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BACKGROUND: Intravascular imaging-guided percutaneous coronary intervention (PCI) with intravascular ultrasound (IVUS) or optical coherence tomography (OCT) showed superior clinical outcomes compared with angiography-guided PCI. However, the comparative effectiveness of OCT-guided and IVUS-guided PCI regarding clinical outcomes is unknown. METHODS: In this prospective, multicenter, open-label, pragmatic trial, we randomly assigned 2008 patients with significant coronary artery lesions undergoing PCI in a 1:1 ratio to undergo either an OCT-guided or IVUS-guided PCI. The primary end point was a composite of death from cardiac causes, target vessel-related myocardial infarction, or ischemia-driven target-vessel revascularization at 1 year, which was powered for noninferiority of the OCT group compared with the IVUS group. Safety outcomes were also assessed. RESULTS: At 1 year, primary end point events occurred in 25 of 1005 patients (Kaplan-Meier estimate, 2.5%) in the OCT group and in 31 of 1003 patients (Kaplan-Meier estimate, 3.1%) in the IVUS group (absolute difference, -0.6 percentage points; upper boundary of one-sided 97.5% CI, 0.97 percentage points; P<0.001 for noninferiority). The incidence of contrast-induced nephropathy was similar (14 patients [1.4%] in the OCT group versus 15 patients [1.5%] in the IVUS group; P=0.85). The incidence of major procedural complications was lower in the OCT group than in the IVUS group (22 [2.2%] versus 37 [3.7%]; P=0.047), although imaging procedure-related complications were not observed. CONCLUSIONS: In patients with significant coronary artery lesions, OCT-guided PCI was noninferior to IVUS-guided PCI with respect to the incidence of a composite of death from cardiac causes, target vessel-related myocardial infarction, or ischemia-driven target-vessel revascularization at 1 year. The selected study population and lower-than-expected event rates should be considered in interpreting the trial. REGISTRATION: URL: https://www. CLINICALTRIALS: gov; Unique number: NCT03394079.
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Enfermedad de la Arteria Coronaria , Stents Liberadores de Fármacos , Infarto del Miocardio , Intervención Coronaria Percutánea , Humanos , Intervención Coronaria Percutánea/efectos adversos , Intervención Coronaria Percutánea/métodos , Angiografía Coronaria/métodos , Tomografía de Coherencia Óptica/métodos , Estudios Prospectivos , Stents Liberadores de Fármacos/efectos adversos , Ultrasonografía Intervencional/efectos adversos , Ultrasonografía Intervencional/métodos , Resultado del Tratamiento , Infarto del Miocardio/etiología , Enfermedad de la Arteria Coronaria/diagnóstico por imagen , Enfermedad de la Arteria Coronaria/cirugíaRESUMEN
BACKGROUND: Artificial intelligence-based quantitative coronary angiography (AI-QCA) has been developed to provide a more objective and reproducible data about the severity of coronary artery stenosis and the dimensions of the vessel for intervention in real-time, overcoming the limitations of significant inter- and intraobserver variability, and time-consuming nature of on-site QCA, without requiring extra time and effort. Compared with the subjective nature of visually estimated conventional CAG guidance, AI-QCA guidance provides a more practical and standardized angiography-based approach. Although the advantage of intravascular imaging-guided PCI is increasingly recognized, their broader adoption is limited by clinical and economic barriers in many catheterization laboratories. METHODS: The FLASH (fully automated quantitative coronary angiography versus optical coherence tomography guidance for coronary stent implantation) trial is a randomized, investigator-initiated, multicenter, open-label, noninferiority trial comparing the AI-QCA-assisted PCI strategy with optical coherence tomography-guided PCI strategy in patients with significant coronary artery disease. All operators will utilize a novel, standardized AI-QCA software and PCI protocol in the AI-QCA-assisted group. A total of 400 patients will be randomized to either group at a 1:1 ratio. The primary endpoint is the minimal stent area (mm2), determined by the final OCT run after completion of PCI. Clinical follow-up and cost-effectiveness evaluations are planned at 1 month and 6 months for all patients enrolled in the study. RESULTS: Enrollment of a total of 400 patients from the 13 participating centers in South Korea will be completed in February 2024. Follow-up of the last enrolled patients will be completed in August 2024, and primary results will be available by late 2024. CONCLUSION: The FLASH is the first clinical trial to evaluate the feasibility of AI-QCA-assisted PCI, and will provide the clinical evidence on AI-QCA assistance in the field of coronary intervention. CLINICAL TRIAL REGISTRATION: URL: https://www. CLINICALTRIALS: gov. Unique identifier: NCT05388357.
