The first patient with atrial fibrillation has been enrolled in the global RE-CIRCUIT study. The study assesses the safety and efficacy of uninterrupted anticoagulation with dabigatran etexilate (Pradaxa) during ablation procedures compared to warfarin. Results from the study are expected during 2016.
Every year more than 200,000 ablation procedures are conducted globally in patients with atrial fibrillation, the most common heart rhythm irregularity. Although ablation is a routine, minimally-invasive procedure to normalise the heart rhythm, patients are at an increased risk of blood clots during and following the procedure. International guidelines therefore recommend that catheter ablations are conducted while patients are therapeutically anticoagulated with vitamin K antagonists. In recent years there has been a trend towards performing ablation on continuous warfarin therapy. After the procedure, anticoagulation therapy is continued for weeks to months to reduce the associated risk of stroke. However, dedicated data on the safety and efficacy of continuous use of any of the novel oral anticoagulants (NOACs) during ablation are still needed.
“RE-CIRCUIT will offer the first comprehensive understanding on the performance of uninterrupted dabigatran during atrial fibrillation ablation,” commented Hugh Calkins, chairman of the RE-CIRCUIT study steering committee and professor of cardiology and director of the Electrophysiology Laboratory and Arrhythmia Service, Johns Hopkins Hospital, Baltimore, USA. “We already know that dabigatran effectively prevents stroke and systemic embolism in patients with atrial fibrillation. We believe that dabigatran can simplify ablation management for physicians and provide a beneficial alternative to standard anticoagulation with warfarin.”
The RE-CIRCUIT study compares the use of uninterrupted dabigatran therapy to uninterrupted warfarin in atrial fibrillation patients undergoing an ablation procedure. Approximately 700 patients with either intermittent or permanent atrial fibrillation will participate in the study with treatment equally and randomly split between dabigatran 150mg twice daily or warfarin.
RE-CIRCUIT is one of a number of new studies recently initiated by Boehringer Ingelheim. The overarching RE-VOLUTION clinical trial programme for dabigatran includes 14 international phase III studies which will involve over 55,000 patients in more than 44 countries worldwide. Four of these studies are currently ongoing.