The International Journal of Cardiovascular Imaging

, Volume 34, Issue 9, pp 1339–1347 | Cite as

Paclitaxel-coated balloon treatment for functionally nonsignificant residual coronary lesions after balloon angioplasty

  • Ae-Young Her
  • Eun-Seok ShinEmail author
  • Joo Myung Lee
  • Scot Garg
  • Joon-Hyung Doh
  • Chang-Wook Nam
  • Bon-Kwon Koo
Original Paper


There is limited data on the efficacy of paclitaxel-coated balloon (PCB) compared to stents for de novo coronary lesions. The purpose of this study was to compare the efficacy of PCB treatment with stent implantation for de novo coronary lesions after successful plain old balloon angioplasty (POBA) guided by fractional flow reserve (FFR). In 200 patients scheduled for elective percutaneous coronary intervention (PCI) for de novo lesions, FFR was measured after POBA (POBA–FFR). If POBA–FFR was ≥ 0.75, patients were treated with PCB (PCB group, n = 78) or stent (Stent group, n = 73). If POBA–FFR was < 0.75, stent was implanted as planned (Reference group, n = 42). The primary endpoint was late lumen loss at 9 months and the secondary endpoint was adverse cardiac events (cardiac death, myocardial infarction, target lesion thrombosis, or repeat revascularization) at 12 months follow-up. There was no between-group differences in the POBA–FFR (0.87 ± 0.05 in PCB, 0.89 ± 0.06 in stent, p = 0.101). At 9 months, late lumen loss was significantly lower in the PCB group compared to the Stent group (0.05 ± 0.33 vs. 0.59 ± 0.76 mm, p < 0.001). Adverse cardiac events were not different between the PCB, Stent and Reference groups (2.6, 5.5, and 9.5% respectively; p = 0.430 for PCB vs. Stent group; p = 0.229 for the reference vs. both other groups). PCB treatment guided by POBA–FFR showed excellent 9 months angiographic and functional results, as well as comparable 12 months clinical outcomes, compared with stent implantation for de novo coronary lesions.


Paclitaxel-coated balloon Stent Fractional flow reserve Balloon angioplasty De novo lesion Coronary artery disease 



The authors wish to thank Eok Rae Cho and Jeong Hoon Jang for their strenuous efforts and unsurpassed assistance in preparing the manuscript. Data analysis was performed by Hyun Ho Kim, Division of Biostatistics, University of Ulsan College of Medicine.

Compliance with ethical standards

Conflict of interest

The authors declare that they have no competing interest.


