Safety and Efficacy of Pitavastatin in Patients With Impaired Fasting Glucose and Hyperlipidemia: A Randomized, Open-labeled, Multicentered, Phase IV Study.

PURPOSE: Although the role of high-intensity lipid-lowering therapy in cardiovascular protection has broadened, concerns still exist about new-onset diabetes mellitus (NODM), especially in vulnerable patients. This study aimed to compare the effect of high-dose (4 mg/d) and usual dose (2 mg/d) pitavastatin on glucose metabolism in patients with hyperlipidemia and impaired fasting glucose (IFG). METHODS: In this 12-month study, glucose tolerance and lipid-lowering efficacy of high-dose pitavastatin (4 mg [study group]) was compared with that of usual dose pitavastatin (2 mg [control group]) in patients with hyperlipidemia and IFG. The primary end point was the change of glycosylated hemoglobin (HbA1c) after 24 weeks of treatment. The secondary end points were as follows: (1) NODM within 1 year after treatment, (2) change of lipid parameters, (3) changes of adiponectin, and (4) change of blood glucose and insulin levels. FINDINGS: Of the total 417 patients screened, 313 patients with hypercholesterolemia and IFG were randomly assigned into groups. The mean (SD) change in HbA1c was 0.06% (0.20%) in the study group and 0.03% (0.22%) in the control group (P = 0.27). Within 1 year, 27 patients (12.3%) developed NODM, including 12 (10.6%) of 113 patients in the study group and 15 (14.2%) of 106 in the control group (P = 0.43). The study group had a significantly higher reduction of total cholesterol and LDL-C levels and a higher increase in apolipoprotein A1/apolipoprotein B ratio (0.68 [0.40] vs 0.51 [0.35], P < 0.01). IMPLICATIONS: The high-dose pitavastatin therapy did not aggravate glucose metabolism compared with the usual dose therapy. Moreover, it had a better effect on cholesterol-lowering and apolipoprotein distribution in the patients with hyperlipidemia and IFG.

A Randomized, Multicenter, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and the Tolerability of a Triple Combination of Amlodipine/Losartan/Rosuvastatin in Patients With Comorbid Essential Hypertension and Hyperlipidemia.

PURPOSE: The objective of this study was to evaluate the efficacy and tolerability of a triple combination of amlodipine/losartan/rosuvastatin in patients with hypertension and hypercholesterolemia. METHODS: A randomized, multicenter, double-blind, placebo-controlled study was conducted. Eligible patients with hypertension and a sitting diastolic blood pressure (SiDBP) of >90 mm Hg and LDL-C levels <250mg/dL were screened. After a 4-week run-in period with therapeutic lifestyle changes and losartan potassium 100mg once daily, patients who met both blood pressure criteria (80 mm Hg ≤ SiDBP < 110 mm Hg) and the LDL-C level criteria (defined in the National Cholesterol Education Program Adult Treatment Panel III cardiovascular risk categories) were randomized to 1 of 3 groups and treated once daily for 8 weeks: losartan potassium 100mg + rosuvastatin 20mg treatment (L/R 100/20) group, amlodipine camsylate 5mg + losartan potassium 100mg treatment (A/L 5/100) group, and amlodipine 5mg+ losartan potassium 100mg + rosuvastatin 20mg (A/L/R 5/100/20) group. The primary efficacy variables were the percent change in LDL-C in the A/L/R 5/100/20 and A/L 5/100 groups and the mean change of SiDBP in the A/L/R 5/100/20 and L/R 100/20 groups after 8 weeks of treatment, relative to baseline values. FINDINGS: A total of 146 patients were enrolled and the demographic characteristics were similar among the 3 treatment groups. After 8 weeks of treatment, the mean (SD) percent change in LDL-C was significantly greater in the A/L/R group than in the A/L group (-48.40% [2.77%] vs -6.70% [3.00%]; P < 0.0001). Moreover, the mean change in SiDBP was significantly greater in the A/L/R group than in the L/R group (-9.75 [0.92] mm Hg vs -1.73 [1.03] mm Hg; P < 0.0001). SiDBP and LDL-C reductions in the A/L/R group were comparable to reductions in the A/L and L/R groups, respectively. Ten adverse events were reported in 7 patients (4.83%), and 1 patient from the A/L group (0.69%) experienced 2 adverse drug reactions (tachycardia and face edema), which were mild and resolved without specific treatment. There were no clinically significant tolerability issues during the treatment period. IMPLICATIONS: Triple combination therapy with amlodipine/losartan/rosuvastatin can be an effective therapeutic strategy in patients with hypertension combined with dyslipidemia. These findings will form the foundation of the future development of a single-pill triple combination. ClinicalTrials.gov identifier: NCT02899455.

