[Multicenter, prospective study comparing enoxaparin with unfractionated heparin in the treatment of submassive...

To compare the safety and efficacy of enoxaparin and unfractionated heparin in the treatment of submassive pulmonary thromboembolism (PTE).

Fifty-six patients with PTE who did not need fibrinolytic treatment were enrolled prospectively. The patients were randomly assigned to 2 treatment groups: Group A received enoxaparin (1 mg/kg every 12 hours) and Group B received adjusted doses of unfractionated heparin. The oral anticoagulant therapy was started on confirmation of the diagnosis and continued for 6 months. Incidences of recurrence of thromboembolism and of severe bleeding were assessed at the end of this period.

Six patients were withdrawn from the study. Twenty-nine of the 50 remaining patients were in Group A (enoxaparin) and 21 in Group B (unfractionated heparin). A recurrence of thromboembolism was diagnosed in 3 patients from Group A (10.7%) and 2 patients from Group B (9.5%). There were no significant differences. Two patients died, one death being attributed to bleeding secondary to the oral anticoagulant treatment (Group A) and the other to a process unrelated to PTE.

Enoxaparin seems to be as effective and safe as unfractionated heparin in the initial treatment of PTE.