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Drug-coated balloons for treatment of coronary artery disease: updated recommendations from a consensus group

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Abstract

Aims

Drug-coated balloon catheters (DCB) are a new clinical treatment modality for coronary and peripheral artery disease. The goal of the consensus group is to develop recommendations for the clinical use of DCB based on randomized clinical trials and the best available clinical evidence. The present paper gives an update on the recommendations against the background of a variety of new data published since the first paper was presented.

Methods and results

The general concept of our recommendations for the coronary use of DCB includes the preparation of the lesion to facilitate drug delivery and to estimate the need for stent implantation, especially after relevant dissections. Lesion preparation includes conventional angioplasty. In more complex lesions, additional treatments and imaging or functional measurements are helpful. In case of no flow-limiting dissection and an acceptable but not stent-like primary result, DCB use without additional stent implantation may be considered. The proposed advantages of the DCB only concept over a direct stent approach include reduced restenosis rates in indications where DES show limited efficacy, the reduction of DAPT especially in patients with contraindications for prolonged DAPT, and the option of leaving no foreign object behind resulting in vascular restoration with potentially plaque regression instead of neo-atherosclerosis.

Conclusions

DCB allow for local drug delivery in endovascular therapy leaving no permanent implant behind.

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References

  1. Gruntzig A (1978) Transluminal dilatation of coronary-artery stenosis. Lancet 1:263

    Article  PubMed  CAS  Google Scholar 

  2. Sigwart U, Puel J, Mirkovitch V, Joffre F, Kappenberger L (1987) Intravascular stents to prevent occlusion and restenosis after transluminal angioplasty. N Engl J Med 316:701–706

    Article  PubMed  CAS  Google Scholar 

  3. Morice MC, Serruys PW, Sousa JE, Fajadet J, Ban Hayashi E, Perin M, Colombo A, Schuler G, Barragan P, Guagliumi G, Molnar F, Falotico R (2002) A randomized comparison of a sirolimus-eluting stent with a standard stent for coronary revascularization. N Engl J Med 346:1773–1780

    Article  PubMed  CAS  Google Scholar 

  4. Joner M, Finn AV, Farb A, Mont EK, Kolodgie FD, Ladich E, Kutys R, Skorija K, Gold HK, Virmani R (2006) Pathology of drug-eluting stents in humans: delayed healing and late thrombotic risk. J Am Coll Cardiol 48:193–202

    Article  PubMed  Google Scholar 

  5. Nakazawa G, Vorpahl M, Finn AV, Narula J, Virmani R (2009) One step forward and two steps back with drug-eluting-stents: from preventing restenosis to causing late thrombosis and nouveau atherosclerosis. JACC Cardiovasc Imaging 2:625–628

    Article  PubMed  Google Scholar 

  6. Scheller B, Speck U, Abramjuk C, Bernhardt U, Bohm M, Nickenig G (2004) Paclitaxel balloon coating, a novel method for prevention and therapy of restenosis. Circulation 110:810–814

    Article  PubMed  CAS  Google Scholar 

  7. Kleber FX, Scheller B, Serruys PW (2011) New technologies in percutaneous coronary interventions: Drug-coated balloons. EuroIntervention 7(Suppl K):K7

    Article  PubMed  Google Scholar 

  8. Scheller B (2011) Opportunities and limitations of drug-coated balloons in interventional therapies. Herz 36:232–240

    Article  PubMed  CAS  Google Scholar 

  9. Scheller B, Hehrlein C, Bocksch W, Rutsch W, Haghi D, Dietz U, Bohm M, Speck U (2006) Treatment of coronary in-stent restenosis with a paclitaxel-coated balloon catheter. N Engl J Med 355:2113–2124

    Article  PubMed  CAS  Google Scholar 

  10. Scheller B, Hehrlein C, Bocksch W, Rutsch W, Haghi D, Dietz U, Bohm M, Speck U (2008) Two year follow-up after treatment of coronary in-stent restenosis with a paclitaxel-coated balloon catheter. Clin Res Cardiol 97:773–781

