Treatment in Myocardial Infarction and Non-Obstructive Coronary Arteries (MINOCA): PROMISE Trial, TCT 2025

The PROMISE trial is the first randomized study to evaluate stratified management in MINOCA, a condition that accounts for up to 10% of all myocardial infarctions but lacks evidence-based treatment guidance.

In this investigator-initiated, multicenter study, 92 patients meeting diagnostic criteria for MINOCA were enrolled across four Italian centers and randomized 1:1 to a stratified treatment arm (n=45) or standard care (n=47). The mean age was 61.8 years, and 48% were women. Stratified management involved a comprehensive diagnostic work-up—including optical coherence tomography (OCT), acetylcholine provocation testing, cardiac magnetic resonance imaging (CMR), and transesophageal echocardiography—to determine the underlying mechanism and tailor therapy accordingly.

Standard-care patients underwent coronary angiography with CMR recommended but no additional testing, followed by conventional acute coronary syndrome (ACS) therapy (single or dual antiplatelet therapy, statins, β-blockers, or ACE inhibitors as indicated).

The primary endpoint, change in angina status at 12 months measured by the Seattle Angina Questionnaire summary score (SAQ-SS), improved by 12.3 ± 5.2 points in the stratified group versus 2.9 ± 9.5 points in the standard-care group, a highly significant between-group difference of 9.4 points (95% CI 6.8–12.0; p<0.001). All SAQ domains, including angina limitation, stability, frequency, treatment satisfaction, and quality of life, showed consistent benefit with the stratified approach.

The secondary endpoint, 12-month major adverse cardiovascular events (MACE: death, MI, stroke, heart failure hospitalization, or repeat angiography), occurred in 2.2% of the stratified group versus 8.5% of the standard-care group (p=0.19), reflecting a favorable trend though not statistically significant due to limited sample size. No adverse events were reported from the advanced diagnostic procedures.

Mechanistic testing successfully reclassified the initial suspected MINOCA etiology in 75.5% of patients. Tailored therapy was then directed accordingly; for instance, dual antiplatelet therapy and statins for plaque instability and, calcium-channel blockers for epicardial spasm.

While the early termination meant no definite conclusions could be drawn regarding hard endpoints like MACE (Major Adverse Cardiac Events), the clear benefit in quality of life and symptom relief establishes stratified care as a superior approach for MINOCA patients. The PROMISE trial establishes the feasibility, safety, and clinical benefit of advanced diagnostic-guided therapy in MINOCA—a population historically managed by empirical protocols.

Reference: Rocco A. MONTONE, Stratified treatment of myocardial infarction with non-obstructive coronary arteries: PROMISE Trial, TCT Conference 2025, San Francisco.

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About the Study Presenter: Rocco A. Montone graduated from Catholic University of the Sacred Heart in Rome with full honors in 2008 and passed the Postgraduate Board in Cardiology with full honors at the same University in 2015. He got a PhD in Cellular, Molecular and Clinical Research in Cardiology in 2020 and a Master of Sciences in Intensive Cardiac Care in 2021. He is Consultant in the Intensive Cardiac Care Unit and Interventional Cardiologist at the Policlinico Universitario A. Gemelli in Rome. He is also Local Associate Editor of the European Heart Journal.

He won the Young Investigator Award of the European Society of Cardiology for his research on Coronary Pathophysiology and microcirculation in 2020. Dr Montone has also received the Most Cited Paper Award from the Italian Society of cardiology in 2020.

He won an important competitive grant from the Italian Ministry of Health in 2020 for the PROMISE Trial to study pathogenic mechanisms and treatment for patients with myocardial infarction and non-obstructive coronary arteries (MINOCA). He is author of more than 100 publications in international peer-review Journal with an H-Index of 19.