Self-management of oral anticoagulation in nonvalvular atrial fibrillation (SMAAF study)

Most patients with atrial fibrillation are at risk of suffering thromboembolic events. This risk can be reduced by two-thirds by efficient anticoagulation. This prospective multi-center trial investigated whether the quality of treatment can be improved by self-management in patients with atrial fibrillations (SMAAF Study) compared to conventional patient management by the family doctor. Methods Two thousand patients suitable for self-management were to be randomized into the two arms of the study. in the period of investigation from December 1999 to July 2001, only 202 patients (64.3 +/- 9.2 years, 69.3% men) consented to participate. The study was discontinued prematurely since the number of patients was too low. As a consequence, the group comparison is confined to the evaluation of the INR values measured using the two-tailed t test. Results Of the 202 patients included, 101 were assigned to the self-management group (64.6 +/- 9.6 years, 71.4% men) and 101 (64.1 +/- 8.9 years, 61.4% men, n.s.) were assigned to the group managed by the family doctor. The total number of INR measurements was 2865. This comprised 2072 measurements in patients under self-management and 793 in the family doctor group. The values were within the target range significantly more frequently (p = 0.0061) in patients under self-management (67.8%) as compared to the family doctor group (58.5%). There was a trend with regard to the time within target range, but the difference was not significant (178.8 +/- 126 days as compared to 155.9 +/- 118.4 days). In the self-management group, there were two severe hemorrhages, and there was one thromboembolic event in the family doctor group. Conclusion Management of oral anticoagulation by INR self-management in patients with atrial fibrillation is not inferior to conventional care.