Left Atrial Appendage Occlusion in Patients With Anticoagulation Failure vs Anticoagulation Contraindication

Errol W Aarnink; Moniek Maarse; Nicolai Fierro; Patrizio Mazzone; Alessandro Beneduce; Claudio Tondo; Alessio Gasperetti; Radoslaw Pracon; Marcin Demkow; Kamil Zieliński; 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; Dabit Arzamendi; Venkata M Alla; Himanshu Agarwal; Ingo Eitel; Christina Paitazoglou; Xavier Freixa; Pedro Cepas-Guillén; Rashaad Chothia; Solomon O Badejoko; Daniel B Spoon; James T Maddux; Mikhael El-Chami; Pradhum Ram; Luca Branca; Marianna Adamo; Hussam S Suradi; Joyce Peper; Vincent F van Dijk; Benno J W M Rensing; Martin J Swaans; Elisa Vireca; Martin W Bergmann; Lucas V A Boersma; STR-OAC LAAO and EWOLUTION Investigators

doi:10.1016/j.jcin.2024.04.012

Left Atrial Appendage Occlusion in Patients With Anticoagulation Failure vs Anticoagulation Contraindication

Errol W Aarnink^*, Moniek Maarse, Nicolai Fierro, Patrizio Mazzone, Alessandro Beneduce, Claudio Tondo, Alessio Gasperetti, Radoslaw Pracon, Marcin Demkow, Kamil Zieliński, 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 HolmesAbdul H Almakadma, Sergio Berti, Maria Rita Romeo, Xavier Millan, Dabit Arzamendi, Venkata M Alla, Himanshu Agarwal, Ingo Eitel, Christina Paitazoglou, Xavier Freixa, Pedro Cepas-Guillén, Rashaad Chothia, Solomon O Badejoko, Daniel B Spoon, James T Maddux, Mikhael El-Chami, Pradhum Ram, Luca Branca, Marianna Adamo, Hussam S Suradi, Joyce Peper, Vincent F van Dijk, Benno J W M Rensing, Martin J Swaans, Elisa Vireca, Martin W Bergmann, Lucas V A Boersma, STR-OAC LAAO and EWOLUTION Investigators

^*Corresponding author for this work

Department of Cardiology

13 Citations (Scopus)

Abstract

BACKGROUND: Left atrial appendage occlusion (LAAO) provides mechanical cardioembolic protection for atrial fibrillation (AF) patients who cannot use oral anticoagulation therapy (OAT). Patients with a thrombotic event despite OAT are at high risk for recurrence and may also benefit from LAAO.

OBJECTIVES: This study sought to investigate the efficacy of LAAO in AF patients with a thrombotic event on OAT compared to: 1) LAAO in AF patients with a contraindication for OAT; and 2) historical data.

METHODS: The international LAAO after stroke despite oral anticoagulation (STR-OAC LAAO) collaboration included patients who underwent LAAO because of thrombotic events on OAT. This cohort underwent propensity score matching and was compared to the EWOLUTION (Evaluating Real-Life Clinical Outcomes in Atrial Fibrillation Patients Receiving the WATCHMAN Left Atrial Appendage Closure Technology) registry, which represents patients who underwent LAAO because of OAT contraindications. The primary outcome was ischemic stroke. Event rates were compared between cohorts and with historical data without OAT, yielding relative risk reductions based on risk scores.

RESULTS: Analysis of 438 matched pairs revealed no significant difference in the ischemic stroke rate between the STR-OAC LAAO and EWOLUTION cohorts (2.5% vs 1.9%; HR: 1.37; 95% CI: 0.72-2.61). STR-OAC LAAO patients exhibited a higher thromboembolic risk (HR: 1.71; 95% CI: 1.04-2.83) but lower bleeding risk (HR: 0.39; 95% CI: 0.18-0.88) compared to EWOLUTION patients. The mortality rate was slightly higher in EWOLUTION (4.3% vs 6.9%; log-rank P = 0.028). Relative risk reductions for ischemic stroke were 70% and 78% in STR-OAC LAAO and EWOLUTION, respectively, compared to historical data without OAT.

