Publications by authors named "Jun Kwan"

75 Publications

Correlation of heart rate recovery and heart rate variability with atrial fibrillation progression.

J Int Med Res 2021 Nov;49(11):3000605211057822

Division of Cardiology, Department of Internal Medicine, 65745Inha University Hospital, Inha University College of Medicine and Inha University Hospital, Incheon, Republic of Korea.

Objective: To examine the combination of heart rate recovery (HRR) and heart rate variability (HRV) in predicting atrial fibrillation (AF) progression.

Methods: Data from patients with a first detected episode of AF who underwent treadmill exercise testing and 24-h Holter electrocardiography were retrospectively analysed. Autonomic dysfunction was verified using HRR values. Sympathetic and parasympathetic modulation was analysed by HRV. AF progression was defined as transition from the first detected paroxysmal episode to persistent/permanent AF.

Results: Of 306 patients, mean LF/HF ratio and HRR did not differ significantly by AF progression regardless of age (< or ≥65 years). However, when the LF/HF ratio was divided into tertiles, in patients aged <65 years, the mid LF/HF (1.60-2.40) ratio was significantly associated with lower AF progression rates and longer maintenance of normal sinus rhythm. For patients aged <65 years, less metabolic equivalents were related to higher AF progression rates. For patients aged ≥65 years, a low HRR was associated with high AF progression rates.

Conclusion: In relatively younger age, high physical capacity and balanced autonomic nervous system regulation are important predictors of AF progression. Evaluation of autonomic function assessed by age could predict AF progression.
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http://dx.doi.org/10.1177/03000605211057822DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8619754PMC
November 2021

Comparison of the Efficacy and Safety of Atorvastatin 40 mg/ω-3 Fatty Acids 4 g Fixed-dose Combination and Atorvastatin 40 mg Monotherapy in Hypertriglyceridemic Patients who Poorly Respond to Atorvastatin 40 mg Monotherapy: An 8-week, Multicenter, Randomized, Double-blind Phase III Study.

Clin Ther 2021 08 29;43(8):1419-1430. Epub 2021 Jul 29.

The Division of Cardiology, Department of Internal Medicine, Kyunghee University Hospital at Gangdong, Seoul, Republic of Korea. Electronic address:

Purpose: Residual cardiovascular risk in patients with hypertriglyceridemia, despite optimal low-density lipoprotein cholesterol levels being achieved with intensive statin treatment, is a global health issue. The purpose of this study was to investigate the efficacy and tolerability of treatment with a combination of high-dose atorvastatin/Ω-3 fatty acid compared to atorvastatin + placebo in patients with hypertriglyceridemia who did not respond to statin treatment.

Methods: In this multicenter, randomized, double-blind, placebo-controlled study, patients who had residual hypertriglyceridemia after a 4-week run-in period of atorvastatin treatment were randomly assigned to receive UI-018 (fixed-dose combination atorvastatin/Ω-3 fatty acid 40 mg/4 g) or atorvastatin 40 mg + placebo (control). The primary efficacy end points were the percentage change from baseline in non-high density lipoprotein cholesterol (non-HDL-C) level at the end of treatment and the adverse events recorded during treatment. A secondary end point was the percentage change from baseline in triglyceride level.

Findings: After 8 weeks of treatment, the percentage changes from baseline in non-HDL-C (-4.4% vs +0.6%; p = 0.02) and triglycerides (-18.5% vs +0.9%; p < 0.01) were significantly greater in the UI-018 group (n = 101) than in the control group (n = 99). These changes were present in subgroups of advanced age (≥65 years), status (body mass index ≥25 kg/m), or without diabetes. The prevalences of adverse events did not differ between the 2 treatment groups.

Implications: In patients with residual hypertriglyceridemia despite receiving statin treatment, a combination of high-dose atorvastatin/Ω-3 fatty acid was associated with a greater reduction of triglyceride and non-HDL-C compared with atorvastatin + placebo, without significant adverse events.
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http://dx.doi.org/10.1016/j.clinthera.2021.07.001DOI Listing
August 2021

Neutrophil-to-Lymphocyte Ratio at Emergency Room Predicts Mechanical Complications of ST-segment Elevation Myocardial Infarction.

J Korean Med Sci 2021 May 17;36(19):e131. Epub 2021 May 17.

Division of Cardiology, Department of Internal Medicine, Inha University College of Medicine and Inha University Hospital, Incheon, Korea.

Background: The neutrophil-to-lymphocyte ratio (NLR) has been proven to be a reliable inflammatory marker. A recent study reported that elevated NLR is associated with adverse cardiovascular events in patients with ST-segment elevation myocardial infarction (STEMI). We investigated whether NLR at emergency room (ER) is associated with mechanical complications of STEMI undergoing primary percutaneous coronary intervention (PCI).

Methods: A total of 744 patients with STEMI who underwent successful primary PCI from 2009 to 2018 were enrolled in this study. Total and differential leukocyte counts were measured at ER. The NLR was calculated as the ratio of neutrophil count to lymphocyte count. Patients were divided into tertiles according to NLR. Mechanical complications of STEMI were defined by STEMI combined with sudden cardiac arrest, stent thrombosis, pericardial effusion, post myocardial infarction (MI) pericarditis, and post MI ventricular septal rupture, free-wall rupture, left ventricular thrombus, and acute mitral regurgitation during hospitalization.

Results: Patients in the high NLR group (> 4.90) had higher risk of mechanical complications of STEMI ( = 0.001) compared with those in the low and intermediate groups (13% vs. 13% vs. 23%). On multivariable analysis, NLR remained an independent predictor for mechanical complications of STEMI (RR = 1.947, 95% CI = 1.136-3.339, = 0.015) along with symptom-to balloon time ( = 0.002) and left ventricular dysfunction ( < 0.001).

Conclusion: NLR at ER is an independent predictor of mechanical complications of STEMI undergoing primary PCI. STEMI patients with high NLR are at increased risk for complications during hospitalization, therefore, needs more intensive treatment after PCI.
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http://dx.doi.org/10.3346/jkms.2021.36.e131DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8129614PMC
May 2021

Valsartan Dosage on Ventriculo-Vascular Coupling Index Dose-Dependency in Heart Failure Patients.

Yonsei Med J 2021 May;62(5):391-399

Gachon Cardiovascular Research Institute, Gachon University, Incheon, Korea.

Purpose: Heart failure (HF) poses significant morbidity and mortality. Recently, the ventriculo-vascular coupling index (VVI) was introduced as an independent prognostic factor reflective of the overall cardiovascular performance index in HF. We aimed to determine the effectiveness of force-titration of valsartan on VVI values in HF patients.

Materials And Methods: In this multicenter and prospective observational trial, the effect of valsartan was stratified according to dosages [non-ceiling dose (NCD) vs. ceiling dose (CD)] in HF patients with left ventricular ejection fraction (LVEF) <55%. Biochemical studies, including N-terminal pro-B-type natriuretic peptide (NT-proBNP), echocardiography with VVI, the treadmill test, and the activity scale index were assessed at baseline and after 24 weeks of treatment.

Results: One-hundred thirty-eight patients were force-titrated to either a CD group (n=81) or a NCD group (n=57). The mean age of the study participants was 59 years and 66% were male. After 6 months of follow up, left ventricular mass index (LVMI) values had significantly improved in the CD group but not in the NCD group. Intriguingly, in HF patients with a reduced ejection fraction (HFrEF) (n=52, LVEF <40%), a significant improvement in VVI was only observed in the CD group (from 2.4±0.6 to 1.8±0.5, <0.001).

Conclusion: CDs of valsartan for 6 months showed better improvement in VVI, as well as LVMI, in patients with HFrEF, compared with NCDs.
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http://dx.doi.org/10.3349/ymj.2021.62.5.391DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8084698PMC
May 2021

Ivabradine-Induced Torsade de Pointes in Patients with Heart Failure Reduced Ejection Fraction.

