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Disappointing Results for Lung-VolumeReduction Surgery
The eagerly awaited National Emphysema Treatment Trial is a randomized multicenter study designed to compare lung-volumereduction surgery (i.e., resection of 20 percent to 35 percent of each lung) with medical treatment for patients with advanced emphysema. An interim analysis by a data and safety monitoring board has identified a subgroup of patients with excessive mortality after this surgery.
Of 1033 patients enrolled in the trial as of June 2001, 140 patients (70 in the surgery group and 70 in the medical-therapy group) were at high risk by virtue of FEV1 no higher than 20 percent of predicted and either homogeneously distributed emphysema on CT scanning or carbon monoxide diffusing capacity no more than 20 percent of predicted. Thirty-day mortality was 16 percent in the surgery group and 0 percent in the medical-therapy group, a significant difference. Overall mortality also was significantly higher in the surgery group (0.43 vs. 0.11 deaths per person-year). Compared with medically treated patients, those in the lung-volumereduction group who survived surgery showed some improvement at 6 months in mean maximal workload (P=0.06) and mean distance walked in 6 minutes (P=0.03). However, mean scores for the 2 groups did not differ at 6 months on a health-related quality-of-life index (P=0.94).
Comment: In this trial, a high-risk subgroup of patients did not benefit from lung-volumereduction surgery: Operative mortality was high, and those who survived experienced unimpressive clinical improvement, according to the authors. The researchers are continuing to enroll patients for this trial, but they are no longer accepting patients with the high-risk characteristics identified in this analysis.
AS Brett
Published in Journal Watch General Medicine September 25, 2001
Citation(s):
National Emphysema Treatment Trial Research Group. Patients at high risk of death after lung-volumereduction surgery. N Engl J Med 2001 Oct 11 345 1075-1083.
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