在NSTEMI和多血管疾病患者中完全血运重建术与仅罪魁祸首病变的PCI -随机Complete -NSTEMI试验的设计和基本原理

IF 3.7 2区医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS

American heart journal Pub Date : 2025-04-08 DOI:10.1016/j.ahj.2025.04.007

Hans-Josef Feistritzer MD, PhD , Alexander Jobs MD , Uwe Zeymer MD , Steffen Schneider PhD , Philipp Lauten MD , Miroslaw Ferenc MD , Maren Weferling MD , Regine Brinkmann MD , Sebastian Winkler MD , Ulf Landmesser MD , Tobias Trippel MD , Christoph Stellbrink MD , Harm Wienbergen MD , Georg Fürnau MD , Helge Möllmann MD , Axel Linke MD , Christian Jung MD , Alexander Lauten MD , Stephan Achenbach MD , Tienush Rassaf MD , Holger Thiele MD

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引用次数: 0

摘要

多支冠状动脉疾病（CAD）存在于30%至70%的非st段抬高型心肌梗死（NSTEMI）患者中，这取决于不同的年龄和风险概况。与STEMI队列相比，只有有限的科学证据来自随机对照试验，指导NSTEMI人群进行完全血运重建的一般决策。主要假设COMPLETE-NSTEMI试验旨在研究在NSTEMI和多血管CAD患者中，多血管经皮冠状动脉介入治疗（PCI）是否优于仅罪魁祸首病变的PCI。DesignCOMPLETE-NSTEMI是一项前瞻性、随机、对照、多中心、平行组、开放标签试验。该研究将在德国和奥地利的65 - 70个地点招募3390名患有多血管CAD的NSTEMI患者。患者将按1:1的比例随机分为PCI完全血运重建术组或仅病灶PCI组。主要疗效终点是随访期间心血管死亡或非致死性心肌梗死再住院的综合指标。该试验是事件驱动的，一旦达到578个主要终点事件，每位患者的最小随访时间为12个月，该试验将停止。第一例患者于2023年10月27日入组。到2025年4月，已经激活了51个位点，并随机分配了500名患者。预计招聘工作将于2027年上半年完成。主要终点的最终结果预计将于2028年公布。OutlookCOMPLETE NSTEMI将是第一个专门回答NSTEMI合并多血管CAD患者最佳血运重建策略问题的试验。试验注册：ClinicalTrials.govNCT05786131

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Complete revascularization versus culprit-lesion only PCI in patients with NSTEMI and multivessel disease – Design and rationale of the randomized COMPLETE-NSTEMI trial

Background

Multivessel coronary artery disease (CAD) is present in 30% to 70% of patients presenting with non-ST-segment elevation myocardial infarction (NSTEMI) depending on varying age and risk profiles. In contrast to the STEMI cohort, there is only limited scientific evidence derived from randomized controlled trials directing the general decision for or against complete revascularization in the NSTEMI population.

Primary hypothesis

The COMPLETE-NSTEMI trial aims to investigate whether multivessel percutaneous coronary intervention (PCI) is superior over culprit-lesion only PCI in patients with NSTEMI and multivessel CAD.

Design

COMPLETE-NSTEMI is a prospective, randomized, controlled, multicenter, parallel group, open-label trial. It will enroll 3390 NSTEMI patients with multivessel CAD at 65 to 70 sites in Germany and Austria. Patients will be randomized 1:1 to either complete revascularization with PCI or culprit lesion-only PCI.

Endpoints

The primary efficacy endpoint is a composite of cardiovascular death or rehospitalization for nonfatal myocardial infarction during follow-up. The trial is event-driven and will be stopped as soon as 578 primary endpoint events and a minimal follow-up duration of 12 months for each patient are reached.

Current status

The first patient was enrolled at October 27, 2023. By April 2025, 51 sites have been activated and >500 patients have been randomized. Completion of recruitment is expected for the first half of 2027. The final results of the primary endpoint are expected in 2028.

Outlook

COMPLETE NSTEMI will be the first dedicated trial to answer the question about the optimal revascularization strategy in patients with NSTEMI and multivessel CAD.

Trial registration: ClinicalTrials.gov

NCT05786131

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来源期刊

American heart journal 医学-心血管系统

CiteScore

8.20

自引率

2.10%

发文量

214

审稿时长

38 days

期刊介绍： The American Heart Journal will consider for publication suitable articles on topics pertaining to the broad discipline of cardiovascular disease. Our goal is to provide the reader primary investigation, scholarly review, and opinion concerning the practice of cardiovascular medicine. We especially encourage submission of 3 types of reports that are not frequently seen in cardiovascular journals: negative clinical studies, reports on study designs, and studies involving the organization of medical care. The Journal does not accept individual case reports or original articles involving bench laboratory or animal research.