Clinical Outcomes of Atherectomy Plus Drug-coated Balloon Versus Drugcoated Balloon Alone in the Treatment of Femoropopliteal Artery Disease

Background and Objectives@#Atherectomy as a pretreatment has the potential to improve the outcomes of drug-coated balloon (DCB) treatment by reducing and modifying atherosclerotic plaques. The present study investigated the outcomes of atherectomy plus DCB (A+DCB) compared with DCB alone for the treatment of femoropopliteal artery disease. @*Methods@#A total of 311 patients (348 limbs) underwent endovascular therapy using DCB for native femoropopliteal artery lesions at two endovascular centers. Of these, 82 limbs were treated with A+DCB and 266 limbs with DCB alone. After propensity score matching based on clinical and lesion characteristics, a total of 82 pairs was compared for immediate and mid-term outcomes. @*Results@#For the matched study groups, the lesion length was 172.7±111.2 mm, and severe calcification was observed in 43.3%. The technical success rate was higher in the A+DCB group than in the DCB group (80.5% vs. 62.2%, p=0.015). However, the A+DCB group showed more procedure-related minor complications (37.0% vs. 13.4%, p=0.047). At 2-year follow-up, primary clinical patency (73.8% vs. 82.6%, p=0.158) and the target lesion revascularization (TLR)-free survival (84.3% vs. 88.2%, p=0.261) did not differ between the two groups. In Cox proportional hazard analysis, atherectomy showed no significant impact on the outcome of DCB treatments. @*Conclusions@#The pretreatment with atherectomy improved technical success of DCB treatment; however, it was associated with increased minor complications. In this study, A+DCB showed no clinical benefit in terms of TLR-free survival or clinical patency compared with DCB treatment alone.

Long-Term Clinical Outcomes of Iliac Artery Endovascular Therapy in the Korean Vascular Intervention Society Endovascular Therapy in Lower Limb Artery Diseases (K-VIS ELLA) Registry

Background and Objectives@#Limited data are available regarding long-term clinical outcomes of iliac artery endovascular therapy (EVT) in real-world practice. This study investigated long-term outcomes according to Trans-Atlantic Inter-Society Consensus (TASC) classifications. @*Methods@#We analyzed data from 1,705 limbs of 1,364 patients from the retrospective cohort of the multicenter Korean Vascular Intervention Society Endovascular Therapy in Lower Limb Artery Disease registry. The primary endpoint was target lesion revascularization (TLR)-free survival. @*Results@#TASC A, B, C, and D lesions were present in 19.4%, 26.2%, 28.7%, and 25.7% of the treated limbs, respectively. The technical success rate was 96.2% and did not differ between TASC lesion types. Complications occurred in 6.8% of cases and more occurred in TASC D (11.8%). Iliac artery EVT showed a 5-year TLR-free survival of 89.2%. The TASC D group had the lowest TLR-free rate of 79.3%. TASC D (hazard ratio [HR], 1.75; 95% confidence interval [CI], 1.12–2.73; p=0.014), plain old balloon angioplasty (HR, 4.25; 95% CI, 2.03–8.88; p<0.001), current smoker (HR, 1.89; 95% CI, 1.26–2.83; p=0.002), previous bypass surgery (HR, 3.04;95% CI, 1.28–7.19; p=0.011), combined femoropopliteal treatment (HR, 4.89; 95% CI, 3.19–7.50; p<0.001), combined below the knee treatment (HR, 2.20; 95% CI, 1.25–3.89; p=0.007), and complications (HR, 1.86; 95% CI, 1.07–3.24; p=0.028) were predictors for TLR. @*Conclusions@#Iliac artery EVT achieved excellent technical success and 5-year TLR-free survival. TASC D showed a favorable but lower 5-year TLR-free survival rate and higher complication rate compared with other TASC groups.

