|
|
|
| * These
news are selected from 'TCT Daily (2004)' provided
by Cardiovascular Research Foundation (CRF). |
Antonio Colombo, Centro Cuore
Columbus in Milan, Italy, MD, presented two-year
results of TAXUS-2.
TAXUS II researchers randomized patients to two
consecutive cohorts of moderate-release and slow-release
Taxus stents as well as matched controls. The objective
of the two-year follow-up presented here was to
evaluate the longevity of the safety profile and
clinical efficacy.
Taxus stents prevented rather than delayed in-stent
restenosis with preserved long-term safety. There
was no indication of toxicity as evidenced by late-acquired
incomplete apposition, coronary aneurysm and late
stent thrombosis rates. Clinical efficacy and safety
were confirmed with QCA and IVUS-imaging analysis
demonstrating preserved neointimal suppression.
Of the original cohort of 545 patients in the TAXUS
II study, 207 were available for QCA analysis including
104 bare-metal stent controls. Forty-nine patients
were in the Taxus (Boston Scientific) moderate-release
group and 54 in the slow-release group.
At two years, minimal lumen diameter (MLD) was 2.35
mm in the moderate-release group and 2.32 mm in
the slow-release group. These were statistically
insignificant changes from the measurements obtained
at six months (2.34 mm and 2.32 mm, respectively).
MLD was lower in the control group, and there was
a significant difference in this parameter at two
years (2.12 mm) and six months (1.96 mm).
Late loss was 0.25 mm in the moderate-release group
and 0.27 mm in the slow-release group at two years,
compared to 0.54 mm in the control group.
IVUS analysis was conducted in 161 patients, of
whom 41 were in the moderate-release group, 43 in
the slow-release group, and 77 in the control group.
Percentage volume obstruction at two years was significantly
lower in the moderate-release group (11.93%, P=.0139)
and the slow-release group (10.59%, P=.0018) compared
to the control group (17.07%).
Incomplete apposition at two years was 6.5% in the
moderate-release group, 8.7% in the slow-release
group and 9% in the control group, an insignificant
difference.
At two years, there was a 14.2% rate of major adverse
cardiac events in the moderate- and slow-release
groups and a 24.6% rate in the control group (P=.0178).
Also at two years, Taxus patients in the slow-release
group had a TLR event rate of 5.5% compared to 3.9%
in moderate-release patients and 15.5% in controls.
Similar differences were noted in the rate of survival
free of TLR. There were no differences in stent
thrombosis rates among the three groups. |
|
|
|
|
|
