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
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
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
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
"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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Penn Medicine is one of the world’s leading academic medical centers, dedicated to the related missions of medical education, biomedical research, and excellence in patient care. Penn Medicine consists of the Raymond and Ruth Perelman School of Medicine at the University of Pennsylvania (founded in 1765 as the nation's first medical school) and the University of Pennsylvania Health System, which together form a $7.8 billion enterprise.
The Perelman School of Medicine has been ranked among the top five medical schools in the United States for the past 20 years, according to U.S. News & World Report’s survey of research-oriented medical schools. The School is consistently among the nation’s top recipients of funding from the National Institutes of Health, with $405 million awarded in the 2017 fiscal year.
The University of Pennsylvania Health System’s patient care facilities include: The Hospital of the University of Pennsylvania and Penn Presbyterian Medical Center — which are recognized as one of the nation’s top “Honor Roll” hospitals by U.S. News & World Report — Chester County Hospital; Lancaster General Health; Penn Medicine Princeton Health; Penn Wissahickon Hospice; and Pennsylvania Hospital – the nation’s first hospital, founded in 1751. Additional affiliated inpatient care facilities and services throughout the Philadelphia region include Good Shepherd Penn Partners, a partnership between Good Shepherd Rehabilitation Network and Penn Medicine, and Princeton House Behavioral Health, a leading provider of highly skilled and compassionate behavioral healthcare.
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