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Cangrelor benefits women undergoing PCI as equally as men
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Both women and men undergoing PCI had greater net clinical benefit with cangrelor than with clopidogrel, according to new data from the CHAMPION PHOENIX study.
Researchers performed an analysis by sex of 11,145 patients (28% women; median age for women, 68 years; median age for men, 62.5 years) from the CHAMPION PHOENIX trial who were randomly assigned cangrelor (Kengreal, The Medicines Company) or clopidogrel while undergoing urgent or elective PCI.
“In the past, questions have been raised about the safety and efficacy of blood thinners in women,” Michelle L. O’Donoghue, MD, MPH, FAHA, from the cardiovascular division at Brigham and Women’s Hospital, said in a press release. “The study provides important reassurance overall that this potent and novel [IV] blood thinner appears to offer as much benefit for women as it does for men.”
The primary efficacy endpoint was death, MI, ischemia-driven revascularization or stent thrombosis at 48 hours. The key secondary endpoint was stent thrombosis at 48 hours. The primary safety endpoint was GUSTO severe bleeding at 48 hours.
Cangrelor favored in both sexes
O’Donoghue and colleagues found that the odds of the primary endpoint occurring were reduced by assignment to cangrelor in women (OR = 0.65; 95% CI, 0.48-0.89) and in men (OR = 0.86; 95% CI, 0.7-1.05; P for interaction = .23).
The odds of stent thrombosis at 48 hours occurring were reduced by assignment to cangrelor in both sexes, although the effect was greater in women (women: OR = 0.39; 95% CI, 0.2-0.77; men: OR = 0.84; 95% CI, 0.53-1.33; P for interaction = .11), the researchers wrote.
Odds of GUSTO severe bleeding were similar for cangrelor and clopidogrel in both sexes (women: cangrelor, 0.3%; clopidogrel, 0.2%; P = .3; men: cangrelor, 0.1%; clopidogrel, 0.1%; P = .41; P for interaction = .88), the researchers wrote.
They determined, however, that the odds of moderate bleeding were higher in women assigned cangrelor (0.9% vs. 0.3%; P = .02) but not in men assigned cangrelor (0.2% vs. 0.2%; P = .68; P for interaction = .04).
“One cannot exclude that higher age, a lower [BMI] and other comorbidities in women may have explained the bleeding signal,” the researchers wrote.
Net clinical benefit
The net clinical benefit, a composite of the primary efficacy and safety endpoints, was more favorable to cangrelor in women (OR = 0.68; 95% CI, 0.5-0.92) and men (OR = 0.87; 95% CI, 0.71-1.06; P for interaction = .26), the researchers found.
“Although it remains unclear whether true biological differences exist at the level of the platelet, several previous studies have demonstrated that women have higher baseline platelet reactivity as compared with men,” O’Donoghue and colleagues wrote. “Therefore, a strategy of platelet inhibition for the prevention of [CV] events could offer particular appeal in women.” – by Erik Swain
Disclosure: The CHAMPION PHOENIX trial was funded by The Medicines Company. O’Donoghue reports receiving research grants from AstraZeneca, Eisai, GlaxoSmithKline and Merck. Please see the full study for a list of the other researchers’ relevant financial disclosures.
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