Must read article on DANGER of Heart Stents - BSX, Medtronic, JNJ, St. Jude

Doctors Rethink Widespread Use of Heart Stents



By BARNABY J. FEDER
Published: October 21, 2006

The medical community is having second thoughts about stents.

Tiny metal sleeves placed in arteries to keep blood flowing, stents have become such a popular quick fix for clogged coronary vessels that Americans will receive more than 1.5 million of them this year.

And stents are a big business, generating $6 billion a year in sales for their makers and thousands of dollars in fees for each procedure performed by the specialists implanting them.

But now stent sales are falling and some doctors are rethinking their faith in the devices, driven by emerging evidence that the newest and most common type — drug-coated stents — can sometimes cause potentially fatal blood clots months or even years after they are implanted.

The Food and Drug Administration said yesterday that it would hold hearings in early December to consider whether to issue new stent safety guidelines.

The evidence indicates that overuse of stents may be leading to thousands of heart attacks and deaths each year, whether because stents are being used in relatively mild cases where drugs should be prescribed instead, or because patients are receiving drug-coated versions where simpler, cheaper bare-metal devices might work just as well.

There is no question that stents have saved countless lives in the short term by preventing impending heart attacks or opening arteries while an attack is being treated. But neither type of stent, no matter how much better it may make a patient feel, has been shown in rigorous clinical trials to improve long-term survival compared with other forms of treatment.

“In the past we’d say, ‘Why not?,’ ” said Dr. William O’Neill, a well-known cardiologist at the University of Miami and longtime advocate of using drug-coated stents. But the new safety data, he said, amounts to “a big why not” for many patients.

The new evidence has added to a long-simmering debate over whether doctors have been too quick to prescribe stenting — whether because drugs would work as well for healthier patients or because bypass surgery might help the sickest ones live longer.

With the older bare-metal stents, the main drawback was the tendency of the repaired artery to become clogged again, in a process known as restenosis, that in severe cases led to repeated procedures or the trauma of more invasive bypass surgery. Drug-coated stents are credited with cutting the frequency of severe restenosis by about half.

But now the drug-coated versions are being shown to carry their own, potentially even more dangerous risks.

Stent makers and some doctors who use them argue that those risks are being overblown. New, less alarming interpretations of the clotting data are expected to be showcased next week at a conference in Washington of stent equipment makers and more than 10,000 doctors who do the procedures.

Those presentations will argue that even if delayed clotting is more common with the drug-coated stents than with metal stents or bypass surgery, the overall death and heart attacks rates are similar, according to spokesmen for the companies and conference organizers.

For those in the industry, the medical question has big financial implications.

The stenting specialists are typically not the physicians who would prescribe surgery or a drug regimen to heart patients. And so a downturn in the use of stents could have a direct impact on the specialists’ livelihoods.

But even some of the nation’s busiest stent centers, like Mt. Sinai Medical Center in New York, say the risk reports have made them more cautious.

“Six months ago, about 92 percent of the stents we used were drug-coated,” said Dr. Samin K. Sharma, the director of interventional cardiology at Mt. Sinai. “Now we are down to 85 percent.”

He cites the case of a patient, Jerry Ford, a 63-year-old Queens woman, who suffered a heart attack on Sept. 10. Last Monday she received three bare-metal stents from Dr. Sharma in a procedure that only a few months ago, he said, would have involved drug-coated devices.

Mrs. Ford said from home the next day that she was happy with the choice because it was clear that Dr. Sharma thought it the best option. “But my daughter and I are going on the Internet now to research more about it,” she said.

Stents, which first came into use in the 1990’s, are inserted in arteries via a thin plastic catheter tube threaded through the circulatory system, usually starting from a small incision in the thigh. The stent, a hollow mesh cylinder, props an artery open after plaque has been pushed aside by inflation of a tiny balloon.

Drug-coated stents cost an average of about $2,200 each in the United States, nearly three times the price of bare-metal ones. Despite the higher price, they quickly captured more than 85 percent of the United States market after their introduction in this country two years ago. Overseas, where national health insurers have been more reluctant to pay the higher prices, drug-coated stents have caught on more slowly.

By reducing restenosis, the drug-coated stents are believed to have saved tens of thousands of patients from the risks of follow-up stenting procedures or bypass surgery. But it would take a study involving tens of thousands of patients and as many as five years to produce highly reliable data on whether those benefits offset the risks of the blood clotting now associated with the drug-coated stents.

 

So far, the published data suggest the clotting risk is small — occurring in perhaps fewer than one in every 500 patients. And yet with so many of the drug-coated devices now in use, at least 2,160 extra deaths occur each year in the United States alone, according to a guest editorial published last week in Cardiosource, the online journal of the American College of Cardiology (www.cardiosource.com/editorials). Clotting has always posed a risk during and shortly after stenting. But the clot risk virtually disappears for bare metal stents after a few months, allowing patients to stop taking anticlotting drugs.

