Abstract: high-sensitivity cardiac troponin assays enable the measurement of cardiac troponin concentrations in the majority of patients with coronary artery disease. The objective of this study was to investigate the prognostic value of sensitive cardiac troponin in patients with stable and unstable angina presenting with undetectable levels of conventional troponin.
Abstract: Bleeding complications in patients undergoing percutaneous coronary interventions (PCIs) are associated with increased risk of subsequent mortality. We undertook this study to characterize the subset of patients with bleeding complications who are at an increased risk of death within the first year after a PCI procedure. The study included 331 patients with bleeding complications among 9 954 patients who underwent PCI. The primary outcome analysis was 1-year mortality. Within the first year following PCI there were 39 deaths among 331 patients (11.8%), with bleeding complications and 240 deaths among 9 623 patients without bleeding complications (Kaplan-Meier estimates of 1-year mortality; 11.8% vs 2.5%, odds ratio 5.09, 95% confidence interval 3.76-6.90, P < 0.001). Time to death (median [25th-75th percentiles]) was 38.5 [7.2-125.9] days in patients with bleeding complications vs 137.1 [68.3-234.0] days in patients without bleeding complications (P < 0.001). Compared with survivors (n = 292), nonsurvivors (n = 39) had a significantly more adverse risk profile. The Cox proportional hazards model identified the elevated troponin level as the only independent correlate of 1-year mortality (hazard ratio = 2.35, 95% confidence interval 1.04-5.31, P = 0.039). In conclusion, patients with peri-PCI bleeding complications who die have a more adverse cardiovascular risk profile than patients with bleeding complications who survive the first year after PCI. Patients with bleeding complications and an elevated troponin level are at high risk of death within the first year following PCI. The majority of deaths in patients with peri-PCI bleeding occur within the first 3 months after PCI procedure.
Abstract: Compared to unfractionated heparin (UFH), bivalirudin decreases bleeding during percutaneous coronary interventions (PCIs). We sought to investigate the association between periprocedural bleeding and 1-year mortality as a function of antithrombotic therapy with bivalirudin or UFH. This analysis of the association between bleeding with bivalirudin or UFH and 1-year mortality included the 4,570 patients with negative biomarkers enrolled in the Intracoronary Stenting and Antithrombotic Regimen: Rapid Early Action for Coronary Treatment (ISAR-REACT 3) trial. Major or minor bleeding occurred in 555 patients (12.1%): 225 patients treated with bivalirudin (9.8%) and 330 patients treated with UFH (14.5%, p <0.001). There were 82 deaths (1.8%) within the first year after PCI: 29 deaths occurred in patients who had bled, and 53 deaths occurred in patients who had not bled (Kaplan-Meier estimates of 1-year mortality 5.2% and 1.3%, odds ratio 4.12, 95% confidence interval 2.59 to 6.54, p <0.001). One year after PCI, there were 15 deaths in patients who bled with bivalirudin versus 14 deaths in patients who bled with UFH (Kaplan-Meier estimates of 1-year mortality 6.7% vs 4.2%, odds ratio 1.61, 95% confidence interval 0.76 to 3.40, p = 0.20). Major bleeding occurred in 70 patients (3.0%) treated with bivalirudin and 104 patients treated with UFH (4.5%, p = 0.008). One-year mortality was 11.4% (n = 8) in patients with major bleeding with bivalirudin versus 4.8% (n = 5) in patients with major bleeding with UFH (p = 0.10). In conclusion, these data suggest that in patients with negative biomarkers undergoing PCI, bivalirudin decreases bleeding after PCI compared to UFH, without affecting 1-year mortality in those who had bled.
Abstract: In ISAR-REACT 3, 30-day outcomes in 4570 biomarker negative patients undergoing percutaneous coronary intervention (PCI) > or =2 h after pre-treatment with 600 mg of clopidogrel revealed less bleeding with bivalirudin compared with unfractionated heparin, but no difference in 30-day net clinical benefit. The objective of the present analysis was to assess the impact of bivalirudin vs. heparin on 1-year outcomes in ISAR-REACT 3.
Abstract: OBJECTIVES AND BACKGROUND:: First generation drug-eluting stents have shown differential efficacy in high-risk patient subsets at 1-year. It is unclear whether these differences endure over the medium- to long-term. We compared the 5-year clinical efficacy and safety of sirolimus-eluting stents (SES) and paclitaxel-eluting stents (PES) in a population of high-risk patients. METHODS:: The patient cohorts of the ISAR-DESIRE, ISAR-DIABETES, and ISAR-SMART-3 randomized trials were followed up for 5 years and data were pooled. The primary efficacy endpoint of the analysis was the need for target lesion revascularisation (TLR) during a 5-year follow-up period. The primary safety endpoint was the combination of death or myocardial infarction (MI) after 5 years. RESULTS:: A total of 810 patients (405 patients in the SES group and 405 patients in the PES group) was included. Over 5 years TLR was reduced by 39% with SES compared to 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). CONCLUSIONS:: In high-risk patient subsets the lower rate of 12-month TLR observed with SES in comparison PES is maintained out to 5 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. (c) 2010 Wiley-Liss, Inc.
Abstract: In the ISAR-TEST-2 (Intracoronary Stenting and Angiographic Results: Test Efficacy of Three Limus-Eluting Stents) randomized trial, a new-generation sirolimus- and probucol-eluting stent (Dual-DES) demonstrated a 12-month efficacy that was comparable to sirolimus-eluting stents (SES) (Cypher, Cordis Corp., Warren, New Jersey) and superior to zotarolimus-eluting stents (ZES) (Endeavor, Medtronic CardioVascular, Santa Rosa, California). The aim of the current study was to investigate the comparative clinical and angiographic effectiveness of SES, Dual-DES, and ZES between 1 and 2 years.
Abstract: In the Bavarian Reperfusion Alternatives Evaluation (BRAVE)-3 study upstream administration of abciximab additional to 600 mg clopidogrel loading did not reduce the infarct size in patients with acute ST-segment elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary interventions. The aim of this study was to investigate 1-year clinical outcomes in the BRAVE-3 study patients.
Abstract: Drug-eluting stent (DES) platforms devoid of durable polymer have potential to enhance long-term safety outcomes. The ISAR-TEST-3 study was a randomised trial comparing three rapamycin-eluting stents with different coating strategies. The present study examined 2-year outcomes of these patients and is the first large-scale trial to report longer-term outcomes with biodegradable polymer and polymer-free DES.
Abstract: Although biodegradable polymer drug-eluting stent (DES) platforms have potential to enhance long-term clinical outcomes, data concerning their efficacy are limited to date. We previously demonstrated angiographic antirestenotic efficacy with a microporous, biodegradable polymer DES. In the current study, we hypothesized that at 12 months, its clinical safety and efficacy would be non-inferior to that of permanent polymer DES.
