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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 followup 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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Objective@#Imaging modalities such as intravascular ultrasonography or computed tomography or angiography have shown limitations in assessing coronary calcification. In this study, we investigated whether quantitative indices of optical coherence tomography (OCT) in calcified lesions are correlated with the late outcome of a coronary stent. @*Methods@#We consecutively enrolled patients who had more than grade 2 coronary calcification on fluoroscopy. OCT was performed at baseline, immediately after stenting, and at 9 months after stenting. We analyzed qualitative and quantitative characteristics of plaque, calcification, and stent-related indices. @*Results@#All images of 3-time points were available in a total of 10 patients. Calcified lesions were frequently associated with thin cap fibroatheroma (100%), plaque erosion (20%), or rupture (20%) before the procedure. Thrombus was found in 100% of cases in the OCT immediately after stenting. Maximal calcium area before stenting was strongly correlated with late luminal loss assessed by 9-month follow-up OCT (r= 0.766, P= 0.01). @*Conclusion@#Preprocedural OCT assessment on calcified coronary lesion may predict high-risk procedure and late stent outcome. Further studies are warranted to confirm these findings.
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Objective@#Imaging modalities such as intravascular ultrasonography or computed tomography or angiography have shown limitations in assessing coronary calcification. In this study, we investigated whether quantitative indices of optical coherence tomography (OCT) in calcified lesions are correlated with the late outcome of a coronary stent. @*Methods@#We consecutively enrolled patients who had more than grade 2 coronary calcification on fluoroscopy. OCT was performed at baseline, immediately after stenting, and at 9 months after stenting. We analyzed qualitative and quantitative characteristics of plaque, calcification, and stent-related indices. @*Results@#All images of 3-time points were available in a total of 10 patients. Calcified lesions were frequently associated with thin cap fibroatheroma (100%), plaque erosion (20%), or rupture (20%) before the procedure. Thrombus was found in 100% of cases in the OCT immediately after stenting. Maximal calcium area before stenting was strongly correlated with late luminal loss assessed by 9-month follow-up OCT (r= 0.766, P= 0.01). @*Conclusion@#Preprocedural OCT assessment on calcified coronary lesion may predict high-risk procedure and late stent outcome. Further studies are warranted to confirm these findings.