Results from PROMISE Announced at TCT 2025 and Published Simultaneously in the European Heart Journal
SAN FRANCISCO – OCTOBER 28, 2025 – The first prospective randomized clinical trial to evaluate optimal management strategy for myocardial infarction with non-obstructive coronary arteries (MINOCA) found that an etiology-guided stratified treatment of MINOCA improves clinical outcomes in patients compared to standard care.
Findings were reported today at TCT® 2025, the annual scientific symposium of the Cardiovascular Research Foundation® (CRF®) and published simultaneously in the European Heart Journal. TCT is the world’s premier educational meeting specializing in interventional cardiovascular medicine.
MINOCA represents up to 10% of all patients with myocardial infarction (MI) presenting for coronary angiography and is associated with a significant risk of mortality, rehospitalization and angina burden. The complex and heterogeneous pathophysiology of MINOCA has posed significant challenges to trial design in this population. The PROMISE trial sought to determine if a personalized treatment would improve outcomes.
From July 2021 to June 2024, 101 patients with suspected MINOCA (defined as acute MI, absence of stenosis greater than 50% at coronary angiography, and no alternative diagnosis for clinical presentation) were randomized one to one to either a stratified treatment based on a comprehensive diagnostic workup aimed at identifying the underlying etiology, or to standard care. Of those, 92 were confirmed to have MINOCA with 45 receiving the stratified treatment and 47 given standard care. The primary endpoint was the between-group difference in the change in angina status at 12 months, assessed by the Seattle Angina Questionnaire summary score (SAQSS). The secondary end point was the incidence of major adverse cardiovascular events (MACE) at 12 months, defined as the composite of all-cause mortality, non-fatal MI, stroke, heart failure rehospitalization and repeated coronary angiography. The trial was terminated early upon recommendation by the Data and Safety Monitoring Board due to clear benefits observed in the intervention group and potential harm in the control group.
At 12-month follow-up, the improvement in SAQSS compared with baseline was significantly higher in the etiology-guided stratified treatment group compared with the standard care group (12.3±5.2 vs. 2.9±9.5, mean between-group difference: 9.38, 95%CI: 6.81-11.95; p<0.001). This difference was consistent across all five SAQ domains. MACE occurred in one patient (2.2%) in the intervention arm and in four patients (8.5%) in the standard care group, though the difference was not statistically significant (p= 0.19). No adverse events were noted as a result of advanced diagnostic evaluation. Additionally, reclassification of the initial suspected diagnosis occurred in 75.5% of cases of the stratified treatment arm.
“This first randomized trial evaluating the management of MINOCA patients shows a clear benefit of stratified treatment,” said Rocco Antonio Montone, MD, PhD, interventional cardiologist, Department of Cardiovascular Sciences, Polyclinic A. Gemelli in Rome, Italy. “Even with the complex and heterogeneous pathophysiology of MINOCA, this approach is safe, effective and feasible for this patient population.”
The study was funded by “Ricerca Finalizzata 2019” Grant (GR-2019-12370197) from the Italian Ministry of Health awarded to Dr. Montone.
Dr. Montone reported no financial relationships to disclose.
