Surveillance Stress Testing After Percutaneous Intervention for Patients With Multivessel or Left Main Coronary Disease.

BACKGROUND: The optimal surveillance strategy after percutaneous coronary intervention (PCI) for high-risk patients with multivessel or left main coronary artery disease (CAD) remains uncertain. OBJECTIVES: This study aims to determine the prognostic role of routine functional testing in patients with multivessel or left main CAD who underwent PCI. METHODS: The POST-PCI (Pragmatic Trial Comparing Symptom-Oriented Versus Routine Stress Testing in High-Risk Patients Undergoing Percutaneous Coronary Intervention) trial randomized high-risk PCI patients to routine functional testing at 1 year or standard care alone during follow-up. This analysis focused on participants with multivessel or left main CAD. The primary outcome was a composite of death from any cause, myocardial infarction, or hospitalization for unstable angina at 2 years. RESULTS: Among 1,706 initially randomized patients, 1,192 patients with multivessel (n = 833) or left main (n = 359) were identified, with 589 in the functional testing group and 603 in the standard care group. Two-year incidences of primary outcome were similar between the functional testing group and the standard care group (6.2% vs 5.7%, respectively; HR: 1.09; 95% CI: 0.68-1.74; P = 0.73). This trend persisted in both groups of multivessel (6.2% vs 5.7%; HR: 1.09; 95% CI: 0.62-1.89; P = 0.78) and left main disease (6.2% vs 5.7%; HR: 1.09; 95% CI: 0.46-2.56; P = 0.85) (P for interaction = 0.90). Routine surveillance functional testing was associated with increased rates of invasive angiography and repeat revascularization beyond 1 year. CONCLUSIONS: In high-risk patients with multivessel or left main CAD who underwent PCI, there was no incremental clinical benefit from routine surveillance functional-testing compared with standard care alone during follow-up. (Pragmatic Trial Comparing Symptom-Oriented Versus Routine Stress Testing in High-Risk Patients Undergoing Percutaneous Coronary Intervention [POST-PCI]; NCT03217877).

Routine stress testing in diabetic patients after percutaneous coronary intervention: the POST-PCI trial.

BACKGROUND AND AIMS: The optimal follow-up surveillance strategy for high-risk diabetic patients with had undergone percutaneous coronary intervention (PCI) remains unknown. METHODS: The POST-PCI (Pragmatic Trial Comparing Symptom-Oriented versus Routine Stress Testing in High-Risk Patients Undergoing Percutaneous Coronary Intervention) study was a randomized trial comparing a follow-up strategy of routine functional testing at 1 year vs. standard care alone after high-risk PCI. Randomization was stratified according to diabetes status. The primary outcome was a composite of death from any cause, myocardial infarction, or hospitalization for unstable angina at 2 years. RESULTS: Among 1706 randomized patients, participants with diabetes (n = 660, 38.7%) had more frequent comorbidities and a higher prevalence of complex anatomical or procedural characteristics than those without diabetes (n = 1046, 61.3%). Patients with diabetes had a 52% greater risk of primary composite events [hazard ratio (HR) 1.52; 95% confidence interval (CI) 1.02-2.27; P = .039]. The 2-year incidences of the primary composite outcome were similar between strategies of routine functional testing or standard care alone in diabetic patients (7.1% vs. 7.5%; HR 0.94; 95% CI 0.53-1.66; P = .82) and non-diabetic patients (4.6% vs. 5.1%; HR 0.89; 95% CI 0.51-1.55; P = .68) (interaction term for diabetes: P = .91). The incidences of invasive coronary angiography and repeat revascularization after 1 year were higher in the routine functional-testing group than the standard-care group irrespective of diabetes status. CONCLUSIONS: Despite being at higher risk for adverse clinical events, patients with diabetes who had undergone high-risk PCI did not derive incremental benefit from routine surveillance stress testing compared with standard care alone during follow-up.

Randomized, multicenter, parallel, open, phase 4 study to compare the efficacy and safety of rosuvastatin/amlodipine polypill versus atorvastatin/amlodipine polypill in hypertension patient with dyslipidemia.

