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Aim Matrix metalloproteinases (MMPs) play critical roles in acute myocardial infarction (AMI). This trial was conducted to determine the potential effects of higher-dose rosuvastatin on circulating MMP levels in patients with AMI. Methods This was a multicenter, open-label, 1:1 randomized, parallel-group study. Patients with AMI were randomly assigned to the appropriate-dose group (10 mg rosuvastatin once daily) or the low-dose group (2.5 mg rosuvastatin once daily) within 24 hours after percutaneous coronary intervention. MMP-2 and MMP-9 levels were measured on day 1 and at week 4, 12, and 24 after enrollment. The primary endpoint was the change in MMP levels at 24 weeks after enrollment. The secondary endpoints were change in MMP levels at day 1 and weeks 4 and 12 after enrollment. Results Between August 2017 and October 2018, 120 patients with AMI from 19 institutions were randomly assigned to either the appropriate-dose or the low-dose group. There were 109 patients who completed the 24-week follow-up. The primary endpoint for both MMP-2 and MMP-9 was not significantly different between the two groups. The change in the active/total ratio of MMP-9 at week 12 after baseline was significantly lower in the appropriate-dose group compared with the low-dose group (0.81 [-52.8-60.1]% vs. 70.1 [-14.5-214.2]%, P=0.004), while the changes in MMP-2 were not significantly different between the two groups during the study period. Conclusions This study could not demonstrate the superiority of appropriate-dose of rosuvastatin in inhibiting serum MMPs levels in patients with AMI.

Ivabradine increases stroke volume, but does not have a negative impact on blood pressure (BP). Thus, a patient with low BP can benefit from treatment with ivabradine. A 72-year-old Japanese woman with asthma and chronic bronchitis presented with dyspnea. Her heart rate (HR) was 126 beats per minute and an electrocardiogram showed sinus tachycardia. The chest X-ray showed cardiomegaly and pulmonary congestion. A transthoracic echocardiogram (TTE) showed reduced left ventricular ejection function (LVEF) and severe functional mitral regurgitation (MR). We diagnosed her with inappropriate sinus tachycardia (IST) and heart failure (HF) due to tachycardia-induced cardiomyopathy. After resolving the pulmonary congestion with diuretics, we administered a minimum dose of bisoprolol, which resulted in re-exacerbation of the HF. Because IST was persistent, we initiated treatment with ivabradine. As soon as ivabradine was started, the HR decreased, the BP gradually increased, and HF compensation was achieved. Bisoprolol was continued and losartan was started. In summary, we used ivabradine for a patient with tachycardia, low BP, a low LVEF, and severe MR. By optimizing the medical therapy, exercise tolerance improved and she was discharged. The serum brain natriuretic peptide was significantly reduced and TTE showed an improved LVEF and reduced MR.

Localization of the esophagus and the left atrium (LA) posterior wall thickness (LAPWT) should be taken into account when delivering radiofrequency energy. To validate the visualization of the esophagus and analyze LAPWT by ICE advanced into the LA in patients with atrial fibrillation (AF) undergoing ablation index (AI)-guided pulmonary vein (PV) isolation. In 73 patients (mean age, 68 ± 12; paroxysmal AF in 45), a 3-dimensional (3D) esophagus image was created with CARTO SoundstarⓇ and its location was compared with contrast esophagography saved in Carto UNIVU™. LAPWT adjacent to the esophagus was measured at 4 levels: left superior PV (LSPV), intervenous carina (IC), left inferior PV (LIPV), and LIPV bottom. A target AI value was 260 (25 W power) on the esophagus demonstrated by ICE. All patients had the esophagus posterior to the left PV antrum. Creating a 3D esophagus and measurement of LAPWT with ICE was done without any complications. ICE esophagus image was completely overlapped with contrast esophagography. LAPWT (mm) was 2.8 (interquartile range, 2.5–3.2), 2.2 (1.9–2.5), 1.9 (1.8–2.1), and 2.1 (1.9–2.4) for LSPV, IC, LIPV, and LIPV bottom, respectively, while LA roof thickness was 3.2 (2.9–3.6) (P

Background: The impact of high-power radiofrequency (RF) application in ablation index (AI)-guided atrial fibrillation (AF) ablation has not been elucidated. Methods and Results: We investigated 1,333 patients undergoing first AF ablation (median age 68 years; interquartile range [IQR] 61–73 years). The first 301 patients underwent AI-guided conventional power RF application (CP group), whereas the following 1,032 patients underwent high-power RF application (HP group). The minimum AI target values were 400, 360, and 260 at the left atrial anterior wall, posterior wall, and esophagus, respectively. RF power in the CP group was 30–40, 20–25, and 20 W at the anterior wall, posterior wall, and esophagus, respectively, compared with 50, 40, and 25, respectively, in the HP group. Procedure time was shorter in the HP than CP group (median 153 [IQR 129–190] vs. 180 (IQR 152–229) min; P

BACKGROUND The impact of chronic kidney disease (CKD) on long-term outcomes following acute myocardial infarction (AMI) in the era of modern primary PCI with optimal medical therapy is still in debate.Methods and Results:A total of 3,281 patients with AMI were enrolled in the J-MINUET registry, with primary PCI of 93.1% in STEMI. CKD stage on admission was classified into: no CKD (eGFR ≥60 mL/min/1.73 m2); moderate CKD (60>eGFR≥30 mL/min/1.73 m2); and severe CKD (eGFR

Thrombolysis in Myocardial Infarction Risk Score for Secondary Prevention (TRS2°P) is a contemporary risk scoring system for secondary prevention based on nine clinical factors. However, this scoring system has not been validated in other populations. The aim of this study was to validate the TRS2°P in patients with acute myocardial infarction (AMI) treated with primary percutaneous coronary intervention (PCI) in a nationwide registry cohort. Among 3283 consecutive patients with AMI enrolled in the Japanese registry of acute Myocardial INfarction diagnosed by Universal dEfiniTion (J-MINUET), a total of 2611 patients who underwent primary PCI were included in this study. The performance of the TRS2°P to predict major adverse cardiovascular events (MACE) composed of all-cause death, non-fatal MI, and non-fatal stroke up to 3 years in the present cohort was evaluated. The TRS2°P had modest discriminative performance in this J-MINUET cohort with a c-statistic of 0.63, similar to that in the derived cohort (TRA2°P-TIMI50, c-statistic 0.67). A strong graded relationship between the TRS2°P and 3-year cardiovascular event rates was also observed in the J-MINUET cohort. Age ≥ 75 years, Killip ≥ 2, prior stroke, peripheral artery disease, anemia, and non-ST-elevation myocardial infarction were identified as independent factors for the incidence of MACE. The TRS2°P modestly predicted secondary cardiovascular events among patients with AMI treated by primary PCI in a nationwide cohort of Japan. Further studies are needed to develop a novel risk score better predicting secondary cardiovascular events.

