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Drug-Coated Balloons: Lessons from the Real World

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Drug-Coated Balloons

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Abstract

Drug-coated balloons (DCBs) offer a non-stent-based antiproliferative drug delivery system to treat coronary lesions. Over the years they were validated in several settings and widely used both in clinical trials and in daily practice. The aim of this chapter is to evaluate the clinical performance and rationale of DCB use in “real-world” scenarios in coronary artery disease.

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References

  1. Basavarajaiah S, Latib A, Shannon J, et al. Drug-eluting balloon in the treatment of in-stent restenosis and diffuse coronary artery disease: real-world experience from our registry. J Interv Cardiol. 2014;27:348–55.

    Article  Google Scholar 

  2. 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;355:2113–24.

    Article  CAS  Google Scholar 

  3. 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;60:2473–80.

    Article  CAS  Google Scholar 

  4. 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;8:1132–4.

    Article  Google Scholar 

  5. 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;29:454–60.

    Article  Google Scholar 

  6. Tanaka A, Latib A, Jabbour RJ, et al. Impact of angiographic result after Predilatation on outcome after drug-coated balloon treatment of in-stent coronary restenosis. Am J Cardiol. 2016;118:1460–5.

    Article  Google Scholar 

  7. 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(4):259–72.

    Article  Google Scholar 

  8. Cowley MJ, Dorros G, Kelsey SF, et al. Acute coronary events associated with percutaneous transluminal coronary angioplasty. Am J Cardiol. 1984;53:12C–6C.

    Article  CAS  Google Scholar 

  9. Cappelletti A, Margonato A, Rosano G, et al. Short- and long-term evolution of unstented nonocclusive coronary dissection after coronary angioplasty. J Am Coll Cardiol. 1999;34:1484–8.

    Article  CAS  Google Scholar 

  10. Tepe G, Zeller T, Schnorr B, et al. High-grade, non-flow-limiting dissections do not negatively impact long-term outcome after paclitaxel-coated balloon angioplasty: an additional analysis from the THUNDER study. J Endovasc Ther. 2013;20:792–800.

    Article  Google Scholar 

  11. Chan YH, Agostoni P. SEDUCEd by optical coherence tomography in drug-eluting balloon assessment. EuroIntervention. 2014;10:415–7.

    Article  Google Scholar 

  12. Agostoni P, Belkacemi A, Voskuil M, et al. Serial morphological and functional assessment of drug- eluting balloon for in-stent restenotic lesions mechanisms of action evaluated with angiography, optical coherence tomography, and fractional flow reserve. JACC Cardiovasc Interv. 2013;6:569–76.

    Article  Google Scholar 

  13. 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(15):2003–9.

    Article  Google Scholar 

  14. Glagov S, Weisenberg E, Zarins CK, et al. Compensatory enlargement of human atherosclerotic coronary arteries. N Engl J Med. 1987;316:1371–5.

    Article  CAS  Google Scholar 

  15. Pires NM, Eefting D, de Vries MR, et al. Sirolimus and paclitaxel provoke different vascular pathological responses after local delivery in a murine model for restenosis on underlying atherosclerotic arteries. Heart. 2007;93:922–7.

    Article  CAS  Google Scholar 

  16. Vogt F, Stein A, Rettemeier G, et al. Long-term assessment of a novel biodegradable paclitaxel-eluting coronary polylactide stent. Eur Heart J. 2004;25:1330–40.

    Article  CAS  Google Scholar 

  17. Speck U, Cremers B, Kelsch B, et al. Do pharmacokinetics explain persistent restenosis inhibition by a single dose of paclitaxel? Circ Cardiovasc Interv. 2012;5:392–400.

    Article  CAS  Google Scholar 

  18. Axel DI, Kunert W, Goggelmann C, et al. Paclitaxel inhibits arterial smooth muscle cell proliferation and migration in vitro and in vivo using local drug delivery. Circulation. 1997;96:636–45.

    Article  CAS  Google Scholar 

  19. 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(3):217–25.

    Article  CAS  Google Scholar 

  20. Kakuta T, Currier JW, Haudenschild CC, et al. Differences in compensatory vessel enlargement, not intimal formation, account for restenosis after angioplasty in the hypercholesterolemic rabbit model. Circulation. 1994;89:2809–15.

    Article  CAS  Google Scholar 

  21. Godino C, Furuichi S, Latib A, et al. Clinical and angiographic follow-up of small vessel lesions treated with paclitaxel-eluting stents (from the TRUE registry). Am J Cardiol. 2008;102:1002–8.

