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

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Presentation transcript:

Results of a randomized clinical trial of external beam radiation to prevent restenosis after superficial femoral artery stenting Eric Therasse, MD, David Donath, MD, Stéphane Elkouri, MD, Jacques Lespérance, MD, Marie-France Giroux, MD, Vincent L. Oliva, MD, Marie-Claude Guertin, PhD, Louis Bouchard, MD, Pierre Perreault, MD, Patrick Gilbert, MD, Gilles Soulez, MD Journal of Vascular Surgery Volume 63, Issue 6, Pages 1531-1540 (June 2016) DOI: 10.1016/j.jvs.2016.02.023 Copyright © 2016 Society for Vascular Surgery Terms and Conditions

Fig 1 Trial flow diagram. The study used a 1:1 randomized control design and intent to treat analysis of primary end point at 24 months. There were 509 consecutive patients screened for enrollment. Among these, 354 patients were excluded for various reasons: the referring physicians did not want the patient to participate in the study (13 patients), the patients refused to participate in the study (133 patients), the patients did not meet the inclusion criteria (91 patients) or presented at least one exclusion criterion (59), and percutaneous transluminal angioplasty (PTA) had to be done on an emergency basis before the scheduled protocol procedure (18 patients). Therefore, 155 patients were randomized, 78 patients in the 0 Gy group and 77 patients in the 14 Gy group. Four patients died of unrelated causes before follow-up angiography, and 15 patients declined to undergo follow-up angiography or were lost to follow-up. Primary end point analysis at 24 months was done in 66 patients in the stent-only group and 70 patients in the stent and external beam radiation (EBR) group. SFA, Superficial femoral artery. Journal of Vascular Surgery 2016 63, 1531-1540DOI: (10.1016/j.jvs.2016.02.023) Copyright © 2016 Society for Vascular Surgery Terms and Conditions

Fig 2 Two-year freedom from restenosis on color duplex ultrasonography (CDU). Freedom from restenosis on CDU was calculated with Kaplan-Meier analysis in 155 patients with superficial femoral artery (SFA) disease who were randomly assigned to receive 0 Gy (placebo) or 14 Gy of external beam radiation (EBR) to the SFA stenting site, the day after SFA stenting. The rates of freedom from restenosis were not significantly different (P = .50) between the two study groups. Journal of Vascular Surgery 2016 63, 1531-1540DOI: (10.1016/j.jvs.2016.02.023) Copyright © 2016 Society for Vascular Surgery Terms and Conditions

Fig 3 Two-year freedom from ankle-brachial index (ABI) decline >0.15. Freedom from ABI decline >0.15 was calculated with Kaplan-Meier analysis in 155 patients with superficial femoral artery (SFA) disease who were randomly assigned to receive 0 Gy (placebo) or 14 Gy of external beam radiation (EBR) to the SFA stenting site, the day after SFA stenting. The rates of freedom from ABI decline >0.15 were not significantly different (P = .22) between the two study groups. Journal of Vascular Surgery 2016 63, 1531-1540DOI: (10.1016/j.jvs.2016.02.023) Copyright © 2016 Society for Vascular Surgery Terms and Conditions

Fig 4 Two-year freedom from major adverse limb event (MALE). Freedom from MALE was calculated with Kaplan-Meier analysis in 155 patients with superficial femoral artery (SFA) disease who were randomly assigned to receive 0 Gy (placebo) or 14 Gy of external beam radiation (EBR) to the SFA stenting site, the day after SFA stenting. The rates of freedom from MALE were not significantly different (P = .98) between the two study groups. Journal of Vascular Surgery 2016 63, 1531-1540DOI: (10.1016/j.jvs.2016.02.023) Copyright © 2016 Society for Vascular Surgery Terms and Conditions

Fig 5 Two-year freedom from target lesion revascularization (TLR) or target vessel thrombosis (TVT). Freedom from TLR or TVT was calculated with Kaplan-Meier analysis in 155 patients with superficial femoral artery (SFA) disease who were randomly assigned to receive 0 Gy (placebo) or 14 Gy of external beam radiation (EBR) to the SFA stenting site, the day after SFA stenting. The rate of freedom from TLR or TVT was significantly lower (P = .049) in the 14 Gy group than in the 0 Gy group. Journal of Vascular Surgery 2016 63, 1531-1540DOI: (10.1016/j.jvs.2016.02.023) Copyright © 2016 Society for Vascular Surgery Terms and Conditions