Drug-Coated Balloon in Peripheral Artery Disease
DCBs in PAD
DOI:
https://doi.org/10.5281/zenodo.8118693Keywords:
Drug-coated balloon, DCBs, paclitaxel, peripheral arterial diseaseAbstract
In the field of interventional cardiology and vascular surgery, drug-coated balloons (DCBs) are a type of medical device used to treat numerous cardiovascular diseases, notably in the peripheral arteries. The interventionist's toolkit has grown thanks to the use of DCBs, which has improved primary patency and freedom from target lesion revascularization. Which technologies may accomplish these goals while simultaneously lowering overall morbidity and mortality is still up for dispute. The purpose of this article is to highlight new developments in the literature pertaining to the usage of balloons with drugs.
References
Jones WS, Patel MR, Dai D, et al. High mortality risks after major lower extremity amputation in Medicare patients with peripheral artery disease. Am Heart J. May 2013;165(5):809-15, 815 e1. doi:10.1016/j.ahj.2012.12.002
Dua A, Lee CJ. Epidemiology of Peripheral Arterial Disease and Critical Limb Ischemia. Tech Vasc Interv Radiol. Jun 2016;19(2):91-5. doi:10.1053/j.tvir.2016.04.001
Scheinert D, Scheinert S, Sax J, et al. Prevalence and clinical impact of stent fractures after femoropopliteal stenting. J Am Coll Cardiol. Jan 18 2005;45(2):312-5. doi:10.1016/j.jacc.2004.11.026
Fortier A, Gullapalli V, Mirshams R. Review of biomechanical studies of arteries and their effect on stent performance. IJC Heart & Vessels. 04/01 2014;4doi:10.1016/j.ijchv.2014.04.007
Scheinert D, Duda S, Zeller T, et al. The LEVANT I (Lutonix paclitaxel-coated balloon for the prevention of femoropopliteal restenosis) trial for femoropopliteal revascularization: first-in-human randomized trial of low-dose drug-coated balloon versus uncoated balloon angioplasty. JACC Cardiovasc Interv. Jan 2014;7(1):10-9. doi:10.1016/j.jcin.2013.05.022
Rosenfield K, Jaff MR, White CJ, et al. Trial of a Paclitaxel-Coated Balloon for Femoropopliteal Artery Disease. N Engl J Med. Jul 9 2015;373(2):145-53. doi:10.1056/NEJMoa1406235
Steiner S, Willfort-Ehringer A, Sievert H, et al. 12-Month Results From the First-in-Human Randomized Study of the Ranger Paclitaxel-Coated Balloon for Femoropopliteal Treatment. JACC Cardiovasc Interv. May 28 2018;11(10):934-941. doi:10.1016/j.jcin.2018.01.276
Lichtenberg M, von Bilderling P, Ranft J, et al. Treatment of femoropopliteal atherosclerotic lesions using the ranger paclitaxel-coated balloon catheter: 12-month results from an all-comers registry. J Cardiovasc Surg (Torino). Feb 2018;59(1):45-50. doi:10.23736/S0021-9509.17.10261-2
Steiner S, Willfort-Ehringer A, Sievert H, et al. 12-Month Results From the First-in-Human Randomized Study of the Ranger Paclitaxel-Coated Balloon for Femoropopliteal Treatment. JACC: Cardiovascular Interventions. 2018;11(10):934-941. doi:doi:10.1016/j.jcin.2018.01.276
Dror M TP, inventor; Releasable coatings on balloon catheters. patent U.S. Patent No. 5,102,402.
