrolled in a prospective multicenter registry for 3-month dual antiplatelet therapy (aspirin 100-200mg+clopidogrel 75 mg daily) followed by aspirin mono-therapy after zotarolimus-eluting stents (ZES). Major exclusion criteria were: cardiogenic shock, stent thrombosis (ST)-segment elevation myocardial infarction (MI) within 48h, previous drug-eluting stent implantation, severe left ventricular dysfunction, bifurcation lesions requiring 2-stenting, left main and graft lesions. The primary outcome was a composite of cardiac death, MI, or ST at 1 year. The median duration of dual antiplatelet therapy was 95 days (interquartile range 90-101). At 1 year, 3 patients (0.4%) had cardiac deaths, 3 patients (0.4%) had MI, and 4 patients (0.5%) had definite or probable ST, leading to the primary outcome in 5 patients (0.6%). Death, MI, or any revascularization occurred in 68 patients (8.3%). Among patients who were event-free at 3 months (n=812), clopidogrel was discontinued at 3 months in 661 patients and was continued for longer than 3 months in 151 patients. Discontinuation of clopidogrel at 3 months did not increase the primary outcome (HR 0.90; 95%CI, 0.09-9.02), death, MI, or any revascularization (HR 0.89; 95%CI, 0.48-1.67) after adjustment for the propensity score.. Three-month dual antiplatelet therapy seems to be feasible after ZES implantation in relatively low-risk patients.

Topics: Aged; Angioplasty, Balloon, Coronary; Aspirin; Cardiovascular Agents; Chi-Square Distribution; Clopidogrel; Coronary Angiography; Coronary Stenosis; Disease-Free Survival; Drug Administration Schedule; Drug Therapy, Combination; Drug-Eluting Stents; Feasibility Studies; Female; Humans; Kaplan-Meier Estimate; Logistic Models; Male; Middle Aged; Myocardial Infarction; Platelet Aggregation Inhibitors; Propensity Score; Proportional Hazards Models; Prospective Studies; Prosthesis Design; Registries; Republic of Korea; Risk Assessment; Risk Factors; Sirolimus; Thrombosis; Ticlopidine; Time Factors; Treatment Outcome

The aim of this study was to assess the 6-year clinical outcome after unrestricted use of sirolimus-eluting stents (SES) or paclitaxel-eluting stents (PES) as compared with bare-metal stents (BMS) in consecutive de novo patients undergoing percutaneous coronary intervention (PCI).. SES and PES have been shown to significantly decrease target vessel revascularization (TVR) rates compared with BMS in "real-world" registries. However, possible higher rates of very-late stent thrombosis and a restenosis "catch-up" trend might jeopardize the benefit.. Three PCI cohorts, each with exclusive use of 1 stent type (BMS = 450; SES = 508; PES = 576), were systematically followed for the occurrence of major adverse cardiac events (MACE).. Very-late stent thrombosis was more common in SES and PES patients than BMS patients (2.4% vs. 0.9% vs. 0.4%, respectively; p = 0.02); however, there were no significant differences between the stent types for all-cause mortality and all-cause mortality/myocardial infarction at 6-year follow-up. Sixty-nine SES patients (Kaplan-Meier estimate 14%) and 72 PES patients (14%) had a TVR, as compared with 79 BMS patients (18%; log-rank p = 0.02), which maintained significance after adjustment for (potential) confounders. Multivariate analysis showed that DES implantation is associated with lower incidence of TVR and MACE than BMS implantation (hazard ratio: 0.65, 95% confidence interval: 0.49 to 0.86; p = 0.003; hazard ratio: 0.79, 95% confidence interval: 0.65 to 0.97; p = 0.02, respectively). Incidence of MACE was also lower in SES and PES patients (30% and 30%, respectively) than in BMS patients (34%); however, significance was borderline.. The unrestricted use of both DES resulted in a sustained advantage in decreasing TVR and, to a lesser extent, MACE compared with BMS at 6 years. The SES and PES are equally safe and effective in the treatment of coronary lesions.

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Chi-Square Distribution; Coronary Artery Disease; Drug-Eluting Stents; Female; Humans; Kaplan-Meier Estimate; Male; Metals; Middle Aged; Myocardial Infarction; Netherlands; Paclitaxel; Proportional Hazards Models; Prosthesis Design; Registries; Risk Assessment; Risk Factors; Sirolimus; Stents; Thrombosis; Time Factors; Treatment Outcome

Topics: Angioplasty, Balloon, Coronary; Cardiovascular Agents; Drug-Eluting Stents; Everolimus; Humans; Hypersensitivity; Myocardial Infarction; Paclitaxel; Prosthesis Design; Sirolimus; Syndrome; Thrombosis; Treatment Outcome

Topics: Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Angiography; Coronary Stenosis; Diabetes Complications; Drug-Eluting Stents; Humans; Hypoglycemic Agents; Insulin; Myocardial Infarction; Paclitaxel; Prosthesis Design; Risk Assessment; Risk Factors; Severity of Illness Index; Sirolimus; Thrombosis; Time Factors; Treatment Outcome

Topics: Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Angiography; Coronary Artery Bypass; Coronary Restenosis; Coronary Stenosis; Drug-Eluting Stents; Humans; Prosthesis Design; Prosthesis Failure; Risk Factors; Sirolimus; Thrombosis; Treatment Outcome

Percutaneous coronary interventions for very small vessels are common in clinical practice despite an unavailability of the 2.25-mm sirolimus-eluting stent (SES) in some countries. We sought to evaluate the clinical and angiographic outcomes of 2.5-mm SES implantation at lower deployment pressures in very small coronary arteries.. Between June 2004 and March 2007, a total of 244 patients underwent percutaneous coronary interventions in vessels with reference diameters less than 2.5 mm at our centers: outcomes in 126 consecutive patients undergoing 2.5-mm SES implantation at lower deployment pressures (< or =10 atmospheres) with predilatation and postdilatation were compared with those in 118 patients who received bare-metal stents (BMS).. In the SES group, rates of predilatation and postdilatation were 73.8 and 81% respectively, and mean deployment pressure was 8.3+/-1.2 atmospheres. At follow-up, in-segment late loss was markedly lower in SES versus BMS (0.21+/-0.41 vs. 0.48+/-0.63 mm, P=0.001), resulting in significantly lower rates of restenosis (14.7 vs. 37.5%, P<0.001). At 1 year, SES versus BMS use was associated with similar rates of stent thrombosis (0.8 vs. 0.8%, P>0.999), but significantly lower rates of major adverse cardiac events (MACE) (11.9 vs. 27.1%, P=0.003), mainly driven by a significantly lower need for target-lesion revascularization (9.5 vs. 26.3%, P=0.001). Multivariable analysis identified the SES use as independently associated with a reduced 1-year MACE risk (hazard ratio: 0.32; 95% confidence interval: 0.15-0.66; P=0.002).. Implantation of 2.5-mm SES in vessels with reference diameters less than 2.5 mm using lower deployment pressures and predilatation and postdilatation may lead to reduced risks of restenosis and MACE without an increased risk of stent thrombosis up to 1 year.

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Cardiovascular Diseases; Coronary Angiography; Coronary Restenosis; Coronary Vessels; Drug-Eluting Stents; Female; Humans; Japan; Kaplan-Meier Estimate; Male; Metals; Middle Aged; Platelet Aggregation Inhibitors; Pressure; Proportional Hazards Models; Prosthesis Design; Risk Assessment; Sirolimus; Stents; Thrombosis; Time Factors; Treatment Outcome

We aimed to evaluate long-term outcomes of a modified mini-crush technique for treating bifurcation lesions.. Coronary bifurcation lesions continue to show a relatively high restenosis rate despite the use of a drug-eluting stent (DES).. We enrolled 52 consecutive patients treated with sirolimus-eluting stent implantation using the modified mini-crush technique for 56 coronary bifurcation lesions (MEDINA 1, 1, 1, 89.2%; left main lesion, 28.6%). To minimize crushing, the proximal marker of the side branch (SB) stent was located in contact with the main vessel (MV) stent. After SB stenting, we drew the SB balloon proximally and dilate the SB ostium at a rated burst pressure. After MV stenting, both vessels were redilated at a high pressure before final kissing balloon (FKB) inflation. Clinical and angiographic follow-ups were performed at 9 months.. Immediate procedural success was obtained in all cases including a FKB success rate of 98%. At 9 months, there was no death or myocardial infarction. The incidences of major adverse cardiac events and target lesion revascularization were 11.8 and 7.8%, respectively. The in-stent restenosis (ISR) rate was 14.9% (SB ostium, 10.6%) and most ISRs were of the focal type and the cause of ISR was intimal hyperplasia but not chronic stent recoil by an intravascular ultrasound study. There was one case (2.0%) of late stent thrombosis without any ischemic symptoms during the follow-up period of 9 months.. Modified mini-crush technique provides excellent technical and angiographic success immediately and it also provides acceptable long-term outcomes.

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

This study sought to investigate the incidence of stent thrombosis (ST) in patients treated with drug-eluting stents (DES) and clearly defined short-term dual antiplatelet therapy (DAT) for three or six months for sirolimus-eluting stents (SES) or paclitaxel-eluting stents (PES), respectively.. A series of 1023 consecutive patients with 1,414 stented lesions and prescribed short-term DAT were followed for at least two years after DES implantation. The individual durations of DAT, the rate of ischaemic events, and survival status were assessed. Follow-up was completed for 1017 patients (99.4%) with a mean follow-up of 3.0 +/- 0.7 years. DAT duration was 2.8 +/- 0.4 and 5.9 +/- 0.8 months in patients with SES and PES, respectively. Adherence to continued single antiplatelet therapy was 98.4%. We identified 14 patients with definite ST (1.4%) and no patients with probable ST with a cumulative incidence of 0.6% at 30 days, of 0.8% at one year, of 1.2% at 2 years, and of 1.4% at three years.. Definite or probable ST after DES implantation and short DAT occurs with a cumulative incidence of 1.4% at 3 years if excellent patient adherence to the continued single antiplatelet therapy can be achieved.