Impact of Contrast Echocardiography on Assessment of Ventricular Function and Clinical Diagnosis in Routine Clinical Echocardiography: Korean Multicenter Study.

BACKGROUND: Fundamental echocardiography has some drawbacks in patients with difficult-to-image echocardiograms. The aim of this study is to evaluate impact of contrast echocardiography (CE) on ventricular function assessment and clinical diagnosis in routine clinical echocardiography. METHODS: Two hundred sixty patients were prospectively enrolled over 3 years in 12 medical centers in Korea. General image quality, the number of distinguishable segments, ability to assess regional wall motion, left ventricular (LV) apex and right ventricle (RV) visualization, LV ejection fraction, changes in diagnostic or treatment plan were documented after echocardiography with and without ultrasound contrast agent. RESULTS: Poor or uninterpretable general image was 31% before contrast use, and decreased to 2% (p<0.05) after contrast use. The average number of visualized LV segments was 9.53 before contrast use, and increased to 14.46 (p<0.001) after contrast use. The percentage of poor or not seen LV regional wall motion was decreased from 28.4% to 3.5% (p<0.001). The percentage of poor or not seen LV apex and RV was decreased from 49.4% to 2.4% (p<0.001), from 30.5% to 10.5% (p<0.001), respectively. Changes in diagnostic procedure and treatment plan after CE were 30% and 29.6%, respectively. CONCLUSION: Compared to fundamental echocardiography, CE impacted LV function assessment and clinical decision making in Korean patients who undergo routine echocardiography.

Severe Aortic Stenosis Associated with Unicommissural Unicuspid Aortic Valve in a Middle Aged Male.

Unicuspid aortic valve (UAV) is an extremely rare form of congenital aortic valvular abnormality. Although UAV shows similar clinical characteristics to bicuspid aortic valve, the clinical symptoms develop at earlier age and progress at a faster pace in UAV. In this report, we are presenting a 42-year-old male with severe aortic stenosis associated with unicommissural UAV. The patients underwent a successful Bentall operation.

Successful device closure of a post-infarction ventricular septal defect.

Ventricular septal defect (VSD) is a lethal complication of myocardial infarction. The event occurs 2-8 days after an infarction and patients should undergo emergency surgical treatment. We report on successful device closure of post-infarction VSD. A previously healthy 66-year-old male was admitted with aggravated dyspnea. Echocardiography showed moderate left ventricular (LV) systolic dysfunction with akinesia of the left anterior descending (LAD) territory and muscular VSD size approximately 2 cm. Coronary angiography showed mid-LAD total occlusion without collaterals. Without percutaneous coronary intervention due to time delay, VSD repair was performed. However, a murmur was heard again and pulmonary edema was not controlled 3 days after the operation. Echocardiography showed remnant VSD, and medical treatment failed. Percutaneous treatment using a septal occluder device was decided on. After the procedure, heart failure was controlled and the patient was discharged without complications. This is the first report on device closure of post-infarction VSD in Korea.

Comparison of long-term clinical outcomes of percutaneous coronary intervention in vasospastic angina patients associated with significant coronary artery stenosis.

