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Clinical Research in Cardiology

, Volume 105, Issue 7, pp 613–621 | Cite as

Drug eluting balloons as stand alone procedure for coronary bifurcational lesions: results of the randomized multicenter PEPCAD-BIF trial

  • Franz X. Kleber
  • Harald Rittger
  • Josef Ludwig
  • Antonia Schulz
  • Detlef G. Mathey
  • Michael Boxberger
  • Ralf Degenhardt
  • Bruno Scheller
  • Ruth H. Strasser
Original Paper

Abstract

Objectives

We set out to investigate the benefit of distal main or side branch treatment with a DCB compared to POBA in coronary bifurcation lesions.

Background

The standard treatment of bifurcation lesions is application of a DES to the main branch with provisional side branch stenting. While this resulted in considerable improvement in overall MACE rate suboptimal side branch results remained a problem.

Methods

The study was performed from 2011 to 2013 in six German centers. Native bifurcation lesions were included if side branch vessel diameter was ≥2 and ≤3.5 mm and no proximal main branch lesions was found. After successful predilatation randomization was performed to either DCB application or no further treatment. Follow-up angiograms for QCA analysis were done after 9 months. Primary endpoint was late lumen loss (LLL).

Results

64 patients were successfully randomized. Minimal lumen diameter and grade of stenosis were equal in both groups. Only five stents were used as bail out. Angiographic follow-up was achieved in 75 % of patients. No patient died. There was one NSTEMI in the POBA group. Restenosis rate was 6 % in the DCB group vs 26 % in the POBA group (p = 0.045). TLR was necessary in one patient of the DCB group vs three patients of the POBA. The primary endpoint LLL was 0.13 mm in the DCB vs 0.51 mm in the POBA group (p = 0.013).

Conclusion

In bifurcation lesions that show only class A or B dissection and recoil not beyond 30 % the use of DCBs is a sound strategy.

Keywords

Drug-coated balloon (DCB) Coronary bifurcation lesions PCI 

Notes

Compliance with ethical standards

Conflict of interest

The authors declare the following conflicts of interest: Franz X. Kleber is a consultant to B.Braun and has received institutional grant support by Medtronic and B. Braun. Antonia Schulz received travel expenses from B. Braun. Bruno Scheller is a consultant to B. Braun, received lecture honoraria by Medtronic and B. Braun and is co-inventor on a patent application by Charité University Hospital. Ralf Degenhardt is employee of the Clinical Research Institute that is paid for conduct of the study. Michael Boxberger is employee as medical director at B. Braun. Harald Rittger, Josef Ludwig, Detlef G. Mathey and Ruth H. Strasser declare no conflict of interest.

Funding

The study was financially supported in part by B. Braun Melsungen AG.

