TAXUS VI - TAXUS VI
The 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 Enrolled: 448
Mean Follow Up: Nine months
Mean Patient Age: Mean age 63 years
De novo lesion, 18-40 mm in length
Target vessel revascularization at nine months
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=0.36). 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), as was late lumen loss (0.39 mm vs. 0.99 mm, p<0.0001). Percent diameter stenosis at nine months was smaller in the paclitaxel-eluting stent group both in-stent (22.2% vs. 42.8%, p<0.0001) and in the analysis segment (30.4% vs. 45.4%, 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).
Two-year follow-up was obtained in >95% of patients (n=428). Target lesion revascularization occurred in 9.7% of the paclitaxel-eluting stent group compared with 21% of the bare-metal stent group.
Among 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.
Follow-up data through two-years show the efficacy of paclitaxel-eluting stent on target lesion revascularization was maintained through the mid-term follow-up.
Dawkins KD, et al. Clinical efficacy of polymer-based paclitaxel-eluting stents in the treatment of complex, long coronary artery lesions from a multicenter, randomized trial: support for the use of drug-eluting stents in contemporary clinical practice. Circulation. 2005 Nov 22;112(21):3306-13.
Presented by Dr. Eberhard Grube at the EuroPCR meeting, Paris France, May 2005.
Presented by Dr. K. Dawkins and E. Grube at the EURO-PCR meeting, May 2004.
Keywords: Paclitaxel, Coronary Artery Disease, Myocardial Infarction, Follow-Up Studies, Hyperlipidemias, Metals, Thrombosis, Drug-Eluting Stents, Constriction, Pathologic, Diabetes Mellitus
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