Thursday, October 8, 2015

In which patient Dabigatran can be considered? With AF valvular or non-valvular patient?

Most of the references, recommended for use in NON-VALVULAR patient:

Reference 1: Malaysian CPG for Atrial Fibrillation

“Where oral anticoagulation is appropriate therapy for patients with non valvular AF, dabigatran may be considered as an alternative to adjusted dose VKA therapy. There is currently no evidence to support the use of dabigatran for AF associated with valve disease, prosthetic valve, in pregnancy and chronic renal failure”

Reference 2: Australian Medicine Handbook 2014

“ Indications: Non-valvular AF and a high risk of stroke or systemic embolism”
“Contraindications: Prosthetic heart valve”


“The U.S. Food and Drug Administration (FDA) is informing health care professionals and the public that the blood thinner (anticoagulant) Pradaxa (dabigatran etexilate mesylate) should not be used to prevent stroke or blood clots (major thromboembolic events) in patients with mechanical heart valves, also known as mechanical prosthetic heart valves. A clinical trial in Europe (the RE-ALIGN trial) was recently stopped because Pradaxa users were more likely to experience strokes, heart attacks, and blood clots forming on the mechanical heart valves than were users of the anticoagulant warfarin. There was also more bleeding after valve surgery in the Pradaxa users than in the warfarin users”

Reference 4: Lexicomp

“Valvular heart disease: use is not recommended in patients with valvular heart disease, including the presence of bioprosthetic heart valve (has not been evaluated); use is contraindicated in patients with mechanical prosthetics heart valve. In addition to several case report (Chu, 2012; Price, 2012; Steward, 2012), one clinical trial reported significantly more thromboembolic events (valve thrombosis, stroke, TIA, and MI) and an excess of major bleeding (predominantly postoperative pericardial effusions requiring intervention for haemodynamic compromise) in patients with mechanical prosthetic heart valves receiving dabigatran compared to those receiving adjusted-dose warfarin.

References
  1. Malaysia CPG for Atrial Fibrillation
  2. Australian Medicine Handbook 2014
  3. http://www.fda.gov/Drugs/DrugSafety/ucm332912.htm
  4.  Lexicomp

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