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Randomized Controlled Trial
. 2019 Dec 1;200(11):1354-1362.
doi: 10.1164/rccm.201902-0383OC.

Improving Lung Function in Severe Heterogenous Emphysema with the Spiration Valve System (EMPROVE). A Multicenter, Open-Label Randomized Controlled Clinical Trial

Gerard J Criner  1 , Antoine Delage  2 , Kirk Voelker  3 , D Kyle Hogarth  4 , Adnan Majid  5 , Michael Zgoda  6 , Donald R Lazarus  7 , Roberto Casal  7 , Sadia B Benzaquen  8 , Robert C Holladay  9 , Adam Wellikoff  9 , Karel Calero  10 , Mark J Rumbak  10 , Paul R Branca  11 , Muhanned Abu-Hijleh  12 , Jorge M Mallea  13 , Ravi Kalhan  14 , Ashutosh Sachdeva  15 , C Matthew Kinsey  16 , Carla R Lamb  17 , Michael F Reed  18 , Wissam B Abouzgheib  19 , Phillip V Kaplan  20 , Gregory X Marrujo  21 , David W Johnstone  22 , Mario G Gasparri  22 , Arturo A Meade  23 , Christopher A Hergott  24 , Chakravarthy Reddy  25 , Richard A Mularski  26 , Amy Hajari Case  27 , Samir S Makani  28 , Ray W Shepherd  29 , Benson Chen  30 , Gregory E Holt  31 , Simon Martel  2
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Randomized Controlled Trial

Improving Lung Function in Severe Heterogenous Emphysema with the Spiration Valve System (EMPROVE). A Multicenter, Open-Label Randomized Controlled Clinical Trial (VSports app下载)

Gerard J Criner et al. Am J Respir Crit Care Med. .

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 VSports手机版. 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). .

Keywords: FEV; chronic obstructive pulmonary disease; quality of life. V体育安卓版.

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Figures

Figure 1.
Figure 1.
Key components of the Spiration Valve.
Figure 2.
Figure 2.
Study subject disposition flow chart.
Figure 3.
Figure 3.
Change in FEV1 at 6 and 12 months; data are shown as mean and 95% Bayesian credible interval (BCI). PP = posterior probability; SVS = Spiration Valve System.
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References

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