Background: Barriers to treatment with intravenous thrombolysis (IVT) for patients with acute ischemic stroke (AIS) in South Korea remain incompletely characterized. We analyze a nationwide prospective cohort to determine patient-level features associated with delayed presentation and non-treatment of potential IVT-eligible patients. Methods: We identified consecutive patients with AIS from 01/2011 to 08/2023 from a multicenter and prospective acute stroke registry in Korea. Patients were defined as IVT candidates if they presented within 4.5 hours from the last known well, had no lab evidence of coagulopathy, and had National Institute of Health Stroke Scale (NIHSS) ≥ 4. Multivariable generalized linear mixed regression models were used to investigate the associations between their characteristics and the IVT candidates or the use of IVT among the candidates. Results: Among 84,103 AIS patients, 41.0% were female, with a mean age of 69 ± 13 years and presentation NIHSS of 4 [interquartile range, 1–8]. Out of these patients, 13,757 (16.4%) were eligible for IVT, of whom 8,179 (59.5%) received IVT. Female sex (adjusted risk ratio [RR], 0.90; 95% confidence interval [CI], 0.86–0.94) and lower years of education (adjusted RR, 0.90; 95% CI, 0.84–0.97 for 0–3 years, compared to ≥ 13 years) were associated with a decreased likelihood of presenting as eligible for IVT after AIS; meanwhile, young age (adjusted RR, 1.12; 95% CI, 1.01–1.24 for ≤ 44 years, compared to 75–84 years) was associated with an increased likelihood of being an IVT candidate. Among those who were eligible for IVT, only age was significantly associated with the use of IVT (adjusted RR, 1.09; 95% CI, 1.03–1.16 for age 65–74 and adjusted RR, 0.83; 95% CI, 0.76–0.90 for ≥ 85 years, respectively). Conclusion Most patients with AIS present outside IVT eligibility in South Korea, and only 60% of eligible patients were ultimately treated. We identified increased age, female sex and lower education as key features on which to focus interventions for improving IVT utilization.

Objective: CT-P13, a biosimilar of infliximab, is widely used for treating ankylosing spondylitis (AS). However, the formation of anti-drug antibodies (ADAs) can reduce its efficacy. This study aimed to identify risk factors associated with high ADA levels in AS patients treated with CT-P13. Methods: A prospective observational study enrolled patients with intravenous CT-P13. Clinical data and disease activity was assessed at baseline, 24 weeks, and 54 weeks after CT-P13 treatment. Blood concentrations of CT-P13 and ADAs were measured at 24 and 54 weeks, and their correlation was investigated. Patients were grouped by ADA levels at 54 weeks. Univariable and multivariable logistic regression identified factors associated with high ADA concentrations. Results: A total of 34 patients was enrolled. Significant decreases in Bath Ankylosing Spondylitis Disease Activity Index and Bath Ankylosing Spondylitis Functional Index scores were observed relative to baseline after 24 weeks of CT-P13 therapy. Serum concentrations of CT-P13 and ADA levels increased following treatment. The median serum CT-P13 concentration was 17.6 [12.8, 22.7] µg/mL at 24 weeks and 23.5 [11.7, 34.2] µg/mL at 54 weeks. ADA levels were 6.7 [6.5, 9.1] AU/mL at 24 weeks and 11.4 [9.0, 28.4] AU/mL at 54 weeks. The serum concentrations of CT-P13 and ADA exhibited a negative correlation. In multivariable analysis, current smoking was associated with high ADA production at 54 weeks. Conclusion Smoking is identified as a significant risk factor for elevated ADAs in AS patients treated with CT-P13. The findings underscore the importance of smoking-cessation strategies in the management of AS patients.

Background: and Purpose Previous research on patients with acute ischemic stroke (AIS) has shown a 0.5% incidence of major gastrointestinal bleeding (GIB) requiring blood transfusion during hospitalization. The existing literature has insufficiently explored the long-term incidence in this population despite the decremental impact of GIB on stroke outcomes. Methods: We analyzed the data from a cohort of patients with AIS admitted to 14 hospitals as part of a nationwide multicenter prospective stroke registry between 2011 and 2013. These patients were followed up for up to 6 years. The occurrence of major GIB events, defined as GIB necessitating at least two units of blood transfusion, was tracked using the National Health Insurance Service claims data. Results: Among 10,818 patients with AIS (male, 59%; mean age, 68±13 years), 947 (8.8%) experienced 1,224 episodes of major GIB over a median follow-up duration of 3.1 years. Remarkably, 20% of 947 patients experienced multiple episodes of major GIB. The incidence peaked in the first month after AIS, reaching 19.2 per 100 person-years, and gradually decreased to approximately one-sixth of this rate by the 2nd year with subsequent stabilization. Multivariable analysis identified the following predictors of major GIB: anemia, estimated glomerular filtration rate <60 mL/min/1.73 m2 , and a 3-month modified Rankin Scale score of ≥4. Conclusion Patients with AIS are susceptible to major GIB, particularly in the first month after the onset of AIS, with the risk decreasing thereafter. Implementing preventive strategies may be important, especially for patients with anemia and impaired renal function at stroke onset and those with a disabling stroke.

