Drug-eluting stents were identified as the probable or certain cause of hypersensitivity reactions in 17 distinct cases, which in some instances were associated with late thrombosis and death.
Do drug-eluting stents cause systemic and intrastent hypersensitivity reactions in patients undergoing coronary stenting?
Drug-eluting stents may cause systemic and intrastent hypersensitivity reactions that can lead to late stent thrombosis and death, distinct from clopidogrel-induced hypersensitivity.
OBJECTIVES We undertook the review of all available cases of hypersensitivity reactions after placement of a drug-eluting stent (DES) and classified potential causes. BACKGROUND Six months after the approval of the first DES, the Food and Drug Administration (FDA) reported 50 hypersensitivity reactions after stent placement but later concluded these were due to concomitantly prescribed medications such as clopidogrel. Nevertheless, the FDA continued to receive reports of hypersensitivity. METHODS Reports available from April 2003 through December 2004 for hypersensitivity-like reactions associated with the sirolimus-eluting stent (CYPHER, Cordis Corp., Miami Lakes, Florida) and paclitaxel-eluting stent (TAXUS, Boston Scientific Corp., Natick, Massachusetts) were reviewed. Sources of reports included the FDA's adverse-device-event database, the published literature, and investigators from the Research on Adverse Drug/Device events And Reports (RADAR) project. Causality was assessed using standardized World Health Organization criteria. RESULTS Of 5,783 reports identified for the DES in the FDA database, 262 unique events included hypersensitivity symptoms. Of these reports, 2 were certainly and 39 unlikely caused by clopidogrel and 1 was certainly, 9 probably, and 13 unlikely caused by the DES. From all sources, we identified 17 distinct cases that were probably or certainly caused by the stent, of which 9 had symptoms that lasted longer than four weeks. Four autopsies confirmed intrastent eosinophilic inflammation, thrombosis, and lack of intimal healing. CONCLUSIONS The FDA reports and autopsy findings suggest that DES may be a cause of systemic and intrastent hypersensitivity reactions that, in some cases, have been associated with late thrombosis and death.
Nebeker et al. (Fri,) conducted a review in Hypersensitivity reactions after drug-eluting stent placement (n=262). Drug-eluting stents (sirolimus-eluting and paclitaxel-eluting) was evaluated on Causality of hypersensitivity reactions assessed using standardized World Health Organization criteria. Drug-eluting stents were identified as the probable or certain cause of hypersensitivity reactions in 17 distinct cases, which in some instances were associated with late thrombosis and death.
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