Intravascular ultrasound-guided drug-coated balloon angioplasty for femoropopliteal artery disease: a clinical trial.

BACKGROUND AND AIMS: Drug-coated balloons (DCBs) have demonstrated favourable outcomes following endovascular therapy for femoropopliteal artery (FPA) disease. However, uncertainty remains whether the use of intravascular ultrasound (IVUS) can improve the outcomes of DCBs. METHODS: This prospective, multicentre, randomized trial, conducted at seven centres in South Korea, compared the outcomes of IVUS-guided vs. angiography-guided angioplasty for treating FPA disease with DCBs. Patients were assigned to receive IVUS-guided (n = 119) or angiography-guided (n = 118) angioplasty using DCBs. The primary endpoint was 12-month primary patency. RESULTS: Between May 2016 and August 2022, 237 patients were enrolled and 204 (86.0%) completed the trial (median follow-up; 363 days). The IVUS guidance group showed significantly higher primary patency [83.8% vs. 70.1%; cumulative difference 19.6% (95% confidence interval 6.8 to 32.3); P = .01] and increased freedom from clinically driven target lesion revascularization [92.4% vs. 83.0%; difference 11.6% (95% confidence interval 3.1 to 20.1); P = .02], sustained clinical improvement (89.1% vs. 76.3%, P = .01), and haemodynamic improvement (82.4% vs. 66.9%, P = .01) at 12 months compared with the angiography guidance group. The IVUS group utilized larger balloon diameters and pressures for pre-dilation, more frequent post-dilation, and higher pressures for post-dilation, resulting in a greater post-procedural minimum lumen diameter (3.90 ± 0.59 vs. 3.71 ± 0.73 mm, P = .03). CONCLUSIONS: Intravascular ultrasound guidance significantly improved the outcomes of DCBs for FPA disease in terms of primary patency, freedom from clinically driven target lesion revascularization, and sustained clinical and haemodynamic improvement at 12 months. These benefits may be attributed to IVUS-guided optimization of the lesion before and after DCB treatment.

Predictors for early cardiac death after discharge from successfully treated acute myocardial infarction.

Background: The use of a cardioverter defibrillator for the primary prevention of sudden cardiac death is not recommended within 40 days after acute myocardial infarction (AMI). We investigated the predictors for early cardiac death among patients who were admitted for AMI and successfully discharged. Methods: Consecutive patients with AMI were enrolled in a multicenter prospective registry. Among 10,719 patients with AMI, 554 patients with in-hospital death and 62 patients with early non-cardiac death were excluded. Early cardiac death was defined as a cardiac death within 90 days after index AMI. Results: Early cardiac death after discharge occurred in 168/10,103 (1.7%) patients. A defibrillator was not implanted in all patients with early cardiac death. Killip class ≥3, chronic kidney disease stage ≥4, severe anemia, cardiopulmonary support usage, no dual antiplatelet therapy at discharge, and left ventricular ejection fraction (LVEF) ≤35% were independent predictors for early cardiac death. The incidence of early cardiac death according to the number of factors added to LVEF criteria in each patient was 3.03% for 0 factor, 8.11% for 1 factor, and 9.16% for ≥2 factors. Each model that sequentially added the factors in the presence of LVEF criteria showed a significant gradual increase in predictive accuracy and an improvement in reclassification capability. A model with all factors showed C-index 0.742 [95% CI 0.702-0.781], p < 0.001; IDI 0.024 [95% CI 0.015-0.033], p < 0.001; and NRI 0.644 [95% CI 0.492-0.795], p < 0.001. Conclusion: We identified six predictors for early cardiac death after discharge from AMI. These predictors would help to discriminate high-risk patients over current LVEF criteria and to provide an individualized therapeutic approach in the subacute stage of AMI.

Association of Glycosylated Hemoglobin with Long-Term Adverse Cardiac Events after Percutaneous Coronary Intervention in Non Diabetes and Controlled Diabetes Patients: An Observational Study from the Korean COACT Registry.

