Han Cheol Lee

Comparison of infarct-related artery vs multivessel revascularization in ST-segment elevation myocardial infarction with multivessel disease: analysis from Korea Acute Myocardial Infarction Registry.

BACKGROUND Many ST-segment elevation myocardial infarction (STEMI) patients have multivessel disease. There is still controversy in treatment strategy in STEMI patients with multivessel disease. We compared clinical outcomes of multivessel revascularization with infarct- related artery (IRA) revascularization in STEMI patients. METHODS The 1,644 STEMI patients with multivessel disease (1,106 in IRA group, 538 in multivessel group) who were received primary percutaneous coronary intervention (PCI) were analyzed from a nationwide Korea Acute Myocardial Infarction Registry. Primary endpoint was 12-month major adverse cardiac events (MACE, defined as death, myocardial infarction, and repeated revascularization). Secondary endpoints were 1-month MACE and each component, stent thrombosis during 12 month follow-up, and each components of the 12-month MACE. RESULTS There were more patients with unfavorable baseline conditions in IRA group. 12-month MACE occurred in 165 (14.9%) patients in IRA group, 81 (15.1%) patients in multivessel group (p = 0.953). There were no statistical significance in the rate of 1-month MACE, each components of 1-month MACE, and stent thrombosis during 12 month follow-up. Each components of 12-month MACE were occurred similarly in both groups except for target lesion revascularization (2.4% in IRA group vs 5.9% in multivessel group, p < 0.0001). After adjusting for confounding factors, multivessel revascularization was not associated with reduced 12-month MACE (OR 1.096, 95% CI 0.676-1.775, p = 0.711). CONCLUSIONS There were no significant differences in clinical outcomes between both groups except for high risk of target lesion revascularization in multivessel revascularization group.

Effects of Intracoronary Administration of Autologous Adipose Tissue-Derived Stem Cells on Acute Myocardial Infarction in a Porcine Model.

Purpose Adipose-derived stem cells (ADSCs) are known to be potentially effective in regeneration of damaged tissue. We aimed to assess the effectiveness of intracoronary administration of ADSCs in reducing the infarction area and improving function after acute transmural myocardial infarction (MI) in a porcine model. Materials and Methods ADSCs were obtained from each pigs abdominal subcutaneous fat tissue by simple liposuction. After 3 passages of 14-days culture, 2 million ADSCs were injected into the coronary artery 30 min after acute transmural MI. At baseline and 4 weeks after the ADSC injection, 99mTc methoxyisobutylisonitrile-single photon emission computed tomography (MIBI-SPECT) was performed to evaluate the left ventricular volume, left ventricular ejection fraction (LVEF; %), and perfusion defects as well as the myocardial salvage (%) and salvage index. At 4 weeks, each pig was sacrificed, and the heart was extracted and dissected. Gross and microscopic analyses with specific immunohistochemistry staining were then performed. Results Analysis showed improvement in the perfusion defect, but not in the LVEF in the ADSC group (n=14), compared with the control group (n=14) (perfusion defect, -13.0±10.0 vs. -2.6±12.0, p=0.019; LVEF, -8.0±15.4 vs. -15.9±14.8, p=0.181). There was a tendency of reducing left ventricular volume in ADSC group. The ADSCs identified by stromal cell-derived factor-1 (SDF-1) staining were well co-localized by von Willebrand factor and Troponin T staining. Conclusion Intracoronary injection of cultured ADSCs improved myocardial perfusion in this porcine acute transmural MI model.

Association between Serum Fibroblast Growth Factor 21 and Coronary Artery Disease in Patients with Type 2 Diabetes

The aim of this study was to evaluate the association of plasma fibroblast growth factor (FGF)-21 with angiographically significant coronary artery disease (CAD) in patients with type 2 diabetes mellitus. Serum FGF-21 was measured in 120 patients undergoing coronary angiography. Patients were divided into 4 groups based on the presence/absence of type 2 diabetes mellitus and of significant CAD. The atherosclerotic burden was obtained by two angiographic scores: Gensini score (GS) and Extent score (ES). FGF-21 levels were higher in type 2 diabetes mellitus than in non-diabetic patients (P = 0.014). FGF-21 levels were significantly correlated with GS (r = 0.358, P < 0.001) and ES (r = 0.324, P < 0.001) in univariate analysis with all patients. After adjusting for several confounding factors, both GS and ES were associated with FGF-21 in all patients (r = 0.271, P = 0.014; r = 0.217, P = 0.041, respectively). However, FGF-21 lost significant correlation with both GS and ES with type 2 diabetes mellitus in the final model. The patients with type 2 diabetes mellitus and CAD feature had elevated FGF-21 levels. Despite of a limited role in diabetic patients, FGF-21 levels are independently associated with angiographic severity and extent of CAD. Graphical Abstract

