Istituto di Cardiologia, Policlinico S Orsola, Bologna, Italy.
Lancet. 2012 Apr 14;379(9824):1393-402. doi: 10.1016/S0140-6736(12)60324-9. Epub 2012 Mar 23.
The relative safety of drug-eluting stents and bare-metal stents, especially with respect to stent thrombosis, continues to be debated. In view of the overall low frequency of stent thrombosis, large sample sizes are needed to accurately estimate treatment differences between stents. We compared the risk of thrombosis between bare-metal and drug-eluting stents.
For this network meta-analysis, randomised controlled trials comparing different drug-eluting stents or drug-eluting with bare-metal stents currently approved in the USA were identified through Medline, Embase, Cochrane databases, and proceedings of international meetings. Information about study design, inclusion and exclusion criteria, sample characteristics, and clinical outcomes was extracted.
49 trials including 50,844 patients randomly assigned to treatment groups were analysed. 1-year definite stent thrombosis was significantly lower with cobalt-chromium everolimus eluting stents (CoCr-EES) than with bare-metal stents (odds ratio [OR] 0·23, 95% CI 0·13-0·41). The significant difference in stent thrombosis between CoCr-EES and bare-metal stents was evident as early as 30 days (OR 0·21, 95% CI 0·11-0·42) and was also significant between 31 days and 1 year (OR 0·27, 95% CI 0·08-0·74). CoCr-EES were also associated with significantly lower rates of 1-year definite stent thrombosis compared with paclitaxel-eluting stents (OR 0·28, 95% CI 0·16-0·48), permanent polymer-based sirolimus-eluting stents (OR 0·41, 95% CI 0·24-0·70), phosphorylcholine-based zotarolimus-eluting stents (OR 0·21, 95% CI 0·10-0·44), and Resolute zotarolimus-eluting stents (OR 0·14, 95% CI 0·03-0·47). At 2-year follow-up, CoCr-EES were still associated with significantly lower rates of definite stent thrombosis than were bare-metal (OR 0·35, 95% CI 0·17-0·69) and paclitaxel-eluting stents (OR 0·34, 95% CI 0·19-0·62). No other drug-eluting stent had lower definite thrombosis rates compared with bare-metal stents at 2-year follow-up.
In randomised studies completed to date, CoCr-EES has the lowest rate of stent thrombosis within 2 years of implantation. The finding that CoCr-EES also reduced stent thrombosis compared with bare-metal stents, if confirmed in future randomised trials, represents a paradigm shift.
The Cardiovascular Research Foundation.
药物洗脱支架和裸金属支架的相对安全性,特别是支架血栓形成的安全性,仍存在争议。鉴于支架血栓形成的总体发生率较低,需要大样本量才能准确估计支架治疗之间的差异。我们比较了裸金属支架和药物洗脱支架的血栓形成风险。
本网络荟萃分析通过 Medline、Embase、Cochrane 数据库和国际会议记录,确定了目前在美国批准使用的不同药物洗脱支架或药物洗脱与裸金属支架的随机对照试验。提取了研究设计、纳入和排除标准、样本特征和临床结局的信息。
分析了 49 项试验,共纳入 50844 例随机分组的患者。1 年时明确的支架血栓形成率明显低于钴铬依维莫司洗脱支架(CoCr-EES)与裸金属支架(比值比 [OR] 0·23,95%CI 0·13-0·41)。30 天时 CoCr-EES 与裸金属支架之间的支架血栓形成差异就具有显著意义(OR 0·21,95%CI 0·11-0·42),31 天至 1 年时也具有显著意义(OR 0·27,95%CI 0·08-0·74)。CoCr-EES 与紫杉醇洗脱支架(OR 0·28,95%CI 0·16-0·48)、永久性聚合物基西罗莫司洗脱支架(OR 0·41,95%CI 0·24-0·70)、磷酸胆碱基佐他莫司洗脱支架(OR 0·21,95%CI 0·10-0·44)和 Resolute 佐他莫司洗脱支架(OR 0·14,95%CI 0·03-0·47)相比,1 年时明确的支架血栓形成率也明显降低。在 2 年随访时,CoCr-EES 与裸金属支架(OR 0·35,95%CI 0·17-0·69)和紫杉醇洗脱支架(OR 0·34,95%CI 0·19-0·62)相比,明确的支架血栓形成率仍显著降低。在 2 年随访时,没有其他药物洗脱支架的明确血栓形成率低于裸金属支架。
在目前完成的随机研究中,CoCr-EES 在植入后 2 年内支架血栓形成的发生率最低。如果在未来的随机试验中证实 CoCr-EES 也能降低与裸金属支架相比的支架血栓形成,这将代表一种范式转变。
心血管研究基金会。