The authors performed this study to investigate the efficacy and safety of a rosuvastatin (RSV)/amlodipine (AML) polypill compared with those of atorvastatin (ATV)/AML polypill. We included 259 patients from 21 institutions in Korea. Patients were randomly assigned to 1 of 3 treatment groups: RSV 10 mg/AML 5 mg, RSV 20 mg/AML 5 mg, or ATV 20 mg /AML 5 mg. The primary endpoint was the efficacy of the RSV 10.20 mg/AML 5 mg via percentage changes in LDL-C after 8 weeks of treatment, compared with the ATV 20 mg /AML 5 mg. There was a significant difference in the mean percentage change of LDL-C at 8 weeks between the RSV 10 mg/AML 5 mg and the ATV 20 mg/AML 5 mg (full analysis set [FAS]: -7.08%, 95% CI: -11.79 to -2.38, p = .0034, per-protocol analysis set [PPS]: -6.97%, 95% CI: -11.76 to -2.19, p = .0046). Also, there was a significant difference in the mean percentage change of LDL-C at 8 weeks between the RSV 20 mg/AML 5 mg and the ATV 20 mg/AML 5 mg (FAS: -10.13%, 95% CI: -15.41 to -4.84, p = .0002, PPS: -10.96%, 95% CI: -15.98 to -5.93, p < .0001). There was no significant difference in the adverse events rates between RSV 10 mg/AML 5 mg, RSV 20 mg/AML 5 mg, and ATV 20 mg/AML 5 mg. In conclusion, while maintaining safety, RSV 10 mg/AML 5 mg and the RSV 20 mg/AML 5 mg more effectively reduced LDL-C compared with the ATV 20 mg /AML 5 mg (Clinical trial: NCT03951207).

Routine Functional Testing or Standard Care in High-Risk Patients after PCI.

BACKGROUND: There are limited data from randomized trials to guide a specific follow-up surveillance approach after myocardial revascularization. Whether a follow-up strategy that includes routine functional testing improves clinical outcomes among high-risk patients who have undergone percutaneous coronary intervention (PCI) is uncertain. METHODS: We randomly assigned 1706 patients with high-risk anatomical or clinical characteristics who had undergone PCI to a follow-up strategy of routine functional testing (nuclear stress testing, exercise electrocardiography, or stress echocardiography) at 1 year after PCI or to standard care alone. The primary outcome was a composite of death from any cause, myocardial infarction, or hospitalization for unstable angina at 2 years. Key secondary outcomes included invasive coronary angiography and repeat revascularization. RESULTS: The mean age of the patients was 64.7 years, 21.0% had left main disease, 43.5% had bifurcation disease, 69.8% had multivessel disease, 70.1% had diffuse long lesions, 38.7% had diabetes, and 96.4% had been treated with drug-eluting stents. At 2 years, a primary-outcome event had occurred in 46 of 849 patients (Kaplan-Meier estimate, 5.5%) in the functional-testing group and in 51 of 857 (Kaplan-Meier estimate, 6.0%) in the standard-care group (hazard ratio, 0.90; 95% confidence interval [CI], 0.61 to 1.35; P = 0.62). There were no between-group differences with respect to the components of the primary outcome. At 2 years, 12.3% of the patients in the functional-testing group and 9.3% in the standard-care group had undergone invasive coronary angiography (difference, 2.99 percentage points; 95% CI, -0.01 to 5.99), and 8.1% and 5.8% of patients, respectively, had undergone repeat revascularization (difference, 2.23 percentage points; 95% CI, -0.22 to 4.68). CONCLUSIONS: Among high-risk patients who had undergone PCI, a follow-up strategy of routine functional testing, as compared with standard care alone, did not improve clinical outcomes at 2 years. (Funded by the CardioVascular Research Foundation and Daewoong Pharmaceutical; POST-PCI ClinicalTrials.gov number, NCT03217877.).

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.

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/m2), 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.

Comparison of apolipoprotein B/A1 ratio, TC/HDL-C, and lipoprotein (a) for predicting outcomes after PCI.

