Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2021 Feb 19;16(14):1187-1194.
doi: 10.4244/EIJ-D-18-01201.

Neointimal hyperplasia of ultra-thin stents with microcrystalline sirolimus or durable polymer everolimus-eluting stents: 6- and 24-month results of the DESSOLVE III OCT study

Krzysztof Milewski  1 , Kuniaki Takahashi, Taku Asano, Yuki Katagiri, Mariusz Hochul, Piotr P Buszman, Mariusz Tomaniak, Bogdan Gorycki, Aleksander Zurakowski, Adam Janas, Adam Mlodziankowski, Mateusz Kachel, Joanna J Wykrzykowska, William Wijns, Robbert J de Winter, Pawel E Buszman, Yoshinobu Onuma, Patrick W Serruys
Affiliations

Neointimal hyperplasia of ultra-thin stents with microcrystalline sirolimus or durable polymer everolimus-eluting stents: 6- and 24-month results of the DESSOLVE III OCT study

Krzysztof Milewski et al. EuroIntervention. .

Abstract

Aims: The DESSOLVE III OCT substudy aimed to compare serially neointimal hyperplasia volume obstruction (%VO) between the thin-strut MiStent with early polymer elimination and nine-month sustained drug release from microcrystalline sirolimus and the durable polymer-coated everolimus-eluting XIENCE stent at six and 24 months after implantation.

Methods and results: The efficacy endpoint was %VO, calculated as abluminal neointimal volume/stent volume. Thirty-six patients (MiStent 16 patients, 16 lesions; XIENCE 20 patients, 22 lesions) underwent serial OCT evaluation at both six and 24 months. At six months, mean abluminal %VO was significantly lower in the MiStent group than in the XIENCE group (14.54±3.70% vs 19.11±6.70%; p=0.011), whereas the difference in %VO between the two groups decreased at 24 months (20.88±5.72% vs 23.50±7.33%; p=0.24). There was no significant difference in percentage malapposed struts and percentage uncovered struts between the two groups at both time points.

Conclusions: In the serial comparative OCT analysis of the MiStent versus the XIENCE, the MiStent showed a more favourable efficacy for preventing neointimal formation with comparable strut tissue coverage, as compared with the XIENCE at six months, but this difference in %VO decreased at 24 months so that the difference in neointima at 24 months was no longer significant.

PubMed Disclaimer

Conflict of interest statement

W. Wijns reports grants from Micell during the conduct of the study, grants from MicroPort, personal fees from Biotronik and Abbott Vascular, outside the submitted work, and being a co-founder of Argonauts, an innovation facilitator. P.W. Serruys reports personal fees from Abbott Laboratories, AstraZeneca, Biotronik, Cardialysis, GLG Research, Medtronic, Sino Medical Sciences Technology, Société Europa Digital & Publishing, Stentys France, Svelte Medical Systems, Philips/Volcano, St. Jude Medical, Qualimed, and Xeltis, outside the submitted work. The Guest Editor is a consultant for Edwards Lifesciences. The other authors have no conflicts of interest to declare.

Figures

Figure 1
Figure 1
Strut thickness calculation on the follow-up OCT analysis. At six months, the asymmetric bioresorbable polymer has disappeared so that the true thickness of the MiStent is approximately 65 μm, whereas with the XIENCE the symmetric durable coating will persist so that the thickness of a combination of metallic struts and coating is approximately 90 μm (81+7.8 ≈ 90). These two values of strut thickness were used in the abluminal OCT assessment. The endoluminal polymer thickness should be negligible for assessment due to the blooming of the metallic strut on OCT.
Figure 2
Figure 2
Flow diagram of participants in the DESSOLVE III OCT substudy.
Figure 3
Figure 3
Representative cases in the DESSOLVE III OCT study involving the MiStent (upper) and the XIENCE stent (lower). Cross-sectional images and 2D fold-out views of strut coverage with colour coding of the neointimal thickness on struts.
See this image and copyright information in PMC

References

    1. Nakazawa G, Otsuka F, Nakano M, Vorpahl M, Yazdani SK, Ladich E, Kolodgie FD, Finn AV, Virmani R. The pathology of neoatherosclerosis in human coronary implants bare-metal and drug-eluting stents. J Am Coll Cardiol. 2011;57:1314–22. doi: 10.1016/j.jacc.2011.01.011. - DOI - PMC - PubMed
    1. Räber L, Magro M, Stefanini GG, Kalesan B, van Domburg RT, Onuma Y, Wenaweser P, Daemen J, Meier B, Jüni P, Serruys PW, Windecker S. Very late coronary stent thrombosis of a newer-generation everolimus-eluting stent compared with early-generation drug-eluting stents: a prospective cohort study. Circulation. 2012;125:1110–21. doi: 10.1161/CIRCULATIONAHA.111.058560. - DOI - PubMed
    1. Wijns W, Suttorp MJ, Zagozdzon L, Morice MC, McClean D, Stella P, Donohoe D, Knape C, Ormiston J. Evaluation of a crystalline sirolimus-eluting coronary stent with a bioabsorbable polymer designed for rapid dissolution: two-year outcomes from the DESSOLVE I and II trials. EuroIntervention. 2016;12:352–5. doi: 10.4244/EIJY15M09_14. - DOI - PubMed
    1. Ormiston J, Webster M, Stewart J, Vrolix M, Whitbourn R, Donohoe D, Knape C, Lansky A, Attizzani G, Fitzgerald P, Kandzari DE, Wijns W. First-in-human evaluation of a bioabsorbable polymer-coated sirolimus-eluting stent: imaging and clinical results of the DESSOLVE I Trial (DES with sirolimus and a bioabsorbable polymer for the treatment of patients with de novo lesion in the native coronary arteries). JACC Cardiovasc Interv. 2013;6:1026–34. doi: 10.1016/j.jcin.2013.05.013. - DOI - PubMed
    1. Lansky AJ, Kastrati A, Edelman ER, Parise H, Ng VG, Ormiston J, Wijns W, Byrne RA. Comparison of the Absorbable Polymer Sirolimus-Eluting Stent (MiStent) to the Durable Polymer Everolimus-Eluting Stent (Xience) (from the DESSOLVE I/II and ISAR-TEST-4 Studies). Am J Cardiol. 2016;117:532–8. doi: 10.1016/j.amjcard.2015.11.044. - DOI - PMC - PubMed