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"Ishibashi, Yuki"
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A bioresorbable everolimus-eluting scaffold versus a metallic everolimus-eluting stent for ischaemic heart disease caused by de-novo native coronary artery lesions (ABSORB II): an interim 1-year analysis of clinical and procedural secondary outcomes from a randomised controlled trial
2015
Despite rapid dissemination of an everolimus-eluting bioresorbable scaffold for treatment for coronary artery disease, no data from comparisons with its metallic stent counterpart are available. In a randomised controlled trial we aimed to compare an everolimus-eluting bioresorbable scaffold with an everolimus-eluting metallic stent. Here we report secondary clinical and procedural outcomes after 1 year of follow-up.
In a single-blind, multicentre, randomised trial, we enrolled eligible patients aged 18–85 years with evidence of myocardial ischaemia and one or two de-novo native lesions in different epicardial vessels. We randomly assigned patients in a 2:1 ratio to receive treatment with an everolimus-eluting bioresorbable scaffold (Absorb, Abbott Vascular, Santa Clara, CA, USA) or treatment with an everolimus-eluting metallic stent (Xience, Abbott Vascular, Santa Clara, CA, USA). Randomisation was stratified by diabetes status and number of planned target lesions. The co-primary endpoints of this study are vasomotion (change in mean lumen diameter before and after nitrate administration at 3 years) and difference between minimum lumen diameter (after nitrate administration) after the index procedure and at 3 years. Secondary endpoints were procedural performance assessed by quantitative angiography and intravascular ultrasound; composite clinical endpoints based on death, myocardial infarction, and coronary revascularisation; device and procedural success; and angina status assessed by the Seattle Angina Questionnaire and exercise testing at 6 and 12 months. Cumulative angina rate based on adverse event reporting was analysed post hoc. This trial is registered at ClinicalTrials.gov, number NCT01425281.
Between Nov 28, 2011, and June 4, 2013, we enrolled 501 patients and randomly assigned them to the bioresorbable scaffold group (335 patients, 364 lesions) or the metallic stent group (166 patients, 182 lesions). Dilatation pressure and balloon diameter at the highest pressure during implantation or postdilatation were higher and larger in the metallic stent group, whereas the acute recoil post implantation was similar (0·19 mm for both, p=0·85). Acute lumen gain was lower for the bioresorbable scaffold by quantitative coronary angiography (1·15 mm vs 1·46 mm, p<0·0001) and quantitative intravascular ultrasound (2·85 mm2vs 3·60 mm2, p<0·0001), resulting in a smaller lumen diameter or area post procedure. At 1 year, however, cumulative rates of first new or worsening angina from adverse event reporting were lower (72 patients [22%] in the bioresorbable scaffold group vs 50 [30%] in the metallic stent group, p=0·04), whereas performance during maximum exercise and angina status by SAQ were similar. The 1-year composite device orientated endpoint was similar between the bioresorbable scaffold and metallic stent groups (16 patients [5%] vs five patients [3%], p=0·35). Three patients in the bioresorbable scaffold group had definite or probable scaffold thromboses (one definite acute, one definite sub-acute, and one probable late), compared with no patients in the metallic stent group. There were 17 (5%) major cardiac adverse events in the bioresorbable scaffold group compared with five (3%) events in the metallic stent group, with the most common adverse events being myocardial infarction (15 cases [4%] vs two cases [1%], respectively) and clinically indicated target-lesion revascularisation (four cases [1%] vs three cases [2%], respectively).
The everolimus-eluting bioresorbable scaffold showed similar 1-year composite secondary clinical outcomes to the everolimus-eluting metallic stent.
Abbott Vascular.
