External beam radiation therapy reduces the rate of re-stenosis in patients treated with femoral stenting: results of a randomised study

• Published in: Radiotherapy and oncology 2005, Vol.74 (1), p.11-16
• Main Authors: Zabakis, Petros, Kardamakis, Dimitrios M., Siablis, Dimitrios, Kalogeropoulou, Christina, Karnabatidis, Dimitrios, Malatara, Georgia, Dimopoulos, Ioannis A.
• Format: Article
• Language: English
• Subjects: Aged; Aged, 80 and over; Angioplasty, Balloon - adverse effects; Female; Femoral Artery - pathology; Graft Occlusion, Vascular - prevention & control; Graft Occlusion, Vascular - radiotherapy; Humans; Hyperplasia - prevention & control; Hyperplasia - radiotherapy; Male; Middle Aged; Peripheral Vascular Diseases - radiotherapy; Peripheral Vascular Diseases - therapy; Prospective Studies; Radiation Injuries; Radiotherapy; Re-stenosis; Stenting; Stents; Superficial femoral artery; Treatment Outcome; Tunica Intima - pathology
• ISSN: 0167-8140; 1879-0887
• DOI: 10.1016/j.radonc.2004.09.010

To evaluate the feasibility and efficacy of external beam irradiation (EBI) for the prevention of re-stenosis due to neointimal hyperplasia, after percutaneous transluminal angioplasty (PTA) and stent placement of the superficial femoral artery. A total of 60 patients with the diagnosis of superficial femoral artery stenoses or occlusions due to peripheral arterial obstructive disease underwent PTA and implantation of a self-expandable stent at their superficial femoral artery. After the procedure, patients were randomised and 30 of them received EBI (6 MV photons, total dose 24 Gy in six fractions in 2 weeks), while the rest 30 received no radiation therapy. EBI was technically feasible in all patients, without serious radiation related side effects. Overall, a statistically significant difference was observed in stenosis categories between the two groups at 6 months follow-up ( P=0.04). More specifically, significantly more patients in the control group presented with stenosis greater or equal than 70% [EBI group 30% (9/30); control group 66.7% (20/30); P=0.009]. This difference in the percentage of re-stenosis had as a consequence significantly lower re-intervention rates among the patients of the irradiated group [17% (5/30) versus 47% (14/30); P=0.025] during the 6 months follow-up period. We also observed that the irradiated patients had re-stenosis at the stent ends, while the non-irradiated had re-stenosis at the stent ends and the lumen. Three of the irradiated patients, who discontinued the anti-platelet treatment, have shown thrombosis of the irradiated artery during the first month from the completion of the treatment. It is our belief that EBI is a feasible, safe and effective method for the prevention of neointimal hyperplasia at the superficial femoral artery. Further studies are deemed necessary to optimise the radiotherapy schedule.