TY - JOUR
T1 - Drug delivering technology for endovascular management of infrainguinal peripheral artery disease
AU - Sarode, Karan
AU - Spelber, David A.
AU - Bhatt, Deepak L.
AU - Mohammad, Atif
AU - Prasad, Anand
AU - Brilakis, Emmanouil S.
AU - Banerjee, Subhash
N1 - Funding Information:
Dr. Bhatt serves on the advisory boards of Elsevier Practice Update Cardiology, Medscape Cardiology, and Regado Biosciences; serves on the boards of directors of Boston VA Research Institute and Society of Cardiovascular Patient Care; chairs the American Heart Association Get With the Guidelines Steering Committee; serves on the data monitoring committees of Duke Clinical Research Institute, Harvard Clinical Research Institute, Mayo Clinic, and Population Health Research Institute; has received honoraria from American College of Cardiology (Editor, Clinical Trials, Cardiosource), Belvoir Publications (Editor-in-Chief, Harvard Heart Letter), Duke Clinical Research Institute (clinical trial steering committees), Harvard Clinical Research Institute (clinical trial steering committee), HMP Communications (Editor-in-Chief, Journal of Invasive Cardiology), Population Health Research Institute (clinical trial steering committee), Slack Publications (Chief Medical Editor, Cardiology Today’s Intervention), and WebMD (Continuing Medical Education steering committees); has received research grants from Amarin , AstraZeneca , Bristol-Myers Squibb , Eisai , Ethicon , Medtronic , Roche , Sanofi-Aventis , and The Medicines Company ; and has performed unfunded research for FlowCo, PLx Pharma, and Takeda. Dr. Prasad has received speaking honoraria from AstraZeneca, Gore, and Abbott Vascular; and serves as a consultant for St. Jude Medical. Dr. Brilakis has received consulting/speaking honoraria from St. Jude Medical, Terumo, Janssen, Sanofi-Aventis, Asahi, Abbott Vascular, and Boston Scientific; has received research support from Guerbet ; and his spouse is an employee of Medtronic. Dr. Banerjee has received research grants from Boston Scientific and The Medicines Company ; has received consulting/speaking honoraria from Gilead, St. Jude Medical, Cordis, Boehinger Ingelheim, Sanofi-Aventis, and Medtronic; has ownership through his spouse of Mdcare Global; and has intellectual property in HygeiaTel. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose. Karan Sarode and David Spelber contributed equally to this paper.
PY - 2014/8
Y1 - 2014/8
N2 - Endovascular intervention has become a well-recognized treatment modality for peripheral artery disease; however, mid- and long-term outcomes have been plagued by limited durability. Plain balloon angioplasty and bare-metal stents have historically suffered from high restenosis rates leading to the need for frequent repeat revascularization procedures. The innovation of locally administered, drug-delivering balloons and stents has been a direct result of technological innovations directed toward prevention and treatment of this limitation. Over the last 5 years, numerous clinical trials investigating the use of drug-coated stents and drug-coated balloons indicate a significant improvement in endovascular treatment durability and outcomes. This review provides an up-to-date assessment of the current evidence for the use of drug-coated stents and drug-coated balloons in the treatment of femoropopliteal and infrapopliteal peripheral artery disease. Additionally, it provides an overview of the development of this technology, highlights landmark ongoing and completed clinical trials, examines evidence to support the use of drug-coated technologies in combination with other modalities, and examines promising new technological developments. Last, it summarizes the challenges and safety concerns that have delayed U.S. Food and Drug Administration approval of these devices.
AB - Endovascular intervention has become a well-recognized treatment modality for peripheral artery disease; however, mid- and long-term outcomes have been plagued by limited durability. Plain balloon angioplasty and bare-metal stents have historically suffered from high restenosis rates leading to the need for frequent repeat revascularization procedures. The innovation of locally administered, drug-delivering balloons and stents has been a direct result of technological innovations directed toward prevention and treatment of this limitation. Over the last 5 years, numerous clinical trials investigating the use of drug-coated stents and drug-coated balloons indicate a significant improvement in endovascular treatment durability and outcomes. This review provides an up-to-date assessment of the current evidence for the use of drug-coated stents and drug-coated balloons in the treatment of femoropopliteal and infrapopliteal peripheral artery disease. Additionally, it provides an overview of the development of this technology, highlights landmark ongoing and completed clinical trials, examines evidence to support the use of drug-coated technologies in combination with other modalities, and examines promising new technological developments. Last, it summarizes the challenges and safety concerns that have delayed U.S. Food and Drug Administration approval of these devices.
KW - drug-coated balloons
KW - drug-coated stents
KW - peripheral artery disease
KW - review
UR - http://www.scopus.com/inward/record.url?scp=84906347752&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=84906347752&partnerID=8YFLogxK
U2 - 10.1016/j.jcin.2014.05.008
DO - 10.1016/j.jcin.2014.05.008
M3 - Review article
C2 - 25147028
AN - SCOPUS:84906347752
SN - 1936-8798
VL - 7
SP - 827
EP - 839
JO - JACC: Cardiovascular Interventions
JF - JACC: Cardiovascular Interventions
IS - 8
ER -