Successful Primary Percutaneous Coronary Intervention without Stenting: Insight from Optimal Coherence Tomography

For patients with acute myocardial infarction, current management guidelines recommend implantation of a drug-eluting stent, dual antiplatelet therapy (including potent P2Y 12 inhibitors) for at least 1 year, and maintenance of life-long antiplatelet therapy.However, a pilot study showed favorable results with antithrombotic therapy without stent implantation when plaque erosion, not definite plaque rupture, was confirmed using optical coherence tomography (OCT), despite the patients having acute myocardial infarction. Here, we present a case where successful primary percutaneous coronary intervention was performed without stenting with the aid of OCT in a patient with ST-elevation myocardial infarction who developed thrombotic total occlusion of the right coronary artery.

Long-term Clinical Outcomes and Prognostic Factors After Endovascular Treatment in Patients With Chronic Limb Threatening Ischemia

Background and Objectives@#Endovascular therapy (EVT) first strategy has been widely adopted for the treatment of chronic limb threatening ischemia (CLTI) patients in realworld practice. This study aimed to investigate long-term outcomes of CLTI patients who underwent EVT and identify prognostic factors. @*Methods@#From the retrospective cohorts of a Korean multicenter endovascular therapy registry, 1,036 patients with CLTI (792 men, 68.8 ± 9.5 years) were included. The primary endpoint was amputation-free survival (AFS) defined as the absence of major amputation or death. Secondary endpoints were major adverse limb events (MALE; a composite of major amputation, minor amputation, and reintervention). @*Results@#Five-year AFS and freedom from MALE were 69.8% and 61%, respectively. After multivariate analysis, age (hazard ratio [HR], 1.476; p<0.001), end-stage renal disease (ESRD; HR, 2.340; p<0.001), Rutherford category (RC) 6 (HR, 1.456; p=0.036), and suboptimal EVT (HR, 1.798; p=0.005) were identified as predictors of major amputation or death, whereas smoking (HR, 0.594; p=0.007) was protective. Low body mass index (HR, 1.505; p=0.046), ESRD (HR, 1.648; p=0.001), femoropopliteal lesion (HR, 1.877; p=0.004), RC-6 (HR, 1.471;p=0.008), and suboptimal EVT (HR, 1.847; p=0.001) were predictors of MALE. The highest hazard rates were observed during the first 6 months for both major amputation or death and MALE. After that, the hazard rate decreased and rose again after 3–4 years. @*Conclusions@#In CLTI patients, long-term outcomes of EVT were acceptable. ESRD, RC-6, and suboptimal EVT were common predictors for poor clinical outcomes.

Ticagrelor Monotherapy After 3-Month Dual Antiplatelet Therapy in Acute Coronary Syndrome by High Bleeding Risk: The Subanalysis From the TICO Trial

Background and Objectives@#Identifying patients with high bleeding risk (HBR) is important when making decisions for antiplatelet therapy strategy. This study evaluated the impact of ticagrelor monotherapy after 3-month dual antiplatelet therapy (DAPT) according to HBR in acute coronary syndrome (ACS) patients treated with drug eluting stents (DESs). @*Methods@#In this post-hoc analysis of the TICO trial, HBR was defined by 2 approaches: meeting Academic Research Consortium for HBR (ARC-HBR) criteria or Predicting Bleeding Complications in Patients Undergoing Stent Implantation and Subsequent DAPT (PRECISEDAPT) score ≥25. The primary outcome was a 3–12 months net adverse clinical event (composite of major bleeding and adverse cardiac and cerebrovascular events). @*Results@#Of the 2,980 patients without adverse events during the first 3 months after DES implantation, 453 (15.2%) were HBR by ARC-HBR criteria and 504 (16.9%) were HBR by PRECISE-DAPT score. The primary outcome rate was higher in HBR versus non-HBR patients (by ARC-HBR criteria: hazard ratio [HR], 2.87; 95% confidence interval [CI], 1.76– 4.69; p<0.001; by PRECISE-DAPT score: HR, 3.09; 95% CI, 1.92–4.98; p<0.001). Ticagrelor monotherapy after 3-month DAPT was associated with lower primary outcome rate than ticagrelor-based 12-month DAPT regardless of HBR by ARC-HBR criteria, with similar magnitudes of therapy effect for HBR and non-HBR patients (p-interaction=0.400). Results were consistent by PRECISE-DAPT score (p-interaction=0.178). @*Conclusions@#In ACS patients treated with DESs, ticagrelor monotherapy after 3-month DAPT was associated with lower rate of adverse clinical outcomes regardless of HBR, with similar magnitudes of therapy effect between HBR and non-HBR.Trial Registration: ClinicalTrials.gov Identifier: NCT02494895

