STENTING VERSUS BALLOOON DILATATION IN PATIENTS WITH TRACHEAL BENIGN STENOSIS – THE STROBE TRIAL

Abstract

<b>Background:</b> Benign tracheal stenosis represents a major therapeutic challenge in patients who cannot undergo open surgery. As alternatives, two endoscopic techniques are used to restore the tracheal patency: balloon dilatation (BA) through laryngoscopy, and tracheal stenting (ST) by rigid bronchoscopy. Purpose of this study is to compare the efficacy of BA and ST to cure benign tracheal stenosis not subjected to surgery. Secondary aim was to compare the onset rate of adverse events in the two treatment groups. <b>Methods:</b> A retrospective, observational cohort study was carried at the University Hospital of Modena (Italy) from November 2012 to November 2017 in two single units. Patients were cured (primary outcome) if they did not present significant respiratory symptoms, or re-stenosis in the long-term (2 years) following the procedure. <b>Results:</b> Sixty-six patients were included (33 in BA and 33 in ST group, respectively). Unadjusted Kaplan- Meier estimates showed greater therapeutic effect of ST compared with BA at 2 years (HR=3.9 95%CI [1.5-9.8], p=0.01). After adjusting for confounders, stratified analyses showed that this effect was significant in patients with complex stenosis, idiopathic etiology, and degree of stenosis &gt;70%. Compared with BA, ST showed a higher rate adverse event (p=0.01). <b>Conclusions:</b> Compared with balloon dilatation, tracheal stenting leads to better stabilization of tracheal patency in complex benign tracheal stenosis. However, it is burdened with a significantly higher number of adverse effects. Findings warrant future prospective study for confirmation.