1.Korean Multicenter Registry of ELUVIA Stent for Femoropopliteal Artery Disease: K-ELUVIA Registry
Joongmin KIM ; Young-Guk KO ; Seung-Jun LEE ; Chul-Min AHN ; Seung-Woon RHA ; Cheol Ung CHOI ; Pil-Ki MIN ; Jong Kwan PARK ; Ji-Yong JANG ; Young Jin YOUN ; Tae-Soo KANG ; Chang-Hwan YOON ; Donghoon CHOI
Korean Circulation Journal 2024;54(9):565-576
Background and Objectives:
The K-ELUVIA study aimed to investigate the clinical effectiveness and safety of Eluvia™, a polymer-coated, paclitaxel-eluting stent, for femoropopliteal artery disease using data from a prospective Korean multicenter registry.
Methods:
A total of 105 patients with femoropopliteal artery disease who received endovascular treatment (EVT) with Eluvia™ stents at 7 Korean sites were enrolled in a prospective cohort and followed for 2 years. The primary endpoint was the 2-year clinical patency. The secondary endpoint was 2-year freedom from clinically driven target lesion revascularization (TLR).
Results:
Mean patient age was 68.2±10.4 years, and most patients (82.7%) were male. Mean lesion length was 168.3±117.6 mm. Chronic total occlusion was found in 57.7% of patients.Trans-Atlantic Inter-Society Consensus for the Management of Peripheral Arterial Disease (TASC II) type C or D lesions were present in 46.1% of patients. Procedural success was achieved in 99.0% of patients. The clinical patency rate was 84.4% at 1 year after EVT and 76.3% at 2 years post-EVT. The freedom from TLR rate was 89.1% at 1 year after EVT and 79.1% at 2 years post-EVT. Chronic total occlusion (hazard ratio [HR], 3.53; 95% confidence interval [CI], 1.08–11.67; p=0.039) and smaller mean stent diameter (HR, 0.40; 95% CI, 0.16– 0.98; p=0.044) were identified as independent predictors of loss of clinical patency at 2 years.
Conclusions
The K-ELUVIA study demonstrated favorable 2-year clinical effectiveness and safety outcomes of Eluvia stent for femoropopliteal artery lesions in real-world practice.
2.Korean Multicenter Registry of ELUVIA Stent for Femoropopliteal Artery Disease: K-ELUVIA Registry
Joongmin KIM ; Young-Guk KO ; Seung-Jun LEE ; Chul-Min AHN ; Seung-Woon RHA ; Cheol Ung CHOI ; Pil-Ki MIN ; Jong Kwan PARK ; Ji-Yong JANG ; Young Jin YOUN ; Tae-Soo KANG ; Chang-Hwan YOON ; Donghoon CHOI
Korean Circulation Journal 2024;54(9):565-576
Background and Objectives:
The K-ELUVIA study aimed to investigate the clinical effectiveness and safety of Eluvia™, a polymer-coated, paclitaxel-eluting stent, for femoropopliteal artery disease using data from a prospective Korean multicenter registry.
Methods:
A total of 105 patients with femoropopliteal artery disease who received endovascular treatment (EVT) with Eluvia™ stents at 7 Korean sites were enrolled in a prospective cohort and followed for 2 years. The primary endpoint was the 2-year clinical patency. The secondary endpoint was 2-year freedom from clinically driven target lesion revascularization (TLR).
Results:
Mean patient age was 68.2±10.4 years, and most patients (82.7%) were male. Mean lesion length was 168.3±117.6 mm. Chronic total occlusion was found in 57.7% of patients.Trans-Atlantic Inter-Society Consensus for the Management of Peripheral Arterial Disease (TASC II) type C or D lesions were present in 46.1% of patients. Procedural success was achieved in 99.0% of patients. The clinical patency rate was 84.4% at 1 year after EVT and 76.3% at 2 years post-EVT. The freedom from TLR rate was 89.1% at 1 year after EVT and 79.1% at 2 years post-EVT. Chronic total occlusion (hazard ratio [HR], 3.53; 95% confidence interval [CI], 1.08–11.67; p=0.039) and smaller mean stent diameter (HR, 0.40; 95% CI, 0.16– 0.98; p=0.044) were identified as independent predictors of loss of clinical patency at 2 years.
