The Efficacy and Tolerability of Irbesartan/Amlodipine Combination Therapy in Patients With Essential Hypertension Whose Blood Pressure Were not Controlled by Irbesartan Monotherapy.

PURPOSE: This study aimed to evaluate the efficacy and tolerability of irbesartan (IRB) and amlodipine (AML) combination therapy in patients with essential hypertension whose blood pressure (BP) was not controlled by IRB monotherapy. METHODS: Two multicenter, randomized, double-blind, placebo-controlled, phase III studies were conducted in Korea (the I-DUO 301 study and the I-DUO 302 study). After a 4-week run-in period with either 150 mg IRB (I-DUO 301 study) or 300 mg IRB (I-DUO 302 study), patients with uncontrolled BP (ie, mean sitting systolic BP [MSSBP] ≥140 mmHg to <180 mmHg and mean sitting diastolic BP <110 mmHg) were randomized to the placebo, AML 5 mg, or AML 10 mg group. A total of 428 participants were enrolled in the 2 I-DUO studies. In the I-DUO 301 study, 271 participants were randomized in a 1:1:1 ratio to receive either IRB/AML 150/5 mg, IRB/AML 150/10 mg, or IRB 150 mg/placebo. In the I-DUO 302 study, 157 participants were randomized in a 1:1 ratio to receive IRB/AML 300/5 mg or IRB 300 mg/placebo. The primary endpoint was the change in MSSBP from baseline to week 8. Tolerability was assessed according to the development of treatment-emergent adverse events (TEAEs) and clinically significant changes in physical examination, laboratory tests, pulse, and 12-lead electrocardiography. FINDINGS: In I-DUO 301, the mean (SD) changes of MSSBP at week 8 from baseline were -14.78 (12.35) mmHg, -21.47 (12.78) mmHg, and -8.61 (12.19) mmHg in the IRB/AML 150/5 mg, IRB/AML 150/10 mg, and IRB 150 mg/placebo groups, respectively. In I-DUO 302, the mean (SD) changes of MSSBP at week 8 from baseline were -13.30 (12.47) mmHg and -7.19 (15.37) mmHg in the IRB/AML 300/5 mg and IRB 300 mg/placebo groups, respectively. In both studies, all combination groups showed a significantly higher reduction in MSSBP than the IRB monotherapy groups (P < 0.001 for both). TEAEs occurred in 10.00%, 10.99%, and 12.22% of participants in the IRB/AML 150/5 mg, IRB/AML 150/10 mg, and IRB 150 mg/placebo groups, respectively, in I-DUO 301 and in 6.33% and 10.67% of participants in the IRB/AML 300/5 mg and IRB 300 mg/placebo groups, respectively, in I-DUO 302, with no significant between-group differences. Overall, there was one serious adverse event throughout I-DUO study. IMPLICATIONS: The combination of IRB and AML has superior antihypertensive effects compared with IRB alone over an 8-week treatment period, with placebo-like tolerability. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT05476354 (I-DUO 301), NCT05475665 (I-DUO 302).

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. CONCLUSION: 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.

Real-world evidence on the strategy of olmesartan-based triple single-pill combination in Korean hypertensive patients: a prospective, multicenter, observational study (RESOLVE-PRO).

BACKGROUND: In this prospective, multicenter, non-comparative observational study, the effectiveness and safety of the triple single-pill combination (SPC) of olmesartan/amlodipine/hydrochlorothiazide (OM/AML/HCTZ) were evaluated in a real clinical practice setting in Korean patients with essential hypertension. METHODS: A total of 3752 patients were enrolled and followed for 12 months after administration of OM/AML/HCTZ. Primary endpoint was change from baseline to month 6 in the mean systolic blood pressure (SBP). Secondary endpoints included changes from baseline in the mean SBP at month 3, 9, 12 and the mean diastolic blood pressure (DBP) at month 3, 6, 9, 12; changes in the mean SBP/DBP according to age and underlying risk factors; and blood pressure control rate (%) at different time points. Adherence to and satisfaction with OM/AML/HCTZ treatment among patients and physicians were assessed by medication possession ratio (MPR) and numeric rating scale, respectively, as exploratory endpoints. Safety was evaluated by the incidence and severity of adverse events (AEs) as well as the discontinuation rate due to AEs. RESULTS: OM/AML/HCTZ administration led to significant reductions in the mean SBP/DBP by 11.5/6.6, 12.3/7.0, 12.3/7.2, and 12.8/7.4 mmHg from baseline to month 3, 6, 9 and 12, respectively (P < 0.0001). The BP reductions were maintained throughout the 1-year observation period in all patients with different age groups and risk factors (diabetes mellitus, cardiovascular disease, and renal disease). The BP control rate (%) of < 140/90 mmHg was 65.9, 67.9, 68.9, and 70.6% at month 3, 6, 9, and 12, respectively. The mean MPR during the observation period was 0.96. The safety results were consistent with the previously reported safety profile of OM/AML/HCTZ. CONCLUSIONS: Treatment with the triple SPC of OM/AML/HCTZ demonstrated significant effectiveness in reducing SBP/DBP and achieving target BP control with high adherence over the 1-year observation period in Korean hypertensive patients and was well-tolerated. TRIAL REGISTRATION: CRIS, KCT0002196 , Registered 3 May 2016.