CONCLUSIONS: LAAO in patients with a thrombotic event on OAT demonstrated comparable stroke rates to the OAT contraindicated population in EWOLUTION. The thromboembolic event rate was higher and the bleeding rate lower, reflecting the intrinsically different risk profile of both populations. Until randomized trials are available, LAAO may be considered in patients with an ischemic event on OAT.

Original language	English
Journal	JACC. Cardiovascular interventions
Volume	17
Issue number	11
Pages (from-to)	1311-1321
Number of pages	11
ISSN	1936-8798
DOIs	https://doi.org/10.1016/j.jcin.2024.04.012
Publication status	Published - 10 Jun 2024

Keywords

anticoagulation failure
atrial fibrillation
ischemic stroke
left atrial appendage occlusion

Access to Document

10.1016/j.jcin.2024.04.012

Cite this

Aarnink, E. W., Maarse, M., Fierro, N., Mazzone, P., Beneduce, A., Tondo, C., Gasperetti, A., Pracon, R., Demkow, M., Zieliński, K., de Backer, O., Korsholm, K., Nielsen-Kudsk, J. E., Estévez-Loureiro, R., Caneiro-Queija, B., Benito-González, T., Pérez de Prado, A., Nombela-Franco, L., Salinas, P., ... STR-OAC LAAO and EWOLUTION Investigators (2024). Left Atrial Appendage Occlusion in Patients With Anticoagulation Failure vs Anticoagulation Contraindication. JACC. Cardiovascular interventions, 17(11), 1311-1321. https://doi.org/10.1016/j.jcin.2024.04.012

Aarnink, EW, Maarse, M, Fierro, N, Mazzone, P, Beneduce, A, Tondo, C, Gasperetti, A, Pracon, R, Demkow, M, Zieliński, K, de Backer, O, Korsholm, K, Nielsen-Kudsk, JE, Estévez-Loureiro, R, Caneiro-Queija, B, Benito-González, T, Pérez de Prado, A, Nombela-Franco, L, Salinas, P, Holmes, D, Almakadma, AH, Berti, S, Romeo, MR, Millan, X, Arzamendi, D, Alla, VM, Agarwal, H, Eitel, I, Paitazoglou, C, Freixa, X, Cepas-Guillén, P, Chothia, R, Badejoko, SO, Spoon, DB, Maddux, JT, El-Chami, M, Ram, P, Branca, L, Adamo, M, Suradi, HS, Peper, J, van Dijk, VF, Rensing, BJWM, Swaans, MJ, Vireca, E, Bergmann, MW, Boersma, LVA & STR-OAC LAAO and EWOLUTION Investigators 2024, 'Left Atrial Appendage Occlusion in Patients With Anticoagulation Failure vs Anticoagulation Contraindication', JACC. Cardiovascular interventions, vol. 17, no. 11, pp. 1311-1321. https://doi.org/10.1016/j.jcin.2024.04.012

@article{0d8cae841698439a977e7131f841bf70,

title = "Left Atrial Appendage Occlusion in Patients With Anticoagulation Failure vs Anticoagulation Contraindication",

abstract = "BACKGROUND: Left atrial appendage occlusion (LAAO) provides mechanical cardioembolic protection for atrial fibrillation (AF) patients who cannot use oral anticoagulation therapy (OAT). Patients with a thrombotic event despite OAT are at high risk for recurrence and may also benefit from LAAO.OBJECTIVES: This study sought to investigate the efficacy of LAAO in AF patients with a thrombotic event on OAT compared to: 1) LAAO in AF patients with a contraindication for OAT; and 2) historical data.METHODS: The international LAAO after stroke despite oral anticoagulation (STR-OAC LAAO) collaboration included patients who underwent LAAO because of thrombotic events on OAT. This cohort underwent propensity score matching and was compared to the EWOLUTION (Evaluating Real-Life Clinical Outcomes in Atrial Fibrillation Patients Receiving the WATCHMAN Left Atrial Appendage Closure Technology) registry, which represents patients who underwent LAAO because of OAT contraindications. The primary outcome was ischemic stroke. Event rates were compared between cohorts and with historical data without OAT, yielding relative risk reductions based on risk scores.RESULTS: Analysis of 438 matched pairs revealed no significant difference in the ischemic stroke rate between the STR-OAC LAAO and EWOLUTION cohorts (2.5\% vs 1.9\%; HR: 1.37; 95\% CI: 0.72-2.61). STR-OAC LAAO patients exhibited a higher thromboembolic risk (HR: 1.71; 95\% CI: 1.04-2.83) but lower bleeding risk (HR: 0.39; 95\% CI: 0.18-0.88) compared to EWOLUTION patients. The mortality rate was slightly higher in EWOLUTION (4.3\% vs 6.9\%; log-rank P = 0.028). Relative risk reductions for ischemic stroke were 70\% and 78\% in STR-OAC LAAO and EWOLUTION, respectively, compared to historical data without OAT.CONCLUSIONS: LAAO in patients with a thrombotic event on OAT demonstrated comparable stroke rates to the OAT contraindicated population in EWOLUTION. The thromboembolic event rate was higher and the bleeding rate lower, reflecting the intrinsically different risk profile of both populations. Until randomized trials are available, LAAO may be considered in patients with an ischemic event on OAT.",