Glycosylated hemoglobin (HbA1c) is an established marker associated with cardiovascular risk, even if it is below the diagnostic threshold for diabetes mellitus (DM). However, whether or not prediabetic and controlled diabetic levels of HbA1c are associated with increased major adverse cardiovascular events (MACE) after percutaneous coronary intervention (PCI) remains unclear. This observational study included a total of 9128 patients who underwent PCI in the COACT registry from eight centers in Korea. A total of 2517 non-DM patients were divided into three groups (Groups I, II, III) according to their HbA1c levels and compared with 965 controlled DM patients (HbA1c < 7.0%, Group IV). During 22 months of median follow-up, there was no significant differences in MACE (p = 0.294) and cardiac death (p = 0.105) among the four groups. In addition, there were also no significant differences in MACE (p = 0.058) between Group III and Group IV. Although patients were diagnosed as DM, they had a similar prognosis in the same range of newly diagnosed DM patients in HbA1c, if they were treated well. The results of this study suggest that intensive treatment is required to reach the Hba1c target in diabetic patients with PCI in order to have a similar prognosis to patients not previously diagnosed with diabetes.

Case Report: Novel Likely Pathogenic ACTN2 Variant Causing Heterogeneous Phenotype in a Korean Family With Left Ventricular Non-compaction.

Left ventricular non-compaction (LVNC) is a very rare primary cardiomyopathy with a genetic etiology, resulting from the failure of myocardial development during embryogenesis, and it carries a high risk of left ventricular dysfunction, thromboembolic phenomenon, and malignant arrhythmias. Here, we report the first case of familial LVNC in Korea, caused by a novel ACTN2 missense variant. We performed duo exome sequencing (ES) to examine the genome of the proband and his father. A 15-year-old boy was admitted for the evaluation of exertional dyspnea for 2 weeks. He was diagnosed with LVNC with a dilated cardiomyopathy phenotype [left ventricular end-diastolic dimension 60 mm, interventricular septal dimension 8.2 mm by transthoracic echocardiography (TTE)]. For the screening of familial cardiomyopathy, TTE and cardiac magnetic resonance imaging (cMRI) were performed, which revealed hypertrophic and isolated LVNC in the proband's father and sister, respectively. In particular, the cMRI revealed dense hypertrabeculation with focal aneurysmal changes in the apical septal wall in the proband's father. ES of the father-son duo identified a novel heterozygous c.668T>C variant of the ACTN2 gene (NM_001103.3:c.668T>C, p.Leu223Pro; no rsID) as the candidate cause of autosomal dominant LVNC. Sanger sequencing confirmed this novel variant in the proband, his father, and sister, but not in the proband's grandmother. Even within families harboring the same variant, a variable risk of adverse outcomes is common. Therefore, familial screening for patients with LVNC associated with ACTN2 variant should be performed for early detection of the LVNC phenotype associated with poor outcomes, such as dilated LVNC.

Comparative effectiveness analysis of percutaneous coronary intervention versus coronary artery bypass grafting in patients with chronic kidney disease and unprotected left main coronary artery disease.

AIMS: Outcomes according to the status of renal insufficiency have not been fully evaluated in left main coronary artery disease (LMCAD). In the present study therefore, we sought to evaluate clinical outcomes in patients with significant LMCAD stratified by the degree of renal insufficiency and the relative clinical outcomes after PCI and CABG stratified by the differential levels of renal function using data from the large multinational "all-comers" Interventional Research Incorporation Society-Left MAIN Revascularization (IRIS-MAIN) registry. METHODS AND RESULTS: Among 4,894 patients with LMCAD, renal insufficiency was graded according to the estimated glomerular filtration rate (eGFR). The primary outcome was major adverse cardiac and cerebrovascular events (MACCE), defined as death, myocardial infarction, stroke, or any revascularisation. The patients were stratified into three groups according to eGFR: 3,824 (78%) in group 1 (eGFR ≥60 ml·min-1·1.73 m2), 838 (17%) in group 2 (eGFR ≥30 and <60), and 232 (5%) in group 3 (eGFR <30). At two years, after adjustment, compared with group 1, the risk of MACCE was significantly higher in group 2 (hazard ratio [HR] 1.46, 95% confidence interval [CI]: 1.18-1.79) and in group 3 (HR 3.39, 95% CI: 2.61-4.40). The p interaction for MACCE across groups was 0.20. The adjusted risk of MACCE was similar between percutaneous coronary intervention (PCI) and coronary artery bypass grafting (CABG) in groups 1 and 2. However, PCI was associated with a significantly higher risk of MACCE compared to CABG (HR 1.88, 95% CI: 1.08-3.25) in group 3. CONCLUSIONS: The degree of renal insufficiency was proportionately associated with unfavourable outcomes in patients with LMCAD. In group 3, PCI was associated with a higher risk of MACCE compared with CABG. Also, the effect of PCI versus CABG on MACCE was consistent, with PCI being associated with less bleeding and CABG being associated with less repeat revascularisation.

Correlation between internal pudendal artery stenosis and erectile dysfunction in patients with suspected coronary artery disease.

