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  • Title: Low-dose oral anticoagulation in patients with mechanical heart valve prostheses: final report from the early self-management anticoagulation trial II.
    Author: Koertke H, Zittermann A, Tenderich G, Wagner O, El-Arousy M, Krian A, Ennker J, Taborski U, Klövekorn WP, Moosdorf R, Saggau W, Koerfer R.
    Journal: Eur Heart J; 2007 Oct; 28(20):2479-84. PubMed ID: 17890730.
    Abstract:
    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.
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