New Pradaxa® clinical study to explore practical management of patients with atrial fibrillation undergoing ablation

Boehringer Ingelheim today announces a new study of Pradaxa® (dabigatran etexilate) in patients with atrial fibrillation (AF). The RE-CIRCUIT™ study will investigate the safety and efficacy of uninterrupted anticoagulant treatment with Pradaxa® in patients with AF who undergo ablation.⁵ Results of the study are expected in 2016.

Ablation is a routine, minimally-invasive procedure which is conducted to normalise the heart rhythm.⁶ Every year more than 200,000 ablation procedures are conducted globally in patients with AF who suffer from an irregular heart rhythm.^1,2,3 For most patients with AF, taking an anticoagulant is essential because their irregular heart beat increases their risk of stroke by up to five times.⁷ Preventing blood clots and stroke is even more important during ablation because the procedure itself temporarily increases the risk of blood clots for patients.⁴

“Currently there are no international guidelines regarding the specific use of novel oral anticoagulants (NOACs) during ablation procedures, despite their wide use in patients with atrial fibrillation. This study will provide valuable insights with regard to the practical management of patients requiring anticoagulation during these procedures,” 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 believe that dabigatran may provide a beneficial alternative to standard anticoagulation with warfarin during ablation procedures. The possibility to provide continuous anticoagulation with dabigatran during ablation would simplify management for physicians.”

RE-CIRCUIT™ is one of a number of new studies currently being initiated by Boehringer Ingelheim within the RE-VOLUTION® clinical trial programme, to further research of Pradaxa® in different clinical situations and new patient populations.⁵ The extensive RE-VOLUTION® clinical trial programme for Pradaxa®, which also encompasses the recently announced RE-DUAL PCI™ and RE-SPECT ESUS™ studies, will include 15 clinical trials involving over 55,000 patients in more than 44 countries globally when the new trials are completed.⁵

Pradaxa® is currently approved in over 100 countries worldwide and is the only novel oral anticoagulant with more than 6 years of long-term data.⁵ The key indication for Pradaxa® is the prevention of stroke and systemic embolism in adult patients with non-valvular AF, for which current guidelines have issued Class I recommendations for use of Pradaxa®.^8,9,10 Clinical experience of Pradaxa® equates to over 3 million patient-years in all licensed indications.⁵

References

1. Auricchio A, et al. The Current Status of Cardiac Electrophysiology in ESC Member Countries. The EHRA White Book 2013. Available at: http://www.escardio.org/communities/EHRA/publications/Documents/ehra-white-book-2013.pdf. Last accessed June 2014.
2. JRCAC Data Center 2013.
3. O’Connor E, Minihan D. Cardium Study: Atrial Fibrillation, Decision Resources, February 2013.
4. 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.
5. Boehringer Ingelheim Data on File.
6. Catheter Ablation. Available at: http://www.heartrhythmcharity.org.uk/www/203/0/Catheter_ablation_/. Last accessed June 2014.
7. Camm AJ, et al. 2012 focused update of the ESC Guidelines for the management of atrial fibrillation. Eur Heart J. 2012;33(21):2719-47.
8. De Caterina R, et al. 2012 Focused update of the ESC Guidelinesfor the management of atrial fibrillation, European Heart Journal (2012) 33:2719–2747.
9. January C, et al. 2014 AHA/ACC/HRS Guideline for the Management of Patients With Atrial Fibrillation: Executive Summary, J Am Coll Cardiol. 2014. Available at: http://content.onlinejacc.org/article.aspx?articleid=1854230. Last accessed: June 2014.
10. Kernan WN, et al. AHA/ASA Guideline: Guidelines for the Prevention of Stroke in Patients With Stroke and Transient Ischemic Attack: A Guideline for Healthcare Professionals From the American Heart Association/American Stroke Association, Stroke. 2014. Available at: http://stroke.ahajournals.org/content/early/2014/04/30/STR.0000000000000024.abstract. Last accessed: June 2014.