西罗莫司洗脱支架防止冠脉支架内再狭窄的研究进展

冠脉内支架置入术目前在临床上广泛应用 ,但内膜增生造成 10 %～ 6 0 % [1] 病人支架内再狭窄 (In StentRestenosis,ISR)。ISR限制了该技术远期的疗效 ,日益成为重要的临床问题。大量实验资料表明西罗莫司 (Sirolimus)能抑制细胞周期 ,减少新生内膜的形成。通过聚合物涂层支架释放西罗莫司可能有效防止ISR。1　西罗莫司西罗莫司 (雷帕霉素 ,Rapamycin)是从吸水性链霉菌 (streptomyceshygroscopicus)发酵液中提取出来的一种大环内脂类化合物 ,西罗莫司于 1975年被发现 ,最初作为低毒性抗真菌的抗生素 ,由于其免疫毒性作为免疫抑制剂进…     

Drug-Eluting Stents Versus Bare-Metal Stents in Large Coronary Artery Revascularization: Systematic Review and Meta-Analysis

ObjectivesWe aim to determine if drug eluting stents (DES) are better than bare-metal stents (BMS) in large coronary artery (diameter ≥ 3 mm) percutaneous coronary intervention (PCI).BackgroundDES have become the standard of care for PCI in coronary artery disease (CAD). However, the superiority of DES over BMS in large vessel CAD is not clear and previous studies have shown conflicting results.MethodsRandomized controlled trials (RCTs) comparing outcomes of PCI with BMS and DES for large vessel CAD were identified from the year 2000 to August 2019. The outcomes were studied individually and included all-cause mortality, myocardial infarction (MI), target lesion revascularization (TLR), and stent thrombosis. Aggregated odds ratio and 95% CI were calculated using a random-effects model.ResultsEight RCTs were included (4 with data for first-generation DES, 3 with data for second-generation DES, and 1 with data for both first- and second-generation DES). Compared to BMS, second generation DES had a significantly lower rate of all-cause mortality (2.4% vs. 3.9%, OR 0.74, 95% CI 0.56–0.98, P 0.04), TLR (3.5% vs. 8.6% OR 0.38 95% CI 0.28–0.53, P < 0.001), and MI (2.1% vs. 2.9% OR 0.73 95% CI 0.53–1.0, P 0.05). The difference in all-cause mortality was not seen with first-generation DES.ConclusionNewer DES are associated with a lower mortality, TLR, and MI and thus should be preferred over BMS for large coronary artery PCI.     

Bare-Metal Stents Versus Drug-Eluting Stents for Primary Angioplasty: Long-Term Outcome

Percutaneous transluminal coronary intervention (PCI) is the most used myocardial revascularization technique for patients with coronary artery disease. Primary PCI with stent implantation is widely considered the gold standard for the treatment of ST-elevation myocardial infarction patients. Coronary stents, compared with balloon angioplasty, have reduced focal lesion restenosis. To reduce in-stent restenosis, drug-eluting stents (DES) were designed to locally release drugs inhibiting neointimal growth. Recent concerns have emerged on the potential higher risk of stent thrombosis with DES that might be even more pronounced among myocardial infarction patients. For these reasons, DES for primary PCI remains an “off-label” use. In the last several years, a number of randomized trials and registries have tested the safety and efficacy of DES in primary PCI. Data from these studies were analyzed in several meta-analyses, reasonably consistently demonstrating that the use of DES significantly decreased the need for revascularization without an increase in the incidence of death, recurrent infarction, or stent thrombosis at long-term follow-up.     

