Clinical Outcomes of Intravascular Brachytherapy for Recurrent In-Stent Restenosis: Is Treatment Failure Predictable?

Abstract

Background: In-stent restenosis (ISR) remains a significant challenge in interventional cardiology, with limited long-term effective treatment options. Intravascular brachytherapy (IVB) has reemerged as a viable treatment modality for ISR, yet predictors of treatment failure remain poorly characterized. This study evaluates the clinical outcomes and identifies predictors of failure following IVB in patients with coronary ISR. Aims: To evaluate the clinical outcomes of intravascular brachytherapy for in-stent restenosis and to identify predictors of treatment response. We hypothesized that specific baseline patient characteristics and procedural factors would be associated with clinical response to IVB at one- and three-year follow-up. Methods: We conducted a retrospective analysis of 199 patients (226 lesions) who underwent IVB for coronary ISR between June 2016 and January 2024 at our institution. Patients were stratified based on clinical response at 1 year: responders (absence of target lesion revascularization [TLR]) and nonresponders (presence of TLR). The primary endpoint was TLR at 1 year. Secondary endpoints included major adverse cardiovascular events (MACE), net adverse cardiovascular events (NACE), thrombosis, bleeding complications, and mortality. Results: At 1-year follow-up, 186 lesions (82.3%) were classified as responders and 40 (17.7%) as nonresponders. Baseline demographic characteristics were similar between groups. Angiographic and procedural characteristics were not significantly different between groups. Nonresponders experienced significantly higher rates of thrombosis (7.5% vs. 0%, p = 0.01), cardiac hospitalization (82.5% vs. 21.5%, p < 0.01), myocardial infarction (37.5% vs. 2.15%, p < 0.01), all-cause mortality (12.5% vs. 3.23%, p = 0.03), and cardiac death (12.5% vs. 1.09%, p < 0.01). Stent implantation was comparable (15% vs. 18.28%, p = 0.62). In multivariate analysis, no baseline or procedural characteristics were significant predictors of TLR. However, stent implantation was associated with increased 3-year all-cause mortality (OR 3.81, 95% CI 1.04−13.99). Conclusions: Our analysis demonstrates that the majority of patients treated with IVB for ISR derive sustained clinical benefit at 1 year. The association between stent implantation and long-term mortality warrants further investigation. These findings highlight the importance of identifying novel predictors of treatment response to optimize patient selection for IVB.