Key result
The Genoss sirolimus-eluting stent demonstrated non-inferior in-stent late lumen loss at 9 months compared to the Promus Element stent (0.11 mm vs. 0.16 mm, p=0.567).
Why the study?
Does the Genoss sirolimus-eluting stent improve in-stent late lumen loss compared to the Promus Element stent in patients with coronary artery disease?
RCT (n=80)
Single-blind
1:1
Yes
Does the Genoss sirolimus-eluting stent improve in-stent late lumen loss compared to the Promus Element stent in patients with coronary artery disease?
Absolute Event Rate: 0.11% vs 0.16%
p-value: p=0.567
The novel Korean-made Genoss sirolimus-eluting stent with a bioresorbable polymer demonstrated non-inferior angiographic and clinical outcomes compared to the Promus Element stent at 9 months.
Supports Genoss stent as a non-inferior option now; extends evidence for bioresorbable polymer DES platforms.
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 DES™ group and 39 patients for the Promus Element™ 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 DES™ stent showed excellent angiographic outcomes for in-stent late lumen loss and major adverse cardiac events over a 9-month follow-up.
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Yang et al. (2017) conducted an RCT in Coronary artery disease (n=80). Genoss drug-eluting stent vs. Promus Element stent was evaluated on In-stent late lumen loss at 9-month quantitative coronary angiography follow-up (p=0.567). The Genoss sirolimus-eluting stent demonstrated non-inferior in-stent late lumen loss at 9 months compared to the Promus Element stent (0.11 mm vs. 0.16 mm, p=0.567).
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