Conclusions
The K-ELUVIA study demonstrated favorable 2-year clinical effectiveness and safety outcomes of Eluvia stent for femoropopliteal artery lesions in real-world practice.
3.Korean Multicenter Registry of ELUVIA Stent for Femoropopliteal Artery Disease: K-ELUVIA Registry
Joongmin KIM ; Young-Guk KO ; Seung-Jun LEE ; Chul-Min AHN ; Seung-Woon RHA ; Cheol Ung CHOI ; Pil-Ki MIN ; Jong Kwan PARK ; Ji-Yong JANG ; Young Jin YOUN ; Tae-Soo KANG ; Chang-Hwan YOON ; Donghoon CHOI
Korean Circulation Journal 2024;54(9):565-576
Background and Objectives:
The K-ELUVIA study aimed to investigate the clinical effectiveness and safety of Eluvia™, a polymer-coated, paclitaxel-eluting stent, for femoropopliteal artery disease using data from a prospective Korean multicenter registry.
Methods:
A total of 105 patients with femoropopliteal artery disease who received endovascular treatment (EVT) with Eluvia™ stents at 7 Korean sites were enrolled in a prospective cohort and followed for 2 years. The primary endpoint was the 2-year clinical patency. The secondary endpoint was 2-year freedom from clinically driven target lesion revascularization (TLR).
Results:
Mean patient age was 68.2±10.4 years, and most patients (82.7%) were male. Mean lesion length was 168.3±117.6 mm. Chronic total occlusion was found in 57.7% of patients.Trans-Atlantic Inter-Society Consensus for the Management of Peripheral Arterial Disease (TASC II) type C or D lesions were present in 46.1% of patients. Procedural success was achieved in 99.0% of patients. The clinical patency rate was 84.4% at 1 year after EVT and 76.3% at 2 years post-EVT. The freedom from TLR rate was 89.1% at 1 year after EVT and 79.1% at 2 years post-EVT. Chronic total occlusion (hazard ratio [HR], 3.53; 95% confidence interval [CI], 1.08–11.67; p=0.039) and smaller mean stent diameter (HR, 0.40; 95% CI, 0.16– 0.98; p=0.044) were identified as independent predictors of loss of clinical patency at 2 years.
Conclusions
The K-ELUVIA study demonstrated favorable 2-year clinical effectiveness and safety outcomes of Eluvia stent for femoropopliteal artery lesions in real-world practice.
4.Korean Multicenter Registry of ELUVIA Stent for Femoropopliteal Artery Disease: K-ELUVIA Registry
Joongmin KIM ; Young-Guk KO ; Seung-Jun LEE ; Chul-Min AHN ; Seung-Woon RHA ; Cheol Ung CHOI ; Pil-Ki MIN ; Jong Kwan PARK ; Ji-Yong JANG ; Young Jin YOUN ; Tae-Soo KANG ; Chang-Hwan YOON ; Donghoon CHOI
Korean Circulation Journal 2024;54(9):565-576
Background and Objectives:
The K-ELUVIA study aimed to investigate the clinical effectiveness and safety of Eluvia™, a polymer-coated, paclitaxel-eluting stent, for femoropopliteal artery disease using data from a prospective Korean multicenter registry.
Methods:
A total of 105 patients with femoropopliteal artery disease who received endovascular treatment (EVT) with Eluvia™ stents at 7 Korean sites were enrolled in a prospective cohort and followed for 2 years. The primary endpoint was the 2-year clinical patency. The secondary endpoint was 2-year freedom from clinically driven target lesion revascularization (TLR).
Results:
Mean patient age was 68.2±10.4 years, and most patients (82.7%) were male. Mean lesion length was 168.3±117.6 mm. Chronic total occlusion was found in 57.7% of patients.Trans-Atlantic Inter-Society Consensus for the Management of Peripheral Arterial Disease (TASC II) type C or D lesions were present in 46.1% of patients. Procedural success was achieved in 99.0% of patients. The clinical patency rate was 84.4% at 1 year after EVT and 76.3% at 2 years post-EVT. The freedom from TLR rate was 89.1% at 1 year after EVT and 79.1% at 2 years post-EVT. Chronic total occlusion (hazard ratio [HR], 3.53; 95% confidence interval [CI], 1.08–11.67; p=0.039) and smaller mean stent diameter (HR, 0.40; 95% CI, 0.16– 0.98; p=0.044) were identified as independent predictors of loss of clinical patency at 2 years.
