Clinical safety and effectiveness of the Genoss drug-eluting stent in real-world clinical practice

Background/Aims@#The Genoss DES™ is a novel, biodegradable, polymer-coated, sirolimus-eluting stent with a cobalt- chromium stent platform and thin strut. Although the safety and effectiveness of this stent have been previously investigated, real-world clinical outcomes data are lacking. Therefore, the aim of this prospective, multicenter trial was to evaluate the clinical safety and effectiveness of the Genoss DES™ in all-comer patients undergoing percutaneous coronary intervention. @*Methods@#The Genoss DES registry is a prospective, single-arm, observational trial for evaluation of clinical outcomes after Genoss DES™ implantation in all-comer patients undergoing percutaneous coronary intervention from 17 sites in South Korea. The primary endpoint was a device-oriented composite outcome of cardiac death, target vessel-related myocardial infarction (MI), and clinically driven target lesion revascularization (TLR) at 12 months. @*Results@#A total of 1,999 patients (66.4 ± 11.1 years of age; 72.8% male) were analyzed. At baseline, 62.8% and 36.7% of patients had hypertension and diabetes, respectively. The implanted stent number, diameter, and length per patient were 1.5 ± 0.8, 3.1 ± 0.5 mm, and 37.0 ± 25.0 mm, respectively. The primary endpoint occurred in 1.8% patients, with a cardiac death rate of 1.1%, target vessel-related MI rate of 0.2%, and clinically driven TLR rate of 0.8%. @*Conclusions@#In this real-world registry, the Genoss DES™ demonstrated excellent safety and effectiveness at 12 months among all-comer patients undergoing percutaneous coronary intervention. These findings suggest that the Genoss DES™ may be a viable treatment option for patients with coronary artery disease.

Lipid-Lowering Efficacy of Combination Therapy With ModerateIntensity Statin and Ezetimibe Versus High-Intensity Statin Monotherapy:A Randomized, Open-Label, NonInferiority Trial From Korea

Objective@#This phase IV, multicenter, randomized controlled, open-label, and parallel clinical trial aimed to compare the efficacy and safety of ezetimibe and moderate intensity rosuvastatin combination therapy to that of high intensity rosuvastatin monotherapy in patients with atherosclerotic cardiovascular disease (ASCVD). @*Methods@#This study enrolled patients with ASCVD and after a four-week screening period, patients were randomly assigned to receive either rosuvastatin and ezetimibe (RE 10/10 group) or high-intensity rosuvastatin (R20 group) only in a 1:1 ratio. The primary outcome was the difference in the percent change in the mean low-density lipoprotein cholesterol (LDL-C) level from baseline to 12 weeks between two groups after treatment. @*Results@#The study found that after 12 and 24 weeks of treatment, the RE10/10 group had a greater reduction in LDL-C level compared to the R20 group (−22.9±2.6% vs. −15.6 ± 2.5% [p=0.041] and −24.2±2.5% vs. −12.9±2.4% [p=0.001] at 12 and 24 weeks, respectively). Moreover, a greater number of patients achieved the target LDL-C level of ≤70 mg/dL after the treatment period in the combination group (74.6% vs. 59.9% [p=0.012] and 76.2% vs. 50.8% [p<0.001] at 12 and 24 weeks, respectively). Importantly, there were no significant differences in the occurrence of overall adverse events and adverse drug reactions between two groups. @*Conclusion@#Moderate-intensity rosuvastatin and ezetimibe combination therapy had better efficacy in lowering LDL-C levels without increasing adverse effects in patients with ASCVD than high-intensity rosuvastatin monotherapy.

Safety and Efficacy of a New Ultrathin Sirolimus-Eluting Stent with Abluminal Biodegradable Polymer in Real-World Practice

BACKGROUND AND OBJECTIVES@#Recently, Genoss drug-eluting stent (DES)™ stent comprising cobalt-chromium platform with an ultrathin strut thickness, sirolimus, and an abluminal biodegradable polymer was developed. Owing to the lack of substantial evidence for the safety and efficacy of this stent, we report 12-month results of the Genoss DES™ stent.@*METHODS@#We analyzed subjects who were eligible for a 12-month follow-up from the ongoing Genoss DES™ registry, which is a prospective, single-arm, observational, multicenter trial to investigate the clinical outcomes after the successful Genoss DES™ stent implantation among all-comers. The primary endpoint was a device-oriented composite outcome, defined as cardiac death, target vessel-related myocardial infarction, and target lesion revascularization at 12-month follow-up.@*RESULTS@#Among 622 subjects, the mean age of subjects was 66.5±10.4 years, 70.6% were males, 67.5% had hypertension, and 38.3% had diabetes. The implanted stent number, diameter, and length per patient were 1.5±0.8, 3.1±0.4 mm, and 36.0±23.3 mm, respectively. At 12-month clinical follow-up, the primary endpoint occurred only in 4 (0.6%) subjects.@*CONCLUSIONS@#The novel Genoss DES™ stent exhibited excellent safety and efficacy in real-world practice.

