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.     

Biodegradable Polymer Drug-Eluting Stents Versus Second-Generation Drug-Eluting Stents for Patients With Coronary Artery Disease: An Update Meta-Analysis

Objective

Permanent polymer drug-eluting stents (DES) are associated with a higher risk of late and very late stent thrombosis (ST); biodegradable polymer drug-eluting stents (BP-DES) were designed to reduce these risks. However, their benefits are not completely clear.

Method

We undertook a meta-analysis of randomized studies identified in systematic searches of MEDLINE, EMBASE, and the Cochrane Database. Eligible studies were those that compared BP-DES with second-generation permanent polymer DES in patients undergoing percutaneous coronary intervention.

Results

Five studies (8,740 patients) with a mean follow-up of 19.2 months were included. Overall, BP-DES were associated with a broadly equivalent risk of definite and probable ST (odds ratio [OR], 1.07; 95 % confidence interval [CI], 0.67 to 1.71; P?=?0.76; I ²?=?5.0 %), target vessel revascularization (OR, 1.04; 95 % CI, 0.87 to 1.24; P?=?0.68; I ²?=?38.0 %), all-cause mortality (OR, 1.10; 95 % CI, 0.87 to 1.41; P?=?0.42; I ²?=?0.0 %), and major adverse cardiac events (OR, 1.03; 95 % CI, 0.88 to 1.20; P?=?0.74; I ²?=?0.0 %) when compared with second-generation DES. However, BP-DES significantly decreased in-stent late luminal loss (standard mean difference [SMD], ?0.01; 95 % CI, ?0.12 to 0.11; P?=?0.93; I ²?=?0.0 %) and in-segment late luminal loss (SMD, ?0.06; 95 % CI, ?0.17 to 0.05; P?=?0.27; I ²?=?0.0 %) compared with second-generation DES.

Conclusions

Compared with second-generation permanent polymer DES, biodegradable stents appear to have equivalent short- to medium-term clinical benefits, and it remains unclear whether they reduce the incidence of very late ST.     

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.     

Comparison of Everolimus-Eluting and Sirolimus-Eluting Coronary Stents: 1-Year Outcomes from the Randomized Evaluation of Sirolimus-Eluting Versus Everolimus-Eluting Stent Trial (RESET)

BACKGROUND: Several recent randomized trials comparing everolimus-eluting stent (EES) and sirolimus-eluting stent (SES) reported similar outcomes. However, only 1 trial was powered for a clinical end point, and no trial was powered for evaluating target-lesion revascularization. METHODS AND RESULTS: Randomized Evaluation of Sirolimus-eluting versus Everolimus-eluting stent Trial is a prospective multicenter randomized open-label trial comparing EES with SES in Japan. The trial was powered for evaluating noninferiority of EES relative to SES in terms of target-lesion revascularization. From February and July 2010, 3197 patients were randomly assigned to receive either EES (1597 patients) or SES (1600 patients). At 1 year, the primary efficacy end point of target-lesion revascularization occurred in 65 patients (4.3%) in the EES group and in 76 patients (5.0%) in the SES group, demonstrating noninferiority of EES to SES (P(noninferiority)<0.0001, and P(superiority)=0.34). Cumulative incidence of definite stent thrombosis was low and similar between the 2 groups (0.32% versus 0.38%, P=0.77). An angiographic substudy enrolling 571 patients (EES, 285 patients and SES, 286 patients) demonstrated noninferiority of EES relative to SES regarding the primary angiographic end point of in-segment late loss (0.06±0.37 mm versus 0.02±0.46 mm, P(noninferiority)<0.0001, and P(superiority)=0.24) at 278±63 days after index stent implantation. CONCLUSIONS: One-year clinical and angiographic outcome after EES implantation was noninferior to and not different from that after SES implantation in a stable coronary artery disease population with relatively less complex coronary anatomy. One-year clinical outcome after both EES and SES use was excellent with a low rate of target-lesion revascularization and a very low rate of stent thrombosis. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT01035450.     

Long-Term Clinical Outcomes of Biodegradable-Polymer Drug-Eluting Stents Versus Second-Generation Durable-Polymer Drug-Eluting Stents for ST-Segment Elevation Myocardial Infarction

BackgroundBiodegradable polymer drug eluting stents (BP-DES) may offer the advantage of vascular healing in ST-segment elevation myocardial infarction (STEMI). Long-term outcome data comparing BP-DES and second-generation durable polymer drug eluting stents (DP-DES) in STEMI is lacking. This study aims to compare the long-term clinical outcomes of BP-DES versus second-generation DP-DES in STEMI.MethodsThis is an observational study of consecutive patients with STEMI who received either BP-DES (n = 854) or DP-DES (n = 708) during primary percutaneous coronary intervention (PCI) from 1st February 2007 to 31st December 2016. The primary outcome was target lesion failure (TLF), a composite of cardiac death, target vessel myocardial infarction (MI), and target lesion revascularization with follow up till 30th November 2019.ResultsThe baseline demographics, lesion and procedural characteristic were similar between the two groups except for more prior MI and chronic obstructive pulmonary disease in the BP-DES group. At a median follow up of 4.2 years (interquartile range: 2.6–6.2 years), the incidence of TLF was similar between BP-DES and DP-DES (adjusted hazard ratio [HR] 0.94, 95% confidence interval [CI] 0.70–1.26). Likewise, incidence of major adverse cardiovascular events (MACE: all-cause death, any MI or target vessel revascularization) and definite stent thrombosis were similar in both groups (MACE: adjusted HR 1.04, 95% CI 0.82–1.32; definite stent thrombosis: adjusted HR 1.06, 95% CI 0.31–3.64).ConclusionAmong patients with STEMI who underwent primary PCI, BP-DES and DP-DES implantation was associated with similar long-term clinical outcomes.     

Sirolimus-Eluting Versus Bare-Metal Stents for the Reduction of Coronary Restenosis

PURPOSE: The GERSHWIN study (German Stent Health Outcome and Economics Within Normal Practice) was designed to evaluate long-term effects of treatment of coronary artery disease (CAD) with sirolimus-eluting stents (SES), as compared to bare-metal stents (BMS). PATIENTS AND METHODS: Within a multicenter, prospective intervention study in 35 hospitals throughout Germany, CAD patients with coronary stenosis and elective percutaneous coronary intervention (PCI) indication were treated either with SES or BMS (sequential control design with a case-to-control ratio of 2 : 1). Standardized questionnaires were completed by patients and their physicians at baseline, 3, 6, 12, and 18 months following PCI to document re-PCI for restenosis, myocardial infarction (MI), coronary bypass surgery (CABG), and death. Angiographic PCI documentation was evaluated by an independent expert. RESULTS: From April 2003 until June 2005, 658 patients were treated with SES (mean age 63 +/- 9 years, 87% male) and 294 patients with BMS (mean age 64 +/- 10 years, 79% male). Significant baseline differences were found by age, gender, household status, three vessel disease, and number of implanted stents. After 18 months, 8% of the SES versus 17% of the BMS group had undergone target vessel revascularization (p adjusted < 0.0001). There were no significant differences between BMS and SES regarding MI, CABG, or death. Re-PCI of target and new non-target vessel lesions was performed at a significantly lower degree of stenosis in SES than in BMS. CONCLUSION: Compared to patients with BMS, patients with implantation of SES experienced considerably fewer target vessel revascularizations. The threshold to perform re-PCI appeared lower in SES than in BMS. An extended evaluation of the effects of SES will be available from the 3-year follow-up of the GERSHWIN study.