The current status and outcomes of in-hospital P2Y12 receptor inhibitor switching in Korean patients with acute myocardial infarction

Background/Aims@#While switching strategies of P2Y12 receptor inhibitors (RIs) have sometimes been used in acute myocardial infarction (AMI) patients, the current status of in-hospital P2Y12RI switching remains unknown. @*Methods@#Overall, 8,476 AMI patients who underwent successful revascularization from Korea Acute Myocardial Infarction Registry-National Institute of Health (KAMIR-NIH) were divided according to in-hospital P2Y12RI strategies, and net adverse cardiovascular events (NACEs), defined as a composite of cardiac death, non-fatal myocardial infarction (MI), stroke, or thrombolysis in myocardial infarction (TIMI) major bleeding during hospitalization were compared. @*Results@#Patients with in-hospital P2Y12RI switching accounted for 16.5%, of which 867 patients were switched from clopidogrel to potent P2Y12RI (C-P) and 532 patients from potent P2Y12RI to clopidogrel (P-C). There were no differences in NACEs among the unchanged clopidogrel, the unchanged potent P2Y12RIs, and the P2Y12RI switching groups. However, compared to the unchanged clopidogrel group, the C-P group had a higher incidence of non-fatal MI, and the P-C group had a higher incidence of TIMI major bleeding. In clinical events of in-hospital P2Y12RI switching, 90.9% of non-fatal MI occurred during pre-switching clopidogrel administration, 60.7% of TIMI major bleeding was related to pre-switching P2Y12RIs, and 71.4% of TIMI major bleeding was related to potent P2Y12RIs. Only 21.6% of the P2Y12RI switching group switched to P2Y12RIs after a loading dose (LD); however, there were no differences in clinical events between patients with and without LD. @*Conclusions@#In-hospital P2Y12RI switching occurred occasionally, but had relatively similar clinical outcomes compared to unchanged P2Y12RIs in Korean AMI patients. Non-fatal MI and bleeding appeared to be mainly related to pre-switching P2Y12RIs.

Prasugrel-based De-Escalation of Dual Antiplatelet Therapy After Percutaneous Coronary Intervention in Patients With STEMI

Background and Objectives@#De-escalation of dual-antiplatelet therapy through dose reduction of prasugrel improved net adverse clinical events (NACEs) after acute coronary syndrome (ACS), mainly through the reduction of bleeding without an increase in ischemic outcomes. Whether the benefits of de-escalation are sustained in highly thrombotic conditions such as ST-elevation myocardial infarction (STEMI) is unknown. We aimed to assess the efficacy and safety of de-escalation therapy in patients with STEMI or non-STsegment elevation ACS (NSTE-ACS). @*Methods@#This is a pre-specified subgroup analysis of the HOST-REDUCE-POLYTECH-ACS trial. ACS patients were randomized to prasugrel de-escalation (5 mg daily) or conventional dose (10 mg daily) at 1-month post-percutaneous coronary intervention. The primary endpoint was a NACE, defined as a composite of all-cause death, non-fatal myocardial infarction, stent thrombosis, clinically driven revascularization, stroke, and bleeding events of grade ≥2 Bleeding Academic Research Consortium (BARC) criteria at 1 year. @*Results@#Among 2,338 patients included in the randomization, 326 patients were diagnosed with STEMI. In patients with NSTE-ACS, the risk of the primary endpoint was significantly reduced with de-escalation (hazard ratio [HR], 0.65; 95% confidence interval [CI], 0.48– 0.89; p=0.006 for de-escalation vs. conventional), mainly driven by a reduced bleeding. However, in those with STEMI, there was no difference in the occurrence of the primary outcome (HR, 1.04; 95% CI, 0.48–2.26; p=0.915; p for interaction=0.271). @*Conclusions@#Prasugrel dose de-escalation reduced the rate of NACE and bleeding, without increasing the rate of ischemic events in NSTE-ACS patients but not in STEMI patients.