Laird JA, Schneider PA, Jaff MR, et al. Long-Term Clinical Effectiveness of a Drug-Coated Balloon for the Treatment of Femoropopliteal Lesions. Circ Cardiovasc Interv. Jun 2019;12(6):e007702. doi:10.1161/CIRCINTERVENTIONS.118.007702
Bunte MC, Shishehbor MH. Next Generation Endovascular Therapies in Peripheral Artery Disease. Prog Cardiovasc Dis. Mar-Apr 2018;60(6):593-599. doi:10.1016/j.pcad.2018.03.003
Schroeder H, Werner M, Meyer DR, et al. Low-Dose Paclitaxel-Coated Versus Uncoated Percutaneous Transluminal Balloon Angioplasty for Femoropopliteal Peripheral Artery Disease: One-Year Results of the ILLUMENATE European Randomized Clinical Trial (Randomized Trial of a Novel Paclitaxel-Coated Percutaneous Angioplasty Balloon). Circulation. Jun 6 2017;135(23):2227-2236. doi:10.1161/CIRCULATIONAHA.116.026493
Krishnan P, Faries P, Niazi K, et al. Stellarex Drug-Coated Balloon for Treatment of Femoropopliteal Disease: Twelve-Month Outcomes From the Randomized ILLUMENATE Pivotal and Pharmacokinetic Studies. Circulation. Sep 19 2017;136(12):1102-1113. doi:10.1161/CIRCULATIONAHA.117.028893
Brodmann M, Werner M, Meyer DR, et al. Sustainable Antirestenosis Effect With a Low-Dose Drug-Coated Balloon: The ILLUMENATE European Randomized Clinical Trial 2-Year Results. JACC Cardiovasc Interv. Dec 10 2018;11(23):2357-2364. doi:10.1016/j.jcin.2018.08.034
Gray WA, Jaff MR, Parikh SA, et al. Mortality Assessment of Paclitaxel-Coated Balloons: Patient-Level Meta-Analysis of the ILLUMENATE Clinical Program at 3 Years. Circulation. Oct 2019;140(14):1145-1155. doi:10.1161/CIRCULATIONAHA.119.040518
Teichgraber U, Lehmann T, Aschenbach R, et al. Two-year Review on Mortality and Morbidity after Femoropopliteal Drug-coated Balloon Angioplasty in the Randomized EffPac Trial. Radiology. Sep 2020;296(3):638-640. doi:10.1148/radiol.2020201370
Tang TY, Yap CJ, Chan SL, et al. Safety and efficacy of Luminor balloon and Angiolite stent on TASC C/D tibial occlusive lesions in CLI patients: 12-month results. The MERLION trial. Int Angiol. Aug 2021;40(4):335-344. doi:10.23736/S0392-9590.21.04690-3
Teichgraber U, Lehmann T, Ingwersen M, et al. Long-Term Effectiveness and Safety of Femoropopliteal Drug-Coated Balloon Angioplasty : 5-Year Results of the Randomized Controlled EffPac Trial. Cardiovasc Intervent Radiol. Dec 2022;45(12):1774-1783. doi:10.1007/s00270-022-03265-1
Feldman DN, Armstrong EJ, Aronow HD, et al. SCAI consensus guidelines for device selection in femoral-popliteal arterial interventions. Catheter Cardiovasc Interv. Jul 2018;92(1):124-140. doi:10.1002/ccd.27635
Werk M, Langner S, Reinkensmeier B, et al. Inhibition of restenosis in femoropopliteal arteries: paclitaxel-coated versus uncoated balloon: femoral paclitaxel randomized pilot trial. Circulation. Sep 23 2008;118(13):1358-65. doi:10.1161/CIRCULATIONAHA.107.735985
Tepe G, Zeller T, Albrecht T, et al. Local delivery of paclitaxel to inhibit restenosis during angioplasty of the leg. N Engl J Med. Feb 14 2008;358(7):689-99. doi:10.1056/NEJMoa0706356
Cassese S, Byrne RA, Ott I, et al. Paclitaxel-coated versus uncoated balloon angioplasty reduces target lesion revascularization in patients with femoropopliteal arterial disease: a meta-analysis of randomized trials. Circ Cardiovasc Interv. Aug 1 2012;5(4):582-9. doi:10.1161/CIRCINTERVENTIONS.112.969972
Giacoppo D, Cassese S, Harada Y, et al. Drug-Coated Balloon Versus Plain Balloon Angioplasty for the Treatment of Femoropopliteal Artery Disease: An Updated Systematic Review and Meta-Analysis of Randomized Clinical Trials. JACC Cardiovasc Interv. Aug 22 2016;9(16):1731-42. doi:10.1016/j.jcin.2016.06.008
Torii S, Kolodgie FD, Virmani R, Finn AV. IN.PACT Admiral drug-coated balloons in peripheral artery disease: current perspectives. Med Devices (Auckl). 2019;12:53-64. doi:10.2147/MDER.S165620
Katsanos K. Paclitaxel-Coated Balloons in the Femoropopliteal Artery: It Is All About the Pharmacokinetic Profile and Vessel Tissue Bioavailability. JACC Cardiovasc Interv. Aug 22 2016;9(16):1743-5. doi:10.1016/j.jcin.2016.06.047