Safety and Efficacy of a New Ultrathin Sirolimus-Eluting Stent with Abluminal Biodegradable Polymer in Real-World Practice

BACKGROUND AND OBJECTIVES: Recently, Genoss drug-eluting stent (DES)™ stent comprising cobalt-chromium platform with an ultrathin strut thickness, sirolimus, and an abluminal biodegradable polymer was developed. Owing to the lack of substantial evidence for the safety and efficacy of this stent, we report 12-month results of the Genoss DES™ stent.METHODS: We analyzed subjects who were eligible for a 12-month follow-up from the ongoing Genoss DES™ registry, which is a prospective, single-arm, observational, multicenter trial to investigate the clinical outcomes after the successful Genoss DES™ stent implantation among all-comers. The primary endpoint was a device-oriented composite outcome, defined as cardiac death, target vessel-related myocardial infarction, and target lesion revascularization at 12-month follow-up.RESULTS: Among 622 subjects, the mean age of subjects was 66.5±10.4 years, 70.6% were males, 67.5% had hypertension, and 38.3% had diabetes. The implanted stent number, diameter, and length per patient were 1.5±0.8, 3.1±0.4 mm, and 36.0±23.3 mm, respectively. At 12-month clinical follow-up, the primary endpoint occurred only in 4 (0.6%) subjects.CONCLUSIONS: The novel Genoss DES™ stent exhibited excellent safety and efficacy in real-world practice.

The Role of Preoperative NT-proBNP in Elderly Orthopedic Patients with Normal Left Ventricular Systolic Function / 대한내과학회지

BACKGROUND/AIMS: Preoperative N-terminal pro-brain natriuretic peptide (NT-proBNP) is a useful predictor of postoperative cardiovascular complications. The present study investigated whether blood NT-proBNP values are suitable for predicting postoperative cardiovascular complications after non-cardiac surgery in elderly patients showing normal left ventricular (LV) function on preoperative echocardiograms. METHODS: This study was performed by analyzing the medical records of elderly patients referred to the cardiology department for the purpose of assessing their cardiac function before orthopedic surgery. Of the patients who underwent echocardiography and NT-proBNP assessment simultaneously, 275 patients aged > or = 70 years and with an LV ejection fraction of > or = 55% were included in the study. RESULTS: Major adverse cardiac and cerebrovascular events (MACCEs) occurred in 33 (12%) of the 275 patients, and the NT-proBNP concentration was higher in patients with complications than in those without complications (1,904.20 +/- 2,300.23 vs. 530.58 +/- 882.27 pg/mL, p 80 years (odds ratio, 2.313; p = 0.047) and an increased blood NT-proBNP concentration (odds ratio, 3.189; p = 0.009) were independent risk factors for the prediction of MACCEs. CONCLUSIONS: Although elderly patients scheduled to undergo non-cardiac surgery may show normal LV systolic function on echocardiography, measurement of their preoperative blood NT-proBNP concentration is useful for predicting MACCEs occurring after non-cardiac surgery.

Complete Revascularization of Juxtarenal Aortic Occlusion by Endovascular Treatment and Adjunctive Anticoagulation / 대한내과학회지

Chronic atherosclerotic occlusion of the abdominal aorta is a rare disease in clinical practice. In this disease, juxtarenal aortic occlusion is defined as the condition extended, adjacent to the renal arteries. The treatment of juxtarenal aortic occlusion is more difficult than a 'simple' abdominal aortic occlusion. Vascular surgery of a juxtarenal aortic occlusion-specifically aortic endarterectomy and bypass grafting-is a challenging procedure that almost invariably requires aortic cross-clamping above the level of the renal arteries, and may be associated with significant morbidity and mortality. With the advent of endovascular treatment, percutaneous transluminal angioplasty and stent implantation have been used increasingly as an alternative to conventional surgery in the management of patients with aortoiliac disease. However, endovascular treatment for juxtarenal aortic occlusion is not common and, also, special attention is needed with regard to possible renal complications. Here, we report the successful revascularization of a case of chronic juxtarenal aortic occlusion with endovascular treatment and adjunctive anticoagulation.