BACKGROUND: Stenoses of internal pudendal arteries (IPAs) appear to be related to erectile dysfunction (ED). Nevertheless, the correlation between the severity of ED and stenosis of the IPAs is not well established. OBJECTIVES: To evaluate angiographic findings of IPAs in patients with suspected coronary artery disease (CAD) and to assess the correlation between the severity of ED and IPA stenosis. MATERIALS AND METHODS: Ninety-one patients who were scheduled for cardiac angiogram (CAG) because of suspected CAD participated. ED was assessed using the International Index of Erectile Function (IIEF) questionnaire. Erectile function (EF) domain scoring was used to assess the severity of ED: severe (EF score = 1-10); moderate (11-16); mild-moderate (17-21); mild (22-25); and no ED (26-30). Angiography was performed in bilateral common, internal iliac, and IPAs and the location and extent of stenoses were measured. We divided patients according to those with maximum stenosis of less than 50% (Group I) and those with more than 50% (Group II), regardless of direction. RESULTS: We diagnosed 88 patients (88/91, 96.70%) with ED. There was no correlation between increasing age and severity of ED (r = - 0.063, p = 0.555). There were 72 patients in Group I and 19 in Group II. In Group I, 62 patients were diagnosed with ED even though there was no stenosis. There was no significant correlation between the severity of ED and the extent of stenosis in IPAs (r = -0.118, p = 0.265). CONCLUSIONS: There was no significant correlation between the severity of ED and the extent of stenosis of IPAs. We believe that this is because the progression of ED is induced by endothelial cell dysfunction, not by mechanical obstruction leading to blood flow reduction.

Association between body mass index and 1-year outcome after acute myocardial infarction.

OBJECTIVES: Beneficial effects of overweight and obesity on mortality after acute myocardial infarction (AMI) have been described as "Body Mass Index (BMI) paradox". However, the effects of BMI is still on debate. We analyzed the association between BMI and 1-year clinical outcomes after AMI. METHODS: Among 13,104 AMI patients registered in Korea Acute Myocardial Infarction Registry-National Institute of Health (KAMIR-NIH) between November 2011 and December 2015, 10,568 patients who eligible for this study were classified into 3 groups according to BMI (Group 1; < 22 kg/m2, 22 ≤ Group 2 < 26 kg/m2, Group 3; ≥ 26 kg/m2). The primary end point was all cause death at 1 year. RESULTS: Over the median follow-up of 12 months, the event of primary end point occurred more frequently in the Group 1 patients than in the Group 3 patients (primary endpoint: adjusted hazard ratio [aHR], 1.537; 95% confidence interval [CI] 1.177 to 2.007, p = 0.002). Especially, cardiac death played a major role in this effect (aHR, 1.548; 95% confidence interval [CI] 1.128 to 2.124, p = 0.007). CONCLUSIONS: Higher BMI appeared to be good prognostic factor on 1-year all cause death after AMI. This result suggests that higher BMI or obesity might confer a protective advantage over the life-quality after AMI.

Incremental age-related one-year MACCE after acute myocardial infarction in the drug-eluting stent era (from KAMIR-NIH registry).

OBJECTIVES: To evaluate the age-related one-year major adverse cardiocerebrovascular events (MACCE) after percutaneous coronary intervention (PCI) in acute myocardial infarction (AMI). We analyzed the association between age and one-year MACCE after AMI. METHODS: A total of 13,104 AMI patients from Korea Acute Myocardial Infarction Registry-National Institue of Health (KAMIR-NIH) between November 2011 and December 2015 were classified into four groups according to age (Group I, < 60 years, n = 4199; Group II, 60-70 years, n = 2577; Group III; 70-80 years, n = 2774; Group IV, ≥ 80 years, n = 1018). Patients were analyzed for one-year composite of MACCE (cardiac death, myocardial infarction, target vessel revascularization, cerebrovascular events) after AMI. RESULTS: The one-year MACCE in AMI were 3.5% (Group I), 6.3% (Group II), 9.6% (Group III) and 17.6% (Group IV). After adjustment for confounding parameters, the analysis results showed that patients with AMI had incremental risk of one-year MACCE [Group II, adjusted hazard ratios (aHR) = 1.224, 95% CI: 0.965-1.525, P = 0.096; Group III, aHR = 1.316, 95% CI: 1.037-1.671, P = 0.024; Group IV, aHR = 1.975, 95% CI: 1.500-62.601, P < 0.001) compared to Group I. Especially, cardiac death in the composite of primary end point played a major role in this effect (Group II, aHR = 1.335, 95% CI: 0.941-1.895, P = 0.106; Group III, aHR = 1.575, 95% CI: 1.122-2.210, P = 0.009; Group IV, aHR = 2.803, 95% CI: 1.937-4.054, P < 0.001). CONCLUSIONS: Despite advanced techniques and medications for PCI in AMI, age still exerts a powerful influence in clinical outcomes. Careful approaches, even in the modern era of developed cardiology are needed for aged-population in AMI intervention.

