Very early neointimal coverage of new biodegradable polymer drug-eluting stent compared with durable polymer everolimus-eluting stent evaluated by optical frequency domain imaging

2017 ◽  
Vol 34 (4) ◽  
pp. 515-522 ◽  
Author(s):  
Norihiro Kobayashi ◽  
Yoshiaki Ito ◽  
Masahiro Yamawaki ◽  
Motoharu Araki ◽  
Tsuyoshi Sakai ◽  
...  
Keyword(s):  
Frequency Domain ◽  
Biodegradable Polymer ◽  
Drug Eluting Stent ◽  
Optical Frequency ◽  
Optical Frequency Domain Imaging ◽  
Durable Polymer ◽  
Drug Eluting ◽  
Neointimal Coverage

Ex vivo optical frequency domain imaging and histopathology of malapposed drug eluting stent in coronary artery

2016 ◽  
Vol 66 (6) ◽  
pp. 354-355
Author(s):  
Akiko Fujino ◽  
Hiroyuki Hao ◽  
Rika Kawakami ◽  
Yasu-aki Tsuchida ◽  
Kenichi Fujii ◽  
...  
Keyword(s):  
Coronary Artery ◽  
Frequency Domain ◽  
Ex Vivo ◽  
Drug Eluting Stent ◽  
Optical Frequency ◽  
Optical Frequency Domain Imaging ◽  
Drug Eluting

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

P2813The improvement of chronic local coagulative response according to the progress of drug eluting stent

2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
K Yamaguchi ◽  
T Wakatsuki ◽  
R Ueno ◽  
Y Kawabata ◽  
T Matsuura ◽  
...  
Keyword(s):  
Coronary Sinus ◽  
Biodegradable Polymer ◽  
Coronary Angioplasty ◽  
Plasma Levels ◽  
Drug Eluting Stent ◽  
Sinus Of Valsalva ◽  
Strut Thickness ◽  
Durable Polymer ◽  
Drug Eluting ◽  
Sirolimus Eluting Stent

Abstract Background We have previously reported local persistent hypercoagulation after sirolimus-eluting stent (SES) implantation by measuring local plasma prothrombin fragment 1+2 (F1+2) levels. The aim of this study is to examine chronic local coagulative response after each generation- drug eluting stent (DES) implantation. Methods Ninety-five patients who were treated about eight months earlier with coronary angioplasty, with no evidence of restenosis, were studied [1stgeneration durable polymer (DP)-DES {SES; Cypher®: 26pts, paclitaxel-eluting stent (PES); Taxus®:16pts}, 2ndgeneration DP-DES {everolimus-eluting stent (EES); Xience®:15pts, zotarolimus-eluting stent (ZES); Endeavor®:15pts}, and 3rdgeneration biodegradable polymer (BP)-DES {BP-biolimus-eluting stent (BES); Nobori®: 11pts and BP-SES; Ultimaster®: 12pts}]. We measured plasma levels of F1+2 sampled in coronary sinus (CS) and sinus of Valsalva (V). The transcardiac gradient (Δ) was defined as CS level minus V level. Results No significant differences were observed in the percent diameter stenosis among 1st, 2nd, and 3rd DES groups (12.5±15.5 vs 16.1±12.9 vs 13.1±11.9%). The ΔF1+2 was significantly lower in the 2nd and 3rd DES groups than in the 1st DES group (9.0±15.4 and 10.0±17.4 vs 27.3±23.8pmol/l, p<0.05, respectively). The ΔF1+2 was significantly lower in the BP-DES groups (BP-BES and BP-SES) than in the DP-DES groups (DP-SES, DP-PES, DP-ZES, and DP-EES) (10.0±17.4 vs 18.1±19.5pmol/l, p<0.05). The ΔF1+2 was significantly lower in the thin strut-DES groups (BP-SES, DP-ZES, and DP-EES) than in the thick strut-DES groups (DP-SES, DP-PES, and BP-BES) (8.4±15.4 vs 21.7±18.5pmol/l, p<0.05). In the BP-DES groups, the ΔF1+2 was lower in the BP-SES group than in the BP-BES group (8.0±16.1 vs 12.7±18.1pmol/l, p=0.08). Conclusions The improvement of chronic local coagulative response was observed according to the progress of DES. These findings might be associated with lower strut thickness and faster polymer resorption in the newer-generation DES.

