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

Autor:	Jiménez D; Respiratory Department, Hospital Ramón y Cajal and Instituto Ramón y Cajal de Investigación Sanitaria IRYCIS, Madrid, Spain.; Medicine Department, Universidad de Alcalá, Madrid, Spain.; CIBER Enfermedades Respiratorias (CIBERES), Madrid, Spain., Agustí A; Respiratory Institute, Hospital Clinic, IDIBAPS, Universitat de Barcelona, CIBERES, Barcelona, Spain., Tabernero E; Respiratory Department, Hospital Universitario Cruces, Biocruces-Bizkaia, Barakaldo, Spain., Jara-Palomares L; Respiratory Department, Virgen del Rocío Hospital and Instituto de Biomedicina, Sevilla., Hernando A; Respiratory Department, Hospital Doce de Octubre, Madrid, Spain., Ruiz-Artacho P; CIBER Enfermedades Respiratorias (CIBERES), Madrid, Spain.; Department of Internal Medicine, Clínica Universidad de Navarra, Madrid; Interdisciplinar Teragnosis and Radiosomics Research Group (INTRA-Madrid), Universidad de Navarra, Madrid, Spain., Pérez-Peñate G; Respiratory Department and Pulmonary Vascular Unit, HUGC Dr. Negrín, Las Palmas GC, Spain., Rivas-Guerrero A; Respiratory Department, Hospital Araba, Vitoria, Spain., Rodríguez-Nieto MJ; CIBER Enfermedades Respiratorias (CIBERES), Madrid, Spain.; Respiratory Department, Fundación Jiménez Díaz, Madrid, Spain., Ballaz A; Respiratory Department, Hospital Galdakao-Usansolo, Bilbao, Spain., Agüero R; Respiratory Department, Hospital Universitario Marqués de Valdecilla, Santander, Spain., Jiménez S; Emergency Department, Hospital Clinic, IDIBAPS, Barcelona, Spain., Calle-Rubio M; Respiratory Department, Hospital Clínico San Carlos, Madrid; Medicine Department, Universidad Complutense, Madrid, Spain., López-Reyes R; Respiratory Department, Hospital La Fe, Valencia, Spain., Marcos-Rodríguez P; Respiratory Department, Complejo Hospitalario Universitario de A Coruña (CHUAC), INIBIC, Universidade da Coruña, A Coruña, Spain., Barrios D; Respiratory Department, Hospital Ramón y Cajal and Instituto Ramón y Cajal de Investigación Sanitaria IRYCIS, Madrid, Spain., Rodríguez C; Respiratory Department, Hospital Ramón y Cajal and Instituto Ramón y Cajal de Investigación Sanitaria IRYCIS, Madrid, Spain., Muriel A; Biostatistics Department, Ramón y Cajal Hospital and Instituto Ramón y Cajal de Investigación Sanitaria IRYCIS, CIBERESP, Madrid, Spain., Bertoletti L; CHU 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., Couturaud F; Department 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., Huisman M; Department of Thrombosis and Hemostasis, Leiden University Medical Center, Leiden, the Netherlands., Lobo JL; Respiratory Department, Hospital Araba, Vitoria, Spain., Yusen RD; Divisions of Pulmonary and Critical Care Medicine and General Medical Sciences, Washington University School of Medicine in St Louis, St Louis, Missouri., Bikdeli B; Cardiovascular Medicine Division, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.; Center for Outcomes Research and Evaluation (CORE), Yale University School of Medicine, New Haven, Connecticut.; Cardiovascular Research Foundation, New York, New York., Monreal M; CIBER Enfermedades Respiratorias (CIBERES), Madrid, Spain.; Department of Internal Medicine, Hospital Universitari Germans Trias i Pujol, Badalona, Barcelona; Universidad Católica de Murcia, Murcia, Spain., Otero R; CIBER Enfermedades Respiratorias (CIBERES), Madrid, Spain.; Respiratory Department, Virgen del Rocío Hospital and Instituto de Biomedicina, Sevilla.
Jazyk:	angličtina
Zdroj:	JAMA [JAMA] 2021 Oct 05; Vol. 326 (13), pp. 1277-1285.
DOI:	10.1001/jama.2021.14846
Abstrakt:	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.
Databáze:	MEDLINE
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