Titre du document / Document title

Efficacy and safety of low molecular weight heparin (ardeparin sodium) compared to warfarin for the prevention of venous thromboembolism after total knee replacement surgery : A double-blind, dose-ranging study

Auteur(s) / Author(s)

Ardeparin Arthroplasty Study Group
HEIT J. A. ⁽¹⁾ ; BERKOWITZ S. D. ⁽²⁾ ; BONA R. ⁽³⁾ ; CABANAS V. ⁽⁴⁾ ; CORSON J. D. ⁽⁵⁾ ; ELLIOTT C. G. ⁽⁶⁾ ; LYONS R. ⁽⁷⁾ ;

Affiliation(s) du ou des auteurs / Author(s) Affiliation(s)

⁽¹⁾ Division of Cardiovascular Diseases and Section of Hematology Research, Mayo Clinic and Mayo Foundation, Rochester, Minnesota, ETATS-UNIS
⁽²⁾ Divisions of Hematology and Cardiology, Duke University, Durham, North Carolina, ETATS-UNIS
⁽³⁾ Hematology-Oncology Division, St. Francis Hospital and Medical Center, Hartford, Connecticut, ETATS-UNIS
⁽⁴⁾ Franciscan Health System of Cincinnati, Inc., Cincinnati, Ohio, ETATS-UNIS
⁽⁵⁾ Department of Surgery, University of Iowa Hospitals and Clinics, Iowa City, Iowa, ETATS-UNIS
⁽⁶⁾ Pulmonary Division, University of Utah School of Medicine, Salt Lake City, Utah, ETATS-UNIS
⁽⁷⁾ Hematology & Oncology Associates of Texas, San Antonio, Texas, ETATS-UNIS

Résumé / Abstract

We performed a double-blind, randomized clinical trial to compare the efficacy and safety of three different subcutaneous (SC) low molecular weight heparin doses (ardeparin sodium 25, 35, or 50 anti-X_aU/kg twice daily [BID]) to adjusted-dose warfarin (international normalized ratio [INR] = 2.0 to 3.0), as venous thromboembolism prophylaxis after total knee replacement surgery. The primary endpoint was total venous thromboembolism prevalence, defined as deep vein thrombosis discovered at postoperative venography of the operated leg, or symptomatic, objectively-documented pulmonary embolism. Of 860 patients randomized, 680 (79%) had an evaluable venogram or pulmonary embolism. The total venous thromboembolism prevalence was significantly greater among patients prophylaxed with warfarin compared to ardeparin 50 BID (38% vs 27%, p = 0.019); the prevalence among ardeparin 25 BID (37%) and 35 BID (28%) patients was similar to warfarin and ardeparin 50 BID patients, respectively. Overt bleeding occurred in 22 (7.9%) ardeparin 50 BID patients compared to 12 (4.4%) warfarin patients (p = 0.08), and in seven ardeparin 25 and 35 BID patients each (5.2% and 5.0%, respectively). Compared to the warfarin group, blood loss was significantly greater in the ardeparin 50 and 25 BID groups, and not different in the ardeparin 35 BID group. Conclusions: Postoperative, unmonitored, fixed-dose ardeparin 50 anti-X_a U/kg SC BID is significantly more effective than adjusted-dose warfarin for this indication. Although overt bleeding among warfarin and ardeparin 50 BID patients did not differ significantly, ardeparin 50 BID patients had significantly greater blood loss. Ardeparin 35 anti-X_a U/kg SC BID may provide efficacy similar to ardeparin 50 anti-X_aU/kg SC BID but with reduced bleeding.

Revue / Journal Title

Thrombosis and haemostasis   ISSN 0340-6245   CODEN THHADQ 

Source / Source

1997, vol. 77, n^o1, pp. 32-38 (18 ref.)

Langue / Language

Anglais

Editeur / Publisher

Schattauer, Stuttgart, ALLEMAGNE  (1976) (Revue)

Mots-clés anglais / English Keywords

Prosthesis ; Hip ; Plasty ; Joint ; Complication ; Treatment efficiency ; Deep vein thrombosis ; Vein ; Thromboembolism ; Ardeparin sodium ; Anticoagulant ; Prevention ; Warfarin ; Low molecular weight heparin ; Chemoprophylaxis ; Double blind study ; Maximal dose ; Toxicity ; Hemorrhage ; Comparative study ; Antivitamin K ; Human ; Heparin ; Surgery ; Diseases of the osteoarticular system ; Cardiovascular disease ; Vascular disease ; Venous disease ; Coumarine derivatives ; Glycosaminoglycan ;

Mots-clés français / French Keywords

Prothèse ; Hanche ; Plastie ; Articulation ; Complication ; Efficacité traitement ; Thrombose profonde ; Veine ; Thromboembolie ; Ardéparine sodique ; Anticoagulant ; Prévention ; Warfarine ; Héparine bas poids moléculaire ; Chimioprophylaxie ; Etude double insu ; Dose maximale ; Toxicité ; Hémorragie ; Etude comparative ; Antivitamine K ; Homme ; Héparine ; Chirurgie ; Système ostéoarticulaire pathologie ; Appareil circulatoire pathologie ; Vaisseau sanguin pathologie ; Veine pathologie ; Coumarine dérivé ; Glycosaminoglycane ;

Mots-clés espagnols / Spanish Keywords

Prótesis ; Cadera ; Plastia ; Articulación ; Complicación ; Eficacia tratamiento ; Trombosis venosa profunda ; Vena ; Tromboembolia ; Ardeparina sódica ; Anticoagulante ; Prevención ; Warfarina ; Heparina bajo peso molecular ; Quimioprofilaxis ; Estudio doble ciego ; Dosis máxima ; Toxicidad ; Hemorragia ; Estudio comparativo ; Antivitamina K ; Hombre ; Heparina ; Cirugía ; Sistema osteoarticular patología ; Aparato circulatorio patología ; Vaso sanguíneo patología ; Vena patología ; Glicosaminoglicano ;

Localisation / Location

INIST-CNRS, Cote INIST : 10255, 35400006225149.0060