The Korean journal of internal medicine

The Korean Association of Internal Medicine (대한내과학회)
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The efficacy and safety of drug-eluting balloons for the treatment of in-stent restenosis as compared with drug-eluting stents and with conventional balloon angioplasty

  • Oh, Pyung Chun (Division of Cardiology, Department of Internal Medicine, Gachon University Gil Medical Center) ;
  • Suh, Soon Yong (Division of Cardiology, Department of Internal Medicine, Gachon University Gil Medical Center) ;
  • Kang, Woong Chol (Division of Cardiology, Department of Internal Medicine, Gachon University Gil Medical Center) ;
  • Lee, Kyounghoon (Division of Cardiology, Department of Internal Medicine, Gachon University Gil Medical Center) ;
  • Han, Seung Hwan (Division of Cardiology, Department of Internal Medicine, Gachon University Gil Medical Center) ;
  • Ahn, Taehoon (Division of Cardiology, Department of Internal Medicine, Gachon University Gil Medical Center) ;
  • Shin, Eak Kyun (Division of Cardiology, Department of Internal Medicine, Gachon University Gil Medical Center)
  • Received : 2014.06.25
  • Accepted : 2015.03.23
  • Published : 2016.05.01
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Abstract

Background/Aims: Treatment of coronary in-stent restenosis (ISR) is still associated with a high incidence of recurrence. We aimed to compare the efficacy and safety of drug-eluting balloons (DEB) for the treatment of ISR as compared with conventional balloon angioplasty (BA) and drug-eluting stents (DES). Methods: Between January 2006 and May 2012 a total of 177 patients (188 lesions, $64.1{\pm}11.7$ years old) who underwent percutaneous coronary intervention for ISR were retrospectively enrolled. Clinical outcomes were compared between patients treated with DEB (n = 58, 32.8%), conventional BA (n = 65, 36.7%), or DES (n = 54, 30.5%). The primary end point was a major adverse cardiac event (MACE), defined as a composite of cardiac death, myocardial infarction, and target lesion revascularization (TLR). Results: Baseline characteristics were not different except for a history of previous MI, which was more frequent in patients treated by conventional BA or DES than in patients treated by DEB (40.0% vs. 48.1% vs. 17.2%, respectively, p = 0.002). The total incidences of MACEs were 10.7%, 7.4%, and 15.4% in patients treated by DEB, DES, or conventional BA, respectively (p > 0.05). TLR was more frequent in patients treated by conventional BA than in patients treated by DEB or DES, but this was not statistically significant (10.8% vs. 6.9% vs. 3.7%, p > 0.05 between all group pairs, respectively). Conclusions: This study showed that percutaneous coronary intervention using DEB might be a feasible alternative to conventional BA or DES implantation for treatment of coronary ISR. Further large-scaled, randomized study assessing long-term clinical and angiographic outcomes will be needed.