Background and Objectives: Among various emerging catheter-based treatments for severe tricuspid regurgitation (TR), the spacer device can reduce the regurgitation orifice without manipulating the valve leaflet. However, its clinical application has been hampered by traumatic anchoring to the myocardium and the coaxial alignment of the balloon resulting in insufficient TR reduction. This study aimed to evaluate the early-stage safety, technical feasibility, and preliminary efficacy of the novel atraumatic vertical spacer in patients with isolated severe TR. Methods: All procedures were guided by fluoroscopy and transthoracic echocardiography.The maximum device placement time with an inflated balloon was 24 hours. Changes in the amount of TR, right ventricular function, and patient hemodynamics were measured during balloon deployment. Results: A total of 7 patients (median age 74), underwent successful device implantation without procedure-related complications. During balloon inflation (median 25 minutes), there were no symptoms or signs indicative of TR intolerance. TR was reduced by 1 grade or greater in all patients, with 2 patients exhibiting a reduction of 3 grades, from torrential TR to a moderate degree. Mild TR after balloon inflation was achieved in 3 patients with baseline severe TR. The TR reduction observed during initial balloon deployment was sustained during the subsequent balloon maintenance period. Conclusions The Pivot-balloon procedure was safe, technically feasible, and effective in reducing TR in patients with severe TR. No periprocedural complications or adverse cardiovascular events were reported during device placement with TR reduction observed in all patients. However, longer-term follow-up is needed to confirm safety and treatment effect.

Objective: CT-P13, a biosimilar of infliximab, is widely used for treating ankylosing spondylitis (AS). However, the formation of anti-drug antibodies (ADAs) can reduce its efficacy. This study aimed to identify risk factors associated with high ADA levels in AS patients treated with CT-P13. Methods: A prospective observational study enrolled patients with intravenous CT-P13. Clinical data and disease activity was assessed at baseline, 24 weeks, and 54 weeks after CT-P13 treatment. Blood concentrations of CT-P13 and ADAs were measured at 24 and 54 weeks, and their correlation was investigated. Patients were grouped by ADA levels at 54 weeks. Univariable and multivariable logistic regression identified factors associated with high ADA concentrations. Results: A total of 34 patients was enrolled. Significant decreases in Bath Ankylosing Spondylitis Disease Activity Index and Bath Ankylosing Spondylitis Functional Index scores were observed relative to baseline after 24 weeks of CT-P13 therapy. Serum concentrations of CT-P13 and ADA levels increased following treatment. The median serum CT-P13 concentration was 17.6 [12.8, 22.7] µg/mL at 24 weeks and 23.5 [11.7, 34.2] µg/mL at 54 weeks. ADA levels were 6.7 [6.5, 9.1] AU/mL at 24 weeks and 11.4 [9.0, 28.4] AU/mL at 54 weeks. The serum concentrations of CT-P13 and ADA exhibited a negative correlation. In multivariable analysis, current smoking was associated with high ADA production at 54 weeks. Conclusion Smoking is identified as a significant risk factor for elevated ADAs in AS patients treated with CT-P13. The findings underscore the importance of smoking-cessation strategies in the management of AS patients.

Background: and Purpose Previous research on patients with acute ischemic stroke (AIS) has shown a 0.5% incidence of major gastrointestinal bleeding (GIB) requiring blood transfusion during hospitalization. The existing literature has insufficiently explored the long-term incidence in this population despite the decremental impact of GIB on stroke outcomes. Methods: We analyzed the data from a cohort of patients with AIS admitted to 14 hospitals as part of a nationwide multicenter prospective stroke registry between 2011 and 2013. These patients were followed up for up to 6 years. The occurrence of major GIB events, defined as GIB necessitating at least two units of blood transfusion, was tracked using the National Health Insurance Service claims data. Results: Among 10,818 patients with AIS (male, 59%; mean age, 68±13 years), 947 (8.8%) experienced 1,224 episodes of major GIB over a median follow-up duration of 3.1 years. Remarkably, 20% of 947 patients experienced multiple episodes of major GIB. The incidence peaked in the first month after AIS, reaching 19.2 per 100 person-years, and gradually decreased to approximately one-sixth of this rate by the 2nd year with subsequent stabilization. Multivariable analysis identified the following predictors of major GIB: anemia, estimated glomerular filtration rate <60 mL/min/1.73 m2 , and a 3-month modified Rankin Scale score of ≥4. Conclusion Patients with AIS are susceptible to major GIB, particularly in the first month after the onset of AIS, with the risk decreasing thereafter. Implementing preventive strategies may be important, especially for patients with anemia and impaired renal function at stroke onset and those with a disabling stroke.