Cordis patient registry to evaluate long-term safety, efficacy of drug-eluting coronary stents

By Lisa Kerner

Erie, Pa.,. May 15 - Cordis Corp. started e-Select, a new global patient registry with three-year follow up designed to evaluate the real-world safety and efficacy of the Cypher Select Sirolimus-eluting Coronary Stent (only available in Europe, Asia Pacific, Latin America and Canada), as well as later generations of Cordis drug-eluting stents.

Enrollment of the first of 30,000 patients has begun in the multi-center, prospective, observational registry, which will evaluate the need for repeat procedures, major adverse cardiac events such as heart attack and death, and in-stent blood clots.

Cordis said the registry population will allow investigators to perform sub-analyses on complex patient groups such as diabetics and those with multi-vessel disease, in-stent re-blockages (restenosis) or a prior history of heart attack.

"The e-Select Registry is the first registry to specifically document the real-world outcomes of patients treated with next-generation Cordis drug-eluting stents like the Cypher Select Stent," vice president, worldwide clinical and regulatory affairs Dennis Donohoe said in a company news release.

"We are optimistic for the initial and long-term results from the e-Select Registry and expect it will provide important safety and efficacy trends that can be confirmed by randomized, controlled clinical trials - the highest form of clinical evidence available."

Miami-based Cordis, a Johnson & Johnson company, develops and manufactures interventional vascular technology.

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