Endovascular therapy with interwoven nitinol stent after sufficient predilation for heavily calcified femoropopliteal artery disease: Results of the BURDOCK study

• Published in: Journal of vascular and interventional radiology
• Main Authors: Fujihara, Masahiko, Takahara, Mitsuyoshi, Iida, Osamu, Kawasaki, Daizo, Soga, Yoshimitsu, Tobita, Kazuki, Horie, Kazunori, Takagi, Tomonari, Okamoto, Shin, Nakama, Tatsuya, Sasaki, Shinya, Tsubakimoto, Yoshinori, Suematsu, Nobuhiro
• Format: Journal Article
• Language: English
• Published: United States 30.07.2023
• Subjects: peripheral artery disease; superficial femoral artery; calcification; endovascular therapy; nitinol stent
• ISSN: 1535-7732

To investigate the one- and two-year clinical outcomes of Supera (Abbott Laboratories, IL, USA) interwoven stent (IWS) implantation for symptomatic femoropopliteal arterial disease with calcification. This prospective multicenter study evaluated 308 limbs (63% with the peripheral arterial calcium scoring system [PACCS] 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 implantation after sufficient predilation (residual stenosis<30%) for calcified femoropopliteal lesions. The primary outcome measure was primary patency (freedom from restenosis) at one and two 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. Kaplan-Meier analysis showed that primary patency was 88.2% (95% confidence interval [CI], 84.5% to 92.1%) at one year and 80.8% (95% CI, 76.1% to 85.8%) at two years. The CD-TLR-free rate was 96.5% and 94.8% at one and two 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 = 0.047 and 0.041, respectively), chronic total occlusion (adjusted hazard ratio, 1.88; p = 0.022), and popliteal involvement (adjusted hazard ratio, 2.60; p = 0.002). The application of IWS stent by sufficient predilatation for calcified femoropopliteal lesions demonstrated clinically acceptable primary patency.