BACKGROUND: Coronary spasm is the major pathophysiology of vasospastic angina (VA). Medical treatment is usually effective in VA patients without significant stenosis. However, there is little information about the percutaneous coronary intervention (PCI) in VA patients with significant coronary artery stenosis (CAS). METHODS: After retrospective screening of all consecutive VA patients from January 2010 to April 2015, we selected significant CAS (>50% of diameter stenosis) after nitrate injection and divided them into two groups according to the presence of PCI. RESULTS: A total of 220 VA patients (41 females, mean age: 58±10years old) were screened, and 85 were included in this study. Males were predominant in the VA with significant CAS group (89 vs 76%, p=0.020). PCI was done in 43 patients (51%). The most common culprit coronary artery was the left anterior descending coronary artery (18, 42%), diameter stenosis was significantly higher (66±9 vs 61±10%, p<0.01), and total number of antianginal medication was significantly lower in the PCI group than in the medical group (1.7±0.9 vs 2.1±0.8, p=0.039). Moreover, 4 patients underwent PCI to control symptoms in the medical treatment group during the follow-up period (26±13months). However, additional antiplatelet therapy was necessary in patients with coronary angioplasty, and there were 2 cases with complication associated with angioplasty (1 restenosis and 1 bleeding complication). CONCLUSION: In VA patients with significant CAS, both treatment modalities showed similar clinical outcomes. Although the PCI can afford symptomatic improvement, it needed additional antiplatelet medications and can be associated with procedural complications.

Comparison of dual antiplatelet therapy prescribed as one-pill versus two-pill regimen. A pooled analysis of individual patient data from the three MR-CAPCIS trials.

Fixed-dose combination (FDC) drugs can simplify the medication regimen and potentially improve adherence. However, evidence is lacking about the efficacy and safety of FDC drugs of clopidogrel plus aspirin. Individual data from the three independent MR-CAPCIS trials were pooled and analysed. In those trials, subjects who had been treated with either dual antiplatelet therapy (DAPT) or aspirin alone after drug-eluting stent (DES) implantation were randomly assigned to one-pill or to two-pill DAPT group. Platelet reactivity was measured with VerifyNow-P2Y12 and aspirin point-of-care assays at baseline and eight weeks after treatment. In the present study, primary efficacy endpoint was changes in platelet reactivity unit (PRU) between baseline and eight weeks. A total of 965 subjects were analysed. In prior clopidogrel and aspirin users, PRU was well maintained regardless of switching to either one-pill or two-pill DAPT (ΔPRU=0.4 vs 0.0, p=0.939). In prior aspirin users, PRU was decreased by 73.7 in one-pill DAPT and 77.5 in two-pill DAPT group, with no differences between them (p=0.499). The incidence of high on-treatment platelet reactivity at eight weeks, defined as PRU≥235 in Western people, was 34.8 % in one-pill DAPT group and 37.6 % in two-pill DAPT group (p=0.380), and that defined as PRU ≥275 in Oriental people was 17.7 vs 21.7 % (p=0.129). Independent predictors of high platelet reactivity on clopidogrel were female gender, increasing age, and diabetes. Study drugs were well tolerated. In conclusion, FDC one-pill DAPT showed similar efficacy to two-pill DAPT in terms of platelet reactivity in patients receiving DES in Korea.

Thread-like Bone Cement in the Right-side Heart and Pulmonary Arteries Causing Diffuse Pulmonary Embolism as a Late Complication.

Pulmonary embolism (PE) is usually associated with deep vein thrombosis (DVT) in the lower extremities. However, foreign bodies in the pulmonary arteries can rarely cause PE without evidence of DVT. In this report, we present a case of diffuse PE associated with a migrated thread-like structure of the right-side heart and pulmonary arteries in a 70 year-old woman. The patient underwent several episodes of percutaneous vertebroplasty (PV) to treat compression fractures. The thread-like foreign bodies were identified as the bone cement injected during the previous PV procedures. We present this case study to emphasise that clinicians should consider the possibility of PE as a late complication, especially those with a history of PV.

