1. Lower rate of major bleeding in very high risk patients undergoing left atrial appendage occlusion: A propensity score-matched comparison with direct oral anticoagulant.
- Author
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Magnocavallo M, Della Rocca DG, Vetta G, Mohanty S, Gianni C, Polselli M, Rossi P, Parlavecchio A, Fazia MV, Guarracini F, De Vuono F, Bisignani A, Pannone L, Raposeiras-Roubín S, Lochy S, Cauti FM, Burkhardt JD, Boveda S, Sarkozy A, Sorgente A, Bianchi S, Chierchia GB, de Asmundis C, Al-Ahmad A, Di Biase L, Horton RP, and Natale A
- Subjects
- Humans, Male, Female, Aged, Administration, Oral, Risk Assessment methods, Hemorrhage chemically induced, Hemorrhage epidemiology, Stroke prevention & control, Stroke etiology, Stroke epidemiology, Risk Factors, Follow-Up Studies, Prospective Studies, Incidence, Treatment Outcome, Thromboembolism prevention & control, Thromboembolism etiology, Thromboembolism epidemiology, Aged, 80 and over, Atrial Fibrillation complications, Atrial Fibrillation drug therapy, Atrial Appendage surgery, Propensity Score, Anticoagulants administration & dosage, Anticoagulants therapeutic use
- Abstract
Background: Long-term oral anticoagulation is the mainstay therapy for thromboembolic (TE) prevention in patients with atrial fibrillation. However, left atrial appendage occlusion (LAAO) could be a safe alternative to direct oral anticoagulants (DOACs) in patients with a very high TE risk profile., Objective: The purpose of this study was to compare the safety and efficacy of LAAO vs DOACs in patients with atrial fibrillation at very high stroke risk (CHA
2 DS2 -VASc [congestive heart failure, hypertension, age ≥ 75 years, diabetes mellitus, prior stroke or transient ischemic attack or thromboembolism, vascular disease, age 65-74 years, sex category] score ≥ 5)., Methods: Data from patients with CHA2 DS2 -VASc score ≥ 5 were extracted from a prospective multicenter database. To attenuate the imbalance in covariates between groups, propensity score matching was used (covariates: CHA2 DS2 -VASc and HAS-BLED [hypertension, abnormal renal or liver function, stroke, bleeding, labile international normalized ratio, elderly, drugs or alcohol] scores), which resulted in a matched population of 277 patients per group. The primary end point was a composite of cardiovascular death, TE events, and clinically relevant bleeding during follow-up., Results: Of 2381 patients, 554 very high risk patients were included in the study (mean age 79 ± 7 years; CHA2 DS2 -VASc score 5.8 ± 0.9; HAS-BLED score 3.0 ± 0.9). The mean follow-up duration was 25 ± 11 months. A higher incidence of the composite end point was documented with DOACs compared with LAAO (14.9 events per 100 patient-years in the DOAC group vs 9.4 events per 100 patient-years in the LAAO group; P = .03). The annualized clinically relevant bleeding risk was higher with DOACs (6.3% vs 3.2%; P = .04), while the risk of TE events was not different between groups (4.1% vs 3.2%; P = .63)., Conclusion: In high-risk patients, LAAO had a similar stroke prevention efficacy but a significantly lower risk of clinically relevant bleeding when compared with DOACs. The clinical benefit of LAAO became significant after 18 months of follow-up., Competing Interests: Disclosures Dr Burkhardt is a consultant for Biosense Webster and Stereotaxis. Dr Chierchia has received compensation for teaching purposes and proctoring from Medtronic, Abbott, Biotronik, Boston Scientific, and Acutus Medical. Dr de Asmundis has received research grants on behalf of the center from Biotronik, Medtronic, Abbott, LivaNova, Boston Scientific, AtriCure, Philips, and Acutus Medical and compensation for teaching purposes and proctoring from Medtronic, Abbott, Biotronik, LivaNova, Boston Scientific, AtriCure, Acutus Medical, and Daiichi Sankyo. Dr Di Biase is a consultant for Biosense Webster, Boston Scientific, Stereotaxis, and St. Jude Medical. Dr Di Biase has received speaker honoraria/travel support from Medtronic, Bristol Meyers Squibb, Pfizer, and Biotronik. Dr Natale has received speaker honoraria from Boston Scientific, Biosense Webster, St. Jude Medical, Biotronik, and Medtronic and is a consultant for Biosense Webster, St. Jude Medical, and Janssen. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2024 Heart Rhythm Society. Published by Elsevier Inc. All rights reserved.)- Published
- 2024
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