scholarly journals Angioscopic evaluation of vascular healing at 1 and 12 months after drug-coated stent implantation

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
S Kosugi ◽  
Y Ueda ◽  
H Abe ◽  
T Mishima ◽  
K Shinouchi ◽  
...  
Keyword(s):  
Dual Antiplatelet Therapy ◽  
Yellow Colour ◽  
Light Yellow ◽  
Durable Polymer ◽  
Carrier Free ◽  
Biolimus A9 ◽  
Drug Eluting ◽  
Neointimal Coverage ◽  
Grade 3 ◽  
Serial Observation

Abstract Background Polymer- and carrier-free Biolimus-A9-coated stent (DCS) is expected better vascular healing compared with conventional durable polymer drug-eluting stents (DES). Moreover, DCS had been demonstrated in clinical trials to allow one-month short dual antiplatelet therapy, which might achieve sufficient healing at only 1 month after implantation. However, the process of vascular healing after DCS implantation has not been elucidated by angioscopic observation. Purpose To evaluate the process of vascular healing at 1 month and 12 months after DCS implantation. Methods This study included 57 patients treated with DCS or durable polymer everolimus-eluting stents (EES) in our hospital from April 2017 to April 2019. Firstly, the angioscopic findings of DCS at 1 month (n=16) and 12 months (n=14) after implantation were respectively compared with EES at 12 months after implantation (EES-12, n=35) as a standard healing status of DES. Secondary, angioscopic findings of DCS at 1 month and 12 months after implantation were compared among the serially observed eight patients. Neointimal coverage (NIC) grade, yellow colour grade, and the presence of thrombus were evaluated. NIC grade was classified as grade 0 (no neointimal coverage), grade 1 (struts were bulged into lumen but covered), grade 2 (struts were embedded in the neointima but visible), or grade 3 (struts were fully embedded and invisible). Yellow colour grade was classified as grade 0 (white), grade 1 (light yellow), grade 2 (yellow), or grade 3 (intensive yellow). Results At 1 month after DCS implantation, dominant NIC grade was lower (0.3±0.5 vs. 1.5±0.7, p<0.001) and the frequency of thrombus was higher (38% vs. 6%, p=0.008) than EES-12. On the other hands, at 12 months after DCS implantation, dominant NIC grade was higher (2.1±0.6 vs. 1.5±0.7, p=0.013) and the frequency of thrombus was not different (7% vs. 6%, p=1.000) in comparison with EES-12. By serial observation of DCS, dominant NIC grade was higher at 12 months than at 1 month (2.3±0.5 vs. 0.4±0.5, p<0.001), while yellow colour grade (1.0±0.5 vs. 1.5±1.2, p=0.227) and the frequency of thrombus adhesion (0% vs. 38%, p=0.200) were not different. Conclusion Compared with EES-12, vascular healing of DCS was inferior at 1 month but superior at 12 months. Figure 1 Funding Acknowledgement Type of funding source: None

P3386Angioscopic comparison between polymer-free biolimus A9-coated stent and durable polymer drug-eluting stent 10 months after the implantation

2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
T Tsujimura ◽  
T Ishihara ◽  
O Iida ◽  
M Asai ◽  
M Masuda ◽  
...  
Keyword(s):  
De Novo ◽  
Drug Eluting Stent ◽  
Light Yellow ◽  
Yellow Color ◽  
Yellow Plaque ◽  
Durable Polymer ◽  
Biolimus A9 ◽  
Drug Eluting ◽  
Neointimal Coverage ◽  
Grade 3

Abstract Background Polymer-free biolimus A9-coated stent (DCS) has currently emerged as expected better arterial healing compared to durable polymer drug-eluting stent (DP-DES). However, superiority of DCS on arterial healing over DP-DES has not been well elucidated using intracoronary images. Methods This study examined 288 stents in 224 patients with de novo coronary artery lesions. We angioscopically compared 55 DCS from 35 patients with 233 DP-DES from 189 patients 10±2 months after the implantation. We assessed thrombus adhesion, which is a marker of incomplete re-endothelialization. Dominant neointimal coverage (NIC) grade, heterogeneity of NIC and maximum yellow color of plaque underneath the stent were also evaluated. Neointimal coverage was graded as follows: grade 0, stent struts exposed; grade 1, struts bulged into the lumen, although covered; grade 2, struts embedded by the neointima, but translucent; grade 3, struts fully embedded and invisible. NIC was judged as heterogeneous when differences in the NIC grade became apparent. Yellow plaque was graded as follows: grade 0, white; grade 1, light yellow; grade 2, yellow; grade 3, intensive yellow. Results Thrombus adhesion was similar between DCS and DP-DES (29% versus 23%, P=0.32). Dominant NIC was greater in DCS than in BP-DES (P<0.001), while NIC was more heterogeneous in DCS than in BP-DES (P=0.001, Figure). Maximum yellow color of stented segment was similar between DCS and DP-DES (P=0.09). Conclusion DCS provided similar thrombus adhesion to DP-DES, which suggested similar re-endothelialization 10 months after implantation. However, DCS showed thick and heterogeneous NIC compared to DP-DES. The specific feature of polymer-free and Biolimus A9 would cause the difference, and further investigation is necessary to evaluate the longer-term safety and efficacy. Acknowledgement/Funding None

scholarly journals Similar degree of intimal coverage and apposition among drug-eluting stents with persistent, absorbable or without polymer at 1 and 6 months after implantation

