Highlights
- •This is the largest study of dabigatran use during cardiovascular interventions in clinical practice from prospectively collected data.
- •Two thirds of the interventions were performed with uninterrupted dabigatran therapy, of which the majority included AF-cardioversions.
- •Continuation of dabigatran therapy during cardiovascular interventions was associated with low risk of major bleeding and stroke/systemic embolism.
Abstract
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.
Keywords
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Article info
Publication history
Published online: June 11, 2021
Accepted:
May 14,
2021
Received in revised form:
May 11,
2021
Received:
February 9,
2021
Identification
Copyright
© 2021 Published by Elsevier B.V. on behalf of European Federation of Internal Medicine.