Age and Phenotype of Patients With Plaque Erosion.

Background A recent study reported that the outcome of patients with plaque erosion treated with stenting is poor when the underlying plaque is lipid rich. However, the detailed phenotype of patients with plaque erosion, particularly as related to different age groups, has not been systematically studied. Methods and Results Patients with acute coronary syndromes caused by plaque erosion were selected from 2 data sets. Demographic, clinical, angiographic, and optical coherence tomography findings of the culprit lesion were compared between 5 age groups. Among 579 erosion patients, male sex and current smoking were less frequent, and hypertension, diabetes, and chronic kidney disease were more frequent in older patients. ST-segment-elevation myocardial infarction was more frequent in younger patients. Percentage of diameter stenosis on angiogram was greater in older patients. The prevalence of lipid-rich plaque (27.3% in age <45 years and 49.4% in age ≥75 years, P<0.001), cholesterol crystal (3.9% in age <45 years and 21.8% in age ≥75 years, P=0.027), and calcification (5.5% in age <45 years and 54.0% in age ≥75 years, P<0.001) increased with age. After adjusting risk factors, younger patients were associated with the presence of thrombus, and older patients were associated with greater percentage of diameter stenosis and the presence of lipid-rich plaque and calcification. Conclusions The demographic, clinical, angiographic, and plaque phenotypes of patients with plaque erosion distinctly vary depending on age. This may affect the clinical outcome in these patients. Registration URL: https://www.clinicaltrials.gov. Unique identifiers: NCT03479723, NCT02041650.

Effects of Asian dust-derived particulate matter on ST-elevation myocardial infarction: retrospective, time series study.

BACKGROUND: Dust storms affect human health by impairing visibility and promoting interactions with microscopic organisms, such as bacteria and fungi. Although ST-elevation MI (STEMI) and non-ST-elevation MI (NSTEMI) differ mechanistically, few studies have investigated the incidence of cardiovascular diseases according to infarction type; these studies have yielded inconsistent findings. This study aimed to examine whether PM size (< 2.5 µm (PM2.5) and < 10 µm (PM10)) modifies the effect of Asian dust on acute myocardial infarction (AMI), with separate analyses for STEMI and NSTEMI. METHODS: MI-related data from 9934 emergency visits were collected from the Korea AMI Registry from 2005 to 2017. Asian dust events were defined as days with visibility of ≤10 km. Generalized linear models were used to analyze data with natural cubic splines. To examine potential modifiers, analyses were stratified by age, smoking status, and body mass index (BMI). RESULTS: No significant associations were observed between Asian dust and AMI. By adjusting for different lag structures, a significant effect was exclusively observed in STEMI. For moving average lags, the largest value at lag 5 (relative risk [RR] 1.083; 95% confidence interval [CI], 1.007-1.166) for single and lags 0-7 (RR 1.067; 95% CI: 1.002-1.136) was observed for PM2.5; for PM10, the largest significant effect was observed at lag 4 (RR 1.075; 95% CI: 1.010-1.144) for single and lags 0-7 (RR 1.067; 95% CI: 1.002-1.136). RRs were significantly higher in < 65-year-olds than in ≥65-year-olds. Additionally, RRs between the BMI < 25 and BMI ≥ 25 groups were not different; statistically significant effects were observed for concentration at lags 0-5 (RR: 1.073; 95% CI: 1.002-1.150) and lags 0-6 (RR: 1.071; 95% CI: 1.001-1.146) in the BMI < 25 group. A negative exposure-response association was observed between daily average visibility-adjusted PM and STEMI and daily average visibility-adjusted PM in < 65-year-olds. CONCLUSIONS: Reducing PM2.5 and PM10 emissions, particularly during the days of Asian dust, may be crucial and reduce STEMI and AMI incidence among < 65-year-olds. These results indicate that the Asian dust alarm system needs revision to protect vulnerable populations.

