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.

Prasugrel-based De-Escalation of Dual Antiplatelet Therapy After Percutaneous Coronary Intervention in Patients With STEMI

Background and Objectives@#De-escalation of dual-antiplatelet therapy through dose reduction of prasugrel improved net adverse clinical events (NACEs) after acute coronary syndrome (ACS), mainly through the reduction of bleeding without an increase in ischemic outcomes. Whether the benefits of de-escalation are sustained in highly thrombotic conditions such as ST-elevation myocardial infarction (STEMI) is unknown. We aimed to assess the efficacy and safety of de-escalation therapy in patients with STEMI or non-STsegment elevation ACS (NSTE-ACS). @*Methods@#This is a pre-specified subgroup analysis of the HOST-REDUCE-POLYTECH-ACS trial. ACS patients were randomized to prasugrel de-escalation (5 mg daily) or conventional dose (10 mg daily) at 1-month post-percutaneous coronary intervention. The primary endpoint was a NACE, defined as a composite of all-cause death, non-fatal myocardial infarction, stent thrombosis, clinically driven revascularization, stroke, and bleeding events of grade ≥2 Bleeding Academic Research Consortium (BARC) criteria at 1 year. @*Results@#Among 2,338 patients included in the randomization, 326 patients were diagnosed with STEMI. In patients with NSTE-ACS, the risk of the primary endpoint was significantly reduced with de-escalation (hazard ratio [HR], 0.65; 95% confidence interval [CI], 0.48– 0.89; p=0.006 for de-escalation vs. conventional), mainly driven by a reduced bleeding. However, in those with STEMI, there was no difference in the occurrence of the primary outcome (HR, 1.04; 95% CI, 0.48–2.26; p=0.915; p for interaction=0.271). @*Conclusions@#Prasugrel dose de-escalation reduced the rate of NACE and bleeding, without increasing the rate of ischemic events in NSTE-ACS patients but not in STEMI patients.

Consensus Statement on Coronary Intervention during the Coronavirus Disease 2019 (COVID-19) Pandemic: from the Korean Society of Interventional Cardiology (KSIC)

Coronavirus disease 2019 (COVID-19) is a highly contagious disease caused by the novel virus severe acute respiratory syndrome coronavirus-2. The first case developed in December, 2019 in Wuhan, China; several months later, COVID-19 has become pandemic, and there is no end in sight. This disaster is also causing serious health problems in the area of cardiovascular intervention. In response, the Korean Society of Interventional Cardiology formed a COVID-19 task force to develop practice guidelines. This special article introduces clinical practice guidelines to prevent secondary transmission of COVID-19 within facilities;the guidelines were developed to protect patients and healthcare workers from this highly contagious virus. We hope these guidelines help healthcare workers and cardiovascular disease patients around the world cope with the COVID-19 pandemic.

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.

Consensus statement on coronary intervention during the coronavirus disease 19 pandemic: from the Korean Society of Interventional Cardiology

Coronavirus disease 2019 (COVID-19) is a highly contagious disease caused by the novel virus severe acute respiratory syndrome coronavirus 2. The first case developed in December, 2019 in Wuhan, China; several months later, COVID-19 has become pandemic, and there is no end in sight. This disaster is also causing serious health problems in the area of cardiovascular intervention. In response, the Korean Society of Interventional Cardiology formed a COVID-19 task force to develop practice guidelines. This special article introduces clinical practice guidelines to prevent secondary transmission of COVID-19 within facilities; the guidelines were developed to protect patients and healthcare workers from this highly contagious virus. We hope these guidelines help healthcare workers and cardiovascular disease patients around the world cope with the COVID-19 pandemic.

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.

Diagnostic Approach to Chest Pain / 대한내과학회지

No abstract available.

Does Pre-Treatment with High Dose Atorvastatin Prevent Microvascular Dysfunction after Percutaneous Coronary Intervention in Patients with Acute Coronary Syndrome?

