Circulation. 2004;109:701-705
Published online before print January 26, 2004, doi: 10.1161/01.CIR.0000116202.41966.D4
Published online before print January 26, 2004, doi: 10.1161/01.CIR.0000116202.41966.D4
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(Circulation. 2004;109:701-705.)
© 2004 American Heart Association, Inc.
Clinical Investigation and Reports |
Localized Hypersensitivity and Late Coronary Thrombosis Secondary to a Sirolimus-Eluting Stent
Should We Be Cautious?
From the Department of Cardiovascular Pathology, Armed Forces Institute of Pathology, Washington, DC (R.V., A.F., F.D.K.), and the Cardiovascular (G.G., G.M., N.G., L.M., M.T., O.V.) and Pathology (T.M.) Departments, Ospedali Riuniti di Bergamo, Bergamo, Italy.
Correspondence to Renu Virmani, MD, Chair, Department of Cardiovascular Pathology, Armed Forces Institute of Pathology, 6825 16th St NW, Washington, DC. E-mail virmani{at}afip.osd.mil
Received December 1, 2003; revision received December 17, 2003; accepted December 29, 2003.
Background— The US Food and Drug Administration recently issued a warning of subacute thrombosis and hypersensitivity reactions to sirolimus-eluting stents (Cypher). The cause and incidence of these events have not been determined.
Methods and Results— We present findings of a 58-year-old man who died of late stent thrombosis 18 months after receiving 2 Cypher stents for unstable angina. Although angiographic and intravascular ultrasound results at 8 months demonstrated the absence of neointimal formation, vessel enlargement was present. An autopsy showed aneurysmal dilation of the stented arterial segments with a severe localized hypersensitivity reaction consisting predominantly of T lymphocytes and eosinophils.
Conclusions— The known pharmacokinetic elution profile of Cypher stents and the presence of polymer fragments surrounded by giant cells and eosinophils suggest that a reaction to the polymer may have caused late stent thrombosis. Careful long-term follow-up of patients with vessel enlargement after Cypher stent placement is recommended.
Key Words: sirolimus • stents • thrombosis • death, sudden
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T. Inoue, M. Sata, Y. Hikichi, R. Sohma, D. Fukuda, T. Uchida, M. Shimizu, H. Komoda, and K. Node Mobilization of CD34-Positive Bone Marrow-Derived Cells After Coronary Stent Implantation: Impact on Restenosis Circulation, February 6, 2007; 115(5): 553 - 561. [Abstract] [Full Text] [PDF]
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 Y. Ramot and A. Nyska Drug-Induced Thrombosis--Experimental, Clinical, and Mechanistic Considerations Toxicol Pathol, February 1, 2007; 35(2): 208 - 225. [Abstract] [Full Text] [PDF]
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K. Ohtani, K. Egashira, K. Nakano, G. Zhao, K. Funakoshi, Y. Ihara, S. Kimura, R. Tominaga, R. Morishita, and K. Sunagawa Stent-Based Local Delivery of Nuclear Factor-{kappa}B Decoy Attenuates In-Stent Restenosis in Hypercholesterolemic Rabbits Circulation, December 19, 2006; 114(25): 2773 - 2779. [Abstract] [Full Text] [PDF]
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M. Pfisterer, H. P. Brunner-La Rocca, P. T. Buser, P. Rickenbacher, P. Hunziker, C. Mueller, R. Jeger, F. Bader, S. Osswald, C. Kaiser, et al. Late Clinical Events After Clopidogrel Discontinuation May Limit the Benefit of Drug-Eluting Stents: An Observational Study of Drug-Eluting Versus Bare-Metal Stents J. Am. Coll. Cardiol., November 1, 2006; (2006) j.jacc.2006.10.026v1. [Abstract] [Full Text] [PDF]
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 R. Gupta, F. Al-Ali, A. J. Thomas, M. B. Horowitz, T. Barrow, N. A. Vora, K. Uchino, M. D. Hammer, L. R. Wechsler, and T. G. Jovin Safety, Feasibility, and Short-Term Follow-Up of Drug-Eluting Stent Placement in the Intracranial and Extracranial Circulation Stroke, October 1, 2006; 37(10): 2562 - 2566. [Abstract] [Full Text] [PDF]
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J. Fajadet, W. Wijns, G.-J. Laarman, K.-H. Kuck, J. Ormiston, T. Munzel, J. J. Popma, P. J. Fitzgerald, R. Bonan, R. E. Kuntz, et al. Randomized, Double-Blind, Multicenter Study of the Endeavor Zotarolimus-Eluting Phosphorylcholine-Encapsulated Stent for Treatment of Native Coronary Artery Lesions: Clinical and Angiographic Results of the ENDEAVOR II Trial Circulation, August 22, 2006; 114(8): 798 - 806. [Abstract] [Full Text] [PDF]