Int Heart J 2020 Sep 12;61(5):1044-1048. Epub 2020 Sep 12.

Department of Cardiology, Inha University Hospital Cardiovascular Center.

Ivabradine is a selective inhibitor of the sinoatrial node "funny" current, prolonging the slow diastolic depolarization. As it has the ability to block the heart rate selectively, it is more effective at a faster heart rate. It is recommended for the treatment of heart failure reduced ejection fraction in the presence of beta-blocker therapy for the further reduction of the heart rate. However, previous reports have shown the association of Torsade de pointes (TdP) with concurrent use of ivabradine and drugs resulting in QT prolongation or blockage of the metabolic breakdown of ivabradine. In this article, we report two cases of patients with heart failure reduced ejection fraction who developed TdP after ivabradine use. Our report highlights the need to exercise caution with the administration of ivabradine in the presence of a reduced repolarization reserve, such as QT prolongation or metabolic insufficiency.
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http://dx.doi.org/10.1536/ihj.20-073DOI Listing
September 2020

Relationship between arterial stiffness and variability of home blood pressure monitoring.

Medicine (Baltimore) 2020 Jul;99(30):e21227

Department of Cardiology, Heart Center, College of Medicine, Konyang University, Deajeon, Korea.

Variability of blood pressure (BP) is known as a prognostic value for the subsequent target organ damage in hypertensive patients. Arterial stiffness is a risk factor for cardiovascular morbidity and mortality. The relationship between the arterial stiffness and the BP variability has been controversial. The objective of the present study was to investigate the relationship between arterial stiffness and home BP variability in patients with high normal BP and new onset hypertension (HTN).Four hundred sixty three patients (252 males, 49 ± 12 year-old) with high normal BP or HTN were enrolled. Using radial applanation tonometry, pulse wave analysis (PWA) was performed for evaluation of systemic arterial stiffness. All patients underwent both home BP monitoring (HBPM) and PWA. Home BP variability was calculated as the standard deviation (SD) of 7 measurements of HBPM. Multiple linear regression analysis was performed to estimate and test the independent effects of home BP variability on the arterial stiffness.Mutivariate analysis showed that both systolic and diastolic morning BP variabilities were correlated with arterial stiffness expressed as augmentation pressure (AP, β-coefficient = 1.622, P = .01 and β-coefficient = 1.07, P = .035). The SDs of systolic and diastolic BP of evening were also associated with AP (β-coefficient = 1.843, P = .001 and β-coefficient = 1.088, P = .036). The SDs of morning and evening systolic BP were associated with augmentation index (AI, β-coefficient = 1.583, P = .02 and β-coefficient = 1.792, P = .001) and heart rate (75 bpm) adjusted AI (β-coefficient = 1.592, P = .001 and β-coefficient = 1.792, P = .001).In present study, the variability of systolic BP was closely related with arterial stiffness. The home BP variability might be important indicator of arterial stiffness.
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http://dx.doi.org/10.1097/MD.0000000000021227DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7387033PMC
July 2020

Mechanical and Pharmacological Revascularization Strategies for Prevention of Microvascular Dysfunction in ST-Segment Elevation Myocardial Infarction: Analysis from Index of Microcirculatory Resistance Registry Data.

J Interv Cardiol 2020 9;2020:5036396. Epub 2020 Jul 9.

Division of Cardiology, Department of Internal Medicine, Inha University Hospital, Incheon, Republic of Korea.

Objectives: We aimed to identify mechanical and pharmacological revascularization strategies correlated with the index of microcirculatory resistance (IMR) in ST-elevation myocardial infarction (STEMI) patients.

Background: Microvascular dysfunction (MVD) after STEMI is correlated with infarct size and poor long-term prognosis, and the IMR is a useful analytical method for the quantitative assessment of MVD. However, therapeutic strategies that can reliably reduce MVD remain uncertain.

Methods: Patients with STEMI who underwent primary percutaneous coronary intervention (PCI) were enrolled. The IMR was measured with a pressure sensor/thermistor-tipped guidewire immediately after primary PCI. High IMR was defined as values ≥66 percentile of IMR in enrolled patients (IMR > 30.9 IU).

Results: A total of 160 STEMI patients were analyzed (high IMR = 54 patients). Clinical factors for Killip class (=0.006), delayed hospitalization from symptom onset (=0.004), peak troponin-I level (=0.042), and multivessel disease (=0.003) were associated with high IMR. Achieving final thrombolysis in myocardial infarction myocardial perfusion grade 3 tended to be associated with low IMR (=0.119), whereas the presence of distal embolization was significantly associated with high IMR (=0.034). In terms of therapeutic strategies that involved adjusting clinical and angiographic factors associated with IMR, preloading of third-generation P2Y12 inhibitors correlated with reducing IMR value ( = -10.30, < 0.001). Mechanical therapeutic strategies including stent diameter/length, preballoon dilatation, direct stenting, and thrombectomy were not associated with low IMR value (all > 0.05), and postballoon dilatation was associated with high IMR ( = 8.30, =0.020).

Conclusions: In our study, mechanical strategies were suboptimal in achieving myocardial salvage. Preloading of third-generation P2Y12 inhibitors revealed decreased IMR value, indicative of MVD prevention.
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http://dx.doi.org/10.1155/2020/5036396DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7368229PMC
November 2020

An analysis of vascular properties using pulse wave analysis in patients with vasovagal syncope.

Clin Cardiol 2020 Jul 18;43(7):781-788. Epub 2020 Jun 18.

Department of Cardiology, Inha University Hospital Cardiovascular Center, Incheon, Republic of Korea.

Background: Vasovagal syncope (VVS) is a common cause of recurrent syncope. Nevertheless, the exact hemodynamic mechanism has not been elucidated. Pulse wave analysis (PWA) is widely used to evaluate vascular properties, as it reflects the condition of the entire arterial system.

Hypothesis: Cardiovascular autonomic modulation may influence the hemodynamic mechanism and result in different vascular properties between VVS patients and healthy individuals.

Methods: We enrolled consecutive patients diagnosed with VVS on head-up tilt testing from January 2014 to August 2019. Healthy subjects were enrolled as the control group. We performed PWA on all participants. Using propensity score matching, we assembled a study population with similar baseline characteristics and compared hemodynamic parameters.

Results: A total of 111 VVS patients (43 ± 18 years, 72 females) and 475 healthy control subjects (48 ± 13 years, 192 females) were enrolled. Compared to the healthy control subjects, the VVS patients had a higher augmentation index (AIx) adjusted to a heart rate of 75 beats per minute ([email protected], 20.5 ± 13.1% vs 16.7 ± 11.9%, P = .003). After 1:1 matched comparison (111 matched control), VVS patients consistently showed higher [email protected] (20.5 ± 13.1% vs 16.7 ± 12.9%, P = .02) than the matched control group. According to age distribution, VVS patients showed significantly higher [email protected] (10.6 ± 11.7% vs 2.5 ± 11.1%, P = .01) in a young age (15-33 years) group.

Conclusions: VVS patients had greater arterial stiffness than healthy subjects. This is one of the plausible mechanisms of the pathophysiology of VVS.
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http://dx.doi.org/10.1002/clc.23380DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7368349PMC
July 2020

Impact of gender on heart failure presentation in non-obstructive hypertrophic cardiomyopathy.

Heart Vessels 2020 Feb 3;35(2):214-222. Epub 2019 Sep 3.

Division of Cardiology, Department of Internal Medicine, Inha University Hospital, 27, Inhang-ro, Jung-gu, Incheon, 400-711, Republic of Korea.

