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药物洗脱支架治疗急性心肌梗死患者的长期安全性和有效性:随机试验的荟萃分析。

Long-term safety and efficacy of drug-eluting stents in patients with acute myocardial infarction: a meta-analysis of randomized trials.

机构信息

Department of Clinical Medicine, Cardiovascular Sciences and Immunology, Federico II University, Via S. Pansini, 5, 80131 Naples, Italy.

出版信息

Atherosclerosis. 2011 Jul;217(1):149-57. doi: 10.1016/j.atherosclerosis.2011.03.007. Epub 2011 Mar 15.

Abstract

BACKGROUND

Despite short-term outcomes of patients with ST-segment elevation myocardial infarction (STEMI) indicate a benefit of DES in terms of reintervention, limited information is available on the long-term safety and efficacy of DES in these patients. Our aim was to perform a meta-analysis of randomized trials evaluating the long-term outcomes of drug-eluting stents (DES) versus bare-metal stents (BMS) in patients with STEMI.

METHODS AND RESULTS

A systematic literature search of MEDLINE, EMBASE, the Cochrane Central Register of Controlled Trials, scientific session abstracts and relevant websites, through September 2010, was performed using specific search terms. Included trials were randomized studies comparing DES to BMS in patients presenting with STEMI, with a follow-up ≥ 3 years. Ten of the 1496 studies initially identified met inclusion criteria, with a total of 6774 patients enrolled. At a mean follow-up of 3.6 years, DES significantly reduced target-vessel revascularization compared with BMS (odds ratio [OR], 0.51; 95% confidence interval [CI], 0.43-0.59; p<0.0001), without increasing mortality (OR, 0.88; 95% CI, 0.72-1.06; p=0.18), reinfarction (OR, 1.02; 95% CI, 0.81-1.27; p=0.88) and overall stent thrombosis (OR, 1.06; 95% CI, 0.83-1.35; p=0.66). Very late stent thrombosis, occurring 1 year after revascularization, was significantly increased with DES (OR, 1.71; 95% CI, 1.05-2.79; p=0.03).

CONCLUSIONS

At long-term follow-up, percutaneous coronary intervention with DES reduces need for target-vessel revascularization, without increasing the risk for death and reinfarction. However, the strong reduction in reintervention with DES trades off a slight but significant increase in very late stent thrombosis.

摘要

背景

尽管 ST 段抬高型心肌梗死(STEMI)患者的短期治疗结果表明药物洗脱支架(DES)在再介入方面具有优势,但关于此类患者应用 DES 的长期安全性和疗效的数据有限。我们的目的是对评估药物洗脱支架(DES)与裸金属支架(BMS)治疗 STEMI 患者的长期疗效的随机试验进行荟萃分析。

方法和结果

通过使用特定的检索词,对 MEDLINE、EMBASE、Cochrane 对照试验中心注册库、科学会议摘要和相关网站进行了系统的文献检索,检索截至 2010 年 9 月。纳入的试验为比较 STEMI 患者中应用 DES 与 BMS 的随机研究,随访时间≥3 年。最初鉴定的 1496 项研究中有 10 项符合纳入标准,共纳入 6774 例患者。平均随访 3.6 年后,DES 与 BMS 相比,显著降低了靶血管血运重建(比值比 [OR],0.51;95%置信区间 [CI],0.43-0.59;p<0.0001),但不增加死亡率(OR,0.88;95% CI,0.72-1.06;p=0.18)、再梗死(OR,1.02;95% CI,0.81-1.27;p=0.88)和总体支架血栓形成(OR,1.06;95% CI,0.83-1.35;p=0.66)。DES 显著增加了血管再通 1 年后的极晚期支架血栓形成(OR,1.71;95% CI,1.05-2.79;p=0.03)。

结论

长期随访结果显示,经皮冠状动脉介入治疗应用 DES 可降低靶血管血运重建的需要,而不增加死亡和再梗死的风险。然而,DES 显著降低再介入的获益与极晚期支架血栓形成的微小但显著增加相关。

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