The new data suggests that the risks never go away for the drug-coated stents that now dominate the market. No one is yet sure why. But many researchers believe the stents can create a home for clots, because either their drugs or the stents’ plastic surfaces inhibit complete healing of the vessel wall.

The safety debate has been simmering since a report put a spotlight on the issue last March at the American College of Cardiology annual meeting.

Doctors really began paying attention at the end of August. That is when two European studies presented at an international medical meeting in Barcelona, Spain, reported evidence of long-term clotting risks with the two best-selling drug-coated stents, which are made by two American companies, Boston Scientific and Johnson & Johnson.

That meeting was followed by a startling disclosure in early September by Boston Scientific, which said that it had met with the F.D.A. on Aug. 1 to share data indicating that its Taxus drug-coated stent showed higher clotting risks than did bare-metal stents.

When the F.D.A. asked Johnson & Johnson about the issue, the company said that, contrary to the reports from Europe, it had yet to find any evidence of higher clotting risks in its drug-coated stent, the Cypher.

The late-summer events had an almost immediate impact on medical practice.

Goodroe Health Solutions, a health care consulting company in Atlanta, said last week that the 78 hospitals responding to its most recent client survey had cut the share of drug-coated stents they used to 84.5 percent in September, down from 86.9 percent in August.

For people who receive drug-coated stents, the standard protection against the clotting risk is long-term use of aspirin and the drug Plavix. But aspirin is a known stomach irritant and some patients get severe rashes from Plavix and bruise easily. And all patients must stop taking Plavix if they require any type of surgery, because it promotes bleeding.

What is more, Dr. O’Neill said, many poor patients cannot afford the drug — a daily dose sells for about $4.

Advocates of drug-coated stents point to evidence that many clotting cases involve stents that were not fitted snugly to the arterial wall.

That misstep can be eliminated if doctors monitor their work during the procedure with new ultrasound scanning technology as well as the standard arterial X-rays known as angiograms, according to Dr. Matthew Holland, a cardiologist in Boulder, Colo.

Dr. Holland says he continues to use drug-coated stents in nearly every case where it is physically possible to fit them into the diseased artery.

But other doctors’ uncertainty is starting to show in the declining sales of stents. Just this week, Boston Scientific said that its third-quarter stent sales, $572 million, were 4.8 percent lower than a year earlier.

Johnson & Johnson, whose Cypher is the only other drug-coated stent currently sold in this country, said this week that its worldwide stent sales of $627 million in the quarter included a 6 percent decline from a year earlier in the United States. Its sales in Europe were down 3 percent.

Several competitors are still anxious to enter the domestic market, including medical giants like Medtronic and Abbott Laboratories and smaller players like Conor Medsystems whose products are already on the market overseas.

Some have claimed that results to date suggest their products have little or none of the clotting risks. Because none of them plan to apply for F.D.A. approval before next year, it is unclear whether or how the agency’s new scrutiny of stent safety will affect their prospects. New stents will not address the issue of whether too many patients get stents instead of first trying therapy with drugs, including statins, that might improve their condition.

“I see it all the time,” said Dr. Sanjay Kaul, a co-author of the recent Cardiosource editorial. He said his cardiology practice at Cedars Sinai Medical Center in Los Angeles included many “high-powered executives” who did not want to be bothered with taking pills to manage attacks of angina, the chest pains associated with narrowing coronary arteries.

Dr. Kaul said the overuse of stenting reflected a quick-fix mentality among patients and the financial incentives of doctors and hospitals to implant stents instead of prescribing drugs.

But stent advocates like Dr. Holland said patients demanded the stents because they provided more complete relief from pain, and because they wanted to avoid the potential side effects of the cocktails of heart drugs, which can include fatigue, sexual dysfunction, depression and light-headedness.

Dr. Holland says a typical patient profile might be a 55-year-old engineer at one of Boulder’s high-technology companies who is an avid outdoorsman and cyclist but hobbled by chest pains. To offer such a person drug therapy instead of the quick and more reliable relief of a stent, Dr. Holland said, “just doesn’t fly.”

 

hard to say, I work with a guy with stent and look like he is doing better than before the operation, smoking 1/2 pack a day as usual.

 

I think the problem is that the coating is only on the surface. Youve got continuous blood flow and hence relentless mechanical abrasion of the surface which will slowly sever the chemical bonds holding the coating to the surface. The solution is to develop a material for these stents that is inherently anticlotting and has the same properties throughout. Not easy. I had BSX, and sold it as soon as they got in that bidding war for Guidant with J&J. That just could not lead to a good outcome regardless. My neighbor works for BSX and he keeps me updated. These stents ought to work OK for a while but then later develop problems as the coating wears off. And that in a nutshell is why they lead to clots "months" or "years" after being implanted. Its exactly the same problem as was seen with early gas permeable contact lenses. At first the approach was to surface modify them, but this did not last. Finally, new polymers that had the same desirable properties all the way through were developed. These work great and don't wear out.

 

LOL 1/2 an hour of exercise each day and that 1.5 million number would be cut in half.