Emergency and Critical Care Center, State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, No. 167 Beilishi Road, Xicheng District, Beijing, People's Republic of China.
Emergency and Critical Care Center, State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, No. 167 Beilishi Road, Xicheng District, Beijing, People's Republic of China.
Thromb Res. 2022 Jan;209:16-22. doi: 10.1016/j.thromres.2021.11.015. Epub 2021 Nov 25.
This study aims to validate the Academic Research Consortium for High Bleeding Risk (ARC-HBR) criteria in Chinese patients with atrial fibrillation (AF) and acute coronary syndrome (ACS) or undergoing percutaneous coronary intervention (PCI) who received both oral anticoagulants (OAC) and antiplatelet therapy (APT).
930 consecutive patients with AF and ACS or undergoing PCI receiving both OAC and APT were recruited and followed up for 1 year. The primary endpoint was BARC type 3 or 5 bleeding. The secondary endpoints included BARC type 2, 3, or 5 bleeding, TIMI major bleeding, TIMI major or minor bleeding, and major adverse cardiovascular events (a composite of all-cause death, stroke, non-central nervous system embolism, myocardial infarction, definite or probable stent thrombosis, and target vessel revascularization). Cox regressions were performed to evaluate the association between the ARC-HBR score and outcomes. Discrimination was evaluated through analysis of the receiver operating characteristic (ROC) curves, net reclassification improvement (NRI), and integrated discrimination improvement (IDI).
Compared to patients with no HBR other than OAC, patients with HBR besides OAC tended to have more comorbidities and worse outcomes. The ARC-HBR score was significantly associated with the primary and secondary endpoints, both as a continuous variable and as a categorical variable. The ARC-HBR score performed better than the HAS-BLED score (c-statistic: 0.692 vs. 0.575, NRI = 0.313, IDI = 0.061) and the PRECISE-DAPT score (c-statistic: 0.692 vs. 0.616, NRI = 0.393, IDI = 0.049).
In patients with AF and ACS or undergoing PCI receiving both OAC and APT, the ARC-HBR score was a significant predictor of 1-year bleeding and ischemic endpoints. The ARC-HBR score performed better than the HAS-BLED score and the PRECISE-DAPT score in BARC type 3 or 5 bleeding prediction.
本研究旨在验证学术研究联盟高出血风险（ARC-HBR）标准在中国房颤（AF）和急性冠状动脉综合征（ACS）或接受经皮冠状动脉介入治疗（PCI）的患者中的适用性，这些患者同时接受口服抗凝剂（OAC）和抗血小板治疗（APT）。
纳入了 930 例连续接受 OAC 和 APT 治疗的 AF 和 ACS 或接受 PCI 的患者，并进行了为期 1 年的随访。主要终点是 BARC 3 型或 5 型出血。次要终点包括 BARC 2 型、3 型或 5 型出血、TIMI 大出血、TIMI 大出血或小出血以及主要不良心血管事件（全因死亡、卒中、非中枢神经系统栓塞、心肌梗死、确定或可能的支架血栓形成和靶血管血运重建的复合终点）。采用 Cox 回归评估 ARC-HBR 评分与结局之间的关系。通过分析接受者操作特征（ROC）曲线、净重新分类改善（NRI）和综合判别改善（IDI）评估区分度。
与除 OAC 外无其他高出血风险的患者相比，同时存在 OAC 和其他高出血风险的患者往往合并更多的疾病且预后更差。ARC-HBR 评分与主要和次要终点均显著相关，无论是作为连续变量还是作为分类变量。ARC-HBR 评分在预测 1 年出血和缺血终点方面的表现优于 HAS-BLED 评分（C 统计量：0.692 与 0.575，NRI=0.313，IDI=0.061）和 PRECISE-DAPT 评分（C 统计量：0.692 与 0.616，NRI=0.393，IDI=0.049）。
在同时接受 OAC 和 APT 治疗的 AF 和 ACS 或接受 PCI 的患者中，ARC-HBR 评分是 1 年出血和缺血终点的重要预测因素。在预测 BARC 3 型或 5 型出血方面，ARC-HBR 评分优于 HAS-BLED 评分和 PRECISE-DAPT 评分。
