Korean Circ J.  2007 Dec;37(12):641-646. 10.4070/kcj.2007.37.12.641.

The Frequency, Treatment and Clinical Outcomes of Stent Thrombosis after Use of TAXUSTM Stent

• Moon JY
• Jeong MH
• Kim IS
• Jun CH
• Cho JS
• Chung JW
• Sim D
• Hong YJ
• Kim JH
• Ahn Y
• Cho JG
• Park JC
• Kang JC

• KMID: 2227040
• DOI: http://doi.org/10.4070/kcj.2007.37.12.641

Abstract

BACKGROUND AND OBJECTIVES: Findings from randomized controlled trials have showed that there is no difference in the development of stent thrombosis (ST) in patients implanted with drug-eluting stents (DES) as compared to the use of bare metal stents. The aim of this study was to evaluate the incidence, clinical characteristics, and clinical outcome of ST after implantation of TAXUSTM stents in routine clinical practice.
SUBJECTS AND METHODS
This was a retrospective, single center cohort study. The study included 1,584 patients that underwent successful TAXUSTM stent implantation (2,513 lesions treated) between May 2004 and Dec 2006.
RESULTS
ST developed in 18 patients (1.14%) of the 1,584 patients. Acute ST occurred in one patient (0.06%), subacute ST occurred in nine patients (0.57%), and late ST developed in eight patients (0.51%). Sixteen patients that developed ST received medication with dual antiplatelet agents. The incidence of ST in patients with acute coronary syndrome (ACS) showed was higher than in patients with stable coronary disease. The mean follow-up duration for patients was 13.3 months. There were 13 myocardial infarctions and 3 deaths attributable to ST.
CONCLUSION
The cumulative incidence of ST that was confirmed by angiography after successful TAXUSTM stent implantation in consecutive "real-world" patients was substantially higher than the rate reported in clinical trials. Patients with ACS should be treated more aggressively as the risk of stent thrombosis is higher than for patients with stable angina. A large prospective study for the identification of predictors of DES thrombosis should be conducted.

Keyword

Stents; Thrombosis; Angina pectoris; Myocardial infarction

MeSH Terms

Acute Coronary Syndrome
Angina Pectoris
Angina, Stable
Angiography
Cohort Studies
Coronary Disease
Drug-Eluting Stents
Follow-Up Studies
Humans
Incidence
Myocardial Infarction
Platelet Aggregation Inhibitors
Retrospective Studies
Stents*
Thrombosis*
Platelet Aggregation Inhibitors

Reference

1. 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.

2. 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.

3. Stone GW, Ellis SG, Cox DA, et al. A polymer-based, paclitaxel-eluting stent in patients with coronary artery disease. N Engl J Med. 2004. 350:221–231.

4. Colombo A, Drzewiecki J, Banning A, et al. Randomized study to assess the effectiveness of slow- and moderate-release polymer-based paclitaxel-eluting stents for coronary artery lesions. Circulation. 2003. 108:788–794.

5. Schampaert E, Cohen EA, Schluter M, et al. The Canadian study of the sirolimus-eluting stent in the treatment of patients with long de novo lesions in small native coronary arteries (C-SIRIUS). J Am Coll Cardiol. 2004. 43:1110–1115.

6. 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.

7. Park SJ, Kim YH, Lee BK, et al. Sirolimus-eluting stent implantation for unprotected left main coronary artery stenosis: comparison with bare metal stent implantation. J Am Coll Cardiol. 2005. 45:351–356.

8. Jeremias A, Sylvia B, Bridges J, et al. Stent thrombosis after successful sirolimus-eluting stent implantation. Circulation. 2004. 109:1930–1932.

9. Park DW, Park SW. Stent thrombosis in the era of the drug-eluting stent. Korean Circ J. 2005. 35:791–794.

10. Park S, Hong GR, Seo HS, Tahk SJ. Stent thrombosis after successful drug-eluting stent implantation. Korean Circ J. 2005. 35:163–171.

11. Daemen J, Garcia-Garcia HM, Kukreja N, et al. The long-term value of sirolimus- and paclitaxel-eluting stents over bare metal stents in patients with diabetes mellitus. Eur Heart J. 2007. 28:26–32.

