基于GRACE风险评分的急性冠状动脉综合征高缺血性和出血风险患者单药氯吡格雷与延长DAPT的比较：OPT-BIRISK随机临床试验的亚组分析

IF 4.7 3区医学 Q1 PHARMACOLOGY & PHARMACY

European journal of pharmacology Pub Date : 2025-09-13 DOI:10.1016/j.ejphar.2025.178151

Shiyu Zhang , Jing Li , Miaohan Qiu , Yi Li , Xiaozeng Wang , Zhifang Wang , Shuhong Su , Yaojun Zhang , Aijun Liu , Yaling Han

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引用次数: 0

摘要

目的：本研究评估氯吡格雷单药治疗与延长双重抗血小板治疗（DAPT）对经皮冠状动脉介入治疗（PCI）后完成9-12个月DAPT治疗并满足高出血和高缺血风险（birisk）的急性冠状动脉综合征（ACS）患者预后的影响，并根据急性冠状动脉事件全球登记（GRACE）风险评分进行分层。方法：在OPT-BIRISK研究中，7758名在PCI术后完成9 -12个月DAPT治疗的ACS患者被随机分为氯吡格雷单药治疗组和延长DAPT治疗组。这项预先指定的亚组分析根据GRACE评分将患者分为中高危组（>88）和低危组（≤88）。研究的主要终点是BARC 2、3或5出血。关键的次要终点是主要不良心脑事件（MACCE，全因死亡、心肌梗死、卒中或临床驱动的血运重建的综合）的发生率。结果：在低风险患者中，氯吡格雷单药组49例（2.7%）发生BARC 2、3或5出血，延长DAPT组69例（3.6%）发生BARC 2、3或5出血（HR 0.73, 95% CI 0.50-1.05; p=0.088）。在中高危患者中，氯吡格雷单药治疗与延长DAPT相比显示BARC 2、3或5出血（2.3% vs. 3.0%; HR 0.77, 95% CI 0.52-1.14; p=0.8377），但显著降低MACCE （2.9% vs. 4.1%; HR 0.69, 95% CI 0.49-0.97; p=0.0332）。在整个试验人群中，GRACE评分和治疗组在主要终点或关键次要终点之间没有显著的相互作用（所有终点的P < 0.05）。结论：在高危ACS患者中，无论GRACE评分如何，氯吡格雷单药治疗与延长DAPT相比，所有出血事件（BARC 1-5）的发生率均较低，但BARC 2、3或5出血的发生率无显著差异。此外，在中高危人群中，与延长DAPT相比，它与较低的MACCE发生率相关。

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Comparison of clopidogrel monotherapy versus prolonged DAPT based on the GRACE risk score in patients with acute coronary syndromes at high ischemic and bleeding risk: a subgroup analysis of the OPT-BIRISK randomized clinical trial

Objective

This study assessed the effect of clopidogrel monotherapy versus extended Dual antiplatelet therapy (DAPT) on outcomes in patients with acute coronary syndromes (ACS) who have completed 9–12 months of DAPT after Percutaneous Coronary Intervention (PCI) and meet both high bleeding and high ischemia risk (birisk), stratified by Global Registry of Acute Coronary Events (GRACE) risk score.

Methods

In the OPT-BIRISK study, 7758 ACS Patients who completed 9–12 months of DAPT after PCI were randomized either to clopidogrel monotherapy or extended DAPT. This prespecified subgroup analysis categorized patients by GRACE score into intermediate-high-risk (>88) and low-risk (≤88) groups. The primary endpoint of the study was BARC 2, 3, or 5 bleeding. The key secondary endpoint was the rate of major adverse cardio-cerebral events (MACCE; the composite of all-cause death, myocardial infarction, stroke or clinically driven revascularization).

Findings

In low-risk patients, BARC 2, 3, or 5 bleeding occurred in 49 (2.7 %) with clopidogrel monotherapy versus 69 (3.6 %) with extended DAPT (HR 0.73, 95 % CI 0.50–1.05; p = 0.088).In intermediate-high-risk patients, clopidogrel monotherapy versus extended DAPT showed comparable BARC 2, 3, or 5 bleeding (2.3 % vs. 3.0 %; HR 0.77, 95 % CI 0.52–1.14; p = 0.8377), but significantly reduced MACCE (2.9 % vs. 4.1 %; HR 0.69, 95 % CI 0.49–0.97; p = 0.0332). In the overall trial population, there was no significant interaction between the GRACE score and treatment group for the primary or key secondary endpoints (P > 0.05 for all outcomes).

Conclusions

Among birisk patients with ACS, clopidogrel monotherapy was associated with lower incidence of all bleeding events (BARC 1–5) versus extended DAPT regardless of GRACE score, but showed no significant difference in BARC 2, 3, or 5 bleeding. Moreover, it was associated with lower MACCE incidence versus extended DAPT in intermediate-high-risk groups.

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来源期刊

European journal of pharmacology 医学-药学

CiteScore

9.00

自引率

0.00%

发文量

572

审稿时长

34 days

期刊介绍： The European Journal of Pharmacology publishes research papers covering all aspects of experimental pharmacology with focus on the mechanism of action of structurally identified compounds affecting biological systems. The scope includes: Behavioural pharmacology Neuropharmacology and analgesia Cardiovascular pharmacology Pulmonary, gastrointestinal and urogenital pharmacology Endocrine pharmacology Immunopharmacology and inflammation Molecular and cellular pharmacology Regenerative pharmacology Biologicals and biotherapeutics Translational pharmacology Nutriceutical pharmacology.