Medical Device Daily Washington Editor

WASHINGTON — This year's edition of the Transcatheter Cardiovascular Therapeutics conference TCT 2008, for short marks the 20th anniversary of the gathering, and the agenda for Sunday's opening day at the Washington Convention Center showed very clearly that the drug-eluting stent (DES) is still a newsmaker despite the slowdown in sales seen over the past two years.

On the other hand, markets outside the industrialized West are opening up, even if native industry is taking up a lion's share of the largest of those markets, namely China.

Martin Leon, MD, the founder and chairman emeritus of the sponsor of the TCT series, the Cardiovascular Research Foundation (New York), led off the DES summit with a brief discussion titled "The Changing Landscape of DES: Finally Stabilizing or Still in Transition?"

He said, "Things have essentially stabilized ... but we have not fully rebounded" to the DES usage numbers seen in 2006. According to Leon, the numbers indicate a reduction of roughly 10% in PCI procedures from 2006, although "we've seen an increase in PCI procedures year to year" since then.

Cardiologists implanted about 15% more DES units as of August last year than in 2006, he said, adding that the numbers indicate that DES use rose by another 7% as of this past August.

Leon said European patients were implanted with about 4.5% more coated stents last year than in 2006, but that there was no increase in Japan. He was pointing out the obvious in remarking that compared to other parts of the world, the market in "the U.S. has been the most subject to change."

Christian Spaulding, MD, of Rene Descartes University (Paris), gave attendees a look at how doctors in Europe deal with the large number of coated stents that have earned a CE mark. The first thing he pointed out was that a CE mark is not the same as a place in the catheter lab arsenal.

"Stents have to go through different hurdles before they end up on the shelf of a cath lab," let alone in someone's chest, he said. He reminded attendees that Europe "is a patchwork of countries" and a CE mark means "you can put the device on the market," but "there are a lot of notified bodies and there is no uniform process in analyzing manufacturing process or clinical data," which are the steps needed to obtain reimbursement.

"Several countries, such as France and Belgium, have several additional hurdles," Spaulding said, noting that in his home nation, "we currently have only four or five reimbursed stents" and they "can only be implanted in some specific indications." Among the indications are patients with new lesions, those with lesions of 3mm in diameter or less, and lesions of 15mm or less in length.

"Things are changing in France," he said, noting that the government "will ask for large trial registries and ... for one-year data" on a range of scores and outcomes. This will slow adoption, he said, "but will be good for safety."

France has a fixed price it pays for stents, Spaulding noted, but hospitals and hospital groups can negotiate prices down. He echoed Leon's remarks about the relative volatility of the European market as a whole, but reminded attendees that there are substantial variations within Europe in terms of reimbursement and market penetration.

Junbo Ge, MD, director of cardiology at Zhongshan Hospital (Shanghai, China), gave attendees a quick look at how the DES is making an impact on care and on the bare-metal stent (BMS) in the world's most populous nation.

He said that the first PCI to be performed in China was in 1982 and from that point, "development was very slow." However, for the past few years, "the interventional market is up 30% each year."

As might be expected, most of this activity is along the heavily urbanized east coast. China has only about 150 medical centers that are authorized to perform percutaneous interventions, Ge said, but Beijing wants to expand that number into the nation's interior.

As for market penetration, the Firebird, a sirolimus-coated stent based on a stainless steel frame, currently holds 30% of the Chinese market. The Firebird is made by Microport (Shanghai), and its biggest competitor, the Partner DES, is manufactured by Lepu (Beijing) and accounts for another 23% of the market.

Perhaps not surprisingly, at least one of China's bigger players is run by a physician who cut his teeth in the U.S. According to the web site for Lepu, the company "was founded in 1999 by Dr. Zhongjie Pu, a Chinese returnee with U.S. post-graduate education in material science and years of research and development experience" with Cordis (Miami Lakes, Florida.)

According to Ge, the first iteration of the Firebird used a strut with a thickness of about .004", but the Firebird 2 is built on struts only .0034". The supporting data is not necessarily easy to come by despite the huge numbers of China's population. "In China, it's very difficult to do a randomized study" because of follow-up issues, he said, so much of the supporting data for the Firebird stents is registry data.

The pivotal study for the Firebird, the FIREMAN (FIREbird sirolimus-eluting stent In coMplex coronAry lesioNs) study placed no limits on the number of stents that could be implanted, and dealt with complex lesions. Ge said the rate of major adverse cardiac events at 12 months was 4.1%, and the target lesion revascularization rate was 2.1%.

Patients in this study were on 100 mg of aspirin and 75 mg of clopidogrel for at least eight months. Roughly 27% of the patients got only one Firebird, but the largest group, at almost 42%, got two stents. Patients with three stents accounted for almost 20%, and there were patients who received more than seven. The total number of patients who were subject to thrombosis at one year was nine out of 1,078.