Acute venous thromboembolism in patients with recent major bleeding. The influence of the site of bleeding and the time elapsed on outcome.

BACKGROUND: Patients with major bleeding who subsequently develop clinically apparent venous thromboembolism (VTE) present a particularly difficult therapeutic dilemma. METHODS: RIETE is a prospective registry of consecutive patients with symptomatic, objectively confirmed, acute VTE. We retrospectively studied those who had experienced recent major bleeding (<30 days prior to VTE) to assess the influence of the site of bleeding and the time elapsed to VTE on their 3 month outcome. RESULTS: Of 12,294 patients enrolled up to July 2005, 306 (2.5%) had recent major bleeding: gastrointestinal (GI) tract, 116 (38%); intracranial, 94 (31%); other, 96 (31%). During the study period, 19 patients [6.2%; 95% confidence interval (CI) 3.5-8.9] with recent bleeding rebled (eight died): 13 of them (68%) during the first 2 weeks. Multivariate analysis confirmed that patients with recent GI bleeding had an increased risk for both major rebleeding (hazard ratio 2.8; 95% CI 1.4-5.3) and death (hazard ratio 1.9; 95% CI 1.2-3.1) compared to those with no recent bleeding. Those who bled in other sites had an increased risk only for death (hazard ratio 2.0; 95% CI 1.2-3.3). An elapsed time of <2 weeks from bleeding to the index VTE event was also associated with an increased risk for major rebleeding (hazard ratio 2.4; 95% CI 1.2-5.0) and death (hazard ratio 2.8; 95% CI 1.8-4.5). CONCLUSION: The incidence of new bleeding or death depends on the site of prior bleeding and the time elapsed until VTE. This information may help to identify the best therapeutic approach for these high-risk patients.

[Usefulness of fast ELISA determination of D-dimer levels for diagnosing pulmonary embolism in an emergency room]. / Utilidad del dímero-D por ELISA rápido en el diagnóstico de la embolia pulmonar en un servicio de urgencias.

OBJECTIVE: To determine the sensitivity and negative predictive value of D-dimer levels measured by fast enzyme-linked immunoabsorbent assay (ELISA) in pulmonary embolism. PATIENTS AND METHODS: Prospective study of consecutive patients with suspicion of pulmonary embolism attended in the Emergency Room of the Hospital de La Princesa in Madrid, Spain. Thromboembolism was diagnosed with an algorithm established in the hospital, and D-dimer levels were determined by fast ELISA (VIDAS D-dimer Assay) in each patient suspected of pulmonary embolism. Patients with negative findings from a test not considered a reference method for thromboembolism were followed for 3 months. RESULTS: Of 132 patients with clinical suspicion, 28 (21.2%) were positive and 104 (78.7%) were negative for embolism. D-dimer levels were below 0.5 microg/mL in 31 patients, 30 of whom did not have pulmonary thromboembolism whereas 1 did. D-dimer levels were abowe 0..5 microg/mL in 101 patients; thromboembolism did not occur in 74 of these but was reported in the remaining 27. For a value of 1 microg/mL, 66 patients had values below the cut off, 3 of whom presented pulmonary embolism. The remaining 66 patients had D-dimer levels above or equal to 1 microg/mL; 25 of them had a positive diagnosis for embolism and 41 had a negative diagnosis. Sensitivity and negative predictive values were 96.4% (95% confidence interval [CI], 79.8%-99.9%) and 96.8% (95% CI, 81.5%-98.8%), respectively, at a cut off of 0.5 microg/mL; and 89.2% (95% CI, 70.6%-97.2%) and 95.45% (95% CI, 86.4%-98.8%), respectively, at a cut off of 1 microg/mL. CONCLUSIONS: In an emergency room, thromboembolism can be excluded if plasma levels of D-dimer measured by fast ELISA are below 0.5 microg/mL because of the high negative predictive value at this cut off.

Fatal bleeding in patients receiving anticoagulant therapy for venous thromboembolism: findings from the RIETE registry.

BACKGROUND: Fatal bleeding is a serious consequence of anticoagulant therapy, but factors associated with fatal bleeding during the first 3 months of treatment of venous thromboembolism (VTE) are uncertain. METHODS: Using data from RIETE, an ongoing registry of consecutive patients with acute VTE, we assessed risk factors for fatal bleeding among all patients. We then used this information to derive a clinical model that would stratify a patient's risk of fatal bleeding during the first 3 months of treatment. RESULTS: Of 24 395 patients, 546 (2.24%) had a major bleed and 135 (0.55%) had a fatal bleed. The gastrointestinal tract was the most common site (40% of fatal bleeds), followed by intracranial bleeding (25%). Fatal bleeding was independently associated with the following factors at the time of VTE diagnosis: age >75 years (OR, 2.16), metastatic cancer (OR, 3.80), immobility > or = 4 days (OR, 1.99), a major bleed within the past 30 days (OR, 2.64), an abnormal prothrombin time (OR, 2.09), a platelet count < 100 x 10(9) L(-1) (OR, 2.23), creatinine clearance < 30 mL min(-1) (OR, 2.27), anemia (OR, 1.54), and distal deep vein thrombosis (OR, 0.39). INR at the time of bleeding is not known. A clinical prediction rule for risk of fatal bleeding that included nine baseline factors was derived. Fatal bleeding occurred in 0.16% (95% CI, 0.11-0.23) of the low-risk, 1.06% (95% CI, 0.85-1.30) of the moderate-risk, and 4.24% (95% CI, 2.76-6.27) of the high-risk category. CONCLUSIONS: Patient characteristics and laboratory variables can identify patients at high risk for fatal bleeding during treatment of VTE.

