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Chronic kidney disease (CKD) might be an important determinant in choosing percutaneous coronary intervention (PCI) and coronary artery bypass grafting (CABG). However, there is a scarcity of studies evaluating the effect of CKD on long-term outcomes after PCI relative to CABG in the population including severe CKD. Among 30257 consecutive patients patients who underwent first coronary revascularization with PCI or isolated CABG in the CREDO-Kyoto PCI/CABG registry Cohort-2 (n = 15330) and Cohort-3 (n = 14,927), we identified the current study population of 12,878 patients with multivessel or left main disease, and compared long-term clinical outcomes between PCI and CABG stratified by the subgroups based on the stages of CKD (no CKD: eGFR >=60 ml/min/1.73m2, moderate CKD: 60> eGFR >=30 ml/min/1.73m2, and severe CKD: eGFR

Objective According to population-based studies, low omega 3 fatty acid (omega3FA) intake and high levels of serum triacylglycerol (TAG) are associated with cardiovascular diseases. Recent advances in mass spectrometry allow molecular lipid (lipidomics) profiling, which may enhance cardiovascular risk prediction. In this study, we assessed the levels of omega3FA-containing phospholipids (PL) and TAG in myocardial tissues of patients with and without myocardial infarction (MI) using a lipidomics profiling method. Methods We performed lipidomics profiling of human left atrial appendage (LAA) tissue of 29 consecutive patients receiving off-pump coronary bypass surgery with standard LAA resection. The patients were divided into the MI group (n=7) and an age- and gender-matched non-MI group (n=7). Results Lipidomics profiling revealed that the MI group tended to have low levels of phosphatidylcholines (PC), phosphatidylethanolamine (PE), lysophosphatidylethanolamine (LPE), and plasmalogen, and high levels of TAG species. Individual molecular species containing omega3FA, such as PC (18:0/20:5; 3,200±1,200 vs. 4,500±910 pmol/g tissue, p=0.04) and plasmalogen (18:1/20:5; 57,000±21,000 vs. 91,000±28,000 pmol/g tissue, p=0.02), were significantly lower in the MI group than in the non-MI group. Conclusions To our knowledge, this is the first study to determine the levels of omega3FA-containing PL and TAG in myocardial tissue using lipidomics profiling. We discovered that lower levels of omega3FA-containing PL and higher levels of TAG existed in myocardial tissues of patients with MI than in those of patients without MI. Accordingly, the lipidomics profiling method for human myocardial tissue may be useful for developing therapy targets for cardiovascular diseases. Funding Acknowledgement Type of funding source: Public grant(s) – National budget only. Main funding source(s): MEXT/JSPS KAKENHI Grant

Background/Introduction; A rapid rule-out or rule-in protocol based on the 0-h/1-hour algorithm using high-sensitivity cardiac troponin T (hs-cTnT) is recommended by the European Society of Cardiology (ESC). Around 40–50% were stratified into “rule-out” group, and their 30-days prognosis was excellent. However, the one-year prognosis is uncertain. We aimed to better characterize these patients. Methods This study was a prospective, multi-center, observational study of patients with suspected non-ST elevation acute coronary syndrome (NSTE-ACS) admitted to 5 hospitals in Japan and Taiwan from 2014 November to 2018 December, respectively. All patients underwent a clinical assessment the included medical history, physical examination, 12-lead ECG, standard blood test, chest radiography. Exclusion criteria were ST elevated myocardial infarction, chronic kidney disease (serum creatinine more than 3 mg/dL) and congestive heart failure, arrhythmia, or infection disease. The patients were divided into three groups according to the algorithm; “rule-out”, “observe” and “rule-in”. The final diagnosis was then adjudicated by 2 independent cardiologists using all available information, including coronary angiography, coronary computed tomography, stress electrocardiography and follow-up data. The presence of acute myocardial infarction (AMI) was defined according to the Fourth Universal Definition of Myocardial Infarction. After hospital discharge patients were follow after one-year b telephone or in written form. Major adverse cardiovascular events (including death myocardial infarction, coronary artery bypass grafting, percutaneous coronary intervention (PCI)) were recorded by establishing contact with the patient and the family physicians. The primary prognosis end point was all-cause mortality. Results Of the 1,187 patients were analyzed after exclusion. The prevalence rate of AMI was 16.1%. According to the algorithm, 42% (n=493) of patients were assigned to “rule-out” group and had no AMI nor death. The most common final adjudicated diagnoses were atypical chest pain (80%), gallstone attack (3%) and vasospastic angina pectoris (2%). All patients with unstable angina (4.7%) underwent PCI. Conclusion(s) Our findings suggest that the “rule-out” group patients according to ESC 0-h/1-hour algorithm provides very high safety and efficacy for the triage toward AMI. Funding Acknowledgement Type of funding source: None

Long-term safety of percutaneous coronary intervention (PCI) as compared with coronary artery bypass grafting (CABG) is still controversial in patients with unprotected left main coronary artery disease (ULMCAD), and there is a scarcity of real-world data on the comparative long-term clinical outcomes between PCI and CABG for ULMCAD in new-generation drug-eluting stents era. The CREDO-Kyoto PCI/CABG registry Cohort-3 enrolled 14927 consecutive patients undergoing first coronary revascularization with PCI or isolated CABG between January 2011 and December 2013, and we identified 855 patients with ULMCAD (PCI: N = 383 [45%], and CABG: N = 472 [55%]). The primary outcome measure was all-cause death. Median follow-up duration was 5.5 (interquartile range: 3.9 to 6.6) years. The cumulative 5-year incidence of all-cause death was not significantly different between the PCI and CABG groups (21.9% vs 17.6%, Log-rank p = 0.13). After adjusting confounders, the excess risk of PCI relative to CABG remained insignificant for all-cause death (HR, 1.00; 95% CI, 0.68 to 1.47; p = 0.99). There were significant excess risks of PCI relative to CABG for myocardial infarction and any coronary revascularization (HR, 2.07; 95% CI, 1.30 to 3.37; p = 0.002, and HR, 2.96; 95% CI, 1.96 to 4.46; p0.001), whereas there was no significant excess risk of PCI relative to CABG for stroke (HR, 0.85; 95% CI, 0.50 to 1.41; p = 0.52). In conclusion, there was no excess long-term mortality risk of PCI relative to CABG, while the excess risks of PCI relative to CABG were significant for myocardial infarction and any coronary revascularization in the present study population reflecting real-world clinical practice in Japan.

Although B-type natriuretic peptide (BNP) has gradually gained recognition as an indicator in risk stratification for patients with acute myocardial infarction (AMI), the prognostic impact on long-term clinical outcomes in patients with non-ST-segment elevation acute myocardial infarction (NSTEMI) without creatine kinase (CK) elevation remains unclear.This prospective multicenter study assessed 3,283 consecutive patients with AMI admitted to 28 institutions in Japan between 2012 and 2014. We analyzed 218 patients with NSTEMI without CK elevation (NSTEMI-CK) for whom BNP was available. In the NSTEMI-CK group, patients were assigned to high- and low-BNP groups according to BNP values (cut-off BNP, 100 pg/mL). The primary endpoint was defined as a composite of all-cause death, non-fatal myocardial infarction, non-fatal stroke, cardiac failure, and urgent revascularization for unstable angina up to 3 years. Primary endpoints were observed in 60 (33.3%) events among patients with NSTEMI-CK. Kaplan-Meier analysis revealed a significantly higher event rate for primary endpoints among patients with high BNP (log-rank P0.001). After adjusting for covariates, a higher BNP level was significantly associated with long-term clinical outcomes in NSTEMI-CK (adjusted hazard ratio, 4.86; 95% confidence interval, 2.18-12.44; P0.001).The BNP concentration is associated with adverse long-term clinical outcomes among patients with NSTEMI-CK who are considered low risk. Careful clinical management may be warranted for secondary prevention in patients with NSTEMI-CK with high BNP levels.

