Effect of Endobronchial Coils vs Usual Care on Exercise Tolerance in Patients With Severe Emphysema: The RENEW Randomized Clinical Trial
| Autor: | Frank C, Sciurba, Gerard J, Criner, Charlie, Strange, Pallav L, Shah, Gaetane, Michaud, Timothy A, Connolly, Gaëtan, Deslée, William P, Tillis, Antoine, Delage, Charles-Hugo, Marquette, Ganesh, Krishna, Ravi, Kalhan, J Scott, Ferguson, Michael, Jantz, Fabien, Maldonado, Robert, McKenna, Adnan, Majid, Navdeep, Rai, Steven, Gay, Mark T, Dransfield, Luis, Angel, Roger, Maxfield, Felix J F, Herth, Momen M, Wahidi, Atul, Mehta, Dirk-Jan, Slebos, C, Egidio |
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| Přispěvatelé: | Groningen Research Institute for Asthma and COPD (GRIAC) |
| Rok vydání: | 2016 |
| Předmět: |
Male
SURGERY medicine.medical_treatment law.invention 0302 clinical medicine Randomized controlled trial Quality of life law Forced Expiratory Volume Single-Blind Method 030212 general & internal medicine LUNG-VOLUME-REDUCTION Lung COPD Exercise Tolerance Minimal clinically important difference General Medicine 11 Medical And Health Sciences Prostheses and Implants Middle Aged 3. Good health Hospitalization Treatment Outcome Pulmonary Emphysema TESTS Female medicine.symptom Life Sciences & Biomedicine medicine.medical_specialty SOCIETY Air trapping OBSTRUCTIVE PULMONARY-DISEASE CAPACITY 03 medical and health sciences Medicine General & Internal Internal medicine General & Internal Medicine MINIMAL IMPORTANT DIFFERENCE Bronchoscopy medicine Humans Pulmonary rehabilitation Aged Science & Technology VALVES business.industry Odds ratio RENEW Study Research Group Pneumonia medicine.disease Surgery Clinical trial HOMOGENEOUS EMPHYSEMA 030228 respiratory system Quality of Life business |
| Zdroj: | JAMA, 315(20), 2178-2189. AMER MEDICAL ASSOC |
| ISSN: | 1538-3598 0098-7484 |
| Popis: | IMPORTANCE Preliminary clinical trials have demonstrated that endobronchial coils compress emphysematous lung tissue and may improve lung function, exercise tolerance, and symptoms in patients with emphysema and severe lung hyperinflation.OBJECTIVE To determine the effectiveness and safety of endobronchial coil treatment.DESIGN, SETTING, AND PARTICIPANTS Randomized clinical trial conducted among 315 patients with emphysema and severe air trapping recruited from 21 North American and 5 European sites from December 2012 through November 2015.INTERVENTIONS Participants were randomly assigned to continue usual care alone (guideline based, including pulmonary rehabilitation and bronchodilators; n = 157) vs usual care plus bilateral coil treatment (n = 158) involving 2 sequential procedures 4 months apart in which 10 to 14 coils were bronchoscopically placed in a single lobe of each lung.MAIN OUTCOMES AND MEASURES The primary effectiveness outcome was difference in absolute change in 6-minute-walk distance between baseline and 12 months (minimal clinically important difference [MCID], 25 m). Secondary end points included the difference between groups in 6-minute walk distance responder rate, absolute change in quality of life using the St George's Respiratory Questionnaire (MCID, 4) and change in forced expiratory volume in the first second (FEV1; MCID, 10%). The primary safety analysis compared the proportion of participants experiencing at least 1 of 7 prespecified major complications.RESULTS Among 315 participants (mean age, 64 years; 52% women), 90% completed the 12-month follow-up. Median change in 6-minute walk distance at 12 months was 10.3 m with coil treatment vs -7.6 m with usual care, with a between-group difference of 14.6 m (Hodges-Lehmann 97.5% CI, 0.4 mto infinity; 1-sided P = .02). Improvement of at least 25 m occurred in 40.0% of patients in the coil group vs 26.9% with usual care (odds ratio, 1.8 [97.5% CI, 1.1 to infinity]; unadjusted between-group difference, 11.8%[97.5% CI, 1.0% to infinity]; 1-sided P = .01). The between-group difference in median change in FEV1 was 7.0%(97.5% CI, 3.4% to infinity; 1-sided P CONCLUSIONS AND RELEVANCE Among patients with emphysema and severe hyperinflation treated for 12 months, the use of endobronchial coils compared with usual care resulted in an improvement in median exercise tolerance that was modest and of uncertain clinical importance, with a higher likelihood of major complications. Further follow-up is needed to assess long-term effects on health outcomes. |
| Databáze: | OpenAIRE |
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