Predictors of recurrent acute myocardial infarction despite successful percutaneous coronary intervention

Background/Aims@#Recurrent acute myocardial infarction (AMI) is an adverse cardiac event in patients with a first AMI. The predictors of recurrent AMI after the first AMI in patients who underwent successful percutaneous coronary intervention (PCI) have not been elucidated. @*Methods@#We analyzed the data collected from 9,869 patients (63.2 ± 12.4 years, men:women = 7,446:2,423) who were enrolled in the Korea Acute Myocardial Infarction Registry-National Institute of Health between November 2011 and October 2015, had suffered their first AMI and had received successful PCI during the index hospitalization. Multivariable logistic regression analysis was performed to identify the independent predictors of recurrent AMI following the first AMI. @*Results@#The cumulative incidence of recurrent AMI after successful PCI was 3.6% (359/9,869). According to the multivariable logistic regression analysis, the significant predictive factors for recurrent AMI were diabetes mellitus, renal dysfunction, atypical chest pain, and multivessel disease. @*Conclusions@#In this Korean prospective cohort study, the independent predictors of recurrent AMI after successful PCI for the first AMI were diabetes mellitus, renal dysfunction, atypical chest pain, and multivessel disease.

Clinical outcomes of endovascular treatment for ruptured thoracic aortic disease

Background/Aims@#Untreated rupture of the thoracic aorta is associated with a high mortality rate. We aimed to review the clinical results of endovascular treatment for ruptured thoracic aortic disease. @*Methods@#We retrospectively reviewed data on 37 patients (mean age, 67.0 ± 15.18 years) treated for ruptured thoracic aortic disease from January 2005 to May 2016. The median follow-up duration was 308 days (interquartile range, 61 to 1,036.5). The primary end-point of the study was the composite of death, secondary intervention, endoleak, and major stroke/paraplegia after endovascular treatment. @*Results@#The etiologies of ruptured thoracic aortic disease were aortic dissection (n = 11, 29.7%), intramural hematoma (n = 7, 18.9%), thoracic aortic aneurysm (n = 14, 37.8%), and traumatic aortic transection (n = 5, 13.5%). Three patients died within 24 hours of thoracic endovascular aortic repair, and one showed type I endoleak. The technical success rate was 89.2% (33/37). The in-hospital mortality rate was 13.5% (5/37); no deaths occurred during follow-up. The composite outcome rate during follow-up was 37.8% (14/37), comprising death (n = 5, 13.5%), secondary intervention (n = 5, 13.5%), endoleak (n = 5, 13.5%), and major stroke/paraplegia (n = 3, 8.1%). Left subclavian artery revascularization and proximal landing zone were not associated with the composite outcome. Low mean arterial pressure (MAP; ≤ 60 mmHg, [hazard ratio, 13.018; 95% confidence interval, 2.435 to 69.583, p = 0.003]) was the most significant predictor and high transfusion requirement in the first 24 hours was associated with event-free survival (log rank p = 0.018). @*Conclusions@#Endovascular treatment achieves high technical success rates and acceptable clinical outcome. High transfusion volume and low MAP were associated with poor clinical outcomes.

Clopidogrel versus Aspirin after Dual Antiplatelet Therapy in Acute Myocardial Infarction Patients Undergoing Drug-Eluting Stenting

BACKGROUND AND OBJECTIVES: There is a paucity of data regarding the benefit of clopidogrel monotherapy after dual antiplatelet therapy (DAPT) in patients treated with drug-eluting stents (DES). This study compared outcome between clopidogrel versus aspirin as monotherapy after DES for acute myocardial infarction (MI).METHODS: From Korea Acute Myocardial Infarction Registry-National Institute of Health database, 1,819 patients treated with DES who were switched to monotherapy with clopidogrel (n=534) or aspirin (n=1,285) after uneventful 12-month DAPT were analyzed. The primary endpoint was net adverse clinical events (NACE), defined as a composite of death from any cause, MI, repeat percutaneous coronary intervention (PCI), stent thrombosis, ischemic stroke, or major bleeding during the period from 12 to 24 months.RESULTS: After adjustment using inverse probability of treatment weighting, patients who received clopidogrel, compared with those treated with aspirin, had a similar incidence of NACE (0.7% and 0.7%; hazard ratio, 1.06; 95% confidence interval, 0.31–3.60; p=0.923). The 2 groups had similar rates of death from any cause (0.1% in each group, p=0.789), MI (0.3% and 0.1%, respectively; p=0.226), repeat PCI (0.1% and 0.3%, respectively; p=0.548), stent thrombosis (0.1% and 0%, respectively; p=0.121), major bleeding (0.2% in each group, p=0.974), and major adverse cardiovascular and cerebrovascular events (0.5% in each group, p=0.924).CONCLUSIONS: Monotherapy with clopidogrel, compared to aspirin, after DAPT showed similar clinical outcomes in patients with acute MI treated with DES.

