Prevention of post-operative thromboembolism in general surgery with enoxaparin: preliminary findings.

Abstract

On the basis of a global interim evaluation of 8738 patients in this large German multicentre trial, the efficacy and safety of enoxaparin were analysed in general surgical patients. Data from 194 hospitals were available for this interim evaluation. The general surgical procedures included abdominal, gynaecological (with the exception of mastectomy) and urological operations, lasting at least 30 min under general anaesthesia and/or spinal/peridural anaesthesia. All complications with an incidence greater than two per 1000 were documented, including: occurrence of thrombosis and pulmonary embolism, which, in cases of clinical signs, were confirmed by objective techniques; bleeding, blood loss and transfusion requirements; changes in platelet count, haematology and transaminases; adverse drug reactions. The incidence of pulmonary embolism in thromboembolic prophylaxis with enoxaparin 20 mg, once daily, in patients undergoing general surgery was found to be 0.26%. With respect to the incidence of fatal (0.03%) and non-fatal (0.23%) pulmonary embolism, this interim evaluation shows a superiority of enoxaparin in the prevention of thromboembolic complications when compared retrospectively with trials using unfractionated heparin. The safety and tolerance following administration of enoxaparin 20 mg, once daily, were shown to be excellent (low incidence of injection haematomas and bleeding, no drug-induced thrombocytopenia, and low incidence of adverse drug reactions).