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Background: Long-term comparative outcomes after percutaneous coronary intervention (PCI) with everolimus-eluting stents and coronary artery bypass grafting (CABG) are limited in patients with multivessel coronary artery disease. Methods: This prospective, multicenter, randomized controlled trial was conducted in 27 international heart centers and was designed to randomly assign 1776 patients with angiographic multivessel coronary artery disease to receive PCI with everolimus-eluting stents or CABG. After inclusion of 880 patients (438 in the PCI group and 442 in the CABG group) between July 2008 and September 2013, the study was terminated early because of slow enrollment. The primary end point was the composite of death from any cause, myocardial infarction, or target vessel revascularization. Results: During a median follow-up of 11.8 years (interquartile range, 10.6–12.5 years; maximum, 13.7 years), the primary end point occurred in 151 patients (34.5%) in the PCI group and 134 patients (30.3%) in the CABG group (hazard ratio [HR], 1.18 [95% CI, 0.88–1.56]; P =0.26). No significant differences were seen in the occurrence of a safety composite of death, myocardial infarction, or stroke between groups (28.8% and 27.1%; HR, 1.07 [95% CI, 0.75–1.53]; P =0.70), as well as the occurrence of death from any cause (20.5% and 19.9%; HR, 1.04 [95% CI, 0.65–1.67]; P =0.86). However, spontaneous myocardial infarction (7.1% and 3.8%; HR, 1.86 [95% CI, 1.06–3.27]; P =0.031) and any repeat revascularization (22.6% and 12.7%; HR, 1.92 [95% CI, 1.58–2.32]; P Conclusions: In patients with multivessel coronary artery disease, there were no significant differences between PCI and CABG in the incidence of major adverse cardiac events, the safety composite end point, and all-cause mortality during the extended follow-up. Registration: URL: https://www.clinicaltrials.gov ; Unique identifiers: NCT05125367 and NCT00997828.

Because of paucity of published data, we evaluated the 2-year major clinical outcomes between early invasive (EI) and delayed invasive (DI) strategies according to the stage of chronic kidney disease (CKD) in patients with non-ST-segment elevation myocardial infarction (NSTEMI), who underwent a successful newer-generation drug-eluting stent (DES) implantation.A total of 8241 NSTEMI patients were recruited from the Korea Acute Myocardial Infarction Registry (KAMIR). Based on baseline estimated glomerular filtration rate (eGFR; ≥90, 60-89, 30-59, and30 mL/min/1.73 mAfter multivariable-adjusted and propensity score-adjusted analyses, the cumulative incidence of MACE (group A, p = 0.139 and p = 0.103, respectively; group B, p = 0.968 and p = 0.608, respectively; group C, p = 0.111 and p = 0.196, respectively; group D, p = 0.882 and p = 0.571, respectively), all-cause death, re-MI, and any repeat revascularization was similar between the EI and DI groups in the 4 different renal function groups.In the era of newer-generation DES, EI and DI strategies showed comparable major clinical outcomes in patients with NSTEMI and CKD during a 2-year follow-up period. However, to confirm these results, further randomized, large-scale, long-term follow-up studies are needed.

Despite similar brachial blood pressure, central hemodynamics could be different. The objective of the present study was to investigate the factors, which could influence the discrepancy between central BP (cBP) and brachial blood pressure. Six hundred forty-seven patients (364 males, 48 ± 12 years old) were enrolled. Using applanation tonometry, cBP was noninvasively derived. The median difference between brachial systolic BP (bSBP) and central systolic BP (cSBP) was 8 mm Hg. We defined the discrepancy between bSBP and cSBP as differences8 mm Hg. For adjustment of cBP, population was divided into 3 groups according to the cBP: group 1,140 mm Hg of cSBP; group 2, 140cSBP160 mm Hg; group 3, =160 mm Hg of cSBP. All the central hemodynamic parameters of the patients, including augmentation pressure, augmentation index (AI), heart rate (75 bpm) adjusted augmentation index (AI@HR75), and subendocardial viability ratio, were measured. Using multivariate logistic regression analysis, we evaluated the factors which could influence the discrepancy between bSBP and cSBP. Age, gender, augmentation pressure, AI, and AI@HR75 were correlated with the discrepancy between bSBP and cSBP. AI@HR75 was significantly correlated with the discrepancy between bSBP and cSBP (β-coefficient = -0.376, P.001 in group 1; β-coefficient = -0.297, P.001 in group 2; and β-coefficient = -0.545, P.001 in group 3). In groups 1 and 2, male gender was significantly correlated with the discrepancy between bSBP and cSBP (β-coefficient = -0.857, P = .035 in group 1; β-coefficient = -1.422, P = .039 in group 2). In present study, arterial stiffness might affect the discrepancy between bSBP and cSBP. Also, male gender was closely related to the discrepancy between bSBP and cSBP especially with cSBP160 mm Hg. Not only cSBP, the discrepancy between cSBP and bSBP should be considered for understanding the central hemodynamics.

Background We assessed the long‐term clinical outcomes of an intermediate lesion (IL) according to the presence of a combined culprit lesion (CCL). Hypothesis Long‐term clinical outcomes of IL may be affected by the presence of a CCL. Methods Angiographic findings (n = 1096) and medical chart were reviewed. Patients with IL were divided into two groups: IL without CCL group (n = 383, 64.5%) and IL with CCL group (n = 211, 35.5%). Results The major adverse cardiovascular events (MACE) in the IL with CCL group were significantly higher than those in the IL without CCL group (death: 12.3% vs. 7.0%, myocardial infarction: 3.3%vs. 0.5%, stroke: 6.6% vs. 2.6%, and revascularization [RVSC]: 25.1% vs. 7.6%) during a mean follow up period of 118.4 ± 5.5 months. IL related RVSC rate in the IL with CCL group was higher than that in the IL without CCL group (5.7% vs. 2.1%, p = 0.020). RVSC rate related to IL in total subjects was lower than that related to stented lesion (3.4% vs. 6.4%). The important predictors of total MACE in total subjects were the presence of CCL, IL percent diameter stenosis, hypertension, history of percutaneous coronary intervention, blood glucose and ejection fraction. The predictors of IL related RVSC were IL percent diameter stenosis and IL located in the right coronary artery. Conclusion 10‐year clinical outcomes of an IL (especially IL without CCL) were better than those of stented lesions. This study suggests that the IL can be safely followed up in sites that do not have ability to assess functional study.

