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- Document type:
- Comparative Study; Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't; Article
- Author(s):
- Mehilli, J; Dibra, A; Kastrati, A; Pache, J; Dirschinger, J; Schömig, A
- Title:
- Randomized trial of paclitaxel- and sirolimus-eluting stents in small coronary vessels.
- Abstract:
- AIMS: Sirolimus- and paclitaxel-eluting stents effectively reduce restenosis in small coronary vessels. The relative efficacy of these drug-eluting stents in this high-risk subset is not known. METHODS AND RESULTS: A total of 360 patients undergoing percutaneous coronary intervention for de novo lesions in native coronary vessels with a diameter of <2.80 mm received randomly paclitaxel-eluting stents (n=180) or sirolimus-eluting stents (n=180). The primary endpoint was in-stent late luminal loss. Secondary endpoints were angiographic restenosis and need of target lesion revascularization. The study intended to show that the paclitaxel-eluting stent is not inferior to the sirolimus-eluting stent with respect to the primary endpoint. The non-inferiority margin was set at 0.16 mm. Follow-up angiography was performed in 87% of the patients. In-stent late luminal loss in the paclitaxel-eluting stent group was 0.32 mm (upper 95% boundary, 0.42 mm), which was greater than that in the sirolimus-eluting stent group, failing to show the non-inferiority of the paclitaxel-eluting stent to the sirolimus-eluting stent (P>0.99). Angiographic restenosis was found in 19.0% of the lesions in the paclitaxel-eluting stent group and 11.4% of the lesions in the sirolimus-eluting stent group (P=0.047). Target lesion revascularization was performed in 14.7% of the lesions treated with paclitaxel-eluting stents and 6.6% of the lesions treated with sirolimus-eluting stents (P=0.008). CONCLUSION: The paclitaxel-eluting stent is associated with a greater late luminal loss and is less effective in reducing restenosis in small coronary vessels than the sirolimus-eluting stent.
- Journal title abbreviation:
- Eur Heart J
- Year:
- 2006
- Journal volume:
- 27
- Journal issue:
- 3
- Pages contribution:
- 260-6
- Language:
- eng
- Fulltext / DOI:
- doi:10.1093/eurheartj/ehi721
- Pubmed ID:
- http://view.ncbi.nlm.nih.gov/pubmed/16401670
- Print-ISSN:
- 0195-668X
- TUM Institution:
- I. Medizinische Klinik und Poliklinik (Kardiologie)
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