    Article  PubMed  Google Scholar 

  11. Scheller B, Clever YP, Kelsch B, Hehrlein C, Bocksch W, Rutsch W, Haghi D, Dietz U, Speck U, Bohm M, Cremers B (2012) Long-term follow-up after treatment of coronary in-stent restenosis with a paclitaxel-coated balloon catheter. JACC Cardiovasc Interv 5:323–330

    Article  PubMed  Google Scholar 

  12. Unverdorben M, Vallbracht C, Cremers B, Heuer H, Hengstenberg C, Maikowski C, Werner GS, Antoni D, Kleber FX, Bocksch W, Leschke M, Ackermann H, Boxberger M, Speck U, Degenhardt R, Scheller B (2009) Paclitaxel-coated balloon catheter versus paclitaxel-coated stent for the treatment of coronary in-stent restenosis. Circulation 119:2986–2994

    Article  PubMed  CAS  Google Scholar 

  13. Unverdorben M, Kleber FX, Heuer H, Figulla HR, Vallbracht C, Leschke M, Cremers B, Hardt S, Buerke M, Ackermann H, Boxberger M, Degenhardt R, Scheller B (2010) Treatment of small coronary arteries with a paclitaxel-coated balloon catheter. Clin Res Cardiol 99:165–174

    Article  PubMed  CAS  Google Scholar 

  14. Mathey DG, Wendig I, Boxberger M, Bonaventura K, Kleber FX (2011) Treatment of bifurcation lesions with a drug-eluting balloon: the pepcad v (paclitaxel eluting ptca balloon in coronary artery disease) trial. EuroIntervention 7(Suppl K):K61–K65

    Article  PubMed  Google Scholar 

  15. Wohrle J, Birkemeyer R, Markovic S, Nguyen TV, Sinha A, Miljak T, Spiess J, Rottbauer W, Rittger H (2011) Prospective randomised trial evaluating a paclitaxel-coated balloon in patients treated with endothelial progenitor cell capturing stents for de novo coronary artery disease. Heart 97:1338–1342

    Article  PubMed  Google Scholar 

  16. Rosli R, Zambahari R et al (2011) Paclitaxel-eluting balloon angioplasty and cobalt-chromium stents versus conventional angioplasty and paclitaxel-eluting stents in the treatment of native coronary artery stenoses in patients with diabetes mellitus. EuroIntervention 7:K83–K91

    Article  Google Scholar 

  17. Habara S, Mitsudo K, Kadota K, Goto T, Fujii S, Yamamoto H, Katoh H, Oka N, Fuku Y, Hosogi S, Hirono A, Maruo T, Tanaka H, Shigemoto Y, Hasegawa D, Tasaka H, Kusunose M, Otsuru S, Okamoto Y, Saito N, Tsujimoto Y, Eguchi H, Miyake K, Yoshino M (2011) Effectiveness of paclitaxel-eluting balloon catheter in patients with sirolimus-eluting stent restenosis. JACC Cardiovasc Interv 4:149–154

    Article  PubMed  Google Scholar 

  18. Rittger H, Brachmann J, Sinha AM, Waliszewski M, Ohlow M, Brugger A, Thiele H, Birkemeyer R, Kurowski V, Breithardt OA, Schmidt M, Zimmermann S, Lonke S, von Cranach M, Nguyen TV, Daniel WG, Wohrle J (2012) 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 59:1377–1382

    Article  PubMed  CAS  Google Scholar 

  19. Tepe G, Zeller T, Albrecht T, Heller S, Schwarzwalder U, Beregi JP, Claussen CD, Oldenburg A, Scheller B, Speck U (2008) Local delivery of paclitaxel to inhibit restenosis during angioplasty of the leg. N Engl J Med 358:689–699

    Article  PubMed  CAS  Google Scholar 

  20. Werk M, Langner S, Reinkensmeier B, Boettcher HF, Tepe G, Dietz U, Hosten N, Hamm B, Speck U, Ricke J (2008) Inhibition of restenosis in femoropopliteal arteries: paclitaxel-coated versus uncoated balloon: Femoral paclitaxel randomized pilot trial. Circulation 118:1358–1365

