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      Vascular restoration therapy and bioresorbable vascular scaffold

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          Abstract

          This article describes the evolution of minimally invasive intervention technologies for vascular restoration therapy from early-stage balloon angioplasty in 1970s, metallic bare metal stent and metallic drug-eluting stent technologies in 1990s and 2000s, to bioresorbable vascular scaffold (BVS) technology in large-scale development in recent years. The history, the current stage, the challenges and the future of BVS development are discussed in detail as the best available approach for vascular restoration therapy. The criteria of materials selection, design and processing principles of BVS, and the corresponding clinical trial results are also summarized in this article.

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          A randomized comparison of a sirolimus-eluting stent with a standard stent for coronary revascularization.

          Marie-Claude Morice, Patrick W. Serruys, J. Eduardo Sousa … (2002)
          The need for repeated treatment of restenosis of a treated vessel remains the main limitation of percutaneous coronary revascularization. Because sirolimus (rapamycin) inhibits the proliferation of lymphocytes and smooth-muscle cells, we compared a sirolimus-eluting stent with a standard uncoated stent in patients with angina pectoris. We performed a randomized, double-blind trial to compare the two types of stents for revascularization of single, primary lesions in native coronary arteries. The trial included 238 patients at 19 medical centers. The primary end point was in-stent late luminal loss (the difference between the minimal luminal diameter immediately after the procedure and the diameter at six months). Secondary end points included the percentage of in-stent stenosis of the luminal diameter and the rate of restenosis (luminal narrowing of 50 percent or more). We also analyzed a composite clinical end point consisting of death, myocardial infarction, and percutaneous or surgical revascularization at 1, 6, and 12 months. At six months, the degree of neointimal proliferation, manifested as the mean (+/-SD) late luminal loss, was significantly lower in the sirolimus-stent group (-0.01+/-0.33 mm) than in the standard-stent group (0.80+/-0.53 mm, P<0.001). None of the patients in the sirolimus-stent group, as compared with 26.6 percent of those in the standard-stent group, had restenosis of 50 percent or more of the luminal diameter (P<0.001). There were no episodes of stent thrombosis. During a follow-up period of up to one year, the overall rate of major cardiac events was 5.8 percent in the sirolimus-stent group and 28.8 percent in the standard-stent group (P<0.001). The difference was due entirely to a higher rate of revascularization of the target vessel in the standard-stent group. As compared with a standard coronary stent, a sirolimus-eluting stent shows considerable promise for the prevention of neointimal proliferation, restenosis, and associated clinical events.
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            Nonoperative dilatation of coronary-artery stenosis: percutaneous transluminal coronary angioplasty.

            W Siegenthaler, A Grüntzig, A Senning (1979)
            In percutaneous transluminal coronary angioplasty, a catheter system is introduced through a systemic artery under local anesthesia to dilate a stenotic artery by controlled inflation of a distensible balloon. Over the past 18 months, we have used this technic in 50 patients. The technic was successful in 32 patients, reducing the stenosis from a mean of 84 to 34 per cent (P less than 0.001) and the coronary-pressure gradient from a mean of 58 to 19 mm Hg (P less than 0.001). Twenty-nine patients showed improvement in cardiac function during follow-up examination. Because of acute deterioration in clinical status, emergency bypass was later necessary in five patients; three showed electrocardiographic evidence of infarcts. Patients with single-vessel disease appear to be most suitable for the procedure, and a short history of pain indicates the presence of a soft (distensible) atheroma likely to respond to dilatation. We estimate that only about 10 to 15 per cent of candidates for bypass surgery have lesions suitable for this procedure. A prospective randomized trial will be necessary to evaluate its usefulness in comparison with surgical and medical management.
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              Initial and 6-month results of biodegradable poly-l-lactic acid coronary stents in humans.

              Hideo Tamai, Keiji Igaki, Eisho Kyo … (2000)
              Although metallic stents are effective in preventing acute occlusion and reducing late restenosis after coronary angioplasty, many concerns still remain. Compared with metallic stents, poly-l-lactic acid (PLLA) stents are biodegradable and can deliver drugs locally. The aim of this study was to evaluate the feasibility, safety, and efficacy of the PLLA stent. Fifteen patients electively underwent PLLA Igaki-Tamai stent implantation for coronary artery stenoses. The Igaki-Tamai stent is made of a PLLA monopolymer, has a thickness of 0.17 mm, and has a zigzag helical coil pattern. A balloon-expandable covered sheath system was used, and the stent expanded by itself to its original size with an adequate temperature. A total of 25 stents were successfully implanted in 19 lesions in 15 patients, and angiographic success was achieved in all procedures. No stent thrombosis and no major cardiac event occurred within 30 days. Coronary angiography and intravascular ultrasound were serially performed 1 day, 3 months, and 6 months after the procedure. Angiographically, both the restenosis rate and target lesion revascularization rate per lesion were 10.5%; the rates per patient were 6.7% at 6 months. Intravascular ultrasound findings revealed no significant stent recoil at 1 day, and they revealed stent expansion at follow-up. No major cardiac event, except for repeat angioplasty, developed within 6 months. Our preliminary experience suggests that coronary PLLA biodegradable stents are feasible, safe, and effective in humans. Long-term follow-up with more patients will be required to validate the long-term efficacy of PLLA stents.
              Article 0 comments Cited 137 times – based on 0 reviews     Review now
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                Author and article information

                Journal
                Journal ID (nlm-ta): Regen Biomater
                Journal ID (iso-abbrev): Regen Biomater
                Journal ID (publisher-id): rb
                Journal ID (hwp): rbio
                Title: Regenerative Biomaterials
                Publisher: Oxford University Press
                ISSN (Print): 2056-3418
                ISSN (Electronic): 2056-3426
                Publication date (Print): November 2014
                Publication date (Electronic): 20 October 2014
                Publication date PMC-release: 20 October 2014
                Volume: 1
                Issue: 1
                Pages: 49-55
                Affiliations
                National Engineering Research Center For Biomaterials, Sichuan University, Chengdu 610064, China
                Author notes
                *Correspondence address. National Engineering Research Center for Biomaterials, Sichuan University, 29 Wangjiang Road, Chengdu 610064, China. Tel: +028-85415280; Fax: +028-85410246; E-mail: yunbing.wang@ 123456scu.edu.cn
                Article
                Publisher ID: rbu005
                DOI: 10.1093/rb/rbu005
                PMC ID: 4669005
                PubMed ID: 26816624
                SO-VID: 0563cafa-5be9-413e-b7b5-26934d76061a
                Copyright © © The Author(s) 2014. Published by Oxford University Press.
                License:

                This is an Open Access article distributed under the terms of the Creative Commons Attribution License ( http://creativecommons.org/licenses/by/4.0/), which permits unrestricted reuse, distribution, and reproduction in any medium, provided the original work is properly cited.

                History
                Date received : 15 August 2014
                Date accepted : 22 August 2014
                Page count
                Pages: 7
                Categories
                Subject: Reviews

                Keywords: bioresorbable vascular scaffold,vascular restoration therapy,vascular reparative therapy,vascular disease,bioresorbable/biodegradable material,drug-eluting stent,drug-eluting biodegradable stent,drug-eluting bioresorbable scaffold
                Data availability:
                Keywords: bioresorbable vascular scaffold, vascular restoration therapy, vascular reparative therapy, vascular disease, bioresorbable/biodegradable material, drug-eluting stent, drug-eluting biodegradable stent, drug-eluting bioresorbable scaffold

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