Enomoto Yoshinari, Gadiyaram Varuna K, Gianni Carola, Horton Rodney P, Trivedi Chintan, Mohanty Sanghamitra, Di Biase Luigi, Al-Ahmad Amin, Burkhardt J David, Narula Arvin, Janczyk Gwen, Price Matthew J, Afzal Muhammad R, Atoui Moustapha, Earnest Matthew, Swarup Vijay, Doshi Shephal K, van der Zee Sarina, Fisher Rebecca, Lakkireddy Dhanunjaya R, Gibson Douglas N, Natale Andrea, Reddy Vivek Y
Helmsley Electrophysiology Center, Icahn School of Medicine at Mount Sinai, New York, New York.
Interventional Electrophysiology, Scripps Clinic, La Jolla, California.
Heart Rhythm. 2017 Jan;14(1):19-24. doi: 10.1016/j.hrthm.2016.10.020. Epub 2016 Oct 19.
In the stroke prevention trials of left atrial appendage closure with the Watchman device (Boston Scientific), a postimplantation antithrombotic regimen of 6 weeks of warfarin was used.
Given the clinical complexity of warfarin use, the purpose of this study was to study the relative feasibility and safety of using non-warfarin oral anticoagulants (NOACs) instead of warfarin during the peri- and initial postimplantation periods after Watchman implantation.
This was a retrospective multicenter study of consecutive patients undergoing Watchman implantation and receiving peri- and postprocedural NOACs or warfarin. Transesophageal echocardiography or chest computed tomography was performed between 6 weeks and 4 months postimplant to assess for device-related thrombosis. Bleeding and thromboembolic events also were evaluated at the time of follow-up.
In 5 centers, 214 patients received NOACs (46% apixaban, 46% rivaroxaban, 7% dabigatran, and 1% edoxaban) in either an uninterrupted (82%) or a single-held-dose (16%) fashion. Compared to a control group receiving uninterrupted warfarin (n = 212), the rates of periprocedural complications, including bleeding events, were similar (2.8% vs 2.4%, P = 1). At follow-up, the rates of device-related thrombosis (0.9% vs 0.5%, P = 1), composite of thromboembolism or device-related thrombosis (1.4% vs 0.9%, P = 1), and postprocedure bleeding events (0.5% vs 0.9%, P = .6) also were comparable between the NOAC and warfarin groups.
NOACs proved to be a feasible peri- and postprocedural alternative regimen to warfarin for preventing device-related thrombosis and thromboembolic complications expected early after appendage closure with the Watchman device, without increasing the risk of bleeding.
在使用Watchman装置(波士顿科学公司)进行左心耳封堵的卒中预防试验中,采用了为期6周的华法林植入后抗栓治疗方案。
鉴于华法林使用的临床复杂性,本研究的目的是探讨在Watchman植入围手术期和植入后初期使用非华法林口服抗凝剂(NOACs)替代华法林的相对可行性和安全性。
这是一项对连续接受Watchman植入并在围手术期和术后接受NOACs或华法林治疗的患者进行的回顾性多中心研究。在植入后6周和4个月之间进行经食管超声心动图或胸部计算机断层扫描,以评估与装置相关的血栓形成。在随访时还评估了出血和血栓栓塞事件。
在5个中心,214例患者以不间断(82%)或单次停药(16%)的方式接受了NOACs(46%阿哌沙班、46%利伐沙班、7%达比加群和1%依度沙班)治疗。与接受不间断华法林治疗的对照组(n = 212)相比,围手术期并发症发生率,包括出血事件,相似(2.8%对2.4%,P = 1)。在随访时,NOAC组和华法林组与装置相关的血栓形成率(0.9%对0.5%,P = 1)、血栓栓塞或与装置相关的血栓形成的复合发生率(1.4%对0.9%,P = 1)以及术后出血事件发生率(0.5%对0.9%,P = 0.6)也相当。
对于预防使用Watchman装置进行心耳封堵后早期预期出现的与装置相关的血栓形成和血栓栓塞并发症,NOACs被证明是华法林在围手术期和术后的一种可行替代方案,且不会增加出血风险。