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.

Ticagrelor Monotherapy After 3-Month Dual Antiplatelet Therapy in Acute Coronary Syndrome by High Bleeding Risk: The Subanalysis From the TICO Trial

Background and Objectives@#Identifying patients with high bleeding risk (HBR) is important when making decisions for antiplatelet therapy strategy. This study evaluated the impact of ticagrelor monotherapy after 3-month dual antiplatelet therapy (DAPT) according to HBR in acute coronary syndrome (ACS) patients treated with drug eluting stents (DESs). @*Methods@#In this post-hoc analysis of the TICO trial, HBR was defined by 2 approaches: meeting Academic Research Consortium for HBR (ARC-HBR) criteria or Predicting Bleeding Complications in Patients Undergoing Stent Implantation and Subsequent DAPT (PRECISEDAPT) score ≥25. The primary outcome was a 3–12 months net adverse clinical event (composite of major bleeding and adverse cardiac and cerebrovascular events). @*Results@#Of the 2,980 patients without adverse events during the first 3 months after DES implantation, 453 (15.2%) were HBR by ARC-HBR criteria and 504 (16.9%) were HBR by PRECISE-DAPT score. The primary outcome rate was higher in HBR versus non-HBR patients (by ARC-HBR criteria: hazard ratio [HR], 2.87; 95% confidence interval [CI], 1.76– 4.69; p<0.001; by PRECISE-DAPT score: HR, 3.09; 95% CI, 1.92–4.98; p<0.001). Ticagrelor monotherapy after 3-month DAPT was associated with lower primary outcome rate than ticagrelor-based 12-month DAPT regardless of HBR by ARC-HBR criteria, with similar magnitudes of therapy effect for HBR and non-HBR patients (p-interaction=0.400). Results were consistent by PRECISE-DAPT score (p-interaction=0.178). @*Conclusions@#In ACS patients treated with DESs, ticagrelor monotherapy after 3-month DAPT was associated with lower rate of adverse clinical outcomes regardless of HBR, with similar magnitudes of therapy effect between HBR and non-HBR.Trial Registration: ClinicalTrials.gov Identifier: NCT02494895

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.

Immediate and Evolutionary Recovery of Left Ventricular Diastolic Function after Transcatheter Aortic Valve Replacement: Comparison with Surgery

Transradial versus transfemoral intervention in ST-segment elevation myocardial infarction patients in Korean population

BACKGROUND/AIMS: Transradial intervention (TRI) is becoming the preferred method over transfemoral intervention (TFI) because TRI is associated with lower incidence of major bleeding and vascular complications. However, there has been limited published data regarding the clinical outcomes of TRI versus TFI in Korean patients with ST-elevation myocardial infarction (STEMI). METHODS: A total of 689 consecutive STEMI patients who underwent primary percutaneous coronary intervention (PCI) with drug-eluting stents (DESs) from January to December of 2009 at nine university hospitals were enrolled in this study. Mid-term angiographic and 12-month cumulative clinical outcomes of the TRI group (n = 220, 31.9%) were compared to those of the TFI group (n = 469, 28.1%). RESULTS: After propensity score matching, in-hospital complications and the 12-month major clinical outcomes during follow-up in the two groups were similar to each other. However, the incidence rates of repeat revascularization (6.4% vs. 0.5%, p = 0.003), target vessel revascularization (6.4% vs. 0.5%, p = 0.003), and major adverse cardiac events (MACE; 11.6% vs. 4.6%, p = 0.018) in the TFI group were higher than those in the TRI group during the 12-month of follow-up. CONCLUSIONS: In our study, TRI in STEMI patients undergoing primary PCI with DESs was associated with lower incidence of access site hematoma, 12-month repeat revascularization, and MACE compared to TFI. Therefore, TRI might play an important role in reducing bleeding complications while improving major clinical outcomes in STEMI patients undergoing primary PCI with DESs.

Ergonovine Stress Echocardiography for the Diagnosis of Vasospastic Angina and Its Prognostic Implications in 3,094 Consecutive Patients

BACKGROUND AND OBJECTIVES@#Ergonovine stress echocardiography (ErgECHO) has been proposed as a noninvasive tool for the diagnosis of coronary vasospasm. However, concern over the safety of ErgECHO remains. This study was undertaken to investigate the safety and prognostic value of ErgECHO in a large population.@*METHODS@#We studied 3,094 consecutive patients from a single-center registry who underwent ErgECHO from November 2002 to June 2009. Medical records, echocardiographic data, and laboratory findings obtained from follow-up periods were analyzed.@*RESULTS@#The overall positive rate of ErgECHO was 8.6%. No procedure-related mortality or myocardial infarction (MI) occurred. Nineteen patients (0.6%) had transient symptomatic complications during ErgECHO including one who was successfully resuscitated. Cumulative major adverse cardiac events (MACEs) occurred in 14.0% and 5.1% of the patients with positive and negative ErgECHO results, respectively (p 220 mg/dL, and positive ErgECHO result itself were independent factors associated with MACEs.@*CONCLUSIONS@#ErgECHO can be performed safely by experienced physicians and its positive result may be an independent risk factor for long-term adverse outcomes. It may also be an alternative tool to invasive ergonovine-provoked coronary angiography for the diagnosis of vasospastic angina.

