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Early vessel healing after implantation of biodegradable-polymer and durable-polymer drug-eluting stent: 3-month angioscopic evaluation of the RESTORE registry

  • Satoshi Suzuki
  • Yohei SotomiEmail author
  • Tomoaki Kobayashi
  • Yuma Hamanaka
  • Shimpei Nakatani
  • Ichiro Shiojima
  • Yasushi Sakata
  • Atsushi Hirayama
  • Yoshiharu Higuchi
Original Paper
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Abstract

The purpose of this study was to evaluate the vessel healing status 3 months after stent implantation of bioresorbable-polymer drug-eluting stents (BP-DESs) in comparison with durable-polymer DESs (DP-DESs) by angioscopy. Study design was a single-center all-comer prospective cohort study: the RESTORE registry (UMIN000033009). All patients who received successful angioscopic examination at planned 3-month follow-up after the DES implantation in the native coronary artery were enrolled. We evaluated main, maximum, minimum strut coverage grades and coverage heterogeneity score defined as a difference between maximum and minimum coverage grades. All lesions were divided into three segments: proximal, mid, and distal segments. A total of 108 patients (66.6 ± 10 years) with 124 lesions were analyzed (BP-DES 57 patients 61 lesions 226 segments vs. DP-DES 57 patients 63 lesions 203 segments; six patients had both BP-DES and DP-DES). Patient and lesion demographics, procedural characteristics were well balanced. Main coverage grade (mean ± standard error; 1.08 ± 0.02 vs. 1.05 ± 0.03, p = 0.354) and minimum coverage grade (1.00 ± 0.00 vs. 1.00 ± 0.00, p > 0.999) were not significantly different between BP-DES and DP-DES groups. Maximum coverage grade was significantly higher in the BP-DES than in the DP-DES (1.45 ± 0.04 vs. 1.35 ± 0.04, p = 0.049). Coverage heterogeneity score did not differ between BP-DES and DP-DES groups (1.05 ± 0.07 vs. 0.90 ± 0.07, p = 0.162). At 3-month follow-up, the current BP-DES had higher maximum stent coverage than the contemporary DP-DES, while main and minimum coverage grades and heterogeneity of the neointimal coverage were comparable. Further prospective randomized trials should be conducted to evaluate the clinical significance of the present imaging results.

Keywords

Coronary angioscopy Drug-eluting stent Biodegradable polymer Durable polymer 

Abbreviations

BP-DES

Bioresorbable-polymer DESs

DES

Drug eluting stent

DP-DES

Durable-polymer DESs

OCT

Optical coherence tomography

PCI

Percutaneous coronary intervention

Notes

Compliance with ethical standards

Conflict of interest

Y. Sotomi, S. Nakatani, and Y. Higuchi received speaker honoraria from Abbott Vascular Japan, Boston Scientific Japan, TERUMO, Cardinal Health, and Medtronic. Y. Sakata reports grants and personal fees from Daiichi-Sankyo, Bayer, Boehringer Ingelheim, and Bristol-Myers Squibb. A. Hirayama reports grants and personal fees from Boston Scientific Japan, Abbott Vascular Japan, Japan Lifeline, and Medtronic. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

