Rivaroxaban has emerged as a potential alternative to warfarin for the prevention of thromboembolism in patients with atrial fibrillation (AF). However, there has been concern for the risk of major bleeding, especially in Asian patients. We investigated the efficacy and safety of rivaroxaban compared to warfarin in Korean real world practice. A total of 2,208 consecutive non-valvular AF patients were divided into the Warfarin group (n=990) and the Rivaroxaban group (n=1218). Propensity matched 1-year clinical outcomes were compared (Warfarin, n=804; Rivaroxaban, n=804). The efficacy outcome was defined as stroke/systemic embolism (SE). The safety outcome was major bleeding. The primary net clinical benefit (NCB) was defined as the composite of stroke/SE, major bleeding, and all-cause mortality. Secondary, NCB was defined as the composite of stroke, SE, and major bleeding. Rivaroxaban had the similar efficacy in terms of thromboembolic event prevention [hazard ratio (HR) 0.69, 95% confidence interval (CI) 0.37–1.32, p=0.266] compared to warfarin. Rivaroxaban significantly lowered the risk of major bleeding [HR 0.41, 95% CI 0.22–0.76, p=0.004]. Primary NCB was significantly low in the rivaroxaban group [HR 0.54, 95% CI 0.36–0.81, p=0.003]. Secondary NCB was also low in the rivaroxaban group [HR 0.62, 95% CI 0.40–0.99, p=0.041]. Both rivaroxaban 15 mg and 20 mg groups had similar efficacy and significantly lower risks of major bleeding as well as primary and secondary NCB compared to the warfarin group. In patients with non-valvular AF, rivaroxaban had a similar efficacy to warfarin in Korean real world practice. However, rivaroxaban had better safety and net clinical outcomes compared to warfarin.
Asian Continental Ancestry Group ; Atrial Fibrillation* ; Cohort Studies* ; Embolism ; Hemorrhage ; Humans ; Mortality ; Rivaroxaban* ; Stroke ; Thromboembolism ; Warfarin*

OBJECTIVE: To evaluate the efficacy of the morphologic-metabolic (M-M) dissociation sign based on computed tomography (CT) and fluorine-18-fluorodeoxyglucose positron emission tomography (PET)/CT in discriminating invasive mucinous adenocarcinoma (IMA) from invasive non-mucinous adenocarcinomas (ADCs) of the lung. MATERIALS AND METHODS: The Institutional Review Board approved this retrospective study. Among surgically resected solitary pulmonary nodule (SPN)-type ADCs (< 3 cm in diameter), 35 patients with IMAs and 329 with invasive non-mucinous ADCs were included. Morphologic malignancy was established if the tumor with lobulated or spiculated margin on CT presented a tumor shadow disappearance rate of < 0.5. The M-M dissociation sign was determined when a malignant-morphologic nodule on CT showed maximum standardized uptake value (SUVmax) < 3.5 on PET/CT. RESULTS: Among 35 IMAs (size: 21 ± 7 mm, SUVmax: 1.8 ± 2.0) and 329 invasive non-mucinous ADCs (size: 21 ± 6 mm, SUVmax: 4.6 ± 4.2), the M-M dissociation sign was observed in 54% of IMAs (19/35) and 10% of invasive non-mucinous ADCs (34/329) (p < 0.001). The diagnostic performance of the sign in discriminating IMA from invasive non-mucinous ADCs showed a sensitivity of 54.3% (95% confidence interval [CI], 36.7–71.2), specificity 89.7% (95% CI, 85.9–92.7), positive predictive value 35.8% (95% CI, 26.5–46.5), and negative predictive value 94.9% (95% CI, 92.8–96.4). Multivariate analyses revealed metabolic benignity (odds ratio [OR] 2.99; 95% CI, 1.01–8.93; p = 0.047) and M-M dissociation sign (OR 6.35; 95% CI, 2.76–14.62; p < 0.001) to be significant predictors of SPN-type IMAs. CONCLUSION: Identification of the absence of M-M dissociation sign is an accurate indicator for excluding IMA from SPN-type lung ADCs.
Adenocarcinoma ; Adenocarcinoma, Mucinous ; Diagnosis ; Ethics Committees, Research ; Fluorodeoxyglucose F18 ; Humans ; Lung ; Mucins ; Multivariate Analysis ; Positron-Emission Tomography ; Positron-Emission Tomography and Computed Tomography ; Retrospective Studies ; Sensitivity and Specificity ; Solitary Pulmonary Nodule

