Korean Circulation Journal

  • 제49권1호
  • /
  • Pages.69-80
  • /
  • 2019
  • /
  • 1738-5520(pISSN)
  • /
  • 1738-5555(eISSN)
대한심장학회 (The Korean Society of Cardiology)
권호 표지
DOI QR코드

DOI QR Code

Safety and Efficacy of Biodegradable Polymer-biolimus-eluting Stents (BP-BES) Compared with Durable Polymer-everolimus-eluting Stents (DP-EES) in Patients Undergoing Complex Percutaneous Coronary Intervention

  • Song, Pil Sang (Division of Cardiology, Cardiovascular Center, Mediplex Sejong General Hospital) ;
  • Park, Kyu Tae (Division of Cardiology, Department of Medicine, Heart Vascular Stroke Institute, Samsung Medical Center, Sungkyunkwan University School of Medicine) ;
  • Kim, Min Jeong (Division of Cardiology, Cardiovascular Center, Mediplex Sejong General Hospital) ;
  • Jeon, Ki-Hyun (Division of Cardiology, Cardiovascular Center, Mediplex Sejong General Hospital) ;
  • Park, Jin-Sik (Division of Cardiology, Cardiovascular Center, Mediplex Sejong General Hospital) ;
  • Choi, Rak Kyeong (Division of Cardiology, Cardiovascular Center, Mediplex Sejong General Hospital) ;
  • Song, Young Bin (Division of Cardiology, Department of Medicine, Heart Vascular Stroke Institute, Samsung Medical Center, Sungkyunkwan University School of Medicine) ;
  • Choi, Seung-Hyuk (Division of Cardiology, Department of Medicine, Heart Vascular Stroke Institute, Samsung Medical Center, Sungkyunkwan University School of Medicine) ;
  • Choi, Jin-Ho (Division of Cardiology, Department of Medicine, Heart Vascular Stroke Institute, Samsung Medical Center, Sungkyunkwan University School of Medicine) ;
  • Lee, Sang Hoon (Division of Cardiology, Department of Medicine, Heart Vascular Stroke Institute, Samsung Medical Center, Sungkyunkwan University School of Medicine) ;
  • Gwon, Hyeon-Cheol (Division of Cardiology, Department of Medicine, Heart Vascular Stroke Institute, Samsung Medical Center, Sungkyunkwan University School of Medicine) ;
  • Jeong, Jin-Ok (Department of Internal Medicine, Chungnam National University Hospital, Chungnam National University School of Medicine) ;
  • Im, Eul Soon (Division of Cardiology, Dongsuwon General Hospital) ;
  • Kim, Sang Wook (Division of Cardiology, Department of Internal Medicine, Chung-Ang University Hospital) ;
  • Chun, Woo Jung (Division of Cardiology, Department of Internal Medicine, Samsung Changwon Hospital, Sungkyunkwan University School of Medicine) ;
  • Oh, Ju Hyeon (Division of Cardiology, Department of Internal Medicine, Samsung Changwon Hospital, Sungkyunkwan University School of Medicine) ;
  • Hahn, Joo-Yong (Division of Cardiology, Department of Medicine, Heart Vascular Stroke Institute, Samsung Medical Center, Sungkyunkwan University School of Medicine)
  • 투고 : 2018.03.28
  • 심사 : 2018.07.24
  • 발행 : 2019.01.31
⟨ 이전 논문 다음 논문 ⟩

초록

Background and Objectives: There are no data comparing clinical outcomes of complex percutaneous coronary intervention (PCI) between biodegradable polymer-biolimus-eluting stents (BP-BES) and durable polymer-everolimus-eluting stents (DP-EES). We sought to evaluate the safety and efficacy of BP-BES compared with DP-EES in patients undergoing complex PCI. Methods: Patients enrolled in the SMART-DESK registry were stratified into 2 categories based on the complexity of PCI. Complex PCI was defined as having at least one of the following features: unprotected left main lesion, ≥2 lesions treated, total stent length >40 mm, minimal stent diameter ≤2.5 mm, or bifurcation as target lesion. The primary outcome was target lesion failure (TLF), defined as a composite of cardiac death, target vessel-related myocardial infarction (TV-MI), or target lesion revascularization (TLR) at 2 years of follow-up. Results: Of 1,999 patients, 1,145 (57.3%) underwent complex PCI: 521 patients were treated with BP-BES and 624 with DP-EES. In propensity-score matching analysis (481 pairs), the risks of TLF (3.8% vs. 5.2%, adjusted hazard ratio [HR], 0.578; 95% confidence interval [CI], 0.246-1.359; p=0.209), cardiac death (2.5% vs. 2.5%, adjusted HR, 0.787; 95% CI, 0.244-2.539; p=0.689), TV-MI (0.5% vs. 0.4%, adjusted HR, 1.128; 95% CI, 0.157-8.093; p=0.905), and TLR (1.1% vs. 2.9%, adjusted HR, 0.390; 95% CI, 0.139-1.095; p=0.074) did not differ between 2 stent groups after complex PCI. Conclusions: Clinical outcomes of BP-BES were comparable to those of DP-EES at 2 years after complex PCI. Our data suggest that use of BP-BES is acceptable, even for complex PCI.

