Left atrial appendage occlusion plus oral anticoagulation in stroke patients despite ongoing anticoagulation: rationale and design of the ADD-LAAO clinical trial
ABSTRACT Introduction and objectives: The prevalence of atrial fibrillation and the number of patients experiencing ischemic strokes despite oral anticoagulation (OAC) are both on the rise, which presents a significant challenge due to the absence of clear and uniform treatment recommendations for t...
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2025-08-01
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| Series: | REC: Interventional Cardiology (English Ed.) |
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| author | Sergio Amaro Ignacio Cruz-González Rodrigo Estévez-Loureiro Xavier Millan Luis Nombela-Franco Joan Gómez-Hospital Eduardo Flores-Umanzor Luis López-Mesonero José Maciñeiras Lluis Prats-Sánchez Patricia Simal Pere Cardona Luis Teruel Pedro Cepas-Guillén Dabit Arzamendi Xavier Freixa |
| author_facet | Sergio Amaro Ignacio Cruz-González Rodrigo Estévez-Loureiro Xavier Millan Luis Nombela-Franco Joan Gómez-Hospital Eduardo Flores-Umanzor Luis López-Mesonero José Maciñeiras Lluis Prats-Sánchez Patricia Simal Pere Cardona Luis Teruel Pedro Cepas-Guillén Dabit Arzamendi Xavier Freixa |
| author_sort | Sergio Amaro |
| collection | DOAJ |
| description | ABSTRACT Introduction and objectives: The prevalence of atrial fibrillation and the number of patients experiencing ischemic strokes despite oral anticoagulation (OAC) are both on the rise, which presents a significant challenge due to the absence of clear and uniform treatment recommendations for these patients. To date, there is no formal combination merging into a high anticoagulant efficacy profile while keeping a low bleeding risk. Transcatheter left atrial appendage occlusion (LAAO) in combination with OAC might provide a balance between safety and efficacy. The objective of this study is to evaluate whether, in ischemic stroke patients, despite anticoagulation, the combination of LAAO plus long-term anticoagulation—direct oral anticoagulants or vitamin K antagonist when indicated—is associated with a lower rate of recurrent cardioembolic events at 12 months vs the optimal medical therapy recommended by the neurologist. Methods: A total of 380 patients with ischemic stroke despite OAC will be included. Patients will be randomized on a 1:1 ratio to receive the optimal medical therapy (control) or the combination of LAAO plus OAC or OAC. The primary endpoint of the study will be the occurrence of a cardioembolic event—ischemic stroke or arterial peripheral embolism—within the first 12 months after inclusion. Conclusions: This study is one of the first randomized clinical trials to compare the LAAO plus OAC combination and optimal medical therapy in patients who have experienced ischemic strokes despite being on OAC. If results confirm the superiority of LAAO plus OAC, it could lead to a paradigm shift in treatment guidelines for these patients. |
| format | Article |
| id | doaj-art-c65335194f97496dae6ff92c1eca1b27 |
| institution | Kabale University |
| issn | 2604-7322 |
| language | English |
| publishDate | 2025-08-01 |
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| series | REC: Interventional Cardiology (English Ed.) |
| spelling | doaj-art-c65335194f97496dae6ff92c1eca1b272025-08-20T03:40:29ZengPermanyerREC: Interventional Cardiology (English Ed.)2604-73222025-08-017314014510.24875/RECICE.M25000507Left atrial appendage occlusion plus oral anticoagulation in stroke patients despite ongoing anticoagulation: rationale and design of the ADD-LAAO clinical trialSergio Amaro0Ignacio Cruz-González1Rodrigo Estévez-Loureiro2Xavier Millan3Luis Nombela-Franco4Joan Gómez-Hospital5Eduardo Flores-Umanzor6Luis López-Mesonero7José Maciñeiras8Lluis Prats-Sánchez9Patricia Simal10Pere Cardona11Luis Teruel12Pedro Cepas-Guillén13Dabit Arzamendi14Xavier Freixa15Departamento de Neurología, Hospital Clínic de Barcelona, Barcelona, SpainDepartamento de Cardiología, Hospital Universitario de Salamanca, Salamanca, SpainDepartamento de Cardiología, Hospital Universitario Álvaro Cunqueiro, Vigo, Pontevedra, SpainDepartamento de Cardiología, Hospital de la Santa Creu i Sant Pau, Barcelona, SpainDepartamento de Cardiología, Hospital Clínico San Carlos, Madrid, SpainDepartamento de Cardiología, Hospital Universitari de Bellvitge, Barcelona, SpainDepartamento de Cardiología, Hospital Clínic de Barcelona, Barcelona, SpainDepartamento