RE-DUAL PCI (the Randomized Evaluation of Dual Antithrombotic Therapy With Dabigatran vs Triple Therapy With Warfarin in Patients With Nonvalvular Atrial Fibrillation Undergoing Percutaneous Coronary Intervention) has shown a significant reduction in the incidence of bleeding complications in patients with non-valvular atrial fibrillation (AF) undergoing stent placement in patients receiving dabigatran dual therapy (dabigatran, plus clopidogrel or ticagrelor) compared to those receiving warfarin triple therapy (warfarin, plus clopidogrel or ticagrelor, and aspirin).
Approximately 20–30% of patients with AF, who are continuously taking an oral anticoagulant to reduce their risk of AF-related stroke, have coexisting coronary artery disease and may require PCI. The current practice of administering triple therapy with warfarin and two antiplatelet agents in patients with AF after a PCI is associated with high rates of major bleeding. RE-DUAL PCI tested an alternative treatment strategy: dual therapy with dabigatran and a single antiplatelet agent (P2Y12 inhibitor).
Selected for one of the meeting’s hotline sessions and simultaneously published in the New England Journal of Medicine (https://doi.org/10.1056/NEJMoa1708454), the results were presented by Lead Investigator Dr Christopher Cannon, (Brigham and Women’s Hospital, Boston, MA, USA). The study – carried out in 2,725 patients – showed significantly lower rates of major or clinically relevant non-major bleeding events (the primary end point) for dual therapy with dabigatran 110 mg and 150 mg twice daily (BD) when compared to triple therapy with warfarin.
Incidence of major or clinically relevant non-major bleeding events was:
- 15.4% for dabigatran 110 mg BD dual therapy versus 26.9% for warfarin triple therapy (hazard ratio [HR] 0.52, p <0.001), which translates into a 48% reduction in risk with dual therapy (absolute risk reduction [ARR] 11.5%)
- 20.2% for dabigatran 150 mg BD dual therapy versus 25.7% for warfarin triple therapy (HR 0.72, p = 0.002), which translates into a 28% reduction in risk with dual therapy (ARR 5.5%)
There were similar rates of overall thromboembolic events in the study. Both dabigatran doses are approved for stroke prevention in non-valvular AF.
The incidence of the key secondary end points (composite of death, myocardial infarction, stroke, systemic embolism or unplanned revascularisation) showed similar rates of events: 13.7% for the two dabigatran dual therapy groups combined, versus 13.4% for warfarin triple therapy.
“For physicians treating patients with atrial fibrillation who have undergone percutaneous coronary intervention with stent placement, it is paramount to balance the efficacy required with the risk of bleeding,” said Dr Cannon. “Previously we have had limited data on non-vitamin K oral anticoagulants in this setting; we hope the results from RE-DUAL PCI on dual therapy with dabigatran will be helpful to clinicians caring for these patients.”
UK RE-DUAL PCI trial centre lead Professor Greg Lip, (Birmingham University) commenting on the results said: “Cardiologists face the daily challenge of choosing medicines that ensure their patients with AF and coronary disease have both their risk of stroke and risk of stent thrombosis managed without exposing them to high risks of bleeding.”
“The results from this study will give clinicians confidence when using either of the two doses of dabigatran available in the UK to reduce the risk of stroke in patients with AF when needed in combination with antiplatelet agents after PCI. The improved safety profile and similar efficacy for both doses of dabigatran in a dual approach will give UK clinicians confidence to move away from a triple therapy regimen with warfarin and two antiplatelet agents which is our current standard of care”, he concluded.
You can find all of our reports from the ESC 2017 here.