scholarly journals PDLLA-Zn-nitrided Fe bioresorbable scaffold with 53-μm-thick metallic struts and tunable multistage biodegradation function

2021 ◽  
Vol 7 (23) ◽  
pp. eabf0614
Author(s):  
Danni Shen ◽  
Haiping Qi ◽  
Wenjiao Lin ◽  
Wanqian Zhang ◽  
Dong Bian ◽  
...  
Keyword(s):  
Sacrificial Layer ◽  
Drug Eluting Stents ◽  
Subsequent Stage ◽  
Bioresorbable Scaffold ◽  
Strut Thickness ◽  
Mechanical Integrity ◽  
Initial Stage ◽  
Radial Strength ◽  
Drug Eluting ◽  
Drug Coating

Balancing the biodegradability and mechanical integrity of a bioresorbable scaffold (BRS) with time after implantation to match the remodeling of the scaffolded blood vessel is important, but a key challenge in doing so remains. This study presents a novel intercalated structure of a metallic BRS by introducing a nanoscale Zn sacrificial layer between the nitrided Fe platform and the sirolimus-carrying poly(d,l-lactide) drug coating. The PDLLA-Zn-FeN BRS shows a multistage biodegradation behavior, maintaining mechanical integrity at the initial stage and exhibiting accelerated biodegradation at the subsequent stage in both rabbit abdominal aortas and human coronary arteries, where complete biodegradation was observed about 2 years after implantation. The presence of the nanoscale Zn sacrificial layer with an adjustable thickness also contributes to the tunable biodegradation of BRS and allows the reduction of the metallic strut thickness to 53 μm, with radial strength as strong as that of the current permanent drug-eluting stents.

Design and Manufacturing of Drug Eluting Depot Stents with Micro-Sized Drug Reservoirs

2013 ◽  
Vol 479-480 ◽  
pp. 225-229
Author(s):  
Hao Ming Hsiao ◽  
Chun Ting Yeh ◽  
Tsung Yuan Wu ◽  
Li Wei Wu ◽  
Bor Hann Huang ◽  
...  
Keyword(s):  
Finite Element ◽  
Fatigue Life ◽  
Fatigue Resistance ◽  
Finite Element Models ◽  
Mechanical Integrity ◽  
Design And Manufacturing ◽  
Radial Strength ◽  
Drug Eluting ◽  
Through Hole

The effects of micro-sized through-hole drug reservoirs on several key clinical attributes of the drug eluting depot stent were investigated. Finite element models were developed to predict the mechanical integrity of a balloon-expandable stent at various stages such as manufacturing and deployment, as well as the stent radial strength and fatigue life. Results show that (1) creating drug reservoirs on a stent could impact the stent fatigue resistance to certain degrees, and (2) drug reservoirs on the stent crowns led to much greater loss in all key clinical attributes than reservoirs on other locations. Based on these findings, an optimized depot stent was proposed/manufactured and proven to be a feasible design.

Biodegradable-polymer versus durable-polymer drug eluting stents for coronary artery disease: systematic review and a meta-analysis

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
T Toyota ◽  
T Morimoto ◽  
T Kitai ◽  
M Park ◽  
Y Sasaki ◽  
...  
Keyword(s):  
Coronary Artery Disease ◽  
Coronary Artery ◽  
Clinical Outcomes ◽  
First Generation ◽  
Meta Analysis ◽  
Drug Eluting Stents ◽  
Target Vessel ◽  
Strut Thickness ◽  
Drug Eluting ◽  
Artery Disease

Abstract Background Biodegradable polymer drug-eluting stents (BP-DES) has been developed to overcome the potential drawbacks of the first-generation durable polymer drug-eluting stents (DP-DES). However, it is still under debate whether BP-DES is associated with superior efficacy and safety over DP-DES. Purpose We sought to compare the effects of BP-DES and DP-DES in patients with coronary artery disease. Methods We performed systematic review and a meta-analysis of randomized controlled trials comparing BP-DES and DP-DES on clinical outcomes in patients with coronary artery disease using CE-mark approved drug-eluting stents (DES) with at least 1-year follow-up. We included 32 studies involving 39,686 patients (BP-DES: 21,439 patients, and DP-DES: 18,247 patients). Primary outcome measure was target vessel failure (TVF; equivalent to the composite of cardiac death, target-vessel myocardial infarction, or ischemia-driven target vessel revascularization). We performed subgroup analysis according to the DP-DES generations (newer-generation DP-DES: 15,179patients, and first-generation DP-DES: 3,068 patients), and the effects of newer-generation DP-DES was compared with the BP-DES according to the BP-DES strut thickness (Ultra-thin strut [<80μm]: 7,572 patients, Thin-strut [80–100μm]: 5,465 patients, and Thick-strut [≥80μm]: 5,876 patients). Results The odds for TVF was not significantly different between the BP-DES group and the DP-DES group in the entire study population (odds ratio [OR] 0.96, 95% confidence interval [CI] [0.90–1.02], P=0.20). The odds for TVF was significantly low in the BP-DES group relative to the first-generation DP-DES group, however the odds were comparable between the BP-DES group and the newer-generation DP-DES group (BP-DES versus first-generation DP-DES: OR 0.82, 95% CI [0.73–0.92], P<0.001, and BP-DES versus newer-generation DP-DES: OR 1.00, 95% CI [0.93–1.08], P=0.99). We also found no significant differences between the BP-DES and newer-generation DP-DES, in all subgroups stratified by the BP-DES strut thickness (Ultra-thin strut BP-DES versus newer-generation DP-DES: OR 0.88, 95% CI [0.76–1.02], P=0.10, Thin-strut BP-DES versus newer-generation DP-DES: OR 1.01, 95% CI [0.90–1.13], P=0.89, and Thick strut BP-DES versus newer-generation DP-DES: OR 1.11, 95% CI [0.99–1.25], P=0.08). Conclusions In this meta-analysis of randomized controlled trials evaluating clinical outcomes, there was no significant differences between BP-DES and DP-DES. We found beneficial effects of BP-DES relative to the first-generation DP-DES, however, there was no statistical differences between BP-DES and newer-generation DP-DES, irrespective of the BP-DES strut thickness. Pooled odds ratios for clinical outcomes Funding Acknowledgement Type of funding source: None