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Angiografía Coronaria , Enfermedad de la Arteria Coronaria , Intervención Coronaria Percutánea , Stents , Tomografía de Coherencia Óptica , Humanos , Tomografía de Coherencia Óptica/métodos , Angiografía Coronaria/métodos , Intervención Coronaria Percutánea/métodos , Enfermedad de la Arteria Coronaria/cirugía , Enfermedad de la Arteria Coronaria/diagnóstico por imagen , Inteligencia Artificial , Femenino , Estenosis Coronaria/diagnóstico por imagen , Estenosis Coronaria/cirugía , Estenosis Coronaria/terapia , Estudios de Equivalencia como Asunto , Masculino , Cirugía Asistida por Computador/métodos , Vasos Coronarios/diagnóstico por imagen , Vasos Coronarios/cirugíaRESUMEN
Exercise-based cardiac rehabilitation (CR) improves the clinical outcomes in patients with cardiovascular diseases. However, few data exist regarding the role of early short-term CR in patients undergoing pacemaker (PM) implantation. We assessed whether short-term CR following PM implantation was sufficient to improve both physical function and quality of life (QOL). A total of 27 patients with a 6-minute walking distance (6MWD) of less than 85% of the predicted value on the day following PM implantation were randomly assigned to either the CR group (n = 12, 44.4%) or the non-CR group (n = 15, 55.6%). The CR group involved individualized exercise-based training with moderate intensity for 4 weeks after PM implantation. Cardiopulmonary exercise test (CPET), 6MWD, muscle strength, and Short Form (SF)-36 were assessed at baseline and at the 4-week follow-up. After a mean follow-up period of 38.3 days, both groups showed significantly improved 6MWD. Peak oxygen uptake improved in both groups on CPET, but the difference was not statistically significant. Knee extension power and handgrip strength were similar in both groups. Regarding QOL, only the CR group showed improved SF-36 scores in the items of vitality and mental health. There was no difference in any subscale in the non-CR group. Neither lead dislodgement nor significant changes in PM parameters were observed in any patient. Early short-term CR following PM implantation was associated with improved psychological subscales and can be safely performed without increasing the risk of procedure-related complications.
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Rehabilitación Cardiaca , Marcapaso Artificial , Rehabilitación Cardiaca/efectos adversos , Ejercicio Físico , Fuerza de la Mano , Humanos , Calidad de VidaRESUMEN
BACKGROUND: The clinical value of intracoronary imaging for percutaneous coronary intervention (PCI) guidance is well acknowledged. Intravascular ultrasound (IVUS) and optical coherence tomography (OCT) are the most commonly used intravascular imaging to guide and optimize PCI in day-to-day practice. However, the comparative effectiveness of IVUS-guided versus OCT-guided PCI with respect to clinical end points remains unknown. METHODS AND DESIGN: The OCTIVUS study is a prospective, multicenter, open-label, parallel-arm, randomized trial comparing the effectiveness of 2 imaging-guided strategies in patients with stable angina or acute coronary syndromes undergoing PCI in Korea. A total of 2,000 patients are randomly assigned in a 1:1 ratio to either an OCT-guided PCI strategy or an IVUS-guided PCI strategy. The trial uses a pragmatic comparative effectiveness design with inclusion criteria designed to capture a broad range of real-world patients with diverse clinical and anatomical features. PCI optimization criteria are predefined using a common algorithm for online OCT or IVUS. The primary end point, which was tested for both noninferiority (margin, 3.1 percentage points for the risk difference) and superiority, is target-vessel failure (cardiac death, target-vessel myocardial infarction, or ischemia-driven target-vessel revascularization) at 1â¯year. RESULTS: Up to the end of July 2020, approximately 1,200 "real-world" PCI patients have been randomly enrolled over 2 years. Enrollment is expected to be completed around the midterm of 2021, and primary results will be available by late 2022 or early 2023. CONCLUSION: This large-scale, multicenter, pragmatic-design clinical trial will provide valuable clinical evidence on the relative efficacy and safety of OCT-guided versus IVUS-guided PCI strategies in a broad population of patients undergoing PCI in the daily clinical practice.