Effect of Operator Volume on In-Hospital Outcomes Following Primary Percutaneous Coronary Intervention for ST-Elevation Myocardial Infarction: Based on the 2014 Cohort of Korean Percutaneous Coronary Intervention (K-PCI) Registry

BACKGROUND AND OBJECTIVES: The relationship between operator volume and outcomes of percutaneous coronary intervention (PCI) in patients with ST-elevation myocardial infarction (STEMI) has not been fully investigated. We aimed to investigate the relationship between operator PCI volume and in-hospital outcomes after primary PCI for STEMI.METHODS: Among the total of 44,967 consecutive cases of PCI enrolled in the Korean nationwide, retrospective registry (K-PCI registry), 8,282 patients treated with PCI for STEMI by 373 operators were analyzed. PCI volumes above the 75th percentile (>30 cases/year), between the 75th and 25th percentile (10–30 cases/year), and below the 25th percentile (<10 cases/year) were defined as high, moderate, and low-volume operators, respectively. In-hospital outcomes including mortality, non-fatal myocardial infarction (MI), stent thrombosis, stroke, and urgent repeat PCI were analyzed.RESULTS: The average number of primary PCI cases performed by 373 operators was 22.2 in a year. In-hospital mortality after PCI for STEMI was 571 cases (6.9%). In-hospital outcomes by operator volume showed no significant differences in the death rate, cardiac death, non-fatal MI, and stent thrombosis. However, the rate of urgent repeat PCI tended to be lower in the high-volume operator (0.6%) than in the moderate-(0.7%)/low-(1.5%) volume operator groups (p=0.095). The adjusted odds ratios for adverse in-hospital outcomes were similar in the 3 groups. Multivariate analysis also showed that operator volume was not a predictor for adverse in-hospital outcomes.CONCLUSIONS: In-hospital outcomes after primary PCI for STEMI were not associated with operator volume in the K-PCI registry.

Clopidogrel versus Aspirin after Dual Antiplatelet Therapy in Acute Myocardial Infarction Patients Undergoing Drug-Eluting Stenting

BACKGROUND AND OBJECTIVES@#There is a paucity of data regarding the benefit of clopidogrel monotherapy after dual antiplatelet therapy (DAPT) in patients treated with drug-eluting stents (DES). This study compared outcome between clopidogrel versus aspirin as monotherapy after DES for acute myocardial infarction (MI).@*METHODS@#From Korea Acute Myocardial Infarction Registry-National Institute of Health database, 1,819 patients treated with DES who were switched to monotherapy with clopidogrel (n=534) or aspirin (n=1,285) after uneventful 12-month DAPT were analyzed. The primary endpoint was net adverse clinical events (NACE), defined as a composite of death from any cause, MI, repeat percutaneous coronary intervention (PCI), stent thrombosis, ischemic stroke, or major bleeding during the period from 12 to 24 months.@*RESULTS@#After adjustment using inverse probability of treatment weighting, patients who received clopidogrel, compared with those treated with aspirin, had a similar incidence of NACE (0.7% and 0.7%; hazard ratio, 1.06; 95% confidence interval, 0.31–3.60; p=0.923). The 2 groups had similar rates of death from any cause (0.1% in each group, p=0.789), MI (0.3% and 0.1%, respectively; p=0.226), repeat PCI (0.1% and 0.3%, respectively; p=0.548), stent thrombosis (0.1% and 0%, respectively; p=0.121), major bleeding (0.2% in each group, p=0.974), and major adverse cardiovascular and cerebrovascular events (0.5% in each group, p=0.924).@*CONCLUSIONS@#Monotherapy with clopidogrel, compared to aspirin, after DAPT showed similar clinical outcomes in patients with acute MI treated with DES.

