左心耳封堵术与口服抗凝药物应用于心房颤动患者有效性及安全性的meta分析

doi:10.3969/j.issn.1674-8115.2021.05.014

摘要/Abstract

摘要：

目的·评估左心耳封堵术（left atrial appendage closure，LAAC）与口服抗凝药物［华法林和新型口服抗凝剂（novel oral anticoagulants，NOAC）］应用于非瓣膜性心房颤动（房颤）患者的有效性及安全性。方法·计算机检索PubMed、Embase、Cochrane Library、万方、中国知网数据库，检索时间范围为各数据库建库至2020年7月。英文检索方式为（"atrial fibrillation" or "AF" or "nonvalvular AF"）and（"left atrial appendage closure" or "LAAC"）and（"new oral anticoagulants" or "NOAC" or "novel oral anticoagulants" or "non-vitamin K antagonist oral anticoagulants" or "warfarin"）。中文检索词包括“心房颤动”“左心耳封堵术”“新型口服抗凝剂”“华法林”。按照纳入及排除标准筛选文献，并进行质量评价和数据提取。应用RevMan 5.3软件对数据进行meta分析，主要观察指标包括复合栓塞事件、出血事件、全因死亡事件及心源性猝死。结果·最终纳入9篇文献，其中随机对照试验（randomized controlled trial，RCT）3篇，非RCT 6篇，总计2 429例研究对象。meta分析结果显示，房颤患者应用LAAC相较于口服抗凝药物治疗，复合栓塞事件差异无统计学意义（OR=0.90，95%CI 0.62~1.31，P=0.59），全因死亡事件发生的差异无统计学意义（OR=1.11，95%CI 0.48~2.59，P=0.81），发生心源性猝死的差异无统计学意义（OR=0.90，95%CI 0.38~2.11，P=0.81）；相比于华法林和NOAC，LAAC出血事件的发生降低，差异有统计学意义（OR=0.48，95%CI 0.35~0.65，P=0.000）。结论·非瓣膜性房颤患者行LAAC，相比于口服抗凝药物，栓塞、死亡风险无明显差异，但有更低的出血风险。

关键词: 心房颤动, 左心耳封堵术, 新型口服抗凝剂, 华法林

Abstract:

Objective·To evaluate the efficacy and safety of left atrial appendage closure (LAAC) and oral anticoagulants [warfarin and novel oral anticoagulants(NOAC)] in non-valvular atrial fibrillation (AF).

Method·The related articles were obtained from PubMed, Embase, Cochrane Library, Wanfang database and CNKI, from the establishment of databases to July 2020. English retrieval method was as follows: ("atrial fibrillation" or "AF" or "nonvalvular AF") and ("left atrial appendage closure" or "LAAC") and ("new oral anticoagulants" or "NOAC" or "novel oral anticoagulants" or "non-vitamin K antagonist oral anticoagulants" or "warfarin"). Chinese keywords were "心房颤动""左心耳封堵术""新型口服抗凝剂" and "华法林". The articles were screened according to inclusion and exclusion criterias, and the quality evaluation and data extraction were carried out. The RevMan 5.3 software was used for meta-analysis of the data. The primary efficacy and safety endpoints were the incidence of embolism events, bleeding events, all-cause mortality events and sudden cardiac death (SCD).

Results·Finally, nine articles was included, including three randomized controlled trials and six non-randomized controlled trials, consisting of 2 429 patients. The result of meta-analysis showed that there was no significant difference in compound embolism events in patients with AF treated with LAAC, compared with oral anticoagulant therapy (OR=0.90, 95%CI 0.62?1.31, P=0.59). There was no significant difference in all-cause mortality events in patients with AF treated with LAAC, compared with oral anticoagulant therapy (OR=1.11, 95%CI 0.48?2.59, P=0.81). There was no significant difference in SCD patients with AF treated with LAAC, compared with oral anticoagulant therapy (OR=0.90,95%CI 0.38?2.11, P=0.81). Compared with warfarin and NOAC, the incidence of bleeding events in patients treated with LAAC was decreased significantly (OR=0.48, 95%CI 0.35?0.65, P=0.000).

