Advertisement

Drug-coated balloon angioplasty: predicting outcomes based on different patterns of drug-eluting stent restenosis

  • Xi Wang
  • Wenjie Lu
  • Xule Wang
  • Liang Pan
  • Wanrong Fu
  • Qiankun Liu
  • Zhanying Han
  • Guoju Sun
  • Xiaofei Qin
  • Ran Li
  • Xiaolin Zheng
  • Yingguang Shan
  • Chunguang QiuEmail author
Original Paper
  • 10 Downloads

Abstract

Although drug-coated balloon (DCB) angioplasty is an effective therapy for drug-eluting stent- in stent restenosis (DES-ISR) after coronary stenting, recurrent ISR after DCB angioplasty still occurs. Different patterns of DES-ISR responding to DCB are largely unknown. This study sought to assess outcomes of different patterns of DES-ISR treated with DCB. From December 2014 to December 2016, a total of 160 DES-ISR lesions treated with DCB were retrospectively evaluated. Restenosis patterns were classified into two groups according to Mehran classification: focal, defined as < 10 mm, 58 lesions (36.3%); non-focal, which were diffuse, proliferative, or obstructive, 102 lesions (63.7%). The primary endpoint was binary restenosis rate at 9-month angiographic follow-up. Secondary endpoint was major adverse cardiac events (MACE) at 24-month follow-up. Baseline characteristics were comparable between the two groups. Angiographic follow-up rate was 93.7% (93.1% in the focal group and 94.1% in the non-focal group). The focal group had a lower recurrent restenosis rate compared to the non-focal group (3.7% vs. 33.3%, respectively; P = 0.003) at an average angiographic follow-up of 10 (10.4 ± 6.2) months. There was no difference in MACE between the two groups (6.9% vs. 11.8%, respectively; P = 0.70) at (22.7 ± 9.1) months clinical follow-up. On multivariate logistic regression analysis, focal pattern (OR 13.033; 95% CI 2.441–69.573, P = 0.003) and post-procedure DS% (OR 1.142; 95% CI 1.070–1.218, P = 0.000) were predictive factors of binary restenosis after DCB angioplasty. On multivariate analysis, focal pattern of ISR was a predictive factor of MACE (OR 0.260; 95% CI 0.071–0.959, P = 0.043), and diabetes mellitus (DM) was an independent predictor of MACE after DCB angioplasty (OR 5.045; 95% CI 1.179–21.590, P = 0.029). The present study suggests that DCB provides much better clinical, angiographic outcomes in patients with focal DES-ISR than non-focal DES-ISR.

Keywords

In-stent restenosis Drug-coated balloon Drug-eluting stent Recurrent in-stent restenosis 

Notes

Compliance with ethical standards

Conflict of interest

The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.

