Functional coronary angiography to indicate and guide revascularization in STEMI patients with multivessel disease: Rationale and design of the AIR-STEMI trial - 08/03/25

Doi : 10.1016/j.ahj.2025.02.012

Andrea Erriquez, MD ^a, Iginio Colaiori, MD ^b, Abdul Hakeem, MD ^c, Vincenzo Guiducci, MD ^d, Mila Menozzi, MD ^e, Marco Barbierato, MD ^f, Manfredi Arioti, MD ^g, Domenico D'Amario, MD ^h, Gianni Casella, MD ⁱ, Roberto Scarsini, MD ^j, Alberto Polimeni, MD ^k, Luca Donazzan, MD ^l, Giorgio Benatti, MD ^m, Gabriele Venturi, MD ⁿ, Marco Ruozzi, MD ^o, Massimo Giordan, MD ^p, Alberto Monello, MD ^q, Francesco Moretti, MD ^r, Francesco Versaci, MD ^b, Jehangir Ali Shah, MD ^c, Ahsan Ali Lakho, MD ^c, Francesca Mantovani, MD ^d, Caterina Cavazza, MD ^e, Giulia Bugani, MD ⁱ, Valerio Lanzilotti, MD ⁱ, Francesco Gallo, MD ^f, Antonio Maria Leone, MD ^s,^t, Matteo Tebaldi, MD ^u, Rita Pavasini, MD ^a, Raffaele Piccolo, MD ^v, Filippo Maria Verardi, MD ^a, Jacopo Farina, MD ^a, Serena Caglioni, MD ^a, Marta Cocco, MD ^a, Gianluca Campo, MD ^a, Simone Biscaglia, MD ^a,^⁎
^a Cardiovascular Institute, AOU di Ferrara, Ferrara, Italy
^b UOC UTIC Emodinamica e Cardiologia, Ospedale Santa Maria Goretti, Latina, Italy
^c National Institute of Cardiovascular Diseases, Karachi, Pakistan
^d Cardiology Unit, Azienda USL-IRCCS Reggio Emilia, S. Maria Nuova Hospital, Reggio Emilia, Italy
^e Cardiovascular Department, Infermi Hospital, Rimini, Italy
^f Interventional Cardiology, Department of Cardio-Thoracic and Vascular Sciences, Ospedale dell'Angelo, Venice, Italy
^g Cardiology Department, S. Maria delle Croci Hospital, Ravenna, Italy
^h Dipartimento Medicina Translazionale, Azienda Ospedaliero-Universitaria Maggiore della Carità, Dipartimento Toraco-Cardio-Vascolare, Unità Operativa Complessa di Cardiologia, Novara, Italy
ⁱ U.O.C. Cardiologia, Ospedale Maggiore, Bologna, Italy
^j Cardiology Unit, AOU Integrata, Verona, Italy
^k Division of Cardiology AOCS, Department of Pharmacy, Health and Nutritional Sciences, University of Calabria, Cosenza, Italy
^l Department of Cardiology, Ospedale Regionale San Maurizio, Bolzano, Italy
^m Division of Cardiology, Parma University Hospital, Parma, Italy
ⁿ Mater Salutis Hospital, Verona, Italy
^o Cardiology Unit, Ospedale Civile di Baggiovara, Modena, Italy
^p Unit of Interventional Cardiology, Ospedale Santa Maria della Misericordia, Rovigo, Italy
^q Cardiology Unit, Ospedale San Guglielmo da Saliceto, Piacenza, Italy
^r Cardiology Unit, ASST Ospedale Papa Giovanni XXIII, Bergamo, Italy
^s Ospedale Isola Tiberina - Gemelli Isola, Rome, Italy
^t Department of Cardiovascular and Thoracic Sciences, Catholic University of the Sacred Heart, Rome, Italy
^u Cardiology Unit, Infermi Hospital, Faenza, Italy
^v Department of Advanced Biomedical Sciences, Federico II University of Naples, Naples, Italy

^⁎Reprint requests: Simone Biscaglia, MD, Cardiovascular Institute, Azienda Ospedaliera Universitaria S. Anna, Via Aldo Moro 8, 44124, Cona (Fe), Italy.Cardiovascular InstituteAzienda Ospedaliera Universitaria S. AnnaVia Aldo Moro 8Cona (Fe)44124Italy

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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Plan

Background

Coronary physiology-guided complete revascularization

Functional coronary artery angiography

Functional coronary angiography in STEMI patients

Methods

Study design and population

Study procedures

Study endpoints

Statistical considerations

Determination of sample size

Predefined substudies

Study organization

Angiographic and functional core-lab

State of the art, timelines, and conclusions

CRediT authorship contribution statement

Export

Vol 284

P. 71-80 - juin 2025 Retour au numéro

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Functional coronary angiography to indicate and guide revascularization in STEMI patients with multivessel disease: Rationale and design of the AIR-STEMI trial - 08/03/25

ABSTRACT

Background

Methods and Design

Implications

Trial Registration

Plan

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