Plasmonic photothermal therapy of atherosclerosis with nanoparticles: long-term outcomes and safety in NANOM-FIM trial.

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.