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At TCT, New Studies Support Drug-Eluting Stents

BUSINESS NEWS

After experiencing a serious downturn caused by concern over possible links between drug-eluting coronary stents and late-term thrombosis, the market for such products has been steadily recovering throughout 2008. That trend toward recovery received another boost in October, with the release of new studies reported at the Trans­catheter Cardiovascular Therapeutics Conference (TCT) in Washington, DC.

The clinical studies revealed at the conference generally concluded that drug-eluting stents are safe and do not increase the incidence of major adverse cardiac events (MACE) as compared with bare-metal stents. More importantly, the TCT studies generally affirmed the long-held belief of interventional cardiologists that drug-eluting stents are significantly more effective than their bare-metal counterparts for combating restenosis, or reclogging of the artery.

"These results provide definitive evidence that drug-eluting stents are superior in efficacy to bare-metal stents and have a comparable safety profile at one year," said Gregg W. Stone, MD, professor of medicine and the director of research and education at the Center for Interventional Vascular Therapy at New York Presbyterian Hospital/Columbia University Medical Center.

Stone's comments were based on the results of the clinical study titled Harmonizing Outcomes with Revascularization and Stents in Acute Myocardial Infarction (HORIZONS AMI). The study was sponsored by the Cardiovascular Research Foundation (CRF; New York City), with research grant support from Boston Scientific Corp. (Natick, MA) and the Medicines Co. (Parsippany, NJ), a developer of intravenous anticoagulants for use in patients undergoing coronary angioplasty. Stone is the chairman of CRF, which organizes the annual TCT conference.

Almost certainly, the stent manufacturer with the most favorable news coming out of TCT was Abbott Vascular, a division of Abbott (Abbott Park, IL). In two clinical studies, Abbott's Xience V drug-eluting stent was found to outperform Boston Scientific's Taxus in both safety and efficacy.

The stent manufacturer receiving the most disappointing news at TCT was perhaps Medtronic Inc. (Minneapolis). One study successfully demonstrated the safety of the company's Endeavor drug-eluting stent compared with its bare-metal version known as Driver. But another study raised serious safety concerns when Endeavor went head to head in a clinical trial with the Cypher drug-eluting stent from Cordis Corp. (Warren, NJ), a Johnson & Johnson company.

At this year's TCT meeting, Cordis—the first company to market a drug-eluting stent--did not attract a great deal of attention from either industry analysts or the media. In study results announced at the meeting, the company's flagship Cypher sirolimus-eluting stent compared favorably in a head-to-head match-up with perennial rival Boston Scientific.

Looking to the future, Cordis demonstrated its development work on a new generation of reservoir-based drug-eluting stents called Nevo, a technology it acquired with its purchase of Conor Med­systems LLC (Menlo Park, CA) in late 2006.

Although the U.S. market for drug-eluting stents remains down sharply from the 85–90% penetration rate of just a few years ago, use of drug-eluting stents has climbed back to a rate around 70%. Current market value is thought to be about $2 billion, which represents a 40–50% decline from the peak in 2006.

With its Xience V drug-eluting stent, Abbott has captured just over 50% of the market, far exceeding even the most optimistic forecasts following FDA approval of the stent in July. The company's market share includes sales under the Xience V brand as well as distribution of the stent under the Promus brand by Boston Scientific, which earned the right to sell the stent as part of its acquisition of Guidant. Boston Scientific reportedly pays Abbott a 40% royalty on every Promus stent it sells.

Boston Scientific's Taxus stent, formerly the market leader, now has a 19% market share. Cordis's Cypher stent has an estimated 15% share, while Medtronic's Endeavor has fallen to 13% in the most recent quarter.

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