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. 2021 Dec;51(12):1001-1014.
doi: 10.4070/kcj.2021.0161.

A First-in-Man Clinical Evaluation of Sirolimus and Ascorbic Acid-Eluting Stent Systems: a Multicenter, Subject-Blinded, Randomized Study

Young-Hyo Lim #  1 , Ji Hyun Youn #  2 , Soon-Jun Hong  3 , Tae-Hoon Ahn  3 , Junghan Yoon  4 , Jun-Kyu Park  5 , Hyo-Soo Kim  6
Affiliations

A First-in-Man Clinical Evaluation of Sirolimus and Ascorbic Acid-Eluting Stent Systems: a Multicenter, Subject-Blinded, Randomized Study

Young-Hyo Lim et al. Korean Circ J. 2021 Dec.

Abstract

Background and objectives: This clinical trial was conducted to evaluate the safety and efficacy of D+Storm™ drug-eluting stent (DES) and BioMatrix Flex™ DES.

Methods: This study was a multicenter, subject-single-blind, randomized, and confirmed comparative clinical trial. According to the inclusion criteria, those diagnosed with stable angina, unstable angina, silent ischemia, or non-ST-segment myocardial infarction were selected among patients with coronary artery stenosis as subjects. Among the subjects with 50% stenosis on coronary angiography, the experiment was performed on those who had a lesion with reference vessel 2.5-4.0 mm in diameter and ≤40 mm in length. The primary endpoint was an in-segment late loss and the secondary endpoints were in-stent late lumen loss, stent malapposition, the incidence of mortality, myocardial infarction, reoperation, and stent thrombosis at 36 weeks.

Results: 57 patients in the D+Storm™ DES group and 55 patients in the BioMatrix Flex™ DES group were enrolled in the study. Fifty-seven patients in the D+Storm™ DES group and Fifty-five patients in the BioMatrix Flex™ DES group were enrolled in the study. An average of in-segment late lumen loss was 0.08±0.13 mm in the D+Storm™ DES group and 0.14±0.32 mm in the BioMatrix Flex™ DES group with no significant difference between the 2 groups (p=0.879). In addition, there was no significant difference in adverse events between D+Storm™ DES and BioMatrix Flex™ DES.

Conclusions: This study demonstrated the clinical effectiveness and safety of D+Storm™ DES implantation in patients with coronary artery disease over a 36-week follow-up period.

Keywords: Absorbable implants; Ascorbic acid; Coronary artery disease; Drug-eluting stents; Sirolimus.

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Conflict of interest statement

Jun-kyu Park and Ji Hyun Youn are researchers at CG Bio, a manufacturer of D+Storm DES. This clinical trial was funded by CG Bio. The other authors report no conflicts.

Figures

Figure 1
Figure 1. The flow-chart of this study.
DES = drug-eluting stent.
See this image and copyright information in PMC

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