Topics: Adult; Aged; Aged, 80 and over; Angioplasty, Balloon, Coronary; Aspirin; Cardiovascular Agents; Clopidogrel; Coronary Artery Disease; Databases as Topic; Drug Administration Schedule; Drug-Eluting Stents; Female; Follow-Up Studies; Humans; Incidence; Kaplan-Meier Estimate; Male; Medication Adherence; Middle Aged; Paclitaxel; Platelet Aggregation Inhibitors; Sirolimus; Thrombosis; Ticlopidine; Time Factors; Treatment Outcome

We sought to examine by angioscopy the neointima formation and thrombogenic potential of the neointima after deployment of a drug-eluting stent (DES).. Late stent thrombosis after DES implantation, a major safety concern, has been associated with poor strut coverage by neointima. Intracoronary angioscopy provides a method for visual evaluation of stent coverage by neointima and detection of thrombus in the stented coronary segment.. Patients undergoing implantation of a sirolimus DES (n = 57) were serially examined by angioscopy immediately after (baseline) and again at 10 months (follow-up) after implantation. The angioscopic color grade of the neointima from white to yellow was assessed in a semiquantitative manner. Stent coverage was classified into not covered (Grade 0), covered by a thin layer (Grade 1), or buried under neointima (Grade 2). The thrombogenic potential of the neointima was evaluated by the prevalence of thrombus on the neointima.. The maximum yellow color grade of the neointima within DES-implanted lesions increased significantly from baseline to follow-up (1.4 +/- 1.1 vs. 1.9 +/- 0.6, p = 0.0008). Even among lesions without yellow color at baseline, yellow color was detected in 94% (17 of 18) of lesions at follow-up. The prevalence of thrombus was significantly higher on the yellow than on the white neointimal areas. Thrombus was detected on yellow and/or Grade-0/1 neointima, but never on the white Grade-2 neointima.. Sirolimus DES promoted formation of atherosclerotic yellow neointima in the stent-implanted lesion at 10-month follow-up. Thrombus was detected more often on the yellow area than on the white area and was never detected where a stent was buried under white neointima. These data suggest that the increased potential risk of late stent thrombosis in DES lesions may be due to the newly formed yellow neotima and cholesterol-laden plaque.

Topics: Aged; Angioplasty, Balloon, Coronary; Angioscopy; Cardiovascular Agents; Coronary Angiography; Coronary Artery Disease; Coronary Vessels; Drug-Eluting Stents; Female; Follow-Up Studies; Humans; Male; Metals; Middle Aged; Prosthesis Design; Retrospective Studies; Sirolimus; Thrombosis; Time Factors; Treatment Outcome; Tunica Intima

Topics: Angioplasty, Balloon, Coronary; Angioscopy; Autopsy; Cardiovascular Agents; Coronary Artery Disease; Coronary Restenosis; Coronary Vessels; Drug-Eluting Stents; Humans; Metals; Prosthesis Design; Registries; Sirolimus; Thrombosis; Time Factors; Treatment Outcome; Tunica Intima

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

Topics: Angioplasty, Balloon, Coronary; Aspirin; Cardiovascular Agents; Clopidogrel; Coated Materials, Biocompatible; Coronary Artery Disease; Coronary Restenosis; Drug Administration Schedule; Drug Therapy, Combination; Drug-Eluting Stents; Humans; Platelet Aggregation Inhibitors; Polymers; Prosthesis Design; Risk Assessment; Sirolimus; Thrombosis; Ticlopidine; Time Factors; Treatment Outcome

Topics: Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Angiography; Coronary Artery Disease; Coronary Restenosis; Drug-Eluting Stents; Humans; Myocardial Infarction; Prosthesis Design; Risk Assessment; Sirolimus; Thrombosis; Time Factors; Treatment Outcome; Ultrasonography, Interventional

We aimed to evaluate the risk of definite stent thrombosis with bare-metal stents (BMS) and drug-eluting stents (DES) in patients treated for acute coronary syndromes.. Acute coronary syndromes (ACS) have been reported as increasing the risk for stent thrombosis.. Between January 2000 and December 2005, 5,816 consecutive patients underwent percutaneous coronary intervention for de novo lesions with a single stent type. These patients consisted of 3 sequential groups of BMS (n = 2,248), sirolimus-eluting stents (n = 822) and paclitaxel-eluting stents (n = 2,746). In total, 3,485 patients presented with an ACS.. After a median follow-up of 1,394 days, patients with ACS had a definite stent thrombosis rate of 2.5% versus 1.0% in patients with stable angina (propensity score-adjusted hazard ratio [HR]: 2.80, 95% confidence interval [CI]: 1.72 to 4.56). ACS patients had a higher risk of early and late stent thrombosis, although the increased risk of very late stent thrombosis was only present in ACS patients treated with DES. In stable patients, any stent thrombosis resulted in a significant increase in mortality (adjusted HR: 4.0, 95% CI: 1.7 to 9.3), although this was particularly evident for late or very late stent thrombosis; in contrast only early stent thrombosis significantly increased mortality in patients with acute coronary syndrome patients (adjusted HR: 2.0, 95% CI: 1.0 to 4.1).. Patients with acute coronary syndromes are at higher risk of early and late stent thrombosis with either BMS or DES, although very late stent thrombosis seems to be uniquely associated with DES. The clinical sequelae of late and very late stent thrombosis are more pronounced in stable patients.

Topics: Acute Coronary Syndrome; Aged; Angina Pectoris; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Drug-Eluting Stents; Female; Humans; Kaplan-Meier Estimate; Male; Metals; Middle Aged; Paclitaxel; Proportional Hazards Models; Prosthesis Design; Registries; Risk Assessment; Risk Factors; Sirolimus; Stents; Thrombosis; Time Factors; Treatment Outcome

The data of long-term outcomes of sirolimus-eluting stent (SES) according to lesion location of unprotected left main coronary artery (LMCA) is scarce.. The purpose of this study was to evaluate the long-term outcomes after implantation of the SES in LMCA.. A total of 84 patients (51 males) who had undergone SES implantation for the treatment of native LMCA stenosis were enrolled. The patients were divided into 2 groups based on angiographic lesion location: those with significant stenosis in the ostium and/or body (group 1; n = 39) and those involving bifurcation (group 2; n = 45).. All of the group 1 patients were treated with simple lesion coverage while different stenting techniques were used in group 2 (cross-over: 44.8%, T: 6.7%, kissing: 37.8%, and crush techniques: 11.1%). The 8-month quantitative angiographic findings and in-hospital and 2 year rates of major adverse cardiac events (MACE) were compared between the 2 groups. Although angiographic success and in-hospital MACE rates were similar in both groups with 1 cardiac death due to acute stent thrombosis in group 2, at 2-year follow-up, the MACE rate was significantly higher in group 2 than in group 1 at 2 years (22.2% vs 2.6%, respectively, P = 0.008). Coronary angiography revealed a significantly higher binary restenosis rate in group 2 compared with group 1 (20% vs 0%, respectively, P = 0.003).. Interventional treatment using SES in left main lesions showed favorable short-term and long-term outcomes in selected patients with lesion location being an important determinant of clinical and angiographic outcomes.

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

The long-term prognosis of Japanese ST-elevation myocardial infarction (STEMI) patients treated with sirolimus-eluting stents (SESs) still remains unclear. We aimed to determine the 3-year outcomes of this population.. Major adverse cardiac events (MACE) defined as all-cause death, reinfarction, and target vessel revascularization during 3 years, angiographic data, and events of stent thrombosis were compared between 95 consecutive STEMI patients treated with SESs and 94 treated with bare-metal stents (BMSs). Significant advantages were discerned in all follow-up angiographic data from the SES group. The rate of target vessel revascularization was significantly less in the SES group than in the BMS group (P = 0.006). There was no significant difference in the rates of mortality (P = 0.258) or reinfarction (P = 0.496). The Kaplan-Meier analysis showed that at a 3-year follow-up, MACE-free survival was significantly higher in the SES group than in the BMS group (log-rank P<0.001). Academic Research Consortium 'definite' or 'probable' stent thrombosis was observed in two patients ('early' and 'very late') in the SES group and no patient in the BMS group. We observed no significant difference in the event rates of stent thrombosis (2.1% SES group vs. 0% BMS group, P = 0.497).. In Japanese STEMI patients, a 3-year follow-up showed that the routine use of SESs reduces the incidence of MACE without increasing the risk of stent thrombosis.

Topics: Aged; Angioplasty, Balloon, Coronary; Asian People; Cardiovascular Agents; Coronary Angiography; Drug-Eluting Stents; Female; Humans; Japan; Kaplan-Meier Estimate; Male; Metals; Middle Aged; Myocardial Infarction; Platelet Aggregation Inhibitors; Proportional Hazards Models; Prosthesis Design; Recurrence; Risk Assessment; Risk Factors; Sirolimus; Stents; Thrombosis; Time Factors; Treatment Outcome

Topics: Anticholesteremic Agents; Anticoagulants; Antihypertensive Agents; Cardiovascular Agents; Coronary Restenosis; Drug Design; Drug Industry; Drug-Eluting Stents; Humans; Platelet Aggregation Inhibitors; Thrombosis; United States; United States Food and Drug Administration

Topics: Alloys; Cardiovascular Agents; Clinical Trials as Topic; Coronary Restenosis; Drug-Eluting Stents; Humans; Hypersensitivity; Incidence; Paclitaxel; Platelet Aggregation Inhibitors; Risk Factors; Sirolimus; Thrombosis; Time Factors

We investigated the impact of sex on outcomes after percutaneous coronary intervention (PCI) with drug-eluting stent (DES).. Women have a higher risk of adverse outcomes after PCI than do men. However, long-term outcomes of women after contemporary PCI with DES have not been fully investigated.. We performed a retrospective cohort study of 4,936 consecutive patients (28.2% women) who underwent PCIs between 2000 and 2004, before and after introduction of DES (bare-metal stent [BMS] group: n = 2,131, DES group: n = 2,805), to assess the impact of sex on long-term PCI outcomes and to compare outcome after PCI of women between the DES and BMS eras.. Compared with men, women undergoing PCIs were 5 years older and more frequently have comorbidities such as diabetes mellitus and hypertension. In patients treated throughout the BMS and DES eras, there were no differences by sex for risk of all-cause death, myocardial infarction, or target vessel revascularization 3 years after procedure. The procedural complexity was higher in the DES era, nevertheless, risk for target vessel revascularization and major adverse cardiac event at 3 years were significantly lower in women treated with DES than in women treated with BMS (adjusted hazard ratio [HR] for target vessel revascularization: 0.52 [95% confidence interval (CI): 0.36 to 0.75], adjusted HR for major adverse cardiac event: 0.63 [95% CI: 0.48 to 0.83]).. Although women had worse baseline characteristics, no differences in 3-year outcomes were observed between men and women. Compared with BMS use, DES use has decreased revascularization rate equally in women and men.

