Abstract
We aimed to quantitatively assess a possible difference of the neointimal quality between biodegradable polymer- (BP-) and durable polymer drug-eluting stents (DP-DESs). We conducted a single-center all-comer prospective cohort study: the RESTORE registry (UMIN000033009). All patients who received successful OCT examination at planned 3-month follow-up after DES implantation were analyzed. Study population was divided into 2 groups, BP-DES versus DP-DES groups. We evaluated standard OCT variables, coverage percent, and the quantitative light property values including light intensity, attenuation, and backscatter. We performed OCT analyses of 121 lesions in 98 patients (BP-DES 55 lesions in 51 patients vs. DP-DES 66 lesions in DP-DES 53 patients). Lesion and procedural characteristics were overall well-balanced between both groups. At 3-month follow-up, neointimal thickness (BP-DES 49.3 [38.2, 57.7] µm versus DP-DES 54.7 [45.1, 70.7] µm, p = 0.059) and coverage percent (BP-DES 94.5 [89.8, 97.0]% vs. DP-DES 95.8 [91.1, 98.1]%, p = 0.083) did not significantly differ. Light intensity of superficial neointima in the BP-DES was lower than that in the DP-DES, whereas that of deep neointima did not differ between both groups. Both superficial and deep neointima of the BP-DES presented significantly lower light attenuation and backscatter than those of the DP-DES did. Almost complete coverage at 3 months in both contemporary BP- and DP-DES would support the ultra-short DAPT strategy in the upcoming decade. Nevertheless, there was a significant difference in the neointimal characteristics on OCT light property 3 months after BP- versus DP-DES implantation.
Trial Registration UMIN000033009.
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Tellez A, Seifert PS, Donskoy E, Sushkova N, Pennington DE, Milewski K, Krueger CG, Kaluza GL, Eppihimer MJ, Huibregtse BA, Dawkins KD, Granada JF (2014) Experimental evaluation of efficacy and healing response of everolimus-eluting stents in the familial hypercholesterolemic swine model: a comparative study of bioabsorbable versus durable polymer stent platforms. Coron Artery Dis 25(3):198–207. https://doi.org/10.1097/mca.0000000000000099
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
El-Hayek G, Bangalore S, Casso Dominguez A, Devireddy C, Jaber W, Kumar G, Mavromatis K, Tamis-Holland J, Samady H (2017) Meta-analysis of randomized clinical trials comparing biodegradable polymer drug-eluting stent to second-generation durable polymer drug-eluting stents. JACC Cardiovasc Interv 10(5):462–473. https://doi.org/10.1016/j.jcin.2016.12.002
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 everolimus-eluting bioresorbable scaffolds and metallic stents in patients with ST-elevation myocardial infarction: quantitative assessments by light intensity, light attenuation, and backscatter on optical coherence tomography in the TROFI II trial. EuroIntervention 14 (6):678–685. https://doi.org/10.4244/eij-d-17-00884
Imanaka T, Fujii K, Hao H, Shibuya M, Saita T, Kawakami R, Fukunaga M, Kawai K, Tamaru H, Miki K, Horimatsu T, Sumiyoshi A, Nishimura M, Hirota S, Masuyama T, Ishihara M (2016) Ex vivo assessment of neointimal characteristics after drug-eluting stent implantation: Optical coherence tomography and histopathology validation study. Int J Cardiol 221:1043–1047. https://doi.org/10.1016/j.ijcard.2016.07.110
Xu C, Schmitt JM, Carlier SG, Virmani R (2008) Characterization of atherosclerosis plaques by measuring both backscattering and attenuation coefficients in optical coherence tomography. J Biomed Optics 13(3):034003. https://doi.org/10.1117/1.2927464
Suzuki S, Sotomi Y, Kobayashi T, Hamanaka Y, Nakatani S, Shiojima I, Sakata Y, Hirayama A, Higuchi Y (2019) Early vessel healing after implantation of biodegradable-polymer and durable-polymer drug-eluting stent: 3-month angioscopic evaluation of the RESTORE registry. Int J Cardiovasc Imaging. doi:https://doi.org/10.1007/s10554-019-01580-2
