Should Left Atrial Appendage Occlusion Devices Be Routinely Used Instead of Oral Anticoagulants to Prevent Thromboembolic Events, Stroke, and Bleeding for Patients With Non‐Valvular Atrial Fibrillation?

INTRODUCTION: Oral anticoagulants (OACs), preferably direct (D)/non-vitamin K (N) dependent OACs [DOACs/NOACs] are recommended for the management of patients with non-valvular atrial fibrillation (AF) at risk for thromboembolic events, including stroke. Left atrial appendage occlusion (LAAO) device implantation has been considered for patients who are unsuitable for OACs or prefer not to take them. Herein, we discuss the clinical evidence for routine use of LAAO instead of OACs for patients with AF at risk of thromboembolic events, stroke, and bleeding. METHOD: From pertinent, recent, randomized clinical trials, the CHAMPION-AF (Watchman Flx vs. NOAC for Embolic Protection in the Management of Patients with Non-Valvular Atrial Fibrillation), and CLOSURE-AF (Catheter-Based Left Atrial Appendage Closure in Patients with Atrial Fibrillation at High Risk of Stroke and Bleeding as Compared with Best Medical Therapy) were selected for review. RESULTS: As interpreted by the authors of the CHAMPION-AF trial, LAAOs were considered non-inferior to NOACs at 3 years. In the CLOSURE-AF trial, non-inferiority criteria were not met. For safety, that is, bleeding, LAAO was considered superior in CHAMPION-AF. We found several points related to both trials that are critical to interpret the results and clinical implications of these trials. These points are particularly related to the interpretation of non-inferiority trial design, selection bias, combined primary endpoint, bleeding and peri-procedural bleeding complications, serious adverse events, cross-over rates, sub-group analyses, conflicts of interest, and mechanism of stroke. CONCLUSION: Data from the CHAMPION-AF and CLOSURE trials do not favor routine and widespread use of LAAO devices in non-valvular AF patients over use of OACs.