Home treatment in pulmonary embolism.

BACKGROUND: Limited data exist on the feasibility of providing outpatient care to patients with acute pulmonary embolism (PE). METHODS: We conducted a multicenter randomized clinical trial in acute symptomatic PE to compare the efficacy and safety of early discharge versus standard hospitalization. A clinical prediction rule was used to identify low-risk patients. All patients were followed for three months. The primary outcomes were venous thromboembolic recurrences, major and minor bleeding, and overall mortality. RESULTS: One hundred and thirty two low-risk patients with acute symptomatic PE were randomized to early discharge (n=72) or standard hospitalization (n=60). Overall mortality was 4.2% (95% CI, 0.5-8.9) in the early discharge group and 8.3% (95% CI, 1.1-15) in the standard hospitalization group (Relative Risk (RR) 0.5; 95% confidence interval [CI], 0.12-2.01). Non-fatal recurrences were 2.8% (95% CI, 1.1-6.6) in the early discharge group and 3.3% (95% CI, 1.3-8%) in the standard hospitalization group (RR 0.8; 95% CI, 0.12-5.74). The rates of clinically relevant bleeding were 5.5% in the early discharge group and 5% in the standard hospitalization group (P=0.60). Short-term mortality was 2.8% (95% CI, 0.8-9.6%) in the early discharge group as compared with 0% in the standard hospitalization group. Based on the rate of short-term death in a carefully selected population, the study was suspended. CONCLUSIONS: In spite of the number of complications in patients with acute symptomatic PE randomized to standard hospitalization or early discharge did not differ significantly. The rate of short-term mortality was unexpectedly high in a (a priori) low-risk group of patients with acute PE. The accuracy of clinical prediction scores needs to be validated in well designed clinical trials. (ClinicalTrials.gov number, NCT00214929.).

Short-term clinical outcome after acute symptomatic pulmonary embolism.

Though studies have identified clinical variables that predict adverse events in patients with acute pulmonary embolism (PE), they have typically not differentiated short-term from long-term predictors. This multicenter prospective cohort study included consecutive outpatients with objectively confirmed symptomatic acute PE. We analyzed the incidence and time course of death, venous thromboembolism (VTE) recurrence, and major bleeding, and we compared event rates during short-term (first week) and long-term (3 months) follow-up after the diagnosis of PE. We also assessed risk factors for short-term mortality. During the first three months after diagnosis of PE, 142 of 1,338 (10.6%) patients died. Thirty-six deaths (2.7%) occurred during the first week after diagnosis of PE, and 61.1% of these were due to PE. Thirty-eight patients (2.8%) had recurrent VTE during the three-month follow-up, though none of the recurrences occurred during the first week after diagnosis of PE. During the three-month follow-up, major bleeding occurred in 48 patients (3.6%). Twenty-one (1.6%) major bleeds occurred during the first week of follow-up, and nine of these were fatal. Short-term mortality was significantly increased in patients who initially presented with systolic arterial hypotension (odds ratio [OR] 3.35; 95% CI, 1.51-5.41) or immobilization due to a medical illness (OR 2.89; 95% confidence interval [CI], 1.31-6.39). In conclusion, during the first week after the diagnosis of PE, death and major bleeding occur more frequently than recurrent VTE. Patients with systolic arterial hypotension and immobilization at the time of PE diagnosis had an increased risk of short-term mortality.

[A clinical prediction rule for identifying short-term risk of adverse events in patients with pulmonary thromboembolism]. / Escala de riesgo de eventos adversos a corto plazo en pacientes con tromboembolia pulmonar.

OBJECTIVE: To identify patients with a low short-term risk of complications following acute pulmonary thromboembolism. PATIENTS AND METHODS: A prospective multicenter study was conducted in 8 Spanish hospitals; 681 consecutive outpatients diagnosed with pulmonary thromboembolism were enrolled. Clinically significant variables were weighted using coefficients derived from a logistic regression model in order to optimize the diagnostic performance of a clinical prediction rule to predict the following complications within 10 days of acute pulmonary thromboembolism: death, recurrent thromboembolism, and major or minor bleeding. RESULTS: Forty-three patients (6.3%) had 51 complications. These included 33 deaths, 12 major bleeding episodes, and 6 minor bleeding episodes. The clinical variables used in the prediction rule were assigned the following scores: recent major bleeding episode and cancer with metastasis, 4 points each; creatinine levels of over 2 mg/dL, 3 points; cancer without metastasis and immobility due to a recent medical condition, 2 points each; and absence of surgery in the past 2 months and an age of over 60 years, 1 point each. A risk score of 2 or less, obtained by 47.8% of patients, indicated a low short-term risk of developing complications following pulmonary thromboembolism. The area under the receiver operating characteristic curve for the prediction rule was 0.75 (95% confidence interval [CI], 0.67-0.83). For this cutoff point, sensitivity was 82.9% (95% CI, 68.7-91.5) and the likelihood ratios for a positive and negative test result were 1.63 (95% CI, 1.39-1.92), and 0.35 (95% CI, 0.18-0.69), respectively. CONCLUSIONS: Our clinical prediction rule could be useful for identifying patients with a low risk of complications in the 10 days following acute pulmonary thromboembolism. Those patients would be eligible for consideration for outpatient treatment.

