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[Low-molecular-weight heparin without oral anticoagulants for the treatment of deep vein thrombosis]. / Tratamiento de la trombosis venosa profunda con heparinas de bajo peso molecular. Estudio comparativo con anticoagulación oral.

BACKGROUND AND METHODS: The available data on the utility of low-molecular-weight heparins (LMWH) in the secondary prophylaxis of deep vein thrombosis (DVT) are limited. We compared two cohorts of patients diagnosed of DVT. One group followed treatment with LMWH and the other group did with oral anticoagulants (acenocoumarol). Safety was evaluated by the rate of major hemorrhage and 2.5-years period fracture rate, and efficacy was evaluated as the rate of early recurrence and one-year recurrence rate. RESULTS: Of 65 patients treated with LMWH, the hemorrhagic rate was 1.5% (95% CI 0.08-9.40), fracture rate was 7.7% (95% CI 2.87-17.75), early recurrence was 1.5% (95% CI 0.08-9.40) and one-year recurrence was 3% (95% CI 53-11.64). In 118 patients treated with oral anticoagulants the hemorrhagic rate was 3.4% (95% CI 1.09-8.97), odds ratio 0.33, the fracture rate was 11% (95% CI 16.23-18.44), odds ratio 0.66, the early recurrence rate was 5% (95% CI 2.08-11.20), odds ratio 0.60 and one-year recurrence was 3.4% (95%CI 1.09-8.97), odds ratio 0.33. CONCLUSIONS: Secondary prophylaxis of DVT with LMWH is as safe and effective as classical treatment with oral anticoagulants. In this study the 2.5-year period fracture rate was similar in both groups of treatment.

Tratamiento de la trombosis venosa profunda con heparinas de bajo peso molecular. Estudio comparativo con anticoagulación oral / Low-molecular-weight heparin without oral anticoagulants for the treatment of deep vein thrombosis

Antecedentes y métodos: Se dispone de datos limitados sobre la utilidad de la profilaxis secundaria de la trombosis venosa profunda (TVP) con heparinas de bajo peso molecular (HBPM). Comparamos dos cohortes de pacientes diagnosticados de TVP. Un grupo tratado con HBPM y otro grupo tratado con anticoagulantes orales. Se valoró la seguridad a la terminación del tratamiento anticoagulante, al año y para la incidencia de fracturas a los 2,5 años. La seguridad se evaluó por la tasa de hemorragias mayores y de fracturas y la eficacia por la tasa de recidiva trombótica precoz (durante el tratamiento anticoagulante) y al año. Resultados: de 65 pacientes tratados con HBPM, presentaron una tasa de hemorragia mayor de 1,5% (IC95% 0,08-9,40) y de fractura de7,7% (IC95% 2,87-17,75), presentaron recidiva temprana 1,5% (IC 95% 0,08-9,40) y recidiva al año 3% (IC95% 0,53-11,64). De 118 pacientes tratados con anticoagulantes orales presentaron una tasa de hemorragia mayor de 3,4% (IC95% 1,09 a 8,97), odds ratio 0,33, una tasa de fractura de 11% (IC95% 16,23 a 18,44), odds ratio 0,66, recidiva temprana de 5% (IC95% 2,08 a 11,20), odds ratio 0,60 y recidiva al año de 3,4% (IC95% 1,09 a 8,97), odds ratio 0,33. Conclusiones: La profilaxis secundaria de la trombosis venosa profunda con HBPM es al menos tan eficaz y segura como el tratamiento con anticoagulantes orales. El tratamiento con HBPM no ha causado incremento de las fracturas

Background and methods: The available data on the utility of low molecular-weight heparins (LMWH) in the secondary prophylaxis of deep vein thrombosis (DVT) are limited. We compared two cohorts of patients diagnosed of DVT. One group followed treatment with LMWH and the other group did with oral anticoagulants (acenocoumarol). Safety was evaluated by the rate of major hemorrhage and 2.5-years period fracture rate, and efficacy was evaluated as the rate of early recurrence and one-year recurrence rate. Results: Of 65 patients treated with LMWH, the hemorrhagic rate was 1.5% (95% CI 0.08-9.40), fracture rate was 7.7% (95% CI 2.87-17.75), early recurrence was 1.5% (95% CI 0.08-9.40) and one-year recurrence was 3% (95% CI 53-11.64). In 118 patients treated with oral anticoagulants the hemorrhagic rate was 3.4% (95% CI 1.09-8.97), odds ratio 0.33, the fracture rate was11% (95% CI 16.23-18.44), odds ratio 0.66, the early recurrence ratewas 5% (95% CI 2.08-11.20), odds ratio 0.60 and one-year recurrence was 3.4% (95%CI 1.09-8.97), odds ratio 0.33. Conclusions: Secondary prophylaxis of DVT with LMWH is as safeand effective as classical treatment with oral anticoagulants. In this study the 2.5-year period fracture rate was similar in both groups of treatment

[Utility of the clinical models for predicting pulmonary thromboembolism]. / Utilidad de los modelos clínicos en la predicción de tromboembolia pulmonar.

