Author/Authors :
Mahaffey، نويسنده , , Kenneth W. and Roe، نويسنده , , Matthew T. and Kilaru، نويسنده , , Rakhi and French، نويسنده , , John K. and Alexander، نويسنده , , John H. and Berdan، نويسنده , , Lisa G. and Van De Werf، نويسنده , , Frans and Simoons، نويسنده , , Maarten L. and Weaver، نويسنده , , W. Douglas and White، نويسنده , , Harvey D. and Lincoff، نويسنده , , A. Michael and Kleiman، نويسنده , , Neal ، نويسنده ,
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.