de Neurología, Hospital Universitario de Salamanca, Salamanca, SpainDepartamento de Neurología, Hospital Universitario Álvaro Cunqueiro, Vigo, SpainDepartamento de Neurología, Hospital de la Santa Creu i Sant Pau, Barcelona, SpainDepartamento de Neurología, Hospital Clínico San Carlos, Madrid, SpainDepartamento de Neurología, Hospital Universitari de Bellvitge, Barcelona, SpainDepartamento de Cardiología, Hospital Universitari de Bellvitge, Barcelona, SpainDepartamento de Cardiología, Hospital Clínic de Barcelona, Barcelona, SpainDepartamento de Cardiología, Hospital de la Santa Creu i Sant Pau, Barcelona, SpainDepartamento de Cardiología, Hospital Clínic de Barcelona, Barcelona, SpainABSTRACT Introduction and objectives: The prevalence of atrial fibrillation and the number of patients experiencing ischemic strokes despite oral anticoagulation (OAC) are both on the rise, which presents a significant challenge due to the absence of clear and uniform treatment recommendations for these patients. To date, there is no formal combination merging into a high anticoagulant efficacy profile while keeping a low bleeding risk. Transcatheter left atrial appendage occlusion (LAAO) in combination with OAC might provide a balance between safety and efficacy. The objective of this study is to evaluate whether, in ischemic stroke patients, despite anticoagulation, the combination of LAAO plus long-term anticoagulation—direct oral anticoagulants or vitamin K antagonist when indicated—is associated with a lower rate of recurrent cardioembolic events at 12 months vs the optimal medical therapy recommended by the neurologist. Methods: A total of 380 patients with ischemic stroke despite OAC will be included. Patients will be randomized on a 1:1 ratio to receive the optimal medical therapy (control) or the combination of LAAO plus OAC or OAC. The primary endpoint of the study will be the occurrence of a cardioembolic event—ischemic stroke or arterial peripheral embolism—within the first 12 months after inclusion. Conclusions: This study is one of the first randomized clinical trials to compare the LAAO plus OAC combination and optimal medical therapy in patients who have experienced ischemic strokes despite being on OAC. If results confirm the superiority of LAAO plus OAC, it could lead to a paradigm shift in treatment guidelines for these patients.https://recintervcardiol.org/en/index.php?option=com_content&view=article&id=2668Left atrial appendage occlusion Recurrent stroke Oral anticoagulation Direct oral anticoagulation |
| spellingShingle | Sergio Amaro Ignacio Cruz-González Rodrigo Estévez-Loureiro Xavier Millan Luis Nombela-Franco Joan Gómez-Hospital Eduardo Flores-Umanzor Luis López-Mesonero José Maciñeiras Lluis Prats-Sánchez Patricia Simal Pere Cardona Luis Teruel Pedro Cepas-Guillén Dabit Arzamendi Xavier Freixa Left atrial appendage occlusion plus oral anticoagulation in stroke patients despite ongoing anticoagulation: rationale and design of the ADD-LAAO clinical trial REC: Interventional Cardiology (English Ed.) Left atrial appendage occlusion Recurrent stroke Oral anticoagulation Direct oral anticoagulation |
| title | Left atrial appendage occlusion plus oral anticoagulation in stroke patients despite ongoing anticoagulation: rationale and design of the ADD-LAAO clinical trial |
| title_full | Left atrial appendage occlusion plus oral anticoagulation in stroke patients despite ongoing anticoagulation: rationale and design of the ADD-LAAO clinical trial |
| title_fullStr | Left atrial appendage occlusion plus oral anticoagulation in stroke patients despite ongoing anticoagulation: rationale and design of the ADD-LAAO clinical trial |
| title_full_unstemmed | Left atrial appendage occlusion plus oral anticoagulation in stroke patients despite ongoing anticoagulation: rationale and design of the ADD-LAAO clinical trial |
| title_short | Left atrial appendage occlusion plus oral anticoagulation in stroke patients despite ongoing anticoagulation: rationale and design of the ADD-LAAO clinical trial |
| title_sort | left atrial appendage occlusion plus oral anticoagulation in stroke patients despite ongoing anticoagulation rationale and design of the add laao clinical trial |
| topic | Left atrial appendage occlusion Recurrent stroke Oral anticoagulation Direct oral anticoagulation |
| url | https://recintervcardiol.org/en/index.php?option=com_content&view=article&id=2668 |
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