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

Mitochondrial Quality Control in the Heart: New Drug Targets for Cardiovascular Disease

Despite considerable efforts to prevent and treat cardiovascular disease (CVD), it has become the leading cause of death worldwide. Cardiac mitochondria are crucial cell organelles responsible for creating energy-rich ATP and mitochondrial dysfunction is the root cause for developing heart failure. Therefore, maintenance of mitochondrial quality control (MQC) is an essential process for cardiovascular homeostasis and cardiac health. In this review, we describe the major mechanisms of MQC system, such as mitochondrial unfolded protein response and mitophagy. Moreover, we describe the results of MQC failure in cardiac mitochondria. Furthermore, we discuss the prospects of 2 drug candidates, urolithin A and spermidine, for restoring mitochondrial homeostasis to treat CVD.

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.

Mitochondrial Quality Control in the Heart: New Drug Targets for Cardiovascular Disease

Despite considerable efforts to prevent and treat cardiovascular disease (CVD), it has become the leading cause of death worldwide. Cardiac mitochondria are crucial cell organelles responsible for creating energy-rich ATP and mitochondrial dysfunction is the root cause for developing heart failure. Therefore, maintenance of mitochondrial quality control (MQC) is an essential process for cardiovascular homeostasis and cardiac health. In this review, we describe the major mechanisms of MQC system, such as mitochondrial unfolded protein response and mitophagy. Moreover, we describe the results of MQC failure in cardiac mitochondria. Furthermore, we discuss the prospects of 2 drug candidates, urolithin A and spermidine, for restoring mitochondrial homeostasis to treat CVD.

Cardioprotective Potential of an SGLT2 Inhibitor Against Doxorubicin-Induced Heart Failure

BACKGROUND AND OBJECTIVES@#Recent studies have shown that sodium-glucose co-transporter 2 (SGLT2) inhibitors reduce the risk of heart failure (HF)-associated hospitalization and mortality in patients with diabetes. However, it is not clear whether SGLT2 inhibitors have a cardiovascular benefit in patients without diabetes. We aimed to determine whether empagliflozin (EMPA), an SGLT2 inhibitor, has a protective role in HF without diabetes.@*METHODS@#Cardiomyopathy was induced in C57BL/6J mice using intraperitoneal injection of doxorubicin (Dox). Mice with HF were fed a normal chow diet (NCD) or an NCD containing 0.03% EMPA. Then we analyzed their phenotypes and performed in vitro experiments to reveal underlying mechanisms of the EMPA's effects.@*RESULTS@#Mice fed NCD with EMPA showed improved heart function and reduced fibrosis. In vitro studies showed similar results. Phloridzin, a non-specific SGLT inhibitor, did not show any protective effect against Dox toxicity in H9C2 cells. SGLT2 inhibitor can cause increase in blood ketone levels. Beta hydroxybutyrate (βOHB), which is well known ketone body associated with SGLT2 inhibitor, showed a protective effect against Dox in H9C2 cells and in Dox-treated mice. These results suggest elevating βOHB might be a convincing mechanism for the protective effects of SGLT2 inhibitor.@*CONCLUSIONS@#SGLT2 inhibitors have a protective effect in Dox-induced HF in mice. This implied that SGLT2 inhibitor therapy could be a good treatment strategy even in HF patients without diabetes.

Cardioprotective Potential of an SGLT2 Inhibitor Against Doxorubicin-Induced Heart Failure

BACKGROUND AND OBJECTIVES: Recent studies have shown that sodium-glucose co-transporter 2 (SGLT2) inhibitors reduce the risk of heart failure (HF)-associated hospitalization and mortality in patients with diabetes. However, it is not clear whether SGLT2 inhibitors have a cardiovascular benefit in patients without diabetes. We aimed to determine whether empagliflozin (EMPA), an SGLT2 inhibitor, has a protective role in HF without diabetes. METHODS: Cardiomyopathy was induced in C57BL/6J mice using intraperitoneal injection of doxorubicin (Dox). Mice with HF were fed a normal chow diet (NCD) or an NCD containing 0.03% EMPA. Then we analyzed their phenotypes and performed in vitro experiments to reveal underlying mechanisms of the EMPA's effects. RESULTS: Mice fed NCD with EMPA showed improved heart function and reduced fibrosis. In vitro studies showed similar results. Phloridzin, a non-specific SGLT inhibitor, did not show any protective effect against Dox toxicity in H9C2 cells. SGLT2 inhibitor can cause increase in blood ketone levels. Beta hydroxybutyrate (βOHB), which is well known ketone body associated with SGLT2 inhibitor, showed a protective effect against Dox in H9C2 cells and in Dox-treated mice. These results suggest elevating βOHB might be a convincing mechanism for the protective effects of SGLT2 inhibitor. CONCLUSIONS: SGLT2 inhibitors have a protective effect in Dox-induced HF in mice. This implied that SGLT2 inhibitor therapy could be a good treatment strategy even in HF patients without diabetes.

