Stent thrombosis with drug-eluting and bare-metal stents: evidence from a comprehensive network meta-analysis
Stent thrombosis with drug-eluting and bare-metal stents: evidence from a comprehensive network meta-analysis
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DOI：
10.1016/s0140-6736(12)60324-9
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发表时间：
2012-04-14
期刊：
影响因子：
168.9
通讯作者：
Stone, Gregg W.
中科院分区：
文献类型：
--
作者：
Palmerini, Tullio;Biondi-Zoccai, Giuseppe;Stone, Gregg W.
背景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方面，仍有争议。鉴于支架内血栓形成的总体频率较低，需要较大的样本量来准确估计支架间的治疗差异。我们比较了裸金属和药物洗脱stents.Methods之间的血栓形成的风险，比较不同的药物洗脱支架或药物洗脱与裸金属stents. Methods的网络荟萃分析，随机对照试验，目前在美国批准的确定通过Medline，Embase，科克伦数据库，和国际会议的程序。有关研究设计，纳入和排除标准，样本特征和临床结局的信息被extracted.Findings 49项试验，包括50 844例患者随机分配到治疗组进行了分析。1-钴铬依维莫司洗脱支架（CoCr-EES）的1年明确支架内血栓形成率显著低于裸金属支架（比值比[OR] 0.23，95%CI 0.13-0.41）。CoCr-EES与裸金属支架之间的支架内血栓形成显著差异早在30天（OR 0.21，95% CI 0.11-0.42）时就很明显，在31天和1年之间也有显著差异（OR 0.27，95% CI 0.08-0.74）。与紫杉醇洗脱支架相比，CoCr-EES的1年明确支架内血栓形成率也显著较低（OR 0.28，95% CI 0.16-0.48），永久性聚合物西罗莫司洗脱支架（OR 0.41，95% CI 0.24-0.70）、磷酰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）。在2年随访时，CoCr-EES的明确支架内血栓形成率仍显著低于裸金属支架（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）。在2年随访时，与裸金属支架相比，没有其他药物洗脱支架的明确血栓形成率更低。解释在迄今为止完成的随机研究中，CoCr-EES在植入后2年内的支架血栓形成率最低。与裸金属支架相比，CoCr-EES还减少了支架内血栓形成，如果在未来的随机试验中得到证实，这一发现代表了一种范式转变。
Background 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.Methods 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.Findings 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.Interpretation 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.