Actualización en la estratificación de riesgo del tromboembolismo pulmonar agudo sintomático / Update on the risk stratification of acute symptomatic pulmonary thromboembolism

La mortalidad precoz en pacientes con tromboembolia pulmonar (TEP) varía desde el 2% en pacientes normotensos al 30% en pacientes con shock cardiogénico. La estratificación actual de riesgo en la TEP sintomática incluye 4 grupos de pacientes y las estrategias terapéuticas recomendadas se basan en dicha estratificación. Los pacientes que se presentan con inestabilidad hemodinámica se consideran de alto riesgo y en ellos se recomienda el tratamiento fibrinolítico. En pacientes normotensos, la estratificación de riesgo ayuda a diferenciar entre aquellos de bajo riesgo, riesgo intermedio-bajo y riesgo intermedio-alto. Actualmente no existe suficiente evidencia sobre el beneficio de una monitorización intensiva y tratamiento fibrinolítico en pacientes con riesgo intermedio-alto. En pacientes de bajo riesgo, está indicada la anticoagulación estándar y podría considerarse la posibilidad de un alta precoz con manejo ambulatorio, aunque su beneficio no está todavía firmemente establecido (AU)

Early mortality in patients with pulmonary thromboembolism (PTE) varies from 2% in normotensive patients to 30% in patients with cardiogenic shock. The current risk stratification for symptomatic PTE includes 4 patient groups, and the recommended therapeutic strategies are based on this stratification. Patients who have haemodynamic instability are considered at high risk. Fibrinolytic treatment is recommended for these patients. In normotensive patients, risk stratification helps differentiate between those of low risk, intermediate-low risk and intermediate-high risk. There is currently insufficient evidence on the benefit of intensive monitoring and fibrinolytic treatment in patients with intermediate-high risk. For low-risk patients, standard anticoagulation is indicated. Early discharge with outpatient management may be considered, although its benefit has still not been firmly established (AU)

Update on the risk stratification of acute symptomatic pulmonary thromboembolism. / Actualización en la estratificación de riesgo del tromboembolismo pulmonar agudo sintomático.

Early mortality in patients with pulmonary thromboembolism (PTE) varies from 2% in normotensive patients to 30% in patients with cardiogenic shock. The current risk stratification for symptomatic PTE includes 4 patient groups, and the recommended therapeutic strategies are based on this stratification. Patients who have haemodynamic instability are considered at high risk. Fibrinolytic treatment is recommended for these patients. In normotensive patients, risk stratification helps differentiate between those of low risk, intermediate-low risk and intermediate-high risk. There is currently insufficient evidence on the benefit of intensive monitoring and fibrinolytic treatment in patients with intermediate-high risk. For low-risk patients, standard anticoagulation is indicated. Early discharge with outpatient management may be considered, although its benefit has still not been firmly established.

[Comparison of the cost-utility of direct oral anticoagulants for the prevention of stroke in patients with atrial fibrillation in Spain]. / Comparacion del coste-utilidad de los anticoagulantes orales de accion directa en la prevencion de ictus en la fibrilacion auricular no valvular en España.

INTRODUCTION: Apixaban, dabigatran and rivaroxaban are three new direct oral anticoagulants (DOACs) used in the prevention of stroke and systemic embolism in patients with non-valvular atrial fibrillation (NVAF) in Spain. AIM: To assess the relative cost-utility of the three DOACs compared with vitamin K antagonists. PATIENTS AND METHODS: A Markov model with 3-month cycles was used to simulate NVAF patients starting with treatment and followed up for their lifetime from the perspective of the National Health System. The model included 36 health states including treatment combinations, disability and events history and considered a hypothetical cohort of 10,000 NVAF patients. Relative efficacy was calculated from a formal indirect treatment comparison using data from the pivotal trials of each DOAC. RESULTS: Dabigatran was associated with the highest number of quality-adjusted life years (QALY) (8.40 QALY), followed by apixaban (8.33 QALY), rivaroxaban (8.15 QALY) and acenocoumarol (8.03 QALY). Patients taking acenocoumarol had the lowest total costs (€22,230), followed by dabigatran (€24,564), apixaban (€24,655) and rivaroxaban (€25,900). Incremental cost-utility ratios compared to vitamin K antagonists, were €6,397, €8,039 and €29,957/QALY for dabigatran, apixaban and rivaroxaban, respectively. If compared together, dabigatran dominated apixaban and rivaroxaban. Sensitivity analyses confirmed the robustness of the baseline case. CONCLUSIONS: All three direct anticoagulants are cost-effective against acenocoumarol. Dabigatran is economically dominant over rivaroxaban and apixaban in the Spanish setting, as it is more effective and cheaper.