Hypertrophic cardiomyopathy (HCM) is a genetic cardiac disease that represents a broad spectrum of morphologic features and clinical presentations. However, little is known about the impact of gender differences in heart failure (HF) development in non-obstructive HCM. We assessed clinical and echocardiographic parameters according to gender in patients with non-obstructive HCM and evaluated the impact of gender on HF presentation and cardiovascular (CV) outcomes in this population. We investigated 202 consecutive patients with non-obstructive HCM. Clinical parameters and conventional echocardiographic measurements including tissue Doppler measurements were evaluated and compared according to gender. Additionally, left ventricular (LV) deformation was assessed with global longitudinal strain (GLS) utilizing 2D speckle tracking software. Of the 202 patients (age = 63 ± 14 years, male: female = 141: 61), 51 patients (24.8%) presented with HF and female patients had HF more frequently (52.5% vs. 12.8%, P < 0.001). Females were older, had a higher prevalence of atrial fibrillation, had increased left atrial volume (LAV), and a higher ratio of early diastolic mitral inflow to early annular velocity (E/e') than males (70 ± 12 years vs. 59 ± 14 years, P < 0.001 for age; 51.4 ± 19.3 mL/m vs. 40.0 [Formula: see text] 13.4 mL/m, P < 0.001 for indexed LAV; 17.2 [Formula: see text] 6.0 vs. 13.0 [Formula: see text] 4.3, P < 0.001 for E/e'). While LV maximal thickness and LV ejection fraction were comparable between men and women, GLS was decreased significantly in female patients (- 13.5 [Formula: see text] 3.4% vs. - 15.6 [Formula: see text] 4.0%, P = 0.001 for GLS). Even after adjusting for clinical factors, female was independently associated with HF presentation (Odd ratio 5.19, 95% CI 2.24-12.03, P < 0.001). During a median follow-up duration 34.0 months, 20 patients (9.9%) had HF hospitalization or CV death. In a multivariable analysis, female gender was associated with higher risk of the composite of HF hospitalization or CV death and HF hospitalization alone than male (Adjusted hazard ratio [HR] = 3.31, 95% CI 1.17-9.35, P = 0.024 for primary composite outcome of HF hospitalization or CV death; adjusted HR = 4.78, 95% CI 1.53-14.96, P = 0.007 for HF hospitalization). In patients with non-obstructive HCM, female patients presented with HF more frequently and showed a higher risk of CV events than male patients. LA volume, E/e' and LV mechanics were different between the genders, suggesting that these might contribute to greater susceptibility to HF in women with HCM.
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http://dx.doi.org/10.1007/s00380-019-01492-0DOI Listing
February 2020

Relationship between arterial stiffness and circadian pattern of blood pressure.

Medicine (Baltimore) 2019 Mar;98(12):e14953

Department of Cardiology, Heart Center, College of Medicine, Konyang University, Deajeon, Republic of Korea.

Arterial stiffness is a risk factor for cardiovascular morbidity and mortality. The relationship between the arterial stiffness and the circadian pattern of blood pressure (BP) has been controversial. The objective of the present study was to investigate the relationship between arterial stiffness by pulse wave analysis (PWA) and variables of 24-hour ambulatory BP monitoring (ABPM) in patients with high normal BP or hypertension (HTN).Five hundred forty-eight patients (304 males, 48 ± 12-year-old) with high normal BP or HTN were enrolled. BP was measured at the outpatient clinic and 24-hour ABPM was performed. Using radial applanation tonometry, PWA was performed for evaluation of systemic arterial stiffness. Patients were classified into four groups according to the dipping patterns: a nocturnal dipping group, an isolated systolic non-dipping group, an isolated diastolic non-dipping group and a both systolic and diastolic non-dipping group. For adjustment of age, population was divided to 2 groups: old group ≥55 year-old (n = 158, 75 males), young group <55 year-old (n = 390, 229 males).According to the dipping patterns, augmentation pressure (AP), augmentation index (AI) and heart rate (75 bpm) adjusted AI ([email protected]) showed statistically significant difference (P = .011, .009, and .018, respectively). Multivariate analysis showed that isolated diastolic non-dipping was correlated with arterial stiffness expressed as AI and [email protected] 75, only in young group (β-coefficient = 12.6, P = .04 and β-coefficient = 7.503, P = .028, respectively).Arterial stiffness might be closely related with the pattern of non-dipping in young patients with HTN and high normal BP.
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http://dx.doi.org/10.1097/MD.0000000000014953DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6709131PMC
March 2019

Relation of blood pressure variability to left ventricular function and arterial stiffness in hypertensive patients.

Singapore Med J 2019 Aug 11;60(8):427-431. Epub 2019 Mar 11.

Division of Cardiology, Inha University College of Medicine, Incheon, South Korea.

Introduction: Variability of blood pressure (BP) has been reported to be related to worse cardiovascular outcomes. We examined the impact of daytime systolic BP variability on left ventricular (LV) function and arterial stiffness in hypertensive patients.

Methods: Ambulatory BP monitoring (ABPM) and echocardiography were performed in 116 hypertensive patients. We assessed BP variability as standard deviations of daytime systolic BP on 24-hour ABPM. Conventional echocardiographic parameters, area strain and three-dimensional diastolic index (3D-DI) using 3D speckle tracking were measured. Arterial stiffness was evaluated by acquiring pulse wave velocity (PWV) and augmentation index.

Results: Patients with higher BP variability showed significantly increased left ventricular mass index (LVMI) and late mitral inflow velocity, as well as decreased E/A (early mitral inflow velocity/late mitral inflow velocity) ratio, area strain and 3D-DI than those with lower BP variability (LVMI: p = 0.02; A velocity: p < 0.001; E/A ratio: p < 0.001; area strain: p = 0.02; 3D-DI: p = 0.04). In addition, increased BP variability was associated with higher PWV and augmentation index (p < 0.001). Even among patients whose BP was well controlled, BP variability was related to LV mass, diastolic dysfunction and arterial stiffness.

Conclusion: Increased BP variability was associated with LV mass and dysfunction, as well as arterial stiffness, suggesting that BP variability may be an important determinant of target organ damage in hypertensive patients.
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http://dx.doi.org/10.11622/smedj.2019030DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6717775PMC
August 2019

A multicenter, randomized, and double-blind phase IV clinical trial to compare the efficacy and safety of fixed-dose combinations of amlodipine orotate/valsartan 5/160 mg versus valsartan/hydrochlorothiazide 160/12.5 mg in patients with essential hypertension uncontrolled by valsartan 160 mg monotherapy.

Medicine (Baltimore) 2018 Sep;97(37):e12329

Department of Cardiovascular Medicine, Chonnam National University Hospital, Gwangju The Catholic University of Korea, Seoul St. Mary's Hospital Kyung Hee University Hospital, Seoul Dongguk University Ilsan Hospital, Goyang Pusan National University Hospital, Busan Soonchunhyang University Seoul Hospital, Seoul Severance Cardiovascular Hospital, Yonsei University College of Medicine, Seoul Inje University Ilsan Paik Hospital, Goyang Inje University Haeundae Paik Hostpital, Busan Chung-Ang University Hospital, Seoul CHA Bundang Medical Center, CHA University, Seongnam Hallym University Kangdong Sacred Heart Hospital, Seoul Hanllym University Sacred Heart Hospital, Anyang Soonchunhyang University Bucheon Hospital, Bucheon Inha University Hospital Heart Center, Gachon University Gil Hospital, Incheon, Republic of Korea.

Background: To determine whether the effectiveness and safety of fixed-dose combinations (FDCs) of amlodipine orotate/valsartan (AML/VAL) 5/160 mg are noninferior to those of valsartan/hydrochlorothiazide (VAL/HCTZ) 160/12.5 mg in hypertensive patients with inadequate response to valsartan 160 mg monotherapy.

Methods: This 8-week, active-controlled, parallel-group, fixed-dose, multicenter, double-blind randomized controlled, and noninferiority trial was conducted at 17 cardiovascular centers in the Republic of Korea. Eligible patients had mean sitting diastolic blood pressure (msDBP) ≥90 mm Hg despite monotherapy with valsartan 160 mg for 4 weeks. Patients were randomly assigned to treatment with AML/VAL 5/160 mg FDC (AML/VAL) group or VAL/HCTZ 160/12.5 mg FDC (VAL/HCTZ) group once daily for 8 weeks. A total of 238 patients were enrolled (AML/VAL group, n = 121; VAL/HCTZ group, n = 117), of whom 228 completed the study.

