Arrhythmia Center, Ningbo First Hospital, Zhejiang University, Ningbo, Zhejiang, China.
Department of Ultrasonography, Ningbo First Hospital, Zhejiang University, Ningbo, Zhejiang, China.
J Formos Med Assoc. 2022 Aug;121(8):1488-1494. doi: 10.1016/j.jfma.2021.10.015. Epub 2021 Nov 2.
BACKGROUND/PURPOSE: Anticoagulant therapy is suggested within 45 days after Watchman device implantation for stroke prevention in patients with atrial fibrillation (AF). A previous study demonstrated that non-vitamin K antagonist oral anticoagulants (NOACs) were a feasible peri- and postprocedural alternative to warfarin. The present study aimed to compare the safety and efficacy of using different anticoagulants (low-dose NOACs vs. warfarin) within 45 days after Watchman device implantation in a Chinese population.
Patients with successful Watchman device implantation from October 2014 to June 2020 were included. All patients received anticoagulants within 45 days after the procedure, and those patients were divided into three groups according to the type of postprocedural anticoagulants. Transesophageal echocardiography follow-up was performed 45 days post procedure to assess residual flow and the occurrence of device-related thrombus (DRT).
A total of 368 patients were enrolled in the study. The study population was divided into three groups: the warfarin group (n = 77), the dabigatran group (n = 165) and the rivaroxaban group (n = 126). Periprocedural major bleeding was higher in the warfarin group (2.6% vs. 0% vs. 0%, P = 0.043), while minor bleeding was comparable among the groups (3.9% vs. 1.2% vs. 0.8%, P = 0.230). No periprocedural transient ischemic attack/stroke occurred. At follow-up, the incidence of DRT was higher in the warfarin group than in the other groups (4.2% vs. 0.6% vs. 0.8%; P = 0.116), but the difference was not statistically significant. The rates of thromboembolic and bleeding events were similar in the three groups.
The safety and efficacy of low-dose dabigatran and rivaroxaban were comparable to those of warfarin within 45 days after Watchman device implantation in a Chinese population.
背景/目的:在心房颤动(AF)患者中,华法林预防中风建议在 Watchman 装置植入后 45 天内进行抗凝治疗。先前的研究表明,非维生素 K 拮抗剂口服抗凝剂(NOACs)是华法林替代方案的可行围手术期和术后选择。本研究旨在比较在中国人中,华法林预防中风建议在 Watchman 装置植入后 45 天内使用不同抗凝剂(低剂量 NOACs 与华法林)的安全性和有效性。
纳入 2014 年 10 月至 2020 年 6 月成功植入 Watchman 装置的患者。所有患者均在术后 45 天内接受抗凝治疗,并根据术后抗凝类型将患者分为三组。术后 45 天进行经食管超声心动图随访,以评估残余血流和装置相关血栓(DRT)的发生情况。
共有 368 例患者入组研究。研究人群分为三组:华法林组(n=77)、达比加群组(n=165)和利伐沙班组(n=126)。华法林组围手术期大出血发生率较高(2.6%比 0%比 0%,P=0.043),而各组间小出血发生率相当(3.9%比 1.2%比 0.8%,P=0.230)。无围手术期短暂性脑缺血发作/中风发生。随访时,华法林组 DRT 发生率高于其他两组(4.2%比 0.6%比 0.8%;P=0.116),但差异无统计学意义。三组血栓栓塞和出血事件发生率相似。
在中国人中,华法林预防中风建议在 Watchman 装置植入后 45 天内,低剂量达比加群和利伐沙班的安全性和有效性与华法林相当。