Prognostic Significance of Findings on CTPA Supporting an Alternative Diagnosis to PE Among Patients Hospitalized for an Exacerbation of COPD: Predefined Subanalysis of the SLICE Trial. / Significado pronóstico de los diagnósticos alternativos a la TEP hallados en la tomografía computarizada de tórax de pacientes ingresados por agudización de EPOC: subanálisis predefinido del ensayo SLICE.

BACKGROUND: Among patients hospitalized for an exacerbation of chronic obstructive pulmonary disease (COPD), the SLICE trial showed that the addition of an active diagnostic strategy for pulmonary embolism (PE) to usual care compared with usual care alone did not improve a composite set of health outcomes. The objective of this subanalysis was to determine the frequency and prognostic significance of findings on computed tomography pulmonary angiogram (CTPA) supporting an alternative diagnosis to PE. METHODS: We analyzed all patients randomized to the intervention in the SLICE trial who received a CTPA that did not show PE. We used multivariable logistic regression to assess the independent association between findings supporting an alternative diagnosis to PE and a composite of readmission for COPD or death within 90 days after randomization. RESULTS: Among the 746 patients who were randomized, this subanalysis included 175 patients in the intervention group who received a CTPA that did not show PE. Eighty-four (48.0%) patients had acute bronchial infection, 13 (7.4%) had lung cancer, 10 (5.7%) had congestive heart failure, 8 (4.6%), 18 (10.3%) had other diagnoses, and 42 (24.0%) had a normal CTPA. In multivariable analysis, findings supporting an alternative diagnosis to PE were not significantly associated with the primary outcome (odds ratio: 0.64; 95% confidence interval: 0.30-1.38; P=0.26). CONCLUSIONS: Among patients hospitalized for an exacerbation of COPD, CTPA identified an alternative diagnosis in 76% of the patients. However, specific management of these patients was not associated with improved outcomes within 90 days after randomization.

Significado pronóstico de los diagnósticos alternativos a la TEP hallados en la tomografía computarizada de tórax de pacientes ingresados por agudización de EPOC: subanálisis predefinido del ensayo SLICE / Prognostic Significance of Findings on CTPA Supporting an Alternative Diagnosis to PE Among Patients Hospitalized for an Exacerbation of COPD: Predefined Subanalysis of the SLICE Trial

Antecedentes: El ensayo clínico SLICE no demostró un beneficio clínico de la búsqueda activa de la tromboembolia de pulmón (TEP) en pacientes que requirieron ingreso por agudización de su EPOC. El objetivo de este subanálisis fue determinar la frecuencia y el significado pronóstico del hallazgo de un diagnóstico alternativo a la TEP en la tomografía computarizada de tórax (TC) realizada a pacientes hospitalizados por EPOC agudizada. Métodos: Analizamos los pacientes del grupo intervención de SLICE que recibieron una TC con resultado negativo para TEP. Evaluamos mediante el uso de regresión logística multivariable la asociación entre un diagnóstico alternativo y el evento primario compuesto de reingreso por EPOC y la mortalidad por cualquier causa en los primeros 90 días después de la aleatorización. Resultados: Este análisis incluyó a 175 pacientes del grupo intervención que recibieron una TC con un resultado negativo para TEP. De ellos, 84 (48,0%) fueron diagnosticados de infección bronquial aguda, 13 (7,4%) de cáncer de pulmón, 10 (5,7%) de insuficiencia cardiaca, 8 (4,6%) de neumonía, 18 (10,3%) de otros diagnósticos, y en 42 (24,0%) pacientes la TC fue normal. En el análisis multivariable, un diagnóstico alternativo no se asoció de manera significativa con el evento primario (odds ratio: 0,64; IC 95%: 0,30-1,38; P=0,26). Conclusiones: Entre los pacientes que requieren ingreso por agudización de EPOC, la TC ofrece un diagnóstico alternativo a la TEP en el 76% de las ocasiones. El tratamiento específico de estas patologías no se asocia a un mejor pronóstico durante el seguimiento. (AU)