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Vasos Coronarios/diagnóstico por imagen , Intervención Coronaria Percutánea , Complicaciones Posoperatorias/prevención & control , Cirugía Asistida por Computador/métodos , Tomografía de Coherencia Óptica/métodos , Ultrasonografía Intervencional/métodos , Investigación sobre la Eficacia Comparativa , Angiografía Coronaria/métodos , Enfermedad de la Arteria Coronaria/diagnóstico , Enfermedad de la Arteria Coronaria/cirugía , Stents Liberadores de Fármacos , Femenino , Humanos , Masculino , Persona de Mediana Edad , Intervención Coronaria Percutánea/efectos adversos , Intervención Coronaria Percutánea/instrumentación , Intervención Coronaria Percutánea/métodos , Complicaciones Posoperatorias/diagnóstico , Ensayos Clínicos Controlados Aleatorios como Asunto , Ajuste de Riesgo/métodosRESUMEN
Device-related problems of drug-eluting stents, including stent thrombosis related to antiproliferative drugs and polymers, can cause adverse events such as inflammation and neointimal hyperplasia. Stent surface modification, wherein the drug and polymer are not required, may overcome these problems. We developed hydrophilic polyethylene glycol (PEG)-coating and hydrophobic octadecylthiol (ODT)-coating stents without a drug and polymer and evaluated their histopathologic response in a porcine coronary restenosis model. PEG-coating stents (n = 12), bare-metal stents (BMS) (n = 12), and ODT-coating stents (n = 10) were implanted with oversizing in 34 porcine coronary arteries. Four weeks later, the histopathologic response, arterial injury, inflammation, and fibrin scores were analyzed. A p value < 0.05 was considered statistically significant. There were significant differences in the internal elastic lamina area, lumen area, neointimal area, percent area of stenosis, arterial injury score, inflammation score, and fibrin score among the groups. Compared to the BMS or ODT-coating stent group, the PEG-coating stent group had significantly increased internal elastic lamina and lumen area (all p < 0.001) and decreased neointimal area and percent area of stenosis (BMS: p = 0.03 and p < 0.001, respectively; ODT-coating: p = 0.013 and p < 0.001, respectively). Similarly, the PEG-coating group showed significantly lower inflammation and fibrin scores than the BMS or ODT-coating groups (BMS: p = 0.013 and p = 0.007, respectively; ODT-coating: p = 0.014 and p = 0.008, respectively). In conclusion, hydrophilic PEG-coating stent implantation was associated with lower inflammatory response, decreased fibrin deposition, and reduced neointimal hyperplasia than BMS or hydrophobic ODT-coating stent implantation in the porcine coronary restenosis model.
