Positive six-month results have emerged from a multicenter, multinational, randomized clinical trial (RCT) of the Pulmonx® Zephyr® Endobronchial Valve (EBV®).
The American Journal of Respiratory and Critical Care Medicine has published the recent data from the TRANSFORM trial into Zephyr EBV treatment.
A frequent visitor to our pages, Zephyr Endobronchial Valves are tiny, minimally-invasive, one-way valves placed via a flexible bronchoscope in airways of the lungs to occlude diseased regions and reduce lung hyperinflation. As a result, the remaining healthier regions can function more efficiently, enabling better breathing and an improved quality of life for patients. Over the past 10 years, approximately 50,000 Zephyr EBVs have been implanted globally in more than 12,000 patients.
The TRANSFORM trial was conducted at 17 centers in six European countries and enrolled 97 patients with heterogeneous emphysema and no collateral ventilation in the target lobe, as determined by the company’s Chartis® System. Patients were randomized 2:1 to Zephyr EBV treatment versus optimal medical therapy.
The study met its primary endpoint, with 67 percent of patients having a 12 percent or greater improvement in lung function (FEV1) at three months in the per protocol group, compared to seven percent in the control group. In the intention-to-treat population at six months, Zephyr EBV patients experienced clinically and statistically greater improvements over the control group across multiple outcome measures, including lung function (29.3 percent increase in FEV1), exercise capacity (78.7m increase in 6MWD), and quality of life (6.5-point decrease in SGRQ score). A majority of EBV patients had an improvement of one or more points in the BODE index, an aggregate measure of health status, which has been associated with a significant decrease in mortality in this population.
Patients in the control arm were allowed to cross over to Zephyr EBV treatment at six months, if desired; 94 percent of control patients opted for Zephyr treatment following their assessments at six months.
The most common serious adverse event seen in the trial was a pneumothorax, which occurred in 29 percent of patients. For comparison, 90 percent of lung volume reduction surgery patients, and four to 42 percent of patients undergoing CT-guided biopsy, experience such events. The study authors noted that the occurrence of pneumothorax does not appear to negatively impact clinical outcomes.
According to the authors, Zephyr EBV 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 heterogeneous emphysema patients with hyperinflation and no collateral ventilation in the target lung lobe.
The authors conclude that, “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 EBV as a viable treatment option in those who remain symptomatic on maximal medical therapy.”
“Zephyr EBV treatment delivers benefits similar to those seen with surgery, with the added benefit of being suitable for a broader range of patients,” said lead author, Dr. Samuel Kemp of the Royal Brompton Hospital in London, England.
“This was one of the most rigorous studies of the Zephyr EBV done to date in emphysema patients with heterogeneous emphysema and one or more lobes without collateral ventilation,” said Pulmonx Chief Executive Officer Glen French. “TRANSFORM shows definitive evidence of the tremendous benefit our technology can bring to patients who otherwise suffer from difficult breathing and are at high risk of morbidity and mortality. It is gratifying to be able to bring new hope to this underserved patient group.”
Source: Pulmonx Corp.