A comparison of recombinant hirudin with a low-molecular-weight heparin to prevent thromboembolic complications after total hip replacement
Randomized controlled trial published in N Engl J Med (1997)
Abstract
BACKGROUND: Patients who undergo total hip replacement have a high risk of thromboembolic complications. Recombinant hirudin (desirudin), a specific inhibitor of thrombin, represents a new development in antithrombotic therapy. We compared the efficacy and safety of desirudin with those of a low-molecular-weight heparin (enoxaparin) for the prevention of thromboembolic complications in patients undergoing primary total hip replacement. METHODS: Both treatments, which were assigned in a randomized, double-blind manner, were started preoperatively: enoxaparin on the evening before surgery, and desirudin within 30 minutes before the start of surgery. The dose of desirudin was 15 mg subcutaneously twice daily, and the dose of enoxaparin was 40 mg subcutaneously once daily. The duration of treatment was 8 to 12 days. Deep-vein thrombosis was verified by bilateral venography performed at the end of the treatment period or earlier, if there were clinical signs of deep-vein thrombosis. RESULTS: At 31 centers in 10 European countries, 2079 eligible patients were randomly assigned to receive desirudin or enoxaparin. A total of 1587 patients were included in the primary analysis of efficacy. In the desirudin group, as compared with the enoxaparin group, there was a significantly lower rate of proximal deep-vein thrombosis (4.5 vs. 7.5 percent, P=0.01; relative reduction in risk, 40.3 percent) and a lower overall rate of deep-vein thrombosis (18.4 vs. 25.5 percent, P=0.001; relative reduction in risk, 28.0 percent). The safety profiles were similar in the two treatment groups. CONCLUSIONS: When administered 30 minutes before total hip replacement surgery, desirudin is more effective than enoxaparin in preventing deep-vein thrombosis.
Abstract sourced from PubMed (NCBI) for the cited record. See the original publication for the authoritative version.
Zusammenfassung
NEJM RCT in 2079 hip replacement patients comparing desirudin (15 mg sc bid) with enoxaparin (40 mg sc qd); desirudin reduced proximal DVT 4.5% vs 7.5% and overall DVT 18.4% vs 25.5%.
Warum dies für die Hirudotherapie relevant ist
Diese multizentrische, randomisierte, doppelblinde Studie verglich subkutanes Desirudin (rekombinantes Hirudin, 15 mg zweimal täglich, Beginn innerhalb von 30 Minuten vor der Operation) mit Enoxaparin (40 mg einmal täglich, Beginn am Vorabend der Operation) zur Prävention thromboembolischer Komplikationen bei 2079 Patienten mit primärer Hüfttotalendoprothese in 31 europäischen Zentren, mit Bestätigung durch bilaterale Venographie. In der 1587 Patienten umfassenden primären Wirksamkeitsanalyse zeigte Desirudin signifikant weniger proximale TVT (4,5 % vs. 7,5 %, p=0,01; 40,3 % relative Risikoreduktion) und Gesamt-TVT (18,4 % vs. 25,5 %, p=0,001; 28 % relative Risikoreduktion), mit ähnlichen Sicherheitsprofilen zwischen den Gruppen. Diese Studie ist für das Fachgebiet der ASH unmittelbar relevant, da sie Head-to-Head-Daten einer klinischen Studie für ein rekombinantes, aus Blutegeln stammendes Antikoagulans gegen ein Standardheparinoid liefert. Die Einschränkung besteht darin, dass Desirudin eine gereinigte pharmazeutische Verbindung ist, keine Blutegeltherapie als Ganzes, und das Abstract Wirksamkeitsdaten aus dem primären Analyse-Set präsentiert, nicht aus allen randomisierten Patienten.
Zitation
A comparison of recombinant hirudin with a low-molecular-weight heparin to prevent thromboembolic complications after total hip replacement.
Eriksson BI et al. · N Engl J Med, 1997
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