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Materiales Biocompatibles Revestidos , Reestenosis Coronaria/cirugía , Stents Liberadores de Fármacos , Intervención Coronaria Percutánea , Animales , Implantación de Prótesis Vascular/instrumentación , Implantación de Prótesis Vascular/métodos , Materiales Biocompatibles Revestidos/química , Materiales Biocompatibles Revestidos/uso terapéutico , Reestenosis Coronaria/patología , Vasos Coronarios/patología , Vasos Coronarios/cirugía , Modelos Animales de Enfermedad , Interacciones Hidrofóbicas e Hidrofílicas , Masculino , Intervención Coronaria Percutánea/instrumentación , Intervención Coronaria Percutánea/métodos , Polietilenglicoles/química , Compuestos de Sulfhidrilo/química , Compuestos de Sulfhidrilo/farmacocinética , PorcinosRESUMEN
INTRODUCTION: Risk factors of embolic stroke (ES) after atrial fibrillation (AF) ablation have not been fully elucidated especially among the Asian subjects, particularly regarding epicardial adipose tissue (EAT) in cardiac imaging. We aimed to assess the incidence of ES during a long-term follow-up period after AF ablation and to identify the risk factors associated with postablation ES, specifically focusing on EAT. METHODS AND RESULTS: We enrolled patients who experienced postablation ES and control subjects from a consortium of AF ablation registries from three institutes in Korea. EAT was assessed using multislice computed tomography before AF ablation. A total of 3464 patients who underwent AF ablation were recruited and followed-up. During a follow-up of 47.2 ± 36.4 months, ES occurred in 47 patients (1.36%) with a CHA2 DS2 -VASc score of 1.48 ± 1.39 and the overall annual incidence of ES was 0.34%. Compared with the control group (n = 190), the ES group showed significantly higher prior thromboembolism (TE) and AF recurrence rates, larger left atrium size, lower creatinine clearance rate (CCr), and greater total and peri-atrial EAT volume. Multivariate regression analysis demonstrated larger peri-atrial EAT volume (hazards ratio, 1.065; 95% confidence interval, 1.005-1.128), in addition to a prior history of TE and lower CCr, was independently associated with postablation ES. When a cut-off value of peri-atrial EAT volume of ≥20.15 mL was applied, patients with smaller peri-atrial EAT volume showed significantly higher ES-free survival. CONCLUSION: Larger peri-atrial EAT volume, in addition to prior TE and lower CCr, was independently associated with postablation ES regardless of AF recurrence and CHA2 DS2 -VASc score. (ClinicalTrials.gov number, NCT03479073).
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Tejido Adiposo/diagnóstico por imagen , Fibrilación Atrial/cirugía , Ablación por Catéter/efectos adversos , Embolia Intracraneal/epidemiología , Tomografía Computarizada Multidetector , Pericardio/diagnóstico por imagen , Accidente Cerebrovascular/epidemiología , Anciano , Fibrilación Atrial/diagnóstico , Fibrilación Atrial/epidemiología , Fibrilación Atrial/fisiopatología , Estudios de Casos y Controles , Femenino , Humanos , Incidencia , Embolia Intracraneal/diagnóstico por imagen , Masculino , Persona de Mediana Edad , Valor Predictivo de las Pruebas , Recurrencia , Sistema de Registros , República de Corea/epidemiología , Medición de Riesgo , Factores de Riesgo , Accidente Cerebrovascular/diagnóstico por imagen , Factores de Tiempo , Resultado del TratamientoRESUMEN
BACKGROUND: Accurate volume measurement is important in the management of patients with congestive heart failure or renal insufficiency. A bioimpedance analyser can estimate total body water in litres and has been widely used in clinical practice due to its non-invasiveness and ease of results interpretation. To change impedance data to volumetric data, bioimpedance analysers use equations derived from data from healthy subjects, which may not apply to patients with other conditions. Bioelectrical impedance vector analysis (BIVA) was developed to overcome the dependence on those equations by constructing vector plots using raw impedance data. BIVA requires normal reference plots for the proper interpretation of individual vectors. The aim of this study was to construct normal reference vector plots of bioelectrical impedance for Koreans. METHODS: Bioelectrical impedance measurements were collected from apparently healthy subjects screened according to a comprehensive physical examination and medical history performed by trained physicians. Reference vector contours were plotted on the RXc graph using the probability density function of the bivariate normal distribution. We further compared them with those of other ethnic groups. RESULTS: A total of 242 healthy subjects aged 22 to 83 were recruited (137 men and 105 women) between December 2015 and November 2016. The centers of the tolerance ellipses were 306.3 Ω/m and 34.9 Ω/m for men and 425.6 Ω/m and 39.7 Ω/m for women. The ellipses were wider for women than for men. The confidence ellipses for Koreans were located between those for Americans and Spaniards without overlap for both genders. CONCLUSION: This study presented gender-specific normal reference BIVA plots and corresponding tolerance and confidence ellipses on the RXc graph, which is important for the interpretation of BIA-reported volume status in patients with congestive heart failure or renal insufficiency. There were noticeable differences in reference ellipses with regard to gender and ethnic groups.
