Airway bypass, sham treatment show comparable efficacy end points for severe emphysema
FRIDAY, Sept. 9 (HealthDay News) -- Airway bypass offers no sustainable benefits for patients with severe homogeneous emphysema, according to a study published Sept. 10 in the special European Respiratory Society issue of The Lancet.
Pallav L. Shah, M.D., from the Royal Brompton Hospital in the United Kingdom, and colleagues assessed the safety and efficacy of airway bypass in 315 patients with severe homogeneous emphysema in the Exhale airway stents for emphysema trial who were randomly allocated (2:1) to receive airway bypass (208 patients) or sham control (107 patients) with a follow-up of 12 months. The masked investigators completed pre-procedure and post-procedure assessments, and the unmasked investigators did bronchoscopies without further patient interactions. Improvement in forced vital capacity of 12 percent or more and a one point or more decrease in the modified Medical Research Council dyspnea score from baseline comprised the six-month co-primary efficacy end point, and five severe adverse events comprised the composite primary safety end point. Bayesian analysis by intention to treat was used to establish whether the posterior probability that airway bypass was superior to sham control.
The investigators found no difference between the airway bypass and sham control groups for the co-primary efficacy end point at six months. Primary safety end points for the airway bypass and sham groups were 14.4 and 11.2 percent, respectively.
"Although our findings showed safety and transient improvements, no sustainable benefit was recorded with airway bypass in patients with severe homogeneous emphysema," the authors write.
Two of the study authors disclosed financial ties with Broncus, which sponsored the study and reimbursed all clinical trial expenses incurred by the study centers.
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