BACKGROUND AND AIMS: The Apo B/A1 ratio is a major factor that predicts future cardiovascular outcomes. However, it is unclear whether the apolipoprotein B (Apo B)/apolipoprotein A1 (Apo A1) is a better predictor of future outcome than the total cholesterol (TC)/HDL-C ratio or lipoprotein (a) (Lp (a)) after the percutaneous coronary intervention (PCI). Therefore, we performed this study to evaluate the impact of the Apo B/A1 ratio on the patients who achieved LDL-C below 70 mg/dL one year after PCI. METHODS: We included 448 PCI patients whose LDL-C levels were below 70 mg/dL at follow-up. The Apo B/A1 ratio, TC/HDL-C ratio, and Lp (a) levels were measured at the time of PCI and follow-up, and decreases in these parameters between baseline and follow-up were assessed as potential markers to predict major cardiovascular adverse events (MACEs). RESULTS: During a median follow-up period of 38.0 months, 115 MACEs were recorded. The tertile with the lowest decrease in the Apo B/A1 ratio (≤ 0.146) showed a lower MACE survival rate compared to the other tertiles. There were no differences in MACE survival rates for the TC/HDL-C ratio or Lp (a) levels. CONCLUSIONS: The Apo B/A1 ratio had better predictive accuracy for clinical outcomes compared to the TC/HDL-C ratio and Lp (a) level. A lower decrease in the Apo B/A1 ratio may be a residual risk factor for MACEs in patients who have reached LDL-C levels below 70 mg/dL after PCI.

Clinical Impact of Lesion Complexity on 2-Year Outcomes After Zotarolimus-Eluting Stents Implantation.

Background: The clinical efficacy and safety of second-generation drug-eluting stents in complex percutaneous coronary interventions (PCIs) are not well established. Objectives: The clinical influence of the lesion complexity after PCI with zotarolimus-eluting stents (ZES) was evaluated. Methods: From a prospective multicenter observational study, a total of 926 patients that underwent successful PCIs with ZES were included. Complex PCIs were defined as patients with ≥3 lesions treated, 3 vessels treated, severe calcified lesions, bifurcated lesions with 2 stents implanted, left main disease, chronic total occlusion lesions, and/or diffuse long (total stent length ≥60 mm) lesions and were compared to the noncomplex group. The primary outcome was incidence of target lesion failures at 2 years, defined as a composite of cardiac death, target lesion-myocardial infarctions, and target lesion revascularization. Results: The patients were divided into complex PCI (n = 249) and noncomplex (n = 677) groups. In the complex PCI group, the 2-year risk of a target lesion failure was not significantly higher than in the noncomplex PCI group (4.8% vs 3.7%; adjusted hazard ratio: 1.373; 95% confidence interval: 0.689-2.738; P = 0.367). The same trend was observed for all composites of the clinical outcomes. Older age and advanced chronic kidney disease were independent predictors for the primary outcome. Conclusions: Up to 2 years after a ZES implantation, the clinical outcomes did not differ according to lesion complexity.

Transition of May Measurement Month to an online hypertension awareness campaign in Korea during the COVID-19 pandemic.

Aims: May Measurement Month (MMM) is a global campaign to enhance hypertension awareness by intensive blood pressure measuring campaign during a month period of May. May Measurement Month 2020 was not officially executed globally, especially in light of COVID-19 pandemic. But in Korea, the MMM committee decided to carry on with self-initiated project to succeed MMM started in 2019 in Korea. And we adopted new online strategies for those with age of 18 or older under the MMM. Methods and results: Korea 2020 theme in Korean of 'Look for the Young Hypertension'. A promotional video, a subtitled translated global promotional video, and four educational contents were uploaded on Youtube®. Seven online posters or card news were uploaded on main blog. And 71 articles by 60 websites from 10 medical media company were published. The MMM keyword exposure in Naver® portal Search Advertisements was 2500 searches per day. There were 3519 visits to the MMM blog, and 114 people participated in snapshot challenges. Four social network service channels were activated, and there was an increase in Facebook and Instagram followers of 6.5- and 5.8-fold, respectively. GoodDoc® application programming interface messages were sent 97876 times (2589 responses). For a user created contents contest, 28 competitors, mostly young, participated. Conclusion: Even during the COVID-19 pandemic, the MMM campaign was able to survive using a 'new normal' online format. The shift to on-line activity during the pandemic will contribute to a breakthrough MMM campaign in the future that can be combined with off-line protocols even after the pandemic.