Although gender difference in long-term outcomes after acute myocardial infarction have been shown previously, impact of age on gender difference is still controversial. This study focused on the association between age and gender difference in long-term outcome. We analyzed data from 3,283 consecutive patients who were included in a prospective, nationwide, multicenter registry (Japan Registry of Acute Myocardial Infarction Diagnosed by Universal Definition) from 2012 to 2014. The primary end point was the major adverse cardiovascular event (MACE), which was defined as a composite of death, myocardial infarction, stroke, heart failure, and revascularization for unstable angina during 3 years. Patients were divided into 4 strata according to age: those with age65 years (group 1: n = 1161), 65 to 74 years (group 2: n = 954), 75 to 84 years (group 3: n = 866) and 84years (group 4: n = 302). Although the crude incidence of 3-year MACE was significantly higher in women than men (36.4% vs. 28.5%, p0.001), there was not significant gender difference in each group (group 1, 19.6% vs 19.0%, p = 0.74; group 2, 33.1% vs 28.3%, p = 0.25; group 3, 38.9% vs 39.6%, p = 0.54; and group 4, 54.0% vs 56.8%, p = 0.24). In conclusion, although women had higher crude incidence of 3-year MACE than men, there was no gender difference in each group.

Background The prevalence of acute myocardial infarction (AMI) in elderly people is increasing worldwide. However, their characteristics and prognosis have been rarely investigated. This study aimed to investigate the characteristics and prognosis in elderly patients with cardiac troponin-positive AMI. Methods Consecutive patients with AMI from the J-MINUET study were divided into the following 3 groups: patients aged less than 65 years, those aged between 65 and 79 years, and those aged 80 years or over. Their characteristics and in-hospital outcomes were compared. Results Patients with AMI aged 80 years or over had the highest incidence of female gender, and the highest incidence of hypertension, chronic kidney disease, and cardiovascular disease, such as peripheral artery disease, atrial fibrillation, and stroke, whereas they had the lowest body mass index, and the lowest incidence of current smoker, diabetes mellitus, and dyslipidemia. Patients with AMI aged 80 years or over had significantly longer onset to door time and longer door to device time, and lower peak creatine kinase (CK). The incidence of ST-segment elevation myocardial infarction (STEMI) was the lowest in the AMI patients aged 80 years or over, but the patients had a higher incidence of in-hospital death and cardiac failure than the other two groups. In addition, the presentation with STEMI and non-ST-segment elevation myocardial infarction with CK elevation among patients aged 80 years or over showed the highest incidence of in-hospital death and cardiac failure. Conclusions J-MINUET showed different clinical characteristics between the aged and younger populations. The incidence of in-hospital death and cardiac failure in patients aged 80 years or over with AMI was poorer than their younger counterparts.

AIMS We aimed to evaluate the validity of the Academic Research Consortium for High Bleeding Risk (ARC-HBR) criteria for East Asian patients undergoing contemporary percutaneous coronary intervention (PCI) from the PENDULUM registry. METHODS AND RESULTS This post hoc analysis included 6,267 Japanese patients undergoing PCI between December 2015 and June 2017 enrolled in PENDULUM. The primary endpoint was the incidence of major bleeding at 12 months post index PCI. In total, 3,185 (50.8%) and 3,082 (49.2%) patients were stratified to the ARC-HBR and non-ARC-HBR groups, respectively, and almost all patients had overlapping criteria. Incidence of major bleeding was 4.2% versus 1.4% in the ARC-HBR group versus the non-ARC-HBR group (hazard ratio 3.00 [95% confidence interval: 2.11-4.27]; p

Aim: Coronary plaque regression is weak in acute coronary syndrome (ACS) patients with diabetes mellitus (DM). We evaluated whether dual lipid-lowering therapy (DLLT) with ezetimibe and atorvastatin attenuates coronary plaques in ACS patients with DM. Methods: The prospective, randomized controlled, multicenter PRECISE-IVUS (Plaque Regression with Cholesterol Absorption Inhibitor or Synthesis Inhibitor Evaluated by Intravascular Ultrasound) trial assigned 246 patients undergoing percutaneous coronary intervention to DLLT or atorvastatin monotherapy and evaluated IVUS-derived changes in percent atheroma volume (ΔPAV), at baseline and 9–12-month follow-up, in 126 ACS cases, including 25 DM patients. The atorvastatin dose was up-titrated to achieve low-density lipoprotein cholesterol (LDL-C) < 70 mg/dL. Results: In DM patients, the monotherapy group (n = 13) and the DLLT group (n = 12) showed a similar prevalence of coronary risks and baseline lipid profiles. During the study, the change in LDL-C level was similar between DM and non-DM patients. Compared with non-DM patients, DM patients showed weaker regression of ΔPAV by DLLT than those who underwent monotherapy (DM: −2.77 ± 3.47% vs. −0.77 ± 2.51%, P = 0.11; non-DM: −2.01 ± 3.36% vs. −0.08 ± 2.66%, P = 0.008). The change in LDL-C level was not correlated with ΔPAV in non-DM patients, but there was significant correlation between the change in LDL-C level and ΔPAV in DM patients (r = 0.52, P = 0.008). Conclusions: ACS patients with DM showed weaker coronary plaque regression than their counterparts. A significant correlation between the change in LDL-C level and ΔPAV in DM patients suggested that more intensive lipid-lowering therapy is required in ACS patients with DM.

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.

New/worsening cognitive and physical impairments following critical care pose significant problems. Multidisciplinary cardiac rehabilitation (CR) can improve physical function after cardiac intensive care (CIC). This observational study aimed to evaluate cognitive function in patients participating in multidisciplinary CR and to identify correlates of impaired cognitive function after CIC. We analyzed 111 consecutive patients admitted to our comprehensive care ward at least 7 days after CIC and assessed factors associated with cognitive function using the Functional Independence Measure (FIM). Patients were stratified into two groups based on the median FIM-Cognitive scores: impaired (n = 56) and preserved cognition (n = 55) groups. Multiple logistic regression analysis identified age [odds ratio (OR) 1.06; 95% confidence interval (CI) 1.00–1.13; p = 0.042], Mini-Nutrition Assessment-Short Form (MNA-SF; OR 0.73; 95% CI 0.56–0.95; p = 0.017), and FIM-Physical scores (OR: 0.94; 95% CI 0.90–0.99; p = 0.012) as significant and independent factors associated with impaired cognition. The median length of hospital stay was 28 (interquartile range: 18, 43) days. The FIM-Cognitive and FIM-Physical scores significantly increased from admission to discharge [32.0 (27.0, 35.0) vs. 34.0 (29.0, 35.0) points; p

Digital, Background Guidelines recommend nonstatin lipid-lowering agents in patients at very high risk for major adverse cardiovascular events (MACE) if low-density lipoprotein cholesterol (LDL-C) remains ≥70 mg/dL on maximum tolerated statin treatment. It is uncertain if this approach benefits patients with LDL-C near 70 mg/dL. Lipoprotein(a) levels may influence residual risk. Objectives In a post hoc analysis of the ODYSSEY Outcomes (Evaluation of Cardiovascular Outcomes After an Acute Coronary Syndrome During Treatment With Alirocumab) trial, the authors evaluated the benefit of adding the proprotein subtilisin/kexin type 9 inhibitor alirocumab to optimized statin treatment in patients with LDL-C levels near 70 mg/dL. Effects were evaluated according to concurrent lipoprotein(a) levels. Methods ODYSSEY Outcomes compared alirocumab with placebo in 18,924 patients with recent acute coronary syndromes receiving optimized statin treatment. In 4,351 patients (23.0%), screening or randomization LDL-C was 13.7 mg/dL or ≤13.7 mg/dL; corresponding adjusted treatment hazard ratios were 0.82 (95% CI: 0.72-0.92) and 0.89 (95% CI: 0.75-1.06), with Pinteraction = 0.43. Conclusions In patients with recent acute coronary syndromes and LDL-C near 70 mg/dL on optimized statin therapy, proprotein subtilisin/kexin type 9 inhibition provides incremental clinical benefit only when lipoprotein(a) concentration is at least mildly elevated. (ODYSSEY Outcomes: Evaluation of Cardiovascular Outcomes After an Acute Coronary Syndrome During Treatment With Alirocumab; NCT01663402), Ciencias Médicas y de la Salud

Aims: The objective of the study is to evaluate the cost-effectiveness of percutaneous mitral valve repair (TMVr) with the MitraClip NT system (MitraClip procedure) for patients with sympto...

