Key result
Over 2 years of follow-up, dabigatran use in Latin American patients with non-valvular atrial fibrillation was associated with a stroke incidence rate of 0.33 per 100 patient-years (95% CI 0.04-1.17).
Why the study?
Real-world data from different regions are needed to support the external validity of controlled trials and evaluate the impact of NOACs in clinical practice.
Does dabigatran prevent stroke and major bleeding in Latin American patients with newly diagnosed non-valvular atrial fibrillation?
Observational (n=378)
Yes
Does dabigatran prevent stroke and major bleeding in Latin American patients with newly diagnosed non-valvular atrial fibrillation?
In a real-world Latin American registry, dabigatran demonstrated sustained safety and effectiveness with low rates of stroke and major bleeding over 2 years in patients with newly diagnosed non-valvular atrial fibrillation.
Low stroke rates with dabigatran in Latin American NVAF may inform prescribing; leaves open need for randomized regional comparisons.
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. “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. 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. 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.
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Dubner et al. (2020) conducted an observational in non-valvular atrial fibrillation (n=378). Dabigatran was evaluated on stroke (95% CI 0.04-1.17). Over 2 years of follow-up, dabigatran use in Latin American patients with non-valvular atrial fibrillation was associated with a stroke incidence rate of 0.33 per 100 patient-years (95% CI 0.04-1.17).