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双药洗脱支架与单药洗脱支架治疗冠状动脉分叉病变后迟发性血栓形成的Meta 分析:随机和观察性研究。

Late thrombosis after double versus single drug-eluting stent in the treatment of coronary bifurcations: a meta-analysis of randomized and observational Studies.

机构信息

Institute of Cardiology and Center of Excellence on Aging, Chieti, Italy.

出版信息

JACC Cardiovasc Interv. 2013 Jul;6(7):687-95. doi: 10.1016/j.jcin.2013.03.012. Epub 2013 Jun 14.

Abstract

OBJECTIVES

This study sought to hypothesize that the higher risk of myocardial infarction (MI) documented after a routine double drug-eluting stent (DES) strategy (DDS) compared with a single DES strategy (SDS) with provisional stenting in percutaneous coronary interventions (PCI) of bifurcation lesions is driven by an increased rate of DES thrombosis.

BACKGROUND

The results of currently available randomized, controlled trials (RCTs) were inconclusive in the choice between SDS and DDS. Meta-analyses have shown an increased risk of MI in the DDS group, without identifying the underlying mechanism(s).

METHODS

We performed a meta-analysis of 12 major (>100 patients) studies of bifurcation DES PCI: 5 RCTs and 7 nonrandomized observational studies, for a total of 6,961 patients. Random-effects models were used to calculate summary risk ratios (RRs). As a primary endpoint, we assessed the RRs and 95% confidence intervals (CIs) of definite DES thrombosis; death, MI, and target vessel revascularization (TVR) were evaluated as secondary endpoints.

RESULTS

Compared with SDS, DDS had an increased risk of DES thrombosis (RR: 2.31; 95% CI: 1.33 to 4.03) and MI (RR: 1.86; 95% CI: 1.34 to 2.60). Mortality (RR: 1.18; 95% CI: 0.85 to 1.65) and TVR (RR: 1.02; 95% CI: 0.80 to 1.30) were similar. The RRs of MI and DES thrombosis were associated (p = 0.040).

CONCLUSIONS

In PCI of coronary bifurcations, SDS should be the preferred approach, as DDS is associated with an increased risk of MI, likely driven by DES thrombosis.

摘要

目的

本研究旨在假设,与经皮冠状动脉介入治疗(PCI)分叉病变中临时支架的单药物洗脱支架(SDS)策略相比,常规双药物洗脱支架(DES)策略(DDS)后记录的心肌梗死(MI)风险增加是由DES 血栓形成的发生率增加所致。

背景

目前可用的随机对照试验(RCT)的结果在 SDS 和 DDS 之间的选择上尚无定论。荟萃分析显示 DDS 组 MI 风险增加,但未确定潜在机制。

方法

我们对 12 项主要(>100 例患者)分叉 DES PCI 研究进行了荟萃分析:5 项 RCT 和 7 项非随机观察性研究,共 6961 例患者。采用随机效应模型计算汇总风险比(RR)。作为主要终点,我们评估了明确 DES 血栓形成的 RR 和 95%置信区间(CI);死亡、MI 和靶血管血运重建(TVR)作为次要终点进行评估。

结果

与 SDS 相比,DDS 发生 DES 血栓形成的风险增加(RR:2.31;95%CI:1.33 至 4.03)和 MI(RR:1.86;95%CI:1.34 至 2.60)。死亡率(RR:1.18;95%CI:0.85 至 1.65)和 TVR(RR:1.02;95%CI:0.80 至 1.30)相似。MI 和 DES 血栓形成的 RR 存在相关性(p = 0.040)。

结论

在冠状动脉分叉处的 PCI 中,SDS 应作为首选方法,因为 DDS 与 MI 风险增加相关,可能由 DES 血栓形成所致。

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