Results of a randomized clinical trial of external beam radiation to prevent restenosis after superficial femoral artery stenting.
J Vasc Surg
; 63(6): 1531-40, 2016 Jun.
Article
em En
| MEDLINE
| ID: mdl-27021377
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.
Texto completo:
1
Base de dados:
MEDLINE
Assunto principal:
Braquiterapia
/
Stents
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Angioplastia com Balão
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Artéria Femoral
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Doença Arterial Periférica
Tipo de estudo:
Clinical_trials
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Etiology_studies
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Prognostic_studies
/
Risk_factors_studies
Limite:
Aged
/
Aged80
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Female
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Humans
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Male
/
Middle aged
País/Região como assunto:
America do norte
Idioma:
En
Ano de publicação:
2016
Tipo de documento:
Article