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Published on: February 28, 2012
Low bleeding and thromboembolic risk with continued dabigatran during cardiovascular interventions: the GLORIA-AF
Sake J van der Wall1, Gregory Y H Lip2, Christine Teutsch3
1Department of Thrombosis and Hemostasis, Leiden University Medical Center, Leiden, the Netherlands; Department of Cardiology, OLVG Hospital, Amsterdam, the Netherlands.
Insights
Uninterrupted dabigatran therapy is safe and effective for patients undergoing cardiovascular procedures like AF-cardioversions. This anticoagulant management showed low risks of stroke, systemic embolism, and major bleeding in a real-world setting.
Area of Science:
- Cardiology
- Pharmacology
- Clinical Trials
Background:
- Limited data exists on managing non-vitamin-K-antagonist oral anticoagulants (NOACs) during cardiovascular interventions.
- Assessing dabigatran's safety and effectiveness during procedures like atrial fibrillation (AF) cardioversions, ablations, and coronary interventions is crucial.
Purpose of the Study:
- To evaluate the safety and effectiveness of uninterrupted dabigatran therapy in patients undergoing various cardiovascular interventions.
- To analyze dabigatran management strategies during AF-cardioversions, AF-ablations, pacemaker implantations, and coronary angiography/stenting.
Main Methods:
- Prospective data collection from the international GLORIA-AF registry program.
- Follow-up of newly diagnosed AF patients on dabigatran for up to 2 years.
- Primary outcome assessment of stroke/systemic embolism and major bleeding within 8 weeks post-intervention.
Main Results:
- 69% of 599 cardiovascular interventions were performed with uninterrupted dabigatran.
- Low rates of major bleeding (0.25%) and systemic embolic events (0.25%) observed post-intervention.
- Most interventions with uninterrupted dabigatran were AF-cardioversions (84%).
Conclusions:
- Uninterrupted dabigatran therapy is frequently used and associated with low risks of major bleeding and thromboembolic events.
- These findings support dabigatran's favorable safety and effectiveness profile in real-world clinical practice.
- Further research may explore optimal dabigatran management across diverse cardiovascular procedures.
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.
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