The ultra-short dual antiplatelet therapy (DAPT) followed by P2Y

Background: A Japanese prospective, nation-wide, multicenter registry (J-MINUET) showed that long-term outcomes were worse in non-ST elevation acute myocardial infarction (NSTEMI), diagnosed by increased cardiac troponin levels, compared to STEMI. This was observed in both non-STEMI with elevated creatine kinase (CK) (NSTEMI+CK) and non-STEMI without elevated CK (NSTEMI-CK). However, predictive factors for long-term outcomes in STEMI, NSTEMI+CK, and NSTEMI-CK have not been elucidated. Methods: Using the Cox proportional hazards model, we determined significant independent predictors of long-term outcomes from a total of 111 parameters evaluated in the J-MINUET study in each of our groups, including STEMI, NSTEMI+CK, and NSTEMI-CK. Then, we calculated the risk score using the regression coefficients for the determined independent predictors for the strict prediction of long-term outcomes. Results: Prognostic factors, as well as composite cardiovascular events and all-cause death, were different between STEMI, NSTEMI+CK, and NSTEMI-CK. Risk scores could effectively and powerfully predict both composite cardiovascular events and all-cause death in each group. Conclusions: The prediction of long-term outcomes using cored parameters of baseline demographics and clinical characteristics is feasible and could prove useful in establishing therapeutic strategies in patients with STEMI, NSTEMI+CK, and NSTEMI-CK.

While prognoses in relation to myocardial infarction (MI) type have been elucidated in past reports, the results were not consistent, perhaps due to occurrence of Type 2 MI with CVS and its mortality. The Japanese registry of acute Myocardial Infarction diagnosed by Universal Definition (J-MINUET) is a prospective multicenter registry in Japan. In contrast to thromboembolic event-related Type 1 myocardial infarction (MI), clinical features of Type 2 MI, including coronary vasospasm (CVS), are varied due to the heterogeneous nature of its development. To elucidate the MI type-related all-cause mortality, 2989 consecutive patients with AMI were stratified as Type 1 MI, Type 2 MI with CVS, and Type 2 MI with non-CVS. Most patients (n = 2834, 94.8%) were classified as Type 1 MI and 155 patients (5.2%) were classified as Type 2 MI. Of the Type 2 MI patients, 87 (56% of Type 2 MI) were diagnosed as MI with CVS. Although the 3-year mortality was comparable between Type 1 and Type 2 MI patients, significant differences were observed between Type 2 MI with CVS and with non-CVS (3.4% and 22.1%, p &lt, 0.001). Among Japanese patients with AMI, mortality rates between Type 1 MI and Type 2 MI are comparable, but further stratification of Type 2 MI (with or without CVS) may be useful in predicting the prognosis of patients with Type 2 MI.

Discordant results have been reported on outcomes of acute myocardial infarction (AMI) patients who present during off-hours.We investigated 3283 consecutive patients with AMI who were selected from the prospective, nationwide, multicenter registry (J-MINUET) database comprising 28 institutions in Japan between July 2012 and March 2014 to determine the current impact of off-hours presentation (defined as weekends, holidays, and weekdays from 8:01 PM to 7:59 AM) at hospitals on long-term clinical outcomes. The primary endpoint was a composite of all-cause death, non-fatal MI, non-fatal stroke, cardiac failure, and urgent revascularization for unstable angina for up to 3 years from the index event.During off-hours, 52% of patients presented. Primary percutaneous coronary intervention was performed in 85% of patients, and the door-to-balloon time was comparable between off-hours and regular hours (74, interquartile range [IQR] 52 to 113 versus 75, IQR 52 to 126 minutes, P = 0.34). Rate of overall primary endpoint overall did not overall significantly differ (25.3% versus 23.5%, log-rank P = 0.26), in patients with ST-elevation myocardial infarction (STEMI) (log-rank P = 0.93) and in patients with non-ST-elevation myocardial infarction (NSTEMI) (log-rank P = 0.14). Multivariate Cox regression analysis showed that off-hours presentation was not significantly associated with long-term clinical events in all cohorts.The impact of presentation during off-hours or regular hours on the long-term clinical outcomes of Japanese patients with AMI is comparable in contemporary practice.

Background: The association between guideline adherence and long-term outcomes in patients with acute myocardial infarction in real-world clinical practice remains unclear. Methods: We investigated 3283 consecutive patients with acute myocardial infarction who were selected from a prospective, nation-wide, multicentre registry (J-MINUET) database covering 28 institutions in Japan between July 2012 and March 2014. Among the 2757 eligible patients, we evaluated the use of seven guideline-recommended therapies, including urgent revascularisation, door-to-balloon time of 90 minutes or less, and five discharge medications (P2Y12 inhibitors on aspirin, beta-blockers, angiotensin-converting enzyme inhibitors/angiotensin receptor blockers, statins, lipid-lowering drugs). The primary endpoint was a composite of all-cause death, non-fatal myocardial infarction, non-fatal stroke, cardiac failure and urgent revascularisation for unstable angina up to 3 years. Results: The overall median composite guideline adherence was 85.7%. Patients were divided into the following three groups: complete (100%) adherence group (n=862); moderate adherence (75% to Conclusion: The use of guideline-based therapies for patients with acute myocardial infarction in contemporary clinical practice was associated with significant decreases in adverse long-term clinical outcomes. Trial registration: UMIN Unique trial Number: UMIN000010037

Previous studies have demonstrated that use of intravascular ultrasound (IVUS) during percutaneous coronary intervention (PCI) was associated with lower incidence of death, myocardial infarction, and target vessel revascularization. Recently, optical coherence tomography (OCT) has emerged as an alternative intravascular imaging device with better resolution. The aim of this study was to investigate frequency and prognostic impact of IVUS or OCT-guided PCI during urgent revascularization for acute myocardial infarction diagnosed by the universal definition. A total of 2788 patients who underwent urgent PCI were selected from a multicenter, Japanese registry of acute myocardial infarction diagnosed by universal definition (J-MINUET). Frequency, clinical characteristics and prognostic impact of the IVUS-, or OCT- guided PCI were investigated. Clinical endpoint was in-hospital death. Angiography-, IVUS-, and OCT-guided urgent PCI were performed in 689 (24.7%), 1947 (69.8%), and 152 (5.5%) patients. In-hospital death in each group was 10.4%, 5.1%, and 3.3%, respectively (P

Although an elevated mean platelet volume (MPV) has been associated with poor clinical outcomes after acute coronary syndrome (ACS), the association between MPV and long-term outcomes in patients with stable coronary artery disease (CAD) remains uncertain. We aimed to investigate the impact of pre-procedural MPV levels in patients following elective percutaneous coronary intervention (PCI).We studied 2872 stable CAD patients who underwent their first PCI and who had available data on pre-procedural MPV between 2002 and 2016. Patients were divided into quartiles based on their MPV. The incidences of major adverse cardiac events (MACE), including all-cause death and non-fatal myocardial infarction, were evaluated.The median MPV was 10.4 fL (interquartile range: 9.8-11.0). During a median follow-up of 5.6 years, 498 (17.3%) MACE were identified, with a cumulative incidence significantly higher in the lowest MPV group than in other groups (p 0.01). After adjustment for platelet count and the other cardiovascular risk factors, the lowest MPV group had a significantly higher risk of MACE compared with the highest MPV groups (hazard ratio: 1.43, 95% confidence interval 1.10-1.86, p = 0.009). Decreasing MPV as a continuous variable was associated with the incidence of MACE (hazard ratio: 1.16 per 1 fL decrease, 95% confidence interval 1.04-1.30, p = 0.007).Contrary to previous studies on ACS patients, this study showed that a low MPV was associated with worse clinical outcomes among stable CAD patients.

It has been shown that the patency of an infarct-related artery (IRA) before primary percutaneous coronary intervention determines post-procedural success, better preservation of left ventricular function, and lower in-hospital mortality. However, the factors associated with pre-procedural Thrombolysis In Myocardial Infarction (TIMI) flow have not been fully investigated.The Japanese registry of acute Myocardial INfarction diagnosed by Universal dEfiniTion (J-MINUET) is a prospective multicenter registry conducted at 28 Japanese medical institutions between July 2012 and March 2014. We enrolled 3,283 consecutive patients with acute myocardial infarction who were admitted to a participating institution within 48 hours of symptom onset. There were 2,262 patients (68.9%) with ST-elevation myocardial infarction (STEMI), among whom 2,182 patients underwent emergent or urgent coronary angiography.Pre-procedural TIMI flow grade 3 was related to post-procedural TIMI flow grade 3 (P < 0.001), lower enzymatic infarct size (P < 0.001), lower ventricular tachycardia and ventricular fibrillation (P = 0.049), and lower in-hospital mortality (P = 0.020). A history of antiplatelet drug use was associated with pre-procedural TIMI flow.Antiplatelet drug use on admission was associated with pre-procedural TIMI flow. The patency of the IRA in patients with STEMI was related to procedural success and decreased enzymatic infarct size, fatal arrhythmic events, and in-hospital mortality.

