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

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; RAF, RAF-DOAC, CROMIS-2, SAMURAI, NOACISP, Erlangen Registry, and Verona Registry

doi:10.1001/jamaneurol.2024.2882

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

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 PradoLuis 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, RAF, RAF-DOAC, CROMIS-2, SAMURAI, NOACISP, Erlangen Registry, and Verona Registry

Afdeling for Hjertesygdomme

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.

Originalsprog	Engelsk
Tidsskrift	JAMA Neurology
Vol/bind	81
Udgave nummer	11
Sider (fra-til)	1150-8
Antal sider	9
ISSN	2168-6149
DOI	https://doi.org/10.1001/jamaneurol.2024.2882
Status	Udgivet - nov. 2024

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10.1001/jamaneurol.2024.2882

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Maarse, M., Seiffge, D. J., Werring, D. J., Boersma, L. V. A., Aarnink, E. W., Fierro, N., Mazzone, P., Beneduce, A., Tondo, C., Gasperetti, A., Pracon, R., Demkow, M., Zielinski, K., de Backer, O., Korsholm, K., Nielsen-Kudsk, J. E., Estévez-Loureiro, R., Caneiro-Queija, B., Benito-González, T., ... RAF, RAF-DOAC, CROMIS-2, SAMURAI, NOACISP, Erlangen Registry, and Verona Registry (2024). Left Atrial Appendage Occlusion vs Standard of Care After Ischemic Stroke Despite Anticoagulation. JAMA Neurology, 81(11), 1150-8. https://doi.org/10.1001/jamaneurol.2024.2882

Maarse, M, Seiffge, DJ, Werring, DJ, Boersma, LVA, Aarnink, EW, Fierro, N, Mazzone, P, Beneduce, A, Tondo, C, Gasperetti, A, Pracon, R, Demkow, M, Zielinski, K, de Backer, O, Korsholm, K, Nielsen-Kudsk, JE, Estévez-Loureiro, R, Caneiro-Queija, B, Benito-González, T, de Prado, AP, Nombela-Franco, L, Salinas, P, Holmes, D, Almakadma, AH, Berti, S, Romeo, MR, Alvarez, XM, Arzamendi, D, Alla, VM, Agarwal, H, Eitel, I, Paitazoglou, C, Freixa, X, Cepas-Guillén, P, Chothia, R, Badejoko, SO, Bergmann, MW, Spoon, DB, Maddux, JT, El-Chami, M, Ram, P, Branca, L, Adamo, M, Suradi, HS, van Dijk, VF, Rensing, BJWM, Zietz, A, Paciaroni, M, Caso, V, Koga, M & RAF, RAF-DOAC, CROMIS-2, SAMURAI, NOACISP, Erlangen Registry, and Verona Registry 2024, 'Left Atrial Appendage Occlusion vs Standard of Care After Ischemic Stroke Despite Anticoagulation', JAMA Neurology, bind 81, nr. 11, s. 1150-8. https://doi.org/10.1001/jamaneurol.2024.2882

@article{d63c09d2b1dd4c539563e9d3f7739716,

title = "Left Atrial Appendage Occlusion vs Standard of Care After Ischemic Stroke Despite Anticoagulation",

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.",

author = "Moniek Maarse and Seiffge, {David J} and Werring, {David J} and Boersma, {Lucas V A} and Aarnink, {Errol W} and Nicolai Fierro and Patrizio Mazzone and Alessandro Beneduce and Claudio Tondo and Alessio Gasperetti and Radoslaw Pracon and Marcin Demkow and Kamil Zielinski and {de Backer}, Ole and Kasper Korsholm and Nielsen-Kudsk, {Jens Erik} and Rodrigo Est{\'e}vez-Loureiro and Berenice Caneiro-Queija and Tom{\'a}s Benito-Gonz{\'a}lez and {de Prado}, {Armando P{\'e}rez} and Luis Nombela-Franco and Pablo Salinas and David Holmes and Almakadma, {Abdul H} and Sergio Berti and Romeo, {Maria Rita} and Alvarez, {Xavier Millan} and Dabit Arzamendi and Alla, {Venkata M} and Himanshu Agarwal and Ingo Eitel and Christina Paitazoglou and Xavier Freixa and Pedro Cepas-Guill{\'e}n and Rashaad Chothia and Badejoko, {Solomon O} and Bergmann, {Martin W} and Spoon, {Daniel B} and Maddux, {James T} and Mikhael El-Chami and Pradhum Ram and Luca Branca and Marianna Adamo and Suradi, {Hussam S} and {van Dijk}, {Vincent F} and Rensing, {Benno J W M} and Annaelle Zietz and Maurizio Paciaroni and Valeria Caso and Masatoshi Koga and {RAF, RAF-DOAC, CROMIS-2, SAMURAI, NOACISP, Erlangen Registry, and Verona Registry}",

year = "2024",

month = nov,

doi = "10.1001/jamaneurol.2024.2882",

language = "English",

volume = "81",

pages = "1150--8",

journal = "JAMA Neurology",

issn = "2168-6149",

publisher = "American Medical Association",

number = "11",

}

TY - JOUR

T1 - Left Atrial Appendage Occlusion vs Standard of Care After Ischemic Stroke Despite Anticoagulation

AU - Maarse, Moniek

AU - Seiffge, David J

AU - Werring, David J

AU - Boersma, Lucas V A

AU - Aarnink, Errol W

AU - Fierro, Nicolai

AU - Mazzone, Patrizio

AU - Beneduce, Alessandro

AU - Tondo, Claudio

AU - Gasperetti, Alessio

AU - Pracon, Radoslaw

AU - Demkow, Marcin

AU - Zielinski, Kamil

AU - de Backer, Ole

AU - Korsholm, Kasper

AU - Nielsen-Kudsk, Jens Erik

AU - Estévez-Loureiro, Rodrigo

AU - Caneiro-Queija, Berenice

AU - Benito-González, Tomás

AU - de Prado, Armando Pérez

AU - Nombela-Franco, Luis

AU - Salinas, Pablo

AU - Holmes, David

AU - Almakadma, Abdul H

AU - Berti, Sergio

AU - Romeo, Maria Rita

AU - Alvarez, Xavier Millan

AU - Arzamendi, Dabit

AU - Alla, Venkata M

AU - Agarwal, Himanshu

AU - Eitel, Ingo

AU - Paitazoglou, Christina

AU - Freixa, Xavier

AU - Cepas-Guillén, Pedro

AU - Chothia, Rashaad

AU - Badejoko, Solomon O

AU - Bergmann, Martin W

AU - Spoon, Daniel B

AU - Maddux, James T

AU - El-Chami, Mikhael

AU - Ram, Pradhum

AU - Branca, Luca

AU - Adamo, Marianna

AU - Suradi, Hussam S

AU - van Dijk, Vincent F

AU - Rensing, Benno J W M

AU - Zietz, Annaelle

AU - Paciaroni, Maurizio

AU - Caso, Valeria

AU - Koga, Masatoshi

AU - RAF, RAF-DOAC, CROMIS-2, SAMURAI, NOACISP, Erlangen Registry, and Verona Registry

PY - 2024/11

Y1 - 2024/11

N2 - 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.

AB - 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.

U2 - 10.1001/jamaneurol.2024.2882

DO - 10.1001/jamaneurol.2024.2882

M3 - Journal article

C2 - 39374446

SN - 2168-6149

VL - 81

SP - 1150

EP - 1158

JO - JAMA Neurology

JF - JAMA Neurology

IS - 11

ER -

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

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