Volume 6, Issue 5, September 2020, Page: 61-66
Safety Issues Associated with Paclitaxel-Eluting Balloons and Progress of Sirolimus-Eluting Balloons
Yu Xia Yin, National United Engineering Laboratory for Biomedical Material Modification, Dezhou, China; School of Materials Science and Engineering, University of Science and Technology, Beijing, China
Zhi Yong Wang, Department of Emergency, Inner Mongolia people's Hospital, Hohhot, China
Lu Ning Wang, School of Materials Science and Engineering, University of Science and Technology, Beijing, China
Ming Kun Cao, National United Engineering Laboratory for Biomedical Material Modification, Dezhou, China
Tian Heng Lu, National United Engineering Laboratory for Biomedical Material Modification, Dezhou, China
Hai Jun Zhang, National United Engineering Laboratory for Biomedical Material Modification, Dezhou, China; Department of Vascular & Intervention, Tenth Peoples' Hospital of Tongji University, Shanghai, China; Department of Health Science and Technology, Faculty of Medicine, Aalborg University, Aalborg, Denmark
Received: Feb. 1, 2020;       Accepted: Sep. 14, 2020;       Published: Sep. 19, 2020
DOI: 10.11648/j.ijcts.20200605.11      View  50      Downloads  24
Drug eluting balloons (DEBs) are semi-compliant angioplasty balloons covered with an antiproliferative drug which is rapidly released locally into the vessel wall during balloon contact. Their advantages include a broader area of drug contact, more homogenous drug-tissue transfer for stent-based local drug delivery, no implant leaving as well as shortened dual antiplatelet therapy. DEBs application was first recommended by the European Society of Cardiology (ESC) and European Association for Cardio-Thoracic Surgery (EACTS) guidelines for the treatment of in-stent restenosis (ISR) after prior bare-metal stent (BMS) (Class IIA, Level B) in 2010. Since then, rapid progress has been made in the use of DEBs for treatment of in-stent restenosis, bifurcation, small vessel diseases, and other de novo occlusive coronary artery diseases even the symptomatic peripheral arterial disease. However, a meta-analysis of 28 randomized controlled trials (RCTs) with 4663 patients investigating paclitaxel-coated devices (DEBs & drug-eluting stent) in the femoral and/or popliteal arteries showed a highly significant association between risk of death and paclitaxel exposure in a dose-time-dependent manner. Safety issues associated with clinical application of paclitaxel DEBs in femoropopliteal artery was widely discussed. This study reviewed the issues, different molecular mechanisms of paclitaxel and sirolimus in antiproliferative effects, and progress of sirolimus-eluting balloons.
Drug Eluting Balloons, Paclitaxel-Eluting Balloons, Sirolimus-Eluting Balloons
To cite this article
Yu Xia Yin, Zhi Yong Wang, Lu Ning Wang, Ming Kun Cao, Tian Heng Lu, Hai Jun Zhang, Safety Issues Associated with Paclitaxel-Eluting Balloons and Progress of Sirolimus-Eluting Balloons, International Journal of Cardiovascular and Thoracic Surgery. Vol. 6, No. 5, 2020, pp. 61-66. doi: 10.11648/j.ijcts.20200605.11
Copyright © 2020 Authors retain the copyright of this article.
This article is an open access article distributed under the Creative Commons Attribution License (http://creativecommons.org/licenses/by/4.0/) which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
Gray W A, Granada J F. Drug-Coated Balloons for the Prevention of Vascular Restenosis [J]. Circulation. 2010; 121: 2672-2680.
Taggart D P, Boyle R, de Belder M A, et al. The 2010 ESC/EACTS guidelines on myocardial revascularisation [J]. Heart, 2011, 97 (6): 445-446.
Windecker S, Kolh P, Alfonso F, et al. 2014 ESC/EACTS Guidelines on myocardial revascularization: The Task Force on Myocardial Revascularization of the European Society of Cardiology (ESC) and the European Association for Cardio-Thoracic Surgery (EACTS) Developed with the special contribution of the European Association of Percutaneous Cardiovascular Interventions (EAPCI). Eur Heart J, 2014, 35 (37): 2541-2619.
Neumann F J, Uva M, Ahlsson A, et al. 2018 ESC/EACTS Guidelines on myocardial revascularization [J]. EuroIntervention, 2018, 14 (14): 1435-1534.
Fröhlich GM, Lansky A J, Ko D T, Archangelidi O, De Palma R, Timmis A, Meier P. Drug eluting balloons for de novo coronary lesions-a systematic review and meta-analysis. BMC Medicine. 2013; 11: 123.
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. Journal of the American Heart Association. 2018; 7: e011245.
Stone GW, Ellis SG, Cox DA, Hermiller J, O'Shaughnessy C, Mann JT, Turco M, Caputo R, Bergin P, Greenberg J, Popma JJ, Russell ME. One-year clinical results with the slow-release, polymer-based, paclitaxel-eluting TAXUS stent: the TAXUS-IV trial. Circulation. 2004; 110: 1942-1947.
