BACKGROUND Abbreviated antiplatelet therapy (APT) reduces bleeding without increasing ischemic events in largely unselected high bleeding risk (HBR) patients undergoing percutaneous coronary intervention (PCI). Diabetes mellitus (DM) is associated with higher ischemic risk, and its impact on the safety and effectiveness of abbreviated APT in HBR PCI patients remains unknown. OBJECTIVES This study sought to investigate the comparative effectiveness of abbreviated (1 month) vs standard (≥3 months) APT in HBR patients with and without DM after biodegradable polymer sirolimus-eluting coronary stent implantation. METHODS This was a prespecified analysis from the MASTER DAPT (Management of High Bleeding Risk Patients Post Bioresorbable Polymer Coated Stent Implantation With a Abbreviated Versus Prolonged DAPT Regimen) trial, which randomized 4,579 HBR patients (1,538 [34%] with DM) to abbreviated (n = 2,295) or standard (n = 2,284) APT. The coprimary outcomes were net adverse clinical events (NACEs; composite of all-cause death, myocardial infarction, stroke, and major bleeding), major adverse cardiac or cerebral events (MACCEs; all-cause death, myocardial infarction, and stroke), and major or clinically relevant nonmajor bleeding at 11 months. RESULTS HBR patients with DM had higher risks of MACCEs (HR: 1.28; 95% CI: 1.00-1.63) and similar net adverse or bleeding events compared with nondiabetic subjects. Abbreviated compared with standard APT was associated with similar NACEs and MACCEs (Pinteraction = 0.47 and 0.59, respectively) and reduced major or clinically relevant nonmajor bleeding (Pinteraction = 0.55) irrespective of diabetes status. CONCLUSIONS MACCE and NACE rates were similar, and bleeding rates were lower with abbreviated APT in patients with or without diabetes. Therefore, diabetes status did not modify the treatment effects of abbreviated vs standard APT in HBR patients after biodegradable polymer sirolimus-eluting coronary stent implantation. (Management of High Bleeding Risk Patients Post Bioresorbable Polymer Coated Stent Implantation With a Abbreviated Versus Prolonged DAPT Regimen [MASTER DAPT]; NCT03023020).

中文翻译：

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高出血风险糖尿病患者 PCI 后简化或标准抗血小板治疗。


背景 简化抗血小板治疗 （APT） 在接受经皮冠状动脉介入治疗 （PCI） 的基本上未经选择的高出血风险 （HBR） 患者中减少出血而不增加缺血事件。糖尿病 （DM） 与较高的缺血风险相关，其对 HBR PCI 患者简化 APT 的安全性和有效性的影响仍然未知。目的 本研究旨在探讨简化 （1 个月） 与标准 （≥3 个月） APT 在可生物降解聚合物西罗莫司洗脱冠状动脉支架植入术后伴和无 DM 的 HBR 患者中的比较有效性。方法 这是来自 MASTER DAPT （生物可吸收聚合物涂层支架植入后高出血风险患者的管理，采用简化与延长的 DAPT 方案的管理） 试验，该试验将 4,579 名 HBR 患者 （1,538 名 [34%] 患有 DM） 随机分配到简化 （n = 2,295） 或标准 （n = 2,284） APT 组。共同主要结局是 11 个月时的净不良临床事件 （NACEs;全因死亡、心肌梗死、卒中和大出血的复合）、主要不良心脏或脑事件 （MACCEs;全因死亡、心肌梗死和卒中）以及大出血或临床相关的非大出血。结果 与非糖尿病受试者相比，HBR 合并 DM 患者发生 MACCEs 的风险更高 （HR： 1.28;95% CI： 1.00-1.63） 和相似的净不良或出血事件。与标准 APT 相比，简化与相似的 NACEs 和 MACCE 相关 （Pinteraction = 0.47 和 0.59），并且减少大出血或临床相关的非大出血 （Pinteraction = 0.55），与糖尿病状态无关。 结论 MACCE 和 NACE 发生率相似，在糖尿病患者或非糖尿病患者中，缩短 APT 的出血发生率较低。因此，糖尿病状态并未改变可生物降解聚合物西罗莫司洗脱冠状动脉支架植入术后 HBR 患者简化与标准 APT 的治疗效果。（使用简化与延长 DAPT 方案 [MASTER DAPT] 管理生物可吸收聚合物涂层支架植入后高出血风险患者;NCT03023020）。