Effect of Operator Volume on In-Hospital Outcomes Following Primary Percutaneous Coronary Intervention for ST-Elevation Myocardial Infarction: Based on the 2014 Cohort of Korean Percutaneous Coronary Intervention (K-PCI) Registry

BACKGROUND AND OBJECTIVES@#The relationship between operator volume and outcomes of percutaneous coronary intervention (PCI) in patients with ST-elevation myocardial infarction (STEMI) has not been fully investigated. We aimed to investigate the relationship between operator PCI volume and in-hospital outcomes after primary PCI for STEMI.@*METHODS@#Among the total of 44,967 consecutive cases of PCI enrolled in the Korean nationwide, retrospective registry (K-PCI registry), 8,282 patients treated with PCI for STEMI by 373 operators were analyzed. PCI volumes above the 75th percentile (>30 cases/year), between the 75th and 25th percentile (10–30 cases/year), and below the 25th percentile (<10 cases/year) were defined as high, moderate, and low-volume operators, respectively. In-hospital outcomes including mortality, non-fatal myocardial infarction (MI), stent thrombosis, stroke, and urgent repeat PCI were analyzed.@*RESULTS@#The average number of primary PCI cases performed by 373 operators was 22.2 in a year. In-hospital mortality after PCI for STEMI was 571 cases (6.9%). In-hospital outcomes by operator volume showed no significant differences in the death rate, cardiac death, non-fatal MI, and stent thrombosis. However, the rate of urgent repeat PCI tended to be lower in the high-volume operator (0.6%) than in the moderate-(0.7%)/low-(1.5%) volume operator groups (p=0.095). The adjusted odds ratios for adverse in-hospital outcomes were similar in the 3 groups. Multivariate analysis also showed that operator volume was not a predictor for adverse in-hospital outcomes.@*CONCLUSIONS@#In-hospital outcomes after primary PCI for STEMI were not associated with operator volume in the K-PCI registry.

Pre-hospital delay and emergency medical services in acute myocardial infarction

Background/Aims@#Minimising total ischemic time (TIT) is important for improving clinical outcomes in patients with ST-segment elevation myocardial infarction who have undergone percutaneous coronary intervention (PCI). TIT has not shown a significant improvement due to persistent pre-hospital delay. This study aimed to investigate the risk factors associated with pre-hospital delay. @*Methods@#Individuals enrolled in the Korea Acute Myocardial Infarction Registry-National Institutes of Health between 2011 and 2015 were included in this study. The study population was analyzed according to the symptom-to-door time (STDT; within 60 or > 60 minutes), and according to the type of hospital visit (emergency medical services [EMS], non-PCI center, or PCI center). @*Results@#A total of 4,874 patients were included in the analysis, of whom 28.4% arrived at the hospital within 60 minutes of symptom-onset. Old age (> 65 years), female gender, and renewed ischemia were independent predictors of delayed STDT. Utilising EMS was the only factor shown to reduce STDT within 60 minutes, even when cardiogenic shock was evident. The overall frequency of EMS utilisation was low (21.7%). Female gender was associated with not utilising EMS, whereas cardiogenic shock, previous myocardial infarction, familial history of ischemic heart disease, and off-hour visits were associated with utilising EMS. @*Conclusions@#Factors associated with delayed STDT and not utilising EMS could be targets for preventive intervention to improve STDT and TIT.

