Drug-coated stents don’t raise risk of clots, new research says

VIENNA, Austria (AP) — Drug-coated heart stents may not increase the risk of blood clots as much as previously thought, according to research presented Sunday at a meeting of cardiologists.

Nearly 6 million people worldwide have the devices, which are implanted into the heart during an angioplasty to prevent new clogs from forming in arteries.

Last year, research suggested that the devices were responsible for an increased number of fatal blood clots. But on Sunday, Dr. Stefan James of the Uppsala Clinical Research Centre in Sweden presented follow-up results from last year’s study to the European Society of Cardiology conference, which runs until Wednesday in Vienna.

With more patients and an extra year of data, the numbers tell a different story.

After four years of tracking patients with the drug-coated stents, James said the results showed no significant difference between patients who received the drug stents and those who received bare metal ones: Patients with drug stents had only a 1 percent increased chance of dying.

What happened

In December, James told a Food and Drug Administration safety hearing that research from the first three years of the study indicated that patients with drug-emitting stents had an 18 percent increased chance of dying compared to patients with bare metal stents.

Those results were later published in the New England Journal of Medicine, and sales for the device have plummeted worldwide, with the U.S. market expected to shrink by about $1 billion.

The FDA never restricted the stents’ use but suggested doctors only recommend them in certain cases. Johnson & Johnson, a major stent-maker, recently cut 5,000 jobs in response to declining sales.

In August, Britain’s health advisory watchdog proposed striking the drug stents from the list of medical devices it would pay for. Drug-coated stents typically cost about $2,300 compared to the approximately $700 for bare metal stents.

Experts are not entirely sure what might explain the research reversal, but more selective stent use might help explain the change, they said.

Newer drug stents are also better than earlier versions, some of which had to be recalled.

Other experts said the backlash against drug-coated stents was an over-reaction.

James said he has no ties to pharmaceutical companies and no conflict of interest. Sweden’s government funded the study.