Drug-coated balloons in cardiovascular disease: benefits, challenges, and clinical applications

References

• Neumann F-J, Sousa-Uva M, Ahlsson A, et al. 2018 ESC/EACTS Guidelines on myocardial revascularization. Eur Heart J. 2018. DOI:10.1093/eurheartj/ehy394
   Web of Science ®Google Scholar
• Grüntzig AR, Senning A, Siegenthaler WE. Nonoperative dilatation of coronary-artery stenosis: percutaneous transluminal coronary angioplasty. N Engl J Med. 1979;301:61–68.
   PubMed Web of Science ®Google Scholar
• Fischman DL, Leon MB, Baim DS, et al. A randomized comparison of coronary-stent placement and balloon angioplasty in the treatment of coronary artery disease. Stent Restenosis Study Investigators. N Engl J Med. 1994;331:496–501.
   PubMed Web of Science ®Google Scholar
• Colombo A, Giannini F, Briguori C. Should we still have bare-metal stents available in our catheterization laboratory? J Am Coll Cardiol. 2017;70:607–619.
   PubMed Web of Science ®Google Scholar
• Stone GW, Ellis SG, Cox DA, et al. A polymer-based, paclitaxel-eluting stent in patients with coronary artery disease. N Engl J Med. 2004;350:221–231.
   PubMed Web of Science ®Google Scholar
• Bangalore S, Kumar S, Fusaro M, et al. Short- and long-term outcomes with drug-eluting and bare-metal coronary stents: a mixed-treatment comparison analysis of 117 762 patient-years of follow-up from randomized trials. Circulation. 2012;125:2873–2891.
   PubMed Web of Science ®Google Scholar
• Alfonso F, Scheller B. State of the art: balloon catheter technologies – drug-coated balloon. EuroIntervention. 2017;13:680–695.
   PubMed Web of Science ®Google Scholar
• Cortese B, Piraino D, Buccheri D, et al. Treatment of bifurcation lesions with drug-coated balloons: A review of currently available scientific data. Int J Cardiol. 2016;220:589–594.
   PubMed Web of Science ®Google Scholar
• Schulz A, Hauschild T, Kleber FX. Treatment of coronary de novo bifurcation lesions with DCB only strategy. Clin Res Cardiol. 2014;103:451–456.
   PubMed Web of Science ®Google Scholar
• Moreno R, Fernández C, Alfonso F, et al. Coronary stenting versus balloon angioplasty in small vessels: a meta-analysis from 11 randomized studies. J Am Coll Cardiol. 2004;43:1964–1972.
   PubMed Web of Science ®Google Scholar
• Siontis GCM, Piccolo R, Praz F, et al. Percutaneous coronary interventions for the treatment of stenoses in small coronary arteries: a network meta-analysis. JACC Cardiovasc Interv. 2016;9:1324–1334.
   PubMed Web of Science ®Google Scholar
• Scheller B, Hehrlein C, Bocksch W, et al. Treatment of coronary in-stent restenosis with a paclitaxel-coated balloon catheter. N Engl J Med. 2006;355:2113–2124.
   PubMed Web of Science ®Google Scholar
• Buccheri D, Lombardo RM, Cortese B. Drug-coated balloons for coronary artery disease: current concepts and controversies. Future Cardiol. 2019;15:437–454.
   PubMed Web of Science ®Google Scholar
• Nestelberger T, Jeger R. Drug-coated balloons for small coronary vessel interventions: a literature review. Interv Cardiol Rev. 2019;14:131–136.
   PubMedGoogle Scholar
• Byrne RA, Neumann F-J, Mehilli J, et al. ISAR-DESIRE 3 investigators, Paclitaxel-eluting balloons, paclitaxel-eluting stents, and balloon angioplasty in patients with restenosis after implantation of a drug-eluting stent (ISAR-DESIRE 3): a randomised, open-label trial. Lancet. 2013;381:461–467.
   PubMed Web of Science ®Google Scholar
• 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 o. Eur Heart J. 2014;35:2541–2619.
   PubMed Web of Science ®Google Scholar
• Jeger RV, Farah A, Ohlow M-A, et al. BASKET-SMALL 2 investigators, drug-coated balloons for small coronary artery disease (BASKET-SMALL 2): an open-label randomised non-inferiority trial. Lancet. 2018;392:849–856.
   PubMed Web of Science ®Google Scholar
• Rissanen TT, Uskela S, Eränen J, et al. drug-coated balloon for treatment of de-novo coronary artery lesions in patients with high bleeding risk (DEBUT): a single-blind, randomised, non-inferiority trial. Lancet. 2019;394:230–239.
