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Self-Management of oral Anticoagulation in nonvalvular Atrial Fibrillation (SMAAF study)

Selbstmanagement der Antikoagulation bei Patienten mit nichtvalvulärem Vorhofflimmern (SMAAF-Studie)

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Zusammenfassung

Der Großteil der Patienten mit Vorhofflimmern ist durch ein thromboembolisches Ereignis gefährdet. Die Komplikationsrate kann durch eine effiziente Antikoagulation um zwei Drittel reduziert werden. Ob die Qualität der Therapieüberwachung durch das Selbstmanagement bei Patienten mit Vorhofflimmern (SMAAF-Studie) im Vergleich zur herkömmlichen bei Hausarzt betreuten Patienten verbessert werden kann, war Gegenstand dieser prospektiven Multicenter- Studie.

Methodik

Bei Eignung zum Selbstmanagement sollten 2 000 Patienten in die beiden Studienarme randomisiert werden. Im Untersuchungszeitraum von 12/99 bis 07/01 gaben lediglich 202 Patienten (64,3±9,2 Jahre, 69,3% Männer) ihr Einverständnis. Bei vorzeitigem Studienabbruch aufgrund zu niedriger Patientenzahl beschränkt sich der Gruppenvergleich auf die Auswertung gemessener INR-Werte mittels zweiseitigem t-Test.

Ergebnisse

Von den 202 eingeschlossenen Patienten wurden 101 der Selbstmanagement-Gruppe (64,6±9,6 Jahre, 71,4% Männer) und 101 (64,1±8,9 Jahre, 61,4% Männer, n.s.) der Hausarztgruppe zugeordnet. Die Gesamtzahl der INR-Messungen betrug 2 865, wobei 2 072 auf Patienten im Selbstmanagement und 793 auf die Hausarztgruppe entfielen. Die Werte lagen bei Patienten im Selbstmanagement mit 67,8% im Vergleich zur Hausarztgruppe mit 58,5% signifikant häufiger (p=0,0061) im Zielbereich. Bezüglich der Verweildauer im therapeutischen Bereich bestand zwar ein Trend zugunsten der Selbstmanagement-Gruppe, jedoch kein signifikanter Unterschied (178,8±126 Tage vs. 155,9±118,4 Tage). In der Selbstmanagement- Gruppe traten zwei schwere Blutungen, in der Hausarztgruppe ein thromboembolisches Ereignis auf.

Schlussfolgerung

Die Therapieüberwachung der oralen Antikoagulation durch das INR-Selbstmanagement ist bei Patienten mit Vorhofflimmern der Betreuung durch den Hausarzt nicht unterlegen.

Summary

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-manage- ment 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.

Conclusion

Management of oral anticoagulation by INR self-management in patients with atrial fibrillation is not inferior to conventional care.

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Authors and Affiliations

  1. Klinik am See, Fachklinik für Innere Medizin, Kardiologie, Seebad 84, 15562, Rüdersdorf/Berlin, Germany

    H. Völler,  J. Glatz &  C. Dovifat

  2. Inst. für Klinische Immunologie und Transfusionsmedizin, Langhansstr. 7, 35392, Gießen, Germany

    K. Heidinger

  3. Deutsche Gesellschaft für Humanplasma, Rheinuferstraße 9, 67061, Ludwigshafen, Germany

    U. Taborski

  4. Klinik Gais Fachklinik für kardiale und psychosomatische Rehabilitation AG, Gäbrisstrasse 43, 9056, Gais, Switzerland

    A. Bernardo

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  1. H. Völler
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  2. J. Glatz
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  4. A. Bernardo
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  5. C. Dovifat
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  6. K. Heidinger
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Correspondence to H. Völler.

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Völler, H., Glatz, J., Taborski, U. et al. Self-Management of oral Anticoagulation in nonvalvular Atrial Fibrillation (SMAAF study). ZS Kardiologie 94, 182–186 (2005). https://doi.org/10.1007/s00392-005-0199-0

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  • DOI: https://doi.org/10.1007/s00392-005-0199-0

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