Maarse Moniek, Seiffge David J, Werring David J, Boersma Lucas V A, Aarnink Errol W, Fierro Nicolai, Mazzone Patrizio, Beneduce Alessandro, Tondo Claudio, Gasperetti Alessio, Pracon Radoslaw, Demkow Marcin, Zielinski Kamil, de Backer Ole, Korsholm Kasper, Nielsen-Kudsk Jens Erik, Estévez-Loureiro Rodrigo, Caneiro-Queija Berenice, Benito-González Tomás, de Prado Armando Pérez, Nombela-Franco Luis, Salinas Pablo, Holmes David, Almakadma Abdul H, Berti Sergio, Romeo Maria Rita, Alvarez Xavier Millan, Arzamendi Dabit, Alla Venkata M, Agarwal Himanshu, Eitel Ingo, Paitazoglou Christina, Freixa Xavier, Cepas-Guillén Pedro, Chothia Rashaad, Badejoko Solomon O, Bergmann Martin W, Spoon Daniel B, Maddux James T, El-Chami Mikhael, Ram Pradhum, Branca Luca, Adamo Marianna, Suradi Hussam S, van Dijk Vincent F, Rensing Benno J W M, Zietz Annaelle, Paciaroni Maurizio, Caso Valeria, Koga Masatoshi, Toyoda Kazunori, Kallmünzer Bernd, Cappellari Manuel, Wilson Duncan, Engelter Stefan, Swaans Martin J
Department of Cardiology, Sint Antonius Ziekenhuis, Nieuwegein, the Netherlands.
Department of Cardiology, Amsterdam UMC, Location AMC, Amsterdam, the Netherlands.
JAMA Neurol. 2024 Sep 23;81(11):1150-8. doi: 10.1001/jamaneurol.2024.2882.
Patients with atrial fibrillation (AF) who have ischemic stroke despite taking oral anticoagulation therapy (OAT) have a very high risk of recurrence. Left atrial appendage occlusion (LAAO) is a mechanical stroke prevention strategy that may provide additional protection in patients with thromboembolic events under OAT.
To compare percutaneous LAAO with continuing OAT alone regarding stroke prevention in patients with AF who had a thromboembolic event despite taking OAT.
DESIGN, SETTING, AND PARTICIPANTS: This cohort study was a propensity score-matched comparison of the STR-OAC LAAO cohort, an international collaboration of 21 sites combining patients from multiple prospective registries of patients who underwent LAAO between 2010 and 2022. STR-OAC LAAO cohort patients who had follow-up longer than 3 months were propensity score-matched to a previously published control cohort comprising patients from an established international collaboration of investigator-initiated prospective studies. This control cohort included patients with nonvalvular AF, recent ischemic stroke or transient ischemic attack, and follow-up longer than 3 months who were taking OAT before the index event. Analyses were adjusted for imbalances in gender, age, hypertension, diabetes, and CHA2 DS2-VASc score.
Left atrial appendage occlusion vs continuation of oral anticoagulation therapy alone (control group).
The primary outcome was time to first ischemic stroke.
Four hundred thirty-three patients from the STR-OAC LAAO cohort (mean [SD] age, 72 [9] years; 171 [39%] females and 262 [61%] males; mean [SD] CHA2 DS2-VASc score, 5.0 [1.6]) were matched to 433 of 1140 patients (38%) from the control group. During 2-year follow-up, 50 patients experienced ischemic stroke: an annualized event rate of 2.8% per patient-year in the STR-OAC LAAO group vs 8.9% per patient-year in the control group. Left atrial appendage occlusion was associated with a lower risk of ischemic stroke (hazard ratio, 0.33; 95% CI, 0.19-0.58; P < .001) compared with the control group. After LAAO, OAT was discontinued in 290 patients (67%), and the remaining 143 patients (33%) continued OAT after LAAO as an adjunctive therapy.
In patients with nonvalvular AF and a prior thromboembolic event despite taking OAT, LAAO was associated with a lower risk of ischemic stroke compared with continued OAT alone. Randomized clinical trial data are needed to confirm that LAAO may be a promising treatment option for this population with a very high risk of stroke.
尽管接受了口服抗凝治疗(OAT),但仍发生缺血性卒中的心房颤动(AF)患者复发风险非常高。左心耳封堵术(LAAO)是一种机械性预防卒中的策略,对于接受OAT治疗但发生血栓栓塞事件的患者可能提供额外的保护。
比较经皮左心耳封堵术与单纯继续OAT在预防尽管接受OAT治疗仍发生血栓栓塞事件的AF患者卒中方面的效果。
设计、设置和参与者:这项队列研究是对STR-OAC LAAO队列进行倾向评分匹配比较,该队列是一个由21个地点组成的国际合作项目,汇集了2010年至2022年间接受LAAO的患者的多个前瞻性登记研究中的患者。对随访时间超过3个月的STR-OAC LAAO队列患者进行倾向评分匹配,与一个先前发表的对照组进行比较,该对照组由来自一项研究者发起的前瞻性研究的既定国际合作项目中的患者组成。该对照组包括非瓣膜性AF、近期缺血性卒中或短暂性脑缺血发作且随访时间超过3个月、在索引事件前接受OAT治疗的患者。分析对性别、年龄、高血压、糖尿病和CHA2 DS2-VASc评分的不平衡进行了调整。
左心耳封堵术与单纯继续口服抗凝治疗(对照组)。
主要结局是首次缺血性卒中的时间。
STR-OAC LAAO队列中的433例患者(平均[标准差]年龄,72[9]岁;171例[39%]为女性,262例[61%]为男性;平均[标准差]CHA2 DS2-VASc评分,5.0[1.6])与对照组1140例患者中的433例(38%)进行了匹配。在2年的随访期间,50例患者发生了缺血性卒中:STR-OAC LAAO组患者每年的事件发生率为2.8%,而对照组为8.9%。与对照组相比,左心耳封堵术与较低的缺血性卒中风险相关(风险比,0.33;95%置信区间,0.19 - 0.58;P <.001)。左心耳封堵术后,290例患者(67%)停用了OAT,其余143例患者(33%)在左心耳封堵术后继续使用OAT作为辅助治疗。
在非瓣膜性AF且尽管接受OAT治疗仍有既往血栓栓塞事件的患者中,与单纯继续OAT相比,左心耳封堵术与较低的缺血性卒中风险相关。需要随机临床试验数据来证实左心耳封堵术可能是这一中风风险非常高的人群的一种有前景的治疗选择。