1.A Real-World, Prospective, Observational Study of Rivaroxaban on Prevention of Stroke and Non-Central Nervous Systemic Embolism in Renally Impaired Korean Patients With Non-Valvular Atrial Fibrillation:XARENAL
Il-Young OH ; Chang Hoon LEE ; Eue-Keun CHOI ; Hong Euy LIM ; Yong-Seog OH ; Jong-Il CHOI ; Min-Soo AHN ; Ju Youn KIM ; Nam-Ho KIM ; Namsik YOON ; Martin SANDMANN ; Kee-Joon CHOI
Korean Circulation Journal 2025;55(2):121-131
Background and Objectives:
Several real-world studies have been done in patients with nonvalvular atrial fibrillation (NVAF); however, information on its safety profile in patients with renal impairment is limited. XARENAL, a real-world study, aimed to prospectively investigate the safety profile of rivaroxaban in patients with NVAF with renal impairment (creatinine clearance [CrCl], 15–49 mL/min).
Methods:
XARENAL is an observational single-arm cohort study in renal impairment NVAF patients. Patients were followed up approximately every 3 months for 1 year or until 30 days following early discontinuation. The primary endpoint was major bleeding events. All adverse events, symptomatic thromboembolic events, treatment duration, and renal function change from baseline were the secondary endpoints.
Results:
XARENAL included 888 patients from 29 study sites. Overall, 713 (80.3%) had moderate renal impairment (CrCl, 30–49 mL/min), and 175 (19.7%) had severe renal impairment (CrCl, 15–29 mL/min) with a mean estimated glomerular filtration rate (eGFR) of 45.2±13.0 mL/min/1.73 m 2 . The mean risk scores were 3.3±1.4 and 1.7±0.9 for CHA 2 DS 2 -VASc score and HAS-BLED score, respectively. An incidence proportion of 5.6% (6.2 events per 100 patient-years) developed major bleeding; however, fatal bleeding occurred in 0.5% (0.5 events per 100 patient-years). The mean change in the eGFR was 2.22±26.47 mL/min/1.73 m 2 per year.
Conclusions
XARENAL observed no meaningful differences in major bleeding events from other previous findings as well as renal function changes in rivaroxaban-treated NVAF patients with renal impairment, which is considered to be acceptable in clinical practice.
2.A Real-World, Prospective, Observational Study of Rivaroxaban on Prevention of Stroke and Non-Central Nervous Systemic Embolism in Renally Impaired Korean Patients With Non-Valvular Atrial Fibrillation:XARENAL
Il-Young OH ; Chang Hoon LEE ; Eue-Keun CHOI ; Hong Euy LIM ; Yong-Seog OH ; Jong-Il CHOI ; Min-Soo AHN ; Ju Youn KIM ; Nam-Ho KIM ; Namsik YOON ; Martin SANDMANN ; Kee-Joon CHOI
Korean Circulation Journal 2025;55(2):121-131
Background and Objectives:
Several real-world studies have been done in patients with nonvalvular atrial fibrillation (NVAF); however, information on its safety profile in patients with renal impairment is limited. XARENAL, a real-world study, aimed to prospectively investigate the safety profile of rivaroxaban in patients with NVAF with renal impairment (creatinine clearance [CrCl], 15–49 mL/min).
Methods:
XARENAL is an observational single-arm cohort study in renal impairment NVAF patients. Patients were followed up approximately every 3 months for 1 year or until 30 days following early discontinuation. The primary endpoint was major bleeding events. All adverse events, symptomatic thromboembolic events, treatment duration, and renal function change from baseline were the secondary endpoints.
Results:
XARENAL included 888 patients from 29 study sites. Overall, 713 (80.3%) had moderate renal impairment (CrCl, 30–49 mL/min), and 175 (19.7%) had severe renal impairment (CrCl, 15–29 mL/min) with a mean estimated glomerular filtration rate (eGFR) of 45.2±13.0 mL/min/1.73 m 2 . The mean risk scores were 3.3±1.4 and 1.7±0.9 for CHA 2 DS 2 -VASc score and HAS-BLED score, respectively. An incidence proportion of 5.6% (6.2 events per 100 patient-years) developed major bleeding; however, fatal bleeding occurred in 0.5% (0.5 events per 100 patient-years). The mean change in the eGFR was 2.22±26.47 mL/min/1.73 m 2 per year.
