on January 26, 2004
Circulation. 2004
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
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
© American Heart Association, Inc.
Special Report |
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
This article has been cited by other articles:
 |
|
 |
|
  L. T. Newsome, M. A. Kutcher, and R. L. Royster Coronary Artery Stents: Part I. Evolution of Percutaneous Coronary Intervention Anesth. Analg., August 1, 2008; 107(2): 552 - 569. [Abstract] [Full Text] [PDF]
|
|
|
|
|
|
L. T. Newsome, R. S. Weller, J. C. Gerancher, M. A. Kutcher, and R. L. Royster Coronary Artery Stents: II. Perioperative Considerations and Management Anesth. Analg., August 1, 2008; 107(2): 570 - 590. [Abstract] [Full Text] [PDF]
|
|
|
|
 |
|
 J. Sullivan and N. Amarshi Dual antiplatelet therapy with clopidogrel and aspirin Am. J. Health Syst. Pharm., June 15, 2008; 65(12): 1134 - 1143. [Abstract] [Full Text] [PDF]
|
|
|
|
 |
|
 J. Mehilli, R. A. Byrne, A. Wieczorek, R. Iijima, S. Schulz, O. Bruskina, J. Pache, R. Wessely, A. Schomig, A. Kastrati, et al. Randomized trial of three rapamycin-eluting stents with different coating strategies for the reduction of coronary restenosis Eur. Heart J., June 11, 2008; (2008) ehn253v1. [Abstract] [Full Text] [PDF]
|
|
|
|
 |
|
 M. I. Hamilos, M. Ostojic, B. Beleslin, D. Sagic, L. Mangovski, S. Stojkovic, M. Nedeljkovic, D. Orlic, B. Milosavljevic, D. Topic, et al. Differential effects of drug-eluting stents on local endothelium-dependent coronary vasomotion. J. Am. Coll. Cardiol., June 3, 2008; 51(22): 2123 - 2129. [Abstract] [Full Text] [PDF]
|
|
|
|
 |
|
 B X Chen, F Y Ma, W Luo, J H Ruan, W L Xie, X Z Zhao, S H Sun, X M Guo, F Wang, T Tian, et al. Neointimal coverage of bare-metal and sirolimus-eluting stents evaluated with optical coherence tomography Heart, May 1, 2008; 94(5): 566 - 570. [Abstract] [Full Text] [PDF]
|
|
|
|
 |
|
 Y. Suzuki, F. Ikeno, T. Koizumi, F. Tio, A. C. Yeung, P. G. Yock, P. J. Fitzgerald, and W. F. Fearon In Vivo Comparison Between Optical Coherence Tomography and Intravascular Ultrasound for Detecting Small Degrees of In-Stent Neointima After Stent Implantation J. Am. Coll. Cardiol. Intv., April 1, 2008; 1(2): 168 - 173. [Abstract] [Full Text] [PDF]
|
|
|
|
|
|
B. L. van der Hoeven, S.-S. Liem, J. Dijkstra, S. C. Bergheanu, H. Putter, M. L. Antoni, D. E. Atsma, M. Bootsma, K. Zeppenfeld, J. W. Jukema, et al. Stent Malapposition After Sirolimus-Eluting and Bare-Metal Stent Implantation in Patients with ST-Segment Elevation Myocardial Infarction: Acute and 9-Month Intravascular Ultrasound Results of the MISSION! Intervention Study J. Am. Coll. Cardiol. Intv., April 1, 2008; 1(2): 192 - 201. [Abstract] [Full Text] [PDF]
|
|
|
|
 |
|
 F. Saia, A. Marzocchi, and A. Branzi Review: The safety of drug-eluting stents Therapeutic Advances in Cardiovascular Disease, February 1, 2008; 2(1): 43 - 52. [Abstract] [PDF]
|
|
|
|
|
|
J. Aoki, A. Kirtane, M. B. Leon, and G. Dangas Coronary Artery Aneurysms After Drug-Eluting Stent Implantation J. Am. Coll. Cardiol. Intv., February 1, 2008; 1(1): 14 - 21. [Abstract] [Full Text] [PDF]
|
|
|
|
|
|
R. Jabara, N. Chronos, D. Conway, W. Molema, and K. Robinson Evaluation of a Novel Slow-Release Paclitaxel-Eluting Stent With a Bioabsorbable Polymeric Surface Coating J. Am. Coll. Cardiol. Intv., February 1, 2008; 1(1): 81 - 87. [Abstract] [Full Text] [PDF]
|
|
|
|
 |
|
