Clinical Studies

STELVIO-Clinical-Study-Summary

The STELVIO Study

Zephyr-Valve-Stelvio-Clinical-Study

Endobronchial-valve treatment in patients with emphysema and a proven absence of interlobar collateral ventilation provided a measurable clinical benefit, with significantly improved lung function, exercise capacity, and quality of life as compared with usual care.”4

 

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Published in The New England Journal of Medicine4

The first prospective randomized controlled trial using Chartis® to select candidates for Zephyr Endobronchial Valve treatment.

Methods & Endpoints

  • 68 patients were confirmed with the Chartis System to be collateral ventilation (CV) negative and likely responders to Zephyr® therapy, and randomized 1:1 to either Zephyr Valve therapy or medical management.
  • Primary outcome measures were differences between groups for changes in FEV1, FVC, and 6-minute walk distance (6MWD) from baseline to 6 months.

Study Design

STELVIO-Study-Design

*The STELVIO trial was performed as an independent physician initiated and conducted trial. Pulmonx was not involved in any part of study.

Results

Primary Outcome in the Intention-to-Treat Population

Mean change from baseline to 6 months

FEV1

STELVIO - FEV1 | amCharts

FVC

STELVIO - FVC | amCharts

6MWD

STELVIO - 6MWD | amCharts

Zephyr Valve Treatment GroupSoCΔ
FEV1+20.9%+3.1%+17.8%
FVC+18.3%+4.0%+14.4%
6MWD+19.6%-3.6%+23.3%

Clinical Benefits for Both Homogeneous and Heterogeneous Emphysema Subgroups

Effectiveness outcomes for all Zephyr Valve-treated patients who completed the study. Mean change from baseline.

Homogeneous Emphysema (n=29)Heterogeneous Emphysema (n=22)
FEV1 (%)+20.1+32.6
RV (%)-16.3-16.6
6MWD (meters)+69+72
SGRQ (points)-13-19
Zephyr-Heterogenous-Homogenous-STELVIO-Clinical-Study

Significantly Greater Responder Rates for Zephyr Valve-treated Patients than Standard of Care

MCID responder results among patients who completed the study.

Change in FEV1

Control Group
n=33
STELVIO - FEV1 - Control Group | amCharts
Zephyr Valve Group
n=25
STELVIO - FEV1 - Zephyr Valve | amCharts
Crossover Zephyr Valve Group
n=26
STELVIO - FEV1 - Crossover | amCharts

Change in 6MWD

Control Group
n=33
STELVIO - 6MWD - Control Group | amCharts
Zephyr Valve Group
n=25
STELVIO - 6MWD - Zephyr Valve | amCharts
Crossover Zephyr Valve Group
n=26
STELVIO - 6MWD - Crossover | amCharts

Change in SGRQ

Control Group
n=33
STELVIO - SGRQ - Control Group | amCharts
Zephyr Valve Group
n=25
STELVIO - SGRQ - Zephyr Valve | amCharts
Crossover Zephyr Valve Group
n=26
STELVIO - SGRQ - Crossover | amCharts

Conclusion

Endobronchial valve treatment significantly improved pulmonary function and exercise capacity in patients with severe emphysema characterized by an absence of interlobar collateral ventilation.

Complications of the Zephyr Endobronchial Valve treatment can include but are not limited to pneumothorax, worsening of COPD symptoms, hemoptysis, pneumonia, dyspnea and, in rare cases, death.

IMPACT-Clinical-Study-Summary

The IMPACT Study

Zephyr-Valve-Impact-Clinical-Study

EBV therapy in selected patients with homogeneous emphysema without collateral ventilation results in clinically meaningful benefits of improved lung function, exercise tolerance, and quality of life. Given the very limited treatment options available for this patient population, EBV therapy should be considered in these patients.”3

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Published in The American Journal of Respiratory and Critical Care Medicine3

The first prospective randomized controlled trial of Zephyr® Endobronchial Valves specifically in patients with homogeneous emphysema and little to no collateral ventilation (CV).