    Article  PubMed  CAS  Google Scholar 

  21. Vajda Z, Guthe T, Perez MA, Heuschmid A, Schmid E, Bazner H, Henkes H (2011) Neurovascular in-stent stenoses: treatment with conventional and drug-eluting balloons. AJNR Am J Neuroradiol 32:1942–1947

    Article  PubMed  CAS  Google Scholar 

  22. Wohrle J, Zadura M, Mobius-Winkler S, Leschke M, Opitz C, Ahmed W, Barragan P, Simon JP, Cassel G, Scheller B (2012) Sequent please world wide registry: clinical results of sequent please paclitaxel-coated balloon angioplasty in a large-scale, prospective registry study. J Am Coll Cardiol 60:1733–1738

    Article  PubMed  Google Scholar 

  23. Kleber FX, Mathey DG, Rittger H, Scheller B (2011) How to use the drug-eluting balloon: recommendations by the german consensus group. EuroIntervention 7(Suppl K):K125–K128

    Article  PubMed  Google Scholar 

  24. Hermans WR, Rensing BJ, Foley DP, Deckers JW, Rutsch W, Emanuelsson H, Danchin N, Wijns W, Chappuis F, Serruys PW (1992) Therapeutic dissection after successful coronary balloon angioplasty: no influence on restenosis or on clinical outcome in 693 patients. The mercator study group (multicenter european research trial with cilazapril after angioplasty to prevent transluminal coronary obstruction and restenosis). J Am Coll Cardiol 20:767–780

    Article  PubMed  CAS  Google Scholar 

  25. Ellis SG, Roubin GS, King SB, Douglas JS, Weintraub WS, Thomas RG, Cox WR (1988) Angiographic and clinical predictors of acute closure after native vessle coronary angioplasty. Circulation 77:372–379

    Article  PubMed  CAS  Google Scholar 

  26. Leimgruber PP, Roubin GS, Anderson HV, Bredlau CE, Whitworth HB, Douglas JS Jr, King SB 3rd, Greuntzig AR (1985) Influence of intimal dissection on restenosis after successful coronary angioplasty. Circulation 72:530–535

    Article  PubMed  CAS  Google Scholar 

  27. Cappelletti A, Margonato A, Rosano G, Mailhac A, Veglia F, Colombo A, Chierchia SL (1999) Short- and long-term evolution of unstented nonocclusive coronary dissection after coronary angioplasty. J Am Coll Cardiol 34:1484–1488

    Article  PubMed  CAS  Google Scholar 

  28. Huber MS, Mooney JF, Madison J, Mooney MR (1991) Use of a morphologic classification to predict clinical outcome after dissection from coronary angioplasty. Am J Cardiol 68:467–471

    Article  PubMed  CAS  Google Scholar 

  29. Sigwart U, Urban P, Golf S, Kaufmann U, Imbert C, Fischer A, Kappenberger L (1988) Emergency stenting for acute occlusion after coronary balloon angioplasty. Circulation 78:1121–1127

    Article  PubMed  CAS  Google Scholar 

  30. Fishman DL, Leoan MB, Baim DS, Schatz RA, Savage MP, Penn I, Detre K, Veltri L, Ricci D, Nobuyoshi M, Cleman M, Heuser R, Almond D, Teirstein PS, Fish RD, Colombo A, Brinker J, Moses J, Shaknovich A, Hirshfeld J, Bailer S, Ellis S, Rake R, Goldberg S (1994) Investigators ftSRS. A randomized comparison of coronary-stent placement and balloon angioplasty in the treatment of coronary artery disease. N Engl J Med 331:496–501

    Article  Google Scholar 

  31. Serruys PW, de Jaegere P, Kiemeneij F, Macaya C, Rutsch W, Heyndrickx G, Emanuelsson H, Marco J, Legrand V, Materne P, Belardi J, Sigwart U, Colombo A, Goy JJ (1994) Heuvel Pvd, Delcan J, Morel M-A, Group ftBS. A comparison of ballon-expandable-stent implantation with balloon angioplasty in patients with coronary artery disease. N Engl J Med 331:489–495