Comparison of transradial and transfemoral coronary intervention in octogenarians with acute myocardial infarction

BACKGROUND The transradial (TR) approach for percutaneous coronary intervention (PCI) is challenging and associated with failure in elderly patients. We compared the TR and transfemoral (TF) approaches in patients>80 years with acute myocardial infarction (MI) undergoing PCI. METHODS A total of 1945 (7.2%) octogenarians were enrolled from among 27,129 patients in the Korea Acute Myocardial Infarction Registry. The TR group (n=336, 17.3%) was compared with the TF group (n=1609, 82.7%) in the overall and propensity-matched cohorts with respect to procedural success, complications, in-hospital mortality, and one-year mortality and total major adverse cardiac event (MACE; death, MI, and revascularization) rate. RESULTS In the overall cohort, the TR group had lower incidence of Killip class III or IV compared to the TF group. The disease extent and lesion severity were similar between groups, as was the procedural success rate (97.7% vs. 98.3%); however, in-hospital complications were significantly lower in the TR group (8.1% vs. 20.3%). In-hospital mortality was significantly lower in the TR group than the TF group (3.4% vs. 11.4%), as were the one-year mortality and total MACE (9.8% vs. 18.4% and 13% vs. 21.9%, respectively). These outcomes were consistent in the propensity-matched cohort. The TR approach was found to be a significant predictor of low in-hospital mortality (OR 0.355, 95% CI 0.139-0.907), but not of one-year mortality (OR 0.644, 95% CI 0.334-1.240). CONCLUSIONS In octogenarians with acute MI undergoing PCI, the TR approach was more effective than the TF approach as it had lower complication rate and better clinical outcomes with comparable procedural success.

Effect of n-3 Polyunsaturated Fatty Acids on Regression of Coronary Atherosclerosis in Statin Treated Patients Undergoing Percutaneous Coronary Intervention.

Background and Objectives Statins remain the mainstay of secondary coronary artery disease (CAD) prevention, but n-3 polyunsaturated fatty acids (ω-3 PUFA) display biological effects that may also reduce the risk of atherosclerosis and CAD. However, data on the possible antiatherosclerotic benefits of adding ω-3 PUFA to statin therapy are limited. This study aimed to investigate the potential additive effects of ω-3 PUFA on regression of atherosclerosis in CAD patients receiving statin therapy and stent implantation. Subjects and Methods Seventy-four CAD patients undergoing percutaneous coronary intervention (PCI) with stent implantation were enrolled, prescribed statins, and randomly assigned to two groups: n-3 group (ω-3 PUFA 3 g/day, n=38) or placebo group (placebo, n=36). All patients completed the study follow-up consisting of an intravascular ultrasound at baseline and at 12 months. Results There was no difference in the baseline characteristics and distribution of other medications. No significant differences were observed in primary endpoints, including changes in atheroma volume index (−12.65% vs. −8.51%, p=0.768) and percent atheroma volume (−4.36% vs. −9.98%, p=0.526), and in secondary endpoints including a change in neointimal volume index (7.84 vs. 4.94 mm3/mm, p=0.087). Conclusion ω-3 PUFA had no definite additional effect on the regression of coronary atherosclerosis when added to statin in CAD patients undergoing PCI.

A Phase III, Multicenter, Randomized, Double-blind, Active Comparator Clinical Trial to Compare the Efficacy and Safety of Combination Therapy With Ezetimibe and Rosuvastatin Versus Rosuvastatin Monotherapy in Patients With Hypercholesterolemia: I-ROSETTE (Ildong Rosuvastatin & Ezetimibe for Hypercholesterolemia) Randomized Controlled Trial

