scholarly journals Thin Strut CoCr Biodegradable Polymer Biolimus A9-Eluting Stents versus Thicker Strut Stainless Steel Biodegradable Polymer Biolimus A9-Eluting Stents: Two-Year Clinical Outcomes

2021 ◽  
Vol 2021 ◽  
pp. 1-7
Author(s):  
Ian B. A. Menown ◽  
Mamas A. Mamas ◽  
James M. Cotton ◽  
David Hildick-Smith ◽  
Franz R. Eberli ◽  
...  

Background. While thinner struts are associated with improved clinical outcomes in bare-metal stents (BMS), reducing strut thickness may affect drug delivery from drug-eluting stents (DES) and there are limited data comparing otherwise similar thin and thick strut DES. We assessed 2-year outcomes of patients treated with a thin strut (84–88um) cobalt-chromium, biodegradable polymer, Biolimus A9-eluting stent (CoCr-BP-BES) and compared these to patients treated with a stainless steel, biodegradable polymer, Biolimus A9-eluting stent (SS-BP-BES). Methods. In total, 1257 patients were studied: 400 patients from 12 centres receiving ≥1 CoCr-BP-BES in the prospective Biomatrix Alpha registry underwent prespecified comparison with 857 patients who received ≥1 Biomatrix Flex SS-BP-BES in the LEADERS study (historical control). The primary outcome was major adverse cardiac events (MACE)—cardiac death, myocardial infarction (MI), or clinically driven target vessel revascularization (cd-TVR). Propensity analysis was used to adjust for differences in baseline variables and a landmark analysis at day-3 to account for differences in periprocedural MI definitions. Results. MACE at 2 years occurred in 6.65% CoCr-BP-BES versus 13.23% SS-BP-BES groups (unadjusted HR 0.48 [0.31–0.73]; P = 0.0005 ). Following propensity analysis, 2-year adjusted MACE rates were 7.4% versus 13.3% (HR 0.53 [0.35–0.79]; P = 0.004 ). Definite or probable stent thrombosis, adjudicated using identical criteria in both studies, occurred less frequently with CoCr-BP-BES (1.12% vs. 3.22%; adjusted HR 0.32 [0.11–0.9]; P = 0.034 ). In day-3 landmark analysis, the difference in 2-year MACE was no longer significant but there was a lower patient-orientated composite endpoint (11.7% vs. 18.4%; HR 0.6 [0.43–0.83]; P = 0.006 ) and a trend to lower target vessel failure (5.8% vs. 9.1%; HR 0.63 [0.4–1.00]; P = 0.078 ). Conclusion. At 2-year follow-up, propensity-adjusted analysis showed the thin strut (84–88um) Biomatrix Alpha CoCr-BP-BES was associated with improved clinical outcomes compared with the thicker strut (114–120um) Biomatrix Flex SS-BP-BES.

Author(s):  
Belen Rodriguez-Garcia ◽  
Christophe Bureau ◽  
Abdul I. Barakat

Abstract Purpose Despite their widespread use, a significant fraction of coronary stents suffer from in-stent restenosis and stent thrombosis. Stent deployment induces extensive injury to the vascular endothelium. Rapid endothelial wound closure is essential for the success of a stenting procedure. A recent study has demonstrated that the BuMA Supreme® sirolimus-eluting stent exhibits particularly attractive strut coverage characteristics. A unique feature of this stent is the presence of a thin brush layer of poly-butyl methacrylate (PBMA), covalently bonded to the stent’s cobalt-chromium frame via electro-grafting (eG™). The present study aimed to determine whether the PBMA coating has an effect on endothelial cell wound healing and stent strut coverage. Methods We used an in vitro coronary artery model whose wall consisted of an annular collagen hydrogel and whose luminal surface was lined with a monolayer of endothelial cells. Mechanical wounding of the endothelial lining was preformed prior to deployment of a bare cobalt-chromium stent either with or without the PBMA layer. The migration of fluorescently labeled endothelial cells was monitored automatically over a period of 48 h to determine endothelial wound healing rates. Results Quantitative assessment of endothelial wound healing rates within the simulated arterial model is achievable using automated image analysis. Wound healing is significantly faster (44% faster at 48 h) for stents with the PBMA eG Coating™ compared to bare metal stents. Conclusion The PBMA eG Coating™ has the effect of promoting endothelial wound healing. Future studies will focus on elucidating the mechanistic basis of this observation.


Circulation ◽  
2014 ◽  
Vol 130 (suppl_2) ◽  
Author(s):  
Masayuki Mori ◽  
Takuya Nakahashi ◽  
Shu Takabatake ◽  
Chiaki Nakanishi ◽  
Kenji Sakata ◽  
...  

