First patient enrolled in dabigatran study comparing anticoagulation strategies during AF ablation

  • RE-CIRCUIT study explores use of uninterrupted dabigatran etexilate therapy in AF patients undergoing ablation
  • Therapeutic guidelines recommend uninterrupted anticoagulation during and following ablation to reduce the associated risk of stroke
  • Dedicated data needed to ascertain efficacy and safety of continuous treatment with novel oral anticoagulants during ablation

Ingelheim, Germany, 13 May, 2015 – The first patient with atrial fibrillation (AF) has been enrolled in the global RE-CIRCUIT™ study.4 The study assesses the safety and efficacy of uninterrupted anticoagulation with dabigatran etexilate (Pradaxa®) during ablation procedures compared to warfarin.1Results from the RE-CIRCUIT™ study are expected during 2016.

Every year more than 200,000 ablation procedures are conducted globally in patients with AF,5,6,7 the most common heart rhythm irregularity.8 Although ablation is a routine, minimally-invasive procedure to normalise the heart rhythm,9 patients are at an increased risk of blood clots during and following the procedure.2 International guidelines therefore recommend that catheter ablations are conducted while patients are therapeutically anticoagulated with vitamin K antagonists.2,3 In recent years there has been a trend towards performing ablation on continuous warfarin therapy.2,3 After the procedure, anticoagulation therapy is continued for weeks to months to reduce the associated risk of stroke.2However, 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 AF ablation,” commented Professor 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 AF. 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 AF patients undergoing an ablation procedure.1 Approximately 700 patients with either intermittent or permanent AF will participate in the study with treatment equally and randomly split between dabigatran 150mg twice daily or warfarin.1

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.1,10-21

NOTES TO THE EDITORS

About RE-CIRCUIT™
The RE-CIRCUIT™ study (Randomized Evaluation of dabigatran etexilate Compared to warfarIn in pulmonaRy vein ablation: assessment of different peri-proCedUral antIcoagulation sTrategies) will compare the use of uninterrupted dabigatran 150mg twice daily to uninterrupted warfarin (INR 2.0-3.0) during ablation. The safety and efficacy of the therapies will be assessed during the 3-4 month treatment period and follow-up visit 1 week after treatment end. In the RE-CIRCUIT™ study, patients will be screened with a transoesophageal echocardiogram before their ablation procedure to determine whether there is a thrombus present in the upper left heart chamber (left atrium).1,4

The primary endpoint of the RE-CIRCUIT™ study is the incidence of major bleeding events, as defined by the International Society on Thrombosis and Haemostasis (ISTH), during the ablation procedure and up to two months post-ablation. Secondary endpoints include thromboembolic events (stroke / systemic embolism / TIA), minor bleeding events or a composite of both the efficacy and safety endpoints during ablation and up to two months after the procedure.1

About Pradaxa® (dabigatran etexilate)
Clinical experience of Pradaxa® (dabigatran etexilate) equates to over 3.9 million patient-years in all licensed indications worldwide. Pradaxa® has been in the market for more than 6 years and is approved in over 100 countries.4

Currently approved indications for Pradaxa® are:22,23

Prevention of stroke and systemic embolism in patients with non-valvular atrial fibrillation and a risk factor for stroke

Primary prevention of venous thromboembolic events in patients undergoing elective total hip replacement surgery or total knee replacement surgery

Treatment of DVT and PE and the prevention of recurrent DVT and recurrent PE in adults

Pradaxa®, a direct thrombin inhibitor (DTI), was the first widely approved drug in a new generation of direct oral anticoagulants, available to target a high unmet medical need in the prevention and treatment of acute and chronic thromboembolic diseases.24 Potent antithrombotic effects are achieved with direct thrombin inhibitors by specifically blocking the activity of thrombin, the central enzyme in the process responsible for clot (thrombus) formation.25 In contrast to vitamin-K antagonists, which variably act via different coagulation factors, Pradaxa® provides effective, predictable and reproducible anticoagulation with a low potential for drug-drug interactions and no drug-food interactions, without the need for routine coagulation monitoring or mandatory dose adjustment.24,26

Boehringer Ingelheim
The Boehringer Ingelheim group is one of the world’s 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, Boehringer Ingelheim operates globally with 146 affiliates and a total of more than 47,700 employees. The focus of the family-owned company, founded in 1885, is researching, developing, manufacturing and marketing new medications of high therapeutic value for human and veterinary medicine.

Social responsibility is an important element of the corporate culture at Boehringer Ingelheim. This includes worldwide involvement in social projects, such as the initiative “Making more Health” and caring for the employees. Respect, equal opportunities and reconciling career and family form the foundation of the mutual cooperation. In everything it does, the company focuses on environmental protection and sustainability.

In 2014, Boehringer Ingelheim achieved net sales of about 13.3 billion euros. R&D expenditure corresponds to 19.9 per cent of its net sales.

For more information please visit www.boehringer-ingelheim.com

This press release is issued from our Corporate Headquarters in Ingelheim, Germany and is intended to provide information about our global business. Please be aware that information relating to the approval status and labels of approved products may vary from country to country, and a country-specific press release on this topic may have been issued in the countries where we do business.

Referências

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  2. Calkins H. et al. 2012 HRS/EHRA/ECAS Expert Consensus Statement on Catheter and Surgical Ablation of Atrial Fibrillation: Recommendations for Patient Selection, Procedural Techniques, Patient Management and Follow-up, Definitions, Endpoints, and Research Trial Design. Europace. 2012;14:528-606.
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