"Dual Antithrombotic Therapy with Dabigatran after PCI in Atrial Fibrillation".The New England Journal of Medicine. 2017. 377(16):1513-1524.
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Contents
1Clinical Question 2Bottom Line 3Major Points 4Guidelines 5Design 6Population 6.1Inclusion Criteria 6.2Exclusion Criteria 6.3Baseline Characteristics 7Interventions 8Outcomes 8.1Primary Outcome 8.2Secondary Outcomes 9Criticisms 10Funding 11Further Reading
In patients with atrial fibrillation who have undergone percutaneous coronary intervention (PCI), does dual antithrombotic therapy with dabigatran reduce the risk of bleeding compared to triple therapy with warfarin?
Dual antithrombotic therapy with dabigatran plus a P2Y12 inhibitor (clopidogrel or ticagrelor) after PCI in patients with atrial fibrillation was associated with a lower risk of bleeding events compared to triple therapy with warfarin, a P2Y12 inhibitor, and aspirin. Dual therapy with dabigatran was also noninferior to triple therapy with warfarin with respect to risk of thromboembolic events.
Triple antithrombotic therapy, with warfarin, a P2Y12 inhibitor, and aspirin, is traditionally indicated post-PCI for patients with atrial fibrillation but is notably associated with a high bleeding risk. The RE-DUAL PCI trial tested whether dual therapy with dabigatran and a P2Y12 inhibitor (clopidogrel or ticagrelor) could lower bleeding risk while maintaining noninferior efficacy in the prevention of thromboembolic events.
Current guidelines now consider dual antithrombotic therapy as an option in this patient population (class IIb recommendation), supported by RE-DUAL PCI and other studies.
- Multicenter, randomized, open-label trial. - N=2,725 patients with atrial fibrillation who had undergone PCI. - Intervention groups: - Dual therapy: dabigatran (110 mg or 150 mg twice daily) + P2Y12 inhibitor (clopidogrel or ticagrelor). - Triple therapy: warfarin + a P2Y12 inhibitor + aspirin (stopped after 1 to 3 months). - Mean follow-up of 14 months. - Primary efficacy analysis: intention-to-treat.
Inclusion Criteria
- Adults ≥18 years with nonvalvular atrial fibrillation. - Successful PCI with a bare-metal or drug-eluting stent within the previous 120 hours.
Exclusion Criteria
- Bioprosthetic or mechanical heart valves, severe renal insufficiency, major coexisting conditions.
Baseline Characteristics
- Mean age: 70.8 years. - Acute coronary syndrome indication for 50.5% of patients. - Drug-eluting stents used in 82.6%.
- Randomization to dual therapy with dabigatran or triple therapy with warfarin. - Duration of aspirin component in triple therapy: 1 month for bare-metal stent, 3 months for drug-eluting stent.
Primary Outcome
- Lower incidence of major or clinically relevant nonmajor bleeding with dual therapy (both dabigatran doses) compared to triple therapy.
- Dual therapy was noninferior to triple therapy regarding thromboembolic events, death, or unplanned revascularization. - No significant difference in serious adverse events between the groups.
- The original protocol called for more patients than were enrolled, potentially limiting power to examine individual efficacy according to dabigatran dose. - Noninferiority margin was based on previous atrial fibrillation studies for a dissimilar endpoint. - Contributions of aspirin omission and oral anticoagulant type regarding outcome differences between dual and triple therapy could only be speculated.
Funded by Boehringer Ingelheim.
Please refer to the New England Journal of Medicine article and included references for more detailed information.