- Compared with warfarin triple therapy, both dabigatran 110 mg and 150 mg dual therapy resulted in substantial reduction in bleeding risks consistently across subgroups of patients with atrial fibrillation (Afib) with acute coronary syndrome (ACS) or elective percutaneous coronary intervention (PCI), and in those treated with ticagrelor or clopidogrel.
Why this matters
- The RE-DUAL PCI trial showed a reduced risk of major or clinically relevant non-major bleeding events with dabigatran (at both 110 mg and 150 mg) dual therapy without aspirin, and non-inferiority for overall thromboembolic events with dabigatran (both doses combined) dual therapy compared with triple therapy (warfarin + aspirin + P2Y12 inhibitor).
- A sub-group analysis evaluated dabigatran dual vs warfarin triple therapy in pre-specified patient subgroups with ACS or elective PCI, and those receiving ticagrelor or clopidogrel.
- Sub-group analysis of the RE-DUAL PCI trial.
- RE-DUAL PCI: 2725 patients with Afib after PCI were randomly assigned to receive 110/150 mg dabigatran + P2Y12 inhibitor (dual therapy) or warfarin + P2Y12 inhibitor + aspirin (triple therapy).
- Primary endpoint was time to first major or clinically relevant non-major bleeding event.
- Funding: Boehringer Ingelheim International GmbH.
- The risk of the primary endpoint was reduced with both dabigatran dual therapies compared with warfarin triple therapy in the following subgroups of patients.
- Patients with ACS
- Dabigatran 110 mg: HR, 0.47; 95% CI, 0.35-0.63
- Dabigatran 150 mg: HR, 0.67; 95% CI, 0.50-0.90
- Elective PCI
- Dabigatran 110 mg: HR, 0.57; 95% CI, 0.43-0.76
- Dabigatran 150 mg: HR, 0.76; 95% CI, 0.56-1.03
- Receiving ticagrelor
- Dabigatran 110 mg: HR, 0.46; 95% CI, 0.28-0.76
- Dabigatran 150 mg: HR, 0.59; 95% CI, 0.34-1.04
- Receiving clopidogrel
- Dabigatran 110 mg: HR, 0.51; 95% CI, 0.41-0.64
- Dabigatran 150 mg: HR, 0.73; 95% CI, 0.58-0.91
- Patients with ACS
- For the composite efficacy endpoint (death, thromboembolic events, or unplanned revascularisation), minor variations were observed for dabigatran 110 or 150 mg dual therapy vs warfarin triple across all subgroups (interaction P-values non-significant).
- Confidence intervals were wider than in the main study as formal statistical testing of each individual subgroups was not possible.