Background: This study investigates the long-term efficacy and safety of evogliptin add-on therapy in patients with inadequately controlled type 2 diabetes mellitus (T2DM) previously received dapagliflozin and metformin (DAPA/MET) combination. Methods: In this multicenter randomized placebo-controlled phase 3 trial, patients with glycosylated hemoglobin (HbA1c) levels 7.0% to 10.5% (n=283) previously used DAPA 10 mg plus MET (≥1,000 mg) were randomly assigned to the evogliptin 5 mg once daily or placebo group (1:1). The primary endpoint was the difference in the HbA1c level from baseline at week 24, and exploratory endpoints included the efficacy and safety of evogliptin over 52 weeks (trial registration: ClinicalTrials.gov NCT04170998). Results: Evogliptin add-on to DAPA/MET therapy was superior in HbA1c reduction compared to placebo at weeks 24 and 52 (least square [LS] mean difference, –0.65% and –0.55%; 95% confidence interval [CI], –0.79 to –0.51 and –0.71 to –0.39; P<0.0001). The proportion of patients achieving HbA1c <7% was higher in the triple combination group at week 52 (32.14% vs. 8.51% in placebo; odds ratio, 5.62; P<0.0001). Evogliptin significantly reduced the fasting glucose levels and mean daily glucose levels with improvement in homeostatic model assessment of β-cell function (LS mean difference, 9.04; 95% CI, 1.86 to 16.21; P=0.0138). Adverse events were similar between the groups, and no serious adverse drug reactions were reported in the evogliptin group. Conclusion Long-term triple combination with evogliptin added to DAPA/MET showed superior HbA1c reduction and glycemic control compared to placebo at 52 weeks and was well tolerated.

Background and objectives: This study aimed to identify the characteristics and clinical outcomes of cancer patients who developed constrictive physiology (CP) after percutaneous pericardiocentesis. Methods: One-hundred thirty-three cancer patients who underwent pericardiocentesis were divided into 2 groups according to follow-up echocardiography (CP vs. non-CP). The clinical history, imaging findings, and laboratory results, and overall survival were compared. Results: CP developed in 49 (36.8%) patients after pericardiocentesis. The CP group had a more frequent history of radiation therapy. Pericardial enhancement and malignant masses abutting the pericardium were more frequently observed in the CP group. Fever and ST segment elevation were more frequent in the CP group, with higher C-reactive protein levels (6.6±4.3mg/dL vs. 3.3±2.5mg/dL, p<0.001). Pericardial fluid leukocytes counts were significantly higher, and positive cytology was more frequent in the CP group. In baseline echocardiography before pericardiocentesis, medial e′ velocity was significantly higher in the CP group (8.6±2.1cm/s vs. 6.5±2.3cm/s, p<0.001), and respirophasic ventricular septal shift, prominent expiratory hepatic venous flow reversal, pericardial adhesion, and loculated pericardial fluid were also more frequent. The risk of all-cause death was significantly high in the CP group (hazard ratio, 1.53; 95% confidence interval,1.10–2.13; p=0.005). Conclusions CP frequently develops after pericardiocentesis, and it is associated with poor survival in cancer patients. Several clinical signs, imaging, and laboratory findings suggestive of pericardial inflammation and/or direct malignant pericardial invasion are frequently observed and could be used as predictors of CP development.

BACKGROUND AND OBJECTIVES: Although anticoagulation with warfarin is recommended as an international normalized ratio (INR) of prothrombin time between 2.0 and 3.0 and mean time in the therapeutic range (TTR) ≥70%, little has been proven that universal criteria might be suitable in Korean atrial fibrillation (AF) patients.METHODS: We analyzed 710 patients with non-valvular AF who took warfarin. INR value and clinical outcomes were assessed during 2-year follow-up. Intensity of anticoagulation was assessed as mean INR value and TTR according to target INR range. Primary net-clinical outcome was defined as the composite of new-onset stroke and major bleeding. Secondary net-clinical outcome was defined as the composite of new-onset stroke, major bleeding and death.RESULTS: Thromboembolism was significantly decreased when mean INR was over 1.6. Major bleeding was significantly decreased when TTR was over 70% and mean INR was less than 2.6. Mean INR 1.6–2.6 significantly reduced thromboembolism (adjusted hazard ratio [HR], 0.40; 95% confidence interval [CI], 0.19–0.85), major bleeding (HR, 0.43; 95% CI, 0.23–0.81), primary (HR, 0.50; 95% CI, 0.29–0.84) and secondary (HR, 0.45; 95% CI, 0.28–0.74) net-clinical outcomes, whereas mean INR 2.0–3.0 did not. Simultaneous satisfaction of mean INR 1.6–2.6 and TTR ≥70% was associated with significant risk reduction of major bleeding, primary and secondary net-clinical outcomes.CONCLUSIONS: Mean INR 1.6–2.6 was better than mean INR 2.0–3.0 for the prevention of thromboembolism and major bleeding. However, INR 1.6–2.6 and TTR ≥70% had similar clinical outcomes to INR 2.0–3.0 and TTR ≥70% in Korean patients with non-valvular AF.
Atrial Fibrillation ; Follow-Up Studies ; Hemorrhage ; Humans ; International Normalized Ratio ; Prothrombin Time ; Risk Reduction Behavior ; Stroke ; Thromboembolism ; Warfarin