It is known that incidence and short-term mortality rate of acute myocardial infarction (AMI) tend to be higher in the cold season. The aim of our study was to investigate the association of onset-season with patient characteristics and long-term prognosis of AMI. This was a prospective, multicenter, Japanese investigation of 3,283 patients with AMI who were hospitalized within 48 h of symptom onset between July 2012 and March 2014. Patients were divided into 3 seasonal groups according to admission date: cold season group (December–March), hot season group (June–September), and moderate season group (April, May, October, and November). We identified 1356 patients (41.3%) admitted during the cold season, 901 (27.4%) during the hot season, and 1026 (31.3%) during the moderate season. We investigated the seasonal effect on patient characteristics and clinical outcomes. Baseline characteristics of each seasonal group were comparable, with the exception of age, Killip class, and conduction disturbances. The rates of higher Killip class and complete atrioventricular block were significantly higher in the cold season group. The 3-year cumulative survival free from major adverse cardiac events (MACE) rate was the lowest in the cold season (67.1%), showing a significant difference, followed by the moderate (70.0%) and hot seasons (72.9%) (p

Beta-blockers are standard therapy for acute myocardial infarction (AMI). However, despite current advances in the management of AMI, it remains unclear whether all AMI patients benefit from β-blockers. We investigated whether admission heart rate (HR) is a determinant of the effectiveness of β-blockers for AMI patients. Methods and Results: We enrolled 3,283 consecutive AMI patients who were admitted to 28 participating institutions in the Japanese Registry of Acute Myocardial Infarction Diagnosed by Universal Definition (J-MINUET) study. According to admission HR, we divided patients into 3 groups: bradycardia (HR60 beats/min, n=444), normocardia (HR 60 to ≤100 beats/min, n=2,013), and tachycardia (HR100 beats/min, n=342). The primary endpoint was major adverse cardiac events (MACE), including all-cause death, non-fatal MI, non-fatal stroke, heart failure (HF), and urgent revascularization for unstable angina, at 3-year follow-up. Beta-blocker at discharge was significantly associated with a lower risk of MACE in the tachycardia group (23.6% vs. 33.0%; P=0.033), but it did not affect rates of MACE in the normocardia group (17.8% vs. 18.4%; P=0.681). In the bradycardia group, β-blocker use at discharge was significantly associated with a higher risk of MACE (21.6% vs. 12.7%; P=0.026). Results were consistent for multivariable regression and stepwise multivariable regression.Admission HR might determine the efficacy of β-blockers for current AMI patients.

Objectives 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. Background 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. Methods 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. Results 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). Conclusions 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.

Background: Despite recommendations in the guidelines and consensus documents, there has been no randomized controlled trial evaluating oral anticoagulation (OAC) alone without antiplatelet therapy (APT) in patients with atrial fibrillation and stable coronary artery disease beyond 1 year after coronary stenting. Methods: This study was a prospective, multicenter, open-label, noninferiority trial comparing OAC alone to combined OAC and single APT among patients with atrial fibrillation beyond 1 year after stenting in a 1:1 randomization fashion. The primary end point was a composite of all-cause death, myocardial infarction, stroke, or systemic embolism. The major secondary end point was a composite of the primary end point or major bleeding according to the International Society on Thrombosis and Haemostasis classification. Although the trial was designed to enroll 2000 patients during 12 months, enrollment was prematurely terminated after enrolling 696 patients in 38 months. Results: Mean age was 75.0±7.6 years, and 85.2% of patients were men. OAC was warfarin in 75.2% and direct oral anticoagulants in 24.8% of patients. The mean CHADS 2 score was 2.5±1.2. During a median follow-up interval of 2.5 years, the primary end point occurred in 54 patients (15.7%) in the OAC-alone group and in 47 patients (13.6%) in the combined OAC and APT group (hazard ratio, 1.16; 95% CI, 0.79–1.72; P =0.20 for noninferiority, P =0.45 for superiority). The major secondary end point occurred in 67 patients (19.5%) in the OAC-alone group and in 67 patients (19.4%) in the combined OAC and APT group (hazard ratio, 0.99; 95% CI, 0.71–1.39; P =0.016 for noninferiority, P =0.96 for superiority). Myocardial infarction occurred in 8 (2.3%) and 4 (1.2%) patients, whereas stroke or systemic embolism occurred in 13 (3.8%) and 19 (5.5%) patients, respectively. Major bleeding occurred in 27 (7.8%) and 36 (10.4%) patients, respectively. Conclusions: This randomized trial did not establish noninferiority of OAC alone to combined OAC and APT in patients with atrial fibrillation and stable coronary artery disease beyond 1 year after stenting. Because patient enrollment was prematurely terminated, the study was underpowered and inconclusive. Future larger studies are required to establish the optimal antithrombotic regimen in this population. Clinical Trial Registration: URL: https://www.clinicaltrials.gov . Unique identifier: NCT01962545.

Background In the RE-DUAL PCI trial, dual anti-thrombotic therapy with dabigatran and a P2Y12inhibitor had a lower risk of bleeding and similar risk reduction of thromboembolic events, compared with warfarin triple therapy, in patients with NVAF undergoing PCI. This subanalysis investigated whether the efficacy and safety of dabigatran dual therapy in Japanese and East-Asian patients enrolled in the RE-DUAL PCI trial were similar to those of the overall patient population of the trial. Methods and Results: RE-DUAL PCI was a multicenter, randomized trial. The primary endpoint was the time to first International Society on Thrombosis and Hemostasis major or clinically relevant non-major bleeding events. Of the East-Asian patients (n=240) enrolled in the RE-DUAL PCI trial, 111 were Japanese and received dabigatran 110 mg (n=50) or 150 mg (n=13) dual therapy, or warfarin triple therapy (n=48). The incidence of the primary endpoint in Japanese patients was 26.0% and 29.2% with dabigatran 110-mg dual therapy and the corresponding warfarin triple therapy, and 23.1% and 30.8% with dabigatran 150-mg dual therapy and the corresponding warfarin triple therapy, respectively. Similar results were observed in the East-Asian population. Conclusions This subanalysis of the RE-DUAL PCI trial demonstrated that, like in the overall patient population, dabigatran dual therapy may offer physicians additional options for managing Japanese and East-Asian patients with NVAF receiving PCI.

