June 14, 2001
Penn Participates in Trial of Stent
Device Designed to Deliver Drugs to Reduce Re-clogging
in Arteries
(Philadelphia,
PA) - Stent implantation, or using a tube-like scaffold
to reopen a blocked artery, has proven an effective
way to reestablish blood flow in coronary artery disease.
Unfortunately, restenosis - the re-clogging of arteries
following stent surgery - affects up to 20 percent of
all patients.
In an effort to find a solution to restenosis, physicians
at the University of Pennsylvania Medical Center have
performed studies in animals to help create a unique
stent designed to deliver medications into the adjacent
arterial wall. They are now participating in a human
trial of this stent, designed to release a restenosis-preventing
medication over time.
The SIRIUS Study is the first human trial of a coated
stent: the Bx Velocity. The Bx Velocity functions like
a normal stent, only it is covered with a medication
called sirolimus, which has the potential to reduce
the recurrence of symptoms after angioplasty in patients
with blockages in their heart arteries.
"The stent releases the medication gradually over
a period of 30 days - long enough to carry a patient
through the critical time after the procedure when restenosis
is likely to develop," said Robert L. Wilensky,
MD, associate professor and director of Interventional
Cardiology Research at the Penn Division of Cardiovascular
Medicine Division.
The SIRIUS Study is a large, randomized, double-blinded
clinical trial sponsored by Cordis, a Johnson &
Johnson company. Cordis received approval on February
2, 2001 from the FDA to conduct the SIRIUS clinical
trial.
Overall, the SIRIUS Study is designed to include 1,100
patients at 55 hospital centers across the United States.
The clinical results of the study will be measured through
on-going patient monitoring and review of angiographic
follow-up. The study follows two pilot trials -totaling
45 patients - involving the Bx Velocity coated stent.
In the pilot studies, there was no evidence of restenosis
12 months after the surgery or adverse events from the
treatment.
"Using a stent to reopen a blocked cardiac artery
is a well-established technique," said Wilensky,
"and this device may solve stent implantation's
biggest long-term problem."
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