Disparities by sex in P2Y12 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 P2Y12 inhibitor new user retrospective cohort analysis of US Medicare claims data
Objectives To determine if comparable older women and men received different durations of P2Y12 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.Sett...
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| Format: | Article |
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BMJ Publishing Group
2021-12-01
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| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/11/12/e050236.full |
| _version_ | 1826945517577306112 |
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| author | Gang Fang Ryan P Hickson Anna M Kucharska-Newton Jo E Rodgers Betsy L Sleath |
| author_facet | Gang Fang Ryan P Hickson Anna M Kucharska-Newton Jo E Rodgers Betsy L Sleath |
| author_sort | Gang Fang |
| collection | DOAJ |
| description | Objectives To determine if comparable older women and men received different durations of P2Y12 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 P2Y12 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: P2Y12 inhibitor duration (modelled as risk of therapy discontinuation). Secondary outcomes: clinical events while on P2Y12 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 P2Y12 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 P2Y12 inhibitor than comparable men, with no difference in bleeding risks. Shorter P2Y12 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. |
| first_indexed | 2024-04-11T20:41:40Z |
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| institution | Directory Open Access Journal |
| issn | 2044-6055 |
| language | English |
| last_indexed | 2025-02-17T20:56:35Z |
| publishDate | 2021-12-01 |
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| spelling | doaj.art-684574ca6d0a414aa1c0521eaf4dbafc2024-12-08T16:50:13ZengBMJ Publishing GroupBMJ Open2044-60552021-12-01111210.1136/bmjopen-2021-050236Disparities by sex in P2Y12 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 P2Y12 inhibitor new user retrospective cohort analysis of US Medicare claims dataGang Fang0Ryan P Hickson1Anna M Kucharska-Newton2Jo E Rodgers3Betsy L Sleath41 Division of Pharmaceutical Outcomes and Policy, UNC Eshelman School of Pharmacy, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA1 Division of Pharmaceutical Outcomes and Policy, UNC Eshelman School of Pharmacy, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA2 Department of Epidemiology, UNC Gillings School of Global Public Health, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA6 Division of Pharmacotherapy and Experimental Therapeutics, UNC Eshelman School of Pharmacy, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA1 Division of Pharmaceutical Outcomes and Policy, UNC Eshelman School of Pharmacy, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USAObjectives To determine if comparable older women and men received different durations of P2Y12 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 P2Y12 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: P2Y12 inhibitor duration (modelled as risk of therapy discontinuation). Secondary outcomes: clinical events while on P2Y12 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 P2Y12 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 P2Y12 inhibitor than comparable men, with no difference in bleeding risks. Shorter P2Y12 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.https://bmjopen.bmj.com/content/11/12/e050236.full |
| spellingShingle | Gang Fang Ryan P Hickson Anna M Kucharska-Newton Jo E Rodgers Betsy L Sleath Disparities by sex in P2Y12 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 P2Y12 inhibitor new user retrospective cohort analysis of US Medicare claims data BMJ Open |
| title | Disparities by sex in P2Y12 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 P2Y12 inhibitor new user retrospective cohort analysis of US Medicare claims data |
| title_full | Disparities by sex in P2Y12 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 P2Y12 inhibitor new user retrospective cohort analysis of US Medicare claims data |
| title_fullStr | Disparities by sex in P2Y12 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 P2Y12 inhibitor new user retrospective cohort analysis of US Medicare claims data |
| title_full_unstemmed | Disparities by sex in P2Y12 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 P2Y12 inhibitor new user retrospective cohort analysis of US Medicare claims data |
| title_short | Disparities by sex in P2Y12 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 P2Y12 inhibitor new user retrospective cohort analysis of US Medicare claims data |
| title_sort | disparities by sex in p2y12 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 p2y12 inhibitor new user retrospective cohort analysis of us medicare claims data |
| url | https://bmjopen.bmj.com/content/11/12/e050236.full |
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