New Findings Buoy Rebounding Drug-Eluting Stent Market

For more than a year, drug-eluting stents have been battered by a storm of negative publicity that questioned the efficacy and safety of the devices. Having captured almost 90% of the coronary stent market shortly after receiving FDA approval, drug-eluting stents experienced a precipitous decline in usage as a result of the widely reported safety concerns.

Over the past year, the worldwide drug-eluting stent market has lost about $1 billion in revenues—falling to a current valuation of around $5 billion. Cordis Corp. (Miami Lakes, FL), a Johnson & Johnson company, reported that third-quarter sales of its Cypher stent fell by 44% in the United States and 40% worldwide compared with the year-ago period. Boston Scientific Corp (Natick, MA), manufacturer of the Taxus drug-eluting stent, reported sales declines of 38% and 22%, respectively.

While signs of a slight rebound in sales were already being seen, stent manufacturers and interventional cardiologists were buoyed by a number of positive clinical studies recently released at the Transcatheter Cardiovascular Therapeutics (TCT) conference in Washington, DC, and the American Heart Association's Scientific Sessions in Orlando, FL.

Gregg Stone, MD, chairman and chief medical officer of the Cardiovascular Research Foundation (New York City), organizer of TCT, said, “The conference released the findings of seven longer-term clinical studies representing more than 61,000 patients—all with serious degrees of coronary artery disease. In each of the studies, drug-eluting stents performed significantly better in preventing restenosis and the need for revascularization, as well as reducing mortality rates, compared to bare-metal stents.”

At the TCT conference—which also marked the 30th anniversary of percutaneous coronary intervention, or angioplasty—experts presented a number of updates from stent-usage registries, including several that had initially called into question the safety of drug-eluting stents. All of the presentations concerned with drug-eluting stent patients reported significant reductions in the need for repeat procedures, as well as no statistically significant increase in stent thrombosis, myocardial infarction, or death.

The tale was much the same in presentations made earlier this month at the Scientific Sessions meeting of the American Heart Association (AHA; Dallas, TX). At the AHA meeting, Laura Mauri, MD, assistant professor of medicine at the Harvard University Medical School (Boston), presented the results of what was reported to be the largest observational study of drug-eluting stents ever conducted in the United States, which included more than 21,000 patients. Mauri, who served as principal investigator, reported that the study found a significantly lower mortality rate and need for revascularization with patients who had received drug-eluting stents compared with those implanted with bare-metal devices. “There has been a long debate about the safety of drug-eluting stents,” said Mauri. “It was very reassuring to see that there was not an increased rate of death or heart attack.”

The mood at the 19th annual TCT meeting was reportedly quite upbeat compared with last year's gathering, which was held just as the impact of studies questioning the safety of drug-eluting stents was firmly taking hold. Reflecting on the events of the past year, Martin Leon, MD, chairman of the Cardiovascular Research Foundation, characterized the situation as a “climate of calamity.”

Looking back, there is a growing consensus among researchers and industry analysts that the concerns about stent thrombosis were blown out of proportion, particularly considering the very low incidence of blood clots associated with drug-eluting stents.

Earlier this month, an article in the New York Times attributed the stent fallout, at least in part, to “alarmist media coverage.” Noted in particular was a report from cable channel MSNBC that described drug-eluting stents as “tiny time bombs,” and included the subheading “Millions face risk from drug-coated stents; Potentially lethal heart devices a frightening problem for patients, doctors.” The report was prepared by Robert Bazell, chief science and health correspondent for NBC News, and was initially aired in November 2006. It subsequently received widespread national coverage in print, broadcast, and electronic media.

Thomas J. Gunderson, managing director and senior medtech analyst with Piper Jaffray & Co. (Minneapolis), agrees that early study results were overinterpreted. “There was a great deal of shooting from the hip on some of the early studies that questioned the safety of drug-eluting stents,” says Gunderson. “The concerns were legitimate, but sweeping inferences were made and conclusions drawn from very limited data.”

Looking ahead to 2008, two additional devices are expected to be available in the United States: the Endeavor drug-eluting stent manufactured by Medtronic Inc. (Minneapolis), and the Xience stent from Abbott Labs (Abbott Park, IL).

Endeavor received a unanimous recommendation for approval from FDA's circulatory systems panel last month and is expected to get full agency approval by early next year. Xience goes before the panel later this month, and FDA approval is expected by the second quarter of 2008. Once approved, the Xience stent will also be marketed by Boston Scientific under the Promus brand, as part of the divestiture agreement necessitated by the company's acquisition of Guidant Corp.

Endeavor and Xience have both received CE marking and are currently sold in numerous countries around the world.

At this year's TCT conference, Abbott also reported on the first clinical trial of its Absorb stent, a bioabsorbable everolimus-eluting device made of polylactic acid, a biocompatible material that is used extensively in such medical products as dissolvable sutures. Results from a one-year, 30-patient trial demonstrated no stent thrombosis and a low incidence of major adverse cardiac events. According to Abbott, the bioabsorbable stent is slowly metabolized by the body and completely absorbed over time. The company has not disclosed a timetable for seeking FDA approval of the Absorb stent.

The once high-flying CoStar drug-eluting stent was back in the news at TCT, with a generally positive report that it performed significantly better than its bare-metal counterpart in reducing restenosis, the need for revascularization, and the incidence of major adverse cardiac events. CoStar was originally manufactured by Conor MedSystems, which was acquired by Cordis Corp. in November 2006. Although the stent received the CE mark in February 2006, Cordis withdrew it from all international markets in May of this year after it performed poorly in a stent-to-stent match-up with Taxus. According to a company spokesperson, CoStar is still in development and will likely be reconfigured before seeking market approval.

With positive news coming out of TCT and the AHA meeting, stent manufacturers are cautiously optimistic about a market rebound. Piper Jaffray's Gunderson says, “The worst of the bad news is over, and we have reached a floor. If, as anticipated, more comprehensive trials and follow-up studies continue to demonstrate the efficacy and safety of drug-eluting stents, the market will recover further.”

No one is expecting a return to penetration rates of 90% any time soon—if ever. But most analysts think that the drug-eluting devices could climb back to a 75% share of the coronary stent market within the next two years.

© 2007 Canon Communications LLC

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