Heart 99:327-333 doi:10.1136/heartjnl-2012-302945
  • Coronary revascularisation
  • Original article

Drug-eluting balloon angioplasty for in-stent restenosis: a systematic review and meta-analysis of randomised controlled trials

  1. Pascal Meier1,2
  1. 1Department of Cardiology, University College London Hospital, London, UK
  2. 2Department of Cardiology, Yale Medical School, New Haven, Connecticut, USA
  3. 3Department of Statistics, Technical University Dortmund, Dortmund, Germany
  4. 4Department of Cardiology, The Chest Hospital, London, UK
  1. Correspondence to Dr Pascal Meier, University College London UCL, London W1G 8PH, UK; pascalmeier74{at}
  • Received 21 August 2012
  • Revised 14 November 2012
  • Accepted 2 December 2012
  • Published Online First 18 January 2013


Context The optimal treatment option for in-stent restenosis is currently unclear.

Objective Systematic review and meta-analysis of the effect of drug-eluting balloons (DEB) to treat in-stent restenosis.

Data sources Trials were identified through a literature search from 2005 through 7 November 2012.

Study selection Randomised clinical trials comparing DEB with a control treatment (plain balloon angioplasty or drug-eluting stents).

Data extraction and synthesis Main endpoints of interest were major adverse cardiac events (MACE), target lesion revascularisation (TLR), binary in-segment restenosis, stent thrombosis (ST), myocardial infarction (MI) and mortality. A random-effects model was used to calculate the pooled relative risks (RR) with 95% CIs.

Results Five studies and a total of 801 patients were included in this analysis. Follow-up duration ranged from 12 to 60months. Most endpoints were significantly reduced for DEB compared with the control groups. For MACE, the relative risk RR was 0.46 (0.31 to 0.70), p<0.001, for TLR it was 0.34 (0.16 to 0.73); p=0.006, for angiographic in-segment restenosis it was 0.28 (0.14 to 0.58); p<0.001. There was a lower mortality for DEB (RR 0.48 (0.24 to 0.95); p=0.034). The incidence of MI was numerically lower, but the differences were not statistically significant (RR 0.68 (0.32 to 1.48); p=0.337). There was no difference in the risk of ST (RR 1.12 (0.23 to 5.50), p=0.891).

Conclusions In-stent restenosis is the bane of coronary angioplasty, and drug-eluting balloon angioplasty is a promising treatment option in this situation. It reduces the risk for MACE compared with plain balloon angioplasty or implantation of a Taxus Liberte drug-eluting stent.

Responses to this article