Topics: Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Artery Disease; Drug-Eluting Stents; Female; Humans; Kaplan-Meier Estimate; Male; Metals; Myocardial Infarction; Netherlands; Proportional Hazards Models; Registries; Retrospective Studies; Risk Assessment; Risk Factors; Severity of Illness Index; Sex Factors; Sirolimus; Stents; Thrombosis; Time Factors; Treatment Outcome; Women's Health

Topics: Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Artery Disease; Drug-Eluting Stents; Female; Humans; Male; Metals; Myocardial Infarction; Risk Assessment; Risk Factors; Severity of Illness Index; Sex Factors; Sirolimus; Stents; Thrombosis; Time Factors; Treatment Outcome; Women's Health

Topics: Angioplasty, Balloon, Coronary; Cardiovascular Agents; Drug-Eluting Stents; Humans; Myocardial Infarction; Platelet Aggregation Inhibitors; Prosthesis Design; Recurrence; Risk Assessment; Risk Factors; Sirolimus; Thrombosis; Time Factors; Treatment Outcome

Topics: Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Angiography; Coronary Restenosis; Coronary Stenosis; Drug-Eluting Stents; Humans; Myocardial Infarction; Paclitaxel; Prosthesis Design; Risk Assessment; Severity of Illness Index; Sirolimus; Thrombosis; Time Factors; Treatment Outcome

The aim of this study was to compare outcomes among unselected patients undergoing percutaneous coronary intervention (PCI) with either sirolimus-eluting (SES) or paclitaxel-eluting stents (PES).. Although the benefits of both SES and PES are well-established, studies comparing these stents directly have yielded conflicting results.. We used data from the EVENT (Evaluation of Drug Eluting Stents and Ischemic Events) registry to compare in-hospital and 1-year outcomes among unselected patients undergoing nonemergent PCI with either SES or PES implantation.. Between July 2004 and June 2006, 6,035 patients underwent PCI with either SES (n = 3,443) or PES (n = 2,592) at 47 U.S. centers. Baseline clinical and angiographic characteristics were generally similar for the 2 stent types. At 1-year, there were no differences in the primary end point of cardiac death or myocardial infarction (MI) between the SES and PES groups (9.1% vs. 10.0%, p = 0.11) or in any individual end points including cardiac death, nonfatal MI, or stent thrombosis. In unadjusted analyses, target lesion revascularization (TLR) was slightly more common with SES than with PES (4.4% vs. 3.3%, p = 0.048), but this difference was no longer apparent after adjusting for baseline characteristics as well as site-related factors (adjusted hazard ratio: 1.09, 95% confidence interval: 0.78 to 1.50).. Among unselected patients undergoing PCI, adjusted rates of both ischemic complications as well as clinically important restenosis were similar for SES and PES. The unexpected finding that TLR was influenced by site characteristics suggests that the correlation between TLR and angiographic restenosis might be weaker than previously described and warrants further study.

Topics: Acute Coronary Syndrome; Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Angiography; Coronary Restenosis; Coronary Stenosis; Drug-Eluting Stents; Female; Humans; Logistic Models; Male; Middle Aged; Myocardial Infarction; Paclitaxel; Proportional Hazards Models; Prospective Studies; Prosthesis Design; Registries; Risk Assessment; Severity of Illness Index; Sirolimus; Thrombosis; Time Factors; Treatment Outcome; United States

The aim of this study was to investigate the angiographic and intravascular ultrasound (IVUS) findings of the Endeavor zotarolimus-eluting stent (ZES) in patients from a "real-world" clinical practice.. From January to March 2006, 100 patients undergoing routine or emergency percutaneous intervention were prospectively enrolled at one institution. Overall, 39% of the patients were diabetics and 80.8% of lesions were type B2/C. A total of 140 lesions were successfully treated with 174 ZES, and procedural success was 98%. Mean vessel diameter was 2.69 mm and mean lesion length was 16.0 mm; at 6-month angiographic follow-up (completed in 96%), in-stent late lumen loss was 0.66 mm, and in-segment restenosis was 8.2%. Angiographic restenosis was increased among diabetics (15.5 vs. 2.6%, p=0.009), and diabetes was the only significant predictor of angiographic restenosis (OR=15.27 [95%CI 2.45-95.04], p=0.003). By IVUS (performed in 88% at 6-month), % volume obstruction was 14.4+/-13.4%, and there was no late acquired incomplete stent apposition (ISA). At 1-year, overall MACE rate was 6%, including 5 TLRs (4% of patients), with no occurrence of stent thrombosis.. In this prospective "real-world" experience, the ZES demonstrated favourable angiographic and IVUS results in complex patients, with overall in-stent late lumen loss of 0.66 mm, and absence of late acquired ISA. At 1-year, there were no safety concerns including absence of death and stent thrombosis.

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Angiography; Coronary Artery Disease; Coronary Restenosis; Drug-Eluting Stents; Female; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Prospective Studies; Prosthesis Design; Registries; Risk Assessment; Risk Factors; Sirolimus; Thrombosis; Time Factors; Treatment Outcome; Ultrasonography, Interventional

The use of drug eluting stents (DES) in patients with a successfully recanalized chronic total occlusion (CTO) has been associated with a significant decrease in the need for repeat revascularization, and a favorable short-term clinical outcome when compared with the use of bare metal stents (BMS). Our group, however, has previously reported similar rates of target lesion revascularisation (TLR) and major adverse cardiovascular events (MACE) at 3 years follow-up in patients with a successfully opened CTO who were treated with either a sirolimus eluting stent (SES) or a BMS. The objective of this report was to evaluate the outcomes of these patients at 5-years clinical follow-up.. A total of 140 (BMS 64, SES 76) patients with successfully opened CTOs were included. Seven patients died in the BMS group whilst nine patients died in the SES group (P = 0.90). Noncardiac death was the major component of all-cause mortality (11 noncardiac deaths vs. 5 cardiac). There were two and three myocardial infarctions (MI) in the BMS and SES group, respectively (P = 1.0). The composite of death and MI occurred in seven (10.9%) and eleven (14.5%) patients in the BMS and SES group, respectively (P = 0.53). Clinically driven TLR was performed in eight patients (12.5%) in the BMS group, and five (6.6%) in the SES group (P = 0.26). Non-TLR target vessel revascularization was performed in one patient in the BMS group, and four in the SES group (P = 0.37). The 5-year device-oriented cumulative MACE rate was 15.6% and 11.8% in the BMS and SES group, respectively (P = 0.56).. In patients with a successfully treated CTO, clinical outcome after 5 years was similar between SES and BMS, however, clinically driven TLR was slightly higher in the BMS group.

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Chronic Disease; Coronary Angiography; Coronary Occlusion; Drug-Eluting Stents; Female; Humans; Kaplan-Meier Estimate; Male; Metals; Middle Aged; Myocardial Infarction; Netherlands; Platelet Aggregation Inhibitors; Proportional Hazards Models; Prospective Studies; Prosthesis Design; Registries; Risk Assessment; Risk Factors; Severity of Illness Index; Sirolimus; Stents; Thrombosis; Time Factors; Treatment Outcome

Late stent thrombosis related to delayed neointimal growth is a major concern after drug-eluting stent (DES) implantation. The time course of neointimal growth and risk factors of uncovered stent struts after sirolimus-eluting stent (SES) was studied using optical coherence tomography (OCT).. The 60 patients were enrolled and classified into G1 (follow-up period <9 months, n=27), G2 (9-24 months, n=18), and G3 (>25 months, n=15). The time elapsed since SES implantation was associated with a significant increase in mean neointimal area and neointimal thickness, and also with a significant decrease in the number of uncovered stent struts (G1: 14.8%, G2: 11.7%, and G3: 4.1%, P<0.001). However, only 17.6% of implanted SES was completely covered by neointima, even in the G3 period. Small-diameter SES, complex coronary lesions with lipid and calcium content adjacent to stent struts, and diabetes predicted delayed neointimal coverage of SES struts in G1.. Neointima inside SES progressively increases after the routine follow-up period, but only a few SES were completely covered at 3 years after implantation. OCT is a useful modality for assessing neointimal formation after SES implantation, and may give important information about the strategy of antiplatelet therapy after DES implantation.

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Cell Proliferation; Coronary Angiography; Coronary Vessels; Drug-Eluting Stents; Female; Follow-Up Studies; Humans; Linear Models; Male; Middle Aged; Platelet Aggregation Inhibitors; Risk Assessment; Risk Factors; Sirolimus; Thrombosis; Time Factors; Tomography, Optical Coherence; Treatment Outcome; Tunica Intima

Topics: Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Restenosis; Coronary Stenosis; Drug-Eluting Stents; Humans; Hyperplasia; Myocardial Infarction; Prosthesis Design; Sirolimus; Thrombosis; Time Factors; Treatment Outcome

After novel findings from genomewide association studies that sequence variation on chromosome 9p21.3 is a genetic factor for coronary heart disease, we investigated whether this locus influenced the clinical and angiographic outcomes after implantation of drug-eluting stents in coronary arteries.. Recently, genomewide association studies have identified a locus on chromosome 9 (approximately 100 kb in band p21.3) as the strongest genetic factor for coronary heart disease.. We studied the rs7865618, rs1537378, rs1333040, and rs1333049 polymorphisms located on chromosome 9p21.3 in a cohort of 2,028 patients who were treated with percutaneous coronary intervention and implantation of sirolimus- or paclitaxel-eluting stents. Records of 3-year adverse clinical outcomes were obtained from all stented patients. Follow-up angiography at 6 to 8 months after stenting was performed in 1,683 patients (83%).. The polymorphisms were not significantly related with clinical outcomes at 3 years, including death (p >or= 0.18), myocardial infarction (p >or= 0.19), repeat revascularization (p >or= 0.08), and the composite end point of adverse events (death, myocardial infarction, repeat revascularization) (p >or= 0.34). No association of the polymorphisms was found with angiographic measures at follow-up, including minimal lumen diameter (p >or= 0.51), diameter stenosis (p >or= 0.31), late lumen loss (p >or= 0.05), and binary restenosis (p >or= 0.31).. Specific polymorphisms in the chromosome 9p21.3 region that were shown to be associated with coronary heart disease in genomewide analyses were not related to the clinical and angiographic outcomes after the placement of drug-eluting stents in coronary arteries.