References

  1. 1.
    Meier B, Gruentzig AR, King SB 3rd, Douglas JS Jr, Hollmann J, Ischinger T, Aueron F, Galan K (1984) Risk of side branch occlusion during coronary angioplasty. Am J Cardiol 53:10–14CrossRefPubMedGoogle Scholar
  2. 2.
    Tanabe K, Hoye A, Lemos PA, Aoki J, Arampatzis CA, Saia F, Lee CH, Degertekin M, Hofma SH, Sianos G, McFadden E, Smits PC, van der Giessen WJ, de Feyter P, van Domburg RT, Serruys PW (2004) Restenosis rates following bifurcation stenting with sirolimus-eluting stents for de novo narrowings. Am J Cardiol 94:115–118CrossRefPubMedGoogle Scholar
  3. 3.
    Colombo A, Moses JW, Morice MC, Ludwig J, Holmes DR Jr, Spanos V, Louvard Y, Desmedt B, Di Mario C, Leon MB (2004) Randomized study to evaluate sirolimus-eluting stents implanted at coronary bifurcation lesions. Circulation 109:1244–1249CrossRefPubMedGoogle Scholar
  4. 4.
    Hoye A, Iakovou I, Ge L, van Mieghem CA, Ong AT, Cosgrave J, Sangiorgi GM, Airoldi F, Montorfano M, Michev I, Chieffo A, Carlino M, Corvaja N, Aoki J, Rodriguez Granillo GA, Valgimigli M, Sianos G, van der Giessen WJ, de Feyter PJ, van Domburg RT, Serruys PW, Colombo A (2006) Long-term outcomes after stenting of bifurcation lesions with the “crush” technique: predictors of an adverse outcome. J Am Coll Cardiol 47:1949–1958CrossRefPubMedGoogle Scholar
  5. 5.
    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 119:2986–2994CrossRefPubMedGoogle Scholar
  6. 6.
    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 4:149–154CrossRefPubMedGoogle Scholar
  7. 7.
    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, Wöhrle 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 59:1377–1382CrossRefPubMedGoogle Scholar
  8. 8.
    Indermuehle A, Bahl R, Lansky AJ, Froehlich GM, Knapp G, Timmis A, Meier P (2013) Drug-eluting balloon angioplasty for in-stent restenosis: a systematic review and meta-analysis of randomised controlled trials. Heart 99:327–333CrossRefPubMedGoogle Scholar
  9. 9.
    Scheller B, Clever YP, Kelsch B, Hehrlein C, Bocksch W, Rutsch W, Haghi D, Dietz U, Speck U, Böhm M, Cremers B (2012) Long-term follow-up after treatment of coronary in-stent restenosis with a paclitaxel-coated balloon catheter. JACC Cardiovasc Interv 5:323–330CrossRefPubMedGoogle Scholar
  10. 10.
    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, ISAR-DESIRE 3 investigators (2013) 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 381:461–467CrossRefPubMedGoogle Scholar
  11. 11.
    Fröhlich GM, Lansky AJ, Ko DT, Archangelidi O, De Palma R, Timmis A, Meier P (2013) Drug eluting balloons for de novo coronary lesions—a systematic review and meta-analysis. BMC Med 11:123CrossRefPubMedPubMedCentralGoogle Scholar
  12. 12.
    Belkacemi A, Agostoni P, Voskuil M, Stella PR (2011) Coronary bifurcation lesions treated with the drug eluting balloon: a preliminary insight from the DEBIUT study. EuroIntervention 7 Suppl K:K66–K69CrossRefPubMedGoogle Scholar
  13. 13.
    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 60:2473–2480CrossRefPubMedGoogle Scholar
  14. 14.
    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 paclitaxelcoated balloon catheter. Clin Res Cardiol 99:165–174CrossRefPubMedGoogle Scholar
  15. 15.
    Wöhrle J, Zadura M, Möbius-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 60:1733–1738CrossRefPubMedGoogle Scholar
  16. 16.
    Zeymer U, Waliszewski M, Spiecker M, Gastmann O, Faurie B, Ferrari M, Alidoosti M, Palmieri C, Heang TN, Ong PJ, Dietz U (2014) Prospective ‘real world’ registry for the use of the ‘PCB only’ strategy in small vessel de novo lesions. Heart 100:311–316CrossRefPubMedGoogle Scholar
  17. 17.
    Ho HH, Ooi YW, Loh KK, Tan J, Aung TH, Jafary FH, Ong PJL (2013) Clinical efficacy and safety of SeQuent Please Paclitaxel-Eluting Balloon in a real-world single-center registry of south–east Asian patients. IJC Heart Vessels 1:37–41CrossRefGoogle Scholar
  18. 18.
    Hildick-Smith D, de Belder AJ, Cooter N, Curzen NP, Clayton TC, Oldroyd KG, Bennett L, Holmberg S, Cotton JM, Glennon PE, Thomas MR, Maccarthy PA, Baumbach A, Mulvihill NT, Henderson RA, Redwood SR, Starkey IR, Stables RH (2010) Randomized trial of simple versus complex drug-eluting stenting for bifurcation lesions: the British Bifurcation Coronary Study: old, new, and evolving strategies. Circulation 121:1235–1243CrossRefPubMedGoogle Scholar
  19. 19.
    Medina A, Suárez de Lezo J, Pan M (2006) A new classification of coronary bifurcation lesions. Rev Esp Cardiol 59:183CrossRefPubMedGoogle Scholar
  20. 20.
    Kleber FX, Mathey DG, Rittger H, Scheller B, German Drug-eluting Balloon Consensus Group (2011) How to use the drug-eluting balloon: recommendations by the German Consensus Group. EuroIntervention 7 Suppl K:K125–K128CrossRefPubMedGoogle Scholar
  21. 21.