Differential cutoff points and clinical impact of stent parameters of various drug-eluting stents for predicting major adverse clinical events: An individual patient data pooled analysis of seven stent-specific registries and 17,068 patients.

BACKGROUND: Stent parameters (length and diameter) are well-known risk factors for adverse outcomes after percutaneous coronary intervention (PCI) with stenting. This study aimed to investigate the differential cutoff criteria and clinical impact of the length and diameter of various drug-eluting stents (DES) for predicting major cardiovascular events. METHODS: Using patient-level data from seven stent-specific, prospective DES registries, we evaluated 17,068 patients who underwent PCI with either various contemporary DES or first-generation DES between July 2007 and July 2015: 3053 treated with cobalt-chromium everolimus-eluting stents (CoCr-EES), 2976 with platinum-chromium EES (PtCr-EES), 2888 with Resolute zotarolimus-eluting stents (Re-ZES), 782 with Biomatrix biolimus-eluting stents (Bi-BES), 1868 with Nobori BES (No-BES), 1934 with Xience Prime cobalt-chromium EES (Pr-CoCr-EES), and 3567 with first-generation sirolimus-eluting stents (SES). Two clinical outcomes were assessed: target-vessel failure (TVF; a composite of cardiac death, target-vessel myocardial infarction, and target-vessel revascularization [TVR]) and TVR. RESULTS: Stent length and stent diameter were important factors for predicting TVF or TVR in the entire cohort and in each DES cohort. For TVF risk prediction, the Youden index-based cutoff of stent length was highest with Bi-BES (45.0 mm) and lowest with No-BES (29.0 mm), and the cutoff of stent diameter was smallest with Pr-CoCr-EES (2.78 mm) and largest with No-BES (3.20 mm). For TVR risk prediction, the cutoff of stent length was the highest with PtCr-EES (48.0 mm) and the lowest with No-BES (29.0 mm), and the cutoff of stent diameter was smallest with CoCr-EES (2.72 mm) and largest with first-generation SES (3.30 mm). The 3-year TVF and TVR rates were substantially different according to the presence or absence of long lesions and small vessels determined using these cutoff points. CONCLUSIONS: For contemporary PCI practice involving diverse types of DES, we identified differential cutoff points of stent length and diameter for predicting adverse clinical outcomes. The clinical impact of these stent parameters on outcomes and its magnitude varied according to different DES. Clinical Trial Registration-URL: http://www.clinicaltrials.gov. Unique identifier: NCT01186133.

Heart failure with reduced ejection fraction: comparison of patient characteristics and clinical outcomes within Asia and between Asia, Europe and the Americas.

AIMS: Nearly 60% of the world's population lives in Asia but little is known about the characteristics and outcomes of Asian patients with heart failure with reduced ejection fraction (HFrEF) compared to other areas of the world. METHODS AND RESULTS: We pooled two, large, global trials, with similar design, in 13 174 patients with HFrEF (patient distribution: China 833, India 1390, Japan 209, Korea 223, Philippines 223, Taiwan 199 and Thailand 95, Western Europe 3521, Eastern Europe 4758, North America 613, and Latin America 1110). Asian patients were younger (55.0-63.9 years) than in Western Europe (67.9 years) and North America (66.6 years). Diuretics and devices were used less, and digoxin used more, in Asia. Mineralocorticoid receptor antagonist use was higher in China (66.3%), the Philippines (64.1%) and Latin America (62.8%) compared to Europe and North America (range 32.8% to 49.6%). The rate of cardiovascular death/heart failure hospitalization was higher in Asia (e.g. Taiwan 17.2, China 14.9 per 100 patient-years) than in Western Europe (10.4) and North America (12.8). However, the adjusted risk of cardiovascular death was higher in many Asian countries than in Western Europe (except Japan) and the risk of heart failure hospitalization was lower in India and in the Philippines than in Western Europe, but significantly higher in China, Japan, and Taiwan. CONCLUSION: Patient characteristics and outcomes vary between Asia and other regions and between Asian countries. These variations may reflect several factors, including geography, climate and environment, diet and lifestyle, health care systems, genetics and socioeconomic influences.

