Department of Internal Medicine and Cardiovascular Center, Seoul National University Hospital, 28 Yeongeon-Dong, Chongno-gu, Seoul 110-744, Korea.
Eur Heart J. 2014 May;35(17):1147-58. doi: 10.1093/eurheartj/eht570. Epub 2014 Jan 23.
The aim of this study was to compare the safety and efficacy of biodegradable-polymer (BP) drug-eluting stents (DES), bare metal stents (BMS), and durable-polymer DES in patients undergoing coronary revascularization, we performed a systematic review and network meta-analysis using a Bayesian framework.
Study stents included BMS, paclitaxel-eluting (PES), sirolimus-eluting (SES), endeavor zotarolimus-eluting (ZES-E), cobalt-chromium everolimus-eluting (CoCr-EES), platinium-chromium everolimus-eluting (PtCr-EES), resolute zotarolimus-eluting (ZES-R), and BP biolimus-eluting stents (BP-BES). After a systematic electronic search, 113 trials with 90 584 patients were selected. The principal endpoint was definite or probable stent thrombosis (ST) defined according to the Academic Research Consortium within 1 year.
Biodegradable polymer-biolimus-eluting stents [OR, 0.56; 95% credible interval (CrI), 0.33-0.90], SES (OR, 0.53; 95% CrI, 0.38-0.73), CoCr-EES (OR, 0.34; 95% CrI, 0.23-0.52), and PtCr-EES (OR, 0.31; 95% CrI, 0.10-0.90) were all superior to BMS in terms of definite or probable ST within 1 year. Cobalt-chromium everolimus-eluting stents demonstrated the lowest risk of ST of all stents at all times after stent implantation. Biodegradable polymer-biolimus-eluting stents was associated with a higher risk of definite or probable ST than CoCr-EES (OR, 1.72; 95% CrI, 1.04-2.98). All DES reduced the need for repeat revascularization, and all but PES reduced the risk of myocardial infarction compared with BMS.
All DESs but PES and ZES-E were superior to BMS in terms of ST within 1 year. Cobalt-chromium everolimus-eluting stents was safer than any DES even including BP-BES. Our results suggest that not only the biodegradability of polymer, but the optimal combination of stent alloy, design, strut thickness, polymer, and drug all combined determine the safety of DES.
本研究旨在比较生物可降解聚合物（BP）药物洗脱支架（DES）、裸金属支架（BMS）和耐用聚合物 DES 在接受冠状动脉血运重建的患者中的安全性和疗效，我们使用贝叶斯框架进行了系统评价和网络荟萃分析。
研究支架包括 BMS、紫杉醇洗脱（PES）、西罗莫司洗脱（SES）、 Endeavor 佐他莫司洗脱（ZES-E）、钴铬依维莫司洗脱（CoCr-EES）、铂铬依维莫司洗脱（PtCr-EES）、Resolute 佐他莫司洗脱（ZES-R）和 BP 生物可降解聚合物雷帕霉素洗脱支架（BP-BES）。经过系统的电子搜索，共选择了 113 项试验，涉及 90584 名患者。主要终点是根据学术研究联盟在 1 年内确定或可能发生的支架血栓形成（ST）。
生物可降解聚合物-比伐卢定洗脱支架（OR，0.56；95%可信区间[CrI]，0.33-0.90）、SES（OR，0.53；95% CrI，0.38-0.73）、CoCr-EES（OR，0.34；95% CrI，0.23-0.52）和 PtCr-EES（OR，0.31；95% CrI，0.10-0.90）在 1 年内均优于 BMS 的确定或可能 ST。在支架植入后所有时间点，钴铬依维莫司洗脱支架的 ST 风险均最低。与 CoCr-EES 相比，生物可降解聚合物-比伐卢定洗脱支架（OR，1.72；95% CrI，1.04-2.98）的确定或可能 ST 风险更高。所有 DES 均降低了再次血运重建的需要，除 PES 外，所有 DES 均降低了心肌梗死的风险与 BMS 相比。
所有 DES（除 PES 和 ZES-E 外）在 1 年内的 ST 发生率均优于 BMS。钴铬依维莫司洗脱支架比任何 DES（包括 BP-BES）都更安全。我们的结果表明，DES 的安全性不仅取决于聚合物的生物降解性，还取决于支架合金、设计、支架厚度、聚合物和药物的最佳组合。
