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紫杉醇洗脱支架或裸金属支架直接经皮冠状动脉介入治疗中血栓抽吸缺乏长期临床获益:PASSION 试验的事后分析。

Lack of long-term clinical benefit of thrombus aspiration during primary percutaneous coronary intervention with paclitaxel-eluting stents or bare-metal stents: post-hoc analysis of the PASSION-trial.

机构信息

Department of Cardiology, Onze Lieve Vrouwe Gasthuis, Amsterdam, The Netherlands.

出版信息

Catheter Cardiovasc Interv. 2012 May 1;79(6):870-7. doi: 10.1002/ccd.23226. Epub 2011 Dec 12.

Abstract

BACKGROUND

Although current clinical guidelines recommend the use of thrombus aspiration (TA) during primary percutaneous coronary intervention (PPCI), previous studies evaluating TA demonstrated contradictory results. The aim of this study was to evaluate long-term clinical outcome after TA in adjunct to PPCI for acute ST-segment myocardial infarction (STEMI), as compared with conventional treatment, with the use of paclitaxel-eluting stents or bare-metal stents.

METHODS

We analyzed data of the PASSION trial, in which 619 patients with STEMI were randomly assigned to a paclitaxel-eluting stent or a bare-metal stent. TA was performed in 311 patients (50.2%). Clinical endpoints at 2 years were compared between patients who received TA during PPCI with patients who underwent conventional PPCI. The primary outcome of interest was a composite of cardiac death, recurrent myocardial infarction (MI), or target-lesion revascularization (TLR). A propensity score model was made to account for baseline differences that could have affected the probability of performing TA.

RESULTS

Complete follow-up was available for 598 patients (96.6%). The cumulative incidence of the combined outcome measure of cardiac death, recurrent MI, or TLR was 40 (13.0%) in the TA group and 41 (13.5%) in the conventional PPCI group (HR 0.96; 95% CI 0.62-1.47; P = 0.84). Also after adjusting for propensity score, no significant difference in event rate was observed between both treatment groups.

CONCLUSIONS

In this post-hoc analysis of the PASSION trial, TA in adjunct to PPCI did not affect rates of major adverse cardiac events at 2 years follow-up, as compared with conventional PPCI.

摘要

背景

虽然目前的临床指南建议在直接经皮冠状动脉介入治疗(PPCI)中使用血栓抽吸(TA),但以前评估 TA 的研究结果却相互矛盾。本研究旨在评估与常规治疗相比,在急性 ST 段抬高型心肌梗死(STEMI)患者中,使用紫杉醇洗脱支架或金属裸支架进行 PPCI 联合 TA 的长期临床结局。

方法

我们分析了 PASSION 试验的数据,该试验共纳入 619 例 STEMI 患者,随机分为紫杉醇洗脱支架组或金属裸支架组。311 例(50.2%)患者行 TA。比较了 PPCI 中接受 TA 治疗的患者和接受常规 PPCI 治疗的患者在 2 年时的临床终点。主要观察终点为心脏性死亡、再发心肌梗死(MI)或靶病变血运重建(TLR)的复合终点。采用倾向评分模型来解释可能影响行 TA 概率的基线差异。

结果

598 例(96.6%)患者获得完整随访。TA 组和常规 PPCI 组的心脏性死亡、再发 MI 或 TLR 复合终点的累积发生率分别为 40 例(13.0%)和 41 例(13.5%)(HR 0.96;95%CI 0.62-1.47;P=0.84)。在调整倾向评分后,两组间事件发生率也无显著差异。

结论

在 PASSION 试验的这项事后分析中,与常规 PPCI 相比,PPCI 联合 TA 并未降低 2 年时主要不良心脏事件的发生率。

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