The Efficacy and Safety of Cangrelor in Women Versus Men During PCI: Insights From the CHAMPION PHOENIX Trial
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 CHAMPION PHOENIX trial randomized 11,145 patients undergoing elective or urgent PCI to cangrelor or clopidogrel. The primary efficacy endpoint was the composite of death, MI, ischemia-driven revascularization, or stent thrombosis (ST) at 48 hours; the key secondary endpoint was ST at 48 hours. The primary safety endpoint was GUSTO severe bleeding at 48 hours. Of subjects analyzed, 3051 (28%) were female. Cangrelor reduced the odds of the primary endpoint by 35% in women (adjusted OR 0.65, 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 ST 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% vs 0.2%, P=0.30 (women); 0.1% vs 0.1%, P=0.41 (men); P interaction=0.88] versus clopidogrel. Cangrelor increased the odds of moderate bleeding in women (0.9% vs 0.3%, P=0.02), but not in men (0.2% vs 0.2%, P=0.68; P interaction=0.040). The net clinical benefit (primary efficacy and safety endpoint) favored cangrelor in both women (OR 0.68, 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 ST in women and men and appeared to offer greater net clinical benefit than clopidogrel.
Clinical Trial Registration Information—clinicaltrials.gov. Identifier: NCT01156571.
- ADP receptor blocker
- P2Y12 inhibitor
- antiplatelet drug
- percutaneous coronary intervention
- Received April 30, 2015.
- Revision received November 20, 2015.
- Accepted November 24, 2015.
Circulation is published on behalf of the American Heart Association, Inc., by Wolters Kluwer. This is an open access article under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/3.0/), which permits use, distribution, and reproduction in any medium, provided that the original work is properly cited.