Endovascular therapy with interwoven nitinol stent after sufficient predilation for heavily calcified femoropopliteal artery disease: Results of the BURDOCK study
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 sc...
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Published in | Journal of vascular and interventional radiology |
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Main Authors | , , , , , , , , , , , , |
Format | Journal Article |
Language | English |
Published |
United States
30.07.2023
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Abstract | 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. |
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AbstractList | 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. |
Author | Horie, Kazunori Fujihara, Masahiko Kawasaki, Daizo Iida, Osamu Takahara, Mitsuyoshi Tobita, Kazuki Takagi, Tomonari Okamoto, Shin Soga, Yoshimitsu Suematsu, Nobuhiro Tsubakimoto, Yoshinori Nakama, Tatsuya Sasaki, Shinya |
Author_xml | – sequence: 1 givenname: Masahiko surname: Fujihara fullname: Fujihara, Masahiko email: masahiko-fujihara@themis.ocn.ne.jp organization: Department of Cardiology, Kishiwada Tokushukai Hospital, Kishiwada, Japan; Department of Medicine and Biosystemic Science, Kyushu University Graduate School of Medical Sciences, Fukuoka, Japan. Electronic address: masahiko-fujihara@themis.ocn.ne.jp – sequence: 2 givenname: Mitsuyoshi surname: Takahara fullname: Takahara, Mitsuyoshi organization: Department of Diabetes Care Medicine, Osaka University Graduate School of Medicine, Suita, Japan – sequence: 3 givenname: Osamu surname: Iida fullname: Iida, Osamu organization: Cardiovascular Center, Kansai Rosai Hospital, Amagasaki, Japan – sequence: 4 givenname: Daizo surname: Kawasaki fullname: Kawasaki, Daizo organization: Cardiovascular Division, Morinomiya Hospital, Osaka, Japan – sequence: 5 givenname: Yoshimitsu surname: Soga fullname: Soga, Yoshimitsu organization: Department of Cardiology, Kokura Memorial Hospital, Kitakyushu, Fukuoka, Japan – sequence: 6 givenname: Kazuki surname: Tobita fullname: Tobita, Kazuki organization: Department of Cardiology, Shonan Kamakura General Hospital, Kanagawa, Japan – sequence: 7 givenname: Kazunori surname: Horie fullname: Horie, Kazunori organization: Department of Cardiology, Sendai Kousei Hospital, Miyagi, Japan – sequence: 8 givenname: Tomonari surname: Takagi fullname: Takagi, Tomonari organization: Cardiovascular Center, Takatsu General Hospital, Kanagawa, Japan – sequence: 9 givenname: Shin surname: Okamoto fullname: Okamoto, Shin organization: Cardiovascular Center, Kansai Rosai Hospital, Amagasaki, Japan – sequence: 10 givenname: Tatsuya surname: Nakama fullname: Nakama, Tatsuya organization: Department of Cardiology, Tokyo Bay Medical Center, Chiba, Japan – sequence: 11 givenname: Shinya surname: Sasaki fullname: Sasaki, Shinya organization: Department of Cardiology, Saka General Hospital, Miyagi Japan – sequence: 12 givenname: Yoshinori surname: Tsubakimoto fullname: Tsubakimoto, Yoshinori organization: Department of Cardiology, Japanese Red Cross Kyoto Daini Hospital, Kyoto, Japan – sequence: 13 givenname: Nobuhiro surname: Suematsu fullname: Suematsu, Nobuhiro organization: Department of Cardiology, Saiseikai Fukuoka General Hospital, Fukuoka Japan |
BackLink | https://www.ncbi.nlm.nih.gov/pubmed/37527768$$D View this record in MEDLINE/PubMed |
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Keywords | peripheral artery disease superficial femoral artery calcification endovascular therapy nitinol stent |
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Title | Endovascular therapy with interwoven nitinol stent after sufficient predilation for heavily calcified femoropopliteal artery disease: Results of the BURDOCK study |
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