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Composición Corporal/fisiología , Impedancia Eléctrica , Insuficiencia Cardíaca/diagnóstico , Insuficiencia Renal/diagnóstico , Adulto , Anciano , Anciano de 80 o más Años , Femenino , Humanos , Masculino , Persona de Mediana Edad , República de Corea , Adulto JovenRESUMEN
This corrects the article on e198 in vol. 34, PMID: 31373183.
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BACKGROUND: Atrial fibrillation (AF) frequently coexists with heart failure (HF) with reduced ejection fraction (EF). This meta-analysis compared AF control strategies, that is, rhythm vs. rate, and catheter ablation (CA) vs. anti-arrhythmic drugs (AAD) in patients with AF combined with HF.MethodsâandâResults:The MEDLINE, EMBASE, and CENTRAL databases were searched, and 13 articles from 11 randomized controlled trials with 5,256 patients were included in this meta-analysis. The outcomes were echocardiographic parameters (left ventricular EF, LVEF), left atrial (LA) size, and left ventricular end-systolic volume, LVESV), clinical outcomes (mortality, hospitalization, and thromboembolism), exercise capacity, and quality of life (QOL). In a random effects model, rhythm control was associated with higher LVEF, better exercise capacity, and better QOL than the rate control. When the 2 different rhythm control strategies were compared (CA vs. AAD), the CA group had significantly decreased LA size and LVESV, and improved LVEF and 6-min walk distance, but mortality, hospitalization, and thromboembolism rates were not different between the rhythm and rate control groups. CONCLUSIONS: In AF combined with HF, even though mortality, hospitalization and thromboembolism rates were similar, a rhythm control strategy was superior to rate control in terms of improvement in LVEF, exercise capacity, and QOL. In particular, the CA group was superior to the AAD group for reversal of cardiac remodeling.
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Antiarrítmicos/uso terapéutico , Fibrilación Atrial/terapia , Ablación por Catéter , Sístole , Disfunción Ventricular Izquierda/fisiopatología , Antiarrítmicos/normas , Fibrilación Atrial/fisiopatología , Ablación por Catéter/normas , Ecocardiografía , Prueba de Esfuerzo , Femenino , Humanos , Masculino , Calidad de Vida , Ensayos Clínicos Controlados Aleatorios como Asunto , Volumen Sistólico , Resultado del TratamientoRESUMEN
BACKGROUD: We investigated reverse left ventricular remodelling (r-LVR), defined as a reduction of >10% in left ventricular end-systolic volume (LVESV) during follow-up, in ST-elevation myocardial infarction (STEMI) patients undergoing primary percutaneous coronary intervention (PPCI). METHODS: STEMI patients (n=1,237) undergoing PPCI with echocardiography at baseline and 6-month follow-up were classified into r-LVR (n=466) and no r-LVR groups (n=771). The primary outcome was composite major adverse cardiac events (MACE; all-cause death, myocardial infarction, any revascularisation). RESULTS: r-LVR occurred in 466 patients (37.7%) and was associated with maximum troponin, door-to-balloon time, direct arrival to PPCI-capable hospital, coronary disease extent, initial left ventricular ejection fraction (LVEF), and LVESV. After propensity score (PS)-matching, initial LVEF and LVESV remained significant. During a median 403-day follow-up, 2-year MACE occurred in 166 patients (13.4%); its frequency was similar between groups (entire cohort: 13.5% vs. 13.4%, p=0.247; PS-matched: 11.8% vs. 11.8%, p=0.987). Kaplan-Meier estimates showed that MACE-free survival was comparable between groups (entire cohort: 86.5% vs. 86.6%, log rank p=0.939; PS-matched: 88.2% vs. 88.2%, log rank p=0.867). In Cox proportional hazard analysis, r-LVR was not associated with MACE (entire cohort: hazard ratio [HR] 1.018, 95% confidential interval [CI] 0.675-1.534, p=0.934; PS-matched: HR 1.001, 95% CI 0.578-1.731, p=0.999). CONCLUSION: We identified independent predictors of r-LVR and showed that while r-LVR occurred in 38% of our patients, it was not associated with clinical outcomes.
