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Heart of the Matter
Dr. Paustian will be
speaking on women and heart disease at "The Heart of the Matter" sponsored
by St. Peter's Hospital on Thursday, February 22, 2007 at The Great Northern
Hotel.
Drug Eluting Stents
SCAI
(Society of Cardiovascular Angiography and Intervention) President
Dr. Gregory J. Dehmer testified Thursday, 12/07/06
before the FDA Advisory Panel considering the safety of drug-eluting stents.
His testimony focused on the importance of analyzing both the benefits and
the risks of the devices. He stressed that, while recent data indicate that
the risk of late-stent thrombosis is real, it is also an infrequent event.
In his testimony, he stated: "My point is fairly simple. We all would agree
that drug-eluting stents reduce the need for subsequent revascularization
procedures. However, the small risk of late stent thrombosis from
drug-eluting stents must be considered in the context of the number of
morbid complications occurring because a revascularization procedure was
necessary for restenosis. Although the risk of harm from drug-eluting stents
we are now discussing may be as high as 1 event in 200 patient years, we
cannot lose focus on the fact that the other patients have experienced no
harm and received the potential benefits of drug-eluting stents -- primarily
avoiding the risk of further revascularization procedures. We cannot simply
focus on the risk side of this equation without appropriately considering
the benefit side."
Dr. Dehmer also pointed to medical history, providing examples of how new
technologies are refined over time to address problems that arise only
outside of the highly controlled environment of clinical trials. He
explained: "Throughout the evolution of interventional cardiology, there
have been challenges and subsequent solutions to these challenges. In fact,
it is difficult to think of any area in medical care where challenges – and
solutions – did NOT occur during introduction of a new therapy into
practice. We are now faced with evidence of a possible problem with
drug-eluting stents – very late stent thrombosis. Like all of the problems
which preceded it, we firmly believe this too will have a rational
solution."
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