Conclusions
XARENAL observed no meaningful differences in major bleeding events from other previous findings as well as renal function changes in rivaroxaban-treated NVAF patients with renal impairment, which is considered to be acceptable in clinical practice.
3.A Real-World, Prospective, Observational Study of Rivaroxaban on Prevention of Stroke and Non-Central Nervous Systemic Embolism in Renally Impaired Korean Patients With Non-Valvular Atrial Fibrillation:XARENAL
Il-Young OH ; Chang Hoon LEE ; Eue-Keun CHOI ; Hong Euy LIM ; Yong-Seog OH ; Jong-Il CHOI ; Min-Soo AHN ; Ju Youn KIM ; Nam-Ho KIM ; Namsik YOON ; Martin SANDMANN ; Kee-Joon CHOI
Korean Circulation Journal 2025;55(2):121-131
Background and Objectives:
Several real-world studies have been done in patients with nonvalvular atrial fibrillation (NVAF); however, information on its safety profile in patients with renal impairment is limited. XARENAL, a real-world study, aimed to prospectively investigate the safety profile of rivaroxaban in patients with NVAF with renal impairment (creatinine clearance [CrCl], 15–49 mL/min).
Methods:
XARENAL is an observational single-arm cohort study in renal impairment NVAF patients. Patients were followed up approximately every 3 months for 1 year or until 30 days following early discontinuation. The primary endpoint was major bleeding events. All adverse events, symptomatic thromboembolic events, treatment duration, and renal function change from baseline were the secondary endpoints.
Results:
XARENAL included 888 patients from 29 study sites. Overall, 713 (80.3%) had moderate renal impairment (CrCl, 30–49 mL/min), and 175 (19.7%) had severe renal impairment (CrCl, 15–29 mL/min) with a mean estimated glomerular filtration rate (eGFR) of 45.2±13.0 mL/min/1.73 m 2 . The mean risk scores were 3.3±1.4 and 1.7±0.9 for CHA 2 DS 2 -VASc score and HAS-BLED score, respectively. An incidence proportion of 5.6% (6.2 events per 100 patient-years) developed major bleeding; however, fatal bleeding occurred in 0.5% (0.5 events per 100 patient-years). The mean change in the eGFR was 2.22±26.47 mL/min/1.73 m 2 per year.
Conclusions
XARENAL observed no meaningful differences in major bleeding events from other previous findings as well as renal function changes in rivaroxaban-treated NVAF patients with renal impairment, which is considered to be acceptable in clinical practice.
4.A Real-World, Prospective, Observational Study of Rivaroxaban on Prevention of Stroke and Non-Central Nervous Systemic Embolism in Renally Impaired Korean Patients With Non-Valvular Atrial Fibrillation:XARENAL
Il-Young OH ; Chang Hoon LEE ; Eue-Keun CHOI ; Hong Euy LIM ; Yong-Seog OH ; Jong-Il CHOI ; Min-Soo AHN ; Ju Youn KIM ; Nam-Ho KIM ; Namsik YOON ; Martin SANDMANN ; Kee-Joon CHOI
Korean Circulation Journal 2025;55(2):121-131
Background and Objectives:
Several real-world studies have been done in patients with nonvalvular atrial fibrillation (NVAF); however, information on its safety profile in patients with renal impairment is limited. XARENAL, a real-world study, aimed to prospectively investigate the safety profile of rivaroxaban in patients with NVAF with renal impairment (creatinine clearance [CrCl], 15–49 mL/min).
Methods:
XARENAL is an observational single-arm cohort study in renal impairment NVAF patients. Patients were followed up approximately every 3 months for 1 year or until 30 days following early discontinuation. The primary endpoint was major bleeding events. All adverse events, symptomatic thromboembolic events, treatment duration, and renal function change from baseline were the secondary endpoints.
