Cannon CP, Bhatt DL, Oldgren J, et al. Dual Antithrombotic Therapy with Dabigatran after PCI in Atrial Fibrillation. N Engl J Med. 2017 Aug 27 [Epub ahead of print].
Pablo Avanzas, Consultant in Interventional Cardiology, Hospital Universitario Central de Asturias
The RE-DUAL PCI trial showed that among patients with atrial fibrillation who had undergone PCI, two different regimens of full-dose anticoagulation therapy with dabigatran (either 110 mg or 150 mg twice daily) plus a P2Y12 inhibitor (clopidogrel or ticagrelor) resulted in a risk of major or clinically relevant non major bleeding events. This was however significantly lower than the risk associated with triple therapy (two antiplatelet agents and warfarin); furthermore, dual therapy with dabigatran was noninferior to triple therapy with warfarin with respect to the composite efficacy end point including thromboembolic events, death, or unplanned revascularization.
The results of this trial are clinically relevant as many people with atrial fibrillation have coronary artery disease that may require PCI with stenting. Until now, there has been limited research on the use of novel oral anticoagulants in this setting.
The strategies for dual therapy with dabigatran differ from previous standard of care (triple therapy with clopidogrel and warfarin). Firstly, they evaluated two doses of dabigatran, each of which has been approved worldwide for stroke prevention and have been shown to be safe and efficacious. The benefits of the treatment with respect to lower rates of bleeding parallel those seen previously in the RE-LY trial (Randomized Evaluation of Long-Term Anticoagulant Therapy) but appear to have been amplified in this patient population, who had a particularly high risk of bleeding and in whom aspirin was discontinued after PCI, at the time of randomization. As such, the RE-DUAL PCI trial is a large randomized trial that validates the concept put forth in the WOEST trial (What is the Optimal Antiplatelet and Anticoagulant Therapy in Patients with Oral Anticoagulation and Coronary Stenting), but with greater statistical power. Secondly, this trial adds information regarding the use of ticagrelor in this context (12% of the patients in this trial received clopidogrel). At this point, we should remember that recent recommendations included in the ‘2017 ESC focused update on dual antiplatelet therapy in coronary artery disease’, also released during the ESC congress, include the use of prasugrel or ticagrelor as part of the triple therapy strategy, as a III class recommendation (should be avoided).