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Interventional cardiology
Distribution of angiographic measures of restenosis after drug-eluting stent implantation
  1. R A Byrne1,
  2. S Eberle2,
  3. A Kastrati1,
  4. A Dibra1,
  5. G Ndrepepa1,
  6. R Iijima1,
  7. J Mehilli1,
  8. A Schömig3
  1. 1
    Deutsches Herzzentrum, Technische Universität, Munich, Germany
  2. 2
    GlaxoSmithKline GmbH & Co KG, Munich, Germany
  3. 3
    1. Medizinische Klinik, Klinikum rechts der Isar, Technische Universität, Munich, Germany
  1. Correspondence to Dr Robert A Byrne, Deutsches Herzzentrum München, Lazarettstrasse 36, 80636 Munich, Germany; byrne{at}dhm.mhn.de

Abstract

Background: A bimodal distribution of measures of restenosis has been demonstrated at 6–8 months after bare metal stent implantation. Drug-eluting stent (DES) treatment has attenuated the impact of certain factors (eg, diabetes) on restenosis but its effect on the distribution of indices of restenosis is not known.

Objective: To perform a detailed analysis of the metrics of restenosis indices after DES implantation.

Design, settings, patients: Prospective observational study of patients undergoing DES implantation (Cypher, sirolimus-eluting stent; or Taxus, paclitaxel-eluting stent) at two German centres, with repeat angiography scheduled at 6–8 months after coronary stenting.

Main outcome measures: In-stent late luminal loss (LLL) and in-segment percentage diameter stenosis (%DS) as determined by quantitative coronary angiography at recatheterisation.

Results: Paired cineangiograms were available for 2057 patients. Overall mean (SD) LLL was 0.31 (0.50) mm; mean (SD) %DS was 30.3 (15.7)%. Distribution of both LLL and %DS differed significantly from normal (Kolmogorov–Smirnov test; p<0.001 for each). For both parameters a mixed distribution model better described the data (likelihood ratio test with 3df; p<0.001 for each). This consisted of two normally distributed subpopulations with means (SD) of 0.10 (0.25) mm and 0.69 (0.60) mm for LLL, and means (SD) of 22.2 (8.6)% and 40.1 (16.6)% for %DS. The results were consistent across subgroups of DES type, “on-label” versus “off-label” indication, and presence or absence of diabetes.

Conclusions: LLL and %DS at follow-up angiography after DES implantation have a complex mixed distribution that may be accurately represented by a bimodal distribution model. The introduction of DES treatment has not resulted in elimination of a variable propensity to restenosis among subpopulations of patients with stented lesions.

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Footnotes

  • Additional tables are published online only at http://heart.bmj.com/content/vol95/issue19

  • Funding RAB was supported by a Research Fellowship in Atherothrombosis from the European Society of Cardiology.

  • Competing interests AK has received lecture fees from Bristol-Myers, Cordis, Lilly, Medtronic and Sanofi-Aventis. No other authors have any conflict of interest to declare.

  • Ethics approval Approval from Deutsches Herzzentrum, Technische Universität, Munich, Germany and 1. Medizinische Klinik, Klinikum rechts der Isar, Technische Universität, Munich, Germany.

  • Provenance and peer review Not commissioned; externally peer reviewed.

  • See Editorial, p 1556

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