    Article  CAS  Google Scholar 

  22. Mehilli J. Randomized trial of paclitaxel- and sirolimus-eluting stents in small coronary vessels. Eur Heart J. 2005;27:260–6.

    Article  Google Scholar 

  23. Herdeg C, Oberhoff M, Baumbach A, et al. Local paclitaxel delivery for the prevention of restenosis: biological effects and efficacy in vivo. J Am Coll Cardiol. 2000;35:1969–76.

    Article  CAS  Google Scholar 

  24. Scheller B. Paclitaxel balloon coating, a novel method for prevention and therapy of restenosis. Circulation. 2004;110:810–4.

    Article  CAS  Google Scholar 

  25. 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;96:1291–6.

    Article  Google Scholar 

  26. Fröhlich GM, Lansky AJ, Ko DT, et al. Drug eluting balloons for de novo coronary lesions—a systematic review and meta-analysis. BMC Med. 2013;11:123.

    Article  Google Scholar 

  27. Giannini F, Latib A, Ancona MB, et al. Propensity score matched comparative study between paclitaxel-coated balloon and Everolimus-eluting stents for the treatment of small coronary vessels. Catheter Cardiovasc Interv. 2017;90(3):380–6.

    Article  Google Scholar 

  28. Giannini F, Latib A, Jabbour RJ, et al. Comparison of paclitaxel drug-eluting balloon and paclitaxel-eluting stent in small coronary vessels in diabetic and nondiabetic patients—results from the BELLO (balloon elution and late loss optimization) trial. Cardiovasc Revasc Med. 2017;18(1):4–9.

    Article  Google Scholar 

  29. Basavarajaiah S, Latib A, Hasegawa T, et al. Assessment of efficacy and safety of combining “paclitaxel” eluting balloon and “limus” eluting stent in the same lesion. J Interv Cardiol. 2013;26(3):259–63.

    Article  Google Scholar 

  30. de Ribamar Costa J Jr, Mintz GS, Carlier SG, Fujii K, et al. Intra-vascular ultrasound assessment of drug-eluting stent expansion. Am Heart J. 2007;153:297–303.

    Article  Google Scholar 

  31. Moussa I, Moses J, Di Mario C, et al. Stenting after optimal lesion debulking (sold) registry. Angiographic and clinical outcome. Circulation. 1998;98:1604–9.

    Article  CAS  Google Scholar 

  32. Lee CW, Park DW, Lee BK, et al. Predictors of restenosis after placement of drug-eluting stents in one or more coronary arteries. Am J Cardiol. 2006;97:506–11.

    Article  CAS  Google Scholar 

  33. D’Ascenzo F, Bollati M, Clementi F, et al. Incidence and predictors of coronary stent thrombosis: evidence from an international collaborative meta-analysis including 30 studies, 221,066 patients, and 4276 thromboses. Int J Cardiol. 2013;167:575–84.

    Article  Google Scholar 

  34. Sharp AS, Latib A, Ielasi A, et al. Long-term follow-up on a large cohort of “full-metal jacket” percutaneous coronary intervention procedures. Circ Cardiovasc Interv. 2009;2:416–22.

    Article  Google Scholar 

  35. Costopoulos C, Latib A, Naganuma T, et al. The role of drug-eluting balloons alone or in combination with drug-eluting stents in the treatment of de novo diffuse coronary disease. JACC Cardiovasc Interv. 2013;6(11):1153–9.

    Article  Google Scholar 

  36. Colombo A, Latib A. Can long-term results following balloon angioplasty be the “crystal ball” to predict outcome following bioresorbable vascular scaffolds? J Am Heart Assoc. 2012;1:e005272.

    Article  Google Scholar 

  37. Tamburino C, Capranzano P, Gori T, et al. 1-year outcomes of everolimus-eluting bioresorbable scaffolds versus everolimus-eluting stents: a propensity-matched comparison of the GHOST-EU and XIENCE V USA registries. JACC Cardiovasc Interv. 2016;9:440–9.

    Article  Google Scholar 

  38. Tanaka A, Latib A, Kawamoto H, et al. Clinical outcomes of a real-world cohort following bioresorbable vascular scaffold implantation utilising an optimised implantation strategy. EuroIntervention. 2017;12:1730–7.

    Article  Google Scholar 

  39. Ormiston JA, Serruys PW, Regar E, et al. A bioabsorbable everolimus-eluting coronary stent system for patients with single de-novo coronary artery lesions (ABSORB): a prospective open-label trial. Lancet. 2008;371:899–907.