Impaired RV global longitudinal strain is associated with poor long-term clinical outcomes in patients with acute inferior STEMI.

OBJECTIVES: The aim of this study was to assess the long-term prognostic value of the global longitudinal strain of the right ventricle (GLSRV) in patients with inferior ST-segment elevation myocardial infarction (STEMI) who underwent primary percutaneous coronary intervention (PCI). BACKGROUND: RV systolic dysfunction is an important prognostic factor in patients with inferior STEMI. METHODS: All consecutive inferior STEMI patients were included from January 2005 to December 2013. RV systolic function was analyzed with GLSRV using velocity vector imaging (Siemens, Mountain View, California), as well as conventional echocardiographic indices, including right ventricular fractional area change (RVFAC) and tricuspid annular plane systolic excursion (TAPSE). RESULTS: We analyzed a total of 282 consecutive inferior STEMI patients (212 men, age 63 ± 13 years) treated with primary PCI. During the follow-up period (54 ± 35 months), 59 patients (21%) had 1 or more major adverse cardiovascular event (MACE) (43 deaths, 7 nonfatal MI, 4 target vessel revascularization, and 6 heart failure admission). The best cutoff value of GLSRV for the prediction of MACE was ≥-15.5% (area under the curve = 0.742, p < 0.001) with a sensitivity of 73% and a specificity of 65%. GLSRV showed better sensitivity and specificity than RVFAC and TAPSE. After multivariate analysis, GLSRV showed a higher c-statistic value (0.770) than RVFAC (0.749) and TAPSE (0.751) in addition to age, Killip class, troponin-I, left ventricular (LV) ejection fraction and RV infarction. Patients with GLSRV≥-15.5% showed significantly lower 5-year survival rate (74 ± 5% vs. 89 ± 3%, p < 0.001) and lower MACE-free survival rate (64 ± 5% vs. 87 ± 3%, p < 0.001) than the control group. CONCLUSIONS: Because GLSRV showed additive predictive value to age and LV function, it can be the strongest parameter of RV systolic function evaluating the prognosis after PCI for acute inferior STEMI particularly in patients with preserved LV function.

Successful percutaneous coronary intervention in an anomalous origin of the right coronary artery from the ascending aorta above the left sinus of the valsalva.

The anomalous origin of the right coronary artery (RCA) is a rare condition. Most RCA anomalies are usually found incidentally, but these findings have clinical significance because many patients, particularly young ones, present with sudden death, myocardial ischemia and syncope without other symptoms. We describe a case of a 39-year-old male patient that presented with effort chest pain and was diagnosed with anomalous RCA that originated from the ascending aorta with prior history of repairing ruptured sinus valsalva and ventricular septal defect. The anomalous origin of RCA was identified by multidetector computed tomography (MDCT). Successful percutaneous coronary intervention was performed guided by MDCT coronary images and intravascular ultrasound.

A randomized comparison of sirolimus- versus paclitaxel-eluting stent implantation in patients with diabetes mellitus: 4-year clinical outcomes of DES-DIABETES (drug-eluting stent in patients with DIABETES mellitus) trial.