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Chromosomes, Human, Pair 9; Coronary Angiography; Coronary Disease; Coronary Restenosis; Drug-Eluting Stents; Female; Gene Frequency; Genetic Predisposition to Disease; Humans; Logistic Models; Male; Middle Aged; Myocardial Infarction; Paclitaxel; Phenotype; Polymorphism, Single Nucleotide; Proportional Hazards Models; Risk Assessment; Risk Factors; Sirolimus; Thrombosis; Time Factors; Treatment Outcome

Topics: Angioplasty, Balloon, Coronary; Cardiovascular Agents; Cell Proliferation; Coronary Angiography; Coronary Vessels; Drug-Eluting Stents; Humans; Platelet Aggregation Inhibitors; Risk Assessment; Risk Factors; Sirolimus; Thrombosis; Time Factors; Tomography, Optical Coherence; Treatment Outcome; Tunica Intima

Topics: Angioplasty, Balloon, Coronary; Cardiovascular Agents; Chronic Disease; Coronary Occlusion; Drug-Eluting Stents; Humans; Metals; Myocardial Infarction; Patient Selection; Platelet Aggregation Inhibitors; Prosthesis Design; Risk Assessment; Risk Factors; Sirolimus; Stents; Thrombosis; Time Factors; Treatment Outcome

Topics: Angioplasty, Balloon, Coronary; Cardiovascular Agents; Clinical Trials as Topic; Coronary Stenosis; Drug-Eluting Stents; Humans; Multicenter Studies as Topic; Myocardial Infarction; Patient Selection; Prosthesis Design; Risk Assessment; Sirolimus; Thrombosis; Time Factors; Treatment Outcome

Although drug-eluting stents have become a mainstay of percutaneous coronary intervention, information about drug-eluting stents outcomes in elderly patients is limited. Data from the paclitaxel-eluting stent (PES) trials and registries were pooled to assess PES benefits relative to advancing patient age, including comparison with bare-metal stents.. Data from 5 randomized trials (2271 patients with PES, 1397 patients with bare-metal stents) and from 2 postmarket registries (7492 patients with PES) were pooled separately. Each dataset was stratified into age groups: <60, 60 to 70, and >70 years. At baseline, patients aged >70 years in both datasets had significantly more adverse characteristics than younger patients. Through 5 years, trial data showed that patients aged >70 years had higher death rates, but comparable rates of myocardial infarction, stent thrombosis, and target lesion revascularization with younger patients. Compared with patients with bare-metal stents, patients with PES aged >70 years had comparable rates of death, myocardial infarction, and stent thrombosis but a significantly lower target lesion revascularization rate (22.2 versus 10.2, P<0.001). These findings were echoed in the registry data through 2 years that showed that PES patients aged >70 years had significantly higher death rates, but lower myocardial infarction, stent thrombosis, and target lesion revascularization rates, compared with younger patients. Although the mortality rates of patients aged >70 years were higher than those of younger patients, they were comparable with those of age- and gender-matched norms in the general population.. This analysis of almost 10 000 patients demonstrated that percutaneous coronary intervention with PES is a safe and an effective treatment option that should not be withheld based on age.

Topics: Age Factors; Aged; Aged, 80 and over; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Artery Disease; Drug-Eluting Stents; Evidence-Based Medicine; Female; Hospital Mortality; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Multicenter Studies as Topic; Myocardial Infarction; Paclitaxel; Patient Selection; Proportional Hazards Models; Randomized Controlled Trials as Topic; Registries; Risk Assessment; Risk Factors; Thrombosis; Time Factors; Treatment Outcome

Topics: Angioplasty, Balloon, Coronary; Cardiovascular Agents; Chronic Disease; Collateral Circulation; Coronary Angiography; Coronary Circulation; Coronary Occlusion; Drug-Eluting Stents; Humans; Male; Middle Aged; Prosthesis Design; Sirolimus; Thrombosis; Tomography, Optical Coherence; Treatment Outcome

Topics: Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Artery Disease; Drug-Eluting Stents; Evidence-Based Medicine; Humans; Myocardial Infarction; Off-Label Use; Paclitaxel; Platelet Aggregation Inhibitors; Practice Patterns, Physicians'; Risk Assessment; Risk Factors; Thrombosis; Time Factors; Treatment Outcome

The aim of this study was to evaluate the efficacy and safety of unrestricted everolimus-eluting stent (EES) implantation in a contemporary cohort of real-world patients.. The randomized SPIRIT (A Clinical Evaluation of the XIENCE V Everolimus Eluting Coronary Stent System in the Treatment of Patients With de Novo Native Coronary Artery Lesions) trials have evaluated the performance of EES, resulting in their approval by the Food and Drug Administration, but data regarding unselected usage, including off-label indications are lacking.. Consecutive patients treated with EES (either PROMUS, Boston Scientific Corp., Natick, Massachusetts, or XIENCE-V, Abbott Vascular Devices, Santa Clara, California) between October 2006 and February 2008 were analyzed. End points were cardiac death, myocardial infarction (MI), ischemic-driven target lesion revascularization (TLR), stent thrombosis (ST), and major adverse cardiac events (MACE) (a composite of cardiac death, MI, TLR) during follow-up.. We identified 345 patients (573 lesions) treated with EES. The majority of patients (71.9%) were treated for > or =1 off-label or untested indication. Clinical follow-up was completed in 99%. At a median follow-up of 378 days (interquartile range 334 to 473), MACE occurred in 36 (10.6%) patients, TLR in 27 (7.9%), MI in 7 (2.1%), and cardiac death in 7 (2.1%). Definite and probable ST was observed in 3 (0.9%) cases. Off-label EES implantation was not associated with a statistically significant increased risk of MACE (12.2% vs. 6.3%, p = 0.17), TLR (9.3% vs. 4.2%, p = 0.18), or ST (0.8% vs. 1.1%, p = 1.0). On multivariable analysis, previous bypass surgery (p = 0.002) and diabetes (p = 0.03) were associated with MACE.. In unrestricted daily practice, EES were implanted predominantly for off-label indications and associated with a relative low rate of MACE and TLR.

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Chi-Square Distribution; Coronary Artery Disease; Drug-Eluting Stents; Everolimus; Female; Humans; Kaplan-Meier Estimate; Logistic Models; Male; Middle Aged; Myocardial Infarction; Practice Guidelines as Topic; Registries; Retrospective Studies; Risk Assessment; Risk Factors; Sirolimus; Thrombosis; Time Factors; Treatment Outcome

We investigated the predictive value of the intravascular ultrasound (IVUS) measured post-intervention minimum stent area (MSA) on 9-month follow-up paclitaxel-eluting stent (PES) patency compared with bare-metal stents (BMS).. Stent underexpansion is a strong predictor for restenosis after sirolimus-eluting stent implantation, but the implication of underexpansion in PES is still unknown.. From the combined TAXUS IV, V, and VI and TAXUS ATLAS Workhorse, Long Lesion, and Direct Stent trials, 1,580 patients (PES 1,098, BMS 482) in IVUS substudies were analyzed. The MSA that best predicted angiographic in-stent restenosis (ISR) (% diameter stenosis > or =50%) was determined.. The post-intervention IVUS MSA was similar in PES and BMS (6.6 +/- 2.5 mm(2) vs. 6.7 +/- 2.3 mm(2), p = 0.92). At 9-month follow-up, ISR was lower in the PES group versus the BMS group (10% vs. 31%, p < 0.0001). Using multivariable logistic regression analysis, post-intervention IVUS MSA was the independent predictor of subsequent ISR in both the PES and BMS groups (p = 0.0002 for PES and p = 0.0002 for BMS). The ability of the post-intervention IVUS MSA to predict ISR was further assessed using receiver operating characteristic analysis. The post-intervention IVUS MSA was found to be a faithful discriminator between patients with and without ISR in both PES (c = 0.6382) and BMS (c = 0.6373). Finally, the optimal thresholds of post-intervention IVUS MSA that best predicted stent patency at 9 months were 5.7 mm(2) for PES and 6.4 mm(2) for BMS.. Post-intervention MSA measured by IVUS can predict 9-month follow-up stent patency after both PES and BMS implantation. (Randomized Trial Evaluating Slow-Release Formulation TAXUS Paclitaxel-Eluting Coronary Stents to Treat De Novo Coronary Lesions; NCT00301522) (Direct Stenting of TAXUS Liberté-SR Stent for the Treatment of Patients With de Novo Coronary Artery Lesions; NCT00371423) (A Study of the TAXUS Liberté Stent for the Treatment of Long De Novo Coronary Artery Lesions; NCT00371475) (A Study of the TAXUS Liberté Stent for the Treatment of de Novo Coronary Artery Lesions in Small Vessels; NCT00371748).