Liu S, Sotomi Y, Eggermont J, Nakazawa G, Torii S, Ijichi T, Onuma Y, Serruys PW, Lelieveldt BPF, Dijkstra J (2017) Tissue characterization with depth-resolved attenuation coefficient and backscatter term in intravascular optical coherence tomography images. J Biomed Optics 22(9):1–16. https://doi.org/10.1117/1.Jbo.22.9.096004
Nakatani S, Sotomi Y, Ishibashi Y, Grundeken MJ, Tateishi H, Tenekecioglu E, Zeng Y, Suwannasom P, Regar E, Radu MD, Raber L, Bezerra H, Costa MA, Fitzgerald P, Prati F, Costa RA, Dijkstra J, Kimura T, Kozuma K, Tanabe K, Akasaka T, Di Mario C, Serruys PW, Onuma Y (2016) Comparative analysis method of permanent metallic stents (XIENCE) and bioresorbable poly-L-lactic (PLLA) scaffolds (Absorb) on optical coherence tomography at baseline and follow-up. EuroIntervention 12 (12):1498–1509. https://doi.org/10.4244/eijy15m10_03
Barbato E, Salinger-Martinovic S, Sagic D, Beleslin B, Vrolix M, Neskovic AN, Jagic N, Verheye S, Mehmedbegovic Z, Wijns W (2015) A first-in-man clinical evaluation of Ultimaster, a new drug-eluting coronary stent system: CENTURY study. EuroIntervention 11 (5):541–548. https://doi.org/10.4244/eijy14m08_06
de la Torre Hernandez JM, Tejedor P, Camarero TG, Duran JM, Lee DH, Monedero J, Laso FS, Calderon MA, Veiga G, Zueco J (2016) Early healing assessment with optical coherence tomography of everolimus-eluting stents with bioabsorbable polymer (synergy) at 3 and 6 months after implantation. Catheter Cardiovasc Interv 88(3):E67–E73. https://doi.org/10.1002/ccd.26299
Kim S, Kim JS, Shin DH, Kim BK, Ko YG, Choi D, Cho YK, Nam CW, Hur SH, Jang Y, Hong MK (2013) Comparison of early strut coverage between zotarolimus- and everolimus-eluting stents using optical coherence tomography. Am J Cardiol 111(1):1–5. https://doi.org/10.1016/j.amjcard.2012.08.037
Konishi A, Iwasaki M, Shinke T, Otake H, Takaya T, Osue T, Nishio R, Kinutani H, Kuroda M, Takahashi H, Terashita D, Shite J, Hirata KI (2018) Favorable early vessel healing after everolimus-eluting stent implantation: 3-, 6-, and 12-month follow-up of optical coherence tomography. J Cardiol 72(3):193–199. https://doi.org/10.1016/j.jjcc.2018.04.005
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
Malle C, Tada T, Steigerwald K, Ughi GJ, Schuster T, Nakano M, Massberg S, Jehle J, Guagliumi G, Kastrati A, Virmani R, Byrne RA, Joner M (2013) Tissue characterization after drug-eluting stent implantation using optical coherence tomography. Arteriosclerosis, thrombosis, and vascular biology 33 (6):1376–1383. doi:https://doi.org/10.1161/atvbaha.113.301227
Nayak BS, Beharry VY, Armoogam S, Nancoo M, Ramadhin K, Ramesar K, Ramnarine C, Singh A, Singh A, Nwachi KU, Teelucksing S, Mathura R, Roberts L (2008) Determination of RBC membrane and serum lipid composition in Trinidadian type II diabetics with and without nephropathy. Vasc Health Risk Manag 4(4):893–899
Kolodgie FD, Gold HK, Burke AP, Fowler DR, Kruth HS, Weber DK, Farb A, Guerrero LJ, Hayase M, Kutys R, Narula J, Finn AV, Virmani R (2003) Intraplaque hemorrhage and progression of coronary atheroma. N Engl J Med 349(24):2316–2325. https://doi.org/10.1056/NEJMoa035655
Chaabane C, Otsuka F, Virmani R, Bochaton-Piallat ML (2013) Biological responses in stented arteries. Cardiovasc Res 99(2):353–363. https://doi.org/10.1093/cvr/cvt115
Nakano M, Virmani R (2015) Histopathology of vascular response to drug-eluting stents: an insight from human autopsy into daily practice. Cardiovasc Interv Ther 30(1):1–11. https://doi.org/10.1007/s12928-014-0281-5
Kobayashi T, Sotomi Y, Suzuki S, Suwannasom P, Nakatani S, Morino Y, Ako J, Kozuma K, Hirayama A, Sakata Y, Higuchi Y (2019) Five-year clinical efficacy and safety of contemporary thin-strut biodegradable polymer versus durable polymer drug-eluting stents: a systematic review and meta-analysis of 9 randomized controlled trials. Cardiovasc Interv Therap. https://doi.org/10.1007/s12928-019-00613-w
