1. Effectiveness and Safety of a Paclitaxel-Eluting Stent for Superficial Femoral Artery Lesions up to 190 mm: One-Year Outcomes of the Single-Arm IMPERIAL Long Lesion Substudy of the Eluvia Drug-Eluting Stent.
- Author
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Golzar J, Soga Y, Babaev A, Iida O, Kawasaki D, Bachinsky W, Park J, Prem JT, Vermassen F, Diaz-Cartelle J, Müller-Hülsbeck S, and Gray WA
- Subjects
- Aged, Amputation, Surgical, Cardiovascular Agents adverse effects, Constriction, Pathologic, Endovascular Procedures adverse effects, Endovascular Procedures mortality, Europe, Female, Humans, Japan, Limb Salvage, Male, Middle Aged, New Zealand, Paclitaxel adverse effects, Patient Safety, Peripheral Arterial Disease diagnostic imaging, Peripheral Arterial Disease mortality, Peripheral Arterial Disease physiopathology, Progression-Free Survival, Prospective Studies, Prosthesis Design, Risk Assessment, Risk Factors, Time Factors, United States, Vascular Calcification diagnostic imaging, Vascular Calcification mortality, Vascular Calcification physiopathology, Vascular Patency, Cardiovascular Agents administration & dosage, Drug-Eluting Stents, Endovascular Procedures instrumentation, Femoral Artery diagnostic imaging, Femoral Artery physiopathology, Paclitaxel administration & dosage, Peripheral Arterial Disease therapy, Vascular Calcification therapy
- Abstract
Purpose: To report the clinical effect of a drug-eluting stent on femoropopliteal occlusive disease in patients with long lesions. Materials and Methods: The global IMPERIAL Long Lesion substudy ( ClinicalTrials.gov identifier NCT02574481) is a prospective, single-arm, multicenter trial of the Eluvia Drug-Eluting Vascular Stent for treating femoropopliteal lesions >140 mm and ≤190 mm in length. Fifty patients (mean age 68.2 years; 32 men) with long lesions (mean length 162.8±34.7 mm) were enrolled; 20 patients had diabetes. Fourteen of the lesions were severely calcified and 16 were occluded. Primary patency (duplex ultrasound peak systolic velocity ratio ≤2.4 in the absence of clinically-driven target lesion revascularization or bypass of the target lesion) and major adverse events [30-day all-cause death and 1-year target limb major amputation or target lesion revascularization (TLR)] were assessed at 12 months. Results: At 12 months, no deaths, target limb amputations, or stent thrombosis had occurred. The Kaplan-Meier estimate of primary patency was 91.0% (95% CI 82.5% to 99.6%). The MAE-free rate at 12 months was 93.5% due to 3 clinically-driven TLRs. The corresponding Kaplan-Meier estimate of freedom from TLR was 93.9% (95% CI 87.2% to 100%). Conclusion: The IMPERIAL Long Lesion substudy demonstrated excellent patency and safety through 1 year among patients with long femoropopliteal occlusive disease treated with the Eluvia stent.
- Published
- 2020
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