BACKGROUND AND OBJECTIVES: There is controversy surrounding whether or not high dose statin administration before percutaneous coronary intervention (PCI) decreases peri-procedural microvascular injury. We performed a prospective randomized study to investigate the mechanisms and effects of pre-treatment high dose atorvastatin on myocardial damage in patients with non-ST-segment elevation acute coronary syndrome (NSTE-ACS) undergoing PCI. SUBJECTS AND METHODS: Seventy seven patients with NSTE-ACS were randomly assigned to either the high dose group (atorvastatin 80 mg loading 12 to 24 h before PCI with a further 40 mg loading 2 h before PCI, n=39) or low dose group (atorvastatin 10 mg administration 12 to 24 h before PCI, n=38). Index of microcirculatory resistance (IMR) was measured after stent implantation. Creatine kinase-myocardial band (CK-MB) and high sensitivity C-reactive protein (CRP) levels were measured before and after PCI. RESULTS: The baseline characteristics were not different between the two patient groups. Compared to the low dose group, the high dose group had lower post PCI IMR (14.1±5.0 vs. 19.2±9.3 U, p=0.003). Post PCI CK-MB was also lower in the high dose group (median: 1.40 ng/mL (interquartile range [IQR: 0.75 to 3.45] vs. 4.00 [IQR: 1.70 to 7.37], p=0.002) as was the post-PCI CRP level (0.09 mg/dL [IQR: 0.04 to 0.16] vs. 0.22 [IQR: 0.08 to 0.60], p=0.001). CONCLUSION: Pre-treatment with high dose atorvastatin reduces peri-PCI microvascular dysfunction verified by post-PCI IMR and exerts an immediate anti-inflammatory effect in patients with NSTE-ACS.

Does Pre-Treatment with High Dose Atorvastatin Prevent Microvascular Dysfunction after Percutaneous Coronary Intervention in Patients with Acute Coronary Syndrome?

BACKGROUND AND OBJECTIVES: There is controversy surrounding whether or not high dose statin administration before percutaneous coronary intervention (PCI) decreases peri-procedural microvascular injury. We performed a prospective randomized study to investigate the mechanisms and effects of pre-treatment high dose atorvastatin on myocardial damage in patients with non-ST-segment elevation acute coronary syndrome (NSTE-ACS) undergoing PCI. SUBJECTS AND METHODS: Seventy seven patients with NSTE-ACS were randomly assigned to either the high dose group (atorvastatin 80 mg loading 12 to 24 h before PCI with a further 40 mg loading 2 h before PCI, n=39) or low dose group (atorvastatin 10 mg administration 12 to 24 h before PCI, n=38). Index of microcirculatory resistance (IMR) was measured after stent implantation. Creatine kinase-myocardial band (CK-MB) and high sensitivity C-reactive protein (CRP) levels were measured before and after PCI. RESULTS: The baseline characteristics were not different between the two patient groups. Compared to the low dose group, the high dose group had lower post PCI IMR (14.1±5.0 vs. 19.2±9.3 U, p=0.003). Post PCI CK-MB was also lower in the high dose group (median: 1.40 ng/mL (interquartile range [IQR: 0.75 to 3.45] vs. 4.00 [IQR: 1.70 to 7.37], p=0.002) as was the post-PCI CRP level (0.09 mg/dL [IQR: 0.04 to 0.16] vs. 0.22 [IQR: 0.08 to 0.60], p=0.001). CONCLUSION: Pre-treatment with high dose atorvastatin reduces peri-PCI microvascular dysfunction verified by post-PCI IMR and exerts an immediate anti-inflammatory effect in patients with NSTE-ACS.

Comparison of Age of Onset and Frequency of Diabetic Complications in the Very Elderly Patients with Type 2 Diabetes

BACKGROUND: The prevalence of type 2 diabetes in elderly people has increased dramatically in the last few decades. This study was designed to clarify the clinical characteristics of type 2 diabetes in patients aged ≥80 years according to age of onset. METHODS: We reviewed the medical records of 289 patients aged ≥80 years with type 2 diabetes at the outpatient diabetes clinics of Kangwon National University Hospital from September 2010 to June 2014. We divided the patients into middle-age-onset diabetes (onset before 65 years of age) and elderly-onset diabetes (onset at 65+ years of age). RESULTS: There were 141 male and 148 female patients. The patients had a mean age of 83.2±2.9 years and the mean duration of diabetes was 14.3±10.4 years. One hundred and ninety-nine patients had elderly-onset diabetes. The patients with elderly-onset diabetes had a significantly lower frequency of diabetic retinopathy and nephropathy, lower serum creatinine levels, lower glycated hemoglobin (HbA1c) levels, and similar coronary revascularization and cerebral infarction rates compared to those with middle-age-onset diabetes. There was no frequency difference in coronary revascularization and cerebral infarction and HbA1c levels between three subgroups (<5, 5 to 15, and ≥15 years) of diabetes duration in elderly onset diabetes. However, both in the elderly onset diabetes and middle-age-onset diabetes, the cumulative incidence of retinopathy was increasing rapidly according to the duration of diabetes. CONCLUSION: We report that individuals with elderly-onset diabetes have a lower frequency of diabetic retinopathy and nephropathy and similar cardiovascular complications compared to those with middle-age-onset diabetes.

