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西罗莫司与紫杉醇洗脱支架治疗冠状动脉分叉病变的介入治疗:五项临床试验的荟萃分析。

Sirolimus- versus paclitaxel-eluting stents for coronary bifurcations intervention: a meta-analysis of five clinical trials.

机构信息

Department of Cardiology, Shanghai Institute of Cardiovascular Diseases, Zhongshan Hospital, Fudan University, Shanghai, People's Republic of China.

出版信息

Catheter Cardiovasc Interv. 2012 Oct 1;80(4):507-13. doi: 10.1002/ccd.23392. Epub 2011 Nov 1.

Abstract

BACKGROUNDS

Relative efficacy and safety of sirolimus-eluting stents (SES) compared with paclitaxel-eluting stents (PES) remains controversial. It is unknown whether there are different effect and safety in coronary bifurcation treatment between SES and PES.

OBJECTIVES

The meta-analysis was performed to compare the clinical outcomes of SES and PES in coronary bifurcation intervention.

METHODS

Five head-to-head clinical trials of SES versus PES in coronary bifurcation intervention were included. A total of 2,567 patients were involved in the meta-analysis. Mean follow-up period ranged from 6 to 35 months. The primary end points were the need for target lesion revascularization (TLR) and main-branch restenosis. Secondary end points were target vessel revascularization (TVR), cardiac death, major adverse cardiac events (MACE), and stent thrombosis.

RESULTS

Compared with PES, SES significantly reduced the risk of TLR (5.3% vs. 10.6%, odds ratio (OR) 0.52; 95% confidence interval (CI) = 0.38-0.70, P < 0.001), main-branch restenosis (4.59% vs. 12.59%, OR 0.31; 95% CI = 0.18-0.55, P < 0.001) and TVR (7.05% vs. 12.57%, OR 0.58; 95% CI = 0.42-0.81, P = 0.001) in coronary bifurcation intervention. In addition, SES group also had a significantly lower incidence of MACE (8.20% vs. 14.13%, OR 0.58; 95% CI = 0.40-0.84, P = 0.004) than PES group. However, there were no statistical difference with respect to the incidence of cardiac death (1.64% vs. 1.09%, P = 0.19) and stent thrombosis (0.84% vs. 1.08%, P = 0.64) between SES and PES groups.

CONCLUSIONS

Compared with PES, SES reduced the incidence of TLR, main-branch restenosis and MACE in coronary bifurcation intervention, while the risk of stent thrombosis was similar between SES and PES groups.

摘要

背景

依维莫司洗脱支架(SES)与紫杉醇洗脱支架(PES)的相对疗效和安全性仍存在争议。尚不清楚在冠状动脉分叉病变介入治疗中,SES 和 PES 是否具有不同的效果和安全性。

目的

本荟萃分析旨在比较 SES 和 PES 在冠状动脉分叉病变介入治疗中的临床结局。

方法

纳入了 5 项 SES 与 PES 治疗冠状动脉分叉病变的头对头临床试验。共有 2567 例患者纳入荟萃分析。平均随访时间为 6 至 35 个月。主要终点为靶病变血运重建(TLR)和主支再狭窄。次要终点为靶血管血运重建(TVR)、心脏死亡、主要不良心脏事件(MACE)和支架血栓形成。

结果

与 PES 相比,SES 显著降低了 TLR(5.3% vs. 10.6%,比值比(OR)0.52;95%置信区间(CI)=0.38-0.70,P<0.001)、主支再狭窄(4.59% vs. 12.59%,OR 0.31;95%CI=0.18-0.55,P<0.001)和 TVR(7.05% vs. 12.57%,OR 0.58;95%CI=0.42-0.81,P=0.001)的风险。此外,SES 组 MACE(8.20% vs. 14.13%,OR 0.58;95%CI=0.40-0.84,P=0.004)的发生率也显著低于 PES 组。然而,SES 组与 PES 组在心脏死亡(1.64% vs. 1.09%,P=0.19)和支架血栓形成(0.84% vs. 1.08%,P=0.64)发生率方面无统计学差异。

结论

与 PES 相比,SES 降低了冠状动脉分叉病变介入治疗中 TLR、主支再狭窄和 MACE 的发生率,而 SES 组与 PES 组支架血栓形成的风险相似。

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