Efficacy and safety of P2Y12 inhibitors comparable between men and women
Potent P2Y12 Inhibitors in Men Versus Women: A Collaborative Meta-Analysis of Randomized TrialsLiterature - Lau ES, Braunwald E, Murphy SA, et al. - J Am Coll Cardiol. 2017;69(12):1549-1559
- Of 87,840 patients, 27.9% were women. Women were significantly more likely to be older and to have comorbidities including diabetes mellitus, hypertension, prior stroke or TIA, prior heart failure and lower eGFR.
- Risk of primary endpoint MACE in women corresponded to an HR of 0.86, 95% CI 0.78-0.94, P=0.002 and in men to an HR of 0.85; 95% CI 0.80-0.90, P<0.001, without heterogeneity (P interaction = 0.93).
- Similar results were observed for the composite of cardiovascular (CV) death, myocardial infarction (MI) or stroke (HR in women 0.89, 95% CI 0.81-0.97, P=0.01, HR in men 0.85, 95% CI 0.80-0.90, P<0.001, P interaction = 0.60).
- In women, risk of MI (HR 0.87, 95% CI 0.78-0.96, P=0.01), CV death (HR 0.87, 95% CI 0.76-1.01, P=0.06) and risk of stroke were reduced (HR 0.92, 95% CI 0.55-1.56, P=0.76).
- In men, risk of CV death (HR 0.85, 95% CI 0.77-0.95, P=0.002, P interaction = 0.86) and of MI were reduced (HR 0.84, 95% CI 0.76-0.91, P<0.001, P interaction = 0.65), and effect was neutral effect on risk of stroke (HR 0.99, 95% CI 0.82-1.18, P=0.87, P interaction = 0.72).
- Risk of stent thrombosis in women (HR 0.49, 95% CI 0.37-0.65, P<0.001) and in men (HR 0.59, 95% CI 0.42-0.84, P=0.003, P interaction = 0.85) was reduced.
- In both men and women, risk of TIMI (non–CABG-related) major bleeding increased (HR in women 1.28, 95% CI 0.87-1.88, P=0.21, HR in men 1.52, 95% CI 1.12-2.07, P<0.01, P interaction = 0.62).
- Risk of intracranial hemorrhage in men was increased (HR 1.47, 95% CI 1.02-2.11, P=0.04), but not in women (HR 0.96, 95% CI 0.46-1.98, P=0.91). However number of events were few and test for heterogeneity by gender was not significant (P interaction = 0.24).
- All-cause mortality was reduced in women (HR 0.89, 95% CI 0.78-1.01, P=0.07) and in men (HR 0.89, 95% CI 0.81-0.99, P=0.02, P interaction = 0.99).
The efficacy and safety of P2Y12 inhibitors is comparable between women and men. These findings support the use of these therapies in both genders with appropriate indications for use.