4.Clinical Outcomes After Drug-Coated Balloon Treatment in Popliteal Artery Disease: K-POP Registry 12-Month Results
Jong-Il PARK ; Young-Guk KO ; Seung-Jun LEE ; Chul-Min AHN ; Seung-Woon RHA ; Cheol-Woong YU ; Jong Kwan PARK ; Sang-Ho PARK ; Jae-Hwan LEE ; Su-Hong KIM ; Yong-Joon LEE ; Sung-Jin HONG ; Jung-Sun KIM ; Byeong-Keuk KIM ; Myeong-Ki HONG ; Donghoon CHOI
Korean Circulation Journal 2024;54(8):454-465
Background and Objectives:
The popliteal artery is generally regarded as a “no-stent zone.”Limited data are available on the outcomes of drug-coated balloons (DCBs) for popliteal artery disease. This study aimed to evaluate the 12-month clinical outcomes among patients who received DCB treatment for atherosclerotic popliteal artery disease.
Methods:
This prospective, multicenter registry study enrolled 100 patients from 7 Korean endovascular centers who underwent endovascular therapy using IN.PACT DCB (Medtronic) for symptomatic atherosclerotic popliteal artery disease. The primary endpoint was 12-month clinical primary patency and the secondary endpoint was clinically driven target lesion revascularization (TLR)–free rate.
Results:
The mean age of the study cohort was 65.7±10.8 years, and 77% of enrolled patients were men. The mean lesion length was 93.7±53.7 mm, and total occlusions were present in 45% of patients. Technical success was achieved in all patients. Combined atherectomy was performed in 17% and provisional stenting was required in 11%. Out of the enrolled patients, 91 patients completed the 12-month follow-up. Clinical primary patency and TLR-free survival rates at 12 months were 76.0% and 87.2%, respectively. A multivariate Cox regression analysis identified female and longer lesion length as the significant independent predictors of loss of patency.
Conclusions
DCB treatment yielded favorable 12-month clinical primary patency and TLRfree survival outcomes in patients with popliteal artery disease.
5.Noninferiority Outcomes of Besifovir Compared to Tenofovir Alafenamide in Treatment-Naïve Patients with Chronic Hepatitis B
Tae Hyung KIM ; Ji Hoon KIM ; Hyung Joon YIM ; Yeon Seok SEO ; Sun Young YIM ; Young-Sun LEE ; Young Kul JUNG ; Jong Eun YEON ; Soon Ho UM ; Kwan Soo BYUN
Gut and Liver 2024;18(2):305-315
Background/Aims:
Besifovir dipivoxil maleate (BSV) and tenofovir alafenamide fumarate (TAF) have been recently approved in Korea as the initial antiviral agents for chronic hepatitis B (CHB).However, the real-world outcome data for these drugs remain limited. Therefore, we conducted a noninferiority analysis using real-world data to compare the clinical outcomes of the two nucleotide analogs in treatment-naïve patients with CHB.
Methods:
We retrospectively investigated a cohort of patients with CHB who received BSV or TAF as first-line antiviral agents. The endpoints were virological response (VR) and liver-related clinical outcomes.
Results:
A total of 537 patients, consisting of 202 and 335 patients administered BSV and TAF, respectively, were followed up for 42 months. No significant difference was observed between the VRs of the patients from the two groups. The rates of biochemical response, virologic breakthrough, and incidence rates of hepatocellular carcinoma did not differ between the groups. However, the hepatitis B e antigen seroclearance rate was higher and the renal function declined less in the BSV group. Multivariable analysis indicated older age, alcohol abuse, cirrhosis and ascites, and lower serum HBV DNA level to be independently associated with increased hepatocellular carcinoma risk. The 1:1 propensity score-matched analysis with 400 patients showed VR rates of 85.0% and 88.7% in the BSV and TAF group patients, respectively, at 2 years. The absolute value of the 95% confidence interval for the difference (–0.04 to 0.12) satisfied the a priori limit of a noninferiority of 0.15.
Conclusions
BSV is noninferior to TAF in terms of VR, and their clinical outcomes are comparable to CHB.
6.Clinical Outcomes After Drug-Coated Balloon Treatment in Popliteal Artery Disease: K-POP Registry 12-Month Results
Jong-Il PARK ; Young-Guk KO ; Seung-Jun LEE ; Chul-Min AHN ; Seung-Woon RHA ; Cheol-Woong YU ; Jong Kwan PARK ; Sang-Ho PARK ; Jae-Hwan LEE ; Su-Hong KIM ; Yong-Joon LEE ; Sung-Jin HONG ; Jung-Sun KIM ; Byeong-Keuk KIM ; Myeong-Ki HONG ; Donghoon CHOI
Korean Circulation Journal 2024;54(8):454-465
Background and Objectives:
The popliteal artery is generally regarded as a “no-stent zone.”Limited data are available on the outcomes of drug-coated balloons (DCBs) for popliteal artery disease. This study aimed to evaluate the 12-month clinical outcomes among patients who received DCB treatment for atherosclerotic popliteal artery disease.