   PubMed Web of Science ®Google Scholar
• Dorros G, Cowley MJ, Simpson J, et al. Percutaneous transluminal coronary angioplasty: report of complications from the national heart, lung, and blood institute PTCA registry. Circulation. 1983;67:723–730.
   PubMed Web of Science ®Google Scholar
• Stefanini GG, Holmes DR. Drug-eluting coronary-artery stents. N Engl J Med. 2013;368:254–265.
   PubMed Web of Science ®Google Scholar
• Kalra A, Rehman H, Khera S, et al. New-generation coronary stents: current data and future directions. Curr Atheroscler Rep. 2017;19:14.
   PubMed Web of Science ®Google Scholar
• Kleber FX, Rittger H, Bonaventura K, et al. Drug-coated balloons for treatment of coronary artery disease: updated recommendations from a consensus group. Clin Res Cardiol. 2013;102:785–797.
   PubMed Web of Science ®Google Scholar
• Cheng Y, Leon MB, Granada JF. An update on the clinical use of drug-coated balloons in percutaneous coronary interventions. Expert Opin Drug Deliv. 2016;13:859–872.
   PubMed Web of Science ®Google Scholar
• Picard F, Doucet S, Asgar AW. Contemporary use of drug-coated balloons in coronary artery disease: where are we now? Arch Cardiovasc Dis. 2017;110:259–272.
   PubMed Web of Science ®Google Scholar
• Venetsanos D, Lawesson SS, Panayi G, et al. Long-term efficacy of drug coated balloons compared with new generation drug-eluting stents for the treatment of de novo coronary artery lesions. Catheter Cardiovasc Interv. 2018;92:E317–E326.
   PubMed Web of Science ®Google Scholar
• Habib A, Finn AV. Endothelialization of drug eluting stents and its impact on dual anti-platelet therapy duration. Pharmacol Res. 2015;93:22–27.
   PubMed Web of Science ®Google Scholar
• Jeger RV, Pfisterer M, Vogt DR, et al. Competing risks of major bleeding and thrombotic events with prasugrel-based dual antiplatelet therapy after stent implantation - An observational analysis from BASKET-PROVE II. PLoS One. 2019;14:e0210821.
   PubMed Web of Science ®Google Scholar
• Scheller B, Speck U, Abramjuk C, et al. Paclitaxel balloon coating, a novel method for prevention and therapy of restenosis. Circulation. 2004;110:810–814.
   PubMed Web of Science ®Google Scholar
• Tepe G, Zeller T, Albrecht T, et al. Local delivery of paclitaxel to inhibit restenosis during angioplasty of the leg. N Engl J Med. 2008;358:689–699.
   PubMed Web of Science ®Google Scholar
• Granada JF, Milewski K, Zhao H, et al. Vascular response to zotarolimus-coated balloons in injured superficial femoral arteries of the familial hypercholesterolemic swine. Circ Cardiovasc Interv. 2011;4:447–455.
   PubMed Web of Science ®Google Scholar
• Lemos PA, Farooq V, Takimura CK, et al. 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;9:148–156.
   PubMed Web of Science ®Google Scholar
• Ali RM, Abdul Kader MASK, Wan Ahmad WA, et al. Treatment of coronary drug-eluting stent restenosis by a sirolimus- or paclitaxel-coated balloon. JACC Cardiovasc Interv. 2019;12:558–566.
   PubMed Web of Science ®Google Scholar
• Unverdorben M, Vallbracht C, Cremers B, et al. Paclitaxel-coated balloon catheter versus paclitaxel-coated stent for the treatment of coronary in-stent restenosis: the three-year results of the PEPCAD II ISR study. EuroIntervention. 2015;11:926–934.
   PubMed Web of Science ®Google Scholar
• Cortese B, Micheli A, Picchi A, et al. Paclitaxel-coated balloon versus drug-eluting stent during PCI of small coronary vessels, a prospective randomised clinical trial. The PICCOLETO study. Heart. 2010;96:1291–1296.
   PubMed Web of Science ®Google Scholar
• Byrne RA, Joner M, Kastrati A. Stent thrombosis and restenosis: what have we learned and where are we going? The andreas grüntzig lecture ESC 2014. Eur Heart J. 2015;36:3320–3331.
   PubMed Web of Science ®Google Scholar
• Iqbal J, Serruys PW, Silber S, et al. Comparison of zotarolimus- and everolimus-eluting coronary stents: final 5-year report of the RESOLUTE all-comers trial. Circ Cardiovasc Interv. 2015;8:e002230.
