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.

Before Coronary CTO PCI: Burden or Location?

no abstract available.

The effect of antiplatelet drug on coronary endothelial and microvascular function: comparison with ticagrelor and clopidogrel

Background/Aims@#Coronary endothelial and microvascular function play important roles in cardiovascular disease. We aimed to evaluate the effect of ticagrelor on coronary artery function and tested the antiplatelet effect of low dose ticagrelor in East-Asian patients. @*Methods@#Sixty-one consecutive patients with non-significant coronary disease were included in the study. Initially, patients were randomized in 1:1:1 ratio to receive drugs: ticagrelor 90 mg twice a day (bid; n = 22), ticagrelor 45 mg bid (n = 19) or clopidogrel 75 mg once a day (qd; n = 20) and then divided into two groups (ticagrelor vs clopidogrel) for evaluation of coronary artery function, and three groups for evaluation of antiplatelet function. Endothelial dysfunction was measured by coronary flow reserve (CFR), and changes in the levels of asymmetric dimethylarginine (ADMA), cluster of differentiation (CD) 40 ligand, and P-selectin. Microvascular function was evaluated as index of microvascular resistance (IMR). Platelet reactivity was assessed by VerifyNow P2Y12 assay. @*Results@#The levels of CFR, ADMA, and CD 40 ligand were not different between the two groups. However, P-selectin was lower in the ticagrelor group compared with clopidogrel group. IMR was significantly lower in the ticagrelor group compared with clopidogrel group (median, 15.0 [interquartile range, 12.0 to 21.0] vs. 47.5 [23.0 to 67.5], p = 0.014). There was significant difference in platelet inhibition among the three groups (ticagrelor 90 mg bid vs. ticagrelor 45 mg bid vs. clopidogrel 75 mg qd; 85.57 ± 47.63 vs. 120.33 ± 51.09 vs. 256.42 ± 55.10, p < 0.001) @*Conclusions@#It is hypothesized that ticagrelor might ameliorate the coronary microvascular function. When compared with clopidogrel, low dose ticagrelor exhibited satisfactory antiplatelet effect in the present study.

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 Impact of Prediabetes on Two-Year Clinical Outcomes in Patients Undergoing Elective Percutaneous Coronary Intervention

PURPOSE: Prediabetes is an independent risk factor for cardiovascular disease. However, data on the long term adverse clinical outcomes of prediabetic patients undergoing percutaneous coronary intervention (PCI) with drug-eluting stents (DESs) are scarce. MATERIALS AND METHODS: The study population comprised 674 consecutive non-diabetic patients who underwent elective PCI between April 2007 and November 2010. Prediabetes was defined as hemoglobin A1c (HbA1c) of 5.7% to 6.4%. Two-year cumulative clinical outcomes of prediabetic patients (HbA1c of 5.7% to 6.4%, n=242) were compared with those of a normoglycemic group (< 5.7%, n=432). RESULTS: Baseline clinical and angiographic characteristics were similar between the two groups, except for higher glucose levels (104.8±51.27 mg/dL vs. 131.0±47.22 mg/dL, p < 0.001) on admission in the prediabetes group. There was no significant difference between the two groups in coronary angiographic parameters, except for a higher incidence of diffuse long lesion in the prediabetes group. For prediabetic patients, trends toward higher incidences of binary restenosis (15.6% vs. 9.8 %, p=0.066) and late loss (0.71±0.70 mm vs. 0.59±0.62 mm, p=0.076) were noted. During the 24 months of follow up, the incidence of mortality in prediabetic patients was higher than that in normoglycemic patients (5.5% vs. 1.5%, p=0.007). CONCLUSION: In our study, a higher death rate and a trend toward a higher incidence of restenosis in patients with prediabetes up to 2 years, compared to those in normoglycemic patients, undergoing elective PCI with contemporary DESs.

