Estudio multicéntrico, prospectivo, de comparación del tratamiento de la tromboembolia pulmonar submasiva con enoxaparina y heparina no fraccionadaMulticenter, prospective study comparing enoxaparin with unfractionated heparin in the treatment of submassive pulmonary thromboembolism

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Objetivo

Evaluar la eficacia y seguridad del tratamiento de la tromboembolia pulmonar submasiva (TEP) con enoxaparina en comparación con heparina no fraccionada

Pacientes Y Métodos

Se incluyó en el estudio, de forma prospectiva, a 56 pacientes con TEP que no precisaron tratamiento fibrinolítico. Se asignaron de forma aleatoria a dos grupos de tratamiento: el grupo A, que recibió enoxaprina (1 mg/kg cada 12 h) y el grupo B, al que se le administraron dosis ajustadas de heparina no fraccionada. La anticoagulación oral se inició una vez que el diagnóstico se comprobó y se mantuvo durante 6 meses. Se evaluó la incidencia de recurrencia tromboembólica y de hemorragia mayor al cabo de ese tiempo

Resultados

Seis pacientes fueron excluidos del estudio. De los 50 finalmente incluidos, 29 fueron asignados al grupo A (enoxaparina) y 21 al grupo B (heparina no fraccionada). Tres pacientes del grupo A (10,7%) fueron diagnosticados de recurrencia tromboembólica, mientras que dicha complicación se constató en dos pacientes del grupo B (9,5%). No se encontraron diferencias significativas. Dos pacientes fallecieron, siendo una de las muertes achacada a hemorragia secundaria a la anticoagulación oral (grupo A) y la otra a un proceso independiente a la enfermedad tromboembólica

Conclusiones

El empleo de enoxaparina en el tratamiento inicial del TEP parece ser tan efectivo y seguro como el uso de heparina no fraccionada

Objective

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

Material And Methods

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

Results

Six patients were withdrawn from the study.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

Conclusions

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

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