2011 ACCF/AHA/HRS Focused Update on the Management of Patients With Atrial Fibrillation (Update on Dabigatran)

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Dabigatran is an alternative to warfarin to help prevent dangerous blood clots in patients with atrial fibrillation, according to 2011 ACCF/AHA/HRS Focused Update on the Management of Patients With Atrial Fibrillation (Update on Dabigatran), released February 14, 2011. This is a Class I (the procedure/treatment SHOULD be performed / administered), Level Evidence B (limited population evaluated 1 data derived from a single randomized trial or nonrandomized studies) recommendation. Read the Heart Rhythm Society press release on the creation and publication of this Update on Dabigatran.

AF Update Webinar The Heart Rhythm Society and the American College of Cardiology produced a new complimentary webinar, The Focused Update on the Management of Patients with Atrial Fibrillation: Who Should Get ‘What’, ‘When,’ on March 7, 6:00 – 7:15 p.m. ET. Learn more and register now »

This “Focused Update” — published in the March 2011 issue of HeartRhythm Journal as well as Circulation and the Journal of the American College of Cardiology — specifically updates the section on emerging antithrombotic agents in the atrial fibrillation treatment guidelines released by the three organizations in December 2010. It focuses on the use of dabigatran, a new antithrombotic agent that was recently approved by the U.S. Food and Drug Administration (FDA), for the management of patients with atrial fibrillation (AF).

This most recent update documents that dabigatran is also useful as an alternative to warfarin to prevent stroke and blood clots in patients with either paroxysmal or permanent atrial fibrillation and with risk factors for stroke or blood clotting who do not have a prosthetic heart valve, significant heart valve disease, severe renal failure or advanced liver disease. Dabigatran was evaluated in a large, open-label, randomized trial (RE-LY*) in which it was compared with warfarin (goal international normalized ratio [INR] 2.0 to 3.0) in 18 113 patients with nonvalvular AF.

2011 Writing Group Members L. Samuel Wann, MD, Chair Anne B. Curtis, MD, FHRS Kenneth A. Ellenbogen, MD, FHRS* N.A. Mark Estes III, MD, FHRS Michael D. Ezekowitz, MB, ChB Warren M. Jackman, MD, FHRS Craig T. January, MD, Ph.D. James E. Lowe, MD Richard L. Page, MD, FHRS* David J. Slotwiner, MD* William G. Stevenson, MD Cynthia M. Tracy, MD * = represented the Heart Rhythm Society

The December AF Focused Update recommended that a combination of aspirin and the oral antiplatelet drug clopidogrel might be considered for patients with atrial fibrillation who are poor candidates for the warfarin. Recommendations for the use of dabigatran were not included in that update because it had not been approved by the U.S. Food and Drug Administration (FDA) at the time of organizational approval of the document.

This focused update is not intended to represent an update based on a full literature review from the date of the previous guideline publication. Consult the ACC/AHA/ESC 2006 Guidelines for the Management of Patients with Atrial Fibrillation executive summary for policy on clinical areas not covered by the focused update. With the exception of the recommendations presented in this document, the guideline remains current. Only the recommendations from the affected section(s) of the full-text guideline are included in this focused update.

* The 2009 publication of Randomized Evaluation of Long-Term Anticoagulation Therapy (RE-LY) was considered important enough to prompt these focused updates. RE-LY was a global, Phase III, randomized trial of more than 18,000 patients enrolled in 951 centers in 44 countries, investigating to assess the safety and efficacy of the investigational oral direct thrombin inhibitor, dabigatran etexilate against warfarin for stroke prevention.