keywords = "anticoagulation failure, atrial fibrillation, ischemic stroke, left atrial appendage occlusion",

author = "Aarnink, \{Errol W\} and Moniek Maarse and Nicolai Fierro and Patrizio Mazzone and Alessandro Beneduce and Claudio Tondo and Alessio Gasperetti and Radoslaw Pracon and Marcin Demkow and Kamil Zieli{\'n}ski 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 \{P{\'e}rez de Prado\}, Armando and Luis Nombela-Franco and Pablo Salinas and David Holmes and Almakadma, \{Abdul H\} and Sergio Berti and Romeo, \{Maria Rita\} and 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 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 Joyce Peper and \{van Dijk\}, \{Vincent F\} and Rensing, \{Benno J W M\} and Swaans, \{Martin J\} and Elisa Vireca and Bergmann, \{Martin W\} and Boersma, \{Lucas V A\} and \{STR-OAC LAAO and EWOLUTION Investigators\}",

year = "2024",

month = jun,

day = "10",

doi = "10.1016/j.jcin.2024.04.012",

language = "English",

volume = "17",

pages = "1311--1321",

journal = "JACC. Cardiovascular interventions",

issn = "1936-8798",

publisher = "Elsevier Inc.",

number = "11",

}

TY - JOUR

T1 - Left Atrial Appendage Occlusion in Patients With Anticoagulation Failure vs Anticoagulation Contraindication

AU - Aarnink, Errol W

AU - Maarse, Moniek

AU - Fierro, Nicolai

AU - Mazzone, Patrizio

AU - Beneduce, Alessandro

AU - Tondo, Claudio

AU - Gasperetti, Alessio

AU - Pracon, Radoslaw

AU - Demkow, Marcin

AU - Zieliński, 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 - Pérez de Prado, Armando

AU - Nombela-Franco, Luis

AU - Salinas, Pablo

AU - Holmes, David

AU - Almakadma, Abdul H

AU - Berti, Sergio

AU - Romeo, Maria Rita

AU - Millan, Xavier

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 - 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 - Peper, Joyce

