Korean Circ J.  2017 Nov;47(6):898-906. 10.4070/kcj.2017.0094.

Clinical and Angiographic Outcomes of the First Korean-made Sirolimus-Eluting Coronary Stent with Abluminal Bioresorbable Polymer

• Yang HM
• Seo KW
• Yoon J
• Kim HS
• Chang K
• Lim HS
• Choi BJ
• Choi SY
• Yoon MH
• Lee SH
• Ahn SG
• Youn YJ
• Lee JW
• Koo BK
• Park KW
• Yang HM
• Han JK
• Seung KB
• Chung WS
• Kim PJ
• Koh YS
• Park HJ
• Tahk SJ

• KMID: 2396483
• DOI: http://doi.org/10.4070/kcj.2017.0094

Abstract

BACKGROUND AND OBJECTIVES
This trial evaluated the safety and efficacy of the Genoss drug-eluting coronary stent.
METHODS
This study was a prospective, multicenter, randomized trial with a 1:1 ratio of Genoss drug-eluting stent (DES)™ and Promus Element™. Inclusion criteria were the presence of stable angina, unstable angina, or silent ischemia. Angiographic inclusion criteria were de novo coronary stenotic lesion with diameter stenosis >50%, reference vessel diameter of 2.5-4.0 mm, and lesion length ≤40 mm. The primary endpoint was in-stent late lumen loss at 9-month quantitative coronary angiography follow-up. Secondary endpoints were in-segment late lumen loss, binary restenosis rate, death, myocardial infarction (MI), target lesion revascularization (TLR), target vessel revascularization (TVR), and stent thrombosis during 9 months of follow-up.
RESULTS
We enrolled 38 patients for the Genoss DESâ„¢ group and 39 patients for the Promus Elementâ„¢ group. In-stent late lumen loss at 9 months was not significantly different between the 2 groups (0.11±0.25 vs. 0.16±0.43 mm, p=0.567). There was no MI or stent thrombosis in either group. The rates of death (2.6% vs. 0%, p=0.494), TLR (2.6% vs. 2.6%, p=1.000), and TVR (7.9% vs. 2.6%, p=0.358) at 9 months were not significantly different.
CONCLUSION
This first-in-patient study of the Genoss DESâ„¢ stent showed excellent angiographic outcomes for in-stent late lumen loss and major adverse cardiac events over a 9-month follow-up.

Keyword

Drug-eluting stents; Coronary artery disease; Sirolimus

MeSH Terms

Angina, Stable
Angina, Unstable
Constriction, Pathologic
Coronary Angiography
Coronary Artery Disease
Drug-Eluting Stents
Follow-Up Studies
Humans
Ischemia
Mortality
Myocardial Infarction
Polymers*
Prospective Studies
Sirolimus
Stents*
Thrombosis
Polymers
Sirolimus

Figure

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  Figure 1 Flow chart of patient enrollment. DES = drug-eluting stent.

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