Methods:
This prospective, multicenter registry study enrolled 100 patients from 7 Korean endovascular centers who underwent endovascular therapy using IN.PACT DCB (Medtronic) for symptomatic atherosclerotic popliteal artery disease. The primary endpoint was 12-month clinical primary patency and the secondary endpoint was clinically driven target lesion revascularization (TLR)–free rate.
Results:
The mean age of the study cohort was 65.7±10.8 years, and 77% of enrolled patients were men. The mean lesion length was 93.7±53.7 mm, and total occlusions were present in 45% of patients. Technical success was achieved in all patients. Combined atherectomy was performed in 17% and provisional stenting was required in 11%. Out of the enrolled patients, 91 patients completed the 12-month follow-up. Clinical primary patency and TLR-free survival rates at 12 months were 76.0% and 87.2%, respectively. A multivariate Cox regression analysis identified female and longer lesion length as the significant independent predictors of loss of patency.
Conclusions
DCB treatment yielded favorable 12-month clinical primary patency and TLRfree survival outcomes in patients with popliteal artery disease.
7.Clinical Outcomes After Drug-Coated Balloon Treatment in Popliteal Artery Disease: K-POP Registry 12-Month Results
Jong-Il PARK ; Young-Guk KO ; Seung-Jun LEE ; Chul-Min AHN ; Seung-Woon RHA ; Cheol-Woong YU ; Jong Kwan PARK ; Sang-Ho PARK ; Jae-Hwan LEE ; Su-Hong KIM ; Yong-Joon LEE ; Sung-Jin HONG ; Jung-Sun KIM ; Byeong-Keuk KIM ; Myeong-Ki HONG ; Donghoon CHOI
Korean Circulation Journal 2024;54(8):454-465
Background and Objectives:
The popliteal artery is generally regarded as a “no-stent zone.”Limited data are available on the outcomes of drug-coated balloons (DCBs) for popliteal artery disease. This study aimed to evaluate the 12-month clinical outcomes among patients who received DCB treatment for atherosclerotic popliteal artery disease.
Methods:
This prospective, multicenter registry study enrolled 100 patients from 7 Korean endovascular centers who underwent endovascular therapy using IN.PACT DCB (Medtronic) for symptomatic atherosclerotic popliteal artery disease. The primary endpoint was 12-month clinical primary patency and the secondary endpoint was clinically driven target lesion revascularization (TLR)–free rate.
Results:
The mean age of the study cohort was 65.7±10.8 years, and 77% of enrolled patients were men. The mean lesion length was 93.7±53.7 mm, and total occlusions were present in 45% of patients. Technical success was achieved in all patients. Combined atherectomy was performed in 17% and provisional stenting was required in 11%. Out of the enrolled patients, 91 patients completed the 12-month follow-up. Clinical primary patency and TLR-free survival rates at 12 months were 76.0% and 87.2%, respectively. A multivariate Cox regression analysis identified female and longer lesion length as the significant independent predictors of loss of patency.
Conclusions
DCB treatment yielded favorable 12-month clinical primary patency and TLRfree survival outcomes in patients with popliteal artery disease.
8.Risk of Lymphedema After Sentinel Node Biopsy in Patients With Breast Cancer
Jinyoung BYEON ; Eunhye KANG ; Ji-Jung JUNG ; Jong-Ho CHEUN ; Kwan Sik SEO ; Hong-Kyu KIM ; Han-Byoel LEE ; Wonshik HAN ; Hyeong-Gon MOON
Journal of Breast Cancer 2024;27(5):323-333
Purpose:
Although numerous studies have identified potential risk factors for ipsilateral lymphedema development in patients with breast cancer following axillary node dissection, the risk factors for lymphedema in patients undergoing sentinel node biopsy without axillary dissection remain unclear. In this study, we aimed to determine the real-world incidence and risk factors for lymphedema in such patients.
Methods:
We conducted a single-center, retrospective review of medical records of patients with breast cancer who underwent sentinel node biopsy alone. The development cohort (5,051 patients, January 2017–December 2020) was analyzed to identify predictors of lymphedema, and a predictive model was subsequently created. A validation cohort (1,627 patients, January 2014–December 2016) was used to validate the model.
Results:
In the development cohort, 49 patients (0.9%) developed lymphedema over a median follow-up of 56 months, with most cases occurring within the first three years post-operation.Multivariate analysis revealed that a body mass index (BMI) of 30 kg/m2 or above, radiation therapy (RTx), chemotherapy, and more than three harvested lymph nodes significantly predicted lymphedema. The predictive model showed an area under the curve of 0.824 for systemic chemotherapy, with the number of harvested lymph nodes being the most significant factor. Patients were stratified into four risk groups, showing lymphedema incidences of 3.3% in the highest-risk group and 0.1% in the lowest-risk group. In the validation cohort, the incidences were 1.7% and 0.2% for the highest and lowest risk groups, respectively.
