SIR 2024
Arterial Interventions and Peripheral Arterial Disease (PAD)
Terumitsu Hasebe, MD, PhD (he/him/his)
Professor
Tokai University Hachioji Hospital, Tokai University School of Medicine, Japan
Financial relationships: Full list of relationships is listed on the CME information page.
Shunto Maegawa, Ph.D. (Eng.)
Visiting Associate Professor
Tokai University School of Medicine, Japan
Disclosure information not submitted.
Kenta Bito, Ph.D (Eng.)
Visiting Associate Professor
Tokai University School of Medicine, Japan
Disclosure information not submitted.
Shunsuke Kamei, M.D.
Assistant Professor
Tokai University Hachioji Hospital, Tokai University School of Medicine, Japan
Disclosure information not submitted.
Yoko Usami, MD, PhD
Lecturer
Saitama Medical University International Medical Center, Japan
Disclosure information not submitted.
Yukihisa Ogawa, MD, PhD
Associate Professor
Tokai University Hachioji Hospital, Tokai University School of Medicine, Japan
Disclosure information not submitted.
Yutaka Okamoto, MS
Resercher
Tokai University Hachioji Hospital, Japan
Disclosure information not submitted.
Taku Ishikawa, BS
Resercher
Tokai University Hachioji Hospital, Japan
Disclosure information not submitted.
Emi Matsuoka, PhD, MBA
Project Assistant Professor
Keio University, Japan
Disclosure information not submitted.
Tomohiro Matsumoto, MD, PhD
Associate Professor
Kochi Medical School, Kochi University, Japan
Disclosure information not submitted.
Takuji Yamagami, MD, PhD
Professor
Kochi Medical School, Kochi University, Japan
Disclosure information not submitted.
Yasutaka Baba, MD, PhD
Professor
Saitama Medical University International Medical Center, Japan
Disclosure information not submitted.
Elazer R. Edelman, M.D., Ph.D., F.A.C.C.
Director, Institute for Medicine, Science and Engineering (IMES)
Medical Engineering and Science, Massachusetts Institute of Technology
Disclosure information not submitted.
The aim of this study is to evaluate in-vivo efficacy of novel hybrid nano-coated nitinol (NiTi) drug-eluting stent (Hybrid-DES) which consists of our original thin-strut (120 µm) stent platform (BMS, Hasebe-Kamei stent) and hybrid nano-coating (fluorinated diamond-like carbon (F-DLC) for anti-thrombogenic “passive” effects with promoting reendothelialization + biodegradable polymer coating with an immunosuppressant drug for antiproliferative “active” effects) in animal model.
Materials and methods:
Drug-eluting stents (DES) are commonly used for superficial femoral artery arteriosclerosis obliterans, but there are no clinically satisfactory stents for below-the-knee (BTK) legions, with percutaneous transluminal angioplasty (PTA) as the standard treatment. PTA, including drug-coated balloons, achieves only approximately 60% one-year patency rate in BTK lesions [1]. In this study, therefore, small-diameter (< 4.5 mm) and thin-strut (< 120 µm) NiTi stents (bare metal stents: BMSs) were newly designed for BTK arteries and Hybrid-DESs assembled by coating biodegradable polymer with sirolimus on BMSs covered with F-DLC nano-coating [2], mounted in 5Fr compatible delivery systems.
To evaluate in vivo efficacy of Hybrid-DESs, both BMSs and Hybrid-DESs were implanted in minipig peripheral arteries including BTK arteries. In-stent restenosis and tissue responses of both BMSs and Hybrid-DESs were assessed through Optical Coherence Tomography (OCT) measurements, intravascular endoscopy and histopathology.
Results:
Hybrid-DESs exhibited favorable histologic findings similar to recent coronary DESs in acute phase of the implantation. Minimal inflammation, mild luminal fibrin, and favorable coverage of endothelial cells were observed, while neointima, neointimal fibrin deposition, and stent-associated vascular injury were nearly absent. In subchronic or chronic phase, furthermore, Hybrid-DESs demonstrated significantly lower volume obstruction percentages than BMSs. No binary angiographic restenosis was observed during follow-up, and intravascular endoscopy images revealed complete endothelial tissue coverage without thrombus formation or inflammation in the Hybrid-DES group.
Conclusion:
This study showed the efficacy of Hybrid-DESs in peripheral arteries and indicated Hybrid-DESs are promising candidate as the newest generation DESs for the therapeutic use in endovascular treatment for BTK atherosclerotic disease.