Department of Cardiology, Aarhus University Hospital, Aarhus, Denmark.
Danish Center for Clinical Health Services Research, Department of Clinical Medicine, Aalborg University, Aalborg, Denmark.
Int J Cardiol. 2022 Sep 15;363:56-63. doi: 10.1016/j.ijcard.2022.06.065. Epub 2022 Jun 30.
This propensity-score matched study investigated clinical outcomes associated with left atrial appendage occlusion (LAAO) versus direct oral anticoagulation (DOAC) in patients with AF and prior ischemic stroke.
AF patients enrolled in the Amulet Observational Study with a history of ischemic stroke and successful LAAO (n = 299) were compared with a propensity-score matched cohort of incident AF patients with prior ischemic stroke and treated by DOAC (n = 301). The control cohort was identified through the Danish National Patient Registries. Propensity score matching was based on covariates of the CHADS-VASc and HAS-BLED scores, with a 1:2 ratio and using Greedy 5:1 digit matching with replacement. The analysis included 2-years follow-up, with a primary composite outcome of ischemic stroke, major bleeding (BARC ≥ 3) or all-cause mortality.
Mean (SD) CHADS-VASc scores were 5.26 (1.42) and 5.40 (1.31) and HAS-BLED scores were 3.95 (0.91) and 4.03 (0.96), for the LAAO and DOAC group, respectively. Total number of primary composite outcome events were 61 (12.4 events/100 patient-years) and 117 (26.9 events/100 patient-years) in the LAAO and DOAC group, respectively. Risk of the primary composite outcome was significantly lower in the LAAO group, hazard rate ratio [HR] 0.48 (95% CI: 0.35-0.65). Ischemic stroke risk was comparable, HR 0.71 (95% CI: 0.34-1.45), while risk of major bleeding, HR 0.41 (95% CI: 0.25-0.67), and all-cause mortality, HR 0.48 (95% CI: 0.32-0.71), were significantly lower with LAAO. Cardiovascular mortality did not differ statistically between the LAAO and DOAC group, HR 0.75 (95% CI: 0.39-1.42). Results were consistent across sensitivity analyses.
This study indicated significantly lower risk of the composite outcome of stroke, major bleeding and all-cause mortality with LAAO therapy compared to DOAC, in patients with AF and prior stroke. The stroke prevention effectiveness appeared similar, with a significantly lower risk of major bleeding events with LAAO. The suggested clinical benefit of LAAO over DOAC require confirmation in the ongoing randomized OCCLUSION-AF trial.
本倾向评分匹配研究调查了在有房颤和既往缺血性卒中病史的患者中，左心耳封堵术（LAAO）与直接口服抗凝剂（DOAC）相关的临床结局。
Amulet 观察性研究中，有既往缺血性卒中病史且 LAAO 成功的房颤患者（n=299）与有既往缺血性卒中病史且接受 DOAC 治疗的新发房颤患者（n=301）进行倾向性评分匹配队列比较。对照队列通过丹麦国家患者登记处确定。倾向评分匹配基于 CHADS-VASc 和 HAS-BLED 评分的协变量，采用 1:2 比例和使用贪婪 5:1 数字匹配替换。分析包括 2 年随访，主要复合结局为缺血性卒中、大出血（BARC ≥ 3）或全因死亡率。
LAAO 和 DOAC 组的平均（SD）CHADS-VASc 评分分别为 5.26（1.42）和 5.40（1.31），HAS-BLED 评分分别为 3.95（0.91）和 4.03（0.96）。LAAO 和 DOAC 组的主要复合结局总事件数分别为 61（100 患者年 12.4 例）和 117（100 患者年 26.9 例）。LAAO 组的主要复合结局风险显著降低，风险比[HR]0.48（95%CI：0.35-0.65）。缺血性卒中风险相当，HR 0.71（95%CI：0.34-1.45），而大出血风险，HR 0.41（95%CI：0.25-0.67）和全因死亡率，HR 0.48（95%CI：0.32-0.71），LAAO 显著降低。LAAO 和 DOAC 组的心血管死亡率无统计学差异，HR 0.75（95%CI：0.39-1.42）。敏感性分析结果一致。
与 DOAC 相比，在有房颤和既往卒中病史的患者中，LAAO 治疗的卒中、大出血和全因死亡率复合结局风险显著降低。卒中预防效果似乎相似，LAAO 大出血风险显著降低。需要在正在进行的 OCCLUSION-AF 随机试验中证实 LAAO 优于 DOAC 的临床获益。