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Clinical Trials as Topic; Coronary Angiography; Coronary Artery Disease; Coronary Restenosis; Double-Blind Method; Drug-Eluting Stents; Female; Humans; Logistic Models; Male; Metals; Middle Aged; Odds Ratio; Paclitaxel; Predictive Value of Tests; Prospective Studies; Prosthesis Design; Risk Assessment; Risk Factors; ROC Curve; Stents; Thrombosis; Time Factors; Treatment Outcome; Ultrasonography, Interventional; Vascular Patency

Topics: Acute Coronary Syndrome; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Angiography; Coronary Artery Disease; Drug-Eluting Stents; Fatal Outcome; Humans; Male; Multiple Organ Failure; Platelet Aggregation Inhibitors; Sirolimus; Thrombosis; Time Factors; Tomography, X-Ray Computed; Treatment Outcome; Ultrasonography, Interventional

To report long-term outcome data on the V technique using drug-eluting stents.. From April 2002 to December 2006, 31 consecutive patients were successfully treated with V stenting of a de novo bifurcation lesion. The technique involves the deployment of two stents in the two branches of a bifurcation, the proximal edges of the stents just touching one another. Patients exclusively received either sirolimus- (10), paclitaxel- (20) or biolimus-eluting (one) stents. On average, 1.5 +/- 0.8 stents with a total length of 26.6 +/- 17.2 mm and 1.1 +/- 0.4 stents with a total length of 18.3 +/- 7.6 mm were deployed in the distal main vessel and side branch respectively. Mean duration of follow-up was 853 +/- 553 days. Within 30 days, three patients died; two other patients had definite stent thrombosis involving the V stents, both requiring re-PCI. Beyond 30 days and within one year, there was one death and three cases of target vessel revascularisation, including one target lesion revascularisation. There were a further three deaths (one cardiac) beyond one year. Eleven patients (35.5%) had angiographic follow-up, exhibiting a binary restenosis rate of 9.1% at 203 +/- 33 days.. In this real-world cohort, late clinical events stand in accord with studies on competitive techniques, but early outcome was less encouraging, probably due to the baseline risks.

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Angiography; Coronary Artery Disease; Coronary Restenosis; Drug-Eluting Stents; Female; Humans; Male; Middle Aged; Netherlands; Paclitaxel; Prosthesis Design; Registries; Retrospective Studies; Risk Assessment; Risk Factors; Sirolimus; Thrombosis; Time Factors; Treatment Outcome

Arterial drug concentrations determine local toxicity. As such the emergent safety concerns surrounding drug-eluting stents mandate an investigation of the factors contributing to fluctuations in arterial drug uptake. Drug-eluting stents were implanted into porcine coronary arteries, arterial drug uptake was followed and modeled using 2-dimensional computational drug transport. Arterial drug uptake in vivo occurred faster than predicted by free drug diffusion, thus an alternate, mechanism for rapid transport has been proposed involving carrier-mediated transport. Though there was minimal variation in vivo in release kinetics from stent to stent, arterial drug deposition varied by up to 114% two weeks after stent implantation. The extent of adherent mural thrombus also fluctuated by 113% within 3 days after implantation. The computational drug transport model predicted that focal and diffuse thrombi elevate arterial drug deposition in proportion to the thrombus size by reducing drug washout subsequently increasing local drug availability. Fluctuations in arterial drug uptake are commonly reported. We now explain that variable peristrut thrombus can explain such observations even in the face of a narrow range of drug release from the stent. The mural thrombus effects on arterial drug deposition may be circumvented by forcing slow, rate limiting arterial transport that cannot be further hindered by mural thrombus.

Topics: Animals; Blood Vessel Prosthesis Implantation; Cardiovascular Agents; Coronary Restenosis; Coronary Vessels; Drug Delivery Systems; Drug-Eluting Stents; Sirolimus; Swine; Swine, Miniature; Thrombosis; Time Factors

The treatment of complex long lesions of proximal left anterior descending artery involving the origin of diagonal branch is controversial. The aim of the present study is the evaluation of safety and clinical results of percutaneous coronary angioplasty with drug-eluting stents.. Since June 2002, we instituted a prospective longitudinal registry of all consecutive patients according to inclusion criteria. Default strategy was drug-eluting stent implantation on left anterior descending coronary artery and provisional stenting of side branch. We enrolled 232 patients; only 35 were sent to surgery, 12 were treated with bare metal stents and eight with medical therapy.. Provisional stenting was possible in 197 patients, whereas two stents were necessary in 35 patients. Final kissing balloon inflation was performed in 90% of patients. Overall, 30-day fatality linked with subacute stent thrombosis was 0.4%. Other in-hospital complications were 2.6% non-Q and 0.4% Q wave myocardial infarction. Global incidence of stent thrombosis was 1.7% (0.8% subacute, 0.4% late and 0.4% very late) with 50% fatality rate. Two patients died during follow-up; early and late mortality was 1.7%. Target lesion revascularization or target vessel revascularization was 7.3%, all managed by additional percutaneous intervention or medically.. In our population of patients with complex 'off-label', bifurcated, long lesion of left anterior descending artery involving the main diagonal branch, the treatment by drug-eluting stents on left anterior descending artery and provisional stenting of the diagonal is possible in the absolute majority of patients with excellent long-term outcome.

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Angiography; Coronary Artery Disease; Drug-Eluting Stents; Female; Humans; Longitudinal Studies; Male; Middle Aged; Myocardial Infarction; Prospective Studies; Registries; Sirolimus; Thrombosis; Time Factors; Treatment Outcome

Drug-eluting stent (DES) therapy reduces restenosis in patients with diabetes when compared with bare metal stent implantation. There are significant differences between commercially available DES platforms both in terms of design characteristics and clinical outcomes. Randomized active-comparator inter-DES trials powered for clinical endpoints are unlikely to be performed in patients with diabetes, however, direct comparison randomized trials utilizing surrogate endpoints support a superior anti-restenotic efficacy with sirolimus- versus paclitaxel-eluting stents. Thrombotic stent occlusion may be higher in patients with diabetes compared with nondiabetic patients, though there is no clear signal of a safety differential between the two platforms. Insufficient data on comparative performance in diabetics exist in relation to the approved zotarolimus-eluting and everolimus-eluting stent platforms. If all other factors are equal, then there seems to be no reason why the diabetic patient should not receive treatment with the sirolimus-eluting stent, which appears to have superior antirestenotic efficacy in this patient group.

Topics: Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Restenosis; Coronary Stenosis; Diabetes Complications; Drug-Eluting Stents; Everolimus; Evidence-Based Medicine; Humans; Hypoglycemic Agents; Insulin; Meta-Analysis as Topic; Metals; Paclitaxel; Patient Selection; Prosthesis Design; Randomized Controlled Trials as Topic; Registries; Risk Assessment; Sirolimus; Thrombosis; Treatment Outcome

The aim of the present study was to compare lesion morphologies after sirolimus-eluting stent (SES) implantation between patients with unstable angina pectoris (UAP) and stable angina pectoris (SAP) with the use of optical coherence tomography (OCT).. The lesion morphologies before and after coronary stenting have been proposed as important predictors of clinical outcome. The high resolution of OCT provides detailed information of coronary vessel wall.. We enrolled 55 patients (UAP: n = 24, SAP: n = 31), and examined lesion morphologies by using OCT at pre- and post-SES implantation and 9 months' follow-up.. The incidence of plaque rupture (42% vs. 3%, p < 0.001), intracoronary thrombus (67% vs. 3%, p < or = 0.001) and thin-capped fibroatheroma (cap thickness <65 microm; 46% vs. 3%, p < 0.001) at pre-intervention was significantly greater in UAP than that in SAP. Although stent profiles and procedural characteristics were not different between the 2 groups, inadequate stent apposition (67% vs. 32%, p = 0.038) and tissue protrusion (79% vs. 42%, p = 0.005) after percutaneous coronary intervention were observed more frequently in patients with UAP. Plaque rupture was significantly increased after percutaneous coronary intervention in patients with UAP (42% to 75%, p = 0.018), and the persistence of core cavity after plaque rupture (28% vs. 4%, p = 0.031) at 9 months' follow-up was observed more frequently in UAP patients compared with SAP patients. At 9 months' follow-up, the incidence of inadequately apposed stent (33% vs. 4%, p = 0.012) and partially uncovered stent by neointima (72% vs. 37%, p = 0.019) was significantly greater in UAP patients than that in SAP patients. All patients took aspirin and ticlopidine during follow-up period, and no patients had stent thrombosis or adverse coronary events.. Serial OCT examinations demonstrated markedly different vascular response up to 9 months after SES implantation between UAP and SAP patients. Although the inadequate lesion morphologies after stenting were observed more frequently in UAP patients, these findings were not associated with adverse outcomes in patients with antiplatelet therapy.

Topics: Aged; Angina Pectoris; Angina, Unstable; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Angiography; Coronary Artery Disease; Coronary Vessels; Drug-Eluting Stents; Female; Humans; Male; Middle Aged; Observer Variation; Platelet Aggregation Inhibitors; Predictive Value of Tests; Prospective Studies; Rupture; Sirolimus; Thrombosis; Time Factors; Tomography, Optical Coherence; Treatment Outcome

Topics: Angina Pectoris; Angina, Unstable; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Angiography; Coronary Artery Disease; Coronary Vessels; Drug-Eluting Stents; Humans; Platelet Aggregation Inhibitors; Predictive Value of Tests; Rupture; Sirolimus; Thrombosis; Time Factors; Tomography, Optical Coherence; Treatment Outcome; Wound Healing

This study sought to determine vasomotor functional responses of conduit coronary artery distal to bare-metal stents (BMS), polymer-only stents (POLY), and sirolimus-eluting stents (SES) in a clinically relevant animal model.. Drug-eluting stents (DES) reduce in-stent restenosis, and also affect neointima formation and vascular remodeling in downstream coronary segments. Whether distal artery vasomotor function is also influenced by DES has not been determined.. Pigs (n = 12) received coronary stent implants, and hearts were harvested at 1 month. Arterial segments >or=15 mm distal to stents were excised and studied in an organ-chamber apparatus. Endothelium-dependent and endothelium-independent relaxation and contraction to classical agonists were measured.. The SES showed increased lumen area and reduced neointima; abnormal vasomotor function of conduit arteries distal to SES also was observed. Contraction to endothelin-1 was significantly enhanced for SES compared with both BMS and POLY. Endothelium-dependent relaxation to a maximal dose of substance P was attenuated for SES compared with both BMS and POLY (46 +/- 6% vs. 71 +/- 3% and 78 +/- 3%, respectively, p < 0.001). Endothelium-independent relaxation to sodium nitroprusside was potentiated for SES, compared with BMS and POLY (100 +/- 5% vs. 69 +/- 7% and 77 +/- 5%, respectively, p = 0.02).. Stent-based local delivery of sirolimus profoundly inhibited neointima formation but caused vasomotor dysfunction in distal conduit vessel segments. These observations suggest that distal coronary vasospasm may be more readily evoked in the presence of DES and contribute to pathophysiological sequela.