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
A Calvo Fernandez ◽  
A Negrete ◽  
H Tizon-Marcos ◽  
R Millan ◽  
N Salvatella ◽  
...  
Keyword(s):  
Biodegradable Polymer ◽  
De Novo ◽  
Neointimal Hyperplasia ◽  
Drug Eluting Stents ◽  
Similar Degree ◽  
Imaging Tool ◽  
Durable Polymer ◽  
Biolimus A9 ◽  
Drug Eluting ◽  
Neointimal Coverage

Abstract Background Despite technological advances in drug-eluting stents (DES) design, delayed vascular healing is still a problem, triggered by the polymers among others. This may induce restenosis and thrombosis. The development of biodegradable polymers and DES without polymer is thought to improve the vascular response and enhance earlier neointimal healing. Optical coherence tomography (OCT) is the best intracoronary imaging tool to evaluate endothelial coverage after stent implantation. Purpose We aimed to quantitatively assess the differences on intimal coverage between biodegradable-polymer, durable-polymer and without-polymer DES at 1 and 6-month follow-up OCT. Methods A total of 94 patients with de novo coronary lesions were treated with DES: 26% were treated with Biolimus A9 (BA9) stent without polymer, 30% were treated with Everolimus DES with biodegradable polymer (EESb) and 44% with Everolimus DES with persistent polymer (EESp). OCT analysis was performed blindly at an independent Core Lab at three stages: implantation, after one month and after six months. The primary endpoint was to compare neointimal coverage and apposition of these three different types of DES with OCT at one and six months after implantation. Results A total of 16034 struts were analysed (24% BA9, 29% EESb and 47% EESp). No significant differences were found among the groups regarding baseline clinical characteristics. When studying the strut coverage, it is remarkable the relatively low percentage of early neointimal coverage with no significant differences among stents one month after implantation (84–87%). After six months, there was better coverage in the three stent groups compared with one month (p&lt;0.001). The stents without polymer had better neointimal coverage at six months compared with the stents with persistent polymer (99% vs 92%, p=0.0002). No significant differences were found in the strut apposition after one or six months among the three stent types. However, the rate of apposition was higher after six months compared with one month in all stent groups (p=0,001). No significant differences were found in the neointimal hyperplasia at one month among the three stent groups. At six months there was a higher hyperplasia in the stent without polymer compared to the stent with persistent polymer (164μm vs 92μm, p=0,003). The degree of hyperplasia after six months was higher compared to one month in all groups (p=0,001). Conclusions The new-generation DES with biodegradable-polymer or without polymer showed relatively poor early neointimal coverage and similar to the last generation durable-polymer EES. According to these results, DAPT may not be shortened in any of the three DES types studied. Funding Acknowledgement Type of funding source: None

scholarly journals Impact of diabetes mellitus on the early-phase arterial healing after drug-eluting stent implantation

2020 ◽  
Vol 19 (1) ◽  
Author(s):  
Takayuki Ishihara ◽  
Yohei Sotomi ◽  
Takuya Tsujimura ◽  
Osamu Iida ◽  
Tomoaki Kobayashi ◽  
...  
Keyword(s):  
Diabetes Mellitus ◽  
Early Phase ◽  
Drug Eluting Stent ◽  
Color Grade ◽  
Light Yellow ◽  
Yellow Color ◽  
Coronary Angioscopy ◽  
Drug Eluting ◽  
Grade 3 ◽  
The Impact

Abstract Background Early arterial healing after drug-eluting stent (DES) implantation may enable short dual-antiplatelet therapy (DAPT) strategy. The impact of diabetes mellitus (DM) on this healing has not been elucidated. We used coronary angioscopy (CAS) to compare intravascular status of DM and non-DM patients in the early phase after DES implantation. Methods This study was a multicenter retrospective observational study. We analyzed CAS findings of 337 lesions from 270 patients evaluated 3–5 months after DES implantation. We divided the lesion into two groups: DM (n = 149) and non-DM (n = 188). We assessed neointimal coverage (NIC) grades (dominant, maximum and minimum), thrombus adhesion and maximum yellow color grade. NIC was graded as follows: grade 0, stent struts were not covered; grade 1, stent struts were covered by thin layer; grade 2, stent struts were buried under neointima. Yellow color was graded as grade 0, white; grade 1, light yellow; grade 2, yellow; grade 3, intensive yellow. Results Minimum NIC grade was significantly lower in DM than in non-DM groups (p = 0.002), whereas dominant and maximum NIC grades were similar between them (p = 0.59 and p = 0.94, respectively), as were thrombus adhesion (44.3% vs. 38.8%, p = 0.32) and maximum yellow color grade (p = 0.78). A multivariate analysis demonstrated that DM was an independent predictor of minimum NIC of grade 0 (odds ratio: 2.14, 95% confidence interval: 1.19–3.86, p = 0.011). Conclusions DM patients showed more uncovered struts than non-DM patients 3–5 months after DES implantation, suggesting that the recent ultra-short DAPT strategy might not be easily applied to DM patients.