Author's summary The Korean Society of Cardiology has recently published the Korea Heart Disease Fact Sheet 2020 to provide overview of the cardiovascular disease (CVD) burden and its temporal changes. CVD mortality, hospitalization, and risk factor distributions were analyzed from nationwide databases. Over the last decade, CVD mortality and hospitalization have increased, while their age-standardized rates have declined. In addition, a considerable proportion of adults had multiple risk factors, which markedly increased with older age. Thus, concerted efforts should be continued to address the rising burden of CVD in Korea., Background and Objectives Cardiovascular disease (CVD) is the leading cause of death and disability worldwide. To provide an overview of the temporal trends in the burden of CVD, the Korean Society of Cardiology has published the Korea Heart Disease Fact Sheet in 2020. Methods We analyzed anonymized data of the Causes of Death Statistics, National Health Insurance Claims Database, and Korea National Health and Nutrition Examination Survey to assess mortality, hospitalizations, and risk factors for CVD. Results The CVD mortality decreased until 2010, then steadily increased up to 123 per 100,000 persons in 2018. Since 2002, the number and rate of CVD hospitalization have continued to grow. In 2018, approximately 12.1 million Korean adults had hypertension, 4.3 million had diabetes, 8.7 million had hypercholesterolemia, 14.9 million had obesity, and 8.8 million were currently smoking. The number of risk factors increased markedly with older age; 58.4% of adults age ≥70 years had ≥2 risk factors. Conclusions CVD mortality and hospitalization have gradually increased in the last decade, and a substantially high proportion of adults were carrying more than 1 cardiovascular risk factor in 2018. With the rapid population aging, a continued increase in CVD appears inevitable in Korea. Concerted and sustained approaches are essential to achieve early prevention and reduce the burden of CVD.

Background The clinical value of intracoronary imaging for percutaneous coronary intervention (PCI) guidance is well acknowledged. Intravascular ultrasound (IVUS) and optical coherence tomography (OCT) are the most commonly used intravascular imaging to guide and optimize PCI in day-to-day practice. However, the comparative effectiveness of IVUS-guided versus OCT-guided PCI with respect to clinical end points remains unknown. Methods and design The OCTIVUS study is a prospective, multicenter, open-label, parallel-arm, randomized trial comparing the effectiveness of 2 imaging-guided strategies in patients with stable angina or acute coronary syndromes undergoing PCI in Korea. A total of 2,000 patients are randomly assigned in a 1:1 ratio to either an OCT-guided PCI strategy or an IVUS-guided PCI strategy. The trial uses a pragmatic comparative effectiveness design with inclusion criteria designed to capture a broad range of real-world patients with diverse clinical and anatomical features. PCI optimization criteria are predefined using a common algorithm for online OCT or IVUS. The primary end point, which was tested for both noninferiority (margin, 3.1 percentage points for the risk difference) and superiority, is target-vessel failure (cardiac death, target-vessel myocardial infarction, or ischemia-driven target-vessel revascularization) at 1 year. Results Up to the end of July 2020, approximately 1,200 "real-world" PCI patients have been randomly enrolled over 2 years. Enrollment is expected to be completed around the midterm of 2021, and primary results will be available by late 2022 or early 2023. Conclusion This large-scale, multicenter, pragmatic-design clinical trial will provide valuable clinical evidence on the relative efficacy and safety of OCT-guided versus IVUS-guided PCI strategies in a broad population of patients undergoing PCI in the daily clinical practice.

Background: Intermediate lesions (ILs) are challenging to treat. This study aimed to assess the impact of ILs on long-term clinical outcomes in patients with significant coronary lesions (SLs).Methods: This was a non-randomized, retrospective, single-center study. The study subjects were patients with SL (n=403, Men=249), followed up for 10 years (118.5±5.5 months), and divided into 2 groups according to the presence of IL (IL (-) and IL (+) groups with 192 and 211 patients, respectively). The primary outcome was the occurrence of major adverse cardiovascular events (MACE), which included all-cause death, myocardial infarction (MI), stroke, and revascularization (RVSC).Results: There were no significant differences in MACEs between the IL (-) and IL (+) groups (death, 7.8% vs. 12.3%; MI, 0.0% vs. 2.4%; stroke, 5.7% vs. 6.6%; and RVSC, 19.8% vs. 24.6%). However, the RVSC rate related to IL was lower (5.2% vs. 13.2%) than that related to stented lesions in all subjects. The important predictors for total MACEs in all subjects were the number of ILs and ejection fraction. The predictors of total RVSC events were IL location (right coronary artery [RCA]) and hypertension. The predictor of IL-related RVSC was the number of ILs.Conclusion: Ten-year clinical outcomes of IL were excellent and better than those of stented lesions in patients with SL. Thus, ILs can be managed with optimal medical treatment with acceptable clinical outcomes in patients with SL. The increased risk of MACE in patients with multiple ILs and ILS in the RCA should be carefully managed.

Background: Drug-eluting stents (DESs) are commonly used in percutaneous coronary intervention (PCI) procedures, however, complications including in-stent restenosis and stent thrombosis are significant challenges. The dual-DES is a stent that elutes two drugs to target various stages of the restenosis reaction. This study investigated the safety and efficacy of dual-DES in clinical practice. Methods: This study included 375 patients who underwent PCI with Cilotax&trade, or DXR&trade, dual-DESs at one of 13 centers in South Korea. The primary endpoint was target lesion failure (TLF) within 1 year. The secondary endpoints were cardiac death, myocardial infarction (MI), target lesion revascularization (TLR), and stent thrombosis. Results: The rates of TLF in dual-DESs (3.7%) were comparable to those reported in conventional DES. In addition, the DXR&trade, group had a significantly lower rate of TLF than the Cilotax&trade, group. In multivariate analysis, the DXR&trade, group had a lower risk of TLF (adjusted hazard ratio (HR) 0.30, 95%CI 0.09&ndash, 0.92, p = 0.036) and MI (adjusted HR 0.16, 95%CI 0.03&ndash, 0.82, p = 0.027) than the Cilotax&trade, group. Conclusion: Dual-DESs had similar clinical outcomes regarding efficacy and safety as conventional DES. Among the dual-DES, the DXR&trade, stent as a new generation dual-DES had more favorable clinical outcomes than the Cilotax&trade, stent.

