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Published on: November 4, 2010
The IBV Valve trial: a multicenter, randomized, double-blind trial of endobronchial therapy for severe emphysema
Douglas E Wood1, Daniel A Nader, Steven C Springmeyer
1*Department of Cardiothoracic Surgery, University of Washington, Seattle ‡Spiration Inc., Redmond #St. Joseph Medical Center, Tacoma, WA †Cancer Treatment Centers of America at Southwestern Regional Medical Center, Oklahoma State University, Tulsa, OK §George E. Whalen DVA Medical Center, Salt Lake City, UT ∥Department of Radiology, Vancouver General Hospital, Vancouver, BC, Canada ¶Department of Medicine at UC Davis, University of California at Davis, Davis ††Department of Medicine at the David Geffen School of Medicine, University of California Los Angeles, Los Angeles, CA **The Center for Health Research, Kaiser Permanente Northwest, Portland, OR ‡‡Johns Hopkins University, Baltimore, MD §§St. George's Hospital Medical School, London, UK ∥∥Cleveland Clinic Main Campus, Cleveland, OH ¶¶University of Pennsylvania Medical Center, Philadelphia, PA.
Background:
Lung volume reduction surgery improves quality of life, exercise capacity, and survival in selected patients but is accompanied by significant morbidity. Bronchoscopic approaches may provide similar benefits with less morbidity.
Methods:
In a randomized, sham procedure controlled, double-blind trial, 277 subjects were enrolled at 36 centers. Patients had emphysema, airflow obstruction, hyperinflation, and severe dyspnea. The primary effectiveness measure was a significant improvement in disease-related quality of life (St. George's Respiratory Questionnaire) and changes in lobar lung volumes. The primary safety measure was a comparison of serious adverse events.
Results:
There were 6/121 (5.0%) responders in the treatment group at 6 months, significantly >1/134 (0.7%) in the control group [Bayesian credible intervals (BCI), 0.05%, 9.21%]. Lobar volume changes were significantly different with an average decrease in the treated lobes of -224 mL compared with -17 mL for the control group (BCI, -272, -143). The proportion of responders in St. George's Respiratory Questionnaire was not greater in the treatment group. There were significantly more subjects with a serious adverse event in the treatment group (n=20 or 14.1%) compared with the control group (n=5 or 3.7%) (BCI, 4.0, 17.1), but most were neither procedure nor device related.
Conclusions:
This trial had technical and statistical success but partial-bilateral endobronchial valve occlusion did not obtain clinically meaningful results. Safety results were acceptable and compare favorably to lung volume reduction surgery and other bronchial valve studies. Further studies need to focus on improved patient selection and a different treatment algorithm.
Trial Registry:
ClinicalTrials.gov NCT00475007.
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