FDA Panel: Benefits of Drug-Coated Stents Outweigh Risks
Posted December 14, 2006 2:55 p.m. EST
Studies show a small risk of blood clots forming inside the devices, which are known as drug-eluting stents. However, a Food and Drug Administration advisory panel reviewed the research and said the benefits of the devices outweigh the safety concerns.
"For the most part, we haven't seen an increase in death or other serious adverse events," said Dr. Kirk Garrat, a cardiologist with Lenox Hill Hospital.
The panel's conclusion was based on studies where patients' cases were usually straightforward.
The panel also looked at the majority of stent surgeries, which are usually more complicated, with narrower or multiple vessel involvement. Dr. Arnold Plotnick, a veterinarian who had a strong family history of heart attacks, needed three stents in his heart.
"I like the idea that drug-eluding stents decrease the possibility of this closing back up again," Plotnick said.
The FDA committee is looking at whether special stents create a dangerous risk of clots. Some experts said there is no easy answer.
"It's difficult to predict exactly what will arise from that meeting. I know physicians are looking for guidance on this from the FDA," said Dr. Deepak Bhatt of the Cleveland Clinic.
For now, patients who have drug-coated stents should remain on the two blood thinners, Plavix and aspirin for a minimum of one year and then be re-evaluated by their cardiologist.