Effect of Low-Dose Nebivolol in Patients with Acute Myocardial Infarction: A Multi-Center Observational Study / 전남의대학술지

The optimal dose of beta blockers after acute myocardial infarction (MI) remains uncertain. We evaluated the effectiveness of low-dose nebivolol, a beta1 blocker and a vasodilator, in patients with acute MI. A total of 625 patients with acute MI from 14 teaching hospitals in Korea were divided into 2 groups according to the dose of nebivolol (nebistol®, Elyson Pharmaceutical Co., Ltd., Seoul, Korea): low-dose group (1.25 mg daily, n=219) and usual- to high-dose group (≥2.5 mg daily, n=406). The primary endpoints were major adverse cardiac and cerebrovascular events (MACCE, composite of death from any cause, non-fatal MI, stroke, repeat revascularization, rehospitalization for unstable angina or heart failure) at 12 months. After adjustment using inverse probability of treatment weighting, the rates of MACCE were not different between the low-dose and the usual- to high-dose groups (2.8% and 3.1%, respectively; hazard ratio: 0.92, 95% confidence interval: 0.38 to 2.24, p=0.860). The low-dose nebivolol group showed higher rates of MI than the usual- to high-dose group (1.2% and 0%, p=0.008). The 2 groups had similar rates of death from any cause (1.1% and 0.3%, p=0.273), stroke (0.4% and 1.1%, p=0.384), repeat PCI (1.2% and 0.8%, p=0.428), rehospitalization for unstable angina (1.2% and 1.0%, p=0.743) and for heart failure (0.6% and 0.7%, p=0.832). In patients with acute MI, the rates of MACCE for low-dose and usual- to high-dose nebivolol were not significantly different at 12-month follow-up.

Effectiveness and Safety of Zotarolimus-Eluting Stent (Resoluteâ„¢ Integrity) in Patients with Diffuse Long Coronary Artery Disease

BACKGROUND AND OBJECTIVES@#Diffuse long coronary artery disease (DLCAD) still has unfavorable clinical outcomes after successful percutaneous coronary intervention (PCI). Therefore, we aimed to evaluate the effectiveness and safety of Resolute™ zotarolimus-eluting stent (R-ZES; Resolute™ Integrity) for patients with DLCAD.@*METHODS@#From December 2011 to December 2014, 1,011 patients who underwent PCI using R-ZES for CAD with longer than 25 mm lesion were prospectively enrolled from 21 hospitals in Korea. We assessed the clinical outcome of major adverse cardiac events (MACE) defined as the composite of cardiac death, non-fatal myocardial infarction (MI), and clinically-driven target vessel revascularization at 12 months.@*RESULTS@#Mean age was 63.8±10.8 years, 701 (69.3%) patients were male, 572 (87.0%) patients had hypertension, 339 (33.8%) patients had diabetes, 549 (54.3%) patients diagnosed with acute MI and 545 (53.9%) patients had multi-vessel disease (MVD). A total of 1,697 stents were implanted into a total of 1,472 lesions. The mean diameter was 3.07±0.38 mm and the length was 28.27±6.97 mm. Multiple overlapping stents were performed in 205 (13.8%) lesions. A 12-month clinical follow-up was available in 1,004 patients (99.3%). The incidences of MACE and definite stent thrombosis at 12-month were 3.0% and 0.3% respectively. On multivariate Cox-regression analysis, multiple overlapping stents implantation, previous congestive heart failure, MVD, and age ≥75 years were independent predictors of one-year MACE.@*CONCLUSIONS@#Our study shows that R-ZES has an excellent 1-year clinical outcome in Korean patients with DLCAD.

Intensity of Statin Treatment in Korean Patients with Acute Myocardial Infarction and Very Low LDL Cholesterol

OBJECTIVE: Data on the intensity of statin therapy for patients with acute myocardial infarction (MI) and very low baseline low-density lipoprotein (LDL) cholesterol level are lacking. We sought to assess the impact of statin intensity in patients with acute MI and LDL cholesterol <70 mg/dL. METHODS: A total of 1,086 patients with acute MI and baseline LDL cholesterol <70 mg/dL from the Korea Acute Myocardial Infarction Registry-National Institute of Health database were divided into less intensive statin (expected LDL reduction <40%, n=302) and more intensive statin (expected LDL reduction ≥40%, n=784) groups. The primary endpoint was major adverse cardiac and cerebrovascular events (MACCEs), a composite of cardiac death, MI, revascularization occurring at least 30 days after admission, and stroke, at 12 months. RESULTS: After 1:2 propensity matching, differences were not observed between less intensive (n=302) and more intensive statin (n=604) groups in incidence of cardiac death (0.3% vs. 0.3%) and hemorrhagic stroke (0.3% vs. 0.5%, p=0.727) at 12 months. Compared with the less intensive statin group, the more intensive statin group showed lower target-vessel revascularization (4.6% vs. 1.8%, p=0.027) and MACCE (11.6% vs. 7.0%, p=0.021). Major bleeding was not different between less intensive and more intensive statin groups (1.0% vs. 2.6%, p=0.118). CONCLUSION: More intensive statin therapy was associated with significantly lower major adverse cardiovascular events in patients with acute MI and very low LDL cholesterol compared with less intensive statin therapy.

