Central Adjudication Identified Additional and Prognostically Important Myocardial Infarctions in Patients Undergoing Percutaneous Coronary Intervention: Results From CHAMPION PHOENIX

BACKGROUND:In the CHAMPION PHOENIX trial, cangrelor reduced the primary composite end point of death, myocardial infarction (MI), ischemia-driven revascularization, or stent thrombosis at 48 hours. This study aimed to explore the impact of event adjudication and the prognostic importance of MI repor...

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Veröffentlicht in:Circulation. Cardiovascular interventions 2019-07, Vol.12 (7), p.e007342-e007342
Hauptverfasser: Olivier, Christoph B, Bhatt, Deepak L, Leonardi, Sergio, Stone, Gregg W, Gibson, C Michael, Steg, Ph Gabriel, Hamm, Christian W, Wilson, Matthew D, Mangum, Stacey, Price, Matthew J, Prats, Jayne, White, Harvey D, Lopes, Renato D, Harrington, Robert A, Mahaffey, Kenneth W
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Sprache:eng
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Zusammenfassung:BACKGROUND:In the CHAMPION PHOENIX trial, cangrelor reduced the primary composite end point of death, myocardial infarction (MI), ischemia-driven revascularization, or stent thrombosis at 48 hours. This study aimed to explore the impact of event adjudication and the prognostic importance of MI reported by a clinical events committee (CEC) or site investigators (SIs). METHODS AND RESULTS:Data from the CHAMPION PHOENIX trial of patients undergoing elective or nonelective percutaneous coronary intervention were analyzed. A CEC systematically identified and adjudicated MI using predefined criteria, a computer algorithm to identify suspected events, and semilogarithmic plots to review biomarker changes. Thirty-day death was modeled using baseline characteristics. Of 10 942 patients, 462 (4.2%) patients had at least 1 MI by 48 hours identified by the CEC (207 [3.8%] cangrelor; 255 [4.7%] clopidogrel; odds ratio [OR] 0.80; 95% CI, 0.67–0.97; P=0.022), and 143 patients had at least 1 MI by 48 hours reported by the SI (60 [1.1%] cangrelor; 83 [1.5%] clopidogrel; OR, 0.72; 95% CI, 0.52–1.01; P=0.053). Of the 462 MIs identified by the CEC, 92 (20%) were reported by SI, and 370 (80%) were not. Of the 143 MI reported by the SI, 51 (36%) were not confirmed by CEC. All categories were associated with an increased adjusted risk for 30-day death (CECOR, 5.35; 95% CI, 2.56–11.2; P
ISSN:1941-7632
1941-7640
1941-7632
DOI:10.1161/CIRCINTERVENTIONS.118.007342