Renewed DES Safety Debate Creates Second Generation Mover Advantage
Recent clinical trial analysis has revived the debate over the safety of drug-eluting stents (DES), creating the possibility that safety, rather than efficacy, may turn out to be a differentiating factor for companies developing next-generation products.
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The real story that came out of this year's Transcatheter Cardiovascular Therapeutics (TCT) meeting held in October in Washington, DC, is not the news per se regarding specific clinical trial results or new device technologies. Instead, it is the story behind the news. Interventional cardiology has been built on the back of evidence-based medicine. That methodology, however, has come under attack in the last year.
For the second year in a row, results from a clinical trial announced at the annual American College of Cardiology (ACC) conference appeared to be bad news for coronary stents. The outcomes from the COURAGE trial, announced at this year's ACC meeting in New Orleans at the end of March, found that angioplasty with stenting did not reduce the risk of major adverse cardiovascular events when added to optimal medical therapy.
Cardiovascular investigators are now asking new questions, including how can treatment be targeted to those most likely to benefit, and when does aggressive treatment become too much? At the 2006 American Heart Association (AHA) meeting, these questions were at the top of everyone's list, and several highly anticipated studies attempted to provide some answers.