Key result
Osstem Cardiotec Centum stent is non-inferior to Xience Alpine for 270-day late lumen loss.
Why the study?
The safety and efficacy of the new everolimus-eluting Osstem Cardiotec Centum stent with an abluminal-coated biodegradable polymer compared to the Xience Alpine stent were not established.
Does the Osstem Cardiotec Centum stent reduce in-segment late lumen loss compared to the Xience Alpine stent in patients with myocardial ischemia undergoing PCI?
RCT (n=121)
Single-blind
Parallel
Yes
Does the Osstem Cardiotec Centum stent reduce in-segment late lumen loss compared to the Xience Alpine stent in patients with myocardial ischemia undergoing PCI?
Absolute Event Rate: 0.09% vs 0.12%
p-value: p=0.0084 for non-inferiority
The Osstem Cardiotec Centum stent is non-inferior to the Xience Alpine stent regarding late lumen loss at 270 days in patients undergoing PCI.
Supports Osstem Cardiotec Centum as alternative to Xience Alpine in PCI; confirms non-inferiority for late lumen loss at 9 months.
BACKGROUND AND OBJECTIVES: To compare the safety and efficacy of a new everolimus-eluting stent with an abluminal-coated biodegradable polymer (Osstem Cardiotec Centum) with those of the Xience Alpine stent (Xience). METHODS: This randomized, prospective, multicenter, parallel-designed, single-blind trial was conducted among patients with myocardial ischemia undergoing percutaneous coronary intervention (PCI) from 21st September 2018 until 3rd July 2020. The primary efficacy endpoint was in-segment late lumen loss (LLL) at 270 days after the procedure and the primary safety endpoints were major adverse cardiac events (MACE), composite of cardiac death, myocardial infarction, and target lesion revascularization. RESULTS: We enrolled 121 patients and analyzed 113 patients who finished 270 days of follow-up for the primary efficacy endpoint. The mean age of the participants was 66.8 years. As for the primary efficacy endpoint, LLL of the Osstem Cardiotec Centum group was 0.09±0.13 mm and that of the Xience group was 0.12±0.14 mm (upper limit of 1-sided 95% confidence interval, 0.02; p for non-inferiority, 0.0084). This result demonstrates the non-inferiority of the Osstem Cardiotec Centum. As for the primary safety endpoint, MACE occurred in one patient (1.59% of the Xience group). Meanwhile, no MACE occurred in the Osstem Cardiotec Centum group. CONCLUSIONS: The Osstem Cardiotec Centum is non-inferior to the Xience Alpine® stent and is confirmed to be safe. It could be safely and effectively applied to patients with coronary artery disease undergoing PCI.
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Yoon et al. (2022) conducted an RCT in myocardial ischemia undergoing percutaneous coronary intervention (n=121). Osstem Cardiotec Centum stent vs. Xience Alpine stent was evaluated on in-segment late lumen loss (LLL) at 270 days (95% CI upper limit 0.02, p=0.0084 for non-inferiority). The Osstem Cardiotec Centum stent was non-inferior to the Xience Alpine stent for in-segment late lumen loss at 270 days (0.09 mm vs 0.12 mm; P=0.0084 for non-inferiority).
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