De-escalation of antiplatelet therapy to evaluate platelet reactivity and clinical outcomes after coronary stenting in patients at high bleeding risk and recent acute coronary syndrome: Rationale and design of the DESC-HBR trial.

IF 2.3 Q3 CARDIAC & CARDIOVASCULAR SYSTEMS

Cardiovascular Revascularization Medicine Pub Date : 2026-08-04 DOI:10.1016/j.carrev.2026.07.022

Francesco Costa, Giampiero Vizzari, Simone Zecchino, Mattia Galli, Claudio Montalto, Gabriele Carciotto, Giorgio Quadri, Rocco Vergallo, Fausto Castriota, Emmanuele Soraci, Alberto Magliarditi, Stefania Lo Giudice, Giustina Iuvara, Andrea Munafò, Federico Giannino, Francesco Pallante, Marco Franzino, Lucio Teresi, Raffaele Piccolo, Ferdinando Varbella, Giuseppe Musumeci, Gianluca Di Bella, Luis Ortega-Paz, Dominick J Angiolillo, Antonio Micari

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引用次数: 0

Abstract

Background: Patients at high bleeding risk (HBR) presenting with acute coronary syndrome (ACS) and treated with percutaneous coronary intervention (PCI) have competing hazards of ischemic and bleeding events. In unselected ACS populations, trials of unguided de-escalation of P2Y₁₂ inhibition reduce bleeding without excess ischemia; however, HBR patients were largely underrepresented in these studies. Comparative evidence across multiple de-escalation regimens in this vulnerable cohort is currently lacking.

Study design: DESC-HBR is a prospective, multicenter, randomized, open-label trial with blinded endpoint adjudication enrolling 200 HBR patients (PRECISE-DAPT ≥25 or ARC-HBR criteria) at 30 ± 7 days after ACS-PCI. Following one month of dual antiplatelet therapy (DAPT) with prasugrel 10 mg once daily or ticagrelor 90 mg twice daily, on a background of aspirin 100 mg, patients are randomized (1: 1:1:1) to clopidogrel 75 mg once daily, prasugrel 5 mg once daily, ticagrelor 60 mg twice daily, or continuation of full-dose potent therapy. The primary endpoint is the proportion of patients achieving optimal platelet reactivity (VerifyNow PRU 85-208) at 14 ± 2 days post-randomization, 2-h after maintenance dose. Key secondary outcomes include BARC bleeding, net adverse clinical events, quality of life and adherence. Pharmacodynamic profiling incorporates VerifyNow and Total Thrombus Formation Analysis (T-TAS). A total sample of 200 patients allows >80% power to detect superiority of each de-escalation arm versus control (α = 0.017).

Conclusions: DESC-HBR is the first randomized trial directly comparing multiple P2Y₁₂ inhibitor de-escalation strategies in HBR patients post-ACS. By integrating pharmacodynamic, clinical, and patient-reported outcomes, it will provide information to guide individualized antiplatelet strategies balancing ischemic protection and bleeding mitigation in HBR patients.

Clinical trial registration unique identifier: NCT05903976, EudraCT 2023-000029-10.

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降低抗血小板治疗的升级以评估高风险和近期急性冠状动脉综合征患者冠状动脉支架置入后血小板反应性和临床结果：DESC-HBR试验的基本原理和设计

背景：急性冠脉综合征（ACS）的高出血风险（HBR）患者接受经皮冠状动脉介入治疗（PCI）具有缺血性和出血事件的相互竞争的危险。在未选择的ACS人群中，无指导降低P2Y12抑制水平的试验减少了出血，但没有过度缺血；然而，在这些研究中，HBR患者在很大程度上没有被充分代表。目前缺乏针对这一弱势群体的多种缓解方案的比较证据。研究设计：DESC-HBR是一项前瞻性、多中心、随机、开放标签试验，采用盲法终点判定，纳入200例HBR患者（precision - dapt≥25或ARC-HBR标准），时间为ACS-PCI术后30±7天。在服用阿司匹林100mg的基础上，使用普拉格雷10mg每日1次或替格瑞洛90mg每日2次的双重抗血小板治疗（DAPT）一个月后，患者随机（1:1:1）接受氯吡格雷75mg每日1次、普拉格雷5mg每日1次、替格瑞洛60mg每日2次或继续全剂量强效治疗。主要终点是在随机化后14±2天，维持剂量后2小时达到最佳血小板反应性的患者比例（VerifyNow PRU 85-208）。主要次要结局包括BARC出血、净不良临床事件、生活质量和依从性。药效学分析包括VerifyNow和总血栓形成分析（T-TAS）。总共200例患者的样本允许bbb80 %的功率来检测每个降级组相对于对照组的优越性（α = 0.017）。结论：DESC-HBR是首个直接比较acs后HBR患者多种P2Y12抑制剂降压策略的随机试验。通过整合药效学、临床和患者报告的结果，该研究将为指导HBR患者平衡缺血保护和出血缓解的个体化抗血小板策略提供信息。临床试验注册唯一标识符：NCT05903976， EudraCT 2023-000029-10。

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来源期刊

Cardiovascular Revascularization Medicine CARDIAC & CARDIOVASCULAR SYSTEMS-

CiteScore

3.30

自引率

5.90%

发文量

687

审稿时长

36 days

期刊介绍： Cardiovascular Revascularization Medicine (CRM) is an international and multidisciplinary journal that publishes original laboratory and clinical investigations related to revascularization therapies in cardiovascular medicine. Cardiovascular Revascularization Medicine publishes articles related to preclinical work and molecular interventions, including angiogenesis, cell therapy, pharmacological interventions, restenosis management, and prevention, including experiments conducted in human subjects, in laboratory animals, and in vitro. Specific areas of interest include percutaneous angioplasty in coronary and peripheral arteries, intervention in structural heart disease, cardiovascular surgery, etc.