Impact of Cigarette Smoking: a 3-Year Clinical Outcome of Vasospastic Angina Patients

BACKGROUND AND OBJECTIVES: Cigarette smoking is a risk significant factor in coronary artery disease (CAD) and vasospastic angina (VSA). However, it is largely unknown whether smoking adds to any long-term clinical risk in VSA patients. SUBJECTS AND METHODS: A total of 2797 patients without significant CAD underwent acetylcholine (Ach) provocation test between November 2004 and October 2010. Patients were divided into three groups, based on the presence of coronary artery spasm (CAS) and smoking habits (non-CAS group: n=1188, non-smoking CAS group: n=1214, smoking CAS group: n=395). All CAS patients were prescribed with anti-anginal medications for at least 6 months. The incidence of major clinical outcomes and recurrent angina of these groups were compared up to 3 years. RESULTS: There were considerable differences in the baseline clinical and angiographic characteristics among the three groups, but there was no difference in the endpoints among the three groups (including individual and composite hard endpoints) such as death, myocardial infarction, de novo percutaneous coronary intervention, cerebrovascular accident, and major adverse cardiac events. However, there was a higher incidence of recurrent angina in both the non-smoking CAS group and smoking CAS group, as compared to the non-CAS group. In multivariable adjusted Cox-proportional hazards regression analysis, smoking CAS group exhibited a higher incidence of recurrent angina compared with the non-CAS group (hazard ratio [HR]; 2.46, 95% confidence interval [CI]; 1.46-4.14, p=0.001) and non-smoking CAS group (HR; 1.76, 95% CI; 1.08-2.87, p=0.021). CONCLUSION: Cigarette smoking CAS group exhibited higher incidence of recurrent angina during the 3-year clinical follow-up compared with both the non-CAS group and non-smoking CAS group. Quitting of smoking, paired with intensive medical therapy and close clinical follow-up, can help to prevent recurrent angina.

Impact of an endothelial progenitor cell capturing stent on coronary microvascular function: comparison with drug-eluting stents

BACKGROUND/AIMS: Although drug-eluting stents (DESs) effectively reduce restenosis following percutaneous coronary intervention (PCI), they also delay re-endothelialization and impair microvascular function, resulting in adverse clinical outcomes. Endothelial progenitor cell (EPC) capturing stents, by providing a functional endothelial layer on the stent, have beneficial effects on microvascular function. However, data on coronary microvascular function in patients with EPC stents versus DESs are lacking. METHODS: Seventy-four patients who previously underwent PCI were enrolled in this study. Microvascular function was evaluated 6 months after PCI based on the index of microvascular resistance (IMR) and the coronary flow reserve (CFR). IMR was calculated as the ratio of the mean distal coronary pressure at maximal hyperemia to the inverse of the hyperemic mean transit time (hTmn). The CFR was calculated by dividing the hTmn by the baseline mean transit time. RESULTS: Twenty-one patients (age, 67.2 +/- 9.6 years; male:female, 15:6) with an EPC stent and 53 patients (age, 61.5 +/- 14.7 years; male:female, 40:13) with second-generation DESs were included in the study. There were no significant differences in the baseline clinical and angiographic characteristics of the two groups. Angiography performed 6 months postoperatively did not show significant differences in their CFR values. However, patients with the EPC stent had a significantly lower IMR than patients with second-generation DESs (median, 25.5 [interquartile range, 12.85 to 28.18] vs. 29.0 [interquartile range, 15.42 to 39.23]; p = 0.043). CONCLUSIONS: Microvascular dysfunction was significantly improved after 6 months in patients with EPC stents compared to those with DESs. The complete re-endothelialization achieved with the EPC stent may provide clinical benefits over DESs, especially in patients with microvascular dysfunction.

Response of Functional Mitral Regurgitation during Dobutamine Infusion in Relation to Changes in Left Ventricular Dyssynchrony and Mitral Valve Geometry