Topics: Angioplasty, Balloon, Coronary; Animals; Cardiovascular Agents; Coronary Vasospasm; Coronary Vessels; Dose-Response Relationship, Drug; Drug-Eluting Stents; Female; Male; Metals; Models, Animal; Prosthesis Design; Sirolimus; Stents; Sus scrofa; Thrombosis; Time Factors; Vasoconstriction; Vasoconstrictor Agents; Vasodilation; Vasodilator Agents

Topics: Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Angiography; Drug-Eluting Stents; Humans; Male; Middle Aged; Paclitaxel; Platelet Aggregation Inhibitors; Suction; Thrombectomy; Thrombosis; Time Factors; Tomography, Optical Coherence; Ultrasonography, Interventional

Topics: Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Restenosis; Coronary Stenosis; Cost-Benefit Analysis; Drug-Eluting Stents; Humans; Paclitaxel; Prosthesis Design; Randomized Controlled Trials as Topic; Research Design; Risk Assessment; Severity of Illness Index; Sirolimus; Thrombosis; Time Factors; Treatment Outcome

The authors present a fatal case of late thrombosis of paclitaxel-eluting stent implanted in the left main stem occurring 6 months after the procedure and 3 weeks after the cessation of clopidogrel. An autopsy has shown the lack of endothelization of deployed stent.

Topics: Angioplasty, Balloon, Coronary; Autopsy; Cardiovascular Agents; Clopidogrel; Coronary Angiography; Drug-Eluting Stents; Endothelial Cells; Fatal Outcome; Humans; Male; Middle Aged; Myocardial Infarction; Paclitaxel; Platelet Aggregation Inhibitors; Prosthesis Design; Thrombosis; Ticlopidine; Treatment Outcome

Topics: Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Artery Bypass; Coronary Artery Disease; Drug-Eluting Stents; Humans; Myocardial Infarction; Paclitaxel; Patient Selection; Risk Assessment; Severity of Illness Index; Sirolimus; Thrombosis; Time Factors; Treatment Outcome

This report describes the prompt resolution of an apical left ventricular (LV)-thrombus complicating transient apical ballooning in a 74-year-old woman. The patient was admitted to our emergency department with acute chest pain and ST-elevation on the electrocardiogram. Coronary angiography showed normal coronary arteries and LV-angiography demonstrated the presence of apical ballooning akinesis associated with basal hypercontraction. Echocardiography and MRI studies confirmed the presence of LV-apex akinesis and detected an apical thrombus. Follow-up echocardiography on day 12 before discharge of the patient, revealed a marked improvement of regional contractility of the LV-apex and surprisingly the complete resolution of the LV-apical thrombus. The patient was diagnosed with takotsubo cardiomyopathy.

Topics: Aged; Angina Pectoris; Anticoagulants; Cardiomyopathies; Cardiovascular Agents; Female; Heart Diseases; Humans; Remission Induction; Thrombosis; Ventricular Dysfunction, Left

To evaluate clinical and angiographic long-term outcome of "the mini-crush" technique for treating bifurcation lesions.. Despite proven efficacy of drug-eluting stent (DES) within most lesions subsets, bifurcation lesions continue to exhibit high restenosis rate using current DES stenting technique.. We report a new stenting technique which was employed in 45 consecutive patients (52 lesions) between April 2004 and July 2005 to treat true bifurcation lesions using DES in both branches.. Using this technique procedural success was obtained in 100% of cases, without complications and with excellent angiographic result in 96.1% and 98.1% of main vessel and side branch. Preprocedure reference vessel diameter and minimal lumen diameter (MLD) were 2.68 +/- 0.48 and 0.90 +/- 0.55 mm for the main branch, respectively and 2.28 +/- 0.34 and 1.14 +/- 0.47 mm for the side branch, respectively. Postprocedure MLD was 2.56 +/- 0.39 mm for the main branch and 2.16 +/- 0.29 mm for the side branch. There were no in-hospital major adverse cardiac events (MACE). At 72 days after procedure there was one case of side branch stent thrombosis (2.2%), which resulted in non Q-wave MI. Angiographic follow up was obtained in 100% of patients at 7.5 +/- 1.3 months. Target lesion revascularization (TLR) was 12.2%; no death and Q-wave MI were observed; reference vessel diameter and MLD for the main branch were 2.79 +/- 0.51 and 1.99 +/- 0.65 mm respectively and for the side branch 2.28 +/- 0.40 and 1.63 +/- 0.48 mm respectively. Restenosis rate in the main branch was 12.2% while in the side branch was 2.0%.. In-hospital outcome indicates that the mini-crush technique for bifurcation lesions with DES can be easily performed. It provides very low total MACE rate and restenosis at 8-month follow-up. These results confirmed the advantage of this specific technique to give complete coverage of the ostium of the side branch using two stents technique.

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Angiography; Coronary Artery Disease; Coronary Restenosis; Databases as Topic; Female; Follow-Up Studies; Humans; Male; Middle Aged; Myocardial Infarction; Paclitaxel; Pilot Projects; Prospective Studies; Prosthesis Design; Sirolimus; Stents; Thrombosis; Time Factors; Treatment Outcome; Ultrasonography, Interventional

Topics: Adult; Angina Pectoris; Anticoagulants; Biopsy; Cardiovascular Agents; Endocardium; Heart Diseases; Heart Failure; Humans; Magnetic Resonance Imaging; Male; Myocarditis; Parvoviridae Infections; Parvovirus B19, Human; Thrombosis

Sirolimus-eluting stents (SES) and paclitaxel-eluting stents (PES) both significantly reduce the need for repeat intervention compared to bare metal stents. Studies comparing the clinical outcomes of these stents in noncomplex subsets of patients and lesions demonstrate a similar safety and efficacy profile. The data for more complex subsets of patients and lesions remains conflicting. This study aimed to compare SES with PES in a selected population with a broad range of complex features.. The patient population consisted of 1,591 consecutive patients with complex features undergoing drug-eluting stent (DES) implantation. In the SES group there were 1,095 patients (1,653 lesions) and in the PES group 496 patients (802 lesions). In-hospital, 30-day, and 12-month clinical outcomes were compared between groups. No discernable difference in major adverse cardiac events (MACE) between SES and PES was detected at intermediate and longer-term follow-up (SES 22.4% vs. PES 20.5% at 12 months; P=0.407). A trend toward increased angiographically documented stent thrombosis was observed in the SES group at both 3 and 12 months (SES 2.2% vs. PES 0.8% at 12 months; P=0.051). When adopting the more inclusive definition of probable stent thrombosis, this trend was no longer seen. After adjusting for baseline differences between the two groups, there still remained no difference in MACE between SES and PES (HR 1.051 [CI 0.826-1.339] P=0.685). The trend toward increased angiographically documented stent thrombosis in the SES group remained after adjustment for baseline differences (HR 2.836 [CI 0.968-8.311] P=0.057).. In a selected population with complex disease the rate of MACE was comparable between SES and PES, with higher overall rates of thrombosis and MACE compared to a noncomplex population. Thus, the focus should be directed to prevent late complications in this complex subset regardless of stent type selection.

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Cardiovascular Diseases; Coronary Angiography; Female; Follow-Up Studies; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Myocardial Ischemia; Paclitaxel; Proportional Hazards Models; Prosthesis Design; Research Design; Retrospective Studies; Risk Assessment; Severity of Illness Index; Sirolimus; Stents; Thrombosis; Time Factors; Treatment Outcome

Drug-eluting stents (DES) seemed likely to mitigate the problem of restenosis and have become the predominant stent deployed during percutaneous coronary intervention (PCI). Sustained concerns about the rate of stent thrombosis (ST), particularly very late ST (>1 year following PCI) led to a meeting of the Circulatory System Devices Advisory Panel to address "on-label" and "off-label" use as well as appropriate duration of dual antiplatelet therapy following DES. Over 40 presentations by members of the FDA, industry personnel, and leaders in the field of interventional cardiology helped set forth the body of data available on DES. Standardized definitions of ST created by the Academic Research Consortium were applied to existing randomized trials and registries. At the end of the 2-day session, the consensus of the panel was that "on-label" DES use is not associated with increased incidence of death and myocardial infarction (MI), although it is associated with increased rates of very late ST. "Off-label" use is associated with increased risk of death or MI when compared with "on-label" use. Insufficient data exist to determine the duration of clopidogrel that would minimize ST and bleeding risk, but the panel agreed with the current ACC/AHA/SCAI guidelines regarding dual antiplatelet therapy for at least 12 months in patients at low risk for bleeding, especially with "off-label" use. More data from trials designed with better control arms and prespecified analyses of complex patients and lesions subsets over longer periods of follow-up are needed.