Conclusion
The lymphedema prediction model identifies RTx, chemotherapy, BMI ≥ 30 kg/m2 , and more than three harvested lymph nodes as significant risk factors. Although the overall incidence is low, the risk is notably influenced by the extent of lymph node removal and systemic therapies. The model’s high negative predictive value supports its application in designing tailored lymphedema surveillance programs for early intervention.
9.Risk of Lymphedema After Sentinel Node Biopsy in Patients With Breast Cancer
Jinyoung BYEON ; Eunhye KANG ; Ji-Jung JUNG ; Jong-Ho CHEUN ; Kwan Sik SEO ; Hong-Kyu KIM ; Han-Byoel LEE ; Wonshik HAN ; Hyeong-Gon MOON
Journal of Breast Cancer 2024;27(5):323-333
Purpose:
Although numerous studies have identified potential risk factors for ipsilateral lymphedema development in patients with breast cancer following axillary node dissection, the risk factors for lymphedema in patients undergoing sentinel node biopsy without axillary dissection remain unclear. In this study, we aimed to determine the real-world incidence and risk factors for lymphedema in such patients.
Methods:
We conducted a single-center, retrospective review of medical records of patients with breast cancer who underwent sentinel node biopsy alone. The development cohort (5,051 patients, January 2017–December 2020) was analyzed to identify predictors of lymphedema, and a predictive model was subsequently created. A validation cohort (1,627 patients, January 2014–December 2016) was used to validate the model.
Results:
In the development cohort, 49 patients (0.9%) developed lymphedema over a median follow-up of 56 months, with most cases occurring within the first three years post-operation.Multivariate analysis revealed that a body mass index (BMI) of 30 kg/m2 or above, radiation therapy (RTx), chemotherapy, and more than three harvested lymph nodes significantly predicted lymphedema. The predictive model showed an area under the curve of 0.824 for systemic chemotherapy, with the number of harvested lymph nodes being the most significant factor. Patients were stratified into four risk groups, showing lymphedema incidences of 3.3% in the highest-risk group and 0.1% in the lowest-risk group. In the validation cohort, the incidences were 1.7% and 0.2% for the highest and lowest risk groups, respectively.
Conclusion
The lymphedema prediction model identifies RTx, chemotherapy, BMI ≥ 30 kg/m2 , and more than three harvested lymph nodes as significant risk factors. Although the overall incidence is low, the risk is notably influenced by the extent of lymph node removal and systemic therapies. The model’s high negative predictive value supports its application in designing tailored lymphedema surveillance programs for early intervention.
10.Risk of Lymphedema After Sentinel Node Biopsy in Patients With Breast Cancer
Jinyoung BYEON ; Eunhye KANG ; Ji-Jung JUNG ; Jong-Ho CHEUN ; Kwan Sik SEO ; Hong-Kyu KIM ; Han-Byoel LEE ; Wonshik HAN ; Hyeong-Gon MOON
Journal of Breast Cancer 2024;27(5):323-333
Purpose:
Although numerous studies have identified potential risk factors for ipsilateral lymphedema development in patients with breast cancer following axillary node dissection, the risk factors for lymphedema in patients undergoing sentinel node biopsy without axillary dissection remain unclear. In this study, we aimed to determine the real-world incidence and risk factors for lymphedema in such patients.
Methods:
We conducted a single-center, retrospective review of medical records of patients with breast cancer who underwent sentinel node biopsy alone. The development cohort (5,051 patients, January 2017–December 2020) was analyzed to identify predictors of lymphedema, and a predictive model was subsequently created. A validation cohort (1,627 patients, January 2014–December 2016) was used to validate the model.
Results:
In the development cohort, 49 patients (0.9%) developed lymphedema over a median follow-up of 56 months, with most cases occurring within the first three years post-operation.Multivariate analysis revealed that a body mass index (BMI) of 30 kg/m2 or above, radiation therapy (RTx), chemotherapy, and more than three harvested lymph nodes significantly predicted lymphedema. The predictive model showed an area under the curve of 0.824 for systemic chemotherapy, with the number of harvested lymph nodes being the most significant factor. Patients were stratified into four risk groups, showing lymphedema incidences of 3.3% in the highest-risk group and 0.1% in the lowest-risk group. In the validation cohort, the incidences were 1.7% and 0.2% for the highest and lowest risk groups, respectively.
Conclusion
The lymphedema prediction model identifies RTx, chemotherapy, BMI ≥ 30 kg/m2 , and more than three harvested lymph nodes as significant risk factors. Although the overall incidence is low, the risk is notably influenced by the extent of lymph node removal and systemic therapies. The model’s high negative predictive value supports its application in designing tailored lymphedema surveillance programs for early intervention.

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