Clinical Studies

Advancing the Clinical Evidence from Randomized Controlled Trials (RCTs) for Which Patients Benefit Most from Zephyr® Endobronchial Valves (EBV).

Clinical evidence supporting Zephyr® EBV treatment of patients with severe emphysema is available from four completed randomized controlled trials (IMPACT1, STELVIO2, BeLieVeR-HIFi4,5, VENT {Euro VENT5 cohort and US VENT6 cohort}) and over 110 publications on EBV. Two additional randomized controlled trials (TRANSFORM and LIBERATE), sponsored by Pulmonx have completed the patient selection and results will be published in 2017. Published studies have confirmed the use of Chartis Pulmonary Assessment System to select patients with low collateral ventilation for EBV therapy in different types of emphysema, including homogeneous emphysema, mildly heterogeneous emphysema and highly heterogeneous emphysema.

IMPACT STUDY

Significantly more patients benefit from therapy with endobronchial valves

New clinical study demonstrates benefits of Pulmonx Zephyr endobronchial valves in patients with homogeneous emphysema

The positive results of the IMPACT STUDY, published in the American Journal of Respiratory and Critical Care Medicine online (Sept. 2016), demonstrate that patients with homogeneous emphysema benefit from treatment with the Zephyr endobronchial valve (EBV) from Pulmonx. Patients pre-selected with the Chartis® system and treated with EBV, experienced significant improvements in lung function, exercise capacity and quality of life through therapy.

The IMPACT STUDY is the first prospective, randomised, multi-centre study examining the effectiveness of the Zephyr EBV specifically in patients with homogeneous emphysema. The study enrolled and randomised 93 patients with severe homogeneous emphysema to compare the safety and effectiveness of Zephyr EBV treatment versus medical management. The Chartis System was used to select patients with little or no collateral ventilation that were most likely to benefit from treatment and advanced imaging technology was used to select a target lobe for treatment.

Three-month results from the IMPACT STUDY showed that patients with homogeneous emphysema and little or no collateral ventilation (assessed using the Chartis System) treated with the Zephyr EBV experienced a 17 percent improvement in FEV1 compared to the control group. EBV-treated patients also experienced improved exercise tolerance, with a 40-meter increase over the control group in the Six Minute Walk Test (6MWD), and improved quality of life, with a 10-point improvement in the St. Georges Respiratory Questionnaire (SGRQ) score over the control group. The results also showed that 97 percent of EBV subjects experienced target lobe volume reduction, indicating effective occlusion of the target lobe following Zephyr EBV placement. These data indicate that EBV therapy can benefit substantially more patients than previously believed.

Click here to detailed information about the IMPACT STUDY.

STELVIO STUDY

Klooster K et al: Endobronchial Valves for Emphysema without Interlobar Collateral Ventilation. N Engl J Med. 2015; 373:2325-2335.

The STELVIO study, published in the New England Journal of Medicine, was independently conducted and is the first prospective RCT validating use of Chartis System to pre-select patients with low or no collateral ventilation, who were then randomized to EBV therapy or medical management. The results showed that the EBV group had statistically and clinically greater improvements than the control group in pulmonary function, exercise capacity and Quality of Life. Patients in the Control group were allowed to crossover to EBV therapy at the end of six months. Control patients that crossed over to receive EBV therapy achieved improvements in pulmonary function and exercise capacity that were similar to the original EBV-treated group. In addition, EBV therapy was shown to be effective in patients with both heterogeneous and homogeneous emphysema with low collateral ventilation.

Table 1: STELVIO Study Publication on Overview 1

STELVIO randomized controlled trial table-preview

BeLieVer-HIFI Study

Davey C, et al: Bronchoscopic lung volume reduction with endobronchial valves for patients with heterogeneous emphysema and intact interlobar fissures (the BeLieVeR-HIFi study): a randomised controlled trial. Lancet. 2015; 386(9998):1066-1073.

