Panel: Drug-Coated Stents Are Safe

Health Advisers Dismiss Heart Attack, Death Risk Of Drug-Coated Stents For Some Patients

(CBS/AP) 
FDA staff, however, believe drug-coated stent patients could face a small but significant chance of blood clots.

"Are you certain of that conclusion?" asked panel member Dr. John Somberg of Rush University Medical Center in Lake Bluff, Ill.

FDA medical officer Dr. Andrew Farb said he was, after acknowledging the difficulty of acting on that information.

"When we have rare events in relatively small numbers, to come up with sweeping conclusions can raise issues," Farb said.

Some researchers believe clotting associated with the stents leads to an increased risk of heart attack and death — a danger the FDA said is unknown.

Boston Scientific acknowledges a slight increase in clotting associated with its drug-coated stent, the Taxus. The company said it has seen no corresponding increase in heart attacks or deaths.

"At the end of the day, the things patients care about — 'Am I more likely to be dead or have a major heart attack?' — the answer is 'no,"' said Dr. Donald Baim, Boston Scientific's executive vice president and chief medical and scientific officer.

Johnson & Johnson said there is no significant difference in clotting, heart attack or death rates between its stent, the Cypher, and bare metal versions.

Both companies said use of the drug-coated stents reduces the need for follow-up surgeries to reopen clogged arteries when compared with bare-metal stents. That accounts for the widespread use of the drug-coated versions since their introduction in 2003.

Multiple studies have suggested the risk of blood clots, heart attack and death rises in patients who stop taking Plavix earlier than now recommended. Some doctors recommend patients stay on it indefinitely until more is learned.

The panel recommended labels on the devices be updated to reflect those studies. Earlier, FDA staff said it is unknown how long patients should take the drug, distributed by Bristol-Myers Squibb Co. and Sanofi-Aventis SA, citing the risk of bleeding. The panel also said patients should talk to their doctors before stopping or restarting use of Plavix.

On Friday, the FDA also will seek recommendations for research on the drug-coated stents on the market or pending approval. Both Medtronic Inc. and Abbott Laboratories hope to enter the more than $5 billion U.S. market for the drug-coated stents.

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Re: "Drug-Coated Stents Are Safe"

Hmmm. How about candy-coated buttplugs?