Journal Article
Response: Association between acute myocardial infarction-to-cardiac rupture time and in-hospital mortality risk—a retrospective analysis of multicenter registry data from the Cardiovascular Research Consortium-8 Universities (CIRC-8U)
by
Kihei Yoneyama
,
Yoshihiro J. Akashi
,
Yuki Ishibashi
in
Biomedical Engineering and Bioengineering
,
Cardiac Surgery
,
Cardiology
2022
Journal Article
Effects of temperature and humidity on acute myocardial infarction hospitalization in a super-aging society
2021
Weather conditions affect the incidence of acute myocardial infarction (AMI). However, little is known on the association of weather temperature and humidity with AMI hospitalizations in a super-aging society. This study sought to examine this association. We included 87,911 consecutive patients with AMI admitted to Japanese acute-care hospitals between April 1, 2012 and March 31, 2015. The primary outcome was the number of AMI hospitalizations per day. Multilevel mixed-effects linear regression models were used to estimate the association of the average temperature and humidity, 1 day before hospital admission, with AMI hospitalizations, after adjusting for weather, hospital, and patient demographics.Lower temperature and humidity were associated with an increased number of AMI hospitalizations (coefficient − 0.500 [− 0.524 to − 0.474] per °C change,
p
< 0.001 and coefficient − 0.012 [− 0.023 to − 0.001] per % change,
p
= 0.039, respectively). The effects of temperature and humidity on AMI hospitalization did not differ by age and sex (all interaction p > 0.05), but differed by season. However, higher temperatures in spring (coefficient 0.089 [0.025 to 0.152] per °C change,
p
= 0.010) and higher humidity in autumn (coefficient 0.144 [0.121 to 0.166] per % change,
p
< 0.001) were risk factors for AMI hospitalization. Increased average temperatures and humidity, 1 day before hospitalization, are associated with a decreased number of AMI hospitalizations.
Journal Article
Weather temperature and the incidence of hospitalization for cardiovascular diseases in an aging society
by
Miyamoto, Yoshihiro
,
Tanabe, Yasuhiro
,
Yasuda, Satoshi
in
692/4019
,
692/4019/592
,
692/4019/592/75
2021
Weather temperatures affect the incidence of cardiovascular diseases (CVD), but there is limited information on whether CVD hospitalizations are affected by changes in weather temperatures in a super-aging society. We aimed to examine the association of diurnal weather temperature changes with CVD hospitalizations. We included 1,067,171 consecutive patients who were admitted to acute-care hospitals in Japan between April 1, 2012 and March 31, 2015. The primary outcome was the number of CVD hospitalizations per day. The diurnal weather temperature range (DTR) was defined as the minimum weather temperature subtracted from the maximum weather temperature on the day before hospitalization. Multilevel mixed-effects linear regression models were used to estimate the association of DTR with cardiovascular hospitalizations after adjusting for weather, hospital, and patient demographics. An increased DTR was associated with a higher number of CVD hospitalizations (coefficient, 4.540 [4.310–4.765]/°C change,
p
< 0.001), with greater effects in those aged 75–89 (
p
< 0.001) and ≥ 90 years (
p
= 0.006) than among those aged ≤ 64 years; however, there were no sex-related differences (
p
= 0.166). Greater intraday weather temperature changes are associated with an increased number of CVD hospitalizations in the super-aging society of Japan, with a greater effect in older individuals.
Journal Article
Association of PM2.5 exposure with hospitalization for cardiovascular disease in elderly individuals in Japan
by
Takumi Higuma
,
Masaki Izumo
,
Mika Watanabe
in
692/4019/592
,
692/700/478/174
,
Cardiovascular disease
2021
Although exposure to particulate matter with aerodynamic diameters ≤ 2.5 µm (PM
2.5
) influences cardiovascular disease (CVD), its association with CVD-related hospitalizations of super-aged patients in Japan remains uncertain. We investigated the relationship between short-term PM
2.5
exposure and CVD-related hospitalizations, lengths of hospital stays, and medical expenses. We analyzed the Japanese national database of patients with CVD (835,405) admitted to acute-care hospitals between 2012 and 2014. Patients with planned hospitalizations and those with missing PM
2.5
exposure data were excluded. We classified the included patients into five quintiles based on their PM
2.5
exposure: PM-5, -4, -3, -2, and -1 groups, in descending order of concentration. Compared with the PM-1 group, the other groups had higher hospitalization rates. The PM-3, -4, and -5 groups exhibited increased hospitalization durations and medical expenses, compared with the PM-1 group. Interestingly, the hospitalization period was longer for the ≥ 90-year-old group than for the ≤ 64-year-old group, yet the medical expenses were lower for the former group. Short-term PM
2.5
exposure is associated with increased CVD-related hospitalizations, hospitalization durations, and medical expenses. The effects of incident CVDs were more marked in elderly than in younger patients. National PM
2.5
concentrations should be reduced and the public should be aware of the risks.