Erratum: Correction of Figure in the Article: Normal Reference Plots for the Bioelectrical Impedance Vector in Healthy Korean Adults

The present erratum notice corrects one figure of the article.

Normal Reference Plots for the Bioelectrical Impedance Vector in Healthy Korean Adults

BACKGROUND: Accurate volume measurement is important in the management of patients with congestive heart failure or renal insufficiency. A bioimpedance analyser can estimate total body water in litres and has been widely used in clinical practice due to its non-invasiveness and ease of results interpretation. To change impedance data to volumetric data, bioimpedance analysers use equations derived from data from healthy subjects, which may not apply to patients with other conditions. Bioelectrical impedance vector analysis (BIVA) was developed to overcome the dependence on those equations by constructing vector plots using raw impedance data. BIVA requires normal reference plots for the proper interpretation of individual vectors. The aim of this study was to construct normal reference vector plots of bioelectrical impedance for Koreans. METHODS: Bioelectrical impedance measurements were collected from apparently healthy subjects screened according to a comprehensive physical examination and medical history performed by trained physicians. Reference vector contours were plotted on the RXc graph using the probability density function of the bivariate normal distribution. We further compared them with those of other ethnic groups. RESULTS: A total of 242 healthy subjects aged 22 to 83 were recruited (137 men and 105 women) between December 2015 and November 2016. The centers of the tolerance ellipses were 306.3 Ω/m and 34.9 Ω/m for men and 425.6 Ω/m and 39.7 Ω/m for women. The ellipses were wider for women than for men. The confidence ellipses for Koreans were located between those for Americans and Spaniards without overlap for both genders. CONCLUSION: This study presented gender-specific normal reference BIVA plots and corresponding tolerance and confidence ellipses on the RXc graph, which is important for the interpretation of BIA-reported volume status in patients with congestive heart failure or renal insufficiency. There were noticeable differences in reference ellipses with regard to gender and ethnic groups.

Effectiveness and Safety of Zotarolimus-Eluting Stent (Resolute™ Integrity) in Patients with Diffuse Long Coronary Artery Disease

BACKGROUND AND OBJECTIVES: Diffuse long coronary artery disease (DLCAD) still has unfavorable clinical outcomes after successful percutaneous coronary intervention (PCI). Therefore, we aimed to evaluate the effectiveness and safety of Resolute™ zotarolimus-eluting stent (R-ZES; Resolute™ Integrity) for patients with DLCAD. METHODS: From December 2011 to December 2014, 1,011 patients who underwent PCI using R-ZES for CAD with longer than 25 mm lesion were prospectively enrolled from 21 hospitals in Korea. We assessed the clinical outcome of major adverse cardiac events (MACE) defined as the composite of cardiac death, non-fatal myocardial infarction (MI), and clinically-driven target vessel revascularization at 12 months. RESULTS: Mean age was 63.8±10.8 years, 701 (69.3%) patients were male, 572 (87.0%) patients had hypertension, 339 (33.8%) patients had diabetes, 549 (54.3%) patients diagnosed with acute MI and 545 (53.9%) patients had multi-vessel disease (MVD). A total of 1,697 stents were implanted into a total of 1,472 lesions. The mean diameter was 3.07±0.38 mm and the length was 28.27±6.97 mm. Multiple overlapping stents were performed in 205 (13.8%) lesions. A 12-month clinical follow-up was available in 1,004 patients (99.3%). The incidences of MACE and definite stent thrombosis at 12-month were 3.0% and 0.3% respectively. On multivariate Cox-regression analysis, multiple overlapping stents implantation, previous congestive heart failure, MVD, and age ≥75 years were independent predictors of one-year MACE. CONCLUSIONS: Our study shows that R-ZES has an excellent 1-year clinical outcome in Korean patients with DLCAD.

