New York University School of Medicine, The Leon H. Charney Division of Cardiology, New York, NY 10016, USA.
Circulation. 2012 Jun 12;125(23):2873-91. doi: 10.1161/CIRCULATIONAHA.112.097014. Epub 2012 May 14.
Drug-eluting stents (DES) have been in clinical use for nearly a decade; however, the relative short- and long-term efficacy and safety of DES compared with bare-metal stents (BMS) and among the DES types are less well defined.
PubMed, Embase, and Cochrane Central Register of Controlled Trials (CENTRAL) were searched for randomized clinical trials, until March 2012, that compared any of the Food and Drug Administration-approved durable stent and polymer DES (sirolimus-eluting stent [SES], paclitaxel-eluting stent [PES], everolimus-eluting stent [EES], zotarolimus-eluting stent [ZES], and ZES-Resolute [ZES-R]) with each other or against BMS for de novo coronary lesions, enrolling at least 100 patients and with follow-up of at least 6 months. Short-term (≤ 1 year) and long-term efficacy (target-vessel revascularization, target-lesion revascularization) and safety (death, myocardial infarction, stent thrombosis) outcomes were evaluated and trial-level data pooled by both mixed-treatment comparison and direct comparison analyses. From 76 randomized clinical trials with 117 762 patient-years of follow-up, compared with BMS, each DES reduced long-term target-vessel revascularization (39%-61%), but the magnitude varied by DES type (EESSESZES-R>PES~ZES>BMS), with a >42% probability that EES had the lowest target-vessel revascularization rate. There was no increase in the risk of any long-term safety outcomes, including stent thrombosis, with any DES (versus BMS). In addition, there was reduction in myocardial infarction (all DES except PES versus BMS) and stent thrombosis (with EES versus BMS: Rate ratio, 0.51; 95% credibility interval, 0.35-0.73). The safest DES appeared to be EES (>86% probability), with reduction in myocardial infarction and stent thrombosis compared with BMS. Short-term outcomes were similar to long-term outcomes, with SES, ZES-R, and everolimus-eluting stent being the most efficacious and EES being the safest stent.
DES are highly efficacious at reducing the risk of target-vessel revascularization without an increase in any safety outcomes, including stent thrombosis. However, among the DES types, there were considerable differences, such that EES, SES, and ZES-R were the most efficacious and EES was the safest stent.
药物洗脱支架（DES）已经在临床应用近十年；然而，与裸金属支架（BMS）相比，DES 的短期和长期疗效和安全性以及不同类型的 DES 之间的疗效和安全性仍不明确。
我们在 PubMed、Embase 和 Cochrane 对照试验中心注册数据库（CENTRAL）中检索了截至 2012 年 3 月比较任何经美国食品和药物管理局批准的耐用支架和聚合物 DES（西罗莫司洗脱支架[SES]、紫杉醇洗脱支架[PES]、依维莫司洗脱支架[EES]、佐他莫司洗脱支架[ZES]和 ZES-Resolute[ZES-R]）与其他支架或与 BMS 治疗新发病变的随机临床试验，至少纳入 100 例患者，随访至少 6 个月。评估短期（≤1 年）和长期疗效（靶血管血运重建、靶病变血运重建）和安全性（死亡、心肌梗死、支架血栓形成）结局，并通过混合治疗比较和直接比较分析汇总试验水平数据。在 76 项随机临床试验中，共随访 117762 患者年，与 BMS 相比，每种 DES 均可降低长期靶血管血运重建率（39%-61%），但 DES 类型不同（EESSESZES-R>PES~ZES>BMS），EES 靶血管血运重建率最低的概率超过 42%。任何 DES 治疗与 BMS 相比，长期安全性结局（包括支架血栓形成）的风险均无增加。此外，DES 治疗组（除 PES 外）心肌梗死发生率（所有 DES 与 BMS 相比）和支架血栓形成发生率（与 BMS 相比，EES：率比，0.51；95%可信度区间，0.35-0.73）降低。安全性最好的 DES 似乎是 EES（EES 降低心肌梗死和支架血栓形成的概率超过 86%）。短期和长期结局相似，SES、ZES-R 和依维莫司洗脱支架的疗效最好，EES 的安全性最好。
DES 能有效降低靶血管血运重建的风险，同时不增加任何安全性结局，包括支架血栓形成。然而，DES 类型之间存在显著差异，EES、SES 和 ZES-R 的疗效最好，EES 的安全性最好。
