Open AccessImproving Lung Function in Severe Heterogenous Emphysema with the Spiration Valve System (EMPROVE). A Multicenter, Open-Label Randomized Controlled Clinical Trial
Author(s) -
Gerard J. Criner,
Antoine Delage,
Kirk Voelker,
D. Kyle Hogarth,
Adnan Majid,
Michael Zgoda,
Donald R. Lazarus,
Roberto F. Casal,
Sadia Benzaquen,
Robert Holladay,
Adam Wellikoff,
Karel Calero,
Mark J. Rumbak,
Paul Branca,
Muhanned AbuHijleh,
Jorge M. Mallea,
Ravi Kalhan,
Ashutosh Sachdeva,
C. Matthew Kinsey,
Carla Lamb,
Michael F. Reed,
Wissam Abouzgheib,
Phillip V. Kaplan,
Gregory X. Marrujo,
David Johnstone,
Mario Gasparri,
Arturo A. Meade,
Christopher A. Hergott,
Chakravarthy Reddy,
Richard A. Mularski,
Amy Hajari Case,
Samir Makani,
Ray W. Shepherd,
Benson Chen,
Gregory E. Holt,
Simon Martel
Publication year - 2019
Publication title -
american journal of respiratory and critical care medicine
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 6.272
H-Index - 374
eISSN - 1535-4970
pISSN - 1073-449X
DOI - 10.1164/rccm.201902-0383oc
Subject(s) - medicine , randomized controlled trial , adverse effect , pneumothorax , incidence (geometry) , clinical endpoint , clinical trial , surgery , physical therapy , physics , optics
Rationale: Less invasive, nonsurgical approaches are needed to treat severe emphysema. Objectives: To evaluate the effectiveness and safety of the Spiration Valve System (SVS) versus optimal medical management. Methods: In this multicenter, open-label, randomized, controlled trial, subjects aged 40 years or older with severe, heterogeneous emphysema were randomized 2:1 to SVS with medical management (treatment) or medical management alone (control). Measurements and Main Results: The primary efficacy outcome was the difference in mean FEV 1 from baseline to 6 months. Secondary effectiveness outcomes included: difference in FEV 1 responder rates, target lobe volume reduction, hyperinflation, health status, dyspnea, and exercise capacity. The primary safety outcome was the incidence of composite thoracic serious adverse events. All analyses were conducted by determining the 95% Bayesian credible intervals (BCIs) for the difference between treatment and control arms. Between October 2013 and May 2017, 172 participants (53.5% male; mean age, 67.4 yr) were randomized to treatment ( n = 113) or control ( n = 59). Mean FEV 1 showed statistically significant improvements between the treatment and control groups-between-group difference at 6 and 12 months, respectively, of 0.101 L (95% BCI, 0.060-0.141) and 0.099 L (95% BCI, 0.048-0.151). At 6 months, the treatment group had statistically significant improvements in all secondary endpoints except 6-minute-walk distance. Composite thoracic serious adverse event incidence through 6 months was greater in the treatment group (31.0% vs. 11.9%), primarily due to a 12.4% incidence of serious pneumothorax. Conclusions: In patients with severe heterogeneous emphysema, the SVS shows significant improvement in multiple efficacy outcomes, with an acceptable safety profile.Clinical trial registered with www.clinicaltrials.gov (NCT01812447).