Subcutaneous adjusted-dose unfractionated heparin vs. fixed-dose low-molecular-weight heparin in the initial treatment of venous thromboembolism

Abstract number: P1866

Prandoni^* P., Carnovali† M., Marchiori^* A., Ghirarduzzi‡ A., Girolami§ B., Quintavalla¶ R., Tropeano# P. F., Alatri† A., Accorsi^** F., Todini†† A. R., Moia‡‡ M., Scannapieco§§ G. L., Villalta§§ S., Cogo## A., Imberti^*** D., Parente††† F., Agnelli‡‡‡ G., Sartori§§§ D., Cuppini¶¶¶ S., Migliacci### R., Corà^**** F., Bagatella^* P., Girolami^* A.

¶¶¶Hospital of Adria, Italy; ^****Hospital of Asiago, Italy ^**Hospital of Bologna, Italy; ###Hospital of Cortona, Italy; †††Hospital of Lecce, Italy; §§§Hospital of Noale, Italy; §Hospital of Padua, Italy; ¶Hospital of Parma, Italy; ^***Hospital of Piacenza, Italy; #Hospital of Pordenone, Italy; ‡Hospital of Reggio Emilia, Italy; †Hospital of Rho, Italy; ††Hospital of Roma, Italy; §§Hospital of Treviso, Italy; ##Hospital of Vicenza, Italy; ‡‡University of Milan, Italy; ^*University of Padua, Italy; ‡‡‡University of Perugia, Italy;

While the initial treatment of the first episode of deep-vein thrombosis with unfractionated (UFH) or low-molecular-weight heparin (LMWH) has been extensively investigated, few reports have addressed the value of these agents in treating the full spectrum of venous thromboembolism (VTE), including recurrent VTE and pulmonary embolism. In an open, multicenter clinical trial 720 consecutive patients with acute symptomatic VTE, including 119 (16.5%) noncritical patients with pulmonary embolism and 102 (14.2%) with recurrent VTE, were randomly assigned to APTT-adjusted-dose subcutaneous UFH, using a weight-based algorithm, or fixed-dose (only adjusted to body-weight) subcutaneous nadroparin. Oral anti-coagulant therapy was started concomitantly and continued for at least three months. 15 of the 360 patients (4.2%) assigned to UFH had recurrent thromboembolic events, as compared to 14 of the 360 patients (3.9%) assigned to nadroparin (absolute difference between rates, 0.3%; 95% CI, -2.5 to 3.1). 4 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% CI, -1.2 to 1.7). Overall mortality was 3.3% in each group. We conclude that subcutaneous APTT-adjusted-dose UFH using a weight-based algorithm is as effective and safe as fixed-dose nadroparin for the initial management of VTE patients, including those with pulmonary embolism and recurrent VTE.