P6241Two-year clinical outcomes of biodegradable polymer versus durable polymer drug-eluting stent implantation in hemodialysis patients after percutaneous coronary intervention

2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
S Okuno ◽  
T Ishihara ◽  
O Iida ◽  
M Asai ◽  
M Masuda ◽  
...  
Keyword(s):  
Percutaneous Coronary Intervention ◽  
Clinical Outcomes ◽  
Outcome Measures ◽  
Biodegradable Polymer ◽  
Coronary Intervention ◽  
Drug Eluting Stent ◽  
Safety And Efficacy ◽  
Durable Polymer ◽  
Percutaneous Coronary ◽  
Drug Eluting

Abstract Background Biodegradable polymer drug-eluting stent (BP-DES) has been developed to improve clinical outcomes after percutaneous coronary intervention (PCI) for patients presenting coronary artery disease (CAD). Although BP-DES showed non-inferior safety and efficacy to durable polymer DES (DP-DES) in several randomized clinical trials, hemodialysis (HD) patients, who have been well known as high risk population for adverse events, were excluded in the most of trials. Therefore, there are limited data comparing the clinical outcomes between BP-DES and DP-DES in HD patients with CAD after PCI. Purpose The purpose of this study was to investigate clinical outcomes in HD patients after BP-DES implantation compared with those after DP-DES implantation. Methods We retrospectively analyzed 234 HD patients (male 74%, mean age 71±10 years) undergoing PCI for 404 lesions with 472 DESs (71 patients for 138 lesions with 170 BP-DESs [91 Ultimaster and 79 Synergy] and 163 HD patients for 266 lesions with 302 DP-DESs [219 Xience, 53 Promus and 30 Resolute]) from 2011 to 2017. Two-year clinical outcomes were compared between BP-DES group and DP-DES group. The primary outcome measure was the incidence of target lesion revascularization (TLR), while the secondary outcome measures were the occurrence of cardiac death (CD), stent thrombosis (ST), myocardial infraction (MI), target vessel revascularization (TVR), non-TVR and major adverse cardiac event (MACE) defined as a composite of CD, MI, and TVR. Outcome measures were estimated by the Kaplan-Meier method and the differences between BP-DES group and DP-DES group were assessed by the log-rank test. We also conducted Cox's proportional hazard model to identify predictors for TLR occurrence. Results Baseline patient and lesion characteristics were similar between the two groups. The two-year incidence of TLR was not significantly different between BP-DES group and DP-DES group (14.1% vs. 22.2%, p=0.391). The two-year incidences of CD (17.3% vs. 17.5%, p=0.381), ST (0% vs. 3.9%, p=0.133), MI (4.2% vs. 5.8%, p=0.965), TVR (21.3% vs. 27.5%, p=0.586), non-TVR (26.1% vs. 31.3%, p=0.439) and MACE (41.1% vs. 42.6%, p=0.526) were also not different between the two groups. After multivariate analysis, diabetes mellitus (hazard ratio 1.97; 95% confidence interval 1.03–3.78, p=0.004) was independently associated with TLR occurrence in HD patients. Two-year clinical outcomes of HD patient Conclusions At two-year follow-up after PCI, BP-DES had comparable safety and efficacy profiles to DP-DES in HD patients presenting CAD. Acknowledgement/Funding None

Early restenosis and late catch-up phenomenon after newer biodegradable- and durable-polymer drug-eluting stent implantations

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
A Masumoto ◽  
M Ohya ◽  
R Murai ◽  
K Miura ◽  
T Shimada ◽  
...  
Keyword(s):  
Biodegradable Polymer ◽  
Bypass Graft ◽  
Drug Eluting Stent ◽  
Lesion Length ◽  
Total Occlusion ◽  
Early Term ◽  
Durable Polymer ◽  
Drug Eluting ◽  
Catch Up ◽  
Early Restenosis

