CYPHER Sirolimus-eluting Stent

admin — Fri, 20 Feb 2004 20:49:04 +0000

On February 18, 2004, Cordis Corporation announced completion of patient enrollment in the first randomized head-to-head coronary stent trial comparing its new CYPHER sirolimus-eluting coronary stent with the Taxus Express (2) paclitaxel-eluting coronary stent. This trial is expressly designed to compare performance differences between the two drug-eluting stents, particularly in high-risk patient group subsets such as diabetics and patients with long lesions and small-diameter vessels. The CYPHER stent is currently the only FDA approved drug-eluting stent available for use in the United States. Boston Scientific’s Taxus paclitaxel-eluting stent has yet to receive approval from the FDA. Unlike traditional or ‘bare metal’ stents, the CYPHER stent is coated with a naturally occurring substance named sirolimus and a unique polymer. The stent props the blocked coronary artery open while the polymer gradually releases the sirolimus into the vessel wall to stop the growth of scar tissue, which causes restenosis. The pivotal Cordis-sponsored Sirius Clinical Trial involving 1,058 patients demonstrated as much as a 91% reduction in in-stent restenosis, and a 75% reduction in target lesion revascularization versus the control arm. Sirolimus is a cytostatic agent, meaning it stops cells from dividing without destroying them. It is an anti-rejection medication first used in kidney transplant patients.

In excess of five million Americans are treated for coronary artery disease each year. Most of these patients (about 80%) are treated medically, however, in excess of 1million patients will require more invasive procedures like Coronary Artery Bypass Grafting (CABG) or angioplasty. Among those patients receiving stents, 15-20% will require repeat treatment for restenosis. The CYPHER stent, approved for U.S. marketing in April 2003, has been used to treat approximately 500,000 patients in more than 80 countries worldwide. Industry analysts value the drug-eluting stent market in the 3-4 billion dollar per annum range. The actual direct cost increase associated with CYPHER compared to a bare metal stent is significant. Each CYPHER stent costs in the $2500 to $3000 range. This represents an increase of 200-300% over the per unit costs of a bare metal stent. It is duly noted that the significant decrease in restenosis rates and therefore revascularization procedures may ultimately reduce the cost per patient treated by a given health services organization.

The CYPHER stent is currently in our High Impact Technology category. All clients with significant cath-lab operations should commence or continue assessment activities as soon as possible.

Technology Details
Target Disease / Indication: Coronary Artery Disease
Technology Classification: Combination Drug/Device
Body System: Cardiovascular System
Program Area: Medicine/Cardiology
Regulatory Status: Approved
BioHorizon Impact Score: 86/100 – High

BioHorizon » Sirolimus

CYPHER Sirolimus-eluting Stent