Ergonovine Stress Echocardiography for the Diagnosis of Vasospastic Angina and Its Prognostic Implications in 3,094 Consecutive Patients

BACKGROUND AND OBJECTIVES: Ergonovine stress echocardiography (ErgECHO) has been proposed as a noninvasive tool for the diagnosis of coronary vasospasm. However, concern over the safety of ErgECHO remains. This study was undertaken to investigate the safety and prognostic value of ErgECHO in a large population. METHODS: We studied 3,094 consecutive patients from a single-center registry who underwent ErgECHO from November 2002 to June 2009. Medical records, echocardiographic data, and laboratory findings obtained from follow-up periods were analyzed. RESULTS: The overall positive rate of ErgECHO was 8.6%. No procedure-related mortality or myocardial infarction (MI) occurred. Nineteen patients (0.6%) had transient symptomatic complications during ErgECHO including one who was successfully resuscitated. Cumulative major adverse cardiac events (MACEs) occurred in 14.0% and 5.1% of the patients with positive and negative ErgECHO results, respectively (p 220 mg/dL, and positive ErgECHO result itself were independent factors associated with MACEs. CONCLUSIONS: ErgECHO can be performed safely by experienced physicians and its positive result may be an independent risk factor for long-term adverse outcomes. It may also be an alternative tool to invasive ergonovine-provoked coronary angiography for the diagnosis of vasospastic angina.

Bioresorbable Vascular Scaffold Korean Expert Panel Report

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

Left ventricular thrombi after simultaneous thrombotic occlusions of multiple coronary arteries presenting acute myocardial infarction: need anticoagulant?

No abstract available.

Left ventricular thrombi after simultaneous thrombotic occlusions of multiple coronary arteries presenting acute myocardial infarction: need anticoagulant?

No abstract available.

Comparison of Paclitaxel-Coated Balloon Treatment and Plain Old Balloon Angioplasty for De Novo Coronary Lesions

PURPOSE: This study compared the angiographic outcomes of paclitaxel-coated balloon (PCB) versus plain old balloon angioplasty (POBA) treatment for de novo coronary artery lesions. At present, there is no available data comparing the efficacy of PCB versus POBA for the treatment of de novo coronary lesions. MATERIALS AND METHODS: This multicenter retrospective observational study enrolled patients with de novo coronary lesions with a reference vessel diameter between 2.5 mm and 3.0 mm and lesion length or =50%) in POBA, compared to PCB (30.4%, n=7 vs. 4.1%, n=2, p<0.001). Target vessel revascularization was higher in the POBA group (13.0%, n=3 vs. 0%, p=0.033). CONCLUSION: PCB treatment of de novo coronary lesions showed better 9-month angiographic outcomes than POBA treatment alone.

Cut-Off Value and Factors Associated with a False Positive D-Dimer Result for Venous Thromboembolism in Koreans / 대한내과학회지

BACKGROUND/AIMS: The D-dimer value is a simple blood test used to evaluate venous thromboembolism (VTE). However, due to its low specificity, another test is needed for a definite diagnosis, such as a radiographic test. We evaluate the factors associated with a false positive D-dimer test and propose a new cut-off value for detecting VTE more effectively in Koreans. METHODS: This was a retrospective, observational study. From January 2009 to December 2009, 2,047 patients (988 men, 63 +/- 15 years) had the D-dimer value checked to evaluate VTE. The main outcome of interest was a positive D-dimer test. Odds ratio and 95% confidence intervals were determined using logistic regression analysis. The new D-dimer cut-off was evaluated using receiver operating characteristics (ROC) curves. RESULTS: The result was positive in 1,093 patients (53%), for a false positive percentage for VTE of 95% and a false negative percentage for VTE of 1%. Significant false positive predictors for a positive D-dimer were increasing age, trauma, postoperative, acute infection, tuberculosis, stroke, malignancy, chronic renal failure, acute coronary syndrome, heart failure, and lung disease. The discriminative value of the D-dimer test was assessed using ROC curve analysis. A D-dimer value of 0.68 mg/L on admission was the best cut-off value for predicting the development of VTE with a sensitivity of 95% and specificity of 57%. CONCLUSIONS: Many factors affect the D-dimer value and we must consider these factors before using the D-dimer value to evaluate VTE. A D-dimer value of 0.68 mg/L appears to be a good cut-off value for evaluating VTE more effectively in Koreans.