Patients with peripheral artery disease (PAD) are at high risk of cardiovascular events, including myocardial infarction (MI), stroke, and cardiovascular death. However, the impact of PAD on prognosis in Japanese patients with acute MI remains unclear.The Japanese registry of acute Myocardial INfarction diagnosed by Universal dEfiniTion (J-MINUET) is a prospective multicenter registry that registered 3283 patients with acute MI. Among them, 2970 patients with available data of PAD were divided into the following 4 groups: 2513 patients without prior MI or PAD (None group), 320 patients with only prior MI (Prior MI group), 100 patients with only PAD (PAD group), and 37 patients with both previous MI and PAD (Both group). The primary endpoint was a composite of all-cause death, non-fatal MI, non-fatal stroke, cardiac failure, and urgent revascularization for unstable angina.The 3-year cumulative incidence of the primary endpoint was 26.9% in None group, 41.4% in Prior MI group, 48.0% in PAD group, and 60.3% in Both group (p 0.001). In multivariate analysis, hazard ratio using None group as reference was 1.55 (95% confidence intervals 1.25-1.91; p 0.001) for MI group, 2.26 (1.61-3.07; p 0.001) for PAD group, and 2.52 (1.52-3.90; p 0.001) for Both group.Concomitant PAD was associated with poor prognosis in Japanese patients with acute MI.

Previous studies have reported the prognostic value of objective nutritional indices such as the Controlling Nutritional Status (CONUT) score, Geriatric Nutritional Risk Index (GNRI) and Prognostic Nutritional Index (PNI). However, the effects of these indices in patients with coronary artery disease (CAD) who have undergone percutaneous coronary intervention (PCI) remain unclear. Furthermore, there are insufficient data to combine these indices. A total of 1984 patients who underwent elective PCI were enrolled. The Combined Objective Nutritional Score was determined by assigning 1 point each for high CONUT score (3–12), low GNRI (

It is unknown whether there is a threshold of creatine kinase (CK) or CK-MB affecting the subsequent mortality for post-discharge myocardial infarction (PDMI) after percutaneous coronary intervention. Current study sought to evaluate the impact of PDMI. The study population included 30,051 patients with successful coronary stenting and discharged alive in the pooled patient-level database of 4 Japanese studies (j-Cypher registry, CREDO-Kyoto PCI/CABG registry cohort-2, RESET, and NEXT). During 4.4 ± 1.4 year follow-up, 915 patients experienced PDMI (cumulative 5-year incidence of 3.6%). Among 466 patients with available peak CK ratio (peak CK/upper limit of normal), peak CK ratio (

Background and aims Low serum albumin level is reportedly associated with worse clinical outcomes in patients with chronic kidney disease (CKD). However, associations between decreased serum albumin level and outcomes in non-CKD patients with coronary artery disease (CAD) remain unclear. Therefore, we aimed to evaluate the prognostic value of serum albumin concentrations in stable CAD patients with preserved renal function. Methods and results We studied 1316 patients with CAD and preserved renal function (estimated glomerular filtration rate ≥60 mL/min/1.73 m 2 ) who underwent their first PCI between 2000 and 2011 and had data available for pre-procedural serum albumin. Patients were assigned to quartiles based on pre-procedural albumin concentrations. The incidence of major adverse cardiac events (MACE), including all-cause death and non-fatal myocardial infarction, was evaluated. Mean albumin concentration was 4.1 ± 0.4 g/dL. During the median follow-up of 7.5 years, 181 events occurred (13.8%). Kaplan–Meier curves revealed that patients with decreased serum albumin concentrations showed a higher event rate for MACE (log-rank, p 4.3 g/dL) as reference, adjusted hazard ratios were 1.97 (95% CI, 1.12–3.55), 1.77 (95% CI, 0.99–3.25), and 1.19 (95% CI, 0.68–2.15) for serum albumin concentrations of Conclusion Decreased serum albumin concentration independently predicted worse long-term prognosis in non-CKD patients after PCI. Pre-procedural serum albumin concentration could offer a useful predictor for patients with CAD and preserved renal function.

Background A rapid rule-out or rule-in protocol based on the 0-hour/1-hour algorithm using high-sensitivity cardiac troponin T is recommended by the European Society of Cardiology. However, Asian data are not available. Methods This prospective cohort study included 413 patients with suspected non-ST elevation myocardial infarction in 3 hospitals in Japan and Taiwan from November 2014 to April 2017. Patients were divided into 3groups—rule-out, observe, and rule-in—according to the algorithm. Major adverse cardiovascular events were evaluated at the 30-dayfollow-up. Results The algorithm ruled out acute myocardial infarction (AMI) in 171 patients with a negative predictive value and sensitivity of 100% (95% confidential interval [CI], 96.8%–100%) and 100% (95% CI, 88.0%–100%), respectively, in the rule-out group. None of the patients were diagnosed with AMI. Among the 127 patients classified into the rule-in group, 47 were diagnosed as having AMI. The positive predictive value and specificity were 33.1% (95% CI, 25.1%–41.9%) and 66.3% (95% CI, 60.2%–72.0%), respectively. Elective catheter intervention was required in 13 patients (5 in the rule-out group, 8 in the observe group) by the 30-dayfollow-up. The Framingham Risk Score (FRS) identified moderate risk in 5 patients and high risk in 8, while the Global Registry of Acute Coronary Events (GRACE) 2.0 risk score identified low risk in 6 patients and moderate risk in 7. Conclusion The ESC0-hour/1-hour algorithm could be sufficient in Asian patients. The combination with FRS may be more precise than that with the GRACE 2.0 risk score.

The association between patients with acute myocardial infarction (AMI) who present during off-hours and clinical outcomes has not been fully elucidated.We investigated 3283 consecutive patients with AMI who were selected from a prospective, nationwide, multicenter registry (J-MINUET) database comprising 28 institutions in Japan between July 2012 and March 2014 to determine the current impact of off-hours presentation on in-hospital mortality among Japanese patients with AMI.Among the patients, 52% presented in off-hours. Baseline characteristics were comparable, although those who presented during off-hours were younger and had a higher incidence of ST-elevation myocardial infarction and advanced Killip Class. The time from symptom onset to presentation time was shorter in off-hour patients (120min, interquartile range 60 to 256 vs. 215min, interquartile range 90 to 610, p0.0001). In contrast, 85% of patients underwent primary percutaneous coronary intervention (PCI) and door to balloon time was comparable between the groups (74min, interquartile range 52 to 113 vs. 75min, interquartile range 52 to 126, p=0.34). The rates of in-hospital mortality were comparable (6.2% vs 6.8%, p=0.39). Multivariate logistic regression analysis revealed that off-hours presentation was not significantly associated with in-hospital mortality [odds ratio (OR) 0.94; 95% CI, 0.68-1.30, p=0.70].The clinical impact of presenting during off-hours or regular hours on AMI patients in Japan is comparable in contemporary practice.UMIN Unique trial Number: UMIN000010037.

The ultra-short dual antiplatelet therapy (DAPT) followed by P2Y12 inhibitor monotherapy might be promising after percutaneous coronary intervention (PCI). However, CYP2C19 loss-of-function (LOF) alleles have been reported to diminish the effect of clopidogrel, and clopidogrel monotherapy has a concern about the increased ischemic risk for patients with such alleles. STOPDAPT-2 is the multicenter prospective open-label, but adjudicator-blinded randomized control study comparing 1-month DAPT followed by clopidogrel monotherapy with the standard 12-month DAPT after PCI with cobalt–chromium everolimus-eluting stents. Among the participants of STOPDAPT-2, selected patients participated in a substudy of the CYP2C19 gene test. Patients with two CYP2C19*2 or *3 alleles were defined as the poor metabolizer (PM), one allele as the intermediate metabolizer (IM), and no allele as the extensive metabolizer (EM). The primary endpoint was the composite of cardiovascular and bleeding events, as defined in STOPDAPT-2. Among 750 (24.9%) patients with known CYP2C19 genotypes, 129 (17.2%) were PM, 367 (49.0%) were IM, and 254 (33.9%) were EM. The hazard ratios of 1-month DAPT relative to 12-month DAPT for the primary endpoint in PM, IM, and EM strata were 0.66 (95% CI 0.11–3.94), 1.94 (95% CI 0.60–6.31), and 0.21 (95% CI 0.02–1.78), respectively (P interaction = 0.17), and those for cardiovascular composite endpoint were 1.00 (95% CI 0.14–7.10), 6.10 (95% CI 0.75–49.55), and 0.26 (95% CI 0.03–2.34), respectively (P interaction = 0.12). In conclusion, for the selected patients in STOPDAPT-2 trial, CYP2C19 LOF alleles had no significant, consistent interaction with the effect of 1-month DAPT relative to 12-month DAPT for clinical outcomes, although the study was overtly underpowered. STOPDAPT-2 ClinicalTrials.gov number, NCT02619760.

