Effect of a Pulmonary Embolism Diagnostic Strategy on Clinical Outcomes in Patients Hospitalized for COPD Exacerbation: A Randomized Clinical Trial
David Jiménez 1 2 3 , Alvar Agustí 4 , Eva Tabernero 5 , Luis Jara-Palomares 6 , Ascensión Hernando 7 , Pedro Ruiz-Artacho 3 8 , Gregorio Pérez-Peñate 9 , Agustina Rivas-Guerrero 10 , María Jesús Rodríguez-Nieto 3 11 , Aitor Ballaz 12 , Ramón Agüero 13 , Sonia Jiménez 14 , Myriam Calle-Rubio 15 , Raquel López-Reyes 16 , Pedro Marcos-Rodríguez 17 , Deisy Barrios 1 , Carmen Rodríguez 1 , Alfonso Muriel 18 , Laurent Bertoletti 19 , Francis Couturaud 20 , Menno Huisman 21 , José Luis Lobo 10 , Roger D Yusen 22 , Behnood Bikdeli 23 24 25 , Manuel Monreal 3 26 , Remedios Otero 3 6 , SLICE Trial Group
Importance: Active search for pulmonary embolism (PE) may improve outcomes in patients hospitalized for exacerbations of chronic obstructive pulmonary disease (COPD).
Objective: To compare usual care plus an active strategy for diagnosing PE with usual care alone in patients hospitalized for COPD exacerbation.
Design, setting, and participants: 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).
Interventions: 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).
Main outcomes and measures: 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.
Results: 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).
Conclusions and relevance: 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.
CITA DEL ARTÍCULO JAMA. 2021 Oct 5;326(13):1277-1285. doi: 10.1001/jama.2021.14846