{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,26]],"date-time":"2026-09-26T11:39:48Z","timestamp":1790422788513,"version":"4.1.0"},"reference-count":57,"publisher":"MDPI AG","issue":"6","license":[{"start":{"date-parts":[[2024,3,19]],"date-time":"2024-03-19T00:00:00Z","timestamp":1710806400000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["JCM"],"abstract":"<jats:p>Background: Chronic limb-threatening ischaemia can be a debilitating disease and may result in limb amputation if untreated. Atherosclerotic disease of the infra-popliteal arteries is particularly challenging to treat due to the small caliber of the vessels and the heavy burden of atherosclerotic plaque. Percutaneous transluminal angioplasty is the conventional first-line approach and is advantageous due to its minimal invasiveness, repeatability, and cost-effectiveness but is limited by high rates of elastic recoil, dissection, and short- to mid-term re-stenosis. Methods: This review analyses the growing body of published and presented clinical data from multiple randomised controlled trials that have investigated the role of coronary drug-eluting stents in the treatment of infrapopliteal disease. Results: Coronary drug-eluting stents demonstrate superior primary patency compared with angioplasty and\/or bare metal stenting alone but are limited to application in short-segment disease and have not been widely adopted due to the nature of the permanent implant. Conclusions: Newer devices like drug-eluting resorbable scaffolds are promising as they allow the restoration of vessel wall vasomotion without a residual foreign body and can be used to treat longer, complex lesions.<\/jats:p>","DOI":"10.3390\/jcm13061757","type":"journal-article","created":{"date-parts":[[2024,3,19]],"date-time":"2024-03-19T04:36:31Z","timestamp":1710822991000},"page":"1757","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":10,"title":["Current Status of and Future Prospects for Drug-Eluting Stents and Scaffolds in Infrapopliteal Arteries"],"prefix":"10.3390","volume":"13","author":[{"given":"Elizabeth","family":"Lim","sequence":"first","affiliation":[{"name":"The Prince of Wales Hospital, Sydney, NSW 2031, Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5611-6991","authenticated-orcid":false,"given":"Ramon","family":"Varcoe","sequence":"additional","affiliation":[{"name":"The Prince of Wales Hospital, University of New South Wales, Sydney, NSW 2031, Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1968","published-online":{"date-parts":[[2024,3,19]]},"reference":[{"key":"ref_1","doi-asserted-by":"crossref","first-page":"e1020","DOI":"10.1016\/S2214-109X(19)30255-4","article-title":"Global, Regional, and National Prevalence and Risk Factors for Peripheral Artery Disease in 2015: An Updated Systematic Review and Analysis","volume":"7","author":"Song","year":"2019","journal-title":"Lancet Glob. Health"},{"key":"ref_2","doi-asserted-by":"crossref","first-page":"3S","DOI":"10.1016\/j.jvs.2019.02.016","article-title":"Global Vascular Guidelines on the Management of Chronic Limb-Threatening Ischemia","volume":"69","author":"Conte","year":"2019","journal-title":"J. Vasc. Surg."},{"key":"ref_3","doi-asserted-by":"crossref","first-page":"e009724","DOI":"10.1161\/JAHA.118.009724","article-title":"Determinants of Long-Term Outcomes and Costs in the Management of Critical Limb Ischemia: A Population-Based Cohort Study","volume":"7","author":"Mustapha","year":"2018","journal-title":"J. Am. Heart Assoc."