Tiosano Shmuel, Banai Ariel, Mulla Wesam, Goldenberg Ido, Bayshtok Gabriella, Amit Uri, Shlomo Nir, Nof Eyal, Rosso Raphael, Glikson Michael, Guetta Victor, Barbash Israel, Beinart Roy
Leviev Heart Center, Sheba Medical Center, Ramat Gan 52621, Israel.
Faculty of Medicine, Tel Aviv University, Ramat Aviv, Tel Aviv 6997801, Israel.
J Clin Med. 2023 Oct 23;12(20):6693. doi: 10.3390/jcm12206693.
Aim To compare the 1-year survival rate of patients with atrial fibrillation (AF) following left atrial appendage occluder (LAAO) implantation vs. treatment with novel oral anticoagulants (NOACs).
We have conducted an indirect, retrospective comparison between LAAO and NOAC registries. The LAAO registry is a national prospective cohort of 419 AF patients who underwent percutaneous LAAO between January 2008 and October 2015. The NOACs registry is a multicenter prospective cohort of 3138 AF patients treated with NOACs between November 2015 and August 2018. Baseline patient characteristics were retrospectively collected from coded diagnoses of hospitalization and outpatient clinic notes. Follow-up data was sorted from coded diagnoses and the national civil registry. Subjects were matched according to propensity score. Baseline characteristics were compared using Chi-Square and student's -test. Survival analysis was performed using Kaplan-Meier survival curves, log-rank test, and multivariable Cox regression, adjusting for possible confounding variables.
This study included 114 subjects who underwent LAAO implantation and 342 subjects treated with NOACs. The mean age of participants was 77.9 ± 7.44 and 77.1 ± 11.2 years in the LAAO and NOAC groups, respectively ( = 0.4). The LAAO group had 70 (61%) men compared to 202 (59%) men in the NOAC group ( = 0.74). No significant differences were found in baseline comorbidities, renal function, or CHADS-VASc score. One-year mortality was observed in 5 (4%) patients and 32 (9%) patients of the LAAO and NOAC groups, respectively. After adjusting for confounders, LAAO was significantly associated with a lower risk for 1-year mortality (HR 0.38, 95%CI 0.14-0.99). In patients with impaired renal function, this difference was even more prominent (HR 0.21 for creatinine clearance (CrCl) < 60 mL/min).
In a pooled analysis of two registries, we found a significantly lower risk for 1-year mortality in patients with AF who were implanted with LAAO than those treated with NOACs. This finding was more prominent in patients with impaired renal function. Future prospective direct studies should further investigate the efficacy and adverse effects of both treatment strategies.
目的 比较左心耳封堵器（LAAO）植入术后房颤（AF）患者与新型口服抗凝药（NOACs）治疗患者的1年生存率。
我们对LAAO和NOACs登记处进行了间接的回顾性比较。LAAO登记处是一个全国性前瞻性队列，纳入了2008年1月至2015年10月期间接受经皮LAAO的419例AF患者。NOACs登记处是一个多中心前瞻性队列，纳入了2015年11月至2018年8月期间接受NOACs治疗的3138例AF患者。从住院编码诊断和门诊病历中回顾性收集患者基线特征。随访数据从编码诊断和国家民事登记处整理而来。根据倾向评分对受试者进行匹配。使用卡方检验和学生t检验比较基线特征。采用Kaplan-Meier生存曲线、对数秩检验和多变量Cox回归进行生存分析，并对可能的混杂变量进行校正。
本研究纳入了114例行LAAO植入术的受试者和342例接受NOACs治疗的受试者。LAAO组和NOACs组参与者的平均年龄分别为77.9±7.44岁和77.1±11.2岁（P=0.4）。LAAO组有70名（61%）男性，NOACs组有202名（59%）男性（P=0.74）。在基线合并症、肾功能或CHADS-VASc评分方面未发现显著差异。LAAO组和NOACs组分别有5例（4%）和32例（9%）患者在1年内死亡。在对混杂因素进行校正后，LAAO与1年死亡风险显著降低相关（风险比0.38，95%置信区间0.14-0.99）。在肾功能受损的患者中，这种差异更为显著（肌酐清除率（CrCl）<60 mL/min时风险比为0.21）。
在对两个登记处的汇总分析中，我们发现植入LAAO的AF患者1年死亡风险显著低于接受NOACs治疗的患者。这一发现在肾功能受损的患者中更为突出。未来的前瞻性直接研究应进一步调查两种治疗策略的疗效和不良反应。
