RE-DUAL PCI (dabigatran 150 mg BID)
Trial question
Is dual antithrombotic therapy with dabigatran superior to triple antithrombotic therapy with warfarin in AF?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
23.0% female
77.0% male
N = 1744
1744 patients (402 female, 1342 male).
Inclusion criteria: patients with AF who had undergone PCI to triple therapy.
Key exclusion criteria: bioprosthetic or mechanical heart valves; severe renal insufficiency or other major coexisting conditions.
Interventions
N=763 dual therapy with dabigatran (dabigatran at a dose of 150 mg BID plus a P2Y12 inhibitor and no aspirin).
N=981 triple therapy with warfarin (warfarin plus a P2Y12 inhibitor and aspirin for 1 to 3 months).
Primary outcome
Major or clinically relevant nonmajor bleeding event during follow-up
20.2%
25.7%
25.7 %
19.3 %
12.8 %
6.4 %
0.0 %
Dual therapy with
dabigatran
Triple therapy with
warfarin
Significant
decrease ▼
NNT = 18
Significant decrease in major or clinically relevant nonmajor bleeding event during follow-up (20.2% vs. 25.7%; HR 0.72, 95% CI 0.58 to 0.88).
Secondary outcomes
No significant difference in thromboembolic events, death, or unplanned revascularization (11.8% vs. 12.8%; HR 0.89, 95% CI 0.67 to 1.19).
No significant difference in thromboembolic events or death (7.9% vs. 7.9%; HR 0.97, 95% CI 0.68 to 1.39).
No significant difference in death (3.9% vs. 4.6%; HR 0.83, 95% CI 0.51 to 1.34).
Safety outcomes
Significant differences in major bleeding (5.6% vs. 8.4%), total bleeding (33.3% vs. 41.4%).
Conclusion
In patients with AF who had undergone PCI to triple therapy, dual therapy with dabigatran was superior to triple therapy with warfarin with respect to major or clinically relevant nonmajor bleeding event during follow-up.
Reference
Christopher P Cannon, Deepak L Bhatt, Jonas Oldgren et al. Dual Antithrombotic Therapy with Dabigatran after PCI in Atrial Fibrillation. N Engl J Med. 2017 Oct 19;377(16):1513-1524.
Open reference URL