Division of Cardiology, Tokai University School of Medicine, Isehara, Japan; Division of Cardiology, Tokai University Hachioji Hospital, Hachioji, Japan.
Division of Cardiology, Tokai University Hachioji Hospital, Hachioji, Japan.
Int J Cardiol. 2023 Dec 1;392:131340. doi: 10.1016/j.ijcard.2023.131340. Epub 2023 Sep 9.
This study estimates the temporal risk variations of ischemic and bleeding events during dual antiplatelet therapy (DAPT) among patients stratified according to the Academic Research Consortium for High Bleeding Risk (ARC-HBR) criteria, suggesting the optimal period for DAPT after acute coronary syndrome (ACS).
A total of 1264 ACS patients receiving either clopidogrel or prasugrel with aspirin were classified by ARC-HBR; HBR (n = 574) and non-HBR groups (n = 690). This study was designed as a multicenter observation to evaluate the primary endpoints of ischemic, including cardiovascular death, myocardial infarction, or ischemic stroke, and bleeding events, defined as Bleeding Academic Research Consortium type 3/5. The temporal risk variations were estimated using the Cox hazard and Royston-Parmar models.
Ischemic and bleeding events were observed in 9.4% and 7.4%, respectively, during an average observation period of 313 days. The HBR group had a higher incidence of both events than the non-HBR group (15.3% vs. 4.5%, P < 0.01 for ischemic; 11.9% vs. 3.8%, P < 0.01 for bleeding). The estimated risk curves for both events revealed peaks and steep declines in the first few days, followed by constant declines. The peak of risk was higher for bleeding than for ischemic events, but this relationship reversed early, with ischemic events displaying a higher risk in both the HBR and non-HBR groups until at least 60 days.
A 60-day period of DAPT is appropriate to balance the risks of adverse events after ACS, regardless of ARC-HBR criteria.
本研究根据学术研究联合会高出血风险（ARC-HBR）标准，对接受双联抗血小板治疗（DAPT）的患者进行分层，评估其缺血和出血事件的时间风险变化，为急性冠脉综合征（ACS）后 DAPT 的最佳时间提供建议。
共纳入 1264 例接受氯吡格雷或普拉格雷联合阿司匹林治疗的 ACS 患者，根据 ARC-HBR 标准分为 HBR 组（n=574）和非 HBR 组（n=690）。本研究为多中心观察性研究，旨在评估主要终点缺血事件（包括心血管死亡、心肌梗死或缺血性卒中）和出血事件（定义为 Bleeding Academic Research Consortium 3/5 型）。采用 Cox 风险和 Royston-Parmar 模型评估时间风险变化。
平均观察 313 天后，缺血和出血事件的发生率分别为 9.4%和 7.4%。HBR 组缺血和出血事件的发生率均高于非 HBR 组（15.3%比 4.5%，P<0.01；11.9%比 3.8%，P<0.01）。缺血和出血事件的风险曲线估计显示，在最初几天内风险先升高后迅速下降，随后呈持续下降趋势。出血风险的峰值高于缺血风险，但这种关系早期发生逆转，在 HBR 和非 HBR 组中，缺血事件的风险均在至少 60 天内更高。
ACS 后 DAPT 时间为 60 天左右较为合适，可平衡不良事件的风险，而与 ARC-HBR 标准无关。
