ABSTRACT
Background and objectives@#To compare the safety and efficacy of a new everolimus-eluting stent with an abluminal-coated biodegradable polymer (Osstem Cardiotec Centum) with those of the Xience Alpine stent (Xience). @*Methods@#This randomized, prospective, multicenter, parallel-designed, single-blind trial was conducted among patients with myocardial ischemia undergoing percutaneous coronary intervention (PCI) from 21st September 2018 until 3rd July 2020. The primary efficacy endpoint was in-segment late lumen loss (LLL) at 270 days after the procedure and the primary safety endpoints were major adverse cardiac events (MACE), composite of cardiac death, myocardial infarction, and target lesion revascularization. @*Results@#We enrolled 121 patients and analyzed 113 patients who finished 270 days of followup for the primary efficacy endpoint. The mean age of the participants was 66.8 years. As for the primary efficacy endpoint, LLL of the Osstem Cardiotec Centum group was 0.09±0.13 mm and that of the Xience group was 0.12±0.14 mm (upper limit of 1-sided 95% confidence interval, 0.02; p for non-inferiority, 0.0084). This result demonstrates the non-inferiority of the Osstem Cardiotec Centum. As for the primary safety endpoint, MACE occurred in one patient (1.59% of the Xience group). Meanwhile, no MACE occurred in the Osstem Cardiotec Centum group. @*Conclusions@#The Osstem Cardiotec Centum is non-inferior to the Xience Alpine ® stent and is confirmed to be safe. It could be safely and effectively applied to patients with coronary artery disease undergoing PCI.
ABSTRACT
Background and Objectives@#This clinical trial was conducted to evaluate the safety and efficacy of D+Storm™ drug-eluting stent (DES) and BioMatrix Flex™ DES. @*Methods@#This study was a multicenter, subject-single-blind, randomized, and confirmed comparative clinical trial. According to the inclusion criteria, those diagnosed with stable angina, unstable angina, silent ischemia, or non-ST-segment myocardial infarction were selected among patients with coronary artery stenosis as subjects. Among the subjects with 50% stenosis on coronary angiography, the experiment was performed on those who had a lesion with reference vessel 2.5–4.0 mm in diameter and ≤40 mm in length. The primary endpoint was an in-segment late loss and the secondary endpoints were in-stent late lumen loss, stent malapposition, the incidence of mortality, myocardial infarction, reoperation, and stent thrombosis at 36 weeks. @*Results@#57 patients in the D+Storm™ DES group and 55 patients in the BioMatrix Flex™ DES group were enrolled in the study. Fifty-seven patients in the D+Storm™ DES group and Fifty-five patients in the BioMatrix Flex™ DES group were enrolled in the study. An average of in-segment late lumen loss was 0.08±0.13 mm in the D+Storm™ DES group and 0.14±0.32mm in the BioMatrix Flex™ DES group with no significant difference between the 2 groups (p=0.879). In addition, there was no significant difference in adverse events between D+Storm™ DES and BioMatrix Flex™ DES. @*Conclusions@#This study demonstrated the clinical effectiveness and safety of D+Storm™ DES implantation in patients with coronary artery disease over a 36-week follow-up period.
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Objective@#The Korean Society of Lipid and Atherosclerosis (KSoLA) has published the Dyslipidemia Fact Sheets in Korea 2020 to provide an overview of magnitude and management status of dyslipidemia and their recent trends therein. @*Methods@#The Fact Sheets were based on the analyses of Korean adults aged 20 years or older of the 2007–2018 Korea National Health and Nutrition Examination Survey (KNHANES) and the 2002–2018 National Health Insurance Big Data (NHI-BD). @*Results@#Between 2007 and 2018, the crude prevalence of hypercholesterolemia increased from 9.0% to 20.7%. During the same period, its management rate also improved yet remained unsatisfactory. In 2018, the prevalence of dyslipidemia was 45.6% in men and 31.3% in women, which increased with older age and presence of metabolic abnormalities.Indeed, the number of people diagnosed with dyslipidemia has increased nearly 8-fold from 1.5 million in 2002 to 11.6 million in 2018; alongside, the number of people receiving pharmacological treatment for dyslipidemia has also risen. Of the 7.7 million people treated for dyslipidemia in 2018, statin accounted for the majority (91.8%) of lipid-lowering drug prescriptions, followed by ezetimibe (14.6%), fibrate (8.5%), and omega-3 acid (5.9%). The most frequently used combination therapy was statin plus ezetimibe, accounting for 72% of dual therapy prescriptions. @*Conclusion@#Dyslipidemia continues to impose a substantial disease burden in Korea. Both healthcare practitioners and patients need to actively adopt guideline-recommended lifestyle modification and pharmacological treatment for comprehensive, timely, and sustained management.