Escala de riesgo de eventos adversos a corto plazo en pacientes con tromboembolia pulmonar / A clinical prediction rule for identifying short-term risk of adverse events in patients with pulmonary thromboembolism

Objetivo: Identificar a pacientes con riesgo bajo de complicaciones a corto plazo tras un episodio agudo de tromboembolia pulmonar (TEP). Pacientes y métodos: Se trata de un estudio multicéntrico y prospectivo, realizado en 8 hospitales españoles, en el que se incluyó a un total de 681 pacientes ambulatorios consecutivos con diagnóstico de TEP. Las variables con significación clínica se ponderaron a partir de los coeficientes del modelo logístico, con el objetivo de maximizar las características diagnósticas de la escala clínica de predicción de eventos a corto plazo: muertes, recidivas tromboembólicas o complicaciones hemorrágicas graves y no graves en los 10 primeros días. Resultados: Hubo 51 complicaciones en 43 pacientes (6,3%): un total de 33 fallecimientos, 12 hemorragias graves y 6 no graves. La puntuación clínica asignada a las variables de la escala de predicción fue la siguiente: hemorragia grave reciente y cáncer con metástasis, 4 puntos cada una; valores de creatinina mayores de 2 mg/dl, 3 puntos; cáncer sin metástasis e inmovilización por enfermedad médica reciente, 2 puntos cada una, y ausencia de cirugía en los últimos 2 meses y edad superior a 60 años, 1 punto cada una. Una puntuación de 2 o menor, que obtuvo el 47,8% de nuestros pacientes, indica un riesgo bajo de presentar complicaciones a corto plazo tras la TEP. El área bajo la curva de eficacia diagnóstica de la escala es de 0,75 (intervalo de confianza [IC] del 95%, 0,67-0,83). Para ese punto de corte la sensibilidad es del 82,9% (IC del 95%, 68,7-91,5), el cociente de probabilidad positiva del 1,63 (IC del 95%, 1,39-1,92) y el cociente de probabilidad negativa de 0,35 (IC del 95%, 0,18-0,69). Conclusiones: Nuestra escala clínica de puntuación podría ser útil para identificar a pacientes con riesgo bajo de presentar complicaciones durante los 10 primeros días tras un episodio de TEP aguda. Estos pacientes serían los candidatos sobre los que plantear un estudio que avale el tratamiento domiciliario de la TEP

Objective: To identify patients with a low short-term risk of complications following acute pulmonary thromboembolism. Patients and methods: A prospective multicenter study was conducted in 8 Spanish hospitals; 681 consecutive outpatients diagnosed with pulmonary thromboembolism were enrolled. Clinically significant variables were weighted using coefficients derived from a logistic regression model in order to optimize the diagnostic performance of a clinical prediction rule to predict the following complications within 10 days of acute pulmonary thromboembolism: death, recurrent thromboembolism, and major or minor bleeding. Results: Forty-three patients (6.3%) had 51 complications. These included 33 deaths, 12 major bleeding episodes, and 6 minor bleeding episodes. The clinical variables used in the prediction rule were assigned the following scores: recent major bleeding episode and cancer with metastasis, 4 points each; creatinine levels of over 2 mg/dL, 3 points; cancer without metastasis and immobility due to a recent medical condition, 2 points each; and absence of surgery in the past 2 months and an age of over 60 years, 1 point each. A risk score of 2 or less, obtained by 47.8% of patients, indicated a low short-term risk of developing complications following pulmonary thromboembolism. The area under the receiver operating characteristic curve for the prediction rule was 0.75 (95% confidence interval [CI], 0.67-0.83). For this cutoff point, sensitivity was 82.9% (95% CI, 68.7-91.5) and the likelihood ratios for a positive and negative test result were 1.63 (95% CI, 1.39-1.92), and 0.35 (95% CI, 0.18-0.69), respectively. Conclusions: Our clinical prediction rule could be useful for identifying patients with a low risk of complications in the 10 days following acute pulmonary thromboembolism. Those patients would be eligible for consideration for outpatient treatment

[Early complications in patients with pulmonary embolism]. / Complicaciones precoces en pacientes con embolia de pulmón.

