左心耳封堵术与新型口服抗凝药预防心房颤动卒中的1年以上疗效和安全性：随机对照试验和观察性研究的系统评价与荟萃分析
Over 1-year efficacy and safety of left atrial appendage occlusion versus novel oral anticoagulants for stroke prevention in atrial fibrillation: A systematic review and meta-analysis of randomized controlled trials and observational studies.
作者信息
Li Xin, Wen Song-Nan, Li Song-Nan, Bai Rong, Liu Nian, Feng Li, Ruan Yan-Fei, Du Xin, Dong Jian-Zeng, Ma Chang-Sheng
机构信息
Department of Cardiology, Beijing Anzhen Hospital, Capital Medical University, National Clinical Research Center for Cardiovascular Diseases, Beijing, China.
Department of Cardiology, Beijing Anzhen Hospital, Capital Medical University, National Clinical Research Center for Cardiovascular Diseases, Beijing, China.
出版信息
Heart Rhythm. 2016 Jun;13(6):1203-14. doi: 10.1016/j.hrthm.2015.12.037. Epub 2015 Dec 24.
BACKGROUND
A direct comparison of the efficacy and safety profiles of left atrial appendage occlusion (LAAO) devices and novel oral anticoagulants (NOACs) for stroke prevention in atrial fibrillation is warranted but currently unavailable.
OBJECTIVE
The aim of this study was to compare the >1-year efficacy and safety of LAAO devices and NOACs for stroke prevention in patients with atrial fibrillation.
METHODS
We performed a systematic review on randomized controlled trials (RCTs) and observational studies. RCTs were analyzed by means of a network meta-analysis method using warfarin as a bridge to compare LAAO to individual NOAC or all NOACs as a whole. Observational studies were analyzed with the meta-proportion function where pooled event rates were compared.
RESULTS
A total of 6 RCTs and 27 observational studies were included. A network meta-analysis of RCTs indicated that LAAO was less effective than NOACs for stroke prevention (odds ratio 0.86), but had a lower rate of hemorrhagic events during follow-up. However, a meta-proportion analysis of observational studies revealed that LAAO devices were associated with a lower rate of both thromboembolic events (1.8 events per 100 patient-years vs 2.4 events per 100 patient-years) and major bleeding events during follow-up (2.2 events per 100 patient-years vs 2.5 events per 100 patient-years) as compared with NOACs. With prolonged follow-up duration after LAAO implantation, the rate of thromboembolic events decreased (2.1, 1.8, and 1.0 events per 100 person-years for 1, 1-2, and >2 years, respectively).
CONCLUSION
Although superiority of LAAO over NOACs was not demonstrated by RCTs in terms of stroke prevention, LAAO was found to be consistently associated with a lower rate of both thromboembolic and hemorrhagic events as compared with NOACs in observational studies.
背景
对于心房颤动患者预防中风，有必要直接比较左心耳封堵（LAAO）装置与新型口服抗凝药（NOAC）的疗效和安全性，但目前尚无相关研究。
目的
本研究旨在比较LAAO装置与NOAC对心房颤动患者预防中风超过1年的疗效和安全性。
方法
我们对随机对照试验（RCT）和观察性研究进行了系统评价。RCT采用以华法林为对照的网络荟萃分析方法进行分析，以比较LAAO与单个NOAC或所有NOAC整体的疗效。观察性研究采用荟萃比例函数进行分析，比较汇总事件发生率。
结果
共纳入6项RCT和27项观察性研究。RCT的网络荟萃分析表明，在预防中风方面，LAAO的效果不如NOAC（优势比0.86），但随访期间出血事件发生率较低。然而，观察性研究的荟萃比例分析显示，与NOAC相比，LAAO装置在随访期间的血栓栓塞事件发生率（每100患者年1.8次事件 vs 每100患者年2.4次事件）和大出血事件发生率（每100患者年2.2次事件 vs 每100患者年2.5次事件）均较低。随着LAAO植入后随访时间的延长，血栓栓塞事件发生率下降（1年、1 - 2年和>2年分别为每100人年2.1次、1.8次和1.0次事件）。
结论
尽管RCT在预防中风方面未证明LAAO优于NOAC，但在观察性研究中发现，与NOAC相比，LAAO始终与较低的血栓栓塞和出血事件发生率相关。
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