TY - JOUR
T1 - Low bleeding and thromboembolic risk with continued dabigatran during cardiovascular interventions
T2 - the GLORIA-AF study
AU - van der Wall, Sake J.
AU - Lip, Gregory Y.H.
AU - Teutsch, Christine
AU - Kalejs, Oskars
AU - Lyrer, Philippe
AU - Hall, Christian
AU - Dubner, Sergio J.
AU - Diener, Hans Christoph
AU - Halperin, Jonathan L.
AU - Ma, Chang Sheng
AU - Rothman, Kenneth J.
AU - Zint, Kristina
AU - Zhai, Dongmei
AU - Huisman, Menno V.
AU - GLORIA-AF Investigators
N1 - Funding Information:
Editorial support in formatting the manuscript was provided by Parexel, with funding from Boehringer Ingelheim. The authors thank the patients who participated in this trial, their families, the investigators, study coordinators, study teams, and nurses.
Publisher Copyright:
© 2021
PY - 2021/9
Y1 - 2021/9
N2 - Background: Prospective data on nonvitamin-K-antagonist oral anticoagulant (NOAC) management during cardiovascular interventions are limited. We therefore evaluated the safety and effectiveness of uninterrupted dabigatran therapy as well as dabigatran management during atrial fibrillation (AF)-cardioversions, AF-ablations, pacemaker implantations and coronary angiography and/or stenting procedures. Method: GLORIA-AF is an international registry programme involving patients with newly diagnosed AF. Dabigatran users were followed for ≤2 years. The primary outcome was occurrence of stroke/systemic embolism and major bleeding ≤8 weeks after a cardiovascular intervention during uninterrupted dabigatran therapy. Results: During the 2-year follow-up, 599 cardiovascular interventions were identified in 479 eligible patients. 412/599 (69%) interventions were performed with uninterrupted dabigatran therapy: 299/354 (84%) AF-cardioversions, 38/89 (43%) AF-ablations, 25/58 (43%) pacemaker implantations, and 50/98 (51%) coronary angiography and/or stenting procedures. During an average follow-up of 8.4 weeks after intervention, one major bleed and one systemic embolic event occurred (risk 0.25% for both outcomes; 95% confidence interval, 0.01%-1.36%). Conclusions: More than two thirds of the interventions were performed with uninterrupted dabigatran therapy, of which most were AF-cardioversions. Uninterrupted dabigatran therapy was associated with low major bleeding and stroke/systemic embolism risk, supporting the favourable safety and effectiveness profile of dabigatran in clinical practice-based settings.
AB - Background: Prospective data on nonvitamin-K-antagonist oral anticoagulant (NOAC) management during cardiovascular interventions are limited. We therefore evaluated the safety and effectiveness of uninterrupted dabigatran therapy as well as dabigatran management during atrial fibrillation (AF)-cardioversions, AF-ablations, pacemaker implantations and coronary angiography and/or stenting procedures. Method: GLORIA-AF is an international registry programme involving patients with newly diagnosed AF. Dabigatran users were followed for ≤2 years. The primary outcome was occurrence of stroke/systemic embolism and major bleeding ≤8 weeks after a cardiovascular intervention during uninterrupted dabigatran therapy. Results: During the 2-year follow-up, 599 cardiovascular interventions were identified in 479 eligible patients. 412/599 (69%) interventions were performed with uninterrupted dabigatran therapy: 299/354 (84%) AF-cardioversions, 38/89 (43%) AF-ablations, 25/58 (43%) pacemaker implantations, and 50/98 (51%) coronary angiography and/or stenting procedures. During an average follow-up of 8.4 weeks after intervention, one major bleed and one systemic embolic event occurred (risk 0.25% for both outcomes; 95% confidence interval, 0.01%-1.36%). Conclusions: More than two thirds of the interventions were performed with uninterrupted dabigatran therapy, of which most were AF-cardioversions. Uninterrupted dabigatran therapy was associated with low major bleeding and stroke/systemic embolism risk, supporting the favourable safety and effectiveness profile of dabigatran in clinical practice-based settings.
KW - Cardiovascular
KW - Dabigatran
KW - Interventions
KW - Nonvitamin-K-antagonist
KW - Oral anticoagulant
UR - http://www.scopus.com/inward/record.url?scp=85107821409&partnerID=8YFLogxK
U2 - 10.1016/j.ejim.2021.05.020
DO - 10.1016/j.ejim.2021.05.020
M3 - Article
C2 - 34120814
AN - SCOPUS:85107821409
SN - 0953-6205
VL - 91
SP - 75
EP - 80
JO - European Journal of Internal Medicine
JF - European Journal of Internal Medicine
ER -