心房颤动患者中左心耳封堵术与口服抗凝药相比的疗效及安全性：一项随机对照试验和倾向匹配研究的荟萃分析
Efficacy and safety of left atrial appendage closure compared with oral anticoagulation in atrial fibrillation: a meta-analysis of randomized controlled trials and propensity-matched studies.
作者信息
Franchin Luca, Piroli Francesco, Demola Pierluigi, Mantovani Francesca, Iannaccone Mario, Manfredi Roberto, D'Ascenzo Fabrizio, Fortuni Federico, Ugo Fabrizio, Meucci Francesco, Navazio Alessandro, Boccuzzi Giacomo
机构信息
Department of Cardiology, San Giovanni Bosco Hospital, Turin, Italy.
Department of Cardiology, Azienda Sanitaria Universitaria Friuli Centrale, Udine, Italy.
出版信息
Front Cardiovasc Med. 2023 Sep 27;10:1212161. doi: 10.3389/fcvm.2023.1212161. eCollection 2023.
BACKGROUNDS
Two recent randomized controlled trials (RCTs), the PROTECT-AF and the PREVAIL, showed that in atrial fibrillation (AF) patients, left atrial appendage closure (LAAC) is comparable to oral anticoagulants (OAC) in the prevention of stroke and could also possibly reduce mortality. Nevertheless, this net clinical benefit was not confirmed in the most recent RCT comparing LAAC vs. OAC, the PRAGUE-17 trial.
AIM
aim of the present study was to evaluate the efficacy and safety of LAAC compared with OAC among available high-quality studies.
METHODS
A systematic search of electronic databases (Medline, Scopus, Embase and the Cochrane Library) was performed to identify eligible RCTs and observational studies with propensity score matching (PSM) analysis. PRISMA guidelines were used for abstracting data and assessing data quality and validity. Outcomes of interest were the occurrence of cardiovascular death (CVD), all-cause death, all-type stroke, and major bleedings.
RESULTS
A total of 3 RCTs and 7 PMS studies involving 25,700 patients were identified. 12,961 patients received LAAC while 12,739 received OAC therapy. After a median follow-up of 2.6 years (IQR 2-4.4), patients who received LAAC had lower risk of CVD (RR = 0.62; 95%CI, 0.51-0.74, = 0%), all-cause death (RR = 0.67; 95% CI, 0.57-0.78, 68%) and major bleedings (RR = 0.68; 95%CI, 0.48-0.95 = 87%) compared with patients on OAC. No difference was found between the two groups regarding strokes incidence (RR = 0.94; 95% CI, 0.77-1.15, = 0%).
CONCLUSIONS
According to this meta-analysis, LAAC has comparable efficacy in the prevention of stroke compared with OAC and a reduced risk of major bleedings, all-cause death and CVD that may be even larger with longer follow-up.
SYSTEMATIC REVIEW REGISTRATION
https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=269768, identifier CRD42021269768.
背景
最近两项随机对照试验（RCT），即PROTECT-AF试验和PREVAIL试验，表明在心房颤动（AF）患者中，左心耳封堵术（LAAC）在预防中风方面与口服抗凝剂（OAC）相当，并且还可能降低死亡率。然而，在最近比较LAAC与OAC的RCT，即PRAGUE-17试验中，这种净临床获益并未得到证实。
目的
本研究的目的是在现有高质量研究中评估LAAC与OAC相比的疗效和安全性。
方法
对电子数据库（Medline、Scopus、Embase和Cochrane图书馆）进行系统检索，以识别符合条件的RCT和采用倾向评分匹配（PSM）分析的观察性研究。PRISMA指南用于提取数据并评估数据质量和有效性。感兴趣的结局是心血管死亡（CVD）、全因死亡、所有类型的中风和大出血的发生情况。
结果
共识别出3项RCT和7项PSM研究，涉及25700例患者。12961例患者接受了LAAC，而12739例接受了OAC治疗。中位随访2.6年（四分位间距2 - 4.4年）后，与接受OAC治疗的患者相比，接受LAAC的患者发生CVD的风险较低（风险比[RR] = 0.62；95%置信区间[CI]，0.51 - 0.74，P = 0%）、全因死亡风险较低（RR = 0.67；95% CI，0.57 - 0.78，P = 68%）和大出血风险较低（RR = 0.68；95% CI，0.48 - 0.95，P = 87%）。两组在中风发生率方面未发现差异（RR = 0.94；95% CI，0.77 - 1.15，P = 0%）。
结论
根据这项荟萃分析，LAAC在预防中风方面与OAC具有相当的疗效，并且大出血风险降低，全因死亡和CVD风险降低，随着随访时间延长，这种降低可能更大。
系统评价注册
https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=269768，标识符CRD42021269768 。
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