The PROMISE trial is the first randomized clinical trial to evaluate an optimal management strategy for myocardial infarction with non-obstructive coronary arteries (MINOCA). This multicenter trial randomized patients 1:1 to either a stratified treatment based on a comprehensive diagnostic workup to identify underlying etiology or to 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 endpoint was the incidence of major adverse cardiovascular events (MACE), a composite of all-cause mortality, myocardial infarction, stroke, heart failure hospitalization, 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. Of 101 randomized patients, 92 were confirmed as MINOCA and included in the final analysis (mean age 62 ± 13 years, 48% women; stratified treatment n = 45; standard care n = 47). At 12-month follow-up, SAQSS was significantly higher in the stratified treatment group than in the standard care group, with a mean between-group difference of +9.38 in favor of stratified treatment (95% confidence interval 6.81 to 11.95; P < .001). MACE occurred in 1 patient (2.2%) in the stratified treatment group and in 4 patients (8.5%) in the standard care group, though the difference was not statistically significant (P = .18). The authors conclude that stratified treatment, based on comprehensive diagnostic assessment and etiology-guided therapy, led to a significant improvement in angina-related health status. They note these results provide the first evidence supporting individualized management in this patient population but require confirmation in a larger prospective study with longer follow-up.
Imagine having a heart attack, but doctors tell you your heart's arteries aren't blocked. This confusing condition, called MINOCA, leaves many patients struggling with chest pain and a high risk of future hospital visits, with no proven treatment plan. For the first time, a randomized trial tested a new approach. Instead of a one-size-fits-all treatment, doctors gave some patients a comprehensive workup to find the specific cause of their heart attack, then tailored their therapy. After one year, patients who received this personalized treatment reported significantly better chest pain symptoms and quality of life than those who got standard care. The trial was stopped early because the benefits for the personalized group were so clear, and there was concern the standard care group might be at a disadvantage. While the study was small, it provides the first solid evidence that finding and treating the root cause matters for people with this often-misunderstood heart condition.
What this means for you: For heart attacks without blocked arteries, a personalized treatment plan significantly improves chest pain and quality of life.
View Original Abstract ↓
BACKGROUND AND AIMS: Myocardial infarction with non-obstructive coronary arteries (MINOCA) is associated with a significant risk of mortality, rehospitalization, and angina burden. Despite its clinical impact, no randomized clinical trials have hitherto evaluated optimal management strategy for MINOCA. The PROMISE trial was designed to assess whether a stratified treatment improves clinical outcomes in patients with MINOCA as compared to standard care.
METHODS: PROMISE is a multicentre randomized trial. Patients with MINOCA were randomized 1:1 to either a stratified treatment based on a comprehensive diagnostic workup aimed at identifying the underlying aetiology, or to 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 endpoint was the incidence of major adverse cardiovascular events (MACE), defined as the composite of all-cause mortality, myocardial infarction, stroke, heart failure hospitalization 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.
RESULTS: Of 101 randomized patients, 92 were confirmed as MINOCA and included in the final analysis (mean age 62 ± 13 years, 48% women; stratified treatment n = 45; standard care n = 47). At 12-month follow-up, SAQSS was significantly higher in the stratified treatment than in standard care group, with a mean between-group difference of +9.38 in favour of the stratified treatment (95% confidence interval 6.81 to 11.95; P < .001). MACE occurred in 1 patient (2.2%) in the stratified treatment and in 4 patients (8.5%) in the standard care group, though the difference was not statistically significant (P = .18).
CONCLUSIONS: In this first randomized trial of treatment strategies in MINOCA, a stratified treatment, based on comprehensive diagnostic assessment and aetiology-guided therapy, led to a significant improvement in angina-related health status. While the study findings provide the first evidence supporting individualized management in this heterogeneous and often under-recognized patient population, these results require confirmation in a larger prospective study with longer follow-up.