    Article  PubMed  CAS  Google Scholar 

  32. Al Suwaidi J, Holmes DR Jr, Salam AM, Lennon R, Berger PB (2004) Impact of coronary artery stents on mortality and nonfatal myocardial infarction: meta-analysis of randomized trials comparing a strategy of routine stenting with that of balloon angioplasty. Am Heart J 147:815–822

    Article  PubMed  Google Scholar 

  33. Colombo A, Hall P, Nakamura S, Almagor Y, Maiello L, Martini G, Gaglione A, Goldberg SL, Tobis JM (1995) Intracoronary stenting without anticoagulation accomplished with intravascular ultrasound guidance. Circulation 91:1676–1688

    Article  PubMed  CAS  Google Scholar 

  34. Leon MB, Baim DS, Popma JJ, Gordon PC, Cutlip DE, Ho KK, Giambartolomei A, Diver DJ, Lasorda DM, Williams DO, Pocock SJ, Kuntz RE (1998) A clinical trial comparing three antithrombotic-drug regimens after coronary-artery stenting. Stent anticoagulation restenosis study investigators. N Engl J Med 339:1665–1671

    Article  PubMed  CAS  Google Scholar 

  35. Latib A, Colombo A, Castriota F, Micari A, Cremonesi A, De Felice F, Marchese A, Tespili M, Presbitero P, Sgueglia GA, Buffoli F, Tamburino C, Varbella F, Menozzi A (2012) 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 60:2473–2480

    Article  PubMed  CAS  Google Scholar 

  36. Kastrati A, Mehilli J, von Beckerath N, Dibra A, Hausleiter J, Pache J, Schuhlen H, Schmitt C, Dirschinger J, Schomig A (2005) Sirolimus-eluting stent or paclitaxel-eluting stent vs balloon angioplasty for prevention of recurrences in patients with coronary in-stent restenosis: a randomized controlled trial. JAMA 293:165–171

    Article  PubMed  CAS  Google Scholar 

  37. Waksman R, Bhargava B, White RL, Chan RC, Gierlach LM, Mehran R, Lansky A, Kent KM, Mintz GS, Satler LF, Pichard AD, Leon MB (1999) Intracoronary radiation for patients with refractory in-stent restenosis: an analysis from the wrist-crossover trial. Washington radiation for in-stent restenosis trial. Cardiovasc Radiat Med 1:317–322

    Article  PubMed  CAS  Google Scholar 

  38. Waksman R (2012) Too early to call. Cardiovasc Revasc Med 13:157–158

    Article  PubMed  Google Scholar 

  39. Mehilli J, Byrne RA, Tiroch K, Pinieck S, Schulz S, Kufner S, Massberg S, Laugwitz KL, Schomig A, Kastrati A (2010) Randomized trial of paclitaxel- versus sirolimus-eluting stents for treatment of coronary restenosis in sirolimus-eluting stents: the isar-desire 2 (intracoronary stenting and angiographic results: Drug eluting stents for in-stent restenosis 2) study. J Am Coll Cardiol 55:2710–2716

    Article  PubMed  CAS  Google Scholar 

  40. Alfonso F, Perez-Vizcayno MJ, Dutary J, Zueco J, Cequier A, Garcia-Touchard A, Marti V, Lozano I, Angel J, Hernandez JM, Lopez-Minguez JR, Melgares R, Moreno R, Seidelberger B, Fernandez C, Hernandez R, Investigators R-IS (2012) Implantation of a drug-eluting stent with a different drug (switch strategy) in patients with drug-eluting stent restenosis: results from a prospective multicenter study (ribs iii [restenosis intra-stent: Balloon angioplasty versus drug-eluting stent]). JACC Cardiovasc Interv 5:728–737

    Article  PubMed  Google Scholar 

  41. Alli OO, Teirstein PS, Satler L, Sketch MH Jr, Popma JJ, Mauri L, Wang HP, Schleckser PA, Cohen SA, Holmes DR Jr, Investigators S (2012) Five-year follow-up of the sirolimus-eluting stents vs vascular brachytherapy for bare metal in-stent restenosis (sisr) trial. Am Heart J 163:438–445