The Biolimus A9-coated BioFreedom™ stent: from clinical efficacy to real-world evidence

2020 ◽  
Author(s):  
Sarah Mauler-Wittwer ◽  
Philippe Garot
Keyword(s):  
Arterial Wall ◽  
Dual Antiplatelet Therapy ◽  
Bleeding Risk ◽  
Free Trial ◽  
Thrombosis Risk ◽  
Real World Evidence ◽  
Biolimus A9 ◽  
Drug Eluting ◽  
Potential Trigger ◽  
High Bleeding Risk

In this state-of-the-art review, we present the findings and a critical analysis of the Leaders Free trial program, evaluating outcomes of a new stent-generation based on polymer-free technology, in this case the BioFreedom™ (Biosensors Europe, Switzerland), in patients at high bleeding risk (HBR). Polymer-free drug-coated stents were designed to obtain a device with the antirestenotic benefits of drug-eluting stents but without the polymer coating as potential trigger for delayed arterial wall healing and subsequent late ischemic adverse events, causing a prolonged dependence on dual antiplatelet therapy after stenting. This offers therefore the potential of a promising device-based strategy in a complex growing population of patients with combined HBR and high thrombosis risk, due to the possible reduction of antithrombotic duration.

scholarly journals Impact of Diabetes Mellitus on the Early-Phase Arterial Healing After Drug-Eluting Stent Implantation

2020 ◽  
Author(s):  
Takayuki Ishihara ◽  
Yohei Sotomi ◽  
Takuya Tsujimura ◽  
Osamu Iida ◽  
Tomoaki Kobayashi ◽  
...  
Keyword(s):  
Diabetes Mellitus ◽  
Early Phase ◽  
Drug Eluting Stent ◽  
Color Grade ◽  
Light Yellow ◽  
Yellow Color ◽  
Coronary Angioscopy ◽  
Drug Eluting ◽  
Grade 3 ◽  
The Impact

Abstract Background: Early arterial healing after drug-eluting stent (DES) implantation may enable short dual-antiplatelet therapy (DAPT) strategy. The impact of diabetes mellitus (DM) on this healing has not been elucidated. We used coronary angioscopy (CAS) to compare intravascular status of DM and non-DM patients in the early phase after DES implantation.Methods: This study was a multicenter retrospective observational study. We analyzed CAS findings of 337 lesions from 270 patients evaluated 3-5 months after DES implantation. We divided the lesion into two groups: DM (n=149) and non-DM (n=188). We assessed neointimal coverage (NIC) grades (dominant, maximum and minimum), thrombus adhesion and maximum yellow color grade. NIC was graded as follows: grade 0, stent struts were not covered; grade 1, stent struts were covered by thin layer; grade 2, stent struts were buried under neointima. Yellow color was graded as grade 0, white; grade 1, light yellow; grade 2, yellow; grade 3, intensive yellow.Results: Minimum NIC grade was significantly lower in DM than in non-DM groups (p=0.002), whereas dominant and maximum NIC grades were similar between them (p=0.59 and p=0.94, respectively), as were thrombus adhesion (44.3% vs. 38.8%, p=0.32) and maximum yellow color grade (p=0.78). A multivariate analysis demonstrated that DM was an independent predictor of minimum NIC of grade 0 (odds ratio: 2.14, 95% confidence interval: 1.19-3.86, p=0.011).Conclusion: DM patients showed more uncovered struts than non-DM patients 3-5 months after DES implantation, suggesting that the recent ultra-short DAPT strategy might not be easily applied to DM patients.

Clinical outcomes with 6 months dual antiplatelet therapy after implantation of Biolimus-A9 drug eluting coronary stents

2014 ◽  
Vol 172 (1) ◽  
pp. 185-189 ◽  
Author(s):  
James Cockburn ◽  
Nilesh Pareek ◽  
Petra Poliacikova ◽  
Smriti Saraf ◽  
Rupert Williams ◽  
...  
Keyword(s):  
Clinical Outcomes ◽  
Antiplatelet Therapy ◽  
Dual Antiplatelet Therapy ◽  
Coronary Stents ◽  
Biolimus A9 ◽  
Drug Eluting
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