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从阿司匹林联合 P2Y12 抑制剂双联抗血小板治疗转换为阿司匹林联合血管剂量利伐沙班的双重途径抑制:转换抗血小板和抗凝治疗(SWAP-AC)研究。

Switching from Dual Antiplatelet Therapy with Aspirin Plus a P2Y12 Inhibitor to Dual Pathway Inhibition with Aspirin Plus Vascular-Dose Rivaroxaban: The Switching Anti-Platelet and Anti-Coagulant Therapy (SWAP-AC) Study.

机构信息

Division of Cardiology, University of Florida College of Medicine, Jacksonville, Florida, United States.

Departmet of Cardiology, Maria Cecilia Hospital, GVM Care and Research, Cotignola, Italy.

出版信息

Thromb Haemost. 2024 Mar;124(3):263-273. doi: 10.1055/a-2098-6639. Epub 2023 May 24.

Abstract

BACKGROUND

To date, there are no data on switching to dual pathway inhibition (DPI) patients who have completed a guideline-recommended dual antiplatelet therapy (DAPT) regimen.

OBJECTIVES

To assess the feasibility of switching from DAPT to DPI and to compare the pharmacodynamic (PD) profiles of these treatments.

METHODS

This was a prospective, randomized, PD study conducted in 90 patients with chronic coronary syndrome (CCS) on DAPT with aspirin (81 mg/qd) plus a P2Y inhibitor (clopidogrel [75 mg/qd;  = 30], ticagrelor [90 mg/bid;  = 30], or prasugrel [10 mg/qd;  = 30]). Patients in each cohort were randomized to maintain DAPT or switch to DPI (aspirin 81 mg/qd plus rivaroxaban 2.5 mg/bid). PD assessments included: VerifyNow P2Y reaction units; light transmittance aggregometry following stimuli with adenosine diphosphate (ADP), tissue factor (TF), and a combination of collagen, ADP, and TF (maximum platelet aggregation %); thrombin generation (TG). Assays were performed at baseline and 30 days postrandomization.

RESULTS

Switching from DAPT to DPI occurred without major side effects. DAPT was associated with enhanced P2Y inhibition, while DPI with reduced TG. Platelet-mediated global thrombogenicity (primary endpoint) showed no differences between DAPT and DPI in the ticagrelor (14.5% [0.0-63.0] vs. 20.0% [0.0-70.0];  = 0.477) and prasugrel (20.0% [0.0-66.0] vs. 4.0% [0.0-70.0];  = 0.482), but not clopidogrel (27.0% [0.0-68.0] vs. 53.0% [0.0-81.0];  = 0.011), cohorts.

CONCLUSION

In patients with CCS, switching from different DAPT regimens to DPI was feasible, showing enhanced P2Y inhibition with DAPT and reduced TG with DPI, with no differences in platelet-mediated global thrombogenicity between DPI and ticagrelor- and prasugrel-, but not clopidogrel-, based DAPT.

CLINICAL TRIAL REGISTRATION

http://www.

CLINICALTRIALS

gov Unique Identifier: NCT04006288.

摘要

背景

迄今为止,尚无关于已完成指南推荐双联抗血小板治疗(DAPT)方案的患者转为双联抗血小板治疗(DPI)的数据。

目的

评估从 DAPT 转为 DPI 的可行性,并比较这些治疗方法的药效学(PD)特征。

方法

这是一项在 90 例接受 DAPT 的慢性冠脉综合征(CCS)患者中进行的前瞻性、随机、PD 研究,DAPT 方案为阿司匹林(81mg/天)加 P2Y 抑制剂(氯吡格雷[75mg/天;=30]、替格瑞洛[90mg/天;=30]或普拉格雷[10mg/天;=30])。每个队列的患者均被随机分为继续 DAPT 或转为 DPI(阿司匹林 81mg/天加利伐沙班 2.5mg/天)。PD 评估包括:VerifyNow P2Y 反应单位;使用二磷酸腺苷(ADP)、组织因子(TF)和胶原、ADP 和 TF 联合刺激后的光透射聚集;血栓生成(TG)。在基线和随机分组后 30 天进行检测。

结果

从 DAPT 转为 DPI 无重大副作用。DAPT 与增强的 P2Y 抑制相关,而 DPI 与降低的 TG 相关。血小板介导的整体血栓形成性(主要终点)在替格瑞洛(14.5%[0.0-63.0]与 20.0%[0.0-70.0];=0.477)和普拉格雷(20.0%[0.0-66.0]与 4.0%[0.0-70.0];=0.482)队列中,DAPT 和 DPI 之间无差异,但在氯吡格雷(27.0%[0.0-68.0]与 53.0%[0.0-81.0];=0.011)队列中存在差异。

结论

在 CCS 患者中,从不同的 DAPT 方案转为 DPI 是可行的,DAPT 表现出增强的 P2Y 抑制,DPI 表现出降低的 TG,DPI 和替格瑞洛-和普拉格雷-而非氯吡格雷-为基础的 DAPT 之间的血小板介导的整体血栓形成性无差异。

临床试验注册

http://www.clinicaltrials.gov。

临床试验

NCT04006288。

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