The ratio of serum eicosapentaenoic acid (EPA) to arachidonic acid (AA) is significantly associated with long-term clinical outcomes in patients with acute myocardial infarction (AMI). However, it has not been conclusively demonstrated that higher serum EPA/AA ratio fares better clinical outcomes in the early phase of AMI. The Japanese registry of acute Myocardial INfarction diagnosed by Universal dEfiniTion (J-MINUET) is a prospective multicenter registry conducted in 28 Japanese medical institutions between July 2012 and March 2014. We enrolled 3,283 consecutive AMI patients who were admitted to participating institutions within 48 h of symptom onset. A serum EPA/AA ratio was available for 629 of these patients. The endpoints were in-hospital mortality and major adverse cardiac events (MACE), defined as a composite of all cause death, cardiac failure, ventricular tachycardia (VT) and/or ventricular fibrillation (VF) and bleeding during hospitalization. Although similar rates of in-hospital mortality, cardiac failure, bleeding, and MACE were found in the lower serum EPA/AA group and higher serum EPA/AA group, the incidence of VT/VF during hospitalization was significantly higher in the low ratio group (p = 0.008). Receiver operating characteristic curve analysis showed that an EPA/AA ratio

Background Limited data exist regarding the association between symptom presentation of acute myocardial infarction (AMI) and in-hospital outcomes. Methods We analyzed data of the Japanese registry of acute Myocardial INfarction diagnosed by Universal dEfiniTion (J-MINUET). This was a prospective and multicenter registry consisting of 3085 AMI patients with available data of symptoms, who were hospitalized within 48 h from onset during July 2012 to March 2014. We defined typical symptoms as any of chest pain or pressure due to myocardial ischemia. Results Of this study population, 642 patients (20.8%) had atypical symptoms (atypical group) and the remaining 2443 patients (79.2%) showed typical symptoms (typical group). Compared to the typical group, the atypical group was associated with higher age, more females, hypertension, diabetes, chronic kidney disease, history of cardiovascular disease, non-ST elevation MI, and Killip class ≥2. In the atypical group, urgent percutaneous coronary intervention was less frequently performed than in the typical group, and in STEMI patients door-to-balloon time was longer in the atypical than typical group. Atypical group had larger infarct size than typical group. Furthermore, in-hospital mortality was significantly higher in atypical than in typical group (19.5% vs. 3.3%, p

Recently, malnutrition has been shown to be related to worse clinical outcomes in patients with heart failure. However, the association between nutritional status and clinical outcomes in patients with coronary artery disease (CAD) remains unclear. We investigated the prognostic value of malnutrition assessed by the Controlling Nutritional Status (CONUT; range 0–12, higher = worse, consisting of serum albumin, cholesterol and lymphocytes) score in patients with CAD. The CONUT score was measured on admission in a total of 1987 patients with stable CAD who underwent elective percutaneous coronary intervention (PCI) between 2000 and 2011. Patients were divided into two groups according to their CONUT score (0–1 vs. ≥2). The incidence of major adverse cardiac events (MACE), including all-cause death and non-fatal myocardial infarction, was evaluated. The median CONUT score was 1 (interquartile range 0–2). During the median follow-up of 7.4 years, 342 MACE occurred (17.2%). Kaplan–Meier curves revealed that patients with high CONUT scores had higher rates of MACE (log-rank p

Malnutrition has been identified as an important predictor of poor clinical outcomes in patients with heart failure. The aim of this study is to examine the prognostic impact of nutritional status in patients with coronary artery disease (CAD) who underwent percutaneous coronary intervention (PCI). The impact of nutrition, assessed using the geriatric nutritional risk index (GNRI) calculated by serum albumin and body mass index, was evaluated in 2,853 patients with CAD who underwent their first PCI between 2000 and 2011. Patients were assigned to tertiles based on their GNRI levels. The incidences of all-cause death and cardiac death were assessed. The median GNRI values were 101 (interquartile range 95 to 106). Lower GNRI levels were associated with older age and higher prevalence of acute coronary syndrome and chronic kidney disease. During the median follow-up period of 7.4 years, Kaplan-Meier curves showed ongoing divergence in rates of mortality among tertiles (GNRI98: 35.1%; 98 to 104: 20.6%; ≥104: 12.1%; log-rank p 0.0001). Stratification analysis by age also showed that the lowest GNRI tertile was associated with mortality in both patients65 years and those ≥65 years. After adjusting for established cardiovascular risk factors, lower GNRI was an independent predictor of all-cause death (hazard ratio 1.55 per 10 decrease, 95% confidence interval 1.30 to 1.84, p 0.0001) and cardiac death (hazard ratio 1.44, 95% confidence interval 1.08 to 1.90, p = 0.01). In conclusion, nutritional status was associated with long-term clinical outcomes in CAD patients after PCI. Evaluation of GNRI carries important prognostic information and may guide the therapeutic approach to such patients.

Epidemiological studies have demonstrated an association between low serum albumin levels and both coronary artery disease (CAD) and mortality. However, the long-term clinical impact of low serum albumin level in patients with CAD undergoing percutaneous coronary intervention (PCI) has not yet been fully investigated. We studied 2860 all-comer patients with CAD who underwent their first PCI and had data available for pre-procedural serum albumin between 2000 and 2011. Patients were assigned to tertiles based on pre-procedural albumin levels. We evaluated the incidence of major adverse cardiac events (MACE), including all-cause death and nonfatal myocardial infarction. Mean albumin level was 4.0 ± 0.5 g/dL. Lower albumin levels were associated with older age, lower body mass index (BMI), and higher prevalences of female sex, ACS and chronic kidney disease (CKD). During the median follow-up period of 7.4 years, Kaplan-Meier curves showed ongoing divergence in rates of MACE among albumin tertiles (albumin3.8 g/dl: 44.3% vs. 3.8-4.1 g/dl: 38.0% vs.4.1 g/dl: 22.9%; log-rank p 0.0001). After adjusting for established cardiovascular risk factors including age, acute coronary syndrome, BMI and CKD, serum albumin levels were significantly associated with incidence of MACE (HR 1.74 per 1-g/dl decrease, 95% CI 1.34-2.26, p 0.0001) and all-cause mortality (HR 1.74, 95% CI 1.30-2.33, p = 0.0002). Pre-PCI low serum albumin level was associated with worse long-term outcomes, independent of traditional risk factors. Assessing albumin levels may allow risk stratification in patients with CAD undergoing PCI.

High-sensitivity C-reactive protein (hs-CRP) has been used to predict the risk of adverse cardiac events in patients with coronary artery disease (CAD) after percutaneous coronary intervention (PCI). Less is known, however, about the association between hs-CRP and long-term outcome after PCI in the Japanese population.Methods and Results:We studied 3,039 all-comer patients with CAD who underwent their first PCI and had data available for preprocedural hs-CRP at Juntendo University between 2000 and 2011. Patients were assigned to tertiles based on preprocedural hs-CRP concentration. We evaluated the incidence of major adverse cardiac events (MACE) including all-cause death, acute coronary syndrome (ACS), and target vessel revascularization (TVR). Patients with higher hs-CRP had a higher prevalence of current smoking, chronic kidney disease and ACS, and a lower prevalence of statin use. During a median follow-up period of 6.5 years, ongoing divergence in MACE with hs-CRP tertile was noted on Kaplan-Meier curves (hs-CRP0.08 mg/L, 26.4%; 0.08-0.25 mg/L, 38.2%;0.25 mg/L, 45.6%; log-rank P0.001). After adjustment for established cardiovascular risk factors, hs-CRP was associated with higher incidence of MACE (hazard ratio [HR], 1.10; 95% CI: 1.04-1.16, P0.001) and higher all-cause mortality (HR, 1.14; 95% CI: 1.06-1.22, P0.001).Preprocedural hs-CRP measurement is clinically useful for long-term risk assessment in Japanese patients with established CAD and undergoing PCI.

