Methods and Findings in Experimental and Clinical Pharmacology
Vol. 25, Suppl. A, 2003
ISSN 0379-0355
Copyright 2003 Prous Science, S.A.
CCC: 0379-0355/2003
http://www.prous.com

Thromboprophylaxis in Patients Undergoing Major Orthopedic Surgery. Is There a Need for New Drugs?

M. Monreal

Servicio de Medicina Interna, Hospital Universitari Germans Trias i Pujol, Badalona, Spain

INTRODUCTION

It has recently been reported that the new selective factor-Xa inhibitor fondaparinux, administered subcutaneously at a dose of 2.5 mg once daily in patients undergoing major surgery reduced the rate of postoperative venographically-detected venous thrombosis (DVT) by >50%, with a similar safety profile to the low-molecular-weight heparin enoxaparin. However, some authors have considered these results as clinically irrelevant, since no advantage was found in terms of overall mortality or symptomatic pulmonary embolism. The main source of controversy is the use of venographic rather than clinical endpoints. However, demonstrating that thromboprophylaxis can prevent fatal pulmonary embolism is not easy, with overall mortality being a more reliable endpoint of clinically efficacy.

MATERIALS AND METHODS

This was a prospective, cohort study aimed to compare the 3-month death rate in two groups of patients after major hip or knee surgery: i) patients with clinical signs of DVT, but normal venography; and ii) a matched series of patients with no clinical signs of DVT (but with possible asymptomatic DVT).

RESULTS

Suspected DVT was ruled out in 252 out of 4,004 patients (6.3%). Five hundred and four patients without suspected DVT were control patients. Forty-six patients (6.1%) died during the 3-month study period. Univariate analysis showed that patients in the possible DVT group had a significantly higher death rate than patients in the definite no DVT group (odds ratio: 2.70).

CONCLUSIONS

Patients in the possible DVT group had a trend towards a higher death rate than patients in the definite no DVT group. Since silent DVT could have been responsible for some of these deaths, the need for an effective thromboprophylaxis seems to be confirmed.

Methods and Findings in Experimental and Clinical Pharmacology Vol. 25, Suppl. A, 2003
ISSN 0379-0355 Copyright 2003 Prous Science, S.A. CCC: 0379-0355/2003 http://www.prous.com