Drug-coated stents top bare metal in diabetics: study

By Bill Berkrot and Ransdell Pierson

NEW ORLEANS (Reuters) - Drug-coated stents were more effective in reducing the risk of repeat surgical procedures, heart attack and death in patients with diabetes, compared with the older bare metal stents, according to results of a study released on Monday.

"We actually saw a significant benefit from using drug- eluting stents in this patient population," said Laura Mauri, lead researcher of the study that was funded by the Massachusetts Department of Public Health.

"As a result we can say that these stents appear to be safe in diabetic patients, whose diabetes puts them at higher risk of mortality and heart attack than the general population," said Mauri, a professor of medicine at Harvard Medical School.

Diabetics make up about a third of all patients who undergo procedures to reopen blocked arteries, said researchers, who presented results of the study at the American Heart Association scientific meeting here.

The data offered welcome news for the companies that sell lucrative drug-coated stents -- Boston Scientific Corp, Johnson & Johnson, Medtronic Inc and Abbott Laboratories -- following recent studies that found they may be used more often than necessary.

J&J spokesman Christopher Allman said the study results were "especially gratifying" given that more than 70 percent of the drug-eluting stent cases involved the company's Cypher stent.

The study also should provide some reassurance following smaller trials that cast doubt on the safety of drug-coated stents.

"Previous studies indicated that drug-eluting stents reduce the rate of restenosis (reclogging), but there has been conflicting evidence from smaller studies," Mauri said.

Some smaller studies actually found higher death rates associated with the newer stents, while others found no safety differences between the two. This study clearly showed lower incidence of death and other adverse heart events.

"I'm not surprised by this news. Diabetics are already prone to more restenosis, so the fact that drug-eluting stents helped them more than non-DES seems to fit with everything else we know about diabetics," said Morningstar analyst Debbie Wang.

Stents are tiny mesh tubes used to prop open arteries that have been cleared of blockages by angioplasty procedures. The newer versions are coated with drugs to help prevent reclogging.

The study looked at more than 5,000 diabetics who underwent artery-clearing procedures and received stents between April 2003 and September 2004.

After three years, researchers found that the risk of death in those who got the drug coated stents was 17.5 percent compared with 20.7 percent in the bare metal group, which they considered a small but significant 3.2 percent reduction with no excess adverse events.

Two-year data also found about a 3 percent reduced risk of heart attack and a 5.4 percent lower rate of need for repeat procedures in the drug-coated stent patients, said researchers. They said three-year data were not yet available in those categories.

Diabetes is becoming a major public health crisis and diabetics represent a growing proportion of high risk patients who require stenting procedures, adding to the significance of this large study, researchers said.