J Korean Med Sci.  2013 Mar;28(3):396-401. 10.3346/jkms.2013.28.3.396.

Seven-Year Clinical Outcomes of Sirolimus-Eluting Stent Versus Bare-Metal Stent: A Matched Analysis From A Real World, Single Center Registry

Affiliations
  • 1Division of Cardiology, Department of Internal Medicine, Yeungnam University Medical Center, Daegu, Korea. pjs@med.yu.ac.kr

Abstract

The aim of this study is to compare clinical outcomes for seven years, between sirolimus-eluting stent (SES) and bare metal stent (BMS). During the BMS and drug-eluting stent (DES) transition period (from April 2002 to April 2004), 434 consecutive patients with 482 lesions underwent percutaneous coronary intervention, using BMS or SES. Using propensity score matching, 186 patients with BMS and 166 patients with SES were selected. Seven year clinical outcomes of major adverse cardiac events (MACE), such as cardiac death, myocardial infarction (MI) and ischemia-driven target vessel revascularization (TVR), and angiographic definite stent thrombosis (ST) were compared. At one-year follow up, patients with SES showed significantly lower MACE (9.1% in BMS vs 3.0% in SES, P = 0.024). However, cumulative MACE for 7 yr was not significantly different between two groups (24.7% in BMS vs 17.4% in SES, P = 0.155). There was no significant difference in MI, TVR, death and ST. The TVR were gradually increased from 1 to 7 yr in SES, on the contrary to that of BMS. In conclusion, although SES showed better clinical outcomes in the early period after implantation, it did not show significant benefits in the long-term follow up, compared with that of BMS.

Keyword

Drug-Eluting Stents; Bare-Metal Stents; Long-term

MeSH Terms

Aged
Angioplasty, Balloon, Coronary/adverse effects/*methods
Coronary Angiography
Coronary Stenosis/mortality/radiography/*therapy
Databases, Factual
*Drug-Eluting Stents
Female
Follow-Up Studies
Humans
Ischemia/etiology
Kaplan-Meier Estimate
Male
Middle Aged
Myocardial Infarction/etiology
Myocardial Revascularization
Registries
Sirolimus/*therapeutic use
*Stents
Thrombosis/etiology
Sirolimus

Figure

  • Fig. 1 Kaplan-Meier curves for major adverse cardiac events (MACE) during each time periods. Panel A shows no differences in MACE for 7 yr between two groups (P = 0.344). However, the rate of MACE was higher in bare-metal stent (BMS) than Sirolimus-eluting stent (SES) for 1 yr after stent implantation (Panel B, P = 0.026). After 1 yr, the rate of MACE was similar between two groups (Panel C, P = 0.754).

  • Fig. 2 Kaplan-Meier curves for ischemia-driven target vessel revascularization (TVR) during each time periods. Panel A shows no difference in TVR between bare-metal stent (BMS) and Sirolimus-eluting stent (SES, P = 0.710). However, there are significant differences during 1 yr after stent implantation (8% in BMS vs 2% in SES, P = 0.020, Panel B). After 1 yr, the rate of TVR was not different between two groups (Panel C, P = 0.144).


