NDLI: Effect of Endobronchial Coils vs Usual Care on Exercise Tolerance in Patients With Severe Emphysema: The RENEW Randomized Clinical Trial

Content Provider	JAMA Network
Author	Sciurba, Frank C. Criner, Gerard J. Strange, Charlie Shah, Pallav L. Michaud, Gaetane Connolly, Timothy A. Deslée, Gaëtan Tillis, William P. Delage, Antoine Marquette, Charles-Hugo Krishna, Ganesh Kalhan, Ravi Ferguson, J. Scott Jantz, Michael Maldonado, Fabien McKenna, Robert Majid, Adnan Rai, Navdeep Gay, Steven Dransfield, Mark T. Angel, Luis Maxfield, Roger Herth, Felix J. F. Wahidi, Momen M. Mehta, Atul Slebos, Dirk-Jan
Copyright Year	2016
Abstract	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 m to ∞; 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 ∞]; unadjusted between-group difference, 11.8% [97.5% CI, 1.0% to ∞]; 1-sided: P = .01). The between-group difference in median change in FEV1was 7.0% (97.5% CI, 3.4% to ∞; 1-sided: P < .001), and the between-group St George’s Respiratory Questionnaire score improved −8.9 points (97.5% CI, −∞ to −6.3 points; 1-sided: P < .001), each favoring the coil group. Major complications (including pneumonia requiring hospitalization and other potentially life-threatening or fatal events) occurred in 34.8% of coil participants vs 19.1% of usual care ( P = .002). Other serious adverse events including pneumonia (20% coil vs 4.5% usual care) and pneumothorax (9.7% vs 0.6%, respectively) occurred more frequently in the coil group. 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. Trial Registrationclinicaltrials.gov Identifier: NCT01608490
Ending Page	2189
Starting Page	2178
Page Count	12
File Format	PDF HTM / HTML
ISSN	00987484
DOI	10.1001/jama.2016.6261
Issue Number	20
Journal	JAMA
Volume Number	315
Language	English
Publisher	American Medical Association
Publisher Date	2016-05-24
Access Restriction	Open
Subject Keyword	chronic obstructive airway disease exercise tolerance pulmonary emphysema lung hyperinflation 6-minute walk test
Content Type	Text
Resource Type	Article
Subject	Medicine

Sl.	Authority	Responsibilities	Communication Details
1	Ministry of Education (GoI), Department of Higher Education	Sanctioning Authority	https://www.education.gov.in/ict-initiatives
2	Indian Institute of Technology Kharagpur	Host Institute of the Project: The host institute of the project is responsible for providing infrastructure support and hosting the project	https://www.iitkgp.ac.in
3	National Digital Library of India Office, Indian Institute of Technology Kharagpur	The administrative and infrastructural headquarters of the project	Dr. B. Sutradhar bsutra@ndl.gov.in
4	Project PI / Joint PI	Principal Investigator and Joint Principal Investigators of the project	Dr. B. Sutradhar bsutra@ndl.gov.in Prof. Saswat Chakrabarti will be added soon
5	Website/Portal (Helpdesk)	Queries regarding NDLI and its services	support@ndl.gov.in
6	Contents and Copyright Issues	Queries related to content curation and copyright issues	content@ndl.gov.in
7	National Digital Library of India Club (NDLI Club)	Queries related to NDLI Club formation, support, user awareness program, seminar/symposium, collaboration, social media, promotion, and outreach	clubsupport@ndl.gov.in
8	Digital Preservation Centre (DPC)	Assistance with digitizing and archiving copyright-free printed books	dpc@ndl.gov.in
9	IDR Setup or Support	Queries related to establishment and support of Institutional Digital Repository (IDR) and IDR workshops	idr@ndl.gov.in

Dynamic hyperinflation and dyspnea during the 6-minute walk test in stable chronic obstructive pulmonary disease patients

Lung Volume Reduction Coil Treatment vs Usual Care in Patients With Severe Emphysema: The REVOLENS Randomized Clinical Trial

Relationships between heart rate target determined in different exercise testing in COPD patients to prescribed with individualized exercise training

Bilateral Endoscopic Lung Volume Reduction in Patients with Severe Emphysema.

Interval versus continuous training in individuals with chronic obstructive pulmonary disease--a systematic review.

Effectiveness of endobronchial coil treatment for lung volume reduction in patients with severe heterogeneous emphysema and bilateral incomplete fissures: a six-month follow-up.

Effect of Endobronchial Coils on Exercise Tolerance and Lung Functions in Patients with Severe Emphysema – A Retrospective Cohort Study of 48 Patients

Dynamic hyperinflation and dyspnea during the 6-minute walk test in stable chronic obstructive pulmonary disease patients

October 2015 Phoenix pulmonary journal club: lung volume reduction

Effect of Endobronchial Coils vs Usual Care on Exercise Tolerance in Patients With Severe Emphysema: The RENEW Randomized Clinical Trial

Similar Documents

Dynamic hyperinflation and dyspnea during the 6-minute walk test in stable chronic obstructive pulmonary disease patients

Lung Volume Reduction Coil Treatment vs Usual Care in Patients With Severe Emphysema: The REVOLENS Randomized Clinical Trial

Relationships between heart rate target determined in different exercise testing in COPD patients to prescribed with individualized exercise training

Bilateral Endoscopic Lung Volume Reduction in Patients with Severe Emphysema.

Interval versus continuous training in individuals with chronic obstructive pulmonary disease--a systematic review.

Effectiveness of endobronchial coil treatment for lung volume reduction in patients with severe heterogeneous emphysema and bilateral incomplete fissures: a six-month follow-up.

Effect of Endobronchial Coils on Exercise Tolerance and Lung Functions in Patients with Severe Emphysema – A Retrospective Cohort Study of 48 Patients

Dynamic hyperinflation and dyspnea during the 6-minute walk test in stable chronic obstructive pulmonary disease patients

October 2015 Phoenix pulmonary journal club: lung volume reduction

Effect of Endobronchial Coils vs Usual Care on Exercise Tolerance in Patients With Severe Emphysema: The RENEW Randomized Clinical Trial