OBJECTIVE: This study investigated the associations of suicidal ideation (SI) evaluated within 2 weeks after an acute coronary syndrome (ACS) episode with functioning, disability, and quality of life (QOL) at a 1-year follow-up assessment. METHODS: This study recruited 1152 consecutive patients within 2 weeks of a confirmed ACS episode; 828 of these patients who were followed up 1 year later comprised the study sample. SI was determined at baseline using the “suicidal thoughts” item of the MontgomeryÅsberg Depression Rating Scale. At both examinations, social and occupational functioning were measured by the Social and Occupational Functioning Assessment Scale (SOFAS), disability was estimated by World Health Organization Disability Assessment Schedule-12 (WHODAS-12), and QOL was assessed using the World Health Organization Quality of Life-Abbreviated form (WHOQOL-BREF). Baseline covariates included sociodemographic data, depression characteristics, cardiovascular risk factors, and current cardiac status. RESULTS: SI at baseline was independently associated with less improved or decreased scores on the SOFAS, WHODAS-12, and WHOQOL-BREF over 1 year after adjusting for relevant covariates. CONCLUSION: SI within 2 weeks of an ACS episode predicted poorer functioning and QOL at a 1-year follow-up assessment. Thus, the simple evaluation of SI in patients with recently developed ACS could be helpful in screening for functioning and QOL during the chronic phase of this disease.
Acute Coronary Syndrome ; Depression ; Follow-Up Studies ; Humans ; Mass Screening ; Quality of Life ; Risk Factors ; Social Adjustment ; Suicidal Ideation ; World Health Organization

BACKGROUND: Combination of metformin to reduce the fasting plasma glucose level and an α-glucosidase inhibitor to decrease the postprandial glucose level is expected to generate a complementary effect. We compared the efficacy and safety of a fixed-dose combination of voglibose plus metformin (vogmet) with metformin monotherapy in drug-naïve newly-diagnosed type 2 diabetes mellitus. METHODS: A total of 187 eligible patients aged 20 to 70 years, with a glycosylated hemoglobin (HbA1c) level of 7.0% to 11.0%, were randomized into either vogmet or metformin treatments for 24 weeks. A change in the HbA1c level from baseline was measured at week 24. RESULTS: The reduction in the levels of HbA1c was −1.62%±0.07% in the vogmet group and −1.31%±0.07% in the metformin group (P=0.003), and significantly more vogmet-treated patients achieved the target HbA1c levels of <6.5% (P=0.002) or <7% (P=0.039). Glycemic variability was also significantly improved with vogmet treatment, estimated by M-values (P=0.004). Gastrointestinal adverse events and hypoglycemia (%) were numerically lower in the vogmet-treated group. Moreover, a significant weight loss was observed with vogmet treatment compared with metformin (−1.63 kg vs. −0.86 kg, P=0.039). CONCLUSION: Vogmet is a safe antihyperglycemic agent that controls blood glucose level effectively, yields weight loss, and is superior to metformin in terms of various key glycemic parameters without increasing the risk of hypoglycemia.
Blood Glucose ; Diabetes Mellitus, Type 2 ; Fasting ; Glucose ; Hemoglobin A, Glycosylated ; Humans ; Hypoglycemia ; Metformin ; Weight Loss

BACKGROUND: Thyroid-stimulating hormone (TSH) suppression is recommended for patients who undergo thyroidectomy for differentiated thyroid cancer (DTC). However, the impact of TSH suppression on clinical outcomes in low-risk DTC remains uncertain. Therefore, we investigated the effects of postoperative TSH levels on recurrence in patients with low-risk DTC after thyroid lobectomy. METHODS: Patients (n=1,528) who underwent thyroid lobectomy for papillary thyroid carcinoma between 2000 and 2012 were included in this study. According to the mean and dominant TSH values during the entire follow-up period or 5 years, patients were divided into four groups (<0.5, 0.5 to 1.9, 2.0 to 4.4, and ≥4.5 mIU/L). Recurrence-free survival was compared among the groups. RESULTS: During the 5.6 years of follow-up, 21 patients (1.4%) experienced recurrence. Mean TSH levels were within the recommended low-normal range (0.5 to 1.9 mIU/L) during the total follow-up period or 5 years in 38.1% or 36.0% of patients. The mean and dominant TSH values did not affect recurrence-free survival. Adjustment for other risk factors did not alter the results. CONCLUSION: Serum TSH levels did not affect short-term recurrence in patients with low-risk DTC after thyroid lobectomy. TSH suppression should be conducted more selectively.
Follow-Up Studies ; Humans ; Recurrence ; Risk Factors ; Thyroid Gland ; Thyroid Neoplasms ; Thyroidectomy ; Thyrotropin

