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Drug-eluting balloon angioplasty for in-stent restenosis: a systematic review and meta-analysis of randomised controlled trials
  1. Andreas Indermuehle1,
  2. Rahul Bahl1,
  3. Alexandra J Lansky2,
  4. Georg M Froehlich1,
  5. Guido Knapp3,
  6. Adam Timmis4,
  7. 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}


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.

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