Keywords

References

  1. Stettler C, Wandel S, Allemann S, et al. Outcomes associated with drug-eluting and bare-metal stents: a collaborative network meta-analysis. Lancet 2007;370:937-948. https://doi.org/10.1016/S0140-6736(07)61444-5
  2. Wohrle J, Nusser T, Kestler HA, Kochs M, Hombach V. Comparison of the slow-release polymer-based paclitaxel-eluting Taxus-Express stent with the bare-metal Express stent for saphenous vein graft interventions. Clin Res Cardiol 2007;96:70-76. https://doi.org/10.1007/s00392-006-0460-1
  3. Dangas GD, Claessen BE, Caixeta A, Sanidas EA, Mintz GS, Mehran R. In-stent restenosis in the drug-eluting stent era. J Am Coll Cardiol 2010;56:1897-1907. https://doi.org/10.1016/j.jacc.2010.07.028
  4. Scheller B. Drug-coated balloons: the new gold standard for treatment of coronary in-stent restenosis? Cardiovasc Revasc Med 2012;13:257-259. https://doi.org/10.1016/j.carrev.2012.07.005
  5. 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;355:2113-2124. https://doi.org/10.1056/NEJMoa061254
  6. Habara S, Mitsudo K, Kadota K, et al. Effectiveness of paclitaxel-eluting balloon catheter in patients with sirolimus-eluting stent restenosis. JACC Cardiovasc Interv 2011;4:149-154. https://doi.org/10.1016/j.jcin.2010.10.012
  7. Scheller B, Clever YP, Kelsch B, et al. Long-term follow-up after treatment of coronary in-stent restenosis with a paclitaxel-coated balloon catheter. JACC Cardiovasc Interv 2012;5:323-330. https://doi.org/10.1016/j.jcin.2012.01.008
  8. Rittger H, Brachmann J, Sinha AM, et al. A randomized, multicenter, single-blinded trial comparing pa-clitaxel-coated balloon angioplasty with plain balloon angioplasty in drug-eluting stent restenosis: the PEPCAD-DES study. J Am Coll Cardiol 2012;59:1377-1382. https://doi.org/10.1016/j.jacc.2012.01.015
  9. Mauri L, Hsieh WH, Massaro JM, Ho KK, D'Agostino R, Cutlip DE. Stent thrombosis in randomized clinical trials of drug-eluting stents. N Engl J Med 2007;356:1020-1029. https://doi.org/10.1056/NEJMoa067731
  10. Mehran R, Dangas G, Abizaid AS, et al. Angiographic patterns of in-stent restenosis: classification and implications for long-term outcome. Circulation 1999;100:1872-1878. https://doi.org/10.1161/01.CIR.100.18.1872
  11. Alfonso F, Zueco J, Cequier A, et al. A randomized comparison of repeat stenting with balloon angioplasty in patients with in-stent restenosis. J Am Coll Cardiol 2003;42:796-805. https://doi.org/10.1016/S0735-1097(03)00852-0
  12. Kastrati A, Mehilli J, von Beckerath N, et al. 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 2005;293:165-171.
  13. Iofina E, Haager PK, Radke PW, et al. Sirolimus- and paclitaxel-eluting stents in comparison with balloon angioplasty for treatment of in-stent restenosis. Catheter Cardiovasc Interv 2005;64:28-34. https://doi.org/10.1002/ccd.20212
  14. Radke PW, Kobella S, Kaiser A, et al. Treatment of in-stent restenosis using a paclitaxel-eluting stent: acute results and long-term follow-up of a matched-pair comparison with intracoronary beta-radiation therapy. Eur Heart J 2004;25:920-925. https://doi.org/10.1016/j.ehj.2004.02.014
  15. Indermuehle A, Bahl R, Lansky AJ, et al. Drug-eluting balloon angioplasty for in-stent restenosis: a systematic review and meta-analysis of randomised controlled trials. Heart 2013;99:327-333. https://doi.org/10.1136/heartjnl-2012-302945
  16. Waksman R, Pakala R. Drug-eluting balloon: the comeback kid? Circ Cardiovasc Interv 2009;2:352-358. https://doi.org/10.1161/CIRCINTERVENTIONS.109.873703
  17. Scheller B, Hehrlein C, Bocksch W, et al. Two year follow-up after treatment of coronary in-stent restenosis with a paclitaxel-coated balloon catheter. Clin Res Cardiol 2008;97:773-781. https://doi.org/10.1007/s00392-008-0682-5
  18. Unverdorben M, Vallbracht C, Cremers B, et al. Paclitaxel-coated balloon catheter versus paclitaxel-coated stent for the treatment of coronary in-stent restenosis. Circulation 2009;119:2986-2994. https://doi.org/10.1161/CIRCULATIONAHA.108.839282
  19. Byrne RA, Neumann FJ, Mehilli J, et al. 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 2013;381:461-467. https://doi.org/10.1016/S0140-6736(12)61964-3

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