Journal Article
Prognostic nutritional index in risk of mortality following fulminant myocarditis
2025
Fulminant myocarditis (FM) is an acute fatal inflammation disease, but its chronic phase is unclear. A Japanese nationwide registry evaluated the long-term mortality in FM patients using a prognostic nutritional index (PNI). The retrospective cohort study included patients with clinically suspected or histologically proven FM available for PNI. PNI was assessed on admission and at discharge. We divided patients into two groups based on PNI at discharge (PNI ≤ 40 or PNI > 40) and analyzed the change in PNI and mortality between the groups. Of 323 patients (the median [first-third quartiles] age of this cohort was 50 [37–64] years, and 143 [44%] were female), PNI ≤ 40 at discharge was in 99 (31%) patients. The median PNI in all patients increased from 41 (36– 46) on admission to 43 (39–48) at discharge (P < 0.0001). Patients with PNI ≤ 40 had a lower event-free rate of death or rehospitalization with cardiovascular causes than those with PNI > 40 (log-rank P = 0.0001). When the PNI at discharge, age, sex, left ventricular ejection fraction, and Barthel index were evaluated in a multivariable Cox regression analysis, PNI ≤ 40 had an independent association with the death or rehospitalization with cardiovascular causes (hazard ratio, 2.14 [95% confidence interval, 1.14–4.01]; P = 0.0191). One-third of FM patients with low PNI at discharge had a higher risk of mortality than those with high PNI in the chronic phase. This study provokes clinical insight into the phenotype of chronic inflammation in FM and optimal follow-up management with low PNI.
Journal Article
Association between acute myocardial infarction-to-cardiac rupture time and in-hospital mortality risk: a retrospective analysis of multicenter registry data from the Cardiovascular Research Consortium-8 Universities (CIRC-8U)
by
Hideaki Yoshino
,
Ken Kozuma
,
Keiki Sugi
in
Aged
,
Angioplasty
,
Biomedical Engineering and Bioengineering
2021
Despite the known association of cardiac rupture with acute myocardial infarction (AMI), it is still unclear whether the clinical characteristics are associated with the risk of in-hospital mortality in patients with AMI complicated by cardiac rupture. The purpose of this study was to investigate the association between the time of cardiac rupture occurrence and the risk of in-hospital mortality after AMI. We conducted a retrospective analysis of multicenter registry data from eight medical universities in Eastern Japan. From 10,278 consecutive patients with AMI, we included 183 patients who had cardiac rupture after AMI, and examined the incidence of in-hospital deaths during a median follow-up of 26 days. Patients were stratified into three groups according to the AMI-to-cardiac rupture time, namely the > 24-h group (
n
= 111), 24–48-h group (
n
= 20), and < 48-h group (
n
= 52). Cox proportional hazards regression analysis was used to estimate the hazard ratio (HR) and the confidence interval (CI) for in-hospital mortality. Around 87 (48%) patients experienced in-hospital death and 126 (67%) underwent a cardiac surgery. Multivariable Cox regression analysis revealed a non-linear association across the three groups for mortality (HR [CI]; < 24 h: 1.0, reference; 24–48 h: 0.73 [0.27–1.86]; > 48 h: 2.25 [1.22–4.15]) after adjustments for age, sex, Killip classification, percutaneous coronary intervention, blood pressure, creatinine, peak creatine kinase myocardial band fraction, left ventricular ejection fraction, and type of rupture. Cardiac surgery was independently associated with a reduction in the HR of mortality (HR [CI]: 0.27 [0.12–0.61]) and attenuated the association between the three AMI-to-cardiac rupture time categories and mortality (statistically non-significant) in the Cox model. These data suggest that the AMI-to-cardiac rupture time contributes significantly to the risk of in-hospital mortality; however, rapid diagnosis and prompt surgical interventions are crucial for improving outcomes in patients with cardiac rupture after AMI.
Journal Article
Effects of temperature and humidity on cerebrovascular disease hospitalization in a super-aging society
2023
Weather conditions influence the incidence of cardiovascular disease. However, few studies have investigated the association between weather temperature and humidity and cerebrovascular disease hospitalizations in a super-aging society. We included 606,807 consecutive patients with cerebrovascular disease admitted to Japanese acute-care hospitals between 2015 and 2019. The primary outcome was the number of cerebrovascular disease hospitalizations per day. Multilevel mixed-effects linear regression models were used to estimate the association of mean temperature and humidity, 1 day before hospital admission, with cerebrovascular disease hospitalizations, after adjusting for air pollution, hospital, and patient demographics. Lower mean temperatures and humidity < 70% or humidity ≧ 70% are associated with an increased incidence of cerebrovascular disease hospitalization (coefficient, − 1.442 [− 1.473 to − 1.411] per °C,
p
< 0.001, coefficient, − 0.084 [− 0.112 to − 0.056] per%,
p
< 0.001, and coefficient, 0.136 [0.103 to 0.168] per %,
p
< 0.001, respectively). Lower mean temperatures and extremely lower or higher humidity are associated with an increased incidence of cerebrovascular disease hospitalization in a super-aging society.