Renin-angiotensin system blockade reduces cardiovascular events in nonheart failure, stable patients with prior coronary intervention.

BACKGROUND: The effects of renin-angiotensin system (RAS) blockade on the clinical outcome in patients with stable coronary artery disease (SCAD) are conflicting. We evaluated the long-term effects of RAS blockers (angiotensin-converting enzyme inhibitor or angiotensin receptor blocker) on the clinical outcomes in patients with SCAD without heart failure (HF) who underwent percutaneous coronary intervention (PCI) with drug-eluting stent using a large-scale, multicenter, prospective cohort registry. METHODS: A total of 5722 patients with SCAD were enrolled and divided into two groups according to the use of RAS blockers after PCI: RAS blocker group included 4070 patients and no RAS blocker group included 1652 patients. Exclusion criteria were left ventricular ejection fraction less than 50% and the history of HF or myocardial infarction. A major adverse cardiovascular event (MACE) was defined as a composite of cardiovascular death, nonfatal myocardial infarction, and stroke. RESULTS: During a median follow-up of 29.7 months, RAS blockers were associated with a significant reduction in the risk of MACE [adjusted hazard ratio (HR): 0.781; 95% confidence interval (CI): 0.626-0.975; P=0.015] and all-cause death (adjusted HR: 0.788; 95% CI: 0.627-0.990; P=0.041) but did not affect the risk of coronary revascularization. In the propensity score matched cohort, overall findings were consistent (MACE: adjusted HR: 0.679; 95% CI: 0.514-0.897; P=0.006; all-cause death: adjusted HR: 0.723; 95% CI: 0.548-0.954; P=0.022), and the benefit of RAS blockade was maintained in all predefined subgroups. CONCLUSION: This study demonstrated that RAS blockers were effective preventive therapies for reducing long-term cardiovascular events in patients with SCAD without HF who underwent PCI.

Clinical implications of combined glucose intolerance in treatment-naïve hypertensive patients.

BACKGROUND: This study is the first study to evaluate clinical significance of combined glucose intolerance (CGI) in treatment-naïve hypertensive patients. METHODS: We compared the results of demographic, anthropometric, clinical, laboratory examinations, echocardiography, arterial stiffness, central blood pressure (BP) and ambulatory BP monitoring (ABPM) between the groups according to fasting blood sugar (FBS), postprandial 2 hour blood glucose (PP2) and gender in treatment-naïve hypertensive patients. A total of 376 concecutively-eligible patients were categorized as follows: (1) normal glucose tolerance (NGT); FBS<100 mg/dL and PP2 < 140 (2) isolated glucose intolerance (IGI); 100≤FBS<126 or 140≤PP2 < 200, but not both 100≤FBS<126 and 140≤PP2 < 200 (3) CGI; both 100≤FBS<126 and 140≤PP2 < 200. RESULTS: Males were divided into NGT (n = 58, 33.1%), IGI (n = 88, 50.3%), CGI (n = 29, 16.6%) and females were divided into NGT (n = 59, 43.1%), IGI (n = 48, 35%), CGI (n = 30, 21.9%). In males multivariate analyses revealed that mitral average E/Ea (IGI vs CGI, p = 0.022), brachial-ankle pulse wave velocity baPWV(Rt.) (IGI vs CGI, p = 0.026), baPWV(Lt.) (IGI vs CGI, p = 0.018), office systolic BP (SBP) (NGT vs. CGI, p = 0.005; IGI vs. CGI, p = 0.001), office diastolic BP (DBP) (NGT vs. CGI, p = 0.034; IGI vs. CGI, p = 0.019), night-time SBP (NGT vs. CGI, p = 0.049; IGI vs. CGI, p = 0.018) were significantly higher in the CGI group than in the NGT or IGI group. However, there were no significant differences between the female groups. CONCLUSIONS: Treatment-naïve hypertensive males with CGI revealed subclinical diastolic dysfunction, arterial stiffness, and BPs.

Computed Tomography Angiography Images of Coronary Artery Stenosis Provide a Better Prediction of Risk Than Traditional Risk Factors in Asymptomatic Individuals With Type 2 Diabetes: A Long-term Study of Clinical Outcomes.