 J. M. Wilson and J. T. Willerson Myocardial Revascularization with Percutaneous Devices Card. Surg. Adult, January 1, 2008; 3(2008): 573 - 598. [Full Text]
|
|
|
|
 |
|
 J. Cosgrave, A. Qasim, A. Latib, T. C. Aranzulla, and A. Colombo Very Late Restenosis after Paclitaxel-Eluting Stent Implantation Ann Intern Med, December 18, 2007; 147(12): 885 - 887. [Full Text] [PDF]
|
|
|
|
 |
|
 K. Egashira, K. Nakano, K. Ohtani, K. Funakoshi, G. Zhao, Y. Ihara, J.-i. Koga, S. Kimura, R. Tominaga, and K. Sunagawa Local Delivery of Anti-Monocyte Chemoattractant Protein-1 by Gene-Eluting Stents Attenuates In-Stent Stenosis in Rabbits and Monkeys Arterioscler. Thromb. Vasc. Biol., December 1, 2007; 27(12): 2563 - 2568. [Abstract] [Full Text] [PDF]
|
|
|
|
 |
|
 B. Doyle, C. S. Rihal, C. J. O'Sullivan, R. J. Lennon, H. J. Wiste, M. Bell, J. Bresnahan, and D. R. Holmes Jr Outcomes of Stent Thrombosis and Restenosis During Extended Follow-Up of Patients Treated With Bare-Metal Coronary Stents Circulation, November 20, 2007; 116(21): 2391 - 2398. [Abstract] [Full Text] [PDF]
|
|
|
|
 |
|
 G. J. Wilson, J. E. Polovick, B. A. Huibregtse, and B. C. Poff Overlapping paclitaxel-eluting stents: Long-term effects in a porcine coronary artery model Cardiovasc Res, November 1, 2007; 76(2): 361 - 372. [Abstract] [Full Text] [PDF]
|
|
|
|
|
|
L. A. Fleisher, J. A. Beckman, K. A. Brown, H. Calkins, E. L. Chaikof, K. E. Fleischmann, W. K. Freeman, J. B. Froehlich, E. K. Kasper, J. R. Kersten, et al. ACC/AHA 2007 Guidelines on Perioperative Cardiovascular Evaluation and Care for Noncardiac Surgery: A Report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Writing Committee to Revise the 2002 Guidelines on Perioperative Cardiovascular Evaluation for Noncardiac Surgery) Developed in Collaboration With the American Society of Echocardiography, American Society of Nuclear Cardiology, Heart Rhythm Society, Society of Cardiovascular Anesthesiologists, Society for Cardiovascular Angiography and Interventions, Society for Vascular Medicine and Biology, and Society for Vascular Surgery J. Am. Coll. Cardiol., October 23, 2007; 50(17): e159 - e242. [Full Text] [PDF]
|
|
|
|
|
|
L. A. Fleisher, J. A. Beckman, K. A. Brown, H. Calkins, E. L. Chaikof, K. E. Fleischmann, W. K. Freeman, J. B. Froehlich, E. K. Kasper, J. R. Kersten, et al. ACC/AHA 2007 Guidelines on Perioperative Cardiovascular Evaluation and Care for Noncardiac Surgery: A Report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Writing Committee to Revise the 2002 Guidelines on Perioperative Cardiovascular Evaluation for Noncardiac Surgery) Circulation, October 23, 2007; 116(17): e418 - e500. [Full Text] [PDF]
|
|
|
|
|
|
A. E. Rodriguez, A. O. Maree, J. Mieres, D. Berrocal, L. Grinfeld, C. Fernandez-Pereira, V. Curotto, A. Rodriguez-Granillo, W. O'Neill, and I. F. Palacios Late loss of early benefit from drug-eluting stents when compared with bare-metal stents and coronary artery bypass surgery: 3 years follow-up of the ERACI III registry Eur. Heart J., September 1, 2007; 28(17): 2118 - 2125. [Abstract] [Full Text] [PDF]
|
|
|
|
|
|
J. Daemen and P. W. Serruys Drug-Eluting Stent Update 2007: Part II: Unsettled Issues Circulation, August 21, 2007; 116(8): 961 - 968. [Full Text] [PDF]
|
|
|
|
|
|
P. Jimenez-Quevedo, M. Sabate, D. J. Angiolillo, F. Alfonso, R. Hernandez-Antolin, M. SanMartin, J. A. Gomez-Hospital, C. Banuelos, J. Escaned, R. Moreno, et al. Long-term clinical benefit of sirolimus-eluting stent implantation in diabetic patients with de novo coronary stenoses: long-term results of the DIABETES trial Eur. Heart J., August 2, 2007; 28(16): 1946 - 1952. [Abstract] [Full Text] [PDF]