Aims: Cardiovascular risk persists despite intensive lipid lowering therapy using statins. Serum levels of lipoprotein (a) [Lp(a)] can be a residual cardiovascular risk for adverse events. Aim of the present study was to evaluate the impact of Lp(a) on long-term clinical outcomes in patients treated with statin after percutaneous coronary intervention. Methods: We prospectively enrolled 3507 consecutive CAD patients who underwent a first percutaneous coronary intervention (PCI) between 1997 and 2011 at our institution. We identified 1768 patients (50.4%) who had treated with statin during PCI. Eligible 1336 patients were stratified to two groups according to Lp(a) levels (median Lp (a) 21.5 mg/dL). The primary outcome was major adverse cardiac events (MACE) including cardiac death and non-fatal acute coronary syndrome. Results: MACE occurred 144 (10.8%) including 34 (2.5%) cardiac death and 110 (8.7%) non-fatal ACS during median follow-up period of 1920 days. The cumulative rate of MACE was significantly higher in group with high Lp(a) group (log-rank p = 0.0460). Multivariate Cox regression analysis showed a significant correlation between Lp (a) levels treated as a natural logarithm-transformed continuous variable and increased MACE (adjusted HR for MACE 1.28, 95%CI 1.04–1.58, p = 0.0184) Conclusion: Elevated levels of Lp(a) is significantly associated with long-term adverse clinical outcomes among CAD patients who received statin therapy after PCI.

Patients with diabetes mellitus (DM) are at twofold to fourfold higher cardiovascular risk than those without DM. Serum levels of lipoprotein(a) (Lp(a)) can be risk factors for adverse events. However, the clinical implications of Lp(a) in patients with DM who underwent percutaneous coronary intervention (PCI) is unknown. The aim of the study was to determine the role of Lp(a) in patients with DM who underwent PCI. A total of 3,508 patients were treated by PCI from 1997 to 2011 at our institution. Among them, we analyzed consecutive 1,546 patients with DM. Eligible 1,136 patients were divided into 2 groups (high Lp(a) [n = 575] and low Lp(a) [n = 561]) by the median of Lp(a) levels. The number of chronic kidney disease, multivessel disease, and the level of LDL-C were higher in the group with high Lp(a) than with low Lp(a). The median follow-up period was 4.7 years. Event rate of all-cause death was same between the 2 groups (p = 0.37). However, cumulative incidence of cardiac death and acute coronary syndrome was significantly higher in the high Lp(a) than in the low Lp(a) group (p = 0.03). Multivariable analysis selected a high Lp(a) level as an independent predictor of cardiac death and acute coronary syndrome (hazard ratio 1.20; 95% confidence interval 1.00 to 1.42; p = 0.04). In conclusion, a high Lp(a) value could be associated with advanced cardiac events after PCI for patients with DM.

Background Reducing delay to percutaneous coronary intervention improves functional outcome and reduces long-term mortality. Transportation by helicopter is often quicker than ground transport and thus may improve overall prognosis through reduced ischemic injury and infarction size. Our hospital is located on the medically-depopulated peninsula surrounded by mountain. The journey from the southern tip of the peninsula to the critical care medical center of our hospital take 1.5 hour by a ground ambulance but only 15 minutes by helicopter. We compared the clinical characteristics and long-term mortality between air and ground transport of ACS patients for primary PCI. Methods We conducted an observational cohort study evaluating 2324 patients (mean age 68.5±12.0, male 75.2%) with ACS underwent primary PCI between April 2004 and December 2017 at our hospital. We divided into three groups according to transportation system type (air, ground, walk-in). The primary outcome was defined as all-cause death during the long-term follow-up. Results Among the entire cohort, 577 patients (24.8%) were transported by air. 1326 (57.1%) patients by ambulance, 421 (18.1%) patients by walk. Baseline characteristics were comparable, but patients by air had a higher prevalence of ST-elevation myocardial infarction. The rate of long-term mortality was comparable during the median follow up of 6 years (air, 21.1% vs. ground, 21.4% vs. walk-in, 21.1%, respectively, log-rank p=0.72). Multivariate Cox regression analysis showed no significant association between air transportation and long-term mortality (Adjusted HR [vs ground] 1.05, 95% CI 0.60–1.78, p=0.85 and [vs walk-in] 0.94, 95% CI 0.62–1.43, respectively, p=0.77). Kaplan-Meier curve Conclusions The rate of long-term mortality in patients with ACS transported by air was comparable with those transported by ground.

Background The European Society Cardiology guidelines recommend that a 0-hour/1-hour (0–1hr) algorithm using high sensitivity cardiac troponin T (hs-cTnT) improves the early triage of patients with suspected non-ST elevation acute coronary syndrome (NSTE-ACS). However, diagnostic uncertainty remains in the 25–30% of patients assigned to “observe” group. Purpose To establish a step wise risk score system using HEART score and 0-hour/1-hour algorithm to identify the low risk group from observation group. Methods This study was a prospective, multi-center, observational study of patients with suspected NSTE-ACS admitted to five hospitals in Japan and Taiwan from 2014 to 2018, respectively. We applied the algorithm and calculated HEART score simultaneously. Patients were divided into three groups according to the algorithm: hs-cTnT below 12 ng/L and delta 1 hour below 3 ng/L were the “rule out” group; hs-cTnT at least 52 ng/L or delta 1 hour at least 5 ng/L were in the “rule in” group; the remaining patients were classified as the “observe” group. All patients underwent a clinical assessment the included medical history, physical examination, 12-lead ECG, continuous ECG monitoring, pulse oximetry, standard blood test, chest radiography, cardiac and abdominal ultrasonography. Patients presenting with congestive heart failure, terminal kidney disease on hemodialysis state, arrhythmia, or infection disease (which causes to increase troponin level) were excluded. Thirty-day MACE was defined as acute myocardial infarction, unstable angina (UA), or death. Results Of the 1,332 patients enrolled, 933 patients were analyzed after exclusion. NSTE-ACS was the final diagnosis for 122 (13.1%) patients and none of death. The HEART score less than 4 points in observation groups identified as very low risk with a negative predictive value (NPV) of 98.1% (95% confidential interval (CI); 90.1%-100%) and sensitivity of 98.0% (95% CI; 89.6%-100%). There were only one patient (0.5%) with AMI. In case of the HEART score less than 5 points, it could also identify as very low risk with a NPV of 96.7% (95% CI; 90.8%-99.3%%) and sensitivity of 94.1% (95% CI; 83.8%-98.8%). There were only three patients (1.2%) with AMI. Conclusion A combination of HEART score and the 0-hour/1-hour algorithm strategy rapidly identified the patient in observation group of 30-day MACE including UA where nor further cardiac testing would be needed. Acknowledgement/Funding JSPS KAKENHI Grant Number JP18K09554

Background/Introduction Implementation of the 2015 ESC 0-hour/1-hour algorithm using high-sensitivity troponin (hs-cTn) T in Asian countries presents a challenge for clinical practice. Purpose We aimed to prospectively validate the 0-hour/1-hour algorithm in Asian countries. Methods We conducted a prospective, multi-center, international cohort already utilizing 0-hour/1-hour algorithm using hs-cTnT for evaluation of patients with suspected of non-ST elevation acute coronary syndrome (NSTE-ACS). All patients underwent a clinical assessment the included medical history, physical examination, 12-lead ECG, continuous ECG monitoring, pulse oximetry, standard blood test, chest radiography, cardiac and abdominal ultrasonography. Patients presenting with congestive heart failure, terminal kidney disease on hemodialysis state, arrhythmia, or infection disease (which cause to increase troponin level) were excluded. Patients were divided into three groups according to the algorithm: hs-cTnT below 12 ng/L and delta 1 hour below 3 ng/L were the “rule out” group; hs-cTnT at least 52 ng/L or delta 1 hour at least 5 ng/L were in the “rule in” group; the remaining patients were classified as the “observational” group. The final diagnosis was then adjudicated by 2 independent cardiologists using all available information, including coronary angiography, coronary computed tomography, stress electrocardiography and follow-up data. The presence of acute myocardial infarction (AMI) was defined according to the Fourth Universal Definition of Myocardial Infarction. Results Of the 1,332 patients enrolled in 2014 to 2018, 933 patients were analyzed after exclusion. AMI was the final diagnosis for 122 (13.1%) patients. The algorithm ruled out AMI in 401 patients with a negative predictive value and sensitivity of 100% (95% confidential interval [CI], 98.6%-100%) and 100% (95% CI, 94.0%-100%), respectively, in the rule-out group. None of the patients were diagnosed with AMI. Among the 211 patients classified into the rule-in group, 90 were diagnosed as having AMI. The positive predictive value and specificity were 43.1% (95% CI, 36.2%-50.2%) and 78.3% (95% CI, 74.5%-81.7%), respectively. The median length of hospital stay was 159 min (142–180) in rule out group. Conclusion(s) Our findings suggest that the 0-hour/1-hour algorithm using hs-cTnT provides very high safety and efficacy for the triage toward rapid rule-out to rule-in of AMI. Acknowledgement/Funding JSPS KAKENHI Grant Number JP18K09554