Background: Among patients hospitalized for an exacerbation of chronic obstructive pulmonary disease (COPD), the SLICE trial showed that the addition of an active diagnostic strategy for pulmonary embolism (PE) to usual care compared with usual care alone did not improve a composite set of health outcomes. The objective of this subanalysis was to determine the frequency and prognostic significance of findings on computed tomography pulmonary angiogram (CTPA) supporting an alternative diagnosis to PE. Methods: We analyzed all patients randomized to the intervention in the SLICE trial who received a CTPA that did not show PE. We used multivariable logistic regression to assess the independent association between findings supporting an alternative diagnosis to PE and a composite of readmission for COPD or death within 90 days after randomization. Results: Among the 746 patients who were randomized, this subanalysis included 175 patients in the intervention group who received a CTPA that did not show PE. Eighty-four (48.0%) patients had acute bronchial infection, 13 (7.4%) had lung cancer, 10 (5.7%) had congestive heart failure, 8 (4.6%), 18 (10.3%) had other diagnoses, and 42 (24.0%) had a normal CTPA. In multivariable analysis, findings supporting an alternative diagnosis to PE were not significantly associated with the primary outcome (odds ratio: 0.64; 95% confidence interval: 0.30-1.38; P=0.26). Conclusions: Among patients hospitalized for an exacerbation of COPD, CTPA identified an alternative diagnosis in 76% of the patients. However, specific management of these patients was not associated with improved outcomes within 90 days after randomization. (AU)

[Translated article] Prognostic Significance of Findings on CTPA Supporting an Alternative Diagnosis to PE Among Patients Hospitalized for an Exacerbation of COPD: Predefined Subanalysis of the SLICE Trial / Significado pronóstico de los diagnósticos alternativos a la TEP hallados en la tomografía computarizada de tórax de pacientes ingresados por agudización de EPOC: subanálisis predefinido del ensayo SLICE

Background: Among patients hospitalized for an exacerbation of chronic obstructive pulmonary disease (COPD), the SLICE trial showed that the addition of an active diagnostic strategy for pulmonary embolism (PE) to usual care compared with usual care alone did not improve a composite set of health outcomes. The objective of this subanalysis was to determine the frequency and prognostic significance of findings on computed tomography pulmonary angiogram (CTPA) supporting an alternative diagnosis to PE. Methods: We analyzed all patients randomized to the intervention in the SLICE trial who received a CTPA that did not show PE. We used multivariable logistic regression to assess the independent association between findings supporting an alternative diagnosis to PE and a composite of readmission for COPD or death within 90 days after randomization. Results: Among the 746 patients who were randomized, this subanalysis included 175 patients in the intervention group who received a CTPA that did not show PE. Eighty-four (48.0%) patients had acute bronchial infection, 13 (7.4%) had lung cancer, 10 (5.7%) had congestive heart failure, 8 (4.6%), 18 (10.3%) had other diagnoses, and 42 (24.0%) had a normal CTPA. In multivariable analysis, findings supporting an alternative diagnosis to PE were not significantly associated with the primary outcome (odds ratio: 0.64; 95% confidence interval: 0.30-1.38; P=0.26). Conclusions: Among patients hospitalized for an exacerbation of COPD, CTPA identified an alternative diagnosis in 76% of the patients. However, specific management of these patients was not associated with improved outcomes within 90 days after randomization. (AU)

Antecedentes: El ensayo clínico SLICE no demostró un beneficio clínico de la búsqueda activa de la tromboembolia de pulmón (TEP) en pacientes que requirieron ingreso por agudización de su EPOC. El objetivo de este subanálisis fue determinar la frecuencia y el significado pronóstico del hallazgo de un diagnóstico alternativo a la TEP en la tomografía computarizada de tórax (TC) realizada a pacientes hospitalizados por EPOC agudizada. Métodos: Analizamos los pacientes del grupo intervención de SLICE que recibieron una TC con resultado negativo para TEP. Evaluamos mediante el uso de regresión logística multivariable la asociación entre un diagnóstico alternativo y el evento primario compuesto de reingreso por EPOC y la mortalidad por cualquier causa en los primeros 90 días después de la aleatorización. Resultados: Este análisis incluyó a 175 pacientes del grupo intervención que recibieron una TC con un resultado negativo para TEP. De ellos, 84 (48,0%) fueron diagnosticados de infección bronquial aguda, 13 (7,4%) de cáncer de pulmón, 10 (5,7%) de insuficiencia cardiaca, 8 (4,6%) de neumonía, 18 (10,3%) de otros diagnósticos, y en 42 (24,0%) pacientes la TC fue normal. En el análisis multivariable, un diagnóstico alternativo no se asoció de manera significativa con el evento primario (odds ratio: 0,64; IC 95%: 0,30-1,38; P=0,26). Conclusiones: Entre los pacientes que requieren ingreso por agudización de EPOC, la TC ofrece un diagnóstico alternativo a la TEP en el 76% de las ocasiones. El tratamiento específico de estas patologías no se asocia a un mejor pronóstico durante el seguimiento. (AU)

