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 ◽  
...  

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.

Circulation ◽  
2020 ◽  
Vol 142 (Suppl_3) ◽  
Author(s):  
Koji Yamaguchi ◽  
Tetsuzo Wakatsuki ◽  
Tomonori Takahashi ◽  
Muneyuki Kadota ◽  
Yutaka Kawabata ◽  
...  

Background: We have previously demonstrated local persistent hypercoagulation after durable polymer (DP)-sirolimus-eluting stent (SES) implantation by measuring plasma prothrombin fragment 1+2 (F1+2) levels. The aim of this study is to evaluate local coagulative response after newer-generation ultrathin strut SES implantation. Method: Forty-five patients who were treated about 6-12 months earlier with coronary stenting, with no evidence of restenosis, were studied [DP-SES (Cypher): 26pts, biodegradable polymer (BP)-SES (older BP-SES, Ultimaster): 12pts and ultrathin strut BP-SES (newer BP-SES, Orsiro): 7pts]. 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 difference was observed in the percent diameter stenosis among DP-SES, older BP-SES, and newer BP-SES groups (10.1 ± 16.5 vs 13.1 ± 12.9 vs 12.1 ± 11.9 %). The ΔF1+2 was significantly lower in the BP-SES groups than in the DP-SES group (8.9 ± 10.1 vs 23.4 ± 21.1 pmol/l, p<0.05). The ΔF1+2 was lower in the newer BP-SES group than in the older BP-SES group, however, significant difference was not observed (7.0 ± 7.0 vs 9.7 ± 12.3 pmol/l). Conclusion: Suppressed local coagulative response after newer-generation ultrathin strut SES implantation was observed. These findings might indicate that lower strut thickness is more important factor than faster polymer resorption in the newer-generation DES era.


2021 ◽  
Vol 42 (Supplement_1) ◽  
Author(s):  
K Yamaguchi ◽  
T Wakatsuki ◽  
Y Okushi ◽  
K Suto ◽  
K Matsumoto ◽  
...  

Abstract Background Neointimal maturation after bioresorbable-polymer (BP) drug-eluting stent (DES) implantation will not be complete in the absorption phase of the polymer. 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 time-dependent local coagulative response after BP-DES implantation. Methods Sixty-four patients who were treated about ten months earlier with coronary angioplasty, with no evidence of restenosis, were studied [durable-polymer (DP)-DES {SES; Cypher®: 26pts and everolimus-eluting stent (EES); Xience®: 16pts} and BP-DES (BP-EES; Synergy®: 10pts and BP-SES; Ultimaster®: 12pts)]. We measured plasma levels of F1+2 sampled in coronary sinus (CS) and sinus of Valsalva (V) at the early (2±1 months) and chronic (10±2 months) phases. The transcardiac gradient (Δ) was defined as CS level minus V level. Results No significant differences were observed in the percent diameter stenosis between the DP- and BP- DES groups (11.5±15.5 vs 14.1±11.9%). The ΔF1+2 was significantly lower in the BP-DES group than in the DP-DES group at the chronic phase (7.5±16.1 vs 16.4±17.1pmol/l, p&lt;0.05). In the BP-DES group, the ΔF1+2 did not differ significantly between the early and chronic phases (7.0±14.1 vs 7.5±16.1pmol/l, NS). Conclusion Lower local coagulative response was observed at the chronic phase after BP-DES implantation compared to DP-DES implantation, and local hypercoagulation after BP-DES implantation was not observed at the early phase compared to the chronic phase. These findings might lead to the possibility of shorter dual antiplatelet therapy after BP-DES implantation. FUNDunding Acknowledgement Type of funding sources: None.


Circulation ◽  
2014 ◽  
Vol 130 (suppl_2) ◽  
Author(s):  
Koji Yamaguchi ◽  
Tetsuzo Wakatsuki ◽  
Akira Takashima ◽  
Mika Bando ◽  
Sachiko Bando ◽  
...  

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.


2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
S Okuno ◽  
T Ishihara ◽  
O Iida ◽  
M Asai ◽  
M Masuda ◽  
...  

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


2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
A Masumoto ◽  
M Ohya ◽  
R Murai ◽  
K Miura ◽  
T Shimada ◽  
...  

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


2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
J C Choe ◽  
K S Cha ◽  
J Y Shin ◽  
J Ahn ◽  
J S Park ◽  
...  

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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