Clinical Comparison of Drug-Eluting Stents and Bare Metal Stents in Large Coronary Arteries

큰 관상동맥 병변에서 약물방출스텐트와 금속스텐트의 임상경과 비교

  • Kim, Woo-Jong (Division of Cardiology, Department of Internal Medicine, St. Carollo Hospital) ;
  • Cho, Jang-Hyun (Division of Cardiology, Department of Internal Medicine, St. Carollo Hospital) ;
  • Jung, Jong-Heok (Division of Cardiology, Department of Internal Medicine, St. Carollo Hospital) ;
  • Lee, Min-Kun (Division of Cardiology, Department of Internal Medicine, St. Carollo Hospital) ;
  • Yoon, Jae-Sung (Division of Cardiology, Department of Internal Medicine, St. Carollo Hospital) ;
  • Ahn, Young-Soo (Division of Cardiology, Department of Internal Medicine, St. Carollo Hospital) ;
  • Hwang, Young-Jun (Division of Cardiology, Department of Internal Medicine, St. Carollo Hospital) ;
  • Jung, Hong-Myung (Division of Cardiology, Department of Internal Medicine, St. Carollo Hospital) ;
  • Kim, Su-Hyun (Division of Cardiology, Department of Internal Medicine, St. Carollo Hospital) ;
  • Kim, Joon-Young (Division of Cardiology, Department of Internal Medicine, St. Carollo Hospital) ;
  • Jeong, Myung-Ho (The Heart Center of Chonnam National University Hospital)
  • 김우종 (성가롤로병원 순환기내과) ;
  • 조장현 (성가롤로병원 순환기내과) ;
  • 정종혁 (성가롤로병원 순환기내과) ;
  • 이민근 (성가롤로병원 순환기내과) ;
  • 윤재성 (성가롤로병원 순환기내과) ;
  • 안용수 (성가롤로병원 순환기내과) ;
  • 황영준 (성가롤로병원 순환기내과) ;
  • 정홍명 (성가롤로병원 순환기내과) ;
  • 김수현 (성가롤로병원 순환기내과) ;
  • 김준영 (성가롤로병원 순환기내과) ;
  • 정명호 (전남대학교병원 심장센터)
  • Published : 2011.06.01

Abstract

Background/Aims: Drug-eluting stents (DES) are superior to bare metal stents (BMS) in reducing restenosis rates across a wide range of patients and lesion subsets.This study compared the clinical outcomes of DES versus BMS in patients with large coronary arteries (${\geq}$ 3.5 mm). Methods: The study compared 134 patients (59.9 ${\pm}$ 10.6 years, 90 men, 44 women) who underwent single vessel angioplasty with DESimplantation in large vessels with 115 patients (60.3 ${\pm}$ 8.9 years, 82 men, 33 women) who received BMS. The clinical outcomes at 12 months were compared between groups. The study end points were major adverse cardiac events (MACE), including cardiac death, nonfatal myocardial infarction, and the need for target vessel and target lesion revascularization. Results: The baseline clinical coronary angiography and procedural characteristics were similar in both groups. The duration of dual antiplatelet therapy was longer in the DES group than in the BMS group (240 ${\pm}$ 2.7 vs. 348 ${\pm}$ 1.7 days, p = 0.042). During the 12-month clinical follow-up, MACE were observed in 13 patients (11.3%) with BMS and 12 patients (9.0%) with DES (p = 0.486). Conclusions: For coronary stents implanted in large coronary arteries, DES seems to be more favorable, although no significant differences were observed in the clinical outcomes between DES and BMS during a 1-year clinical follow-up.

목적: 일반적으로 약물방출스텐트(DES, drug-eluting stent)가 시술 이후 추적검사에서 합병증 발생률이 낮은 것으로 알려져 있어 일반 금속스텐트(BMS, bare metal stent)보다 주로 시술에 이용되고 있다. 본 연구에서는 관상동맥의 혈관직경에 따라서 DES와 BMS 사이에서의 후기 합병증 차이를 밝히고자 하였으며 특히 동맥직경이 3.5 mm 이상인 혈관을 대상으로 연구를 시행하였다. 방법: 2000년 9월에서 2008년 6월까지 경피적 관상동맥 중재술을 시술 받은 환자 중 DES를 시술 받은 134예(59.9 ${\pm}$ 10.6세, 남자 90명, 68.7%)와 BMS를 시술한 115예(60.3 ${\pm}$ 8.9세, 남자 82명, 71.3%)를 대상으로, 시술 후 12개월 동안 임상경과와 주요 심혈관계사고, 즉 심장사, 심근경색, 재관류를 위한 관상동맥우회술 등을 비교하였다. 결과: 혈관병변의 길이는 DES와 BMS 사이에 차이가 없었고(19.7 ${\pm}$ 9.1 mm vs. 18.6 ${\pm}$ 4.5 mm, p = 0.248), 길이도 DES의 경우에 더 긴 경향을 보였으나, 통계적으로 유의한 차이는 없었다(22.6 ${\pm}$ 5.2 mm vs. 21.9 ${\pm}$ 4.5 mm, p = 0.207). 시술 12개월 후의 추적검사에서 주요심혈관사고는 BMS군과 DES군에서 통계적인 차이가 없었다(BMS 13명, 11.3% vs. DES 12명 9.0%, p = 0.486). 이중 항혈소판제(dual antiplatelet therapy) 투여기간은 DES 시술군에서 BMS 시술군보다 길었다(240 ${\pm}$ 2.7일 vs. 348 ${\pm}$ 1.7일, p = 0.042). 결론: 큰 관상동맥에서 DES 시술은 BMS에 비하여 임상경과에서 유의한 이득이 없었으므로, 큰 관상동맥 질환 병변이 있는 경우에 BMS 시술을 우선적으로 고려해 볼 수 있다고 생각되었다.