The natural history of intermediate coronary lesions (30 to 70% angiographic stenosis) and the prognostic predictors in predicting very long-term clinical outcomes is unknown.Patients (n = 82, mean 60 years old) with intermediate non-culprit coronary lesions (NCL, n = 86), evaluated by virtual histology-intravascular ultrasound (VH-IVUS), were followed for 10 years. Major adverse cardiovascular events (MACE; all-cause death, myocardial infarction, stroke, and revascularization) were collected over follow-up period and stratified by culprit lesion (CL)-related, NCL-related and indeterminate/unrelated to CL or NCL lesions. NCL-related MACE was further stratified into intermediate and minimal NCL-related events.Twenty two (25.6%) out of 86 intermediate NCL were associated with MACE in 20/82 (24.4%) study patients. Ten-year cumulative intermediate NCL-related MACE rate was twice (25.6% vs. 12.8%) compared to treated culprit lesion (CL)-related MACE. Ten-year cumulative revascularization rate of the intermediate NCL lesions was similar (17.4% vs. 15.1%) to those of CL, but higher than that of minimal (stenosed30% at baseline) NCL (8.1%). Important intermediate NCL VH-IVUS predictor for MACE was area stenosis ≥50%, and for revascularization were percent diameter stenosis, plaque burden ≥70%, and fibrofatty area.Ten-year MACE rate of intermediate NCL was double that of CL and ten-year revascularization rate of intermediate NCL was similar or slightly higher than that of CL. VH-IVUS may play an important role in determining the very long-term clinical outcomes in patients with intermediate NCL. This study suggests that Intermediate NCL can be safely followed up in terms of revascularization risk.

Atherosclerosis - the pathophysiological mechanism shared by most cardiovascular diseases - can be directly or indirectly assessed by a variety of clinical tests including measurement of carotid intima-media thickness, carotid plaque, ankle-brachial index, pulse wave velocity, and coronary artery calcium. the Prospective Studies of Atherosclerosis (Proof-ATHERO) consortium (https://clinicalepi.i-med.ac.at/research/proof-athero/) collates de-identified individual-participant data of studies with information on atherosclerosis measures, risk factors for cardiovascular disease, and incidence of cardiovascular diseases. It currently comprises 74 studies that involve 106,846 participants from 25 countries and over 40 cities. in summary, 21 studies recruited participants from the general population (n = 67,784), 16 from high-risk populations (n = 22,677), and 37 as part of clinical trials (n = 16,385). Baseline years of contributing studies range from April 1980 to July 2014; the latest follow-up was until June 2019. Mean age at baseline was 59 years (standard deviation: 10) and 50% were female. Over a total of 830,619 person-years of follow-up, 17,270 incident cardiovascular events (including coronary heart disease and stroke) and 13,270 deaths were recorded, corresponding to cumulative incidences of 2.1% and 1.6% per annum, respectively. the consortium is coordinated by the Clinical Epidemiology Team at the Medical University of Innsbruck, Austria. Contributing studies undergo a detailed data cleaning and harmonisation procedure before being incorporated in the Proof-ATHERO central database. Statistical analyses are being conducted according to pre-defined analysis plans and use established methods for individual-participant data meta-analysis. Capitalising on its large sample size, the multi-institutional collaborative Proof-ATHERO consortium aims to better characterise, understand, and predict the development of atherosclerosis and its clinical consequences. (c) 2020 S. Karger AG, Basel, Austrian Science Fund (FWF)Austrian Science Fund (FWF) [P 32488]; Dr.-Johannes-and-Hertha-Tuba Foundation, This work was funded by the Austrian Science Fund (FWF) (P 32488) and the Dr.-Johannes-and-Hertha-Tuba Foundation. Funders of individual studies contributing to the present analysis arelisted onthe Proof-ATHERO webpage(https://clinicalepi.i-med.ac.at/research/proof-athero/studies/).

BACKGROUND AND OBJECTIVES The relationship between operator volume and outcomes of percutaneous coronary intervention (PCI) in patients with ST-elevation myocardial infarction (STEMI) has not been fully investigated. We aimed to investigate the relationship between operator PCI volume and in-hospital outcomes after primary PCI for STEMI. METHODS Among the total of 44,967 consecutive cases of PCI enrolled in the Korean nationwide, retrospective registry (K-PCI registry), 8,282 patients treated with PCI for STEMI by 373 operators were analyzed. PCI volumes above the 75th percentile (>30 cases/year), between the 75th and 25th percentile (10-30 cases/year), and below the 25th percentile (

Monitoring and analyzing the operations of construction equipment is critical in the construction engineering and management domain. The ability to detect and classify major activities that construction equipment performs can support a project manager in making proper project-related decisions such as resource allocation and scheduling, resulting in improved productivity. Earth-moving activities as performed by an excavator, which is one of the most frequently used pieces of construction equipment, are normally repetitive by nature and possess unique features in terms of their patterns of operation. This study develops an activity identification algorithm capable of automatically classifying predefined earth-moving activities that are currently in progress. Given that the excavator is operated using joysticks, the joystick signals include unique patterns that exhibit the similar overall shapes but may not uniformly line up with time for a specific activity. The proposed study examines a dynamic time warping algorithm that determines similarities between a predefined activity and a measured signal distorted in time. The feasibility of the algorithm is verified through experiments involving activities such as digging, leveling, lifting, and trenching that were easily and accurately identified by the algorithm. The proposed task-identification algorithm could be used to develop an automated system of establishing machine parameters and to calculate the durations of operations and cycle times.