Transcatheter Aortic Valve Replacement with Minimal Contrast Dye in Patients with Renal Insufficiency

Purpose@#Concerns have been consistently raised in regards to the considerable amount of contrast dye used during transcatheter aortic valve replacement (TAVR) in patients with renal insufficiency. In the present study, we introduced minimal contrast TAVR and compared its 30-day clinical outcomes with conventional TAVR. @*Materials and Methods@#We retrospectively investigated 369 patients who underwent TAVR between July 2011 and April 2020 in our institute. Among them, 93 patients with severe aortic stenosis and renal insufficiency (estimated glomerular filtration rate ≤50 mL/min/1.73 m2 ) were included and divided into a conventional TAVR group (n=56) and a minimal contrast TAVR group (n=37). In the minimal contrast TAVR group, the total amount of contrast was <10 mL during the entire TAVR procedure. Thirty-day major adverse clinical events (MACE), including death, stroke, implantation of permanent pacemaker, and initiation of hemodialysis, were investigated. @*Results@#The incidence of MACE was significantly lower in the minimal contrast TAVR group than the conventional TAVR group (16.2% vs. 42.9%, p=0.010). Death occurred in 9 patients (16.1%) in the conventional TAVR group and in 0 patients in the minimal contrast group (p=0.011). Hemodialysis was initiated in 2 patients (5.4%) in the minimal contrast TAVR group and in 7 patients (12.5%) in the conventional TAVR group (p=0.256). Multivariate regression analysis showed that the minimal contrast TAVR procedure was an independent predictor for reducing MACE (hazard ratio 0.208, 95% confidence interval: 0.080–0.541, p=0.001). @*Conclusion@#Minimal contrast TAVR is feasible and shows more favorable short-term clinical outcomes than conventional TAVR in patients with renal insufficiency.

Korean Multicenter Registry Study of EPIC Stents for the Treatment of Iliac Artery Disease: K-EPIC Registry

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.

Comparison of Transcatheter Aortic Valve Replacement between SelfExpanding versus Balloon-Expandable Valves in Patients with Small Aortic Annulus

Background and Objectives@#Transcatheter aortic valve replacement (TAVR) has been reported as a good alternative for surgical aortic valve replacement in patients with small aortic annulus. Head-to-head comparisons of different transcatheter aortic valves in these patients are insufficient. We compared the outcomes after TAVR between two different types of recent transcatheter aortic valves (self-expanding vs. balloon-expandable) in patients with small aortic annulus. @*Methods@#A total of 70 patients with severe aortic stenosis and small annulus (mean diameter ≤23 mm or minimal diameter ≤21 mm on computed tomography) underwent TAVR with either a self-expanding valve with supra-annular location (n=45) or a balloon-expandable valve with intra-annular location (n=25). The echocardiographic hemodynamic parameters after TAVR and 1-year follow-up were compared. @*Results@#Between the self-expanding and balloon-expandable valve-treated patients, the clinical outcomes including permanent pacemaker implantation (11.1% vs. 8.0%), acute kidney injury stage 2 or 3 (4.4% vs. 4.0%), and major vascular complication (4.4% vs. 0.0%) were similar without all-cause mortality, stroke, and life-threatening bleeding during 30-day follow-up. Compared with the balloon-expandable valve-treated patients, the self-expanding valve-treated patients presented larger effective orifice area (EOA) (1.46±0.28 vs. 1.75±0.42 cm2 , p=0.002) and indexed EOA (0.95±0.21 vs. 1.18±0.28 cm2 /m2 , p=0.001), whereas mean aortic valve gradient (11.7±2.9 vs. 8.9±5.2 mmHg, P=0.005) and incidence of ≥moderate prosthesis-patient mismatch (36.0% vs. 8.9%, p=0.009) were lower. These hemodynamic differences were maintained at 1-year follow-up. @*Conclusions@#TAVR with self-expanding valves was associated with superior hemodynamic outcomes compared with balloon-expandable valves in patients with small aortic annulus.

