title: Effect of Endobronchial Coils vs Usual Care on Exercise Tolerance in Patients With Severe Emphysema: The RENEW Randomized Clinical Trial.
abstract: OBJECTIVE
  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.
  
  
  METHODS
  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.
  
  
  METHODS
  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.
  
  
  METHODS
  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
  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.
  
  
  BACKGROUND
  clinicaltrials.gov Identifier: NCT01608490.
authors.affiliation: University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania.
authors.forename: Frank C
authors.initials: FC
authors.lastname: Sciurba
authors.affiliation: Lewis Katz School of Medicine at Temple University, Philadelphia, Pennsylvania.
authors.forename: Gerard J
authors.initials: GJ
authors.lastname: Criner
authors.affiliation: Medical University of South Carolina, Charleston.
authors.forename: Charlie
authors.initials: C
authors.lastname: Strange
authors.affiliation: National Institute for Health Research Unit, Royal Brompton and Harefield NHS Foundation Trust, Imperial College, London, England5Chelsea and Westminster Hospital, London, England.
authors.forename: Pallav L
authors.initials: PL
authors.lastname: Shah
authors.affiliation: New York University School of Medicine, New York, New York.
authors.forename: Gaetane
authors.initials: G
authors.lastname: Michaud
authors.affiliation: Pulmonary, Critical Care, and Sleep Medicine, Houston, Texas.
authors.forename: Timothy A
authors.initials: TA
authors.lastname: Connolly
authors.affiliation: University Hospital of Reims, INSERM U903, Reims, France.
authors.forename: Gaëtan
authors.initials: G
authors.lastname: Deslée
authors.affiliation: OSF HealthCare-Illinois Lung and Critical Care Institute, Peoria.
authors.forename: William P
authors.initials: WP
authors.lastname: Tillis
authors.affiliation: Quebec Heart and Lung Institute, Quebec City, Quebec, Canada.
authors.forename: Antoine
authors.initials: A
authors.lastname: Delage
authors.affiliation: University Nice Sophia Antipolis, IRCAN, ONCOAGE, Nice, France.
authors.forename: Charles-Hugo
authors.initials: CH
authors.lastname: Marquette
authors.affiliation: Palo Alto Medical Foundation/El Camino Hospital, Mountain View, California.
authors.forename: Ganesh
authors.initials: G
authors.lastname: Krishna
authors.affiliation: Northwestern University, Chicago, Illinois.
authors.forename: Ravi
authors.initials: R
authors.lastname: Kalhan
authors.affiliation: University of Wisconsin School of Medicine, Madison.
authors.forename: J Scott
authors.initials: JS
authors.lastname: Ferguson
authors.affiliation: University of Florida, Gainesville.
authors.forename: Michael
authors.initials: M
authors.lastname: Jantz
authors.affiliation: Mayo Clinic, Rochester, Minnesota.
authors.forename: Fabien
authors.initials: F
authors.lastname: Maldonado
authors.affiliation: Cedars-Sinai Medical Center, Los Angeles, California.
authors.forename: Robert
authors.initials: R
authors.lastname: McKenna
authors.affiliation: Beth Israel Deaconess Medical Center, Boston, Massachusetts.
authors.forename: Adnan
authors.initials: A
authors.lastname: Majid
authors.affiliation: Franciscan Research Center, Tacoma, Washington.
authors.forename: Navdeep
authors.initials: N
authors.lastname: Rai
authors.affiliation: University of Michigan, Ann Arbor.
authors.forename: Steven
authors.initials: S
authors.lastname: Gay
authors.affiliation: University of Alabama at Birmingham, Birmingham.
authors.forename: Mark T
authors.initials: MT
authors.lastname: Dransfield
authors.affiliation: University of Texas, San Antonio.
authors.forename: Luis
authors.initials: L
authors.lastname: Angel
authors.affiliation: New York Presbyterian Hospital/Columbia University, New York, New York.
authors.forename: Roger
authors.initials: R
authors.lastname: Maxfield
authors.affiliation: Thoraxklinik at the University of Heidelberg, Heidelberg, Germany.
authors.forename: Felix J F
authors.initials: FJ
authors.lastname: Herth
authors.affiliation: Duke University Medical Center, Durham, North Carolina.
authors.forename: Momen M
authors.initials: MM
authors.lastname: Wahidi
authors.affiliation: Cleveland Clinic Foundation, Cleveland, Ohio.
authors.forename: Atul
authors.initials: A
authors.lastname: Mehta
authors.affiliation: University of Groningen, University Medical Center Groningen, Groningen, the Netherlands.
authors.forename: Dirk-Jan
authors.initials: DJ
authors.lastname: Slebos
mesh_terms: D000368:Aged; D001999:Bronchoscopy; D017079:Exercise Tolerance; D005260:Female; D005541:Forced Expiratory Volume; D006760:Hospitalization; D006801:Humans; D008168:Lung / Q000503:physiopathology; D008297:Male; D008875:Middle Aged; D011014:Pneumonia / Q000209:etiology; D019736:Prostheses and Implants / Q000009:adverse effects*; D011656:Pulmonary Emphysema / Q000503:physiopathology* / Q000628:therapy*; D011788:Quality of Life; D016037:Single-Blind Method; D016896:Treatment Outcome