TITLE: Comparacion del coste-utilidad de los anticoagulantes orales de accion directa en la prevencion de ictus en la fibrilacion auricular no valvular en España.Introduccion. El apixaban, el dabigatran y el rivaroxaban son tres anticoagulantes orales de accion directa (ACOD) indicados para la prevencion del ictus y la embolia sistemica en pacientes con fibrilacion auricular no valvular (FANV) en España. Objetivo. Comparar el coste-utilidad de los tres ACOD frente a los antivitamina K. Pacientes y metodos. Se utilizo un modelo Markov con ciclos trimestrales para simular pacientes con FANV desde que inician su tratamiento hasta el resto de su vida desde la perspectiva del Sistema Nacional de Salud. El modelo incorporo 36 estados de salud, incluyendo combinaciones de tratamientos, discapacidad y antecedentes de eventos, y considero una cohorte hipotetica de 10.000 pacientes con FANV. La eficacia relativa se calculo a partir de una comparacion indirecta formal de los tratamientos segun los datos de los ensayos pivotales de cada ACOD. Resultados. El dabigatran se asocio al valor maximo de años de vida ajustados por calidad (AVAC) (8,40 AVAC), seguido del apixaban (8,33 AVAC), el rivaroxaban (8,15 AVAC) y el acenocumarol (8,03 AVAC). Los costes totales fueron menores con el acenocumarol (22.230 €), seguido del dabigatran (24.564 €), el apixaban (24.655 €) y el rivaroxaban (25.900 €). La ratio coste-utilidad incremental frente a los antivitamina K fue de 6.397, 8.039 y 29.957 €/AVAC para el dabigatran, el apixaban y el rivaroxaban, respectivamente. Comparados entre ellos, el dabigatran domino al apixaban y al rivaroxaban. Los analisis de sensibilidad confirmaron la robustez del caso base. Conclusiones. Los tres ACOD son coste-efectivos frente al acenocumarol. El dabigatran es economicamente dominante frente al rivaroxaban y al apixaban en España, al ser mas efectivo y menos costoso.

[Current indications of heparin treatment]. / Indicaciones actuales del tratamiento con heparinas.

The last guidelines on treatment of venous thromboembolic disease recommend the use of unfractionated heparin (UFH) or low molecular weight heparin (LMWH). In the case of deep venous thrombosis in out-patients, LMWH is preferred, associated to dicumarinics from the first day. In regards to prophylaxis, administration of UFH or LMWH is recommended in surgical patients of moderate to high risk but not in those undergoing minor surgery, under 40 years and without other risk factors. In patients with acute coronary syndrome without ST elevation, the administration of LMWH at fixed doses together with platelet antiaggregants is recommended. In patients with acute cerebral ischemia and without other criteria for thrombolytic treatment, treatment with heparin is not recommended but rather the administration of platelet antiaggregants.

Indicaciones actuales del tratamiento con heparinas / Present indications of heparin treatment

Las últimas guías sobre tratamiento de la enfermedad tromboembólica venosa recomiendan el uso de heparina no fraccionada (HNF) o de bajo peso molecular (HBPM). En el caso de trombosis venosa profunda en pacientes ambulatorios se prefiere la HBPM, asociada a dicumarínicos desde el primer día. En cuanto a profilaxis, en pacientes quirúrgicos se recomienda la administración de HNF o HBPM en pacientes de moderado a alto riesgo, pero no en pacientes sometidos a cirugía menor, menores de 40 años y sin otros factores de riesgo. En los pacientes con síndrome coronario agudo sin elevación del ST se recomienda la administración de HBPM a dosis fijas junto con antiagregantes plaquetarios. En los pacientes con isquemia cerebral aguda y sin criterios para tratamiento trombolítico no se aconseja el tratamiento con heparina, sino la administración de antiagregantes plaquetarios

The last guidelines on treatment of venous thromboembolic disease recommend the use of unfractionated heparin (UFH) or low molecular weight heparin (LMWH). In the case of deep venous thrombosis in out-patients, LMWH is preferred, associated to dicumarinics from the first day. In regards to prophylaxis, administration of UFH or LMWH is recommended in surgical patients of moderate to high risk but not in those undergoing minor surgery, under 40 years and without other risk factors. In patients with acute coronary syndrome without ST elevation, the administration of LMWH at fixed doses together with platelet antiaggregants is recommended. In patients with acute cerebral ischemia and without other criteria for thrombolytic treatment, treatment with heparin is not recommended but rather the administration of platelet antiaggregants

[Computerized registry of patients with thromboembolic disease in Spain (RIETE): background, objectives, methods, and preliminary results]. / Registro informatizado de pacientes con enfermedad tromboembólica en España (RIETE): justificación, objetivos, métodos y resultados preliminares.

