Long-Term Follow-Up of High-Risk Patients in the?National Emphysema Treatment Trial

摘要

SubjectsTreatment GroupsQuality of Life Data CollectionUniversity of California San Diego Shortness of Breath QuestionnaireQuality of Life Measurement: QWB-SAStatistical AnalysisResultsThe National Emphysema Treatment Trial (NETT) was a randomized clinical trial designed to?compare lung volume reduction surgery (LVRS) with?maximal medical care for patients with severe emphysema. The trial was halted early for a subgroup of patients with severe lung disease. We report longer term follow-up for this high-risk subgroup.MethodsIn a randomized clinical trial, patients with moderate to severe emphysema were assigned to LVRS plus maximal medical care or to maximal medical care alone and followed prospectively for vital status over 15?years. We focus on 140 high-risk patients. Quality of life data were available through 6 years of follow-up and?were assessed using the University of California, San Diego Shortness of Breath Questionnaire and the Self-Administered Quality of Well-Being Scale.ResultsThrough the first 3 years of follow-up, surgical patients in the high-risk subgroup had a significantly higher probability of death. However, the mortality curves crossed and there was a trend favoring surgical treatment through the remainder of the follow-up. The log-rank test suggested that the 2 groups were not significantly different (p?= 0.95) in survival. Quality of life data suggested an advantage of LVRS through the first 5 years of follow-up (p < 0.01). The combined quality-adjusted survival model favored the medical group for the first few years of follow-up and favored the LVRS group after 4 years.ConclusionsThe NETT was stopped early for high-risk patients with severe lung disease. Longer term follow-up suggests that surgical patients in this high-risk subgroup ultimately achieved comparable outcomes. The high risk of death within 30 days of the surgery may discourage use of the procedure for high-risk patients despite the potential for better long-term outcomes.CTSNet classification:11The National Emphysema Treatment Trial (NETT) was a randomized clinical trial evaluating lung volume reduction surgery (LVRS). The trial randomly assigned adults with moderate to severe emphysema to either LVRS plus maximal medical care or to maximal medical care alone. The study demonstrated that LVRS improved survival in selected subgroups of patients. In particular, patients with predominantly upper lobe emphysema who, at baseline, had low exercise capacity experienced greater improvements in life expectancy and quality of life [