OBJECTIVES: We compared 4-year efficacy and safety of sirolimus-eluting stents (SES) and paclitaxel-eluting stents (PES) in patients with diabetes mellitus (DM). BACKGROUND: Four-year comparison of SES with PES in diabetic patients has not been evaluated in a randomized manner. METHODS: This prospective, multicenter, randomized study compared SES (n = 200) and PES (n = 200) implantation in diabetic patients. We evaluated 4-year major adverse cardiac events (MACE) including death, myocardial infarction (MI), and target lesion revascularization (TLR). RESULTS: The 2 groups had similar baseline characteristics. At 2 years, TLR (3.5% vs. 11.0%, log-rank, p < 0.01) and MACE (3.5% vs. 12.5%, log-rank, p < 0.01) were significantly lower in SES versus PES group with no difference of death or MI. At 4 years there were no differences in death (3.0% vs. 5.0%, p = 0.45) or MI (1.5% vs. 1.0%, p = 0.99) between SES and PES group. The TLR (7.5% vs. 12.0%, log-rank, p = 0.10) and MACE (11.0% vs. 16.0%, log-rank, p = 0.10) were statistically not different between SES and PES group. At multivariate Cox regression, post-procedural minimal lumen diameter (hazard ratio [HR]: 0.44, 95% confidence interval [CI]: 0.24 to 0.81, p < 0.01), hypercholesterolemia (HR: 2.21, 95% CI: 1.29 to 3.79, p < 0.01), and use of intravascular ultrasound (HR: 0.51, 95% CI: 0.26 to 0.99, p = 0.049) were independent predictors of 4-year MACE. CONCLUSIONS: Superiority of SES over PES during 2 years was attenuated between 2 years and 4 years in diabetic patients. Use of intravascular ultrasound and larger post-procedural minimal lumen diameter were independent predictors of the improved long-term clinical outcomes.

Long-term safety and efficacy of sirolimus- vs. paclitaxel-eluting stent implantation for acute ST-elevation myocardial infarction: 3-year follow-up of the PROSIT trial.

BACKGROUND: Meta-analysis of randomized trials showed superior efficacy and similar safety of drug-eluting stent over bare-metal stent in acute ST-elevation myocardial infarction (STEMI) patients. However, long-term relative outcomes of sirolimus- (SES) vs. paclitaxel-eluting stent (PES) have not been fully evaluated in randomized studies. This study compared long-term safety and efficacy of these two stents in STEMI. METHODS: A total of 308 STEMI patients were randomly treated with SES (n = 154) or PES (n = 154). Three-year clinical outcomes were assessed. Primary outcome of interest was incidence of major adverse cardiac events (MACE) including death, myocardial infarction (MI), stent thrombosis or target vessel revascularization (TVR). Secondary outcome of interest was occurrence of very late stent thrombosis. RESULTS: Both groups had similar baseline characteristics. During follow-up, there was no difference between the two groups in terms of death (6.5% for SES and 10.4% for PES, p = 0.22), MI (2.6% vs. 3.9%, p = 0.75), stent thrombosis (1.9% vs. 3.2%, p = 0.72), TVR (3.9% vs. 8.4%, p = 0.15) and MACE (12.3% vs. 18.8%, p = 0.12). Eight patients in overall population had stent thrombosis: definite 3, probable 1, and possible 4. Cumulative incidence of stent thrombosis was gradually increased; 0.6% at 30 days, 0.6% at 1 year, 1.6% at 2 years, and 2.6% at 3 years. Very late stent thrombosis, definite or probable, occurred in 0.6% for both. CONCLUSION: Among non-selected STEMI patients who underwent primary angioplasty, both SES and PES might be safe and SES showed similar three-year clinical outcomes compared to PES.

A successful primary percutaneous coronary intervention twelve days after a cabrol composite graft operation in marfan syndrome.

The Cabrol procedure is one of several techniques used for re-implantation of a coronary artery. After replacement of the ascending aorta and aortic valve using a composite graft, second Dacron tube grafts are used for anastomosis between the ascending aortic graft and the coronary arteries. Ostial stenosis is one of the complications associated with the Cabrol operation. However, there have been no reported cases of acute thrombosis of a Cabrol graft. Here we report a case with acute ST elevation myocardial infarction due to thrombotic total occlusion of a right Cabrol graft-to-right coronary artery (RCA) twelve days after surgery in a patient with Marfan syndrome. He was successfully treated with primary percutaneous coronary intervention (PCI).

Effect of modest alcohol consumption over 1-2 weeks on the coronary microcirculation of normal subjects.