Keywords

References

  1. Steinberg DH, Mishra S, Javaid A, et al. Comparison of effectiveness of bare metal stents versus drug-eluting stents in large (> or = 3.5 mm) coronary arteries. Am J Cardiol 2007;99: 599-602. https://doi.org/10.1016/j.amjcard.2006.09.105
  2. Quizhpe AR, Feres F, de Ribamar Costa J Jr, et al. Drug-eluting stents vs bare metal stents for the treatment of large coronary vessels. Am Heart J 2007;154:373-378. https://doi.org/10.1016/j.ahj.2007.04.027
  3. Joen DJ, Hong GR, Bae JH, et al. Immediate and follow-up results after long stent implantaton in diffuse long coronary lesions. Korean J Med 2000;58:48-57.
  4. James SK, Stenestrand U, Lindback J, et al. Long-term safety and efficacy of drug-eluting versus bare-metal stents in Sweden. N Engl J Med 2009;360:1933-1945. https://doi.org/10.1056/NEJMoa0809902
  5. Kishore JH, Ricardo C, Pichard L. Clinical outcomes following drug-eluting versus bare metal stent implantation for lesion subsets excluded from pivotal clinical trials: finding from the GHOST Study (Guthrie Health System Off-Label StenT Study). J Interv Cardiol 2008;21:315-324. https://doi.org/10.1111/j.1540-8183.2008.00380.x
  6. Koutouzis M, Nikolidakis S, Arealis G, Kyriakides ZS. Very late in-stent restenosis in a bare metal stent. Cardiology 2007;107: 360-361. https://doi.org/10.1159/000099051
  7. Malenka DJ, Kaplan AV, Lucas FL, Sharp SM, Skinner JS. Outcomes Following Coronary Stenting in the era of bare-metal vs. the era of drug-eluting stents. JAMA 2008;299:2868-2876. https://doi.org/10.1001/jama.299.24.2868
  8. Strozzi M, Anic D. Comparison of stent graft, sirolimus stent, and bare metal stent implanted in patients with acute coronary syndrome: clinical and angiographic follow-up. Croat Med J 2007;48:348-352.
  9. Khattab AA, Otto A, Hochadel M, Toelg R, Geist V, Richardt G. Drug-eluting stents versus bare metal stents following rotational atherectomy for heavily calcified coronary lesions: late angiographic and clinical follow-up results. J Interv Cardiol 2007;20:100-106. https://doi.org/10.1111/j.1540-8183.2007.00243.x
  10. Jensen J, Lagerqvist B, Aasa M, Sarev T, Nilsson T, Tornvall P. Clinical and angiographic follow-up after coronary drug-eluting and bare metal stent implantation: do drug-eluting stents hold the promise? J Intern Med 2006;260:118-124. https://doi.org/10.1111/j.1365-2796.2006.01669.x
  11. Steinberg DH, Waksman R. Drug-eluting stent thrombosis vs bare metal stent restenosis: finding the lesser of two evils. Am Heart Hosp J 2007;5:151-154. https://doi.org/10.1111/j.1541-9215.2007.07282.x
  12. Spaulding C, Daemen J, Boersma E, Cutlip DE, Serruys PW. A pooled analysis of data comparing sirolimus-eluting stents with bare-metal stents. N Engl J Med 2007;356:989-997. https://doi.org/10.1056/NEJMoa066633
  13. Fuchs AT, Kuehnl A, Pelisek J, et al. Meta-analysis shows similar risk of thrombosis after drug-eluting stent, bare-metal stent, or angioplasty. Endothelium 2008;15:93-100. https://doi.org/10.1080/10623320802092534
  14. Lee SH, Jeong MH, Hong YJ, et al. A long stent is the only predictive factor for coronary stent restenosis. Korean J Med 2001;60:529-536.
  15. Barlis P, Kaplan S, Dimopoulos K, Ferrante G, Di Mario C. Comparison of bare-metal and sirolimus-or paclitaxel-eluting stents for aorto-ostial coronary disease. Cardiology 2008;111: 270-276. https://doi.org/10.1159/000128602
  16. Stone GW, Ellis SG, Cannon L, et al. Comparison of a polymerbased paclitaxel-eluting stent with a bare metal stent in patients with complex coronary artery disease: a randomized controlled trial. JAMA 2005;294:1215-1223. https://doi.org/10.1001/jama.294.10.1215
