PMID- 27179849 OWN - NLM STAT- MEDLINE DCOM- 20160607 LR - 20220321 IS - 1538-3598 (Electronic) IS - 0098-7484 (Linking) VI - 315 IP - 20 DP - 2016 May 24-31 TI - Effect of Endobronchial Coils vs Usual Care on Exercise Tolerance in Patients With Severe Emphysema: The RENEW Randomized Clinical Trial. PG - 2178-89 LID - 10.1001/jama.2016.6261 [doi] 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 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 < .001), and the between-group St George's Respiratory Questionnaire score improved -8.9 points (97.5% CI, -infinity 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. FAU - Sciurba, Frank C AU - Sciurba FC AD - University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania. FAU - Criner, Gerard J AU - Criner GJ AD - Lewis Katz School of Medicine at Temple University, Philadelphia, Pennsylvania. FAU - Strange, Charlie AU - Strange C AD - Medical University of South Carolina, Charleston. FAU - Shah, Pallav L AU - Shah PL AD - National Institute for Health Research Unit, Royal Brompton and Harefield NHS Foundation Trust, Imperial College, London, England5Chelsea and Westminster Hospital, London, England. FAU - Michaud, Gaetane AU - Michaud G AD - New York University School of Medicine, New York, New York. FAU - Connolly, Timothy A AU - Connolly TA AD - Pulmonary, Critical Care, and Sleep Medicine, Houston, Texas. FAU - Deslee, Gaetan AU - Deslee G AD - University Hospital of Reims, INSERM U903, Reims, France. FAU - Tillis, William P AU - Tillis WP AD - OSF HealthCare-Illinois Lung and Critical Care Institute, Peoria. FAU - Delage, Antoine AU - Delage A AD - Quebec Heart and Lung Institute, Quebec City, Quebec, Canada. FAU - Marquette, Charles-Hugo AU - Marquette CH AD - University Nice Sophia Antipolis, IRCAN, ONCOAGE, Nice, France. FAU - Krishna, Ganesh AU - Krishna G AD - Palo Alto Medical Foundation/El Camino Hospital, Mountain View, California. FAU - Kalhan, Ravi AU - Kalhan R AD - Northwestern University, Chicago, Illinois. FAU - Ferguson, J Scott AU - Ferguson JS AD - University of Wisconsin School of Medicine, Madison. FAU - Jantz, Michael AU - Jantz M AD - University of Florida, Gainesville. FAU - Maldonado, Fabien AU - Maldonado F AD - Mayo Clinic, Rochester, Minnesota. FAU - McKenna, Robert AU - McKenna R AD - Cedars-Sinai Medical Center, Los Angeles, California. FAU - Majid, Adnan AU - Majid A AD - Beth Israel Deaconess Medical Center, Boston, Massachusetts. FAU - Rai, Navdeep AU - Rai N AD - Franciscan Research Center, Tacoma, Washington. FAU - Gay, Steven AU - Gay S AD - University of Michigan, Ann Arbor. FAU - Dransfield, Mark T AU - Dransfield MT AD - University of Alabama at Birmingham, Birmingham. FAU - Angel, Luis AU - Angel L AD - University of Texas, San Antonio. FAU - Maxfield, Roger AU - Maxfield R AD - New York Presbyterian Hospital/Columbia University, New York, New York. FAU - Herth, Felix J F AU - Herth FJ AD - Thoraxklinik at the University of Heidelberg, Heidelberg, Germany. FAU - Wahidi, Momen M AU - Wahidi MM AD - Duke University Medical Center, Durham, North Carolina. FAU - Mehta, Atul AU - Mehta A AD - Cleveland Clinic Foundation, Cleveland, Ohio. FAU - Slebos, Dirk-Jan AU - Slebos DJ AD - University of Groningen, University Medical Center Groningen, Groningen, the Netherlands. CN - RENEW Study Research Group LA - eng SI - ClinicalTrials.gov/NCT01608490 PT - Journal Article PT - Multicenter Study PT - Randomized Controlled Trial PT - Research Support, Non-U.S. Gov't PL - United States TA - JAMA JT - JAMA JID - 7501160 SB - IM CIN - Am J Respir Crit Care Med. 2017 Feb 1;195(3):394-396. PMID: 27911567 MH - Aged MH - Bronchoscopy MH - *Exercise Tolerance MH - Female MH - Forced Expiratory Volume MH - Hospitalization MH - Humans MH - Lung/physiopathology MH - Male MH - Middle Aged MH - Pneumonia/etiology MH - Prostheses and Implants/*adverse effects MH - Pulmonary Emphysema/*physiopathology/*therapy MH - Quality of Life MH - Single-Blind Method MH - Treatment Outcome FIR - Herth, F J F IR - Herth F FIR - Gompelmann, D IR - Gompelmann D FIR - Schuhmann, M IR - Schuhmann M FIR - Eberhardt, R IR - Eberhardt R FIR - Harzheim, D IR - Harzheim D FIR - Rump, B IR - Rump B FIR - Slebos, D-J IR - Slebos DJ FIR - ten Hacken, N IR - ten Hacken N FIR - Klooster, K IR - Klooster K FIR - Shah, P IR - Shah P FIR - Singh, S IR - Singh S FIR - McNulty, W IR - McNulty W FIR - Garner, J IR - Garner J FIR - Deslee, G IR - Deslee G FIR - Vallerand, H IR - Vallerand H FIR - Dury, S IR - Dury S FIR - Gras, D IR - Gras D FIR - Verdier, M IR - Verdier M FIR - Marquette, C-H IR - Marquette CH FIR - Sanfiorenzo, C IR - Sanfiorenzo C FIR - Clary, C IR - Clary C FIR - Leheron, C IR - Leheron C FIR - Pradelli, J IR - Pradelli J FIR - Korzeniewski, S IR - Korzeniewski S FIR - Wolter, P IR - Wolter P FIR - Arfi, T IR - Arfi T FIR - Macone, F IR - Macone F FIR - Poudenx, M IR - Poudenx M FIR - Leroy, S IR - Leroy S FIR - Guillemart, A IR - Guillemart A FIR - Griffonnet, J IR - Griffonnet J FIR - Strange, C IR - Strange C FIR - Argula, R IR - Argula R FIR - Silvestri, G IR - Silvestri G FIR - Huggins, J T IR - Huggins J FIR - Pastis, N IR - Pastis N FIR - Woodford, D IR - Woodford D FIR - Schwarz, L IR - Schwarz L FIR - Walker, D IR - Walker D FIR - Criner, G IR - Criner G FIR - Mamary, A J IR - Mamary A FIR - Marchetti, N IR - Marchetti N FIR - Desai, P IR - Desai P FIR - Shenoy, K IR - Shenoy K FIR - Garfield, J L IR - Garfield J FIR - Travaline, J IR - Travaline J FIR - Criner, H IR - Criner H FIR - Srivastava-Malhotra, S IR - Srivastava-Malhotra S FIR - Tauch, V IR - Tauch V FIR - Maxfield, R IR - Maxfield R FIR - Brenner, K IR - Brenner K FIR - Bulman, W IR - Bulman W FIR - Whippo, B A IR - Whippo B FIR - Jellen, P A IR - Jellen P FIR - Kalhan, R IR - Kalhan R FIR - Gillespie, C T IR - Gillespie C FIR - Rosenberg, S IR - Rosenberg S FIR - DeCamp, M McAvoy IR - DeCamp M FIR - Rogowski, A S IR - Rogowski A FIR - Hixon, J IR - Hixon J FIR - Angel, L F IR - Angel L FIR - Dib, O IR - Dib O FIR - Sciurba, F C IR - Sciurba F FIR - Chandra, D IR - Chandra D FIR - Crespo, M IR - Crespo M FIR - Field, J Bon IR - Field J FIR - Tedrow, J Rahul IR - Tedrow J FIR - Ledezma, C IR - Ledezma C FIR - Consolaro, P IR - Consolaro P FIR - Beckner, M IR - Beckner M FIR - Majid, A IR - Majid A FIR - Cheng, G IR - Cheng G FIR - Cardenas-Garcia, J IR - Cardenas-Garcia J FIR - Beach, D IR - Beach D FIR - Folch, E IR - Folch E FIR - Agnew, A IR - Agnew A FIR - Hori, W IR - Hori W FIR - Nathanson, A IR - Nathanson A FIR - Wahidi, M IR - Wahidi M FIR - Shofer, S IR - Shofer S FIR - Hartwig, M IR - Hartwig M FIR - Mahmood, K IR - Mahmood K FIR - Smathers, E IR - Smathers E FIR - Tillis, W IR - Tillis W FIR - Verma, K IR - Verma K FIR - Taneja, D IR - Taneja D