PURPOSE: Functional mitral regurgitation (FMR) and myocardial dyssynchrony commonly occur in patients with dilated cardiomyopathy (DCM). The aim of this study was to elucidate changes in FMR in relation to those in left ventricular (LV) dyssynchrony as well as geometric parameters of the mitral valve (MV) in DCM patients during dobutamine infusion. MATERIALS AND METHODS: Twenty-nine DCM patients (M:F=15:14; age: 62+/-15 yrs) with FMR underwent echocardiography at baseline and during peak dose (30 or 40 ug/min) of dobutamine infusion. Using 2D echocardiography, LV end-diastolic volume, end-systolic volume (LVESV), ejection fraction (EF), and effective regurgitant orifice area (ERO) were estimated. Dyssynchrony indices (DIs), defined as the standard deviation of time interval-to-peak myocardial systolic contraction of eight LV segments, were measured. Using the multi-planar reconstructive mode from commercially available 3D image analysis software, MV tenting area (MVTa) was measured. All geometrical measurements were corrected (c) by the height of each patient. RESULTS: During dobutamine infusion, EF (28+/-8% vs. 39+/-11%, p=0.001) improved along with significant decrease in cLVESV (80.1+/-35.2 mm3/m vs. 60.4+/-31.1 mm3/m, p=0.001); cMVTa (1.28+/-0.48 cm2/m vs. 0.79+/-0.33 cm2/m, p=0.001) was significantly reduced; and DI (1.31+/-0.51 vs. 1.58+/-0.68, p=0.025) showed significant increase. Despite significant deterioration of LV dyssynchrony during dobutamine infusion, ERO (0.16+/-0.09 cm2 vs. 0.09+/-0.08 cm2, p=0.001) significantly improved. On multivariate analysis, DeltacMVTa and DeltaEF were found to be the strongest independent determinants of DeltaERO (R2=0.443, p=0.001). CONCLUSION: Rather than LV dyssynchrony, MV geometry determined by LV geometry and systolic pressure, which represents the MV closing force, may be the primary determinant of MR severity.

Significant Response to Lower Acetylcholine Dose Is Associated with Worse Clinical and Angiographic Characteristics in Patients with Vasospastic Angina

BACKGROUND AND OBJECTIVES: The intracoronary injection of acetylcholine (Ach) has been shown to induce coronary spasms in patients with variant angina. Clinical significance and angiographic characteristics of patients with a significant response to lower Ach dosages are as-yet non-clarified compared with patients responding to higher Ach doses. SUBJECTS AND METHODS: A total of 3034 consecutive patients underwent coronary angiography with Ach provocation tests from January 2004 to August 2010. Ach was injected in incremental doses of 20, 50, 100 microg into the left coronary artery. Significant coronary artery spasm was defined as focal or diffuse severe transient luminal narrowing (>70%) with/without chest pain or ST-T change on the electrocardiogram (ECG). We compared the clinical and angiographic characteristics of patients who responded to a lower Ach dose (20 or 50 microg, n=556) to those that responded to a higher Ach dose (100 microg, n=860). RESULTS: The baseline clinical and procedural characteristics are well balanced between the two groups, except diabetes was higher in the lower Ach dose group and there were differences in medication history. After adjusting for confounding factors, the lower Ach dose group showed more frequent temporary ST elevation and atrioventricular block on the ECG. Furthermore, the group of patients who responded to the lower Ach dose was associated with a higher incidence of baseline and severe spasm than those who responded to a higher Ach dose. CONCLUSION: Patients with a significant response to a lower Ach dose were associated with more frequent ST elevation, baseline spasm, and more severe spasm compared with those who responded to a higher Ach dose, suggesting more intensive medical therapy with close clinical follow-up is required for those patients.

Intercoronary Communication between the Circumflex and Right Coronary Arteries Coexisted with Coronary Vasospasm

Intercoronary arterial connection between normal coronary arteries is a rare variant of coronary anatomy in which there is open-ended circulation. It is distinguished from collaterals seen in the occlusive coronary artery disease. We report a case of bidirectional intercoronary communication between the left circumflex artery and the right coronary artery without occlusive coronary artery disease, but with left anterior descending artery spasm.

Pill-induced Intramural Hematoma of the Esophagus

Intramural hematoma of the esophagus is a rare cause of chest pain. Varying degrees of submucosal dissection and rupture of the esophagus can induce intramural hematoma of the esophagus. It is viewed as a complication of endoscopic sclerotherapy of esophageal varices, and is likely caused by an elevation in intraesophageal pressure due to factors such as blood coagulation abnormality, drugs, trauma or vomiting. We describe one case of pill-induced spontaneous intramural hematoma that was successfully managed by conservative treatment and discuss the case with a review of the literature.

