title: Self-management of oral anticoagulation in nonvalvular atrial fibrillation (SMAAF study).
abstract: Most patients with atrial fibrillation are at risk of suffering thromboembolic events. This risk can be reduced by twothirds 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 2 865. This comprised 2 072 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.
  
  
  CONCLUSIONS
  Management of oral anticoagulation by INR self-management in patients with atrial fibrillation is not inferior to conventional care.
authors.affiliation: Klinik am See, Fachklinik für Innere Medizin, Kardiologie, Seebad 84, 15562 Rüdersdorf/Berlin, Germany. heinz.voeller@klinikamsee.com
authors.forename: H
authors.initials: H
authors.lastname: Völler
authors.forename: J
authors.initials: J
authors.lastname: Glatz
authors.forename: U
authors.initials: U
authors.lastname: Taborski
authors.forename: A
authors.initials: A
authors.lastname: Bernardo
authors.forename: C
authors.initials: C
authors.lastname: Dovifat
authors.forename: K
authors.initials: K
authors.lastname: Heidinger
mesh_terms: D000284:Administration, Oral; D000368:Aged; D000925:Anticoagulants / Q000008:administration & dosage* / Q000009:adverse effects; D001281:Atrial Fibrillation / Q000097:blood / Q000150:complications / Q000188:drug therapy*; D005194:Family Practice; D005260:Female; D006470:Hemorrhage / Q000097:blood / Q000139:chemically induced; D006801:Humans; D019934:International Normalized Ratio; D008297:Male; D008875:Middle Aged; D017063:Outcome Assessment, Health Care / Q000706:statistics & numerical data; D011446:Prospective Studies; D012648:Self Care; D013923:Thromboembolism / Q000097:blood / Q000517:prevention & control*
chemical_list: D000925:Anticoagulants