Conclusions
The K-ELUVIA study demonstrated favorable 2-year clinical effectiveness and safety outcomes of Eluvia stent for femoropopliteal artery lesions in real-world practice.
5.Similar long-term outcomes between endovascular aneurysm repair and open surgical repair for abdominal aortic aneurysms in octogenarian patients:a single-center study
Jun Gyo GWON ; Seonjeong JEONG ; Hana JIN ; Gi-Young KO ; Yong-Pil CHO ; Tae-Won KWON
Annals of Surgical Treatment and Research 2022;103(6):372-377
Purpose:
Endovascular aneurysm repair (EVAR) has lower perioperative mortality and morbidity rates and shorter hospital stays when compared to open surgical repair (OSR) in octogenarian patients. However, its long-term results remain unclear. Hence, we aimed to analyze and compare the long-term outcomes of OSR and EVAR in this aging population.
Methods:
This single-center, retrospective, observational study analyzed the data of patients older than 80 years who underwent primary repair of an abdominal aortic aneurysm (AAA) between 2011 and 2016 in our hospital. The primary outcomes were in-hospital complications and 30-day mortality, while the secondary outcomes included all-cause mortality and reintervention rate.
Results:
Among the 48 patients with elective AAA repair, 13 underwent OSR and 35 underwent EVAR. In-hospital complications occurred in 10 patients (20.8%), 5 for OSR (38.5%) and 5 for EVAR (14.3%) with no significant difference between the groups (P = 0.067). In the OSR group, pulmonary complications were the most common events; in the EVAR group, 2 patients had ischemic colitis diagnosed with sigmoidoscopy and recovered by conservative treatment. The 1- and 5-year survival rates were 77.8% and 55.6% in the OSR group, and 66.0% and 54.9% in the EVAR group, respectively. The reintervention rate was 8.6% for the EVAR group; none of the OSR group were readmitted.
Conclusion
The difference in procedures did not affect patient survival. Therefore, OSR does not necessarily have a worse prognosis than EVAR. Individual risk stratification must be preceded before the selection of an appropriate treatment method.
6.Preventive effect of biodegradable stents on biliary stricture and fibrosis after biliary anastomosis in a porcine model
Chang-Il KWON ; Sung Hoon CHOI ; Kyu Seok KIM ; Jong Pil MOON ; Sehwan PARK ; Jinkyung JEON ; Gwangil KIM ; Jae Young JANG ; Min Je SUNG ; Kwang Hyun KO ; Jun Sik SON
Annals of Surgical Treatment and Research 2022;102(2):90-99
Purpose:
The current drain tubes for preventing surgically biliary anastomotic stricture are not naturally and easily removed. If a drain tube using biodegradable material is easily available and the degradation time of the tube is well controlled, surgical anastomotic stricture and fibrosis could be prevented. The aim of this animal study was to evaluate the preventive effect of novel biodegradable stents (BS) on biliary stricture and fibrosis after duct-to-duct (DD) biliary anastomosis.
Methods:
Ten mini-pigs were allocated to the control group (n = 5) and or the stent group (n = 5). The common bile duct was exposed through surgical laparotomy and then resected transversely. In the stent group, a 4-mm or 6-mm polydioxanone/ magnesium sheath-core BS was inserted according to the width of the bile duct, followed by DD biliary anastomosis. In the control group, DD biliary anastomosis was performed without BS insertion.
Results:
In the stent group, stents were observed without deformity for up to 4 weeks in all animals. Eight weeks later, histopathologic examination revealed that the common bile duct of the anastomosis site was relatively narrower in circumference in the control group compared to the stent group. The degree of fibrosis in the control group was more marked than in the stent group (3.84 mm vs. 0.68 mm, respectively; P < 0.05).
Conclusion
Our study showed that novel BS maintained their original shape and radial force for an adequate time and then disappeared without adverse events. The BS could prevent postoperative complications and strictures after DD biliary anastomosis.
