Pleural disease · Primary spontaneous pneumothorax
Conservative versus Interventional Treatment for Spontaneous Pneumothorax
| Design | Open-label, multicentre, non-inferiority trial |
|---|---|
| Treatment | Conservative observational management |
| Control | Immediate interventional management |
| Population | 316 patients aged 14 to 50 with a first, unilateral, moderate-to-large primary spontaneous pneumothorax |
| Follow-up | 12 months |
| Primary endpoint | Lung re-expansion within 8 weeks |
| Result | In the conservative group 137 of 162 (84.6%) needed no intervention. Complete-case analysis showed re-expansion in 129 of 131 (98.5%) with intervention versus 118 of 125 (94.4%) conservatively — risk difference -4.1 percentage points (95% CI -8.6 to 0.5, p=0.02 for non-inferiority), within the -9 point margin. Imputing all missing data as failure gave a risk difference of -11.0 points (-18.4 to -3.5), outside the margin. Conservative management had fewer serious adverse events and less recurrence. |
| Secondary endpoints | Serious adverse events, pneumothorax recurrence, time off work |
Although the primary outcome was not statistically robust to conservative assumptions about missing data, the trial provides modest evidence that conservative management of primary spontaneous pneumothorax was noninferior to interventional management, with a lower risk of serious adverse events.
The trial authors, in the published abstract
The authors' own restraint is the model here: they report that their conclusion does not survive the pessimistic imputation, and say so in the abstract. Practice has shifted toward observation anyway, on the strength of 85% needing nothing and fewer adverse events. Compare RAMPP for those who do need a device.
Brown SGA, Ball EL, Perrin K, et al. Conservative versus Interventional Treatment for Spontaneous Pneumothorax. N Engl J Med 2020 Jan 30;382(5):405-415.