The rationale, design, and methods of a randomized, controlled trial to evaluate the efficacy and safety of an active strategy for the diagnosis and treatment of acute pulmonary embolism during exacerbations of chronic obstructive pulmonary disease. Issue 3 (25th February 2019)

• Record Type: Journal Article
• Authors: Jiménez, David; Agustí, Alvar; Monreal, Manuel; Otero, Remedios; Huisman, Menno V.; Lobo, José L.; Quezada, Andrés; Jara‐Palomares, Luis; Hernando, Ascensión; Tabernero, Eva; Marcos, Pedro; Ruiz‐Artacho, Pedro; Ballaz, Aitor; Bertoletti, Laurent; Couturaud, Francis; Yusen, Roger
• Other Names: Jimenez David investigator.; Agustí Alvar investigator.; Bertoletti Laurent investigator.; Couturaud Francis investigator.; Huisman Menno V. investigator.; Jimenez David investigator.; Lobo Jose Luis investigator.; Monreal Manuel investigator.; Otero Remedios investigator.; Yusen Roger D. investigator.; Muriel Alfonso investigator.; Guerassimova Ina investigator.; Morillo Raquel investigator.; Barrios Deisy investigator.; Quezada Andrés investigator.; Gallego Ignacio investigator.; Vicente Agustina investigator.
• Is Part Of: Clinical cardiology. Volume 42:Issue 3(2019)
• Page Start: 346
• Page End: 351
• Publication Date: 2019-02-25
• Subjects: chronic obstructive pulmonary disease -- exacerbation -- pulmonary embolism -- treatment; Cardiology -- Periodicals; 616.12005
• DOI: 10.1002/clc.23161
• Languages: English
• ISSNs: 0160-9289

Abstract

Abstract : Introduction: Some previous studies have suggested a high prevalence of pulmonary embolism (PE) during exacerbations of chronic obstructive pulmonary disease (ECOPD). The SLICE trial aims to assess the efficacy and safety of an active strategy for the diagnosis and treatment of PE (vs usual care) in patients hospitalized because of ECOPD. Methods: SLICE is a phase III, prospective, international, multicenter, randomized, open‐label, and parallel‐group trial. A total of 746 patients hospitalized because of ECOPD will be randomized in a 1:1 fashion to receive either an active strategy for the diagnosis and anticoagulant treatment of PE or usual care (ie, standard care without any diagnostic test for diagnosing PE). The primary outcome is a composite of all‐cause death, non‐fatal (recurrent) venous thromboembolism (VTE), or readmission for ECOPD within 90 days after enrollment. Secondary outcomes are (a) death from any cause within 90 days after enrollment, (b) non‐fatal (recurrent) VTE within 90 days after enrollment, (c) readmission within 90 days after enrollment, and (d) length of hospital stay. Results: Enrollment started in September 2014 and is expected to proceed until 2020. Median age of the first 443 patients was 71 years (interquartile range, 64‐78), and 26% were female. Conclusions: This multicenter trial will determine the value of detecting PEs in patients with ECOPD. This has implications for COPD patient morbidity and mortality. Trial registration number: NCT02238639.