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Original Investigation |

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

Frank C. Sciurba, MD1; Gerard J. Criner, MD2; Charlie Strange, MD3; Pallav L. Shah, MD4,5; Gaetane Michaud, MD6; Timothy A. Connolly, MD7; Gaëtan Deslée, MD8; William P. Tillis, MD9; Antoine Delage, MD10; Charles-Hugo Marquette, MD, PhD11; Ganesh Krishna, MD12; Ravi Kalhan, MD13; J. Scott Ferguson, MD14; Michael Jantz, MD15; Fabien Maldonado, MD16; Robert McKenna, MD17; Adnan Majid, MD18; Navdeep Rai, MD19; Steven Gay, MD20; Mark T. Dransfield, MD21; Luis Angel, MD22; Roger Maxfield, MD23; Felix J. F. Herth, MD24; Momen M. Wahidi, MD25; Atul Mehta, MD26; Dirk-Jan Slebos, MD, PhD27 ; for the RENEW Study Research Group
[+] Author Affiliations
1University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania
2Lewis Katz School of Medicine at Temple University, Philadelphia, Pennsylvania
3Medical University of South Carolina, Charleston
4National Institute for Health Research Unit, Royal Brompton and Harefield NHS Foundation Trust, Imperial College, London, England
5Chelsea and Westminster Hospital, London, England
6New York University School of Medicine, New York, New York
7Pulmonary, Critical Care, and Sleep Medicine, Houston, Texas
8University Hospital of Reims, INSERM U903, Reims, France
9OSF HealthCare–Illinois Lung and Critical Care Institute, Peoria
10Quebec Heart and Lung Institute, Quebec City, Quebec, Canada
11University Nice Sophia Antipolis, IRCAN, ONCOAGE, Nice, France
12Palo Alto Medical Foundation/El Camino Hospital, Mountain View, California
13Northwestern University, Chicago, Illinois
14University of Wisconsin School of Medicine, Madison
15University of Florida, Gainesville
16Mayo Clinic, Rochester, Minnesota
17Cedars-Sinai Medical Center, Los Angeles, California
18Beth Israel Deaconess Medical Center, Boston, Massachusetts
19Franciscan Research Center, Tacoma, Washington
20University of Michigan, Ann Arbor
21University of Alabama at Birmingham, Birmingham
22University of Texas, San Antonio
23New York Presbyterian Hospital/Columbia University, New York, New York
24Thoraxklinik at the University of Heidelberg, Heidelberg, Germany
25Duke University Medical Center, Durham, North Carolina
26Cleveland Clinic Foundation, Cleveland, Ohio
27University of Groningen, University Medical Center Groningen, Groningen, the Netherlands
JAMA. 2016;315(20):2178-2189. doi:10.1001/jama.2016.6261.
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Published online

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 FEV1 was 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 Registration  clinicaltrials.gov Identifier: NCT01608490

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Figure 1.
Participant Flow in the RENEW Randomized Clinical Trial

aMost patients with missing values were included in all categories of missing data.

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Figure 2.
Distribution of Effectiveness End Points for the Intention-to-Treat Analysis for Key Outcome Measures

For all measures, the response rates were higher in the endobronchial coil group based on reported minimal clinically important differences (MCIDs).16,17,19,23 In contrast, the proportion of participants declining an MCID equivalent was numerically greater for all measures in the usual care group. Note the small number of very significant 6-minute walk distance decliners, particularly in the coil group, that lowered the mean response. All improver and decliner rates were calculated with logistic regression with data from the full intention-to-treat analysis set, with multiple imputation. For each histogram, the bin interval was set at half of the MCID for that measure. In each bin, the data are equal to or greater than the lower limit and less than the upper limit of the bin. The bin widths for each histogram are for residual volume, 175 mL; forced expiratory volume in the first second (FEV1), 5%; 6-minute walk distance, 12.5 m; and St George’s Respiratory Questionnaire, 2 points.

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Figure 3.
Intention-to-Treat Analysis Response Rates for 4 Effectiveness Measures in Subgroups Stratified by Emphysema Distribution and Degree of Air Trapping

The greatest and most consistent improvements occurred in the residual volume ≥225% subgroups, particularly those with heterogeneous disease. Response rates were calculated with logistic regression with data from the full intention-to-treat analysis set, with multiple imputation. FEV1 indicates forced expiratory volume in the first second.

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