Dabigatran – The End of ‘Coumadin Clinics’?

Bradley P. Knight, MD, FACC, FHRS, Editor-in-Chief
Bradley P. Knight, MD, FACC, FHRS, Editor-in-Chief
Dear Readers, Patients with atrial fibrillation (AF) can be at high risk of stroke. Warfarin therapy reduces that risk by about 70%. However, the limitations of anticoagulation therapy using warfarin are well known. There is also a major impact of warfarin therapy on the health care system itself. For example, although centralized anticoagulation clinics have been shown to improve the management and outcome of patients treated with warfarin, these clinics are often not profitable and require hospital subsidies. In the May 2009 issue of EP Lab Digest, my editorial focused on the WATCHMAN® device (Atritech, Plymouth, MN), a percutaneous left atrial appendage (LAA) occluder designed to prevent stroke in patients with AF and risk factors for stroke. The device has been under development as a nonpharmacological alternative to warfarin and was the subject of an FDA advisory panel on April 23, 2009. Despite a conditional recommendation by the panel to approve the device (7 to 5 in favor), the device has yet to be approved and remains unavailable except at centers that are participating in the continued access protocol. In the interim, alternatives to warfarin besides LAA occlusion devices have gained ground. The results of the Randomized Evaluation of Long-term Anticoagulation Therapy (RE-LY®) trial were published in the New England Journal of Medicine in August.1 RE-LY was a noninferiority study comparing two different doses of dabigatran, a new oral direct thrombin inhibitor, given in a blinded fashion to open-label, dose-adjusted warfarin. In this trial, over 18,000 patients with AF and a risk of stroke were randomly assigned to receive fixed doses of dabigatran, 110 mg or 150 mg twice daily, or warfarin. The average duration of follow-up was 2.0 years. The annual rates of the primary outcome, which was stroke or systemic embolism, were 1.7% in the warfarin group, as compared with 1.5% in the group that received 110 mg of dabigatran (P