Association between Body Mass Index and Clinical Outcomes of Peripheral Artery Disease after Endovascular Therapy: Data from K-VIS ELLA Registry

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.

Transcatheter Aortic Valve Replacement with Minimal Contrast Dye in Patients with Renal Insufficiency

Purpose@#Concerns have been consistently raised in regards to the considerable amount of contrast dye used during transcatheter aortic valve replacement (TAVR) in patients with renal insufficiency. In the present study, we introduced minimal contrast TAVR and compared its 30-day clinical outcomes with conventional TAVR. @*Materials and Methods@#We retrospectively investigated 369 patients who underwent TAVR between July 2011 and April 2020 in our institute. Among them, 93 patients with severe aortic stenosis and renal insufficiency (estimated glomerular filtration rate ≤50 mL/min/1.73 m2 ) were included and divided into a conventional TAVR group (n=56) and a minimal contrast TAVR group (n=37). In the minimal contrast TAVR group, the total amount of contrast was <10 mL during the entire TAVR procedure. Thirty-day major adverse clinical events (MACE), including death, stroke, implantation of permanent pacemaker, and initiation of hemodialysis, were investigated. @*Results@#The incidence of MACE was significantly lower in the minimal contrast TAVR group than the conventional TAVR group (16.2% vs. 42.9%, p=0.010). Death occurred in 9 patients (16.1%) in the conventional TAVR group and in 0 patients in the minimal contrast group (p=0.011). Hemodialysis was initiated in 2 patients (5.4%) in the minimal contrast TAVR group and in 7 patients (12.5%) in the conventional TAVR group (p=0.256). Multivariate regression analysis showed that the minimal contrast TAVR procedure was an independent predictor for reducing MACE (hazard ratio 0.208, 95% confidence interval: 0.080–0.541, p=0.001). @*Conclusion@#Minimal contrast TAVR is feasible and shows more favorable short-term clinical outcomes than conventional TAVR in patients with renal insufficiency.

Korean Multicenter Registry Study of EPIC Stents for the Treatment of Iliac Artery Disease: K-EPIC Registry

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.

Comparison of Transcatheter Aortic Valve Replacement between SelfExpanding versus Balloon-Expandable Valves in Patients with Small Aortic Annulus

Background and Objectives@#Transcatheter aortic valve replacement (TAVR) has been reported as a good alternative for surgical aortic valve replacement in patients with small aortic annulus. Head-to-head comparisons of different transcatheter aortic valves in these patients are insufficient. We compared the outcomes after TAVR between two different types of recent transcatheter aortic valves (self-expanding vs. balloon-expandable) in patients with small aortic annulus. @*Methods@#A total of 70 patients with severe aortic stenosis and small annulus (mean diameter ≤23 mm or minimal diameter ≤21 mm on computed tomography) underwent TAVR with either a self-expanding valve with supra-annular location (n=45) or a balloon-expandable valve with intra-annular location (n=25). The echocardiographic hemodynamic parameters after TAVR and 1-year follow-up were compared. @*Results@#Between the self-expanding and balloon-expandable valve-treated patients, the clinical outcomes including permanent pacemaker implantation (11.1% vs. 8.0%), acute kidney injury stage 2 or 3 (4.4% vs. 4.0%), and major vascular complication (4.4% vs. 0.0%) were similar without all-cause mortality, stroke, and life-threatening bleeding during 30-day follow-up. Compared with the balloon-expandable valve-treated patients, the self-expanding valve-treated patients presented larger effective orifice area (EOA) (1.46±0.28 vs. 1.75±0.42 cm2 , p=0.002) and indexed EOA (0.95±0.21 vs. 1.18±0.28 cm2 /m2 , p=0.001), whereas mean aortic valve gradient (11.7±2.9 vs. 8.9±5.2 mmHg, P=0.005) and incidence of ≥moderate prosthesis-patient mismatch (36.0% vs. 8.9%, p=0.009) were lower. These hemodynamic differences were maintained at 1-year follow-up. @*Conclusions@#TAVR with self-expanding valves was associated with superior hemodynamic outcomes compared with balloon-expandable valves in patients with small aortic annulus.