PURPOSE Combination therapy with ezetimibe and statins is recommended in cases of statin intolerance or insufficiency. The objective of this study was to compare the efficacy and safety of combination therapy with ezetimibe and rosuvastatin versus those of rosuvastatin monotherapy in patients with hypercholesterolemia. METHODS I-ROSETTE (Ildong ROSuvastatin & ezETimibe for hypercholesTElolemia) was an 8-week, double-blind, multicenter, Phase III randomized controlled trial conducted at 20 hospitals in the Republic of Korea. Patients with hypercholesterolemia who required medical treatment according to National Cholesterol Education Program Adult Treatment Panel III guidelines were eligible for participation in the study. Patients were randomly assigned to receive ezetimibe 10 mg/rosuvastatin 20 mg, ezetimibe 10 mg/rosuvastatin 10 mg, ezetimibe 10 mg/rosuvastatin 5 mg, rosuvastatin 20 mg, rosuvastatin 10 mg, or rosuvastatin 5 mg in a 1:1:1:1:1:1 ratio. The primary end point was the difference in the mean percent change from baseline in LDL-C level after 8 weeks of treatment between the ezetimibe/rosuvastatin and rosuvastatin treatment groups. All patients were assessed for adverse events (AEs), clinical laboratory data, and vital signs. FINDINGS Of 396 patients, 389 with efficacy data were analyzed. Baseline characteristics among 6 groups were similar. After 8 weeks of double-blind treatment, the percent changes in adjusted mean LDL-C levels at week 8 compared with baseline values were -57.0% (2.1%) and -44.4% (2.1%) in the total ezetimibe/rosuvastatin and total rosuvastatin groups, respectively (P < 0.001). The LDL-C-lowering efficacy of each of the ezetimibe/rosuvastatin combinations was superior to that of each of the respective doses of rosuvastatin. The mean percent change in LDL-C level in all ezetimibe/rosuvastatin combination groups was >50%. The number of patients who achieved target LDL-C levels at week 8 was significantly greater in the ezetimibe/rosuvastatin group (180 [92.3%] of 195 patients) than in the rosuvastatin monotherapy group (155 [79.9%] of 194 patients) (P < 0.001). There were no significant differences in the incidence of overall AEs, adverse drug reactions, and serious AEs; laboratory findings, including liver function test results and creatinine kinase levels, were comparable between groups. IMPLICATIONS Fixed-dose combinations of ezetimibe/rosuvastatin significantly improved lipid profiles in patients with hypercholesterolemia compared with rosuvastatin monotherapy. All groups treated with rosuvastatin and ezetimibe reported a decrease in mean LDL-C level >50%. The safety and tolerability of ezetimibe/rosuvastatin therapy were comparable with those of rosuvastatin monotherapy. ClinicalTrials.gov identifier: NCT02749994.

The predictive value of echocardiography for chronic thromboembolic pulmonary hypertension after acute pulmonary embolism in Korea

BACKGROUND/AIMS Chronic thromboembolic pulmonary hypertension (CTEPH) is a life-threatening complication after acute pulmonary embolism (APE) and is associated with substantial morbidity and mortality. This study aimed to investigate the incidence of CTEPH after APE in Korea and to determine echocardiographic predictors of CTEPH. METHODS Among 381 patients with APE confirmed by chest computed tomography (CT) between January 2007 and July 2013, 246 consecutive patients with available echocardiographic data were enrolled in this study. CTEPH was defined as a persistent right ventricular systolic pressure (RVSP) greater than 35 mmHg on echocardiography during follow-up and persistent pulmonary embolism on the follow-up CT. RESULTS Fifteen patients (6.1%) had CTEPH. The rate of right ventricular (RV) dilatation (66.7% vs. 28.1%, p = 0.002) and the RVSP (75.5 mmHg vs. 39.0 mmHg, p < 0.001) were significantly higher in the CTEPH group. D-dimers, RV dilatation, RV hypertrophy, RVSP, and intermediate-risk APE were associated with the risk of CTEPH after APE (odds ratio [OR] 0.59, 5.11, 7.82, 1.06, and 4.86, respectively) on univariate analysis. RVSP remained as a significant predictor of CTEPH on multivariate analysis (OR, 1.056; 95% confidence interval, 1.006 to 1.109; p = 0.029). CONCLUSIONS This study showed that the incidence of CTEPH after APE in Korea was 6.1% and that initial RVSP by echocardiography was a strong prognostic factor for CTEPH.

