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药物洗脱支架置入后冠状动脉分叉病变的明确支架血栓形成:来自 14 项随机试验的 3107 例患者的荟萃分析。

Definite stent thrombosis after drug-eluting stent implantation in coronary bifurcation lesions: A meta-analysis of 3,107 patients from 14 randomized trials.

机构信息

Institution of Cardiovascular Research, Xinqiao Hospital, Third Military Medical University, Chongqing, China.

State and Local Joint Engineering Laboratory for Vascular Implants, Bioengineering College of Chongqing University, China.

出版信息

Catheter Cardiovasc Interv. 2018 Oct 1;92(4):680-691. doi: 10.1002/ccd.27443. Epub 2017 Dec 7.

DOI:10.1002/ccd.27443
PMID:29214736
Abstract

BACKGROUND

Bifurcation percutaneous coronary intervention (PCI) is a challenging procedure, but there are currently inadequate data about definite stent thrombosis (ST) rates of single-stent versus double-stent strategies (SS and DS, respectively).

METHODS AND RESULTS

Randomized clinical trials (RCTs) comparing SS and DS strategies were searched through PubMed, Embase, and the Cochrane Central Register of Controlled Trials. Fourteen RCTs involving 3,107 patients were analyzed. Owing to the high crossover rate (16.49%), both intention-to-treat (ITT) and as-treated (AT) analyses were performed. In the ITT population, there was a significantly lower rate of early definite ST in the SS group (0.26%; DS group 1.14%; P = 0.021). Similarly, in the AT population, there was a significantly lower rate of early definite ST in the SS group (0.23%, DS group 1.07%; P = 0.042). True bifurcation subgroup analysis also showed a significantly lower early definite ST in the SS group (OR = 0.36, 95% CI = 0.15-0.86, P = 0.042) in the ITT population. There was no significant difference of overall, acute, subacute, and late definite ST between the 2 groups.

CONCLUSIONS

Early definite ST is reduced when a SS strategy is used in bifurcation lesions.

摘要

背景

分叉经皮冠状动脉介入治疗(PCI)是一项具有挑战性的操作,但目前关于单支架与双支架策略(SS 和 DS)的明确支架血栓形成(ST)发生率的数据不足。

方法和结果

通过 PubMed、Embase 和 Cochrane 对照试验中心注册库搜索比较 SS 和 DS 策略的随机临床试验(RCT)。分析了 14 项涉及 3107 例患者的 RCT。由于高交叉率(16.49%),进行了意向治疗(ITT)和实际治疗(AT)分析。在 ITT 人群中,SS 组的早期明确 ST 发生率明显较低(0.26%;DS 组为 1.14%;P=0.021)。同样,在 AT 人群中,SS 组的早期明确 ST 发生率也明显较低(0.23%,DS 组为 1.07%;P=0.042)。真正的分叉亚组分析也显示,在 ITT 人群中 SS 组的早期明确 ST 发生率明显较低(OR=0.36,95%CI=0.15-0.86,P=0.042)。两组间的总、急性、亚急性和晚期明确 ST 无显著差异。

结论

在分叉病变中使用 SS 策略可降低早期明确 ST 的发生率。

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