},{"key":"ref_4","doi-asserted-by":"crossref","first-page":"1798","DOI":"10.1016\/S0140-6736(23)00462-2","article-title":"A Vein Bypass First versus a Best Endovascular Treatment First Revascularisation Strategy for Patients with Chronic Limb Threatening Ischaemia Who Required an Infra-Popliteal, with or without an Additional More Proximal Infra-Inguinal Revascularisation Procedure to Restore Limb Perfusion (BASIL-2): An Open-Label, Randomised, Multicentre, Phase 3 Trial","volume":"401","author":"Bradbury","year":"2023","journal-title":"Lancet"},{"key":"ref_5","doi-asserted-by":"crossref","first-page":"2290","DOI":"10.1016\/j.jacc.2012.08.989","article-title":"A Prospective Randomized Multicenter Comparison of Balloon Angioplasty and Infrapopliteal Stenting with the Sirolimus-Eluting Stent in Patients with Ischemic Peripheral Arterial Disease: 1-Year Results from the Achilles Trial","volume":"60","author":"Scheinert","year":"2012","journal-title":"J. Am. Coll. Cardiol."},{"key":"ref_6","doi-asserted-by":"crossref","first-page":"390","DOI":"10.1016\/j.jvs.2011.07.099","article-title":"Randomized Comparison of Everolimus-Eluting versus Bare-Metal Stents in Patients with Critical Limb Ischemia and Infrapopliteal Arterial Occlusive Disease","volume":"55","author":"Bosiers","year":"2012","journal-title":"J. Vasc. Surg."},{"key":"ref_7","doi-asserted-by":"crossref","first-page":"1048","DOI":"10.1016\/j.jcin.2014.04.015","article-title":"Paclitaxel-Coated Balloon Angioplasty versus Drug-Eluting Stenting for the Treatment of Infrapopliteal Long-Segment Arterial Occlusive Disease: The IDEAS Randomized Controlled Trial","volume":"7","author":"Siablis","year":"2014","journal-title":"JACC Cardiovasc. Interv."},{"key":"ref_8","doi-asserted-by":"crossref","first-page":"e002376","DOI":"10.1161\/CIRCINTERVENTIONS.114.002376","article-title":"Percutaneous Transluminal Angioplasty and Drug-Eluting Stents for Infrapopliteal Lesions in Critical Limb Ischemia (PADI) Trial","volume":"9","author":"Spreen","year":"2016","journal-title":"Circ. Cardiovasc. Interv."},{"key":"ref_9","doi-asserted-by":"crossref","first-page":"587","DOI":"10.1016\/j.jacc.2012.04.035","article-title":"Sirolimus-Eluting Stents for Treatment of Infrapopliteal Arteries Reduce Clinical Event Rate Compared to Bare-Metal Stents: Long-Term Results from a Randomized Trial","volume":"60","author":"Rastan","year":"2012","journal-title":"J. Am. Coll. Cardiol."},{"key":"ref_10","doi-asserted-by":"crossref","first-page":"626","DOI":"10.1177\/1526602820944402","article-title":"Twelve-Month Results of Tack-Optimized Balloon Angioplasty Using the Tack Endovascular System in Below-the-Knee Arteries (TOBA II BTK)","volume":"27","author":"Geraghty","year":"2020","journal-title":"J. Endovasc. Ther."},{"key":"ref_11","doi-asserted-by":"crossref","first-page":"393","DOI":"10.1177\/15266028221083462","article-title":"Twenty-Four Month Results of Tack-Optimized Balloon Angioplasty Using the Tack Endovascular System in Below-the-Knee Arteries","volume":"30","author":"Adams","year":"2023","journal-title":"J. Endovasc. Ther."},{"key":"ref_12","first-page":"100964","article-title":"Evaluation of an Infrapopliteal Drug-Eluting Resorbable Scaffold: Design Methodology for the LIFE-BTK Randomized Controlled Trial","volume":"2","author":"Varcoe","year":"2023","journal-title":"J. Soc. Cardiovasc. Angiogr. Interv."},{"key":"ref_13","unstructured":"(2023, December 24). National Institute for Health and Care Excellence Peripheral Arterial Disease: Diagnosis and Management. Available online: https:\/\/www.nice.org.uk\/guidance\/cg147."