    Article  CAS  Google Scholar 

  40. Tanaka A, Jabbour RJ, Mitomo S, et al. Hybrid percutaneous coronary intervention with Bioresorbable vascular scaffolds in combination with drug-eluting stents or drug-coated balloons for complex coronary lesions. JACC Cardiovasc Interv. 2017;10:539–47.

    Article  Google Scholar 

  41. Kawamoto H, Jabbour RJ, Tanaka A, et al. Contained coronary rupture following bioresorbable scaffold implantation in a small vessel. Int J Cardiol. 2016;209:24–5.

    Article  Google Scholar 

  42. Jamshidi P, Nyffenegger T, Sabti Z, et al. A novel approach to treat in-stent restenosis: 6- and 12-month results using the everolimus-eluting bioresorbable vascular scaffold. EuroIntervention. 2016;11:1479–86.

    Article  Google Scholar 

  43. Ielasi A, Miyazaki T, Geraci S, et al. Hybrid strategy with a bioresorbable scaffold and a drug-coated balloon for diffuse coronary artery disease: the “no more metallic cages” multicentre pilot experience. EuroIntervention. 2016;11:e1589–95.

    Article  Google Scholar 

  44. Toyofuku M, Kimura T, Morimoto T, et al. Comparison of 5-year outcomes in patients with and without unprotected left main coronary artery disease after treatment with sirolimus-eluting stents: insights from the j-Cypher registry. JACC Cardiovasc Interv. 2013;6:654–63.

    Article  Google Scholar 

  45. Toyofuku M, Kimura T, Morimoto T, et al. Three-year outcomes after sirolimus-eluting stent implantation for unprotected left main coronary artery disease: insights from the j-Cypher registry. Circulation. 2009;120:1866–74.

    Article  Google Scholar 

  46. Palmerini T, Marzocchi A, Tamburino C, et al. Impact of bifurcation technique on 2-year clinical outcomes in 773 patients with distal unprotected left main coronary artery stenosis treated with drug-eluting stents. Circ Cardiovasc Interv. 2008;1:185–92.

    Article  Google Scholar 

  47. Takagi K, Naganuma T, Chieffo A, et al. Comparison between 1- and 2-stent strategies in unprotected distal left main disease: the Milan and New-Tokyo registry. Circ Cardiovasc Interv. 2016;9:e003359.

    Article  Google Scholar 

  48. Cortese B, Piraino D, Buccheri D, Alfonso F. Treatment of bifurcation lesions with drug-coated balloons: a review of currently available scientific data. Int J Cardiol. 2016;220:589–94.

    Article  Google Scholar 

  49. Piraino D, Cortese B, Buccheri D, Dendramis G, Andolina G. Healing after coronary artery dissection: the effect of a drug coated balloon angioplasty in a bifurcation lesion. A lesson from intravascular ultrasound analysis. Int J Cardiol. 2016;203:298–300.

    Article  Google Scholar 

  50. Jackson D, Tong D, Layland J. A review of the coronary applications of the drug coated balloon. Int J Cardiol. 2017;226:77–86.

    Article  Google Scholar 

  51. 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;80:1138–46.

    Article  Google Scholar 

  52. Alfonso F, Perez-Vizcayno MJ, Cardenas 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;63:1378–86.

    Article  CAS  Google Scholar 

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Author information

Authors and Affiliations

  1. Unit of Cardiovascular Interventions, IRCCS San Raffaele Scientific Institute, San Raffaele University Hospital, Milan, Italy

    Damiano Regazzoli, Marco Bruno Ancona, Pier Pasquale Leone & Azeem Latib

Authors
  1. Damiano Regazzoli
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  2. Marco Bruno Ancona
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  3. Pier Pasquale Leone
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  4. Azeem Latib
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Editors and Affiliations

  1. Cardiac Department, San Carlo Clinic, Milano, Italy

    Bernardo Cortese

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Regazzoli, D., Ancona, M.B., Leone, P.P., Latib, A. (2019). Drug-Coated Balloons: Lessons from the Real World. In: Cortese, B. (eds) Drug-Coated Balloons . Springer, Cham. https://doi.org/10.1007/978-3-319-92600-1_18

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  • DOI: https://doi.org/10.1007/978-3-319-92600-1_18

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  • Publisher Name: Springer, Cham

  • Print ISBN: 978-3-319-92599-8

  • Online ISBN: 978-3-319-92600-1

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