6/29/23, 1:44 AM Primary Spontaneous Pneumothorax Pathway Feedback Search Clinical Topics Home Studies Primary Spontaneous Pneumothorax Primary Spontaneous Pneumothorax Disease Pneumothorax Trial question Is conservative management of primary spontaneous pneumothorax noninferior to interventional management for uncomplicated, moderate-to-large primary spontaneous pneumothorax? Study design Multi-center Open label RCT Population Characteristics of study participants 14.0% female N = 316 86.0% male 316 patients (44 female, 272 male) Inclusion criteria: patients 14 to 50 years of age with a first-known, unilateral, moderate-to-large primary spontaneous pneumothorax Key exclusion criteria: secondary pneumothorax, previous spontaneous pneumothorax on the same side, coexistent hemothorax, bilateral pneumothorax, clinical instability suggesting tension pneumothorax, pregnancy, air travel within the next 12 weeks Interventions N=162 conservative management (a conservative observational approach with a minimum observation of 4 hours before repeat chest radiograph) https://web.pathway.md/studies/rec11fPh8vm82GumY 1/2 6/29/23, 1:44 AM Primary Spontaneous Pneumothorax Pathway N=154 interventional management (an immediate standard interventional treatment of the pneumothorax) Primary outcome Rate of lung reexpansion within 8 weeks 98.5 % 98.5 94.4 73.9 % 49.3 % Difference not exceeding nonferiority margin 24.6 % 0.0 % Conservative management Interventional management Difference not exceeding nonferiority margin in the rate of lung reexpansion within 8 weeks (94.4% vs. 98.5%; ARD -4.1, 95% CI -8.6 to 0.5) Secondary outcomes Borderline significant decrease in median time until radiographic resolution (30 days vs. 16 days; HR 0.49, 95% CI 0.39 to 0.63) No significant difference in the rate of pneumothorax recurrence within 12 months (8.8% vs. 16.8%; HR 0.59, 95% CI 0.34 to 1.02) No significant difference in median time until symptom resolution (14 days vs. 15.5 days; HR 1.11, 95% CI 0.88 to 1.4) Safety outcomes No significant differences in hemothorax, tension pneumothorax. Significant differences in adverse events (8.0% vs. 26.6%), serious adverse events (3.7% vs. 12.3%). Conclusion In patients 14 to 50 years of age with a first-known, unilateral, moderate-to-large primary spontaneous pneumothorax, conservative management was noninferior to interventional management with respect to the rate of lung reexpansion within 8 weeks. Reference Simon G A Brown, Emma L Ball, Kyle Perrin et al. Conservative versus Interventional Treatment for Spontaneous Pneumothorax. N Engl J Med. 2020 Jan 30;382(5):405-415. Open reference URL https://web.pathway.md/studies/rec11fPh8vm82GumY 2/2