    Article  PubMed  Google Scholar 

  42. Raber L, Magro M, Stefanini GG, Kalesan B, van Domburg RT, Onuma Y, Wenaweser P, Daemen J, Meier B, Juni P, Serruys PW, Windecker S (2012) Very late coronary stent thrombosis of a newer-generation everolimus-eluting stent compared with early-generation drug-eluting stents: a prospective cohort study. Circulation 125:1110–1121

    Article  PubMed  Google Scholar 

  43. Wijns W, Kolh P, Danchin N, Di Mario C, Falk V, Folliguet T, Garg S, Huber K, James S, Knuuti J, Lopez-Sendon J, Marco J, Menicanti L, Ostojic M, Piepoli MF, Pirlet C, Pomar JL, Reifart N, Ribichini FL, Schalij MJ, Sergeant P, Serruys PW, Silber S, Sousa Uva M, Taggart D, Vahanian A, Auricchio A, Bax J, Ceconi C, Dean V, Filippatos G, Funck-Brentano C, Hobbs R, Kearney P, McDonagh T, Popescu BA, Reiner Z, Sechtem U, Sirnes PA, Tendera M, Vardas PE, Widimsky P, Alfieri O, Dunning J, Elia S, Kappetein P, Lockowandt U, Sarris G, Vouhe P, von Segesser L, Agewall S, Aladashvili A, Alexopoulos D, Antunes MJ, Atalar E, Brutel de la Riviere A, Doganov A, Eha J, Fajadet J, Ferreira R, Garot J, Halcox J, Hasin Y, Janssens S, Kervinen K, Laufer G, Legrand V, Nashef SA, Neumann FJ, Niemela K, Nihoyannopoulos P, Noc M, Piek JJ, Pirk J, Rozenman Y, Sabate M, Starc R, Thielmann M, Wheatley DJ, Windecker S, Zembala M (2010) 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). Eur Heart J 31:2501–2555

    Article  PubMed  Google Scholar 

  44. Byrne RA, Neumann FJ, Mehilli J, Pinieck S, Wolff B, Tiroch K, Schulz S, Fusaro M, Ott I, Ibrahim T, Hausleiter J, Valina C, Pache J, Laugwitz KL, Massberg S, Kastrati A (2013) Investigators I-D. 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 381:461–467

    Article  PubMed  CAS  Google Scholar 

  45. Bonaventura K, Leber AW, Sohns C, Roser M, Boldt LH, Kleber FX, Haverkamp W, Dorenkamp M (2012) Cost-effectiveness of paclitaxel-coated balloon angioplasty and paclitaxel-eluting stent implantation for treatment of coronary in-stent restenosis in patients with stable coronary artery disease. Clin Res Cardiol 101:573–584

    Article  PubMed  Google Scholar 

  46. Dorenkamp M, Boldt J, Leber A, Sohns C, Roser M, Boldt L, Haverkamp W, Bonaventura K (2013) Cost-effectiveness of paclitaxel-coated balloon angioplasty in patients with drug-eluting stent restenosis. Clin. Cardiol 36:407–413

    Article  PubMed  Google Scholar 

  47. Cremers B, Clever Y, Schaffner S, Speck U, Bohm M, Scheller B (2010) Treatment of coronary in-stent restenosis with a novel paclitaxel urea coated balloon. Minerva Cardioangiol 58:583–588

    PubMed  CAS  Google Scholar 

  48. Hehrlein C, Dietz U, Kubica J, Jorgensen E, Hoffmann E, Naber C, Lesiak M, Schneider H, Wiemer M, Tolg R, Richardt G (2012) Twelve-month results of a paclitaxel releasing balloon in patients presenting with in-stent restenosis first-in-man (pepper) trial. Cardiovasc Revasc Med 13:260–264

    Article  PubMed  Google Scholar 

  49. Bondesson P, Lagerqvist B, James SK, Olivecrona GK, Venetsanos D, Harnek J (2012) Comparison of two drug-eluting balloons: a report from the scaar registry. EuroIntervention 8:444–449

