Background: Brachytherapy is the only effective treatment for in-stent restenosis (ISR). The preliminary data regarding cutting balloon angioplasty (CBA) are encouraging and suggest a possible additive effect of CBA with combination with vascular brachytherapy. Hence, in this study, we evaluated the efficacy, feasibility and safety of cutting balloon angioplasty followed by intracoronary Holmium (166Ho) brachytherapy for the treatment of in-stent restenosis.
Methods and materials: Fifty-six patients with in-stent restenosis were treated with cutting balloon angioplasty and intracoronary 166Ho brachytherapy. For irradiation, a balloon approximately 10 mm longer than the initially deployed stent was filled with liquid 166Ho and placed at the in-stent restenosis lesion. The patients were followed angiographically at 6 months and clinically for 19.0+/-9.8 months.
Results: The initial procedures were successful in all of the patients. The preprocedural average minimal luminal diameter (MLD) and stenosis rate were 0.57+/-0.30 mm and 80.2+/-11.6%, respectively. The MLD and residual stenosis immediately after the procedure was 2.43+/-0.37 and 13.8+/-9.9%, respectively. Thirty-nine (69.6%) patients have completed their angiographic follow-up at 6 months. The MLD, late loss and loss index at follow-up were 1.97+/-0.79 mm, 0.72+/-0.69 mm and 0.36+/-0.34, respectively. The target lesion restenosis rate was 20.5% and the target lesion revascularization rate was 3.6%. None of these patients presented with adverse coronary events such as MI, sudden cardiac death or stent thrombosis during the follow up period.
Conclusion: The combination therapy using cutting balloon angioplasty and intracoronary 166Ho brachytherapy may be an effective new treatment modality for in-stent restenosis.