Localized Hypersensitivity and Late Coronary Thrombosis Secondary to a Sirolimus-Eluting Stent: Should We Be Cautious?

Circulation

Volumn 109, Issue 6, 2004, Pages 701-705

  Virmani, Renu ^a   Guagliumi, Giulio ^b   Farb, Andrew ^a   Musumeci, Giuseppe ^b   Grieco, Niccolo ^b   Motta, Teresio ^b   Mihalcsik, Laurian ^b   Tespili, Maurizio ^b   Valsecchi, Orazio ^b   Kolodgie, Frank D ^a  

^a ARMED FORCES INSTITUTE OF PATHOLOGY   (United States)

^b OSPEDALI RIUNITI   (Italy)

Author keywords

Death, sudden; Sirolimus; Stents; Thrombosis

Indexed keywords

ACETYLSALICYLIC ACID; BETA ADRENERGIC RECEPTOR BLOCKING AGENT; CD20 ANTIGEN; CD45 ANTIGEN; CD68 ANTIGEN; CLOPIDOGREL; ETHYLENE VINYL ACETATE COPOLYMER; GLYCERYL TRINITRATE; POLY(N BUTYL METHACRYLATE); POLYMER; POLYMETHACRYLIC ACID; RAPAMYCIN; TICLOPIDINE; UNCLASSIFIED DRUG;

ACUTE HEART INFARCTION; ADULT; ANEURYSM; ANGIOCARDIOGRAPHY; ARTICLE; AUTOPSY; CASE REPORT; CORONARY ARTERY OBSTRUCTION; CORONARY ARTERY THROMBOSIS; CORONARY STENT; DRUG ELUTING STENT; EOSINOPHIL; GIANT CELL; HEART RUPTURE; HUMAN; HYPERSENSITIVITY; INTRAVASCULAR ULTRASOUND; MALE; PRIORITY JOURNAL; PRURITUS; RASH; SKIN IRRITATION; T LYMPHOCYTE; UNSTABLE ANGINA PECTORIS; VASCULITIS;

ANGINA, UNSTABLE; CORONARY ANGIOGRAPHY; CORONARY THROMBOSIS; DRUG DELIVERY SYSTEMS; FATAL OUTCOME; HUMANS; HYPERSENSITIVITY; MALE; MIDDLE AGED; MYOCARDIAL INFARCTION; SIROLIMUS; STENTS;

EID: 10744229988     PISSN: 00097322     EISSN: None     Source Type: Journal    
DOI: 10.1161/01.CIR.0000116202.41966.D4     Document Type: Article

References (31)