Acute and Long-Term Angiographic Outcomes of Side Branch Stenosis after Randomized Treatment of Zotarolimus-, Sirolimus-, and Paclitaxel-Eluting Stent for Coronary Artery Stenosis

This was designed to assess the outcomes of side branch (SB) stenosis after implantation of three drug-eluting stents (DES). From 2,645 patients in the ZEST (Comparison of the Efficacy and Safety of Zotarolimus-Eluting Stent with Sirolimus-Eluting and PacliTaxel-Eluting Stent for Coronary Lesions) Trial, 788 patients had 923 bifurcation lesions with SB > or = 1.5 mm were included. SB was treated in 150 lesions, including 35 (3.8%) receiving SB stenting. Of untreated SB with baseline stenosis < 50%, the incidences of periprocedural SB compromise was similar in the zotarolimus (15.8%), sirolimus (17.2%), and paclitaxel (16.6%) stent groups (P = 0.92). At follow-up angiography, delayed SB compromise occurred in 13.9%, 3.2%, and 9.4% (P = 0.010) of these groups. When classified into four groups (< 50%, 50%-70%, 70%-99%, and 100%), 9.0% of untreated SB were worsened, whereas improvement and stationary were observed in 9.6% and 81.4%. In a multivariable logistic regression model, main branch (MB) stenosis at follow-up (%) was the only independent predictor of SB stenosis worsening (odds ratio, 1.03; 95% confidence interval, 1.01-1.04; P < 0.001). After MB stenting in bifurcation lesions, a minority of SB appears to worsen. DES with strong anti-restenotic efficacy may help maintain SB patency.

Deep Vein as a Graft Conduit: 2 case reports / 대한흉부외과학회지

The ideal graft requires acceptable size, less tissue toxicity, resistance to infection, and long-term durability. Great saphenous veins are gaining popularity as acceptable graft conduits, but they require time to grow in caliber. We report 2 cases of graft bypass and reconstruction using superficial femoral veins to acheive immediate high-flow patency.

Massive Paradoxical Air Embolism in Brain Occurring after Central Venous Catheterization: A Case Report

Cerebral air embolism is a rare but fatal complication of central venous catheterization. Here, we report a case of paradoxical cerebral air embolism associated with central venous catheterization. An 85-yr-old man underwent right internal jugular vein catheterization, and became obtunded. Brain MR imaging and CT revealed acute infarction with multiple air bubbles on the side of catheter insertion. The possibility of cerebral air embolism should be considered in patients developing neurological impairment after central venous catheterization, and efforts should be made to limit cerebral damage.

A Case of Aconitum Intoxication After Ingestion of a Large Amount of Aconitine Decoction in a Suicide Attempt

Aconitine has been used as a folk remedy for centuries to treat pain and as an inotropic agent. However, because its therapeutic range is very narrow, it often causes many side effects when not controlled carefully. These include nausea, vomiting, paresthesia, cardiac arrhythmia and hypotension. Most of the aconitine intoxication cases have been attributed to accidental overdose of aconitine-containing medicines. In this case, a 53-year-old woman attempted suicide by intentionally overdosing herself with an aconitine decoction. She suffered paresthesia in both arms and showed junctional rhythm on an electrocardiogram at admission. Here we report that early gastric lavage and other symptomatic therapies were helpful for treating aconitine intoxication. Similar to intoxication with other drugs, these supportive measures can prevent the patient's hospitalization.

