European Heart Journal Advance Access published online on September 21, 2007
European Heart Journal, doi:10.1093/eurheartj/ehm391
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Low-dose oral anticoagulation in patients with mechanical heart valve prostheses: final report from the early self-management anticoagulation trial II
1 Department of Thoracic and Cardiovascular Surgery, Heart and Diabetes Center North Rhine-Westphalia Bad Oeynhausen, University Hospital of the Ruhr-University of Bochum, Georgstr.11 32545, Bad Oeynhausen, Germany
2 Evangelisches Johanniter Klinikum, Duisburg, Germany
3 HeartCenter Lahr, Lahr, Germany
4 Kerckhoff-Klinik, Bad Nauheim, Germany
5 Heart Center Marburg, Clinic of the Philipps-University Marburg, Marburg, Germany
6 Klinikum Ludwigshafen, Clinic for Heart Surgery, Ludwigshafen, Germany
Received 17 January 2007; revised 30 July 2007; accepted 23 August 2007.
* Corresponding author. Tel: +49 5731 97 2319; fax: +49 5731 97 1871. E-mail address: hkoertke{at}hdz-nrw.de
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.
Key Words: Oral anticoagulation • INR self-management • Heart valve prostheses • Thrombo-embolism • Bleeding