We describe the occurrence of acute type A aortic dissection in a patient with situs inversus totalis. A 37-year-old man presented to the emergency department with acute chest pain. Initial chest X-ray findings showed a right-sided heart and a left-sided liver. Contrast-enhanced computed tomography revealed a Stanford type A acute aortic dissection, aortic root dilatation, and situs inversus totalis. All of the thoracic structures were mirror-image reversed and an abnormal coronary artery was observed. The Bentall operation was performed. This report demonstrates that computed tomography and echocardiography were useful for understanding the anatomy and the presence or absence of concurrent anomalies in a patient with situs inversus totalis. The patient’s postoperative course was uneventful.

BACKGROUND AND OBJECTIVES: Although anticoagulation with warfarin is recommended as an international normalized ratio (INR) of prothrombin time between 2.0 and 3.0 and mean time in the therapeutic range (TTR) ≥70%, little has been proven that universal criteria might be suitable in Korean atrial fibrillation (AF) patients. METHODS: We analyzed 710 patients with non-valvular AF who took warfarin. INR value and clinical outcomes were assessed during 2-year follow-up. Intensity of anticoagulation was assessed as mean INR value and TTR according to target INR range. Primary net-clinical outcome was defined as the composite of new-onset stroke and major bleeding. Secondary net-clinical outcome was defined as the composite of new-onset stroke, major bleeding and death. RESULTS: Thromboembolism was significantly decreased when mean INR was over 1.6. Major bleeding was significantly decreased when TTR was over 70% and mean INR was less than 2.6. Mean INR 1.6–2.6 significantly reduced thromboembolism (adjusted hazard ratio [HR], 0.40; 95% confidence interval [CI], 0.19–0.85), major bleeding (HR, 0.43; 95% CI, 0.23–0.81), primary (HR, 0.50; 95% CI, 0.29–0.84) and secondary (HR, 0.45; 95% CI, 0.28–0.74) net-clinical outcomes, whereas mean INR 2.0–3.0 did not. Simultaneous satisfaction of mean INR 1.6–2.6 and TTR ≥70% was associated with significant risk reduction of major bleeding, primary and secondary net-clinical outcomes. CONCLUSIONS Mean INR 1.6–2.6 was better than mean INR 2.0–3.0 for the prevention of thromboembolism and major bleeding. However, INR 1.6–2.6 and TTR ≥70% had similar clinical outcomes to INR 2.0–3.0 and TTR ≥70% in Korean patients with non-valvular AF.

Background: The long-term outcomes of patients discharged from the hospital after successful care in intensive care unit (ICU) are not briskly evaluated in Korea. The aim of this study was to assess long-term mortality of patients treated in the ICU and discharged alive from the hospital and to identify predictive factors of mortality. Methods: In 3,679 adult patients discharged alive from the hospital after ICU care between 2006 and 2011, the 1-year mortality rate (primary outcome measure) was investigated. Various factors were entered into multivariate analysis to identify independent factors of 1-year mortality, including sex, age, severity of illness (APACHE II score), mechanical ventilation, malignancy, readmission, type of admission (emergency, elective surgery, and medical), and diagnostic category (trauma and non-trauma). Results: The 1-year mortality rate was 13.4%. Risk factors that were associated with 1-year mortality included age (hazard ratio: 1.03 [95% CI, 1.02–1.04], P < 0.001), APACHE II score (1.03 [1.01–1.04], P < 0.001), mechanical ventilation (1.96 [1.60–2.41], P < 0.001), malignancy (2.31 [1.82–2.94], P < 0.001), readmission (1.65 [1.31–2.07], P < 0.001), emergency surgery (1.66 [1.18–2.34], P = 0.003), ICU admission due to medical causes (4.66 [3.68–5.91], P < 0.001), and non-traumatic diagnostic category (6.04 [1.50–24.38], P = 0.012). Conclusions The 1-year mortality rate was 13.4%. Old age, high APACHE II score, mechanical ventilation, malignancy, readmission, emergency surgery, ICU admission due to medical causes, and non-traumatic diagnostic category except metabolic/endocrinologic category were associated with 1-year mortality.

