[Critical appraisal: Subcutaneous adjusted-dose unfractionated heparin vs fixed-dose low-molecular-weight heparin in the initial treatment of venous thromboembolism. Prandoni P, Carnovali M, Marchiori A, Galilei investigators. Arch Intern Med 2004; 164: 1077-83].

Abstract

BACKGROUND:

Few reports have addressed the value of unfractionated heparin (UFH) or low-molecular-weight heparin in treating the fill spectrum of patients with venous thromboembolism (VTE), including recurrent VTE and pulmonary embolism.

METHODS:

In an open, multicenter clinical trial, 720 consecutive patients with acute symptomatic VTE, including 119 noncritically ill patients (16.5%) with pulmonary embolism and 102 (14.2%) with recurrent VTE, were randomly assigned to treatment with subcutaneous UFH with dose adjusted by activated partial thromboplastin time by means of a weight-based algorithm (preceded by an intravenous loading dose), or fixed-dose (adjusted only to body weight) subcutaneous nadroparin calcium. Oral anticoagulant therapy was started concomitantly and continued for at least 3 months. We recorded the incidence of major bleeding during the initial heparin treatment and that of recurrent VTE and death during 3 months of follow-up.

RESULTS:

Fifteen (4.2%) of the 360 patients assigned to UFH had recurrent thromboembolic events, as compared with 14 (3.9%) of the 360 patients assigned to nadroparin (absolute difference between rates, 0.3%; 95% confidence interval, -2.5% to 3.1%). Four patients assigned to UFH (1.1%) and 3 patients assigned to nadroparin (0.8%) had episodes of major bleeding (absolute difference between rates, 0.3%; 95% confidence interval, -1.2% to 1.7%). Overall mortality was 3.3% in each group.

CONCLUSIONS:

Subcutaneous UFH with dose adjusted by activated partial thromboplastin time by means of a weight-based algorithm is as effective and safe as fixed-dose nadroparin for the initial treatment of patients with VTE, including those with pulmonary embolism and recurrent VTE.

• Authors: Mauricio Burotto, Luigi Gabrielli, Nicolás Crossley
• Journal: Revista medica de Chile (Rev Med Chil) Vol. 132 Issue 9 Pg. 1140-3 (Sep 2004) ISSN: 0034-9887 [Print] Chile
• Vernacular Title: Análisis critico de un artículo. Heparina no-fraccionada subcutánea versus heparina de bajo peso molecular en el tratamiento inicial de la enfermedad tromboembólica. Prandoni P, Carnovali M, Marchiori A, Galilei investigators. Arch Intern Med 2004; 164: 1077-83.
• PMID: 15543773 (Publication Type: Comment, English Abstract, Journal Article)