Efficacy and Safety of Cangrelor in Women Versus Men During Percutaneous Coronary Intervention: Insights From the Cangrelor versus Standard Therapy to Achieve Optimal Management of Platelet Inhibition (CHAMPION PHOENIX) Trial
Author(s)
Type
Journal Article
Abstract
Background—Cangrelor is an intravenous ADP receptor antagonist that leads to potent and reversible inhibition of platelet aggregation. The relative safety and efficacy of some antiplatelet drugs in women has been disputed.
Methods and Results—The Cangrelor versus Standard Therapy to Achieve Optimal Management of Platelet Inhibition (CHAMPION PHOENIX) trial randomized 11 145 patients undergoing elective or urgent percutaneous coronary intervention to cangrelor or clopidogrel. The primary efficacy end point was the composite of death, myocardial infarction, ischemia-driven revascularization, or stent thrombosis at 48 hours; the key secondary end point was stent thrombosis at 48 hours. The primary safety end point was GUSTO severe bleeding at 48 hours. Of subjects analyzed, 3051 (28%) were female. Cangrelor reduced the odds of the primary end point by 35% in women (adjusted odds ratio [OR], 0.65; 95% confidence interval [CI], 0.48–0.89) and by 14% in men (OR, 0.86; 95% CI, 0.70–1.05; P interaction=0.23) compared with clopidogrel. Cangrelor reduced the odds of stent thrombosis by 61% in women (OR, 0.39; 95% CI, 0.20–0.77) and 16% in men (OR, 0.84; 95% CI, 0.53–1.33; P interaction=0.11). The odds of severe bleeding were similar in both women and men treated with cangrelor (0.3% versus 0.2%, P=0.30 [women]; 0.1% versus 0.1%, P=0.41 [men]; P interaction=0.88) versus clopidogrel. Cangrelor increased the odds of moderate bleeding in women (0.9% versus 0.3%, P=0.02), but not in men (0.2% versus 0.2%, P=0.68; P interaction=0.040). The net clinical benefit (primary efficacy and safety end point) favored cangrelor in both women (OR, 0.68; 95% CI, 0.50–0.92) and men (OR, 0.87; 95% CI, 0.71–1.06; P interaction=0.26).
Conclusions—In CHAMPION PHOENIX, cangrelor reduced the odds of major adverse cardiovascular events and stent thrombosis in women and men and appeared to offer greater net clinical benefit than clopidogrel.
Methods and Results—The Cangrelor versus Standard Therapy to Achieve Optimal Management of Platelet Inhibition (CHAMPION PHOENIX) trial randomized 11 145 patients undergoing elective or urgent percutaneous coronary intervention to cangrelor or clopidogrel. The primary efficacy end point was the composite of death, myocardial infarction, ischemia-driven revascularization, or stent thrombosis at 48 hours; the key secondary end point was stent thrombosis at 48 hours. The primary safety end point was GUSTO severe bleeding at 48 hours. Of subjects analyzed, 3051 (28%) were female. Cangrelor reduced the odds of the primary end point by 35% in women (adjusted odds ratio [OR], 0.65; 95% confidence interval [CI], 0.48–0.89) and by 14% in men (OR, 0.86; 95% CI, 0.70–1.05; P interaction=0.23) compared with clopidogrel. Cangrelor reduced the odds of stent thrombosis by 61% in women (OR, 0.39; 95% CI, 0.20–0.77) and 16% in men (OR, 0.84; 95% CI, 0.53–1.33; P interaction=0.11). The odds of severe bleeding were similar in both women and men treated with cangrelor (0.3% versus 0.2%, P=0.30 [women]; 0.1% versus 0.1%, P=0.41 [men]; P interaction=0.88) versus clopidogrel. Cangrelor increased the odds of moderate bleeding in women (0.9% versus 0.3%, P=0.02), but not in men (0.2% versus 0.2%, P=0.68; P interaction=0.040). The net clinical benefit (primary efficacy and safety end point) favored cangrelor in both women (OR, 0.68; 95% CI, 0.50–0.92) and men (OR, 0.87; 95% CI, 0.71–1.06; P interaction=0.26).
Conclusions—In CHAMPION PHOENIX, cangrelor reduced the odds of major adverse cardiovascular events and stent thrombosis in women and men and appeared to offer greater net clinical benefit than clopidogrel.
Date Issued
2016-01-18
Date Acceptance
2015-11-24
Citation
Circulation, 2016, 133 (3), pp.248-255
ISSN
0009-7322
Publisher
American Heart Association
Start Page
248
End Page
255
Journal / Book Title
Circulation
Volume
133
Issue
3
Copyright Statement
© 2016 The Authors. This is an open access article under the terms of the Creative Commons Attribution License, which permits use, distribution, and reproduction in any medium, provided that the original work is properly cited.
License URL
Subjects
Science & Technology
Life Sciences & Biomedicine
Cardiac & Cardiovascular Systems
Peripheral Vascular Disease
Cardiovascular System & Cardiology
ADP receptor antagonist
cangrelor
clopidogrel
percutaneous coronary intervention
RANDOMIZED CONTROLLED-TRIALS
ASSOCIATION TASK-FORCE
COLLABORATIVE METAANALYSIS
CARDIOVASCULAR-DISEASE
MYOCARDIAL-INFARCTION
RECEPTOR ANTAGONIST
PRACTICE GUIDELINES
AMERICAN-COLLEGE
SEX
ASPIRIN
Adenosine Monophosphate
Aged
Aged, 80 and over
Disease Management
Female
Hemorrhage
Humans
Male
Middle Aged
Myocardial Infarction
Percutaneous Coronary Intervention
Platelet Aggregation Inhibitors
Sex Characteristics
Treatment Outcome
CHAMPION PHOENIX Investigators
Cardiovascular System & Hematology
1103 Clinical Sciences
1102 Cardiovascular Medicine And Haematology
1117 Public Health And Health Services
Publication Status
Published