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- Dokumenttyp:
- Comparative Study; Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't; Article
- Autor(en):
- Byrne, RA; Mehilli, J; Iijima, R; Schulz, S; Pache, J; Seyfarth, M; Schömig, A; Kastrati, A
- Titel:
- A polymer-free dual drug-eluting stent in patients with coronary artery disease: a randomized trial vs. polymer-based drug-eluting stents.
- Abstract:
- 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.
- Zeitschriftentitel:
- Eur Heart J
- Jahr:
- 2009
- Band / Volume:
- 30
- Heft / Issue:
- 8
- Seitenangaben Beitrag:
- 923-31
- Sprache:
- eng
- Volltext / DOI:
- doi:10.1093/eurheartj/ehp044
- PubMed:
- http://view.ncbi.nlm.nih.gov/pubmed/19240066
- Print-ISSN:
- 0195-668X
- TUM Einrichtung:
- I. Medizinische Klinik und Poliklinik (Kardiologie)
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