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Ventrículos Cardíacos/fisiopatología , Intervención Coronaria Percutánea , Complicaciones Posoperatorias/epidemiología , Infarto del Miocardio con Elevación del ST/fisiopatología , Función Ventricular Izquierda/fisiología , Remodelación Ventricular , Anciano , Ecocardiografía , Femenino , Estudios de Seguimiento , Ventrículos Cardíacos/diagnóstico por imagen , Humanos , Incidencia , Masculino , Persona de Mediana Edad , Complicaciones Posoperatorias/diagnóstico , Complicaciones Posoperatorias/fisiopatología , Pronóstico , República de Corea/epidemiología , Infarto del Miocardio con Elevación del ST/diagnóstico , Infarto del Miocardio con Elevación del ST/cirugíaRESUMEN
OBJECTIVES: The aim of this study was to explore the effect of one stenosis in a daughter artery on the fractional flow reserve (FFR) of another stenosis parallels in side branch. BACKGROUND: The impact of one stenosis on the FFR of another parallel stenosis has not been evaluated. METHODS: The proximal segments of the left anterior descending (LAD) and left circumflex (LCX) arteries were exposed and encircled with a Teflon pledget complex in seven swine (55-70 kg). Five degrees of stenosis (to approximate angiographic diameter stenoses of 0%, 25%, 50%, 75%, and 100%) were made by tightening the pledgets. FFR was evaluated simultaneously in the LAD and the LCX with two pressure wires in each coronary artery. A mixed-effects linear model was used to evaluate the association between the FFR values. RESULTS: A total of 115 paired FFR values were obtained. The FFR of the LAD and LCX were not significantly associated with each other (F = 0.237 and P = 0.627 for the LCX FFR to predict the LAD FFR; F = 0.541 and P = 0.463 for the LAD FFR to predict the LCX FFR). CONCLUSIONS: The individual FFR values of each parallel stenosis in the LAD and the LCX were not significantly influenced by each other. This relationship was independent of the mean aortic pressure and heart rate. © 2016 Wiley Periodicals, Inc.
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Estenosis Coronaria/fisiopatología , Vasos Coronarios/fisiopatología , Reserva del Flujo Fraccional Miocárdico , Animales , Aorta/fisiopatología , Presión Arterial , Cateterismo Cardíaco , Angiografía Coronaria , Estenosis Coronaria/diagnóstico por imagen , Vasos Coronarios/diagnóstico por imagen , Modelos Animales de Enfermedad , Frecuencia Cardíaca , Modelos Lineales , Masculino , Modelos Cardiovasculares , Análisis Multivariante , Índice de Severidad de la Enfermedad , PorcinosRESUMEN
Statins are primarily metabolized by cytochrome P450 3A4 (CYP3A4), which reduces clopidogrel to its active metabolite. Recent studies suggest that CYP3A4-metabolized statins attenuate clopidogrel's anti-aggregatory effect on platelets. We aimed to assess the impact of concomitant CYP3A4-metabolized statin and clopidogrel use on antiplatelet activity and clinical outcomes in patients undergoing percutaneous coronary intervention (PCI). We enrolled 1187 patients from the HOST-ASSURE trial with platelet reactivity unit (PRU) values at both baseline and 1 month. Patients were assigned to the CYP3A4-metabolized statin group (group A, n = 725) or non-CYP3A4-metabolized statin group (group B, n = 462) according to type of statin used. Co-primary outcomes were the differences between PRU at baseline and 1 month and the composite of cardiovascular death, recurrent myocardial infarction, stent thrombosis, revascularization, and cerebrovascular accident. We found that follow-up PRU values did not change in group A and decreased significantly in group B (mean difference: -15 ± 79, p < 0.001) in both the crude and matched cohorts. Patients with a high PRU value at baseline, irrespective of statin type, had a significant reduction in mean PRU difference (group A, -62 ± 78, p < 0.001; group B, -59 ± 69, p < 0.001) in both the crude and matched cohorts. The composite of clinical events did not differ between groups in either cohort. CYP3A4-metabolized statins slightly inhibit the antiplatelet activity of clopidogrel during dual antiplatelet therapy. However, they do not inhibit clopidogrel's antiplatelet effect in patients with high platelet reactivity or increase clinical events in patients following PCI.
