Department of Cardiology, Japanese Red Cross Ashikaga Hospital, 284-1 Yobe-cho, Ashikaga, Tochigi, Japan.
Department of Cardiovascular Medicine, Dokkyo Medical University Hospital, Mibu, Japan.
Heart Vessels. 2021 Sep;36(9):1350-1358. doi: 10.1007/s00380-021-01813-2. Epub 2021 Mar 2.
The Academic Research Consortium (ARC) recently published a definition of patients at high bleeding risk (HBR) undergoing percutaneous coronary intervention. However, the prevalence of the ARC-HBR criteria in patients undergoing endovascular therapy (EVT) for peripheral artery disease in lower extremities has not been thoroughly investigated. This study sought to investigate the prevalence and impact of the ARC-HBR criteria in patients undergoing EVT. We analyzed 277 consecutive patients who underwent their first EVT from July 2011 to September 2019. We applied the full ARC-HBR criteria to the study population. The primary end point was a composite outcome of all-cause mortality, Bleeding Academic Research Consortium 3 or 5 bleeding, and lower limb amputation within 12 months of EVT. Among the 277 patients, 193 (69.7%) met the ARC-HBR criteria. HBR patients had worse clinical outcomes compared with non-HBR patients at 12 months after EVT, including a higher incidence of the composite primary outcome (19.2% vs. 3.6%, p < 0.001) and all-cause death (7.8% vs. 0%, p = 0.007). In a multivariate Cox proportional hazards regression analysis, presence of the ARC-HBR criteria [hazard ratio (HR) 4.15, 95% confidence interval (CI) 1.25-13.80, p = 0.020], body mass index (HR 1.13, 95% CI 1.01-1.27, p = 0.042), diabetes mellitus (HR 2.70, 95% CI 1.28-5.69, p = 0.009), hyperlipidemia (HR 0.41, 95% CI 0.21-0.80, p = 0.009), and infrapopliteal lesions (HR 3.51, 95% CI 1.63-7.56, p = 0.001) were independent predictors of the primary composite outcome. Approximately 70% of Japanese patients undergoing EVT met the ARC-HBR criteria, and its presence was strongly associated with adverse outcomes within 12 months of EVT.
学术研究联合会(ARC)最近发布了经皮冠状动脉介入治疗中高出血风险(HBR)患者的定义。然而,下肢血管腔内治疗(EVT)患者中 ARC-HBR 标准的患病率尚未得到充分研究。本研究旨在探讨 ARC-HBR 标准在 EVT 患者中的患病率和影响。我们分析了 2011 年 7 月至 2019 年 9 月首次接受 EVT 的 277 例连续患者。我们将完整的 ARC-HBR 标准应用于研究人群。主要终点是 EVT 后 12 个月内全因死亡率、出血学术研究联合会 3 或 5 级出血和下肢截肢的复合结局。在 277 例患者中,193 例(69.7%)符合 ARC-HBR 标准。与非 HBR 患者相比,HBR 患者在 EVT 后 12 个月的临床结局更差,包括复合主要结局的发生率更高(19.2%比 3.6%,p<0.001)和全因死亡率(7.8%比 0%,p=0.007)。在多变量 Cox 比例风险回归分析中,ARC-HBR 标准的存在[风险比(HR)4.15,95%置信区间(CI)1.25-13.80,p=0.020]、体重指数(HR 1.13,95%CI 1.01-1.27,p=0.042)、糖尿病(HR 2.70,95%CI 1.28-5.69,p=0.009)、高脂血症(HR 0.41,95%CI 0.21-0.80,p=0.009)和小腿以下病变(HR 3.51,95%CI 1.63-7.56,p=0.001)是主要复合结局的独立预测因素。大约 70%的日本 EVT 患者符合 ARC-HBR 标准,其存在与 EVT 后 12 个月内的不良结局密切相关。