Silica-gold nanoparticles for atheroprotective management of plaques: results of the NANOM-FIM trial / Kharlamov Alexander N.,Tyurnina Anastasiya E.,Veselova Vera S.,Kovtun Olga P.,Shur Vladimir Y.,Gabinsky Jan L. // NANOSCALE. - 2015. - V. 7, l. 17. - P. 8003-8015.

ISSN/EISSN:

2040-3364 / 2040-3372

Type:

Article

Abstract:

Background: Atheroregression becomes an attractive target for cardiovascular treatment. Some clinical trials have demonstrated that intensive therapy with rosuvastatin or recombinant ApoA-I Milano can partially reduce the total atheroma volume (TAV) up to 6.38 mm(3) or 14.1 mm(3) respectively. Our previous bench studies of selected nanotechnologies documented TAV reduction up to an unprecedented 79.4 mm(3). Methods: The completed observational three arms (n = 180) first-in-man trial (the NANOM FIM trial) assessed (NCT01270139) the safety and feasibility of two delivery techniques for nanoparticles (NP), and plasmonic photothermal therapy (PPTT). Patients were assigned to receive either (1) nano-intervention with delivery of silica-gold NP in a bioengineered on-artery patch (n = 60), or (2) nano-intervention with delivery of silica-gold iron-bearing NP with targeted micro-bubbles and stem cells using a magnetic navigation system (n = 60) versus (3) stent implantation (n = 60). The primary outcome was TAV at 12 months. Results: The mean TAV reduction at 12 months in the Nano group was 60.3 mm(3) (SD 39.5; min 41.9 mm(3), max 94.2 mm(3); p < 0.05) up to mean 37.8\% (95\% CI: 31.1\%, 51.7\%; p < 0.05) plaque burden. The analysis of the event free survival of the ongoing clinical follow-up shows the significantly lower risk of cardiovascular death in the Nano group when compared with others (91.7\% vs. 81.7\% and 80\% respectively; p < 0.05) with no cases of the target lesion-related complications. Conclusions: PPTT using silica-gold NP associated with significant regression of coronary atherosclerosis.

Author keywords:

ATHEROSCLEROTIC PLAQUES; THERAPY; NANOTECHNOLOGY; ANGIOPLASTY; GUIDANCE; DISEASE; BALLOON

DOI:

10.1039/c5nr01050k

Web of Science ID:

ISI:000353981700059

Соавторы в МНС:

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Другие поля

Поле	Значение
Publisher	ROYAL SOC CHEMISTRY
Address	THOMAS GRAHAM HOUSE, SCIENCE PARK, MILTON RD, CAMBRIDGE CB4 0WF, CAMBS, ENGLAND
Language	English
EISSN	2040-3372
Keywords-Plus	ATHEROSCLEROTIC PLAQUES; THERAPY; NANOTECHNOLOGY; ANGIOPLASTY; GUIDANCE; DISEASE; BALLOON
Research-Areas	Chemistry; Science \& Technology - Other Topics; Materials Science; Physics
Web-of-Science-Categories	Chemistry, Multidisciplinary; Nanoscience \& Nanotechnology; Materials Science, Multidisciplinary; Physics, Applied
Author-Email	drkharlamov@icloud.com
ResearcherID-Numbers	Kharlamov, Alexander/I-3692-2015 Kovtun, Olga/G-7182-2016 Shur, Vladimir/J-9078-2015
ORCID-Numbers	Kharlamov, Alexander/0000-0003-4631-1261 Kovtun, Olga/0000-0002-5250-7351
Number-of-Cited-References	33
Usage-Count-Last-180-days	2
Usage-Count-Since-2013	13
Journal-ISO	Nanoscale
Doc-Delivery-Number	CH4DI