Treatment of Diffuse In-stent Restenosis with Rotational Atherectomy Followed by Radiation Therapy with a 188Re-MAG3-Filled Balloon

ABSTRACT

BACKGROUND: Rotational atherectomy has been shown to be safe and efficient for the treatment of ISR, but the recurrence rate is still high. Intracoronary-irradiation after rotational atherectomy may be a reasonable approach to prevent recurrent ISR. SUBJECTS & METHODS: Fifty consecutive patients with diffuse ISR (length > 10 mm) in native coronary arteries underwent rotational atherectomy and adjunctive balloon angioplasty followed by beta irradiation using a 188Re-MAG3-filled balloon catheter. The radiation dose was 15 Gy at 1.0 mm deep into vessel wall. RESULTS: Mean length of the lesion and irradiated segment was 25.6 +/- 12.7 mm and 37.6 +/- 11.2 mm, respectively. The radiation was delivered successfully to all patients, with a mean irradiation time of 201.8 61.7 seconds. No adverse event including myocardial infarction, death, or stent thrombosis occurred during the follow-up period (mean 10.3 +/- 3.7 months) and non-target vessel revascularization was needed in one patient. Six-month binary angiographic restenosis rate was 10.4 % and loss index was 0.17 +/- 0.31. CONCLUSIONS: beta irradiation using 188Re-MAG3-filled balloon following rotational atherectomy is safe and feasible for patients with diffuse ISR, and it may improve the clinical and angiographic outcomes. Further prospective randomized trials are warranted to evaluate the synergistic effect of debulking and irradiation in patients with diffuse ISR.