AIMS: It has been reported that imbibing red wine increases coronary blood flow reserve acutely. In the absence of changes in coronary driving pressure, any increases in coronary blood flow reserve should occur through a decrease in capillary resistance, which in turn is determined by capillary dimensions and whole-blood viscosity. Since alcohol intake is unlikely to acutely change capillary dimensions, we hypothesized that it must increase coronary blood flow reserve by reducing whole-blood viscosity. METHODS AND RESULTS: Forty-five normal subjects were randomly assigned to water (n = 12), vodka (n = 11), white wine (n = 11), and red wine (n = 11). Myocardial blood flow reserve was measured at baseline and after up to 2 weeks of beverage consumption using myocardial contrast echocardiography. In addition, whole-blood viscosity and its principal determinants (haematocrit; erythrocyte deformability, mobility, and charge; plasma fibrinogen; and total serum protein, glucose, and lipids) were also measured. Systolic and diastolic blood pressure and heart rate did not change between the two examinations either at rest or following dipyridamole infusion. Neither did myocardial blood flow reserve nor whole-blood viscosity or any of its determinants. Only high-density lipoprotein-2 increased for all alcohol consumers (12.4 +/- 5.3 vs. 10.9 +/- 4.7, P = 0.007). CONCLUSION: It is concluded that modest alcohol consumption for up to 2 weeks does not increase myocardial blood flow reserve. It also does not alter whole-blood viscosity or any of its principal determinants. Therefore, the beneficial cardiovascular effects of modest alcohol consumption over 1-2 weeks cannot be attributed either to its effect on the coronary microcirculation or haemorheology.

Effect of Lacidipine on Blood Pressure and Endothelial Function in Mild-to-Moderate Essential Hypertension Patients With Diabetes in Korea.

BACKGROUND AND OBJECTIVES: The aim of this study was to evaluate the efficacy of lacidipine in reducing blood pressure (BP) and to determine its effect on endothelial function in mild-to-moderate hypertensive patients with type 2 diabetes mellitus (DM). SUBJECTS AND METHODS: This was a prospective, multicenter, open-label, single-arm study, enrolling 290 patients with mild-to-moderate hypertension and type 2 DM. Patients were initially treated with 2 mg lacidipine orally once daily for 4 weeks, which was then increased as necessary every 4 weeks to a maximal dose of 6 mg daily. The primary endpoint was the mean change in systolic blood pressure (SBP) from baseline after 12 weeks of treatment. Secondary endpoints included mean changes in diastolic blood pressure (DBP), flow-mediated vasodilatation (FMD), and serum concentrations of biochemical markers such as high-sensitivity C-reactive protein (hs-CRP), monocyte chemo-attractant protein-1 (MCP-1), matrix metalloproteinase-9 (MMP-9), and plasminogen activator inhibitor-1 (PAI-1). RESULTS: Lacidipine treatment significantly reduced SBP by -13.4±13.0 mmHg (p<0.001) and DBP by -6.2±9.3 mmHg (p<0.001). Lacidipine treatment did not improve endothelial-dependent vasodilatation, despite significantly improved nitroglycerin-induced, endothelial-independent vasodilatation. MCP-1 levels significantly decreased from 283.66±110.08 pg/mL to 257.83±100.23 pg/mL (p<0.001); whereas there were no significant changes in the levels of hs-CRP, MMP-9, or PAI-1. CONCLUSION: Twelve weeks of treatment with lacidipine was effective and well tolerated in mild-to-moderate hypertensive patients with type 2 DM. In spite of inducing a significant reduction in MCP-1 levels, lacidipine did not improve endothelial function.

Prospective randomized comparison of sirolimus- versus paclitaxel-eluting stents for the treatment of acute ST-elevation myocardial infarction: pROSIT trial.