BACKGROUND AND OBJECTIVE: Mortality, recurrences and hemorrhages are the most serious early complications of pulmonary embolism (PE). We intended to ascertain the frequency and mechanisms of complications within the first 10 days after PE was diagnosed. PATIENTS AND METHOD: We included patients suspected of suffering PE between December 2003 and August 2004 from 8 hospitals. We performed a multicenter observational prospective study of 8 Spanish hospitals with consecutive outpatients diagnosed with PE. Database of clinical variables: computerized Registry of Patients with Venous Thromboembolism (RIETE). Statistic analysis included chi2 and Student's t test to compare the 2 groups of patients (with and without complications). RESULTS: Six hundred eighty one patients were included, 336 men and 345 women (mean age 66 and 70, respectively). During the first 10 days, 33 (4.8%) of them died, and 22 (3.2%) had an hemorrhage yet no recurrences appeared. Previous immobilization and the presence of respiratory failure, cancer or renal failure were significantly associated with early complications while previous surgery and thoracic pain were not associated with those. CONCLUSIONS: Early complications and some of the associated factors were in agreement with published data. Other situations such as previous surgery or thoracic pain appeared to be protective factors.

Complicaciones precoces en pacientes con embolia de pulmón / Early complications in patients with pulmonary embolism

Fundamento y objetivo: Las complicaciones precoces más graves de la embolia pulmonar (EP) son la mortalidad, las recidivas y las hemorragias. Los objetivos de este estudio fueron conocer cuáles son las complicaciones más frecuentes y los factores a ellas asociados en los primeros 10 días siguientes al diagnóstico de EP. Pacientes y método: Se incluyó prospectivamente en el estudio a todos los pacientes ingresados por sospecha de EP entre diciembre de 2003 y agosto de 2004, procedentes de 8 hospitales. Se evaluó la aparición de complicaciones durante los primeros 10 días. Las variables clínicas recogidas se incluyeron en el Registro Informatizado de la Enfermedad Tromboembólica en España (RIETE). El análisis estadístico se realizó mediante las pruebas de la *2 y de la t de Student para la comparación de los grupos según presentaran o no complicaciones; se efectuó un análisis multivariado para averiguar qué factores estaban relacionados con la aparición de complicaciones. Resultados: El número de pacientes fue de 681, 336 hombres y 345 mujeres, edad media 66 y 70 años, respectivamente. En los primeros 10 días, 33 (4,8%) fallecieron y 22 (3,2%) presentaron alguna hemorragia. No hubo ninguna recidiva de la EP. El antecedente de inmovilización y la presencia de insuficiencia respiratoria, de un cáncer o de insuficiencia renal fueron las variables asociadas con más frecuencia a la aparición de complicaciones. La cirugía y el dolor torácico fueron las asociadas a menos complicaciones. Conclusiones: La frecuencia de presentación de complicaciones precoces de la EP y una parte de los factores asociados a ellas coinciden con los ya conocidos. Sin embargo, este estudio demuestra que otros factores como la cirugía previa o el dolor torácico protegen a los pacientes frente a su aparición

Background and objective: Mortality, recurrences and hemorrhages are the most serious early complications of pulmonary embolism (PE). We intended to ascertain the frequency and mechanisms of complications within the first 10 days after PE was diagnosed. Patients and method: We included patients suspected of suffering PE between December 2003 and August 2004 from 8 hospitals. We performed a multicenter observational prospective study of 8 Spanish hospitals with consecutive outpatients diagnosed with PE. Database of clinical variables: computerized Registry of Patients with Venous Thromboembolism (RIETE). Statistic analysis included *2 and Student's t test to compare the 2 groups of patients (with and without complications). Results: Six hundred eighty one patients were included, 336 men and 345 women (mean age 66 and 70, respectively). During the first 10 days, 33 (4.8%) of them died, and 22 (3.2%) had an hemorrhage yet no recurrences appeared. Previous immobilization and the presence of respiratory failure, cancer or renal failure were significantly associated with early complications while previous surgery and thoracic pain were not associated with those. Conclusions: Early complications and some of the associated factors were in agreement with published data. Other situations such as previous surgery or thoracic pain appeared to be protective factors