Wednesday, March 28, 2007 3:14:24 PM
Stent Study Shouldn't Impact Sales Long-term
5:12 PM EDT March 27, 2007
By Val Brickates Kennedy
BOSTON (Dow Jones) -- Analysts said Tuesday that they don't expect a long-term impact on stent sales from the recent release of a major study showing stent therapy doesn't ward off heart attacks or cardiac death.
On Tuesday, researchers unveiled a large-scale, multi-year study called Courage that compared the outcomes of cardiac patients who had undergone procedures known as percutaneous coronary interventions, or PCIs, to those who used drug therapy alone. PCIs include such procedures as angioplasty with the insertion of coronary stents to keep arteries clear.
While researchers found that PCI patients experienced a higher rate of relief from angina, or chest pain, for at least three years, they also had the same rates of heart attack and cardiac death as those who had only taken cardiac drugs.
The study, which ran until 2004, primarily focused on bare-metal stents, rather than the newer drug-coated stents, which are covered with a medication designed to discourage the formation of scar tissue in the treated artery. The study was sponsored in part by Pfizer (PFE) and Merck (MRK) , which market such popular heart medications as Lipitor, Zocor and Vytorin, according to Dow Jones Newswires.
"The results weren't a huge surprise. Physicians generally use stents for symptoms relief rather than for any expected mortality benefit," wrote Caris & Co. analyst Timothy Lee, in his note on Tuesday.
Boston Scientific (BSX) and Johnson & Johnson (JNJ) are the leading marketers of drug-coated stents. Medtronic (MDT) and Abbott Laboratories (ABT) have substantial stakes in the bare-metal stent market, and both are preparing to soon enter the drug-coated stent arena.
Results from the Courage study were presented Monday at the annual meeting of the American College of Cardiology and will be published in the New England Journal of Medicine.
Analysts on Tuesday said that the Courage study just underscored what physicians have already come to expect from stent therapy.
"The trial, which compared primary coronary interventions (primarily bare metal stenting or balloon angioplasty) with optimal medical therapy (drugs alone), failed to show a mortality benefit for PCI. Said another way, stents showed no mortality or heart attack benefit over drugs alone," wrote Lehman Brothers analyst Bob Hopkins, in his note.
"This outcome, while it creates a loud headline that will be in every major paper, is exactly what was expected, as no prior trial has ever demonstrated a statistically significant improvement in mortality for stents versus drug therapy, and there have been at least six trials looking at this in the past," Hopkins added.
As a result, analysts said they don't expect physicians to change their thinking on the use of stents.
"Although headline risk remains, we suspect limited changes to practice patterns. In turn, we anticipate limited impact to the stent manufacturers, particularly Boston Scientific, which has the most exposure to DES [drug-coated stents] on a relative basis," wrote Goldman Sachs analyst Lawrence Keusch.
Piper Jaffray analysts agreed. "We do not believe this trial will result in a sustained change in cardiologist practice patterns once the media frenzy dies down and patients start listening to their doctors," the Piper Jaffray analysts said.
However, analysts did point out that negative media attention will probably temporarily dampen patient demand.
"The Courage results are likely to play on patient fears and negatively affect the market in the near-term but education should return the market to "normal" in the mid- to long-term," wrote RBC Dominion Securities analyst Douglas Miehm.
Likewise, fellow RBC analyst Phil Nalbone said that the Courage results could put further short-term pressure on sales of drug-coated stents, which have already been slowed by reports that they can carry a slightly higher risk certain patients developing blood clots than bare-metal, or uncoated, stents.
"Results of studies being released at ACC -- including the high-profile Courage trial - are likely to take a further toll on drug-eluting stent penetration levels over the next several months," wrote Nalbone.
"We said coming into the ACC meeting that we would not be surprised to see another modest erosion -- in the neighborhood of 5-percentage-points -- over the next couple of quarters," Nalbone added.
Nalbone concluded, however, that the slowdown should be temporary.
"We do not believe retrenchment in DES [drug-coated stent] use caused by Courage will last for very long. Patients may be able to put off decisions about interventional therapy without fearing any increased risk of heart attack or death, but we believe eventually elect to be treated with devices in an effort to improve their overall quality of life and function," Nalbone said.
(END) Dow Jones Newswires
03-27-07 1711ET
Copyright (c) 2007 Dow Jones & Company, Inc.
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