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ST 段抬高型心肌梗死患者心绞痛相关生活质量的完全血运重建与罪犯病变血运重建的经皮冠状动脉介入治疗比较:来自 COMPLETE 随机临床试验的结果。

Complete Revascularization vs Culprit Lesion-Only Percutaneous Coronary Intervention for Angina-Related Quality of Life in Patients With ST-Segment Elevation Myocardial Infarction: Results From the COMPLETE Randomized Clinical Trial.

机构信息

Population Health Research Institute, McMaster University and Hamilton Health Sciences, Hamilton, Ontario, Canada.

University of British Columbia, Vancouver, British Columbia, Canada.

出版信息

JAMA Cardiol. 2022 Nov 1;7(11):1091-1099. doi: 10.1001/jamacardio.2022.3032.

DOI:10.1001/jamacardio.2022.3032
PMID:36129696
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC9494273/
Abstract

IMPORTANCE

In patients with multivessel coronary artery disease (CAD) presenting with ST-segment elevation myocardial infarction (STEMI), complete revascularization reduces major cardiovascular events compared with culprit lesion-only percutaneous coronary intervention (PCI). Whether complete revascularization also improves angina-related health status is unknown.

OBJECTIVE

To determine whether complete revascularization improves angina status in patients with STEMI and multivessel CAD.

DESIGN, SETTING, AND PARTICIPANTS: This secondary analysis of a randomized, multinational, open label trial of patient-reported outcomes took place in 140 primary PCI centers in 31 countries. Patients presenting with STEMI and multivessel CAD were randomized between February 1, 2013, and March 6, 2017. Analysis took place between July 2021 and December 2021.

INTERVENTIONS

Following PCI of the culprit lesion, patients with STEMI and multivessel CAD were randomized to receive either complete revascularization with additional PCI of angiographically significant nonculprit lesions or to no further revascularization.

MAIN OUTCOMES AND MEASURES

Seattle Angina Questionnaire Angina Frequency (SAQ-AF) score (range, 0 [daily angina] to 100 [no angina]) and the proportion of angina-free individuals by study end.

RESULTS

Of 4041 patients, 2016 were randomized to complete revascularization and 2025 to culprit lesion-only PCI. The mean (SD) age of patients was 62 (10.7) years, and 3225 (80%) were male. The mean (SD) SAQ-AF score increased from 87.1 (17.8) points at baseline to 97.1 (9.7) points at a median follow-up of 3 years in the complete revascularization group (score change, 9.9 [95% CI, 9.0-10.8]; P < .001) compared with an increase of 87.2 (18.4) to 96.3 (10.9) points (score change, 8.9 [95% CI, 8.0-9.8]; P < .001) in the culprit lesion-only group (between-group difference, 0.97 points [95% CI, 0.27-1.67]; P = .006). Overall, 1457 patients (87.5%) were free of angina (SAQ-AF score, 100) in the complete revascularization group compared with 1376 patients (84.3%) in the culprit lesion-only group (absolute difference, 3.2% [95% CI, 0.7%-5.7%]; P = .01). This benefit was observed mainly in patients with nonculprit lesion stenosis severity of 80% or more (absolute difference, 4.7%; interaction P = .02).

CONCLUSIONS AND RELEVANCE

In patients with STEMI and multivessel CAD, complete revascularization resulted in a slightly greater proportion of patients being angina-free compared with a culprit lesion-only strategy. This modest incremental improvement in health status is in addition to the established benefit of complete revascularization in reducing cardiovascular events.

摘要

重要性

在因 ST 段抬高型心肌梗死 (STEMI) 而就诊的多支冠状动脉疾病 (CAD) 患者中,与仅罪犯病变经皮冠状动脉介入治疗 (PCI) 相比,完全血运重建可降低主要心血管事件。完全血运重建是否也能改善与心绞痛相关的健康状况尚不清楚。

目的

确定 STEMI 和多支 CAD 患者的完全血运重建是否能改善心绞痛状况。

设计、地点和参与者:这是一项对患者报告结局的随机、多国、开放性试验的二次分析,在 31 个国家的 140 个初级 PCI 中心进行。于 2013 年 2 月 1 日至 2017 年 3 月 6 日,因 STEMI 和多支 CAD 就诊的患者被随机分为两组:罪犯病变 PCI 后行完全血运重建(加行造影提示有意义的非罪犯病变 PCI)或不行进一步血运重建。

干预措施

在罪犯病变 PCI 后,STEMI 和多支 CAD 患者被随机分为两组,一组接受完全血运重建,加行造影提示有意义的非罪犯病变 PCI,另一组不行进一步血运重建。

主要结局和测量指标

西雅图心绞痛问卷心绞痛频率(SAQ-AF)评分(范围,0 [每日心绞痛]至 100 [无心绞痛])和研究结束时无心绞痛的个体比例。

结果

在 4041 例患者中,2016 例患者被随机分配至完全血运重建组,2025 例患者被随机分配至仅罪犯病变 PCI 组。患者的平均(SD)年龄为 62(10.7)岁,3225 例(80%)为男性。完全血运重建组的基线时 SAQ-AF 评分平均(SD)为 87.1(17.8)分,中位随访 3 年时为 97.1(9.7)分(评分变化,9.9 [95%CI,9.0-10.8];P<0.001),而仅罪犯病变 PCI 组的评分变化为 87.2(18.4)至 96.3(10.9)分(评分变化,8.9 [95%CI,8.0-9.8];P<0.001)(两组间差值,0.97 分 [95%CI,0.27-1.67];P=0.006)。总的来说,完全血运重建组中 1457 例(87.5%)患者无心绞痛(SAQ-AF 评分 100),而仅罪犯病变 PCI 组中 1376 例(84.3%)患者无心绞痛(绝对差值,3.2% [95%CI,0.7%-5.7%];P=0.01)。这一获益主要见于非罪犯病变狭窄程度为 80%或更高的患者(绝对差值,4.7%;交互 P=0.02)。

结论和相关性

在 STEMI 和多支 CAD 患者中,与仅罪犯病变策略相比,完全血运重建使更多患者无心绞痛。与完全血运重建在降低心血管事件方面的既定获益相比,这种健康状况的适度增量改善是额外获益。

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