Improving lung function in severe heterogenous Emphysema with the Spiration Valve System (EMPROVE) a multicenter, open-label randomized controlled clinical trial

Gerard J. Criner*, Antoine Delage, Kirk Voelker, D. Kyle Hogarth, Adnan Majid, Michael Zgoda, Donald R. Lazarus, Roberto Casal, Sadia B. Benzaquen, Robert C. Holladay, Adam Wellikoff, Karel Calero, Mark J. Rumbak, Paul R. Branca, Muhanned Abu-Hijleh, Jorge M. Mallea, Ravi Kalhan, Ashutosh Sachdeva, C. Matthew Kinsey, Carla R. LambMichael F. Reed, Wissam B. Abouzgheib, Phillip V. Kaplan, Gregory X. Marrujo, David W. Johnstone, Mario G. Gasparri, Arturo A. Meade, Christopher A. Hergott, Chakravarthy Reddy, Richard A. Mularski, Amy Hajari Case, Samir S. Makani, Ray W. Shepherd, Benson Chen, Gregory E. Holt, Simon Martel

*Corresponding author for this work

Research output: Contribution to journalArticle

20 Scopus citations

Abstract

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 FEV1 from baseline to 6 months. Secondary effectiveness outcomes included: Difference in FEV1 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 FEV1 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.

Original languageEnglish (US)
Pages (from-to)1354-1362
Number of pages9
JournalAmerican journal of respiratory and critical care medicine
Volume200
Issue number11
DOIs
StatePublished - Dec 1 2019

Keywords

  • Chronic obstructive pulmonary disease
  • FEV
  • Quality of life

ASJC Scopus subject areas

  • Pulmonary and Respiratory Medicine
  • Critical Care and Intensive Care Medicine

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