Usefulness of Calculation of Cardiovascular Risk Factors to Predict Outcomes in Patients With Acute Myocardial Infarction.

Cardiovascular risk factors contribute differently to short-term prognosis of acute myocardial infarction (AMI); hypertension and diabetes increase adverse outcomes, whereas hyperlipidemia, smoking, and obesity seem to paradoxically decrease these in post-MI patients. We aimed to investigate whether a simple calculation of conventional risk factors, PARADOCS (Pressure of ARtery elevAtion, Diabetes, Obesity, Cholesterol, Smoking) score, would improve the ability to predict major adverse cardiac and cerebrovascular events (MACCEs) in post-MI patients. Between November 2011 and December 2015, 13,104 patients with diagnosis of AMI were analyzed in this study from Korean AMI Registry - National Institute of Health database. PARADOCS score was calculated as follows: (number of nonparadoxical risk factors - number of paradoxical risk factors) + 3 where nonparadoxical risk factors are hypertension and diabetes, and paradoxical risk factors are hyperlipidemia, smoking, and obesity. PARADOCS score was significantly greater in patients with 1-year MACCEs compared with those without MACCEs (3.43 ± 1.03 vs 2.88 ± 1.11, p <0.001). In Cox proportional hazards model, PARADOCS score was an independent predictor of 1-year MACCEs (hazards ratio 1.23, 95% confidence interval 1.16 to 1.30; p <0.001) after adjusting for confounding variables. In Kaplan-Meier survival curve, patients with greater PARADOCS score had worse clinical outcome. In conclusion, although it needs more validation, a simple calculation of risk factors, PARADOCS score, could provide useful prognostic information of MI patients to clinicians.

Association of potent P2Y12 blockers with ischemic and bleeding outcomes in non-ST-segment elevation myocardial infarction.

BACKGROUND: Potent P2Y12 blockers are preferred in patients with acute non-ST-segment elevation myocardial infarction (NSTEMI) undergoing percutaneous coronary intervention (PCI). However, the risk of bleeding remains a major concern. We assessed the association of potent P2Y12 blockers with ischemic and bleeding outcomes in patients with NSTEMI. METHODS: From the Korea Acute Myocardial Infarction Registry-National Institute of Health database, 4927 patients with NSTEMI receiving drug-eluting stents (DES) were divided into potent P2Y12 blocker (ticagrelor or prasugrel, n=901) and clopidogrel (n=3180) groups. Propensity-matched 12-month ischemic and bleeding events were compared. Patients who received anticoagulants or who discontinued P2Y12 blockers or switched between potent P2Y12 blockers and clopidogrel were excluded. RESULTS: In the overall population, patients at higher ischemic and bleeding risks more often received clopidogrel. After propensity matching (n=901 in each group), 12-month rates of major adverse cardiac and cerebrovascular events were lower (7.3% vs. 10.1%, p=0.038), but Thrombolysis in Myocardial Infarction (TIMI) major or minor bleeding rates were higher (5.9% vs. 2.2%, p<0.001) with potent P2Y12 blockers. Twelve-month rates of death from any cause, MI, stroke, or TIMI major bleeding were not different. On multivariate analysis, 12-month risk of TIMI major or minor bleeding was higher with B2 or C lesion, potent P2Y12 blocker use, body weight <60kg, and lower with time to PCI <12h and radial artery access. CONCLUSIONS: In patients with NSTEMI receiving DES, potent P2Y12 blockers were associated with reduced ischemic but increased bleeding risk with similar net clinical benefits.

Clinical Outcomes of Elderly Patients with Non ST-Segment Elevation Myocardial Infarction Undergoing Coronary Artery Bypass Surgery.

The aim of this study is to investigate the clinical outcomes of the elderly patients with Non ST-segment elevation myocardial infarction (NSTEMI) undergoing coronary artery bypass surgery (CABG) compared to non-elderly patients. Patients with NSTEMI and undergoing CABG (n=451) who were registered in the Korea Acute Myocardial Infarction Registry between December 2003 and August 2012 were divided into two groups.; the non-elderly group (<75 years, n=327) and the elderly group (≥75 years, n=124). In-hospital mortality was higher in the elderly group (4.9% vs. 11.3%, p=0.015), but cardiac death, myocardial infarction, and major adverse cardiovascular events (MACE) including cardiac death, myocardial infarction, percutaneous revascularization, and redo-CABG after a one-year follow up were not different between the two groups. Predictors of in-hospital mortality in patients with NSTEMI undergoing CABG were left ventricular (LV) dysfunction (ejection fraction ≤40%) [hazard ratio (HR): 2.76, 95% confidence interval (CI): 1.16-6.57, p=0.022] and age (HR: 1.05, 95% CI: 1.01-1.10, p=0.047). So elderly NSTEMI patients should be considered for CABG if appropriate, but careful consideration for surgery is required, especially if the patients have severe LV systolic dysfunction.