},{"key":"ref_14","first-page":"e686","article-title":"2016 AHA\/ACC Guideline on the Management of Patients with Lower Extremity Peripheral Artery Disease: Executive Summary: A Report of the American College of Cardiology\/American Heart Association Task Force on Clinical Practice Guidelines","volume":"135","author":"Gornik","year":"2017","journal-title":"Circulation"},{"key":"ref_15","doi-asserted-by":"crossref","first-page":"9","DOI":"10.1016\/j.ejvs.2023.08.067","article-title":"Editor\u2019s Choice\u2014European Society for Vascular Surgery (ESVS) 2024 Clinical Practice Guidelines on the Management of Asymptomatic Lower Limb Peripheral Arterial Disease and Intermittent Claudication","volume":"67","author":"Nordanstig","year":"2024","journal-title":"Eur. J. Vasc. Endovasc. Surg."},{"key":"ref_16","doi-asserted-by":"crossref","first-page":"e284","DOI":"10.1097\/MJT.0000000000000916","article-title":"New Directions in the Management of Peripheral Artery Disease","volume":"26","author":"Chioncel","year":"2019","journal-title":"Am. J. Ther."},{"key":"ref_17","doi-asserted-by":"crossref","first-page":"547","DOI":"10.1177\/1526602820931488","article-title":"Balloon Angioplasty of Infrapopliteal Arteries: A Systematic Review and Proposed Algorithm for Optimal Endovascular Therapy","volume":"27","author":"Giannopoulos","year":"2020","journal-title":"J. Endovasc. Ther."},{"key":"ref_18","doi-asserted-by":"crossref","first-page":"975","DOI":"10.1016\/j.jvs.2008.01.005","article-title":"Meta-Analysis of Infrapopliteal Angioplasty for Chronic Critical Limb Ischemia","volume":"47","author":"Romiti","year":"2008","journal-title":"J. Vasc. Surg."},{"key":"ref_19","doi-asserted-by":"crossref","first-page":"260","DOI":"10.1007\/s00270-009-9765-6","article-title":"Angioplasty or Primary Stenting for Infrapopliteal Lesions: Results of a Prospective Randomized Trial","volume":"33","author":"Randon","year":"2010","journal-title":"Cardiovasc. Interv. Radiol."},{"key":"ref_20","doi-asserted-by":"crossref","first-page":"1881","DOI":"10.1007\/s00270-020-02602-6","article-title":"10-Year Paclitaxel Dose-Related Outcomes of Drug-Eluting Stents Treated Below the Knee in Patients with Chronic Limb-Threatening Ischemia (The PADI Trial)","volume":"43","author":"Konijn","year":"2020","journal-title":"Cardiovasc. Interv. Radiol."},{"key":"ref_21","doi-asserted-by":"crossref","first-page":"2619","DOI":"10.1002\/1097-0142(20000601)88:11<2619::AID-CNCR26>3.0.CO;2-J","article-title":"Paclitaxel-Induced Cell Death","volume":"88","author":"Wang","year":"2000","journal-title":"Cancer"},{"key":"ref_22","doi-asserted-by":"crossref","first-page":"1709","DOI":"10.1056\/NEJMoa1510188","article-title":"Paclitaxel-Eluting versus Everolimus-Eluting Coronary Stents in Diabetes","volume":"373","author":"Kaul","year":"2015","journal-title":"N. Engl. J. Med."},{"key":"ref_23","doi-asserted-by":"crossref","first-page":"121","DOI":"10.23736\/S0392-9590.19.04049-5","article-title":"The Use of Drug-Eluting Stents in Infrapopliteal Arteries: An Updated Systematic Review and Meta-Analysis of Randomized Trials","volume":"38","author":"Varcoe","year":"2019","journal-title":"Int. Angiol."},{"key":"ref_24","doi-asserted-by":"crossref","first-page":"316","DOI":"10.1161\/CIRCULATIONAHA.106.621342","article-title":"Drug-Eluting Stent Update 2007: Part I: A Survey of Current and Future Generation Drug-Eluting Stents: Meaningful Advances or More of the Same?","volume":"116","author":"Daemen","year":"2007","journal-title":"Circulation"},{"key":"ref_25","doi-asserted-by":"crossref","first-page":"571","DOI":"10.1177\/1358863X231199489","article-title":"Primary Results of the SAVAL Randomized Trial of a Paclitaxel-Eluting Nitinol Stent versus Percutaneous Transluminal Angioplasty in Infrapopliteal Arteries","volume":"28","author":"Nakamura","year":"2023","journal-title":"Vasc. Med."