National Clinical Research Center for Cardiovascular Diseases, State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.
Department of Cardiology, Xinxiang Central Hospital, Xinxiang, China.
Clin Appl Thromb Hemost. 2022 Jan-Dec;28:10760296221113344. doi: 10.1177/10760296221113344.
Patients with diabetes mellitus (DM) are considered to increase the risk of thrombosis and bleeding. However, whether DM is an independent risk factor for events in patients anticoagulated with bivalirudin during elective percutaneous coronary intervention (PCI) is not clear. Patients anticoagulated with bivalirudin during elective PCI from January 2017 to August 2018 in 3 centers were enrolled. The primary endpoint of thrombotic events was major adverse cardiac and cerebrovascular events (MACCE, including all-cause death, myocardial infarction, ischemic revascularization, stent thrombosis, and stroke); the primary endpoint of bleeding events was Bleeding Academic Research Consortium (BARC) 2, 3 or 5 bleeding. 1152 patients were finally enrolled. After one-year follow-up, 89 (7.7%) MACCE and 21 (1.8%) BARC 2, 3 or 5 bleeding occurred. Multivariate Cox regression analysis showed DM was not an independent risk factor for MACCE (hazard ratio [HR]: 1.029, 95% confidence interval [CI]: 0.674-1.573, = .893), but peripheral artery disease (PAD) history (HR: 2.200, 95%CI: 1.290-3.751, = .004) was an independent risk factor for MACCE. DM was not an independent risk factor for BARC 2, 3 or 5 bleeding (HR: 0.732, 95%CI: 0.293-1.831, = .505), but PAD history (HR: 3.029, 95%CI: 1.102-8.332, = .032) and low hemoglobin level (HR = 0.972, 95%CI: 0.947-0.998, = .036) were independent risk factors for BARC 2, 3 or 5 bleeding. DM was not an independent risk factor for one-year thrombotic and bleeding events in patients anticoagulated with bivalirudin during elective PCI. More attention should be paid to PAD history and hemoglobin level to identify high-risk patients.
患有糖尿病（DM）的患者被认为会增加血栓形成和出血的风险。然而，在择期经皮冠状动脉介入治疗（PCI）期间使用比伐卢定抗凝的患者中，DM 是否是事件的独立危险因素尚不清楚。
在 3 个中心，招募了 2017 年 1 月至 2018 年 8 月期间接受择期 PCI 时使用比伐卢定抗凝的患者。血栓形成事件的主要终点是主要不良心脑血管事件（MACCE，包括全因死亡、心肌梗死、缺血血运重建、支架血栓形成和中风）；出血事件的主要终点是 Bleeding Academic Research Consortium（BARC）2、3 或 5 级出血。最终纳入了 1152 例患者。经过 1 年随访，发生 89 例（7.7%）MACCE 和 21 例（1.8%）BARC 2、3 或 5 级出血。多变量 Cox 回归分析显示，DM 不是 MACCE 的独立危险因素（风险比 [HR]：1.029，95%置信区间 [CI]：0.674-1.573， = 0.893），但外周动脉疾病（PAD）病史（HR：2.200，95%CI：1.290-3.751， = 0.004）是 MACCE 的独立危险因素。DM 不是 BARC 2、3 或 5 级出血的独立危险因素（HR：0.732，95%CI：0.293-1.831， = 0.505），但 PAD 病史（HR：3.029，95%CI：1.102-8.332， = 0.032）和低血红蛋白水平（HR = 0.972，95%CI：0.947-0.998， = 0.036）是 BARC 2、3 或 5 级出血的独立危险因素。在择期 PCI 期间使用比伐卢定抗凝的患者中，DM 不是 1 年内血栓形成和出血事件的独立危险因素。应更加关注 PAD 病史和血红蛋白水平，以识别高危患者。
