Department of Neurosurgery, University of Illinois at Chicago, Chicago, IL, USA.
Department of Internal Medicine, Temple University Hospital, Philadelphia, PA, USA.
J Cardiol. 2024 Mar;83(3):163-168. doi: 10.1016/j.jjcc.2023.07.015. Epub 2023 Aug 3.
The WATCHMAN device (Boston Scientific; Marlborough, MA, USA) is noninferior to warfarin in preventing ischemic strokes while reducing bleeding risks associated with long term anticoagulation in nonvalvular atrial fibrillation (AFib). The device's performance compared to direct oral anticoagulants (DOAC) is less well known.
To compare 5-year major bleeding and ischemic stroke rates in patients with nonvalvular AFib who received a WATCHMAN device or DOAC therapy after a major bleeding event.
This retrospective, multicenter, 1:1 matched cohort study was derived from the PearlDiver Mariner database from 2010 to 2020. Patients with nonvalvular AFib on oral anticoagulation who had a major bleeding event were identified. Those who received either WATCHMAN or DOAC after resolution of the bleeding event were selected. The two groups were exactly matched 1:1 based on various comorbidities. Rates of ischemic stroke, transient ischemic attack (TIA), major bleeding, and hemorrhagic stroke were compared over 5 years.
Each cohort consisted of 2248 patients after 1:1 matching. The mean CHADS2-VASC score was 4.81 ± 1.25. At 5 years, the WATCHMAN cohort had significantly lower rates of major bleeding events [OR 0.24 (0.21, 0.27)], TIAs [OR 0.75 (0.58, 0.95)], and ischemic strokes [OR 0.72 (0.61, 0.86)]. There was no significant difference in hemorrhagic strokes [OR 1.14 (0.83, 1.58)].
Even in a high-risk population, the WATCHMAN is comparable to DOAC therapy in the primary prevention of hemorrhagic strokes and may provide benefit in the rates of bleeding events, TIAs, and ischemic strokes.
WATCHMAN 装置（波士顿科学公司；美国马萨诸塞州马尔伯勒）在预防非瓣膜性心房颤动（AFib）患者的缺血性中风方面不劣于华法林，同时降低了长期抗凝治疗相关的出血风险。该装置与直接口服抗凝剂（DOAC）的性能比较鲜为人知。
比较非瓣膜性 AFib 患者在发生大出血事件后接受 WATCHMAN 装置或 DOAC 治疗 5 年后的主要出血和缺血性中风发生率。
这是一项回顾性、多中心、1:1 匹配队列研究，来自 2010 年至 2020 年的 PearlDiver Mariner 数据库。确定正在接受口服抗凝治疗且发生大出血事件的非瓣膜性 AFib 患者。在出血事件解决后，选择接受 WATCHMAN 或 DOAC 治疗的患者。根据各种合并症，两组进行了 1:1 精确匹配。比较两组患者在 5 年内缺血性中风、短暂性脑缺血发作（TIA）、主要出血和脑出血的发生率。
1:1 匹配后，每组各有 2248 例患者。平均 CHADS2-VASC 评分为 4.81±1.25。在 5 年内，WATCHMAN 组的主要出血事件[比值比（OR）0.24（0.21，0.27）]、TIA[OR 0.75（0.58，0.95）]和缺血性中风[OR 0.72（0.61，0.86）]发生率显著降低。但两组患者的脑出血发生率[OR 1.14（0.83，1.58）]无显著差异。
即使在高危人群中，WATCHMAN 与 DOAC 治疗在预防出血性中风方面同样有效，并且可能在出血事件、TIA 和缺血性中风的发生率方面提供获益。
