Drug-Coated Stents Get Boost From Study

By Allison M. Heinrichs

Using drug-coated stents to open cholesterol-clogged arteries is safer and more effective than using uncoated stents in patients with complex heart disease, according to a locally led analysis published in today’s New England Journal of Medicine.

An international team led by the University of Pittsburgh Medical Center announced the findings Wednesday from an analysis of 6,500 patient records, the largest study to date.

Coating the tiny metal tubes with drugs is a controversial medical treatment that the federal government has questioned.

"This was a very necessary, important study," said Dr. Chet Rihal, director of the cardiac catheterization laboratory at Mayo Clinic, who did not participate in the research. "The more hard numbers we have … the better informed physicians will be and the better informed our patients will be."

Heart disease is the leading cause of death in the United States, killing about 650,00 people each year — 13,000 in Allegheny County. About 25.6 million Americans have been diagnosed with heart disease, according to the U.S. Centers for Disease Control and Prevention.

In addition to lifestyle changes and medicine, one of the most common treatments is the surgical insertion of stents into clogged veins. Stents hold cholesterol plaque against artery walls, keeping the center open for blood flow.

However, the body can react to stents and create scar tissue, which re-blocks the artery. Drug-coated — also known as drug- eluting — stents slowly release medication that prevents scar tissue.

About a year ago, doctors presented research at an international cardiac conference showing that patients who received drug-coated stents were at an increased long-term risk for poor outcomes, including death. The FDA convened an advisory panel that called for more study.

Dr. Oscar Marroquin, lead author of the research paper, analyzed the records of 6,551 patients who received stents and were tracked by the National Heart, Lung, and Blood Institute Dynamic Registry, which is managed by Pitt’s Graduate School of Public Health. After one year, there was no difference in the risk of death or heart attack between patients with drug-eluting and bare-metal stents.

However, patients with drug-eluting stents were 37 percent less likely than patients with bare-metal stents to need repeat procedures.

"These results should be seen as, at least, more evidence than we used to have on the safety and efficacy of these devices when used for these complex patients," said Marroquin, director of UPMC’s Center for Interventional Cardiology Research. "It still doesn’t mean that we can use a cookie-cutter approach. In the end you still always have to individualize each patient’s care."

The FDA would not comment on the study.

Dr. Deepak Bhatt, associate director of the Cleveland Clinic Cardiovascular Coordinating Center, once criticized drug-eluting stents. In light of analyses such as Marroquin’s, he has since reversed that view.

"I think this paper does a lot to help reassure doctors and patients," Bhatt said.

Dr. Tony Farah, director of Allegheny General Hospital’s cardiac catheterization lab, said questions raised about drug-eluting stents encouraged doctors to re-evaluate when they should be used. It also reinforced the need for patients to consult with their cardiologist before stopping medications to prevent blood clots, a deadly complication associated with stents.

"There’s always room for physicians to step back and say, ‘Are we using those stents — whether bare-metal or drug-eluting — in applications for which there is a benefit?’" Farah said.

Mike Oare, 56, of Mars had three drug-eluting stents inserted by Marroquin two years ago after a burning sensation in his chest was found to be a heart attack. He received the stents before the FDA raised questions.

"At the time that they put them in, it was the greatest thing since canned beer," said Oare, an engineer. For a year, Marroquin kept him on medication to prevent blood clots and included him in the analysis published today.

"I had no complications at all," Oare said.