European Heart Journal Advance Access originally published online on February 24, 2009
European Heart Journal 2009 30(8):923-931; doi:10.1093/eurheartj/ehp044
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A polymer-free dual drug-eluting stent in patients with coronary artery disease: a randomized trial vs. polymer-based drug-eluting stents
1 ISAR Centre, Deutsches Herzzentrum, Technische Universität, Lazarettstrasse 36, 80636 Munich, Germany
2 1. Medizinische Klinik rechts der Isar, Munich, Germany
Received 27 October 2008; revised 5 December 2008; accepted 19 December 2008; online publish-ahead-of-print 24 February 2009.
* Corresponding author. Tel: +49 89 1218 1538, Fax: +49 89 1218 1539, Email: byrne{at}dhm.mhn.de; robebyrne{at}hotmail.com
Aims: Long-term polymer residue in the coronary milieu is a consequence of current drug-eluting stent (DES) therapy and has been implicated in late adverse events. We developed a novel polymer-free rapamycin- and probucol-eluting stent (Dual-DES) and compared its efficacy against commercially available permanent polymer-based sirolimus-eluting (SES; Cypher) and zotarolimus-eluting (ZES; Endeavor) stents.
Methods and results: Between March 2006 and July 2007, a total of 1007 patients undergoing coronary stenting of de novo lesions, in native vessels, were randomized to treatment with SES (n = 335), Dual-DES (n = 333), or ZES (n = 339). The primary endpoint was binary angiographic restenosis at 6–8 month follow-up angiography. Secondary endpoints were angiographic in-stent late loss; and target lesion revascularization (TLR), death/myocardial infarction and stent thrombosis at 12 months. Follow-up angiographic data were available for 828 (82.2%) patients. There was a significant difference in both binary restenosis and TLR across treatment groups (P = 0.003 and P < 0.001, respectively). Binary restenosis in the Dual-DES group (11.0%) was significantly lower than that in the ZES group (19.3%; P = 0.002) but comparable with that in the SES group (12.0%; P = 0.68). Similarly, TLR with Dual-DES (6.8%) was significantly lower than ZES (13.6%; P = 0.001) but not different to that of SES (7.2%; P = 0.83). These differences were mirrored in the extent of late loss across the groups. No differences were observed between stent groups in terms of death/myocardial infarction or stent thrombosis.
Conclusion: A novel polymer-free Dual-DES is associated with high anti-restenotic efficacy without recourse to carrier polymer. Potential long-term clinical advantage of this platform remains subject to investigation.
Study registered at ClinicalTrials.gov. Identifier number: NCT00332397 [ClinicalTrials.gov] .
Key Words: Antioxidants • Drug-eluting stents • Follow-up studies • Polymer • Probucol • Randomized control trial • Rapamycin • Restenosis
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  R. A. Byrne, A. Kastrati, S. Kufner, S. Massberg, K. A. Birkmeier, K.-L. Laugwitz, S. Schulz, J. Pache, M. Fusaro, M. Seyfarth, et al. Randomized, non-inferiority trial of three limus agent-eluting stents with different polymer coatings: the Intracoronary Stenting and Angiographic Results: Test Efficacy of 3 Limus-Eluting Stents (ISAR-TEST-4) Trial Eur. Heart J., October 2, 2009; 30(20): 2441 - 2449. [Abstract] [Full Text] [PDF]
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 R A Byrne, S Kufner, K Tiroch, S Massberg, K-L Laugwitz, A Birkmeier, S Schulz, J Mehilli, and for the Intracoronary Stenting and Angiographic Re Randomised trial of three rapamycin-eluting stents with different coating strategies for the reduction of coronary restenosis: 2-year follow-up results Heart, September 15, 2009; 95(18): 1489 - 1494. [Abstract] [Full Text] [PDF]
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