ABSTRACT
Objective@#The Korean Society of Lipid and Atherosclerosis (KSoLA) has published the Dyslipidemia Fact Sheets in Korea 2020 to provide an overview of magnitude and management status of dyslipidemia and their recent trends therein. @*Methods@#The Fact Sheets were based on the analyses of Korean adults aged 20 years or older of the 2007–2018 Korea National Health and Nutrition Examination Survey (KNHANES) and the 2002–2018 National Health Insurance Big Data (NHI-BD). @*Results@#Between 2007 and 2018, the crude prevalence of hypercholesterolemia increased from 9.0% to 20.7%. During the same period, its management rate also improved yet remained unsatisfactory. In 2018, the prevalence of dyslipidemia was 45.6% in men and 31.3% in women, which increased with older age and presence of metabolic abnormalities.Indeed, the number of people diagnosed with dyslipidemia has increased nearly 8-fold from 1.5 million in 2002 to 11.6 million in 2018; alongside, the number of people receiving pharmacological treatment for dyslipidemia has also risen. Of the 7.7 million people treated for dyslipidemia in 2018, statin accounted for the majority (91.8%) of lipid-lowering drug prescriptions, followed by ezetimibe (14.6%), fibrate (8.5%), and omega-3 acid (5.9%). The most frequently used combination therapy was statin plus ezetimibe, accounting for 72% of dual therapy prescriptions. @*Conclusion@#Dyslipidemia continues to impose a substantial disease burden in Korea. Both healthcare practitioners and patients need to actively adopt guideline-recommended lifestyle modification and pharmacological treatment for comprehensive, timely, and sustained management.
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Background and Objectives@#The Sapien 3 (S3) valve has not been compared to the Sapien XT (SXT) valve in Korea. We compared procedural and clinical outcomes between the 2 devices. @*Methods@#A total of 189 patients who underwent transcatheter aortic valve replacement (TAVR) with S3 (n=95) or SXT (n=94) valve was analyzed. The primary endpoint was cardiovascular mortality at 1 year. The median follow-up duration was 438 days. @*Results@#The Society of Thoracic Surgeons score was similar between the 2 groups. The device success rate (90.4% vs. 97.9%; p=0.028) was higher in the S3 than in the SXT. The S3 showed significantly fewer cases of moderate or severe paravalvular leakage (PVL) (16.7% vs.0.0%; p=0.001) than the SXT. However, effective orifice area (EOA) (2.07±0.61 vs. 1.70±0.49 cm2 ; p<0.001) was smaller in the S3. Multivariable Cox regression analysis showed the S3 was associated with significantly fewer cardiovascular mortality at 1 year compared to the SXT (5.4% vs. 1.1%; hazard ratio, 0.031; 95% confidence interval, 0.001–0.951; p=0.047). Periprocedural complication rates, composite of disabling stroke or all-cause mortality, allcause mortality, and disabling stroke at 1 year were similar between the 2 groups. @*Conclusions@#Cardiovascular mortality was lower in the S3 group than in the SXT group over 1 year of follow-up. The reduction in PVL was attributed to the higher device success rate of TAVR with the S3 valve. However, the benefit of S3 obtained at the expense of reduced EOA should be meticulously re-evaluated in larger studies during long-term follow-up.