Results:
XARENAL included 888 patients from 29 study sites. Overall, 713 (80.3%) had moderate renal impairment (CrCl, 30–49 mL/min), and 175 (19.7%) had severe renal impairment (CrCl, 15–29 mL/min) with a mean estimated glomerular filtration rate (eGFR) of 45.2±13.0 mL/min/1.73 m 2 . The mean risk scores were 3.3±1.4 and 1.7±0.9 for CHA 2 DS 2 -VASc score and HAS-BLED score, respectively. An incidence proportion of 5.6% (6.2 events per 100 patient-years) developed major bleeding; however, fatal bleeding occurred in 0.5% (0.5 events per 100 patient-years). The mean change in the eGFR was 2.22±26.47 mL/min/1.73 m 2 per year.
Conclusions
XARENAL observed no meaningful differences in major bleeding events from other previous findings as well as renal function changes in rivaroxaban-treated NVAF patients with renal impairment, which is considered to be acceptable in clinical practice.
6.Reliable Estimation of Atopic Dermatitis:New Diagnostic Tool for Atopic Dermatitis Using Questionnaires
Hong Euy KIM ; Sook Jung YUN ; Jee-Bum LEE ; Seong Jin KIM ; Seung Chul LEE
Korean Journal of Dermatology 2023;61(3):155-161
Background:
Diagnosis of atopic dermatitis (AD) in adults is problematic due to its heterogeneous pathogenesis and diverse clinical symptoms. Although various diagnostic tools for AD have been proposed, most focused on pediatric AD.
Objective:
This study aimed to determine whether the Reliable Estimation of Atopic Dermatitis in Childhood (REACH), a previously reported questionnaire-based diagnostic tool for pediatric AD, may be applicable to adult patients with AD, and to propose a new diagnostic tool for adult AD based on the REACH methodology.
Methods:
We administered the REACH questionnaire to adult patients with clinically confirmed AD and a control group consisting of patients with other systemic skin diseases that required clinical differentiation from AD. Based on the results of the REACH survey, the sensitivity, specificity, and positive and negative predictive values (PPV and NPV, respectively) of the REACH criteria as compared with clinically confirmed AD were analyzed.
Results:
A total of 141 adult patients participated in the survey: 91 patients with AD and 50 controls. The sensitivity, specificity, PPV, and NPV of REACH were 92.3%, 46.0%, 78.5%, and 79.4%, respectively. Also, unlike children, adult patients with AD showed a high rate of localized eczema.
Conclusion
The accuracy statistics of the REACH methodology for diagnosing adult AD showed significant agreement with clinical diagnosis. We propose the more inclusive Reliable Estimation of Atopic Dermatitis (READ) as a diagnostic tool for detecting AD in both children and adults. Adult AD can present with atypical clinical features, and READ has the potential to assist in diagnosis.
7.Analysis of clinical risk factors of failed electrical cardioversion in patients with persistent atrial fibrillation or atrial flutter
Ki‑Hun KIM ; Ha‑Young CHOI ; Jino PARK ; Yeo‑Jeong SONG ; Seunghwan KIM ; Dong‑Kie KIM ; Sang‑Hoon SEOL ; Doo‑Il KIM ; Pil‑Sung YANG ; Hong Euy LIM ; Junbeum PARK ; Jae‑Min SHIM ; Jinhee AHN ; Sung Ho LEE ; Sung Il IM ; Ju Youn KIM
International Journal of Arrhythmia 2023;24(3):17-
Background:
Although rhythm control could be the best for symptomatic atrial fibrillation (AF), some patients fail to achieve sinus rhythm (SR). This study aimed to identify clinical risk factors of failed electrical cardioversion (ECV).
Methods:
A total of 248 patients who received ECV for persistent AF or atrial flutter (AFL) were retrospectivelyreviewed. Patients were divided into three groups: Group 1 maintained SR for > 1 year, group 2 maintained SR ≤ 1 yearafter ECV, and group 3 failed ECV. SR maintenance was assessed using regular electrocardiography or Holter monitoring.