Background and objective A prior history of stroke is associated with increased adverse cardiovascular outcomes in patients with acute coronary syndrome (ACS), however the prognostic impact on long-term outcomes remains unclear. Methods We conducted an observational cohort study of ACS patients underwent primary percutaneous coronary intervention (PCI) between January 1999 and May 2015 at our hospital. The aim of the present study is to evaluate the overall prevalence and clinical impact of a history of stroke. The primary outcome was cardiac death during the median follow-up period of 5yrs. Results Among 2562 ACS patients of the current cohort, 268 patients (10.5%) had a history of stroke at the onset of ACS. The cumulative incidence of cardiac death was higher in patients with a history of stroke (11.4% vs. 19.7%, log-rank p Kaplan-Meier curve Conclusion Among ACS patients treated with primary PCI, a history of stroke was not rare and was associated with increased long term cardiac mortality.

Background Thrombolysis in Myocardial Infarction (TIMI) Risk Score for Secondary Prevention and CREDO-Kyoto Thrombotic Risk Score are contemporary secondary prevention risk scoring systems. However, these scoring systems have not been validated in other populations. Purpose The aim of this study was to validate of the TIMI Risk Score for Secondary Prevention and CREDO-Kyoto Thrombotic Risk Score in patients in the early phase of acute myocardial infarction (AMI). Methods The Japanese registry of acute Myocardial INfarction diagnosed by Universal dEfiniTion (J-MINUET) is a prospective multicenter registry conducted in 28 Japanese medical institutions. We enrolled 3,283 consecutive patients with AMI who were admitted to participating institutions within 48 hours of symptom onset between July 2012 and May 2014. Among them, 3,070 patients were included in this study after excluding 213 patients who died in the hospital. Clinical follow-up data were obtained up to 3 years. The primary endpoint was a composite of all-cause death, non-fatal MI and non-fatal stroke. The patients were stratified by the TIMI Risk Score for Secondary Prevention and CREDO-Kyoto Thrombotic Risk Score. Results At the 3-year follow-up, the primary endpoint had occurred in 337 patients (11.0%). All-cause death, non-fatal MI and non-fatal stroke had occurred in 177 (5.8%), 80 (2.6%) and 80 (2.6%) patients, respectively. TIMI Risk Score for Secondary Prevention and CREDO-Kyoto Thrombotic Risk Score showed a graded association with the composite of all-cause death, non-fatal MI and non-fatal stroke at 3 years in the J-MINUET population (Figure). Validation of atherothrombotic risk Conclusions TIMI Risk Score for Secondary Prevention and CREDO-Kyoto Thrombotic Risk Score were shown to be applicable to the patients in the early phase of AMI.

Background Cardiac troponin (cTn) is the preferred biomarker for the diagnosis of acute myocardial infarction (AMI). Octogenarians who presented cTn positive AMI are not usually recruited in clinical trials. Therefore, their clinical characteristics and prognosis are rarely investigated. Objective To study the characteristics and prognosis in octogenarians who presented cTn positive AMI. Methods and results The Japanese registry of acute Myocardial INfarction diagnosed by Universal dEfiniTion (J-MINUET) is a prospective and multicenter registry. A total of 3,283 consecutive AMI patients who were diagnosed by cTn-based criteria were included. The patients were divided into non-octogenarians (n=2,593) and octogenarians (n=690). Compared with non- octogenarians, octogenarians showed significantly lower incidence of diabetes mellitus (37.6% and 31.9%, p=0.006) and dyslipidemia (53.6% and 45.6%, p Conclusions J-MINUET showed the poor prognosis of octogenarians who were diagnosed as AMI based on cTn. Acknowledgement/Funding None

Background Intravascular ultrasound (IVUS) and Optical Coherence Tomography (OCT) has been widely used in clinical settings. Although favorable results of imaging-guided percutaneous coronary intervention (PCI) compared with angio-guided PCI were observed in several studies, impacts of institutional-based usage frequency, about imaging-guided PCI, have not been well elucidated. Methods To elucidate the impact of imaging-guided PCI and the effects of frequency of its usage, we analyzed data of the Japanese registry of acute Myocardial INfarction diagnosed by Universal dEfiniTion (J-MINUET). This was a prospective and multicenter registry consisting of 3,283 AMI patients, who were hospitalized within 48 hours of onset from July 2012 to March 2014. Clinical follow-up data was obtained for 3 years. In this sub-study, a total of 2,788 patients who underwent urgent PCI having detailed procedural information were enrolled. We analyzed the differences of utilization rates of imaging-guided PCI among the participating institutions and the impacts for the clinical events. The participating institutions were divided into 3 groups by the frequency of IVUS usage: low frequency institutions: under 50%; moderate frequency institutions: 50% to 90%; and, high frequency institutions: over 90%. Results In this cohort registry, patients were enrolled from 28 institutions. The utilization rate of coronary imaging varied widely depending on each institution from 15.4% to 100% (mean 85.7%±24.3, median 97.4%). When the institutions were divided into 3 groups by the frequency of intravascular imaging usage, four low frequency institutions enrolled 295 patients, five moderate frequency institutions enrolled 624 patients, and 19 high frequency institutions enrolled 1,491 patients. Although the incidence of MACE (death, MI, stroke, cardiac failure, or revascularization for unstable angina) decreased stepwise (33.2%, 23.7%, and 19.7%) (gray bar in the Figure), the event rates of the imaging-guided PCI cases among the 3 groups were comparable (21.6%, 21.9%, and 19.6%) (white bar in the Figure). On the other hand, a gradual event reduction between the 3 groups was observed in the angio-guided PCI cases (black bar in the Figure). In comparison of MACE rate between imaging-guided and angio-guided PCI, there were statistically significant differences in the low frequency and moderate frequency institutions (p=0.001 and p=0.012, respectively). In contrast, comparable event rates were observed in the high frequency institutions (p=0.441). MACE rate by imaging usage frequency Conclusions In Japanese ACS patients treated with imaging-guided PCI, better suppression of clinical events during 3-year was found in the institutions with the more frequent use of intravascular imaging, mainly due to stepwise event suppression in the cases of angio-guided PCI. On the other hand, the clinical benefit of coronary imaging was obtained independently of the frequency of use and its experience.

Background The CHADS2score has mainly been used to predict the likelihood of cerebrovascular accidents in patients with atrial fibrillation. However, increasing attention is being paid to this scoring system for risk stratification of patients with coronary artery disease. We investigated the value of the CHADS2 score in predicting cardiovascular events in Japanese acute myocardial infarction (AMI) patients without atrial fibrillation. Methods To elucidate the prognostic value of CHADS2score in AMI patients, we analysed data of the Japanese registry of acute Myocardial INfarction diagnosed by Universal dEfiniTion (J-MINUET). This was a prospective and multicenter registry consisting of 3,283 AMI patients, who were hospitalized within 48-hours of onset from July 2012 to March 2014. We calculated the CHADS2 scores for 3,044 patients without clinical evidence of atrial fibrillation. The presence of heart failure was substituted by Killip classification>2 on admission. Clinical follow-up data was obtained for 3 years. In addition to the in-hospital mortality,we evaluated cardiovascular events, defined as all cause deathor non-fatal MI during 3-year follow up periods. Results In this study, enrolled patients were classified into low- (point 0–1), intermediate- (point 2–3), and high-score (point 4–6) groups by calculating CHADS2 score. Overall patients with low, intermediate and high score were divided into 1,395, 1,393 and 256 patients, respectively. In-hospital mortality among low, intermediate, and high score groups were 2.8%, 7.4% and 14.8%, respectively (P Conclusion This large cohort study indicated that the CHADS2 score is useful for the prediction of in-hospital mortality and the cardiovascular events during 3-year follow up in Japanese AMI patients without atrial fibrillation.

