Drug-Eluting Stent Associated With Thrombosis

July 09, 2003

Medscape Staff Report

July 9, 2003 -- The sirolimus-eluting stent (Cypher) may cause rare cases of thrombosis, according to a notice from the U.S. Food and Drug Administration (FDA) MedWatch safety information and adverse event reporting program. Cordis Corporation, the maker of the stent, has sent a letter to healthcare professionals to alert them of the issue.

The Cypher stent was approved by the FDA in April for patients undergoing angioplasty procedures. Of the estimated 50,000 patients who have received the stent, the FDA has received 47 reports of stent thrombosis at the time of implantation or within a few days.

The FDA is reviewing the adverse event reports and is working with Cordis to determine the extent of the problem. At this point, "it is unclear what effect the Cypher stent has on thrombosis risk and what factors may contribute to the risk," an FDA news release stated.

In its letter to healthcare professionals, Cordis made the following recommendations regarding the use of the stent:

  • Select the appropriate stent size. The stent size should match the diameter of the vessel as closely as possible.

  • Select appropriate patients. The stent is indicated for improving coronary luminal diameter in previously untreated vessels and is not indicated for the treatment of restenosis.

  • Use an adequate antiplatelet regimen. Doctors are reminded to give adequate doses of medication that reduce the risk of clot formation.

  • Use the proper technique for stent deployment. The stent should be fully deployed and in contact with the vessel wall. Poor stent deployment is a factor that can increase thrombosis risk. Also, predilate the lesion with a PTCA catheter.

The full text of the Cordis letter can be found on the FDA Web site in PDF format at http://www.fda.gov/bbs/topics/news/cordis_ltr.pdf.

Reviewed by Gary D. Vogin, MD