Rationale and design of a randomized clinical trial to compare two antithrombotic strategies after left atrial appendage
- PDF / 343,549 Bytes
- 7 Pages / 595.276 x 790.866 pts Page_size
- 41 Downloads / 178 Views
Rationale and design of a randomized clinical trial to compare two antithrombotic strategies after left atrial appendage occlusion: double antiplatelet therapy vs. apixaban (ADALA study) Eduardo Josué Flores-Umanzor 1 & Pedro L. Cepas-Guillen 1 & Dabit Arzamendi 2 & Ignacio Cruz-González 3 & Ander Regueiro 1 & Xavier Freixa 1 Received: 6 July 2020 / Accepted: 21 September 2020 # Springer Science+Business Media, LLC, part of Springer Nature 2020
Abstract Background Data on antithrombotic therapy after percutaneous left atrial appendage occlusion (LAAO) is scarce and no randomized evaluation has been performed to demonstrate what is the best antithrombotic strategy. Up to date, different antithrombotic regimens with variable durations are currently used. In fact, the use of oral anticoagulation (OAC) or dual antiplatelet therapy (DAPT) with aspirin and clopidogrel during the initial phase (∓ 3 months postLAAO) has been proposed as valid strategies. However, antiplatelet and OAC therapies have never been compared in a randomized study after left atrial appendage closure (LAAC). The purpose of the present study is to ascertain an optimal antithrombotic strategy after LAAC in terms of safety and efficacy. The study will compare a novel OAC (NOAC) with a highly safety profile like apixaban 5 mg/12 h or 2.5 mg/12 h (after dose adjustment or in high-risk patients) with standard antiplatelet therapy with DAPT. The aim of the study was to compare a strategy of anticoagulation with apixaban 5 mg/2.5 mg bid to the current standard of care (DAPT with aspirin and clopidogrel) after LAAO in patients with non-valvular atrial fibrillation (AF). Methods This is a phase IV multicenter randomized, open-label, controlled trial comparing the efficacy and safety of apixaban vs. DAPT after LAAO, both for 3 months. The primary endpoint is a combined endpoint of death, myocardial infarction, stroke, thromboembolic complications, and major or significant bleeding at 3 months of follow-up. Approximately 160 subjects will be enrolled and followed 12 months from randomization. Conclusions Considering the high risk of both thromboembolic and hemorrhagic events of patients undergoing LAAO, establishment of an appropriate antithrombotic therapy in terms of efficacy and safety after LAAO is of vital importance. Trial registration EudraCT number: 2018-001013-32 Keywords LAA . Atrial Fibrillation . Stroke . Oral Anticoagulation
1 Introduction Non-valvular heart disease (non-VHD) atrial fibrillation (AF) is the most common rhythm disturbance in clinical
* Xavier Freixa [email protected] 1
Cardiology Department, Cardiovascular Institute, Hospital Clinic, University of Barcelona, C/Villarroel, 170, 08036 Barcelona, Spain
2
Cardiology Department, Hospital Universitari de la Santa Creu i Sant Pau, Barcelona, Spain
3
University Hospital of Salamanca, Institute of Biomedical Research in Salamanca (IBSAL), Faculty of Medicine, University of Salamanca, CIBERCV, Salamanca, Spain
practice. Its incidence is correlated with age; therefore, a significant
Data Loading...
