Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2024 Sep 23;81(11):1150-1158.
doi: 10.1001/jamaneurol.2024.2882. Online ahead of print.

Left Atrial Appendage Occlusion vs Standard of Care After Ischemic Stroke Despite Anticoagulation

Moniek Maarse  1   2 , David J Seiffge  3 , David J Werring  4 , Lucas V A Boersma  1   2 ; RAF, RAF-DOAC, CROMIS-2, SAMURAI, NOACISP, Erlangen Registry, and Verona Registry; STR-OAC LAAO Group; Errol W Aarnink  1   2 , Nicolai Fierro  5 , Patrizio Mazzone  6 , Alessandro Beneduce  7 , Claudio Tondo  8   9 , Alessio Gasperetti  8   10 , Radoslaw Pracon  11 , Marcin Demkow  11 , Kamil Zielinski  11 , Ole de Backer  12 , Kasper Korsholm  13 , Jens Erik Nielsen-Kudsk  13 , Rodrigo Estévez-Loureiro  14 , Berenice Caneiro-Queija  14 , Tomás Benito-González  15 , Armando Pérez de Prado  15 , Luis Nombela-Franco  16 , Pablo Salinas  16 , David Holmes  17 , Abdul H Almakadma  17 , Sergio Berti  18 , Maria Rita Romeo  18 , Xavier Millan Alvarez  19 , Dabit Arzamendi  19 , Venkata M Alla  20 , Himanshu Agarwal  20 , Ingo Eitel  21   22 , Christina Paitazoglou  21   22 , Xavier Freixa  23 , Pedro Cepas-Guillén  23 , Rashaad Chothia  24 , Solomon O Badejoko  24 , Martin W Bergmann  25 , Daniel B Spoon  26 , James T Maddux  26 , Mikhael El-Chami  27 , Pradhum Ram  27 , Luca Branca  28 , Marianna Adamo  28 , Hussam S Suradi  29 , Vincent F van Dijk  1 , Benno J W M Rensing  1 , Annaelle Zietz  30 , Maurizio Paciaroni  31 , Valeria Caso  31 , Masatoshi Koga  32 , Kazunori Toyoda  32 , Bernd Kallmünzer  33 , Manuel Cappellari  34 , Duncan Wilson  35   36 , Stefan Engelter  30   37 , Martin J Swaans  1 ; STR-OAC LAAO Group
Collaborators, Affiliations

Left Atrial Appendage Occlusion vs Standard of Care After Ischemic Stroke Despite Anticoagulation

Moniek Maarse et al. JAMA Neurol. .

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.

PubMed Disclaimer

Conflict of interest statement

Conflict of Interest Disclosures: Dr Maarse reported an unrestricted educational grant during her research work in St. Antonius Hospital. Dr Seiffge reported grants from Bangerter Rhyner Foundation during the conduct of the study; consulting or speaker fees paid to their institution from Bayer, Pfizer, Abbott outside the submitted work; and personal fees from Bayer, Alexion, and VarmX outside the submitted work. Dr Werring reported grant funding from the Stroke Association and British Heart Foundation; speaking honoraria from Bayer during the conduct of the study; speaking and chairing honoraria from Alexion and Novo Nordisk outside the submitted work; and consultant fees from Alnylam, Bayer, and Novo Nordisk. Dr Boersma reported consultant and proctor fees paid to their department from Medtronic and Boston Scientific outside the submitted work. Dr Beneduce reported personal fees from Boston Scientific, Medtronic, and Abiomed outside the submitted work. Dr Tondo reported serving on the advisory board for Boston Scientific and lecture and tutoring fees from Boston Scientific and Abbott Medical outside the submitted work. Dr Pracon reported proctoring honoraria from Abbott outside the submitted work. Dr Demkow reported proctoring fees from Boston Scientific and Abbott outside the submitted work. Dr de Backer received institutional research grants and consulting fees from Abbott and Boston Scientific. Dr Korsholm reported speaker honoraria from Boston Scientific and Abbott outside the submitted work. Dr Nielsen-Kudsk reported research grants from Abbott and Boston Scientific during the conduct of the study. R. Estévez-Loureiro reported being a proctor for Abbott Vascular, Boston Scientific, and Lifetech and personal fees from SMT outside the submitted work. Dr Pérez de Prado reported proctorship fees and grants from Boston Scientific during the conduct of the study and grants from Abbott Vascular, Medtronic, Terumo, iVascular, Iberhospitex, Shockwave, B, Braun, and SMT outside the submitted work. Dr Nombela-Franco reported proctorship fees from Abbott Vascular, lecture fees from Boston Scientific, and proctorship fees from Edwards Lifesciences outside the submitted work. Dr Salinas reported speaker fees from Abbott outside the submitted work. Dr Berti reported proctorship fees from Edwards, Boston Scientific, and Abbott. Dr Millan Alvarez reported consultant fees/honoraria from Abbott Laboratories and Boston Scientific during the conduct of the study. Dr Arzamendi reported consultant fees/honoraria from Abbott Laboratories and Boston Scientific. Dr Agarwal reported being a member of the speaker bureau and proctor for Medtronic, Abbott, Edwards Lifesciences, and Boston Scientific. Dr Freixa reported personal fees from Abbott Medical and Boston Scientific outside the submitted work. Dr Bergmann reported speaker honoraria and research support from Boston Scientific and Abbott. Dr Spoon reported being a speaker for Medtronic, Abiomed, and Abbott. Dr El-Chami reported being a consultant for Medtronic and Boston Scientific outside the submitted work. Dr Adamo reported speaker honoraria from Abbott Structural Heart. Dr Paciaroni reported being a member of the speaker bureau for Daiichi Sankyo, Pfizer, Bristol Myers Squibb, Sanofi Aventis, and iRhythm Technologies outside the submitted work. Dr Caso reported grants from Boehringer Ingelheim, Bayer, and Daiichi Sankyo outside the submitted work. Dr Koga reported honoraria from Bayer Yakuhin, Daiichi Sankyo, Mitsubishi Tanabe Pharma Corporation, BMS/Pfizer, and BMS/Janssen Pharmaceuticals and research supports from Daiichi Sankyo and Nippon Boehringer Ingelheim, all outside the submitted work. Dr Toyoda reported personal fees from Daiichi Sankyo, Janssen, Otsuka, Bayer, and Bristol Myers Squibb outside the submitted work. Dr Kallmünzer reported personal fees from Medtronic outside the submitted work. Dr Engelter reported grants to their institution from Daiichi Sankyo and Pfizer and other from Bayer and Boehringer Ingelheim to their institution during the conduct of the study. Dr Swaans reported proctor/lecturer fees from Abbott Vascular, Bioventrix, Boston Scientific, Cardiac Dimensions, Edwards Lifesciences, Philips Healthcare, GE Healthcare, Siemens, and P&F outside the submitted work. No other disclosures were reported.