    Article  PubMed  Google Scholar 

  50. Moreno R, Fernandez C, Alfonso F, Hernandez R, Perez-Vizcayno MJ, Escaned J, Sabate M, Banuelos C, Angiolillo DJ, Azcona L, Macaya C (2004) Coronary stenting versus balloon angioplasty in small vessels: a meta-analysis from 11 randomized studies. J Am Coll Cardiol 43:1964–1972

    Article  PubMed  Google Scholar 

  51. Agostoni P, Biondi-Zoccai GG, Gasparini GL, Anselmi M, Morando G, Turri M, Abbate A, McFadden EP, Vassanelli C, Zardini P, Colombo A, Serruys PW (2005) Is bare-metal stenting superior to balloon angioplasty for small vessel coronary artery disease? Evidence from a meta-analysis of randomized trials. Eur Heart J 26:881–889

    Article  PubMed  Google Scholar 

  52. Brunner-La Rocca HP, Kaiser C, Pfisterer M (2007) Targeted stent use in clinical practice based on evidence from the basel stent cost effectiveness trial (basket). Eur Heart J 28:719–725

    Article  PubMed  Google Scholar 

  53. Cortese B, Micheli A, Picchi A, Coppolaro A, Bandinelli L, Severi S, Limbruno U (2010) Paclitaxel-coated balloon versus drug-eluting stent during pci of small coronary vessels, a prospective randomised clinical trial. The piccoleto study. Heart 96:1291–1296

    Article  PubMed  Google Scholar 

  54. Behan MW, Holm NR, Curzen NP, Erglis A, Stables RH, de Belder AJ, Niemela M, Cooter N, Chew DP, Steigen TK, Oldroyd KG, Jensen JS, Lassen JF, Thuesen L, Hildick-Smith D (2011) Simple or complex stenting for bifurcation coronary lesions: A patient-level pooled-analysis of the nordic bifurcation study and the british bifurcation coronary study. Circ Cardiovasc Interv 4:57–64

    Article  PubMed  Google Scholar 

  55. Steigen TK, Maeng M, Wiseth R, Erglis A, Kumsars I, Narbute I, Gunnes P, Mannsverk J, Meyerdierks O, Rotevatn S, Niemela M, Kervinen K, Jensen JS, Galloe A, Nikus K, Vikman S, Ravkilde J, James S, Aaroe J, Ylitalo A, Helqvist S, Sjogren I, Thayssen P, Virtanen K, Puhakka M, Airaksinen J, Lassen JF, Thuesen L (2006) Randomized study on simple versus complex stenting of coronary artery bifurcation lesions: The Nordic bifurcation study. Circulation 114:1955–1961

    Article  PubMed  Google Scholar 

  56. Erglis A, Kumsars I, Niemela M, Kervinen K, Maeng M, Lassen JF, Gunnes P, Stavnes S, Jensen JS, Galloe A, Narbute I, Sondore D, Makikallio T, Ylitalo K, Christiansen EH, Ravkilde J, Steigen TK, Mannsverk J, Thayssen P, Hansen KN, Syvanne M, Helqvist S, Kjell N, Wiseth R, Aaroe J, Puhakka M, Thuesen L (2009) Randomized comparison of coronary bifurcation stenting with the crush versus the culotte technique using sirolimus eluting stents: the Nordic stent technique study. Circ Cardiovasc Interv 2:27–34

    Article  PubMed  Google Scholar 

  57. Stella PR, Belkacemi A, Dubois C, Nathoe H, Dens J, Naber C, Adriaenssens T, van Belle E, Doevendans P, Agostoni P (2012) 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 80:1138–1146

    Article  PubMed  Google Scholar 

  58. Ali RM, Degenhardt R, Zambahari R, Tresukosol D, Ahmad WA, Kamar HH, Kui-Hian S, Ong TK, bin Ismail O, bin Elis S, Udychalerm W, Ackermann H, Boxberger M, Unverdorben M (2011) Paclitaxel-eluting balloon angioplasty and cobalt-chromium stents versus conventional angioplasty and paclitaxel-eluting stents in the treatment of native coronary artery stenoses in patients with diabetes mellitus. EuroIntervention 7(Suppl K):K83–K92