依维莫司洗脱支架与西莫罗斯洗脱支架治疗冠状动脉疾病随机临床对照试验的Meta分析

目的 探讨依维莫司洗脱支架与西莫罗斯洗脱支架在治疗冠状动脉疾病疗效方面的差别.方法 计算机检索Medline(1960年～2012年1月)、CENTRAL(1989年～2012年1月)、EMBASE(1980年～2012年1月)和中国期刊全文数据库(CNKI1979年～2012年1月)公开发表的依维莫司洗脱支架对比西莫罗斯洗脱支架治疗冠状动脉疾病的随机临床对照研究(RCT).以两组患者随访期间发生不良事件的相对危险度(RR)为效应指标,评价两种洗脱支架治疗冠状动脉疾病的差别.统计分析采用Stata11.0软件完成.结果 共6项RCT,5196例患者纳入分析.Meta分析结果显示两种药物洗脱支架在再发重大心血管事件(死亡/再发心肌梗死)方面(RR=1.00,95％CI:0.84～1.17,P=0.96)、支架内血栓形成(RR=0.53,95％CI:0.24～ 1.16,P=0.11)及再血管化方面(RR=0.88,95％ CI:0.70 ～ 1.09,P=0.24)差异均无统计学意义.结论 依维莫司洗脱支架与西莫罗斯洗脱支架在治疗冠状动脉疾病疗效方面并无明显差异.     

Drug-Eluting Stents Versus Bare-Metal Stents in Patients With End-Stage Renal Disease

Background

The clinical outcomes of drug-eluting stents versus bare-metal stents in end-stage renal disease patients remains controversial.

Ultrathin Bioresorbable-Polymer Sirolimus-Eluting Stents Versus Thin Durable-Polymer Everolimus-Eluting Stents for Coronary Revascularization: 3-Year Outcomes From the Randomized BIOFLOW V Trial

ObjectivesThe aim of this study was to compare late-term clinical outcomes among patients treated with ultrathin-strut (60-μm) bioresorbable-polymer sirolimus-eluting stents (BP SES) and thin-strut (81μm) durable-polymer everolimus-eluting stents (DP EES).BackgroundEmerging evidence from comparative studies of drug-eluting stents demonstrates improved safety and efficacy with ultrathin-strut drug-eluting stents, but limited insight exists regarding late-term outcomes.MethodsBIOFLOW V (Biotronik Prospective Randomized Multicenter Study to Assess the Safety and Effectiveness of the Orsiro Sirolimus Eluting Coronary Stent System in the Treatment of Subjects With Up to Three De Novo or Restenotic Coronary Artery Lesions V) is an international randomized trial comparing coronary revascularization with BP SES and DP EES regarding the primary endpoint of 12-month target lesion failure. Analysis of pre-specified 3-year clinical outcomes was performed.ResultsAmong 1,334 patients randomized to treatment with BP SES (n = 884) or DP EES (n = 450), the 3-year rate of target lesion failure was 8.2% for BP SES and 13.6% for DP EES (p = 0.002), driven by differences in both target vessel myocardial infarction (MI) (5.0% vs. 9.2%; p = 0.003) and clinically driven target lesion revascularization (3.2% vs. 6.7%; p = 0.006). In landmark analysis, significant differences in target vessel MI and target lesion revascularization were observed favoring treatment with BP SES. Definite or probable late or very late stent thrombosis was significantly lower with BP SES (0.1% vs. 1.2%; p = 0.018). Cardiac death or MI rates were 7.7% and 11.7% (p = 0.017) for BP SES and DP EES, respectively.ConclusionsIn a large randomized trial, both target lesion failure and the outcomes of target vessel MI, clinically driven target lesion revascularization, and late or very late stent thrombosis at 3 years were significantly lower among patients treated with BP SES versus DP EES. The results endorse the continued superiority of ultrathin-strut BP SES compared with DP EES. (Safety and Effectiveness of the Orsiro Sirolimus Eluting Coronary Stent System in Subjects With Coronary Artery Lesions [BIOFLOW-V]; NCT02389946)     

涂层支架对冠状动脉支架内再狭窄的防治

随着冠状动脉内支架植入术的广泛应用 ,支架内再狭窄 (in stentrestenosis,ISR)的问题也越来越突出 ,很多冠心病患者在接受支架治疗后的缺血事件复发与ISR有关。目前配合口服抗凝、抗血小板聚集剂及局部放射疗法等对ISR有所改善 ,但不能彻底解决问题。随着ISR病理生理机制的逐渐阐明 ,许多心血管病医生 ,尤其是介入心脏病医生寄希望于———涂层支架。即把能够抑制术后再狭窄的物质 (包括药物、抗凝剂、抗增殖剂、转基因载体、放射物质等 )与支架整合在一起以充分发挥局部作用。这一方法在防治研究中的地位日益受到重视 ,并且某些涂层…