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在急性心肌梗死后,老年女性与可比男性相比,P2Y 抑制剂治疗持续时间是否存在性别差异,或者缺血获益和出血风险临床结局的平衡是否存在差异?利用美国医疗保险索赔数据的 P2Y 抑制剂新使用者回顾性队列分析。

Disparities by sex in P2Y 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 inhibitor new user retrospective cohort analysis of US Medicare claims data.

机构信息

Division of Pharmaceutical Outcomes and Policy, UNC Eshelman School of Pharmacy, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA

Department of Epidemiology, UNC Gillings School of Global Public Health, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA.

出版信息

BMJ Open. 2021 Dec 1;11(12):e050236. doi: 10.1136/bmjopen-2021-050236.

DOI:10.1136/bmjopen-2021-050236
PMID:34853104
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC8638457/
Abstract

OBJECTIVES

To determine if comparable older women and men received different durations of P2Y 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 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 inhibitor duration (modelled as risk of therapy discontinuation).

SECONDARY OUTCOMES

clinical events while on P2Y 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 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 inhibitor than comparable men, with no difference in bleeding risks. Shorter P2Y 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.

摘要

目的

确定急性心肌梗死(AMI)后接受 P2Y 抑制剂治疗的老年女性和男性患者的治疗持续时间是否存在差异,以及这种差异是否与缺血获益和/或出血风险的差异有关。

设计

回顾性队列研究。

地点

2007-2015 年美国医疗保险按服务项目付费行政索赔数据的 20%样本。

参与者

≥66 岁的 P2Y 抑制剂新使用者,在 2008-2013 年 AMI 住院后(N=30613)。老年女性与具有相似研究结果预测风险的老年男性相比。

主要和次要结局指标

主要结局:P2Y 抑制剂治疗持续时间(模型为停药风险)。

次要结局

P2Y 抑制剂治疗期间的临床事件,包括(1)死亡/临终关怀入院,(2)缺血事件(AMI/中风/血运重建)的复合终点,(3)住院出血。使用 Aalen-Johansen 累积发生率曲线和 bootstrap 95%置信区间估计特定原因风险和相对风险(RR)。

结果

10486 名女性与 10486 名男性匹配,他们具有所有 4 项研究结果的相似预测风险。在 12 个月时未观察到治疗停药的差异(女性 31.2%的风险;男性 30.9%的风险;RR 1.01;95%CI 0.97 至 1.05),但在 24 个月时女性比男性更有可能停止治疗(分别为 54.4%和 52.9%的风险;RR 1.03;95%CI 1.00 至 1.05)。在未停止 P2Y 抑制剂治疗的患者中,女性 24 个月的缺血结局风险低于男性(分别为 13.1%和 14.7%;RR 0.90;95%CI 0.84 至 0.96),24 个月的死亡/临终关怀入院风险可能较低(分别为 5.0%和 5.5%;RR 0.91;95%CI 0.82 至 1.02),但女性和男性的 24 个月出血风险均为 2.5%(RR 0.98;95%CI 0.82 至 1.14)。

结论

与可比男性相比,仍在接受 P2Y 抑制剂治疗的女性患者的死亡/临终关怀和缺血事件风险较低,出血风险无差异。AMI 后 12 至 24 个月期间,老年女性比可比男性接受的 P2Y 抑制剂治疗时间更短,这可能反映了一种不公平的差异,而这种差异并不是基于临床需求的差异。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/b5a4/8638457/fb83eee9ec7a/bmjopen-2021-050236f04.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/b5a4/8638457/01169707f1f3/bmjopen-2021-050236f01.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/b5a4/8638457/9338669c9963/bmjopen-2021-050236f02.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/b5a4/8638457/e6eae5b1cf89/bmjopen-2021-050236f03.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/b5a4/8638457/fb83eee9ec7a/bmjopen-2021-050236f04.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/b5a4/8638457/01169707f1f3/bmjopen-2021-050236f01.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/b5a4/8638457/9338669c9963/bmjopen-2021-050236f02.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/b5a4/8638457/e6eae5b1cf89/bmjopen-2021-050236f03.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/b5a4/8638457/fb83eee9ec7a/bmjopen-2021-050236f04.jpg

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