Purpose: To assess the long-term outcome of external beam irradiation (EBI) for the prevention of restenosis due to neointimal hyperplasia, following percutaneous transluminal angioplasty (PTA) and stenting of the superficial femoral artery.
Methods: Sixty consecutive patients with peripheral arterial disease, who were treated with "bail-out" stent implantation in the superficial femoral artery due to suboptimal PTA, were included in this study. Patients were randomly allocated into two groups, receiving either external beam irradiation (6 MV photons, total dose 24 Gy in a hypofractionated schedule) plus antiplatelet therapy (EBI group) or antiplatelet therapy alone (control group).
Results: No procedure-related complications occurred, and all patients of the EBI group received the full dose of 24 Gy. During the long-term follow-up, an overall statistically significant difference was demonstrated in favor of the EBI group patients, regarding both the in-stent (log-rank test, p = 0.0072) and the in-segment binary restenosis (log-rank test, p = 0.0103). The primary patency rates were also significantly better in the EBI group at specific time-points, such as in the first (74.2% vs 46.5%, p = 0.019), second (62.5% vs 33.8%, p = 0.020), and third (54.6% vs 29.0%, p = 0.039) year, respectively. Moreover, the overall clinically driven reintervention rate was significantly lower among patients of the irradiated group (log-rank test, p = 0.038).
Conclusion: Our long-term follow-up analysis revealed that EBI following femoral artery PTA and stenting significantly reduces restenosis and reintervention rates, while improving primary patency.