Efficacy and Tolerability of Combination Therapy Versus Monotherapy with Candesartan and/or Amlodipine for Dose Finding in Essential Hypertension: A Phase II Multicenter, Randomized, Double-blind Clinical Trial.

PURPOSE: Intensive blood pressure (BP) lowering is important for the treatment of hypertension; however, it has been a challenge to achieve target BP in many patients. The purpose of this study was to explore the optimal dosage of a fixed-dose combination of candesartan cilexetil (CAN) and amlodipine besylate (AML), by examining the tolerability and efficacy of CAN/AML combination therapy compared with those of monotherapy with either drug in patients with essential hypertension. METHODS: This Phase II multicenter, randomized, double-blind clinical trial enrolled patients aged 19 years or older with essential hypertension, defined as a mean sitting diastolic BP (msDBP) between 95 and 115 mm Hg, and a mean sitting systolic BP (msSBP) of <200 mm Hg after a 2-week placebo run-in period. A total of 635 patients were screened, of whom 439 were randomized to receive treatment; 425 patients were included in the full analysis set (combination therapy, 212; monotherapy, 213). Participants were randomly assigned to receive 1 of 8 treatments: CAN (8 or 16 mg), AML (5 or 10 mg), CAN/AML (8 mg/5 mg, 8 mg/10 mg, 16 mg/5 mg, or 16 mg/10 mg), once daily for 8 weeks. FINDINGS: After 8 weeks of treatment, changes in msDBP were significantly greater in the groups receiving CAN/AML combination therapies compared with monotherapies at matched doses, with the exception of CAN 8 mg/AML 10 mg versus AML 10 mg. The response to treatment and the achievement of target BP (both msSBP and msDBP) at week 8 were significantly greater overall in the groups that received combination therapy versus monotherapy. All medications were relatively well tolerated in each group. IMPLICATIONS: Eight-week administration of CAN/AML (8 mg/5 mg, 16 mg/5 mg, and 16 mg/10 mg) resulted in a significantly greater BP reduction than that with CAN or AML monotherapy, and was determined to be well tolerated. ClinicalTrials.gov identifier: NCT02944734.

Manual thrombus aspiration during primary percutaneous coronary intervention: Impact of total ischemic time.

BACKGROUND: The benefit of manual thrombus aspiration (TA) during primary percutaneous coronary intervention (PCI) remains uncertain, and the effect of TA in relation to total ischemic time has not been evaluated. METHODS: We analyzed 5641 patients with ST-elevation myocardial infarction (STEMI) (<12h) from the Korea Acute Myocardial Infarction Registry undergoing primary PCI. Patients were divided into 2 groups: TA (n=1245) and PCI only (n=4396). Propensity-matched 12-month clinical outcome was compared between the groups according to different total ischemic times (≤2h, 2-4h, 4-6h, >6h). RESULTS: Twelve-month rates of death and major adverse cardiac events (MACE: composite of death, recurrent myocardial infarction, target-vessel revascularization, and coronary artery bypass grafting) were not different between TA and PCI only. After propensity matching (n=1162 for each group), there were no differences in the 12-month outcome between TA and PCI only, which was consistent across subgroups. In the propensity-matched cohort, the effect of TA on 12-month outcome showed a U-shaped relationship with longer total ischemic time: TA in patients with total ischemic time between 4 and 6h was associated with lower rates of death [hazard ratio (HR): 0.53, 95% confidence interval (CI): 0.24-1.19, p for interaction=0.01] and MACE (HR: 0.28, 95% CI: 0.12-0.66, p for interaction=0.01). CONCLUSIONS: Manual TA during primary PCI was not associated with improved clinical outcome at 12 months. The impact of TA may become clinically relevant with longer total ischemic time, forming a U-shaped relationship.

Comparative clinical implications of admission electrocardiographic findings for patients with non-ST-segment elevation myocardial infarction.