},{"key":"ref_26","first-page":"100024","article-title":"Drug-Eluting Stents Versus Conventional Endovascular Therapies in Symptomatic Infrapopliteal Peripheral Artery Disease: A Meta-Analysis","volume":"1","author":"Changal","year":"2022","journal-title":"J. Soc. Cardiovasc. Angiogr. Interv."},{"key":"ref_27","doi-asserted-by":"crossref","first-page":"1284","DOI":"10.1016\/j.jcin.2013.08.007","article-title":"Drug-Eluting Stents for Revascularization of Infrapopliteal Arteries","volume":"6","author":"Fusaro","year":"2013","journal-title":"JACC Cardiovasc. Interv."},{"key":"ref_28","doi-asserted-by":"crossref","first-page":"131","DOI":"10.1583\/1545-1550-20.2.131","article-title":"Meta-Analysis of Outcomes of Endovascular Treatment of Infrapopliteal Occlusive Disease With Drug-Eluting Stents","volume":"20","author":"Antoniou","year":"2013","journal-title":"J. Endovasc. Ther."},{"key":"ref_29","doi-asserted-by":"crossref","first-page":"645","DOI":"10.1007\/s00270-013-0578-2","article-title":"Systematic Review of Infrapopliteal Drug-Eluting Stents: A Meta-Analysis of Randomized Controlled Trials","volume":"36","author":"Katsanos","year":"2013","journal-title":"Cardiovasc. Interv. Radiol."},{"key":"ref_30","doi-asserted-by":"crossref","first-page":"42","DOI":"10.23736\/S0392-9590.20.04462-4","article-title":"A Systematic Review and Meta-Analysis of Bioresorbable Vascular Scaffolds for below-the-Knee Arterial Disease","volume":"40","author":"Ipema","year":"2021","journal-title":"Int. Angiol."},{"key":"ref_31","doi-asserted-by":"crossref","first-page":"9","DOI":"10.1056\/NEJMoa2305637","article-title":"Drug-Eluting Resorbable Scaffold versus Angioplasty for Infrapopliteal Artery Disease","volume":"390","author":"Varcoe","year":"2024","journal-title":"N. Engl. J. Med."},{"key":"ref_32","doi-asserted-by":"crossref","first-page":"2277","DOI":"10.1016\/j.jcin.2020.06.045","article-title":"Randomized Controlled Trial of Acotec Drug-Eluting Balloon Versus Plain Balloon for Below-the-Knee Angioplasty","volume":"13","author":"Liistro","year":"2020","journal-title":"JACC Cardiovasc. Interv."},{"key":"ref_33","doi-asserted-by":"crossref","first-page":"1614","DOI":"10.1016\/j.jcin.2015.07.011","article-title":"Paclitaxel-Coated Balloon in Infrapopliteal Arteries","volume":"8","author":"Zeller","year":"2015","journal-title":"JACC Cardiovasc. Interv."},{"key":"ref_34","doi-asserted-by":"crossref","first-page":"1568","DOI":"10.1016\/j.jacc.2014.06.1198","article-title":"Drug-Eluting Balloon Versus Standard Balloon Angioplasty for Infrapopliteal Arterial Revascularization in Critical Limb Ischemia","volume":"64","author":"Zeller","year":"2014","journal-title":"J. Am. Coll. Cardiol."},{"key":"ref_35","first-page":"E11","article-title":"Drug-Coated versus Uncoated Percutaneous Transluminal Angioplasty Balloons for the Treatment of Infrapopliteal Peripheral Artery Disease: A Systematic Review and Meta-Analysis of Randomized Controlled Trials","volume":"2","author":"Templeton","year":"2022","journal-title":"J. Crit. Limb Ischemia"},{"key":"ref_36","unstructured":"Brodmann, M. (2020, January 12\u201315). Results and Interim Safety Analyses at Three Years. Proceedings of the Amputation Prevention Symposium, Virtual."