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Background and Objectives@#Vascular smooth muscle cell (SMC) proliferation and migration play a critical role in neointimal formation. Focal adhesion is involved in cell proliferation and migration, and talin is known to be a key regulator of these processes. We synthesized a new talin modulator that binds to the talin protein, and investigated its effects on SMCs and neointimal formation after vascular injury. @*Methods@#Human aortic SMCs (HAoSMCs) were treated with a newly synthesized talin modulator. Apolipoprotein E knockout (ApoE KO) mice were subjected to left femoral arterial injury and orally administered with the talin modulator daily. Laser Doppler imager was used to compare the blood flow, and injured femoral arteries and blood serum were analyzed after 28 days. @*Results@#The talin modulator significantly inhibited cell proliferation in a concentration-dependent manner and suppressed the migration of HAoSMCs. Treatment with a talin modulator resulted in a significant reduction in the phosphorylation of focal adhesion molecules and downstream signaling molecules related to cell proliferation and migration. The effects of the talin modulator in HAoSMCs were found to be reversible, as evidenced by the reactivation of signaling pathways upon its removal. After 28 days of administration of the talin modulator, an improvement in the blood flow and reduction in neointimal formation in the injured femoral arteries were observed. @*Conclusions@#We demonstrated the inhibitory effects of a talin modulator on SMC proliferation and migration, and that were associated with downregulation of signaling pathways, resulting in the attenuation of neointimal formation in ApoE KO mice.
ABSTRACT
No abstract available.
Subject(s)
Hydroxymethylglutaryl-CoA Reductase Inhibitors , Korea , Myocardial InfarctionABSTRACT
Lowering serum low-density lipoprotein cholesterol (LDL-C) is the mainstay for reduction of risk of cardiovascular disease (CVD), the second most common cause of death in Korea. The 2015 Korean guidelines for management of dyslipidemia strongly recommend the use of statins in patients at risk of CVD. Statin therapy, which is the gold standard for CVD, reduces LDL-C level by 40% to 60% and is generally well tolerated. However, many patients are intolerant to statins and discontinue therapy or become nonadherent to therapy because of actual/perceived side effects. The most common of these side effects is the statin-associated muscle symptom (SAMS). Discontinuation and repetitive re-challenge with statins can help identify SAMS. If serum creatinine kinase level is more than 10 times the upper limit of normal, statin therapy must be stopped immediately, and the physician should identify possible causes including rhabdomyolysis and treat appropriately. In other patients, it might help to switch to a less potent statin or to use statins at intermittent non-daily dosing. To achieve target LDL-C level, non-statin lipid-lowering therapies such as dietary modifications, ezetimibe, and bile acid sequestrants may be added. Several new drugs have recently been approved for lowering LDL-C level. Alirocumab and evolocumab are monoclonal antibodies that inhibit proprotein convertase subtilisin/kexin type 9, and both drugs cause large reductions in LDL-C, similar to statins. Lomitapide and mipomersen are orphan drugs used as adjuncts to other lipid-lowering therapies in patients with homozygous familial hypercholesterolemia.
Subject(s)
Humans , Antibodies, Monoclonal , Bile , Cardiovascular Diseases , Cause of Death , Cholesterol , Creatinine , Dyslipidemias , Ezetimibe , Feeding Behavior , Hydroxymethylglutaryl-CoA Reductase Inhibitors , Hyperlipoproteinemia Type II , Korea , Lipoproteins , Orphan Drug Production , Phosphotransferases , Proprotein Convertases , RhabdomyolysisABSTRACT
BACKGROUND/AIMS: Although epigallocatechin-3-gallate (EGCG), which is found in high contents in the dried leaves of green tea, has been reported to have an anti-platelet effect, synergistic effects of EGCG in addition to current anti-platelet medications remains to be elucidated. METHODS: Blood samples were obtained from 40 participants who took aspirin (ASA, n = 10), clopidogrel (CPD, n = 10), ticagrelor (TCG, n = 10) and no anti-platelet medication (Control, n = 10). Ex vivo platelet aggregation and adhesion under various stimulators were analyzed by multiple electrode aggregometry (MEA) and Impact-R systems. PAC-1 and P-selectin expressions in human platelets were analyzed by flow cytometry. RESULTS: In MEA analysis, adenosine diphosphate (ADP) and thrombin receptor activating peptide (TRAP)-induced platelet aggregations were lower in the CPD and the TCG groups; arachidonic acid (AA)-induced platelet aggregation was lower in the ASA group, whereas collagen (COL)-induced platelet aggregations were comparable among four groups. EGCG significantly reduced ADP- and COL-induced platelet aggregation in dose-dependent manner (ADP, p = 0.04; COL, p < 0.01). There were no additional suppressions of platelet aggregation stimulated by AA in the ASA group, and by ADP in the CPD and TCG groups. Moreover, EGCG suppressed shear stress-induced platelet adhesion on Impact-R, and had no effect on P-selectin and PAC-1 expressions. CONCLUSIONS: Ex vivo treatment of EGCG inhibited platelet adhesion and aggregation without changes in P-selectin and PAC-1 expression. There was no additional suppressions in platelet aggregation stimulated by AA in the ASA group and ADP in the CPD and TCG groups.