Association between Body Mass Index and Clinical Outcomes of Peripheral Artery Disease after Endovascular Therapy: Data from K-VIS ELLA Registry

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.

Clinical Outcomes of Transcatheter Aortic Valve Implantation for Native Aortic Valves in Patients with Low Coronary Heights

Purpose@#Acute coronary occlusion is a rare but fatal complication that may occur during trans-catheter aortic valve implantation (TAVI) and appears more frequently in patients with low coronary heights. We evaluated the feasibility of self-expanding valves in patients with low coronary heights undergoing TAVI. @*Materials and Methods@#TAVI for native aortic valve stenosis was conducted in 276 consecutive patients between 2015 and 2019 at our institute. Using multi-detector computed tomography (MDCT), information on the aortic valve, coronary arteries, and vascular anatomy in 269 patients was analyzed. Patients with low coronary heights were defined as those with coronary heights of 10 mm or less during MDCT analysis. @*Results@#Among the 269 patients, 29 (10.8%) patients had coronary arteries with low heights. The mean coronary height was 8.9±1.2 mm in the left coronary artery. These patients with low coronary heights were treated with self-expandable (n=28) or balloon-expandable (n=1) valves. Prophylactic coronary protection with a guidewire, balloon, or stent prepositioned down at-risk coronary arteries was not pursued in all patients. No acute coronary occlusion occurred in any of these patients during TAVI. Five patients (17.9%) died during follow-up (average of 553.8 days), including four from non-cardiogenic causes and one from a cardiogenic (aggravation of heart failure) cause. @*Conclusion@#A considerable number of patients with low coronary heights were observed among TAVI candidates in this study. Use of a self-expandable valve may be feasible for successful TAVI without acute coronary occlusion in patients with low coronary heights.

Lipid-Lowering Efficacy and Safety of a New Generic Rosuvastatin in Koreans: an 8-Week Randomized Comparative Study with a Proprietary Rosuvastatin

Objective@#The aim of this study was to investigate whether a new generic rosuvastatin is non-inferior to a proprietary one in terms of lipid-lowering efficacy. We also evaluated its non-lipid effects including adverse events. @*Methods@#One-hundred and fifty-eight patients with cardiovascular risks requiring pharmacological lipid-lowering therapy were screened. After a 4-week run-in period, 126 individuals who met the lipid criteria for drug therapy were randomly assigned to receive the new generic or proprietary rosuvastatin 10 mg daily for 8 weeks. The primary outcome variables were low-density lipoprotein-cholesterol (LDL-C) reduction and LDL-C target achievement. Hematological and biochemical parameters and adverse events were assessed. @*Results@#After 8 weeks of drug treatment, the mean percentage change in LDL-C was not different between the groups (−45.5%±19.9% and −45.1%±19.0% for generic and proprietary rosuvastatin, respectively; p=0.38). The LDL-C target achievement rate was similar between the groups (75.0% and 77.1% for generic and proprietary rosuvastatin, respectively; p=0.79). The percentage change in the other lipid profiles was not significantly different. Although generic- and proprietary rosuvastatins modestly affected creatine kinase and blood pressure, respectively, the changes were all within normal ranges. Incidence of adverse events did not differ between the receivers of the 2 formulations. @*Conclusion@#The new generic rosuvastatin was non-inferior to the proprietary rosuvastatin in terms of lipid-lowering efficacy. The rosuvastatin formulations did not exhibit clinically significant non-lipid effects with good safety profiles. Our study provides comprehensive data regarding 2 rosuvastatin formulations in East Asian subjects.