Cassese S, Ndrepepa G, Kufner S, et al. Drug-coated balloon angioplasty for in-stent restenosis of femoropopliteal arteries: a meta-analysis. EuroIntervention. Jul 20 2017;13(4):483-489. doi:10.4244/EIJ-D-16-00735
Steiner S, Schmidt A, Zeller T, et al. COMPARE: prospective, randomized, non-inferiority trial of high- vs. low-dose paclitaxel drug-coated balloons for femoropopliteal interventions. Eur Heart J. Jul 14 2020;41(27):2541-2552. doi:10.1093/eurheartj/ehaa049
Albrecht T, Waliszewski M, Roca C, et al. Two-Year Clinical Outcomes of the CONSEQUENT Trial: Can Femoropopliteal Lesions be Treated with Sustainable Clinical Results that are Economically Sound? Cardiovasc Intervent Radiol. Jul 2018;41(7):1008-1014. doi:10.1007/s00270-018-1940-1
Katsanos K, Spiliopoulos S, Paraskevopoulos I, Diamantopoulos A, Karnabatidis D. Systematic Review and Meta-analysis of Randomized Controlled Trials of Paclitaxel-Coated Balloon Angioplasty in the Femoropopliteal Arteries: Role of Paclitaxel Dose and Bioavailability. J Endovasc Ther. Apr 2016;23(2):356-70. doi:10.1177/1526602815626557
Cassese S, Wolf F, Ingwersen M, et al. Drug-Coated Balloon Angioplasty for Femoropopliteal In-Stent Restenosis. Circ Cardiovasc Interv. Dec 2018;11(12):e007055. doi:10.1161/CIRCINTERVENTIONS.118.007055
Grotti S, Liistro F, Angioli P, et al. Paclitaxel-Eluting Balloon vs Standard Angioplasty to Reduce Restenosis in Diabetic Patients With In-Stent Restenosis of the Superficial Femoral and Proximal Popliteal Arteries: Three-Year Results of the DEBATE-ISR Study. J Endovasc Ther. Feb 2016;23(1):52-7. doi:10.1177/1526602815614555
Katsanos K, Spiliopoulos S, Reppas L, Karnabatidis D. Debulking Atherectomy in the Peripheral Arteries: Is There a Role and What is the Evidence? Cardiovasc Intervent Radiol. Jul 2017;40(7):964-977. doi:10.1007/s00270-017-1649-6
Zeller T, Langhoff R, Rocha-Singh KJ, et al. Directional Atherectomy Followed by a Paclitaxel-Coated Balloon to Inhibit Restenosis and Maintain Vessel Patency: Twelve-Month Results of the DEFINITIVE AR Study. Circ Cardiovasc Interv. Sep 2017;10(9):e004848. doi:10.1161/CIRCINTERVENTIONS.116.004848
Cioppa A, Stabile E, Salemme L, et al. Combined use of directional atherectomy and drug-coated balloon for the endovascular treatment of common femoral artery disease: immediate and one-year outcomes. EuroIntervention. Feb 20 2017;12(14):1789-1794. doi:10.4244/EIJ-D-15-00187
Gandini R, Del Giudice C, Merolla S, Morosetti D, Pampana E, Simonetti G. Treatment of chronic SFA in-stent occlusion with combined laser atherectomy and drug-eluting balloon angioplasty in patients with critical limb ischemia: a single-center, prospective, randomized study. J Endovasc Ther. Dec 2013;20(6):805-14. doi:10.1583/13-4308MR.1
Shishehbor MH, Scheinert D, Jain A, et al. Comparison of Drug-Coated Balloons vs Bare-Metal Stents in Patients With Femoropopliteal Arterial Disease. J Am Coll Cardiol. Jan 24 2023;81(3):237-249. doi:10.1016/j.jacc.2022.10.016
Tepe G, Brodmann M, Micari A, et al. 5-Year Outcomes of Drug-Coated Balloons for Peripheral Artery In-Stent Restenosis, Long Lesions, and CTOs. JACC Cardiovasc Interv. May 8 2023;16(9):1065-1078. doi:10.1016/j.jcin.2023.03.032
Soga Y, Takahara M, Iida O, et al. Vessel Patency and Associated Factors of Drug-Coated Balloon for Femoropopliteal Lesion. J Am Heart Assoc. Jan 3 2023;12(1):e025677. doi:10.1161/JAHA.122.025677
Bausback Y, Wittig T, Schmidt A, et al. Drug-Eluting Stent Versus Drug-Coated Balloon Revascularization in Patients With Femoropopliteal Arterial Disease. J Am Coll Cardiol. Feb 19 2019;73(6):667-679. doi:10.1016/j.jacc.2018.11.039
Wang J, Chen X, Zhao J, Zhang WW. Systematic Review and Meta-analysis of the Outcomes of Drug-Eluting Stent Versus Drug-Coated Balloon Angioplasty for Lower Extremity Peripheral Artery Diseases. Ann Vasc Surg. Sep 2022;85:1-8 e5. doi:10.1016/j.avsg.2022.04.039