Topics: Angioplasty, Balloon, Coronary; Biomedical Research; Cardiovascular Agents; Device Approval; Humans; Practice Guidelines as Topic; Prosthesis Design; Stents; Thrombosis; United States; United States Food and Drug Administration

Topics: Angioplasty; Attitude of Health Personnel; Cardiovascular Agents; Health Knowledge, Attitudes, Practice; Humans; Patient Selection; Physician-Patient Relations; Practice Guidelines as Topic; Prosthesis Design; Risk Assessment; Risk Factors; Stents; Thrombosis; Treatment Outcome

Topics: Angioplasty, Balloon, Coronary; Cardiovascular Agents; Cardiovascular Diseases; Humans; Myocardial Ischemia; Paclitaxel; Patient Selection; Prosthesis Design; Risk Assessment; Severity of Illness Index; Sirolimus; Stents; Thrombosis; Treatment Outcome

Topics: Angioplasty, Balloon, Coronary; Cardiovascular Agents; Cardiovascular Diseases; Coronary Angiography; Coronary Restenosis; Coronary Stenosis; Drug-Eluting Stents; Humans; Sirolimus; Thrombosis; Time Factors; Treatment Outcome; Ultrasonography, Interventional

The aim of our study was to evaluate the safety and midterm clinical results of dexamethasone-eluting stent (DexES) implantation in ST-segment elevation acute myocardial infarction (STEMI).. Inflammation plays a pivotal role in both inestabilization of coronary atherosclerotic plaques and development of restenosis after stent placement. Antiinflammatory agents may attenuate those mechanisms and improve clinical outcomes. There is little information about clinical results of DexES and no data are available about their utilization during percutaneous coronary intervention (PCI) in STEMI.. Consecutive patients with STEMI that underwent primary or rescue PCI in our institution were treated with DexES. Clinical follow-up with routine realization of noninvasive test for detection of myocardial ischemia and coronariography if necessary, were performed. The objective of the study was to evaluate the rate of MACE (death, reinfarction, or target lesion revascularization) during midterm follow-up.. The procedure was successful in 96.7% of cases. There were no in-hospital deaths or reinfarctions. One acute stent thrombosis occurred and no subacute thrombosis were observed. During a mean follow-up period of 384 days, cardiac-related death was 1.1%, there were no reinfarctions or late stent thrombosis and target lesion revascularization rate was 4.2%.. We conclude that utilization of DexES for PCI in STEMI is safe and provides good midterm clinical outcomes.

Topics: Adult; Aged; Aged, 80 and over; Angioplasty, Balloon, Coronary; Anti-Inflammatory Agents; Cardiovascular Agents; Cardiovascular Diseases; Dexamethasone; Drug-Eluting Stents; Feasibility Studies; Female; Follow-Up Studies; Humans; Male; Middle Aged; Myocardial Infarction; Secondary Prevention; Stroke Volume; Thrombosis; Time Factors; Treatment Outcome; Ventricular Function, Left; Ventricular Pressure

Although drug-eluting stents (DES) significantly reduce restenosis, they require 3 to 6 months of thienopyridine therapy to prevent stent thrombosis. The rate and consequences of prematurely discontinuing thienopyridine therapy after DES placement for acute myocardial infarction (MI) are unknown.. We used prospectively collected data from a 19-center study of MI patients to examine the prevalence and predictors of thienopyridine discontinuation 30 days after DES treatment. We then compared the mortality and cardiac hospitalization rates for the next 11 months between those who stopped and those who continued thienopyridine therapy. Among 500 DES-treated MI patients who were discharged on thienopyridine therapy, 68 (13.6%) stopped therapy within 30 days. Those who stopped were older, less likely to have completed high school or be married, more likely to avoid health care because of cost, and more likely to have had preexisting cardiovascular disease or anemia at presentation. They were also less likely to have received discharge instructions about their medications or a cardiac rehabilitation referral. Patients who stopped thienopyridine therapy by 30 days were more likely to die during the next 11 months (7.5% versus 0.7%, P<0.0001; adjusted hazard ratio=9.0; 95% confidence interval=1.3 to 60.6) and to be rehospitalized (23% versus 14%, P=0.08; adjusted hazard ratio=1.5; 95% confidence interval=0.78 to 3.0).. Almost 1 in 7 MI patients who received a DES were no longer taking thienopyridines by 30 days. Prematurely stopping thienopyridine therapy was strongly associated with subsequent mortality. Strategies to improve the use of thienopyridines are needed to optimize the outcomes of MI patients treated with DES.

Topics: Aged; Aged, 80 and over; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Cause of Death; Clopidogrel; Combined Modality Therapy; Coronary Restenosis; Drug Administration Schedule; Drug Implants; Female; Follow-Up Studies; Hospitalization; Humans; Life Tables; Male; Middle Aged; Mortality; Myocardial Infarction; Patient Education as Topic; Platelet Aggregation Inhibitors; Prevalence; Proportional Hazards Models; Prospective Studies; Pyridines; Registries; Sirolimus; Stents; Survival Analysis; Thrombosis; Ticlopidine; Treatment Outcome; Treatment Refusal

Decisions about chronic treatments during the perioperative period must be made at the presurgical anesthesia consultation. It is increasingly rare to stop treatment during this period, because: This new rule is applied particularly to patients with cardiovascular disorders. Beta blockers have a special role in preventing the onset of postoperative cardiovascular events. The role of statins requires further precision but they appear to fit into the same preventive approach. Interruption of antiplatelet agents appears to be associated with a risk of arterial thrombosis in patients with coronary conditions, notably those with conventional stents and most especially those with drug-eluting stents.

Topics: Adrenergic beta-Antagonists; Anesthesia; Angioplasty, Balloon, Coronary; Angiotensin Receptor Antagonists; Angiotensin-Converting Enzyme Inhibitors; Cardiovascular Agents; Cardiovascular Diseases; Case-Control Studies; Clinical Trials as Topic; Cohort Studies; Drug Interactions; Humans; Hypolipidemic Agents; Multicenter Studies as Topic; Platelet Aggregation Inhibitors; Postoperative Complications; Prospective Studies; Receptors, Angiotensin; Retrospective Studies; Risk Factors; Stents; Surgical Procedures, Operative; Thrombosis

Perfusion of the abdomen is determined by cardiac function and circulation. Intestinal ischemia can be caused by Non occlusive bowel ischemia (NOD) that is important in internal as well as surgical intensive care medicine. Cardiac medication can influence perfusion of the bowel: 1) digitalis increases muscular tonus and decreases perfusion regulation b) diuretics lead to hypovolemia, hypotonia and malperfusion, c) antihypertensive medication can cause intraoperative hypotension that demands catecholamines, d) catecholamines can reduce perfusion by pathologic vasoconstriction in the splanchnicus area. Preoperative medication should respect 1) preoperatively taken ACE-inhibitors should be given postoperatively, as they have protective influence on the microcirculation of the bowel, 2) beta-blockers stabilize the myogenic tonus of the abdominal vessels, reduce an overshot of the parasympatheticus and diminish the risk of neurogenic abdominal shock, 3) catecholamines should be used with respect to ischemia of the bowel. Therapy of NOD should be focused on the primary vascular and hemodynamic causes and also take care for bacterial translocation and consecutive sepsis.

Topics: Aged; Cardiovascular Agents; Coronary Circulation; Hemodynamics; Humans; Intestines; Ischemia; Male; Mesenteric Vascular Occlusion; Risk Factors; Shock, Cardiogenic; Splanchnic Circulation; Systemic Inflammatory Response Syndrome; Thrombosis

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

Topics: Animals; Arrhythmias, Cardiac; Cardiovascular Agents; Cardiovascular Diseases; Humans; Thrombosis

A 48-year-old patient with dilated cardiomyopathy complained of dyspnea at rest, severe sleeplessness and a slight pain in the stomach. The clinical examination was normal except for a murmur at the apex of the heart. There was no evidence of edema or congestion of the jugular veins.. The echocardiography demonstrated a dilated left ventricle with severely compromised function. No ventricular thrombi were present at this time. Coronary artery disease was excluded by coronary angiography. Endomyocardial biopsies were obtained from the right ventricular septum. The immunohistological analysis of the endomyocardial biopsy specimens revealed pathologically increased lymphocytic infiltrates and increased expression of interstitial and endothelial MHC I and II antigens. Flow cytometric analysis of platelets surface antigens (P-selectin, GP53, thrombospondin) was performed as a measure for intravasal platelet activation. Our patient compared to a healthy control group (> 4 SD) and to other patients with dilated cardiomyopathy (> 2 SD). A high grade increase of platelet activation was found.. ACE inhibitor, diuretics, spironolactone and digitalis were used to treat the heart insufficiency. Due to the severe left ventricular dysfunction phenprocoumone and aspirin were also prescribed. A follow-up echocardiography was performed 6 months later. Comparable to the first examination left ventricular contractility was found to be severely reduced. In addition, a marginal thrombus was now present in the left ventricle despite antithrombotic therapy.. An increased platelet activation was found in the peripheral circulation of our patient with dilated cardiomyopathy. After 6 months, ventricular thrombi were found in the dilated ventricle, although aspirin and phenprocoumone had been administred. We speculate that an additional thrombotic treatment with clopidogrel is necessary in patients with dilated cardiomyopathy and increased platelet activation.

Topics: Anticoagulants; Aspirin; Cardiomyopathy, Dilated; Cardiovascular Agents; Drug Therapy, Combination; Heart Failure; Heart Ventricles; Humans; Male; Middle Aged; Phenprocoumon; Platelet Activation; Risk Factors; Thrombosis; Treatment Failure; Ultrasonography

1. The methyl ester prodrug roxifiban is an orally active, potent and selective antagonist of the platelet glycoprotein GPIIb/IIIa receptor and is being developed for the prevention and treatment of arterial thrombosis. 2. Roxifiban was rapidly hydrolyzed to the zwitterion XV459 in vivo and by liver slices from the rat, mouse and human and by intestinal cores from dog. XV459 was metabolized to only a small extent in vitro and in vivo. 3. Studies with rat and dog given radiolabelled roxifiban showed limited oral absorption with the majority of the radiolabel being excreted in faeces. After i.v. doses of 14C-roxifiban, most of the radioactivity was recovered in the urine of rat whereas the dog excreted significant amounts of radioactivity in bile and urine. 4. XV459 could be metabolized extrahepatically by dog gut flora to produce an isoxazoline ring-opened metabolite. In vitro hepatic metabolism of XV459 was mainly by hydroxylation at the prochiral and chiral centres of the isoxazoline ring. These hydroxylated metabolites were not detected in the urine and plasma of human volunteers administered roxifiban. 5. Initial LC/MS identification of metabolites was achieved by dosing the rat with an equimolar mixture of d0:d4 roxifiban and detecting isotopic clusters of pseudomolecular ions. Unequivocal characterization of these metabolites was achieved by LC/MS, LC/NMR and high-field NMR techniques using synthetic standards of the metabolites. 6. The synthesis of one hydroxylated metabolite enabled the assignment of the correct stereochemistry of the substituted hydroxyl group on the isoxazoline ring.

