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Test Results Due Out Soon Are Crucial to Stents’ Future 2007-03-24
By Barnaby Feder

Test Results Due Out Soon Are Crucial to Stents’ Future

Physicians and Wall Street analysts are eagerly awaiting news next week about heart stents that could have big implications for patients and stent makers alike.

At a national cardiology meeting on Tuesday, researchers plan to share the results of a major clinical trial investigating whether heart patients with chronic chest pains actually benefit from getting stents placed in their clogged coronary arteries. Financial analysts say any negative findings could hurt the two companies that dominate the $3.2 billion domestic stent business: Boston Scientific and Johnson & Johnson.

Many Wall Street analysts say they expect the trial to show that while stents improve blood flow by propping open the arteries, the devices do not perform any better than drugs in helping such patients live longer or avoid heart attacks. Some analysts predict that such findings would make cardiologists more cautious about recommending stenting to patients.

That would be bad news for stent makers, although much of it may already be anticipated by investors — Boston Scientific’s shares, which fell 37 cents, to $15.22 yesterday, have already declined more than 11 percent this year. Analysts estimate that patients who frequently suffer chest pains when they exert themselves, a condition known as stable angina, account for 30 percent to 40 percent of the stent market.

Tuesday’s trial data, to be presented at the American College of Cardiology meeting in New Orleans, will come at a sensitive moment.

Domestic sales of the companies’ drug-coated stents have declined since last spring, on reports that deadly clots form in a small percentage of the devices long after they are implanted. Those findings have led cardiologists and their angina patients to consider other options in some cases — whether bypass surgery, using older bare-metal stents, or relying entirely on drug therapy.

Whatever the news on Tuesday, Wall Street is not expecting any data that calls into question two benefits that stents have demonstrated over standard drug therapy in previous studies: greater relief from angina symptoms and reduced rates of hospitalization to treat those symptoms.

“It’s the symptoms and hospitalizations that would really swing people’s opinions,” Matthew Dodds, who follows the device industry for Citigroup, said in an interview Thursday.

Wall Street also has its eye on other reports at the New Orleans meeting, which starts today and is expected to attract 30,000 doctors, industry executives, analysts and investors.

Those include an update today on the trial in humans of a plastic stent from Abbott Laboratories that is designed to be slowly absorbed by the body instead of remaining permanently in place, as current metal stents do. Abbott and the big device maker Medtronic will also be presenting new safety and performance data on metal drug-coated stents each company is already selling in Europe while working toward federal approval to offer them in the United States.

And a series of studies scheduled for Monday may shed light on the recent trial failures of promising drugs from Pfizer and AtheroGenics that doctors had hoped would reduce the buildup of dangerous plaque in coronary arteries.

But it is Tuesday’s stent study that is likely to have the biggest market impact. Dr. Steven Nissen, the departing president of the cardiology college, has been describing it as the “blockbuster” report in recent interviews, causing some analysts to wonder whether it might contain data that could lead to unexpectedly negative headlines and more trouble for the stent companies.

The trial, called Courage —for clinical outcomes utilizing revascularization and aggressive drug evaluation — followed 2,287 patients treated in the United States and Canada from 1999 to 2004. In it, the long-term outcomes for patients who received only the battery of drugs currently used to treat the buildup of plaque in coronary arteries were compared with those who were treated both with drugs and stents.

The device makers have already begun playing down the study’s significance.

Other research has credited stents with life-saving outcomes for some types of patients, like those who receive them during or immediately after heart attacks. Device makers say that if, as they anticipate along with Wall Street, the Courage study fails to show that stents prolong lives and head off heart attacks in chronic angina patients, cardiology stent specialists would be hearing something they already know, and thus would not change what they are telling patients or doing to them.

“I don’t think doctors are representing that stents have a survival advantage in this group,” said Donald Baim, the chief medical officer at Boston Scientific. Instead, he said, the focus has been on relieving symptoms.

“You get stents,” said Sean Salmon, “because you can’t walk up the stairs — not to save your life.” Mr. Salmon is general manager for the coronary group for Medtronic, which expects clearance to sell its Endeavor drug-coated stent in the United States as early as this summer.

The devices companies, moreover, have dismissed Courage as “historical,” because the stents used were almost entirely the older bare-metal devices rather than the newer drug-coated varieties. The drug-coated stents, which first reached the United States in 2003, reduce the risk that scar tissue growing around and through the stent will reclose the artery.

The makers concede that no significant studies suggest chronic angina patients live longer or have fewer heart attacks with the newer stents. But they say patients getting current drug-coated stents would be expected to have to return to the hospital less often and and undergo fewer repeat procedures than the Courage patients who got bare metal stents.

That is an advantage patients value, the companies say, even if getting a drug-coated stent does force them to take daily doses of anti-coagulating drugs to reduce clotting risks.

At the very least, according to some leading interventional cardiologists like Dr. Deepak Bhatt at the Cleveland Clinic Foundation, the Courage results are likely to add to the pressure on doctors to make sure angina patients understand that stenting is unlikely to protect them from a heart attack. Many patients — and even doctors — have a hard time believing that, Dr. Bhatt said.


 
 
 
Patent Pending:   60/481641
 
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