Alexander N Kharlamov1,2, John A Feinstein1, John A Cramer1, John A Boothroyd1, Ekaterina V Shishkina3, Vladimir Shur3. 1. Department of Interventional Cardiovascular Biomedicine, De Haar Research Foundation, Handelsplein 15, Rotterdam 3071PR, The Netherlands. 2. Departments of Science & Interventional Cardiology, Ural Institute of Cardiology, 8th March Street, 78A, Yekaterinburg 620144, Russia. 3. Ural Center of Modern Nanotechnologies, School of Natural Sciences & Mathematics, Ural Federal University, Yekaterinburg 620000, Russia.
Abstract
AIM: The safety options in nanomedicine raise an issue of the optimal niche at the real-world clinical practice. METHODS: This is an observational prospective cohort analysis of the 5-year clinical outcomes at the intention-to-treat population (nano vs ferro vs stenting; n = 180) of NANOM first-in-man trial (NCT01270139). RESULTS: Mortality (6 vs 9 vs 10 cases of cardiac death in groups, p < 0.05), major adverse cardiovascular events (14.3 vs 20.9 vs 22.9%, p = 0.04), late thrombosis (2 vs 4 vs 6, p < 0.05) and target lesion revascularization (3.8 vs 4.8 vs 5.7%, p = 0.04) were significantly higher in ferro group and stent control at 60 months. CONCLUSION: NANOM first-in-man trial demonstrates high safety with better rate of mortality, major adverse cardiovascular events and target lesion revascularization at the long-term follow-up if compare with stent XIENCE V.
AIM: The safety options in nanomedicine raise an issue of the optimal niche at the real-world clinical practice. METHODS: This is an observational prospective cohort analysis of the 5-year clinical outcomes at the intention-to-treat population (nano vs ferro vs stenting; n = 180) of NANOM first-in-man trial (NCT01270139). RESULTS: Mortality (6 vs 9 vs 10 cases of cardiac death in groups, p < 0.05), major adverse cardiovascular events (14.3 vs 20.9 vs 22.9%, p = 0.04), late thrombosis (2 vs 4 vs 6, p < 0.05) and target lesion revascularization (3.8 vs 4.8 vs 5.7%, p = 0.04) were significantly higher in ferro group and stent control at 60 months. CONCLUSION: NANOM first-in-man trial demonstrates high safety with better rate of mortality, major adverse cardiovascular events and target lesion revascularization at the long-term follow-up if compare with stent XIENCE V.
Entities:
Keywords:
long-term outcomes; nanomedicine; regression of atherosclerosis; safety; silica-gold nanoparticles
Authors: Jun Chen; Xixi Zhang; Reid Millican; Jennifer Sherwood; Sean Martin; Hanjoong Jo; Young-Sup Yoon; Brigitta C Brott; Ho-Wook Jun Journal: Adv Drug Deliv Rev Date: 2021-01-09 Impact factor: 15.470