Impact of different antihypertensives on carotid arterial wall thickness.

Hypertension has been associated with atherosclerosis and cardiovascular disease. Carotid intima media thickness is increased in hypertensive patients. But, the correlation between carotid intima media thickness and antihypertensive agents is still uncertain. Therefore, we investigated carotid intima media thickness based on types of antihypertensive agents. 1809 patients were enrolled in this study and it showed that 1079 hypertensive patients had thicker carotid intima media thickness than non-hypertensive patients, with carotid intima media thicknesses of (0.72 ± 17 mm vs 0.64 ± 15 mm, P < .001), (0.31 ± 0.07 mm vs 0.30 ± 0.06 mm, P < .001), and (0.41 ± 0.13 mm vs 0.35 ± 0.12 mm, P < .001). Additionally, hypertensive patients on beta-blockers also had thicker carotid intima media thickness than the non-beta-blocker group, with carotid intima media thicknesses of (0.74 ± 0.18 mm vs 0.71 ± 0.16 mm, P = .018), (0.33 ± 0.09 mm vs 0.31 ± 0.07 mm, P = .029), and (0.43 ± 0.13 mm vs 0.40 ± 0.13 mm, P = .035). Multivariate analysis showed that carotid intima thickness was only correlated with beta-blockers (odds ratio = 2.489, confidence interval = 1.183-5.239, P = .016); however, this study showed that beta-blocker could be associated with increased carotid wall thickness as well.

A coronary artery fistula having connection between 2 coronary arteries and the left ventricle: A case report.

RATIONALE: Cases of coronary artery fistula having a connection with the cardiac cavity are rare. Here, we report a case in which 2 coronary arteries empty into the left ventricular cavity together. PATIENT CONCERNS: A 63-year-old woman who was diagnosed as having hypertension 20 years prior presented with dyspnea. DIAGNOSES: The coronary angiography revealed coronary artery fistula. INTERVENTIONS: Chest X-ray showed pulmonary edema. Transthoracic echocardiography revealed moderately decreased left ventricular (LV) function and increased LV end-diastolic volume and mass index. Coronary angiography and cardiac computed tomography revealed that 2 coronary arteries joined together at the distal end and directly drained into the left ventricular cavity bypassing the myocardial capillary vessels. We started medical treatment for heart failure with an angiotensin-converting-enzyme inhibitor, loop diuretic, and spironolactone. OUTCOMES: The pulmonary edema improved rapidly. The patient did not experience dyspnea after discharge, and follow-up echocardiography showed improved cardiac function. MAIN LESSON: Coronary artery fistula could be found incidentally on coronary angiography performed for varied reasons. Physicians must decide carefully whether the fistula needs to be treated in view of the clinical context.

Bioresorbable Vascular Scaffold Korean Expert Panel Report.

Bioresorbable vascular scaffold (BRS) is an innovative device that provides structural support and drug release to prevent early recoil or restenosis, and then degrades into nontoxic compounds to avoid late complications related with metallic drug-eluting stents (DESs). BRS has several putative advantages. However, recent randomized trials and registry studies raised clinical concerns about the safety and efficacy of first generation BRS. In addition, the general guidance for the optimal practice with BRS has not been suggested due to limited long-term clinical data in Korea. To address the safety and efficacy of BRS, we reviewed the clinical evidence of BRS implantation, and suggested the appropriate criteria for patient and lesion selection, scaffold implantation technique, and management.

Evaluation of the impact of statin therapy on the obesity paradox in patients with acute myocardial infarction: A propensity score matching analysis from the Korea Acute Myocardial Infarction Registry.