Results:
Patients were divided into group 1 (73, 29%), group 2 (146, 59%), and group 3 (29, 12%). The mean ageof patients was 60 ± 10 years, and 197 (79%) were male. Age, sex, and baseline characteristics were similar amonggroups. However, increased cardiac size, digoxin use, heart failure (HF), and decreased left ventricular ejection frac‑ tion (LVEF) were more common in group 3. Univariate analysis of clinical risk factors for failed ECV was increasedcardiac size [hazard ratio (HR) 2.14 (95% confidence interval [CI], 1.06–4.34, p = 0.030)], digoxin use [HR 2.66 (95% CI, 1.15–6.14), p = 0.027], HF [HR 2.60 (95% CI, 1.32–5.09), p = 0.005], LVEF < 40% [HR 3.45 (95% CI, 1.00–11.85), p = 0.038], and decreased LVEF [HR 2.49 (95% CI, 1.18–5.25), p = 0.012]. Among them, HF showed clinical significance only by multivariate analysis [HR 3.01 (95% CI, 1.13–7.99), p = 0.027].
Conclusions
Increased cardiac size, digoxin use, HF, LVEF < 40%, and decreased LVEF were related to failed ECV for persistent AF or AFL. Among these, HF was the most important risk factor. Further multi-center studies including greater number of participants are planned.
9.Erythema Nodosum after Vaccination against Coronavirus Disease 2019
Na Gyeong YANG ; Jeong Yeon HONG ; Jae Yun KIM ; Sung Yul LEE ; Jung Eun KIM ; Shi Nae YU ; Euy Hyun CHUNG
Korean Journal of Dermatology 2022;60(6):383-386
Erythema nodosum (EN) is the most common form of panniculitis and may be triggered by a variety of stimuli, including infections, drugs, pregnancy, sarcoidosis, inflammatory bowel disease, and malignancies. Rare cases of vaccination-related EN have been reported, but none due to the coronavirus disease 2019 (COVID-19) vaccine of Pfizer have been documented. We report a case of EN associated with the Pfizer vaccine. A 43-year-old woman presented with acute-onset painful nodular lesions that appeared bilaterally on the extensor surface of the lower legs. These lesions appeared 5 days after the first dose of Pfizer vaccination. The patient reported no recent infectious history other than fever for 3 days after vaccination. Skin biopsy revealed inflammation extending into the subcutaneous fat with a septal distribution. It is important for physicians to be aware of the side effects of the COVID-19 vaccine because more people are bound to be vaccinated.
10.Skin Manifestations Following COVID-19 Vaccination: A Multicenter Case Series Study in Korea
Hee Jung YOON ; Min Jung KWON ; Eun Ji HONG ; Yun Su EUN ; Euy Hyun CHUNG ; Jung Eun KIM ; SangHoon LEE ; Young Lip PARK ; Sul Hee LEE
Korean Journal of Dermatology 2022;60(9):576-584
Background:
During the coronavirus disease 2019 (COVID-19) pandemic, large-scale vaccinations have been performed worldwide without sufficient verification of safety profiles. So far, little is known about skin manifestations following COVID-19 vaccination in Korean patients.
Objective:
We investigated the epidemiological and clinical characteristics of patients who had skin manifestations following COVID-19 vaccination in Korea.
Methods:
We retrospectively reviewed the data of 123 patients that presented with skin manifestations within 1 month after COVID-19 vaccination from two tertiary referral hospitals in Korea. The types of COVID-19 vaccinations administered to the patients, demographics, comorbidities, and clinical course of the patients were obtained from the data. Statistical analyses of the extracted data were performed using Microsoft Excel.
Results:
Skin manifestations following COVID-19 vaccination were mostly observed in patients in their 40s (23.6%), according to our data. Urticarial eruption was the most common manifestation, followed by macular rash (17.1%) and papulosquamous eruption (17.1%). Notably, 70% of the patients showed delayed reactions. More than half of the patients showed a good prognosis, and their symptoms were relieved with conservative treatment, including corticosteroids and antihistamines, even after additional vaccination.
Conclusion
We statistically analyzed the prevalence and characteristics of skin manifestations after COVID-19 vaccination. Urticarial eruptions are the most common skin manifestations associated with the COVID-19 vaccination. We believe that this real-world retrospective study will provide valuable information for doctors who treat patients with skin manifestations after COVID-19 vaccination by providing real-world experience in Korea.

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