Subject(s)
Humans , Adenosine Diphosphate , Arachidonic Acid , Aspirin , Blood Platelets , Catechin , Collagen , Electrodes , Flow Cytometry , P-Selectin , Platelet Aggregation , Platelet Aggregation Inhibitors , Receptors, Thrombin , TeaABSTRACT
Bioresorbable vascular scaffold (BRS) is an innovative device that provides structural support and drug release to prevent early recoil or restenosis, and then degrades into nontoxic compounds to avoid late complications related with metallic drug-eluting stents (DESs). BRS has several putative advantages. However, recent randomized trials and registry studies raised clinical concerns about the safety and efficacy of first generation BRS. In addition, the general guidance for the optimal practice with BRS has not been suggested due to limited long-term clinical data in Korea. To address the safety and efficacy of BRS, we reviewed the clinical evidence of BRS implantation, and suggested the appropriate criteria for patient and lesion selection, scaffold implantation technique, and management.
Subject(s)
Humans , Coronary Disease , Drug Liberation , Drug-Eluting Stents , Korea , Stents , ThrombosisABSTRACT
Coronary ostial stenosis after aortic valve replacement (AVR) is a rare but life-threatening complication. Here, we report a case of right coronary artery ostial stenosis in a patient who had a history of re-do AVR and normal preoperative coronary angiographic findings. The patient was successfully treated with a drug-eluting stent.
Subject(s)
Humans , Aortic Valve Stenosis , Aortic Valve , Constriction, Pathologic , Coronary Vessels , Drug-Eluting Stents , Percutaneous Coronary Intervention , Postoperative ComplicationsABSTRACT
Over the past decade, stem cell therapy has been extensively studied for clinical application for heart diseases. Among various stem cells, adipose tissue-derived stem cell (ADSC) is still an attractive stem cell resource due to its abundance and easy accessibility. In vitro studies showed the multipotent differentiation potentials of ADSC, even differentiation into cardiomyocytes. Many pre-clinical animal studies have also demonstrated promising therapeutic results of ADSC. Furthermore, there were several clinical trials showing the positive results in acute myocardial infarction using ADSC. The present article covers the brief introduction, the suggested therapeutic mechanisms, application methods including cell dose and delivery, and human clinical trials of ADSC for myocardial regeneration.
Subject(s)
Animals , Humans , Adipose Tissue , Heart Diseases , In Vitro Techniques , Myocardial Infarction , Myocardium , Myocytes, Cardiac , Regeneration , Stem CellsABSTRACT
OBJECTIVE: Black raspberry (Rubus occidentalis) has been known for its anti-inflammatory and anti-oxidant effects and for improving vascular endothelial function in patients at high-risk for cardiovascular disease. We investigated short-term effects of black raspberry on lipid profiles, vascular endothelial function and circulating endothelial progenitor cells in statin naïve participants with metabolic syndrome. METHODS: Patients with metabolic syndrome (n=51) without lipid lowering medications were prospectively randomized into the black raspberry group (n=26, 750 mg/day) and placebo group (n=25) during the 12-week follow-up. Lipid profiles, brachial artery flow-mediated dilatation (baFMD) and inflammatory cytokines such as IL-6, TNF-α, C-reactive protein, adiponectin, sICAM-1, sVCAM-1 were measured at baseline and at 12-week follow-up. Central blood pressure and augmentation index were also measured at baseline and at 12-week follow-up. RESULTS: Decreases from baseline in total cholesterol levels (-22.7±34.3 mg/dL vs. 0.0±34.7mg/dL, p<0.05, respectively) and total cholesterol/HDL ratio (-0.34±0.68 vs. 0.17±0.56, p<0.05, respectively) were significantly greater in the black raspberry group when compared to the placebo group. Decreases from baseline in IL-6 (-0.5±1.4 pg/mL vs. -0.1±1.1 pg/mL, p<0.05, respectively) and TNF-α levels (-5.4±4.5 pg/mL vs. -0.8±4.0 pg/mL, p<0.05, respectively) were significantly greater in the black raspberry group. Increases from the baseline in adiponectin levels (2.9±2.1 µg/mL vs. -0.2±2.5 µg/mL, p<.05) were significant in the black raspberry group. Increases in baFMD at 12-week follow-up were significantly greater in the black raspberry group when compared to the placebo group (2.9±3.6 mm vs. 1.0±3.9 mm, p<0.05, respectively). Radial augmentation indexes were significantly decreased in the black raspberry group when compared to the placebo group (-2±10% vs. 4±13%, p<0.05). CONCLUSION: The use of black raspberry significantly decreased serum total cholesterol levels, inflammatory cytokines, and augmentation index, thereby improving vascular endothelial function in statin naïve participants with metabolic syndrome during the 12-week follow-up.
