title: External beam radiation therapy reduces the rate of re-stenosis in patients treated with femoral stenting: results of a randomised study.
abstract: OBJECTIVE
  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.
  
  
  METHODS
  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.
  
  
  RESULTS
  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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Department of Radiology, University Hospital of Patras Medical School, 265 00 Patras, Greece.
authors.forename: Petros
authors.initials: P
authors.lastname: Zabakis
authors.forename: Dimitrios M
authors.initials: DM
authors.lastname: Kardamakis
authors.forename: Dimitrios
authors.initials: D
authors.lastname: Siablis
authors.forename: Christina
authors.initials: C
authors.lastname: Kalogeropoulou
authors.forename: Dimitrios
authors.initials: D
authors.lastname: Karnabatidis
authors.forename: Georgia
authors.initials: G
authors.lastname: Malatara
authors.forename: Ioannis A
authors.initials: IA
authors.lastname: Dimopoulos
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000800:Angioplasty, Balloon / Q000009:adverse effects*; D005260:Female; D005263:Femoral Artery / Q000473:pathology*; D006083:Graft Occlusion, Vascular / Q000517:prevention & control* / Q000532:radiotherapy*; D006801:Humans; D006965:Hyperplasia / Q000517:prevention & control / Q000532:radiotherapy; D008297:Male; D008875:Middle Aged; D016491:Peripheral Vascular Diseases / Q000532:radiotherapy* / Q000628:therapy*; D011446:Prospective Studies; D011832:Radiation Injuries; D015607:Stents; D016896:Treatment Outcome; D017539:Tunica Intima / Q000473:pathology