1. Sousa JE, Costa MA, Abizaid A, et al. Lack of neointimal proliferation after implantation of sirolimus-coated stents in human coronary arteries: a quantitative coronary angiography and three-dimensional intravascular ultrasound study. Circulation. 2001;103:192-195.
2. Suzuki T, Kopia G, Hayashi S, et al. Stent-based delivery of sirolimus reduces neointimal formation in a porcine coronary model. Circulation. 2001;104:1188-1193.
3. FDA advises physicians of adverse events associated with Cordis Cypher coronary stents. US Food and Drug Administration Public Health Web Notification. October 29 2003;T03-T71.
4. Morice MC, Serruys PW, Sousa JE, et al. A randomized comparison of a sirolimus-eluting stent with a standard stent for coronary revascularization. N Engl J Med. 2002;346:1773-1780.
5. Schofer J, Schluter M, Gershlick AH, et al. Sirolimus-eluting stents for treatment of patients with long atherosclerotic lesions in small coronary arteries: double-blind, randomised controlled trial (E-SIRIUS). Lancet. 2003;362:1093-1099.
6. Moses JW, Leon MB, Popma JJ, et al. Sirolimus-eluting stents versus standard stents in patients with stenosis in a native coronary artery. N Engl J Med. 2003;349:1315-1323.
7. Sousa JE, Costa MA, Sousa AG, et al. Two-year angiographic and intravascular ultrasound follow-up after implantation of sirolimus-eluting stents in human coronary arteries. Circulation. 2003;107:381-383.
8. Sousa JE, Serruys PW, Costa MA. New frontiers in cardiology: drugeluting stents, I. Circulation. 2003;107:2274-2279.
9. Sousa JE, Serruys PW, Costa MA. New frontiers in cardiology: drugeluting stents, II. Circulation. 2003;107:2383-2389.
10. Koster R, Vieluf D, Kiehn M, et al. Nickel and molybdenum contact allergies in patients with coronary in-stent restenosis. Lancet. 2000;356:1895-1897.
11. Farb A, Weber DK, Kolodgie FD, et al. Morphological predictors of restenosis after coronary stenting in humans. Circulation. 2002;105:2974-2980.
12. Farb A, Burke AP, Kolodgie FD, et al. Pathological mechanisms of fatal late coronary stent thrombosis in humans. Circulation. 2003;108:1701-1706.
13. Klugherz BD, Llanos G, Lieuallen W, et al. Twenty-eight-day efficacy and pharmacokinetics of the sirolimus-eluting stent. Coron Artery Dis. 2002;13:183-188.
14. Hardinger KL, Cornelius LA, Trulock EP III, et al. Sirolimus-induced leukocytoclastic vasculitis. Transplantation. 2002;74:739-743.
15. Francischi JN, Conroy D, Maghni K, et al. Rapamycin inhibits airway leukocyte infiltration and hyperreactivity in guinea pigs. Agents Actions. 1993;39 Spec No:C139-C141.
16. Brara PS, Moussavian M, Grise MA, et al. Pilot trial of oral rapamycin for recalcitrant restenosis. Circulation. 2003;107:1722-1724.
17. Charpentier B, Groth CG, Backman L, et al. Bicetre hospital experience with sirolimus-based therapy in human renal transplantation: the Sirolimus European Renal Transplant Study. Transplant Proc. 2003;35:58S-61S.
18. Leggat PA, Kedjarune U. Toxicity of methyl methacrylate in dentistry. Int Dent J. 2003;53:126-131.
19. Ahmed DD, Sobczak SC, Yunginger JW. Occupational allergies caused by latex. Immunol Allergy Clin North Am. 2003;23:205-219.
20. Pretorius E. Allergic reactions caused by dental restorative products. SADJ. 2002;57:372-375.
21. van Beusekom HM, Schwartz RS, van der Giessen WJ. Synthetic polymers. Semin Interv Cardiol. 1998;3:145-148.
22. van der Giessen WJ, Lincoff AM, Schwartz RS, et al. Marked inflammatory sequelae to implantation of biodegradable and nonbiodegradable polymers in porcine coronary arteries. Circulation. 1996;94:1690-1697.
23. van Beusekom HM, Serruys PW, van der Giessen WJ. Coronary stent coatings. Coron Artery Dis. 1994;5:590-596.
24. Revell PA, Braden M, Freeman MA. Review of the biological response to a novel bone cement containing poly(ethyl methacrylate) and n-butyl methacrylate. Biomaterials. 1998;19:1579-1586.
25. Niemi SM, Fox JG, Brown LR, et al. Evaluation of ethylene-vinyl acetate copolymer as a non-inflammatory alternative to Freund's complete adjuvant in rabbits. Lab Anim Sci. 1985;35:609-612.
26. Kornowski R, Hong MK, Virmani R, et al. Granulomatous "foreign body reactions" contribute to exaggerated in-stent restenosis. Coron Artery Dis. 1999;10:9-14.
27. Serruys PW, Degertekin M, Tanabe K, et al. Intravascular ultrasound findings in the multicenter, randomized, double-blind RAVEL (RAndomized study with the sirolimus-eluting VElocity balloon-expandable stent in the treatment of patients with de novo native coronary artery Lesions) trial. Circulation. 2002;106:798-803.
28. Degertekin M, Serruys PW, Tanabe K, et al. Long-term follow-up of incomplete stent apposition in patients who received sirolimus-eluting stent for de novo coronary lesions: an intravascular ultrasound analysis. Circulation. 2003;108:2747-2750.
29. Leon MB, Abizaid A, Moses JW. Subgroup analysis from the Cypher clinical trials. In: The Cypher Stent: A New Gold Standard in the Treatment of Coronary Artery Disease. New York, NY: Cardiovascular Research Foundation; 2003:54-57.
30. Mintz GS, Shah VM, Weissman NJ. Regional remodeling as the cause of late stent malapposition. Circulation. 2003;107:2660-2663.
31. Grunig G, Warnock M, Wakil AE, et al. Requirement for IL-13 independently of IL-4 in experimental asthma. Science. 1998;282:2261-2263.