Low-dose oral anticoagulation in patients with mechanical heart valve prostheses: final report from the early self-management anticoagulation trial II

• Published in: European heart journal Vol. 28; no. 20; pp. 2479 - 2484
• Main Authors: Koertke, Heinrich, Zittermann, Armin, Tenderich, Gero, Wagner, Otto, El-Arousy, Mahmoud, Krian, Arno, Ennker, Juergen, Taborski, Uwe, Klövekorn, Wolf Peter, Moosdorf, Rainer, Saggau, Werner, Koerfer, Reiner
• Format: Journal Article
• Language: English
• Published: Oxford Oxford University Press 01.10.2007; Oxford Publishing Limited (England)
• Subjects: Administration, Oral; Aged; Anticoagulants - therapeutic use; Aortic Valve - surgery; Biological and medical sciences; Bleeding; Blood and lymphatic vessels; Cardiology. Vascular system; Diseases of the peripheral vessels. Diseases of the vena cava. Miscellaneous; Female; Heart valve prostheses; Heart Valve Prosthesis - adverse effects; Humans; INR self-management; International Normalized Ratio; Male; Medical sciences; Middle Aged; Oral anticoagulation; Postoperative Hemorrhage - etiology; Postoperative Hemorrhage - prevention & control; Prospective Studies; Self Care; Statistics as Topic; Thrombo-embolism; Thromboembolism - etiology; Thromboembolism - prevention & control; Oral anticoagulation; Thrombo-embolism; Heart valve prostheses; INR self-management; Bleeding; Self evaluation; Cardiovascular disease; Anticoagulant; Review; Heart valve; Hemorrhage; Phlebology; Vascular disease; Selfcare; Clinical trial; Cardiology; Thromboembolism; Human; Removable prosthesis; Low dose; Oral administration; Patient; Valve prosthesis; Oral cavity; Early; Circulatory system
• ISSN: 0195-668X; 1522-9645
• DOI: 10.1093/eurheartj/ehm391

Aims In mechanical heart valve recipients, low-dose international normalized ratio (INR) self-management of oral anticoagulants can reduce the risk of developing thrombo-embolic events and improve long-term survival compared with INR control by a general practitioner. Here, we present data on the safety of low-dose INR self-management. Methods and results In a prospective, randomized multi-centre trial, 1346 patients with a target INR range of 2.5–4.5 and 1327 patients with a target INR range of 1.8–2.8 for aortic valve recipients and an INR range of 2.5–3.5 for mitral or double valve recipients were followed up for 24 months. The incidence of thrombo-embolic events that required hospital admission was 0.37 and 0.19% per patient year in the conventional and low-dose groups, respectively (P = 0.79). No thrombo-embolic events occurred in the subgroups of patients with mitral or double valve replacement. The incidence of bleeding events that required hospital admission was 1.52 and 1.42%, respectively (P = 0.69). In the majority of patients with bleeding events, INR values were < 3.0. Mortality rate did not differ between the study groups. Conclusion Data demonstrate that low-dose INR self-management does not increase the risk of thrombo-embolic events compared with conventional dose INR self-management. Even in patients with low INR target range, the risk of bleeding events is still higher than the risk of thrombo-embolism.