We present a survey of globular clusters (GCs) in the massive gravitational lens cluster SMACS J0723.3-7327 at $z=0.39$ based on the early released JWST/NIRCam images. In the color-magnitude diagrams of the point sources we find clearly a rich population of intracluster GCs that spread in a wide area of the cluster. Their ages, considering the cluster redshift, are younger than 9.5 Gyr. The F200W (AB) magnitudes of these GCs, $26.5, 25 pages, 12 figures, Accepted for publication in ApJL

The clinical efficacy and safety of second-generation drug-eluting stents in complex percutaneous coronary interventions (PCIs) are not well established.The clinical influence of the lesion complexity after PCI with zotarolimus-eluting stents (ZES) was evaluated.From a prospective multicenter observational study, a total of 926 patients that underwent successful PCIs with ZES were included. Complex PCIs were defined as patients with ≥3 lesions treated, 3 vessels treated, severe calcified lesions, bifurcated lesions with 2 stents implanted, left main disease, chronic total occlusion lesions, and/or diffuse long (total stent length ≥60 mm) lesions and were compared to the noncomplex group. The primary outcome was incidence of target lesion failures at 2 years, defined as a composite of cardiac death, target lesion-myocardial infarctions, and target lesion revascularization.The patients were divided into complex PCI (n = 249) and noncomplex (n = 677) groups. In the complex PCI group, the 2-year risk of a target lesion failure was not significantly higher than in the noncomplex PCI group (4.8% vs 3.7%; adjusted hazard ratio: 1.373; 95% confidence interval: 0.689-2.738;Up to 2 years after a ZES implantation, the clinical outcomes did not differ according to lesion complexity.

Patient: Female, 21-year-old Final Diagnosis: Toxocariasis-associated acute perimyocarditis with cardiogenic shock Symptoms: Dizziness • epigastric pain • headache • vomiting Medication: — Clinical Procedure: — Specialty: Cardiology Objective: Rare disease Background: Toxocariasis is an infection due to ingestion of the helminth parasite larvae found in dogs (Toxocara canis) or cats (Toxocara cati). Symptoms vary from being asymptomatic to shock, depending on the organ invaded by the parasite. However, cardiac involvement with shock in toxocariasis is very rare. Case Report: A 21-year-old woman without any history of underlying conditions visited the Emergency Department because of epigastric pain, vomiting, headache, and dizziness. Her blood pressure was 80/60 mmHg. Computed tomography (CT) of the brain showed no abnormal lesions. The abdominal-pelvic CT with contrast showed right pleural effusion, pericardial effusion, and focal ascites in the pelvic cavity. Laboratory tests revealed an elevation of eosinophils (40%) and cardiac enzymes (creatinine kinase-MB 27.6 ng/mL, high-sensitive cardiac troponin T 1.21 ng/mL). The transthoracic echocardiogram showed left ventricular systolic dysfunction (ejection fraction 44%) and moderate pericardial effusion. She was presumptively diagnosed with hypereosinophilic perimyocarditis and admitted to the Intensive Care Unit for shock. The pericardial effusion increased during treatment; therefore, pericardiocentesis was performed. Analysis of the pericardial effusion showed eosinophilia (eosinophils 90%) and the serologic test for parasites was positive for Toxocara and Sparganum. A combination therapy of albendazole, praziquantel, and corticosteroid resolved the pericardial effusion and the peripheral blood eosinophil count normalized. She was discharged without any other complications. At Outpatient Clinic follow-ups and observations over the next 2 years there were no abnormal findings, including pericardial effusion or eosinophilia. Conclusions: Toxocariasis rarely causes perimyocarditis with cardiogenic shock. Patients who present with pericardial effusion and eosinophilia need to be evaluated for parasitic infection.

Background The benefits and risks of prolonged dual antiplatelet therapy (DAPT) have not been studied extensively across a broad spectrum of acute coronary syndromes. In this study we investigated whether treatment effects of prolonged DAPT were consistent in patients presenting with ST-segment elevation myocardial infarction (STEMI) vs. non-STEMI (NSTEMI).Methods and Results:As a post hoc analysis of the SMART-DATE trial, effects of ≥12 vs. 6 months DAPT were compared among 1,023 patients presenting with STEMI and 853 NSTEMI patients. The primary outcome was a composite of recurrent myocardial infarction (MI) or stent thrombosis at 18 months after the index procedure. Compared with the 6-month DAPT group, the rate of the composite endpoint was significantly lower in the ≥12-month DAPT group (1.2% vs. 3.8%; hazard ratio [HR] 0.31, 95% confidence interval [CI] 0.12-0.77; P=0.012). The treatment effect of ≥12- vs. 6-month DAPT on the composite endpoint was consistent among NSTEMI patients (0.2% vs. 1.2%, respectively; HR 0.20, 95% CI 0.02-1.70; P=0.140; Pinteraction=0.718). In addition, ≥12-month DAPT increased Bleeding Academic Research Consortium (BARC) Type 2-5 bleeding among both STEMI (4.4% vs. 2.0%; HR 2.18, 95% CI 1.03-4.60; P=0.041) and NSTEMI (5.1% vs. 2.2%; HR 2.37, 95% CI 1.08-5.17; P=0.031; Pinteraction=0.885) patients. Conclusions Compared with 6-month DAPT, ≥12-month DAPT reduced recurrent MI or stent thrombosis regardless of the type of MI at presentation.

Aims. High-risk carotid plaque remains an important risk factor for atherosclerotic cardiovascular disease (ASCVD). We sought to evaluate the characteristics of carotid plaque and to find out the predictors for high-risk carotid plaque in asymptomatic Koreans. Methods. Subjects ( n = 801 ) without a history of ASCVD from 12 university hospitals in Korea underwent carotid ultrasound. The images were standardized at core laboratory. Morphologic characteristics of plaque were analyzed with laboratory and clinical characteristics. High-risk carotid plaque features included the highest quartile of carotid plaque score (cPS), irregular plaque surface, and hypoechoic and ulcerated plaque. Results. The carotid plaque prevalence was 22.1% (177/801 persons, 293 plaques). The plaque was increased with age ( p < 0.001 ) and conventional ASCVD risk estimator ( p < 0.001 ) and the most frequently found in bulb ( n = 190 , 64.8%). The number of the highest quartile of cPS was 44/177 (24.9%). Irregular plaque was seen in 20.8% out of total plaque (61/293) and was more frequent in the high-risk 10-year ASCVD risk group than in the low-risk group (36.1% vs. 15.8%, p = 0.023 ). Hypoechoic and ulcerated plaques were seen in 14.3% (42/293) and 2% (6/293), respectively. The independent predictors for high-risk plaque were age ( β = 0.052 , p < 0.001 ), HbA1c ( β = 0.182 , p = 0.004 ), male ( β = 0.118 , p = 0.006 ), hypertension ( β = 0.090 , p = 0.032 ), and multiple plaques (OR: 4.810 (two plaques) and 8.621 (three plaques), all p < 0.001 ). Conclusions. This study suggests that high-risk carotid plaque was seen in 12.4% (99/801). The high-risk plaque was associated with diabetes control status reflected by the HbA1c level as well as traditional risk factors in asymptomatic Korean population.