Daemen J, Wenaweser P, Tsuchida K, Abrecht L, Vaina S, Morger C, Kukreja N, Jüni P, Sianos G, Hellige G, van Domburg RT, Hess OM, Boersma E, Meier B, Windecker S, Serruys PW. Early and late coronary stent thrombosis of sirolimus-eluting and paclitaxel-eluting stents in routine clinical practice: data from a large two-institutional cohort study. Digest of the World Core Medical Journals. 2007; 369: 667-678.
Stone GW, Ellis SG, Colombo A, Grube E, Popma JJ, Uchida T, Bleuit JS, Dawkins KD, Russell ME. Long-term safety and efficacy of paclitaxel-eluting stents final 5-year analysis from the TAXUS clinical trial program. JACC Cardiovasc Interv. 2011; 4: 530–542.
Milojevic M, Head SJ, Parasca CA, Serruys PW, Mohr FW, Morice MC, Mack MJ, Stahle E, Feldman TE, Dawkins KD, Colombo A, Kappetein AP, Holmes DR Jr. Causes of Death Following PCI Versus CABG in Complex CAD: 5-Year Follow-Up of SYNTAX. J Am Coll Cardiol. 2016; 67: 42–55.
Morice MC, Colombo A, Meier B, Serruys P, Tamburino C, Guagliumi G, Sousa E, Stoll HP. Sirolimus- vs Paclitaxel-Eluting Stents in De Novo Coronary Artery Lesions: The REALITY Trial: A Randomized Controlled Trial. JAMA. 2006; 295: 895-904.
Stone GW, Moses JW, Ellis SG, Schofer J, Dawkins KD, Morice MC, Colombo A, Schampaert E, Grube E, Kirtane AJ, Cutlip DE, Fahy M, Pocock SJ, Mehran R, Leon MB. Safety and Efficacy of Sirolimus- and Paclitaxel-Eluting Coronary Stents. N Engl J Med. 2007; 356: 998-1008.
Gongora CA, Shibuya M, Wessler JD, McGregor J, Tellez A, Cheng Y, Conditt GB, Kaluza GL, Granada JF. Impact of paclitaxel dose on tissue pharmacoki- netics and vascular healing: a comparative drug-coated balloon study in the familial hypercholesterolemic swine model of superficial femoral in-stent restenosis. JACC Cardiovasc Interv. 2015; 8: 1115–1123.
Granada JF, Stenoien M, Buszman PP, Tellez A, Langanki D, Kaluza GL, Leon MB, Gray W, Jaff MR, Schwartz RS. Mechanisms of tissue uptake and retention of paclitaxel-coated balloons: impact on neointimal proliferation and healing. Open Heart. 2014; 1: e000117.
Secemsky EA, Kundi H, Weinberg I, Jaff MR, Krawisz A, Parikh SA, Beckman JA, Mustapha J, Rosenfield K. Association of Survival With Femoropopliteal Artery Revascularization With Drug-Coated Devices. JAMA Cardiol. 2019.
Schneider PA, Laird JR, Doros G, Gao Q, Ansel G, Brodmann M, Micari A, Shishehbor MH, Tepe G, Zeller T. Mortality Not Correlated With Paclitaxel Exposure: An Independent Patient-Level Meta-Analysis of a Drug-Coated Balloon. J Am Coll Cardiol. 2019; 73: 2550-2563.
Anantha-Narayanan M, Shah SM, Jelani QU, Garcia S, Ionescu C, Regan C. Mena-Hurtado CDrug-coated balloon versus plain old balloon angioplasty in femoropopliteal disease: An updated meta-analysis of randomized controlled trials. Catheter Cardiovasc Interv. 2019.
Albrecht T, Schnorr B, Kutschera M, Waliszewski MW. Two-Year Mortality After Angioplasty of the Femoro-Popliteal Artery with Uncoated Balloons and Paclitaxel-Coated Balloons-A Pooled Analysis of Four Randomized Controlled Multicenter Trials. Cardiovasc Intervent Radiol. 2019; 42: 949-955.
U. S. Food and Drug Administration. Treatment of peripheral arterial disease with paclitaxel-coated balloons and paclitaxel-eluting stents potentially associated with increased mortality–Letter to health care providers. Published on: August 7, 2019. Available at: https://www.fda.gov/medical-devices/letters-health-care-providers/august-7-2019-update.
Kastrati A, Dibra A, Eberle S, Mehilli J, Suárez de Lezo J, Goy JJ, Ulm K, Schömig A. Sirolimus-eluting stents vs paclitaxel-eluting stents in patients with coronary artery disease: meta-analysis of randomized trials. JAMA. 2005; 294: 819–825.
