September 6, 2007 – Boston Scientific Corp. announced at the ESC 2007 conference in Vienna, Austria, that results from the five-year TAXUS II clinical trial found that the TAXUS paclitaxel-eluting stent showed no additional stent thrombosis between years four and five, while the bare-metal control experienced one stent thrombosis during this same period.
The results from the study mark the third consecutive year of TAXUS II follow-up with no stent thrombosis seen in the TAXUS stent patient group.
TAXUS II is a randomized, double-blind, controlled study of 536 patients in 15 countries designed to evaluate the safety and efficacy of a TAXUS paclitaxel-eluting coronary stent, in which two sequential cohorts of patients with standard risk, de novo coronary artery lesions were treated with different dose formulations.
The efficacy advantage of the TAXUS Stent seen at six months was maintained through the five years following stent implantation, with the commercialized slow-release (SR) version of the TAXUS Stent reducing Target Lesion Revascularization (TLR) by 44 percent versus bare-metal stents (TAXUS SR 10.3%, BMS 18.4%, p=0.0003). Safety of the TAXUS stent was also maintained with Major Adverse Cardiac Events (MACE) for the TAXUS SR stent showing a 35 percent reduction over the bare-metal control stent (TAXUS SR 20.4%, BMS 27.6%, p=0.01). The overall myocardial infarction (MI) rate for the TAXUS SR stent was 4.7 percent as compared to 7.1 in the bare-metal group (TAXUS SR 4.7%, BMS 7.1%, p=NS).
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