Cyclic AMP prolongs graft survival by suppressing apoptosis and inflammatory gene expression in acute cardiac allograft rejection

This study was designed to investigate the effects of cAMP on immune regulation and apoptosis during acute rat cardiac allograft rejection. We found that the production of immune markers such as inflammatory cytokines (IL-1beta, IL-6, and TNF-alpha), iNOS expression, and nitric oxide (NO) production, was significantly increased in the blood and transplanted hearts of allograft recipients, but not of isograft controls. These increases were effectively suppressed by the administration of the membrane permeable cAMP analog dibutyryl cAMP (db-cAMP). Administration of db-cAMP reduced allograft-induced elevation of several biochemical markers, such as adhesion molecule expression, iron-nitrosyl complex formation, caspase-3 activation, and apoptotic DNA fragmentation in an animal model. Furthermore, treatment of allograft recipients with db-cAMP prolonged median graft survival to 11 days compared with a median graft survival time of 8 days in saline-treated allograft recipients. These results suggest that db-cAMP exerts a beneficial effect on murine cardiac allograft survival by modulating allogeneic immune response and cytotoxicity.

Comparison of Quality of Cardiopulmonary Resuscitation in Manikins with a Change in the Compression to Ventilation Ratio from 30:2 to 15:1

PURPOSE: To minimize an interruption in chest compression, reduce the hands-off time, the American Heart Association has recommended changing the ratio of chest compression to ventilation ratio to 30:2. However, current studies have shown that the hands-off time was >10 seconds with that method. For this reason, we reasoned that a chest compression to ventilation ratio of 15:1 would be a more suitable way to reduce hands-off time because this ratio will not change the total compression and ventilation count. METHODS: The subjects were asked to perform CPR for 5 cycles with a compression to ventilation ratio of 30:2. The subjects rested for 5 minutes, then performed CPR with a compression to ventilation of 15:1. The skill performance was measured and analyzed using a statistical program. RESULTS: In the group which performed CPR with a chest compression to ventilation ratio of 30:2, the average number of compressions per minute was 76+/-9, while at a chest compression to ventilation ratio of 15:1, the average number of compressions per minute was 68+/-9. Between the compression to ventilation ratios of 30:2 and 15:1, the count gap was 8.3+/-3.2. When CPR was performed at a chest compression to ventilation ratio of 30:2, the average hands-off time was 9.3+/-1.9. When CPR was performed at a chest compression to ventilation ratio of 15:1, the average hands-off time was 6.7+/-1.3. Between chest compression to ventilation ratios of 30:2 and 15:1, the time gap of the average hands-off time was 2.7+/-1.2 seconds. CONCLUSION: When the chest compression to ventilation ratio was 15:1, the hands-off time was significantly reduced, but the compressions per minute were also reduced.

Surgical Venous Thrombectomy for Chronic May-Thurner Sysndrome: 2 cases report / 대한흉부외과학회지

May-Thurner syndrome is a deep vein thrombosis of the ilio-femoral vein due to compression of the left common iliac vein by the overlying right common iliac artery. Although, catheter directed thrombectomy (CDT) and thrombolysis with stent insertion has become the standard treatment method for acute or subacute May-Thurner syndrome, because of technical feasibility and lower recurrence rate, however, sometimes this methods make fatal complications. Furthermore, there are few reports on optimal treatment strategies for patients in a chronic state of May-Thurner syndrome,. We now present two cases of chronic (>1 month since onset of symptoms) May-Thurner syndrome treated by surgical thrombectomy and femoral arteriovenous shunt with simultaneous stent insertion after failed endovascular treatment. This technique may provide a significant benefit for patients who are not suitable for conventional endovascular treatment.

Surgical Treatment of Popliteal Artery Injury as a Complication of Arthroscopic Surgery: 2 case reports / 대한흉부외과학회지

The indications and applications of arthroscopic surgery for the knee joint have increased with the development in surgical techniques and the improvement of arthroscopic equipment. The use of arthroscopic surgery has led to a significant decrease in morbidity for the patient with intra-articular abnormalities, in terms of both the diagnosis and the surgical treatments. Even though arthroscopy is a minimally invasive technique with relatively low morbidity, it is not without risk of complications, of which neurovascular complications are among the most serious and devastating. Here we report on 2 cases of popliteal artery injury during arthroscopic knee surgery and its specific diagnosis and treatment.