Conclusion·There is no significant difference in embolism and death in patients of non-valvular AF treated with LAAC, compared with oral anticoagulants. But it has a lower risk of bleeding.

Key words: atrial fibrillation (AF), left atrial appendage closure (LAAC), novel oral anticoagulant (NOAC), warfarin

中图分类号:

R541.4

任艳霞, 安智晶, 张得梅, 郭雪娅. 左心耳封堵术与口服抗凝药物应用于心房颤动患者有效性及安全性的meta分析[J]. 上海交通大学学报(医学版), 2021, 41(5): 642-647.

Yan-xia REN, Zhi-jing AN, De-mei ZHANG, Xue-ya GUO. Meta-analysis of efficacy and safety of left atrial appendage closure and oral anticoagulants in atrial fibrillation[J]. JOURNAL OF SHANGHAI JIAOTONG UNIVERSITY (MEDICAL SCIENCE), 2021, 41(5): 642-647.

图/表 6

参考文献 23

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Study	Research type	Treatment/n	Control/n	Follow-up	Outcome	Quality evaluation
Osmancik^[10], 2020	RCT	LAAC/201	NOAC/201	19.9 months	thromboemlic events SCD hemorrhagic events	4.0
Reddy^[8], 2014	RCT	LAAC/463	Warfarin/244	3.8 years	thromboemlic events all-cause death SCD hemorrhagic events	4.0
Holmes^[9], 2014	RCT	LAAC/269	Warfarin/138	18 months	thromboemlic events all-cause death SCD	4.0
Godino^[13], 2020	Observational study	LAAC/193	NOAC/189	2 years	thromboemlic events all-cause death SCD hemorrhagic events	7.0
Zhao^[14], 2020	Observational study	LAAC/52	NOAC/52 Warfarin/52	3 months	thromboemlic events hemorrhagic events	6.0
Ma^[15], 2015	Observational study	LAAC/8	Warfarin/49	1 year	thromboemlic events hemorrhagic events	5.0
Ding^[16], 2019	Observational study	LAAC/80	Warfarin/80	1 year	thromboemlic events hemorrhagic events	6.0
Wang^[17], 2018	Observational study	LAAC/54	Warfarin/54	1 year	thromboemlic events all-cause death hemorrhagic events	6.5
Wang^[18], 2016	Observational study	LAAC/25	Warfarin/25	1 year	thromboemlic events all-cause death hemorrhagic events	7.0

Study	Research type	Treatment/n	Control/n	Follow-up	Outcome	Quality evaluation
Osmancik^[10], 2020	RCT	LAAC/201	NOAC/201	19.9 months	thromboemlic events SCD hemorrhagic events	4.0
Reddy^[8], 2014	RCT	LAAC/463	Warfarin/244	3.8 years	thromboemlic events all-cause death SCD hemorrhagic events	4.0
Holmes^[9], 2014	RCT	LAAC/269	Warfarin/138	18 months	thromboemlic events all-cause death SCD	4.0
Godino^[13], 2020	Observational study	LAAC/193	NOAC/189	2 years	thromboemlic events all-cause death SCD hemorrhagic events	7.0
Zhao^[14], 2020	Observational study	LAAC/52	NOAC/52 Warfarin/52	3 months	thromboemlic events hemorrhagic events	6.0
Ma^[15], 2015	Observational study	LAAC/8	Warfarin/49	1 year	thromboemlic events hemorrhagic events	5.0
Ding^[16], 2019	Observational study	LAAC/80	Warfarin/80	1 year	thromboemlic events hemorrhagic events	6.0
Wang^[17], 2018	Observational study	LAAC/54	Warfarin/54	1 year	thromboemlic events all-cause death hemorrhagic events	6.5
Wang^[18], 2016	Observational study	LAAC/25	Warfarin/25	1 year	thromboemlic events all-cause death hemorrhagic events	7.0

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