Effectiveness and safety of dabigatran in Latin American patients with atrial fibrillation: Two years follow up results from GLORIA-AF registry

Sergio Dubner; José Francisco Kerr Saraiva; Juan Carlos Nunez Fragoso; Gonzalo Barón-Esquivias; Christine Teutsch; Venkatesh Kumar Gurusamy; Sabrina Marler; Menno V Huisman; Gregory Y H Lip; Cecilia Zeballos

doi:10.1016/j.ijcha.2020.100666

Effectiveness and safety of dabigatran in Latin American patients with atrial fibrillation: Two years follow up results from GLORIA-AF registry

Int J Cardiol Heart Vasc. 2020 Nov 3:31:100666. doi: 10.1016/j.ijcha.2020.100666. eCollection 2020 Dec.

Affiliations

¹ Clinica y Maternidad Suizo Argentino Buenos Aires, Argentina.
² Pontificia Universidade Catolica de Campinas, Santa Cândida Campina.
³ Hospital General Regional No. 1, Tijuana, BC, Mexico.
⁴ Cardiology and Cardiac Surgery Department. Hospital Universitario Virgen del Rocío. Universidad de Sevilla Institution, Seville, Spain.
⁵ Boehringer Ingelheim International GmbH, Ingelheim am Rhein, Germany.
⁶ Boehringer Ingelheim Inc., Ridgefield, CT, USA.
⁷ Leiden University Medical Center, Leiden, the Netherlands.
⁸ Liverpool Centre for Cardiovascular Science, University of Liverpool, and Liverpool Heart and Chest Hospital, Liverpool, UK.
⁹ Aalborg Thrombosis Research Unit, Department of Clinical Medicine, Aalborg University, Aalborg, Denmark.
¹⁰ Boehringer Ingelheim SA, Buenos Aires, Argentina.

Abstract

Background: Real-world data from different regions are needed to support the external validity of controlled trials and assess the impact of new oral anticoagulants (NOAC) in clinical practice.

Methods: "GLORIA-AF" is a large, ongoing, multicenter, global, prospective registry program in patients with newly diagnosed non-valvular atrial fibrillation (NVAF) at risk of stroke. Newly diagnosed patients with NVAF (within 4.5 months) and a CHA₂DS₂-VASc score ≥ 1 were consecutively enrolled. The study objective was to estimate the incidence rate of stroke and major bleeding after a two year follow up of patients on dabigatran that participated in the "GLORIA-AF" study (Phase II) in Latin America.

Results: Latin America included 378 eligible patients that received dabigatran in eight countries (Argentina, Brazil, Chile, Colombia, Ecuador, Mexico, Perú, and Venezuela): 56.3% were male; mean age was 70.3 ± 10.8 years; 43.4% had paroxysmal AF; 36.0% persistent AF and 20.6% permanent AF. Mean CHA₂DS₂-VASc score was 3.2 ± 1.4; mean HAS-BLED score was 1.2 ± 0.8. Incidence rates for clinical events after 2-years of follow-up per 100 patient-years were as follows: stroke 0.33 (95% CI: 0.04-1.17), major bleeding 0.49 (95% CI: 0.10-1.42) and all-cause death 4.06 (95% CI: 2.63-6.00). Persistence with dabigatran at 6, 12 and 24 months was 91%, 86%, and 80%, respectively.

Conclusion: These regional data shows the sustained safety and effectiveness of dabigatran over two years of follow-up, consistent with already available evidence. An increase in accessibility and incorporation of NOAC to anticoagulant treatment strategies could potentially have a positive impact on AF stroke prevention in Latin America.

Keywords: Dabigatran; Latin America (LA); New oral anticoagulants (NOAC); Non-valvular atrial fibrillation (NVAF).