ST 段抬高型心肌梗死患者分期非罪犯血管血运重建的时机：COMPLETE 试验。
Timing of Staged Nonculprit Artery Revascularization in Patients With ST-Segment Elevation Myocardial Infarction: COMPLETE Trial.
机构信息
Centre for Cardiovascular Innovation, St. Paul's and Vancouver General Hospitals, University of British Columbia, Vancouver, British Columbia, Canada.
Centre for Cardiovascular Innovation, St. Paul's and Vancouver General Hospitals, University of British Columbia, Vancouver, British Columbia, Canada.
出版信息
J Am Coll Cardiol. 2019 Dec 3;74(22):2713-2723. doi: 10.1016/j.jacc.2019.09.051.
BACKGROUND
The COMPLETE (Complete vs Culprit-only Revascularization to Treat Multi-vessel Disease After Early PCI for STEMI) trial demonstrated that staged nonculprit lesion percutaneous coronary intervention (PCI) reduced major cardiovascular (CV) events in patients with ST-segment elevation myocardial infarction (STEMI) and multivessel coronary artery disease (CAD).
OBJECTIVES
The purpose of this study was to determine the effect of nonculprit-lesion PCI timing on major CV outcomes and also the time course of the benefit of complete revascularization.
METHODS
Following culprit-lesion PCI, 4,041 patients with STEMI and multivessel CAD were randomized to staged nonculprit-lesion PCI or culprit-lesion only PCI. Randomization was stratified according to investigator-planned timing of nonculprit-lesion PCI: during or after the index hospitalization. The first coprimary outcome was the composite of CV death or myocardial infarction (MI). In pre-specified analyses, hazard ratios (HRs) were calculated for each time stratum. Landmark analyses of the entire population were performed within 45 days and after 45 days.
RESULTS
For nonculprit-lesion PCI planned during the index hospitalization (actual time: median 1 day), CV death or MI was reduced with complete revascularization compared with culprit-lesion only PCI (HR: 0.77; 95% confidence interval [CI]: 0.59 to 1.00). For nonculprit lesion PCI planned to occur after hospital discharge (actual time: median 23 days), CV death or MI was also reduced with complete revascularization (HR: 0.69; 95% CI: 0.49 to 0.97; interaction p = 0.62). Landmark analyses demonstrated an HR of 0.86 (95% CI: 0.59 to 1.24) during the first 45 days and 0.69 (95% CI: 0.54 to 0.89) from 45 days to the end of follow-up for intended nonculprit lesion PCI versus culprit lesion only PCI.
CONCLUSIONS
Among STEMI patients with multivessel disease, the benefit of complete revascularization over culprit-lesion only PCI was consistent irrespective of the investigator-determined timing of nonculprit-lesion intervention. The benefit of complete revascularization on hard clinical outcomes emerged mainly over the long term.
背景
COMPLETE（完全血运重建与罪犯血管血运重建治疗 ST 段抬高型心肌梗死患者早期经皮冠状动脉介入治疗后多支血管病变）试验表明，分期非罪犯病变经皮冠状动脉介入治疗（PCI）可降低 ST 段抬高型心肌梗死（STEMI）和多支血管病变患者的主要心血管（CV）事件。
目的
本研究旨在确定非罪犯病变 PCI 时机对主要 CV 结局的影响，以及完全血运重建获益的时间过程。
方法
在罪犯病变 PCI 后，4041 例 STEMI 合并多支血管 CAD 患者被随机分为分期非罪犯病变 PCI 或罪犯病变单独 PCI 组。根据非罪犯病变 PCI 的研究者计划时间进行分层随机化：在指数住院期间或之后。主要复合终点为 CV 死亡或心肌梗死（MI）。在预先指定的分析中，计算了每个时间亚组的风险比（HR）。对整个人群进行了 45 天内和 45 天后的 landmark 分析。
结果
对于在指数住院期间计划进行的非罪犯病变 PCI（实际时间：中位数 1 天），与罪犯病变单独 PCI 相比，完全血运重建可降低 CV 死亡或 MI（HR：0.77；95%置信区间[CI]：0.59 至 1.00）。对于计划在出院后进行的非罪犯病变 PCI（实际时间：中位数 23 天），完全血运重建也可降低 CV 死亡或 MI（HR：0.69；95%CI：0.49 至 0.97；交互 p = 0.62）。 landmark 分析显示，在最初的 45 天内，与罪犯病变单独 PCI 相比，计划进行的非罪犯病变 PCI 的 HR 为 0.86（95%CI：0.59 至 1.24），从 45 天到随访结束时为 0.69（95%CI：0.54 至 0.89）。
结论
在多支血管病变的 STEMI 患者中，完全血运重建与罪犯病变单独 PCI 相比的获益是一致的，而与研究者确定的非罪犯病变干预时机无关。完全血运重建对硬临床结局的获益主要是长期的。
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