title: Drug delivering technology for endovascular management of infrainguinal peripheral artery disease.
abstract: 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.
authors.affiliation: Veterans Affairs North Texas Health Care System, Dallas, Texas; University of Texas Southwestern Medical Center, Dallas, Texas.
authors.forename: Karan
authors.initials: K
authors.lastname: Sarode
authors.affiliation: University of Texas Health Science Center at San Antonio, San Antonio, Texas.
authors.forename: David A
authors.initials: DA
authors.lastname: Spelber
authors.affiliation: Brigham and Women's Hospital Heart and Vascular Center and Harvard Medical School, Boston, Massachusetts.
authors.forename: Deepak L
authors.initials: DL
authors.lastname: Bhatt
authors.affiliation: Veterans Affairs North Texas Health Care System, Dallas, Texas; University of Texas Southwestern Medical Center, Dallas, Texas.
authors.forename: Atif
authors.initials: A
authors.lastname: Mohammad
authors.affiliation: University of Texas Health Science Center at San Antonio, San Antonio, Texas.
authors.forename: Anand
authors.initials: A
authors.lastname: Prasad
authors.affiliation: Veterans Affairs North Texas Health Care System, Dallas, Texas; University of Texas Southwestern Medical Center, Dallas, Texas.
authors.forename: Emmanouil S
authors.initials: ES
authors.lastname: Brilakis
authors.affiliation: Veterans Affairs North Texas Health Care System, Dallas, Texas; University of Texas Southwestern Medical Center, Dallas, Texas. Electronic address: Subhash.banerjee@va.gov.
authors.forename: Subhash
authors.initials: S
authors.lastname: Banerjee
mesh_terms: D020341:Absorbable Implants; D000818:Animals; D002317:Cardiovascular Agents / Q000008:administration & dosage* / Q000009:adverse effects; D020099:Coated Materials, Biocompatible; D003251:Constriction, Pathologic; D004337:Drug Carriers; D054855:Drug-Eluting Stents; D057510:Endovascular Procedures / Q000009:adverse effects / Q000295:instrumentation*; D005263:Femoral Artery / Q000187:drug effects* / Q000503:physiopathology; D006801:Humans; D058729:Peripheral Arterial Disease / Q000175:diagnosis / Q000188:drug therapy* / Q000503:physiopathology; D011150:Popliteal Artery / Q000187:drug effects* / Q000503:physiopathology; D011474:Prosthesis Design; D012307:Risk Factors; D016896:Treatment Outcome; D062666:Vascular Access Devices; D014654:Vascular Patency / Q000187:drug effects
chemical_list: D002317:Cardiovascular Agents; D020099:Coated Materials, Biocompatible; D004337:Drug Carriers
keywords: drug-coated balloons; drug-coated stents; peripheral artery disease; review