Myocardial Ischemia Caused by Paroxysmal Supraventricular Tachycardia in a Patient with Anomalous Origin of Right Coronary Artery Arising from Left Sinus of Valsalva

Anomalous origin of a coronary artery is rare and does not generally lead to myocardial infarction and paroxysmal supraventricular tachycardia (PSVT). We report an uncommon case of anomalous origin of the right coronary artery (RCA) originating from the left sinus of Valsalva with PSVT and myocardial ischemia. A 58-year-old man presented with PSVT. After arrhythmia subsided, electrocardiogram showed ST and T wave abnormalities, and transient cardiac enzymes were found to be elevated. Coronary CT angiography confirmed that there was anomalous origin of the RCA originating from the left sinus of Valsalva and no intracoronary stenotic lesion. He was managed with conservative treatment, having no symptoms on clinical follow-up for 4 years.

Myocardial Ischemia Caused by Paroxysmal Supraventricular Tachycardia in a Patient with Anomalous Origin of Right Coronary Artery Arising from Left Sinus of Valsalva

Anomalous origin of a coronary artery is rare and does not generally lead to myocardial infarction and paroxysmal supraventricular tachycardia (PSVT). We report an uncommon case of anomalous origin of the right coronary artery (RCA) originating from the left sinus of Valsalva with PSVT and myocardial ischemia. A 58-year-old man presented with PSVT. After arrhythmia subsided, electrocardiogram showed ST and T wave abnormalities, and transient cardiac enzymes were found to be elevated. Coronary CT angiography confirmed that there was anomalous origin of the RCA originating from the left sinus of Valsalva and no intracoronary stenotic lesion. He was managed with conservative treatment, having no symptoms on clinical follow-up for 4 years.

Fatal Delayed Coronary Artery Perforation After Coronary Stent Implantation

Most type I and II perforations are predominately caused by hydrophilic and stiff wires, often presented in the delayed form, and do not require pericardial drainage or surgical interventions. However, we report a type III delayed coronary artery perforation at the site of stent implantation after intervention without any evidence of immediate perforations. To the best of our knowledge, this is the first case report of angiographic documentation and treatment of delayed coronary perforation at the site of stent, presented as a cardiac arrest.

Pulmonary tumor thrombotic microangiopathy in a patient with breast cancer / 대한내과학회지

Pulmonary tumor thrombotic microangiopathy (PTTM) is a rare malignancy-related complication causing severe pulmonary hypertension, right heart failure, and death. PTTM is characterized by diffuse fibrocellular intimal proliferation and multiple thrombi formation in the pulmonary arteries and arterioles, which result from invasion of the pulmonary blood vessels by tumor cells. Establishing the diagnosis of PTTM is very difficult and few cases are diagnosed ante mortem. We report the case of a 48-year-old woman diagnosed with PTTM before death who developed breast cancer and presented with persistent dyspnea on exertion.

A Case of Coronary Artery Aneurysm after Sirolimus-Eluting Stent Implantation

This report describes the case of a 26-year-old male diagnosed with angina on exertion. A diagnostic coronary angiography revealed significant luminal narrowing at the middle third of the left anterior descending artery and proximal circumflex artery. The patient underwent implantation of sirolimus-eluting stents. Eight months after implantation of the stents, a follow-up coronary angiography showed intrastent coronary artery aneurysms. We suggest that the implantation of the sirolimus-eluting stent caused late formation of a coronary artery aneurysm.

Analysis of Korean Carotid Intima-Media Thickness in Korean Healthy Subjects and Patients with Risk Factors: Korea Multi-Center Epidemiological Study

BACKGROUND AND OBJECTIVES: We performed this study to evaluate the common carotid artery intima-media thickness (CCA IMT), and its correlation with several clinical variables, including the 10 year coronary heart disease (10 Yr CHD) risk in both healthy and hyperlipidemic hypertensive (HH) Koreans. SUBJECTS AND METHODS: This was a multi-centered prospective epidemiological study. The study population consisted of 227 healthy subjects without risk factors, with the exception of age (mean 49 years old, 114 males), and 243 HH subjects (mean 51 years old, 120 males). The carotid IMT and presence of plaques were semi automatically measured in both carotid arteries at a central reading facility. RESULTS: Linear regression analysis of all the subjects revealed that the independent factors of both CCA IMT were age, pulse pressure (PP) and HDL-cholesterol, and that of the right CCA IMT were sex and 10 Yr CHD risk. In healthy subjects, the independent factor of both CCA IMTs was age, and that of the right CCA IMT was body weight. In the HH subjects, age, sex, total cholesterol, HDL-cholesterol and PP were independent factors of both CCA IMTs, but 10 Yr CHD risk was an independent factor of only the right CCA IMT. Carotid plaques were seen in 17% of the healthy subjects and 35% of the HH subjects. An ROC curve analysis showed a right CCA IMT of 0.646 mm and left CCA IMT of 0.656 mm demonstrated 60% sensitivity and specificity in differentiating healthy from HH subjects. CONCLUSION: This result reliably demonstrates the Korean CCA IMT, as well as several other significant pieces of information.