Reference

1. Morice MC, Serruys PW, Sousa JE, Fajadet J, Ban Hayashi E, Perin M, Colombo A, Schuler G, Barragan P, Guagliumi G, 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. Räber L, Wohlwend L, Wigger M, Togni M, Wandel S, Wenaweser P, Cook S, Moschovitis A, Vogel R, Kalesan B, et al. Five-year clinical and angiographic outcomes of a randomized comparison of sirolimus-eluting and paclitaxel-eluting stents: results of the Sirolimus-Eluting Versus Paclitaxel-Eluting Stents for Coronary Revascularization LATE trial. Circulation. 2011. 123:2819–2828.
3. Nakagawa Y, Kimura T, Morimoto T, Nomura M, Saku K, Haruta S, Muramatsu T, Nobuyoshi M, Kadota K, Fujita H, et al. Incidence and risk factors of late target lesion revascularization after sirolimus-eluting stent implantation (3-year follow-up of the j-Cypher Registry). Am J Cardiol. 2010. 106:329–336.
4. Kimura T, Abe K, Shizuta S, Odashiro K, Yoshida Y, Sakai K, Kaitani K, Inoue K, Nakagawa Y, Yokoi H, et al. Long-term clinical and angiographic follow-up after coronary stent placement in native coronary arteries. Circulation. 2002. 105:2986–2991.
5. Cutlip DE, Windecker S, Mehran R, Boam A, Cohen DJ, van Es GA, Steg PG, Morel MA, Mauri L, Vranckx P, et al. Clinical end points in coronary stent trials: a case for standardized definitions. Circulation. 2007. 115:2344–2351.
6. Kimura T, Yokoi H, Nakagawa Y, Tamura T, Kaburagi S, Sawada Y, Sato Y, Yokoi H, Hamasaki N, Nosaka H, et al. Three-year follow-up after implantation of metallic coronary-artery stents. N Engl J Med. 1996. 334:561–566.
7. Carter AJ, Aggarwal M, Kopia GA, Tio F, Tsao PS, Kolata R, Yeung AC, Llanos G, Dooley J, Falotico R. Long-term effects of polymer-based, slow-release, sirolimus-eluting stents in a porcine coronary model. Cardiovasc Res. 2004. 63:617–624.
8. Virmani R, Guagliumi G, Farb A, Musumeci G, Grieco N, Motta T, Mihalcsik L, Tespili M, Valsecchi O, Kolodgie FD. Localized hypersensitivity and late coronary thrombosis secondary to a sirolimus-eluting stent: should we be cautious? Circulation. 2004. 109:701–705.
9. Caixeta A, Leon MB, Lansky AJ, Nikolsky E, Aoki J, Moses JW, Schofer J, Morice MC, Schampaert E, Kirtane AJ, et al. 5-year clinical outcomes after sirolimus-eluting stent implantation insights from a patient-level pooled analysis of 4 randomized trials comparing sirolimus-eluting stents with bare-metal stents. J Am Coll Cardiol. 2009. 54:894–902.
10. Pocock SJ, Lansky AJ, Mehran R, Popma JJ, Fahy MP, Na Y, Dangas G, Moses JW, Pucelikova T, Kandzari DE, et al. Angiographic surrogate end points in drug-eluting stent trials: a systematic evaluation based on individual patient data from 11 randomized, controlled trials. J Am Coll Cardiol. 2008. 51:23–32.
11. Byrne RA, Kastrati A, Kufner S, Massberg S, Birkmeier KA, Laugwitz KL, Schulz S, Pache J, Fusaro M, Seyfarth M, et al. Randomized, non-inferiority trial of three limus agent-eluting stents with different polymer coatings: the Intracoronary Stenting and Angiographic Results: Test Efficacy of 3 Limus-Eluting Stents (ISAR-TEST-4) Trial. Eur Heart J. 2009. 30:2441–2449.
12. Shiode N, Shirota K, Tsunoda F, Kato Y, Fujiwara M, Mimura A. Late progression after sirolimus-eluting stent implantation for de novo lesions: comparison with bare metal stent implantation. Circ J. 2010. 74:1104–1110.
13. Park KW, Kim CH, Lee HY, Kang HJ, Koo BK, Oh BH, Park YB, Kim HS. Does late catch-up exist in drug-eluting stents: insights from a serial quantitative coronary angiography analysis of sirolimus versus paclitaxel-eluting stents. Am Heart J. 2010. 159:446–453.
Full Text Links
  • JKMS
Actions
Cited
CITED
export Copy
Close
Share
  • Twitter
  • Facebook
Similar articles
Copyright © 2024 by Korean Association of Medical Journal Editors. All rights reserved.     E-mail: koreamed@kamje.or.kr