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”
Reference 3: http://www.fda.gov/Drugs/DrugSafety/ucm332912.htm
“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
- Malaysia CPG for Atrial Fibrillation
- Australian Medicine Handbook 2014
- http://www.fda.gov/Drugs/DrugSafety/ucm332912.htm
- Lexicomp
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