Although high-sensitivity C-reactive protein (hs-CRP) has been used to predict the risk of adverse cardiac events in patients with coronary artery disease (CAD) after percutaneous coronary interventions (PCIs), little is known about the association between hs-CRP and long-term outcomes in patients with preserved renal function.Here, we studied 1,153 patients with stable CAD and preserved renal function (estimated glomerular filtration rate: > 60 mL/minute/1.73 m2) who underwent their first PCI between 2000 and 2011. Those with available data on preprocedural hs-CRP were included. Patients were assigned to tertiles according to preprocedural hs-CRP levels. The incidence of major adverse cardiac events (MACE), including all-cause death and nonfatal myocardial infarction, was evaluated. During a median follow-up period of 7.5 years, Kaplan-Meier curves showed ongoing divergence in the rates of MACE among the hs-CRP tertiles (hs-CRP 0.17 mg/L, 21.6%; log-rank P = 0.003). After adjusting for the established cardiovascular risk factors, hs-CRP levels were found to be associated with a higher incidence of MACE (hazard ratio [HR]: 3.65, 95% confidence interval [CI]: 1.77-7.07; P = 0.0008) and a higher rate of all-cause mortality (HR: 5.14, 95% CI: 2.38-10.30; P < 0.0001).In conclusion, this long-term registry showed that preprocedural hs-CRP measurement is clinically useful for long-term risk assessments in patients with stable CAD and preserved renal function.

Background A low 1,5-anhydro-d-glucitol (AG) blood level is considered a clinical marker of postprandial hyperglycemia. Previous studies reported that 1,5-AG levels were associated with vascular endothelial dysfunction and coronary artery disease (CAD). However, the association between 1,5-AG levels and coronary artery plaque in patients with CAD is unclear. Methods This study included 161 patients who underwent percutaneous coronary intervention for CAD. The culprit plaque characteristics and the extent of coronary calcification, which was measured by the angle of its arc, were assessed by preintervention intravascular ultrasound (IVUS). Patients with chronic kidney disease or glycosylated hemoglobin ≥ 7.0 were excluded. Patients were divided into 2 groups according to serum 1,5-AG levels ( 180°) (OR 2.64, 95% CI 1.10–6.29, p = 0.03). Conclusions Low 1,5-AG level, which indicated postprandial hyperglycemia, was associated with the severity of coronary artery calcification. Further studies are needed to clarify the effects of postprandial hyperglycemia on coronary artery calcification.

BACKGROUND Consciousness disturbance is one of the major clinical signs associated with shock state, but its prognostic value has not been previously evaluated in cardiovascular shock patients. We aimed to evaluate the prognostic value of neurological status for 30-day mortality in cardiovascular shock patients without out-of-hospital cardiac arrest (OHCA). Methods and Results: Patients with out-of-hospital onset cardiovascular shock were recruited from the Japanese Circulation Society Shock Registry. Neurological status upon hospital arrival was evaluated using the Japan Coma Scale (JCS). Patients were divided into 4 groups according to the JCS: alert, JCS 0; awake, JCS 1-3 (not fully alert but awake without any stimuli); arousable, JCS 10-30 (arousable with stimulation); and coma JCS 100-300 (unarousable). The primary endpoint was 30-day all-cause death. In total, 700 cardiovascular shock patients without OHCA were assessed. The coma group was associated with a higher incidence of 30-day all-cause death compared with other groups (alert, 15.3%; awake, 24.4%; arousable, 36.8%; coma, 48.5%, P

One-month duration of dual antiplatelet therapy (DAPT) has widely been adopted after bare-metal stent (BMS) implantation in the real clinical practice. However, it has not been adequately addressed yet whether DAPT for only 1-month could provide sufficient protection from ischemic events beyond 1-month after BMS implantation. We assessed the effects of short DAPT relative to prolonged DAPT on clinical outcomes with the landmark analysis at 2 month after BMS implantation. Among 13,058 consecutive patients enrolled in the CREDO-Kyoto registry cohort-2, this study population consisted of 4905 patients treated with BMS only in whom the information on the status of antiplatelet therapy was available at 2 month after stent implantation [single-antiplatelet therapy (SAPT) group: N = 2575 (acute myocardial infarction (AMI): N = 1257, and non-AMI: N = 1318), and DAPT group: N = 2330 (AMI: N = 1304, and non-AMI: N = 1026)]. Cumulative 3-year incidence of the primary outcome measure (a composite of cardiovascular death, myocardial infarction, stroke, definite stent thrombosis, and GUSTO moderate/severe bleeding) was not significantly different between the SAPT and DAPT groups (9.8 versus 10.6 %, P = 0.34). After adjusting confounders, the risk of SAPT relative to DAPT for the primary outcome measure remained insignificant in the entire cohort (HR 0.97, 95 % CI 0.79–1.19, P = 0.77), and in both AMI and non-AMI strata without any significant interaction between clinical presentation (AMI versus non-AMI) and the effect of SAPT relative to DAPT (P interaction = 0.56). In conclusion, short DAPT

Risk scores and cardiac biomarker tests allow clinicians to accurately diagnose acute coronary syndrome (ACS) and perform early risk stratification. However, few investigations have evaluated the use of these risk scores and biomarkers for predicting risk of cardiovascular events in drug-eluting stent (DES) era.This prospective cohort study included 861 patients with ACS. Three risk scores-Global Registry of Acute Coronary Events (GRACEs), Platelet glycoprotein IIb/IIIa in Unstable angina: Receptor Suppression Using Integrilin, and Thrombolysis In Myocardial Infarction-and levels of four biomarkers-N-terminal pro-B-type natriuretic peptide (NT pro-BNP), high-sensitivity troponin T, heart-fatty acid binding protein, and high-sensitivity C-reactive protein-were recorded on admission. Major adverse cardiac events (MACE) (death, cardiovascular events) were evaluated at 30-day and 1-year follow-up.At 30-day follow-up, there were 23 (3.1%) deaths from cardiovascular events and 4 (0.5%) cerebral accidents. NT pro-BNP levels and GRACE score were strong MACE predictors, with adjusted odds ratios (ORs) (95% CI) of 2.90 (1.63-5.20) and 1.01 (1.00-1.02), respectively, in logistic model. The C-statistic of NT pro-BNP (0.77; 95% CI, 0.67-0.86) was similar to that of GRACE score (0.76; 95% CI, 0.66-0.87); however, the combined C-statistic was higher (0.81), yielding a net reclassification improvement of 13% (p0.01). At 1-year follow-up, there were 51 (6.8%) deaths and 10 (1.3%) cerebral accidents.In the DES era, GRACE score and biomarkers can still predict major cardiac events in patients with ACS for both acute and long-term prognoses.

Acute coronary syndrome (ACS) is an important cause of mortality and morbidity in the general population. Recent advances in percutaneous coronary intervention (PCI) and optimal medical treatment have helped to improve the prognosis of patients with ACS. The previous reports indicated that women with ACS have a higher risk of adverse outcomes. However, sex differences in clinical outcomes with contemporary coronary revascularization and medical therapy for ACS have not been elucidated. We analyzed data from 676 consecutive patients with ACS (female, n = 166; male, n = 510) who were treated by emergency PCI between 2011 and 2014 at Juntendo Shizuoka Hospital. The patients were grouped according to sex. We defined major adverse cardiovascular events as a composite of all-cause death and ACS recurrence at 1 year and compared rates of major adverse cardiac events (MACE) between the groups. Women were older (75.4 ± 11.0 vs. 66.2 ± 12.2 years) and had a higher rate of multi-vessel disease, chronic kidney disease, and Killip IV at presentation. The cumulative rate of MACE at 1 year was significantly higher among women than men (17.5 vs. 10.2 %, p = 0.02, log-rank test). However, the association between women and a higher risk of MACE was attenuated after adjusting for age (HR 1.25, 95 % CI 0.77-2.00, p = 0.36) and other variables (HR 0.93, 95 % CI 0.36-2.44, p = 0.88). Adjustment for age and other risk factors attenuated sex differences in mid-term clinical outcomes among patients with ACS after emergency PCI.