Relationship between Clinical Outcomes and Cardiopulmonary Resuscitation Time in Patients with Acute Myocardial Infarction Treated by Extracorporeal Membrane Oxygenation-Assisted Primary Percutaneous Coronary Intervention

BACKGROUND AND OBJECTIVES@#Extracorporeal membrane oxygenation (ECMO) support is increasingly used in primary percutaneous coronary intervention (PCI) during cardiopulmonary resuscitation (CPR) to treat acute myocardial infarction (AMI) patients who experienced cardiogenic shock. However, to date, there have been no studies on the relationship between clinical outcomes and CPR time in such patients with AMI treated by ECMO-assisted primary PCI.@*METHODS@#From July 2008 to March 2016, we analyzed data from 42 AMI with cardiogenic shock patients who underwent CPR and were treated by ECMO-assisted primary PCI. The primary outcome was 30-day in-hospital mortality after primary PCI. The predictors of mortality were determined using a Cox proportional hazards model.@*RESULTS@#Thirty-day in-hospital mortality was observed for 33 patients (78.6%). The mean CPR time was 37.0±37.3 minutes. The best cut-off CPR time value associated with clinical outcome was calculated to be 12.5 minutes using receiver operating characteristic curve analysis. Multivariate analysis revealed that CPR time of > 12.5 minutes was an independent predictor of 30-day mortality (adjusted hazard ratio, 4.71; 95% confidence interval, 1.30–17.406; p=0.018).@*CONCLUSIONS@#Despite ECMO support, the clinical outcomes of AMI patients with a complication of cardiogenic shock remain poor. Prolonged CPR time is associated with a poor prognosis in patients with AMI treated by ECMO-assisted primary PCI.

Relationship between Clinical Outcomes and Cardiopulmonary Resuscitation Time in Patients with Acute Myocardial Infarction Treated by Extracorporeal Membrane Oxygenation-Assisted Primary Percutaneous Coronary Intervention

BACKGROUND AND OBJECTIVES: Extracorporeal membrane oxygenation (ECMO) support is increasingly used in primary percutaneous coronary intervention (PCI) during cardiopulmonary resuscitation (CPR) to treat acute myocardial infarction (AMI) patients who experienced cardiogenic shock. However, to date, there have been no studies on the relationship between clinical outcomes and CPR time in such patients with AMI treated by ECMO-assisted primary PCI. METHODS: From July 2008 to March 2016, we analyzed data from 42 AMI with cardiogenic shock patients who underwent CPR and were treated by ECMO-assisted primary PCI. The primary outcome was 30-day in-hospital mortality after primary PCI. The predictors of mortality were determined using a Cox proportional hazards model. RESULTS: Thirty-day in-hospital mortality was observed for 33 patients (78.6%). The mean CPR time was 37.0±37.3 minutes. The best cut-off CPR time value associated with clinical outcome was calculated to be 12.5 minutes using receiver operating characteristic curve analysis. Multivariate analysis revealed that CPR time of > 12.5 minutes was an independent predictor of 30-day mortality (adjusted hazard ratio, 4.71; 95% confidence interval, 1.30–17.406; p=0.018). CONCLUSIONS: Despite ECMO support, the clinical outcomes of AMI patients with a complication of cardiogenic shock remain poor. Prolonged CPR time is associated with a poor prognosis in patients with AMI treated by ECMO-assisted primary PCI.

Multi-vessel intractable coronary spasm development in a patient with aborted sudden cardiac death: a case study with intravascular ultrasound findings / 영남의대학술지

Coronary spasm generally occurs in patients with minimal atherosclerotic plaque lesion, and it has a rather favorable prognosis. However, in some cases, coronary spasm may induce myocardial infarction and even sudden cardiac death (SCD). Here, we report a case in which multi-vessel intractable coronary vasospasm suddenly occurred in a diffuse atherosclerotic lesion after percutaneous coronary intervention (PCI) in a patient with aborted SCD. We identified the characteristics of the spasm portion in intravascular ultrasound (IVUS) images and conducted percutaneous cardiopulmonary bypass support-PCI with stenting as treatment. Intima and media thickening and a large attenuated plaque burden with rupture were identified in IVUS images at the obstructive spasm portion.

Multi-vessel intractable coronary spasm development in a patient with aborted sudden cardiac death: a case study with intravascular ultrasound findings / 영남의대학술지

Coronary spasm generally occurs in patients with minimal atherosclerotic plaque lesion, and it has a rather favorable prognosis. However, in some cases, coronary spasm may induce myocardial infarction and even sudden cardiac death (SCD). Here, we report a case in which multi-vessel intractable coronary vasospasm suddenly occurred in a diffuse atherosclerotic lesion after percutaneous coronary intervention (PCI) in a patient with aborted SCD. We identified the characteristics of the spasm portion in intravascular ultrasound (IVUS) images and conducted percutaneous cardiopulmonary bypass support-PCI with stenting as treatment. Intima and media thickening and a large attenuated plaque burden with rupture were identified in IVUS images at the obstructive spasm portion.

Recurrent Acute Myocardial Infarction Caused by Intra-cardiac Metastatic Undifferentiated Pleomorphic Sarcoma during Cancer Treatment

No abstract available.