Results of a randomized clinical trial of external beam radiation to prevent restenosis after superficial femoral artery stenting

Abstract

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. In this Institutional Review Board-approved study, patients who provided written informed consent were randomly assigned to 0Gy or 14Gy of EBR to the stent site 24hours after SFA stenting. The primary end point was the angiographic binary restenosis rate 2years 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. The study included 155 patients, 46 women and 109 men (mean age, 66years; range, 45-85years). In the 0 and 14Gy groups, binary restenosis was present, respectively, in 44% (34/77) and 68% (52/76; P= .003) 2years after stenting. Stent thrombosis occurred in 13% (10/78) of the 0Gy group and in 33% (25/77) of the 14Gy group (P=.003). Target lesion revascularization at 2years was 26% (25/78) in the 0Gy group and 30% (23/77) in the 14Gy group (P= .56). There were no significant differences in total walking distances change from baseline to 2years (46±100 and 26± 79m, respectively, in the 0Gy and 14Gy group; P= .25). There were no procedure-related deaths and no major amputations. A single 14Gy dose of EBR to the SFA stenting site did not prevent in-stent restenosis.