Methods

  • 93 patients with homogeneous emphysema were confirmed with the Chartis® System to be CV negative and likely responders to Zephyr Valve treatment and randomized 1:1 to either Zephyr Valve treatment or medical management.

  • For Zephyr Valve-treated patients, target lobes were selected based on emphysema destruction scores and regional perfusion impairments and were then completely occluded with valves.

  • If patients did not feel a benefit, the valve position was assessed at 30 days by CT and removed and replaced if necessary.

Study Design

IMPACT-Study-Design

Results

Primary Outcome in the Intention-to-Treat Population

FEV1 Percent change from baseline to 3 months

IMPACT - FEV1 - with Bracket | amCharts

Secondary Endpoints in the Intention-to-Treat Population

Zephyr Valve n=43, Control Group n=50
Change in 6MWD

IMPACT - 6MWD - Line | amCharts

Change in SGRQ

IMPACT - SGRQ - Line | amCharts

Change in RV

IMPACT - RV - Line | amCharts

Change in FEV1

IMPACT - FEV1 - Line | amCharts

Change in mMRC Dyspnea Score

IMPACT - mMRC - Line | amCharts

Conclusion

Patients with homogeneous emphysema can achieve clinically meaningful benefits in lung function, exercise tolerance, and quality of life with endobronchial valve treatment when they are pre-selected for absence of collateral ventilation and have complete lobar occlusion.

 

Complications of the Zephyr Endobronchial Valve treatment can include but are not limited to pneumothorax, worsening of COPD symptoms, hemoptysis, pneumonia, dyspnea and, in rare cases, death.

TRANSFORM-Clinical-Study-Summary

The TRANSFORM Study

Zephyr-Valve-Transform-Clinical-Study

Benefits are in line with those seen with LVRS (lung volume reduction surgery), and the consistent trial results, potential reduction in post-procedure morbidity, and reversibility of the procedure position Zephyr treatment as a viable treatment option in those who remain symptomatic on maximal medical therapy.”2

 

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Published in The American Journal of Respiratory and Critical Care Medicine2

A multicenter, multinational randomized controlled trial of Zephyr® Endobronchial Valves in patients with heterogenous emphysema and little to no collateral ventilation

Methods & Endpoints

  • 97 patients with heterogeneous emphysema were confirmed with the Chartis® System to be collateral ventilation (CV) negative and likely responders to Zephyr Valve treatment, and randomized 2:1 to either Zephyr Valve treatment or medical management.

  • For Zephyr Valve-treated patients, target lobes were selected based on emphysema destruction scores and regional perfusion impairments and were then completely occluded with valves.

  • Valve position was assessed at 45 days post-implant by CT and removed and replaced, if necessary.

Study Design

TRANSFORM-Study-Design

Reasons for Withdrawn Consents

  • 5 Zephyr Valve subjects before 3-month visit: 1 difficult anatomy for Zephyr Valve placement; 1 experienced two pneumothoraces and worsening COPD; 2 for lack of perceived benefit; 1 non-compliant, withdrawn by investigator
  • 1 Zephyr Valve subject between 3- and 6-month visit: Worsening COPD, all valves removed, subject withdrew consent
  • 1 SoC subject before 3-month visit: Exited study to pursue Zephyr Valve treatment outside of the study

Results

Primary Endpoint

Percent of subjects achieving a 12% or greater improvement in FEV1 (L)

TRANSFORM - Percent of Subjects with FEV, Change of >= 12% | amCharts

Secondary Endpoints in the Intent-to-Treat Population

Figure 2a: FEV1 Improvement
TRANSFORM - FEV1 - Line | amCharts
Figure 2b: 6MWD Improvement
TRANSFORM - 6MWD - Line | amCharts
Figure 2c: RV Improvement
TRANSFORM - RV - Line | amCharts
Figure 2d: SGRQ Improvement
TRANSFORM - SGRQ - Line | amCharts
Figure 2e: BODE Index Improvement
TRANSFORM - BODE - Line | amCharts
3 Months
Zephyr Valve n=65, SoC n=32
6 Months
Zephyr Valve n=65, SoC n=32
Legend to Figure 2: Data presented are mean ± SEM for changes from baseline to 3 and 6 months post bronchoscopy for Zephyr Valve, SoC, and difference between Zephyr Valve and SoC. Figure 2a: FEV1 (L); Figure 2b: 6-Minute Walk Distance (m); Figure 2c: RV (L); Figure 2d: St. George’s Respiratory Questionnaire; and Figure 2e: BODE Index.

