New research suggests risks of drug stents

WASHINGTON – A flurry of recent research has raised alarm about the safety of a new generation of stents that have quickly become the most commonly used devices for treating clogged arteries, creating widespread concern about how to care for millions of heart disease patients.

The stents, tiny drug-secreting mesh tubes used to prop coronary arteries open, appear to carry a small but significantly increased risk of causing blood clots, compared with older “bare metal” versions. That may boost the chances of suffering a heart attack or dying, according to the studies, including one released Tuesday.

The accumulating evidence prompted the Food and Drug Administration to convene an urgent two-day meeting of a panel of outside experts Dec. 7 to assess the devices, known as drug-eluting stents, including whether their risks outweigh their benefits.

“This is a public-health issue of great importance,” the FDA’s Daniel Schultz said Tuesday. “Our goal is to provide the American public with a coherent, understandable explanation of the risks and benefits associated with these products.”