Results of a randomized clinical trial of external beam radiation to prevent restenosis after superficial femoral artery stenting
| Autor: | Gilles Soulez, Vincent L. Oliva, Jacques Lespérance, Patrick Gilbert, David Donath, Marie-Claude Guertin, Marie-France Giroux, Pierre Perreault, Louis Bouchard, Eric Therasse, Stéphane Elkouri |
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| Rok vydání: | 2016 |
| Předmět: |
Male
medicine.medical_specialty Time Factors medicine.medical_treatment Brachytherapy Constriction Pathologic Kaplan-Meier Estimate Femoral artery 030204 cardiovascular system & hematology Disease-Free Survival 030218 nuclear medicine & medical imaging law.invention Peripheral Arterial Disease 03 medical and health sciences 0302 clinical medicine Randomized controlled trial Restenosis Recurrence Risk Factors law medicine.artery Angioplasty medicine Clinical endpoint Humans Aged Aged 80 and over medicine.diagnostic_test business.industry Quebec Angiography Digital Subtraction Stent Radiotherapy Dosage Middle Aged medicine.disease 3. Good health Surgery Femoral Artery Treatment Outcome Angiography Female Stents Radiology Cardiology and Cardiovascular Medicine business Angioplasty Balloon |
| Zdroj: | Journal of Vascular Surgery. 63:1531-1540 |
| ISSN: | 0741-5214 |
| DOI: | 10.1016/j.jvs.2016.02.023 |
| Popis: | 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. |
| Databáze: | OpenAIRE |
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