Drug-eluting balloons in coronary interventions: the quiet revolution?

References

• Byrne RA, Joner M, Alfonso F, et al. Drug-coated balloon therapy in coronary and peripheral artery disease. Nat Rev Cardiol. 2014 Jan;11(1):13–23.
   PubMed Web of Science ®Google Scholar
• Loh JP, Barbash IM, Waksman R. The current status of drug-coated balloons in percutaneous coronary and peripheral interventions. EuroIntervention. 2013 Dec;9(8):979–988.
   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 Jun;13(6):859–872.
   PubMed Web of Science ®Google Scholar
• Cortese B, Granada JF, Scheller B, et al. Drug-coated balloon treatment for lower extremity vascular disease intervention: an international positioning document. Eur Heart J. 2016 Apr 7; 37(14):1096–1103.
   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 Jun 28;220:589–594.
   PubMed Web of Science ®Google Scholar
• Alfonso F, Fernandez C. Second-generation drug-eluting stents. Moving the field forward. J Am Coll Cardiol. 2011 Jun 28;58(1):26–29.
   PubMed Web of Science ®Google Scholar
• Alfonso F. New drug-eluting stents: polymer-free, biodegradable polymers or bioabsorbable scaffolds? Rev Esp Cardiol (Engl Ed). 2013 Jun;66(6):423–426.
   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 Nov 16; 355(20):2113–2124.
   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 Aug 17;110(7):810–814.
   PubMed Web of Science ®Google Scholar
• Scheller B, Speck U, Schmitt A, et al. Addition of paclitaxel to contrast media prevents restenosis after coronary stent implantation. J Am Coll Cardiol. 2003 Oct 15;42(8):1415–1420.
   PubMed Web of Science ®Google Scholar
• Gray WA, Granada JF. Drug-coated balloons for the prevention of vascular restenosis. Circulation. 2010 Jun 22;121(24):2672–2680.
   PubMed Web of Science ®Google Scholar
• Cremers B, Kelsch B, Clever YP, et al. Inhibition of neointimal proliferation after bare metal stent implantation with low-pressure drug delivery using a paclitaxel-coated balloon in porcine coronary arteries. Clin Res Cardiol. 2012 May;101(5):385–391.
   PubMed Web of Science ®Google Scholar
• Joner M, Byrne RA, Lapointe J-M, et al. Comparative assessment of drug-eluting balloons in an advanced porcine model of coronary restenosis. Thromb Haemost. 2011;105:864–872.
   PubMed Web of Science ®Google Scholar
• Milewski K, Afari ME, Tellez A, et al. Evaluation of efficacy and dose response of different paclitaxel-coated balloon formulations in a novel swine model of iliofemoral in-stent restenosis. JACC Cardiovasc Interv. 2012 Oct;5(10):1081–1088.
   PubMed Web of Science ®Google Scholar
• Cassese S, Byrne RA, Ndrepepa G, et al. Everolimus-eluting bioresorbable vascular scaffolds versus everolimus-eluting metallic stents: a meta-analysis of randomised controlled trials. Lancet. 2016 Feb 6;387(10018):537–544.
   PubMed Web of Science ®Google Scholar
• Yazdani SK, Pacheco E, Nakano M, et al. Vascular, downstream, and pharmacokinetic responses to treatment with a low dose drug-coated balloon in a swine femoral artery model. Catheter Cardiovasc Interv. 2014 Jan 1;83(1):132–140.
   PubMed Web of Science ®Google Scholar
• Scheller B, Clever YP, Kelsch B, et al. Long-term follow-up after treatment of coronary in-stent restenosis with a paclitaxel-coated balloon catheter. JACC Cardiovasc Interv. 2012 Mar;5(3):323–330.
   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: insights from the PEPCAD-DES study (treatment of drug-eluting stent [DES] in-stent restenosis with SeQuent Please paclitaxel-coated percutaneous transluminal coronary angioplasty [PTCA] catheter). JACC Cardiovasc Interv. 2015 Nov;8(13):1695–1700.
   PubMed Web of Science ®Google Scholar
• Habara S, Mitsudo K, Kadota K, et al. Effectiveness of paclitaxel-eluting balloon catheter in patients with sirolimus-eluting stent restenosis. JACC Cardiovasc Interv. 2011 Feb;4(2):149–154.
   PubMed Web of Science ®Google Scholar
• Habara S, Iwabuchi M, Inoue N, et al. A multicenter randomized comparison of paclitaxel-coated balloon catheter with conventional balloon angioplasty in patients with bare-metal stent restenosis and drug-eluting stent restenosis. Am Heart J. 2013 Sep;166(3):527–533.
   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 Jun 16;119(23):2986–2994.
   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 Feb;7(2):204–211.
   PubMed Web of Science ®Google Scholar
• Byrne RA, Neumann F-J, Mehilli J, et al. 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 Feb 9; 381(9865):461–467.
   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 stent). J Am Coll Cardiol. 2014 Apr 15;63(14):1378–1386.
   PubMed Web of Science ®Google Scholar
• Pleva L, Kukla P, Kusnierova P, et al. Comparison of the efficacy of paclitaxel-eluting balloon catheters and everolimus-eluting stents in the treatment of coronary in-stent restenosis: the treatment of in-stent restenosis study. Circ Cardiovasc Interv. 2016 Apr;9(4):e003316. DOI:10.1161/CIRCINTERVENTIONS.115.003316
   PubMed Web of Science ®Google Scholar
• Adriaenssens T, Dens J, Ughi G, et al. Optical coherence tomography study of healing characteristics of paclitaxel-eluting balloons vs. everolimus-eluting stents for in-stent restenosis: the SEDUCE (Safety and Efficacy of a Drug elUting balloon in Coronary artery rEstenosis) randomised clinical trial. EuroIntervention. 2014 Aug;10(4):439–448.
