Status of Cardiac Stents Focus of NEJM Article

17 Nov 2006

Drug-coated stent or bare-metal stent? The question of which device is the best for opening blocked coronary arteries is addressed by a University at Buffalo physician in the current issue of the New England Journal of Medicine.

Miriam Shuchman, M.D., a physician-journalist and UB clinical assistant professor of psychiatry, is author of the "Perspective" article, which reviews findings from the FDA, industry and several academic investigators in advance of a meeting called by the FDA in early December to discuss the topic.

The issue has gained significant attention recently as studies, including those conducted by manufacturers, have shown that although drug-coated, also referred to as drug-eluting, metal-mesh devices prevent arterial wall tissue from growing through the mesh and reclogging the artery, patients with these stents are more likely to develop more troublesome blockages inside the device.

The Circulatory System Devices Advisory Panel meeting in December is to be attended by physicians, scientists and representatives from Boston Scientific and Johnson and Johnson, the two leaders (and rivals) in a stent industry estimated at $5.5 billion.

In the article, Shuchman discusses several reports presented by researchers at the World Cardiology Congress in Barcelona in September that showed increases in deaths and heart attacks among recipients of drug-eluting stents compared to patients who received bare stents. Further data presented at a symposium in October in Washington, D.C., showed a risk of blockages occurring one year after patients received the drug-coated stents.

"These data challenge the golden reputation of drug-eluting stents," says Shuchman in the article. "The devices have reduced the need for both emergency cardiac surgery and additional angioplasty, they are associated with substantially lower restenosis rates at six months than are bare-metal stents and successful outcomes are visible on angioplasty."

However, she notes that some cardiologists feel "blindsided" by the new morbidity and mortality findings. Manufacturers counter that problems with drug-eluting stents remain very low, even though adverse events are slightly higher than initially believed.
The current findings regarding drug-eluting stents may stem to some degree from their wide off-label use, says Shuchman. "The FDA approved drug-eluting stents for single blockages involving short lesions in small vessels, but they are used routinely for longer lesions, in larger vessels and for multiple lesions.

"Drug eluting stents are used in more than 90 percent of angioplasty procedures, but that's changing due to the new findings," she says. "Their use has dropped slightly while physicians wait to see what the FDA will do."

(Source: New England Journal of Medicine : University at Buffalo: November 2006.)