Jang JY, Kim JS, Shin DH, Kim BK, Ko YG, Choi D, Jang Y, Hong MK (2015) Favorable effect of optimal lipid-lowering therapy on neointimal tissue characteristics after drug-eluting stent implantation: qualitative optical coherence tomographic analysis. Atherosclerosis 242(2):553–559. https://doi.org/10.1016/j.atherosclerosis.2015.08.014
Hong YJ, Jeong MH, Choi YH, Park SY, Rhew SH, Kim SS, Jeong YW, Jeong HC, Cho JY, Jang SY, Lee KH, Park KH, Sim DS, Yoon NS, Yoon HJ, Kim KH, Park HW, Kim JH, Ahn Y, Cho JG, Park JC (2014) Relation between renal function and neointimal tissue characteristics after drug-eluting stent implantation: virtual histology-intravascular ultrasound analysis. J Cardiol 64(2):98–104. https://doi.org/10.1016/j.jjcc.2013.11.019
Taniwaki M, Windecker S, Zaugg S, Stefanini GG, Baumgartner S, Zanchin T, Wenaweser P, Meier B, Juni P, Raber L (2015) The association between in-stent neoatherosclerosis and native coronary artery disease progression: a long-term angiographic and optical coherence tomography cohort study. Eur Heart J 36(32):2167–2176. https://doi.org/10.1093/eurheartj/ehv227
Vergallo R, Yonetsu T, Uemura S, Park SJ, Lee S, Kato K, Jia H, Abtahian F, Tian J, Hu S, Lee H, McNulty I, Prasad A, Yu B, Zhang S, Porto I, Biasucci LM, Crea F, Jang IK (2013) Correlation between degree of neointimal hyperplasia and incidence and characteristics of neoatherosclerosis as assessed by optical coherence tomography. Am J Cardiol 112(9):1315–1321. https://doi.org/10.1016/j.amjcard.2013.05.076
Sotomi Y, Onuma Y, Dijkstra J, Eggermont J, Liu S, Tenekecioglu E, Zeng Y, Asano T, de Winter RJ, Popma JJ, Kozuma K, Tanabe K, Serruys PW, Kimura T (2016) Impact of implantation technique and plaque morphology on strut embedment and scaffold expansion of polylactide bioresorbable scaffold- insights from ABSORB Japan Trial. Circ J 80(11):2317–2326. https://doi.org/10.1253/circj.CJ-16-0818
Sotomi Y, Tateishi H, Suwannasom P, Dijkstra J, Eggermont J, Liu S, Tenekecioglu E, Zheng Y, Abdelghani M, Cavalcante R, de Winter RJ, Wykrzykowska JJ, Onuma Y, Serruys PW, Kimura T (2016) Quantitative assessment of the stent/scaffold strut embedment analysis by optical coherence tomography. Int J Cardiovasc Imaging 32(6):871–883. https://doi.org/10.1007/s10554-016-0856-6
Naidu SS, Krucoff MW, Rutledge DR, Mao VW, Zhao W, Zheng Q, Wilburn O, Sudhir K, Simonton C, Hermiller JB (2012) Contemporary incidence and predictors of stent thrombosis and other major adverse cardiac events in the year after XIENCE V implantation: results from the 8,061-patient XIENCE V United States study. JACC Cardiovasc Interv 5(6):626–635. https://doi.org/10.1016/j.jcin.2012.02.014
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Y. Sotomi, S. Nakatani, and Y. Higuchi received speaker honoraria from Abbott Vascular Japan, Boston Scientific Japan, TERUMO, Cardinal Health, and Medtronic. Y. Onuma and P. Serruys are members of the Advisory Board for Abbott Vascular.A. Hirayama reports grants and personal fees from Boston Scientific Japan, Abbott Vascular Japan, Japan Lifeline, and Medtronic. Y. Sakata reports grants and personal fees from Daiichi-Sankyo, Bayer, Boehringer Ingelheim, and Bristol-Myers Squibb. 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.
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Kobayashi, T., Sotomi, Y., Suzuki, S. et al. Neointimal characteristics comparison between biodegradable-polymer and durable-polymer drug-eluting stents: 3-month follow-up optical coherence tomography light property analysis from the RESTORE registry. Int J Cardiovasc Imaging 36, 205–215 (2020). https://doi.org/10.1007/s10554-019-01718-2
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DOI: https://doi.org/10.1007/s10554-019-01718-2