Background: Safety and efficacy of clopidogrel monotherapy after very short dual antiplatelet therapy (DAPT) is uncertain in patients undergoing complex percutaneous coronary intervention (PCI). Methods: We conducted a post hoc subgroup analysis based on the complexity of PCI in the STOPDAPT-2 trial (Short and Optimal Duration of Dual Antiplatelet Therapy-2), which randomly compared 1-month DAPT followed by clopidogrel monotherapy with 12-month DAPT after cobalt-chromium everolimus-eluting stent implantation. Complex PCI was defined as any of the following: 3 vessels treated, ≥3 stents implanted, ≥3 lesions treated, bifurcation with 2 stents, >60 mm total stent lengths, and target of chronic total occlusion. The primary end point was the composite of cardiovascular (cardiovascular death/myocardial infarction/definite stent thrombosis/stroke) and bleeding (TIMI [Thrombolysis in Myocardial Infarction] major/minor) end points. The major secondary end points were the cardiovascular and bleeding end points. Results: Among the 3009 study patients, there were 509 patients (16.9%) with complex PCI (1-month DAPT: N=245, and 12-month DAPT: N=264) and 2500 patients (83.1%) without complex PCI (1-month DAPT: N=1255, and 12-month DAPT: N=1245). There were no significant interactions between the complexity of PCI and the effects of 1-month DAPT versus 12-month DAPT on the primary end point (complex PCI: 1.67% versus 5.32%, hazard ratio, 0.30 [95% CI, 0.10–0.92], P =0.04, and noncomplex PCI: 2.50% versus 3.35%, hazard ratio, 0.75 [95% CI, 0.47–1.20], P =0.23; P interaction =0.14), and on the major secondary cardiovascular end point (complex PCI: 1.67% versus 3.04%, hazard ratio, 0.54 [95% CI, 0.16–1.79], P =0.31, and noncomplex PCI: 2.02% versus 2.39%, hazard ratio, 0.86 [95% CI, 0.50–1.47], P =0.58; P interaction =0.49). The cumulative 1-year incidence of the major secondary bleeding end point was significantly lower in the 1-month DAPT group than in the 12-month DAPT group regardless of the complexity of PCI (complex PCI: 0% versus 2.29%, log-rank P =0.02, and noncomplex PCI: 0.48% versus 1.38%, log-rank P =0.02). Conclusions: The effects of clopidogrel monotherapy after 1-month DAPT relative to 12-month DAPT for the primary and major secondary end points were comparable in complex PCI and noncomplex PCI without significant interactions. Registration: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT02619760.

Background: Extracorporeal cardiopulmonary resuscitation (E-CPR) using venoarterial extracorporeal membrane oxygenation (VA-ECMO) is a novel lifesaving method for refractory cardiac arrest (CA). However, VA-ECMO increases damaged left ventricular (LV) afterload. The percutaneous microaxial pump, Impella, can reduce LV preload with simultaneous circulatory support, which may have significant effect on clinical outcome by concomitant use of VA-ECMO and IMPELLA (ECPELLA). In the current retrospective cohort study, we assessed factors affecting outcome of CA patients who underwent E-CPR.Method: We retrospectively reviewed 149 consecutive CA patients with E-CPR from January 2012 through December 2020 in our institute. Patients were divided into three groups, ECEPLLA (n=29), IABP + VA-ECMO (n=78), and single VA-ECMO (n=42). We assessed 30-day survival and neurological outcome using the Cerebral Performance Categories (CPC). Results: There were no significant differences in age, gender, out of hospital CA, acute coronary syndrome among groups. The ECPELLA showed the highest cumulative 30-day survival (ECPELLA: 55%, IABP + VA-ECMO: 23%, VA-ECMO: 9.5; p=0.001) and the rates of CPC score 1 or 2 (ECPELLA: 31%, IABP + VA-ECMO: 13%, VA-ECMO: 7%; p=0.02). Multivariate analysis revealed that age (hazard ratio [HR], 1.30, 95% confidence interval [CI], 1.13-1.52, P=0.005) and Time from CA to ECMO support (HR, 1.22, 95%CI, 1.13-1.31, PConclusion: Earlier initiation of E-CPR is critical to improve patient survival and neurological outcome. Additional Impella support, ECPELLA, appears to significantly improve the clinical outcome.

Background: Clinical studies on heart failure (HF) using diagnosis procedure combination (DPC) databases have attracted attention recently, but data obtained from such databases may lack important information essential for determining the severity of HF. Methods and Results: Using a HF database that collates DPC data and electronic medical records from 3 hospitals in Japan, we investigated factors contributing to prolonged hospitalization and in-hospital death, based on clinical characteristics and data obtained early during hospitalization in 2,750 Japanese patients with HF hospitalized between 2011 and 2015. Mean age was 77.0±13.0 years; 55.3% (n=1,520) were men, and 39.1% (n=759) had left ventricular ejection fraction

Background: Lethal arrhythmias including ventricular tachycardia and fibrillation (VT/VF) are common complications of acute myocardial infarction (AMI). Predictors of in-hospital VT/VF after AMI, however, have not been thoroughly investigated. In this study, we sought to elucidate the predictors of in-hospital VT/VF events after AMI in the Japanese registry of acute Myocardial INfarction diagnosed by Universal dEfiniTion (J-MINUET). Methods and Results: In-hospital VT/VF was defined as a hemodynamically unstable VT or VF in the first week of hospitalization, on which the patients were classified as the VT/VF group. Of the patients in the J-MINUET study, 3,175 were finally enrolled in this study. A total of 114 patients had VT/VF. On multivariate logistic analysis, maximum creatine kinase >3,000 IU/L (adjusted OR, 1.67; 95% CI: 1.085–2.572; P=0.02), Killip class III or IV (adjusted OR, 8.93; 95% CI: 5.668–14.082; P

Background Outcomes with prasugrel single antiplatelet therapy (SAPT) vs. dual antiplatelet therapy (DAPT) in Japanese percutaneous coronary intervention (PCI) patients with high bleeding risk (HBR) are currently unknown.Methods and Results:Data from 1,173 SAPT and 2,535 DAPT patients from the PENDULUM mono and PENDULUM registry studies (respective median DAPT durations: 108 vs. 312 days) were compared. The adjusted cumulative incidence of Bleeding Academic Research Consortium (BARC) 2, 3, or 5 bleeding from 1 to 12 months after PCI (primary endpoint) was 2.8% (95% confidence interval [CI], 1.9-4.2) and 4.1% (95% CI, 3.3-5.1), respectively (hazard ratio [HR], 0.69; 95% CI, 0.45-1.06; P=0.090). The adjusted cumulative incidences of BARC 2, 3, or 5 bleeding from 0 to 12 months after PCI (secondary endpoint) were 3.8% (95% CI, 2.7-5.3) and 5.6% (95% CI, 4.7-6.7), respectively (HR, 0.68; 95% CI, 0.47-0.98; P=0.039). There was no significant difference in major adverse cardiac and cerebrovascular events (MACCE) from 1 to 12 months after PCI (HR, 0.93; 95% CI, 0.63-1.37; P=0.696) and at 12 months after PCI (HR, 0.85; 95% CI, 0.61-1.19; P=0.348) between the groups. Conclusions Prasugrel SAPT may reduce BARC 2, 3, or 5 bleeding, without increasing MACCE, in Japanese patients with HBR.