Results: At 8 weeks after randomization, msDBP was significantly decreased in both groups (-9.44 ± 0.69 mm Hg in the AML/VAL group and -7.47 ± 0.71 mm Hg in the VAL/HCTZ group, both P < .001 vs baseline). Between group difference was -1.96 ± 1.00 mm Hg, indicating that AML/VAL 5/160 mg FDC was not inferior to VAL/HCTZ 160/12.5 mg FDC at primary efficacy endpoint. Control rate of BP defined as the percentage of patients achieving mean sitting SBP (msSBP) <140 mm Hg or msDBP <90 mm Hg (target BP) from baseline to week 8 was significantly higher in the AML/VAL group than that in the VAL/HCTZ group (84.3% [n = 102] in the AML/VAL group vs 71.3% [n = 82] in the VAL/HCTZ group, P = .016). At 8 weeks after randomization, mean uric acid level was significantly increased in the VAL/HCTZ group compared to that at baseline (0.64 ± 0.08 mg/dL; P < .001). However, it was slightly decreased from baseline in the AML/VAL group (-0.12 ± 0.08 mg/dL; P = .085). The intergroup difference was significant (P < .001).

Conclusion: The effectiveness and safety AML/VAL 5/160 mg FDC are noninferior to those of VAL/HCTZ 160/12.5 mg FDC in patients with hypertension inadequately controlled by valsartan 160 mg monotherapy.
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http://dx.doi.org/10.1097/MD.0000000000012329DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6156014PMC
September 2018

Prognostic Impact of Left Atrial Minimal Volume on Clinical Outcome in Patients with Non-Obstructive Hypertrophic Cardiomyopathy.

Int Heart J 2018 Sep 29;59(5):991-995. Epub 2018 Aug 29.

Division of Cardiology, Department of Internal Medicine, Inha University Hospital.

Maximal left atrial volume (LAVmax) has been suggested to be an important indicator of left ventricular (LV) diastolic function and a prognosticator in patients with hypertrophic cardiomyopathy (HCM). However, LAVmax can be influenced by LV longitudinal systolic function, which causes systolic descent of the mitral plane. We investigated the prognostic role of LAVmin in patients with HCM and tested if LAVmin is better than LAVmax in predicting clinical outcome in these patients. A total of 167 consecutive patients with HCM were enrolled (age = 64.7 ± 13.5 years, male: female = 120:47). Clinical parameters and conventional echocardiographic measurement including tissue Doppler measurement were evaluated. Left atrial maximal and minimal volumes were measured just before mitral valve opening and at mitral valve closure respectively using the biplane disk method. The relationship between LAVmin and the clinical outcome of hospitalization for heart failure (HF), stroke or all-cause mortality was evaluated. During a median follow-up of 25.0 ± 17.8 months, the primary end point of HF hospitalization, stroke or death occurred in 35 patients (21%). Indexed LAVmin was predictive of HF, stroke or death after adjustment for age, diabetes, hypertension, atrial fibrillation, LV ejection fraction, and E/e'in a multivariate analysis (P = 0.001). The model including indexed LAVmin was superior to the model including indexed LAVmax in predicting a worse outcome in patients with HCM (P = 0.02). In conclusion, LAVmin was independently associated with increased risk of HF, stroke, or mortality in patients with HCM and was superior to LAVmax in predicting clinical outcome in this population.
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http://dx.doi.org/10.1536/ihj.17-606DOI Listing
September 2018

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.

Clin Ther 2018 02;40(2):226-241.e4

Division of Cardiology, Department of Internal Medicine, Seoul National University Hospital, Seoul National University College of Medicine, Seoul, Republic of Korea. Electronic address:

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.
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http://dx.doi.org/10.1016/j.clinthera.2017.12.018DOI Listing
February 2018

Comparison of Fixed-dose Combinations of Amlodipine/Losartan Potassium/Chlorthalidone and Amlodipine/Losartan Potassium in Patients With Stage 2 Hypertension Inadequately Controlled With Amlodipine/Losartan Potassium: A Randomized, Double-blind, Multicenter, Phase III Study.

Clin Ther 2017 Oct 19;39(10):2049-2060. Epub 2017 Sep 19.

Department of cardiology cardiovascular center, Seoul Medical center, Seoul, Republic of Korea.

Purpose: The goal of this study was to compare the efficacy and safety of fixed-dose combinations of amlodipine/losartan potassium/chlorthalidone (A/L/C) and A/L in Korean patients with stage 2 hypertension inadequately controlled by A/L.

Methods: This study was an 8-week, randomized double-blind, multicenter, phase III clinical trial. Three hundred forty volunteer patients with stage 2 hypertension were randomized to receive A/L/C or A/L. The primary end point was a change in sitting systolic blood pressure (SitSBP) after 8 weeks of treatment. As secondary end points, the change in SitSBP after 2 weeks of treatment and the change in sitting diastolic blood pressure (SitDBP) were compared between treatment groups. All patients were assessed for adverse events, clinical laboratory data, and vital signs.

Findings: Of 330 patients from 33 medical centers, 328 patients who had available efficacy data were analyzed. After 8 weeks of double-blind treatment, the mean (SD) changes in SitSBP at 8 weeks were -16.4 (0.9) mm Hg and -6.9 (1.0) mm Hg in the A/L/C and A/L groups, respectively. A/L/C had a statistically superior blood pressure-lowering effect compared with that of A/L (mean [SD] difference, 9.5 [1.3] mm Hg; P < 0.001). The mean (SD) change in SitDBP at 8 weeks was significantly greater with A/L/C (-8.0 [0.6] mm Hg) than with A/L (-3.6 [0.6] mm Hg) (P < .001). In terms of the mean (SD) change in SitDBP at 2 weeks compared with baseline, A/L/C (-5.9 [0.5] mm Hg) was statistically different from A/L (-2.9 [0.5] mm Hg) (P < .001). Mean (SD) SitSBP change from baseline to week 2 was -13.2 (0.9) and -5.5 (0.9) in the A/L/C and A/L groups, respectively, with a statistically significant blood pressure-lowering effect (P < 0.001). The number of participants who achieved target blood pressure at week 8 was significantly higher in the A/L/C group (93 patients [55.7%]) than in the A/L group (48 [29.8%]) (P < 0.001). Adverse drug reactions were observed in 23 patients (7.0%), and the incidence of dizziness was significantly higher in the A/L/C group than in the A/L group (4.8% vs 0.6%, P = 0.037) There were no serious adverse events associated with the study drugs.

Implications: The results of this study suggest that A/L/C had a significantly increased blood pressure-lowering efficacy compared with that of A/L and had a good safety profile. ClinicalTrials.gov identifier: NCT02916602.
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http://dx.doi.org/10.1016/j.clinthera.2017.08.013DOI Listing
October 2017

The efficacy and safety of co-administration of fimasartan and rosuvastatin to patients with hypertension and dyslipidemia.

BMC Pharmacol Toxicol 2017 01 5;18(1). Epub 2017 Jan 5.

Division of Cardiology, Korea University Guro Hospital, 148, Gurodong-ro, Guro-gu, Seoul, 08308, Republic of Korea.

Background: Hypertension and dyslipidemia are major risk factors of cardiovascular disease (CVD) events. The objective of this study was to evaluate the efficacy and safety of the co-administration of fimasartan and rosuvastatin in patients with hypertension and hypercholesterolemia.

Methods: We conducted a randomized double-blind and parallel-group trial. Patients who met eligible criteria after 4 weeks of therapeutic life change were randomly assigned to the following groups. 1) co-administration of fimasartan 120 mg/rosuvastatin 20 mg (FMS/RSV), 2) fimasartan 120 mg (FMS) alone 3) rosuvastatin 20 mg (RSV) alone. Drugs were administered once daily for 8 weeks.

