Characterization of myocardial infarction as an end point in two large trials of acute coronary syndromes

Am J Cardiol. 2005 Jun 15;95(12):1404-8. doi: 10.1016/j.amjcard.2005.02.005.

Abstract

Myocardial infarction (MI) is a key component of composite end points in trials that evaluate new therapies in non-ST-segment elevation acute coronary syndromes. Types of MI events in these trials have not been well characterized. A similar clinical-events classification process adjudicated all suspected MI end points in the PURSUIT and PARAGON B trials. All MI end points were classified as nonprocedural, related to percutaneous coronary intervention, or related to coronary artery bypass grafting. A total of 16,173 patients was enrolled in the 2 trials, and 1,802 MI end points occurred during a 30-day follow-up. Nearly 66% of MI end points were not related to percutaneous coronary intervention or coronary artery bypass grafting. Patients who had MI compared with those who did not had higher 30-day mortality rates (13.6% vs 2.3%, p <0.001) and 6-month mortality rates (18.4% vs 4.4%, p <0.001). Patients who had been randomized to glycoprotein IIb/IIIa inhibition showed trends toward fewer MI events regardless of type. Two-thirds of MI end points in 2 large trials of acute coronary syndrome were not related to procedure. All MI types were associated with worse short- and long-term outcomes. Characterization of the type of MI provides an opportunity for more informed interpretation of clinical trial results and improved planning for future trials.

Publication types

  • Comparative Study

MeSH terms

  • Angioplasty, Balloon, Coronary
  • Anticoagulants / therapeutic use
  • Coronary Artery Bypass
  • Creatine Kinase / blood
  • Creatine Kinase, MB Form
  • Drug Therapy, Combination
  • Follow-Up Studies
  • Heparin / therapeutic use
  • Hospital Mortality
  • Humans
  • Isoenzymes / blood
  • Length of Stay
  • Myocardial Infarction / blood
  • Myocardial Infarction / mortality
  • Myocardial Infarction / therapy*
  • Myocardial Revascularization / methods*
  • Platelet Aggregation Inhibitors / therapeutic use
  • Platelet Glycoprotein GPIIb-IIIa Complex / antagonists & inhibitors
  • Randomized Controlled Trials as Topic
  • Survival Rate
  • Syndrome
  • Treatment Outcome

Substances

  • Anticoagulants
  • Isoenzymes
  • Platelet Aggregation Inhibitors
  • Platelet Glycoprotein GPIIb-IIIa Complex
  • Heparin
  • Creatine Kinase
  • Creatine Kinase, MB Form