References

  1. 1.
    Dai K, Matsuoka H, Kawakami H, Sato T, Watanabe K, Nakama Y, Ishihara M (2016) Comparison of chronic angioscopic findings of bare metal stents, 1st-generation drug-eluting stents and 2nd-generation drug-eluting stents-multicenter study of intra-coronary angioscopy after stent (MICASA). Circ J 80(9):1916–1921.  https://doi.org/10.1253/circj.CJ-16-0121 CrossRefGoogle Scholar
  2. 2.
    Natsuaki M, Kozuma K, Morimoto T, Kadota K, Muramatsu T, Nakagawa Y, Akasaka T, Igarashi K, Tanabe K, Morino Y, Ishikawa T, Nishikawa H, Awata M, Abe M, Okada H, Takatsu Y, Ogata N, Kimura K, Urasawa K, Tarutani Y, Shiode N, Kimura T, Investigators N (2013) Biodegradable polymer biolimus-eluting stent versus durable polymer everolimus-eluting stent: a randomized, controlled, noninferiority trial. J Am Coll Cardiol 62(3):181–190.  https://doi.org/10.1016/j.jacc.2013.04.045 CrossRefGoogle Scholar
  3. 3.
    Saito S, Valdes-Chavarri M, Richardt G, Moreno R, Iniguez Romo A, Barbato E, Carrie D, Ando K, Merkely B, Kornowski R, Eltchaninoff H, James S, Wijns W (2014) A randomized, prospective, intercontinental evaluation of a bioresorbable polymer sirolimus-eluting coronary stent system: the CENTURY II (clinical evaluation of new terumo drug-eluting coronary stent system in the treatment of patients with coronary artery disease) trial. Eur Heart J 35(30):2021–2031.  https://doi.org/10.1093/eurheartj/ehu210 CrossRefGoogle Scholar
  4. 4.
    Serruys PW, Farooq V, Kalesan B, de Vries T, Buszman P, Linke A, Ischinger T, Klauss V, Eberli F, Wijns W, Morice MC, Di Mario C, Corti R, Antoni D, Sohn HY, Eerdmans P, Rademaker-Havinga T, van Es GA, Meier B, Juni P, Windecker S (2013) Improved safety and reduction in stent thrombosis associated with biodegradable polymer-based biolimus-eluting stents versus durable polymer-based sirolimus-eluting stents in patients with coronary artery disease: final 5-year report of the LEADERS (limus eluted from a durable versus erodable stent coating) randomized, noninferiority trial. JACC Cardiovasc Interv 6(8):777–789.  https://doi.org/10.1016/j.jcin.2013.04.011 CrossRefGoogle Scholar
  5. 5.
    Chevalier B, Smits PC, Carrie D, Mehilli J, Van Boven AJ, Regar E, Sawaya FJ, Chamie D, Kraaijeveld AO, Hovasse T, Vlachojannis GJ (2017) Serial assessment of strut coverage of biodegradable polymer drug-eluting stent at 1, 2, and 3 months after stent implantation by optical frequency domain imaging: the DISCOVERY 1TO3 study (evaluation with OFDI of strut coverage of terumo new drug eluting stent with biodegradable polymer at 1, 2, and 3 months). Circ Cardiovasc Interv.  https://doi.org/10.1161/circinterventions.116.004801 Google Scholar
  6. 6.
    Varenne O, Cook S, Sideris G, Kedev S, Cuisset T, Carrie D, Hovasse T, Garot P, El Mahmoud R, Spaulding C, Helft G, Diaz Fernandez JF, Brugaletta S, Pinar-Bermudez E, Mauri Ferre J, Commeau P, Teiger E, Bogaerts K, Sabate M, Morice MC, Sinnaeve PR (2018) Drug-eluting stents in elderly patients with coronary artery disease (SENIOR): a randomised single-blind trial. Lancet 391(10115):41–50.  https://doi.org/10.1016/s0140-6736(17)32713-7 CrossRefGoogle Scholar
  7. 7.
    Yokoyama S, Takano M, Yamamoto M, Inami S, Sakai S, Okamatsu K, Okuni S, Seimiya K, Murakami D, Ohba T, Uemura R, Seino Y, Hata N, Mizuno K (2009) Extended follow-up by serial angioscopic observation for bare-metal stents in native coronary arteries: from healing response to atherosclerotic transformation of neointima. Circ Cardiovasc interv 2(3):205–212.  https://doi.org/10.1161/circinterventions.109.854679 CrossRefGoogle Scholar
  8. 8.
    Ueda Y, Asakura M, Yamaguchi O, Hirayama A, Hori M, Kodama K (2001) The healing process of infarct-related plaques: Insights from 18 months of serial angioscopic follow-up. J Am Coll Cardiol 38(7):1916–1922.  https://doi.org/10.1016/S0735-1097(01)01673-4 CrossRefGoogle Scholar
  9. 9.
    Ueda Y, Nanto S, Komamura K, Kodama K (1994) Neointimal coverage of stents in human coronary arteries observed by angioscopy. J Am Coll Cardiol 23(2):341–346.  https://doi.org/10.1016/0735-1097(94)90417-0 CrossRefGoogle Scholar
  10. 10.
