1. Endovascular Therapy with Interwoven Nitinol Stent Placement after Predilation for Heavily Calcified Femoropopliteal Artery Disease: Results of the BURDOCK Study.
- Author
-
Fujihara M, Takahara M, Iida O, Kawasaki D, Soga Y, Tobita K, Horie K, Takagi T, Okamoto S, Nakama T, Sasaki S, Tsubakimoto Y, and Suematsu N
- Subjects
- Humans, Femoral Artery diagnostic imaging, Popliteal Artery diagnostic imaging, Prospective Studies, Prosthesis Design, Risk Factors, Stents, Treatment Outcome, Vascular Patency, Arctium, Endovascular Procedures, Peripheral Arterial Disease diagnostic imaging, Peripheral Arterial Disease therapy
- Abstract
Purpose: To investigate the 1-year and 2-year clinical outcomes of interwoven stent (IWS) implantation for symptomatic femoropopliteal arterial disease with calcification., Material and Methods: This prospective multicenter study evaluated 308 limbs (63% with the peripheral arterial calcium scoring system 3 and 4 severe calcification and 87% with ≥180° calcification on intravascular ultrasound) of 299 patients (diabetes in 66.9%, chronic renal failure in 52.8%, and dialysis in 49.2%) who underwent IWS (Supera; Abbott, Abbott Park, Illinois) implantation after sufficient predilation (residual stenosis < 30%) for calcified femoropopliteal lesions. The primary outcome measure was primary patency (freedom from restenosis) at 1 and 2 years, whereas the secondary outcome measure included freedom from clinically driven target lesion revascularization (CD-TLR). Clinical parameters associated with loss of patency were explored., Results: Kaplan-Meier analysis showed that primary patency was 88.2% (95% confidence interval [CI], 84.5%-92.1%) at 1 year and 80.8% (95% CI, 76.1%-85.8%) at 2 years. The CD-TLR-free rate was 96.5% and 94.8% at 1 and 2 years, respectively. The characteristics associated with loss of patency were restenotic lesion with and without stent implantation (adjusted hazard ratio, 1.96 and 2.40; P = .047 and .041, respectively), chronic total occlusion (adjusted hazard ratio, 1.88; P = .022), and popliteal involvement (adjusted hazard ratio, 2.60; P = .002)., Conclusions: The implantation of IWS after sufficient predilation for calcified femoropopliteal atherosclerotic disease demonstrated clinically acceptable primary patency., (Copyright © 2023 SIR. Published by Elsevier Inc. All rights reserved.)
- Published
- 2023
- Full Text
- View/download PDF