| We are studying the
TAXUS™ product in a broad range of patients, including patients
with in-stent restenosis, small vessels, long lesions, and diabetes.
To gather more complete information, we assembled the largest Intravascular
Ultrasound (IVUS) data sets for both drug-eluting stents and controls
in the field rather than relying on angiograms alone.
TAXUS I. In 2001, we reported data
from our TAXUS I clinical trial, which tested our slow-release drug-eluting
platform and demonstrated a zero percent restenosis rate at six
months. TAXUS I was a feasibility study designed to assess safety.
It was a 61-patient, randomized, double-blind, multi-center safety
trial conducted at three centers in Germany. No stent thrombosis
was reported at six months. The 30-day Major Adverse Cardiac Events
(MACE) rate was zero percent in the control group (that received
a bare metal stent) and the TAXUS stent group. In addition, the
six-month MACE rate was 7 percent in the control group and zero
percent in the TAXUS stent group. At twelve months the MACE rate
was 10 percent and 3 percent in the control and TAXUS stent groups,
respectively, demonstrating excellent long-term safety.
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