Rho-Associated Kinase 2 Polymorphism in Patients With Vasospastic Angina

BACKGROUND AND OBJECTIVES: Recent studies indicate that in response to vasoconstrictor stimuli, the small GTPase RhoA and its down-stream effector, Rho-associated kinase 2 (ROCK)/Rho-kinase, are associated with hypercontraction of the vascular smooth muscle of coronary arteries through augmentation of myosin light chain phosphorylation and Ca2+ sensitization. Expression of ROCK/Rho-kinase mRNA was significantly increased and up-regulated in the spastic coronary artery in a porcine model, and a specific inhibitor of ROCK/Rho-kinase inhibited coronary artery spasm in humans. We therefore explored the role of ROCK2 polymorphisms in the pathogenesis of vasospastic angina (VA). SUBJECTS AND METHODS: We studied 106 patients with VA who exhibited spontaneous or provoked coronary spasm during coronary angiography and compared the prevalence of ROCK2 polymorphisms between this group of patients with VA and controls whose angiograms were normal, and in whom the ergonovine test did not cause spasm (n=107). Five single nucleotide polymorphisms (SNPs) of the ROCK2 gene were selected. SNPs were genotyped by high-resolution melting. Linkage disequilibrium and haplotype analyses were performed using the SHEsis program. RESULTS: The prevalence of genotypes of the 5 interesting SNPs in patients with VA was not different from that in the control group. In haplotype analysis, the haplotype G-T-C-T-G (in order of rs978906, rs2271621, rs2230774, rs1515210, and rs3771106) was significantly associated with a decreased risk of VA (p=0.007). CONCLUSION: The haplotype G-T-C-T-G in the ROCK2 gene had a protective effect against VA, suggesting the involvement of ROCK2 in VA pathogenesis.

Antithrombotic or Anti-Platelet Agents in Patients Undergoing Permanent Pacemaker Implantation

BACKGROUND AND OBJECTIVES: The growing implantations of electrophysiological devices in the context of increasing rates of chronic antithrombotic therapy in cardiovascular disease patients underscore the importance of an effective periprocedural prophylactic strategy for prevention of bleeding complications. We assessed the risk of significant bleeding complications in patients receiving anti-platelet agents or anticoagulants at the time of permanent pacemaker (PPM) implantation. SUBJECTS AND METHODS: We reviewed bleeding complications in patients undergoing PPM implantation. The use of aspirin or clopidogrel was defined as having taking drugs within 5 days of the procedure and warfarin was changed to heparin before the procedure. A significant bleeding complication was defined as a bleeding incident requiring pocket exploration or blood transfusion. RESULTS: Permanent pacemaker implantations were performed in 164 men and 96 women. The mean patient age was 73+/-11 years old. Among the 260 patients, 14 patients took warfarin (in all of them, warfarin was changed to heparin at least 3 days before procedure), 54 patients took aspirin, 4 patients took clopidogrel, and 25 patients took both. Significant bleeding complications occurred in 8 patients (3.1%), all of them were patients with heparin bridging (p<0.0001). Heparin bridging markedly increased the length of required hospital stay when compare with other groups and the 4 patients (1.5%) that underwent the pocket revision for treatment of hematoma. CONCLUSION: This study suggests that hematoma formation after PPM implantation was rare, even among those who had taken the anti-platelet agents. The significant bleeding complications frequently occurred in patients with heparin bridging therapy. Therefore, heparin bridging therapy was deemed as high risk for significant bleeding complication in PPM implantation.

Progressive Familial Heart Block Type I in a Korean Patient

A 29-year-old man was referred to the emergency department with a complaint of abdominal pain and dizziness. He had experienced two previous syncopal episodes. His family history revealed that his mother and his two uncles had received permanent pacemaker implantation. His initial heart rate was 49 beats per minute. The electrocardiography (ECG) showed atrial flutter and right bundle branch block (RBBB) with left anterior fascicular block (LAFB). On admission, 24-hour Holter showed ventricular pause up to 16 seconds during syncope. Radio frequency catheter ablation (RFCA) of atrial flutter was performed. The ECG revealed bifascicular block (RBBB and LAFB) and first-degree atrioventricular block. He received a permanent pacemaker implantation. His brother's and his sister's ECGs also showed trifascicular block and the pedigree showed autosomal dominant inheritance. This patient was diagnosed with a progressive familial heart block (PFHB) type I. This would be the first report of a PFHB type I case documented in Korea.

