New York University School of Medicine, New York, NY 10016, USA.
Circ Cardiovasc Interv. 2013 Aug;6(4):378-90. doi: 10.1161/CIRCINTERVENTIONS.113.000415. Epub 2013 Aug 6.
The efficacy and safety of drug-eluting stents (DES) in patients with ST-segment-elevation myocardial infarction (STEMI) is controversial. Consequently, DES implantation has a class IIa indication in the American College of Cardiology/American Heart Association and the European Society of Cardiology STEMI guidelines.
PUBMED, EMBASE, and CENTRAL were searched for randomized clinical trials, until March 2013, comparing any of the 5 Food and Drug Administration-approved durable stent and polymer DES (sirolimus eluting stent, paclitaxel eluting stent, everolimus-eluting stent [EES], zotarolimus-eluting stent, and zotarolimus-eluting stent resolute), against each other or bare metal stents (BMS), and enrolling ≥ 50 patients with STEMI. Efficacy (target vessel revascularization) and safety (death, myocardial infarction, and stent thrombosis) outcomes at the longest reported follow-up times were evaluated. Twenty-eight randomized clinical trials with 34 068 patient-years of follow-up on subjects with STEMI fulfilled the inclusion criteria. When compared with BMS (reference rate ratio [RR] of 1), sirolimus eluting stent (RR, 0.46; 95% credibility interval [CrI], 0.36-0.56), paclitaxel eluting stent (RR, 0.69; 95% CrI, 0.53-0.87), and EES (RR, 0.42; 95% CrI, 0.26-0.62) were associated with a statistically significant reduction in rate of target vessel revascularization, with the point estimate for zotarolimus-eluting stent resolute trending in a similar direction. There was no increase in the risk of death, myocardial infarction, or stent thrombosis with any DES compared with BMS. Moreover, EES was associated with a statistically significant reduction in the rate of stent thrombosis when compared with sirolimus eluting stent (RR, 0.38; 95% CrI, 0.21-0.74), paclitaxel eluting stent (RR, 0.39; 95% CrI, 0.21-0.73), and even BMS (RR, 0.42; 95% CrI, 0.23-0.76). There was a 74% probability that EES had the lowest rate of any stent thrombosis when compared with all other stent types (no data on zotarolimus-eluting stent resolute). There was no increase in very late stent thrombosis with EES versus BMS (RR, 0.89; 95% CrI, 0.09-8.67).
In patients with STEMI, DES versus BMS was associated with substantial decrease in the risk of target vessel revascularization without compromising safety. EES had the added advantage of substantial reduction in the risk of stent thrombosis when compared with first-generation DES and BMS with no increase in very late stent thrombosis.
药物洗脱支架（DES）在 ST 段抬高型心肌梗死（STEMI）患者中的疗效和安全性仍存在争议。因此，在美国心脏病学会/美国心脏协会和欧洲心脏病学会 STEMI 指南中，DES 的植入被列为 IIa 类适应证。
检索了 PUBMED、EMBASE 和 CENTRAL 数据库，纳入比较任何 5 种美国食品药品监督管理局批准的耐用支架和聚合物 DES（西罗莫司洗脱支架、紫杉醇洗脱支架、依维莫司洗脱支架[EES]、佐他莫司洗脱支架和佐他莫司洗脱支架 resolute）与各自对照组（BMS）的随机临床试验，纳入的试验均有≥50 例 STEMI 患者。在最长报道的随访时间评估疗效（靶血管血运重建）和安全性（死亡、心肌梗死和支架血栓形成）结局。符合纳入标准的 28 项随机临床试验共纳入 34068 患者年的 STEMI 患者随访数据。与 BMS（参考率比值[RR]为 1）相比，西罗莫司洗脱支架（RR，0.46；95%可信区间[CrI]，0.36-0.56）、紫杉醇洗脱支架（RR，0.69；95% CrI，0.53-0.87）和 EES（RR，0.42；95% CrI，0.26-0.62）与靶血管血运重建的发生率显著降低相关，而佐他莫司洗脱支架 resolute 的点估计值呈相似的降低趋势。与 BMS 相比，DES 并不增加死亡、心肌梗死或支架血栓形成的风险。此外，与西罗莫司洗脱支架（RR，0.38；95% CrI，0.21-0.74）、紫杉醇洗脱支架（RR，0.39；95% CrI，0.21-0.73）甚至 BMS（RR，0.42；95% CrI，0.23-0.76）相比，EES 与支架血栓形成发生率显著降低相关。与其他所有支架类型相比，EES 发生任何支架血栓形成的概率有 74%的可能性最低（无佐他莫司洗脱支架 resolute 的相关数据）。与 BMS 相比，EES 发生极晚期支架血栓形成的风险无显著增加（RR，0.89；95% CrI，0.09-8.67）。
在 STEMI 患者中，DES 与 BMS 相比可显著降低靶血管血运重建的风险，同时不影响安全性。与第一代 DES 和 BMS 相比，EES 具有降低支架血栓形成风险的额外优势，且不增加极晚期支架血栓形成的风险。
