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Since this strategy has not been evaluated in a clinical study with
humans, there is a need for such a study to validate these findings.
A multicenter prospective randomized clinical trial will be performed
at the Montreal Heart Institute. This study will involve 4-6 clinical
centers across Canada chosen for the quality of previous work in interventional
cariology research. The trial will be coordinated by the hemodynamica
laboratory of the Montreal Heart Institute.
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EXPECTED RESULTS
This study will give important information on the potential impact
of local 17B-E after PCI and the role of this therapy to prevent restenosis.
The importance of this strategy to promote a better vascular healing
can be placed in perspective of the fact that brachytherapy may retard
reendotheiliazation and impair vessel wall recovery leading to late
thrombosis and a potential catch-up phenomena with the loss of the initial
gains as a long-term follow-up. "It is our understanding from our
results and the data available in the literature that local 17B-E offers
a promising new approach to vessel passivation after PCI. It is our
intent to pursue in this field and propose to the patient needing improved
vascular healing an ESTRACURE solution including catheter and drug coated
stent delivery of 17B-E Estradiol to improve clinical outcome. THE DATA
OBTAINED MAY LEAD TO SIGNIFICANT ADVANCES IN THERAPEUTIC STRATEGIES
TO IMPROVE PATIENT CARE AND REDUCE RESTENOSIS." (Montreal Heart
Institute.)
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RECENT MEDICAL ADVANCES
(DRUG-COATED STENTS)
On Tuesday, September 4, 2001, researchers from Johnson & Johnson's
Cordis Unit reported that their antibiotic-coated (drug Siolimus) stent
reduced the incidence of restenosis to zero. These RAVEL findings were
presented on that Tuesday at the European Society of Cardiology Annual
Congress in Stockholm. Sirolimus is an immunosuppressant drug used to
prevent kidney transplant rejection. It's in a class of drugs know as
cell cycle inhibitors and works by preventing cell overgrowth.
Later in September, Boston Scientific reported promising result on
the initial human tests of drug-coated stents, used in propping up clogged
arteries. After six months, there were no signs of blood clots or scarring
of the artery around the stent. "The results were extremely impressive
and demonstrate that Boston Scientific 's...stents hold enormous promise
as a dramatic new therapy for coronary artery disease," said Dr.
Eberhard Grube of the Sieburg Heart Center in Germany.
The stent market is presently at 2.3 billion and its is expected to
rise to over 4 billion in the next few years as prices increase and
more people espouse this therapy.
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IMPACT OF THESE NEW ADVANCES
These advances only serve to heighten the studies being done at the
Montreal Heart Institute in findings a solution to restenosis. Going
beyond the coating of a stent to the possibility of a one-dose application
to remedy the problem, the Institute's findings go well beyond the initial
case of restenosis to the possibility of a stentless approach that would
eliminate restenosis. As Dr. Karl Karsch, head of Cardiology at Bristol
University in England, says, "You're dealing with a systemic disease.
Artherosclerosis is all over the body. You are just interfering at a
lesion, you are not interfering with the disease." Moreover, angioplasty
and stenting places an upper limit on how many stents a patient may
have.
Thus the significance of what is being accomplished at the Montreal
Heart Institute takes into account the possibility of a coated stent
but also goes beyond this to isolate the gene involved in restenosis
and to give equal protection to all vessels in the brain and in other
vascular systems.
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