BACKGROUND/AIMS: It is well known that gender differences are associated with clinical outcomes in patients with acute myocardial infarction (AMI). However, it is not clear whether gender differences affect the prognosis of elderly patients with AMI. METHODS: We analyzed the incidence of in-hospital complications and mortality in the Korea Acute Myocardial Infarction Registry-National Institutes of Health from November 2011 to June 2015. This study included elderly patients (≥ 75 years) diagnosed with AMI. RESULTS: A total of 2,953 patients were eligible for this study. Among them, 1,529 (51.8%) patients were female, and the mean age of the female group was older than that of the male group (80.7 ± 4.4 vs. 79.6 ± 4.0 years, respectively, p < 0.001). Elderly females utilized emergency medical services less frequently compared with elderly males (11.5 vs. 15.4%, respectively, p < 0.001). Elderly female AMI patients had a similar rate of in-hospital mortality compared with elderly males (7.1 vs. 8.4%, respectively, p = 0.196). The rate of major cardiac adverse events (MACEs) was lower in elderly females than males during a 12-month follow-up (hazard ratio [HR] 1.19, 95% confidence interval [CI] 1.00-1.41, p = 0.045). According to multivariate analysis, the male gender is an independent factor for predicting 1-year MACEs (HR 1.37, 95% CI 1.14-1.65, p < 0.001). CONCLUSIONS: No significant differences in peri-procedural complications or in-hospital mortality were observed between male and female elderly patients with AMI. However, elderly female patients had a more favorable prognosis than male patients during a 1-year clinical follow-up.
Academies and Institutes ; Aged ; Emergency Medical Services ; Female ; Follow-Up Studies ; Hospital Mortality ; Humans ; Incidence ; Korea ; Male ; Mortality ; Multivariate Analysis ; Myocardial Infarction ; Prognosis

BACKGROUND AND OBJECTIVES: Although current guidelines recommend early initiation of statin in patients with acute myocardial infarction (AMI), there is no consensus for optimal timing of statin initiation. METHODS: A total of 3,921 statin-naïve patients undergoing percutaneous coronary intervention were analyzed, and divided into 3 groups according to statin initiation time: group 1 (statin initiation <24 hours after admission), group 2 (24–48 hours) and group 3 (≥48 hours). We also made 3 stratified models to reduce bias: model 1 (<24 hours vs. ≥24 hours), model 2 (<48 hours vs. ≥48 hours) and model 3 (<24 hours vs. 24–48 hours). The endpoint was major adverse cardiac events (MACE; composite of cardiac death, myocardial infarction and target-vessel revascularization) during median 3.8 years. RESULTS: During follow-up, incidence of MACE was lower in early statin group in both model 1 (14.3% vs. 18.4%, hazard ratio [HR], 0.77; 95% confidence interval [CI], 0.66–0.91; p=0.002) and model 2 (14.6% vs. 19.7%, HR, 0.81; 95% CI, 0.67–0.97; p=0.022). After propensity-score matching, results remained unaltered. Statin initiation <24 hours reduced MACE compared to statin initiation ≥24 hours in model 1. Statin initiation <48 hours also reduced MACE compared to statin initiation later in model 2. However, there was no difference in incidence of MACE between statin initiation <24 hours and 24–48 hours) in model 3. CONCLUSIONS: Early statin therapy within 48 hours after admission in statin-naïve patients with AMI reduced long-term clinical outcomes compared with statin initiation later. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02385682
Bias (Epidemiology) ; Consensus ; Death ; Follow-Up Studies ; Humans ; Hydroxymethylglutaryl-CoA Reductase Inhibitors ; Incidence ; Myocardial Infarction ; Percutaneous Coronary Intervention

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*

BACKGROUND/AIMS: It is well known that gender differences are associated with clinical outcomes in patients with acute myocardial infarction (AMI). However, it is not clear whether gender differences affect the prognosis of elderly patients with AMI. METHODS: We analyzed the incidence of in-hospital complications and mortality in the Korea Acute Myocardial Infarction Registry-National Institutes of Health from November 2011 to June 2015. This study included elderly patients (≥ 75 years) diagnosed with AMI. RESULTS: A total of 2,953 patients were eligible for this study. Among them, 1,529 (51.8%) patients were female, and the mean age of the female group was older than that of the male group (80.7 ± 4.4 vs. 79.6 ± 4.0 years, respectively, p < 0.001). Elderly females utilized emergency medical services less frequently compared with elderly males (11.5 vs. 15.4%, respectively, p < 0.001). Elderly female AMI patients had a similar rate of in-hospital mortality compared with elderly males (7.1 vs. 8.4%, respectively, p = 0.196). The rate of major cardiac adverse events (MACEs) was lower in elderly females than males during a 12-month follow-up (hazard ratio [HR] 1.19, 95% confidence interval [CI] 1.00-1.41, p = 0.045). According to multivariate analysis, the male gender is an independent factor for predicting 1-year MACEs (HR 1.37, 95% CI 1.14-1.65, p < 0.001). CONCLUSIONS No significant differences in peri-procedural complications or in-hospital mortality were observed between male and female elderly patients with AMI. However, elderly female patients had a more favorable prognosis than male patients during a 1-year clinical follow-up.