There are new stents out on the market and they have renewed an old controversey: should the cardiologist take drastic heroic-like measures to ttreat patients with invasive techniniques like angiograms, angioplasty, stents and coronary artery bypass surgery, or should they take a more conservative, less physically traumatic approach.
According to a story in today's Washington Post, there is accumulating evidence that new drug impregnated stents cause blood clots that can reblock the arteries. The Food and Drug Administration is holding an urgent two-day meeting of a panel of outside experts tomorrow to assess the devices, known as drug-eluting stents, including whether their risks outweigh their benefits.
"This is a public health issue of great importance," the FDA's Daniel Schultz said yesterday. "Our goal is to provide the American public with a coherent, understandable explanation of the risks and benefits associated with these products."
The situation, which has triggered an intense, sometimes bitter debate among cardiologists, illustrates the potential dangers of assuming that new technologies are necessarily superior and of adopting them widely before long-term studies are done, experts said.
"Everybody wants to be perceived as doing the most modern thing for their patients and fear being labeled someone who is old-fashioned and not using the latest and greatest thing," said Spencer King of the American College of Cardiology.
The issue also has major financial implications, with worldwide sales of drug-eluting stents now estimated at about $6 billion annually. Boston Scientific Corp. and Johnson & Johnson, which make the two drug-eluting stents sold in the United States, defend the safety of the devices.The coronary artery bypass graft was in use well before Cleveland Clinic did any studies regarding its safety and efficacy and now noninvasive cardiologists are beginning to agree it is overprescribed. Now if we can only get the surgeons and hospitals weaned off of the big bucks they earn performing CABGs.