BACKGROUND/AIMS: Little evidence is available about the effect of change in nonalcoholic fatty liver disease (NAFLD) status on risk of diabetes mellitus (DM) development. In this study, we tried to analyze the DM risk according to change in NAFLD status over time. METHODS: Among a total of 10,141 individuals for whom routine healthcare assessment was performed, 2,726 subjects were selected according to the inclusion/exclusion criteria. NAFLD status change was determined by using serial abdominal ultrasonography and fatty liver index (FLI) during the follow-up period. RESULTS: Subjects were categorized according to change in NAFLD status as follows: 670 subjects in the persistent NAFLD group, 155 subjects in the resolved NAFLD group, 498 subjects in the incident NAFLD group, and 1,403 subjects in the no NAFLD group. Multivariate Cox regression analysis revealed that incident NAFLD (hazard ratio [HR], 1.94; 95% confidence interval [CI], 1.08 to 3.50; p=0.026) and persistent NAFLD (HR, 3.59; 95% CI, 2.05 to 6.27; p<0.001) were independent risk factors for predicting DM development, whereas the risk with resolved NAFLD was not significantly different from that with no NAFLD. FLI could reproduce the results acquired by ultrasonography. CONCLUSIONS: This study demonstrated that future DM risk could be influenced by changes in NAFLD status over time. Resolution of NAFLD could reduce the risk of future DM development, while the development of new NAFLD could increase the risk of DM development.
Delivery of Health Care ; Diabetes Mellitus ; Diabetes Mellitus, Type 2 ; Fatty Liver ; Follow-Up Studies ; Non-alcoholic Fatty Liver Disease ; Obesity ; Risk Factors ; Ultrasonography

BACKGROUND/AIMS: Barcelona Clinic Liver Cancer (BCLC) C stage demonstrates considerable heterogeneity because it includes patients with either symptomatic tumors (performance status [PS], 1–2) or with an invasive tumoral pattern reflected by the presence of vascular invasion (VI) or extrahepatic spread (EHS). This study aimed to derive a more relevant staging system by modification of the BCLC system considering the prognostic implication of PS. METHODS: A total of 7,501 subjects who were registered in the Korean multicenter hepatocellular carcinoma (HCC) registry database from 2008 to 2013 were analyzed. The relative goodness-of-fit between staging systems was compared using the Akaike information criterion (AIC) and integrated area under the curve (IAUC). Three modified BCLC (m-BCLC) systems (#1, #2, and #3) were devised by reducing the role of PS. RESULTS: As a result, the BCLC C stage, which includes patients with PS 1–2 without VI/EHS, was reassigned to stage 0, A, or B according to their tumor burden in the m-BCLC #2 model. This model was identified as the most explanatory and desirable model for HCC staging by demonstrating the smallest AIC (AIC=70,088.01) and the largest IAUC (IAUC=0.722), while the original BCLC showed the largest AIC (AIC=70,697.17) and the smallest IAUC (IAUC=0.705). The m-BCLC #2 stage C was further subclassified into C1, C2, C3, and C4 according to the Child-Pugh score, PS, presence of EHS, and tumor extent. The C1 to C4 subgroups showed significantly different overall survival distribution between groups (p<0.001). CONCLUSIONS: An accurate and relevant staging system for patients with HCC was derived though modification of the BCLC system based on PS.
Carcinoma, Hepatocellular ; Humans ; Liver Neoplasms ; Liver ; Population Characteristics ; Tumor Burden