    Article  PubMed  Google Scholar 

  59. Scheller B, Clever Y, Bohm M, Cremers B (2012) Drug coated balloons in acute coronary syndromes–opportunities and limitations. Curr Vasc Pharmacol 10:472–475

    Article  PubMed  CAS  Google Scholar 

  60. Belkacemi A, Agostoni P, Nathoe HM, Voskuil M, Shao C, Van Belle E, Wildbergh T, Politi L, Doevendans PA, Sangiorgi GM, Stella PR (2012) 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 59:2327–2337

    Article  PubMed  Google Scholar 

  61. Werk M, Albrecht T, Meyer DR, Ahmed MN, Behne A, Dietz U, Eschenbach G, Hartmann H, Lange C, Schnorr B, Stiepani H, Zoccai GB, Hanninen EL (2012) Paclitaxel-coated balloons reduce restenosis after femoro-popliteal angioplasty: evidence from the randomized pacifier trial. Circ Cardiovasc Interv 5:831–840

    Article  PubMed  CAS  Google Scholar 

  62. Schmidt A, Piorkowski M, Werner M, Ulrich M, Bausback Y, Braunlich S, Ick H, Schuster J, Botsios S, Kruse HJ, Varcoe RL, Scheinert D (2011) First experience with drug-eluting balloons in infrapopliteal arteries restenosis rate and clinical outcome. J Am Coll Cardiol 58:1105–1109

    Article  PubMed  CAS  Google Scholar 

  63. Serruys PW, Onuma Y, Dudek D, Smits PC, Koolen J, Chevalier B, de Bruyne B, Thuesen L, McClean D, van Geuns RJ, Windecker S, Whitbourn R, Meredith I, Dorange C, Veldhof S, Hebert KM, Sudhir K, Garcia-Garcia HM, Ormiston JA (2011) Evaluation of the second generation of a bioresorbable everolimus-eluting vascular scaffold for the treatment of de novo coronary artery stenosis: 12-month clinical and imaging outcomes. J Am Coll Cardiol 58:1578–1588

    Article  PubMed  CAS  Google Scholar 

  64. Wohrle J, Werner GS (2012) Paclitaxel-coated balloon with bare-metal stenting in patients with chronic total occlusions in native coronary arteries. Catheter Cardiovasc Interv 81:793–799

    Article  PubMed  Google Scholar 

  65. Adriaenssens T, Dens J, Ughi G, Coosemans M, Onsea K, Dubois C, Sinnaeve P, Vrolix M, Desmet W (2011) Optical coherence tomography (oct) in pci for in-stent restenosis (isr): rationale and design of the seduce (safety and efficacy of a drug eluting balloon in coronary artery restenosis) study. EuroIntervention 7(Suppl K):K100–K105

    Article  PubMed  Google Scholar 

  66. Poerner TC, Otto S, Gassdorf J, Janiak F, Danzer C, Ferrari M, Figulla HR (2011) A prospective randomised study using optical coherence tomography to assess endothelial coverage and neointimal proliferation at 6-months after implantation of a coronary everolimus-eluting stent compared with a bare metal stent postdilated with a paclitaxel-eluting balloon (octopus trial): rationale, design and methods. EuroIntervention 7(Suppl K):K93–K99

    Article  PubMed  Google Scholar 

  67. Fanggiday JC, Stella PR, Guyomi SH, Doevendans PA (2008) Safety and efficacy of drug-eluting balloons in percutaneous treatment of bifurcation lesions: the debiut (drug-eluting balloon in bifurcation utrecht) registry. Catheter Cardiovasc Interv 71:629–635

    Article  PubMed  Google Scholar 

  68. Stella PR, Belkacemi A, Waksman R, Stahnke S, Torguson R, von Strandmann RP, Agostoni P, Sangiorgi G, Silber S, Valentine I (2011) The valentine’s trial: results of the first one week worldwide multicentre enrolment trial, evaluating the real world usage of the second generation dior paclitaxel drug-eluting balloon for in-stent restenosis treatment. EuroIntervention 7:705–710

