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.repce.2020.07.020.
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.
本研究旨在评估与左心耳封堵术(LAAO)相比,新型口服抗凝药物(NOAC)在既往有卒中史和非瓣膜性心房颤动(AF)患者中的一级和二级卒中预防作用。
这是一项前瞻性、单中心、非随机队列研究,共纳入 302 例非瓣膜性 AF 且卒中风险较高的连续患者。比较了两种治疗策略:LAAO(n=91)和长期 NOAC 治疗(n=149)。主要终点是死亡、卒中和大出血的复合终点。采用倾向评分和死因分析比较结局。
平均随访 13 个月时,有 30 例死亡(LAAO 8.8% vs. NOAC 14.8%)、5 例卒中和 6 例大出血(LAAO 1.1% vs. NOAC 3.4%)。LAAO 组主要终点发生率较低(11.0% vs. 20.9%;HR 0.42,95%CI 0.17-1.05,p=0.064),但无统计学意义。仅考虑 LAAO 组的二级预防患者(LAAO 组的 34.1%),主要终点发生率也较低(LAAO 6.5% vs. 20.9%;HR 0.30,95%CI 0.07-1.39,p=0.12)。尽管约五分之一的 LAAO 患者因装置植入后反复小出血而在术后 6 个月停止抗血小板治疗,但该亚组患者未发生不良心血管事件或大出血。
在本基于注册的研究中,LAAO 是高卒中风险患者预防全因死亡率、卒中和大出血的复合终点的一种合理替代方案。