title: Characterization of myocardial infarction as an end point in two large trials of acute coronary syndromes.
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.
authors.affiliation: Division of Cardiology and Duke Clinical Research Institute, Duke University Medical Center, Durham, North Carolina 27715, USA. mahaf002@mc.duke.edu
authors.forename: Kenneth W
authors.initials: KW
authors.lastname: Mahaffey
authors.forename: Matthew T
authors.initials: MT
authors.lastname: Roe
authors.forename: Rakhi
authors.initials: R
authors.lastname: Kilaru
authors.forename: John K
authors.initials: JK
authors.lastname: French
authors.forename: John H
authors.initials: JH
authors.lastname: Alexander
authors.forename: Lisa G
authors.initials: LG
authors.lastname: Berdan
authors.forename: Frans
authors.initials: F
authors.lastname: Van De Werf
authors.forename: Maarten L
authors.initials: ML
authors.lastname: Simoons
authors.forename: W Douglas
authors.initials: WD
authors.lastname: Weaver
authors.forename: Harvey D
authors.initials: HD
authors.lastname: White
authors.forename: A Michael
authors.initials: AM
authors.lastname: Lincoff
authors.forename: Neal S
authors.initials: NS
authors.lastname: Kleiman
authors.forename: Eric J
authors.initials: EJ
authors.lastname: Topol
authors.forename: Robert A
authors.initials: RA
authors.lastname: Harrington
mesh_terms: D015906:Angioplasty, Balloon, Coronary; D000925:Anticoagulants / Q000627:therapeutic use; D001026:Coronary Artery Bypass; D003402:Creatine Kinase / Q000097:blood; D052279:Creatine Kinase, MB Form; D004359:Drug Therapy, Combination; D005500:Follow-Up Studies; D006493:Heparin / Q000627:therapeutic use; D017052:Hospital Mortality; D006801:Humans; D007527:Isoenzymes / Q000097:blood; D007902:Length of Stay; D009203:Myocardial Infarction / Q000097:blood / Q000401:mortality / Q000628:therapy*; D009204:Myocardial Revascularization / Q000379:methods*; D010975:Platelet Aggregation Inhibitors / Q000627:therapeutic use; D019039:Platelet Glycoprotein GPIIb-IIIa Complex / Q000037:antagonists & inhibitors; D016032:Randomized Controlled Trials as Topic; D015996:Survival Rate; D013577:Syndrome; D016896:Treatment Outcome
chemical_list: D000925:Anticoagulants; D007527:Isoenzymes; D010975:Platelet Aggregation Inhibitors; D019039:Platelet Glycoprotein GPIIb-IIIa Complex; D006493:Heparin; D003402:Creatine Kinase; D052279:Creatine Kinase, MB Form