   PubMed Web of Science ®Google Scholar
• Buccheri D, Piraino D, Andolina G, et al. Understanding and managing in-stent restenosis: a review of clinical data, from pathogenesis to treatment. J Thorac Dis. 2016;8:E1150–E1162.
   PubMed Web of Science ®Google Scholar
• Rittger H, Brachmann J, Sinha A-M, et al. A randomized, multicenter, single-blinded trial comparing paclitaxel-coated balloon angioplasty with plain balloon angioplasty in drug-eluting stent restenosis: the PEPCAD-DES study. J Am Coll Cardiol. 2012;59:1377–1382.
   PubMed Web of Science ®Google Scholar
• Rittger H, Waliszewski M, Brachmann J, et al. Long-term outcomes after treatment with a paclitaxel-coated balloon versus balloon angioplasty. JACC Cardiovasc Interv. 2015;8:1695–1700.
   PubMed Web of Science ®Google Scholar
• Unverdorben M, Vallbracht C, Cremers B, et al. Paclitaxel-coated balloon catheter versus paclitaxel-coated stent for the treatment of coronary in-stent restenosis. Circulation. 2009;119:2986–2994.
   PubMed Web of Science ®Google Scholar
• Alfonso F, Pérez-Vizcayno MJ, Cárdenas A, et al. A randomized comparison of drug-eluting balloon versus everolimus-eluting stent in patients with bare-metal stent-in-stent restenosis: the RIBS V clinical trial (restenosis intra-stent of bare metal stents: paclitaxel-eluting balloon vs. everolimus-eluting. J Am Coll Cardiol. 2014;63:1378–1386.
   PubMed Web of Science ®Google Scholar
• Alfonso F, Pérez-Vizcayno MJ, García Del Blanco B, et al. Long-term results of everolimus-eluting stents versus drug-eluting balloons in patients with bare-metal in-stent restenosis. JACC Cardiovasc Interv. 2016;9:1246–1255.
   PubMed Web of Science ®Google Scholar
• Xu B, Gao R, Wang J, et al. A prospective, multicenter, randomized trial of paclitaxel-coated balloon versus paclitaxel-eluting stent for the treatment of drug-eluting stent in-stent restenosis: results from the PEPCAD China ISR trial. JACC Cardiovasc Interv. 2014;7:204–211.
   PubMed Web of Science ®Google Scholar
• Xu B, Qian J, Ge J, et al. Two-year results and subgroup analyses of the PEPCAD China in-stent restenosis trial: A prospective, multicenter, randomized trial for the treatment of drug-eluting stent in-stent restenosis. Catheter Cardiovasc Interv. 2016;87:624–629.
   PubMed Web of Science ®Google Scholar
• Alfonso F, Pérez-Vizcayno MJ, Cárdenas A, et al. A prospective randomized trial of drug-eluting balloons versus everolimus-eluting stents in patients with in-stent restenosis of drug-eluting stents: the RIBS IV randomized clinical trial. J Am Coll Cardiol. 2015;66:23–33.
   PubMed Web of Science ®Google Scholar
• Cortese B. The PICCOLETO study and beyond. EuroIntervention. 2011;7(Suppl K):K53–6.
   PubMedGoogle Scholar
• Scheller B, Fontaine T, Mangner N, et al. A novel drug-coated scoring balloon for the treatment of coronary in-stent restenosis: results from the multi-center randomized controlled PATENT-C first in human trial. Catheter Cardiovasc Interv. 2016;88:51–59.
   PubMed Web of Science ®Google Scholar
• Siontis GCM, Stefanini GG, Mavridis D, et al. Percutaneous coronary interventional strategies for treatment of in-stent restenosis: a network meta-analysis. Lancet. 2015;386:655–664.
   PubMed Web of Science ®Google Scholar
• Giacoppo D, Alfonso F, Xu B, et al. Paclitaxel-coated balloon angioplasty vs. drug-eluting stenting for the treatment of coronary in-stent restenosis: a comprehensive, collaborative, individual patient data meta-analysis of 10 randomized clinical trials (DAEDALUS study). Eur Heart J. 2019. DOI:10.1093/eurheartj/ehz594
   Google Scholar
• Bajraktari G, Jashari H, Ibrahimi P, et al. Comparison of drug-eluting balloon versus drug-eluting stent treatment of drug-eluting stent in-stent restenosis: A meta-analysis of available evidence. Int J Cardiol. 2016;218:126–135.
   PubMed Web of Science ®Google Scholar
• Her A-Y, Shin E-S, Bang LH, et al. Drug-coated balloon treatment in coronary artery disease: recommendations from an Asia-Pacific Consensus Group. Cardiol J. 2013. DOI:10.5603/CJ.a2019.0093
   Google Scholar
• Kufner S, Joner M, Schneider S, et al. Neointimal modification with scoring balloon and efficacy of drug-coated balloon therapy in patients with restenosis in drug-eluting coronary stents: a randomized controlled trial. JACC Cardiovasc Interv. 2017;10:1332–1340.