The BeLieVeR-HIFi Study published in the Lancet was an independently-conducted, randomized, double-blind, sham-controlled study in patients with both heterogeneous emphysema and a target lobe with intact interlobar fissures on CT of the thorax. The study included patients with low collateral ventilation determined by chest CT imaging; Chartis System assessments were also performed to evaluate collateral ventilation, but not used to determine inclusion in the study. Using the most rigorous study design available, a sham procedure as a control, the study exceeded its primary endpoint, with a 20.9% average improvement in FEV1 (% predicted).

Table 2: BeLieVeR-HIFi Study Publication Overview 2, 3

BeLieVeR_HIFi randomized controlled trial table-preview

European (EU) VENT Study

Herth FJF et al: Efficacy predictors of lung volume reduction with Zephyr valves in a European cohort. Eur Respir J 2012; 39: 1334-1342.

The EU VENT Study represented the analysis of outcomes in the European VENT study cohort of the Endobronchial Valve for Emphysema Palliation Trial (VENT) which was a multicenter, prospective, randomized, controlled trial conducted to evaluate safety and effectiveness of unilateral endobronchial valve (EBV) treatment. The results showed that unilateral lobar occlusion with EBV therapy was effective in achieving total lung volume reduction (TLVR) and improving lung mechanics, exercise performance, and health-related quality of life measures in European patients with severe emphysema. Patients having CT suggestive of complete fissure and lobar occlusion with the EBV demonstrated significantly improved clinical results with EBV therapy.

Table 3: European VENT Study Publication Overview 4

European VENT randomized controlled trial table-preview

US VENT Study

Sciurba SF et al: A Randomized Study of Endobronchial Valves for Advanced Emphysema. N Engl J Med 2010; 363:1233-1244.

The US VENT study was the first randomized clinical trial evaluating the safety and efficacy of endobronchial-valve (EBV) therapy in patients with heterogeneous emphysema versus standard medical care. The data showed statistically significant benefits in the EBV treated group, but showed that patients with low collateral ventilation between lobes gained substantially more benefit than those with high collateral ventilation. This study highlighted the importance of identifying the right patients for treatment and was the basis for subsequent studies using the Chartis system for measuring collateral ventilation.

Table 4: US VENT Study Publication Overview 5

 US VENT randomized controlled trial table-preview
  1. Valipour A, et al. Am J Respir Crit Care Med. 2016.
  2. Klooster K, ten-Hacken Nick HT, Hartman JE, Kerstjens Huib AM, van Rikxoort EM, and Slebos DJ. Endobronchial Valves for Emphysema without Interlobar Collateral Ventilation. N Engl J Med. 2015; 373:2325-2335.
  3. Davey C, Zoumot Z, Jordan S, McNulty WH, Carr DH, Hind MD, Hansell DM, Rubens MB, Banya W, Polkey MI, Shah PL, and Hopkinson NS. Bronchoscopic lung volume reduction with endobronchial valves for patients with heterogeneous emphysema and intact interlobar fissures (the BeLieVeR-HIFi study): a randomised controlled trial. Lancet. 2015; 386(9998):1066-1073.
  4. Zoumot Z, Davey C, Jordan S, McNulty WH, Carr DH, Hind MD, et al. A randomised controlled study of Bronchoscopic Lung Volume Reduction with endobronchial valves for patients with Heterogeneous emphysema and Intact interlobar Fissures: the BeLieVeR-HIFi study. Efficacy Mech Eval 2015;2(5).
  5. Herth FJF, Noppen M, Valipour A, Leroy S, Vergnon J-M, Ficker JH, Egan JJ, Gasperini S, Agusti C, Holmes-Higgins D, Ernst A, on behalf of the VENT Study Group. Efficacy predictors of lung volume reduction with Zephyr valves in a European cohort. Eur Respir J 2012; 39: 1334-1342.
  6. Sciurba S. F, Ernst A, Herth FJF, Strange C, Criner GJ, Marquette CH, Kovitz KL, Chiacchierini RP, Goldin J, and McLennan G, for the VENT Study Research Group. A Randomized Study of Endobronchial Valves for Advanced Emphysema. N Engl J Med 2010; 363:1233-1244.