Adjusted D-dimer cutoff levels to rule out pulmonary embolism in patients hospitalized for COPD exacerbation: results from the SLICE trial.

BACKGROUND: For patients with suspected pulmonary embolism (PE), age- or clinically-adjusted D-dimer threshold level can be used to define a negative test that safely excludes PE and reduces the use of imaging. However, the utility of this approach in patients hospitalized for chronic obstructive pulmonary disease (COPD) exacerbation is undefined. METHODS: We ran an analysis of the patients hospitalized for COPD exacerbation and randomized to the intervention in the SLICE trial. Using the conventional strategy as the reference, we compared the proportion of patients with a negative D-dimer result, and the negative predictive value and sensitivity of three D-dimer threshold strategies for initial PE or subsequent diagnosis of venous thromboembolism (VTE): the age-adjusted strategy, the Wells-adjusted strategy, and the YEARS-adjusted strategy. RESULTS: We included 368 patients. Using a conventional threshold, 182 (49.5%) patients had negative D-dimer values, of whom 1 (0.6%) had PE (sensitivity, 94.1%). The use of an age-adjusted threshold increased the number of patients in whom PE could be excluded from 182 to 233 patients (63.3%), and the proportion of false-negative findings increased from 0.5% to 1.7% (sensitivity, 76.5%). With the use of the Wells or YEARS strategies, 64.4% and 71.5% had negative values, and the proportion of false-negative findings was 2.5% (sensitivity, 64.7%) and 2.7% (sensitivity, 58.8%), respectively. CONCLUSIONS: In patients hospitalized for COPD exacerbation, compared with the conventional strategy, age- or clinically-adjusted strategies of D-dimer interpretation were associated with a larger proportion of patients in whom PE was ruled out with a higher failure rate. TRIAL REGISTRATION: ClinicalTrials.gov number: NCT02238639 .

Refinement of a modified simplified Pulmonary Embolism Severity Index for elderly patients with acute pulmonary embolism.

OBJECTIVE: To evaluate the utility of a modified (i.e., without the variable "Age >80 years") simplified Pulmonary Embolism Severity Index (sPESI) in elderly patients with acute symptomatic pulmonary embolism (PE), and to derive and validate a refined version of the sPESI for identification of elderly patients at low risk of adverse events. METHODS: The study included normotensive patients aged >80 years with acute PE enrolled in the RIETE registry. We used multivariable logistic regression analysis to create a new risk score to predict 30-day all-cause mortality. We externally validated the new risk score in elderly patients from the COMMAND VTE registry. RESULTS: Multivariable logistic regression identified four predictors for mortality: high-risk sPESI, immobilization, coexisting deep vein thrombosis (DVT), and plasma creatinine >2 mg/dL. In the RIETE derivation cohort, the new model classified fewer patients as low risk (4.0% [401/10,106]) compared to the modified sPESI (35% [3522/10,106]). Low-risk patients based on the new model had a lower 30-day mortality than those based on the modified sPESI (1.2% [95% CI, 0.4-2.9%] versus 4.7% [95% CI, 4.0-5.4%]). In the COMMAND VTE validation cohort, 1.5% (3/206) of patients were classified as having low risk of death according to the new model, and the overall 30-day mortality of this group was 0% (95% CI, 0-71%), compared to 5.9% (95% CI, 3.1-10.1%) in the high-risk group. CONCLUSIONS: For predicting short-term mortality among elderly patients with acute PE, this study suggests that the new model has a substantially higher sensitivity than the modified sPESI. A minority of these patients might benefit from safe outpatient therapy of their disease.