Early risk stratification is crucial for appropriate management using invasive strategies in non-ST elevation myocardial infarction (NSTEMI), and electrocardiography (ECG) has been widely used for risk stratification. However, ECG findings in NSTEMI vary, and there is a need to define the clinical characteristics and outcomes according to ECG.We analyzed the admission ECGs of 345 NSTEMI patients who underwent coronary angiography from 2006 to 2013. Demographics, procedural characteristics, and clinical outcomes were analyzed.The ST-segment depression, T-wave inversion, and no ECG change groups included 114, 90, and 141 patients, respectively. The ST-segment depression group trended toward older, nonsmoking, and female, with a lower body mass index (BMI) and a higher incidence of comorbidities, than the no ECG change group. The ST-segment depression group also had a higher Killip class, a lower left ventricular ejection fraction, a higher regional wall motion score index (RWMSI), and 3-vessel coronary artery disease angiographically, than the no ECG change group. Patients with T-wave inversion trended toward older, female, lower BMI, less smoking, lower creatine kinase MB, and more left anterior descending (LAD) artery involvement, than the no ECG change group. In clinical outcomes, the ST-segment depression group had a higher mortality rate at 30 days and 12 months after the index procedure than the no ECG change group, whereas the T-wave inversion group showed similar clinical outcomes.Patients with ST-segment depression have a greater burden of comorbidities with risk factors and worse clinical outcomes, whereas patients with T-wave inversion have an intermediate number of risk factors but similar outcomes, compared with the no ECG change group. Further study is necessary to evaluate the prognostic impact of the baseline ECG on admission.

Pharmacoinvasive Strategy Versus Primary Percutaneous Coronary Intervention in Patients With ST-Segment-Elevation Myocardial Infarction: A Propensity Score-Matched Analysis.

BACKGROUND: The Strategic Reperfusion Early After Myocardial Infarction trial and the French Registry of Acute ST-elevation or Non-ST-elevation Myocardial Infarction 2015 suggested that pharmacoinvasive strategy compares favorably with primary percutaneous coronary intervention (PPCI). We sought to assess the clinical impact of pharmacoinvasive strategy compared with PPCI in real-world patients with ST-segment-elevation myocardial infarction. METHODS AND RESULTS: We used the Korea Acute Myocardial Infarction Registry to identify ST-segment-elevation myocardial infarction patients receiving either pharmacoinvasive strategy defined as fibrinolysis followed by percutaneous coronary intervention (rescue/urgent or routine elective; n=708) or PPCI (n=8878). Patients receiving facilitated percutaneous coronary intervention within 3 hours from fibrinolysis were excluded. Propensity-matched 12-month clinical outcome was compared. In the propensity-matched cohort (n=706 in each group), the pharmacoinvasive group had shorter time to reperfusion therapy (165 versus 241 minutes; P<0.001) and higher rate of pre-percutaneous coronary intervention Thrombolysis in Myocardial Infarction grade 3 (50.4% versus 13.7%; P<0.001). Incidences of major bleeding and stroke during hospitalization were not different. Twelve-month rates of death and major adverse cardiac events (composite of death, recurrent myocardial infarction, target-vessel revascularization, and coronary artery bypass graft surgery) were similar between pharmacoinvasive strategy and PPCI: 4.4% versus 4.1% and 7.5% versus 7.8%, respectively. Equipoise between pharmacoinvasive strategy and PPCI for 12-month major adverse cardiac events occurred when percutaneous coronary intervention-related delay was ≈100 minutes. CONCLUSIONS: ST-segment-elevation myocardial infarction patients receiving pharmacoinvasive treatment, compared with PPCI, had shorter time to reperfusion, higher culprit-vessel patency, and similar 12-month clinical outcome.

Clinical impact of immediate invasive strategy in patients with non-ST-segment elevation myocardial infarction.

BACKGROUND: Immediate invasive approach for non-ST-segment elevation myocardial infarction (NSTEMI) may permit treatment of the underlying plaque rupture as early as possible with subsequent reduction of death and myocardial infarction (MI). We sought to assess clinical impact of immediate percutaneous coronary intervention (PCI) for NSTEMI. METHODS: A total of 6134 NSTEMI patients undergoing PCI from the Korea Acute Myocardial Infarction Registry were divided into group 1 (immediate PCI within 4h, n=1132) and group 2 (non-immediate PCI after 4h, n=5002). Propensity-matched 12-month clinical outcome was compared. RESULTS: In all patients and propensity-matched cohort (n=1131 in each group), group 1 had higher peak troponin level, higher rate of pre-PCI Thrombolysis In Myocardial Infarction (TIMI) grade 0 or 1, higher use of glycoprotein IIb/IIIa inhibitor, and lower use of unfractionated heparin and nitrates. In all patients, 12-month rates of MI and death/MI were higher in group 1. No differences were observed in 12-month death and major adverse cardiac events (MACE: composite of death, MI, target-vessel revascularization, and coronary artery bypass graft surgery). In propensity-matched cohort, no significant differences were observed in 12-month rates of death, MI, death/MI or MACE. However, group 1 had less major bleeding (0.8% vs. 3.0%, p=0.024) and shorter hospital stay. CONCLUSIONS: Immediate PCI for patients with NSTEMI was associated with lower pre-PCI culprit vessel patency and not with improved 12-month clinical outcome.

