Department of Cardiology, Bern University Hospital, Bern, Switzerland.
EuroIntervention. 2020 Aug 28;16(5):371-379. doi: 10.4244/EIJ-D-20-00052.
The Academic Research Consortium for High Bleeding Risk (ARC-HBR) defined consensus-based criteria for patients at high bleeding risk (HBR) undergoing percutaneous coronary intervention (PCI). We aimed to validate the ARC-HBR criteria for the bleeding outcomes using a large cohort of patients undergoing PCI.
Between 2009 and 2016, patients undergoing PCI were prospectively included in the Bern PCI Registry. Patients were considered to be at HBR if at least one major criterion or two minor criteria were met. The primary endpoint was Bleeding Academic Research Consortium (BARC) 3 or 5 bleeding at one year; ischaemic outcomes were assessed using the device-oriented composite endpoints (DOCE) of cardiac death, target vessel myocardial infarction, and target lesion revascularisation. Among 12,121 patients, those at HBR (n=4,781, 39.4%) had an increased risk of BARC 3 or 5 bleeding (6.4% vs 1.9%; p<0.001) and DOCE (12.5% vs 6.1%; p<0.001) compared with those without HBR. The degree of risk and prognostic value were related to the risk factors composing the criteria. The ARC-HBR criteria had higher sensitivity than the PRECISE-DAPT score and the PARIS bleeding risk score (63.8%, 53.1%, 31.9%), but lower specificity (62.7%, 71.3%, 86.5%) for BARC 3 or 5 bleeding.
Patients at HBR defined by the ARC-HBR criteria had a higher risk of BARC 3 or 5 bleeding as well as DOCE. The bleeding risk was related to its individual components. The ARC-HBR criteria were more sensitive for identifying patients with future bleedings than other contemporary risk scores at the cost of specificity. ClinicalTrials.gov Identifier: NCT02241291
学术研究协会高出血风险（ARC-HBR）为接受经皮冠状动脉介入治疗（PCI）的高出血风险（HBR）患者定义了基于共识的标准。我们旨在使用接受 PCI 的大量患者来验证 ARC-HBR 标准对出血结果的预测价值。
2009 年至 2016 年间，前瞻性纳入接受 PCI 的患者参加伯尔尼 PCI 注册研究。如果至少存在一个主要标准或两个次要标准，则认为患者存在 HBR。主要终点为一年时出血学术研究协会（BARC）3 或 5 级出血；使用器械导向复合终点（DOCE）评估缺血结局，包括心源性死亡、靶血管心肌梗死和靶病变血运重建。在 12121 例患者中，HBR 患者（n=4781，39.4%）BARC 3 或 5 级出血（6.4%比 1.9%；p<0.001）和 DOCE（12.5%比 6.1%；p<0.001）风险增加。标准组成因素与风险程度和预后价值相关。与 PRECISE-DAPT 评分和 PARIS 出血风险评分相比，ARC-HBR 标准（63.8%、53.1%、31.9%）对 BARC 3 或 5 级出血的预测具有更高的敏感性，但特异性较低（62.7%、71.3%、86.5%）。
ARC-HBR 标准定义的 HBR 患者 BARC 3 或 5 级出血和 DOCE 的风险更高。出血风险与其个体组成部分相关。与其他当代风险评分相比，ARC-HBR 标准对识别未来出血患者更敏感，但特异性降低。临床试验注册号：NCT02241291