References

  1. 1.
    Scheller B, Hehrlein C, Bocksch W et al (2006) Treatment of coronary in-stent restenosis with a paclitaxel-coated balloon catheter. N Engl J Med 355:2113–2124CrossRefGoogle Scholar
  2. 2.
    Unverdorben M, Vallbracht C, Cremers B et al (2009) Paclitaxel-coated balloon catheter versus paclitaxel-coated stent for the treatment of coronary in-stent restenosis. Circulation 119:2986–2994CrossRefGoogle Scholar
  3. 3.
    Taggart DP, Boyle R, de Belder MA et al (2011) The 2010 ESC/EACTS guidelines on myocardial revascularization. Heart 97:445–446CrossRefGoogle Scholar
  4. 4.
    Rittger H, Brachmann J, Sinha AM et al (2012) A randomized, multicenter, single-blind trial comparing paclitaxel-coated balloon angioplasty with plain balloon angioplasty in drug-eluting stent restenosis. J Am Coll Cardiol 59:1377–1382CrossRefGoogle Scholar
  5. 5.
    Byrne RA, Neumann FJ, Mehilli J et al (2013) ISAR-DESIRE 3 investigators. Paclitaxel-eluting balloons, paclitaxel-eluting stents, and balloon angioplasty in patients with restenosis after implantation of a drug-eluting stent (ISAR-DESIRE 3): a randomized, open-label trial. Lancet 381:461–467CrossRefGoogle Scholar
  6. 6.
    Alfonso F, Pérez-Vizcayno MJ, Cárdenas A et al (2014) Rationale and design of the RIBS IV randomized clinical trial (drug-eluting balloons versus everolimus-eluting stents for patients with drug-eluting stent restenosis). EuroIntervention 11(3):336–342CrossRefGoogle Scholar
  7. 7.
    Kolh P, Windecker S, Alfonso F et al (2014) 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 J Cardiothorac Surg 46:517–592CrossRefGoogle Scholar
  8. 8.
    Kastrati A, Mehilli J, vonBeckerath N et al (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(2):165–171CrossRefGoogle Scholar
  9. 9.
    Alfonso F, Pérez-Vizcayno MJ, Hernandez R et al (2006) A randomized comparison of sirolimus-eluting stent with balloon angioplasty in patients with in-stent restenosis: results of the restenosis intrastent: balloon angioplasty versus elective sirolimus-eluting stenting (RIBS-II) trial. J Am Coll Cardiol 47:2152–2160CrossRefGoogle Scholar
  10. 10.
    Dibra A, Kastrati A, Alfonso F et al (2007) Effectiveness of drug-eluting stents in patients with bare-metal in-stent restenosis: meta-analysis of randomized trials. J Am Coll Cardiol 49(5):616–623CrossRefGoogle Scholar
  11. 11.
    Li J, Liu WL, Yi X et al (2015) Paclitaxel-coated balloons for the treatment of patients with in-stent restenosis: a meta-analysis of angiographic and clinical data. Exp Ther Med 9(6):2285–2292CrossRefGoogle Scholar
  12. 12.
    Cosgrave J, Melzi G, Biondi-Zoccai GG et al (2006) Drug-eluting stentrestenosis the pattern predicts the outcome. J Am Coll Cardiol 47:2399–2404CrossRefGoogle Scholar
  13. 13.
    Mehran R, Dangas G, Abizaid AS, Mintz GS, Lansky AJ, Satler LF et al (1999) Angiographic patterns of in-stent restenosis: classification and implications for long-term outcome. Circulation 100:1872–1878CrossRefGoogle Scholar
  14. 14.
    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:K125–K128CrossRefGoogle Scholar
  15. 15.
    Cutlip DE, Windecker S, Mehran R et al (2007) Clinical end points in coronary stent trials: a case for standardized definitions. Circulation 115:2344–2351CrossRefGoogle Scholar
  16. 16.
    Habara S, Mitsudo K, Kadota K et al (2011) Effectiveness of Paclitaxel-eluting balloon catheter in patients with sirolimus-eluting stent restenosis. JACC Cardiovasc Interv 4(2):149–154CrossRefGoogle Scholar
  17. 17.
    Rittger H, Brachmann J, Sinha AM et al (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(15):1377–1382CrossRefGoogle Scholar
  18. 18.
    Habara S, Iwabuchi M, Inoue N et al (2013) 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 166:527–533CrossRefGoogle Scholar
  19. 19.
    Piccolo R, Galasso G, Piscione F et al (2014) Meta-analysis of randomized trials comparing the effectiveness of different strategies for the treatment of drug-eluting stent restenosis. Am J Cardiol 114:1339–1346CrossRefGoogle Scholar
  20. 20.
    Alfonso F, Pérez-Vizcayno MJ, Cárdenas A, for the RIBS IV Study Investigators (under the auspices of the Interventional Cardiology Working Group of the Spanish Society of Cardiology), et al (2015) 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 66:23–33Google Scholar
  21. 21.
    Siontis GCM, Stefanini GG, Mavridis D et al (2015) Percutaneous coronary interventional strategies for treatment of in-stent restenosis: a network meta-analysis. The Lancet 386:655–664CrossRefGoogle Scholar

Copyright information

© Springer Nature B.V. 2020

Authors and Affiliations

  • Xi Wang
    • 1
  • Wenjie Lu
    • 1
  • Xule Wang
    • 1
  • Liang Pan
    • 1
  • Wanrong Fu
    • 1
  • Qiankun Liu
    • 1
  • Zhanying Han
    • 1
  • Guoju Sun
    • 1
  • Xiaofei Qin
    • 1
  • Ran Li
    • 1
  • Xiaolin Zheng
    • 1
  • Yingguang Shan
    • 1
  • Chunguang Qiu
    • 1
    Email author
  1. 1.Department of CardiologyThe First Affiliated Hospital of Zhengzhou UniversityZhengzhouChina

Personalised recommendations