Background: Guidelines strongly recommend patients with ST-elevation myocardial infarction (STEMI) receive timely mechanical reperfusion, defined as door-to-balloon time (DTBT) ≤90 minutes. Objective: To evaluate the impact of the prehospital mobile cloud ECG transmission system (C-ECG) on DTBT and mortality in patients with STEMI. Methods: On June 2018, eight mobile C-ECG systems (SCUNA®, MEHERGEN GROUP) were implemented into the Uki and Kamimashiki fire departments in Kumamoto, Japan. Within two years, 428 ECGs of patients complaining of chest pain, difficulty in breathing and any other symptom that the emergency staff deemed necessary were transmitted to our hospital. 119 patients were diagnosed with ACS, 93 received emergency CAG and 69 were diagnosed with STEMI. After excluding eight patients with onset to arrival over 24 hours, a total of 137 consecutive STEMI patients received emergency PCI during the study period. Among them, 68 received PCI during the pre-C-ECG period (Pre: from June 2016 to May 2018), whereas 69 were received during the post-C-ECG period (Post: June 2018 to May 2020). We compared the DTBT, Onset to Recanalization time (OTRT), and in-hospital mortality between the two periods. Results: There was no significant difference in age, gender, Killip classification, and number of diseased coronary lesion between the two periods. The door to Cath-Lab time (DTCT) and DTBT were significantly shorter in the post-C-ECG period compared to the pre-C-ECG period (Pre: 34 min [IQR; 23-44] vs. Post: 24 min [IQR; 18-38]; P=0.01, Pre: 66 min [IQR; 48-80] vs. Post: 49 min [IQR; 42-71]; P=0.02, respectively). Furthermore, OTRT was also significantly shorter in the post-C-ECG period compared to the pre-C-ECG period (Pre: 190 min [IQR; 137-343] vs. Post: 153 min [IQR; 110-247]; P=0.02). However, peak-CPK and in-hospital mortality were not significantly different between the two periods (Pre: 2254 IU/L [IQR; 1153-4257] vs. Post: 1985 IU/L [IQR; 740-4021]; P=0.2, Pre: 5.9% vs. Post: 4.4%; P=0.7, respectively). Conclusion: Prehospital mobile cloud ECG transmission system reduced not only the DTBT but also OTRT.

Background: Various predictors in patients with acute pulmonary embolism (PE) have been reported for in-hospital mortality and chronic thromboembolic pulmonary hypertension (CTEPH), but none have been established conclusively. Methods and Results: We retrospectively analyzed data that might be associated with in-hospital mortality and CTEPH from patients with acute PE who were admitted to our hospital. Among 163 patients (aged 69.3± 14.6 years) with acute PE, 11 patients (6.7%) died in the hospital. We examined the following acute and chronic-phase data: vital signs, echocardiography values, medications, laboratory test results, blood gas data and heparin infusion time. Multivariate logistic regression analysis showed that the acute-phase levels of plasma B-type natriuretic peptide (BNP) (odds ratio (OR), 1.003; 95% confidence interval (CI), 1.0004-1.0053; P = 0.034,) and arterial blood gas lactate (OR, 1.306; 95% CI, 1.056-1.615; P = 0.014) were significant independent predictors of in-hospital mortality. The area under the receiver operating characteristic (AUROC) curves of BNP and arterial blood lactate levels for in-hospital mortality were 0.846 and 0.921, respectively. (BNP, 400.65 pg/mL [sensitivity 77.8%, specificity 84.6%]; lactate 7.9 mmol/L [sensitivity 81.8%, specificity 89.5%]). In univariate logistic regression analysis, the plasma BNP level > 400.65 pg/mL and lactate level > 7.9 mmol/L on admission were significant predictors for in-hospital mortality (OR 62.5, 95% CI 10.0-390.3; P = 0.0001). Among 152 patients (aged 68.9±14.6 years) with acute PE who did not die in-hospital, 15 (9.8%) patients progressed to CTEPH. Multivariate logistic regression analysis showed that right ventricular systolic pressure (RVSP) at admission was an independent and significant predictor for CTEPH (OR, 1.183; 95% CI, 1.090-1.285; P = 0.0001). The AUROC curve of RVSP for developing CTEPH was 0.944. (RVSP, 51.4 mm Hg [sensitivity 86.7%, specificity 83.8%]). Conclusions: In patients with acute PE, the acute-phase BNP and arterial blood lactate levels are effective predictors of in-hospital mortality. And RVSP during the acute phase, but not during the chronic phase is an effective predictor of progression to CTEPH.

Background: Extracorporeal CPR (E-CPR) using a veno-arterial ECMO (VA-ECMO) is effective for patients with refractory cardiac arrest. Intra-aortic balloon pumping (IABP) is often combined with VA-ECMO to increase coronary perfusion. However, this combination significantly increases left ventricular afterload. Recent studies showed VA-ECMO combined with IMPELLA pump (ECPELLA) had beneficial effect on refractory cardiogenic shock. Objective: Evaluate outcome of ECPELLA patients who underwent E-CPR as compared to ECMO with IABP. Method: We retrospectively reviewed 140 consecutive patients who underwent E-CPR from January 2012 through May 2020 in our institute. Thirty-eight patients who received ECMO alone were excluded, and 102 patients were recruited. Twenty-four patients underwent ECPELLA (ECPELLA group) and 78 patients underwent ECMO with IABP (IABP group). The 30-day survival rate and the rate of grades 1 and 2 Cerebral Performance Categories (CPC) as the neurological prognosis were assessed. Result: ECPELLA group showed significantly shorter time from cardiac arrest to ECMO placement compared to IABP group (24 min [IQR; 13-41] vs. 49 min [IQR; 28-75]; P=0.0003). The rate of favorable neurological prognosis were significantly higher in the ECPELLA group (38% vs. 13% ; P=0.01). The 30-day all-cause mortality of ECPELLA was significantly lower than IABP (P=0.005 by log-rank test). Multivariate cox proportional hazard analysis including the age, Out of hospital cardiac arrest, shockable rhythm, Acute coronary syndrome, Collaapse-to-ECMO under 60min, and ECPELLA revealed that the age (hazard ratio [HR], 1.34 (10 years increase), 95%CI, 1.11-1.63, P=0.002), Collapse-to-ECMO under 60 min (HR, 0.45, 95%CI, 0.23-0.87, P=0.02) and ECPELLA (HR, 0.48, 95%CI, 0.22-0.95, P=0.035) were significantly associated with 30-day mortality. Conclusion: ECPELLA improves mortality and favorable neurological outcome in patients who underwent E-CPR.