  1. 1.
    Lee JM, Park J, Kang J, Jeon KH, Jung JH, Lee S et al (2015) Comparison among drug-eluting balloon, drug-eluting stent, and plain balloon angioplasty for the treatment of in-stent restenosis: a network meta-analysis of 11 randomized, controlled trials. JACC Cardiovasc Interv 8:382–394CrossRefPubMedGoogle Scholar
  2. 2.
    Siontis GC, Stefanini GG, Mavridis D, Siontis KC, Alfonso F, Perez-Vizcayno MJ et al (2015) Percutaneous coronary interventional strategies for treatment of in-stent restenosis: a network meta-analysis. Lancet 386:655–664CrossRefPubMedGoogle Scholar
  3. 3.
    Ann SH, Balbir Singh G, Lim KH, Koo BK, Shin ES (2016) Anatomical and physiological changes after paclitaxel-coated balloon for atherosclerotic de novo coronary lesions: serial IVUS-VH and FFR study. PLoS ONE 11:e0147057CrossRefPubMedPubMedCentralGoogle Scholar
  4. 4.
    Her AY, Ann SH, Singh GB, Kim YH, Yoo SY, Garg S et al (2016) Comparison of paclitaxel-coated balloon treatment and plain old balloon angioplasty for de novo coronary lesions. Yonsei Med J 57:337–341CrossRefPubMedPubMedCentralGoogle Scholar
  5. 5.
    Shin ES, Ann SH, Balbir Singh G, Lim KH, Kleber FX, Koo BK (2016) Fractional flow reserve-guided paclitaxel-coated balloon treatment for de novo coronary lesions. Catheter Cardiovasc Interv 88:193–200CrossRefPubMedGoogle Scholar
  6. 6.
    Waksman R, Serra A, Loh JP, Malik FT, Torguson R, Stahnke S et al (2013) Drug-coated balloons for de novo coronary lesions: results from the Valentines II trial. EuroIntervention 9(5):613–619CrossRefPubMedGoogle Scholar
  7. 7.
    Bech GJ, Pijls NH, De Bruyne B, Peels KH, Michels HR, Bonnier HJ et al (1999) Usefulness of fractional flow reserve to predict clinical outcome after balloon angioplasty. Circulation 99:883–888CrossRefPubMedGoogle Scholar
  8. 8.
    Ann SH, Her AY, Singh GB, Okamura T, Koo BK, Shin ES (2016) Serial morphological and functional assessment of the paclitaxel-coated balloon for de novo lesions. Rev Esp Cardiol 69:1026–1032CrossRefPubMedGoogle Scholar
  9. 9.
    Legalery P, Schiele F, Seronde MF, Meneveau N, Wei H, Didier K et al (2005) One-year outcome of patients submitted to routine fractional flow reserve assessment to determine the need for angioplasty. Eur Heart J 26:2623–2629CrossRefPubMedGoogle Scholar
  10. 10.
    Davies RF, Goldberg AD, Forman S, Pepine CJ, Knatterud GL, Geller N et al (1997) Asymptomatic Cardiac Ischemia Pilot (ACIP) study two-year follow-up: outcomes of patients randomized to initial strategies of medical therapy versus revascularization. Circulation 95:2037–2043CrossRefPubMedGoogle Scholar
  11. 11.
    Shin ES, Lee JH, Yoo SY, Park Y, Hong YJ, Kim MH et al (2014) A randomised, multicentre, double blind, placebo controlled trial to evaluate the efficacy and safety of cilostazol in patients with vasospastic angina. Heart 100:1531–1536CrossRefPubMedGoogle Scholar
  12. 12.
    Cutlip DE, Windecker S, Mehran R, Boam A, Cohen DJ, van Es GA et al (2007) Clinical end points in coronary stent trials: a case for standardized definitions. Circulation 115:2344–2351CrossRefPubMedGoogle Scholar
  13. 13.
    Vranckx P, Cutlip DE, Mehran R, Kint PP, Silber S, Windecker S et al (2010) Myocardial infarction adjudication in contemporary all-comer stent trials: balancing sensitivity and specificity. EuroIntervention 5:871–874CrossRefPubMedGoogle Scholar
  14. 14.
    Kleber FX, Rittger H, Bonaventura K, Zeymer U, Wohrle J, Jeger R et al (2013) Drug-coated balloons for treatment of coronary artery disease: updated recommendations from a consensus group. Clin Res Cardiol 102:785–797CrossRefPubMedGoogle Scholar
  15. 15.
    Anderson HV, Roubin GS, Leimgruber PP, Cox WR, Douglas JS Jr, King SB 3rd et al (1986) Measurement of transstenotic pressure gradient during percutaneous transluminal coronary angioplasty. Circulation 73:1223–1230CrossRefPubMedGoogle Scholar
  16. 16.
    Berger A, Botman KJ, MacCarthy PA, Wijns W, Bartunek J, Heyndrickx GR et al (2005) Long-term clinical outcome after fractional flow reserve-guided percutaneous coronary intervention in patients with multivessel disease. J Am Coll Cardiol 46:438–442CrossRefPubMedGoogle Scholar
  17. 17.
    Bech GJ, De Bruyne B, Pijls NH, de Muinck ED, Hoorntje JC, Escaned J et al (2001) Fractional flow reserve to determine the appropriateness of angioplasty in moderate coronary stenosis: a randomized trial. Circulation 103:2928–2934CrossRefPubMedGoogle Scholar
  18. 18.
    Spring DA (1985) Coronary artery dissection during PTCA: a necessary evil? Catheter Cardiovasc Diagn 11:1–3CrossRefGoogle Scholar
  19. 19.
    Cortese B, Berti S, Biondi-Zoccai G, Colombo A, Limbruno U, Bedogni F et al (2014) Drug-coated balloon treatment of coronary artery disease: a position paper of the Italian Society of Interventional Cardiology. Catheter Cardiovasc Interv 83:427–435CrossRefPubMedGoogle Scholar

Copyright information

© Springer Science+Business Media B.V., part of Springer Nature 2018

Authors and Affiliations

  • Ae-Young Her
    • 1
  • Eun-Seok Shin
    • 2
    Email author
  • Joo Myung Lee
    • 3
  • Scot Garg
    • 4
  • Joon-Hyung Doh
    • 5
  • Chang-Wook Nam
    • 6
  • Bon-Kwon Koo
    • 7
  1. 1.Division of Cardiology, Department of Internal MedicineKangwon National University School of MedicineChuncheonSouth Korea
  2. 2.Division of Cardiology, Ulsan University HospitalUniversity of Ulsan College of MedicineUlsanSouth Korea
  3. 3.Department of Internal Medicine and Cardiovascular Center, Samsung Medical CenterSungkyunkwan University School of MedicineSeoulSouth Korea
  4. 4.East Lancashire Hospitals NHS TrustBlackburnUK
  5. 5.Division of CardiologyInje University Ilsan Paik HospitalGoyangSouth Korea
  6. 6.Department of Internal Medicine, Dongsan Medical CenterKeimyung University College of MedicineTaeguSouth Korea
  7. 7.Department of Internal Medicine and Cardiovascular CenterSeoul National University HospitalSeoulSouth Korea

Personalised recommendations