AF Guidelines Updated to Incorporate Dabigatran Reply

Less than two months after the publication of the 2010 updated atrial fibrillation (AF) guidelines, the AHA, the ACC, and the HRS have released a new focused update incorporating recommendations and a discussion concerning the direct thrombin inhibitor dabigatran, which gains a Class I recommendation:

Class I: Dabigatran is useful as an alternative to warfarin for the prevention of stroke and systemic thromboembolism in patients with paroxysmal to permanent AF and risk factors for stroke or systemic embolization who do not have a prosthetic heart valve or hemodynamically significant valve disease, severe renal failure (creatinine clearance 15 mL/min), or advanced liver disease (impaired baseline clotting function). (Level of Evidence: B)


The update does not recommend routinely switching patients to dabigatran who are already successfully taking warfarin:

Because of the twice-daily dosing and greater risk of nonhemorrhagic side effects with dabigatran, patients already taking warfarin with excellent INR control may have little to gain by switching to dabigatran.

Here is the discussion about choosing between dabigatran and warfarin:

Selection of patients with AF and at least 1 additional risk factor for stroke who could benefit from treatment with dabigatran as opposed to warfarin should consider individual clinical features, including the ability to comply with twice-daily dosing, availability of an anticoagulation management program to sustain routine monitoring of INR, patient preferences, cost, and other factors.

This post is republished with permission from CardioExchange, a new website for cardiovascular healthcare professionals from the New England Journal of Medicine. CardioBrief readers who are healthcare professionals are invited to join the site.

Here is the press release from the AHA:

American College of Cardiology/American Heart Association /Heart Rhythm Society Guidelines:
New anti-clotting drug added to recommendations for treating irregular heartbeat

Statement Highlights:

  • A new anti-clotting drug, dabigatran, is added to recommendations for treating atrial fibrillation.
  • Dabigatran is an alternative to the anti-clotting drug warfarin.
  • Previous recommendations for warfarin still stand.

DALLAS, Feb. 14, 2011 — The newly approved drug dabigatran is an alternative to warfarin to help prevent dangerous blood clots in patients with atrial fibrillation, according to updated guidelines from the American College of Cardiology, American Heart Association and the Heart Rhythm Society.

The “Focused Update” — published in Circulation: Journal of the American Heart Association, Journal of the American College of Cardiology and HeartRhythm Journal — specifically updates the section on emerging antithrombotic agents in atrial fibrillation treatment guidelines released by the three organizations on Dec. 20, 2010.

Atrial fibrillation is an irregular heart rhythm that occurs when the heart’s two upper chambers beat erratically, causing the chambers to pump blood rapidly, unevenly and inefficiently. Blood can pool and clot in the chambers, increasing the risk of stroke or heart attack. More than two million Americans live with the condition.

According to this most recent update, dabigatran is useful as an alternative to warfarin to prevent stroke and blood clots in patients with either paroxysmal (recurrent episodes that stop after seven days) or permanent (an on-going episode) 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.

Warfarin, an anti-clotting drug used since the 1950s, requires patients to have regular testing to monitor its effectiveness and dosage adjustment.

In December 2010 the atrial fibrillation guidelines were updated and recommended that a combination of aspirin and the oral antiplatelet drug clopidogrel might be considered to prevent stroke or other types of blood clots in patients with atrial fibrillation who are poor candidates for the clot-preventing drug warfarin.

Authors are: L. Samuel Wann, M.D., Writing Committee chair; Anne B. Curtis, M.D.; Kenneth A. Ellenbogen, M.D.; N.A. Mark Estes III, M.D.; Michael D. Ezekowitz, M.B.; Warren M. Jackman, M.D.; Craig T. January, M.D., Ph.D.; James E. Lowe, M.D.; Richard L. Page, M.D.; David J. Slotwiner, M.D.; William G. Stevenson, M.D.; and Cynthia M. Tracy, M.D.

Author disclosures are on the manuscript.

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