Roles of High-Density Lipoprotein Cholesterol in Patients With Acute Myocardial Infarction.

Many observational studies showed hogh-density lipoprotein cholesterol (HDL-C) is a strong inverse predictor of cardiovascular (CV) outcome. However, recent large clinical trials evaluating therapies to raise HDL-C level in those already on statin therapy have been discouraging. This complexity is not well-known.A total of 28,357 acute myocardial infarction (AMI) patients were enrolled in the Korea Acute Myocardial Infarction Registry (KAMIR), which was a prospective, multicenter, nationwide, web-based database of AMI in Korea. From this registry, we evaluated 3574 patients with AMI who have follow-up HDL-C level to investigate its association with clinical outcomes. The primary endpoint was the relationship between follow-up change in HDL-C and a 12-month composite of major adverse cardiac events (MACEs).Patients with initial HDL-C ≥ 40 mg/dL showed significantly lower rates of 12-month MACEs, especially cardiac and all-cause mortalities (P < 0.001). When patients were stratified into 4 groups according to the change of HDL-C, patients with decreasing HDL-C showed significantly higher rates of 12-month MACEs as comparable with patients with increasing HLD-C. A multivariate analysis indicated that HDL-C level was a significant predictor of CV events (hazard ratio, 1.38; 95% confidence interval, 1.12-1.71) after correcting for confounding variables.The follow-up change in HDL-C level was significantly related with CV outcomes in patients with AMI.

Multicenter Cohort Study of Acute Myocardial Infarction in Korea　- Interim Analysis of the Korea Acute Myocardial Infarction Registry-National Institutes of Health Registry.

BACKGROUND: The Korea Acute Myocardial Infarction Registry (KAMIR)-National Institutes of Health (NIH) registry has the aim of evaluating the clinical characteristics, management, and long-term outcomes of patients with acute myocardial infarction (AMI) in Korea. METHODS AND RESULTS: Patients hospitalized for AMI in 20 tertiary university hospitals in Korea have been enrolled since November 2011. The study is expected to complete the scheduled enrollment of approximately 13,000 patients in October 2015, and follow-up duration is up to 5 years for each patient. As of October 2015, an interim analysis of 13,623 subjects was performed to understand the baseline clinical profiles of the study population. The mean age was 64.1 years; 73.5% were male; and 48.2% were diagnosed with ST-segment elevation AMI. Hypertension is a leading cause of AMI in Korea (51.2%), followed by smoking (38.5%) and diabetes mellitus (28.6%). Percutaneous coronary intervention was performed in 87.4% and its success rate was very high (99.4%). In-hospital, 1-year, and 2-year mortality rates were 3.9%, 4.3%, and 8.6%, respectively. The rates of major adverse cardiac events at 1 and 2 years were 9.6% and 18.8%, respectively. CONCLUSIONS: This analysis demonstrated the clinical characteristics of Korean AMI patients in comparison with those of other countries. It is necessary to develop guidelines for Asian populations to further improve their prognosis. (Circ J 2016; 80: 1427-1436).

Efficacy and Safety Study of Olmesartan Medoxomil, Amlodipine, and Hydrochlorothiazide Combination Therapy in Patients with Hypertension Not Controlled with Olmesartan Medoxomil and Hydrochlorothiazide Combination Therapy: Results of a Randomized, Double-Blind, Multicenter Trial.