Background: Extracorporeal CPR (E-CPR) is a lifesaving method for refractory cardiac arrest (CA), and IABP has been often used as the additional circulatory support. However, veno-arterial extracorporeal membrane oxygenation (VA-ECMO) increase damaged left ventricular (LV) afterload. The percutaneous microaxial pump, IMPELLA, can reduce damaged LV preload and afterload with circulatory support. Concomitant use of VA-ECMO and IMPELLA (ECPELLA) may have significant effect on clinical outcome. Objective: This study is to evaluate the effects of ECPELLA on clinical outcome of patients with out of hospital cardiac arrest (OHCA) or CA at the emergency room (ERCA) who underwent E-CPR. Method: We retrospectively reviewed 140 consecutive patients who underwent E-CPR from January 2012 through May 2020 in our institute. Seventy-four in-hospital CA patients were excluded, and 66 patients with OHCA or ERCA were recruited. Patients were divided into three groups ECEPLLA (n=13), ECMO with IABP (n=40), and ECMO alone (n=13). The primary endpoint was 30-day mortality. Secondary endpoint was good neurological outcome at hospital discharge defined as cerebral performance categories (CPC) of 1 or 2. Result: There were no significant differences in age, sex, OHCA, acute coronary syndrome in all three groups. The rate of shockable rhythm was higher in the ECPELLA and ECMO with IABP groups than ECMO alone. ECPELLA had the shortest time from CA to ECMO support compared with other groups. The 30-day survival and favorable neurological prognosis rates were significantly higher in the ECPELLA group, compared with other groups (ECPELLA: 61% vs. IABP: 18% vs. ECMO alone: 15%; P=0.008, ECPELLA: 38% vs. IABP: 8% vs. ECMO alone: 8%; P=0.03). Multivariate cox regression analysis including age, sex, time from CA to ECMO support and ECPELLA revealed that age (hazard ratio [HR], 1.36 (10 years increase), 95% confidence interval [CI], 1.11-1.67, P=0.04), male (HR, 2.42, 95%CI, 1.04-5.66, P=0.04), time from CA to ECMO support (HR, 1.01, 95%CI, 1.01-1.03, P=0.04), and ECPELLA (HR, 0.35, 95%CI, 0.13-0.91, P=0.03) were significantly associated with 30-day mortality. Conclusion: ECPELLA could improve 30-day mortality and neurological outcome in OHCA or ERCA patients who underwent E-CPR.

Background In the recent the Reduction of Cardiovascular Events with EPA-Intervention Trial (REDUCE-IT), statin therapy plus high-dose eicosapentaenoic acid (EPA) significantly reduced the risk of cardiovascular death in patients with coronary artery disease (CAD) with elevated triglyceride (TG) levels. An epidemiologic study has shown that increasing the intake of long-chain n-3 polyunsaturated fatty acids, especially EPA and docosahexaenoic acid (DHA), are associated with a lower risk of fatal CAD. However, the anti-atherosclerotic effect of high-dose EPA/DHA has not be clarified. We reported that coronary high-intensity plaques (HIPs) detected with non-contrast T1-weighted imaging (T1WI) on cardiac magnetic resonance (CMR), which can be uniquely quantitative assessed using the plaque-to-myocardium signal intensity ratio (PMR) of ≥1.4, are significantly associated with future coronary events. Moreover, we demonstrated that intensive statin therapy reduces the PMR of coronary HIPs by 19% but is unlikely to completely resolve HIP (PMR In the AQUAMARINE EPA/DHA study, our goal was to assess the anti-atherogenic effect of EPA/DHA in an exploratory manner by examining the change in PMR of coronary HIPs after 12 months of EPA/DHA therapy in patients with CAD on statin therapy. Methods This study was designed as a single-center, triple-arm, parallel-group, randomized controlled, open-label, superiority trial examining the effect of 12 months of additional EPA/DHA therapy on coronary HIPs in patients with CAD who receiving statin therapy. Eligible subjects are randomly assigned to the 2 g/day EPA/DHA group (n=26), the 4 g/day group (n=23), or the no EPA/DHA (statin-only) group (n=24) between May 2014 and December 2017. The PMR was defined as the signal intensity of the coronary plaque divided by that of nearby left ventricular myocardium. The primary endpoint is the change in PMR after EPA/DHA treatment. Results These 3 groups were well matched at baseline, with no statistically significant differences in age, male sex, conventional coronary risk factors, TG level, medications, and PMR. Figure 1 shows subgroup analysis of patients with high triglyceride levels (>150mg/dl). In the patient-based analysis (A), 12 months of EPA/DHA therapy significantly reduced the PMR of primary lesions. In the segment-based analysis (B), additional reduction of PMR was observed in the high-dose EPA/DHA group compared with the no EPA/DHA treatment group. Discussion The present study of patients with high triglyceride levels demonstrated that EPA/DHA had a dose-dependent anti-atherosclerotic effect. This finding may provide additional information of EPA/DHA for lowering the residual risk in patients with CAD on statin therapy. Funding Acknowledgement Type of funding source: Private company. Main funding source(s): Takeda Pharmaceutical Co., Ltd.

Background Extracorporeal Cardio-Pulmonary Resuscitation (E-CPR) is an effective tool for patients with refractory cardiac arrest (CA). Since VA-ECMO provides strong afterload, IABP is often used to increase left ventricular load. Recently, in Japan, the effectiveness of VA-ECMO in combination with IMPELLA, a forward flow mechanical circulatory support device (ECPELLA) is gaining attention. Purpose We investigated usefulness of ECPELLA in patients with refractory CA. Method We reviewed 133 patients that had E-CPR from January 2012 through January 2020 {mean age: 67±15 years, male 65%, Out of hospital Cardiac Arrest (OHCA) 35%, Acute coronary Syndrome (ACS) 54%}. We divided these patients into ECMO with IMPELLA (ECPELLA group), ECMO with IABP (IABP group) and ECMO alone (ECMO alone group). The primary endpoint is 30-day survival and good neurological prognosis defined as CPC (cerebral performance categories) 1 or 2. Result During the study period, of the 133 patients, there were 20 in the ECPELLA group, 78 in the IABP group, 35 in the ECMO alone group. There were no significant differences in age in all three groups. There were more males, shockable rhythm, OHCA and ACS in the ECPELLA and IABP groups compared to the ECMO alone group. But there was no significant difference between the ECPELLA and IABP groups. Compared with other groups, ECPELLA had the shortest time from cardiac arrest to ECMO placement. Regarding endpoints, the rate of 30-day survival and favorable neurological prognosis were higher in the ECPELLA group, followed by the IABP group and then the ECMO alone group. (ECPELLA: 55% vs. IABP: 23% vs. ECMO alone: 9%; P=0.0009, ECPELLA: 35% vs. IABP: 13% vs. ECMO alone: 9%; P=0.04) Next, Kaplan Meier analysis was performed to analyze 30-day all-cause mortality. The ECPELLA group had a significantly higher survival rate (P=0.01 by log-rank test). Multivariate cox proportional hazard analysis including the age, OHCA, shockable rhythm, ACS, Collapse-to-ECMO under 60 min revealed that the age (hazard ratio [HR], 1.28 (10 years increase), 95% confidence interval [CI], 1.08–1.53, P=0.004) and Collapse-to-ECMO under 60 min (HR, 0.37, 95% CI, 0.21–0.68, P=0.001) or ECPELLA (HR, 0.46, 95% CI, 0.20–0.694, P=0.03) were significantly associated with mortality. Conclusion ECPELLA used with E-CPR is an effective tool to improve mortality and neurologic status. Funding Acknowledgement Type of funding source: None