OBJECTIVE: We investigated the efficacy of coronary computed tomography angiography (CCTA) in predicting the long-term risks in asymptomatic patients with type 2 diabetes and compared it with traditional risk factors. RESEARCH DESIGN AND METHODS: We analyzed 933 patients with asymptomatic type 2 diabetes who underwent CCTA. Stenosis was considered obstructive (≥50%) in each coronary artery segment using CCTA. The extent and severity scores for coronary artery disease (CAD) were evaluated. The primary end point was major adverse cardiovascular events (MACE), including all-cause mortality, nonfatal myocardial infarction, and late coronary revascularization during a mean follow-up period of 5.5 ± 2.1 years. RESULTS: Ninety-four patients with MACE exhibited obstructive CAD with a greater extent and higher severity scores (P < 0.001 for all). After adjusting for confounding risk factors, obstructive CAD remained an independent predictor of MACE (hazard ratio 3.11 [95% CI 2.00-4.86]; P < 0.001]). The performance of a risk prediction model based on C-statistics was significantly improved (C-index 0.788 [95% CI 0.747-0.829]; P = 0.0349) upon the addition of a finding of obstructive CAD using CCTA to traditional risk factors, including age, male, hypertension, hyperlipidemia, smoking, estimated glomerular filtration rate, and HbA1c. Both integrated discrimination improvement (IDI) and net reclassification improvement (NRI) analyses further supported this finding (IDI 0.046 [95% CI 0.020-0.072], P < 0.001, and NRI 0.55 [95% CI 0.343-0.757], P < 0.001). In contrast, the risk prediction power of the coronary artery calcium score remained unimproved (C-index 0.740, P = 0.547). CONCLUSIONS: Based on our data, the addition of CCTA-detected obstructive CAD to models that include traditional risk factors improves the predictions of MACE in asymptomatic patients with type 2 diabetes.

Prognostic importance of mitral regurgitation complicated by acute myocardial infarction during a 5-year follow-up period in the drug-eluting stent era.

BACKGROUND: Mitral regurgitation (MR) is a frequent complication of left-ventricular dysfunction, with an incidence ranging from 13 to 59% after acute myocardial infarction (AMI), which is associated with poor clinical outcome. The aim of this study was to assess the clinical and angiographic characteristics associated with MR, the incidence and predictors of MR, and the outcomes of MR after AMI in those who were successfully treated with primary percutaneous coronary intervention (PCI) using a drug-eluting stent. METHODS: We analyzed a multicenter all-comer AMI registry and identified 4748 patients between January 2004 and December 2009. Of these, 1894 patients were treated with PCI using a drug-eluting stent and had MR. The association between MR and the composite of major adverse cardiac and cerebrovascular events (MACCE; all-cause death, recurrent nonfatal myocardial infarction, stroke, and any revascularization) was examined. RESULTS: Patients with MR after the index PCI showed significantly higher cumulative incidence of MACCE compared with no-MR patients over the 5-year survival period (P=0.002). When the MR groups were compared on the basis of the severity of MR, ranging from mild to severe grades, a higher grade of MR was found to be associated with a higher incidence of MACCE (P<0.001). Multivariate Cox proportional hazard analysis revealed that no reflow, left-ventricular ejection fraction less than 50%, and anemia, in addition to MR, were consistently associated with increased all-cause death during the 5-year period (adjusted hazard ratio 1.408, 95% confidence interval 1.052-1.884, P=0.021). CONCLUSION: MR after AMI in patients successfully treated with primary PCI was associated with poor long-term outcome regardless of ST-segment elevation at diagnosis during the drug-eluting stent era.

A case of anorexia nervosa complicated with strongly suspected stress-induced cardiomyopathy and mural thrombus.

Stress-induced cardiomyopathy is a unique reversible cardiovascular disease precipitated by acute emotional or physical stress. It is associated with a high prevalence of chronic anxiety disorder that precedes the onset of cardiomyopathy, as well as comorbid cardiovascular risk factors that are similar to the ST segment elevation of myocardial infarction. A thirty-five-year-old woman suffering from anorexia nervosa visited our hospital complaining of severe general weakness. She was diagnosed with stress-induced cardiomyopathy and mural thrombus using a transthoracic echocardiogram. Therefore, she was given anticoagulation therapy and nutrition with immediate psychiatric interventions. After two weeks of treatment, the follow-up echocardiogram indicated a significant improvement of the left ventricular dysfunction and mural thrombus.