Importance After percutaneous coronary intervention (PCI), patients withCYP2C19*2or*3loss-of-function (LOF) variants treated with clopidogrel have increased risk of ischemic events. Whether genotype-guided selection of oral P2Y12 inhibitor therapy improves ischemic outcomes is unknown. Objective To determine the effect of a genotype-guided oral P2Y12 inhibitor strategy on ischemic outcomes inCYP2C19LOF carriers after PCI. Design, Setting, and Participants Open-label randomized clinical trial of 5302 patients undergoing PCI for acute coronary syndromes (ACS) or stable coronary artery disease (CAD). Patients were enrolled at 40 centers in the US, Canada, South Korea, and Mexico from May 2013 through October 2018; final date of follow-up was October 2019. Interventions Patients randomized to the genotype-guided group (n = 2652) underwent point-of-care genotyping.CYP2C19LOF carriers were prescribed ticagrelor and noncarriers clopidogrel. Patients randomized to the conventional group (n = 2650) were prescribed clopidogrel and underwent genotyping after 12 months. Main Outcomes and Measures The primary end point was a composite of cardiovascular death, myocardial infarction, stroke, stent thrombosis, and severe recurrent ischemia at 12 months. A secondary end point was major or minor bleeding at 12 months. The primary analysis was in patients withCYP2C19LOF variants, and secondary analysis included all randomized patients. The trial had 85% power to detect a minimum hazard ratio of 0.50. Results Among 5302 patients randomized (median age, 62 years; 25% women), 82% had ACS and 18% had stable CAD; 94% completed the trial. Of 1849 withCYP2C19LOF variants, 764 of 903 (85%) assigned to genotype-guided therapy received ticagrelor, and 932 of 946 (99%) assigned to conventional therapy received clopidogrel. The primary end point occurred in 35 of 903CYP2C19LOF carriers (4.0%) in the genotype-guided therapy group and 54 of 946 (5.9%) in the conventional therapy group at 12 months (hazard ratio [HR], 0.66 [95% CI, 0.43-1.02];P = .06). None of the 11 prespecified secondary end points showed significant differences, including major or minor bleeding inCYP2C19LOF carriers in the genotype-guided group (1.9%) vs the conventional therapy group (1.6%) at 12 months (HR, 1.22 [95% CI, 0.60-2.51];P = .58). Among all randomized patients, the primary end point occurred in 113 of 2641 (4.4%) in the genotype-guided group and 135 of 2635 (5.3%) in the conventional group (HR, 0.84 [95% CI, 0.65-1.07];P = .16). Conclusions and Relevance AmongCYP2C19LOF carriers with ACS and stable CAD undergoing PCI, genotype-guided selection of an oral P2Y12 inhibitor, compared with conventional clopidogrel therapy without point-of-care genotyping, resulted in no statistically significant difference in a composite end point of cardiovascular death, myocardial infarction, stroke, stent thrombosis, and severe recurrent ischemia based on the prespecified analysis plan and the treatment effect that the study was powered to detect at 12 months. Trial Registration ClinicalTrials.gov Identifier:NCT01742117

Variability of blood pressure (BP) is known as a prognostic value for the subsequent target organ damage in hypertensive patients. Arterial stiffness is a risk factor for cardiovascular morbidity and mortality. The relationship between the arterial stiffness and the BP variability has been controversial. The objective of the present study was to investigate the relationship between arterial stiffness and home BP variability in patients with high normal BP and new onset hypertension (HTN). Four hundred sixty three patients (252 males, 49 ± 12 year-old) with high normal BP or HTN were enrolled. Using radial applanation tonometry, pulse wave analysis (PWA) was performed for evaluation of systemic arterial stiffness. All patients underwent both home BP monitoring (HBPM) and PWA. Home BP variability was calculated as the standard deviation (SD) of 7 measurements of HBPM. Multiple linear regression analysis was performed to estimate and test the independent effects of home BP variability on the arterial stiffness. Mutivariate analysis showed that both systolic and diastolic morning BP variabilities were correlated with arterial stiffness expressed as augmentation pressure (AP, β-coefficient = 1.622, P = .01 and β-coefficient = 1.07, P = .035). The SDs of systolic and diastolic BP of evening were also associated with AP (β-coefficient = 1.843, P = .001 and β-coefficient = 1.088, P = .036). The SDs of morning and evening systolic BP were associated with augmentation index (AI, β-coefficient = 1.583, P = .02 and β-coefficient = 1.792, P = .001) and heart rate (75 bpm) adjusted AI (β-coefficient = 1.592, P = .001 and β-coefficient = 1.792, P = .001). In present study, the variability of systolic BP was closely related with arterial stiffness. The home BP variability might be important indicator of arterial stiffness.