  17. Tanigawa J, Sutaria N, Goktekin O, Di Mario C. Treatment of unprotected left main coronary artery stenosis in the drug-eluting stent era. J Interv Cardiol 2005;18:455-465. https://doi.org/10.1111/j.1540-8183.2005.00086.x
  18. Tanzilli G, Pelliccia F, Pasceri V, et al. Randomized study on provisional stenting with sirolimus-eluting stent vs. bare metal stent for the treatment of true coronary bifurcations: the PROSUMER (PROvisional with sirolimus-eluting vs. bare metal stents in truE bifuRcations) study. Int J Cardiol 2011;146:240-241. https://doi.org/10.1016/j.ijcard.2010.10.052
  19. Beohar N, Davidson CJ, Kip KE, et al. Outcomes and complications associated with off-label and untested use of drug-eluting stents. JAMA 2007;297:1992-2000. https://doi.org/10.1001/jama.297.18.1992
  20. Ma X, Oyamada S, Gao F, et al. Paclitaxel/sirolimus combination coated drug-eluting stent: in vitro and in vivo drug release studies. J Pharm Biomed Anal 2011;54:807-811. https://doi.org/10.1016/j.jpba.2010.10.027
  21. Zimarino M, Renda G, De Caterina R. Optimal duration of antiplatelet therapy in recipients of coronary drug-eluting stents. Drugs 2005;65:725-732. https://doi.org/10.2165/00003495-200565060-00001
  22. Moohebati M, Falsoleiman H, Dehghani M, et al. Serum inflammatory and immune marker response after bare-metal or drug-eluting stent implantation following percutaneous coronary intervention. Angiology 2011;62:184-190. https://doi.org/10.1177/0003319710375086
  23. Alt E, Haehnel I, Beilharz C, et al. Inhibition of neointima formation after experimental coronary artery stenting: a new biodegradable stent coating releasing hirudin and the prostacyclin analogue iloprost. Circulation 2000;101:1453-1458. https://doi.org/10.1161/01.CIR.101.12.1453
  24. Ho PM, Peterson ED, Wang L, et al. Incidence of death and acute myocardial infarction associated with stopping clopidogrel after acute coronary syndrome. JAMA 2008;299:532-539. https://doi.org/10.1001/jama.299.5.532
  25. Mauri L, Hsieh WH, Massaro JM, Ho KK, D'Agostino R, Cutlip DE. Stent thrombosis in randomized clinical trials of drug-eluting stents. N Engl J Med 2007;356:1020-1029. https://doi.org/10.1056/NEJMoa067731
  26. Chechi T, Vittori G, Biondi Zoccai GG, et al. Single-center randomized evaluation of paclitaxel-eluting versus conventional stent in acute myocardial infarction (SELECTION). J Interv Cardiol 2007;20:282-291. https://doi.org/10.1111/j.1540-8183.2007.00270.x
  27. De Felice F, Fiorilli R, Parma A, et al. Comparison of one-year cardiac events with drug-eluting versus bare metal stent implantation in rescue coronary angioplasty. Am J Cardiol 2011;107: 210-214. https://doi.org/10.1016/j.amjcard.2010.08.064
  28. Seo YU, Koh YY, Kang MJ, Chang KS, Hong SP. Predictors of side branch occlusions just after coronary stenting. Korean J Med 2004;67:153-160.
  29. Lee SW, Lee SW, Hong MK, et al. Bail-out stenting for left main coronary artery dissection during catheter-based procedure: acute and long-term results. Korean J Med 2004;66:571-575.
  30. Rossini R, Capodanno D, Lettieri C, et al. Prevalence, predictors, and long-term prognosis of premature discontinuation of oral antiplatelet therapy after drug eluting stent implantation. Am J Cardiol 2011;107:186-194. https://doi.org/10.1016/j.amjcard.2010.08.067
  31. Kaiser C, Galatius S, Erne P, et al. Drug-Eluting versus bare-metal stents in large coronary arteries. N Engl J Med 2010;363: 2310-2319. https://doi.org/10.1056/NEJMoa1009406