Randomized trial of three rapamycin-eluting stents with different coating strategies for the reduction of coronary restenosis

Eur Heart J. 2008 Aug;29(16):1975-82. doi: 10.1093/eurheartj/ehn253. Epub 2008 Jun 11.


Aims: The objective of this study was to assess the non-inferiority, in terms of anti-restenotic efficacy, of both biodegradable-polymer (BP) and polymer-free (PF) stents compared with permanent-polymer rapamycin-eluting (PP; Cypher) stent.

Methods and results: Patients with de novo coronary lesions in native vessels were randomly assigned to receive a BP stent, a PF stent or a PP stent. The primary endpoint was in-stent late lumen loss at follow-up angiogram. A total of 605 patients were enrolled: 202 patients received BP stents, 202 were treated with PP stents, and 201 received PF stents. Repeat angiography was available for 492 patients (81.3%). Mean late lumen loss at 6-8-month angiographic follow-up was 0.17 +/- 0.45 mm in the BP stent group, 0.23 +/- 0.46 mm in the PP cohort, and 0.47 +/- 0.56 mm in the PF stent group. The BP stent met pre-specified criteria for non-inferiority (P < 0.001), whereas the PF stent did not (P = 0.94). There were no differences in safety outcomes.

Conclusion: Both BP and PF stents have a 1-year safety profile similar to that of the PP stent. Whereas the PF stent provided an inferior efficacy, the BP stent is at least as effective as the PP stent in terms of anti-restenotic efficacy.

Publication types

  • Comparative Study
  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Aged
  • Coated Materials, Biocompatible*
  • Coronary Restenosis / diagnostic imaging
  • Coronary Restenosis / prevention & control*
  • Coronary Stenosis / diagnostic imaging
  • Coronary Stenosis / drug therapy
  • Drug-Eluting Stents / standards
  • Female
  • Humans
  • Male
  • Polymers*
  • Prospective Studies
  • Radiography
  • Sirolimus / therapeutic use*
  • Stents / standards*
  • Treatment Outcome
  • Tubulin Modulators / therapeutic use*


  • Coated Materials, Biocompatible
  • Polymers
  • Tubulin Modulators
  • Sirolimus