Clinical Implications of Thrombocytopenia at Cardiogenic Shock Presentation: Data from a Multicenter Registry

Purpose@#Thrombocytopenia (platelet count <150×103 /μL) is associated with poor outcomes in various critical illness settings. However, the prognostic value of platelet count in patients with cardiogenic shock (CS) remains unclear. @*Materials and Methods@#We enrolled 1202 patients between January 2014 and December 2018 from a multicenter retrospective– prospective cohort registry of CS. Clinical characteristics and treatment outcomes were compared between the patients with and without thrombocytopenia. @*Results@#At presentation with CS, 244 (20.3%) patients had thrombocytopenia. The patients with thrombocytopenia had lower blood pressure, hemoglobin level, and worse liver and renal functions compared to the patients without. During hospitalization, the patients with thrombocytopenia had more frequent gastrointestinal bleeding (10.5% vs. 3.8%, p=0.009), sepsis (8.3% vs. 2.6%, p=0.013), requirement of renal replacement therapy (36.5% vs. 18.9%, p<0.001), requirement of mechanical ventilation (65.2% vs.54.4%, p=0.003), longer intensive care unit stay (8 days vs. 4 days, p<0.001), and thirty-day mortality (40.2% vs. 28.5%, p<0.001) compared to those without. In addition, the platelet count was an independent predictor of 30-day mortality (per 103 /µL decrease; adjusted hazard ratio: 1.002, 95% confidence interval: 1.000–1.003, p=0.021). @*Conclusion@#Thrombocytopenia at CS presentation was associated with worse clinical findings, higher frequencies of complications, and longer stay at the intensive care unit. Also, thrombocytopenia was independently associated with increased 30-day mortality.(Clinical trial registration No. NCT02985008).

Determinants and Clinical Outcomes of Extended Dual Antiplatelet Therapy over 3 Years after Drug-Eluting Stent Implantation: A Retrospective Analysis

Purpose@#Although current guidelines recommend the administration of dual antiplatelet therapy (DAPT) for up to 12 months after the implantation of a drug-eluting stent (DES), extended DAPT is frequently used in real-world practice. @*Materials and Methods@#From the Korean Multicenter Angioplasty Team registry, we identified a total of 1414 patients who used DAPT for >3 years after DES implantation (extended-DAPT group) and conducted a landmark analysis at 36 months after the index procedure. We evaluated the determinants for and long-term outcomes of extended DAPT and compared the occurrence of major adverse cardiovascular and cerebrovascular events (MACCE), defined as the composite of all-cause death, myocardial infarction, stent thrombosis, and stroke, between the extended-DAPT group and the guideline-DAPT group [DAPT <1 year after DES implantation (n=1273)]. @*Results@#Multivariate analysis indicated the occurrence of acute coronary syndrome as the most significant clinical determinant of the use of extended DAPT. Bifurcation, stent diameter ≤3.0 mm, total stented length ≥28 mm, and use of first-generation DESs were also significant angiographic and procedural determinants. MACCE rates were similar between the extended-DAPT group and the guideline-DAPT group in crude analysis [hazard ratio (HR), 1.08; 95% confidence interval (CI), 0.69–1.68; p=0.739] and after propensity matching (HR, 1.22; 95% CI, 0.72–2.07; p=0.453). Major bleeding rates were comparable between the two groups. @*Conclusion@#In patients undergoing percutaneous coronary intervention, indefinite use of DAPT does not show superior outcomes to those of guideline-DAPT. Major bleeding rates are also similar.

Current State and Strategy for Establishing a Digitally Innovative Hospital - Memorial Review Article for Opening of Yongin Severance Hospital -

The emergence of new technologies, especially digital transformation, influences the entire society, including the medical aspects. Therefore, the concept of digital hospital has been emerging. Here we present the Yongin Severance Hospital, which has developed various novel solutions to serve as foundations for the establishment of a digitally innovative hospital. Further strategies have also been provided to implement consistent and long-term planning.

