Subcutaneous Recombinant Hirudin (HBW 023) Versus Intravenous Sodium Heparin in Treatment of Established Acute Deep Vein Thrombosis of the Legs: a Multicentre Prospective Dose-ranging Randomized Trial

François Schiele; Folke Lindgaerde; Henry Eriksson; Jean-Pierre Bassand; Anders Wallmark; Per-Olaf Hansson; Gilles Grollier; Malvin Sjo; Marco Moia; Anne Camez; Vince Smyth; Michael Walker; for the International Multicentre Hirudin Study Group

doi:10.1055/s-0038-1656063

Thrombosis and Haemostasis, Inhaltsverzeichnis

Thromb Haemost 1997; 77(05): 0834-0838
DOI: 10.1055/s-0038-1656063

Cinical Studies

Schattauer GmbH Stuttgart

Subcutaneous Recombinant Hirudin (HBW 023) Versus Intravenous Sodium Heparin in Treatment of Established Acute Deep Vein Thrombosis of the Legs: a Multicentre Prospective Dose-ranging Randomized Trial

Autor*innen

François Schiele

¹The Hôpital Saint-Jacques, Besançon, France
Folke Lindgaerde

³Malmö Almanna Syukhus, Malmö, Sweden
Henry Eriksson

⁴Oestra Sjukhuset CK plan 2, Gothenburg, Sweden
Jean-Pierre Bassand

¹The Hôpital Saint-Jacques, Besançon, France
Anders Wallmark

³Malmö Almanna Syukhus, Malmö, Sweden
Per-Olaf Hansson

⁴Oestra Sjukhuset CK plan 2, Gothenburg, Sweden
Gilles Grollier

²Hôpital de la Côte de Nacre, Caen, France
Malvin Sjo

⁵Regionsykehuset I Tromsö, Norway
Marco Moia

⁶Ospedale Maggiore, Milan, Italy
Anne Camez

⁷Laboratoires Hoechst, Paris, France
Vince Smyth

⁸Manchester Royal Infirmary, Manchester, Great Britain

for the International Multicentre Hirudin Study Group

Michael Walker

⁸Manchester Royal Infirmary, Manchester, Great Britain

Abstract

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Summary

The aim of this multicentre, prospective, randomised, dose-ranging study was to compare the safety and efficacy of subcutaneous recombinant hirudin (HBW 023) against intravenous sodium heparin in acute lower limb deep venous thrombosis (DVT). Patients were randomized to treatment with either HBW 023 or heparin for 5 ±1 days. HBW 023 was given according to body-weight in three dose groups. Thromboembolic disease was assessed by phlebography and ventilation/perfusion (V/Q) scanning on Bay 1 and Day 5±1. One hundred and fifty-five patients were enrolled, of these 121 were evaluable for efficacy analysis. Significantly fewer patients on HBW 023 developed new V/Q abnormalities during the treatment period, (p = 0.006). There was no difference between the groups in thrombus extension or regression, major bleeding complications or serious adverse events. There were significantly fewer findings of new V/Q mismatch after treatment with HBW 023, and anticoagulant control was superior in these patients.

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Referenzen

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