Moniek Maarse, David J Seiffge, David J Werring, Lucas V A Boersma, Errol W Aarnink, Nicolai Fierro, Patrizio Mazzone, Alessandro Beneduce, Claudio Tondo, Alessio Gasperetti, Radoslaw Pracon, Marcin Demkow, Kamil Zielinski, Ole de Backer, Kasper Korsholm, Jens Erik Nielsen-Kudsk, Rodrigo Estévez-Loureiro, Berenice Caneiro-Queija, Tomás Benito-González, Armando Pérez de Prado, Luis Nombela-Franco, Pablo Salinas, David Holmes, Abdul H Almakadma, Sergio Berti, Maria Rita Romeo, Xavier Millan Alvarez, Dabit Arzamendi, Venkata M Alla, Himanshu Agarwal, Ingo Eitel, Christina Paitazoglou, Xavier Freixa, Pedro Cepas-Guillén, Rashaad Chothia, Solomon O Badejoko, Martin W Bergmann, Daniel B Spoon, James T Maddux, Mikhael El-Chami, Pradhum Ram, Luca Branca, Marianna Adamo, Hussam S Suradi, Vincent F van Dijk, Benno J W M Rensing, Annaelle Zietz, Maurizio Paciaroni, Valeria Caso, Masatoshi Koga, Kazunori Toyoda, Bernd Kallmünzer, Manuel Cappellari, Duncan Wilson, Stefan Engelter, Martin J Swaans
{"title":"Left Atrial Appendage Occlusion vs Standard of Care After Ischemic Stroke Despite Anticoagulation.","authors":"Moniek Maarse, David J Seiffge, David J Werring, Lucas V A Boersma, Errol W Aarnink, Nicolai Fierro, Patrizio Mazzone, Alessandro Beneduce, Claudio Tondo, Alessio Gasperetti, Radoslaw Pracon, Marcin Demkow, Kamil Zielinski, Ole de Backer, Kasper Korsholm, Jens Erik Nielsen-Kudsk, Rodrigo Estévez-Loureiro, Berenice Caneiro-Queija, Tomás Benito-González, Armando Pérez de Prado, Luis Nombela-Franco, Pablo Salinas, David Holmes, Abdul H Almakadma, Sergio Berti, Maria Rita Romeo, Xavier Millan Alvarez, Dabit Arzamendi, Venkata M Alla, Himanshu Agarwal, Ingo Eitel, Christina Paitazoglou, Xavier Freixa, Pedro Cepas-Guillén, Rashaad Chothia, Solomon O Badejoko, Martin W Bergmann, Daniel B Spoon, James T Maddux, Mikhael El-Chami, Pradhum Ram, Luca Branca, Marianna Adamo, Hussam S Suradi, Vincent F van Dijk, Benno J W M Rensing, Annaelle Zietz, Maurizio Paciaroni, Valeria Caso, Masatoshi Koga, Kazunori Toyoda, Bernd Kallmünzer, Manuel Cappellari, Duncan Wilson, Stefan Engelter, Martin J Swaans","doi":"10.1001/jamaneurol.2024.2882","DOIUrl":null,"url":null,"abstract":"<p><strong>Importance: </strong>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.</p><p><strong>Objective: </strong>To compare percutaneous LAAO with continuing OAT alone regarding stroke prevention in patients with AF who had a thromboembolic event despite taking OAT.</p><p><strong>Design, setting, and participants: </strong>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.</p><p><strong>Exposure: </strong>Left atrial appendage occlusion vs continuation of oral anticoagulation therapy alone (control group).</p><p><strong>Main outcomes and measures: </strong>The primary outcome was time to first ischemic stroke.</p><p><strong>Results: </strong>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.</p><p><strong>Conclusions and relevance: </strong>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.</p>","PeriodicalId":14677,"journal":{"name":"JAMA neurology","volume":" ","pages":""},"PeriodicalIF":20.4000,"publicationDate":"2024-09-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11420820/pdf/","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"JAMA neurology","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1001/jamaneurol.2024.2882","RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"CLINICAL NEUROLOGY","Score":null,"Total":0}
引用次数: 0
Abstract
Importance: 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.
Objective: 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.
Exposure: Left atrial appendage occlusion vs continuation of oral anticoagulation therapy alone (control group).
Main outcomes and measures: The primary outcome was time to first ischemic stroke.
Results: 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.
Conclusions and relevance: 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.
期刊介绍:
JAMA Neurology is an international peer-reviewed journal for physicians caring for people with neurologic disorders and those interested in the structure and function of the normal and diseased nervous system. The Archives of Neurology & Psychiatry began publication in 1919 and, in 1959, became 2 separate journals: Archives of Neurology and Archives of General Psychiatry. In 2013, their names changed to JAMA Neurology and JAMA Psychiatry, respectively. JAMA Neurology is a member of the JAMA Network, a consortium of peer-reviewed, general medical and specialty publications.