Why the study?
Although the FDA initially attributed post-DES hypersensitivity reactions to concomitant medications, reports of hypersensitivity continued, prompting a comprehensive review and causality classification.
Do drug-eluting stents cause systemic and intrastent hypersensitivity reactions in patients undergoing coronary stenting?
Population
Reports of hypersensitivity-like reactions after placement of a DES from April 2003 through December 2004
Comparison
Sirolimus-eluting stent vs paclitaxel-eluting stent
Design
Review of adverse event databases, published literature, and RADAR project reports
Key result
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.
Authors
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Clinicians should consider drug-eluting stent hypersensitivity in unexplained late thrombosis; leaves open the need for prospective confirmation of causality.
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.
Nebeker et al. (2005) 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.