Get ready for the next drug-coated stent showdown, which starts Sunday at the annual American College of Cardiology conference in Orlando, Fla.
The main event will be the results of a head-to-head -- or artery-to-artery -- test comparing the Cypher stent from
Johnson & Johnson
versus the Taxus stent from
Another big attraction features research comparing
experimental Endeavor drug-coated stent with an uncoated Medtronic stent.
The stakes are big for all three companies. J&J hopes a company-financed study will help convince cardiologists to switch to Cypher from Taxus, which entered the market in March 2004, 11 months after Cypher.
Boston Scientific has shrugged off
a stent recall this summer to retain its dominant position. The companies don't agree on market-share figures, but roughly speaking, Taxus has about a 2-to-1 edge.
Medtronic is hoping that its Endeavor test will provide enough compelling information to gain an accelerated review by the Food and Drug Administration. To many analysts, these results will indicate whether the company's stent enters the U.S. market in 2006 or 2007.
Every minute counts because
, which is being acquired by J&J, and
also are working on drug-coated stents.
Drug-coated stents are meshlike metal tubes inserted into arteries after vessel-clogging plaque has been removed. The stents facilitate blood flow and reduce the risk of heart attack. The drug-coated stents, also known as drug-eluting stents, release chemicals into the arteries periodically to reduce the risk of arteries reclogging. Uncoated stents reduce the reclogging risk, too, but the drug-coated devices do a better job.
The Cypher versus Taxus performance will be unveiled via a J&J-sponsored test nicknamed Reality. "Even if the data revealed slightly more favorable, non-significant trends for Cypher, the difference ... is likely not enough to induce a material shift away from Taxus use," said a recent research report from Goldman Sachs. And if Cypher's results appeared slightly better, "Taxus use is likely to be dictated more so by the delivery/flexibility" of the Taxus delivery system.
"We continue to expect that clinical outcomes for the two stents will be similar," the firm concluded. "We would not expect any significant market share shifts as a result of Reality data."
Goldman Sachs analysts don't own shares in any of the medical device companies mentioned in this article. They have outperform ratings on Medtronic and Boston Scientific but no rating on J&J. The firm has had investment banking relationships with each company, and Goldman Sachs is advising J&J in its acquisition of Guidant.
In January, the
Journal of the American Medical Association
published an article saying that
Cypher "may be superior" to Taxus based on a direct comparison of the two stents.
But the study contained many qualifications -- including a small sample size -- and the authors said a better comparison would be the Reality test, which tracks nearly 1,400 people. The study was conducted by German hospital researchers and financed by a German university-based hospital. They originally presented their findings at a cardiology conference in Munich in September.
More Stent Studies
Also in Orlando, Boston Scientific will present results of continuing research on Taxus to determine how well a slow-release version of the drug-coated stent deals with hard-to-treat cases.
If these Taxus results aren't convincing, Boston Scientific "always has the option of developing the moderate release version of Taxus, which showed impressive results" in another company-funded study, Goldman Sachs said.
As for Medtronic, analysts appear to have modest expectations for the Endeavor study. Goldman Sachs analysts predict that Endeavor data "will suggest that the stent is viable in niche applications," adding that they doubt the stent could reach the U.S. market until late 2007.
"We would not anticipate any significant risk in Medtronic's stock" after the test results are presented, the Goldman Sachs report said. "On the other hand, there is a chance albeit small, that the ... results could be better than expected, suggesting solid upside to the shares."