A Case of IgA Nephropathy Associated with LV Thrombus and Cerebral Infarction / 대한신장학회잡지

Thrombosis is one of the important complications in nephrotic syndrome and related to the hypercoagulable state of the nephrotic syndrome, although the exact mechanism is under the debate. While venous trombosis is frequently encountered, arterial thrombosis is rare. Renal vein thrombosis occurs frequently in the patients with nephrotic syndrome due to membranous glomerulonephritis (MGN), membranoproliferative glomerulonephritis (MPGN). It, however, rarely happens in IgA nephropathy. Intracardiac thrombus in the nephrotic syndrome have been described few in the earlier literatures. We reported a case of IgA nephropathy with LV thrombus and cerebral infarction that has been treated successfully with thrombolytic theraphy. So far, the patient on the outpatient clinics have reported no specific complaints.

Feasibility Study of the Real-Time IMRT Dosimetry Using a Scintillation Screen / 대한방사선종양학회지

PURPOSE: To study the feasibility of verifying real-time 2-D dose distribution measurement system with the scintillation screen for the quality assurance. MATERIALS AND METHODS: The water phantom consisted of a scintillation screen (LANEX fast screen, Kodak, USA) that was axially located in the middle of an acrylic cylinder with a diameter of 25 cm. The charge-coupled device (CCD) camera was attached to the phantom in order to capture the visible light from the scintillation screen. To observe the dose distribution in real time, the intensity of the light from the scintillator was converted to a dosage. The isodose contours of the calculations from RTP and those of the measurements using the scintillation screen were compared for the arc therapy and the intensity modulated radiation therapy (IMRT). RESULTS: The kernel, expressed as a multiplication of two error functions, was obtained in order to correct the sensitivity of the CCD of the camera and the scintillation screen. When comparing the calculated isodose and measured isodose, a discrepancy of less than 8 mm in the high dose region was observed. CONCLUSIONS: Using the 2-D dosimetry system, the relationship between the light and the dosage could be found, and real-time verification of the dose distribution was feasible.

A Case of Primary Pulmonary Hypertension Diagnosed in Puerperium

Primary pulmonary hypertension is a condition characterized by sustained elevations of pulmonary artery pressure without demonstrable cause. It is incurable and progressive clinical entity. The incidence has been estimated at approximately 1 to 2 cases per million people in the general population. The maternal mortality of primary pulonary hypertension in pregnancy was said to be 30% and the first month after delivery represents the period of highest risk. We experienced a 27-year-old women with primary pulmonary hypertension diagnosed in postpartum period. She was transferred from the department of obstetrics to internal medicine due to dyspnea on the first day of postpartum. She was diagnosed by perfusion lung scan, chest CT and confirmed by echocardiography. This diagnosis were supported by findings of pulmonary angiogram and cardiac catheterization. Initially she was treated with diuretics, aspirin and anticoagulant therapy, and as a result of the treatment, her symptoms improved. However after 8months has elapsed, exertional dyspnea was worsening. Thus she was treated with calcium channel blocker, aspirin and diuretics and was followed at 1 month interval on the outpatient clinics.

Comparative Analysis of Cerebral Infarction patients treated with Western and Oriental Therapies; a Proposition for a Western-Oriental Cooperative Therapeutic Standard

PURPOSE: Korea has a parallel system of western and oriental medicine. Therefore doctors of each department have distrust of the other, which in turn confuses the patients and cause discontentment with medical standards. To upgrade the satisfaction of patients that want oriental therapy, we have studied the western-oriental cooperative therapy system to identify its flaw, if any, and tried to find a standard of therapy. METHODS: The 105 Patients included in this study were diagnosed as having a cerebral infarction and were admitted to the neurology department or the oriental medicine department via the emergency department from January to July 2002. We retrospectively analyzed sex, age, severity, admission periods, therapeutic methods and result, and frequency of consulting other departments. RESULTS: At times of admission, the scale of severity showed that there were more severe patients in the western-therapy group. There was no difference in the total prognosis between two groups. In mild patients (GCS>12), western therapeutic results were more favorable than those of the oriental group. In the western-therapy group, 32 (55.2%) patients also received oriental treatment, and 38 (80.9%) patients in the oriental-therapy group received combination of western and oriental therapy. CONCLUSION: From the above study, we propose that patients with unstable vital signs or with acute cerebral infarction should be treated with weatern therapy primarily, with oriental therapy after stabilization, and that mild or longstanding cerebral infarction patients can be admitted to whichever department they want.

