Department of Biomedical Sciences, Humanitas University, Via Rita Levi Montalcini 4, Pieve Emanuele, Milan, Italy.
Cardio Center, IRCCS Humanitas Research Hospital, via Manzoni 56, Rozzano, Milan, Italy.
Catheter Cardiovasc Interv. 2024 Nov;104(6):1129-1138. doi: 10.1002/ccd.31255. Epub 2024 Oct 3.
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).
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.
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 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.
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.
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.
我们对 POEM 试验进行了预设的亚组分析，以评估在高出血风险（HBR）患者中，经皮冠状动脉介入治疗（PCI）后使用生物可吸收聚合物依维莫司洗脱支架（BP-EES）并接受为期 1 个月的双联抗血小板治疗（DAPT）后，性别与临床结局之间的关联。
在使用现代药物洗脱支架的情况下，缩短 PCI 后的 DAPT 时间是一种有效的避免出血策略。性别是否会影响 PCI 后的不良事件风险仍存在争议。
我们招募了接受 BP-EES 行 PCI 并具有 HBR 的患者，并对其进行 1 个月的 DAPT 治疗。如果需要抗凝治疗，研究参与者在 1 个月内接受口服抗凝剂（OAC）加 P2Y 抑制剂治疗，之后仅接受 OAC 治疗。主要终点是 12 个月时的心脏死亡、心肌梗死或确定/可能的支架血栓形成的复合终点。我们报告了 POEM 研究中包含的患者的性别相关结局。
我们纳入了 129 名（29.1%）女性和 314 名（70.9%）男性。女性年龄更大，血红蛋白水平更低，肾功能更差。相应地，她们符合更多的 HBR 标准，且 PARIS 出血评分更高。然而，她们并没有明显更高的主要终点风险（男性与女性：5.17%与 3.94%；HR 1.30；95%CI：0.48-3.54，p=0.61），或任何出血和缺血性次要终点。
POEM 试验的这项预设亚组分析表明，在 HBR 患者中，使用 BP-EES 行 PCI 后进行为期 1 个月的 DAPT 可能是一种安全有效的治疗策略。