키워드

과제정보

This research was supported by a grant of the Korea Health Technology R&D Project through the Korea Health Industry Development Institute (KHIDI), funded by the Ministry of Health & Welfare, Republic of Korea (Grant number: HI10C2020) and Biosensors Inc.

참고문헌

  1. Park DW, Park SW. Stent thrombosis in the era of the drug-eluting stent. Korean Circ J 2005;35:791-4. https://doi.org/10.4070/kcj.2005.35.11.791
  2. Minha S, Barbash IM, Dvir D, et al. Second-generation everolimus-eluting stents compared to first-generation drug-eluting stents in patients treated for multivessel disease. J Interv Cardiol 2013;26:561-9. https://doi.org/10.1111/joic.12063
  3. Grundeken MJ, Wykrzykowska JJ, Ishibashi Y, et al. First generation versus second generation drug-eluting stents for the treatment of bifurcations: 5-year follow-up of the LEADERS all-comers randomized trial. Catheter Cardiovasc Interv 2016;87:E248-60. https://doi.org/10.1002/ccd.26344
  4. Vlachojannis GJ, Smits PC, Hofma SH, et al. Biodegradable polymer biolimus-eluting stents versus durable polymer everolimus-eluting stents in patients with coronary artery disease: final 5-year report from the COMPARE II trial (abluminal biodegradable polymer biolimus-eluting stent versus durable polymer everolimus-eluting stent). JACC Cardiovasc Interv 2017;10:1215-21. https://doi.org/10.1016/j.jcin.2017.02.029
  5. Im E, Kim GS, Shin DH, et al. Long-term clinical outcomes of a biodegradable polymer-based biolimus-eluting stent. J Interv Cardiol 2016;29:162-7. https://doi.org/10.1111/joic.12283
  6. Cavalcante R, Sotomi Y, Mancone M, et al. Impact of the SYNTAX scores I and II in patients with diabetes and multivessel coronary disease: a pooled analysis of patient level data from the SYNTAX, PRECOMBAT, and BEST trials. Eur Heart J 2017;38:1969-77. https://doi.org/10.1093/eurheartj/ehx138
  7. Hausleiter J, Kastrati A, Mehilli J, et al. Impact of lesion complexity on the capacity of a trial to detect differences in stent performance: results from the ISAR-STEREO trial. Am Heart J 2003;146:882-6. https://doi.org/10.1016/S0002-8703(03)00435-6
  8. Lee DH, Park TK, Song YB, et al. Clinical outcomes of biodegradable polymer biolimus-eluting BioMatrix stents versus durable polymer everolimus-eluting Xience stents. PLoS One 2017;12:e0183079. https://doi.org/10.1371/journal.pone.0183079
  9. Cutlip DE, Windecker S, Mehran R, et al. Clinical end points in coronary stent trials: a case for standardized definitions. Circulation 2007;115:2344-51. https://doi.org/10.1161/CIRCULATIONAHA.106.685313
  10. Ho DE, Imai K, King G, Stuart EA. MatchIt: nonparametric preprocessing for parametric causal inference. J Stat Softw 2011;42:1-28.
  11. Austin PC. The use of propensity score methods with survival or time-to-event outcomes: reporting measures of effect similar to those used in randomized experiments. Stat Med 2014;33:1242-58. https://doi.org/10.1002/sim.5984
  12. Smits PC, Hofma S, Togni M, et al. Abluminal biodegradable polymer biolimus-eluting stent versus durable polymer everolimus-eluting stent (COMPARE II): a randomised, controlled, non-inferiority trial. Lancet 2013;381:651-60. https://doi.org/10.1016/S0140-6736(12)61852-2
  13. Kaiser C, Galatius S, Jeger R, et al. Long-term efficacy and safety of biodegradable-polymer biolimus-eluting stents: main results of the Basel Stent Kosten-Effektivitats Trial-PROspective Validation Examination II (BASKET-PROVE II), a randomized, controlled noninferiority 2-year outcome trial. Circulation 2015;131:74-81. https://doi.org/10.1161/CIRCULATIONAHA.114.013520