An Iatrogenic Coronary Arteriovenous Fistula Caused by Guidewire Trauma during Percutaneous Coronary Intervention / 대한내과학회지

We report the case of a 51-year-old man who presented with worsening exertional chest pain in whom subsequent percutaneous coronary intervention resulted in a coronary arteriovenous fistula. Fortunately, the patient was stable and coronary angiography revealed resolution of the fistula 20 minutes later. This case study emphasizes the management of iatrogenic coronary perforations, depending on the type and severity of perforation, which generally involves initial conservative management.

A Case of Acute Carbon Monoxide Poisoning Resulting in an ST Elevation Myocardial Infarction

Carbon monoxide (CO) is a well-known chemical asphyxiant, which causes tissue hypoxia with prominent neurological and cardiovascular injury. After exposure to CO, several cardiac manifestations have been reported, including arrhythmias, acute myocardial infarction, and pulmonary edema. However, an ST elevation myocardial infarction (STEMI) due to CO poisoning is a very rare presentation, and the treatment for STEMI due to CO poisoning is not well established. Here, we report a rare case of STEMI complicated by increased thrombogenicity secondary to acute CO poisoning and complete revascularization after antithrombotic treatment.

Acute Cerebral Infarction Following Intravenous Glycoprotein IIb/IIIa Inhibitor for Acute Myocardial Infarction

Stroke is a rare but serious complication of acute myocardial infarction (AMI). Currently, glycoprotein (GP) IIb/IIIa inhibitor is used in clinical practice for acute coronary syndromes and percutaneous coronary interventions (PCIs). The incidence of stroke in patients receiving GP IIb/IIIa inhibitor during PCIs is very low. We report the case of a 47-year-old man who presented with AMI and suffered an acute cerebral infarction after infusion of a GP IIb/IIIa inhibitor following primary PCI.

Role of Dyssynchrony on Functional Mitral Regurgitation in Patients with Idiopathic Dilated Cardiomyopathy: A Comparison Study with Geometric Parameters of Mitral Apparatus

BACKGROUND: Functional mitral regurgitation (FMR) occurs commonly in patients with dilated cardiomyopathy (DCM). This study was conducted to explore the role of left ventricular (LV) dyssynchrony in developing FMR in patients with DCM in comparison with geometric parameters of the mitral apparatus. METHODS: Twenty patients without FMR and 33 patients with FMR [effective regurgitant orifice area (ERO) = 0.17 +/- 0.10 cm2] were enrolled. MR severity was estimated with ERO area. Dyssynchrony indices (DI) were measured using the standard deviations of time to peak myocardial systolic velocity between eight segments. Using real time 3D echocardiography, mitral valve tenting area (MVTa), anterior (APMD) and posterior papillary muscle distances (PPMD), LV sphericity, and tethering angle of anterior (Aalpha) and posterior leaflets (Palpha) were estimated. All geometrical measurements were corrected (c) by the height of each patient. RESULTS: The patient with FMR had significantly higher cDI, cMVTa, cAPMD and cPPMD, LV sphericity, Aalpha, and Palpha than the patients without FMR (all p < 0.05). With multiple logistic regression analysis, cMVTa (p = 0.017) found to be strongest predictor of FMR development. In patients with FMR, cMVTa (r = 0.868), cAPMD (r = 0.801), cPPMD (r = 0.742), Aalpha (r = 0.454), LV sphericity (r = 0.452), and DI (r = 0.410) showed significant correlation with ERO. On multivariate regression analysis, cMVTa and cAPMD (p < 0.001, p = 0.022, respectively) remained the strongest determinants of the degree of ERO and cAPMD (p < 0.001) remained the strongest determinant of the degree of cMVTa. CONCLUSION: Displacement of anterior papillary muscle and consequent mitral valve tenting seem to play a major role in developing FMR in DCM, while LV dyssynchrony seems to have no significant role.

