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Peripheral DES safe, effective in long lesions: IMPERIAL substudy
LAS VEGAS — A peripheral drug-eluting stent was as safe and effective in long lesions as it was in shorter lesions, according to late-breaking data presented at VIVA 18.
Researchers conducted a nonrandomized, single-arm substudy of the IMPERIAL trial in which 50 patients (mean age, 68 years; 64% men) with lower limb ischemia and atherosclerotic lesions between 14 cm and 19 cm (mean, 16.28 cm) in the superficial femoral or proximal popliteal arteries were treated with the DES (Eluvia, Boston Scientific).
The lesions in these patients were approximately twice as long as those in patients from the IMPERIAL randomized trial, in which, as Cardiology Today’s Intervention previously reported, those assigned Eluvia had better 12-month patency than those assigned another peripheral DES (Zilver PTX, Cook Medical). The Eluvia device received FDA approval in September on the basis of the IMPERIAL trial data and is available in sizes as large as 150 mm.
“The results observed in this long-lesion cohort — in line with the IMPERIAL randomized controlled trial and the MAJESTIC independent registry — suggest excellent performance regardless of lesion complexity,” William A. Gray, MD, system chief of the division of cardiovascular disease at Main Line Health and president of the Lankenau Heart Institute in Wynnewood, Pennsylvania, said during a presentation.
Among the cohort, 42% had moderate calcification, 28% had severe calcification and 32% had a chronic total occlusion, Gray said during a press conference. He noted patients received an average of 1.3 stents.
The primary efficacy endpoint was primary patency, defined as peak systolic velocity ratio less than or equal to 2.4 without clinically driven target lesion revascularization or major target limb amputation. The primary safety endpoint was major adverse events, defined as all-cause death at 1 month or clinically driven TLR or major target limb amputation at 12 months.
Primary patency at 12 months was 87.9% and the 12-month TLR rate was 6.5%, which accounted for the entirety of the major adverse events, Gray said.
There were no cases of death, stent thrombosis or major target limb amputation, and there were two stent fractures in one patient (2.1% of all stents placed), he said during the press conference, noting that researchers had not been able to discern anything unusual about the patient that had the stent fractures.
In addition, he said, 91.5% of patients improved at least one Rutherford class without need for TLR (P < .001).
“Patients with long femoropopliteal lesions treated with Eluvia maintained primary patency at a rate of 87.9%,” he said. “There was significant improvement in patient outcomes through 1 year, and there was a good safety profile.”
Gray also noted that in contrast to trials of other peripheral devices, there was no loss in patency between 12 months and 13 months, “which suggests the elution profile is working very well.” – by Erik Swain
Reference:
Gray WA, et al. Late-Breaking Clinical Trials. Presented at: VIVA 18; Nov. 5-8, 2018; Las Vegas.
Disclosures: The study was funded by Boston Scientific. Gray reports he received honoraria from Boston Scientific and Medtronic, consulted for Abbott Vascular, Boston Scientific, Cook Medical, Intact Vascular, Medtronic and W.L. Gore and Associates, holds equity in BioCardia, Contego Medical and Silk Road Medical and received research funding from Boston Scientific, Intact Vascular and W.L. Gore and Associates.
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The main take-home message is that, with using a long stent, our fracture rate did not go up proportionately and that patency rates were not affected dramatically compared with shorter lesions at 1 year. This is a significant difference because, typically in trials, lesion length has affected patency results.
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