The phenomenon of obesity paradox after acute myocardial infarction (AMI) has been reported under strong recommendation of statin therapy. However, the impact of statin therapy on this paradox has not been investigated. This study investigated the impact of statin therapy on 1-year mortality according to obesity after AMI. A total of 2745 AMI patients were included from the Korea Acute Myocardial Infarction Registry after 1:4 propensity score matching analysis (n = 549 for nonstatin group and n = 2196 for statin group). Primary and secondary outcomes were all-cause and cardiac death, respectively. During 1-year follow-up, the incidence of all-cause (8.4% vs 3.7%) and cardiac (6.2% vs 2.3%) death was higher in nonstatin group than in statin (P < .001, respectively). In nonstatin group, the incidence of all-cause (7.2% vs 9.0%) and cardiac (5.5% vs 6.5%) death did not differ significantly between obese and nonobese patients. However, in statin group, obese patients had lower 1-year rate of all-cause (1.7% vs 4.8%) and cardiac (1.2% vs 2.9%) death (P < .05, respectively), and lower cumulative rates by Kaplan-Meier analysis of all-cause and cardiac death compared with nonobese patients (log-rank P < .05, respectively). The overall risk of all-cause death was significantly lower in obese than in nonobese patients only in statin group (hazard ratio: 0.35; P = .001). After adjusting for confounding factors, obesity was independently associated with decreased risk of all-cause death in statin group. In conclusion, the greater benefit of statin therapy for survival in obese patients is further confirmation of the obesity paradox after AMI.

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.

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.

Epicardial Fat Thickness is Correlated with Vagal Hyperactivity in Patients with Neurally-Mediated Syncope.

BACKGROUND: Epicardial fat tissue has unique endocrine and paracrine functions that affect the cardiac autonomic system. The head-up tilt test (HUTT) is a simple non-invasive measurement that assesses autonomic nervous system dysfunction. We investigated the association between epicardial fat thickness (EFT) and autonomic neural tone, such as vagal tone. METHODS: A total of 797 consecutive patients (mean age 46.5 years, male: 45.7%) who underwent HUTT and echocardiography between March 2006 and June 2015 were enrolled. EFT was measured during the diastolic phase of the parasternal long axis view. We excluded patients with prior percutaneous coronary intervention, old age (* 70 years old), valvular heart disease, symptomatic arrhythmias and diabetes. We divided patients into two groups based on the HUTT (positive vs. negative). RESULTS: There were 329 patients (41.3%) with a negative HUTT result and 468 patients (58.7%) with a positive result. The HUTT-positive patients showed a significantly lower waist circumference, body mass index and systolic and diastolic blood pressure, although a significantly higher EFT as compared to the HUTT-negative patients (HUTT-positive, 5.69 ± 1.76 mm vs. HUTT-negative, 5.24 ± 1.60 mm; p < 0.001). EFT > 5.4 mm was associated with a positive HUTT result with 51.7% sensitivity and 63.8% specificity (p < 0.001) on receiving operator characteristic analysis. Multivariate Cox regression analysis revealed that EFT (hazard ratio: 1.02, 95% confidence interval: 1.01-1.30, p = 0.004) was an independent predictor of HUTT-positivity. CONCLSION: EFT was significantly correlated with positive HUTT, which suggests an association between EFT and autonomic dysregulation.

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

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

Impact of low high-density lipoprotein-cholesterol level on 2-year clinical outcomes after acute myocardial infarction in patients with diabetes mellitus.