BACKGROUND: This study was to evaluate the efficacy and safety of triple fixed-dose combination (FDC) therapy with olmesartan medoxomil (OM) 20 mg, amlodipine (AML) 5 mg, and hydrochlorothiazide (HCTZ) 12.5 mg (OM/AML/HCTZ 20/5/12.5) in Korean patients with moderate hypertension not controlled with dual FDC therapy (OM/HCTZ 20/12.5). METHODS: In this multicenter, randomized, double-blind, parallel-group study, Korean patients aged 20 to 75 years with stage 2 hypertension who had a mean seated diastolic blood pressure (msDBP) ≥100 mmHg were enrolled when their BP was uncontrolled [mean seated systolic BP (msSBP)/msDBP >140/90 mmHg or msSBP/msDBP >130/80 mmHg with diabetes or chronic kidney disease] with 4-week dual FDC therapy (OM/HCTZ 20/12.5). The patients were randomized to receive either OM/AML/HCTZ 20/5/12.5 or OM/HCTZ 20/12.5 once daily for 8 weeks. At the end of 8 weeks, patients with uncontrolled BP were assigned to receive either OM/AML/HCTZ 40/5/12.5 or OM/AML/HCTZ 20/5/12.5 in an additional 8-week open-label extension period. RESULTS: A total of 623 patients received a 4-week run-in treatment with OM/HCTZ, 341 patients were randomized, and finally, 167 patients in the OM/AML/HCTZ group and 171 patients in the OM/HCTZ group were analyzed for the full analysis set. Non-responders after the 8 weeks of double-blind treatment continued the 8-week open-label treatment with OM/AML/HCTZ 40/5/12.5 mg (n = 32) or OM/AML/HCTZ 20/5/12.5 mg (n = 71). After 8 weeks of double-blind treatment, the changes in msDBP were -9.50 (8.46) mmHg in the OM/AML/HCTZ group and -4.23 (7.41) mmHg in the OM/HCTZ group (both p < 0.0001 vs. baseline; p < 0.0001 between groups). The response rates for both msSBP and msDBP at week 8 were 65.27 % in the OM/AML/HCTZ group and 37.43 % in the OM/HCTZ group (p < 0.0001 between groups). The response rates for both msSBP and msDBP at week 16 after open-label treatment were 18.75 % in the OM/AML/HCTZ 40/5/12.5 group and 46.48 % in the OM/AML/HCTZ 20/5/12.5 group (p = 0.0073 between groups). All medications were well tolerated. CONCLUSION: In Korean patients with moderate hypertension not controlled with dual FDC therapy (OM/HCTZ 20/12.5) as first-line therapy, switching to triple FDC therapy (OM/AML/HCTZ 20/5/12.5) was associated with significant BP reductions and greater achievement of BP goals, and was well tolerated (ClinicalTrials.gov Identifier: NCT01838850).

Incidence and Morphological Predictors of Intrastent Coronary Thrombus After Drug-Eluting Stent Implantation (from a Multicenter Registry).

The mechanisms responsible for late and very late stent thrombosis remain incompletely understood. This study aimed to evaluate the incidence and morphologic predictors of intrastent thrombus in patients after drug-eluting stent (DES) implantation using optical coherence tomography (OCT). A total of 208 patients with 262 DES who underwent follow-up OCT examination >6 months after DES implantation were included. The detailed vascular morphology including characteristics of neointima was analyzed. Thrombus was identified in 24 patients (11.5%) 11 months after DES implantation. Minimal lumen cross-sectional area was significantly smaller in the thrombus group than in the nonthrombus group (2.9 ± 1.7 vs 4.6 ± 2.0 mm(2); p <0.001). No difference was found in the frequency of uncovered or malapposed struts between the 2 groups. Thin-cap fibroatheroma (20.6% vs 0.1%; p <0.001) and heterogeneous neointima (22.2% vs 9.0%; p = 0.001) were more frequently detected in the thrombus group compared to the nonthrombus group. Second-generation DES showed lower incidence of thrombus, uncovered struts, and extrastent lumen compared with first-generation DES. In conclusion, the present OCT study revealed that smaller lumen cross-sectional area and neointimal morphology are important factors associated with intrastent thrombus. Second-generation DES demonstrated improved arterial healing and a lower incidence of intrastent thrombus compared with first-generation DES.

Clinical Characteristics and Outcomes of Acute ST-Segment Elevation Myocardial Infarction in Younger Korean Adults.

