Key result
Treatment with the Supralimus-Core sirolimus-eluting stent in patients with de novo coronary lesions resulted in an 8-month in-stent late loss of 0.39 mm and a 12-month MACE rate of 7%.
Why the study?
Is a sirolimus-eluting, biodegradable polymer coated cobalt chromium stent safe and effective in patients with de novo native coronary artery lesions?
Is a sirolimus-eluting, biodegradable polymer coated cobalt chromium stent safe and effective in patients with de novo native coronary artery lesions?
A novel sirolimus-eluting, biodegradable polymer coated cobalt chromium stent demonstrated promising safety and efficacy with low late lumen loss and MACE rates in a first-in-man study.
Supports evaluation of this biodegradable-polymer stent; leaves open comparative efficacy versus established DES in randomized trials.
INTRODUCTION: Despite considerable benefits associated with current drug-eluting stents, continued attention to the safety, efficacy, and deliverability of available drug-eluting stent has led to the development of newer stent. METHODS: This study was a single-centre, prospective, non-randomized, first-in-man study which included clinical follow-up data was collected at 1, 8 and 12 months after the procedure. The study included 105 patients with de novo native coronary artery lesions including multi-vessel disease treated with Supralimus-Core® stent. Repeat angiography was performed 8 months post-stent implantation. RESULTS: At quantitative coronary angiography 8-month luminal late loss was 0.39 ± 0.33 mm in-stent and 0.33 ± 0.35 mm in-segment. The incidence of any major adverse cardiac event at 30 days, 8 months and 12 months was 1 (1%), 6 (6%) and 7 (7%) respectively. CONCLUSION: This study demonstrates that the Supralimus-Core® SES is a safe and effective treatment for patients with obstructive coronary artery disease. ClinicalTrials.gov ID: NCT00811616.
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Seth et al. (2012) studied obstructive coronary artery disease (n=105). Supralimus-Core stent was evaluated on major adverse cardiac event at 12 months. Treatment with the Supralimus-Core sirolimus-eluting stent in patients with de novo coronary lesions resulted in an 8-month in-stent late loss of 0.39 mm and a 12-month MACE rate of 7%.
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