One-month DAPT after biodegradable-polymer everolimus-eluting stent implantation in women at high-bleeding risk: Insights from the POEM trial

IF 2.1 3区医学 Q3 CARDIAC & CARDIOVASCULAR SYSTEMS

Catheterization and Cardiovascular Interventions Pub Date : 2024-10-03 DOI:10.1002/ccd.31255

Matteo Maurina MD, Carlo Andrea Pivato MD, Vijay Kunadian MD, Luca Testa MD, PhD, Carlo Briguori MD, PhD, Andrea Pacchioni MD, Alessia Chiara Latini MD, Nicola Cesani MD, Raffale Piccolo MD, PhD, Carmine Musto MD, PhD, Gennaro Sardella MD, Ciro Indolfi MD, Damiano Regazzoli MD, Valeria Paradies MD, Giulio Stefanini MD, PhD, MSc

{"title":"One-month DAPT after biodegradable-polymer everolimus-eluting stent implantation in women at high-bleeding risk: Insights from the POEM trial","authors":"Matteo Maurina MD, Carlo Andrea Pivato MD, Vijay Kunadian MD, Luca Testa MD, PhD, Carlo Briguori MD, PhD, Andrea Pacchioni MD, Alessia Chiara Latini MD, Nicola Cesani MD, Raffale Piccolo MD, PhD, Carmine Musto MD, PhD, Gennaro Sardella MD, Ciro Indolfi MD, Damiano Regazzoli MD, Valeria Paradies MD, Giulio Stefanini MD, PhD, MSc","doi":"10.1002/ccd.31255","DOIUrl":null,"url":null,"abstract":"<div>\n \n \n <section>\n \n <h3> Aims</h3>\n \n <p>We conducted a prespecified subanalysis of the POEM trial to assess the association between sex and clinical outcomes following a short 1-month dual-antiplatelet-therapy (DAPT) period after percutaneous coronary intervention (PCI) with bioresorbable polymer everolimus-eluting stent (BP-EES) among patients at high bleeding risk (HBR).</p>\n </section>\n \n <section>\n \n <h3> Background</h3>\n \n <p>Shortening the DAPT period after PCI is an effective bleeding avoidance strategy with contemporary drug-eluting stents. Whether sex affects the risk of adverse events following PCI is still debated.</p>\n </section>\n \n <section>\n \n <h3> Methods</h3>\n \n <p>Patients at HBR undergoing PCI with BP-EES were enrolled and treated with 1-month DAPT. If anticoagulation was needed, study participants received an oral anticoagulant (OAC) in addition to a P2Y<sub>12</sub> inhibitor for 1 month, followed by OAC only thereafter. The primary endpoint was a composite of cardiac death, myocardial infarction, or definite/probable stent thrombosis at 12 months. We report sex-based outcomes of patients included in the POEM study.</p>\n </section>\n \n <section>\n \n <h3> Results</h3>\n \n <p>We enrolled 129 (29.1%) women and 314 (70.9%) men. Women were older, with lower hemoglobin levels, and worse renal function. Accordingly, they had a trend for a greater number of HBR criteria fulfilled and a higher PARIS bleeding score. However, they were not at a significantly higher risk for the primary endpoint (men vs. women: 5.17% vs. 3.94%; HR 1.30; 95% CI: 0.48-3.54, <i>p</i> = 0.61), or any of the hemorrhagic and ischemic secondary endpoints.</p>\n </section>\n \n <section>\n \n <h3> Conclusions</h3>\n \n <p>This prespecified subanalysis of the POEM trial suggests that 1-month DAPT following PCI with BP-EES may be a safe and effective therapeutic strategy for women at HBR.</p>\n </section>\n </div>","PeriodicalId":9650,"journal":{"name":"Catheterization and Cardiovascular Interventions","volume":"104 6","pages":"1129-1138"},"PeriodicalIF":2.1000,"publicationDate":"2024-10-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1002/ccd.31255","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Catheterization and Cardiovascular Interventions","FirstCategoryId":"3","ListUrlMain":"https://onlinelibrary.wiley.com/doi/10.1002/ccd.31255","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q3","JCRName":"CARDIAC & CARDIOVASCULAR SYSTEMS","Score":null,"Total":0}

引用次数: 0

Abstract

Aims

We conducted a prespecified subanalysis of the POEM trial to assess the association between sex and clinical outcomes following a short 1-month dual-antiplatelet-therapy (DAPT) period after percutaneous coronary intervention (PCI) with bioresorbable polymer everolimus-eluting stent (BP-EES) among patients at high bleeding risk (HBR).

