New study says drug-eluting stents safe

March 31, 2009 2:01:51 PM PDT
A study of over a quarter of a million patients may have just settled the controversy over a commonly used device called a drug eluting stent.

Lead author Dr. Pamela Douglas, professor of medicine at Duke University ? a great talker - says that we can now say with confidence that drug eluting stents "are not killing people."

In fact, this study found that the overall risk of death in patients with drug eluting stents was lowered by 25% compared to those who received a different cheaper type. There were also fewer heart attacks and a reduced risk of bleeding in the drug eluting stent group. The risk of stroke was the same.

Stents are the tiny wire tubes used to prop open blocked heart vessels when someone is having a heart attack and to prevent the blockage from causing future harm. Drug eluting stents are coated with medicine to prevent blood clots from forming, which can sometimes be a problem with "bare metal" stents.

There has been controversy over whether drug eluting stents are dangerous to patients ? some studies have found increased death rates due to heart attacks while others found a benefit to patients.

Nearly six million patients worldwide have received drug eluting stents in recent years, and the market is estimated at more than $5 billion a year. Coated stents cost around three times as much as bare-metal ones.

Questions have plagued the use of the devices for several years. And some cardiologists said they were moving away from using drug eluting stents. "If there's a suspicion, why take the risk?" asked Dr. Steven Nissen, head of cardiovascular medicine at the Cleveland Clinic.

After the release of the new study, at the American College of Cardiologists, Dr. David Holmes, professor of medicine at the Mayo Clinic called this a "landmark work" for demonstrating the safety of these stents. Dr. Holmes also said the study sets a landmark for demonstrating how to move forward with the Obama administration's mandate for comparing the effectiveness of different therapies to determine which ones insurance programs should cover.

The researchers did a neat trick by comparing two databases ? one that had information about people who got stents but that doesn't contain follow-up data, and a second that has all the Medicare claims, so which contained a vast amount of follow-up data on persons over 65.

Dr. Douglas says that this shows the "tremendous opportunity" available to match hospital databases with real world databases to study cost effectiveness, and to follow the safety of devices and medications following their FDA approval.

The paper will be published in the Journal of the American College of Cardiology.

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