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Enfermedad de la Arteria Coronaria/terapia , Inhibidores de Hidroximetilglutaril-CoA Reductasas/administración & dosificación , Inhibidores de Agregación Plaquetaria/administración & dosificación , Agregación Plaquetaria/efectos de los fármacos , Ticlopidina/análogos & derivados , Anciano , Clopidogrel , Quimioterapia Combinada , Femenino , Humanos , Modelos Logísticos , Masculino , Persona de Mediana Edad , Análisis Multivariante , Intervención Coronaria Percutánea/efectos adversos , Puntaje de Propensión , Estudios Prospectivos , República de Corea , Ticlopidina/administración & dosificación , Resultado del TratamientoRESUMEN
Percutaneous device closure for secundum atrial septal defects (ASDs) has been performed commonly and safely with high success rates. However, it is still challenging to close ASDs that are surrounded with deficient or hypermobile rims and could be compromised with an unexpected migration of device. We report a case of percutaneous Amplazter Septal Occluder (ASO; St. Jude Medical Inc., St. Paul, Minnesota, USA) device closure for an ASD with a thin and floppy interatrial septum, which immediately migrated into the right atrium and was not pulled back into the delivery sheath. To our knowledge, this is the first report on a successful percutaneous retrieval and redeployment of the device in such a situation, preventing any vascular injury or unplanned emergency open heart surgery.
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Defectos del Tabique Interatrial/terapia , Dispositivo Oclusor Septal , Ecocardiografía Tridimensional , Ecocardiografía Transesofágica , Femenino , Fluoroscopía , Atrios Cardíacos/diagnóstico por imagen , Humanos , Persona de Mediana EdadAsunto(s)
Composición Corporal , Adulto , Antropometría , Impedancia Eléctrica , Humanos , República de CoreaRESUMEN
BACKGROUND: Little is known about the effects of selective intracoronary administration of ergonovine into a coronary artery on the artery on the other side. This study aimed to evaluate the effect of intracoronarily administered ergonovine on the contralateral coronary artery. SUBJECTS AND METHODS: From June 2011 to August 2013, coronary spasm provocation tests were performed in 85 consecutive patients using selective intracoronary administration of methylergometrine maleate (ER).The doses increased in a step-wise manner up to 60 µg for the left coronary artery (LCA) and up to 50 µg for the right coronary artery (RCA).The coronary artery diameters were measured and analysed by repeated-measures ANOVA. RESULTS: Twenty-four (28%) patients had a spasm-positive result. The mean diameter of the spasm segment in the contralateral artery decreased from 2.83 to 2.68 mm (5.1 ± 0.1% change, P < 0.001) in the negative spasm group and from 2.40 to 2.10 mm (11.1 ± 2.2% change, P = 0.001) in the positive spasm group. There were no serious procedure-related complications. CONCLUSIONS: Intracoronary administration of ER resulted in a statistically significant decrease of lumen diameter of the contralateral coronary artery. However, from the clinical perspective, the extent of the decrease was relatively small and the test may be conducted safely unless there is a significant coronary artery luminal narrowing.
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Angina Pectoris Variable/diagnóstico , Vasoespasmo Coronario/inducido químicamente , Vasos Coronarios/efectos de los fármacos , Ergonovina/administración & dosificación , Oxitócicos/administración & dosificación , Angiografía Coronaria , Femenino , Humanos , Inyecciones Intraarteriales , Masculino , Persona de Mediana EdadRESUMEN
OBJECTIVE: Predicting mortality after acute myocardial infarction (AMI) is crucial for timely prescription and treatment of AMI patients, but there are no appropriate AI systems for clinicians. Our primary goal is to develop a reliable and interpretable AI system and provide some valuable insights regarding short, and long-term mortality. MATERIALS AND METHODS: We propose the RIAS framework, an end-to-end framework that is designed with reliability and interpretability at its core and automatically optimizes the given model. Using RIAS, clinicians get accurate and reliable predictions which can be used as likelihood, with global and local explanations, and "what if" scenarios to achieve desired outcomes as well. RESULTS: We apply RIAS to AMI prognosis prediction data which comes from the Korean Acute Myocardial Infarction Registry. We compared FT-Transformer with XGBoost and MLP and found that FT-Transformer has superiority in sensitivity and comparable performance in AUROC and F1 score to XGBoost. Furthermore, RIAS reveals the significance of statin-based medications, beta-blockers, and age on mortality regardless of time period. Lastly, we showcase reliable and interpretable results of RIAS with local explanations and counterfactual examples for several realistic scenarios. DISCUSSION: RIAS addresses the "black-box" issue in AI by providing both global and local explanations based on SHAP values and reliable predictions, interpretable as actual likelihoods. The system's "what if" counterfactual explanations enable clinicians to simulate patient-specific scenarios under various conditions, enhancing its practical utility. CONCLUSION: The proposed framework provides reliable and interpretable predictions along with counterfactual examples.
