Preclinical randomised safety, efficacy and physiologic study of the silicon dioxide inert-coated Axetis and bare metal stent: short-, mid- and long-term outcome.
OBJECTIVE
To evaluate the short-, mid- and long-term safety, efficacy and vascular physiology of Axetis silicon dioxide (SiO2, abrading the micropores) inert-coated stent implantation in a randomised preclinical setting.


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 angiography, 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 myography (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 SiO2-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.
Department of Cardiology, Medical University of Vienna, Vienna, Austria.
Noemi
N
Pavo
Bonni
B
Syeda
Andreas
A
Bernhart
Eszter
E
Szentirmai
Rayyan
R
Hemetsberger
Eslam
E
Samaha
Christian
C
Plass
Katrin
K
Zlabinger
Imre J
IJ
Pavo
Zsolt
Z
Petrasi
Örs
Ö
Petnehazy
Simon P
SP
Hoerstrup
Gerald
G
Maurer
Mariann
M
Gyöngyösi
D000818:Animals; D020099:Coated Materials, Biocompatible; D017023:Coronary Angiography; D003331:Coronary Vessels / Q000000981:diagnostic imaging / Q000473:pathology / Q000503:physiopathology; D005240:Feasibility Studies; D005260:Female; D008297:Male; D008422:Materials Testing; D008670:Metals; D023421:Models, Animal; D058426:Neointima; D062645:Percutaneous Coronary Intervention / Q000009:adverse effects / Q000295:instrumentation*; D011474:Prosthesis Design; D012822:Silicon Dioxide; D015607:Stents; D034421:Sus scrofa; D013997:Time Factors; D041623:Tomography, Optical Coherence; D018084:Ultrasonography, Interventional; D014664:Vasodilation
D020099:Coated Materials, Biocompatible; D008670:Metals; D012822:Silicon Dioxide