Results: Of 140 randomized patients, 135 for whom efficacy data were available were analyzed. After 8 weeks of treatment, the FMS/RSV treatment group showed greater reductions in sitting systolic (siSBP) and diastolic (siDBP) blood pressures than those in the group receiving RSV alone (both p < 0.001). Reductions in siSBP and siDBP were not significantly different between the FMS/RSV and FMS alone groups (p = 0.500 and p = 0.734, respectively). After 8 weeks of treatment, FMS/RSV treatment showed greater efficacy in percentage reduction of low-density lipoprotein cholesterol (LDL-C) level from baseline than that shown by FMS alone treatment (p < 0.001). The response rates of siSBP with FMS/RSV, FMS alone, and RSV alone treatments were 65.22, 55.56, and 34.09%, respectively (FMS/RSV vs. RSV, p = 0.006). The LDL-C goal attainment rates with FMS/RSV, RSV alone, and FMS alone treatments were 80.43%, 81.82%, and 15.56%, respectively (FMS/RSV vs. FMS, p < 0.001). Incidence of adverse drug reactions with FMS/RSV treatment was 8.33%, which was similar to those associated with FMS and RSV alone treatments.

Conclusion: This study demonstrated that the co-administration of fimasartan and rosuvastatin to patients with both hypertension and hypercholesterolemia was efficacious and safe.

Trial Registration: ClinicalTrials.gov Identifier: NCT02166814 . 16 June 2014.
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http://dx.doi.org/10.1186/s40360-016-0112-7DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5217661PMC
January 2017

Prognostic Implications of Newly Developed T-Wave Inversion After Primary Percutaneous Coronary Intervention in Patients With ST-Segment Elevation Myocardial Infarction.

Am J Cardiol 2017 02 16;119(4):515-519. Epub 2016 Nov 16.

Department of Cardiology, Inha University Hospital, Incheon, Republic of Korea.

We investigated the prognostic value of newly developed T-wave inversion after primary percutaneous coronary intervention (PCI) in patients with ST-segment elevation myocardial infarction. New T-wave inversion was defined as new onset of T-wave inversion after the primary PCI, without negative T waves on the presenting electrocardiogram. The primary end point was the occurrence of major adverse cardiac events (MACE), which consisted of cardiovascular mortality, nonfatal myocardial infarction, and rehospitalization for heart failure. A total of 271 patients were analyzed and followed up for 24 months in this study. New T-wave inversion was observed in 194 patients (72%), whereas the remaining 77 patients (28%) did not show T-wave inversion after the index PCI. Post-PCI Thrombolysis In Myocardial Infarction flow grade 2 or 3 was observed more frequently in patients with new T-wave inversion (97% vs 90%; p = 0.011). The cumulative MACE rate was significantly lower in patients with new T-wave inversion than in those without new T-wave inversion (8% vs 30%; odds ratio 0.197, 95% confidential interval 0.096 to 0.403; p <0.001). In multivariate Cox regression analysis, new T-wave inversion was an independent prognostic factor for MACE (hazard ratio 0.297, 95% confidential interval 0.144 to 0.611; p = 0.001). In conclusion, newly developed T-wave inversion after primary PCI was associated with favorable long-term outcome.
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http://dx.doi.org/10.1016/j.amjcard.2016.10.039DOI Listing
February 2017

Relation Between Neutrophil-to-Lymphocyte Ratio and Index of Microcirculatory Resistance in Patients With ST-Segment Elevation Myocardial Infarction Undergoing Primary Percutaneous Coronary Intervention.

Am J Cardiol 2016 Nov 13;118(9):1323-1328. Epub 2016 Aug 13.

Department of Cardiology, Inha University Hospital, Incheon, Republic of Korea.

The neutrophil-to-lymphocyte ratio (NLR) has been proved as a reliable inflammatory marker for the atherosclerotic process and as a predictor for clinical outcomes in patients with various cardiovascular diseases. A recent study reported that elevated NLR is associated with impaired myocardial perfusion in patients with ST-segment elevation myocardial infarction (STEMI). We investigated whether NLR is associated with coronary microcirculation as assessed by the index of microcirculatory resistance (IMR) in patients with STEMI who had undergone primary percutaneous coronary intervention (PCI). A total of 123 patients with STEMI who underwent successful primary PCI were enrolled in this study. NLR was obtained on admission, and patients were divided into 3 groups by NLR tertile. IMR was measured using an intracoronary thermodilution-derived method immediately after index PCI. Symptom onset-to-balloon time was significantly longer (p = 0.005), and IMR was significantly higher in the high NLR group than that in the low and intermediate groups (21.94 ± 12.87 vs 23.22 ± 12.73 vs 32.95 ± 20.60, p = 0.003). Furthermore, in multiple linear regression analysis, NLR showed an independent positive correlation with IMR (r = 0.205, p = 0.009). In conclusion, NLR has shown positive correlation with IMR, whereas negative association with infarct-related artery patency in patients with STEMI who underwent primary PCI. Therefore, NLR at admission could reflect myocardial damage and the status of coronary microcirculation in patients with STEMI (ClinicalTrials.gov number, NCT02828137).
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http://dx.doi.org/10.1016/j.amjcard.2016.07.072DOI Listing
November 2016

Randomised trial to compare a protective effect of Clopidogrel Versus TIcagrelor on coronary Microvascular injury in ST-segment Elevation myocardial infarction (CV-TIME trial).

EuroIntervention 2016 Oct 10;12(8):e964-e971. Epub 2016 Oct 10.

Department of Internal Medicine, Inha University Hospital, Incheon, South Korea.

Aims: Ticagrelor has shown greater, more rapid and more consistent platelet inhibition than clopidogrel. However, the superiority of ticagrelor for preventing ischaemic damage in STEMI patients has not been proven. The aim of this trial was to assess whether ticagrelor is superior to clopidogrel in preventing microvascular injury in ST-elevation myocardial infarction (STEMI).

Methods And Results: Patients with STEMI underwent prospective random assignment to receive a loading dose (LD) of clopidogrel 600 mg or ticagrelor 180 mg (1:1 ratio) before primary percutaneous coronary intervention (PCI). As the primary endpoint, the index of microcirculatory resistance (IMR) was measured immediately after primary PCI. The secondary endpoint was the infarct size estimated from the wall motion score index (WMSI). A total of 76 patients were enrolled (clopidogrel group=38, ticagrelor group=38). The IMR in the ticagrelor group was significantly lower than that in the clopidogrel group (22.2±18.0 vs. 34.4±18.8 U, p=0.005). Cardiac enzymes were less elevated in the ticagrelor group than in the clopidogrel group (CK peak; 2,651±1,710 vs. 3,139±2,698 ng/ml, p=0.06). Infarct size, estimated by WMSI, was not different between the ticagrelor and clopidogrel groups at baseline (1.55±0.30 vs. 1.61±0.29, p=0.41) or after three months (1.42±0.33 vs. 1.47±0.33, p=0.57).

Conclusions: In patients with STEMI treated by primary PCI, a 180 mg LD of ticagrelor might be more effective in reducing microvascular injury than a 600 mg LD of clopidogrel, as demonstrated by IMR immediately after primary PCI.
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http://dx.doi.org/10.4244/EIJV12I8A159DOI Listing
October 2016

Impact of area strain by 3D speckle tracking on clinical outcome in patients after acute myocardial infarction.

Echocardiography 2016 Dec 25;33(12):1854-1859. Epub 2016 Aug 25.

Division of Cardiology, Inha University College of Medicine, Incheon, South Korea.

Background: Three-dimensional (3D) speckle tracking echocardiography (STE) has been developed to overcome the limitations of two-dimensional (2D) STE and has been applied in the several clinical settings. However, no data exist about the prognostic value of 3DSTE-based strain on clinical outcome after myocardial infarction (MI). This study was designed to investigate the prognostic value of area strain (AS) by 3D speckle tracking in predicting clinical outcome after acute MI.

