A1 Refereed original research article in a scientific journal
The Impact of CHA(2)DS(2)-VASc and HAS-BLED Scores on Clinical Outcomes in the Amplatzer Amulet Study
Authors: Giuseppe Tarantini, Gianpiero D’Amico, Boris Schmidt, Patrizio Mazzone, Sergio Berti, Sven Fischer, Juha Lund, Matteo Montorfano, Paolo Della Bella, Simon Cheung Chi Lam, Ignacio Cruz-Gonzalez, Ryan Gage, Hong Zhao, Heyder Omran, Jacob Odenstedt, Jens Erik Nielsen-Kudsk
Publisher: ELSEVIER SCIENCE INC
Publication year: 2020
Journal:: JACC: Cardiovascular Interventions
Journal name in source: JACC-CARDIOVASCULAR INTERVENTIONS
Journal acronym: JACC-CARDIOVASC INTE
Volume: 13
Issue: 18
First page : 2099
Last page: 2108
Number of pages: 10
ISSN: 1936-8798
eISSN: 1876-7605
DOI: https://doi.org/10.1016/j.jcin.2020.06.003
Web address : https://www.sciencedirect.com/science/article/pii/S1936879820312875?via%3Dihub
OBJECTIVES The aim of this study was to evaluate the impact of CHA(2)DS(2)-VASc and HAS-BLED scores on ischemic and bleeding events of patients enrolled in the Amplatzer Amulet Observational Study.BACKGROUND Baseline CHA(2)DS(2)-VASc and HAS-BLED scores have been validated in atrial fibrillation patients to guide about anticoagulation but not in patients treated by left atrial appendage occlusion (LAAO).METHODS Subjects were stratified according to CHA(2)DS(2)-VASc and HAS-BLED scores. Clinical outcomes were collected through 2 years and adjudicated by an independent committee.RESULTS Subjects were considered at low (n = 156), moderate (n 715), and high (n 215) risk for ischemic stroke, corresponding to CHA(2)DS(2)-VASc scores of <3, 3 to 5, and >= 6, respectively. The annual rates of ischemic stroke were 1.1%, 2.0%, and 3.5%, respectively. When compared with the predicted rate, LAAO reduced the risk of ischemic stroke by 56%, 69%, and 68%. Device-related thrombus occurred in 0.7%, 1.5%, and 3.0% of subjects at tow, moderate, and high risk for ischemic stroke, respectively. The HAS-BLED score was <= 3 in 629 subjects and >3 in 456 subjects, respectively. Non-peri-procedural major bleeding was reduced by 11% and 9% compared with predicted rates in the low and high bleeding risk groups, respectively.CONCLUSIONS LAAO with the Amplatzer Amulet reduced the risk of ischemic stroke compared with the predicted rate, with a greater magnitude among patients at high thromboembolic risk without increasing the bleeding risk. (C) 2020 by the American College of Cardiology Foundation.