Valgimigli Marco, Sabaté Manel, Kaiser Christoph, Brugaletta Salvatore, de la Torre Hernandez Jose Maria, Galatius Soeren, Cequier Angel, Eberli Franz, de Belder Adam, Serruys Patrick W, Ferrante Giuseppe
Thoraxcenter, Erasmus Medical Center, 3015 CE Rotterdam, Netherlands
University Hospital Clinic, IDIBAPS, Cardiology Department, 08036 Barcelona, Spain.
BMJ. 2014 Nov 4;349:g6427. doi: 10.1136/bmj.g6427.
To examine the safety and effectiveness of cobalt-chromium everolimus eluting stents compared with bare metal stents.
Individual patient data meta-analysis of randomised controlled trials. Cox proportional regression models stratified by trial, containing random effects, were used to assess the impact of stent type on outcomes. Hazard ratios with 95% confidence interval for outcomes were reported.
Medline, Embase, the Cochrane Central Register of Controlled Trials. Randomised controlled trials that compared cobalt-chromium everolimus eluting stents with bare metal stents were selected. The principal investigators whose trials met the inclusion criteria provided data for individual patients.
The primary outcome was cardiac mortality. Secondary endpoints were myocardial infarction, definite stent thrombosis, definite or probable stent thrombosis, target vessel revascularisation, and all cause death.
The search yielded five randomised controlled trials, comprising 4896 participants. Compared with patients receiving bare metal stents, participants receiving cobalt-chromium everolimus eluting stents had a significant reduction of cardiac mortality (hazard ratio 0.67, 95% confidence interval 0.49 to 0.91; P=0.01), myocardial infarction (0.71, 0.55 to 0.92; P=0.01), definite stent thrombosis (0.41, 0.22 to 0.76; P=0.005), definite or probable stent thrombosis (0.48, 0.31 to 0.73; P<0.001), and target vessel revascularisation (0.29, 0.20 to 0.41; P<0.001) at a median follow-up of 720 days. There was no significant difference in all cause death between groups (0.83, 0.65 to 1.06; P=0.14). Findings remained unchanged at multivariable regression after adjustment for the acuity of clinical syndrome (for instance, acute coronary syndrome v stable coronary artery disease), diabetes mellitus, female sex, use of glycoprotein IIb/IIIa inhibitors, and up to one year v longer duration treatment with dual antiplatelets.
This meta-analysis offers evidence that compared with bare metal stents the use of cobalt-chromium everolimus eluting stents improves global cardiovascular outcomes including cardiac survival, myocardial infarction, and overall stent thrombosis.
比较钴铬依维莫司洗脱支架与裸金属支架的安全性和有效性。
随机对照试验的个体患者数据荟萃分析。采用按试验分层并包含随机效应的Cox比例回归模型，评估支架类型对结局的影响。报告结局的风险比及95%置信区间。
Medline、Embase、Cochrane对照试验中央注册库。选择比较钴铬依维莫司洗脱支架与裸金属支架的随机对照试验。试验符合纳入标准的主要研究者提供个体患者的数据。
主要结局为心脏死亡率。次要终点为心肌梗死、明确的支架内血栓形成、明确或可能的支架内血栓形成、靶血管血运重建和全因死亡。
检索得到5项随机对照试验，共4896名参与者。与接受裸金属支架的患者相比，接受钴铬依维莫司洗脱支架的参与者在中位随访720天时，心脏死亡率显著降低（风险比0.67，95%置信区间0.49至0.91；P = 0.01）、心肌梗死（0.71，0.55至0.92；P = 0.01）、明确的支架内血栓形成（0.41，0.22至0.76；P = 0.005）、明确或可能的支架内血栓形成（0.48，0.31至0.73；P < 0.001）以及靶血管血运重建（0.29，0.20至0.41；P < 0.001）。两组间全因死亡无显著差异（0.83，0.65至1.06；P = 0.14）。在对临床综合征的严重程度（如急性冠状动脉综合征与稳定型冠状动脉疾病）、糖尿病、女性、糖蛋白IIb/IIIa抑制剂的使用以及双联抗血小板治疗长达一年与更长疗程进行调整后的多变量回归分析中，研究结果保持不变。
这项荟萃分析提供的证据表明，与裸金属支架相比，使用钴铬依维莫司洗脱支架可改善整体心血管结局，包括心脏存活率、心肌梗死和总体支架内血栓形成。
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