BACKGROUND: It is still unclear whether low high-density lipoprotein cholesterol (HDL-C) affects cardiovascular outcomes after acute myocardial infarction (AMI), especially in patients with diabetes mellitus. METHODS: A total of 984 AMI patients with diabetes mellitus from the DIabetic Acute Myocardial InfarctiON Disease (DIAMOND) Korean multicenter registry were divided into two groups based on HDL-C level on admission: normal HDL-C group (HDL-C ≥ 40 mg/dL, n = 519) and low HDL-C group (HDL-C < 40 mg/dL, n = 465). The primary endpoint was 2-year major adverse cardiovascular events (MACE), defined as a composite of cardiac death, non-fatal myocardial infarction (MI), and target vessel revascularization (TVR). RESULTS: The median follow-up duration was 730 days. The 2-year MACE rates were significantly higher in the low HDL-C group than in the normal HDL-C group (MACE, 7.44% vs. 3.49%, p = 0.006; cardiac death, 3.72% vs. 0.97%, p = 0.004; non-fatal MI, 1.75% vs. 1.55%, p = 0.806; TVR, 3.50% vs. 0.97%, p = 0.007). Kaplan-Meier analysis revealed that the low HDL-C group had a significantly higher incidence of MACE compared to the normal HDL-C group (log-rank p = 0.013). After adjusting for conventional risk factors, Cox proportional hazards analysis suggested that low HDL-C was an independent risk predictor for MACE (hazard ratio [HR] 3.075, 95% confidence interval [CI] 1.034-9.144, p = 0.043). CONCLUSIONS: In patients with diabetes mellitus, low HDL-C remained an independent risk predictor for MACE after adjusting for multiple risk factors during 2-year follow-up of AMI. TRIAL REGISTRATION: This study was the sub-analysis of the prospective multi-center registry of DIAMOND (Diabetic acute myocardial infarction Disease) in Korea. This is the observational study supported by Bayer HealthCare, Korea. Study number is 15614. First patient first visit was 02 April 2010 and last patient last visit was 09 December 2013.

Blood Pressure and Cholesterol-lowering Efficacy of a Fixed-dose Combination With Irbesartan and Atorvastatin in Patients With Hypertension and Hypercholesterolemia: A Randomized, Double-blind, Factorial, Multicenter Phase III Study.

PURPOSE: A fixed-dose combination of a stain and an antihypertensive drug may be useful for the treatment of patients with hypertension and hyperlipidemia. It may also improve patient drug compliance to help control risk factors of cardiovascular disease. This study was designed to evaluate the blood pressure-lowering and cholesterol-lowering effect of a fixed-dose combination of irbesartan-atorvastatin compared with monotherapy by either agent over an 8-week treatment period. METHODS: Patients with comorbid hypertension and hypercholesterolemia were screened for this randomized, double-blind, Phase III study. Eligible study patients were randomly assigned to test groups receiving a combination of irbesartan 300 mg and atorvastatin 40 mg or 80 mg (IRB300 + ATO40 and IRB300 + ATO80). Comparator groups comprised monotherapy groups with irbesartan 300 mg (IRB300) or atorvastatin 40 mg (ATO40) or atorvastatin 80 mg (ATO80), or placebo. Patients who were eligible at screening were subjected to a 4- to 6-week washout period before commencing 8 weeks of therapy per their assigned group. The primary efficacy end points were percent change in LDL-C and sitting diastolic blood pressure (DBP) levels from baseline to end of therapy. Tolerability profiles of combination therapy were compared with other groups. FINDINGS: A total of 733 patients with comorbid hypertension and hypercholesterolemia were screened for this study; 230 eligible patients were randomized to treatment. The mean age of patients was 58.9 (8.5) years, and their mean body mass index was 25.8 (3.2) kg/m2. More than two thirds (70.9%) of the study patients were male. Mean LDL-C and sitting DBP levels at baseline were 149.54 (29.19) mg/dL and 92.32 (6.03) mm Hg, respectively. Percent reductions in LDL-C after 8 weeks were 46.74% (2.06%) in the IRB300 + ATO40 group and 48.98% (2.12%) in the IRB300 + ATO80 group; these values were 47.13% (3.21%) and 48.30% (2.98%) in the ATO40 and ATO80 comparator groups. Similarly, a reduction in sitting DBP after 8 weeks was -8.50 (1.06) mm Hg in the IRB300 + ATO40 group and 10.66 (1.08) mm Hg in the IRB300 + ATO80 group compared with 8.40 (1.65) mm Hg in the IRB300 group. The incidence rate for treatment-emergent adverse events was 22.27% and was similar between the monotherapy and combination groups. IMPLICATIONS: A once-daily combination product of irbesartan and atorvastatin provided an effective, safe, and more compliable treatment for patients with coexisting hypertension and hyperlipidemia. ClinicalTrials.gov identifier: NCT01442987.