Department of Cardiovascular Medicine, Saga University, Japan (M.N.).
Department of Clinical Epidemiology, Hyogo College of Medicine, Nishinomiya, Japan (T.M.).
Circ Cardiovasc Interv. 2019 Nov;12(11):e008307. doi: 10.1161/CIRCINTERVENTIONS.119.008307. Epub 2019 Nov 11.
Recently, the Academic Research Consortium for High Bleeding Risk (ARC-HBR) has been proposed to standardize the definition of HBR, which was arbitrarily defined as a Bleeding Academic Research Consortium 3 or 5 bleeding ≥4% at 1-year. However, the prevalence and the expected bleeding event rate of HBR patients defined by ARC-HBR criteria are currently unknown in the real-world percutaneous coronary intervention practice.
We applied the ARC-HBR criteria in the CREDO-Kyoto (Coronary Revascularization Demonstrating Outcome Study in Kyoto) registry cohort-2, a multicenter registry that enrolled 13 058 consecutive patients who underwent their first percutaneous coronary intervention. The primary bleeding end point was defined as the Global Utilization of Streptokinase and Tissue plasminogen activator for Occluded coronary arteries moderate/severe bleeding. There were 5570 patients (43%) in the HBR group and 7488 patients in the no-HBR group.
Cumulative incidence of the primary bleeding end point was much higher in the HBR group than in the no-HBR group (10.4% versus 3.4% at 1-year, and 18.9% versus 6.6% at 5-year, <0.0001). Presence of each ARC-HBR major or even minor criterion, in isolation, with the exception of liver cirrhosis and prior ischemic stroke, was also associated with major bleeding risk higher than 4% at 1-year. Cumulative 5-year incidence of the primary bleeding end point got incrementally higher as the number of the ARC-HBR major criteria increased (≥3 majors: 49.9%, 2 majors: 30.6%, 1 major: 18.5%, ≥2 minors: 14.7%, and no-HBR: 6.6%, <0.0001).
ARC-HBR criteria successfully identified those patients with very HBR after percutaneous coronary intervention, who represented 43% of patients in this all-comers registry.
最近,学术研究联合会高出血风险(ARC-HBR)提出了标准化高出血风险的定义,该定义任意定义为出血学术研究联合会 3 或 5 级出血≥4%,时间为 1 年。然而,目前在真实世界经皮冠状动脉介入治疗实践中,ARC-HBR 标准定义的高出血风险患者的患病率和预期出血事件发生率尚不清楚。
我们在 CREDO-Kyoto(京都冠状动脉血运重建研究)登记研究队列-2 中应用 ARC-HBR 标准,这是一项纳入了 13058 例首次行经皮冠状动脉介入治疗的连续患者的多中心登记研究。主要出血终点定义为全球应用链激酶和组织型纤溶酶原激活剂治疗闭塞性冠状动脉中度/重度出血。HBR 组有 5570 例(43%)患者,无 HBR 组有 7488 例患者。
HBR 组的主要出血终点累积发生率明显高于无 HBR 组(1 年时为 10.4%比 3.4%,5 年时为 18.9%比 6.6%,<0.0001)。除肝硬化和既往缺血性卒中外,ARC-HBR 主要或甚至次要标准的存在均与 1 年时出血风险>4%相关。随着 ARC-HBR 主要标准数量的增加,5 年主要出血终点的累积发生率逐渐升高(≥3 项主要标准:49.9%,2 项主要标准:30.6%,1 项主要标准:18.5%,≥2 项次要标准:14.7%,无 HBR:6.6%,<0.0001)。
ARC-HBR 标准成功识别了经皮冠状动脉介入治疗后高出血风险极高的患者,这些患者占该所有患者登记研究的 43%。