   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 Jul 7;66(1):23–33.
   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 Aug 15; 386(9994):655–664.
   PubMed Web of Science ®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 Sep 1;218:126–135.
   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 of the European Association of Percutaneous Cardiovascular Interventions (EAPCI). Eur Heart J. 2014 Oct 1;35(37):2541–2619.
   PubMed Web of Science ®Google Scholar
• Alfonso F, Byrne RA, Rivero F, et al. Current treatment of in-stent restenosis. J Am Coll Cardiol. 2014 Jun 24; 63(24):2659–2673.
   PubMed Web of Science ®Google Scholar
• Alfonso F, Pérez-Vizcayno MJ, Gómez-Recio M, et al. Implications of the “watermelon seeding” phenomenon during coronary interventions for in-stent restenosis. Catheter Cardiovasc Interv. 2005 Dec;66(4):521–527.
   PubMed Web of Science ®Google Scholar
• Byrne R. ISAR-DESIRE 4: scoring balloon predilation effective at 1 year in patients with DES restenosis. 2015. Available from: http://www.tctmd.com/show.aspx?id=132441
   Google Scholar
• Sandoval J, Medina M, Alfonso F. Neointimal tissue healing patterns after paclitaxel-eluting balloon treatment of in-stent restenosis: optical coherence tomography and intravascular ultrasound insights. J Invasive Cardiol. 2012 Oct;24(10):E215–E218.
   PubMed Web of Science ®Google Scholar
• Alfonso F, Jimenez-Quevedo P, Gonzalo N, et al. Neoatherosclerosis after paclitaxel-coated balloon angioplasty for in-stent restenosis. Circulation. 2014 Feb 25;129(8):923–925.
   PubMed Web of Science ®Google Scholar
• Gutiérrez-Chico JL, Van Geuns RJ, Koch KT, et al. Paclitaxel-coated balloon in combination with bare metal stent for treatment of de novo coronary lesions: an optical coherence tomography first-in-human randomised trial, balloon first vs. stent first. EuroIntervention. 2011 Oct 30;7(6):711–722.
   PubMed Web of Science ®Google Scholar
• Wöhrle J, Birkemeyer R, Markovic S, et al. Prospective randomised trial evaluating a paclitaxel-coated balloon in patients treated with endothelial progenitor cell capturing stents for de novo coronary artery disease. Heart. 2011 Aug;97(16):1338–1342.
   PubMed Web of Science ®Google Scholar
• Fischer D, Scheller B, Schäfer A, et al. Paclitaxcel-coated balloon plus bare metal stent vs. sirolimus-eluting stent in de novo lesions: an IVUS study. EuroIntervention. 2012 Aug;8(4):450–455.
   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 Mar;104(3):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 Dec 28; 8(15):2003–2009.
   PubMed Web of Science ®Google Scholar
• Alfonso F, García-Guimaraes M. Optimal coronary interventions in small vessels: is size all that matters? JACC Cardiovasc Interv. 2016 Jul 11;9(13):1335–1337.
   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 Aug;96(16):1291–1296.
   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 Dec 18; 60(24):2473–2480.
   PubMed Web of Science ®Google Scholar
• Alfonso F, Cárdenas A, Cuevas C, et al. Paclitaxel-eluting balloons for small-vessel disease. J Am Coll Cardiol. 2013 Apr 30;61(17):1831–1832.
   PubMed Web of Science ®Google Scholar
• Alfonso F, Pan M. Do we know how to treat bifurcation coronary lesions? Rev Esp Cardiol (Engl Ed). 2014 Oct;67(10):790–793.
   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 Dec 1;80(7):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 May;10(1):50–57.
   PubMed Web of Science ®Google Scholar
• Belkacemi A, Agostoni P, Nathoe HM, et al. First results of the DEB-AMI (drug eluting balloon in acute ST-segment elevation myocardial infarction) trial: a multicenter randomized comparison of drug-eluting balloon plus bare-metal stent versus bare-metal stent versus drug-eluting stent in primary percutaneous coronary intervention with 6-month angiographic, intravascular, functional, and clinical outcomes. J Am Coll Cardiol. 2012 Jun 19;59(25):2327–2337.
   PubMed Web of Science ®Google Scholar
• Garcia-Touchard A. Long-term vascular healing response of paclitaxel-eluting balloons after bare-metal stent versus bare-metal stent only implantation in STEMI: the PEBSI randomised trial OCT substudy. Hot line – DES trials and registries. Euro PCR. 2015. Available from: http://www.pcronline.com/EuroPCR/EuroPCR-2015/Hot-line-DES-trials-and-registries
   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 May 20;9(1):148–156.
   PubMed Web of Science ®Google Scholar
• Cremers B, Toner JL, Schwartz LB, et al. Inhibition of neointimal hyperplasia with a novel zotarolimus coated balloon catheter. Clin Res Cardiol. 2012 Jun;101(6):469–476.
   PubMed Web of Science ®Google Scholar
• Clever YP, Peters D, Calisse J, et al. Novel sirolimus-coated balloon catheter: in vivo evaluation in a porcine coronary model. Circ Cardiovasc Interv. 2016 Apr;9(4):e003543.
   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 Aug 20;12(6):740–747.
   PubMed Web of Science ®Google Scholar