Background In addition to fractional flow reserve (FFR), resting indexes (RI) have been shown as another physiological measure to evaluate myocardial ischemia. Despite the clinical usefulness of RI without the use of intravenous vasodilatory agent, discrepancy between FFR and RI infrequently occurs. Whether this physiological mismatch is derived by specific plaque feature remains unknown. Purpose To characterize coronary plaques associated with coronary physiological mismatch. Methods We analyzed 59 coronary arteries (LAD/RCA/LCX=49/4/6) with FFR≤0.80 in 57 stable CAD subjects receiving PCI. Following measurement of FFR and RI, culprit lesion was evaluated by near-infrared spectroscopy and intravascular ultrasound (NIRS/IVUS). The analyzed vessels were stratified according to FFR and RI values: FFR≤0.75+RI>0.89 (n=6: physiological mismatch), FFR>0.75+RI>0.89 (n=6), FFR≤0.75+RI≤0.89 (n=33) and FFR>0.75+RI≤0.89 (n=14). Results The median values of percent diameter stenosis, FFR and RI were 51%, 0.75 and 0.87, respectively. Physiological mismatch was observed in 10.1% (=6/59) of analyzed vessels. On IVUS imaging, maximum percent plaque area was greater than 70% in all groups (p=0.29). Furthermore, there were no significant differences in angiographic and IVUS-derived minimum lumen area across 4 groups (Table). However, culprit lesions exhibiting physiological mismatch contained a substantially larger amount of lipid plaque, reflected by a higher maximum 4-mm lipid-core burned index (maxLCBI4mm: p=0.04) on NIRS imaging (Table). Multivariate analysis demonstrated maxLCBI4mm as the only plaque feature associated with physiological mismatch (odds ratio=1.010, 95% CI: 1.001–1.019, p=0.02). Conclusion Plaque feature associated with coronary physiological mismatch was the extent of lipidic materials but not the quantity of coronary atheroma. Since the accumulation of lipidic plaque component is caused by endothelial dysfunction, this vascular substrate could impair baseline vasomotion, thereby causing a lower FFR despite preserved RI value. Evaluation of lipidic burden may be a potential option to avoid unnecessary deferral of revascularization in subjects with normal RI value. maxLCBI4mm in each group Funding Acknowledgement Type of funding source: None

Background Atherosclerotic cardiovascular disease including acute myocardial infarction (AMI) has become one of major co-existing diseases in cancer patients due to their improved survival rate. Current guideline recommends dual-antiplatelet therapy (DAPT) in patients with AMI. Given that the presence of cancer elevates not only coagulability but bleeding risks, these substrate may further worsen cardiovascular outcomes and bleeding risks in cancer subjects with AMI receiving DAPT. Methods We retrospectively analyzed 712 AMI patients treated by primary PCI with drug-eluting stent and DAPT between 2007 and 2017. The diagnosis of cancer was determined through medical record review. Clinical characteristics, thromboembolic (=all-cause death+non-fatal MI+stroke) and bleeding events were compared in AMI subjects with vs. without cancer. Results Cancer was identified in 11.1% (=79/712) of study subjects. Of these, around 40% of them had gastrointestinal cancer (=35/79), followed by lung cancer (=5/79) and breast cancer (=8/79). Cancer patients were more likely to be older (77±7 v. 69±13 years, p Conclusions Under the use of guideline recommended DAPT, the concomitance of cancer in AMI subjects was a predictor for thromboembolic as well as bleeding events. In particular, the relationship between cancer and bleeding was significant. These observations underscore the appropriate selection and duration of anti-thrombotic agents in AMI subjects with cancer. Cardiac/Bleeding Events in AMI Subjects Funding Acknowledgement Type of funding source: None

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.

Background There is a scarcity of data on short-duration dual antiplatelet therapy (DAPT) followed by P2Y12 inhibitor monotherapy as compared with aspirin monotherapy after percutaneous coronary intervention (PCI).Methods and Results:STOPDAPT-1 is a prospective trial enrolling patients who agreed to 3-month DAPT followed by aspirin monotherapy after everolimus-eluting stent (EES) implantation. STOPDAPT-2 is a randomized trial comparing 1-month DAPT followed by clopidogrel monotherapy with 12-month DAPT after EES implantation. We compared the clinical outcomes of patients assigned to the 1-month DAPT group in STOPDAPT-2 and the 3-month DAPT group enrolled in STOPDAPT-1. The current study population consisted of 1,480 patients in STOPDAPT-2 and 1,339 patients in STOPDAPT-1. The primary endpoint was a composite of cardiovascular death, myocardial infarction, stroke, definite stent thrombosis and TIMI major/minor bleeding. Cumulative 1-year incidence of the primary endpoint was not significantly different between STOPDAPT-2 and STOPDAPT-1 (2.3% vs. 2.3%, P=0.98). After adjusting for confounders, there was no excess risk of STOPDAPT-2 relative to STOPDAPT-1 for the primary endpoint. Between 3 and 12 months, the cumulative incidence of primary endpoint was not significantly different between STOPDAPT-2 and STOPDAPT-1 (1.7% vs. 1.6%, P=0.77). Conclusions The effect of 1-month DAPT followed by clopidogrel monotherapy on clinical outcomes was similar to that of 3-month DAPT followed by aspirin monotherapy in patients receiving PCI.

Percutaneous coronary intervention (PCI) has significantly advanced over the last 40 years, but it is not clear whether there have been any changes in prognosis in recent years. The Kumamoto Intervention Conference Study Real-World Registry is a multi-center registry that enrolls consecutive patients undergoing PCI in 17 centers in Kyushu, Japan. To elucidate the clinical impact of recent changes in treatment strategies, 8841 consecutive participants (historical PCI: n = 4038, enrolled between January 2013 and December 2014, and current PCI: n = 4803, between January 2015 and March 2017) with 1-year follow-up data were analyzed. The incidences of major adverse cardiovascular and other clinical events were comparable between historical PCI and current PCI, even though complex lesions were more frequent during the more recent period. During this period, the use of radial approaches, drug eluting stents, and coronary imaging was greater. The use of prasugrel was more frequent (P

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.

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

Although there is accumulating evidence for the usefulness of imaging-guided percutaneous coronary intervention (PCI), there are few studies for acute coronary syndrome (ACS), and the impact of the frequency of use has not been well addressed. From the Kumamoto Intervention Conference Study; a Japanese registry comprising 17 institutions, consecutive patients undergoing successful PCI from April 2008 through March 2014 were enrolled. Subjects were divided into two groups: imaging-guided PCI and angiography-guided PCI. Clinical outcome was a composite of cardiac death, non-fatal myocardial infarction, and stent thrombosis within 1 year. A total of 6025 ACS patients were enrolled: 3613 and 2412 patients with imaging- and angiography-guided PCI, respectively. Adverse cardiac events were significantly lower in the imaging-guided PCI group (long-rank P P = 0.004). To assess the effects of frequency of imaging usage, we divided the 17 institutions into six low-, six moderate-, and five high-frequency groups. The event rates decreased depending on the frequency, seemingly driven by stepwise event suppression in angiography-guided PCI. In Japanese ACS patients, the incidence of adverse clinical events in patients treated with imaging-guided PCI were significantly lower than that in patients with angiography-guided PCI. Better clinical result was found in the institutions using intravascular imaging more frequently. University Hospital Medical Information Network (UMIN)-CTR (http://www.umin.ac.jp/ctr/). Identifier: KICS (UMIN000015397).

