Mechanical heart valve
State after implantation of a mechanical heart valve prosthesis. Lifelong anticoagulation with warfarin is mandatory. Direct oral anticoagulants are contraindicated.
ICD-10 Z95.23 drugs
Also known as: Prosthetic heart valve, Mechanical valve prosthesis
Drugs used for this condition
Marketing claims without evidence base
The drug is promoted for these uses outside international guidelines. Each entry below is analyzed against AEMPS, FDA, EMA, Cochrane and major RCTs.
- FApixabanNot recommended · Direct oral anticoagulants (factor Xa inhibitors)Direct oral anticoagulants are contraindicated in patients with mechanical heart valves. The RE-ALIGN trial with dabigatran was stopped early due to increased valve thrombosis and bleeding compared with warfarin. No analogous RCT exists for apixaban, and the class effect is extrapolated. In these patients, warfarin remains first-line with INR target 2.5–3.5 depending on valve position and generation.
- FDabigatranNot recommended · Direct thrombin inhibitorIn mechanical aortic or mitral valve prostheses, dabigatran is contraindicated. The RE-ALIGN trial (NEJM 2013) was stopped early because of increased thromboembolism and bleeding with dabigatran versus warfarin in patients with mechanical valves. The standard anticoagulation in this population is warfarin with INR monitoring at 2.0–3.0 (aortic prosthesis) or 2.5–3.5 (mitral or LV dysfunction).
How to read tiers A–F
Evidence tiers belong to the drug-indication pair, not to the drug as a whole: the same substance can be A for one condition and F for another.
- AStrong evidence – first or second line in international guidelines
- BRecommended in selected cases
- CStudy data contradict each other
- DBenefit not proven, no documented harm
- FDocumented harm, or risk without benefit