Dataset Information

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.

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.

SUBMITTER: Jimenez D

PROVIDER: S-EPMC6712316 | biostudies-literature | 2019 Mar

REPOSITORIES: biostudies-literature

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Publications

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.

Jiménez David D Agustí Alvar A Monreal Manuel M Otero Remedios R Huisman Menno V MV Lobo José L JL Quezada Andrés A Jara-Palomares Luis L Hernando Ascensión A Tabernero Eva E Marcos Pedro P Ruiz-Artacho Pedro P Ballaz Aitor A Bertoletti Laurent L Couturaud Francis F Yusen Roger R

Clinical cardiology 20190225 3

<h4>Introduction</h4>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.<h4>Methods</h4>SLICE is a phase III, prospective, international, multicenter, randomized, open-label, and parallel-group trial. A total of 746 patients ...[more]

PMID: 30706520

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Project description:The early detection and diagnosis of chronic obstructive pulmonary disease (COPD) is critical to providing appropriate and timely treatment. We explored a new active case-finding strategy for COPD using handheld spirometry.We recruited subjects over 40 years of age with a smoking history of more than 10 pack-years who visited a primary clinic complaining of respiratory symptoms. A total of 190 of subjects were enrolled. Medical information was obtained from historical records and physical examination by general practitioners. All subjects had their pulmonary function evaluated using handheld spirometry with a COPD-6 device. Because forced expiratory volume in 6 seconds (FEV6) has been suggested as an alternative to FVC, we measured forced expiratory volume in 1 second (FEV1)/FEV6 for diagnosis of airflow limitation. All subjects were then referred to tertiary referral hospitals to complete a "Could it be COPD?" questionnaire, handheld spiromtery, and conventional spirometry. The results of each instrument were compared to evaluate the efficacy of both handheld spirometry and the questionnaire.COPD was newly diagnosed in 45 (23.7%) patients. According to our receiver-operating characteristic (ROC) curve analysis, sensitivity and specificity were maximal when the FEV1/FEV6 ratio was less than 77%. The area under the ROC curve was 0.759. The sensitivity, specificity, positive predictive value, and negative predictive value were 72.7%, 77.1%, 50%, and 90%, respectively. The area under the ROC curve of respiratory symptoms listed on the questionnaire ranged from 0.5 to 0.65, which indicates that there is almost no difference compared with the results of handheld spirometry.The present study demonstrated the efficacy of handheld spirometry as an active case-finding tool for COPD in a primary clinical setting. This study suggested that physicians should recommend handheld spirometry for people over the age of 40, who have a smoking history of more than 10 pack-years, regardless of respiratory symptoms. Furthermore, people who have abnormal results, determined using the FEV1/FEV6 ≤0.77 cut-off, should be referred for further conventional spirometry to confirm the diagnosis of COPD. However, further studies within the general population are necessary to establish efficacy in the public.

Dataset Information

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.

Introduction

Methods

Results

Conclusions

Trial registration number

Publications

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.

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