Journal Article
Treatment of long COVID complicated by postural orthostatic tachycardia syndrome—Case series research
by
Ohira, Yoshiyuki
,
Hirose, Masanori
,
Akashi, Yoshihiro
in
Cardiac arrhythmia
,
Chronic fatigue syndrome
,
COVID-19
2024
Background Coronavirus disease 2019 (COVID‐19) sequelae, also known as long COVID, can present with various symptoms. Among these symptoms, autonomic dysregulation, particularly postural orthostatic tachycardia syndrome (POTS), should be evaluated. However, previous studies on the treatment of POTS complicated by COVID‐19 are lacking. Therefore, this study aimed to investigate the treatment course of long COVID complicated by POTS. Methods The medical records of patients who complained of fatigue and met the criteria for POTS diagnosis were reviewed. We evaluated the treatment days, methods and changes in fatigue score, changes in heart rate on the Schellong test, and social situation at the first and last visits. Results Thirty‐two patients with long COVID complicated by POTS were followed up (16 males; median age: 28 years). The follow‐up period was 159 days, and the interval between COVID‐19 onset and initial hospital attendance was 97 days. Some patients responded to β‐blocker therapy. Many patients had psychiatric symptoms that required psychiatric intervention and selective serotonin reuptake inhibitor prescription. Changes in heart rate, performance status, and employment/education status improved from the first to the last visit. These outcomes were believed to be because of the effects of various treatment interventions and spontaneous improvements. Conclusions Our study suggests that the condition of 94% of patients with POTS complicated by long COVID will improve within 159 days. Therefore, POTS evaluation should be considered when patients with long COVID complain of fatigue, and attention should be paid to psychological symptoms and the social context. Long COVID can present with various symptoms. Among these symptoms, autonomic dysregulation, particularly postural orthostatic tachycardia syndrome should be evaluated. This study aimed to investigate the treatment course of long COVID complicated by POTS.
Journal Article
Imaging characteristics and clinical outcomes of hemodialysis vs. non-hemodialysis patients undergoing transcatheter aortic valve replacement: a Japanese single-center experience
2025
In 2021, Japan approved transcatheter aortic valve replacement (TAVR) for end-stage renal disease patients on hemodialysis (ESRD-HD). Yet, clinical/anatomical differences and outcomes between patients with and without ESRD-HD remain underexplored. This single-center study enrolled consecutive patients who underwent TAVR with the SAPIEN 3 between 2021 and 2023. Baseline characteristics and outcomes up to 1 year were compared. Inverse probability treatment weighting (IPTW) approach and Cox regression were used. Among 287 eligible patients, 59 had ESRD-HD. Patients with ESRD-HD were predominantly male (59.2% vs. 40.7%;
p
= 0.01), younger (78.0 [73.5–83.5] vs. 84.0 [79.8–88.0]; < 0.001), with lower body mass index (21.4 [19.6–23.3] vs. 22.9 [20.3–25.3];
p
= 0.02], higher surgical risk (Society of Thoracic Surgeons Predicted Risk of Mortality ≧8%: 28 [47.5%] vs. 34 [14.9%];
p
< 0.001), and more peripheral artery disease (25.4% vs. 4.8%;
p
< 0.001). Patients with ESRD-HD had a significantly higher prevalence of severely calcified femoral arteries (12.5% vs. 2.6%;
p
< 0.001). However, there were no differences in the computed-tomographic (CT) anatomical characteristics of the aortic valve complex (AVC), including the aortic valve calcium score (1995 [1372–3374] vs. 2195 [1380–3172];
p
= 0.65) or the presence of moderate or severe left ventricular outflow tract calcification (4.3% vs. 5.2%;
p
> 0.99). Major vascular complications were rare, and technical (98.3% vs. 98.7%;
p
> 0.99) and device success (75.9% vs. 82.4%;
p
= 0.26) rates were high in both. At 1 year, there were no significant differences in a composite endpoint of death, stroke, major bleeding, or myocardial infarction (32.4% vs. 33.2%; HR 1.12; 95% CI 0.45–2.80;
p
= 0.81), nor its components after baseline adjustment.
Journal Article