The objective of the present study was to evaluate the efficacy, safety and healthcare resource utilization of long-term treatment with
tinzaparin in symptomatic patients with acute
pulmonary embolism as compared to standard
therapy. In this open-label trial, 102 patients with objectively confirmed
pulmonary embolism were randomized to receive, after initial treatment with
tinzaparin, either
tinzaparin (175 IU/kg/day) or international normalized ratio-adjusted
acenocoumarol for 6 months. Clinical endpoints were assessed during the 6 months of treatment. A pharmacoeconomic analysis was carried out to evaluate the cost of the long-term treatment with
tinzaparin in comparison with the standard one. In an intention-to-treat analysis, one of 52 patients developed recurrent
venous thromboembolism in the
tinzaparin group compared with none of the 50 patients in the
acenocoumarol group. One patient in each group had a major haemorrhagic complication. Six patients in the
acenocoumarol group had minor
bleeding compared with none in the
tinzaparin group (P = 0.027). Median hospital
length of stay was shorter in the
tinzaparin group compared to the
acenocoumarol group (7 versus 9 days; P = 0.014). When all the direct and indirect cost components were combined for the entire population, we found a slight, nonstatistically significant (mean difference €345; 95% CI 1382-2071; P = 0.69) reduction in total cost with
tinzaparin. Symptomatic acute
pulmonary embolism treatment with full therapeutic doses of
tinzaparin for 6 months is a feasible alternative to conventional treatment with
vitamin K antagonists.