I read the news today, oh boy

Posted on December 9, 2006 by Gene

Now, as if it weren’t scary enough having a heart attack at a young age and emerging with three drug-eluding stents in my arteries, there’s this news today:

New drug-oozing stents widely used to prop open clogged arteries are associated with an increased risk of blood clots, heart attacks and death for the majority of patients receiving the devices, an expert panel concluded yesterday.

Based on the finding, the special 21-member Food and Drug Administration panel recommended that the agency issue new warnings to doctors and patients that the devices’ safety has not been established except for relatively low-risk patients, for whom the stents were originally tested and approved.

“If you use the device outside that indication, you’re going to have a higher incidence of complications,” said William H. Maisel of the Beth Israel Deaconess Medical Center in Boston, who chaired the panel.

The panel stressed that the tiny metal-lattice struts, known as drug-eluting stents, offer advantages over older bare-metal versions for some patients, with the benefits outweighing the risks for the relatively healthy patients for whom the devices have been tested.

It remains unclear whether the devices are causing the complications in other patients; the side effects could be occurring because these patients tend to be sicker. But panel members concluded that until that question can be answered, doctors and patients should be alerted about the potential risks. Several members said they hoped that would make doctors more cautious about using the devices.

… The panel also recommended that patients who have the stents take anti-clotting drugs for at least a year.

More than 6 million people worldwide have gotten the drug-coated devices, including perhaps 3 million in the United States. At least 800,000 new patients get them each year, making the stents the most common device used to treat heart disease and one of the most common medical procedures of any kind. The panel’s recommendations apply to at least 60 percent of those patients.

… The newer stents are coated with a polymer impregnated with drugs that are released slowly, inhibiting scar-tissue growth. Because the devices were shown to be highly effective, they were hailed as a major advance and quickly replaced bare-metal versions for most patients, though the newer stents were tested on and approved for only low-risk patients.

The FDA called for the meeting after studies looking at patients outside tightly controlled clinical trials indicated that a year or more after implantation, patients with drug-coated stents faced increased risks compared with those with bare-metal models. Some researchers have estimated the newer devices might be causing thousands of heart attacks and deaths a year.

Some researchers, along with Boston Scientific Corp. and Johnson & Johnson, which make the two drug-eluting stents sold domestically, say any risks from the devices are offset by the reduced need for repeated procedures and bypass surgery, which carry their own risks.

Patients who get the stents had been advised to take aspirin and the drug Plavix for three to six months to reduce the risk of blood clots. Recent studies have indicated that patients may need to take the drugs longer, perhaps indefinitely. But Plavix is expensive and increases the risk of serious bleeding.

I bet there will be a flurry of questions waiting for cardiologists on Monday, mine included. Am I one of the “relatively healthy” patients to which this warning doesn’t apply? Or am I part of the 60% who should be worried? My cardiologist does have me on Plavix for a year, I’m on Coumadin right now to prevent clots but I think I’ll be going off that shortly. Or will I?