Long-term effects of novel biolimus eluting DEVAX AXXESS plus nitinol self-expanding stent in a porcine coronary model.
OBJECTIVE
The purpose of this study was to evaluate the long-term effects of the DEVAX AXXESS biolimus eluting stent (BES) in a porcine coronary model, compared with those of bare metal stent (BMS) and polymer only stent (POS) controls.


BACKGROUND
Excessive neointimal growth has been identified as a major cause of late failure of percutaneous coronary interventions. The effect of drug eluting from self-expanding stents for prevention of neointimal hyperplasia has not been studied before. The DEVAX AXXESS is a self-expanding nickel titanium stent, coated with antiproliferative compound-biolimus.


METHODS
Twenty juvenile farm swine, 25-35 kg in weight, 3-6 months in age were used. Each animal received a stent to the left anterior descending artery, left circumflex or right coronary arteries as permitted per anatomy. The chronic vascular response after BES implantation was compared with that after BMS and POS implantation at 28, 90, and 180 days follow-up.


RESULTS
The 28-day outcome by quantitative coronary angiography (QCA) showed significant increase in minimal luminal diameter (MLD) in the BES (MLD: 2.90 +/- 0.97, 2.39 +/- 0.90, 1.59 +/- 0.91; P = 0.009) compared with BMS and POS, respectively. By histomorphometric analysis, there was also a corresponding significant reduction in neointimal tissue proliferation in the BES (average neointimal area: 2.78 +/- 0.07, 5.46 +/- 0.66, 8.42 +/- 0.85; P = 0.002) compared with that in BMS and POS controls, respectively at 28-days follow-up. At 90 and 180 days, the mean neointimal area was not significantly different between the BES and the controls.


CONCLUSIONS
BES favorably modulates the neointimal tissue formation for 28 days, in the porcine coronary model. Long-term inhibition of neointimal hyperplasia is not sustained most likely because of the delayed cellular proliferation and inflammation in the vessel wall.
Cilingiroglu
Mehmet
M
Division of Cardiology, Department of Medicine, University of Texas Health Science Center in San Antonio, Texas 78229-3900, USA.
Elliott
Jim
J
Patel
Devang
D
Tio
Furman
F
Matthews
Holly
H
McCasland
Melissa
M
Trauthen
Brett
B
Elicker
John
J
Bailey
Steven R
SR
D000497:Alloys; D000818:Animals; D020099:Coated Materials, Biocompatible / Q000008:administration & dosage*; D017023:Coronary Angiography; D006965:Hyperplasia; D007166:Immunosuppressive Agents / Q000008:administration & dosage; D023421:Models, Animal; D011091:Polyesters; D011474:Prosthesis Design; D020123:Sirolimus / Q000008:administration & dosage; D015607:Stents; D013552:Swine; D013997:Time Factors; D017539:Tunica Intima / Q000473:pathology
D000497:Alloys; D020099:Coated Materials, Biocompatible; D007166:Immunosuppressive Agents; D011091:Polyesters; C505727:poly(epsilon-caprolactone-co-lactide); C013616:nitinol; D020123:Sirolimus