7-Year Outcomes of a Randomized Trial Comparing the First-Generation Sirolimus-Eluting Stent Versus the New-Generation Everolimus-Eluting Stent

Shiomi, Hiroki; Kozuma, Ken; Morimoto, Takeshi; Kadota, Kazushige; Tanabe, Kengo; Morino, Yoshihiro; Abe, Mitsuru; Takeji, Yasuaki; Suwa, Satoru; Ito, Yoshiaki; Kobayashi, Masakazu; Dai, Kazuoki; Nakao, Kōichi; Tarutani, Yasuhiro; Taniguchi, Ryoji; Nishikawa, Hideo; Yamamoto, Yorimasa; Nakagawa, Yoshihisa; Ando, Koji; Kobayashi, Koichi; Kawai, Kensuke; Hibi, Kiyoshi; Kimura, Takeshi; Investigators, Reset

doi:10.1016/j.jcin.2019.01.234

Cited by 25 publications

(16 citation statements)

References 13 publications

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“…1). The present frequency of MACE in impaired CEC group was similar to the Japanese large-scale multicenter RESET trial (approximately 20% to 23% in a 7-year follow-up) 16) . This frequency of MACE was several times higher than that of ASCVD, which ranged from approximately 2% to 4% at a 6-year clinical follow-up in the relatively lower values of CEC in healthy young subjects 4) .…”

Section: Advance Publication Journal Of Atherosclerosis and Thrombosissupporting

confidence: 82%

High-Density Lipoprotein Cholesterol Efflux Capacity as a Novel Prognostic Surrogate for Coronary Artery Disease

Hisauchi

Ishikawa

Ayaori

et al. 2021

JAT

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We examined the impact of baseline high-density lipoprotein cholesterol efflux capacity (CEC) on major cardiac adverse events (MACE) in patients with coronary artery disease (CAD) during a long-term secondary prevention. Method: CEC was measured using a cell-based efflux system in (3)[H]-cholesterol-labeled J774 macrophages in apolipoprotein B-depleted plasma between January 2011 and January 2013. Patients with CAD were divided into 2 groups as a boundary CEC value of 1: 0.19 ≤ CEC 1 (impaired CEC group, mean CEC of 0.76 0.16, n 136), and 1 ≤ CEC ≤ 2.08 (enhanced CEC group, 1.20 0.19, n 44). MACE, comprised the incidence of cardiac death, non-fatal myocardial infarction, and any revascularizations (RV) without restenosis approximately 1 year after vascularization, was retrospectively investigated at September 2019. Impact of enhanced CEC on MACE among 22 variables was examined by applying a Cox proportional hazard model. Result:The frequency of MACE in impaired CEC group (16.9%, mean observational interval of 2111 888 days) was significantly higher than that in enhanced CEC group (2.3%, 2,252 685, p 0.013), largely driven by the significantly higher RV incidence (14.0 % versus 2.3 %, p 0.032). Enhancement of CEC was the significant predictor of MACE (hazard ratio: 0.11; 95% CI: 0.013-0.879; p 0.038). Conclusion:A baseline CEC level of more than 1 in patients with CAD brought favorable long-term clinical outcomes, suggesting that CEC is a useful prognostic and therapeutic surrogate for secondary prevention of CAD.apy of LDL-C 1) . Among the pleiotropic atheroprotective effects of high-density lipoprotein cholesterol (HDL-C), cholesterol efflux from macrophage (cholesterol efflux capacity, CEC) was consistently demonstrated as a negative predictor of CAD, independent of HDL-C and LDL-C levels 2, 3) . In addition, the CEC in asymptomatic healthy subjects predicts the incidence of atherosclerotic cardiovascular events

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Section: Advance Publication Journal Of Atherosclerosis and Thrombosissupporting

confidence: 82%

High-Density Lipoprotein Cholesterol Efflux Capacity as a Novel Prognostic Surrogate for Coronary Artery Disease

Hisauchi

Ishikawa

Ayaori

et al. 2021

JAT

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“…Widespread use of second‐generation DES has resolved several clinical issues related to major adverse cardiac events. 12 , 13 , 14 In our cohort, the TLF was dominated by clinical indicated TLR and the annual incidence of late clinical indicated TLR beyond 5 years after X‐EES implantation remained at 0.67% per year; this rate is much lower than that reported by previous studies. 6 , 7 , 12 , 13 Serruys et al, based on intravascular ultrasound (IVUS) findings, have suggested that X‐EES is more effective in reducing neointimal hyperplasia than the first‐generation DES.…”

Section: Discussioncontrasting

confidence: 68%

Long‐term (beyond 5 years) clinical impact of Xience everolimus‐eluting stent implantation