Marzlin N, Jan MF, Kostopoulos L, Moreno ACP, Bajwa T, Allaqaband SQ. Peripheral Artery Disease Intervention: Drug-Coated Balloon vs Drug-Eluting Stent, A Long-Term Comparison. J Interv Cardiol. 2022;2022:5175607. doi:10.1155/2022/5175607
Koifman E, Lipinski MJ, Buchanan K, et al. Comparison of treatment strategies for femoro-popliteal disease: A network meta-analysis. Catheter Cardiovasc Interv. Jun 2018;91(7):1320-1328. doi:10.1002/ccd.27484
Sridharan ND, Boitet A, Smith K, et al. Cost-effectiveness analysis of drug-coated therapies in the superficial femoral artery. J Vasc Surg. Jan 2018;67(1):343-352. doi:10.1016/j.jvs.2017.06.112
Deloose K, Callaert J. Less is more: the "As Less As Reasonably Achievable Stenting" (ALARAS) strategy in the femoropopliteal area. J Cardiovasc Surg (Torino). Aug 2018;59(4):495-503. doi:10.23736/S0021-9509.18.10583-0
Lee YJ, Kook H, Ko YG, et al. Drug Eluting Stent vs. Drug Coated Balloon for Native Femoropopliteal Artery Disease: A Two Centre Experience. Eur J Vasc Endovasc Surg. Feb 2021;61(2):287-295. doi:10.1016/j.ejvs.2020.10.008
Fusaro M, Cassese S, Ndrepepa G, et al. Drug-eluting stents for revascularization of infrapopliteal arteries: updated meta-analysis of randomized trials. JACC Cardiovasc Interv. Dec 2013;6(12):1284-93. doi:10.1016/j.jcin.2013.08.007
Schmidt A, Piorkowski M, Werner M, et al. First experience with drug-eluting balloons in infrapopliteal arteries: restenosis rate and clinical outcome. J Am Coll Cardiol. Sep 6 2011;58(11):1105-9. doi:10.1016/j.jacc.2011.05.034
Liistro F, Porto I, Angioli P, et al. Drug-eluting balloon in peripheral intervention for below the knee angioplasty evaluation (DEBATE-BTK): a randomized trial in diabetic patients with critical limb ischemia. Circulation. Aug 6 2013;128(6):615-21. doi:10.1161/CIRCULATIONAHA.113.001811
Patel MR, Conte MS, Cutlip DE, et al. Evaluation and treatment of patients with lower extremity peripheral artery disease: consensus definitions from Peripheral Academic Research Consortium (PARC). J Am Coll Cardiol. Mar 10 2015;65(9):931-41. doi:10.1016/j.jacc.2014.12.036
Cassese S, Ndrepepa G, Liistro F, et al. Drug-Coated Balloons for Revascularization of Infrapopliteal Arteries: A Meta-Analysis of Randomized Trials. JACC Cardiovasc Interv. May 23 2016;9(10):1072-80. doi:10.1016/j.jcin.2016.02.011
P. G. Lutonix BTK IDE study: 12 months results
and interim safety analysis at three years. 2020:
Katsanos K, Spiliopoulos S, Kitrou P, Krokidis M, Karnabatidis D. Risk of Death Following Application of Paclitaxel-Coated Balloons and Stents in the Femoropopliteal Artery of the Leg: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. J Am Heart Assoc. Dec 18 2018;7(24):e011245. doi:10.1161/JAHA.118.011245
Shishehbor MH, Secemsky EA, Varcoe RL. Is There a Real Association Between Paclitaxel Devices and Mortality? Time to Pause and Re-Evaluate What We Know About This Statistical Finding. J Am Heart Assoc. May 21 2019;8(10):e012524. doi:10.1161/JAHA.119.012524
Dake MD, Ansel GM, Bosiers M, et al. Paclitaxel-Coated Zilver PTX Drug-Eluting Stent Treatment Does Not Result in Increased Long-Term All-Cause Mortality Compared to Uncoated Devices. Cardiovasc Intervent Radiol. Jan 2020;43(1):8-19. doi:10.1007/s00270-019-02324-4
Secemsky EA, Kundi H, Weinberg I, et al. Association of Survival With Femoropopliteal Artery Revascularization With Drug-Coated Devices. JAMA Cardiol. Apr 1 2019;4(4):332-340. doi:10.1001/jamacardio.2019.0325
Secemsky EA, Kundi H, Weinberg I, et al. Drug-Eluting Stent Implantation and Long-Term Survival Following Peripheral Artery Revascularization. J Am Coll Cardiol. May 28 2019;73(20):2636-2638. doi:10.1016/j.jacc.2019.02.020
Liistro F, Angioli P, Porto I, et al. Drug-Eluting Balloon Versus Drug-Eluting Stent for Complex Femoropopliteal Arterial Lesions: The DRASTICO Study. J Am Coll Cardiol. Jul 16 2019;74(2):205-215. doi:10.1016/j.jacc.2019.04.057
Downloads
Published
How to Cite
Issue
Section
License
Copyright (c) 2023 Advances in Cardiac Research
This work is licensed under a Creative Commons Attribution 4.0 International License.
