SCAI president testifies before FDA on safety of drug-eluting stents

disease. Aspirin can cause gastrointestinal complications, including death in a very small percentage of patients. "However, for the vast majority of patients, the benefits of aspirin therapy outweigh the risks," Dr. Dehmer said. "Likewise, with drug-eluting stents we now need a thoughtful assessment of the risks versus the benefits."

SCAI has previously published a position paper on drug-eluting stents followed by a task force report and is developing a thirda clinical alert to be released later this month. For now, the Society has developed the following recommendations:

  • A drug-eluting stent should be used only when, in the judgment of the interventional cardiologist, the benefits of preventing restenosis in a particular lesion outweigh the risks of late stent thrombosis;
  • The patient must be an appropriate candidate for drug-eluting stent therapy; specifically, being willing and able to take two different anti-clotting medications for a minimum of six months after stent implantation;
  • The drug-eluting stent must be implanted properly, with particular attention to stent sizing, expansion, and fit against the artery wall; and
  • Both patients and physicians must be educated as to the importance of adhering to therapy with dual anti-clotting medications.

Further research is needed to determine the exact incidence of late stent thrombosis in patients treated with drug-eluting stents, Dr. Dehmer said. It is also important to determine why some patients develop this problem but many others do not, so physicians can better understand how to care for their patients.


Contact: Wayne Powell
Society for Cardiovascular Angiography and Interventions

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