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Hypersensitivity Cases Associated With Drug-Eluting Coronary Stents

A Review of Available Cases From the Research on Adverse Drug Events and Reports (RADAR) Project

Jonathan R. Nebeker, MS, MD^_*,||,_*, Renu Virmani, MD, Charles L. Bennett, MD, PhD, MPP^,¶, Jennifer M. Hoffman, PharmD^_*,||, Matthew H. Samore, MD^_*,||, Jorge Alvarez, MD^,#, Charles J. Davidson, MD^¶, June M. McKoy, MD, MPH, JD^¶, Dennis W. Raisch, PhD^,_**, Brian K. Whisenant, MD^_*,||, Paul R. Yarnold, PhD^¶, Steven M. Belknap, MD^¶, Dennis P. West, PhD^¶, Jonathan E. Gage, MD, Richard E. Morse, MA^,¶, Gordana Gligoric, MD, PhD^,#, Laura Davidson^,¶ and Marc D. Feldman, MD, FACC^,#

^_* Veterans Administration Salt Lake City, Salt Lake City, Utah
Veterans Administration Chicago, Chicago, Illinois
Veterans Administration San Antonio, San Antonio, Texas
Veterans Administration Albuquerque, Albuquerque, New Mexico
^|| University of Utah, Salt Lake City, Utah
^¶ Northwestern University, Chicago, Illinois
^# University of Texas Health Science Center at San Antonio, San Antonio, Texas
^_** University of New Mexico, Albuquerque, New Mexico
Armed Forces Institute of Pathology, Bethesda, Maryland
Yale University, New Haven, Connecticut

View larger version (30K): [in a new window]   Figure 1 Reports received by the Food and Drug Administration for hypersensitivity-like symptoms associated with drug-eluting coronary stents.

View larger version (137K): [in a new window]   Figure 2 Photomicrograph of the non-stented coronary artery of Patient #2 just proximal to the stent showing severe stenosis and non-occlusive luminal thrombus (th) (A). In B is shown the proximal stented artery with marked inflammatory reaction around stent struts; high-power magnification of the boxed areas in B is shown in C and D, note that there is severe granulomatous reaction consisting of macrophages (arrowheads) and giant cells (arrows). In between the stent struts, there is severe eosinophilic and T-cell infiltration (high-power E) with only rare spindle-shaped cells seen close to the lumen. There is absence of endothelium in D; instead there is a surface thrombus.