Background: Although the current guidelines endorse the PRECISE-DAPT score (Predicting Bleeding Complications in Patients Undergoing Stent Implantation and Subsequent Dual Antiplatelet Therapy) to inform clinical decisions regarding duration of DAPT in patients undergoing percutaneous coronary intervention, use of the PRECISE-DAPT score to guide duration of DAPT has not been properly validated by randomized trials focused on the population with acute coronary syndrome. This study aimed to evaluate the usefulness of the PRECISE-DAPT score for predicting future bleeding and ischemic events and to compare clinical outcomes of short-term and long-term DAPT duration according to the PRECISE-DAPT score in patients with acute coronary syndrome. Methods: This was a substudy of the SMART-DATE trial (6- Versus 12-Month or Longer Dual Antiplatelet Therapy After Percutaneous Coronary Intervention in Patients With Acute Coronary Syndrome), in which patients with acute coronary syndrome undergoing percutaneous coronary intervention were randomly assigned to either 6- (n=1357) or 12-month or longer DAPT (n=1355). Major bleeding (Bleeding Academic Research Consortium type 3–5) and ischemic (myocardial infarction, stent thrombosis, or ischemic stroke) events at 18 months after the index procedure were compared between the 6- and 12-month or longer DAPT groups, according to PRECISE-DAPT score. Results: The PRECISE-DAPT score was moderately effective at predicting bleeding events (area under the curve, 0.754 [95% CI, 0.655–0.854]; P P =0.040; absolute risk difference, +1.3%; P =0.035) with similar bleeding risk (0.4% versus 0.3%; HR, 2.00 [95% CI, 0.37–10.94]; P =0.422; absolute risk difference, +0.2%; P =0.498), compared with 12-month or longer DAPT. Among patients with high PRECISE-DAPT score (≥25, n=745 [27.5%]), 6-month DAPT presented a similar ischemic risk (4.8% versus 3.4%; HR, 1.43 [95% CI, 0.68–2.98], P =0.348; absolute risk difference, +1.5%; P =0.327) but significantly reduced major bleeding risk (0.6% versus 2.3%; HR, 0.25 [95% CI, 0.05–1.17]; P =0.079; absolute risk difference, −1.7%; P =0.045). Conclusions: Consistent with current guidelines, determination of the duration of DAPT according to PRECISE-DAPT score could improve the clinical outcomes in patients with acute coronary syndrome after percutaneous coronary intervention with current-generation drug-eluting stents. Registration: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT01701453.

Background Despite the chronicled success of low-density lipoprotein cholesterol (LDLc)-lowering statin therapy, substantial residual cardiovascular (CV) disease risk remains a problem worldwide, highlighting the need to for combination therapies targeting non-LDLc factors, such as with fenofibrate. Methods/design The STAFENO trial is a prospective, randomized, open-label, multi-center trial to compare the effect of statin plus fenofibrate with statin alone on the reduction and stabilization of plaque in non-diabetic, combined dyslipidemia patients with non-intervened, intermediate coronary artery disease (CAD) using virtual histology-intravascular ultrasound at 12 months. A total of 106 eligible patients are planned to be randomized to receive either a combination therapy (rosuvastatin 10 mg plus fenofibrate 160 mg/day) or monotherapy (rosuvastatin 10 mg/day) for 12 months. The primary endpoint of this study is the percentage change in the necrotic core volume. Secondary endpoints include changes in tissue characteristics and 1-year major CV events, including all-cause mortality, CV mortality, nonfatal myocardial infarction, stroke, and revascularization of the intervened and non-intervened lesions. Discussion The STAFENO trial will address whether combination treatment of statin and fenofibrate has an additive beneficial effect compared to statin alone on the reduction and stabilization of plaque and CV events in non-diabetic, combined dyslipidemia patients with non-intervened intermediate CAD. Trial registration ClinicalTrials.gov, NCT02232360. Registered 9 February 2014. https://register.clinicaltrials.gov/prs/app/action/SelectProtocol?sid=S0004ULE&selectaction=Edit&uid=U00023SZ&ts=2&cx=juppd2

Background: The mechanism of in-stent restenosis (ISR) is multifactorial, which includes biological, mechanical and technical factors. This study hypothesized that increased inflammatory reaction, which is known to be an important atherosclerotic process, at a culprit lesion may lead to higher restenosis rates. Methods: The study population consisted of 241 patients who had undergone percutaneous coronary intervention with virtual histology-intravascular ultrasound (VH-IVUS) and a 9-month follow-up coronary angiography. Compared herein is the coronary plaque composition between patients with ISR and those without ISR. Results: Patients with ISR (n = 27) were likely to be older (66.2 ± 9.5 years vs. 58.7 ± 11.7 years, p = 0.002) and have higher levels of high-sensitivity C-reactive protein (hs-CRP, 1.60 ± 3.59 mg/dL vs. 0.31 ± 0.76 mg/dL, p < 0.001) than those without ISR (n = 214). VH-IVUS examination showed that percent necrotic core volume (14.3 ± 8.7% vs. 19.5 ± 9.1%, p = 0.005) was higher in those without ISR than those with ISR. Multivariate analysis revealed that hs-CRP (odds ratio [OR] 3.334, 95% con­fidence interval [CI] 1.158–9.596, p = 0.026) and age (OR 3.557, 95% CI 1.242–10.192, p = 0.018) were associated with ISR. Conclusions: This study suggests that ISR is not associated with baseline coronary plaque composition but is associated with old age and increased expression of the inflammatory marker of hs-CRP. (Cardiol J 2018; 25, 1: 7–13)

Hypertension has been associated with atherosclerosis and cardiovascular disease. Carotid intima media thickness is increased in hypertensive patients. But, the correlation between carotid intima media thickness and antihypertensive agents is still uncertain. Therefore, we investigated carotid intima media thickness based on types of antihypertensive agents. 1809 patients were enrolled in this study and it showed that 1079 hypertensive patients had thicker carotid intima media thickness than non-hypertensive patients, with carotid intima media thicknesses of (0.72 ± 17 mm vs 0.64 ± 15 mm, P

