TAXUS V1 trial

TAXUS VI Trial Goal of the TAXUS VI trial was to evaluate paclitaxel-eluting stents compared with bare metal stents for treatment of long, de novo lesions.
Patients were randomized to bare metal stent (n=227) or paclitaxel-eluting moderate-release stent (n=219). Stent lengths were 8, 16, 24, and 32 mm and diameters were 2.5, 3.0, and 3.5 mm.
Baseline characteristics were well matched between the treatment groups, with 58% hypertensives, 20% diabetics, and 72% with hyperlipidemia. Baseline minimum lumen diameter was 0.84 mm versus 0.87 mm (p=0.39) and diameter stenosis was 70.2% versus 68.6% (p=0.12) for the paclitaxel-eluting stent group versus the bare metal stent group, respectively. Average lesion length was 20.9 mm versus 20.3 mm (p=0.38).
Procedural success was reported in 92.7% of the paclitaxel-eluting stent group and 95.2% of the bare metal stent group (p=0.32).
At nine-month angiographic follow-up, in-stent binary restenosis was lower in the paclitaxel-eluting stent group (9.1% vs. 32.9%, p<0.0001),>
The primary endpoint of target vessel revascularization at nine months was lower in the paclitaxel-eluting stent group (9.1% vs. 19.4%, p=0.003).
There was no significant difference in major cardiac adverse events at nine months (16.4% vs. 22.5%, p=0.12).
There was also no difference in cardiac death (0% vs. 0.9%, p=0.50), Q-wave myocardial infarction (MI) (1.4% vs. 1.3%, p=1.0), or non-Q-wave MI (6.8% vs. 4.8%, p=0.42).
Stent thrombosis occurred in 0.5% of the paclitaxel-eluting stent group and 1.3% of the bare metal stent group (p=0.62). InterpretationAmong patients with long, de novo lesions, treatment with the paclitaxel-eluting moderate-release stent was associated with a reduction in target vessel revascularization at nine months compared with treatment with bare metal stent.
The present study is the first large-scale trial of the paclitaxel-eluting stent to focus specifically on patients with long lesions.
The earlier TAXUS I and II studies have included patients with shorter lesions of ≤12 mm.
Despite the longer lesion length, the rate of safety events such as stent thrombosis was not increased with the paclitaxel-eluting stent compared with bare metal stent, and was comparable to other TAXUS trials of the same stent.
Presented by Dr. K. Dawkins and E. Grube at the EURO-PCR meeting, May 2004.
Summary Written By
Sabina A. Murphy, M.P.H. Author Disclosure:Research Grants: Astra, Aventis, Boston Scientific, Bristol Myers Squibb, COR Therapeutics, DVI Guidant, Eli Lilly, Genentech, Merck, Millennium Pharmaceuticals, Pfizer, SmithKline Beecham, Sonus, NIH, Percusurge, Pharmadigm, Point Biomedical, TIMI 3 Systems.
source: cardiosource


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