The influence of strut thickness and cell design on immediate apposition of drug-eluting stents assessed by optical coherence tomography

2009 ◽  
Vol 134 (2) ◽  
pp. 180-188 ◽  
Author(s):  
Jun Tanigawa ◽  
Peter Barlis ◽  
Konstantinos Dimopoulos ◽  
Miles Dalby ◽  
Philip Moore ◽  
...  
Keyword(s):  
Optical Coherence Tomography ◽  
Drug Eluting Stents ◽  
Cell Design ◽  
Optical Coherence ◽  
Strut Thickness ◽  
Drug Eluting

Meta-Analysis of the Impact of Strut Thickness on Outcomes in Patients With Drug-Eluting Stents in a Coronary Artery

2018 ◽  
Vol 122 (10) ◽  
pp. 1652-1660 ◽  
Author(s):  
Micaela Iantorno ◽  
Michael J. Lipinski ◽  
Hector M. Garcia-Garcia ◽  
Brian J. Forrestal ◽  
Toby Rogers ◽  
...  
Keyword(s):  
Coronary Artery ◽  
Meta Analysis ◽  
Drug Eluting Stents ◽  
Strut Thickness ◽  
Drug Eluting ◽  
The Impact

Abstract 13607: Differential Response of Local Coagulation after Implantation of New Generation Drug-Eluting Stents Compared with Sirolimus-Eluting Stent

Circulation ◽  
2014 ◽  
Vol 130 (suppl_2) ◽  
Author(s):  
Koji Yamaguchi ◽  
Tetsuzo Wakatsuki ◽  
Akira Takashima ◽  
Mika Bando ◽  
Sachiko Bando ◽  
...  
Keyword(s):  
Coronary Artery ◽  
Coronary Sinus ◽  
Drug Eluting Stents ◽  
Sinus Of Valsalva ◽  
Stent Group ◽  
Strut Thickness ◽  
Stent Length ◽  
Drug Eluting ◽  
Sirolimus Eluting Stent ◽  
New Generation

Purpose: We have previously demonstrated local persistent hypercoagulation after sirolimus-eluting stent (SES) implantation by measuring plasma prothrombin fragment F1+2(frF1+2) levels. The aim of this study is to examine local coagulation response after biolimus-eluting stent (BES) and everolimus-eluting stent (EES) implantation. Methods: Sixty-eight patients who were treated with stents about eight months earlier to the mid-segment of the left anterior descending coronary artery, with no evidence of restenosis, were studied (BES: 12pts, EES: 15pts, SES: 23pts, and BMS: 18pts). We measured plasma levels of frF1+2 sampled in coronary sinus (CS) and sinus of Valsalva (V). The transcardiac frF1+2 gradients (ΔfrF1+2) were defined as CS level minus V level. The patients were divided into 2 groups according to total stent length [longer stent group (≥24mm) or shorter stent group (<24mm)]. Results: A larger percent diameter stenosis was observed in the BMS group than in the SES, EES, and BES groups (25.1±15.6 vs 7.1±16.5, 12.5±12.8, 10.3±14.2%, p<0.05, respectively). The ΔfrF1+2 was greater in the SES group than in the BMS, EES, and BES groups, and no significant differences were observed among the BMS, EES, and BES groups (23.4±21.1 vs 4.7±13.4, 3.2±11.7, 1.5±11.1 pmol/l, p<0.05, respectively). The ΔfrF1+2 in longer stent group (n=11) was significantly greater than in shorter stent group (n=12) (27.4±12.1 vs 19.2±10.1 pmol/l, p<0.05) only in the SES group, however, no significant differences were observed according to total stent length in other groups. Conclusions: A lower response of local coagulation after BES and EES implantation was shown, and significant correlation between local hypercoagulation and total stent length was observed only after SES implantation. These findings might be associated with lower strut thickness and unique characteristics of polymer in second-generation drug-eluting stents.

Sign in / Sign up

Export Citation Format

Share Document