7.Association between Body Mass Index and Clinical Outcomes of Peripheral Artery Disease after Endovascular Therapy: Data from K-VIS ELLA Registry
Chewan LIM ; Hoyoun WON ; Young-Guk KO ; Seung-Jun LEE ; Chul-Min AHN ; Pil-Ki MIN ; Jae-Hwan LEE ; Chang-Hwan YOON ; Cheol Woong YU ; Seung Whan LEE ; Sang-Rok LEE ; Seung Hyuk CHOI ; In-Ho CHAE ; Donghoon CHOI ;
Korean Circulation Journal 2021;51(8):696-707
Background and Objectives:
Few studies have investigated the obesity paradox in clinical outcomes of peripheral artery disease (PAD). We investigated the association between body massindex (BMI) and clinical outcomes in PAD patients undergoing endovascular therapy (EVT).
Methods:
Patients (n=2,914) from the retrospective Korean Vascular Intervention Society Endovascular Therapy in Lower Limb Artery Disease registry were categorized according to BMI: underweight (<18.5 kg/m2 , n=204), normal weight (18.5–25 kg/m2 , n=1,818), overweight (25–30 kg/m2 , n=766), or obese (≥30 kg/m2 , n=126). Groups were compared for major adverse cardiovascular events (MACE) and major adverse limb events (MALE).
Results:
The underweight and obese groups were older and had more frequent critical limb ischemia and infrapopliteal artery disease than the normal or overweight groups (all p<0.001). Hypertension and diabetes were more frequent and current smoking was less frequent in the overweight and obese groups than the underweight or normal weight groups (all p <0.001). The underweight group showed the higher rates of MACE and MALE at 3 years (17.2%, 15.7%) compared with the normal weight (10.8%, 11.7%), overweight (8.4%, 10.7%), or obese groups (8.7%, 14.3%) (log-rank p<0.001, p=0.015). In contrast, the risk of MACE was lower in the overweight than the normal weight group (adjusted hazard ratio, 0.706; 95% CI, 0.537–0.928).
Conclusions
In PAD patients undergoing EVT, underweight was an independent predictor for MACE and MALE, whereas MACE risk was lower for overweight than normal weight patients.
8.Korean Multicenter Registry Study of EPIC Stents for the Treatment of Iliac Artery Disease: K-EPIC Registry
Dae-Young KIM ; Young-Guk KO ; Seung-Jun LEE ; Chul-Min AHN ; Seung-Woon RHA ; Cheol Ung CHOI ; Jong Kwan PARK ; Chang-Hwan YOON ; Seung-Hyuk CHOI ; Pil-Ki MIN ; Jang-Whan BAE ; Jung-Kyu HAN ; Sang Ho PARK ; Donghoon CHOI
Korean Circulation Journal 2021;51(5):441-451
Background and Objectives:
The EPIC™ stent is a self-expanding, nitinol stent that has been designed to enhance flexibility and provide expansion within vessels. The aim of the present study was to investigate the clinical efficacy and safety of the EPIC™ stent when used to treat iliac artery diseases in a prospective Korean multicenter registry.
Methods:
A total of 138 patients with iliac artery diseases who received endovascular treatment with EPIC™ stents at 9 Korean sites were enrolled in a prospective cohort and followed for 1 year. The primary endpoint was the 1-year freedom from target lesion revascularization (TLR). The secondary endpoints were 1-year clinical patency and freedom from major adverse events (MAEs).
Results:
The mean age of the study subjects was 66.8±8.5 years and most subjects were male (86.2%). The most frequent lesion type was Trans-Atlantic Inter-Society Consensus B (43.5%) and the majority (56.5%) of the target lesions were located in the common iliac artery. Procedural success was obtained in 99.3% of patients. The freedom from TLR and the clinical patency at 1-year follow-up were 94.9% and 92.3%, respectively. The 1-year rate of MAEs was 5.1%. Combined coronary artery disease (hazard ratio [HR], 5.91; 95% confidence interval [CI], 1.13–30.89; p=0.035) and smaller stent diameter (HR, 0.38; 95% CI, 0.17–0.88;p=0.023) were identified as independent risk factors of TLR after EPIC™ stent implantation.
Conclusions
The EPIC™ stents demonstrated excellent immediate and 1-year efficacy and safety outcomes in iliac artery lesions in this multicenter, prospective, registry-based study.