    Kleber FX, Rittger H, Bonaventura K, Zeymer U, Wöhrle J, Jeger R, Levenson B, Möbius-Winkler S, Bruch L, Fischer D, Hengstenberg C, Pörner T, Mathey D, Scheller B (2013) Drug-coated balloons for treatment of coronary artery disease: updated recommendations from a consensus group. Clin Res Cardiol 102:785–797CrossRefPubMedGoogle Scholar
  22. 22.
    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 68:467–471CrossRefPubMedGoogle Scholar
  23. 23.
    Steigen TK, Maeng M, Wiseth R, Erglis A, Kumsars I, Narbute I, Gunnes P, Mannsverk J, Meyerdierks O, Rotevatn S, Niemelä M, Kervinen K, Jensen JS, Galløe A, Nikus K, Vikman S, Ravkilde J, James S, Aarøe J, Ylitalo A, Helqvist S, Sjögren I, Thayssen P, Virtanen K, Puhakka M, Airaksinen J, Lassen JF, Thuesen L, Nordic PCI Study Group (2006) Randomized study on simple versus complex stenting of coronary artery bifurcation lesions: the Nordic bifurcation study. Circulation 114:1955–1961CrossRefPubMedGoogle Scholar
  24. 24.
    Niemelä M, Kervinen K, Erglis A, Holm NR, Maeng M, Christiansen EH, Kumsars I, Jegere S, Dombrovskis A, Gunnes P, Stavnes S, Steigen TK, Trovik T, Eskola M, Vikman S, Romppanen H, Mäkikallio T, Hansen KN, Thayssen P, Aberge L, Jensen LO, Hervold A, Airaksinen J, Pietilä M, Frobert O, Kellerth T, Ravkilde J, Aarøe J, Jensen JS, Helqvist S, Sjögren I, James S, Miettinen H, Lassen JF, Thuesen L, Nordic-Baltic PCI Study Group (2011) Randomized comparison of final kissing balloon dilatation versus no final kissing balloon dilatation in patients with coronary bifurcation lesions treated with main vessel stenting: the Nordic-Baltic Bifurcation Study III. Circulation 123:79–86CrossRefPubMedGoogle Scholar
  25. 25.
    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–K65CrossRefPubMedGoogle Scholar
  26. 26.
    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: 6-month angiographic and 12-month clinical results of the drug-eluting balloon in bifurcations trial. Catheter Cardiovasc Interv 80:1138–1146CrossRefPubMedGoogle Scholar
  27. 27.
    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 8:444–449CrossRefPubMedGoogle Scholar
  28. 28.
    Colombo A, Bramucci E, Saccà S, Violini R, Lettieri C, Zanini R, Sheiban I, Paloscia L, Grube E, Schofer J, Bolognese L, Orlandi M, Niccoli G, Latib A, Airoldi F (2009) Randomized study of the crush technique versus provisional side-branch stenting in true coronary bifurcations: the CACTUS (coronary bifurcations: application of the crushing technique using sirolimus-eluting stents) study. Circulation 119:71–78CrossRefPubMedGoogle Scholar
  29. 29.
    Kleber FX, Schulz A, Waliszewski M, Hauschild T, Böhm M, Dietz U, Cremers B, Scheller B, Clever YP (2014) Local paclitaxel induces late lumen enlargement in coronary arteries after balloon angioplasty. Clin Res Cardiol 104:217–225CrossRefPubMedGoogle Scholar
  30. 30.
    Herrador JA, Fernandez JC, Guzman M, Aragon V (2013) Drug-eluting vs. conventional balloon for side branch dilation in coronary bifurcations treated by provisional T stenting. J Interv Cardiol 26:454–462CrossRefPubMedGoogle Scholar
  31. 31.
    Sgueglia GA, Todaro D, Bisciglia A, Conte M, Stipo A, Pucci E (2011) Kissing inflation is feasible with all second-generation drug-eluting balloons. Cardiovasc Revasc Med 12:280–285CrossRefPubMedGoogle Scholar
  32. 32.
    Chin K, Rajagopal P (2014) The combined use of bioresorbable scaffold or DES and drug coated balloon in bifurcation stenting. EuroIntervention Euro14A-MA045 (Abstract) Google Scholar
  33. 33.
    López Mínguez JR, Nogales Asensio JM, Doncel Vecino LJ, Sandoval J, Romany S, Martínez Romero P, Fernández Díaz JA, Fernández Portales J, González Fernández R, Martínez Cáceres G, Merchán Herrera A, Alfonso Manterola F, Investigators BABILON (2014) A prospective randomised study of the paclitaxel-coated balloon catheter in bifurcated coronary lesions (BABILON trial): 24-month clinical and angiographic results. EuroIntervention 10:50–57CrossRefPubMedGoogle Scholar
  34. 34.
    Schulz A, Hauschild T, Kleber FX (2014) Treatment of de novo coronary bifurcation lesions with DCB only strategy. Clin Res Cardiol 103:451–456CrossRefPubMedGoogle Scholar

Copyright information

© Springer-Verlag Berlin Heidelberg 2016

Authors and Affiliations

  • Franz X. Kleber
    • 1
  • Harald Rittger
    • 2
  • Josef Ludwig
    • 2
  • Antonia Schulz
    • 1
  • Detlef G. Mathey
    • 3
  • Michael Boxberger
    • 4
  • Ralf Degenhardt
    • 5
  • Bruno Scheller
    • 6
  • Ruth H. Strasser
    • 7
  1. 1.Cardio Centrum Berlin, Academic Teaching InstitutionCharité University Medicine BerlinBerlinGermany
  2. 2.Universitätsklinikum ErlangenErlangenGermany
  3. 3.Universitäres Herz- und Gefäßzentrum HamburgHamburgGermany
  4. 4.Medical Scientific AffairsB. Braun Melsungen AGMelsungenGermany
  5. 5.Center for Cardiovascular DiseasesRotenburg a.d. FuldaGermany
  6. 6.Universitätsklinikum des SaarlandesHomburgGermany
  7. 7.Technische Universität Dresden, Herzzentrum DresdenUniversitätsklinik DresdenDresdenGermany

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