BACKGROUND: Second generation of drug eluting stents (DES) has attempted to improve safety using abluminal sirolimus drug delivery with biodegradable polymers matrix. The present preclinical study was designed to investigate the safety and efficacy profile of Abluminus™ stents (SES). This is a new coronary stent with sirolimus and biodegradable polymer matrix coated on abluminal stent and balloon surface. METHODS: SES were compared with two controls: bare metal stent (BMS) and BMS + polymer coated stents (PC). All devices (40 stents) were implanted in porcine coronary arteries with primary endpoint of endothelialization at 7 days and subsequent histological and morphometric evaluations at 7, 30 and 90 days. RESULTS: Early endothelialization at seven days was complete in all stents. Histology at 30 days revealed minimum inflammation in all groups and increased at 90 days in PC group while it was absent at 180 days. Thirty day morphometry showed significantly reduction of neointimal area in Abluminus™ (SES 0.96±0.48 mm(2); BMS 1.83±0.34 mm(2); PC 1.76±0.55 mm(2); P<0.05); after 90 days neointimal area was 1.10±0.54 mm(2) for SES; 1.92±0.36 mm(2) for BMS; and 1.94±0.48 mm(2) for PC; P<0.05). Neointimal thickness at 30 and 90 days respectively was 0.15±0.07 and 0.18±0.10 mm for SES, 0.57±0.08 and 0.61±0.09 mm for BMS and 0.52±0.09 and 0.59±0.08 mm, P<0.001 for PC group. CONCLUSIONS: The most significant experimental evidence appears to be earlier endothelialization at 7 days for SES which led to safety of the device. Efficacy of the device was also observed by a reduced neointimal thickness and minimized inflammatory score at all follow-ups. Termination of antiplatelet at 30 days has not shown any further complications. Polymer thickness was almost in negligible amount at 180 days with no inflammation.
BACKGROUND: Second generation of drug eluting stents (DES) has attempted to improve safety using abluminal sirolimus drug delivery with biodegradable polymers matrix. The present preclinical study was designed to investigate the safety and efficacy profile of Abluminus™ stents (SES). This is a new coronary stent with sirolimus and biodegradable polymer matrix coated on abluminal stent and balloon surface. METHODS: SES were compared with two controls: bare metal stent (BMS) and BMS + polymer coated stents (PC). All devices (40 stents) were implanted in porcine coronary arteries with primary endpoint of endothelialization at 7 days and subsequent histological and morphometric evaluations at 7, 30 and 90 days. RESULTS: Early endothelialization at seven days was complete in all stents. Histology at 30 days revealed minimum inflammation in all groups and increased at 90 days in PC group while it was absent at 180 days. Thirty day morphometry showed significantly reduction of neointimal area in Abluminus™ (SES 0.96±0.48 mm(2); BMS 1.83±0.34 mm(2); PC 1.76±0.55 mm(2); P<0.05); after 90 days neointimal area was 1.10±0.54 mm(2) for SES; 1.92±0.36 mm(2) for BMS; and 1.94±0.48 mm(2) for PC; P<0.05). Neointimal thickness at 30 and 90 days respectively was 0.15±0.07 and 0.18±0.10 mm for SES, 0.57±0.08 and 0.61±0.09 mm for BMS and 0.52±0.09 and 0.59±0.08 mm, P<0.001 for PC group. CONCLUSIONS: The most significant experimental evidence appears to be earlier endothelialization at 7 days for SES which led to safety of the device. Efficacy of the device was also observed by a reduced neointimal thickness and minimized inflammatory score at all follow-ups. Termination of antiplatelet at 30 days has not shown any further complications. Polymer thickness was almost in negligible amount at 180 days with no inflammation.
Authors: Pieter Cornelis Smits; Sjoerd Hofma; Mario Togni; Nicolás Vázquez; Mariano Valdés; Vassilis Voudris; Ton Slagboom; Jean-Jaques Goy; Andre Vuillomenet; Antoni Serra; Ramiro Trillo Nouche; Peter den Heijer; Martin van der Ent Journal: Lancet Date: 2013-01-30 Impact factor: 79.321
Authors: Ayala Hezi-Yamit; Carol Sullivan; Jennifer Wong; Laura David; Mingfei Chen; Peiwen Cheng; David Shumaker; Josiah N Wilcox; Kishore Udipi Journal: J Biomed Mater Res A Date: 2009-07 Impact factor: 4.396
Authors: Aloke V Finn; Gaku Nakazawa; Michael Joner; Frank D Kolodgie; Erik K Mont; Herman K Gold; Renu Virmani Journal: Arterioscler Thromb Vasc Biol Date: 2007-05-17 Impact factor: 8.311
Authors: Lakshmana K Pendyala; Jinsheng Li; Toshiro Shinke; Sarah Geva; Xinhua Yin; Jack P Chen; Spencer B King; Keith A Robinson; Nicolas A F Chronos; Dongming Hou Journal: JACC Cardiovasc Interv Date: 2009-03 Impact factor: 11.195