Anticoagulación preventiva: ejemplo de análisis de riesgo/beneficio / No disponible

No disponible

Utilidad del dímero-D por ELISA rápido en el diagnóstico de la embolia pulmoar en un servicio de urgencias / Usefulness of fast ELISA determination of D-dimer levels for diagnosing pulmonary embolism in an emergency room

Objetivo: Determinar la sensibilidad y el valor predictivo negativo del dímero-D, por enzimoinmunoanálisis (ELISA) rápido, en la embolia pulmonar. Pacientes y métodos: Estudio prospectivo de pacientes atendidos consecutivamente por sospecha clínica de embolia en el Servicio de Urgencias del Hospital de La Princesa de Madrid. El diagnóstico de tromboembolia se basó en el algoritmo establecido en el hospital, y se determinó el dímero-D por ELISA (VIDAS) en cada paciente con sospecha de embolia pulmonar. A los pacientes con resultado negativo para tromboembolia, establecido por una prueba no considerada de referencia, se les realizó seguimiento clínico a los 3 meses. Resultados: De 132 pacientes con sospecha clínica, 28 (21,2%) fueron positivos y 104 (78,7%) negativos para embolia. El dímero-D fue 0,5 mg/ml, en 74 no se produjo tromboembolia y en 27 sí. Si se considera como punto de corte 1 mg/ml, hubo 66 pacientes con valores inferiores, de los que 3 presentaron embolia pulmonar. Otros 66 pacientes mostraron un dímero-D >= 1 mg/ml; de ellos, 25 tuvieron un diagnóstico positivo para embolia y 41 negativo. La sensibilidad y el valor predictivo negativo para 0,5 mg/ml fue de 96,4 (intervalo de confianza [IC] del 95%, 79,8-99,9) y 96,8 (IC del 95%, 81,5-98,8), respectivamente; para 1 mg/ml fue de 89,2 (IC del 95%, 70,6-97,2) y 95,45 (IC del 95%, 86,4-98,8), respectivamente. Conclusiones: Los valores de dímero-D plasmático, determinados por la técnica de ELISA rápido (VIDAS), < 0,5 mg/ml permiten excluir con alto valor predictivo negativo una tromboembolia pulmonar en un servicio de urgencias

Objective: To determine the sensitivity and negative predictive value of D-dimer levels measured by fast enzyme-linked immunoabsorbent assay (ELISA) in pulmonary embolism. Patients and Methods: Prospective study of consecutive patients with suspicion of pulmonary embolism attended in the Emergency Room of the Hospital de La Princesa in Madrid, Spain. Thromboembolism was diagnosed with an algorithm established in the hospital, and D-dimer levels were determined by fast ELISA (VIDAS D-dimer Assay) in each patient suspected of pulmonary embolism. Patients with negative findings from a test not considered a reference method for thromboembolism were followed for 3 months. Results: Of 132 patients with clinical suspicion, 28 (21.2%) were positive and 104 (78.7%) were negative for embolism. D-dimer levels were below 0.5 mg/mL in 31 patients, 30 of whom did not have pulmonary thromboembolism whereas 1 did. D-dimer levels were abowe 0..5 mg/mL in 101 patients; thromboembolism did not occur in 74 of these but was reported in the remaining 27. For a value of 1 mg/mL, 66 patients had values below the cut off, 3 of whom presented pulmonary embolism. The remaining 66 patients had D-dimer levels above or equal to 1 mg/mL; 25 of them had a positive diagnosis for embolism and 41 had a negative diagnosis. Sensitivity and negative predictive values were 96.4% (95% confidence interval [CI], 79.8%-99.9%) and 96.8% (95% CI, 81.5%-98.8%), respectively, at a cut off of 0.5 mg/mL; and 89.2% (95% CI, 70.6%-97.2%) and 95.45% (95% CI, 86.4%-98.8%), respectively, at a cut off of 1 mg/mL. Conclusions: In an emergency room, thromboembolism can be excluded if plasma levels of D-dimer measured by fast ELISA are below 0.5 mg/mL because of the high negative predictive value at this cut off