BACKGROUND: Patients with peripheral artery disease have an increased risk of cardiovascular morbidity and mortality. Antiplatelet agents are widely used to reduce these complications.METHODS: This was a multicentre, double-blind, randomised placebo-controlled trial for which patients were recruited at 602 hospitals, clinics, or community practices from 33 countries across six continents. Eligible patients had a history of peripheral artery disease of the lower extremities (previous peripheral bypass surgery or angioplasty, limb or foot amputation, intermittent claudication with objective evidence of peripheral artery disease), of the carotid arteries (previous carotid artery revascularisation or asymptomatic carotid artery stenosis of at least 50%), or coronary artery disease with an ankle-brachial index of less than 0·90. After a 30-day run-in period, patients were randomly assigned (1:1:1) to receive oral rivaroxaban (2·5 mg twice a day) plus aspirin (100 mg once a day), rivaroxaban twice a day (5 mg with aspirin placebo once a day), or to aspirin once a day (100 mg and rivaroxaban placebo twice a day). Randomisation was computer generated. Each treatment group was double dummy, and the patient, investigators, and central study staff were masked to treatment allocation. The primary outcome was cardiovascular death, myocardial infarction or stroke; the primary peripheral artery disease outcome was major adverse limb events including major amputation. This trial is registered with ClinicalTrials.gov, number NCT01776424, and is closed to new participants.FINDINGS: Between March 12, 2013, and May 10, 2016, we enrolled 7470 patients with peripheral artery disease from 558 centres. The combination of rivaroxaban plus aspirin compared with aspirin alone reduced the composite endpoint of cardiovascular death, myocardial infarction, or stroke (126 [5%] of 2492 vs 174 [7%] of 2504; hazard ratio [HR] 0·72, 95% CI 0·57-0·90, p=0·0047), and major adverse limb events including major amputation (32 [1%] vs 60 [2%]; HR 0·54 95% CI 0·35-0·82, p=0·0037). Rivaroxaban 5 mg twice a day compared with aspirin alone did not significantly reduce the composite endpoint (149 [6%] of 2474 vs 174 [7%] of 2504; HR 0·86, 95% CI 0·69-1·08, p=0·19), but reduced major adverse limb events including major amputation (40 [2%] vs 60 [2%]; HR 0·67, 95% CI 0·45-1·00, p=0·05). The median duration of treatment was 21 months. The use of the rivaroxaban plus aspirin combination increased major bleeding compared with the aspirin alone group (77 [3%] of 2492 vs 48 [2%] of 2504; HR 1·61, 95% CI 1·12-2·31, p=0·0089), which was mainly gastrointestinal. Similarly, major bleeding occurred in 79 (3%) of 2474 patients with rivaroxaban 5 mg, and in 48 (2%) of 2504 in the aspirin alone group (HR 1·68, 95% CI 1·17-2·40; p=0·0043).INTERPRETATION: Low-dose rivaroxaban taken twice a day plus aspirin once a day reduced major adverse cardiovascular and limb events when compared with aspirin alone. Although major bleeding was increased, fatal or critical organ bleeding was not. This combination therapy represents an important advance in the management of patients with peripheral artery disease. Rivaroxaban alone did not significantly reduce major adverse cardiovascular events compared with asprin alone, but reduced major adverse limb events and increased major bleeding.FUNDING: Bayer AG.

Background/Aims We evaluated the efficacy and safety and influence on glucose tolerance by different doses of pitavastatins in acute myocardial infarction (AMI) patients. Methods Consecutive 1,101 AMI patients who were enrolled in Livalo in Acute Myocardial Infarction Study (LAMIS)-II were randomly assigned to receive either 2 mg of pitavastatin or 4 mg of pitavastatin orally per day. Primary efficacy endpoint was composite of cardiac death, nonfatal myocardial infarction, target-lesion revascularization, and hospitalization for unstable angina, heart failure or arrhythmic events at 12-month. Results There was no significant difference in primary efficacy endpoint between 2 mg and 4 mg groups (9.07% vs. 9.13%, p = 0.976). The degree of the reduction of low density lipoprotein cholesterol (LDL-C) was significantly greater in 4 mg group compared to 2 mg group from baseline to follow-up (–42.05 ± 32.73 mg/dL vs. –34.23 ± 31.66 mg/dL, p = 0.002). Fasting plasma glucose level was reduced significantly in both groups (–20.16 ± 54.49 mg/dL in 4 mg group and –24.45 ± 63.88 mg/dL in 2 mg group, p < 0.001 and p < 0.001, respectively) and there was no significant change of glycated hemoglobin in two groups from baseline to follow-up (–0.13% ± 1.21% in 4 mg group and –0.04% ± 1.10% in 2 mg group, p = 0.256 and p = 0.671, respectively). Conclusions Although LDL-C was reduced more significantly by using 4 mg of pitavastatin compared to 2 mg of pitavastatin, the event rate was comparable without adverse effects on glucose tolerance in both groups in AMI patients who were enrolled in LAMIS-II.

We evaluated the relationship among BMI, carotid sonographic findings, and long-term (5 years) cardiovascular events in Asian patients with coronary artery disease (CAD).The study population consisted of 1342 consecutive patients with CAD, who were stratified into four groups according to weight status, as defined by the WHO for the Asian population: underweight (group I: BMI18.5 kg/m, n=38); normal weight (group II: 18.5≤BMI23.5 kg/m, n=352); overweight (group III: 23.5≤BMI27.5 kg/m, n=700); and obese (group IV: BMI≥27.5 kg/m, n=252). All patients underwent carotid ultrasonography. Multivariate analysis was performed to identify predictors of long-term mortality, and the results were expressed in terms of hazard ratio (HR) with 95% confidence interval (95% CI).Compared with the other groups, groups I and II included older patients and had a higher incidence of multivessel CAD, carotid plaque (group I: 42.1%; group II: 42.3%; group III: 27.9%; group IV: 24.6%; P=0.003), and major cardiovascular events including cardiac death, acute myocardial infarction, and stroke. In multivariate analysis, old age, lower ejection fraction, high carotid intima-media thickness, and presence of carotid plaque were positive independent predictors for mortality, whereas BMI was a negative independent predictor (group II: HR=0.28, 95% CI=0.14-0.57, P0.001; group III: HR=0.26, 95% CI=0.13-0.51, P0.001; group IV: HR=0.08, 95% CI=0.03-0.22, P0.001).In patients with CAD, underweight and normal-weight status was associated with higher long-term mortality rates and incidence of major cardiovascular events, suggesting that the obesity paradox is also manifested in Asian patients with CAD.

The aim of this study was to evaluate the efficacy and tolerability of rosuvastatin/ezetimibe combination therapy in Korean patients with high cardiovascular risk.This was a 12-week, randomized, double-blind, placebo-controlled, multicenter study. A total of 337 patients were screened. After a 4-week run-in period, 245 of these patients with high or moderately high risk as defined by the National Cholesterol Education Program Adult Treatment Panel III guidelines were randomly assigned. Patients received 1 of 6 regimens for 8 weeks as follows: (1) rosuvastatin 5 mg, (2) rosuvastatin 5 mg/ezetimibe 10 mg, (3) rosuvastatin 10 mg, (4) rosuvastatin 10 mg/ezetimibe 10 mg, (5) rosuvastatin 20 mg, or (6) rosuvastatin 20 mg/ezetimibe 10 mg. The primary outcome variable was percentage change in the level of LDL-C at week 8 of drug treatment. Secondary outcome variables included percentage changes of other lipid variables and achievement rates of LDL-C targets. Tolerability analyses were also performed.The percentage change of LDL-C ranged from -45% to -56% (mean, -51%) in the monotherapy groups and from -58% to -63% (mean, -60%) in the combination therapy groups. The percentage change was greater in the pooled combination therapy group than in the counterpart (P0.001 for the pooled groups); this difference was more obvious for regimens with a lower statin dose. The percentage reductions of total cholesterol and triglycerides were greater in the combination groups than in the monotherapy groups. The LDL-C target achievement rates were 64% to 87% (mean, 73%) in the monotherapy groups and 87% to 95% (mean, 91%) in the combination groups (P = 0.01 for the pooled groups). The rates were significantly greater in patients receiving the combination therapy than in the monotherapy at lower doses of rosuvastatin. The proportions of patients with various adverse events were not significantly different between the groups.Rosuvastatin/ezetimibe combination therapy has better efficacy and target achievement rates than rosuvastatin monotherapy in patients with high cardiovascular risk.