Background

Shortening the DAPT period after PCI is an effective bleeding avoidance strategy with contemporary drug-eluting stents. Whether sex affects the risk of adverse events following PCI is still debated.

Methods

Patients at HBR undergoing PCI with BP-EES were enrolled and treated with 1-month DAPT. If anticoagulation was needed, study participants received an oral anticoagulant (OAC) in addition to a P2Y₁₂ inhibitor for 1 month, followed by OAC only thereafter. The primary endpoint was a composite of cardiac death, myocardial infarction, or definite/probable stent thrombosis at 12 months. We report sex-based outcomes of patients included in the POEM study.

Results

We enrolled 129 (29.1%) women and 314 (70.9%) men. Women were older, with lower hemoglobin levels, and worse renal function. Accordingly, they had a trend for a greater number of HBR criteria fulfilled and a higher PARIS bleeding score. However, they were not at a significantly higher risk for the primary endpoint (men vs. women: 5.17% vs. 3.94%; HR 1.30; 95% CI: 0.48-3.54, p = 0.61), or any of the hemorrhagic and ischemic secondary endpoints.

Conclusions

This prespecified subanalysis of the POEM trial suggests that 1-month DAPT following PCI with BP-EES may be a safe and effective therapeutic strategy for women at HBR.

Abstract Image

查看原文本刊更多论文

高出血风险女性植入生物可降解聚合物依维莫司洗脱支架后一个月的 DAPT：POEM 试验的启示。

目的：我们对 POEM 试验进行了一项预先指定的子分析，以评估高出血风险（HBR）患者在使用生物可吸收聚合物依维莫司洗脱支架（BP-EES）进行经皮冠状动脉介入治疗（PCI）后，在短短 1 个月的双重抗血小板治疗（DAPT）后，性别与临床结果之间的关系：背景：PCI术后缩短DAPT时间是当代药物洗脱支架的一种有效避免出血的策略。性别是否会影响 PCI 术后不良事件的风险仍存在争议：方法：在 HBR 接受 BP-EES PCI 的患者入组并接受为期 1 个月的 DAPT 治疗。如果需要抗凝，研究参与者在服用 P2Y12 抑制剂的同时服用口服抗凝剂 (OAC) 1 个月，之后只服用 OAC。主要终点是 12 个月时心脏死亡、心肌梗死或明确/可能的支架血栓形成的综合结果。我们报告了 POEM 研究中患者的性别结果：我们共纳入了 129 名女性（29.1%）和 314 名男性（70.9%）。女性年龄较大，血红蛋白水平较低，肾功能较差。因此，她们有更多符合 HBR 标准和 PARIS 出血评分更高的趋势。然而，他们在主要终点（男性 vs. 女性：5.17% vs. 3.94%；HR 1.30；95% CI：0.48-3.54，p = 0.61）或任何出血和缺血次要终点上的风险并不明显更高：POEM试验的这项预设子分析表明，PCI术后1个月DAPT配合BP-EES可能是HBR女性患者安全有效的治疗策略。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

求助全文

约1分钟内获得全文求助全文

来源期刊

Catheterization and Cardiovascular Interventions 医学-心血管系统

CiteScore

5.40

自引率

8.70%

发文量

419

审稿时长

2 months

期刊介绍： Catheterization and Cardiovascular Interventions is an international journal covering the broad field of cardiovascular diseases. Subject material includes basic and clinical information that is derived from or related to invasive and interventional coronary or peripheral vascular techniques. The journal focuses on material that will be of immediate practical value to physicians providing patient care in the clinical laboratory setting. To accomplish this, the journal publishes Preliminary Reports and Work In Progress articles that complement the traditional Original Studies, Case Reports, and Comprehensive Reviews. Perspective and insight concerning controversial subjects and evolving technologies are provided regularly through Editorial Commentaries furnished by members of the Editorial Board and other experts. Articles are subject to double-blind peer review and complete editorial evaluation prior to any decision regarding acceptability.