BACKGROUND/AIMS: Pancreatic ductal adenocarcinoma (PDA) is associated with an extremely poor prognosis. This study assessed the genetic diversity among patients with PDA and compared their mutational profiles before and after treatment. METHODS: Tumors and matched blood samples were obtained from 22 PDA patients treated with neoadjuvant chemoradiation therapy. The somatic mutations were analyzed with comprehensive cancer gene panel (CCP). In addition, the biopsy samples obtained at diagnosis and the surgically resected samples after treatment were compared for seven patients. The CCP provided formalin-fixed paraffin-embedded sample-compatible multiplexed target selection for 409 genes implicated in cancer. RESULTS: Assessments of the MLH1, MLH3, MSH2, and PMS2 genes showed that the four patients with the highest relative burdens of mutations harbored somatic mutations in at least three of these genes. Genes in the histone-lysine N-methyltransferase 2 (KMT2) family, such as KMT2D, KMT2A, and KMT2C, were frequently mutated in tumor samples. Survival was worse in patients with ARID1A gene mutations than those without ARID1A gene mutations. Mutation patterns were compared between tissue samples before and after neoadjuvant treatment in seven patients who underwent surgical resection. The allelic fraction of mutations in KRAS codon 12 was lower in the surgically resected samples than in the endoscopic ultrasonography-guided fine needle aspiration biopsy samples of six patients. The number of mutant alleles of the histone lysine methyltransferase gene WHSC1 also decreased after treatment. CONCLUSIONS: These results indicate that tumor tissue from PDA patients is genetically diverse and suggest that ARID1A mutations may be a potential prognostic marker for PDA.
Adenocarcinoma ; Alleles ; Biopsy ; Biopsy, Fine-Needle ; Codon ; Diagnosis ; Genes, Neoplasm ; Genetic Variation ; Histone-Lysine N-Methyltransferase ; Humans ; Neoadjuvant Therapy ; Pancreatic Ducts ; Pancreatic Neoplasms ; Prognosis

BACKGROUND: Patients with acute myocardial infarction (AMI) have worse clinical outcomes than those with stable coronary artery disease despite revascularization. Non-culprit lesions of AMI also involve more adverse cardiovascular events. This study aimed to investigate the influence of AMI on endothelial function, neointimal progression, and inflammation in target and non-target vessels. METHODS: In castrated male pigs, AMI was induced by balloon occlusion and reperfusion into the left anterior descending artery (LAD). Everolimus-eluting stents (EES) were implanted in the LAD and left circumflex (LCX) artery 2 days after AMI induction. In the control group, EES were implanted in the LAD and LCX in a similar fashion without AMI induction. Endothelial function was assessed using acetylcholine infusion before enrollment, after the AMI or sham operation, and at 1 month follow-up. A histological examination was conducted 1 month after stenting. RESULTS: A total of 10 pigs implanted with 20 EES in the LAD and LCX were included. Significant paradoxical vasoconstriction was assessed after acetylcholine challenge in the AMI group compared with the control group. In the histologic analysis, the AMI group showed a larger neointimal area and larger area of stenosis than the control group after EES implantation. Peri-strut inflammation and fibrin formation were significant in the AMI group without differences in injury score. The non-target vessel of the AMI also showed similar findings to the target vessel compared with the control group. CONCLUSION: In the pig model, AMI events induced endothelial dysfunction, inflammation, and neointimal progression in the target and non-target vessels.
Acetylcholine ; Arteries ; Balloon Occlusion ; Constriction, Pathologic ; Coronary Artery Disease ; Drug-Eluting Stents ; Endothelium ; Fibrin ; Follow-Up Studies ; Humans ; Inflammation ; Male ; Myocardial Infarction ; Reperfusion ; Stents ; Swine ; Vasoconstriction

OBJECTIVES: This study aimed to evaluate the addiction to highly caffeinated drinks among university students, and we investigated the relationships between smartphone addiction, depression, anxiety, attention-deficit/hyperactivity disorder (ADHD), burnout, self-esteem, impulsiveness in high caffeine drink addiction risk group (high caffeine group). We also compared these mental health factors differences between the high caffeine group and the control group; and, investigated the relative risk between the independent variables of the high caffeine group. METHODS: This study was conducted in Korea, from June 2015 to July 2016. A set of questionnaires was administered on 511 college students. RESULTS: The participants who belonged to the high caffeine group were more likely to demonstrate the symptoms of ADHD and higher levels of burnout and impulsiveness. Further, the results of logistic regression analysis confirmed the association between the high caffeine group and burnout. CONCLUSION: These behaviors among university students addicted to highly caffeinated drinks suggests the need for timely and effective interventions for those at risk of addiction.
Anxiety ; Caffeine ; Depression ; Humans ; Korea ; Logistic Models ; Mental Health ; Smartphone