Unit of Clinical Cardiology, IRCCS San Raffaele Hospital, Milan, Italy -
Vita-Salute San Raffaele University, Milan, Italy -
Panminerva Med. 2023 Jun;65(2):227-233. doi: 10.23736/S0031-0808.21.04446-3. Epub 2021 Oct 19.
Patients with non-valvular atrial fibrillation (nvAF) who experienced a cardioembolic (CE) event despite adequate oral anticoagulation (OAC) are at high risk of recurrence, and further prevention strategies are deemed necessary. The present study aimed to evaluate the safety and efficacy of off-label use of left atrial appendage closure (LAAC) in this subset of patients.
Seventy-five consecutive patients with nvAF who experienced a CE event despite adequate OAC therapy were retrospectively enrolled from two Italian centers. Patients were divided according to the treatment strategy following the index event: DOAC group (49 patients who continued OAC therapy with DOACs) and LAAC group (26 patients who underwent LAAC procedure). 1:1 propensity-score matching between the two groups was performed. LAAC group was made up of two subgroups according to the post-procedural pharmacological regimen: 1) dual antiplatelet therapy (DAPT) for 3 months followed by indefinite single antiplatelet therapy (LAAC+SAPT); or 2) aspirin plus DOAC for 3 months followed by indefinite DOAC therapy (LAAC+DOAC). The primary endpoint was a composite of CE event, major bleeding, or procedure-related major complication.
During a median follow-up of 3.4 years (IQR: 2.0-5.3), LAAC was a predictor of primary endpoint-free survival (HR=0.28, 95% CI: 0.08-0.97; P=0.044); within LAAC group, no procedure-related major complication occurred. Moreover, a trend toward a lower rate of both CE events and major bleedings was observed in LAAC group, particularly in the subgroup LAAC+DOAC.
LAAC is a reasonable therapeutic option in nvAF patients who suffered a CE event despite adequate OAC therapy.
尽管接受了充分的口服抗凝治疗（OAC），但患有非瓣膜性心房颤动（nvAF）的患者仍发生心源性栓塞（CE）事件，其复发风险较高，需要进一步采取预防策略。本研究旨在评估左心耳封堵（LAAC）在这部分患者中的安全性和有效性。
本研究回顾性纳入了意大利两个中心的 75 例连续 nvAF 患者，这些患者尽管接受了充分的 OAC 治疗，但仍发生了 CE 事件。根据索引事件后的治疗策略，患者分为 DOAC 组（49 例继续接受 DOAC 治疗）和 LAAC 组（26 例行 LAAC 手术）。对两组进行 1:1 倾向评分匹配。LAAC 组根据术后药物治疗方案进一步分为两组：1）双联抗血小板治疗（DAPT）3 个月，然后无限期单抗血小板治疗（LAAC+SAPT）；或 2）阿司匹林加 DOAC 治疗 3 个月，然后无限期 DOAC 治疗（LAAC+DOAC）。主要终点是 CE 事件、大出血或与手术相关的主要并发症的复合事件。
在中位数为 3.4 年（IQR：2.0-5.3）的随访期间，LAAC 是主要终点无事件生存的预测因素（HR=0.28，95%CI：0.08-0.97；P=0.044）；在 LAAC 组中，未发生与手术相关的主要并发症。此外，在 LAAC 组中观察到 CE 事件和大出血的发生率均呈下降趋势，尤其是在 LAAC+DOAC 亚组中。
在接受充分 OAC 治疗后仍发生 CE 事件的 nvAF 患者中，LAAC 是一种合理的治疗选择。