Figures

Figure 1.
Figure 1.. Flowchart of Patient Inclusion
LAAO indicates left atrial appendage occlusion; OAT, oral anticoagulation therapy. aPatients who switched or continued OAT from a previously published cohort by Seiffge et al.
Figure 2.
Figure 2.. Medication Use for Members of the STR-OAC LAAO Cohort During the First and Last Follow-Up
APT indicates antiplatelet therapy; DAPT, dual antiplatetet therapy; OAT, oral anticoagulation therapy.
Figure 3.
Figure 3.. Kaplan-Meier Curves and Relative Risk Reductions (RRRs)
A, Primary outcome was ischemic stroke in the STR-OAC Left Atrial Appendage Occlusion (LAAO) group vs oral anticoagulation therapy (OAT) group (control). B, Observed annualized event rates (total number of events per patient-years of follow-up) for ischemic stroke; the composite of ischemic stroke, transient ischemic attack (TIA), and systemic embolism (SE); and nonprocedural major bleeding were calculated and compared with predicted event rates based on CHA2 DS2-VASc and HAS-BLED scores, for the STR-OAC LAAO cohort.
See this image and copyright information in PMC

References

    1. Hindricks G, Potpara T, Dagres N, et al. ; ESC Scientific Document Group . 2020 ESC guidelines for the diagnosis and management of atrial fibrillation developed in colaboration with the European Association of Cardio-Thoracic Surgery (EACTS). Eur Heart J. 2021;42(5):373-498. doi: 10.1093/eurheartj/ehaa612 - DOI - PubMed
    1. Meinel TR, Branca M, De Marchis GM, et al. ; Investigators of the Swiss Stroke Registry . Prior anticoagulation in patients with ischemic stroke and atrial fibrillation. Ann Neurol. 2021;89(1):42-53. doi: 10.1002/ana.25917 - DOI - PMC - PubMed
    1. Polymeris AA, Meinel TR, Oehler H, et al. Aetiology, secondary prevention strategies and outcomes of ischaemic stroke despite oral anticoagulant therapy in patients with atrial fibrillation. J Neurol Neurosurg Psychiatry. 2022;93(6):588-598. doi: 10.1136/jnnp-2021-328391 - DOI - PMC - PubMed
    1. Seiffge DJ, De Marchis GM, Koga M, et al. ; RAF, RAF-DOAC, CROMIS-2, SAMURAI, NOACISP, Erlangen, and Verona registry collaborators . Ischemic stroke despite oral anticoagulant therapy in patients with atrial fibrillation. Ann Neurol. 2020;87(5):677-687. doi: 10.1002/ana.25700 - DOI - PMC - PubMed
    1. Benz AP, Hohnloser SH, Eikelboom JW, et al. Outcomes of patients with atrial fibrillation and ischemic stroke while on oral anticoagulation. Eur Heart J. 2023;44(20):1807-1814. doi: 10.1093/eurheartj/ehad200 - DOI - PMC - PubMed