Lung volume reduction surgery plus medical therapy
Control
Medical therapy alone
Population
1218 patients with severe emphysema
Follow-up
Median 29 months
Primary endpoint
Mortality and maximal exercise capacity at 24 months
Result
Overall mortality 0.11 deaths per person-year in both groups (risk ratio 1.01, p=0.90). Exercise capacity improved by more than 10 W in 15% after surgery versus 3% with medical therapy (p<0.001). Among patients with predominantly upper-lobe emphysema and low exercise capacity, mortality was lower with surgery (risk ratio 0.47, p=0.005). Patients with non-upper-lobe emphysema and high exercise capacity did worse.
Secondary endpoints
Quality of life, lung function, subgroup outcomes by emphysema distribution
Overall, lung-volume-reduction surgery increases the chance of improved exercise capacity but does not confer a survival advantage over medical therapy. It does yield a survival advantage for patients with both predominantly upper-lobe emphysema and low base-line exercise capacity.
The trial authors, in the published abstract
How it has aged
A model of how to rescue a neutral trial: the subgroup analysis was prespecified, and it defined the phenotype that still selects patients for volume reduction today. It also identified who is harmed — non-upper-lobe disease with preserved exercise capacity. Bronchoscopic valves have since taken over much of this ground.
Publications
A randomized trial comparing lung-volume-reduction surgery with medical therapy for severe emphysema
Fishman A, Martinez F, Naunheim K, et al. A randomized trial comparing lung-volume-reduction surgery with medical therapy for severe emphysema. N Engl J Med 2003 May 22;348(21):2059-73.
No overall survival advantage over medical therapy
Improved exercise capacity in 15% versus 3%
Survival benefit confined to upper-lobe emphysema with low baseline exercise capacity
Increased mortality in non-upper-lobe emphysema with high exercise capacity