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Original Investigation
October 5, 2021

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

Author Affiliations
  • 1Respiratory Department, Hospital Ramón y Cajal and Instituto Ramón y Cajal de Investigación Sanitaria IRYCIS, Madrid, Spain
  • 2Medicine Department, Universidad de Alcalá, Madrid, Spain
  • 3CIBER Enfermedades Respiratorias (CIBERES), Madrid, Spain
  • 4Respiratory Institute, Hospital Clinic, IDIBAPS, Universitat de Barcelona, CIBERES, Barcelona, Spain
  • 5Respiratory Department, Hospital Universitario Cruces, Biocruces-Bizkaia, Barakaldo, Spain
  • 6Respiratory Department, Virgen del Rocío Hospital and Instituto de Biomedicina, Sevilla
  • 7Respiratory Department, Hospital Doce de Octubre, Madrid, Spain
  • 8Department of Internal Medicine, Clínica Universidad de Navarra, Madrid; Interdisciplinar Teragnosis and Radiosomics Research Group (INTRA-Madrid), Universidad de Navarra, Madrid, Spain
  • 9Respiratory Department and Pulmonary Vascular Unit, HUGC Dr. Negrín, Las Palmas GC, Spain
  • 10Respiratory Department, Hospital Araba, Vitoria, Spain
  • 11Respiratory Department, Fundación Jiménez Díaz, Madrid, Spain
  • 12Respiratory Department, Hospital Galdakao-Usansolo, Bilbao, Spain
  • 13Respiratory Department, Hospital Universitario Marqués de Valdecilla, Santander, Spain
  • 14Emergency Department, Hospital Clinic, IDIBAPS, Barcelona, Spain
  • 15Respiratory Department, Hospital Clínico San Carlos, Madrid; Medicine Department, Universidad Complutense, Madrid, Spain
  • 16Respiratory Department, Hospital La Fe, Valencia, Spain
  • 17Respiratory Department, Complejo Hospitalario Universitario de A Coruña (CHUAC), INIBIC, Universidade da Coruña, A Coruña, Spain
  • 18Biostatistics Department, Ramón y Cajal Hospital and Instituto Ramón y Cajal de Investigación Sanitaria IRYCIS, CIBERESP, Madrid, Spain
  • 19CHU de St-Etienne, Service de Médecine Vasculaire et Thérapeutique; INSERM, UMR1059, Université Jean-Monnet; INSERM, CIC-1408, CHU de Saint-Etienne; INNOVTE, CHU de Saint-Etienne; all in F-42055, Saint-Etienne, France
  • 20Department of Internal Medicine and Chest Diseases, EA3878 (G.E.T.B.O.), CIC INSERM 0502, University Hospital of Brest, European University of Occidental Brittany, Brest, France
  • 21Department of Thrombosis and Hemostasis, Leiden University Medical Center, Leiden, the Netherlands
  • 22Divisions of Pulmonary and Critical Care Medicine and General Medical Sciences, Washington University School of Medicine in St Louis, St Louis, Missouri
  • 23Cardiovascular Medicine Division, Brigham and Women’s Hospital, Harvard Medical School, Boston, Massachusetts
  • 24Center for Outcomes Research and Evaluation (CORE), Yale University School of Medicine, New Haven, Connecticut
  • 25Cardiovascular Research Foundation, New York, New York
  • 26Department of Internal Medicine, Hospital Universitari Germans Trias i Pujol, Badalona, Barcelona; Universidad Católica de Murcia, Murcia, Spain
JAMA. 2021;326(13):1277-1285. doi:10.1001/jama.2021.14846
Key Points

Question  Does an active search for pulmonary embolism (PE) improve outcomes in patients hospitalized for exacerbations of chronic obstructive pulmonary disease (COPD)?

Findings  This multicenter randomized clinical trial included 746 patients who required hospitalization for exacerbation of COPD and were randomized to receive usual care plus an active strategy for diagnosing PE or usual care alone. The primary outcome (a composite of nonfatal symptomatic venous thromboembolism, readmission for COPD, or death within 90 days after randomization) occurred in 29.7% of patients in the intervention group vs 29.2% in the control group, a difference that was not statistically significant.

Meaning  Among patients hospitalized for an exacerbation of COPD, addition of an active diagnostic strategy for PE to usual care compared with usual care alone did not improve a composite set of health outcomes.

Abstract

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.

Trial Registration  ClinicalTrials.gov Identifier: NCT02238639

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