AU - van Dijk, Vincent F

AU - Rensing, Benno J W M

AU - Swaans, Martin J

AU - Vireca, Elisa

AU - Bergmann, Martin W

AU - Boersma, Lucas V A

AU - STR-OAC LAAO and EWOLUTION Investigators

PY - 2024/6/10

Y1 - 2024/6/10

N2 - BACKGROUND: Left atrial appendage occlusion (LAAO) provides mechanical cardioembolic protection for atrial fibrillation (AF) patients who cannot use oral anticoagulation therapy (OAT). Patients with a thrombotic event despite OAT are at high risk for recurrence and may also benefit from LAAO.OBJECTIVES: This study sought to investigate the efficacy of LAAO in AF patients with a thrombotic event on OAT compared to: 1) LAAO in AF patients with a contraindication for OAT; and 2) historical data.METHODS: The international LAAO after stroke despite oral anticoagulation (STR-OAC LAAO) collaboration included patients who underwent LAAO because of thrombotic events on OAT. This cohort underwent propensity score matching and was compared to the EWOLUTION (Evaluating Real-Life Clinical Outcomes in Atrial Fibrillation Patients Receiving the WATCHMAN Left Atrial Appendage Closure Technology) registry, which represents patients who underwent LAAO because of OAT contraindications. The primary outcome was ischemic stroke. Event rates were compared between cohorts and with historical data without OAT, yielding relative risk reductions based on risk scores.RESULTS: Analysis of 438 matched pairs revealed no significant difference in the ischemic stroke rate between the STR-OAC LAAO and EWOLUTION cohorts (2.5% vs 1.9%; HR: 1.37; 95% CI: 0.72-2.61). STR-OAC LAAO patients exhibited a higher thromboembolic risk (HR: 1.71; 95% CI: 1.04-2.83) but lower bleeding risk (HR: 0.39; 95% CI: 0.18-0.88) compared to EWOLUTION patients. The mortality rate was slightly higher in EWOLUTION (4.3% vs 6.9%; log-rank P = 0.028). Relative risk reductions for ischemic stroke were 70% and 78% in STR-OAC LAAO and EWOLUTION, respectively, compared to historical data without OAT.CONCLUSIONS: LAAO in patients with a thrombotic event on OAT demonstrated comparable stroke rates to the OAT contraindicated population in EWOLUTION. The thromboembolic event rate was higher and the bleeding rate lower, reflecting the intrinsically different risk profile of both populations. Until randomized trials are available, LAAO may be considered in patients with an ischemic event on OAT.

AB - BACKGROUND: Left atrial appendage occlusion (LAAO) provides mechanical cardioembolic protection for atrial fibrillation (AF) patients who cannot use oral anticoagulation therapy (OAT). Patients with a thrombotic event despite OAT are at high risk for recurrence and may also benefit from LAAO.OBJECTIVES: This study sought to investigate the efficacy of LAAO in AF patients with a thrombotic event on OAT compared to: 1) LAAO in AF patients with a contraindication for OAT; and 2) historical data.METHODS: The international LAAO after stroke despite oral anticoagulation (STR-OAC LAAO) collaboration included patients who underwent LAAO because of thrombotic events on OAT. This cohort underwent propensity score matching and was compared to the EWOLUTION (Evaluating Real-Life Clinical Outcomes in Atrial Fibrillation Patients Receiving the WATCHMAN Left Atrial Appendage Closure Technology) registry, which represents patients who underwent LAAO because of OAT contraindications. The primary outcome was ischemic stroke. Event rates were compared between cohorts and with historical data without OAT, yielding relative risk reductions based on risk scores.RESULTS: Analysis of 438 matched pairs revealed no significant difference in the ischemic stroke rate between the STR-OAC LAAO and EWOLUTION cohorts (2.5% vs 1.9%; HR: 1.37; 95% CI: 0.72-2.61). STR-OAC LAAO patients exhibited a higher thromboembolic risk (HR: 1.71; 95% CI: 1.04-2.83) but lower bleeding risk (HR: 0.39; 95% CI: 0.18-0.88) compared to EWOLUTION patients. The mortality rate was slightly higher in EWOLUTION (4.3% vs 6.9%; log-rank P = 0.028). Relative risk reductions for ischemic stroke were 70% and 78% in STR-OAC LAAO and EWOLUTION, respectively, compared to historical data without OAT.CONCLUSIONS: LAAO in patients with a thrombotic event on OAT demonstrated comparable stroke rates to the OAT contraindicated population in EWOLUTION. The thromboembolic event rate was higher and the bleeding rate lower, reflecting the intrinsically different risk profile of both populations. Until randomized trials are available, LAAO may be considered in patients with an ischemic event on OAT.

KW - anticoagulation failure

KW - atrial fibrillation

KW - ischemic stroke

KW - left atrial appendage occlusion

UR - https://www.scopus.com/pages/publications/85194484364

U2 - 10.1016/j.jcin.2024.04.012

DO - 10.1016/j.jcin.2024.04.012

M3 - Journal article

C2 - 38795093

SN - 1936-8798

VL - 17

SP - 1311

EP - 1321

JO - JACC. Cardiovascular interventions

JF - JACC. Cardiovascular interventions

IS - 11

ER -

Left Atrial Appendage Occlusion in Patients With Anticoagulation Failure vs Anticoagulation Contraindication

Abstract

Keywords

Access to Document

Other files and links

Fingerprint

Cite this