   PubMed Web of Science ®Google Scholar
• Mohiaddin H, Wong TDFK, Burke-Gaffney A, et al. Drug-coated balloon-only percutaneous coronary intervention for the treatment of de novo coronary artery disease: a systematic review. J Invasive CardiolCardiol Ther. 2018;7:127–149.
   Google Scholar
• Biondi-Zoccai G, Moretti C, Abbate A, et al. Percutaneous coronary intervention for small vessel coronary artery disease. Cardiovasc Revasc Med. n.d.;11:189–198.
   PubMedGoogle Scholar
• Biondi-Zoccai GGL, Sangiorgi GM, Antoniucci D, et al. Taxus in real-life usage evaluation study, testing prospectively the effectiveness and safety of paclitaxel-eluting stents in over 1000 very high-risk patients: design, baseline characteristics, procedural data and in-hospital outcomes of the multicenter Taxus in Real-life Usage Evaluation (TRUE). Int J Cardiol. 2007;117:349–354.
   PubMed Web of Science ®Google Scholar
• Briguori C, Tobis J, Nishida T, et al. Discrepancy between angiography and intravascular ultrasound when analysing small coronary arteries. Eur Heart J. 2002;23:247–254.
   PubMed Web of Science ®Google Scholar
• Akiyama T, Moussa I, Reimers B, et al. Angiographic and clinical outcome following coronary stenting of small vessels: a comparison with coronary stenting of large vessels. J Am Coll Cardiol. 1998;32:1610–1618.
   PubMed Web of Science ®Google Scholar
• Biondi-Zoccai GGL, Sangiorgi GM, Chieffo A, et al. Validation of predictors of intraprocedural stent thrombosis in the drug-eluting stent era. Am J Cardiol. 2005;95:1466–1468.
   PubMed Web of Science ®Google Scholar
• Mauri L, Orav EJ, Kuntz RE. Late loss in lumen diameter and binary restenosis for drug-eluting stent comparison. Circulation. 2005;111:3435–3442.
   PubMed Web of Science ®Google Scholar
• Ellis SG, Popma JJ, Lasala JM, et al. Relationship between angiographic late loss and target lesion revascularization after coronary stent implantation: analysis from the TAXUS-IV trial. J Am Coll Cardiol. 2005;45:1193–1200.
   PubMed Web of Science ®Google Scholar
• Sinaga DA, Ho HH, Watson TJ, et al. Drug-coated balloons: A safe and effective alternative to drug-eluting stents in small vessel coronary artery disease. J Interv Cardiol. 2016;29:454–460.
   PubMed Web of Science ®Google Scholar
• Sim HW, Ananthakrishna R, Chan SP, et al. Treatment of very small de novo coronary artery disease with 2.0 mm drug-coated balloons showed 1-year clinical outcome comparable with 2.0 mm drug-eluting stents. J Invasive Cardiol. 2018;30:256–261.
   PubMed Web of Science ®Google Scholar
• Latib A, Colombo A, Castriota F, et al. A randomized multicenter study comparing a paclitaxel drug-eluting balloon with a paclitaxel-eluting stent in small coronary vessels: the BELLO (Balloon Elution and Late Loss Optimization) study. J Am Coll Cardiol. 2012;60:2473–2480.
   PubMed Web of Science ®Google Scholar
• Latib A, Ruparelia N, Menozzi A, et al. 3-year follow-up of the Balloon Elution and Late Loss Optimization Study (BELLO). JACC Cardiovasc Interv. 2015;8:1132–1134.
   PubMed Web of Science ®Google Scholar
• Tang Y, Qiao S, Su X, et al. Drug-coated balloon versus drug-eluting stent for small-vessel disease: the RESTORE SVD china randomized trial. JACC Cardiovasc Interv. 2018;11:2381–2392.
   PubMed Web of Science ®Google Scholar
• Megaly M, Rofael M, Saad M, et al. Outcomes with drug-coated balloons in small-vessel coronary artery disease. Catheter Cardiovasc Interv. 2019;93:E277–E286.
   PubMed Web of Science ®Google Scholar
• Loh JP, Waksman R. Paclitaxel drug-coated balloons: a review of current status and emerging applications in native coronary artery de novo lesions. JACC Cardiovasc Interv. 2012;5:1001–1012.