FIR - Peil, M IR - Peil M FIR - Chittivelu, S IR - Chittivelu S FIR - Doloszycki, P IR - Doloszycki P FIR - Whitten, P E IR - Whitten P FIR - Aulakh, B IR - Aulakh B FIR - Ikadios, O IR - Ikadios O FIR - Michel, J IR - Michel J FIR - Crabb, J IR - Crabb J FIR - McVay, B IR - McVay B FIR - Scott, A IR - Scott A FIR - Pautler, E A IR - Pautler E FIR - Connolly, T A IR - Connolly T FIR - Santacruz, J F IR - Santacruz J FIR - Kopas, L IR - Kopas L FIR - Parham, R IR - Parham R FIR - Solis, B IR - Solis B FIR - Krimsky, W IR - Krimsky W FIR - Gregoire, F IR - Gregoire F FIR - King, S IR - King S FIR - Mehta, A IR - Mehta A FIR - Almeida, F IR - Almeida F FIR - Gildea, T IR - Gildea T FIR - Cicenia, J IR - Cicenia J FIR - Machuzak, M IR - Machuzak M FIR - Sethi, S IR - Sethi S FIR - Meli, Y M IR - Meli Y FIR - Baran, J IR - Baran J FIR - Rice, R IR - Rice R FIR - Faile, D IR - Faile D FIR - Rai, N IR - Rai N FIR - Jensen, K IR - Jensen K FIR - Kahlstrom, R IR - Kahlstrom R FIR - Haroon, A IR - Haroon A FIR - Ionita, R IR - Ionita R FIR - White, F IR - White F FIR - Watkins, D IR - Watkins D FIR - Moore, B IR - Moore B FIR - Soukiasian, H IR - Soukiasian H FIR - Merry, H IR - Merry H FIR - Mosenifar, Z IR - Mosenifar Z FIR - Ghandehari, S IR - Ghandehari S FIR - Balfe, D IR - Balfe D FIR - Park, J IR - Park J FIR - Mardirosian, R IR - Mardirosian R FIR - Ferguson, J S IR - Ferguson J FIR - Kanne, J IR - Kanne J FIR - Sonetti, D IR - Sonetti D FIR - Modi, D IR - Modi D FIR - Regan, M IR - Regan M FIR - Maloney, J IR - Maloney J FIR - Hackbarth, M IR - Hackbarth M FIR - Gilles, M IR - Gilles M FIR - Harris, A IR - Harris A FIR - Maser, A IR - Maser A FIR - Puchalski, J T IR - Puchalski J FIR - Rochester, C IR - Rochester C FIR - Possick, J IR - Possick J FIR - Johnson, K IR - Johnson K FIR - Dabre, Z IR - Dabre Z FIR - Kovitz, K IR - Kovitz K FIR - Joo, M IR - Joo M FIR - DeLisa, J IR - DeLisa J FIR - Villalan, S V IR - Villalan S FIR - Krishna, G IR - Krishna G FIR - Canfield, J IR - Canfield J FIR - Marfatia, A IR - Marfatia A FIR - Seeley, E IR - Seeley E FIR - Villalan, S V IR - Villalan S FIR - Utz, J IR - Utz J FIR - Midthun, D IR - Midthun D FIR - Kern, R IR - Kern R FIR - Edell, E S IR - Edell E FIR - Boras, L L IR - Boras L FIR - Gay, S IR - Gay S FIR - Bauman, K A IR - Bauman K FIR - Han, M King IR - Han M FIR - Sagana, R L IR - Sagana R FIR - Nelson, K IR - Nelson K FIR - Meldrum, C IR - Meldrum C FIR - Jantz, M IR - Jantz M FIR - Mehta, H J IR - Mehta H FIR - Eagan, C IR - Eagan C FIR - West, J IR - West J FIR - Delage, A IR - Delage A FIR - Martel, S IR - Martel S FIR - LeBlanc, P IR - LeBlanc P FIR - Maltais, F IR - Maltais F FIR - Lacasse, Y IR - Lacasse Y FIR - Lampron, N IR - Lampron N FIR - Laberge, F IR - Laberge F FIR - Milot, J IR - Milot J FIR - Picard, J IR - Picard J FIR - Breton, M-J IR - Breton MJ FIR - Dransfield, M IR - Dransfield M FIR - Wells, J M IR - Wells J FIR - Bhatt, S IR - Bhatt S FIR - Smith, P IR - Smith P FIR - Seabron-Harris, E N IR - Seabron-Harris E FIR - Hammond, K IR - Hammond K FIR - Egidio, C IR - Egidio C EDAT- 2016/05/18 06:00 MHDA- 2016/06/09 06:00 CRDT- 2016/05/16 06:00 PHST- 2016/05/16 06:00 [entrez] PHST- 2016/05/18 06:00 [pubmed] PHST- 2016/06/09 06:00 [medline] AID - 2522517 [pii] AID - 10.1001/jama.2016.6261 [doi] PST - ppublish SO - JAMA. 2016 May 24-31;315(20):2178-89. doi: 10.1001/jama.2016.6261.