|
|
|
|
|
|
M. R Bennett Vascular pathology as a result of drug-eluting stents Heart, August 1, 2007; 93(8): 895 - 896. [Abstract] [Full Text] [PDF]
|
|
|
|
|
|
N. M M Pires, D. Eefting, M. R de Vries, P. H A Quax, and J W. Jukema Sirolimus and paclitaxel provoke different vascular pathological responses after local delivery in a murine model for restenosis on underlying atherosclerotic arteries Heart, August 1, 2007; 93(8): 922 - 927. [Abstract] [Full Text] [PDF]
|
|
|
|
 |
|
 F. S. Santiago, H. Ishii, S. Shafi, R. Khurana, P. Kanellakis, R. Bhindi, M. J. Ramirez, A. Bobik, J. F. Martin, C. N. Chesterman, et al. Yin Yang-1 Inhibits Vascular Smooth Muscle Cell Growth and Intimal Thickening by Repressing p21WAF1/Cip1 Transcription and p21WAF1/Cip1-Cdk4-Cyclin D1 Assembly Circ. Res., July 20, 2007; 101(2): 146 - 155. [Abstract] [Full Text] [PDF]
|
|
|
|
|
|
J. Daemen and P. W. Serruys Drug-Eluting Stent Update 2007: Part I: A Survey of Current and Future Generation Drug-Eluting Stents: Meaningful Advances or More of the Same? Circulation, July 17, 2007; 116(3): 316 - 328. [Full Text] [PDF]
|
|
|
|
|
|
R. Jaffe and B. H. Strauss Late and Very Late Thrombosis of Drug-Eluting Stents: Evolving Concepts and Perspectives J. Am. Coll. Cardiol., July 10, 2007; 50(2): 119 - 127. [Abstract] [Full Text] [PDF]
|
|
|
|
|
|
D. R. Holmes Jr, D. J. Kereiakes, W. K. Laskey, A. Colombo, S. G. Ellis, T. D. Henry, J. J. Popma, P. W.J.C. Serruys, T. Kimura, D. O. Williams, et al. Thrombosis and Drug-Eluting Stents: An Objective Appraisal J. Am. Coll. Cardiol., July 10, 2007; 50(2): 109 - 118. [Abstract] [Full Text] [PDF]
|
|
|
|
|
|
A. V. Finn, G. Nakazawa, M. Joner, F. D. Kolodgie, E. K. Mont, H. K. Gold, and R. Virmani Vascular Responses to Drug Eluting Stents: Importance of Delayed Healing Arterioscler. Thromb. Vasc. Biol., July 1, 2007; 27(7): 1500 - 1510. [Abstract] [Full Text] [PDF]
|
|
|
|
 |
|
 R. A. Harrington and E. M. Ohman The Enigma of Drug-Eluting Stents: Hope, Hype, Humility, and Advancing Patient Care JAMA, May 9, 2007; 297(18): 2028 - 2030. [Full Text] [PDF]
|
|
|
|
|
|
S. Cook, P. Wenaweser, M. Togni, M. Billinger, C. Morger, C. Seiler, R. Vogel, O. Hess, B. Meier, and S. Windecker Incomplete Stent Apposition and Very Late Stent Thrombosis After Drug-Eluting Stent Implantation Circulation, May 8, 2007; 115(18): 2426 - 2434. [Abstract] [Full Text] [PDF]
|
|
|
|
|
|
A. V. Finn, M. Joner, G. Nakazawa, F. Kolodgie, J. Newell, M. C. John, H. K. Gold, and R. Virmani Pathological Correlates of Late Drug-Eluting Stent Thrombosis: Strut Coverage as a Marker of Endothelialization Circulation, May 8, 2007; 115(18): 2435 - 2441. [Abstract] [Full Text] [PDF]
|
|
|
|
 |
|
 G. M. Howard-Alpe, J. de Bono, L. Hudsmith, W. P. Orr, P. Foex, and J. W. Sear Coronary artery stents and non-cardiac surgery Br. J. Anaesth., May 1, 2007; 98(5): 560 - 574. [Abstract] [Full Text] [PDF]
|
|
|
|
|
|
B. Scheller, U. Speck, and M. Bohm Prevention of restenosis: is angioplasty the answer? Heart, May 1, 2007; 93(5): 539 - 541. [Abstract] [Full Text] [PDF]
|
|
|
|
|
|
H. M.M. van Beusekom, F. Saia, J. D. Zindler, P. A. Lemos, S. L. S.-t. Hoor, M. A.H. van Leeuwen, P. J. de Feijter, P. W. Serruys, and W. J. van der Giessen Drug-eluting stents show delayed healing: paclitaxel more pronounced than sirolimus Eur. Heart J., April 12, 2007; (2007) ehm064v1. [Abstract] [Full Text] [PDF]
