Randomised trial of three rapamycin-eluting stents with different coating strategies for the reduction of coronary restenosis: 2-year follow-up results
- R A Byrne1,
- S Kufner1,
- K Tiroch2,
- S Massberg1,
- K-L Laugwitz2,
- A Birkmeier1,
- S Schulz1,
- J Mehilli1,
- for the Intracoronary Stenting and Angiographic Restenosis–Test Efficacy of Rapamycin-Eluting STents with Different Polymer Coating Strategies (ISAR-TEST-3) Investigators
- 1Deutsches Herzzentrum, Technische Universität, Munich, Germany
- 21.Medizinische Klinik, Klinikum rechts der Isar, Technische Universität, Munich, Germany
- Correspondence to Dr Robert A Byrne, ISAResearch Centre, Deutsches Herzzentrum München, Lazarettstrasse 36, 80636 Munich, Germany; byrne{at}dhm.mhn.de
- Accepted 30 June 2009
- Published Online First 9 July 2009
Abstract
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.
Footnotes
-
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.