Background Despite large reductions in door-to-balloon times over the period, several studies from regional and national data showed that annual mortality rates were not decreased among patients who underwent primary percutaneous coronary intervention (PCI). However, these studies mostly focused on door-to-balloon time, and there was no consideration of total ischemic time in a trend of mortality. The aim of this study was to assess the annual trend between time to treatment and 1-month mortality among patients undergoing primary PCI. Methods and results The study population consisted of 8040 patients who underwent primary PCI at hospitals participating in the nationwide prospective Korea Acute Myocardial Infarction Registry (KAMIR) between January 2008 and December 2011. The primary end point of this study was 1-month all-cause mortality, and time to treatment (door-to-balloon time, symptom-to-balloon time). One-month death occurred in 452 patients (5.6%) from 2008 to 2011. Additional reductions in door-to-balloon time were not translated into parallel reductions in mortality rate and total ischemic time. After adjustment using clinical risk, shorter total ischemic time was an independent predictor of 1-month mortality [adjusted odds ratio (OR) 0.78, 95% confidential interval (CI) 0.62–0.99, p = 0.04]. Total ischemic time could be reduced by using emergency medical services. Conclusion Despite improvements in door-to-balloon time, no parallel reductions in mortality rate and total ischemic time were observed. Total ischemic time was associated with mortality. The present study suggests that additional efforts are needed to shorten total ischemic time including patient and pre-hospital systemic delay for better prognosis after primary PCI.

Background Successful percutaneous coronary intervention (PCI) of the occluded infarct-related artery (IRA) in latecomers may improve long-term survival mainly by reducing left ventricular remodeling. It is not clear whether inhibition of renin–angiotensin system (RAS) brings additional better clinical outcomes in this specific population subset. Methods Between January 2008 and June 2013, 669 latecomer patients with acute ST-segment elevation myocardial infarction (STEMI) (66.2 ± 12.1 years, 71.0% males) in Korea Acute Myocardial Infarction Registry (KAMIR) who underwent a successful PCI were enrolled. The study population underwent a successful PCI for a totally occluded IRA. They were divided into two groups according to whether they were prescribed RAS inhibitors at the time of discharge: group I (RAS inhibition, n = 556), and group II (no RAS inhibition, n = 113). Results During the one-year follow-up, major adverse cardiac events (MACE), which consist of cardiac death and myocardial infarction, occurred in 71 patients (10.6%). There were significantly reduced incidences of MACE in the group I (hazard ratio = 0.34, 95% confidence interval 0.199–0.588, p = 0.001). In subgroup analyses, RAS inhibition was beneficial in patients with male gender, history of hypertension or diabetes mellitus, and even in patients with left ventricular ejection fraction (LVEF) ≥40%. In the baseline and follow-up echocardiographic data, benefit in changes of LVEF and left ventricular end-systolic volume was noted in group I. Conclusions In latecomers with STEMI, RAS inhibition improved long-term clinical outcomes after a successful PCI, even in patients with low risk who had relatively preserved LVEF.

It is unclear whether simvastatin-ezetimibe could be an alternative therapy to high-intensity statin therapy in high-risk patients. The aim of this study was to compare the clinical outcomes of simvastatin-ezetimibe and high-intensity statin therapy in patients with acute myocardial infarction (AMI), and especially in those with high-risk factor.A total of 3520 AMI patients in the KAMIR (Korea Acute Myocardial Infarction Registry) were classified into simvastatin-ezetimibe group (n=1249) and high-intensity statin group (n=2271). Multivariate analysis and propensity-score matching analysis were performed. The primary endpoint was major adverse cardiac events (MACE) at 12-months follow-up.In overall AMI patients, MACE occurred in 116 patients (9.3%) in simvastatin-ezetimibe group and 116 patients (5.1%) in high-intensity statin group. The difference in MACE between groups was driven by repeat revascularization (5.9% vs. 2.2%). After propensity matching analysis, simvastatin-ezetimibe was associated with a higher incidence of MACE than high-intensity statin therapy (adjusted hazard ratio: 3.090, 95% confidence interval: 1.715 to 5.566, p0.001). However, in patients with high-risk factors, such as diabetes, old age, or heart failure, simvastatin-ezetimibe had similar incidence of MACE compared with high-intensity statin therapy in further adjusted analysis.In overall AMI patients, high-intensity statin therapy had better clinical outcomes than simvastatin-ezetimibe. However, in patients with high-risk factor, simvastatin-ezetimibe had comparable clinical outcomes to high-intensity statin therapy. Therefore, simvastatin-ezetimibe could be used as an alternative to high-intensity statin therapy in such patients.

SummaryAim It is still unclear which layer (intima or media) is mainly involved in increased carotid intima-media thickness (CIMT) by aging and also unclear regarding CIMT value suggesting high cardiovascular risk, although 75th percentile value of CIMT is known as a high risk in asymptomatic adults. We sought to find the changes of carotid intima thickness (CIT) and carotid media thickness (CMT) by aging and the 75th percentile value of CIMT in asymptomatic Korean adults. Method This is an observational cohort study. Carotid ultrasound findings (n=2204 from 12 hospitals) were prospectively collected. The carotid images were sent to Korea Research Institute of Standards and Science for analysis using specialized software which can measure intima and media wall also. Results Mean age was 58.1±13.5 years old (52% of men). Pearson's correlation coefficient between age and right CIMT (r=.489, P