Schömig A, Dibra A, Windecker S, Mehilli J, Suárez de Lezo J, Kaiser C, Park SJ, Goy JJ, Lee JH, Di Lorenzo E, Wu J, Jüni P, Pfisterer ME, Meier B, Kastrati A. A meta-analysis of 16 randomized trials of sirolimus-eluting stents versus paclitaxel-eluting stents in patients with coronary artery disease. J Am Coll Cardiol. 2007; 50: 1373–1380.
Stone GW, Midei M, Newman W, Sanz M, Hermiller JB, Williams J, Farhat N, Mahaffey KW, Cutlip DE, Fitzgerald PJ, Sood P, Su X, Lansky AJ. Comparison of an everolimus- eluting stent and a paclitaxel-eluting stent in patients with coronary artery disease: a randomized trial. JAMA. 2008; 299: 1903–1913.
Koltin Y, Faucette L, Bergsma DJ, Levy MA, Cafferkey R, Koser PL, Johnson RK, Livi GP. Rapamycin sensitivity in Saccharomyces cerevisiae is mediated by a peptidyl-prolyl cis-trans isomerase related to human FK506-binding protein. Mol Cell Biol. 1991; 11: 1718–1723.
Marx SO, Jayaraman T, Go LO, Marks AR. Rapamycin-FKBP inhibits cell cycle regulators of proliferation in vascular smooth muscle cells. Circ. Res. 1995; 76: 412–417.
Rao S, Krauss NE, Heerding JM, Swindell CS, Ringel I, Orr GA, Horwitz SB. 3′-(p-Azidobenzamido)taxol photolabels the N-terminal 31 amino acids of β-tubulin. J. Biol. Chem. 1994; 269: 3132–3134.
Rowinsky EK, Donehower RC. Paclitaxel (Taxol). N Engl J Med. 1995; 332: 1004–1014.
Heldman AW, Cheng L, Jenkins GM, Heller PF, Kim DW, Ware M Jr, Nater C, Hruban RH, Rezai B, Abella BS, Bunge KE, Kinsella JL, Sollott SJ, Lakatta EG, Brinker JA, Hunter WL, Froehlich JP. Paclitaxel stent coating inhibits neointimal hyperplasia at 4 weeks in a porcine model of coronary restenosis. Circulation. 2001; 103: 2289–2295.
Lemos PA, Farooq V, Takimura CK, Gutierrez PS, Virmani R, Kolodgie F, Christians U, Kharlamov A, Doshi M, Sojitra P, van Beusekom HM, Serruys PW. 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. EuroIntervention. 2013; 9: 148-56.
Sojitra P, Yazdani S, Otsuka F, Doshi M, Kolodgie F, Virmani R. CRT-123 a novel Nano particle sirolimus delivery via coated balloon. JACC Cardiovasc Interv. 2013; 6: S40.
Dani S, Shah D, Sojitra P, Parikh K, Shetty R, di Palma G, Cortese B. A novel nanocarrier sirolimus-coated balloon for coronary interventions: 12-Month data from the Nanoluté Registry. Cardiovasc Revasc Med. 2019; 20: 235-240.
Dani S, Parikh K, Pillai P K N, Shetty R, Hiremath J, Shah D. CRT-100.84 Long-term Clinical Outcomes After the Treatment of Coronary Stenosis With Sirolimus-coated Balloon Angioplasty: Results From NANOLUTE Real-World Registry. Jacc Cardiovascular Interventions. 2018; 11: S24.
Clever YP, Peters D, Calisse J, Bettink S, Berg MC, Sperling C, Stoever M, Cremers B, Kelsch B, Böhm M, Speck U, Scheller B. Novel Sirolimus–Coated Balloon Catheter. Circulation: Cardiovascular Interventions. 2016; 9: e003543.
Mohd AR, Ali SAKM, Azman WAW, Kiam TO, Bang HL, Scheller B. TCTAP A-001 Treatment of Coronary DES Restenosis with a Sirolimus or Paclitaxel Coated Balloon. Journal of the American College of Cardiology. 2018; 71: S1.
Elicker R J, Shulze J E, Ahlering M T, et al. TCT-843 Preclinical Evaluation of the SELUTION Sirolimus Drug Coated Balloon in a Porcine Coronary Overstretch Model [J]. Journal of the American College of Cardiology, 2016, 68 (18): B340-B341.
Granada JF, Tellez A, Baumbach WR, Bingham B, Keng YF, Wessler J, Conditt G, McGregor J, Stone G, Kaluza GL, Leon MB. In vivo delivery and long-term tissue retention of nano- encapsulated sirolimus using a novel porous balloon angioplasty system. EuroIntervention. 2016; 12: 740–747.
Verheye S, Vrolix M, Kumsars I, Erglis A, Sondore D, Agostoni P, Cornelis K, Janssens L, Maeng M, Slagboom T, Amoroso G, Jensen LO, Granada JF, Stella P. The SABRE Trial (Sirolimus Angioplasty Balloon for Coronary In-Stent Restenosis): Angiographic Results and 1-Year Clinical Outcomes. Jacc Cardiovascular Interventions. 2017; 10: 2029-2037.
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