Abstract Background It is yet to be known whether mechanisms underlying restenosis in newer-generation durable-polymer (DP) and biodegradable-polymer (BP) drug-eluting stents (DES) are different. Purpose This study aims to assess the incidences and predictors of early restenosis and late catch-up phenomenon after newer-generation durable-polymer (DP) and biodegradable-polymer (BP) DES. Methods Between 2010 and 2017, 13858 lesions in 6350 patients were treated with DES (4393 BP-DES, 9465 DP-DES). The early-term (within 1 year) and late-term (from 1 to 2 years) follow-up angiographies were scheduled. Late catch-up phenomenon was defined as in-stent restenosis (ISR) in lesions that evaded ISR within 1 year after stent implantation. ISR was defined as angiographic restenosis of more than 50%. Results The mean patient age was 71 years, and 76.7% were male. Early-term angiographies were performed in 10955 lesions (79.0%). Of those without early-term ISR, late-term angiographies were performed in 7771 lesions (56.1%). The incidences of mid-term restenosis and late catch-up phenomenon were 6.6% and 3.9%, respectively. In the multivariate regression analyses, history of diabetes, hemodialysis and previous PCI were independent predictors of both early restenosis and late catch-up phenomenon. Also, some lesion characteristics such as chronic total occlusion, right coronary artery ostial lesion, small vessel (defined as reference diameter &lt;2.5mm), long lesion (defined as lesion length &gt;30mm) and treatment of ISR lesion were independent predictors of both early restenosis and late catch-up phenomenon. Bifurcation lesion and heavily calcified lesion treated with rotablator were independent risk of early restenosis. Bypass graft lesion was an independent predictor of late catch-up phenomenon. Early restenosis was observed less frequently in DP-DES than in BP-DES (6.3% versus 7.4%, P=0.012). On the contrary, late catch-up phenomenon was observed more frequently in DP-DES than in BP-DES (4.3% versus 2.9%, P=0.026). Conclusions Some lesion characteristics were independent predictors of early restenosis and late catch-up phenomenon after newer-generation DES implantation. The deployment of BP-DES resulted in more early restenosis and less late catch-up phenomenon compared to that of DP-DES. Early Restenosis and Late Catch-Up Funding Acknowledgement Type of funding source: None

3334Updated meta-analysis of biodegradable polymer drug-eluting stent versus second-generation durable polymer drug-eluting stent implantations

2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
J C Choe ◽  
K S Cha ◽  
J Y Shin ◽  
J Ahn ◽  
J S Park ◽  
...  
Keyword(s):  
Clinical Outcomes ◽  
Biodegradable Polymer ◽  
Cardiac Death ◽  
Second Generation ◽  
Meta Analysis ◽  
Coronary Intervention ◽  
Drug Eluting Stent ◽  
Landmark Analysis ◽  
Durable Polymer ◽  
Drug Eluting

Abstract Background Data regarding clinical outcomes of biodegradable polymer drug-eluting stent (BP-DES) versus second-generation durable polymer drug-eluting stent (DP-DES) in patients undergoing percutaneous coronary intervention (PCI) are inconclusive. Purpose We aimed to perform a meta-analysis to investigate the clinical outcomes of BP-DES compared with second-generation DP-DES in patients who have undergone PCI. Methods We searched PubMed, MEDLINE, EMBASE, and Cochrane databases through January 2019 for randomized controlled trials comparing BP-DES with second-generation DP-DES in patients treated with PCI. All-cause death, cardiac death, myocardial infarction (MI), target vessel revascularization (TVR), target lesion revascularization (TLR), definite/probable stent thrombosis (ST) were compared between the groups. Additionally, a landmark analysis with the landmark set at 1 year and a subgroup analysis according to stent characteristics were performed. Results Data from 23 trials including 28802 randomized patients were analyzed. At a median follow up of 3.1 years, no significant differences were found in terms of all-cause death (odds ratio [OR] 1.05, 95% confidence interval [CI] 0.95–1.16), cardiac death (OR 1.01, 95% CI 0.87–1.17), MI (OR 0.92, 95% CI 0.82–1.03), TVR (OR 0.97, 95% CI 0.86–1.11), TLR (OR 0.97, 95% CI 0.85–1.11), and definite/probable ST (OR 0.86, 95% CI 0.70–1.07) between the groups. Landmark analysis showed that there were similar risks in all-cause death (OR 1.04, 95% CI 0.93–1.17), cardiac death (OR 1.11, 95% CI 0.92–1.36), MI (OR 0.94, 95% CI 0.79–1.13), TVR (OR 0.95, 95% CI 0.73–1.23), TLR (OR 1.00, 95% CI 0.80–1.24), and definite/probable ST (OR 0.92, 95% CI 0.67–1.28) between the groups. The similar tendency of any study endpoints between the groups was consistent in the subgroup, including stent platform (stainless steel vs. alloy), the drug coating distribution (abluminal vs. circumferential), the polymer degradation period (<6 months vs. >6 months), or the drug release duration (<6 months vs. >6 months) of BP-DES, or the DAPT duration (≥6 months vs. ≥12 months). However, the uses of BP-DES with sirolimus-eluting (OR 0.84, 95% CI 0.72–0.98) or ultrathin strut (defined as <70μm; OR 0.81, 95% CI 0.68–0.97) were predictive for lower risk of MI. Clinical outcomes Conclusions In our updated meta-analysis, BP-DES implantation was associated with comparable clinical outcomes compared with second-generation DP-DES implantation. However, PCI with ultrathin biodegradable polymer sirolimus-eluting stent could reduce the risk of MI.

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