FDA to probe safety of popular heart stents

Some doctors say stents were approved based on studies that were too small, too short and in low-risk patients. Doctors also have used them for cases other than the types of blockages for which they were approved. Success is being further undermined by many patients quitting Plavix too soon.

“They just don’t understand how important it is to continue,” said Dr. Sidney Smith of the University of North Carolina, past president of the American Heart Association.

Longer Plavix treatment now is being urged “a little bit to get the doctor off the hook,” said Dr. David Williams of Brown University. “We’re saying indefinite for some patients even though we have no idea what that means” in terms of safety, he acknowledged.

“I find that a very unsettling recommendation,” said Dr. Spencer King, a cardiologist at Fuqua Heart Center in Piedmont Hospital in Atlanta and past president of the American College of Cardiology.

Plavix carries a risk of serious bleeding, he noted. Requiring coated stent patients to take it indefinitely puts them at risk of a clot if they have to temporarily stop Plavix to prevent excessive bleeding before a hip replacement or other surgery. Already, there are reports of people suffering such clots when going off Plavix for colonoscopies.

Many people can’t afford Plavix. Medicare doesn’t cover it unless people have the supplemental drug benefit, and half of angioplasties are done in people over 65.

“In the whole saga, the most important thing comes down to whether the patient is going to take Plavix or not,” said Dr. Samin Sharma of Mount Sinai Medical Center in New York.

More research is needed to clarify the drug’s role, Cannon said.

“There’s a risk that’s there when you don’t have (Plavix). What we don’t have are studies that show what’s the risk with it,” he said.