There has been no previous prospective study evaluating 3-month dual antiplatelet therapy (DAPT) after cobalt-chromium everolimus-eluting stent (CoCr-EES) implantation in patients with acute coronary syndrome (ACS). The STOPDAPT trial is a prospective multi-center single-arm study evaluating 3-month DAPT duration in all-comer population after CoCr-EES implantation. Among 1525 study patients enrolled from 58 Japanese centers, the present study compared the 1-year clinical outcomes between ACS patients (N = 487) and stable coronary artery disease (CAD) patients (N = 1038). In the ACS group, 228 patients (47%) had unstable angina and 259 patients (53%) had myocardial infarction. The primary endpoint was a composite of cardiovascular death, myocardial infarction, stroke, definite stent thrombosis (ST) and TIMI major/minor bleeding. Thienopyridine was discontinued within 4-month in 455 patients (94.0%) in the ACS group and 977 patients (94.3%) in the stable CAD group. Cumulative 1-year incidence of and the adjusted risk for the primary endpoint were not significantly different between the ACS and stable CAD groups (2.3% vs. 3.0%, P = 0.42, and HR 0.94, 95%CI 0.44–1.87, P = 0.87). In the 3-month landmark analysis, cumulative incidence of the primary endpoint was also not significantly different between the ACS and stable CAD groups (1.3% vs. 2.4%, P = 0.16). There was no definite/probable ST through 1-year in both groups. In the propensity matched analysis, the cumulative 1-year incidence of the primary endpoint were similar between the ACS and stable CAD groups (2.3% versus 2.1%, P = 0.82). In conclusion, stopping DAPT at 3 months after CoCr-EES implantation in patients with ACS including 47% of unstable angina was as safe as that in patients with stable CAD.

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

Chronic kidney disease (CKD) deteriorates the prognosis of patients undergoing percutaneous coronary intervention (PCI). Because coronary artery disease (CAD) is the major cause of death in CKD patients, cardiovascular risk reduction has been clinically important in CKD. We hypothesized intensive lipid-lowering with statin/ezetimibe attenuated coronary atherosclerotic development even in patients with CKD.In the prospective, randomized, controlled, multicenter PRECISE-IVUS trial, 246 patients undergoing intravascular ultrasound (IVUS)-guided PCI were randomly assigned to receive atorvastatin/ezetimibe combination or atorvastatin alone (the dosage of atorvastatin was up-titrated to achieve the level of low-density lipoprotein cholesterol 70 mg/dL). Serial volumetric IVUS findings obtained at baseline and 9-12 month follow-up to quantify the coronary plaque response in 202 patients were compared stratified by the presence or absence of CKD.CKD was observed in 52 patients (26%) among 202 enrolled patients. Compared with the non-CKD group, the CKD group was significantly older (71.5 ± 8.6 years vs. 64.4 ± 9.6 years, P 0.001) with similar prevalence of comorbid coronary risk factors and lipid profiles. Similar to the non-CKD group (-1.4 [-2.8 to -0.1]% vs. -0.2 [-1.7 to 1.0]%, P = 0.002), the atorvastatin/ezetimibe combination significantly reduced ∆PAV compared with atorvastatin alone even in the CKD group (-2.6 [-5.6 to -0.4]% vs. -0.9 [-2.4 to 0.2]%, P = 0.04).As with non-CKD, intensive lipid-lowering therapy with atorvastatin/ezetimibe demonstrated stronger coronary plaque regression effect even in patients with CKD compared with atorvastatin monotherapy.NCT01043380 (ClinicalTrials.gov).

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.

Background and aims We aimed to examine the effect of serum sitosterol, a cholesterol absorption marker, on clinical outcomes in acute coronary syndrome patients with dyslipidaemia. Methods This is a sub-analysis of the HIJ-PROPER trial that assesses the effect of aggressive low-density lipoprotein cholesterol (LDL-C) lowering treatment with pitavastatin + ezetimibe in 1734 acute coronary syndrome (ACS) patients with dyslipidaemia. Patients were divided into two groups based on sitosterol level at enrolment (cut-off value was 2.2 μg/mL; a median of baseline sitosterol level), and clinical outcomes were examined. Results The mean LDL-C level after 3 years in the low sitosterol group was 84.8 ± 20.1 mg/dL with pitavastatin-monotherapy and 64.6 ± 20.3 mg/dL with pitavastatin + ezetimibe, while corresponding values in the high sitosterol group were 91.0 ± 22.9 mg/dL and 71.1 ± 23.3 mg/dL, respectively. In the high sitosterol group, the Kaplan-Meier event rate for the primary endpoint at 3 years was 26.0% in the pitavastatin + ezetimibe group, as compared with 34.3% in the pitavastatin-monotherapy group (hazard ratio, 0.71; 95% confidence interval, 0.56–0.91; p = 0.006, p-value for interaction = 0.010). However, in the low sitosterol group, there was no significant reduction of the primary endpoint by pitavastatin + ezetimibe therapy. Conclusions Aggressive lipid-lowering treatment with ezetimibe had a positive effect on clinical outcomes in the high sitosterol subset of ACS patients with dyslipidaemia, but not in the low sitosterol subset. This effect was independent of LDL-C reduction and suggests that sitosterol measurement on admission in ACS patients might contribute to a “personalised” lipid-lowering approach.

Pioglitazone has superior antiatherosclerotic effects compared with other classes of antidiabetic agents, and there is substantial evidence that pioglitazone improves cardiovascular (CV) outcomes. However, there is also a potential risk of worsening heart failure (HF). Therefore, it is clinically important to determine whether pioglitazone is safe in patients with type 2 diabetes mellitus (T2DM) who require treatment for secondary prevention of CV disease, since they have an intrinsically higher risk of HF. This prospective, multicenter, open-label, randomized study investigated the effects of pioglitazone on cardiometabolic profiles and CV safety in T2DM patients undergoing elective percutaneous coronary intervention (PCI) using bare-metal stents or first-generation drug-eluting stents. A total of 94 eligible patients were randomly assigned to either a pioglitazone or conventional (control) group, and pioglitazone was started the day before PCI. Cardiometabolic profiles were evaluated before PCI and at primary follow-up coronary angiography (5–8 months). Pioglitazone treatment reduced HbA1c levels to a similar degree as conventional treatment (pioglitazone group 6.5 to 6.0%, P

While primary percutaneous coronary intervention (PCI) has significantly contributed to improve the mortality in patients with ST segment elevation myocardial infarction even in cardiogenic shock, primary PCI is a standard of care in most of Japanese institutions. Whereas there are high numbers of available facilities providing primary PCI in Japan, there are no clear guidelines focusing on procedural aspect of the standardized care. Whilst updated guidelines for the management of acute myocardial infarction were recently published by European Society of Cardiology, the following major changes are indicated; (1) radial access and drug-eluting stent over bare metal stent were recommended as Class I indication, and (2) complete revascularization before hospital discharge (either immediate or staged) is now considered as Class IIa recommendation. Although the primary PCI is consistently recommended in recent and previous guidelines, the device lag from Europe, the frequent usage of coronary imaging modalities in Japan, and the difference in available medical therapy or mechanical support may prevent direct application of European guidelines to Japanese population. The Task Force on Primary Percutaneous Coronary Intervention of the Japanese Association of Cardiovascular Intervention and Therapeutics (CVIT) has now proposed the expert consensus document for the management of acute myocardial infarction focusing on procedural aspect of primary PCI.