Subject(s)
Humans , Adiponectin , Antioxidants , Blood Pressure , Brachial Artery , C-Reactive Protein , Cardiovascular Diseases , Cholesterol , Cytokines , Dilatation , Endothelial Progenitor Cells , Follow-Up Studies , Hydroxymethylglutaryl-CoA Reductase Inhibitors , Interleukin-6 , Prospective Studies , RubusABSTRACT
OBJECTIVE: This study aims to analyze cost-effectiveness of two most-commonly used statins from the perspective of the Korean national health system. METHODS: The scope of the analysis included rosuvastatin (5 mg, 10 mg, and 20 mg) and atorvastatin (10 mg, 20 mg, 40 mg, and 80 mg). Effectiveness was defined as percentage (%) and absolute (mg/dL) reductions of low-density lipoprotein cholesterol (LDL-C) from the baseline. They were derived from published randomized controlled studies for rosuvastatin and atorvastatin. Effectiveness was defined as reductions in LDL-C levels per mg dose of the drugs. The annual direct medical costs including drug acquisition costs and monitoring costs over the one-year time horizon were calculated for each alternative. The average cost-effectiveness ratios (ACERs) and incremental cost-effectiveness ratios (ICERs) for each statin dose were calculated. RESULTS: The ACERs for all doses of rosuvastatin (5 mg, 10 mg, and 20 mg) were lower than those for all doses of atorvastatin (10 mg, 20 mg, 40 mg, and 80 mg). Rosuvastatin 10 mg was the most cost-effective statin for LDL-C reduction. In cost-effectiveness analyses for corresponding doses of rosuvastatin and atorvastatin, rosuvastatin was the superior strategy which suggests both higher effectiveness and lower costs than atorvastatin. However, we have to consider this analysis is highly influenced by current price of statins in each market. CONCLUSIONS: For reduction of LDL-C levels in Korean patients with dyslipidemia, rosuvastatin 10mg is the most cost-effective statin in the current Korean market.
Subject(s)
Humans , Acer , Atorvastatin , Cholesterol , Cost-Benefit Analysis , Dyslipidemias , Hydroxymethylglutaryl-CoA Reductase Inhibitors , Lipoproteins , Rosuvastatin CalciumABSTRACT
BACKGROUND: Exercise-stress electrocardiography (ECG) is initially recommended for the diagnosis of coronary artery disease. But its value has been questioned in women because of suboptimal diagnostic accuracy. Stress echocardiography had been reported to have comparable test accuracy in women. But the data comparing the diagnostic accuracy of exercise-stress ECG and stress echocardiography directly are few. The aim of the study was to compare the diagnostic accuracy of exercise-stress ECG and dobutamine stress echocardiography (DSE) in Korean women. METHODS: 202 consecutive female patients who presented with chest pain in outpatient clinic, and who underwent treadmill exercise test (TET), DSE and coronary angiography were included for the study. The diagnostic accuracy TET and DSE were calculated by the definition of > 50% or > 75% coronary artery stenosis (CAS). RESULTS: The sensitivity and specificity were higher with DSE (70.4, 94.6%) than TET (53.7, 73.6%) for detection of > 50% CAS. The higher accuracy of DSE was maintained after exclusion of the patients who could not achieve over 85% age predicted heart rate before ischemia induction. DSE also showed greater diagnostic accuracy than TET by > 75% CAS criteria, and in subsets of patient with intermediate pretest probability. CONCLUSION: In the diagnosis of CAS, DSE showed higher accuracy than TET in female patients who presented with chest pain. As well as the test accuracy, adequate stress was more feasible with DSE than TET. These finding suggests DSE may be used as the first-line diagnostic tool in the detection of CAS in women with chest pain.
