Dabigatran versus Warfarin in Patients with Mechanical Heart Valves

• Published in: The New England journal of medicine Vol. 369; no. 13; pp. 1206 - 1214
• Main Authors: Eikelboom, John W, Connolly, Stuart J, Brueckmann, Martina, Granger, Christopher B, Kappetein, Arie P, Mack, Michael J, Blatchford, Jon, Devenny, Kevin, Friedman, Jeffrey, Guiver, Kelly, Harper, Ruth, Khder, Yasser, Lobmeyer, Maximilian T, Maas, Hugo, Voigt, Jens-Uwe, Simoons, Maarten L, Van de Werf, Frans
• Format: Journal Article
• Language: English
• Published: Waltham, MA Massachusetts Medical Society 26.09.2013
• Subjects: Aged; Anticoagulants; Anticoagulants - administration & dosage; Anticoagulants - adverse effects; Aorta; Atrial Fibrillation - drug therapy; Benzimidazoles - administration & dosage; Benzimidazoles - adverse effects; beta-Alanine - administration & dosage; beta-Alanine - adverse effects; beta-Alanine - analogs & derivatives; Biological and medical sciences; Bleeding; Blood. Blood coagulation. Reticuloendothelial system; Dabigatran; Drug therapy; Female; Fibrillation; General aspects; Heart; Heart Valve Prosthesis; Hemorrhage - chemically induced; Humans; Ischemia; Male; Medical sciences; Middle Aged; Pharmacology. Drug treatments; Population studies; Stroke - prevention & control; Thrombin; Thromboembolism; Thromboembolism - chemically induced; Thromboembolism - prevention & control; Thrombosis; Warfarin; Warfarin - administration & dosage; Warfarin - adverse effects; Human; Warfarin; Serine endopeptidases; Enzyme; Coumarine derivatives; Enzyme inhibitor; Thrombin; Anticoagulant; Dabigatran; Heart valve; Antithrombin; Medicine; Antivitamin K; Peptidases; Antithrombotic agent; Hydrolases; Comparative study
• ISSN: 0028-4793; 1533-4406
• DOI: 10.1056/NEJMoa1300615

In a phase 2 trial, patients with mechanical heart valves were randomly assigned to receive either dabigatran or warfarin for anticoagulation. Dabigatran was associated with higher rates of ischemic stroke (5%, vs. 0% with warfarin) and major bleeding (4% vs. 2%). Prosthetic heart-valve replacement is recommended for many patients with severe valvular heart disease and is performed in several hundred thousand patients worldwide each year. 1 Mechanical valves are more durable than bioprosthetic valves 2 but typically require lifelong anticoagulant therapy. The use of vitamin K antagonists provides excellent protection against thromboembolic complications in patients with mechanical heart valves 3 but requires restrictions on food, alcohol, and drugs and lifelong coagulation monitoring. Because of the limitations of vitamin K antagonists, many patients opt for a bioprosthesis rather than a mechanical valve, despite the higher risk of premature valve failure requiring repeat valve-replacement surgery with . . .