Recent Insights Into the Mechanisms of Vasospastic Angina

Coronary artery spasm plays an important role in the pathogenesis of many types of ischemic heart disease, not only in vasospastic angina but also in myocardial infarction and sudden death, particularly in the asian population. Patients with vasospastic angina are known to have defective endothelial function due to reduced nitric oxide bioavailability. Moreover, markers of oxidative stress and plasma levels of C-reactive protein are elevated. Smoking, polymorphysms of endothelial nitric oxide synthetase (eNOS), and low-grade inflammation have been regarded as the most important risk factors for vasospastic angina. The recent body of evidence indicates that RhoA and its down stream effector, ROCK/Rho-kinase, are associated with hypercontraction of vascular smooth muscle of the coronary artery and regulation of eNOS activity. Thus, endothelial dysfunction through abnormalities of eNOS and enhanced contractility of vascular smooth muscle in coronary artery segments are considered major mechanisms in vasospastic angina. However, the precise mechanisms for coronary vasospasm are not well understood. This article will review current understanding of the mechanism of coronary artery spasm.

Long-Term Prognosis and Clinical Characteristics of Patients With Variant Angina

BACKGROUND AND OBJECTIVES: The overall prognosis of patients with vasospastic angina (VA) is relatively good. However, the long-term prognosis and its influencing factors are not well understood in Korean patients. SUBJECTS AND METHODS: Between August 1996 and January 2007, 256 consecutive patients with VA were reviewed (215 men, 53+/-9 years). Coronary spasm was confirmed via intravenous ergonovine provocation in all study patients during coronary angiography. Major adverse cardiac events (MACEs) were defined as myocardial infarction (MI), resuscitation from cardiac arrest, or repeat hospitalization due to recurrent angina. RESULTS: The 256 patients were followed for an average of 59 months (range, 5 months to 11 years). Thirty-one patients (12.1%) were lost to follow-up. Cardiac deaths occurred in 6 patients (2.3%), non-fatal MIs occurred in 3 patients (1.2%), and MACEs occurred in 52 patients (20.3%). The rates of survival at 1, 3, and 5 years were 99%, 97%, and 97%, respectively, and the rates of MI-free survival at 1, 3, and 5 years were 99%, 96%, and 95%, respectively. Rates of MACE-free survival at 1, 3, and 5 years were 91%, 81%, and 62%, respectively. MI at initial presentation and current smoking were factors significantly associated with MACEs; these factors were also independent predictors of MACE-free survival. CONCLUSION: Despite treatment with calcium channel blockers, recurrent episodes of angina were frequently observed, whereas sudden cardiac death and non-fatal MI were rare. Smoking and myocardial infarction at admission were independent risk factors for cardiac death, non-fatal MI, and repeat hospitalization due to recurrent angina in patients with variant angina.

Precordial ST-Segment Elevation in Acute Right Ventricular Myocardial Infarction

It is rare to observe ST-segment elevations in the precordial leads that are caused by an occlusion of the right coronary artery and/or its branches. We report here on two cases of acute occlusion of the right coronary artery or its branches that caused acute right ventricular myocardial infarction with ST-segment elevations in the anterior precordial leads. These cases should remind us that the presence of diffuse ST-segment elevations in the precordial leads could be due to acute occlusion of the right coronary artery.

The Effect of Preload Reduction on a New Parameter to Evaluate Left Ventricular Diastolic Function

BACKGROUND AND OBJECTIVES: The time interval between the onset of the mitral inflow and the mitral annulus velocity (TE'-E) has been proposed as a new index for representing the left ventricular (LV) relaxation and this is related to the LV filling pressure. This index has been reported to be a preload independent parameter in an experimental canine model. However, the impact of the preload on this index has not been studied in humans. SUBJECTS AND METHODS: Forty-five patients (29 men, mean age: 51+/-14 years old) who had end-stage renal disease underwent echocardiography immediately before and after hemodialysis (HD). The two-dimensional and Doppler parameters were measured, including the peak early (E) and late (A) transmitral inflow velocity. The mitral annulus velocity (E') at the septal, lateral, anterior and inferior corners of the mitral annulus, as accessed by Doppler tissue imaging (DTI), and the flow propagation velocity (Vp), as accessed by color M-mode, were also measured. The time intervals between the peak of the R wave and the onset of the mitral E velocity and also between the peak R wave and the onset of E' at the four corners of the mitral annulus were measured. RESULTS: The mean ejection fraction was 62+/-16%. The average weight reduction by the HD was 2.9+/-1.1 kg. The dimensions of the LV end-diastole, left atrium and inferior vena cava were significantly reduced. After the HD, the peak E, A and E/A ratio, the average peak E' and the Vp were significantly decreased. The TE'-E did not change significantly after the HD regardless of the LV systolic function. CONCLUSION: A new parameter for the diastolic function, i.e., the time interval between the onset of mitral inflow and the mitral annulus velocity, appears to be preload-independent in the patients with a normal or decreased LV systolic function.