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C. Kimmelstiel Multislice Computed Tomography After Left Main Drug-Eluting Stenting: Are We Putting the CarT Before the Horse? Circulation, August 15, 2006; 114(7): 616 - 619. [Full Text] [PDF]
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N. G. Kounis, G. N. Kounis, S. N. Kouni, G. D. Soufras, C. Niarchos, and A. Mazarakis Allergic Reactions Following Implantation of Drug-Eluting Stents: A Manifestation of Kounis Syndrome? J. Am. Coll. Cardiol., August 1, 2006; 48(3): 592 - 593. [Full Text] [PDF]
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M. Joner, A. V. Finn, A. Farb, E. K. Mont, F. D. Kolodgie, E. Ladich, R. Kutys, K. Skorija, H. K. Gold, and R. Virmani Pathology of Drug-Eluting Stents in Humans: Delayed Healing and Late Thrombotic Risk J. Am. Coll. Cardiol., July 4, 2006; 48(1): 193 - 202. [Abstract] [Full Text] [PDF]
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R. Tung, S. Kaul, G. A. Diamond, and P. K. Shah Narrative review: drug-eluting stents for the management of restenosis: a critical appraisal of the evidence. Ann Intern Med, June 20, 2006; 144(12): 913 - 919. [Abstract] [Full Text] [PDF]
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P. Jimenez-Quevedo, M. Sabate, D. J. Angiolillo, M. A. Costa, F. Alfonso, J. A. Gomez-Hospital, R. Hernandez-Antolin, C. Banuelos, J. Goicolea, F. Fernandez-Aviles, et al. Vascular Effects of Sirolimus-Eluting Versus Bare-Metal Stents in Diabetic Patients: Three-Dimensional Ultrasound Results of the Diabetes and Sirolimus-Eluting Stent (DIABETES) Trial J. Am. Coll. Cardiol., June 6, 2006; 47(11): 2172 - 2179. [Abstract] [Full Text] [PDF]
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S. Tsimikas Drug-Eluting Stents and Late Adverse Clinical Outcomes: Lessons Learned, Lessons Awaited J. Am. Coll. Cardiol., May 16, 2006; 47(10): 2112 - 2115. [Full Text] [PDF]
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C Roiron, P Sanchez, A Bouzamondo, P Lechat, and G Montalescot Drug eluting stents: an updated meta-analysis of randomised controlled trials Heart, May 1, 2006; 92(5): 641 - 649. [Abstract] [Full Text] [PDF]
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A. E. Rodriguez, J. F. Granada, M. Rodriguez-Alemparte, C. F. Vigo, J. Delgado, C. Fernandez-Pereira, A. Pocovi, A. M. Rodriguez-Granillo, D. Schulz, A. E. Raizner, et al. Oral Rapamycin After Coronary Bare-Metal Stent Implantation to Prevent Restenosis: The Prospective, Randomized Oral Rapamycin in Argentina (ORAR II) Study J. Am. Coll. Cardiol., April 18, 2006; 47(8): 1522 - 1529. [Abstract] [Full Text] [PDF]
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A. T.L. Ong, R. T. van Domburg, J. Aoki, K. Sonnenschein, P. A. Lemos, and P. W. Serruys Sirolimus-Eluting Stents Remain Superior to Bare-Metal Stents at Two Years: Medium-Term Results From the Rapamycin-Eluting Stent Evaluated at Rotterdam Cardiology Hospital (RESEARCH) Registry J. Am. Coll. Cardiol., April 4, 2006; 47(7): 1356 - 1360. [Abstract] [Full Text] [PDF]
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U. Sigwart Drug-Eluting Stents Are Safe and Effective: Right or Wrong? J. Am. Coll. Cardiol., April 4, 2006; 47(7): 1361 - 1362. [Full Text] [PDF]
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P. Urban, A. H. Gershlick, G. Guagliumi, P. Guyon, C. Lotan, J. Schofer, A. Seth, J. E. Sousa, W. Wijns, C. Berge, et al. Safety of Coronary Sirolimus-Eluting Stents in Daily Clinical Practice: One-Year Follow-Up of the e-Cypher Registry Circulation, March 21, 2006; 113(11): 1434 - 1441. [Abstract] [Full Text] [PDF]
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S. G. Raja Drug-Eluting Stents and the Future of Coronary Artery Bypass Surgery: Facts and Fiction. Ann. Thorac. Surg., March 1, 2006; 81(3): 1162 - 1171. [Abstract] [Full Text] [PDF]
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P. K. Kuchulakanti, W. W. Chu, R. Torguson, P. Ohlmann, S.-W. Rha, L. C. Clavijo, S.-W. Kim, A. Bui, N. Gevorkian, Z. Xue, et al. Correlates and Long-Term Outcomes of Angiographically Proven Stent Thrombosis With Sirolimus- and Paclitaxel-Eluting Stents Circulation, February 28, 2006; 113(8): 1108 - 1113. [Abstract] [Full Text] [PDF]
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R. Wessely, A. Schomig, and A. Kastrati Sirolimus and Paclitaxel on Polymer-Based Drug-Eluting Stents: Similar But Different J. Am. Coll. Cardiol., February 21, 2006; 47(4): 708 - 714. [Abstract] [Full Text] [PDF]
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