P5333Dual antithrombotic therapy with dabigatran vs triple therapy with warfarin after PCI in patients with atrial fibrillation and diabetes mellitus (a RE-DUAL PCI subgroup analysis)

Abstract

BACKGROUND: Patients with diabetes and coronary artery disease have a higher risk of major adverse cardiac and cerebral events than patients without diabetes. In the RE‐DUAL PCI™ trial (NCT02164864), dual therapy with dabigatran was compared with triple antithrombotic therapy with warfarin in patients with atrial fibrillation (AF) who underwent percutaneous coronary intervention (PCI). OBJECTIVE: The aim of this post‐hoc subgroup analysis of the RE‐DUAL PCI trial was to assess if patients with diabetes and AF, who underwent PCI, are adequately protected against bleeding events by dual versus triple antithrombotic therapy while remaining protected against thromboembolic events. ENDPOINTS The treatment effects of dabigatran dual therapies and warfarin triple therapy on the risk of the following two endpoints were assessed during follow‐up (mean follow‐up, 14 months) in patients with or without diabetes: Safety: a first International Society on Thrombosis and Haemostasis (ISTH) major bleeding event (MBE) or clinically relevant non‐major bleeding event (CRNMBE) Efficacy: a composite of death, thromboembolic event (stroke, myocardial infarction and systemic embolism), or unplanned revascularization. RESULTS: Study Outcomes No interaction between treatment and diabetes subgroup could be observed, neither for the bleeding nor for the composite efficacy endpoint. The risk of bleeding (first ISTH MBE or CRNMBE) was lower with dabigatran 110 mg dual therapy and dabigatran 150 mg dual therapy compared with warfarin triple therapy in patients with and without diabetes (Figure 2). Diabetes subgroup did not change the treatment effect of dabigatran dual therapy (110 mg or 150 mg) versus warfarin triple therapy with regard to the composite efficacy endpoint. CONCLUSIONS: Results of this post‐hoc subgroup analysis are consistent with the overall study results. The risk of bleeding was lower with dabigatran 110 and 150 mg dual therapy compared with warfarin triple therapy, irrespective of the presence/absence of diabetes. Dabigatran 110 and 150 mg dual therapy had a comparable risk of overall thromboembolic events compared with warfarin triple therapy regardless of the diabetes subgroup. (Figure Presented).