Topics: Amidines; Amino Acids; Animals; Cardiovascular Agents; Chromatography, High Pressure Liquid; Dogs; Feces; Gas Chromatography-Mass Spectrometry; Humans; Isoxazoles; Liver; Magnetic Resonance Spectroscopy; Mass Spectrometry; Mice; Platelet Glycoprotein GPIIb-IIIa Complex; Rats; Thrombosis

Topics: Animals; Cardiovascular Agents; Cricetinae; Dipeptides; Dogs; Graft Occlusion, Vascular; Guinea Pigs; Humans; In Vitro Techniques; Platelet Aggregation Inhibitors; Platelet Glycoprotein GPIIb-IIIa Complex; Thrombosis

We tested the hypothesis that dismutation of superoxide anion increases endogenous levels of nitric oxide, resulting in inhibition of cyclic variations in blood flow in arteries that are injured and stenotic.. Platelet adhesion and aggregation leading to cyclic flow variations might result, in part, from generation of superoxide anion that can deplete endogenously produced nitric oxide.. Spontaneous cyclic flow variations, monitored with a proximal Doppler probe, were induced in the carotid artery of anesthetized rabbits by clamping the vessel with forceps and placing a high grade stenosis at the site of injury. Bovine copper/zinc superoxide dismutase (12 mg/kg body weight, n = 5), a synthetic low molecular weight mimetic (12 mg/kg, n = 8) or buffer vehicle (n = 8) was administered intravenously as divided boluses over 45 min, and the frequency of cyclic flow variations was monitored for 4 h.. Cyclic flow variations remained stable for 4 h in vehicle-treated animals (15 +/- 1 [mean +/- SEM]/30 min at baseline and 16 +/- 1/30 min after 4 h, n = 8) but exhibited a marked and persistent reduction in animals given copper/zinc superoxide dismutase (from 14 +/- 1/30 min at baseline to 4 +/- 1/30 min after 4 h) or the mimetic (from 15 +/- 1/30 min at baseline to 3 +/- 1/30 min after 4 h, p < 0.005). They were restored in three of four mimetic-treated animals during infusion of NG-monomethyl- L-arginine (100 mg/kg), an inhibitor of nitric oxide production. In addition, levels of cyclic guanosine 5'-monophosphate in platelets were elevated after administration of the mimetic (from 2.4 +/- 0.5 fmol/10(6) platelets at baseline to 4.9 +/- 0.6 fmol/10(6) platelets 45 min after the mimetic, p < 0.03, n = 6), whereas mean arterial blood pressure was decreased and flow velocity in the carotid artery was increased consistent with mediation of the effect on cyclic flow variations by increased endogenous nitric oxide.. Dismutation of superoxide anion appears to attenuate platelet thrombus formation at a site of vessel injury by potentiation of endogenously produced nitric oxide. This approach may have utility to inhibit platelet-rich thrombosis in injured and stenotic arteries where production of superoxide anion is increased.

Topics: Animals; Arteries; Aspirin; Blood Platelets; Cardiovascular Agents; Constriction, Pathologic; Cyclic GMP; Drug Evaluation, Preclinical; Drug Synergism; Nitric Oxide; Nitroglycerin; Organometallic Compounds; Rabbits; Random Allocation; Superoxide Dismutase; Thrombosis; Time Factors

Propionyl carnitine, a derivative of carnitine, has metabolic and cardiovascular effects similar to carnitine but with more pronounced peripheral haemodynamic activity. In these experiments we propose to prove that the administration of propionyl carnitine could prevent the experimental tail thrombosis in the rat induced by endothelin (ET-1), serotonin and K-carrageenin. In this new test of experimental thrombosis, propionyl carnitine was able to reduce the extent of tail thrombosis in a more significant manner than that of carnitine. A possible explanation of this antithrombotic effect of propionyl carnitine is its capacity to counteract the vasoconstrictor activity of endothelin modulating the release of prostanoids induced by endothelin itself.

Topics: Animals; Cardiovascular Agents; Carnitine; Carrageenan; Endothelins; Male; Rats; Rats, Wistar; Regional Blood Flow; Serotonin; Tail; Thrombosis; Vascular Diseases

Pretreatment of rats by the cyclooxygenase inhibitors diclofenac, phenylbutazone, and aminophenazone did not influence kappa-carrageenin (KC) rat tail thrombosis (RTT) whereas pretreatment by aspirin, at high doses, and particularly sulfinpyrazone decreased RTT frequency, PGI2 or iloprost i.v. injection showed strong RTT preventing effects as it was also seen by thromboxane synthesis inhibitors (benzydamine, imidazole) at high doses. The PAF antagonist BN 52020 weakly protected. Lipoxygenase inhibitors (quercetin, oxphaman a.o.) proved ineffective. Therefore, thromboxane/PGI2 balance and partly PAF seem to be involved in the mechanism of KC RTT.

Topics: Aminopyrine; Animals; Aspirin; Benzydamine; Cardiovascular Agents; Carrageenan; Diclofenac; Epoprostenol; Female; Iloprost; Imidazoles; Phenylbutazone; Rats; Rats, Inbred Strains; Thrombosis; Thromboxanes; Trapidil

Patients with heparin-induced platelet activation who are reexposed to heparin may have recurrent thrombocytopenia, intravascular thrombosis, arterial emboli, or sudden death. To permit carotid endarterectomy in two patients with confirmed heparin-induced platelet activation, we compared the efficacies of aspirin and iloprost, a stable analogue of prostacyclin, in preventing heparin-induced platelet activation. In the first patient, although aspirin prevented both in vitro heparin-induced platelet aggregation (70% without and 7.5% with aspirin) and 14C serotonin release (48% without and 0% with aspirin), intraoperative administration of heparin resulted in an increase in plasma levels of platelet factor 4 from 8 to 260 ng/ml and beta-thromboglobulin levels from 29 to 39 ng/ml. In addition, the circulating platelet count decreased from 221,000 to 174,000 microliters, and 15% spontaneous platelet aggregation was observed. Fortunately, fibrinopeptide A levels remained less than 10 ng/ml intraoperatively, and no thrombotic complications occurred. In the second patient, aspirin did not prevent heparin-induced platelet aggregation in vitro (65% without and 41% with aspirin); however, iloprost (0.01 mumol/L) prevented both in vitro heparin-induced platelet aggregation (59.5% without and 0.0% with iloprost) and 14C serotonin release (56.7% without and 0.0% with iloprost). Therefore, a continuous infusion of iloprost was begun before administration of heparin and was continued until 20 minutes after reversal of heparin with protamine. After intraoperative administration of heparin, plasma levels of platelet factor 4 increased from 19 to 200 ng/ml, and beta-thromboglobulin levels increased from 56 to 76 ng/ml.(ABSTRACT TRUNCATED AT 250 WORDS)

Topics: Aged; Aspirin; beta-Thromboglobulin; Cardiovascular Agents; Carotid Arteries; Drug Evaluation; Endarterectomy; Epoprostenol; Fibrinopeptide A; Heparin; Humans; Iloprost; Male; Platelet Activating Factor; Platelet Aggregation; Platelet Count; Platelet Factor 4; Preoperative Care; Thrombosis

Topics: Animals; Anticoagulants; Blood Coagulation; Blood Platelets; Cardiovascular Agents; Dose-Response Relationship, Drug; Female; In Vitro Techniques; Male; Mice; Phenanthrenes; Rats; Thrombosis

Topics: Angina Pectoris; Anti-Arrhythmia Agents; Antihypertensive Agents; Arrhythmias, Cardiac; Cardiotonic Agents; Cardiovascular Agents; Cardiovascular Diseases; Fibrinolytic Agents; Hemodynamics; Humans; Hypertension; Platelet Aggregation; Thrombosis

Kappa-carrageenins cause disseminated intravascular coagulation with thrombosis of the tail in rats and mice. Frequency and extent of tail thrombosis were used for determining antithrombotic effects after systemic and local external administration of substances. Inhibitors of cyclooxygenase and thromboxane synthetase caused irregular inhibition of thrombosis after relatively high doses. The cyclooxygenase/lipoxygenase inhibitor BW755C was ineffective after 50 mg/kg. Hitherto, no effective substances could be found after external administration on the tail of mice. At present, no convincing explanation for thrombogenic activity of kappa-carrageenin can be given. The advantages of the thrombosis model are discussed.

Topics: Animals; Anti-Inflammatory Agents; Cardiovascular Agents; Carrageenan; Disease Models, Animal; Female; Male; Rats; Rats, Inbred Strains; Thrombosis

Topics: Benzothiadiazines; Cardiovascular Agents; Diuretics; Drug Therapy; Edema; Flavonoids; Humans; Leg; Potassium; Potassium Chloride; Thrombosis

Topics: Adrenal Cortex Hormones; Anticoagulants; Cardiovascular Agents; Ethyl Biscoumacetate; Heparin; Heparinoids; Humans; Muscle Relaxants, Central; Retinal Vein; Retinal Vessels; Thrombosis; Trypsin; Vasodilator Agents

Topics: Cardiovascular Agents; Edema; Ergoloid Mesylates; Ergot Alkaloids; Leucine; para-Aminobenzoates; Thrombosis

Topics: Aminobenzoates; Cardiovascular Agents; Ergoloid Mesylates; Ergot Alkaloids; Leucine; para-Aminobenzoates; Thrombosis

Topics: Aminobenzoates; Aorta; Aortic Diseases; Cardiovascular Agents; Disease; Ergoloid Mesylates; Ergot Alkaloids; Leucine; para-Aminobenzoates; Thrombosis

Topics: Aminobenzoates; Anticoagulants; Cardiovascular Agents; Ergot Alkaloids; Humans; Leucine; para-Aminobenzoates; Thrombosis

Topics: Cardiovascular Agents; Ganglionic Blockers; Muscle Relaxants, Central; Parasympatholytics; Pulmonary Embolism; Sympatholytics; Thrombosis