  14. Bangalore S, Toklu B, Amoroso N, et al. Bare metal stents, durable polymer drug eluting stents, and biodegradable polymer drug eluting stents for coronary artery disease: mixed treatment comparison meta-analysis. BMJ 2013;347:f6625. https://doi.org/10.1136/bmj.f6625
  15. Navarese EP, Tandjung K, Claessen B, et al. Safety and efficacy outcomes of first and second generation durable polymer drug eluting stents and biodegradable polymer biolimus eluting stents in clinical practice: comprehensive network meta-analysis. BMJ 2013;347:f6530. https://doi.org/10.1136/bmj.f6530
  16. Kang SH, Park KW, Kang DY, et al. Biodegradable-polymer drug-eluting stents vs. bare metal stents vs. durable-polymer drug-eluting stents: a systematic review and Bayesian approach network meta-analysis. Eur Heart J 2014;35:1147-58. https://doi.org/10.1093/eurheartj/eht570
  17. Sakurai R, Burazor I, Bonneau HN, Kaneda H. Long-term outcomes of biodegradable polymer biolimus-eluting stents versus durable polymer everolimus-eluting stents: a meta-analysis of randomized controlled trials. Int J Cardiol 2016;223:1066-71. https://doi.org/10.1016/j.ijcard.2016.07.078
  18. Grube E, Buellesfeld L. BioMatrix Biolimus A9-eluting coronary stent: a next-generation drug-eluting stent for coronary artery disease. Expert Rev Med Devices 2006;3:731-41. https://doi.org/10.1586/17434440.3.6.731
  19. Pache J, Kastrati A, Mehilli J, et al. Intracoronary stenting and angiographic results: strut thickness effect on restenosis outcome (ISAR-STEREO-2) trial. J Am Coll Cardiol 2003;41:1283-8. https://doi.org/10.1016/S0735-1097(03)00119-0
  20. Kolandaivelu K, Swaminathan R, Gibson WJ, et al. Stent thrombogenicity early in high-risk interventional settings is driven by stent design and deployment and protected by polymer-drug coatings. Circulation 2011;123:1400-9. https://doi.org/10.1161/CIRCULATIONAHA.110.003210
  21. Sim DS, Jeong MH, Park DS, et al. Effect of pretreatment of ezetimibe/simvastatin on arterial healing and endothelialization after drug-eluting stent implantation in a porcine coronary restenosis model. Korean Circ J 2015;45:110-6. https://doi.org/10.4070/kcj.2015.45.2.110
  22. Giustino G, Baber U, Aquino M, et al. Safety and efficacy of new-generation drug-eluting stents in women undergoing complex percutaneous coronary artery revascularization: from the win-des collaborative patient-level pooled analysis. JACC Cardiovasc Interv 2016;9:674-84. https://doi.org/10.1016/j.jcin.2015.12.013
  23. Migliorini A, Valenti R, Parodi G, et al. Angiographic and clinical outcomes after everolimus-eluting stenting for unprotected left main disease and high anatomic coronary complexity. JACC Cardiovasc Interv 2016;9:1001-7. https://doi.org/10.1016/j.jcin.2016.02.016
  24. Gwon HC, Hahn JY, Park KW, et al. Six-month versus 12-month dual antiplatelet therapy after implantation of drug-eluting stents: the Efficacy of Xience/Promus Versus Cypher to Reduce Late Loss After Stenting (EXCELLENT) randomized, multicenter study. Circulation 2012;125:505-13. https://doi.org/10.1161/CIRCULATIONAHA.111.059022

피인용 문헌

  1. Long-Term Outcomes of Biodegradable Versus Second-Generation Durable Polymer Drug-Eluting Stent Implantations for Myocardial Infarction vol.13, pp.1, 2019, https://doi.org/10.1016/j.jcin.2019.08.020
  2. Histopathologic and physiologic effect of bifurcation stenting: current status and future prospects vol.17, pp.3, 2019, https://doi.org/10.1080/17434440.2020.1733410
  3. Clopidogrel monotherapy in patients with and without on-treatment high platelet reactivity: a SMART-CHOICE substudy vol.17, pp.11, 2019, https://doi.org/10.4244/eij-d-21-00223