A Serial Echocardiograhic Obesrvation of Acute Myocardial Injury Associated with Pheoechromocytoma Crisis

Pheochromocytoma may cause anatomic and functional cardiac abnormalities. Various echocardiographic abnormalities have been observed, including systolic anterior movement, global hypokinesis as well as hypokinesis of the base and the apex of LV. There are no previous reports of serial echocardiographic finding in patients with pheochromocytoma. We experienced a 38-year-old woman with pheochromocytoma who suffered from acute myocardial injury. Echocardiography revealed that the acute myocardial injury started in the base in the early phase and subsequently extended to the mid-portion of left ventricule. The injury persisted longer in the base than the mid-portion. than 1.5 times the adjacent normal coronary artery.

A Case of Aortic Dissection with Compromised Superior Mesenteric Artery Treated with Stents Insertion at Origin of the Artery

The treatment of a thoracic aortic dissection is guided by prognostic and anatomical information. Stanford type A aortic dissection requires surgery, but the appropriate treatment of a Stanford type B aortic dissection has not been determined, especially in patients with visceral artery compromise associated with the aortic dissection due to the failure of surgery to improve the prognosis.We report a case of a 35-year-old man, with a Stanford type B aortic dissection, where the superior mesenteric artery was obstructed. This condition was successfully treated with stents inserted at the origin of the artery.

Impairment of diastolic function in newly diagnosed non-insulin-dependent diabetes mellitus / 대한내과학회지

BACKGROUND: Heart failure is one of the major cause of premature mortality and morbidity in diabetes mellitus. It has been well recognized that left ventricular diastolic dysfunction caused by autonomic neuropathy, hyperinsulinemia, hyperlipidemia might be a preceding underlying mechanism of heart failure in diabetes. Also, an impairment of diastolic function in early diabetic patients has been reported in some literature. So, we evaluated the diastolic function in newly diagnosed diabetics with echocardiography. METHODS: All patients with newly diagnosed NIDDM in Pundang Cha general hospital from December 1996 to June 1998 were enrolled (n=20). The 20 healthy volunteers comparable for age, sex, body surface area were enrolled as a control group. The echocardiography was performed in all patients before any treatment. Blood pressure, pulse rate, fasting and postprandial sugar and insulin level, serum total cholesterol, triglyceride, HDL-cholesterol, LDL-cholesterol were also checked in all patients. RESULTS: There were no significant difference in blood pressure, pulse rate, total cholesterol, triglyceride, HDL-cholesterol and LDL-cholesterol level between both groups. E and A ratio of mitral inflow and peak diastolic velocity of pulmonary vein flow were significantly decreased in NIDDM group compared with control group (p<0.01). But there were no significant difference in left ventricular mass index, isovolumic relaxation time, deceleration time and peak atrial reversal velocity. CONCLUSION: This study demonstrates that an impairment of left ventricular diastolic function occurs early in the NIDDM and investigation of diastolic function should be performed in the clinical evaluation of early diabetic patients.

A Case of Cerebral Thromboembolism Occurred after Restoration to Sinus Rhythm of Paroxysmal Atrial Flutter in Apical Hypertropic Cardiomyopathy with Spontaneous Echo Contrast(SEC)

Atrial flutter occurs most often in patients with organic heart disease. It appears that chronic atrial flutter is associated with a remarkably high risk of clinically apparent thromboembolism and effective anticoagulation appears to reduce this risk, but acute or recent onset, postoperative atrial flutter may have a lower risk of thromboembolism than those with chronic atrial flutter. In chronic atrial flutter or fibrillation with organic heart disease, anticoagulation is generally justified but there is some debate about anticoagulation in paroxysmal atrial flutter. The spontaneous echo contrast is generally accepted one of the major risk factor of thromboembolism and usually occurred in mitral stenosis, dilated cardiomyopathy, and enlarged left atrium, but rarely observed in apical hypertrophic cardiomyopathy. We experienced a patient with apical hypertrophic cardiomyopathy, who visited to emergency medical center due to dizziness and suffered from cerebral thromboembolism after restoration of sinus rhythm. In transesophageal echocardiography, there was moderate to severe spontaneous echo contrast in left atrium. This patient showed that transesophageal echocardiography evaluation of left atrium might be mandatory in patients with paroxysmal atrial flutter and organic heart disease.