TY - JOUR
T1 - Effectiveness and safety of dabigatran in Latin American patients with atrial fibrillation
T2 - Two years follow up results from GLORIA-AF registry
AU - Dubner, Sergio
AU - Saraiva, José Francisco Kerr
AU - Fragoso, Juan Carlos Nunez
AU - Barón-Esquivias, Gonzalo
AU - Teutsch, Christine
AU - Gurusamy, Venkatesh Kumar
AU - Marler, Sabrina
AU - Huisman, Menno V.
AU - Lip, Gregory Y.H.
AU - Zeballos, Cecilia
N1 - © 2020 The Authors.
PY - 2020/12
Y1 - 2020/12
N2 - 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.
AB - 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.
KW - Dabigatran
KW - Latin America (LA)
KW - New oral anticoagulants (NOAC)
KW - Non-valvular atrial fibrillation (NVAF)
UR - http://www.scopus.com/inward/record.url?scp=85094872141&partnerID=8YFLogxK
U2 - 10.1016/j.ijcha.2020.100666
DO - 10.1016/j.ijcha.2020.100666
M3 - Journal article
C2 - 33195793
AN - SCOPUS:85094872141
SN - 2352-9067
VL - 31
JO - IJC Heart and Vasculature
JF - IJC Heart and Vasculature
M1 - 100666
ER -