Safety and Efficacy of an Aortic Arch Stent Graft with Window-Shaped Fenestration for Supra-Aortic Arch Vessels: an Experimental Study in Swine

Background and Objectives Thoracic endovascular aortic repair exhibits limitations in cases where the aortic pathology involves the aortic arch. We had already developed a fenestrated aortic stent graft (FASG) with a preloaded catheter for aortic pathology involving the aortic arch. FASG was suitable for elective cases. Materials and Methods An aortic arch stent graft with a window-shaped fenestration (FASG-W) for supra-aortic arch vessels is suitable for emergent cases. This study aims to test a FASG-W for supra-aortic arch vessels and to perform a preclinical study in swine to evaluate the safety and efficacy of this device. Six FASG-Ws with 1 preloaded catheter were advanced through the iliac artery in 6 swine. The presence of endoleak and the patency and deformity of the grafts were examined with computed tomography (CT) at 4 weeks postoperatively. A postmortem examination was performed at 8 weeks. The mean procedure time for FASG-W was 27.15±4.02 minutes. The mean time for the selection of the right carotid artery was 5.72±0.72 minutes. Results Major adverse events were not observed in any of the 6 pigs who survived for 8 weeks. For the FASG-W, no endoleaks, no disconnection, and no occlusion of the stent grafts were observed in the CT findings or the postmortem gross findings. Conclusion The procedure with the FASG-W was able to be performed safely in a relatively short procedure time and involved an easy technique. The FASG-W was found to be safe and convenient for use in this preclinical study of swine.

Waist-hip ratio and 1-year clinical outcome in patients with non-ST-elevation myocardial infarctions.

ObjectivesObesity is a well-known cardiovascular disease risk factor. We evaluated the relationship between the waist–hip ratio (WHR), as a surrogate marker of central obesity, and clinical outcomes in patients with non-ST-segment elevation myocardial infarctions (NSTEMIs) undergoing percutaneous coronary interventions (PCIs). MethodsBetween 2008 and 2010, NSTEMI patients who underwent PCI and who had available anthropometric data were divided into three groups according to their WHR tertile range. Clinical outcomes in the groups were analyzed. ResultsIncreasing incidences of hypertension and diabetes mellitus were associated with increasing WHR. As the WHR increased, a disintegration of patient metabolic patterns was documented in laboratory findings. There was no difference in the 1-year mortality rates between the three groups. However, increasing 1-year major adverse cardiovascular event rates were documented as the WHR increased (13, 14.7, and 19.4% in tertile groups 1–3, respectively; P=0.005). After adjusting for confounding variables, the highest tertile group was associated with increased 1-year mortality and major adverse cardiovascular event rates compared with the lowest tertile group. These differences arose from the female subgroup, suggesting that the magnitude of the central obesity effect might be greater in female than in male patients. ConclusionCentral obesity, represented by WHR, was associated with poor clinical outcomes in NSTEMI patients undergoing PCI, particularly among women.

The impact of transferring patients with ST-segment elevation myocardial infarction to percutaneous coronary intervention-capable hospitals on clinical outcomes.

BACKGROUND Primary percutaneous coronary intervention (PCI) is recommended for ST-segment elevation myocardial infarction (STEMI) patients even when the patient must be transported to a PCI-capable hospital. This study aimed to evaluate the long-term clinical outcomes of STEMI patients who were transferred for primary PCI compared to patients who arrived directly to PCI-capable hospitals. METHODS A total of 3,576 STEMI patients with less than 12 h of symptom onset-to-door time from the Korea Acute Myocardial Infarction Registry were divided into transfer (n = 2,176) and direct-arrival (n = 1,400) groups according to their status. The primary outcome was the composite of major adverse cardiac event (MACE), defined as death, non-fatal myocardial infarction, and revascularization at 1 year. RESULTS In the transfer vs. the direct-arrival group, the median symptom onset-to-firstmedical contact time was significantly shorter (60 vs. 80 min, p < 0.001), but the median symptom onset-to-door time was significantly longer (194 vs. 90 min, p < 0.001). The median door-to-balloon time was significantly shorter in the transfer group vs. the direct-arrival group (75 vs. 91 min, p < 0.001). Total death and the composite of MACE were not significantly different during hospitalization (5.1 vs. 3.9%, p = 0.980; 5.4 vs. 4.8%, p = 0.435, respectively) and at 1-year (8.2 vs. 6.6%, p = 0.075; 13.7 vs. 13.9%, p = 0.922, respectively). CONCLUSIONS Transferring STEMI patients to PCI-capable hospitals with a time delay did not affect clinical outcomes after 1 year. This study suggests that inter-hospital transfer should be encouraged even with delay for STEMI patients who require primary PCI in areas with a similar geographic accessibility.