Effectiveness and Safety of Biolimus A9™-Eluting stEnt in Patients with AcUTe Coronary sYndrome; A Multicenter, Observational Study (BEAUTY Study)

PURPOSE: This study sought to determine the 1-year clinical effectiveness and safety of a biodegradable, polymer-containing Biolimus A9™-eluting stent (BES) in Korean patients with acute coronary syndrome (ACS). MATERIALS AND METHODS: A total of 1000 ACS patients with 1251 lesions who underwent implantation of BESs at 22 centers in Korea were enrolled between May 2011 and July 2013. We assessed major adverse cardiac events (MACE) defined as the composite of cardiac death, non-fatal myocardial infarction (MI), and clinical-driven target vessel revascularization at 12 months. RESULTS: Patient mean age was 62.6±11.4 years. 72.8% of the patients were male, 28.5% had diabetes, 32.8% had multi-vessel disease (MVD), and 47.9% presented with acute MI (AMI). The mean global registry of acute coronary events risk score of all patients was 103.0±27.6. The number of stents per patient was 1.3±0.6. The incidences of MACE and definite stent thrombosis at 12 months were 3.9% and 0.2%, respectively. On multivariate Cox-regression analysis, age ≥65 years was identified as an independent predictors of 1-year MACE (hazard ratio=2.474; 95% confidence interval=1.202−5.091). Subgroup analyses revealed no significant differences in the incidence of MACE between patients with and without diabetes (4.3% vs. 3.7%, p=0.667), between those who presented with and without AMI (4.4% vs. 3.4%, p=0.403), and between those with and without MVD (4.6% vs. 3.5%, p=0.387). CONCLUSION: Our study demonstrated excellent 1-year clinical outcomes of BES implantation in patients at low-risk for ACS.

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.

Efficacy and safety of pitavastatins in patients with acute myocardial infarction: Livalo in Acute Myocardial Infarction Study (LAMIS) II

BACKGROUND/AIMS: We evaluated the efficacy and safety and influence on glucose tolerance by different doses of pitavastatins in acute myocardial infarction (AMI) patients. METHODS: Consecutive 1,101 AMI patients who were enrolled in Livalo in Acute Myocardial Infarction Study (LAMIS)-II were randomly assigned to receive either 2 mg of pitavastatin or 4 mg of pitavastatin orally per day. Primary efficacy endpoint was composite of cardiac death, nonfatal myocardial infarction, target-lesion revascularization, and hospitalization for unstable angina, heart failure or arrhythmic events at 12-month. RESULTS: There was no significant difference in primary efficacy endpoint between 2 mg and 4 mg groups (9.07% vs. 9.13%, p = 0.976). The degree of the reduction of low density lipoprotein cholesterol (LDL-C) was significantly greater in 4 mg group compared to 2 mg group from baseline to follow-up (–42.05 ± 32.73 mg/dL vs. –34.23 ± 31.66 mg/dL, p = 0.002). Fasting plasma glucose level was reduced significantly in both groups (–20.16 ± 54.49 mg/dL in 4 mg group and –24.45 ± 63.88 mg/dL in 2 mg group, p < 0.001 and p < 0.001, respectively) and there was no significant change of glycated hemoglobin in two groups from baseline to follow-up (–0.13% ± 1.21% in 4 mg group and –0.04% ± 1.10% in 2 mg group, p = 0.256 and p = 0.671, respectively). CONCLUSIONS: Although LDL-C was reduced more significantly by using 4 mg of pitavastatin compared to 2 mg of pitavastatin, the event rate was comparable without adverse effects on glucose tolerance in both groups in AMI patients who were enrolled in LAMIS-II.

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.

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.