Methods: We assessed 96 patients (62±14 years, 72% male) with acute MI and who had undergone a coronary angiography. Clinical parameters and conventional echocardiographic measurements including the left atrial (LA) size and tissue Doppler measurements were evaluated. The global left ventricular (LV) AS was measured using 3D speckle tracking software. The relationship between the AS and clinical outcome of death or hospitalization for heart failure (HF) was assessed.

Results: During a median follow-up of 33±10 months, primary endpoint of death or HF occurred in 12 patients (12.5%). AS was predictive of death or HF after adjustment for age, gender, peak CK-MB, LA volume, LV end-systolic volume, LV mass, the ratio of early mitral inflow velocity to early mitral annular velocity, and LV ejection fraction in a multivariate Cox model (HR 1.23, 95% CI 1.02-1.47, P=.03). In addition, AS added incremental value in predicting death or heart failure on a model based on clinical and standard echocardiographic measures (P=.008).

Conclusion: AS is independently associated with increased risk of death or HF after acute MI, suggesting that it can be a useful prognostic parameter in the patients following MI.
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http://dx.doi.org/10.1111/echo.13354DOI Listing
December 2016

Beneficial Effects of Bariatric Surgery on Cardiac Structure and Function in Obesity.

Obes Surg 2017 03;27(3):620-625

Division of Cardiology, Department of Internal Medicine, Inha University Hospital, Inha University College of Medicine, 7-206, 3-Ga, Shinheung-Dong, Jung-Gu, Incheon, 400-711, South Korea.

Background: Bariatric surgery is being considered as a therapeutic option for morbidly obese patients. Data are accumulating showing that this surgical intervention may improve in major cardiovascular morbidity and mortality. We evaluated the effects of bariatric surgery on left ventricular (LV) structure and function including LV mechanics in obese patients.

Methods: Thirty-seven patients (age = 36 ± 10 years; male:female = 11:26) undergoing bariatric surgery were enrolled. Echocardiography was performed before and after at least 1 year of bariatric surgery. Conventional echocardiographic parameters, including tissue Doppler measurements, were measured. LV global longitudinal, circumferential, and radial deformations were assessed utilizing 2D speckle tracking software.

Results: Patients decreased body mass index by 11.8 ± 4.7 over 15.6 ± 5.5 months. Bariatric surgery led to significant decreases in left ventricular (LV) size and mass (51.0 ± 3.3 to 49.1 ± 3.4 mm, p < 0.001 for LV end-diastolic dimension; 192.6 ± 33.5 to 146.2 ± 29.1 g, p < 0.001 for LV mass), and increases were noted in the ratio of early-to-late diastolic mitral inflow (E/A), early diastolic tissue Doppler velocity (Em), and LV longitudinal strain (1.42 ± 0.52 to 1.59 ± 0.56, p = 0.04 for E/A ratio; 9.7 ± 2.0 to 11.0 ± 2.4 cm/s, p < 0.001 for Em; 14.1 ± 1.9 to 16.2 ± 1.4 %, p < 0.001 for longitudinal strain). Changes of LV longitudinal strain were related to LV mass reduction (p = 0.04). However, LV ejection fraction, LV circumferential, and radial strains were all comparable at follow-up.

Conclusion: Significant weight loss by bariatric surgery was associated with improved LV structure and function in obese patients, suggesting potential favorable effects of bariatric surgery to prevent future cardiovascular events.
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http://dx.doi.org/10.1007/s11695-016-2330-xDOI Listing
March 2017

Prognostic Impact of Combined Contrast-Induced Acute Kidney Injury and Hypoxic Liver Injury in Patients with ST Elevation Myocardial Infarction Undergoing Primary Percutaneous Coronary Intervention: Results from INTERSTELLAR Registry.

PLoS One 2016 14;11(7):e0159416. Epub 2016 Jul 14.

Department of Cardiology, Gil Medical Center, Gachon University, Incheon, Republic of Korea.

Background: Besides contrast-induced acute kidney injury(CI-AKI), adscititious vital organ damage such as hypoxic liver injury(HLI) may affect the survival in patients with ST-elevation myocardial infarction (STEMI). We sought to evaluate the prognostic impact of CI-AKI and HLI in STEMI patients who underwent primary percutaneous coronary intervention (PCI).

Methods: A total of 668 consecutive patients (77.2% male, mean age 61.3±13.3 years) from the INTERSTELLAR STEMI registry who underwent primary PCI were analyzed. CI-AKI was defined as an increase of ≥0.5 mg/dL in serum creatinine level or 25% relative increase, within 48h after the index procedure. HLI was defined as ≥2-fold increase in serum aspartate transaminase above the upper normal limit on admission. Patients were divided into four groups according to their CI-AKI and HLI states. Major adverse cardiovascular and cerebrovascular events (MACCE) defined as a composite of all-cause mortality, non-fatal MI, non-fatal stroke, ischemia-driven target lesion revascularization and target vessel revascularization were recorded.

Results: Over a mean follow-up period of 2.2±1.6 years, 94 MACCEs occurred with an event rate of 14.1%. The rates of MACCE and all-cause mortality were 9.7% and 5.2%, respectively, in the no organ damage group; 21.3% and 21.3% in CI-AKI group; 18.5% and 14.6% in HLI group; and 57.7% and 50.0% in combined CI-AKI and HLI group. Survival probability plots of composite MACCE and all-cause mortality revealed that the combined CI-AKI and HLI group was associated with the worst prognosis (p<0.0001 for both).

Conclusion: Combined CI-AKI after index procedure and HLI on admission is associated with poor clinical outcomes in patients with STEMI who underwent primary PCI. (INTERSTELLAR ClinicalTrials.gov number, NCT02800421.).
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http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0159416PLOS
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4945029PMC
July 2017

Epicardial Artery Stenosis with a High Index of Microcirculatory Resistance Is Frequently Functionally Insignificant as Estimated by Fractional Flow Reserve (FFR).

Intern Med 2016 15;55(2):97-103. Epub 2016 Jan 15.

Department of Internal Medicine, Inha University Hospital, South Korea.

Objective Differences in microvascular integrity can diversely influence the functional assessment of epicardial coronary artery disease in each patient. We investigated the relevance of the index of microcirculatory resistance (IMR) and fractional flow reserve (FFR) of intermediate coronary lesions. Methods The IMR and FFR were measured in 67 intermediate coronary lesions of the left anterior descending artery of 67 patients, by using a pressure sensor/thermistor-tipped guidewire. Results To assess the differences in FFR in relationship to the IMR value, patients were divided into tertile IMR groups as follows: Low-IMR (n=22, IMR 14±3), Mid-IMR (n=23, IMR 21±2), and High-IMR (n=22, IMR 36±10). An analysis of variance showed that the High-IMR group had significantly higher FFR values (0.87±0.07) than the Low-IMR group (0.81±0.08) (p=0.03). Functionally significant lesions with FFR ≤0.8 accounted for 9% of lesions in the High-IMR group, 36% in the Low-IMR group and 22% in the Mid-IMR group (p=0.02). In the multivariate logistic analysis, the IMR value was an independent determinant of FFR ≤0.8 (p=0.03). Conclusion In patients with a high IMR, intermediate lesions as identified with visual estimation were more frequently functionally insignificant. The IMR can provide additional information in understanding the mismatch between the anatomical and functional severity of intermediate coronary stenosis.
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http://dx.doi.org/10.2169/internalmedicine.55.4080DOI Listing
August 2016

Comprehensive assessment of microcirculation after primary percutaneous intervention in ST-segment elevation myocardial infarction: insight from thermodilution-derived index of microcirculatory resistance and coronary flow reserve.

Coron Artery Dis 2016 Jan;27(1):34-9

Department of Internal Medicine, Division of Cardiology, Inha University Hospital, Incheon, South Korea.

