Chen Shaojie, Chun K R Julian, Ling Zhiyu, Liu Shaowen, Zhu Lin, Wang Jiazhi, Schratter Alexandra, Acou Willem-Jan, Kiuchi Márcio Galindo, Yin Yuehui, Schmidt Boris
Cardioangiologisches Centrum Bethanien (CCB), Kardiologie, Medizinische Klinik III, Agaplesion Markus Krankenhaus, Akademisches Lehrkrankenhaus der Goethe-Universität Frankfurt am Main, 60431 Frankfurt am Main, Germany.
Die Sektion Medizin, Universität zu Lübeck, 23538 Lübeck, Germany.
J Cardiovasc Dev Dis. 2021 Jun 11;8(6):69. doi: 10.3390/jcdd8060069.
Transcatheter left atrial appendage occlusion (LAAO) is non-inferior to vitamin K antagonists (VKAs) in preventing thromboembolic events in atrial fibrillation (AF). Non-vitamin K antagonists (NOACs) have an improved safety profile over VKAs; however, evidence regarding their effect on cardiovascular and neurological outcomes relative to LAAO is limited. Up-to-date randomized trials or propensity-score-matched data comparing LAAO vs. NOACs in high-risk patients with AF were pooled in our study. A total of 2849 AF patients (LAAO: 1368, NOACs: 1481, mean age: 75 ± 7.5 yrs, 63.5% male) were enrolled. The mean CHA2DS2-VASc score was 4.3 ± 1.7, and the mean HAS-BLED score was 3.4 ± 1.2. The baseline characteristics were comparable between the two groups. In the LAAO group, the success rate of device implantation was 98.8%. During a mean follow-up of 2 years, as compared with NOACs, LAAO was associated with a significant reduction of ISTH major bleeding ( = 0.0002). There were no significant differences in terms of ischemic stroke ( = 0.61), ischemic stroke/thromboembolism ( = 0.63), ISTH major and clinically relevant minor bleeding ( = 0.73), cardiovascular death ( = 0.63), and all-cause mortality ( = 0.71). There was a trend toward reduction of combined major cardiovascular and neurological endpoints in the LAAO group (OR: 0.84, 95% CI: 0.64-1.11, = 0.12). In conclusion, for high-risk AF patients, LAAO is associated with a significant reduction of ISTH major bleeding without increased ischemic events, as compared to "contemporary NOACs". The present data show the superior role of LAAO over NOACs among high-risk AF patients in terms of reduction of major bleeding; however, more randomized controlled trials are warranted.
经导管左心耳封堵术（LAAO）在预防心房颤动（AF）血栓栓塞事件方面不劣于维生素K拮抗剂（VKA）。非维生素K拮抗剂（NOAC）相对于VKA具有更好的安全性；然而，关于它们相对于LAAO对心血管和神经学结局影响的证据有限。我们的研究汇总了最新的比较AF高危患者中LAAO与NOAC的随机试验或倾向评分匹配数据。共纳入2849例AF患者（LAAO组：1368例，NOAC组：1481例，平均年龄：75±7.5岁，男性占63.5%）。平均CHA2DS2-VASc评分为4.3±1.7，平均HAS-BLED评分为3.4±1.2。两组基线特征具有可比性。在LAAO组中，器械植入成功率为98.8%。在平均2年的随访期间，与NOAC相比，LAAO与国际血栓与止血学会（ISTH）定义的大出血显著减少相关（P = 0.0002）。在缺血性卒中（P = 0.61）、缺血性卒中/血栓栓塞（P = 0.63）、ISTH定义的大出血和临床相关小出血（P = 0.73）、心血管死亡（P = 0.63）以及全因死亡率（P = 0.71）方面无显著差异。LAAO组有降低主要心血管和神经学联合终点的趋势（OR：0.84，95%CI：0.64 - 1.11，P = 0.12）。总之，对于AF高危患者，与“当代NOAC”相比，LAAO与ISTH定义的大出血显著减少相关，且缺血事件未增加。目前的数据显示，在减少大出血方面，LAAO在AF高危患者中优于NOAC；然而，仍需要更多的随机对照试验。