BACKGROUND: Venous thromboembolic disease (VTD) is a common and severe condition. Its anticoagulation-based treatment is not without complications and failures. OBJECTIVE: To create in Internet a broad database of patients with venous thromboembolic disease attended at spanish hospitals which might be helpful in the clinical practice. METHODS: Computerized registry of all incident cases of patients with objective diagnosis of VTD attended at 27 spanish hospitals since March, 1st, 2001. All data related to diagnosis, treatment and follow-up during at least a 3-month period were collected. RESULTS: Since March 1st to August 31st, 2001, 573 patients were included (399 with VTD, 108 with PE and 66 with VTD and PE). The mean age of patients was 65.8 years. 10.5 % of patients had at least one risk factor: 5.2% hypoprothrombinemia (< 50%), 3% history of recent hemorrhage, 1.8% creatinine higher than 3 mg/dl, 1.3% hemodynamic unstability, 1.1% pregnancy, and 1% thrombopenia lower than 60000 platelets/mm3. The three-month follow-up period was completed by 35.4% of patients, 21.8 % of them with events (death [4.7%], hemorrhage [12.5%], and VTD relapse [4.2%]). Hypoprothrombinemia was significantly associated with increased risk of complications and history of recent hemorrhage with relapse. CONCLUSIONS: It is feasible to create a database containing information on a relevant number of VTD patients, 10.5% of them with complications. Such information will allow its utilization at short-term for the decision-marking process, particularly for patients with complications.

Registro informatizado de pacientes con enfermedad tromboembólica en España (RIETE): justificación, objetivos, métodos y resultados preliminares / Computerized registry of patients with thromboembolic disease in Spain (RIETE): background, objectives, methods, and preliminary results

Justificación. La enfermedad tromboembólica venosa (ETEV) es una patología frecuente y grave cuyo tratamiento basado en la utilización de anticoagulantes no está exento de complicaciones y fracasos. Objetivo. Disponer en Internet de una amplia base de datos de pacientes con ETEV, atendidos en los hospitales españoles, que sirva de ayuda en la práctica clínica. Métodos. Registro informatizado de todos los casos incidentes con diagnóstico objetivo de ETEV atendidos en 27 hospitales españoles desde el 1 de marzo de 2001. Se recogen todos los datos relacionados con el diagnóstico, tratamiento y seguimiento durante un período de al menos tres meses. Resultados. Desde el 1 de marzo hasta el 31 de agosto de 2001 se han incluido 573 pacientes (399 con trombosis venosa profunda [TVP], 108 con embolismo pulmonar [EP] y 66 con TVP y EP), con una edad media de 65,8 años. Un 10,5 por ciento presentaba al menos una situación de riesgo: 5,2 por ciento hipoprotrombinemia (< 50 por ciento), 3 por ciento antecedentes de hemorragia reciente, 1,8 por ciento creatinina mayor a 3 mg/dl, 1,3 por ciento inestabilidad hemodinámica, 1,1 por ciento embarazo y 1 por ciento trombopenia inferior a 60.000 plaquetas/mm3. Han finalizado el seguimiento de tres meses el 35,4 por ciento, un 21,8 por ciento con incidencias (defunción [4,7 por ciento], hemorragia [12,5 por ciento] y recidiva de la ETEV [4,2 por ciento]). La hipoprotrombinemia se asoció significativamente a mayor riesgo de complicaciones y los antecedentes de hemorragia reciente a recidiva. Conclusiones. Es factible disponer de información sobre un número importante de pacientes con ETEV, de los cuales el 10,5 por ciento son pacientes complicados, lo que permitirá a corto plazo poder utilizarla para la toma de decisiones, especialmente en estos últimos (AU)

La embolia pulmonar en las puertas del siglo XXI / Pulmonary embolism in the century XXI door

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