Background: The stent with biolimus A9 coated by a bioresorbable polymer (Nobori ® ) has the potential to reduce thrombosis by degradation of polymer over the period. However, few data exist regarding the vessel response and endothelialization at ultra-early phase after its implantation. Therefore, we examined ultra-early endothelialization of Nobori ® in porcine model. Methods and Results: Fifteen Nobori ® and 14 control bare-metal stents (S-Stent TM ) were implanted in 12 swine (mean weight 31.9 kg). Histopathological evaluation of stented segments were performed at 2 and 14 days after implantation. Morphometric analysis of the inflammation (graded as score 0 to 3) and the intimal fibrin content (graded as score 1 to 3) was also assessed. At 14 days, neointimal thickness and % neointimal area, defined as 100 х neointimal area / stent area, were significantly lower in Nobori ® than in S-Stent TM (51.4 ± 5.9 μm vs 76.4 ± 9.6 μm, p < 0.05 and 11.2 ± 1.1 % vs 15.7 ± 1.3 %, p < 0.01, respectively). Importantly, there were no significant differences in these parameters between 2 groups at 2 days (17.3 ± 6.1 μm vs 26.7 ± 6.1 μm, p = NS and 3.8 ± 1.3% vs 6.9 ± 1.7%, p = NS, respectively). Under these conditions, stent surface endothelialization evaluated by scanning electron microscope at 2 days showed similar appearance of endothelial coverage above the struts in Nobori ® compared with S-Stent TM (Figure). Furthermore, there were no significant differences in inflammatory (1.3 ± 0.1 vs 1.3 ± 0.1, p = NS) and intimal fibrin content (2.5 ± 0.1 vs 2.3 ± 0.1, p = NS) scores. Conclusion: These results demonstrated that endothelialization could occur at ultra-early phase after Nobori ® implantation with similar inflammatory reaction to bare-metal stent, probably contributing to low frequency of in-stent thrombosis and restenosis. The use of Nobori ® may have a potential benefit even at early phase before the degradation of polymer as well as long-term benefit.


Circulation ◽  
2008 ◽  
Vol 118 (suppl_18) ◽  
Author(s):  
Refat Jabara ◽  
Sarah Geva ◽  
Dongming Hou ◽  
Jinsheng Li ◽  
Nicolas Chronos ◽  
...  

Stent-strut thickness is related to in-stent restenosis. Therefore, modern bare-metal stents (BMS) with lower strut thickness are in development. We sought to evaluate a new ‘third-generation’ BMS comprising an ultra-thin-strut, cobalt-chromium platform with fixed geometry and uniform cell sizes, in a clinically relevant animal model. 36 BMS of two types were implanted in pig coronaries using quantitative coronary angiography (QCA) to optimize stent apposition: a commercially available cobalt alloy thin-strut stent (91μm) as control (n=18), and an ultra-thin-strut (65μm) cobalt-chromium stent (Protea CoCr; n=18). Animals underwent angiographic restudy and termination 1-wk and 1-mo post-implant for coronary artery histology. In addition, 12 overlapping Protea CoCr stents were analyzed at 1-mo. All stents deployed without difficulties. Thin neointima and mild inflammation was seen in both groups at 1-wk. For 1-mo, QCA % diameter stenosis was significantly less for Protea CoCr (2±5% vs. 17±16%, p=0.032). By histomorphometry, intima thickness (0.11±0.05mm vs. 0.23±0.11mm, p=0.003) and % area stenosis (19±1% vs. 32±11%, respectively, p=0.004) were also significantly lower for Protea CoCr. The strut injury score was low and similar between the two groups. QCA % stenosis; intima thickness; and % area stenosis of overlapping Protea CoCr were 3±3%, 0.13±0.02mm, and 22±4%, respectively. Stable fibrocellular neointimal incorporation of all stents including overlapped Protea CoCr, with complete endothelialization and minimal inflammation, was seen at one month. Protea CoCr showed favorable arterial response with significant reduction of neointima formation compared to a commercial cobalt alloy BMS, one month post implant in pig coronary arteries. This ultra-thin-strut stent platform therefore appears to be a suitable and attractive alternative to current BMS. Combining the lower levels of neointima formation, fixed geometry, and uniform cell size, the Protea CoCr may be a preferred platform for next-generation drug-eluting stents.


2008 ◽  
Vol 101 (1) ◽  
pp. 58-62 ◽  
Author(s):  
Jiro Aoki ◽  
Ajay J. Kirtane ◽  
George D. Dangas ◽  
Alexandra J. Lansky ◽  
Andy Morales ◽  
...  

2010 ◽  
Vol 3 (10) ◽  
pp. 1051-1058 ◽  
Author(s):  
Cihan Simsek ◽  
Michael Magro ◽  
Eric Boersma ◽  
Yoshinobu Onuma ◽  
Sjoerd T. Nauta ◽  
...  

Sign in / Sign up

Export Citation Format

Share Document