title: Results of a randomized clinical trial of external beam radiation to prevent restenosis after superficial femoral artery stenting.
abstract: OBJECTIVE
  The objective of this study was to evaluate the safety and efficacy of external beam radiation (EBR) in preventing restenosis after superficial femoral artery (SFA) stenting in comparison with a control group treated with SFA stenting only.
  
  
  METHODS
  In this Institutional Review Board-approved study, patients who provided written informed consent were randomly assigned to 0 Gy or 14 Gy of EBR to the stent site 24 hours after SFA stenting. The primary end point was the angiographic binary restenosis rate 2 years after stenting. Categorical and continuous end points were respectively analyzed using logistic regression models and Wilcoxon tests. End points expressed as time to event were analyzed using a log-rank test.
  
  
  RESULTS
  The study included 155 patients, 46 women and 109 men (mean age, 66 years; range, 45-85 years). In the 0 and 14 Gy groups, binary restenosis was present, respectively, in 44% (34/77) and 68% (52/76; P = .003) 2 years after stenting. Stent thrombosis occurred in 13% (10/78) of the 0 Gy group and in 33% (25/77) of the 14 Gy group (P = .003). Target lesion revascularization at 2 years was 26% (25/78) in the 0 Gy group and 30% (23/77) in the 14 Gy group (P = .56). There were no significant differences in total walking distances change from baseline to 2 years (46 ± 100 and 26 ± 79 m, respectively, in the 0 Gy and 14 Gy group; P = .25). There were no procedure-related deaths and no major amputations.
  
  
  CONCLUSIONS
  A single 14 Gy dose of EBR to the SFA stenting site did not prevent in-stent restenosis.
authors.affiliation: Department of Radiology, Centre Hospitalier de l'Université de Montréal (CHUM), Montreal, Quebec, Canada; Centre de Recherche du Centre Hospitalier de l'Université de Montréal (CRCHUM), Montreal, Quebec, Canada. Electronic address: eric.therasse.chum@ssss.gouv.qc.ca.
authors.forename: Eric
authors.initials: E
authors.lastname: Therasse
authors.affiliation: Department of Radiation Oncology, Centre Hospitalier de l'Université de Montréal (CHUM), Montreal, Quebec, Canada.
authors.forename: David
authors.initials: D
authors.lastname: Donath
authors.affiliation: Department of Surgery, Centre Hospitalier de l'Université de Montréal (CHUM), Montreal, Quebec, Canada.
authors.forename: Stéphane
authors.initials: S
authors.lastname: Elkouri
authors.affiliation: Department of Radiology, Montreal Heart Institute, Montreal, Quebec, Canada.
authors.forename: Jacques
authors.initials: J
authors.lastname: Lespérance
authors.affiliation: Department of Radiology, Centre Hospitalier de l'Université de Montréal (CHUM), Montreal, Quebec, Canada.
authors.forename: Marie-France
authors.initials: MF
authors.lastname: Giroux
authors.affiliation: Department of Radiology, Centre Hospitalier de l'Université de Montréal (CHUM), Montreal, Quebec, Canada.
authors.forename: Vincent L
authors.initials: VL
authors.lastname: Oliva
authors.affiliation: Department of Biostatistics, Montreal Heart Institute, Montreal, Quebec, Canada.
authors.forename: Marie-Claude
authors.initials: MC
authors.lastname: Guertin
authors.affiliation: Department of Radiology, Centre Hospitalier de l'Université de Montréal (CHUM), Montreal, Quebec, Canada.
authors.forename: Louis
authors.initials: L
authors.lastname: Bouchard
authors.affiliation: Department of Radiology, Centre Hospitalier de l'Université de Montréal (CHUM), Montreal, Quebec, Canada.
authors.forename: Pierre
authors.initials: P
authors.lastname: Perreault
authors.affiliation: Department of Radiology, Centre Hospitalier de l'Université de Montréal (CHUM), Montreal, Quebec, Canada.
authors.forename: Patrick
authors.initials: P
authors.lastname: Gilbert
authors.affiliation: Department of Radiology, Centre Hospitalier de l'Université de Montréal (CHUM), Montreal, Quebec, Canada; Centre de Recherche du Centre Hospitalier de l'Université de Montréal (CRCHUM), Montreal, Quebec, Canada.
authors.forename: Gilles
authors.initials: G
authors.lastname: Soulez
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D015901:Angiography, Digital Subtraction; D000800:Angioplasty, Balloon / Q000009:adverse effects / Q000295:instrumentation*; D001918:Brachytherapy / Q000009:adverse effects / Q000379:methods*; D003251:Constriction, Pathologic; D018572:Disease-Free Survival; D005260:Female; D005263:Femoral Artery / Q000000981:diagnostic imaging / Q000528:radiation effects*; D006801:Humans; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D058729:Peripheral Arterial Disease / Q000000981:diagnostic imaging / Q000628:therapy*; D011792:Quebec; D011879:Radiotherapy Dosage; D012008:Recurrence; D012307:Risk Factors; D015607:Stents; D013997:Time Factors; D016896:Treatment Outcome