FDA Enters Stent Safety Debate
Proposed Guidelines for New Drug-Coated Stents Stress Patient Issues
March 26, 2008 -- To get new drug-coated stents approved, makers of the
artery-opening devices will have to focus on patient issues, FDA draft
After balloon angioplasty unclogs arteries, mesh tubes called stents are
used to prop the arteries open. Newer stents are coated with chemicals that
prevent reclogging. But these drug-eluting stents slow healing, adding a small
but serious risk of deadly blood clots.
After the FDA approved three of these devices, doctors have struggled to
understand exactly when drug-coated stents should be used, and how best to
prevent blood clots. Currently, it's recommended that patients getting these
stents should receive anticlotting treatment with Plavix for at least a year.
Proposed Guidelines for Drug-Eluting Stents
Now the FDA has proposed new guidelines for makers of new drug-eluting
stents. To get approved, the agency suggests, stent makers will have to perform
- The effects the new devices have on reducing patient deaths, heart attacks,
and need for repeat procedures.
- Overall rates of death and heart
attack in patients receiving the new stents.
- The rate at which blood clots occur in patients receiving the new
- The impact of anticlotting treatment on patients, including how well
patients comply with the treatment, how often patients need extended
anticlotting treatment, how often anticlotting treatment has to be interrupted,
the number of surgical procedures deferred due to anticlotting treatment, and
the rate of significant bleeding complications of anticlotting treatment.
In addition, the FDA requires information on the safety of all drugs given off by the stents.
"This draft guidance is part of FDA's ongoing effort to provide
regulated industry with recommendations on measures that can minimize the risks
while preserving for patients the benefits of drug-eluting stents," Daniel
G. Schultz, MD, director of the FDA's Center for Devices and Radiological
Health, says in a news release.
The proposed guidelines also help device makers understand what the FDA
needs for approval of products that are both medical devices and drugs.
These aren't small issues. Every year, about a million Americans undergo
procedures to treat blocked arteries near the heart. About 650,000 of these
patients receive drug-eluting stents.
The FDA plans to hold public hearings to discuss the proposed