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两种依维莫司洗脱支架:12 项随机试验与其他雷帕霉素洗脱支架的荟萃分析及调整后的间接比较。

Two zotarolimus-eluting stent generations: a meta-analysis of 12 randomised trials versus other limus-eluting stents and an adjusted indirect comparison.

机构信息

Deutsches Herzzentrum, Technische Universität, Lazaretstr. 36, Munich 80636, Germany.

出版信息

Heart. 2012 Nov;98(22):1632-40. doi: 10.1136/heartjnl-2012-302519. Epub 2012 Sep 4.

Abstract

OBJECTIVE

To evaluate efficacy and safety of two zotarolimus-eluting stent generations versus other limus-eluting stents (LES), and to compare Resolute zotarolimus-eluting stents (R-ZES) with Endeavor zotarolimus-eluting stents (E-ZES).

BACKGROUND

The performance of zotarolimus-eluting stents versus other LES, and the possible improvements of R-ZES versus E-ZES still remain to be defined.

METHODS

We undertook a meta-analysis of trials in which patients were randomly assigned to percutaneous coronary interventions (PCI) with R-ZES versus LES, or with E-ZES versus LES, as well as an indirect comparison of R-ZES versus E-ZES, with LES as common comparator. The primary efficacy endpoint was ischaemia-driven target vessel revascularisation (ID-TVR); the primary safety endpoints were myocardial infarction (MI), cardiac death and cumulative definite/probable stent thrombosis (ST).

RESULTS

Overall, 13'709 patients were assigned to PCI with R-ZES versus LES (n=7185) or with E-ZES versus LES (n=6524). The risk of ID-TVR (OR (95% CI)=1.06 (0.90 to 1.25), p=0.47), MI (1.00 (0.81 to 1.25), p=0.97), cardiac death (0.99 (0.69 to 1.42), p=0.96) and ST (1.18 (0.68 to 2.03), p=0.56) did not differ between R-ZES and LES. Patients receiving E-ZES were more likely to undergo ID-TVR as compared with those receiving LES (1.95 (1.40 to 2.73), p<0.0001). The risk of MI (0.91 (0.54 to 1.54), p=0.73), cardiac death (1.02 (0.54 to 1.91), p=0.96) and ST (1.10 (0.50 to 2.44), p=0.81) was similar between E-ZES and LES. At indirect comparison, PCI with R-ZES versus E-ZES reduced the risk of ID-TVR (0.54 (0.37 to 0.78), p=0.001), without increasing MI (1.09 (0.62 to 1.93), p=0.74), cardiac death (0.97 (0.46 to 2.00), p=0.93) and ST (1.07 (0.40 to 2.80), p=0.88).

CONCLUSIONS

The antirestenotic efficacy of Resolute zotarolimus-eluting stents is superior to Endeavor zotarolimus-eluting stents and similar to other limus-eluting stents. Endeavor zotarolimus-eluting stents increase the risk of reinterventions as compared with other limus-eluting stents. First and second-generation zotarolimus-eluting stents have similar thrombogenicity compared with other limus-eluting stents.

摘要

目的

评估两种依维莫司洗脱支架与其他雷帕霉素洗脱支架(LES)的疗效和安全性,并比较 Resolute 依维莫司洗脱支架(R-ZES)与 Endeavor 依维莫司洗脱支架(E-ZES)。

背景

依维莫司洗脱支架与其他 LES 的性能,以及 R-ZES 与 E-ZES 的可能改进仍有待确定。

方法

我们对接受 R-ZES 与 LES 或 E-ZES 与 LES 随机分组的经皮冠状动脉介入治疗(PCI)患者进行了荟萃分析,以及 R-ZES 与 E-ZES 的间接比较,以 LES 作为共同比较器。主要疗效终点为缺血驱动的靶血管血运重建(ID-TVR);主要安全性终点为心肌梗死(MI)、心脏死亡和累积明确/可能的支架血栓形成(ST)。

结果

共有 13709 名患者被分配接受 R-ZES 与 LES(n=7185)或 E-ZES 与 LES(n=6524)的 PCI。ID-TVR 的风险(OR(95%CI)=1.06(0.90 至 1.25),p=0.47)、MI(1.00(0.81 至 1.25),p=0.97)、心脏死亡(0.99(0.69 至 1.42),p=0.96)和 ST(1.18(0.68 至 2.03),p=0.56)在 R-ZES 和 LES 之间没有差异。与接受 LES 的患者相比,接受 E-ZES 的患者更有可能接受 ID-TVR(1.95(1.40 至 2.73),p<0.0001)。MI(0.91(0.54 至 1.54),p=0.73)、心脏死亡(1.02(0.54 至 1.91),p=0.96)和 ST(1.10(0.50 至 2.44),p=0.81)的风险在 E-ZES 和 LES 之间相似。在间接比较中,与 E-ZES 相比,R-ZES 降低了 ID-TVR 的风险(0.54(0.37 至 0.78),p=0.001),而不增加 MI(1.09(0.62 至 1.93),p=0.74)、心脏死亡(0.97(0.46 至 2.00),p=0.93)和 ST(1.07(0.40 至 2.80),p=0.88)。

结论

Resolute 依维莫司洗脱支架的抗再狭窄疗效优于 Endeavor 依维莫司洗脱支架,与其他雷帕霉素洗脱支架相似。与其他雷帕霉素洗脱支架相比,Endeavor 依维莫司洗脱支架增加了再次介入治疗的风险。第一代和第二代依维莫司洗脱支架与其他雷帕霉素洗脱支架相比,其血栓形成的可能性相似。

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