Postcardiac Injury Syndrome after Percutaneous Coronary Intervention

The post cardiac injury syndrome is characterized by the development of a fever, pleuropericarditis, and parenchymal pulmonary infiltrates in the weeks following trauma to the pericardium or myocardium. According to previous reports, almost all cases develop after major cardiac surgery or a myocardial infarction. Recently, a few reports have described post cardiac injury syndrome as a complication of endovascular procedures such as percutaneous cardiac intervention. Here we describe an unusual case of post cardiac injury syndrome after a percutaneous coronary intervention.

A Case of Acute Myocardial Infarction with the Anomalous Origin of the Right Coronary Artery from the Ascending Aorta above the Left Sinus of Valsalva and Left Coronary Artery from the Posterior Sinus of Valsalva

Coronary anomalies are rare angiographic findings. Moreover, there are few reports of cases of an anomalous origin of the right coronary artery from the left sinus of Valsalva and of the left coronary artery from the posterior sinus of Valsalva. Here, we report a case with an anomalous origin of the right coronary artery from the ascending aorta above the left sinus of Valsalva and the left coronary artery from the posterior sinus of Valsalva. This was observed in a patient who was treated for a myocardial infarction of the inferior wall caused by a thrombus in the proximal right coronary artery. The patient was treated successfully with the implantation of a stent in the anomalous origin of the right coronary artery using a 6Fr Amplatz left 1 catheter.

Change of the P wave duration and P wave dispersion according to treatment strategy in patients with a acute myocardial infarction / 대한내과학회지

BACKGROUND: P wave dispersion (PWD) and P wave duration have been used to evaluate the discontinuous propagation of sinus impulse and the prolongation of atrial conduction time, respectively. This study was conducted to compare the change of the maximal P wave duration (Pmax) and PWD according to the treatment strategy used in patients with an acute myocardial infarction (AMI). METHODS: We retrospectively evaluated 86 patients that experienced an AMI. Patients were classified into three groups according to the treatment strategy: primary percutaneous coronary intervention (PCI), thrombolytic therapy, and delayed PCI. ECGs that were obtained from all patients on admission and on the second day were analyzed. The Pmax and minimum P wave duration (Pmin) were measured from a 12-lead ECG. The PWD was calculated as the difference between the Pmax and Pmin. RESULT: There was no significant difference in the age, gender, medication, coronary risk factor, ejection fraction, left atrial diameter, basal Pmax and PWD among the groups. However, there were significant differences in P max and PWD between the primary PCI group and the other groups on the second day after hospital admission. In the thrombolytic therapy and delayed PCI groups, the PWD was significantly lower in the patients with a patent infarct-related artery (IRA) than in patients without a patent IRA on the second day after hospital admission. CONCLUSIONS: These findings suggest that a primary PCI decreased the Pmax and PWD more than thrombolytic therapy or a delayed PCI.

The Relationship between the Left Atrial Volume and the Maximum P-wave and P-wave Dispersion in Patients with Congestive Heart Failure

PURPOSE: A maximum P-wave duration (Pmax) of > or = 110msec and a P-wave dispersion (PWD) > or = 40msec are accepted indicators of a disturbance in interatrial conduction and an inhomogeneous propagation of the sinus impulse, respectively. The left atrial (LA) volume has been reported to be strongly associated with a systolic and diastolic dysfunction and is considered to be an index of atrial remodeling. We aimed to investigate the relationship between LA volume and Pmax or PWD in patients with congestive heart failure (CHF). PATIENTS AND METHODS: Sixty-one patients with CHF were enrolled in this study. The study population was classified into four groups: two groups were divided according to the Pmax (> or = 110msec or or = 40msec or or = 110ms or a PWD > or = 40ms and those with a Pmax < 110ms or a PWD < 40ms. The LAVi was independently associated with a disturbance in interatrial conduction and an inhomogeneous propagation of the sinus impulse. The LAVi can be used to identify patients with a disturbance in interatrial conduction and an inhomogeneous propagation of the sinus impulse with reasonably good accuracy. CONCLUSION: We concluded that a disturbance in interatrial conduction and an inhomogenous propagation of the sinus impulse in patients with CHF is associated with an increase in the LA volume and a deleterious systolic and diastolic dysfunction.