Subject(s)
Female , Humans , Ambulatory Care Facilities , Chest Pain , Coronary Angiography , Coronary Artery Disease , Coronary Stenosis , Coronary Vessels , Diagnosis , Echocardiography, Stress , Electrocardiography , Exercise Test , Head , Heart Rate , Ischemia , Sensitivity and SpecificityABSTRACT
No abstract available.
Subject(s)
Acute Coronary Syndrome , Percutaneous Coronary InterventionABSTRACT
We present a case of a 52-year-old woman with iatrogenic stent deformation occurred after deployment of the left main (LM) stent due to the unintentional undermining of the proximal part of the LM stent with subsequent balloon dilatation. We tried to crush the deformed part of the LM stent against the left coronary cusp by pushing it with a guiding catheter. The deformed stent was stabilized after stent crushing and the patient didn't have any cardiovascular events. This case highlights that stent deformation could be successfully managed by crushing the deformed part of the stent to the coronary sinus.
Subject(s)
Female , Humans , Middle Aged , Catheters , Coronary Angiography , Coronary Sinus , Coronary Vessels , Dilatation , Multidetector Computed Tomography , StentsABSTRACT
BACKGROUND: Endothelial dysfunction has been documented in patients with type 2 diabetes especially when combined with hypertension. We prospectively investigated the effects of pioglitazone in improving endothelial function in hypertensive type 2 diabetic patients during the 6-month follow-up. METHODS: Hypertensive type 2 diabetic patients were randomly assigned to pioglitazone (n = 25) or placebo (n = 25). Primary endpoint was to compare changes in brachial artery flow-mediated dilation (baFMD) between the 2 groups during the 6-month follow-up. Secondary endpoints were to compare changes in the circulating levels of microRNA-17, -21, 92a, -126, and -145 which have been known as indicators of endothelial cell migration and atherosclerosis progression during the 6-month follow-up. Inflammatory markers such as interleukin-6 (IL-6), tumor necrosis factor-alpha (TNF-alpha), high-sensitive C-reactive protein, adiponectin, soluble intercellular adhesion molecule-1 (sICAM-1), and soluble vascular cell adhesion molecule-1 (sVCAM-1) were compared during the follow-up. RESULTS: The prevalences of risk factors such as hyperlipidemia, smoking, stroke, and family history of coronary artery disease did not show significant differences between the 2 groups. Increases in baFMD (0.33 +/- 0.34 mm vs. 0.02 +/- 0.25 mm, p < 0.05, respectively) and in the level of circulating microRNA-21 (0.23 +/- 0.05 vs. -0.06 +/- 0.04, p < 0.05, respectively) were significantly greater in the pioglitazone group when compared to the placebo group during the 6-month follow-up. No significant differences in the prevalences of new onset heart failure, fracture, and bladder cancer were noted during the follow-up between the 2 groups. Decreases in the levels of inflammatory marker such as IL-6 (-2.54 +/- 2.32 pg/mL vs. -1.34 +/- 2.12 pg/mL, p < 0.05, respectively), TNF-alpha (-1.54 +/- 1.51 pg/mL vs. 0.14 +/- 1.12 pg/mL, p < 0.05, respectively), sICAM-1 (-39 +/- 52 ng/mL vs. 6 +/- 72 ng/mL, p < 0.05, respectively), and sVCAM-1 (-154 +/- 198 ng/mL vs. -11 +/- 356 ng/mL, p < 0.05, respectively) were significantly greater in the pioglitazone group compared to the placebo group during the follow-up. CONCLUSIONS: In hypertensive type 2 diabetic patients, pioglitazone may increase baFMD and circulatory microRNA-21 and decrease inflammatory cytokines including IL-6, TNF-alpha, sICAM-1, and sVCAM-1.