A Study of the Investigative Method of Cause of Death for Making out a Death Certificate

PURPOSE: We address investigative or analytical methods to report death in drawing up a death certificate. METHOD: This study was based on the death certificates completed at the emergency department, Kangwon University hospital, from September 2003 to August 2005. The data were collected through notices about drawing up death certificates and included the death certificate and the medical records in the emergency department. RESULTS: The research subjects were 29,059 patients who came to the emergency room during the period of study. Death certificates or medical certificates of death were issued to 793 of these. As to the place of death, 537 (72.5%) deaths occurred at home, 1 (0.1%) in medical institutions, 12 (1.6%) in public institutions, 48 (6.5%) patients was dead on arrival, 2 (0.3%) at industrial factories, 20 (2.7%) on road, 120 (16.2%) at other places and 1 (0.13%) was not defined. As to the types of death, death from disease was the highest (445, 60.1%), and death from external causes was next (168, 22.7%), followed by death from other or unknown causes (128, 17.3%). For death from external causes, traffic accident was 24 (14.1%), poisoning was 13 (7.6%), accidental fall was 18 (10.6%), accidental drowning was 27, 15.9%), suicide was (64, 37.6%), murder was 1 (0.6%), and other was 23 (13.5%). The study on the cause of death, 92 (16.4%) of 562 patients was found to have been helped in diagnosing the cause of death. However, in the case of death from external causes, except for death from disease, 109 patients were surveyed, the study helped to identify the cause of death in only 46 (42.2%). Likewise, in 14 (60.7%) of 23 patients the study helped to identify the cause of death as sudden death. CONCLUSION: Simple X-rays and laboratory examinations were used to determine the cause of death when drawing up a death certificate, and these helped more in identifying the causes of death from external causes than in identifying the causes of death from diseases. Especially, these worked much better for sudden death.

Primary Sirolimus-Eluting Stent Implantation for Patients with Acute ST-Segment Elevation Myocardial Infarction

BACKGROUND AND OBJECTIVES: Sirolimus-eluting stents (SES) have been shown to significantly inhibit neointimal hyperplasia, resulting in reduced restenosis compared with bare metal stents (BMS). However, the efficacy and safety of SES implantation for patients with acute ST-segment elevation myocardial infarction (STEMI) remain unclear. SUBJECTS AND METHODS: Primary stenting was performed using SES in 74 patients (mean age: 58.0+/-12.7 years, 59 males) and BMS in 88 patients (mean age: 59.3+/-10.7 years, 63 males) between April 2003 and July 2004. We retrospectively compared the incidence of 6-month angiographic restenosis and the major adverse cardiac events (MACE) defined as cardiac death, non-fatal myocardial infarction and target lesion revascularization (TLR), between the SES group and the BMS group. RESULTS: The SES group had smaller vessels (3.04+/-0.47 mm vs. 3.24+/-0.56 mm, respectively, p=0.02) and a longer stent length (33.7+/-14.3 mm vs. 25.0+/-9.6 mm, p=0.00). The procedural success rate (87.8% vs. 92.0%, respectively, p=0.37) and the peak creatine kinase-MB (239+/-196 ng/mL vs. 274+/-188 ng/mL, p=0.26) were similar. The 6-month angiographic restenosis rate (0.0% vs. 30.4%, respectively, p=0.00) and late loss (-0.03+/-0.55 mm vs. 1.28+/-0.58 mm, p=0.00) were significantly lower in the SES group compared with the BMS group. Stent thrombosis developed in only 1 case of the SES group (1.4% vs. 0.0%, respectively, p=0.45). At 6 months, SES implantation significantly reduced the incidence of MACE (6.9% vs. 19.5%, respectively, p=0.04), because of a reduction in the incidence of TLR (1.4% vs. 11.5%, p=0.01). Likewise, the MACE-free survival rate was significantly higher in the SES group (93.06% vs. 80.46%, respectively, p=0.03). CONCLUSION: Compared with the BMS, the SES was effective in reducing the incidence of 6-month angiographic restenosis and MACE without any increased risk of stent thrombosis in the patients with STEMI who received primary stenting.