EXPERIMENTAL RESEARCH
CORONARY INTERVENTIONS
EuroIntervention 2015;11:433-441 published online ahead of print April 2014 DOI: 10.4244/EIJV11I4A85
433
© Europa Digital & Publishing 2015. All rights reserved.
*Corresponding author: Department of Cardiology, Medical University of Vienna, Waehringer Guertel 18-20, A-1090 Wien,
Austria. E-mail: mariann.gyongyosi@meduniwien.ac.at
Preclinical randomised safety, efficacy and physiologic study
of the silicon dioxide inert-coated Axetis and bare metal
stent: short-, mid- and long-term outcome
Noemi Pavo
1
, MD, MSc; Bonni Syeda
1
, MD; Andreas Bernhart
1
, MD; Eszter Szentirmai
2
, PhD;
Rayyan Hemetsberger
1
, MD; Eslam Samaha
1
, MD; Christian Plass
1
, MD; Katrin Zlabinger
1
, BSc;
Imre J. Pavo
1
, MD; Zsolt Petrasi
2
, PhD; Örs Petnehazy
2
, PhD; Simon P. Hoerstrup
3
, MD, VMD;
Gerald Maurer
1
, MD; Mariann Gyöngyösi
1
*, MD, PhD
1. Department of Cardiology, Medical University of Vienna, Vienna, Austria; 2. Institute of Diagnostic Imaging and Radiation
Oncology, University of Kaposvar, Kaposvar, Hungary; 3. Cardiovascular Research and Regenerative Medicine Program,
University and University Hospital, Zürich, Switzerland
N. Pavo and B. Syeda contributed equally to the work.
The references can be found in the online version of this paper at the following website: http://www.pcronline.com/eurointervention/87th_issue/85
Abstract
Aims: To evaluate the short-, mid- and long-term safety, efficacy and vascular physiology of Axetis silicon
dioxide (SiO
2
, abrading the micropores) inert-coated stent implantation in a randomised preclinical setting.
Methods and results: Coronary arteries of domestic pigs were randomised to receive either Axetis or
BMS (same design) stents with one-, three- and six-month follow-up (FUP), controlled by coronary angi-
ography, optical coherence tomography (OCT), intravascular ultrasound (IVUS) and histology (n=32). The
time-dependent vasomotor reaction of coronary arteries to stenting was measured using modified myogra-
phy (n=12). Complete endothelialisation of the Axetis stent was confirmed by OCT, IVUS and histology at
one-month FUP. Histopathology revealed continuous healing of the vessel wall with a gradual reduction of
inflammation and fibrin score during the six-month FUP in both stent types. Significantly smaller neointimal
area and %area stenosis were measured in Axetis stents compared with BMS at each FUP time point. Vascular
reactivity measurements showed significantly better endothelium-dependent vasodilation of stented arteries
with Axetis implantation.
Conclusions: Implantation of the Axetis SiO
2
-coated stent resulted in a significantly better safety, efficacy
and vessel physiology profile compared with BMS of the same design with a continuous decrease in vessel
inflammation during the six-month FUP.
KEYWORDS
• histology
• inert-coated stent
• late lumen loss
• preclinical study
• stent thrombosis
• vascular response
SUBMITTED ON 03/10/2012 - REVISION RECEIVED ON 06/03/2013 - ACCEPTED ON 14/05/2013