Article Text

Download PDFPDF
Interventional cardiology
Randomised trial of three rapamycin-eluting stents with different coating strategies for the reduction of coronary restenosis: 2-year follow-up results
  1. R A Byrne1,
  2. S Kufner1,
  3. K Tiroch2,
  4. S Massberg1,
  5. K-L Laugwitz2,
  6. A Birkmeier1,
  7. S Schulz1,
  8. J Mehilli1,
  9. for the Intracoronary Stenting and Angiographic Restenosis–Test Efficacy of Rapamycin-Eluting STents with Different Polymer Coating Strategies (ISAR-TEST-3) Investigators
  1. 1
    Deutsches Herzzentrum, Technische Universität, Munich, Germany
  2. 2
    1.Medizinische Klinik, Klinikum rechts der Isar, Technische Universität, Munich, Germany
  1. Correspondence to Dr Robert A Byrne, ISAResearch Centre, Deutsches Herzzentrum München, Lazarettstrasse 36, 80636 Munich, Germany; byrne{at}


Background: Drug-eluting stent (DES) platforms devoid of durable polymer have potential to enhance long-term safety outcomes. The ISAR-TEST-3 study was a randomised trial comparing three rapamycin-eluting stents with different coating strategies. The present study examined 2-year outcomes of these patients and is the first large-scale trial to report longer-term outcomes with biodegradable polymer and polymer-free DES.

Methods: Patients with de novo coronary lesions in native vessels were randomly assigned to receive biodegradable polymer (BP; n = 202), permanent polymer (PP; Cypher; n = 202) and polymer-free (PF; n = 201) stents. The 2-year endpoints of interest were target lesion revascularisation (TLR), death/myocardial infarction (MI), stent thrombosis and delayed angiographic late luminal loss (LLL) between 6–8 months and 2 years.

Results: There were no significant differences in TLR (8.4%, 10.4% and 13.4% for BP, PP and PF stents, respectively; p = 0.19), death/MI (5.9%, 6.4% and 6.5% with BP, PP and PF respectively; p = 0.97) or stent thrombosis (definite/probable 0.5%, 1.0% and 1.0% with BP, PP and PF, respectively; p = 0.82). Paired angiographic follow-up at 6–8 months and 2 years was available for 302 patients (69.0% of eligible patients). Delayed LLL was significantly different across the treatment groups: 0.17 (0.42) mm, 0.16 (0.41) mm and −0.01 (0.36) mm for BP, PP and PF stents, respectively (p<0.001).

Conclusion: Clinical antirestenotic efficacy was maintained with all three platforms between 1 and 2 years, although angiographic surveillance showed ongoing delayed LLL with both BP and PP stent platforms. At 2 years there was no signal of a differential safety profile between the three stent platforms.

Statistics from

Request Permissions

If you wish to reuse any or all of this article please use the link below which will take you to the Copyright Clearance Center’s RightsLink service. You will be able to get a quick price and instant permission to reuse the content in many different ways.


  • Funding Study design and analysis were performed by Deutsches Herzzentrum, Munich, and funding was industry independent, provided in part by the Bavarian Research Foundation (BFS-ISAR Aktenzeichen AZ: 504/02 and BFS-DES Aktenzeichen AZ: 668/05).

  • Competing interests None.

  • The abstract of this work was presented as an oral contribution at the American College of Cardiology Scientific Sessions 2009 in Orlando, Florida, USA.

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