Background Three-year clinical follow-up of patients with diabetes mellitus (DM) in the Japan-Drug Eluting Stents Evaluation; a Randomized Trial (J-DESsERT) using 2 different drug eluting stents (DES). A recent study demonstrated that efficacy of sirolimus eluting stents (SES) attenuated over time in diabetic patients. Methods In the largest trial of its kind, 1724 DM patients out of 3533 enrolled patients were randomized to either SES or paclitaxel eluting stents (PES). Results There were no significant differences in baseline clinical characteristics aside from hypertension. Incidence of major adverse cardiac cerebrovascular events (MACCE) mainly due to higher target vessel failure (TVF) initially indicated a benefit in SES (MACCE rate at 1year: SES 9.4%, PES 12.2%, p =0.08); however this had attenuated by the time of the 3-year follow-up (MACCE rate from 1 to 3years: SES 8.4%, PES 6.1%, p =0.10). A similar pattern was observed in insulin-treated patients: MACCE rate from 1 to 3years was 10.5% in SES and 6.4% in PES ( p =0.25). Angiographic follow-up also resulted in higher major adverse cardiac event (MACE) rates at 1year (presence 11.5%, absence 8.3%, p =0.04); however by 3years rates were similar regardless of the presence of angiographic follow-up (MACE rate at 3years: presence 16.0%, absence 14.5%, p =0.35). Conclusions The superiority of SES over PES in MACCE at 1year had attenuated by 3-year follow-up. Eventually, the 3-year safety and efficacy profiles were similar regardless of insulin treatment.

Background LR11, a member of LDL receptor family, is a novel marker of the proliferation of intimal smooth muscle cells (SMCs). LR11 is released in soluble form (sLR11) by proteolytic shedding and has biological activity toward SMC migration. We previously showed that circulating sLR11 positively correlates with carotid intima-medial thickness (IMT) independently of classical atherosclerotic risk factors and that it significantly associates with the severity of CAD. However, the association between sLR11 and long-term clinical outcomes remain uncertain. Methods and results This study included 438 consecutive patients (mean age, 65.8 ± 9.6 y; male, 82.4%) who underwent coronary intervention between March 2003 and December 2004 at our institution. The patients were assigned to quartiles according to pre-procedural sLR11 values. The primary endpoints were composite cardiovascular disease (CVD) endpoints including cardiovascular death, non-fatal acute coronary syndrome and non-fatal stroke. During median follow-up of 2876 days, composite CVD endpoints occurred 97 (22.1%) patients including 41 (9.4%) with cardiovascular disease (CVD)-related death, 36 (8.2%) non-fatal ACS and 20 (4.6%) non-fatal strokes. The hazard ratio (HR) for composite CVD endpoints significantly and dose-dependently increased with sLR11 levels (p for trend = 0.0077). A higher logarithm-transformed sLR11 value was associated with a greater risk of composite CVD endpoints, and the increased number of adverse long-term clinical outcomes persisted even after adjustment for other independent variables (HR 1.87 95%CI 1.02–3.31, p = 0.0435). Conclusions Elevated sLR11 levels were significantly associated with higher long-term adverse cardiac events in patients with CAD. Further extensive studies are expected to elucidate the mechanistic role of sLR11 and its clinical value as a prognostic marker in the development of atherosclerosis.

Background— Female sex was reported to be associated with lower risk for midterm restenosis and repeat revascularization after bare-metal stent implantation. However, the influence of sex on very long-term outcomes after bare-metal stent implantation has not been yet reported. Methods and Results— Among the 9877 patients in the multicenter Coronary Revascularization Demonstrating Outcome study in Kyoto (CREDO-Kyoto) registry cohort-1, bare-metal stent implantation was performed in 5313 patients (men, n=3742 and women, n=1571). Follow-up was completed in 4515 patients (85.0%) at 10 years (duration, 10.3±3.1 [0.0–14.1] years). The cumulative incidence of target-lesion revascularization (TLR) was 27% at 1 year and 34% at 10 years (0.8%/y beyond 1 year). Non–target-lesion revascularization (non-TLR) was the dominant coronary revascularization beyond 1 year (13% at 1 year and 31% at 10 years [2.0%/y beyond 1 year]). Cumulative incidence of stent thrombosis was low (1.2% at 1 year and 1.9% at 10 years). Women were older and had greater prevalence of cardiovascular risk factors than men. The cumulative 10-year incidences of and adjusted risk for TLR were significantly higher in men than in women (36% versus 30%, P P Conclusions— TLR and stent thrombosis continued to occur without attenuation up to 10 years after bare-metal stent implantation. Men in comparison with women were associated with higher adjusted 10-year risks for all-cause death, myocardial infarction, stroke, coronary artery bypass grafting, TLR, and non-TLR.

A 73-year-old male suddenly felt chest pain and nausea in his home. The fire department requested the dispatch of a physician-staffed helicopter. When the medical staff of the helicopter checked him, his 12-lead electrocardiogram showed ST elevation at the II, III, and aVF leads. After being fitted with pads for monitoring and defibrillation, he was transferred to the helicopter. Before landing at the base hospital a few minutes later, his electrocardiogram suddenly demonstrated ventricular fibrillation (VF). The patient received an electric shock. When the helicopter landed on the base hospital, he still showed VF. After being directly transferred to the catheter room, he received advanced cardiac life support with percutaneous cardiopulmonary support. A trans-arterial coronary angiogram revealed total occlusion of the right coronary artery. After recanalization of the occluded artery, he regained spontaneous circulation. He received intensive care, including targeted temperature management, and he regained consciousness and achieved social rehabilitation. We herein report the first case of VF safely treated with an electric shock during air evacuation by a rotary-wing aircraft in the English literature. Preparations in advance are necessary to perform electric shock safely during a flight aboard rotary-wing aircraft.

Background Suvorexant, an orexin receptor antagonist, is known as a safe and effective sleep medication. Many patients with heart failure (HF) have sleep-disordered breathing (SDB) and are short sleepers, and it is unknown whether suvorexant is effective in HF patients and can improve insomnia safely. The aim of this study is to examine the effect of suvorexant on SDB in patients with HF. Methods The Heart Failure with Insomnia and Suvorexant trial of Juntendo University Hospital and Juntendo Shizuoka Hospital (J-FLAVOR trial) is a multicenter trial with a randomized double crossover design. We will enroll a total of 30 HF patients treated in the Juntendo University Hospital and Juntendo Shizuoka Hospital. Eligible patients will undergo portable sleep monitoring twice with or without oral administration of suvorexant in a randomly assigned order. Before the study night, patients in the suvorexant first group will receive suvorexant for 4 consecutive days. There are at least 3 wash-out days between the study nights with and without suvorexant. Primary outcome measures of the non-inferiority trial of suvorexant include the apnea-hypopnea index and the severity of SDB, and the results will be compared between the study nights with and without suvorexant. Conclusion The present study can determine whether suvorexant can be used in HF patients without affecting their SDB. This is a pilot study to primarily assess whether suvorexant affects the severity of SDB in patients with HF. Therefore, further study is warranted to investigate whether suvorexant alters short- and long-term clinical outcomes by providing longer and better sleep in patients with HF.

The aim of this study was to compare 7-year outcomes between the first-generation sirolimus-eluting stent (SES) and the new-generation everolimus-eluting stent (EES) in a randomized clinical trial.There is a scarcity of very long-term (beyond 5 years) data from clinical trials investigating whether new-generation drug-eluting stents have clear clinical advantages over first-generation drug-eluting stents.RESET (Randomized Evaluation of Sirolimus-Eluting Versus Everolimus-Eluting Stent Trial) is the largest randomized trial comparing EES with SES (NCT01035450). Among a total of 3,197 patients in the original RESET population from 100 centers, the present extended 7-year follow-up study was conducted in 2,667 patients from 75 centers after excluding those patients enrolled from centers that denied participation. Complete 7-year follow-up was achieved in 91.5% of patients.The cumulative 7-year incidence of the primary efficacy endpoint of target lesion revascularization was not significantly different between EES and SES (10.2% vs. 11.7%; hazard ratio: 0.87; 95% confidence interval: 0.68 to 1.10; p = 0.24). The risk for the primary safety endpoint of death or myocardial infarction trended lower with EES than with SES (20.6% vs. 23.6%; hazard ratio: 0.85; 95% confidence interval: 0.72 to 1.005; p = 0.06). The cumulative 7-year incidence of definite stent thrombosis was very low and similar between EES and SES (0.9% vs. 1.0%; p = 0.82). The lower risk of EES relative to SES was significant for the composite secondary endpoint of target lesion failure (13.3% vs. 18.1%; hazard ratio: 0.72; 95% confidence interval: 0.59 to 0.88; p = 0.001).During 7 years of follow-up, the risk for target lesion revascularization was not significantly different between the new-generation EES and the first-generation SES.