高出血风险患者经皮冠状动脉介入治疗后双联抗血小板治疗与或不联合口服抗凝治疗:一项开放标签、随机、对照试验。

Abbreviated Antiplatelet Therapy in Patients at High Bleeding Risk With or Without Oral Anticoagulant Therapy After Coronary Stenting: An Open-Label, Randomized, Controlled Trial.

机构信息

Department of Cardiology, Maasstad Hospital, Rotterdam, The Netherlands (P.C.S.).

Clinical Trial Unit, University of Bern, Switzerland (E.F., D.H.).

出版信息

Circulation. 2021 Oct 12;144(15):1196-1211. doi: 10.1161/CIRCULATIONAHA.121.056680. Epub 2021 Aug 29.

DOI:10.1161/CIRCULATIONAHA.121.056680

PMID:34455849

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC8500374/

Abstract

BACKGROUND

The optimal duration of antiplatelet therapy (APT) in patients at high bleeding risk with or without oral anticoagulation (OAC) after coronary stenting remains unclear.

METHODS

In the investigator-initiated, randomize, open-label MASTER DAPT trial (Management of High Bleeding Risk Patients Post Bioresorbable Polymer Coated Stent Implantation With an Abbreviated Versus Standard DAPT Regimen), 4579 patients at high bleeding risk were randomized after 1-month dual APT to abbreviated or nonabbreviated APT strategies. Randomization was stratified by concomitant OAC indication. In this subgroup analysis, we report outcomes of populations with or without an OAC indication. In the population with an OAC indication, patients changed immediately to single APT for 5 months (abbreviated regimen) or continued ≥2 months of dual APT and single APT thereafter (nonabbreviated regimen). Patients without an OAC indication changed to single APT for 11 months (abbreviated regimen) or continued ≥5 months of dual APT and single APT thereafter (nonabbreviated regimen). Coprimary outcomes at 335 days after randomization were net adverse clinical outcomes (composite of all-cause death, myocardial infarction, stroke, and Bleeding Academic Research Consortium 3 or 5 bleeding events); major adverse cardiac and cerebral events (all-cause death, myocardial infarction, and stroke); and type 2, 3, or 5 Bleeding Academic Research Consortium bleeding.

RESULTS

Net adverse clinical outcomes or major adverse cardiac and cerebral events did not differ with abbreviated versus nonabbreviated APT regimens in patients with OAC indication (n=1666; hazard ratio [HR], 0.83 [95% CI, 0.60-1.15]; and HR, 0.88 [95% CI, 0.60-1.30], respectively) or without OAC indication (n=2913; HR, 1.01 [95% CI, 0.77-1.33]; or HR, 1.06 [95% CI, 0.79-1.44]; =0.35 and 0.45, respectively). Bleeding Academic Research Consortium 2, 3, or 5 bleeding did not significantly differ in patients with OAC indication (HR, 0.83 [95% CI, 0.62-1.12]) but was lower with abbreviated APT in patients without OAC indication (HR, 0.55 [95% CI, 0.41-0.74]; =0.057). The difference in bleeding in patients without OAC indication was driven mainly by a reduction in Bleeding Academic Research Consortium 2 bleedings (HR, 0.48 [95% CI, 0.33-0.69]; =0.021).

CONCLUSIONS

Rates of net adverse clinical outcomes and major adverse cardiac and cerebral events did not differ with abbreviated APT in patients with high bleeding risk with or without an OAC indication and resulted in lower bleeding rates in patients without an OAC indication. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT03023020.

摘要

背景

在有或无口服抗凝剂（OAC）的高出血风险患者中，经皮冠状动脉介入治疗（PCI）后抗血小板治疗（APT）的最佳持续时间仍不清楚。

方法

在这项由研究者发起的、随机的、开放性标签的 MASTER DAPT 试验（经生物可吸收聚合物涂层支架植入后，采用简化与标准 DAPT 方案治疗高出血风险患者的管理）中，4579 例高出血风险患者在 1 个月的双重 APT 后随机分为简化或非简化 APT 策略。随机分组按同时伴有 OAC 适应证进行分层。在本次亚组分析中，我们报告了伴有或不伴有 OAC 适应证的患者的结局。在伴有 OAC 适应证的患者中，患者在 5 个月内立即转为单一 APT（简化方案），或继续进行至少 2 个月的双重 APT 和随后的单一 APT（非简化方案）。不伴有 OAC 适应证的患者改为单一 APT 11 个月（简化方案），或继续进行至少 5 个月的双重 APT 和随后的单一 APT（非简化方案）。随机分组后 335 天的主要复合终点为净不良临床结局（全因死亡、心肌梗死、卒中和 Bleeding Academic Research Consortium 3 或 5 级出血事件的复合终点）；主要心脏不良事件（全因死亡、心肌梗死和卒中等）；以及 Bleeding Academic Research Consortium 2、3 或 5 级出血。

结果

伴有 OAC 适应证的患者（n=1666）中，简化与非简化 APT 方案的净不良临床结局或主要心脏不良事件发生率无差异（风险比[HR]，0.83[95%置信区间[CI]，0.60-1.15]；和 HR，0.88[95%CI，0.60-1.30]），不伴有 OAC 适应证的患者（n=2913）中也无差异（HR，1.01[95%CI，0.77-1.33]；或 HR，1.06[95%CI，0.79-1.44]；=0.35 和 0.45）。伴有 OAC 适应证的患者中 Bleeding Academic Research Consortium 2、3 或 5 级出血无显著差异（HR，0.83[95%CI，0.62-1.12]），但不伴有 OAC 适应证的患者中简化 APT 出血发生率较低（HR，0.55[95%CI，0.41-0.74]；=0.057）。不伴有 OAC 适应证的患者中出血差异主要归因于 Bleeding Academic Research Consortium 2 级出血减少（HR，0.48[95%CI，0.33-0.69]；=0.021）。