Objectives: A pathophysiological mechanism of microvascular dysfunction in ST-segment elevation myocardial infarction (STEMI) is multifactorial; thus, multiple modalities were needed to precisely evaluate a microcirculation.

Methods: We complementarily assessed microcirculation in STEMI by the index of microcirculatory resistance (IMR) and coronary flow reserve (CFR) immediately after a primary percutaneous intervention in 89 STEMI patients. Cardiovascular and cerebrovascular events (MACCE) including cardiovascular death, target vessel failure, heart failure, and stroke were assessed during a mean follow-up period of 3.0 years.

Results: The microcirculation of enrolled patients was classified into four groups using cutoff CFR and IMR values (CFR>2 and mean IMR): group-1 (n=23, CFR>2 and IMR ≤ 27); group-2 (n=31, CFR ≤ 2 and IMR ≤ 27); group-3 (n=9, CFR>2 and IMR>27); and group-4 (n=26, CFR<2 and IMR>27). On echocardiography 3 months later, improvement in the wall motion score index was shown in group-1 (P<0.01), group-2 (P<0.01), and group-3 (P=0.04), whereas group-4 did not show improvement in wall motion score index (P=0.06). During clinical follow-up, there were no MACCE in group-1 and the patients in group-2 and group-3 showed significantly lower MACCE compared with group-4 (group-1=0%, group-2, and group-3=10%, group-4=23.1%, P=0.04).

Conclusion: Complimentary assessment of microcirculation by the IMR and CFR may be useful to evaluate myocardial viability and the long-term prognosis of STEMI patients.
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http://dx.doi.org/10.1097/MCA.0000000000000310DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4885592PMC
January 2016

Clinical and Echocardiographic Factors Affecting Tricuspid Regurgitation Severity in the Patients with Lone Atrial Fibrillation.

J Cardiovasc Ultrasound 2015 Sep 24;23(3):136-42. Epub 2015 Sep 24.

Division of Cardiology, Department of Internal Medicine, Inha University Hospital, Incheon, Korea.

Background: Atrial fibrillation (AF) can be a risk factor for development of significant tricuspid regurgitation (TR). We investigated which clinical and echocardiographic parameters were related to severity of functional TR in patients with lone AF.

Methods: A total of 89 patients with lone AF were enrolled (75 ± 11 years; 48% male): 13 patients with severe TR, 36 patients with moderate TR, and 40 consecutive patients with less than mild TR. Clinical parameters and echocardiographic measurements including right ventricular (RV) remodeling and function were evaluated.

Results: Patients with more severe TR were older and had more frequently persistent AF (each p < 0.001). TR severity was related to right atrial area and tricuspid annular systolic diameter (all p < 0.001). The patients with moderate or severe TR had larger left atrial (LA) volume and increased systolic pulmonary artery pressure (SPAP) than the patients with mild TR (p = 0.04 for LA volume; p < 0.001 for SPAP). RV remodeling represented by enlarged RV area and increased tenting height was more prominent in severe TR than mild or moderate TR (all p < 0.001). Multivariate analysis showed type of AF, LA volume, tricuspid annular diameter and tenting height remained as a significant determinants of severe TR. In addition, tenting height was independently associated with the presence of severe TR (p = 0.04).

Conclusion: In patients with lone AF, TR was related to type of AF, LA volume, tricuspid annular diameter and RV remodeling. Especially, tricuspid valvular tethering seemed to be independently associated with development of severe functional TR.
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http://dx.doi.org/10.4250/jcu.2015.23.3.136DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4595700PMC
September 2015

Comparative effect on platelet function of a fixed-dose aspirin and clopidogrel combination versus separate formulations in patients with coronary artery disease: A phase IV, multicenter, prospective, 4-week non-inferiority trial.

Int J Cardiol 2016 Jan 21;202:331-5. Epub 2015 Sep 21.

Division of Cardiology, Department of Internal Medicine, Maryknoll Medical Center, Busan, Republic of Korea.

Background/objectives: The effect of aspirin and clopidogrel in a fixed-dose combination (FDC) on platelet function was compared with separate formulations in patients that had undergone percutaneous coronary intervention (PCI) with drug-eluting stent (DES).

Methods: This was a phase IV, prospective, multicenter, single-arm, non-inferiority study. Patients that had taken aspirin 100 mg and clopidogrel 75 mg once daily as separate formulations for >6 months after PCI with DES were enrolled, and then switched to an aspirin/clopidogrel FDC once-daily for 4 weeks. Platelet reactivity was determined using the VerifyNow® P2Y12 assay at baseline (immediately prior to switching) and 4 weeks later.

Results: A total of 648 patients (the full-analysis population; age, 63.6±9.0 years; male, 76.5%) finished the study, and 565 (the per-protocol population) completed without protocol violations. In the per-protocol population, the % inhibitions of P2Y12 and ARU were not significantly different between baseline and after 4 weeks of FDC treatment (29.2±20.0% to 29.0±19.9%, P=0.708; 445.1±69.2 to 446.2±63.0, P=0.799, respectively) and the difference in P2Y12 inhibition observed did not exceed the predetermined limit of non-inferiority (95% CI, -0.9 to 1.3). In the full-analysis population, the % inhibitions of P2Y12, PRU, and ARU were not significantly changed after 4 weeks of FDC treatment.

Conclusions: This study demonstrates that the efficacy of platelet inhibition by an aspirin/clopidogrel FDC was not inferior to that of separate aspirin and clopidogrel formulations in patients that had undergone PCI with DES.
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http://dx.doi.org/10.1016/j.ijcard.2015.09.024DOI Listing
January 2016

Relationship between J Waves and Vagal Activity in Patients Who Do Not Have Structural Heart Disease.

Ann Noninvasive Electrocardiol 2015 Sep 25;20(5):464-73. Epub 2015 Aug 25.

Division of Cardiology, Inha University Hospital, Incheon, South Korea.

Background: J waves are associated with increased vagal activity in patients with idiopathic ventricular fibrillation in several studies to date. However, the relationship between J waves and autonomic nervous activity in patients without structural heart disease remains under investigation. We investigated whether the presence of a J wave on the surface electrocardiogram (ECG) was related to increased vagal activity in patients without structural heart disease.

Methods: This retrospective study included 684 patients without structural heart disease who had undergone Holter ECG and surface ECG monitoring. Based on the presence of J waves on the surface ECG, patients were divided into two groups: those with J waves (group 1) and those without J waves (group 2). We compared heart rate variability (HRV), reflecting autonomic nervous activity, using 24-h Holter ECG between the groups.

Results: J waves were present in 92 (13.4%) patients. Heart rate (HR) in group 1 was significantly lesser than that in group 2 (P = 0.031). The ratio of low-frequency (LF) components to high-frequency (HF) components (LF/HF) in group 1 was significantly lower than that in group 2 (P = 0.001). The square root of the mean squared differences of successive NN intervals in group 1 was also significantly higher than that in group 2 (P = 0.047). In a multivariate regression analysis, male sex, HR, and LF/HF ratio remained independent determinants for the presence of J waves (P = 0.039, P = 0.036, and P < 0.001, respectively).

Conclusion: In patients without structural heart disease, the presence of a J wave was associated with a slow HR, male sex, and increased vagal activity, independently.
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http://dx.doi.org/10.1111/anec.12302DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6931496PMC
September 2015

Clinical and Angiographic Predictors of Microvascular Dysfunction in ST-Segment Elevation Myocardial Infarction.

Yonsei Med J 2015 Sep;56(5):1235-43

Division of Cardiology, Inha University Hospital, Incheon, Korea.

Purpose: We aimed to discover clinical and angiographic predictors of microvascular dysfunction using the index of microcirculatory resistance (IMR) in patients with ST-segment elevation myocardial infarction (STEMI).

