CDU Washington Editor

Given the growing evidence concerning the need for anti-platelet drug therapy following implantation of a drug-eluting stent (DES), Boston Scientific (Natick, Massachusetts), maker of the Taxus DES, on the eve of the Scientific Sessions of the American College of Cadiology (Washington) unveiled a program intended to promote increased compliance with anti-platelet therapy.

The effort will consist of what the company termed a patient education effort intended to encourage long-term compliance with the recommended duration.

The company said it will provide up to $40 million for the program. This will not involve payments for any drugs, but the company said it will offer “a patient assistance program designed to facilitate access to financial support for anti-platelet therapy for patients who qualify.”

Funding will go to education, outreach and patient follow-up, consisting primarily of phone calls, e-mails and standard mail pieces. The company said it will begin training for “the initial education component” of the initiative immediately and launch it in the U.S. “later this year.”

Paul LaViolette, company COO, said in a statement that the program isn’t just for those implanted with Taxus. “We are pleased to offer this program to all DES patients, not just Taxus patients, to encourage participation in the program for all physicians.”

The ideal duration of anti-platelet therapy, which usually entails the use of both Plavix and aspirin, was the subject of some discussion but few firm conclusions at recent FDA hearings on DES. Following those hearings, FDA issued a statement that 12 months is probably as good an estimate as any for anti-platelet use.

On its web site, the agency indicates that “patients [should] receive aspirin indefinitely plus a minimum of three months (for Cypher patients) or six months (for TAXUS patients) of clopidogrel, with therapy extended to 12 months in patients at a low risk of bleeding.”

Charles Rudnick, director of corporate communications for Boston Scientific, said that the company has no plans to extend the program to those implanted with bare-metal stents, but “maybe down the road” if conditions warrant.