Effect of a Pulmonary Embolism Diagnostic Strategy on Clinical Outcomes in Patients Hospitalized for COPD Exacerbation: A Randomized Clinical Trial

Active search for pulmonary embolism (PE) may improve outcomes in patients hospitalized for exacerbations of chronic obstructive pulmonary disease (COPD). To compare usual care plus an active strategy for diagnosing PE with usual care alone in patients hospitalized for COPD exacerbation. Randomized...

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Published in:JAMA : the journal of the American Medical Association Vol. 326; no. 13; p. 1277
Main Authors: Jiménez, David, Agustí, Alvar, Tabernero, Eva, Jara-Palomares, Luis, Hernando, Ascensión, Ruiz-Artacho, Pedro, Pérez-Peñate, Gregorio, Rivas-Guerrero, Agustina, Rodríguez-Nieto, María Jesús, Ballaz, Aitor, Agüero, Ramón, Jiménez, Sonia, Calle-Rubio, Myriam, López-Reyes, Raquel, Marcos-Rodríguez, Pedro, Barrios, Deisy, Rodríguez, Carmen, Muriel, Alfonso, Bertoletti, Laurent, Couturaud, Francis, Huisman, Menno, Lobo, José Luis, Yusen, Roger D, Bikdeli, Behnood, Monreal, Manuel, Otero, Remedios
Format: Journal Article
Language:English
Published: United States 05.10.2021
Subjects:
Aged
Cause of Death
Computed Tomography Angiography - statistics & numerical data
Confidence Intervals
Disease Progression
Female
Fibrin Fibrinogen Degradation Products - analysis
Hemorrhage - etiology
Hospitalization
Humans
Male
Patient Readmission
Pulmonary Disease, Chronic Obstructive - complications
Pulmonary Disease, Chronic Obstructive - therapy
Pulmonary Embolism - blood
Pulmonary Embolism - diagnosis
Pulmonary Embolism - etiology
Pulmonary Embolism - therapy
Recurrence
Spain
Treatment Outcome
Venous Thromboembolism
Spain
ISSN:1538-3598, 1538-3598
Online Access:Get more information
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Summary:Active search for pulmonary embolism (PE) may improve outcomes in patients hospitalized for exacerbations of chronic obstructive pulmonary disease (COPD). To compare usual care plus an active strategy for diagnosing PE with usual care alone in patients hospitalized for COPD exacerbation. Randomized clinical trial conducted across 18 hospitals in Spain. A total of 746 patients were randomized from September 2014 to July 2020 (final follow-up was November 2020). Usual care plus an active strategy for diagnosing PE (D-dimer testing and, if positive, computed tomography pulmonary angiogram) (n = 370) vs usual care (n = 367). The primary outcome was a composite of nonfatal symptomatic venous thromboembolism (VTE), readmission for COPD, or death within 90 days after randomization. There were 4 secondary outcomes, including nonfatal new or recurrent VTE, readmission for COPD, and death from any cause within 90 days. Adverse events were also collected. Among the 746 patients who were randomized, 737 (98.8%) completed the trial (mean age, 70 years; 195 [26%] women). The primary outcome occurred in 110 patients (29.7%) in the intervention group and 107 patients (29.2%) in the control group (absolute risk difference, 0.5% [95% CI, -6.2% to 7.3%]; relative risk, 1.02 [95% CI, 0.82-1.28]; P = .86). Nonfatal new or recurrent VTE was not significantly different in the 2 groups (0.5% vs 2.5%; risk difference, -2.0% [95% CI, -4.3% to 0.1%]). By day 90, a total of 94 patients (25.4%) in the intervention group and 84 (22.9%) in the control group had been readmitted for exacerbation of COPD (risk difference, 2.5% [95% CI, -3.9% to 8.9%]). Death from any cause occurred in 23 patients (6.2%) in the intervention group and 29 (7.9%) in the control group (risk difference, -1.7% [95% CI, -5.7% to 2.3%]). Major bleeding occurred in 3 patients (0.8%) in the intervention group and 3 patients (0.8%) in the control group (risk difference, 0% [95% CI, -1.9% to 1.8%]; P = .99). Among patients hospitalized for an exacerbation of COPD, the addition of an active strategy for the diagnosis of PE to usual care, compared with usual care alone, did not significantly improve a composite health outcome. The study may not have had adequate power to assess individual components of the composite outcome. ClinicalTrials.gov Identifier: NCT02238639.
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ISSN:1538-3598
1538-3598
DOI:10.1001/jama.2021.14846