},{"key":"ref_37","doi-asserted-by":"crossref","first-page":"555","DOI":"10.1177\/15266028211007457","article-title":"World\u2019s First Experience Treating TASC II C and D Tibial Occlusive Disease Using the Selution SLR Sirolimus-Eluting Balloon: Six-Month Results from the PRESTIGE Study","volume":"28","author":"Tang","year":"2021","journal-title":"J. Endovasc. Ther."},{"key":"ref_38","doi-asserted-by":"crossref","first-page":"146","DOI":"10.4244\/EIJV9I1A21","article-title":"Emerging Technologies: Polymer-Free Phospholipid Encapsulated Sirolimus Nanocarriers for the Controlled Release of Drug from a Stent-plus-Balloon or a Stand-Alone Balloon Catheter","volume":"9","author":"Lemos","year":"2013","journal-title":"EuroIntervention"},{"key":"ref_39","doi-asserted-by":"crossref","first-page":"143","DOI":"10.1016\/j.carrev.2022.03.035","article-title":"12-Months Results from the PRESTIGE Study Using Sirolimus Drug-Eluting Balloons in the Treatment of Complex BTK Tibial Atherosclerotic Lesions in CLTI Patients","volume":"43","author":"Tang","year":"2022","journal-title":"Cardiovasc. Revascularization Med."},{"key":"ref_40","doi-asserted-by":"crossref","first-page":"1716","DOI":"10.1007\/s00270-022-03213-z","article-title":"Sirolimus-Coated Balloon Angioplasty of Infra-Popliteal Lesions for the Treatment of Chronic Limb-Threatening Ischemia: Study Protocol for the Randomized Controlled LIMES Study","volume":"45","author":"Platzer","year":"2022","journal-title":"Cardiovasc. Intervent Radiol."},{"key":"ref_41","doi-asserted-by":"crossref","first-page":"S50","DOI":"10.1016\/j.jcin.2023.01.162","article-title":"CRT-300.3 SELUTION4BTK\u2014A Randomized Clinical Trial Evaluating Selution SLR Sirolimus-Eluting Balloon in the Treatment of Below-the-Knee Lesions in Patients With Chronic Limb-Threatening Ischemia","volume":"16","author":"Armstrong","year":"2023","journal-title":"JACC Cardiovasc. Interv."},{"key":"ref_42","unstructured":"ClinicalTrials.Gov (2024, March 02). SirolimUs CoaTed Balloon for the TrEatment of Below the Knee Arterial Disease (FUTURE-BTK), Available online: https:\/\/clinicaltrials.gov\/study\/NCT04511247."},{"key":"ref_43","doi-asserted-by":"crossref","first-page":"1489","DOI":"10.1016\/j.jvir.2014.06.018","article-title":"Contemporary Systematic Review and Meta-Analysis of Early Outcomes with Percutaneous Treatment for Infrapopliteal Atherosclerotic Disease","volume":"25","author":"Razavi","year":"2014","journal-title":"J. Vasc. Interv. Radiol."},{"key":"ref_44","unstructured":"Phillips (2022). TOBA II BTK Clinical Study 36-Month Summary, Royal Philips (Technology Company)."},{"key":"ref_45","doi-asserted-by":"crossref","first-page":"142","DOI":"10.1002\/ccd.29327","article-title":"Long-Term Results of a Prospective, Single-Arm Evaluation of Everolimus-Eluting Bioresorbable Vascular Scaffolds in Infrapopliteal Arteries","volume":"97","author":"Varcoe","year":"2021","journal-title":"Catheter. Cardiovasc. Interv."},{"key":"ref_46","doi-asserted-by":"crossref","first-page":"1905","DOI":"10.1056\/NEJMoa1509038","article-title":"Everolimus-Eluting Bioresorbable Scaffolds for Coronary Artery Disease","volume":"373","author":"Ellis","year":"2015","journal-title":"N. Engl. J. Med."},{"key":"ref_47","doi-asserted-by":"crossref","first-page":"524","DOI":"10.1177\/1526602820921555","article-title":"New Innovations and Devices in the Management of Chronic Limb-Threatening Ischemia","volume":"27","author":"Kim","year":"2020","journal-title":"J. Endovasc. Ther."},{"key":"ref_48","unstructured":"Rand, T. (2022, January 6\u20139). MOTIV Bioresorbable BTK Scaffold Pilot Study Preliminary Results through 6 Months. Proceedings of the Leipzig Interventional Course, Leipzig, Germany."