OBJECTIVE: The aim of this study was to compare effectiveness of the Sirolimus- (SES) and Paclitaxel-eluting stent (PES) in primary angioplasty for acute ST-elevation myocardial infarction (STEMI). BACKGROUND: It has been reported that SES and PES have been more effective than bare-metal stents in reducing restenosis and cardiac events in a broad range of patients with coronary artery disease. However, it is unknown whether there may be differences between these two drug-eluting stents in terms of efficacy in the setting of acute STEMI. METHODS: Acute STEMI patients (n = 308) undergoing primary angioplasty were randomly assigned to SES (n = 154) or PES (n = 154) deployment. The routine angiographic follow-up was performed at 6 months and clinical follow-up data was obtained at 12 months. The primary end point was major adverse cardiac events (MACE) including death, reinfarction, stent thrombosis, and target lesion revascularization (TLR) at 12 months. RESULTS: The baseline clinical, angiographic, and procedural characteristics were similar between the 2 groups. Two patients (all from the PES group) experienced stent thrombosis (1 acute and 1 subacute). The SES group revealed lower in-segment restenosis (5.9% vs. 14.8%, P = 0.03) and in-segment late loss (0.09 +/- 0.45 vs. 0.33 +/- 0.68 mm, P = 0.002) than PES group on follow-up angiography. Twelve-month TLR rates (2.6% vs. 6.5%, P = 0.17) were similar between two groups. MACE rates were lower in the SES group than in the PES group, but it did not reach statistical significance (5.8% vs. 11.7%, P = 0.07). CONCLUSION: In the setting of primary angioplasty for STEMI, there were no statistically significant differences between the SES and the PES in terms of 12-month MACE. However, binary angiographic in-segment restenosis and in-segment late loss were significantly lower in the SES group.

Comparison of the efficacy and tolerability of pitavastatin and atorvastatin: an 8-week, multicenter, randomized, open-label, dose-titration study in Korean patients with hypercholesterolemia.

BACKGROUND: Although previous studies have examined the efficacy of pitavastatin, its tolerability and effects on lipid concentrations have not been compared with those of atorvastatin in a multicenter, randomized study. OBJECTIVE: This trial compared the efficacy and tolerability of pitavastatin and atorvastatin in hypercholesterolemic Korean adults. METHODS: This 8-week, multicenter, randomized, open-label, dose-titration study was conducted at 18 clinical centers in Korea between May 2005 and February 2006. After a 4-week dietary lead-in period, patients with hypercholesterolemia were randomized to receive either pitavastatin 2 mg/d or atorvastatin 10 mg/d. Patients who had not reached the low-density lipoprotein cholesterol (LDL-C) goal by week 4 received a double dose of the assigned medication for an additional 4 weeks. Efficacy was evaluated in terms of achievement of the National Cholesterol Education Program Adult Treatment Panel III LDL-C goals and changes from baseline in other lipids and high-sensitivity C-reactive protein (hs-CRP). The tolerability profile was assessed by physical and electro-cardiographic examinations, laboratory tests, and recording adverse reactions at all visits. RESULTS: A total of 268 patients were randomized to treatment, and 222 (82.8%) completed the study (149 women, 73 men; mean age, 59 years; mean weight, 63.5 kg). At the end of the study, there was no significant difference between the pitavastatin and atorvastatin groups in the proportion of patients achieving the LDL-C goal (92.7% [102/110] vs 92.0% [103/112], respectively). In addition, there were no significant differences between groups in terms of the percent changes from baseline in LDL-C, total cholesterol, triglycerides, high-density lipoprotein cholesterol (HDL-C), or hs-CRP. Twenty-six of 136 patients (19.1%) taking pitavastatin reported 35 treatment-emergent adverse reactions; 33 of 132 patients (25.0%) taking atorvastatin reported 39 treatment-emergent adverse reactions. Elevations in creatine kinase were observed in 6 patients (4.4%) in the pitavastatin group and 7 patients (5.3%) in the atorvastatin group. There were no serious adverse drug reactions in either group. CONCLUSIONS: In these adult Korean patients with hypercholesterolemia, pitavastatin and atorvastatin did not differ significantly in terms of the proportions of patients achieving the LDL-C goal; reductions in LDL-C, total cholesterol, and triglycerides; or increases in HDL-C. Both drugs were well tolerated.

