The FAST-MI 2005-2010-2015 registries in the light of the COMPASS trial: The COMPASS criteria applied to a post-MI population

BACKGROUND: The COMPASS trial assessed the impact of adding low dose rivaroxaban to aspirin in selected patients (pts). After an acute myocardial infarction (MI), when dual antiplatelet treatment is no longer needed, patients might be eligible for aspirin/rivaroxaban co-therapy. The characteristics and risks of such a population are unclear. METHODS: Data were extracted from the FAST-MI 2005, 2010 and 2015 nationwide French registries. Characteristics and long-term mortality were compared according to COMPASS eligibility and between registry and trial populations. RESULTS: Among 9954 patients alive and free of events at one year, 4402 (44%) were classified as COMPASS-Like (i.e. meeting COMPASS inclusion and without exclusion criteria), 1720 (17%) COMPASS-Excluded (i.e. meeting any exclusion criterion) and 3832 (39%) Non-COMPASS (i.e. meeting neither COMPASS inclusion nor exclusion criteria). COMPASS-Like patients were at higher risk and had higher 5-year mortality compared with Non-COMPASS patients. COMPASS-Excluded patients had the highest mortality. COMPASS enrichment criteria defined a population at increased risk of death: eligible pts. had 40% higher 5-year adjusted mortality (Hazard Ratio = 1.40 [1.15; 1.70]), while excluded pts. had 57% higher risk (Hazard Ratio = 1.57 [1.25; 1.97]). Patients meeting the COMPASS criteria one year after MI differed from those included in the randomized trial. CONCLUSIONS: Based on the population included in the French FAST-MI registries, enrichment criteria used in COMPASS defined a population representing 44% of the overall population of MI patients surviving to one year, and these patients are at high risk of 5-year mortality. They were at higher risk compared to chronic stable vascular patients enrolled in the trial. Registered with Clinicaltrials.gov under the number: NCT00673036.