Confusion over anti-clotting therapy hinders drug-eluting stent rebound.
Blanket recommendations for one year of dual antiplatelet therapy for patients who receive drug-eluting stents may be the biggest cloud over the market for the devices, cardiologists suggest.
Drug-eluting stents accounted for only 62% of stent placements in the United States in September, an all-time low. And at Washington Hospital Center, one of the highest volume cath labs in the country, physicians used drug-eluting stents instead of bare-metal only 52% of the time, says Ron Waksman, who practices interventional cardiology at the D.C. hospital.
"At the end of the day, the main reason in Washington that we don't use drug-eluting stents is because of the limitation of the prolonged antiplatelet therapy," he said during the Transcatheter Cardiovascular Therapeutics conference Oct. 20.
Dual antiplatelet therapy was a hot topic among clinicians. regulators, and industry representatives alike at the Washington, D.C., meeting, which wrapped up Oct. 25.
Following the signs of increased late thrombosis from drug-eluting stents that emerged last year, professional societies changed their guidelines and FDA moved to change device labeling to recommend one year of dual antiplatelet therapy--clopidogrel (Plavix) and aspirin--for patients with the devices.
Johnson and Johnson's Cypher was initially approved for use with a three-month drug regimen, and Boston Scientific's Taxus with a six-month regimen.
Waksman noted that his hospital now will not give drug-eluting stents to patients who are unwilling or unable to take clopidogrel for the one-year duration--for instance patients already on the blood thinner warfarin, patients who are scheduled for surgery, or patients who cannot pay for the prescription.
Clopidogrel costs $3 to $4 per day and carries a risk of bleeding complications.
Figuring out more specifics about which subpopulations may benefit the most from long-term antiplatelet therapy and who may benefit the least should be a top research priority, Waksman said, since most doctors agree that a full year is not likely necessary in all cases.
"We have one of the rare scenarios where the professional society recommendations around the world all have agreed to a one-year time frame, when there's not a single pivotal trial of drug-eluting stents that has been conducted using a one-year time flame," Mitchell Krucoff. an interventionalist at Duke University, said. "The simple fact is we have absolutely no idea."
Andrew Farb, a medical officer in CDRH's cardiology devices review branch, said a new focus for FDA in drug-eluting stent trials going forward will be to have sponsors more closely track actual prescription patterns for dual antiplatelet therapy and see if there is any relation to clinical events.
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|Title Annotation:||Regulatory Report|
|Publication:||Medical Design Technology|
|Date:||Nov 1, 2007|
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