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

Comments

Popular posts from this blog

Inflammatory Bowel Disease an Independent Risk Factor for MI

The Council of the European Union has decided that the European Medicines Agency (EMA) will be relocated to the City of Amsterdam.

What makes prostate cancer aggressive? Or not so....Study investigates