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.
Resumen
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%.
Por qué esto importa para la hirudoterapia
Este ensayo multicéntrico, aleatorizado y doble ciego comparó desirudina subcutánea (hirudina recombinante, 15 mg dos veces al día, iniciándola dentro de los 30 minutos previos a la cirugía) con enoxaparina (40 mg una vez al día, iniciándola la noche anterior a la cirugía) para la prevención de complicaciones tromboembólicas en 2079 pacientes sometidos a reemplazo total primario de cadera en 31 centros europeos, con confirmación mediante venografía bilateral. En el análisis primario de eficacia sobre 1587 pacientes, la desirudina mostró una TVP proximal significativamente menor (4,5% vs. 7,5%; p=0,01; reducción del riesgo relativo del 40,3%) y una TVP global menor (18,4% vs. 25,5%; p=0,001; reducción del riesgo relativo del 28%), con perfiles de seguridad similares entre los grupos. Este estudio es directamente relevante para el dominio de la ASH porque aporta datos de un ensayo clínico comparativo directo entre un anticoagulante recombinante derivado de la sanguijuela y un heparinoides estándar. La salvedad es que la desirudina es un compuesto farmacéutico purificado, no una terapia con sanguijuelas completas, y el resumen presenta datos de eficacia del conjunto del análisis primario en lugar de todos los pacientes aleatorizados.
Citación
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
Contexto clínico relacionado
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Añadido a la biblioteca ASH: May 27, 2026 · Última actualización del sitio: 18 de junio de 2026