   PubMed Web of Science ®Google Scholar
• Shin E-S, Ann SH, Balbir Singh G, et al. Fractional flow reserve-guided paclitaxel-coated balloon treatment for de novo coronary lesions. Catheter Cardiovasc Interv. 2016;88:193–200.
   PubMed Web of Science ®Google Scholar
• Ann SH, Balbir Singh G, Lim KH, et al. Anatomical and physiological changes after paclitaxel-coated balloon for atherosclerotic de novo coronary lesions: serial IVUS-VH and FFR study. PLoS One. 2016;11:e0147057.
   PubMed Web of Science ®Google Scholar
• Poerner TC, Duderstadt C, Goebel B, et al. Fractional flow reserve-guided coronary angioplasty using paclitaxel-coated balloons without stent implantation: feasibility, safety and 6-month results by angiography and optical coherence tomography. Clin Res Cardiol. 2017;106:18–27.
   PubMed Web of Science ®Google Scholar
• Yu X, Ji F, Xu F, et al. Treatment of large de novo coronary lesions with paclitaxel-coated balloon only: results from a Chinese institute. Clin Res Cardiol. 2019;108:234–243.
   PubMed Web of Science ®Google Scholar
• Kleber FX, Schulz A, Waliszewski M, et al. Local paclitaxel induces late lumen enlargement in coronary arteries after balloon angioplasty. Clin Res Cardiol. 2015;104:217–225.
   PubMed Web of Science ®Google Scholar
• Cortese B, Silva Orrego P, Agostoni P, et al. Effect of drug-coated balloons in native coronary artery disease left with a dissection. JACC Cardiovasc Interv. 2015;8:2003–2009.
   PubMed Web of Science ®Google Scholar
• Stella PR, Belkacemi A, Dubois C, et al. A multicenter randomized comparison of drug-eluting balloon plus bare-metal stent versus bare-metal stent versus drug-eluting stent in bifurcation lesions treated with a single-stenting technique: six-month angiographic and 12-month clinical results of the drug-eluting balloon in bifurcations trial. Catheter Cardiovasc Interv. 2012;80:1138–1146.
   PubMed Web of Science ®Google Scholar
• López Mínguez JR, Nogales Asensio JM, Doncel Vecino LJ, et al. A prospective randomised study of the paclitaxel-coated balloon catheter in bifurcated coronary lesions (BABILON trial): 24-month clinical and angiographic results. EuroIntervention. 2014;10:50–57.
   PubMed Web of Science ®Google Scholar
• Naganuma T, Latib A, Costopoulos C, et al. Drug-eluting balloon versus second-generation drug-eluting stent for the treatment of restenotic lesions involving coronary bifurcations. EuroIntervention. 2016;11:989–995.
   PubMed Web of Science ®Google Scholar
• Kleber FX, Rittger H, Ludwig J, et al. Drug eluting balloons as stand alone procedure for coronary bifurcational lesions: results of the randomized multicenter PEPCAD-BIF trial. Clin Res Cardiol. 2016;105:613–621.
   PubMed Web of Science ®Google Scholar
• Her A-Y, Ann SH, Singh GB, et al. Serial morphological changes of side-branch ostium after paclitaxel-coated balloon treatment of de novo coronary lesions of main vessels. Yonsei Med J. 2016;57:606–613.
   PubMed Web of Science ®Google Scholar
• 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. 2019;140:1145–1155.
   PubMed Web of Science ®Google Scholar
• Ouriel K, Adelman MA, Rosenfield K, et al. Safety of paclitaxel-coated balloon angioplasty for femoropopliteal peripheral artery disease. JACC Cardiovasc Interv. 2019;12:2515–2524.
   PubMed Web of Science ®Google Scholar
• Katsanos K, Spiliopoulos S, Kitrou P, et al. 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. 2018;7:e011245.
   PubMed Web of Science ®Google Scholar
• Fanelli F, Cortese B, Zeller T. Use of paclitaxel-eluting technologies in the femoropopliteal segment under scrutiny over possible link to late all-cause mortality: time to panic or an opportunity to resurge? J Endovasc Ther. 2019;26:41–43.
   PubMed Web of Science ®Google Scholar
• Granada JF, Tellez A, Baumbach WR, et al. In vivo delivery and long-term tissue retention of nano-encapsulated sirolimus using a novel porous balloon angioplasty system. EuroIntervention. 2016;12:740–747.
   PubMed Web of Science ®Google Scholar
• Cortese B, Buccheri D, Piraino D, et al. Drug-coated balloon without stent implantation for chronic total occlusion of coronary arteries: description of a new strategy with an optical coherence tomography assistance. Int J Cardiol. 2015;191:75–76.
   PubMed Web of Science ®Google Scholar