Materials And Methods: We enrolled 113 patients with STEMI (age, 56±11 years; 95 men) who underwent primary percutaneous coronary intervention (PCI). The IMR was measured with a pressure sensor/thermistor-tipped guidewire after primary PCI. The patients were divided into three groups based on IMR values: Low IMR [<18 U (12.9±2.6 U), n=38], Mid IMR [18-31 U (23.9±4.0 U), n=38], and High IMR [>31 U (48.1±17.1 U), n=37].

Results: The age of the Low IMR group was significantly lower than that of the Mid and High IMR groups. The door-to-balloon time was <90 minutes in all patients, and it was not significantly different between groups. Meanwhile, the symptom-onset-to-balloon time was significantly longer in the High IMR group, compared to the Mid and Low IMR groups (p<0.001). In the high IMR group, the culprit lesion was found in a proximal location significantly more often than in a non-proximal location (p=0.008). In multivariate regression analysis, age and symptom-onset-to-balloon time were independent determinants of a high IMR (p=0.013 and p=0.003, respectively).

Conclusion: Our data suggest that age and symptom-onset-to-balloon time might be the major predictors of microvascular dysfunction in STEMI patients with a door-to-balloon time of <90 minutes.
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http://dx.doi.org/10.3349/ymj.2015.56.5.1235DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4541652PMC
September 2015

Evaluation of the Efficacy and Safety of the Lercanidipine/Valsartan Combination in Korean Patients With Essential Hypertension Not Adequately Controlled With Lercanidipine Monotherapy: A Randomized, Multicenter, Parallel Design, Phase III Clinical Trial.

Clin Ther 2015 Aug 8;37(8):1726-39. Epub 2015 Jul 8.

Hallym University Sacred Heart Hospital, Seoul, Korea.

Purpose: The objective of this study was to evaluate the efficacy and safety of the lercanidipine/valsartan combination compared with lercanidipine monotherapy in patients with hypertension.

Methods: Part 1 of this study was the randomized, multicenter, double-blind, parallel group, Phase III, 8-week clinical trial to compare superiority of lercanidipine 10 mg/valsartan 80 mg (L10/V80) and lercanidipine 10 mg/valsartan 160 mg (L10/V160) combinations with lercanidipine 10 mg (L10) monotherapy. At screening, hypertensive patients, whose diastolic blood pressure (DBP) was >90 mm Hg after 4 weeks with L10, were randomized to 3 groups of L10, L10/V80, and L10/V160. The primary end point was the change in the mean sitting DBP from baseline (week 0) after 8 weeks of therapy. Patients who were randomly assigned to L10/V160 and whose mean DBP was still ≥ 90 mm Hg in part 1 were enrolled to the up-titration extension study with lercanidipine 20 mg/valsartan 160 mg (L20/V160) (part 2).

Findings: Of 772 patients screened, 497 were randomized to 3 groups (166 in the L10 group, 168 in the L10/V80 group, and 163 in the L10/V160 group). Mean (SD) age was 55 (9.9) years, and male patients comprised 69%. The mean (SD) baseline systolic blood pressure (SBP)/DBP were 148.4 (15.1)/94.3 (9.5) mm Hg. No significant differences were found between groups in baseline characteristics except the percentages of previous history of antihypertensive medication. The primary end points, the changes of mean (SD) DBP at week 8 from the baseline were -2.0 (8.8) mm Hg in the L10 group, -6.7 (8.5) mm Hg in L10/V80 group, and -8.1 (8.4) mm Hg in L10/V160 group. The adjusted mean difference between the combination groups and the L10 monotherapy group was -4.6 mm Hg (95% CI, -6.5 to -2.6; P < 0.001) in the L10/V80 group and -5.9 mm Hg (95% CI, -7.9 to -4.0, P < 0.001) in the L10/V160 group, which had significantly greater efficacy in BP lowering. A total of 74 patients were enrolled in the part 2 extension study. Changes of mean (SD) DBP and SBP from week 8 to week 12 and week 16 were -5.6 (7.9)/-8.0 (12.0) mm Hg and -5.5 (7.0)/-8.5 (11.3) mm Hg, respectively. For evaluation of the safety profile, the frequencies of adverse events between groups were also not significantly different. The most frequently reported adverse events were headache (6 cases, 20.7%) in the L10 group, dizziness (8 cases, 16.3%) in L10/V80 group, and nasopharyngitis (3 cases, 9.4%) in L10/V160 group, and the incidences of adverse events were not different between groups.

Implications: Treatment of L10/V80 or L10/V160 combination therapy resulted in significantly greater BP lowering compared with L10 monotherapy. Moreover, the L20/V160 high dose combination had additional BP lowering effect compared with nonresponders with the L10/V160 combination. ClinicalTrials.gov: NCT01928628.
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August 2015

A Randomized, Multicenter, Double-blind, Placebo-controlled, 3 × 3 Factorial Design, Phase II Study to Evaluate the Efficacy and Safety of the Combination of Fimasartan/Amlodipine in Patients With Essential Hypertension.

Clin Ther 2015 Nov 4;37(11):2581-2596.e3. Epub 2015 Apr 4.

Samsung Medical Center, Seoul, Republic of Korea. Electronic address:

Purpose: The objective of this study was to evaluate the efficacy and safety of a fimasartan/amlodipine combination in patients with hypertension and to determine the optimal composition for a future single-pill combination formulation.

Methods: This Phase II study was conducted by using a randomized, multicenter, double-blind, placebo-controlled, 3 × 3 factorial design. After a 2-week placebo run-in period, eligible hypertensive patients (with a sitting diastolic blood pressure [SiDBP] between 90 and 114 mm Hg) were randomized to treatment. They received single or combined administration of fimasartan at 3 doses (0, 30, and 60 mg) and amlodipine at 3 doses (0, 5, and 10 mg) for 8 weeks. The primary efficacy end point was the change in SiDBP from baseline and at week 8; secondary end points included the change in SiDBP from baseline and at week 4 and the changes in sitting systolic blood pressure from baseline and at weeks 4 and 8. Treatment-emergent adverse events (AEs) were also assessed.

Findings: 420 Korean patients with mild to moderate hypertension were randomly allocated to the 9 groups. Mean (SD) SiDBP changes in each group after 8 weeks were as follows: placebo, -6.0 (8.5) mm Hg; amlodipine 5 mg, -10.6 (9.2) mm Hg; amlodipine 10 mg, -15.9 (7.2) mm Hg; fimasartan 30 mg, -10.1 (9.1) mm Hg; fimasartan 60 mg, -13.0 (10.0) mm Hg; fimasartan 30 mg/amlodipine 5 mg, -16.2 (8.5) mm Hg; fimasartan 30 mg/amlodipine 10 mg, -19.5 (7.5) mm Hg; fimasartan 60 mg/amlodipine 5 mg, -16.6 (6.9) mm Hg; and fimasartan 60 mg/amlodipine 10 mg, -21.5 (8.3) mm Hg. All treatment groups produced significantly greater reductions in blood pressure compared with the placebo group. In addition, all combination treatment groups had superior reductions in blood pressure compared with the monotherapy groups. In the combination treatment groups, doubling fimasartan dose in the given dose of amlodipine did not show further BP reduction, whereas doubling amlodipine dose showed significantly further BP reduction in the given dose of fimasartan. During the study period, 75 (17.9%) of 419 patients experienced 110 AEs. Ninety-five AEs were mild, 9 were moderate, and 6 were severe in intensity. Eight patients discontinued the study due to AEs. There was no significant difference in incidence of AEs among groups (P = 0.0884). The most common AE was headache (12 patients [2.9%]), followed by dizziness (11 patients [2.6%]) and elevated blood creatine phosphokinase levels (6 patients [1.4%]).

Implications: Fimasartan combined with amlodipine produced superior blood pressure reductions and low levels of AEs compared with either monotherapy. Therefore, a single-pill combination with fimasartan 60 mg/amlodipine 10 mg will be developed. ClinicalTrials.gov: NCT01518998.
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November 2015
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