Functional coronary angiography to indicate and guide revascularization in STEMI patients with multivessel disease: Rationale and design of the AIR-STEMI trial

IF 3.7 2区医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS

American heart journal Pub Date : 2025-02-19 DOI:10.1016/j.ahj.2025.02.012

Andrea Erriquez MD , Iginio Colaiori MD , Abdul Hakeem MD , Vincenzo Guiducci MD , Mila Menozzi MD , Marco Barbierato MD , Manfredi Arioti MD , Domenico D'Amario MD , Gianni Casella MD , Roberto Scarsini MD , Alberto Polimeni MD , Luca Donazzan MD , Giorgio Benatti MD , Gabriele Venturi MD , Marco Ruozzi MD , Massimo Giordan MD , Alberto Monello MD , Francesco Moretti MD , Francesco Versaci MD , Jehangir Ali Shah MD , Simone Biscaglia MD

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引用次数: 0

Abstract

Background

Complete revascularization has been shown to be superior to culprit-only treatment in patients with ST-segment elevation myocardial infarction (STEMI) and multivessel disease. However, it remains unclear whether complete revascularization should be guided by coronary physiology or conventional angiography. Angiography-derived physiology may allow functional assessment and procedural guidance using angiograms from primary percutaneous coronary intervention (PCI), potentially maximizing the benefits of a physiology-guided approach. We present the design of a dedicated study that will address this research gap.

Methods and Design

The Functional Coronary Angiography to Indicate and Guide Revascularization in STEMI Patients with Multivessel Disease (AIR-STEMI) trial is a prospective, randomized, international, multicenter, open-label study with blinded adjudicated evaluation of outcomes. After successful treatment of the culprit lesion, patients will be randomized to receive PCI of the nonculprit lesions guided by conventional angiography or by angiography-derived fractional flow reserve (FFR). The primary endpoint is the composite endpoint of all-cause death, any myocardial infarction (MI), any cerebrovascular accident, or any revascularization. It will be censored once the last enrolled patient reaches 1-year follow-up. The secondary endpoint will be the composite of cardiovascular death or MI and each single component of the primary endpoint. All endpoints will be tested also at 3 and 5 years. The sample size for the study is a minimum of 1,800 patients.

Implications

The AIR-STEMI trial will provide novel evidence on whether a specific complete revascularization strategy should be applied to patients with STEMI and multivessel disease to improve their clinical outcomes.

Trial Registration

ClinicalTrials.gov NCT05818475.

查看原文本刊更多论文

功能性冠状动脉造影指示和指导STEMI合并多血管疾病患者的血运重建：AIR-STEMI试验的原理和设计：STEMI患者的功能性冠状动脉造影

背景：对于st段抬高型心肌梗死（STEMI）和多血管疾病患者，完全血运重建术已被证明优于单纯的罪魁祸首治疗。然而，目前尚不清楚完全血运重建术是否应由冠状动脉生理学或常规血管造影指导。血管造影衍生的生理学可以利用经皮冠状动脉介入治疗（PCI）的血管造影进行功能评估和程序指导，从而最大限度地发挥生理学指导方法的优势。我们提出了一项专门研究的设计，以解决这一研究差距。方法和设计：功能性冠状动脉造影指示和指导STEMI合并多血管疾病患者血运重建术（AIR-STEMI）试验是一项前瞻性、随机、国际、多中心、开放标签的研究，采用盲法评价结果。罪魁祸首病变治疗成功后，患者将随机接受常规血管造影或血管造影衍生分数血流储备（FFR）引导下的非罪魁祸首病变PCI治疗。主要终点为全因死亡、任何心肌梗死（MI）、任何脑血管意外或任何血运重建术的复合终点。一旦最后一名入组患者达到1年随访，将进行审查。次要终点将是心血管死亡或心肌梗死与主要终点的单个组成部分的复合。所有终点也将在3年和5年进行测试。该研究的样本量至少为1800名患者。意义：AIR-STEMI试验将为是否应该对STEMI和多血管疾病患者应用特定的完全血运重建策略以改善其临床结果提供新的证据。试验注册：ClinicalTrials.gov NCT05818475。

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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.