by Sruthi Valluri
, DOTmed News | April 19, 2011
Courage was closely followed by other studies, which continued to undermine the popularity of stents. In 2009, a National Institute of Health study titled BARI 2D, found that among some patients, bypass surgery yields far better results than stents. That same year, Boston Scientific Corp. sponsored a study that found surgery should be the standard of care in patients with severe coronary artery disease because there are fewer adverse effects experienced than with procedures involving stents.
SCAI’s White, who is also the principle investigator for a study on carotid stents sponsored by Boston Scientific Corp., points out that before Courage and the subsequent studies, interventional cardiology was aggressive in its treatment of blocked arteries. “At the time we thought that opening as many arteries as we possibly could, was the best way to treat patients, but Courage and the other [studies] made us understand that’s not the best thing.”
The U.S. Food and Drug Administration ratcheted up the controversy when it took on another dispute that was slowly unfolding: drug eluting stents, a new generation of stents coated with drugs to prevent arteries from re-clogging. The stents received a very warm reception upon their introduction in 2003. By 2004, Boston Scientific’s Taxus, for example, generated sales of more than $2 billion. By 2006, drug-eluting stents accounted for nearly 90 percent of all stent procedures, according to the American Heart Association.
But the rapid rise of drug-eluting stents was hobbled. In 2006, reports emerged of cases in which drug-eluting stents were found to have caused strokes. The FDA convened an emergency Advisory Panel to discuss the potential risk and make recommendations.
“Whenever something new comes out, it’s the best thing since sliced bread. Like drug-coated stents,” says Gacioch. “The pendulum swings in its favor, and then you figure out, it might not be the best thing. So the pendulum swings back.”
According to the AHA, drug-eluting stents now account for only 70 percent of stent procedures, a significant decline.
White, who also acts as the system chairman for cardiovascular diseases at the John Ochsner Heart & Vascular Institute in New Orleans, says that many of the patients who walk through his clinic’s door are initially scared.
“It’s the hyperboles that they hear,” says White, pointing out that the issue can seem alarming when many of the details are misunderstood.
Gacioch has noticed a similar pattern in his own practice. “When things first come out, there’s a fear factor that kicks in,” says Gacioch. “Some people get unnecessarily scared; some people might even avoid having things done that they should have done.”