Thiamine deficiency as a rare cause of reversible severe pulmonary hypertension.

In developed countries, the incidence of cardiac beriberi is rare. It can lead to high output cardiac failure and pulmonary hypertension. We hereby report an atypical case of beriberi heart with reversible right heart failure and severe pulmonary hypertension. Thiamine deficiency can cause reversible pulmonary hypertension, and it must be included in the differential diagnosis in patients with high risk of nutritional deficiency.

Myocardial injury occurs earlier than myocardial inflammation in acute experimental viral myocarditis.

Endomyocardial biopsy often fails to show myocardial inflammation for patients with clinically suspected myocarditis. The serum isoforms of troponin T (cTnT) level is a very sensitive marker of myocardial injury and it is elevated even in the absence of myocardial inflammation. We investigated the correlations for myocardial injury, virus titers and inflammation in acute viral infection. Using the murine coxsackievirus group B3 (CVB3) myocarditis model, the histopathologic findings and virus titers in mouse hearts were compared with the serum cTnT levels measured by ELISA at various time points. Viable virus titers in the hearts peaked at 3 days after infection (8.22 +/- 0.13 log10 PFU/100 mg of heart); they decreased at day 7 and no viable virus was detected from day 14. Myocardial inflammation was minimal at day 3, peaked at day 7 and markedly decreased at day 14. The individual serum TnT levels were significantly increased at day 3 (7.37 +/- 1.46 ng/ml), persisted to day 7 (0.73 +/- 0.08 ng/ml), and normalized at day 14. Serum cTnT levels were correlatable with virus titers in the heart (r = 0.744, P <0.01), but the serum cTnT levels were not correlated with the degrees of inflammation. Using the less myocarditic strain of CVB3, similar relationships were observed between the changes for the serum cTnT levels and the heart virus titers. During the course of viral infection, myocardial injury precedes the pathologic evidence of inflammation, and the elevated cTnT levels provide evidence of myocardial injury even in the absence of any histologic findings of myocarditis.

Clinical and angiographic follow-up after long versus short stenting in unselected chronic coronary occlusions.

BACKGROUND: Few data are available on the efficacy of long stenting for lesions in unselected chronic total occlusion (CTO). HYPOTHESIS: The study was undertaken to evaluate the angiographic restenosis and long-term clinical outcomes after long stent implantation in patients with CTO. METHODS: Our retrospective analysis includes a consecutive series of stent implantation in 220 patients with CTO. We compared angiographic restenosis, target lesion revascularization, and long-term clinical outcomes of short stenting (< 20 mm, Group 1, n = 113) with a concurrent series of long stenting (> or = 20 mm, Group 2, n = 107). RESULTS: Angiographic follow-up was obtained in 174 patients (79.5% of those eligible), and the rates of angiographic restenosis were 19.3% in Group 1 and 33.7% in Group 2 (p < 0.05). In multivariate analysis, the postinterventional minimal lumen diameter was the only independent predictor of restenosis (odds ratio = 0.20, 95% confidence interval 0.08-0.49, p < 0.01). The angiographic restenosis rate was significantly lower in Group 1 than in Group 2 in patients with final minimal lumen diameter < 3.0 mm (28.9 vs. 55.9%, respectively, p < 0.05). However, the angiographic restenosis rate was not significantly different between the two groups in patients with final minimal lumen diameter > or = 3 mm (12.0 vs. 19.2%, respectively, p = NS). During the follow-up (29.1 +/- 10.8 months), there was no difference between the two groups in death, nonfatal myocardial infarction, and target lesion revascularization. CONCLUSIONS: The use of long (> or = 20 mm) versus short (< 20 mm) stents in patients with CTO is associated with a higher angiographic restenosis rate, but there is an equivalent risk of restenosis in selected patients with relatively large-sized vessels.