Nine-month results from
the TAXUS VI trial, testing Boston Scientific's
moderate-release-formulation paclitaxel-eluting
stent in longer lesions in complex patients, Dr
Eberhard Grube (Heart Center Siegburg, Germany)
presented that the TAXUS MR had significantly
reduced target lesion revascularization (TLR)
and binary restenosis rates, compared with bare-metal
stents. Diabetic patients, who represented 20%
of the TAXUS VI population, also benefited from
the coated stent. TAXUS VI enrolled patients with
smaller vessels (2.5 to 3.75 mm) and a high proportion
of diabetics and condoned the use of multiple
overlapping stents. The target vessel revascularization
(TVR), the primary end point of TAXUS VI, was
9.1% in the Taxus MR arm, compared with 19.4%
in the control arm, a statistically significant
difference. TLR rates and MACE were also reduced
in the Taxus group. However, stent thrombosis
rates were low in both groups. Binary restenosis
rates, both in-stent and in-segment, were significantly
lower in the Taxus group. QCA data showed improved
outcomes in terms of percent diameter stenosis,
minimum lumen diameter, and in-segment late loss.
Dr Grube said: "This trial clearly shows
the lowest TLR rate reported in any long lesion
trial. Despite excellent results in the control
arm, the TAXUS MR patients demonstrates an excellent
safety profile comparable to control, with a 64%
improvement in TLR."
Major TAXUS VI results
| End
point |
Taxus
stent
(n=219) |
Bare-metal
stent
(227) |
p |
| TVR (%) |
9.1 |
19.4
|
0.0027
|
| TLR (%) |
6.8 |
18.9
|
0.0001
|
| MACE (%) |
16.4
|
22.5
|
NS |
| Stent thrombosis (%) |
0.5
|
1.3
|
0.62
|
| Binary restenosis (in-segment*)
(%) |
12.4
|
35.7
|
<0.0001 |
| Binary restenosis (in-stent)
(%) |
9.1
|
32.9
|
<0.0001 |
| Diameter stenosis (in-segment)
(%) |
30.4
|
45.4
|
<0.0001 |
| Minimum lumen diameter
(in-segment) (mm) |
1.97
|
1.51
|
0.0001 |
| Late lumen loss (in-segment)
(mm) |
0.24
|
0.66
|
<0.0001 |
| *Stented segment plus 5 mm beyond
stent edge |
TAXUS VI: Diabetic results
| End
point |
Taxus
stent |
Bare-metal
stent |
p |
| Binary restenosis (in-segment)
(%) |
10.8
|
47.6
|
0.0005
|
| TLR (%) |
2.6
|
22
|
0.0103
|
|