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

Br J Clin Pharmacol. 2017 Sep;83(9):2056-2065. doi: 10.1111/bcp.13291. Epub 2017 May 5.

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.

Keywords: coronary disease; epidemiology; haemorrhage; myocardial infarction; secondary prevention; stroke.

Publication types

  • Comparative Study

MeSH terms

  • Aged
  • Anticoagulants / therapeutic use*
  • Databases, Factual
  • Diabetes Complications / drug therapy
  • Female
  • France
  • Hemorrhage / chemically induced
  • Hemorrhage / complications
  • Hospitalization / statistics & numerical data
  • Humans
  • Kidney Failure, Chronic / complications
  • Kidney Failure, Chronic / drug therapy
  • Male
  • Myocardial Infarction / complications
  • Myocardial Infarction / drug therapy*
  • Myocardial Infarction / mortality
  • Platelet Aggregation Inhibitors / therapeutic use
  • Time Factors
  • Treatment Outcome

Substances

  • Anticoagulants
  • Platelet Aggregation Inhibitors