Stent and Resection Anastomosis in patients with complex tracheal stenosis: the STARS retrospective multicenter trial.

Objectives: Complex tracheal stenosis poses significant treatment challenges, especially in patients deemed inoperable due to anatomical or clinical factors. The aim of this study was to assess the outcomes of two primary interventions—tracheal resectionanastomosis and tracheal stenting—in an observational, international, retrospective cohort. Methods: Multicentre study conducted on adult patients with benign complex tracheal stenosis who underwent either tracheal resection or silicone stent placement between 2009 and 2023, and who had at least 24 months of follow-up after resection-anastomosis or 12-months of follow-up after stent removal. Complete clinical resolution, defined as absence of symptoms and no need for re-intervention one year after treatment, was the primary outcome. Secondary analyses assessed the impact of treatment modality and patient risk profile on outcomes. Results: Clinical resolution was achieved in 110 of 125 patients. Resection-anastomosis was associated with significantly higher hazard risk of resolution compared to stenting (adjusted HR: 2.0; 95% CI 1.26–3.33; p = 0.003). In low-risk patients, surgery was notably superior (crude resolution HR = 3.01, 95% CI 1.37-7.93, p=0.004), while outcomes were not significantly different between the two treatments in high-risk patients with cardiorespiratory comorbidities or extended stenosis. Approximately 70% of patients treated with stenting remained symptom-free after one year. Conclusions: Resection-anastomosis remains the preferred treatment for operable complex tracheal stenosis, offering the highest likelihood of long-term resolution. However, in high-risk or inoperable patients, endoscopic stenting provides a valuable alternative with acceptable outcomes. A tailored, multidisciplinary approach is essential to optimize treatment selection and avoid unnecessary tracheotomies.