Department of Cardiology, Tianjin Chest Hospital.
NHC Key Laboratory of Hormones and Development, Tianjin Key Laboratory of Metabolic Diseases, Chu Hsien-I Memorial Hospital & Tianjin Institute of Endocrinology, Tianjin Medical University, Tianjin, China.
Medicine (Baltimore). 2021 Mar 12;100(10):e25003. doi: 10.1097/MD.0000000000025003.
The efficacy and safety of bivalirudin in percutaneous coronary intervention (PCI) has always been a hot topic in perioperative antithrombotic therapy, but there are still some controversies. So studies are needed to provide more evidence, especially the real world study which includes patients excluded from previous RCT studys. Our study aimed to investigate these information and analyze the independent predictors of postoperative adverse events.A retrospective study enrolled 1416 patients underwent PCI in Tianjin Chest Hospital from May 2016 to October 2017. The incidence of stent-thrombosis and net clinical adverse events, including all-cause death, myocardial infarction, stroke, urgent target-vessel revascularization and bleeding, were followed up for 30 days and 1 year. Logistic regression and COX regression were respectively used to analyze independent predictors of bleeding events within 30-days, and independent predictors of Major adverse cardiovascular and cerebrovascular events (MACCE) in patients with stent implantation within 1-year.Seven hundred six patients were treated with bivalirudin while 710 with unfractionated heparin (UFH). The proportions of diabetes, hypertension, anemia, myocardial-infarction history, PCI history, moderate-to-severe renal-impairment, gastrointestinal-bleeding history in the bivalirudin group were significantly higher (P < .05). Women, anemia were independent risk factors for bleeding within 30-days (P < .05). Among 682 patients with stent implantation in bivalirudin group, anemia, Body Mass Index (BMI) >25 kg/m2, KILLIP ≥2, ejection fraction (EF) <45%, eGFR <60 ml/minutes were independent risk factors for MACCE, while Statins, proton pump inhibitor (PPI) were independent protective factors for MACCE with-in 1-year (P < .05).Bivalirudin have good anticoagulant effect and lower bleeding risk during PCI, especially in patients with higher bleeding risk. In patients treated with bivalirudin, female, anemia were independent predictors of bleeding within 30-days, BMI >25 kg/m2, anemia, KILLIP ≥2, EF <45%, eGFR <60 ml/minutes were independent risk factors and Statins, PPI were independent protective factors of MACCE within 1-year.
比伐卢定在经皮冠状动脉介入治疗（PCI）中的疗效和安全性一直是围手术期抗栓治疗的热点，但仍存在一些争议。因此，需要研究提供更多的证据，特别是包括先前 RCT 研究中排除的患者的真实世界研究。我们的研究旨在调查这些信息，并分析术后不良事件的独立预测因素。
一项回顾性研究纳入了 2016 年 5 月至 2017 年 10 月在天津市胸科医院接受 PCI 的 1416 例患者。随访 30 天和 1 年，观察支架血栓形成和净临床不良事件（包括全因死亡、心肌梗死、卒中和紧急靶血管血运重建以及出血）的发生率。分别采用 Logistic 回归和 COX 回归分析 30 天内出血事件的独立预测因素，以及支架植入患者 1 年内主要不良心血管和脑血管事件（MACCE）的独立预测因素。
706 例患者接受比伐卢定治疗，710 例患者接受未分级肝素（UFH）治疗。比伐卢定组糖尿病、高血压、贫血、心肌梗死史、PCI 史、中重度肾功能不全、胃肠道出血史的比例明显较高（P＜0.05）。女性、贫血是 30 天内出血的独立危险因素（P＜0.05）。在 706 例接受比伐卢定治疗的患者中，贫血、体重指数（BMI）＞25kg/m2、Killip 分级≥2、射血分数（EF）＜45%、肾小球滤过率（eGFR）＜60ml/min 是 MACCE 的独立危险因素，而他汀类药物、质子泵抑制剂（PPI）是 1 年内 MACCE 的独立保护因素（P＜0.05）。
比伐卢定在 PCI 中具有良好的抗凝效果和较低的出血风险，尤其是在出血风险较高的患者中。在接受比伐卢定治疗的患者中，女性、贫血是 30 天内出血的独立预测因素，BMI＞25kg/m2、贫血、Killip 分级≥2、EF＜45%、eGFR＜60ml/min 是 MACCE 的独立危险因素，而他汀类药物、PPI 是 1 年内 MACCE 的独立保护因素。
