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Lee and Park: Can Genoss DES™ Stand Out in the Crowd of Stents?
After the introduction of coronary stenting, reducing restenosis and stent thrombosis are the main issue in the interventional cardiology field. The drug-eluting stent (DES) inhibiting endothelial growth has been one option to reduce restenosis. However, potent inhibition of endothelial growth along with hypersensitivity reaction to polymer increased the incidence of stent thrombosis, and the first-generation of DES had been withdrawn due to increased incidence of late or very late stent thrombosis.1) There are newer-generation DESs with a biocompatible polymer containing new drugs to reduce these complications. Recently, we have several newer-generation DESs in the clinical fields with improved safety and efficacy than the first-generation DES.2)
Genoss DES™ (Genoss Company Limited, Suwon, Korea) is one of newer-generation stents with a cobalt-chromium platform with an abluminal biodegradable polymer containing sirolimus.3) The Genoss DES™ is the first Korean sirolimus-eluting stent on the market and it has ultrathin strut with 70 μm strut thickness with 3 μm thin abluminal polymer coating containing Sirolimus. Table 1 listed the comparison of the Genoss DES™ with other second-generation DES. The polymer is designed to release approximately 70% of the total drug amount within 30 days of the implantation and is entirely absorbable within 9 months. Thus, only the metal component of the stent will remain. In the first-in-man trial comparing Genoss DES™ and Promus Element™ stent (Boston Scientific Co., Natick, MA, USA), there was a similar result in angiographic and clinical outcomes at a 9-month follow-up.3) However, the study was too small to conclude that the Genoss DES™ is safe and efficient for de novo coronary stenosis. Thus, we needed a study with a large number of population to prove its safety and efficacy.
In this current study, Youn et al.4) published clinical performance with the Genoss DES™. They included 622 consecutive patients in the prospective, single-arm, observational, and multi-center registry and found the incidence of a device-oriented composite outcome (DOCO), defined as cardiac death, target vessel-related myocardial infarction and target lesion revascularization occurred only in 4 patients (0.6%) at 12 months. Among 4 patients with DOCO, there were 1 cardiovascular death, 1 target vessel myocardial infarction and 3 target lesion revascularization. Although this study was an interim analysis of the prospective ongoing registry which planned to include 2,000 subjects originally, it can give us valuable information about the safety and efficacy of the Genoss DES™.
However, there are still a lot of hurdles for the Genoss DES™ to stand out in the crowd of numerous stents. As mentioned in the limitation section of the study, the authors should include more patients in this prospective registry and report the clinical outcome. Moreover, we need clinical studies including a large number of patients comparing the Genoss DES™ with other DESs in a prospective and randomized manner. These studies should include patients with diverse clinical settings including acute myocardial infarction or complex coronary lesions and should have longer term follow-up to evaluate the incidence of very late stent thrombosis or late restenosis. It should also be able to overcome very severe calcified and angulated lesions without migration or damage and to expand well with a sufficient radial strength. To stand out in the ordinary stones, the developers should try to improve the product and to get better clinical results with sufficient support.

Figures and Tables

Table 1

Comparative characteristics of contemporary coronary drug-eluting stents

kcj-50-328-i001
Biodegradable polymer Durable polymer
Brand name Genoss Synergy Orsiro Biomatrix Flex Xience Sierra Resolute Onyx
Company Genoss Boston Scientific Biotronik Biosensors Abbott Medtronic
Country Korea USA Germany Singapore USA USA
Drug Sirolimus Everolimus Sirolimus Biolimus Evelorimus Zotarolimus
Stent
Material CoCr PtCr CoCr 316L stainless steel L-605 CoCr CoNi with Pt-Ir
Thickness 70–78 79–81 60–80 112 81 81–91
Polymer
Material PLLA/PGLA PGLA PLLA PDLLA PVDF-HFP BiolLinx
Coating distribution Abluminal Abluminal Conformal Abluminal Conformal Conformal
Coating thickness (µm) 3 4 7.4 16.6 8 4.8
Drug elution time 3–4 months 3 months 100–120 days 180 days 120 days 180 days
Polymer absorption time 6–9 months 3–4 months 15 months 6–9 months Permanent Permanent
Strut cross section kcj-50-328-i002 kcj-50-328-i003 kcj-50-328-i004 kcj-50-328-i005 kcj-50-328-i006 kcj-50-328-i007
CoCr = cobalt-chromium; PtCr = platinum-chromium; CoNi = cobalt-nickel; Pt-Ir = platinum-iridium; PLLA = poly-L-lactic acid; PLGA = poly-lactic co-glycolic acid; PDLLA = poly-D,L-lactic acid; PVDF-HFP = co-polymer of vinylidene fluoride and hexafluoropropylene.

Notes

Conflict of Interest The authors have no financial conflicts of interest.

Author Contributions

  • Conceptualization: Lee JH, Park JH.

  • Supervision: Park JH.

  • Writing - original draft: Lee JH, Park JH.

  • Writing - review & editing: Lee JH, Park JH.

The contents of the report are the author's own views and do not necessarily reflect the views of the Korean Circulation Journal.

References

1. Holmes DR Jr, Kereiakes DJ, Laskey WK, et al. Thrombosis and drug-eluting stents: an objective appraisal. J Am Coll Cardiol. 2007; 50:109–118.
2. El-Hayek G, Bangalore S, Casso Dominguez A, et al. Meta-analysis of randomized clinical trials comparing biodegradable polymer drug-eluting stent to second-generation durable polymer drug-eluting stents. JACC Cardiovasc Interv. 2017; 10:462–473.
crossref
3. Yang HM, Seo KW, Yoon J, et al. Clinical and angiographic outcomes of the first Korean-made sirolimus-eluting coronary stent with abluminal bioresorbable polymer. Korean Circ J. 2017; 47:898–906.
crossref
4. Youn YJ, Yoo SY, Lee JW, et al. Safety and efficacy of a new ultrathin sirolimus-eluting stent with abluminal biodegradable polymer in real-world practice. Korean Circ J. 2020; 50:317–327.
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ORCID iDs

Jae-Hwan Lee
https://orcid.org/0000-0002-6561-7760

Jae-Hyeong Park
https://orcid.org/0000-0001-7035-286X

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