},{"key":"ref_49","unstructured":"ClinicalTrials.gov (2023, December 23). MOTIV BTK Randomized Controlled Trial, Available online: https:\/\/clinicaltrials.gov\/study\/NCT05406622."},{"key":"ref_50","unstructured":"Secemski, E. (November, January 31). RESOLV FIH 6-Month Results by Rutherford Classification. Proceedings of the Vascular InterVentional Advances, Las Vegas, NV, USA."},{"key":"ref_51","first-page":"1","article-title":"Clinical Outcomes and Cost Comparisons of Stent and Non-Stent Interventions in Infrainguinal Peripheral Artery Disease: Insights from the Excellence in Peripheral Artery Disease (XLPAD) Registry","volume":"31","author":"Banerjee","year":"2019","journal-title":"J. Invasive Cardiol."},{"key":"ref_52","doi-asserted-by":"crossref","first-page":"e002107","DOI":"10.1136\/openhrt-2022-002107","article-title":"Bioresorbable Vascular Scaffolds versus Conventional Drug-Eluting Stents across Time: A Meta-Analysis of Randomised Controlled Trials","volume":"9","author":"Zioupos","year":"2022","journal-title":"Open Heart"},{"key":"ref_53","doi-asserted-by":"crossref","first-page":"e414","DOI":"10.4244\/EIJ-D-23-00326","article-title":"A New Resorbable Magnesium Scaffold for de Novo Coronary Lesions (DREAMS 3): One-Year Results of the BIOMAG-I First-in-Human Study","volume":"19","author":"Haude","year":"2023","journal-title":"EuroIntervention"},{"key":"ref_54","doi-asserted-by":"crossref","first-page":"101940","DOI":"10.1016\/j.eclinm.2023.101940","article-title":"Safety and Performance of the Third-Generation Drug-Eluting Resorbable Coronary Magnesium Scaffold System in the Treatment of Subjects with de Novo Coronary Artery Lesions: 6-Month Results of the Prospective, Multicenter BIOMAG-I First-in-Human Study","volume":"59","author":"Haude","year":"2023","journal-title":"EClinicalMedicine"},{"key":"ref_55","first-page":"100341","article-title":"Intravascular Lithotripsy for Peripheral Artery Calcification: Mid-Term Outcomes from the Randomized Disrupt PAD III Trial","volume":"1","author":"Tepe","year":"2022","journal-title":"J. Soc. Cardiovasc. Angiogr. Interv."},{"key":"ref_56","doi-asserted-by":"crossref","first-page":"499","DOI":"10.1177\/1526602818783989","article-title":"Safety and Feasibility of Intravascular Lithotripsy for Treatment of Below-the-Knee Arterial Stenoses","volume":"25","author":"Brodmann","year":"2018","journal-title":"J. Endovasc. Ther."},{"key":"ref_57","doi-asserted-by":"crossref","first-page":"164","DOI":"10.1177\/1358863X20979738","article-title":"Association of Infrapopliteal Medial Arterial Calcification with Lower-Limb Amputations in High-Risk Patients: A Systematic Review and Meta-Analysis","volume":"26","author":"Losurdo","year":"2021","journal-title":"Vasc. Med."}],"container-title":["Journal of Clinical Medicine"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/www.mdpi.com\/2077-0383\/13\/6\/1757\/pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,10,10]],"date-time":"2025-10-10T14:15:43Z","timestamp":1760105743000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.mdpi.com\/2077-0383\/13\/6\/1757"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2024,3,19]]},"references-count":57,"journal-issue":{"issue":"6","published-online":{"date-parts":[[2024,3]]}},"alternative-id":["jcm13061757"],"URL":"https:\/\/doi.org\/10.3390\/jcm13061757","relation":{},"ISSN":["2077-0383"],"issn-type":[{"value":"2077-0383","type":"electronic"}],"subject":[],"published":{"date-parts":[[2024,3,19]]}}}