Safety of withholding anticoagulant therapy in patients who have clinically suspected pulmonary embolism and negative results on helical computed tomography.

BACKGROUND: Several studies have focused on the safety of withholding anticoagulant therapy in patients with negative results on helical computed tomography (CT). However, these studies were either retrospective or had a selection bias, since spiral CT was performed only in selected patients. Moreover, no special attention has been directed towards an alternative diagnosis which might explain patients' signs and symptoms. OBJECTIVES: To determine the safety of withholding anticoagulants in patients with clinically suspected pulmonary embolism (PE) and negative CT results when ultrasonography (US) was performed only in patients with clinical suspicion of deep vein thrombosis (DVT). Another goal was to evaluate the effect of CT findings on the final clinical diagnosis. METHODS: Among 192 consecutive patients who underwent CT for possible acute PE, 98 patients had negative images and 88 of them-- without clinical suspicion of DVT-- were prospectively followed up for 3 months for evidence of subsequent thromboembolic disease. They did not receive anticoagulation. Clinical probability of PE was assessed applying the Geneva score. These patients were also classified into several diagnostic categories according to the CT findings and clinical presentation. In addition, all patients who were alive (or a member of his or her family) were interviewed by phone once the last patient's follow-up was completed. RESULTS: One patient was lost to follow-up. Among the remaining 87 patients (35 with low, 47 with intermediate and 5 with high clinical probability), subsequent thromboembolic disease was found in 1 (1.1%; 95%CI: 0.03-6.2%). Two patients died during the follow-up period, but no deaths were attributed to PE. Alternative diagnoses were: nonspecific thoracic pain (43.3%), nonspecific pleuritis (19.5%), pneumonia (18.4%), other (18.8%). The telephone survey was performed in 74 patients (median follow-up: 11 months; range: 4-23). None of them had newly diagnosed episodes of PE and none of them had received anticoagulation for any reason. CONCLUSIONS: With the limitations of a small single-center series, our data suggest that withholding anticoagulation in patients with suspected acute PE and negative CT results appears to be safe when the clinical probability of PE is assessed as low or intermediate. This technique also provides useful information to pose an alternative diagnosis. US could be avoided in patients without clinical suspicion of DVT.

[Multicenter, prospective study comparing enoxaparin with unfractionated heparin in the treatment of submassive pulmonary thromboembolism]. / Estudio multicéntrico, prospectivo, de comparación del tratamiento de la tromboembolia pulmonar submasiva con enoxaparina y 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.

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

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 por ciento) fueron diagnosticados de recurrencia tromboembólica, mientras que dicha complicación se constató en dos pacientes del grupo B (9,5 por ciento). 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 (AU)