Anti-Inflammatory Effect for Atherosclerosis Progression by Sodium-Glucose Cotransporter 2 (SGLT-2) Inhibitor in a Normoglycemic Rabbit Model

BACKGROUND AND OBJECTIVES@#We sought to investigate an anti-atherosclerotic and anti-inflammatory effect of sodium-glucose cotransporter-2 (SGLT-2) inhibitors in normoglycemic atherosclerotic rabbit model.@*METHODS@#Male New Zealand white rabbits (n=26) were fed with a 1% high-cholesterol diet for 7 weeks followed by normal diet for 2 weeks. After balloon catheter injury, the rabbits were administered with the Dapagliflozin (1mg/kg/day) or control-medium for 8 weeks (n=13 for each group). All lesions were assessed with angiography, optical coherence tomography (OCT), and histological assessment.@*RESULTS@#Atheroma burden (38.51±3.16% vs. 21.91±1.22%, p<0.01) and lipid accumulation (18.90±3.63% vs. 10.20±2.03%, p=0.047) was significantly decreased by SGLT-2 inhibitor treatment. The SGLT-2 inhibitor group showed lower macrophage infiltration (20.23±1.89% vs. 12.72±1.95%, p=0.01) as well as tumor necrosis factor (TNF)-α expression (31.17±4.40% vs. 19.47±2.10%, p=0.025). Relative area of inducible nitric oxide synthase+ macrophages was tended to be lower in the SGLT-2 inhibitor-treated group (1.00±0.16% vs. 0.71±0.10%, p=0.13), while relative proportion of Arg1⁺ macrophage was markedly increased (1.00±0.27% vs. 2.43±0.64%, p=0.04). As a result, progression of atherosclerosis was markedly attenuated in SGLT-2 inhibitor treated group (OCT area stenosis, 32.13±1.20% vs. 22.77±0.88%, p<0.01). Mechanistically, SGLT-2 treatment mitigated the inflammatory responses in macrophage. Especially, Toll-like receptor 4uclear factor-kappa B signaling pathway, and their downstream effectors such as interleukin-6 and TNF-α were markedly suppressed by SGLT-2 inhibitor treatment.@*CONCLUSIONS@#These results together suggest that SGLT-2 inhibitor exerts an anti-atherosclerotic effect through favorable modulation of inflammatory response as well as macrophage characteristics in non-diabetic situation.

Differential efficacy between stenting and plain balloon angioplasty for femoropopliteal disease with or without total occlusion

Background/Aims@#Whether the presence of chronic total occlusion (CTO) affects patency after stenting in femoropopliteal lesions is unknown. We determined the effects of plain balloon angioplasty (POBA) in comparison with those of stenting on patency for femoropopliteal CTO and stenosis (non-CTO). @*Methods@#We analyzed data from the Korean Vascular Intervention Society Endovascular Therapy in Lower-Limb Artery Diseases Registry, a multicenter cohort of patients with lower extremity peripheral arterial disease. Data from 1,329 patients and 1558 limbs treated with endovascular intervention for at least one femoropopliteal lesion were evaluated. @*Results@#Among the 1,558 limbs, 345, 432, 275, and 506 were in the non-CTO-POBA,non-CTO-stent, CTO-POBA, and CTO-stent groups, respectively. During follow-up, loss of clinical primary patency, a composite of freedom from restenosis or clinically driven target lesion revascularization, occurred in 65 (18.8%), 68 (15.7%), 62 (22.5%), and 113 limbs (22.3%) in the non-CTO-POBA, non-CTO-stent, CTO-POBA, and CTO-stent groups, respectively. The patients in the non-CTOstent group showed a significantly better clinical primary patency than those in the no-CTO-POBA group, whereas those in the CTO-stent and CTO-POBAgroups showed no significant differences. After inverse probability of treatment weighting to balance the differences among covariates between the non-CTOstent and non-CTO-POBA groups, the non-CTO-stent group still showed superior clinical primary patency as compared with the non-CTO-POBA group. @*Conclusions@#In the patients with femoropopliteal stenosis without CTO, stenting resulted in better clinical outcomes than balloon angioplasty. The presence of CTO in the femoropopliteal lesion should be considered when selecting a suitable device for performing endovascular procedures.