Matsuda

Suzuki

2021

Health Science Reports

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Objects We aim at examining the long‐term clinical outcome after Xience everolimus‐eluting stent (X‐EES) implantation. Background Long‐term clinical outcomes beyond 5 years after X‐EES implantation remain unclear. Methods This retrospective study has collected data from 1184 consecutive patients, corresponding to 1463 lesions, who were treated with X‐EES alone in the Nagoya Heart Center between January 2010 and December 2013. The primary endpoint was the 10‐year cumulative incidence of target lesion failure (TLF), defined as cardiac death, target vessel myocardial infarction (MI), and clinically indicated target lesion revascularization (TLR). Definite/probable stent thrombosis (ST) was evaluated as a secondary outcome. Results At 10 years, the cumulative incidence of TLF was recorded to be 12.4%, whereas that of cardiac death, target vessel MI, and clinically indicated TLR was at 4.4%, 4.1%, and 7.8%, respectively. The cumulative rate of definite/probable ST was observed to remain low (0.3% at 30 days; 0.3% at 1 year; 0.6% at 5 years; and 1.1% at 10 years). In the multivariate analysis, the risk factors of TLF were insulin‐treated diabetes (hazard ratio (HR), 1.93; 95% confidence interval (CI), 1.13‐3.29; P = .02), left ventricular dysfunction (HR, 2.28; 95% CI, 1.43‐3.62; P < .01), hemodialysis (HR, 2.22; 95% CI, 1.39‐3.56; P < .01), prior percutaneous coronary intervention (HR, 1.68; 95% CI, 1.18‐2.41; P < .01), peripheral vascular disease (HR, 1.70; 95% CI, 1.07‐2.69; P < .01), severe calcification (HR, 2.08; 95% CI, 1.36‐3.09; P < .01), and in‐stent restenosis (HR, 2.93; 95% CI, 1.64‐4.89; P < .01). Conclusions The incidence rates of the long‐term adverse effects after X‐EES implantation, such as late TLR and ST, were determined to be low in this study; however, they increased over time until 10 years after stent implantation.

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“…However, this is in line with the findings of a large multicenter trial in Japan, which found that approximately 70% of patients who experienced major bleeding were on DAPT at the time of the event. 23 This low rate of persistent discontinuation of DAPT may have enhanced the difference in bleeding events between the HBR and non-HBR group. In addition, the rate of DAPT discontinuation did not differ between the HBR and non-HBR groups during the long follow-up period.…”

Section: Discussionmentioning

confidence: 99%

Academic Research Consortium for High Bleeding Risk Definitions for Early, Late, and Very Late Bleeding Events

Miura

Yuki

Okabe

et al. 2021

Circ J

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Background:The validity of the Academic Research Consortium for High Bleeding Risk (ARC-HBR) definitions of early (<1 year), late (1-4 years), and very late (>4 years) bleeding events is unknown. Methods and Results:This study was performed on patients (n=3,453) implanted with second-generation drug-eluting stents (DES) between 2010 and 2013. Data on all criteria of the ARC-HBR definition were collected retrospectively. The primary endpoint was Bleeding Academic Research Consortium Type 3 or 5 bleeding events; the ischemic endpoint was a composite of cardiac death, myocardial infarction, and ischemic stroke. The mean follow-up period was 7.5 years. Compared with non-high bleeding risk (HBR) patients, HBR patients (n=1,840; 53.3%) had an increased risk of the primary endpoint (early events, 3.6% vs. 0.5% [P<0.0001]; late events, 5.3% vs. 2.5% [P<0.0001]; very late events, 5.5% vs. 2.1% [P<0.0001]) and of ischemic events during follow-up. The discrimination ability of the ARC-HBR definition for late and very late bleeding events was comparable to that of early bleeding events (C statistics 0.679, 0.621, and 0.620, respectively) with high negative predictive value (96.6%, 95.1%, and 93.1%, respectively). Multivariate analysis revealed the different effects of individual criteria on bleeding events in each follow-up period. Conclusions:The ARC-HBR definition consistently identified patients at risk of long-term bleeding and ischemic events after second-generation DES implantation.

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7-Year Outcomes of a Randomized Trial Comparing the First-Generation Sirolimus-Eluting Stent Versus the New-Generation Everolimus-Eluting Stent

Cited by 25 publications

References 13 publications

High-Density Lipoprotein Cholesterol Efflux Capacity as a Novel Prognostic Surrogate for Coronary Artery Disease

High-Density Lipoprotein Cholesterol Efflux Capacity as a Novel Prognostic Surrogate for Coronary Artery Disease

Long‐term (beyond 5 years) clinical impact of Xience everolimus‐eluting stent implantation

Academic Research Consortium for High Bleeding Risk Definitions for Early, Late, and Very Late Bleeding Events

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