Disparities by sex in P2Y(12) inhibitor therapy duration, or differences in the balance of ischaemic-benefit and bleeding-risk clinical outcomes in older women versus comparable men following acute myocardial infarction? A P2Y(12) inhibitor new user retrospective cohort analysis of US Medicare claims data

OBJECTIVES: To determine if comparable older women and men received different durations of P2Y(12) inhibitor therapy following acute myocardial infarction (AMI) and if therapy duration differences were justified by differences in ischaemic benefits and/or bleeding risks. DESIGN: Retrospective cohort. SETTING: 20% sample of 2007–2015 US Medicare fee-for-service administrative claims data. PARTICIPANTS: ≥66-year-old P2Y(12) inhibitor new users following 2008–2013 AMI hospitalisation (N=30 613). Older women compared to older men with similar predicted risks of study outcomes. PRIMARY AND SECONDARY OUTCOME MEASURES: Primary outcome: P2Y(12) inhibitor duration (modelled as risk of therapy discontinuation). Secondary outcomes: clinical events while on P2Y(12) inhibitor therapy, including (1) death/hospice admission, (2) composite of ischaemic events (AMI/stroke/revascularisation) and (3) hospitalised bleeds. Cause-specific risks and relative risks (RRs) estimated using Aalen-Johansen cumulative incidence curves and bootstrapped 95% CIs. RESULTS: 10 486 women matched to 10 486 men with comparable predicted risks of all 4 study outcomes. No difference in treatment discontinuation was observed at 12 months (women 31.2% risk; men 30.9% risk; RR 1.01; 95% CI 0.97 to 1.05), but women were more likely than men to discontinue therapy at 24 months (54.4% and 52.9% risk, respectively; RR 1.03; 95% CI 1.00 to 1.05). Among patients who did not discontinue P2Y(12) inhibitor therapy, women had lower 24-month risks of ischaemic outcomes than men (13.1% and 14.7%, respectively; RR 0.90; 95% CI 0.84 to 0.96), potentially lower 24-month risks of death/hospice admission (5.0% and 5.5%, respectively; RR 0.91; 95% CI 0.82 to 1.02), but women and men both had 2.5% 24-month bleeding risks (RR 0.98; 95% CI 0.82 to 1.14). CONCLUSIONS: Risks for death/hospice and ischaemic events were lower among women still taking a P2Y(12) inhibitor than comparable men, with no difference in bleeding risks. Shorter P2Y(12) inhibitor durations in older women than comparable men observed between 12 and 24 months post-AMI may reflect a disparity that is not justified by differences in clinical need.