Zusammenfassung
Hintergrund
Ziel dieser Studie war der Vergleich der Effektivität und Verträglichkeit von Enoxaparin zur Thromboseprophylaxe [tiefe Venenthrombosen (TVT)] nach operativen Eingriffen ambulant und im Krankenhaus.
Material und Methoden
Dokumentation von 2005 ambulanten und 1360 primär stationären Patienten unter Thromboseprophylaxe mit 20 oder 40 mg Enoxaparin und Nachbeobachtung über 4–6 Wochen.
Ergebnisse
Ambulante Patienten waren jünger (48,4 vs. 58,5 Jahre; p<0,01), hatten weniger kardiovaskuläre Erkrankungen (7,1 vs. 20,8%; p<0,01) und hatten weniger komplexe Eingriffe (Arthroskopien 33,6 vs. 7,5%; p<0,01). Sie erhielten häufiger 20 statt 40 mg Enoxaparin (60,7 vs. 38,3%; p<0,01). Die Dauer der Thromboseprophylaxe war mit 12,6 Tagen kürzer als stationär (15,3 Tage). Die Inzidenz nicht schwerwiegender Blutungen betrug 1,8% unter 20 mg und 3,4% unter 40 mg (4,7 mit 20 mg/4,5% mit 40 mg stationär); die von schwerwiegenden Blutungen jeweils 0,1% (0,0 mit 20 mg/0,3% mit 40 mg stationär). Es kam zu 0,4% tiefe Venenthrombosen unter 20 mg und 0,6% unter 40 mg (0,0% mit 20 mg/0,9% mit 40 mg stationär). Kein Auftreten von Lungenembolien im ambulanten Bereich (0,2 mit 20 mg/0,5% mit 40 mg stationär).
Schlussfolgerung
Eine Thromboseprophylaxe mit Enoxaparin ist unter ambulanten Rahmenbedingungen gut verträglich; schwerwiegende Blutungskomplikationen sind selten.
Abstract
Background
The aim of this study was to compare the efficacy and tolerability of enoxaparin for preventing thromboembolism after surgery in the out-patient and in-hospital settings.
Materials and methods
A total of 2,005 out-patient and 1,360 hospitalized patients were included in the study. Prophylaxis was carried out with 20 or 40 mg enoxaparin and follow-up examination after 4-6 weeks.
Results
Out-patients were younger (mean 48.4 vs. 58.5 years, p<0.01), had less cardiovascular comorbid diseases (7.1 vs. 20.8%, p<0.01) and underwent less complex interventions (arthroscopy 33.6 vs. 7.5%, p<0.01). Out-patients also received 20 instead of 40 mg enoxaparin more frequently (60.7 vs. 38.3%, p<0.01). The mean duration of thromboprophylaxis was reduced (12.6 vs. 15.3 days). For patients treated with 20 and 40 mg minor bleeding was observed in 1.8 and 3.4%, respectively (4.7 with 20 mg and 4.5% with 40 mg in hospital), major bleeding was 0.1% for both doses in out-patients and 0.0% with 20 mg and 0.3% with 40 mg in-hospital. Deep vein thrombosis (DVT) occurred in 0.4% of out-patients receiving 20 mg enoxaparin and 0.6% with 40 mg (0.0% with 20 mg and 0.9% with 40 mg in-hospital). There were no cases of pulmonary embolism (PE) in out-patients but PE was observed in 0.2% and 0.5% with 20 mg and 40 mg in-hospital patients, respectively.
Conclusions
Thromboprophylaxis with enoxaparin is well tolerated under clinical conditions as well as under out-patient treatment and severe bleeding complications are rare.
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Interessenkonflikt
Der korrespondierende Autor weist auf folgende Beziehungen hin: Diese nicht-interventionelle Studie wurde von der Sanofi Aventis Deutschland GmbH, Berlin durchgeführt. Peter Bramlage hat für die Firma Vorträge gehalten und Forschungsunterstützung erhalten. Die übrigen Autoren geben keinen Interessenskonflikt an.
Danksagung
Wir möchten allen an der Studie beteiligten Ärzten und deren Assistenzpersonal für die Teilnahme an dieser Studie danken.
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Fecher, K., Ewald, W., Fürst, A. et al. Prophylaxe thromboembolischer Ereignisse in der Chirurgie. Unfallchirurg 116, 246–254 (2013). https://doi.org/10.1007/s00113-011-2094-7
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DOI: https://doi.org/10.1007/s00113-011-2094-7