Paiva Luís, Coelho José, Barra Sérgio, Costa Marco, Sargento-Freitas João, Cunha Luís, Gonçalves Lino
Serviço de Cardiologia, Centro Hospitalar e Universitário de Coimbra, Coimbra, Portugal; Faculdade de Medicina, Universidade de Coimbra, Coimbra, Portugal.
Serviço de Neurologia, Centro Hospitalar e Universitário de Coimbra, Coimbra, Portugal.
Rev Port Cardiol (Engl Ed). 2021 May;40(5):357-365. doi: 10.1016/j.repc.2020.07.021. Epub 2021 Apr 12.
This study aimed to evaluate the performance of non-vitamin K antagonist oral anticoagulation (NOAC) in patients with previous stroke and non-valvular atrial fibrillation (AF) compared with left atrial appendage occlusion (LAAO) in primary and secondary stroke prevention settings.
This was a prospective, single-center, non-randomized cohort study of 302 consecutive patients with non-valvular AF and at high risk for stroke. Two treatment strategies were compared: LAAO (n=91) and long-term treatment with NOAC (n=149). The primary outcome was the composite endpoint of death, stroke and major bleeding. Propensity score and cause-of-death analyses were performed to compare outcomes.
In a mean follow-up of 13 months, there were 30 deaths (LAAO 8.8% vs. NOAC 14.8%), five strokes (LAAO 1.1% vs. NOAC 2.7%) and six major bleeds (LAAO 1.1% vs. NOAC 3.4%). There was a non-significant trend for a lower incidence of the primary endpoint in the LAAO group (11.0% vs. 20.9%; HR 0.42, 95% CI 0.17-1.05, p=0.064). Considering only secondary prevention LAAO patients (34.1% of the LAAO group), there was also a non-significant lower incidence of the primary endpoint (LAAO 6.5% vs. 20.9%; HR 0.30, 95% CI 0.07-1.39, p=0.12). While about a fifth of LAAO patients stopped antiplatelet treatment six months after device implantation due to recurrent minor bleeding, no adverse cardiovascular event or major bleeding occurred in this subset of patients.
In this registry-based study, LAAO was a reasonable alternative to NOAC for the prevention of a composite endpoint of all-cause mortality, stroke and major bleeding in patients at high risk for stroke.
本研究旨在评估在原发性和继发性卒中预防背景下，与左心耳封堵术（LAAO）相比，非维生素K拮抗剂口服抗凝药（NOAC）在既往有卒中史和非瓣膜性心房颤动（AF）患者中的疗效。
这是一项对302例连续的非瓣膜性AF且卒中高危患者进行的前瞻性、单中心、非随机队列研究。比较了两种治疗策略：LAAO（n = 91）和NOAC长期治疗（n = 149）。主要结局是死亡、卒中和大出血的复合终点。进行倾向评分和死因分析以比较结局。
平均随访13个月时，有30例死亡（LAAO组为8.8%，NOAC组为14.8%），5例卒中（LAAO组为1.1%，NOAC组为2.7%）和6例大出血（LAAO组为1.1%，NOAC组为3.4%）。LAAO组主要终点发生率有降低的趋势，但无统计学意义（11.0% 对20.9%；HR 0.42，95%CI 0.17 - 1.05，p = 0.064）。仅考虑LAAO组中的二级预防患者（占LAAO组的34.1%）时，主要终点发生率也有降低趋势，但无统计学意义（LAAO组为6.5%，NOAC组为20.9%；HR 0.30，95%CI 0.07 - 1.39，p = 0.12）。约五分之一的LAAO患者在装置植入6个月后因反复轻微出血而停止抗血小板治疗，该亚组患者未发生不良心血管事件或大出血。
在这项基于注册研究中，对于卒中高危患者预防全因死亡、卒中和大出血的复合终点，LAAO是NOAC的合理替代方案。