9.Association between Body Mass Index and Clinical Outcomes of Peripheral Artery Disease after Endovascular Therapy: Data from K-VIS ELLA Registry
Chewan LIM ; Hoyoun WON ; Young-Guk KO ; Seung-Jun LEE ; Chul-Min AHN ; Pil-Ki MIN ; Jae-Hwan LEE ; Chang-Hwan YOON ; Cheol Woong YU ; Seung Whan LEE ; Sang-Rok LEE ; Seung Hyuk CHOI ; In-Ho CHAE ; Donghoon CHOI ;
Korean Circulation Journal 2021;51(8):696-707
Background and Objectives:
Few studies have investigated the obesity paradox in clinical outcomes of peripheral artery disease (PAD). We investigated the association between body massindex (BMI) and clinical outcomes in PAD patients undergoing endovascular therapy (EVT).
Methods:
Patients (n=2,914) from the retrospective Korean Vascular Intervention Society Endovascular Therapy in Lower Limb Artery Disease registry were categorized according to BMI: underweight (<18.5 kg/m2 , n=204), normal weight (18.5–25 kg/m2 , n=1,818), overweight (25–30 kg/m2 , n=766), or obese (≥30 kg/m2 , n=126). Groups were compared for major adverse cardiovascular events (MACE) and major adverse limb events (MALE).
Results:
The underweight and obese groups were older and had more frequent critical limb ischemia and infrapopliteal artery disease than the normal or overweight groups (all p<0.001). Hypertension and diabetes were more frequent and current smoking was less frequent in the overweight and obese groups than the underweight or normal weight groups (all p <0.001). The underweight group showed the higher rates of MACE and MALE at 3 years (17.2%, 15.7%) compared with the normal weight (10.8%, 11.7%), overweight (8.4%, 10.7%), or obese groups (8.7%, 14.3%) (log-rank p<0.001, p=0.015). In contrast, the risk of MACE was lower in the overweight than the normal weight group (adjusted hazard ratio, 0.706; 95% CI, 0.537–0.928).
Conclusions
In PAD patients undergoing EVT, underweight was an independent predictor for MACE and MALE, whereas MACE risk was lower for overweight than normal weight patients.
10.Korean Multicenter Registry Study of EPIC Stents for the Treatment of Iliac Artery Disease: K-EPIC Registry
Dae-Young KIM ; Young-Guk KO ; Seung-Jun LEE ; Chul-Min AHN ; Seung-Woon RHA ; Cheol Ung CHOI ; Jong Kwan PARK ; Chang-Hwan YOON ; Seung-Hyuk CHOI ; Pil-Ki MIN ; Jang-Whan BAE ; Jung-Kyu HAN ; Sang Ho PARK ; Donghoon CHOI
Korean Circulation Journal 2021;51(5):441-451
Background and Objectives:
The EPIC™ stent is a self-expanding, nitinol stent that has been designed to enhance flexibility and provide expansion within vessels. The aim of the present study was to investigate the clinical efficacy and safety of the EPIC™ stent when used to treat iliac artery diseases in a prospective Korean multicenter registry.
Methods:
A total of 138 patients with iliac artery diseases who received endovascular treatment with EPIC™ stents at 9 Korean sites were enrolled in a prospective cohort and followed for 1 year. The primary endpoint was the 1-year freedom from target lesion revascularization (TLR). The secondary endpoints were 1-year clinical patency and freedom from major adverse events (MAEs).
Results:
The mean age of the study subjects was 66.8±8.5 years and most subjects were male (86.2%). The most frequent lesion type was Trans-Atlantic Inter-Society Consensus B (43.5%) and the majority (56.5%) of the target lesions were located in the common iliac artery. Procedural success was obtained in 99.3% of patients. The freedom from TLR and the clinical patency at 1-year follow-up were 94.9% and 92.3%, respectively. The 1-year rate of MAEs was 5.1%. Combined coronary artery disease (hazard ratio [HR], 5.91; 95% confidence interval [CI], 1.13–30.89; p=0.035) and smaller stent diameter (HR, 0.38; 95% CI, 0.17–0.88;p=0.023) were identified as independent risk factors of TLR after EPIC™ stent implantation.
Conclusions
The EPIC™ stents demonstrated excellent immediate and 1-year efficacy and safety outcomes in iliac artery lesions in this multicenter, prospective, registry-based study.

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