Conclusion

Zephyr® Valve treatment results in clinically meaningful and statistically significant benefits in lung function, dyspnea, exercise tolerance, and quality of life over current standard of care medical therapy when used in hyperinflated subjects with heterogeneous emphysema without collateral ventilation in the target lobe.

Complications of the Zephyr Endobronchial Valve treatment can include but are not limited to pneumothorax, worsening of COPD symptoms, hemoptysis, pneumonia, dyspnea and, in rare cases, death.

LIBERATE-Clinical-Study-Summary

The LIBERATE Study

Zephyr-Valve-Liberate-Clinical-Study

The benefits are comparable to those seen with LVRS (lung volume reduction surgery) but with a reduction in post-procedure morbidity.”1

 

Download Study Summary

Published in The American Journal of Respiratory and Critical Care Medicine1

A multicenter, multinational randomized controlled trial of Zephyr® Endobronchial Valves in patients with heterogenous emphysema and little to no collateral ventilation.

Methods & Endpoints

  • First multicenter to evaluate effectiveness and safety of Zephyr Endobronchial Valves in patients with little to no collateral ventilation (CV) out to 12 months
  • 190 subjects with hyperinflation (mean baseline RV, 225% pred.; FEV1, 27% pred.; DLCO, 34% pred.) randomized 2:1 (128 Zephyr Valve: 62 SoC)

Study Design

LIBERATE-Study-Design

Results in ITT Population

Primary Endpoint Responder Analysis

Percent of Subjects with FEV1 Change of ≥15%
LIBERATE - Percent of Subjects with FEV1 Change of ≥15% at 12 Months | amCharts

Other Responder Analysis

Proportion of Patients Achieving MCID
LIBERATE - MCID - Radar | amCharts

Secondary Endpoints

Change in St. George’s Resp Questionnaire
LIBERATE - SGRQ - Line | amCharts
Change in FEV1
LIBERATE - FEV1 - Line | amCharts
Change in 6MWD
LIBERATE - 6MWD - Line | amCharts

Safety: Pulmonary Serious Adverse Events (SAEs) Occurring in at Least 3.0% of Subjects in Either Group

Treatment Period
(0–45 Days)		Longer Term Period
(46 Days–1 Year)
Zephyr Valve (n=128)SoC (n=62)Zephyr Valve (n=122)SoC (n=62)
Death3.1%0%0.8%1.6%
Pneumothorax26.6%*0%6.6%0%
COPD exacerbation7.8%4.8%23.0%30.6%
Pneumonia0.8%0%5.7%8.1%
Respiratory failure1.6%0%0.8%3.2%
*Statistically different from SoC
Pulmonx-Zephyr-LIBERATE-Clinical-Study-Table
  • Increased SAE rate with Zephyr Valve treatment compared to SoC in the short-term (first 45 days post-procedure)
  • Reduced SAE rate long-term (46 days to 12 months) with Zephyr Valve treatment compared to standard of care
  • 5 of the 8 subjects experiencing a pneumothorax in the longer-term period had recently undergone a secondary bronchoscopy for valve replacement and/or removal

Conclusion

Zephyr® Endobronchial Valve treatment in carefully selected patients with little or no collateral ventilation in the target lobe provides clinically meaningful and statistically significant benefits in lung function, exercise tolerance, dyspnea, and quality of life over current standard of care medical therapy out to at least 12 months.

Complications of the Zephyr Endobronchial Valve treatment can include but are not limited to pneumothorax, worsening of COPD symptoms, hemoptysis, pneumonia, dyspnea and, in rare cases, death.

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