Outcomes in patients after myocardial infarction similar to those of the PEGASUS-TIMI 54 trial: A cohort study in the French national claims database

Abstract

Aims: The present study aims to describe real-life outcomes in stable patients after-myocardial infarction (MI) similar to those in the PEGASUS-TIMI 54 trial (PEGASUS), which found long-term benefits of ticagrelor in patients with a history of MI. Methods: One-year event-free post-MI patients were identified in the French claims database representative 1/97 sample (2005–2010) and followed for up to 3 years. A PEGASUS-like (PL) population included patients with age ≥ 65 years, or age ≥ 50 and diabetes, renal dysfunction or prior MI, without stroke, end-stage renal failure or oral anticoagulation. Outcomes were: a composite of all-cause death or hospital admission for MI or stroke; individual events; major bleeding. Results: There were 1585 post-MI patients totalling 3926 person–years including 865 PL patients (2114 PY); 68% were male; mean age was 66 (standard deviation 15) in post-MI, 74 (10) in PL. Outcomes per 100 person–years [95% confidence interval] were, respectively, in post-MI and PL 6.3 [5.6–7.1] and 7.8 [6.7–8.9] for the composite outcome; 5.1 [4.4–5.8] and 6.5 [5.5–7.6] for death; 1.0 [0.7–1.3] and 1.0 [0.6–1.4] for MI; 0.6 [0.4–0.9] and 0.9 [0.5–1.2] for stroke; 1.3 [0.9–1.6] and 1.4 [0.9–1.9] for major bleeding. Event rates were stable over the 3 study years. Placebo patients in the PEGASUS-TIMI54 Study were younger, more often male and had lower event rates, especially for all-cause death and major bleeding. Conclusions: Patients selected using the criteria described in PEGASUS were older with more comorbidities, resulting in higher all-cause death and bleeding rates, but similar MI recurrence rates.