OBJECTIVE: We considered to evaluate the efectivity of the clinical models for predicting pulmonary thromboembolism (PE). METHODS: Retrospective application of three published clinical models (Wells or Canadian model, Geneva model and Pisa model) to patients unequivocally diagnosed of acute PE. RESULTS: We evaluate 120 patients [Mean age 71+/-13 years, males 63 (52%)]: Nineteen (16%) diagnosed with pulmonary arteriography and 101 (84%) diagnosed with helical computed tomography. In the Canadian model 24% patients were of high clinical probability, 59% intermediate and 17% low clinical probability. In Geneva model 21% patients belonged to high clinical probability, 69% intermediate and 10% low clinical probability. In Pisa model 49% patients were of high clinical probability, 45% intermediate and 6% of low clinical probability. Sensitivity was 0.59, 0.67 and 0.89 respectively. Factors associated with low probability were in Canadian model the heart rate, the absence of signs of deep venous thrombosis, the presence of an alternative diagnosis and the low rate of cancer. In Geneva model, age, normal heart rate and PaO2 higher 70 mm Hg were associated with low probability, while in Pisa model normal chest X-Ray and radiological signs of pulmonary oedema were also associated with low clinical probability. CONCLUSIONS: Although all three clinical model showed deficiencies Pisa model was the most suitable clinical model for predicting PE. An intermediate clinical probability in the three models, should not serve to rule out PE, besides it is remarkable that patients with low clinical probability still could have PE, providing for clinical models with a limited value.

Utilidad de los modelos clínicos en la predicción de tromboembolia pulmonar / Utility of the clinical model for predicting pulmonary thromboembolism

Objetivo: Valorar la efectividad de los modelos de predicción clínica de tromboembolia pulmonar (TEP). Material y métodos: Aplicación retrospectiva de los tres modelos (canadiense, Ginebra y Pisa) a pacientes diagnosticados inequívocamente de TEP por arteriografía o tomografía computerizada (TAC) helicoidal. Resultados: Analizamos 120 pacientes [edad media 71 ± 13 años, varones 63 (52%)] diagnosticados 19 (16%) por arteriografía y 101 (84%) por TAC helicoidal. La distribución en el modelo canadiense fue alta probabilidad 24%, intermedia 59% y baja 17%. En el modelo Ginebra fue de alta probabilidad 21%, intermedia 69% y baja 10%. En el modelo Pisa la distribución fue de alta probabilidad 49%, intermedia 45% y baja 6%. La sensibilidad de los modelos fue respectivamente 0,59, 0,67 y 0,89. Factores que condicionaron baja probabilidad fueron en el modelo canadiense la frecuencia cardiaca, la ausencia de signos de trombosis venosa, la existencia de un diagnóstico alternativo y la baja tasa de cáncer. En el modelo Ginebra fueron la edad, la frecuencia cardiaca y la PaO2. En el modelo Pisa condicionaron baja probabilidad diagnóstica la radiografía de tórax normal y la existencia de edema pulmonar. Conclusiones: En los tres modelos de predicción clínica de TEP se observan deficiencias, siendo el modelo Pisa el más adecuado para predecir la probabilidad de TEP. La probabilidad intermedia en modo alguno debe servir para excluir el diagnóstico, y aún con baja probabilidad un número de pacientes en los tres modelos tendrán TEP. En conjunto la utilidad de los modelos de predicción clínica muestran un valor limitado

Objective: We considered to evaluate the efectivity of the clinical models for predicting pulmonary thromboembolism (PE). Methods: Retrospective application of three published clinical models (Wells or Canadian model, Geneva model and Pisa model) to patients unequivocally diagnosed of acute PE. Results: We evaluate 120 patients [Mean age 71±13 years, males 63 (52%)]: Nineteen (16%) diagnosed with pulmonary arteriography and 101 (84%) diagnosed with helical computed tomography. In the Canadian model 24% patients were of high clinical probability, 59% intermediate and 17% low clinical probability. In Geneva model 21% patients belonged to high clinical probability, 69% intermediate and 10% low clinical probability. In Pisa model 49% patients were of high clinical probability, 45% intermediate and 6% of low clinical probability. Sensitivity was 0.59, 0.67 and 0.89 respectively. Factors associated with low probability were in Canadian model the heart rate, the absence of signs of deep venous thrombosis, the presence of an alternative diagnosis and the low rate of cancer. In Geneva model, age, normal heart rate and PaO2 higher 70 mm Hg were associated with low probability, while in Pisa model normal chest X-Ray and radiological signs of pulmonary oedema were also associated with low clinical probability. Conclusions: Although all three clinical model showed deficiencies Pisa model was the most suitable clinical model for predicting PE. An intermediate clinical probability in the three models, should not serve to rule out PE, besides it is remarkable that patients with low clinical probability still could have PE, providing for clinical models with a limited value