    Sotomi Y, Onuma Y, Suwannasom P, Tateishi H, Tenekecioglu E, Zeng Y, Cavalcante R, Jonker H, Dijkstra J, Foin N, Koon JN, Collet C, de Winter RJ, Wykrzykowska JJ, Stone GW, Popma JJ, Kozuma K, Tanabe K, Serruys PW, Kimura T (2016) Is quantitative coronary angiography reliable in assessing the lumen gain after treatment with the everolimus-eluting bioresorbable polylactide scaffold? EuroIntervention 12 (8):e998-e1008.  https://doi.org/10.4244/eijv12i8a163 CrossRefGoogle Scholar
  11. 11.
    Higo T, Ueda Y, Oyabu J, Okada K, Nishio M, Hirata A, Kashiwase K, Ogasawara N, Hirotani S, Kodama K (2009) Atherosclerotic and thrombogenic neointima formed over sirolimus drug-eluting stent: an angioscopic study. JACC Cardiovasc Imag 2(5):616–624.  https://doi.org/10.1016/j.jcmg.2008.12.026 CrossRefGoogle Scholar
  12. 12.
    Suzuki S, Nakatani S, Sotomi Y, Shiojima I, Sakata Y, Higuchi Y (2018) Fate of different types of intrastent tissue protrusion: optical coherence tomography and angioscopic serial observations at baseline and 9-day and 3-month follow-up. JACC Cardiovasc Interv 11(1):95–97.  https://doi.org/10.1016/j.jcin.2017.10.012 CrossRefGoogle Scholar
  13. 13.
    Nishimoto Y, Ueda Y, Sugihara R, Murakami A, Ueno K, Takeda Y, Hirata A, Kashiwase K, Higuchi Y, Yasumura Y (2017) Comparison of angioscopic findings among second-generation drug-eluting stents. J Cardiol 70(3):297–302.  https://doi.org/10.1016/j.jjcc.2016.11.012 CrossRefGoogle Scholar
  14. 14.
    Ueda Y, Matsuo K, Nishimoto Y, Sugihara R, Hirata A, Nemoto T, Okada M, Murakami A, Kashiwase K, Kodama K (2015) In-stent yellow plaque at 1 year after implantation is associated with future event of very late stent failure: the DESNOTE study (detect the event of very late stent failure from the drug-eluting stent not well covered by neointima determined by angioscopy). JACC Cardiovasc Interv 8(6):814–821.  https://doi.org/10.1016/j.jcin.2014.12.239 CrossRefGoogle Scholar
  15. 15.
    Awata M, Uematsu M, Sera F, Ishihara T, Watanabe T, Fujita M, Onishi T, Iida O, Ishida Y, Nanto S, Nagata S (2011) Angioscopic assessment of arterial repair following biodegradable polymer-coated biolimus A9-eluting stent implantation. Comparison with durable polymer-coated sirolimus-eluting stent. Circ J 75(5):1113–1119CrossRefGoogle Scholar
  16. 16.
    Chen SL, Xu T, Zhang JJ, Ye F, Hu ZY, Tian NL, Zhang YJ, Kotani J, Zhang JX (2012) Angioscopy study from a large patient population comparing sirolimus-eluting stent with biodegradable versus durable polymer. Catheter Cardiovasc Interv 80(3):420–428.  https://doi.org/10.1002/ccd.23306 CrossRefGoogle Scholar
  17. 17.
    Sotomi Y, Onuma Y, Liu S, Asano T, Eggermont J, Katagiri Y, Cavalcante R, de Winter RJ, Wykrzykowska JJ, Brugaletta S, Raber L, Sabate M, Windecker S, Dijkstra J, Serruys PW (2018) Quality difference of neointima following the implantation of bioresorbable scaffold and metallic stent in patients with ST elevation myocardial infarction: quantitative assessments by light intensity, light attenuation, and backscatter on optical coherence tomography in TROFI II trial. EuroIntervention.  https://doi.org/10.4244/eij-d-17-00884 Google Scholar
  18. 18.
    Mori H, Cheng Q, Lutter C, Smith S, Guo L, Kutyna M, Torii S, Harari E, Acampado E, Joner M, Kolodgie FD, Virmani R, Finn AV (2017) Endothelial barrier protein expression in biodegradable polymer sirolimus-eluting versus durable polymer everolimus-eluting Metallic stents. JACC Cardiovasc Interv 10(23):2375–2387.  https://doi.org/10.1016/j.jcin.2017.06.059 CrossRefGoogle Scholar

Copyright information

© Springer Nature B.V. 2019

Authors and Affiliations

  • Satoshi Suzuki
    • 1
  • Yohei Sotomi
    • 1
    Email author
  • Tomoaki Kobayashi
    • 1
  • Yuma Hamanaka
    • 1
  • Shimpei Nakatani
    • 1
  • Ichiro Shiojima
    • 2
  • Yasushi Sakata
    • 3
  • Atsushi Hirayama
    • 1
  • Yoshiharu Higuchi
    • 1
  1. 1.Department of CardiologyOsaka Police HospitalOsakaJapan
  2. 2.Department of Medicine IIKansai Medical UniversityHirakataJapan
  3. 3.Department of Cardiovascular MedicineOsaka University Graduate School of MedicineOsakaJapan

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