RE-DUAL PCI Trial Summary

RE-DUAL PCI trial was a multi-center, randomized trial that compared the outcomes of triple and dual therapy as well as warfarin and dabigatran. Patients with AF who have undergone PCI (N=2,725) were randomly assigned to either triple therapy (aspirin, warfarin and a P2Y12 inhibitor) or dual therapy (dabigatran 150mg BD or 110mg BD and a P2Y12 inhibitor). In the triple therapy group, aspirin was discontinued 1 month in those who received a bare metal stent and after 3 months in those who received a drug eluting stent. In the warfarin group, the dose of warfarin was adjusted to maintain the INR between 2 and 3. It is important to note that elderly patients outside of the US were assigned to either the 110mg BD group or warfarin group (not dabigatran 150mg BD).

The primary end-point of the study was the first ISTH major bleed or clinically relevant non-major bleed. The trial also tested for noninferiority in the efficacy of dual therapy with dabigatran (both doses combined) to triple therapy with warfarin and the occurrence of a composite of MI, stroke, systemic embolization, death, or unplanned revascularization. The mean duration of treatment with the anticoagulants was 12.3 months, and the mean follow up was 14.0 months. Of the patients enrolled, 50.5% received a PCI for ACS. Most patients received clopidogrel, and only 12.0% received ticagrelor. In the triple therapy group, the mean percentage of time within the therapeutic INR range was 64%

Compared with the warfarin group, the primary safety endpoint occurred in a smaller proportion of the dual therapy group with 110mg BD of dabigatran (15.4%, HR 0.52, 95% CI 0.42-0.63, P<0.001), followed by the 150mg BD group (20.2%, HR 0.72, 95% CI 0.58-0.88, P<0.001). The incidence of the primary endpoint in the warfarin group was 26.9% in all patients and 25.7% when excluding elderly patients outside the US. The incidence of the composite efficacy endpoint in the combined dabigatran group and triple therapy groups were 13.7% and 13.4% respectively (HR 1.04, 95% CI 0.84-1.29, P=0.005 for noninferiority).

Summarized by Dr. Tarek Nafee