Key result
BioMime SES shows comparable 12-month angiographic late loss in patients with and without diabetes.
Why the study?
The clinical effects of BioMime sirolimus-eluting stent in patients with diabetes have not been evaluated compared to those without diabetes.
Cohort (n=231)
Absolute Event Rate: 0.04% vs 0.01%
p-value: p=0.158
Comparable late loss supports BioMime performance across diabetes status; hypothesis-generating and leaves open randomized confirmation before practice change.
INTRODUCTION: Drug-eluting stents (DES) significantly improved angiographic and clinical outcomes compared with bare-metal stents in patients with diabetes. The clinical effects of BioMime sirolimus-eluting stent (SES) in patients with diabetes have not been evaluated. Therefore, we compared the efficacy of BioMime DES in coronary artery disease (CAD) patients with versus without diabetes. METHODS: This prospective analytical study compared angiographic in-segment late loss and clinical effectiveness of BioMime SES stents in treating patients with (patients: 77 and lesions: 83) versus without (patients: 154 and lesions: 162) diabetes. The purpose of this study was the comparison of angiographic in-segment late loss at 12 months. Major adverse cardiac events (MACEs) were also monitored as secondary outcomes 24 months after the index procedure. RESULTS: Of 231 patients enrolled in the study, the mean age was 63.3 years and 153 patients were male. Angiographic follow-up rate was 84.8% (patients: 196) and intravascular ultrasound (IVUS) follow-up rate was 67.9% (patients: 157) at 12 months. Diabetic patients were comparable to nondiabetic patients for 12-month in-segment late loss (0.01 ± 0.31 mm for the nondiabetes group versus 0.04 ± 0.11 mm for the diabetes group; P = 0.158; P < 0.05). At 24 months, MACEs, including death, myocardial infarction and ischemic-driven target lesion revascularization were not statistically different between the two treatment groups. CONCLUSIONS: BioMime SES stents in treating patients with diabetes were comparable in reducing angiographic restenosis at 12 months and MACEs at 24 months compared to nondiabetic patients with CAD.
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Yun et al. (2022) conducted a cohort in Coronary artery disease (n=231). Diabetes mellitus vs. No diabetes mellitus was evaluated on Angiographic in-segment late loss at 12 months (p=0.158). In patients treated with BioMime sirolimus-eluting stents, 12-month angiographic in-segment late loss was comparable between patients with and without diabetes (0.04 vs 0.01 mm; P=0.158).
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