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.

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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.