Zhang Xiaochun, Jin Qinchun, Kong Dehong, Pan Cuizhen, Zhang Xian, Zhou Dan, Shen Zhiyun, Zhou Daxin, Ge Junbo
Department of Cardiology, Zhongshan Hospital, Fudan University, Research Unit of Cardiovascular Techniques and Devices, Chinese Academy of Medical Sciences, Shanghai, China.
National Clinical Research Center for Interventional Medicine, Shanghai, China.
Ann Transl Med. 2021 Apr;9(8):629. doi: 10.21037/atm-20-4755.
Prior studies have suggested that patients with atrial fibrillation (AF) referred for left atrial appendage occlusion (LAAO) are confronted with considerable risk of periprocedural thromboembolism and hemmorhagic events. The purpose of this study was to evaluate the safety and feasibility of bivalirudin during LAAO.
This retrospective, observational study included 420 AF patients who were evaluated as being at high risk of stroke or bleeding and indicated for LAAO at our center between June 2018 and June 2019 (158 with bivalirudin and 262 with heparin). The primary outcome was the incidence of any bleeding within 48 hours of LAAO. Secondary outcomes were major adverse cardiac events (MACE) between 48 hours and 60 days post-procedure and overall bleeding events during follow up.
No significant difference was observed between bivalirudin and heparin for major periprocedural bleeding (1.27% for bivalirudin 2.29% for heparin, P=0.716) or minor bleeding (1.27% 1.15%, P>0.9). At 48 hours post-procedure, strokes occurred at a rate of 0.63% in the bivalirudin group and 1.15% in the heparin group (P>0.9), and one case treated with bivalirudin developed systemic embolization. At 60 days, the rates of MACE (1.90% 2.29%, P>0.9), a device-related thrombus (DRT) (1.27% 1.52%, P>0.9), and overall bleeding events (5.06% 4.96%, P=0.963) were comparable between the 2 cohorts. Upon Kaplan-Meier survival analysis, early safety during the 60-day follow-up was 93.67% in the bivalirudin group and 91.60% in the heparin group (P=0.570).
Bivalirudin has a comparable safety and efficacy profile to heparin as an intraprocedural anticoagulant, but currently, it should still be reserved for patients in which heparin is contraindicated.
先前的研究表明，因左心耳封堵术（LAAO）而接受治疗的房颤（AF）患者面临着较高的围手术期血栓栓塞和出血事件风险。本研究的目的是评估比伐卢定在LAAO期间的安全性和可行性。
这项回顾性观察研究纳入了420例房颤患者，这些患者被评估为具有高卒中或出血风险，并于2018年6月至2019年6月期间在我们中心接受LAAO治疗（158例使用比伐卢定，262例使用肝素）。主要结局是LAAO后48小时内任何出血的发生率。次要结局是术后48小时至60天内的主要不良心脏事件（MACE）以及随访期间的总体出血事件。
比伐卢定和肝素在主要围手术期出血（比伐卢定为1.27%，肝素为2.29%，P = 0.716）或轻微出血（1.27%对1.15%，P>0.9）方面未观察到显著差异。术后48小时，比伐卢定组卒中发生率为0.63%，肝素组为1.15%（P>0.9），1例接受比伐卢定治疗的患者发生全身栓塞。在60天时，两个队列的MACE发生率（1.90%对2.29%，P>0.9）、器械相关血栓（DRT）发生率（1.27%对1.52%，P>0.9）和总体出血事件发生率（5.06%对4.96%，P = 0.963）相当。根据Kaplan-Meier生存分析，比伐卢定组60天随访期间的早期安全性为93.67%，肝素组为91.60%（P = 0.570）。
作为术中抗凝剂，比伐卢定与肝素具有相当的安全性和有效性，但目前，它仍应保留用于肝素禁忌的患者。
