Piccolo Raffaele, Stefanini Giulio G, Franzone Anna, Spitzer Ernest, Blöchlinger Stefan, Heg Dik, Jüni Peter, Windecker Stephan
From the Department of Cardiology, Bern University Hospital, Bern, Switzerland (R.P., G.G.S., A.F., E.S., S.B., S.W.); and Clinical Trials Unit (D.H., P.J., S.W.), Institute of Social and Preventive Medicine (D.H.), Institute of Primary Health Care (BIHAM) (P.J.), University of Bern, Bern, Switzerland.
Circ Cardiovasc Interv. 2015 Apr;8(4). doi: 10.1161/CIRCINTERVENTIONS.114.002223.
Although new-generation drug-eluting stents represent the standard of care among patients undergoing percutaneous coronary intervention, there remains debate about differences in efficacy and the risk of stent thrombosis between the Resolute zotarolimus-eluting stent (R-ZES) and the everolimus-eluting stent (EES). The aim of this study was to evaluate the safety and efficacy of the R-ZES compared with EES in patients undergoing percutaneous coronary intervention.
A systematic literature search of electronic resources was performed using specific search terms until September 2014. Random-effects meta-analysis was performed comparing clinical outcomes between patients treated with R-ZES and EES up to maximum available follow-up. The primary efficacy end point was target-vessel revascularization. The primary safety end point was definite or probable stent thrombosis. Secondary safety end points were cardiac death and target-vessel myocardial infarction. Five trials were identified, including a total of 9899 patients. Compared with EES, R-ZES had similar risks of target-vessel revascularization (risk ratio [RR], 1.06; 95% confidence interval [CI], 0.90-1.24; P=0.50), definite or probable stent thrombosis (RR, 1.26; 95% CI, 0.86-1.85; P=0.24), cardiac death (RR, 1.01; 95% CI, 0.79-1.30; P=0.91), and target-vessel myocardial infarction (RR, 1.10; 95% CI, 0.89-1.36; P=0.39). Moreover, R-ZES and EES had similar risks of late definite or probable very late stent thrombosis (RR, 1.06; 95% CI, 0.53-2.11; P=0.87). No evidence of significant heterogeneity was observed across trials.
R-ZES and EES provide similar safety and efficacy among patients undergoing percutaneous coronary intervention.
尽管新一代药物洗脱支架是接受经皮冠状动脉介入治疗患者的标准治疗手段,但关于雷帕霉素洗脱支架(R-ZES)与依维莫司洗脱支架(EES)在疗效及支架血栓形成风险方面的差异仍存在争议。本研究旨在评估在接受经皮冠状动脉介入治疗的患者中,R-ZES与EES相比的安全性和疗效。
使用特定检索词对电子资源进行系统文献检索,直至2014年9月。进行随机效应荟萃分析,比较接受R-ZES和EES治疗的患者直至最大可用随访期的临床结局。主要疗效终点为靶血管血运重建。主要安全性终点为明确或可能的支架血栓形成。次要安全性终点为心源性死亡和靶血管心肌梗死。共纳入5项试验,总计9899例患者。与EES相比,R-ZES在靶血管血运重建风险(风险比[RR],1.06;95%置信区间[CI],0.90 - 1.24;P = 0.50)、明确或可能的支架血栓形成(RR,1.26;95% CI,0.86 - 1.85;P = 0.24)、心源性死亡(RR,1.01;95% CI,0.79 - 1.30;P = 0.91)及靶血管心肌梗死(RR,1.10;95% CI,0.89 - 1.36;P = 0.39)方面相似。此外,R-ZES和EES在晚期明确或可能的极晚期支架血栓形成风险方面相似(RR,1.06;95% CI,0.53 - 2.11;P = 0.87)。各试验未观察到显著异质性的证据。
在接受经皮冠状动脉介入治疗的患者中,R-ZES和EES具有相似的安全性和疗效。