|
|
|
|
 |
|
 S. Luthra, J. Tatoulis, and R. J. Warren Drug-Eluting Stent-Induced Left Anterior Descending Coronary Artery Aneurysm: Repair by Pericardial Patch--Where Are We Headed? Ann. Thorac. Surg., April 1, 2007; 83(4): 1530 - 1532. [Abstract] [Full Text] [PDF]
|
|
|
|
|
|
E. Camenzind, P. G. Steg, and W. Wijns A Cause for Concern Circulation, March 20, 2007; 115(11): 1440 - 1455. [Full Text] [PDF]
|
|
|
|
 |
|
 C. Spaulding, J. Daemen, E. Boersma, D. E. Cutlip, and P. W. Serruys A Pooled Analysis of Data Comparing Sirolimus-Eluting Stents with Bare-Metal Stents N. Engl. J. Med., March 8, 2007; 356(10): 989 - 997. [Abstract] [Full Text] [PDF]
|
|
|
|
|
|
G. W. Stone, J. W. Moses, S. G. Ellis, J. Schofer, K. D. Dawkins, M.-C. Morice, A. Colombo, E. Schampaert, E. Grube, A. J. Kirtane, et al. Safety and Efficacy of Sirolimus- and Paclitaxel-Eluting Coronary Stents N. Engl. J. Med., March 8, 2007; 356(10): 998 - 1008. [Abstract] [Full Text] [PDF]
|
|
|
|
|
|
B. Lagerqvist, S. K. James, U. Stenestrand, J. Lindback, T. Nilsson, L. Wallentin, and the SCAAR Study Group Long-Term Outcomes with Drug-Eluting Stents versus Bare-Metal Stents in Sweden N. Engl. J. Med., March 8, 2007; 356(10): 1009 - 1019. [Abstract] [Full Text] [PDF]
|
|
|
|
|
|
C. L. Grines, R. O. Bonow, D. E. Casey Jr, T. J. Gardner, P. B. Lockhart, D. J. Moliterno, P. O'Gara, and P. Whitlow Prevention of Premature Discontinuation of Dual Antiplatelet Therapy in Patients With Coronary Artery Stents: A Science Advisory From the American Heart Association, American College of Cardiology, Society for Cardiovascular Angiography and Interventions, American College of Surgeons, and American Dental Association, With Representation From the American College of Physicians J. Am. Coll. Cardiol., February 13, 2007; 49(6): 734 - 739. [Abstract] [Full Text] [PDF]
|
|
|
|
|
|
C. L. Grines, R. O. Bonow, D. E. Casey Jr, T. J. Gardner, P. B. Lockhart, D. J. Moliterno, P. O'Gara, and P. Whitlow Prevention of Premature Discontinuation of Dual Antiplatelet Therapy in Patients With Coronary Artery Stents: A Science Advisory From the American Heart Association, American College of Cardiology, Society for Cardiovascular Angiography and Interventions, American College of Surgeons, and American Dental Association, With Representation From the American College of Physicians Circulation, February 13, 2007; 115(6): 813 - 818. [Abstract] [Full Text] [PDF]
|
|
|
|
|
|
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]
|
|
|
|
 |
|
 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]
|
|
|
|
|
|
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]
|
|
|
|
|
|
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]
|
|
|
|
 |
|
 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]
|
|
|
|
|
|
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]
|
|
|
|
|
|
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]
|
|
|
|
|
|
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]
|
|
|
|
|
|
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]
|
|
|
|
|
|
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]
|
|
|
|
|
|
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]
|
|
|
|
|
|
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]
|
|
|
|
|
|
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]
|
|
|
|
|
|
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]
|
|