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Ann Thorac Surg 2007;83:24-29
© 2007 The Society of Thoracic Surgeons
Department of Cardiothoracic Surgery, Heart Center North-Rhine-Westphalia Bad Oeynhausen, Clinic of the Ruhr University Bochum, Germany
Accepted for publication August 11, 2006.
* Address correspondence to Dr Koertke, Herz- und Diabeteszentrum NRW, Georgstr.11, 32545 Bad Oeynhausen, Germany (Email: hkoertke{at}hdz-nrw.de).
BACKGROUND: The Early Self-Controlled Anticoagulation Trial has demonstrated that in patients with mechanical heart valve replacement self-management of oral anticoagulation results in less major thromboembolic events than conventional measurement by the general practitioner. However, the effects of self-management on long-term survival are currently not known.
METHODS: Nine hundred thirty patients participated in a follow-up study of the aforementioned trial (488 from the self-management group and 442 from the conventional group). Long-term survival was assessed 12 years after the study began using the intent-to treat analysis as well as the per protocol analysis. Univariate and multivariate analyses were performed in order to assess independent predictors of survival.
RESULTS: In total, the 930 patients accrued 8,315 patient-years of observation. During follow-up, 236 patients died. According to the intent-to treat analysis, 10-year survival was 76.1% in the conventional group and 84.5% in the self-management group. The corresponding values for the per protocol analysis were 67.7% and 80.6%, respectively. Age, kind of valve surgery, and study group were independent predictors of survival. Self-management of oral anticoagulation increased long-term survival by 23% (intent-to-treat analysis) and 33% (per protocol analysis), respectively, compared with conventional measurement by the general practitioner. Possible reasons for these advantageous results in the self-management group are fewer thromboembolic events due to a higher percentage of international normalized ratio values lying in the target range compared with the conventional group.
CONCLUSIONS: Data indicate that self-management of oral anticoagulation is a promising strategy in order to increase long-term survival in patients with mechanical prosthetic valves.
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