12. Ellis SG, Colombo A, Grube E, et al. Incidence, timing, and correlates of stent thrombosis with the polymeric paclitaxel drug-eluting stent: a TAXUS II, IV, V, and VI meta-analysis of 3,445 patients followed for up to 3 years. J Am Coll Cardiol. 2007. 49:1043–1051.

13. Moreno R, Fernandez C, Hernandez R, et al. Drug-eluting stent thrombosis: results from a pooled analysis including 10 randomized studies. J Am Coll Cardiol. 2005. 45:954–959.

14. Schampaert E, Moses JW, Schofer J, et al. Sirolimus-eluting stents at two years: a pooled analysis of SIRIUS, E-SIRIUS, and C-SIRIUS with emphasis on late revascularizations and stent thromboses. Am J Cardiol. 2006. 98:36–41.

15. Farb A, Boam AB. Stent thrombosis redux: the FDA perspective. N Engl J Med. 2007. 356:984–987.

16. De Luca G, Carbone G, Maione A, Gregorio G. In-stent thrombosis after discontinuation of antiplatelet therapy 2 years after DES implantation: a case report. Int J Cardiol. 2007. 116:399–400.

17. Artang R, Dieter RS. Analysis of 36 reported cases of late thrombosis in drug-eluting stents placed in coronary arteries. Am J Cardiol. 2007. 99:1039–1043.

18. Grines CL, Bonow RO, Casey DE Jr, et al. 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. Catheter Cardiovasc Interv. 2007. 69:334–340.

19. Burzotta F, Romagnoli E, Manzoli A, et al. The Outcome of PCI for stent-ThrombosIs MultIcentre Study (OPTIMIST): rationale and design of a multicenter registry. Am Heart J. 2007. 153:377.e1. 377.e5.

20. Iakovou I, Schmidt T, Bonizzoni E, et al. Incidence, predictors, and outcome of thrombosis after successful implantation of drug-eluting stents. JAMA. 2005. 293:2126–2130.

21. Daemen J, Wenaweser P, Tsuchida K, et al. Early and late coronary stent thrombosis of sirolimus-eluting and paclitaxel-eluting stents in routine clinical practice: data from a large two-institutional cohort study. Lancet. 2007. 369:667–678.

22. Oyabu J, Ueda Y, Ogasawara N, Okada K, Hirayama A, Kodama K. Angioscopic evaluation of neointima coverage: sirolimus drug-eluting stent versus bare metal stent. Am Heart J. 2006. 152:1168–1174.

23. Park HW, Jeong MH, Park OY, et al. The long-term clinical effects of heparin coated coronary stent. Korean Circ J. 2002. 32:773–780.

24. Kim W, Jeong MH, Cha KS, et al. The effect of anti-oxidants (carvedilol and probucol) loaded stents in a porcine coronary restenosis model. Circ J. 2005. 69:101–106.

25. Kim W, Jeong MH, Hong YJ, et al. The long-term clinical results of a platelet glycoprotein IIb/IIIa receptor blocker (Abciximab: ReoPro®) coated stent in patients with acute myocardial infarction. Korean Circ J. 2004. 34:1063–1069.

26. Hong YJ, Jeong MH, Kim W, et al. Effect of abciximab-coated stent on in-stent intimal hyperplasia in human coronary arteries. Am J Cardiol. 2004. 94:1050–1054.

27. Park OY, Jeong MH, Kim JH, et al. The inhibitory effects of a platelet glycoprotein IIb/IIIa receptor blocker-coated stent on neointima formation and inflammatory response in porcine coronary stent restenosis. Korean Circ J. 2003. 33:439–445.

28. Lim SY, Jeong MH. Is heparin-coated stent effective in patients with acute myocardial infarction? Korean Circ J. 2004. 34:537–539.

29. Kim W, Jeong MH, Kim KH, et al. The clinical results of a platelet glycoprotein IIb/IIIa receptor blocker (abciximab-ReoPro)-coated stent in acute myocardial infarction. J Am Coll Cardiol. 2006. 47:933–938.

30. Lim SY, Bae EH, Jeong MH, et al. The effect of oral administration of alpha lipoic acid and alpha lipoic acid coated stent in porcine in-stent restenosis model. Korean Circ J. 2006. 36:495–502.