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@article{Sciurba:2016:10.1001/jama.2016.6261,
author = {Sciurba, FC and Criner, GJ and Strange, C and Shah, PL and Michaud, G and Connolly, TA and Deslee, G and Tillis, WP and Delage, A and Marquette, C-H and Krishna, G and Kalhan, R and Ferguson, JS and Jantz, M and Maldonado, F and McKenna, R and Majid, A and Rai, N and Gay, S and Dransfield, MT and Angel, L and Maxfield, R and Herth, FJF and Wahidi, MM and Mehta, A and Slebos, D-J},
doi = {10.1001/jama.2016.6261},
journal = {Journal of the American Medical Association},
pages = {2178--2189},
title = {Effect of endobronchial coils vs usual care on exercise tolerance in patients with severe emphysema the RENEW randomized clinical trial},
url = {http://dx.doi.org/10.1001/jama.2016.6261},
volume = {315},
year = {2016}
}

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TY  - JOUR
AB  - 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.
AU  - Sciurba,FC
AU  - Criner,GJ
AU  - Strange,C
AU  - Shah,PL
AU  - Michaud,G
AU  - Connolly,TA
AU  - Deslee,G
AU  - Tillis,WP
AU  - Delage,A
AU  - Marquette,C-H
AU  - Krishna,G
AU  - Kalhan,R
AU  - Ferguson,JS
AU  - Jantz,M
AU  - Maldonado,F
AU  - McKenna,R
AU  - Majid,A
AU  - Rai,N
AU  - Gay,S
AU  - Dransfield,MT
AU  - Angel,L
AU  - Maxfield,R
AU  - Herth,FJF
AU  - Wahidi,MM
AU  - Mehta,A
AU  - Slebos,D-J
DO  - 10.1001/jama.2016.6261
EP  - 2189
PY  - 2016///
SN  - 0002-9955
SP  - 2178
TI  - Effect of endobronchial coils vs usual care on exercise tolerance in patients with severe emphysema the RENEW randomized clinical trial
T2  - Journal of the American Medical Association
UR  - http://dx.doi.org/10.1001/jama.2016.6261
UR  - http://gateway.webofknowledge.com/gateway/Gateway.cgi?GWVersion=2&SrcApp=PARTNER_APP&SrcAuth=LinksAMR&KeyUT=WOS:000376343000014&DestLinkType=FullRecord&DestApp=ALL_WOS&UsrCustomerID=1ba7043ffcc86c417c072aa74d649202
UR  - http://hdl.handle.net/10044/1/43433
VL  - 315
ER  -

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