    Article  PubMed  Google Scholar 

  69. Vaquerizo B, Serra A, Miranda-Guardiola F, Martinez V, Antoni Gomez-Hospital J, Iniguez A, Fernandez E, Ramon Rumoroso J, Bosa F, Otaegui I (2011) One-year outcomes with angiographic follow-up of paclitaxel-eluting balloon for the treatment of in-stent restenosis: insights from Spanish multicenter registry. J Interv Cardiol 24:518–528

    Article  PubMed  Google Scholar 

  70. Mieres J, Fernandez-Pereira C, Risau G, Solorzano L, Pauletto R, Rodriguez-Granillo AM, Rubilar B, Stella P, Rodriguez AE (2012) One-year outcome of patients with diabetes mellitus after percutaneous coronary intervention with three different revascularization strategies: results from the diabetic Argentina registry (dear). Cardiovasc Revasc Med 13:265–271

    Article  PubMed  Google Scholar 

  71. Gutierrez-Chico JL, van Geuns RJ, Koch KT, Koolen JJ, Duckers H, Regar E, Serruys PW (2011) 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 7:711–722

    Article  PubMed  Google Scholar 

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Acknowledgments

Franz X. Kleber has received lecture fees and study grants from B. Braun. Harald Rittger has received speaker honoraria and study grants from B. Braun. Klaus Bonaventura has received lecture fees from B. Braun. Jochen Wöhrle has received lecture fees and study grants from B. Braun. Raban Jeger has received study grants from B. Braun and travel support from Medtronic, Biotronik, and B. Braun. Dieter Fischer has received lecture fees from B. Braun. Bruno Scheller has received lecture fees from B. Braun and Medtronic, travel support from Medtronic and B. Braun; he was named on a patent application of Charite university hospital, Berlin and is a shareholder of InnoRa GmbH, Berlin.

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Authors and Affiliations

  1. Charité, University Medicine, Berlin, Germany

    Franz X. Kleber

  2. Medizinische Klinik 2, Universitätsklinikum Erlangen, Erlangen, Germany

    Harald Rittger

  3. Klinik für Kardiologie Und Angiologie, Ernst von Bergmann Klinikum, Potsdam, Germany

    Klaus Bonaventura

  4. Medizinische Klinik B, Klinikum Ludwigshafen, Ludwigshafen, Germany

    Uwe Zeymer

  5. Klinik für Innere Medizin II, Universitätsklinikum Ulm, Ulm, Germany

    Jochen Wöhrle

  6. Kardiologie, Universitätsspital Basel, Basel, Switzerland

    Raban Jeger

  7. Kardiologische Gemeinschaftspraxis Charlottenburg, Berlin, Germany

    Benny Levenson

  8. Klinik für Kardiologie, Weißenfels, Germany

    Sven Möbius-Winkler

  9. Klinik für Innere Medizin, Unfallkrankenhaus, Berlin, Germany

    Leonhard Bruch

  10. Department für Kardiologie und Angiologie, Universitätsklinikum Münster, Münster, Germany

    Dieter Fischer

  11. Klinik für Herz- und Kreislauferkrankungen, Deutsches Herzzentrum München, Munich, Germany

    Christian Hengstenberg

  12. Klinik für Innere Medizin I, Universitätsklinikum Jena, Jena, Germany

    Tudor Pörner

  13. Universitäres Herz- und Gefäßzentrum, Hamburg, Germany

    Detlef Mathey

  14. Klinik für Innere Medizin III, Universitätsklinkum des Saarlandes, Homburg/Saar, Germany

    Bruno Scheller

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  1. Franz X. Kleber
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  2. Harald Rittger
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  14. Bruno Scheller
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Correspondence to Bruno Scheller.

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Kleber, F.X., Rittger, H., Bonaventura, K. et al. Drug-coated balloons for treatment of coronary artery disease: updated recommendations from a consensus group. Clin Res Cardiol 102, 785–797 (2013). https://doi.org/10.1007/s00392-013-0609-7

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  • DOI: https://doi.org/10.1007/s00392-013-0609-7

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