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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)

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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 post-LAAO) 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

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Funding

The ADALA study is funded by a competitive grant from Bristol Myers Squibb/Pfizer Alliance, within the European Thrombosis Investigator–Initiated Research Program (ERISTA). Eduardo Flores-Umanzor received an Interventional Cardiology Scholarship from Dr. Alfonso Medina of the Spanish Society of Cardiology. The funders had no role in the design and conduct of the study including collection, management, analysis, and interpretation of the data.

Author information

Authors and Affiliations

  1. Cardiology Department, Cardiovascular Institute, Hospital Clinic, University of Barcelona, C/Villarroel, 170, 08036, Barcelona, Spain

    Eduardo Josué Flores-Umanzor, Pedro L. Cepas-Guillen, Ander Regueiro & Xavier Freixa

  2. Cardiology Department, Hospital Universitari de la Santa Creu i Sant Pau, Barcelona, Spain

    Dabit Arzamendi

  3. University Hospital of Salamanca, Institute of Biomedical Research in Salamanca (IBSAL), Faculty of Medicine, University of Salamanca, CIBERCV, Salamanca, Spain

    Ignacio Cruz-González

Authors
  1. Eduardo Josué Flores-Umanzor
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  2. Pedro L. Cepas-Guillen
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  3. Dabit Arzamendi
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  4. Ignacio Cruz-González
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  5. Ander Regueiro
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  6. Xavier Freixa
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Contributions

All authors had access to the data and played a role in writing this manuscript.

Corresponding author

Correspondence to Xavier Freixa.

Ethics declarations

The study was approved by the Ethics Committee of each center and adhered to the principles outlined in the Declaration of Helsinki.

Conflict of interest

XF, IC, and DA are proctors for Abbott Medical.

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Flores-Umanzor, E.J., Cepas-Guillen, P.L., Arzamendi, D. et al. 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). J Interv Card Electrophysiol 59, 471–477 (2020). https://doi.org/10.1007/s10840-020-00884-x

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