The Impact of CHA2DS2-VASc and HAS-BLED Scores on Clinical Outcomes in the Amplatzer Amulet Study
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, 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
Abstract
Objectives: The aim of this study was to evaluate the impact of CHA2DS2-VASc and HAS-BLED scores on ischemic and bleeding events of patients enrolled in the Amplatzer Amulet Observational Study.
Background: Baseline CHA2DS2-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 CHA2DS2-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 CHA2DS2-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 low, 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. (Amplatzer™Amulet™ Post-Market Study [Amulet™PMS]; NCT02447081).
Keywords: Amplatzer Amulet occluder; atrial fibrillation; left atrial appendage closure.
Copyright © 2020 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.
Source: PubMed