BACKGROUND AND OBJECTIVES: This study aims to investigate the clinical features, angiographic findings, and outcomes of younger Korean ST-segment elevation myocardial infarction (STEMI) patients. SUBJECTS AND METHODS: We analyzed major adverse cardiac events (MACE) in the Korea Acute Myocardial Infarction Registry from November 2005 to October 2010. The registered patients were divided into two groups; young age group (<65 years) and old age group (≥65 years). RESULTS: The young age group included 5281 patients (age, 53±7.8 years), and the old age group included 4896 patients (age, 74.3±6.5 years). Male gender, smoking, family history, dyslipidemia, and metabolic syndrome were more frequently observed in the young age group than in the old age group (89.5% vs. 59.3%, p<0.001; 77.3% vs. 47.2%, p<0.001; 11% vs. 4.6%, p<0.001; 11.2% vs. 7.7%, p<0.001; 67.6% vs. 62.9%, p<0.001). Most of the young Korean adults with STEMI complained of typical chest pain (89.8%), and they had a shorter symptom-to-door time (12±53.2 hours vs. 17.3±132 hours, p=0.010). The young age group showed a favorable prognosis, which was represented by the MACE, compared with the old age group at one month (1.8% vs. 2.8%, p=0.028), six months (6.8% vs. 8.2%, p<0.001), and twelve months (10.1% vs. 11.9%, p=0.025). However, there was no significant difference in the adjusted MACE rate at one month {hazard ratio (HR) 0.95, 95% confidence interval (CI) 0.60-1.51, p=0.828} and twelve months (HR 0.86, 95% CI 0.68-1.10, p=0.233). CONCLUSION: Younger Korean adults with STEMI have clinical outcomes similar to old aged patients, and therefore, they should be treated intensively like the elderly patients.

Comparison of Neoatherosclerosis and Neovascularization Between Patients With and Without Diabetes: An Optical Coherence Tomography Study.

OBJECTIVES: This study aimed to investigate the characteristics of neoatherosclerosis (NA) in patients with diabetes mellitus (DM) after drug-eluting stent (DES) implantation using optical coherence tomography. BACKGROUND: NA is an important substrate for stent failure. In vivo NA characteristics in DM patients have not been investigated. METHODS: A total of 397 patients with 452 DES who underwent follow-up optical coherence tomography examination after DES implantation were enrolled. Characteristics of NA were compared between DM and non-DM patients. Neovascularization was defined as signal-poor holes or tubular structures with a diameter of 50 to 300 µm. RESULTS: A total of 123 DES with NA lesions in 115 patients were identified. The incidence of NA was similar between DM and non-DM patients (29.6% vs. 28.6%; p = 0.825). Compared with the non-DM group, neovascularization was more frequently observed in the DM group (55.1% vs. 32.4%; p = 0.012). The multivariate logistic model demonstrated that DM (odds ratio: 3.00; 95% confidence interval: 1.31 to 6.81; p = 0.009) and follow-up duration (odds ratio: 1.03; 95% confidence interval: 1.02 to 1.05; p < 0.001) were the independent predictors for neovascularization in NA lesions. DM patients with glycated hemoglobin ≥7.0% had a higher prevalence of thin-cap fibroatheroma compared with those with glycated hemoglobin <7.0% (40.0% vs. 8.3%; p = 0.01). CONCLUSIONS: The incidence of NA was similar between patients with and without DM. Neovascularization in NA lesions was more frequent in those with DM. Poorly controlled DM patients had a higher incidence of thin-cap fibroatheroma, compared with those with well-controlled DM.

Impact of smoking on clinical outcomes in female patients with acute myocardial infarction.

BACKGROUND AND OBJECTIVES: Cigarette smoking has been recognized as a prominent threat to women's health. We investigated the impact of smoking on clinical outcomes in Korean female patients after acute myocardial infarction (AMI). SUBJECTS AND METHODS: Out of the AMI patients who enrolled in the Korea AMI Registry, 4444 female patients were included in this study. Patients were divided into two groups-non-smoker and smoker-according to their current smoking status. We compared in-hospital mortality and major adverse cardiac events (MACE), including cardiac death, myocardial infarction, repeated percutaneous coronary intervention (PCI), or coronary artery bypass grafting during the one-year clinical follow-up period between two groups. RESULTS: The non-smoker group had more hypertension (HTN) and diabetes mellitus. The levels of total cholesterol, triglyceride, and low-density lipoprotein cholesterol were higher in the non-smoker group. However, in-hospital mortality was significantly higher in the smoker group (1.0% vs. 2.4%, p=0.002), and cardiac death during the 12-month clinical follow-up was significantly more frequent in the smoker group (2.2% vs. 4.5%, p=0.003). Total MACEs during the 12 months were higher in the smoker group (4.9% vs. 6.8%, p=0.014). Smoking and HTN were independent predictors of MACE {odds ratio (OR): 1.742, 95% confidence interval (CI): 1.010-3.000, p=0.046; OR: 1.573, 95% CI: 1.003-2.466, p=0.049, respectively}. CONCLUSION: Female smokers with AMI showed significantly higher in-hospital mortality and MACE rates during the one-year clinical follow-up period.