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Inteligencia Artificial , Infarto del Miocardio , Humanos , Infarto del Miocardio/mortalidad , Infarto del Miocardio/diagnóstico , Pronóstico , Masculino , Sistema de Registros , Femenino , República de Corea , Reproducibilidad de los Resultados , Anciano , Persona de Mediana EdadRESUMEN
BACKGROUND: Optical coherence tomography (OCT) and intravascular ultrasound (IVUS) have shown comparable outcomes in guiding percutaneous coronary intervention (PCI). However, their comparative effectiveness in complex coronary artery lesions remains unclear. OBJECTIVES: This study compared the effectiveness and safety of OCT-guided vs IVUS-guided PCI for complex coronary artery lesions. METHODS: This was a prespecified, main subgroup analysis of complex coronary artery lesions in the OCTIVUS (Optical Coherence Tomography Versus Intravascular Ultrasound Guided Percutaneous Coronary Intervention) trial, which included unprotected left main disease, bifurcation disease, an aorto-ostial lesion, a chronic total occlusion, a severely calcified lesion, an in-stent restenotic lesion, a diffuse long lesion, or multivessel PCI. The primary endpoint was a composite of death from cardiac causes, target vessel-related myocardial infarction, or ischemia-driven target vessel revascularization. RESULTS: In 2,008 randomized patients, 1,475 (73.5%) underwent imaging-guided PCI for complex coronary artery lesions; 719 (48.7%) received OCT-guided and 756 (51.3%) IVUS-guided PCI. At a median follow-up of 2.0 years, primary endpoint event had occurred in 47 patients (6.5%) in the OCT-guided group and in 56 patients (7.4%) in the IVUS-guided group (HR: 0.87; 95% CI: 0.59-1.29; P = 0.50). These findings were consistent in adjusted analyses. The incidence of contrast-induced nephropathy was similar between the 2 groups (1.9% vs 1.5%; P = 0.46). The incidence of major procedural complications was lower in the OCT-guided group than in the IVUS-guided group (1.7% vs 3.4%; P = 0.03). CONCLUSIONS: Among patients with complex coronary artery lesions, OCT-guided PCI showed a similar risk of primary composite event of death from cardiac causes, target vessel-related myocardial infarction, or target vessel revascularization as compared with IVUS-guided PCI. (Optical Coherence Tomography Versus Intravascular Ultrasound Guided Percutaneous Coronary Intervention [OCTIVUS]; NCT03394079).
Asunto(s)
Enfermedad de la Arteria Coronaria , Stents Liberadores de Fármacos , Infarto del Miocardio , Intervención Coronaria Percutánea , Humanos , Tomografía de Coherencia Óptica/métodos , Angiografía Coronaria/métodos , Intervención Coronaria Percutánea/métodos , Stents Liberadores de Fármacos/efectos adversos , Ultrasonografía Intervencional/métodos , Resultado del Tratamiento , Enfermedad de la Arteria Coronaria/diagnóstico por imagen , Enfermedad de la Arteria Coronaria/cirugía , Infarto del Miocardio/etiologíaRESUMEN
BACKGROUND: The polygon of confluence (POC) represents the zone of confluence of the distal left main (LM), ostial left anterior descending (LAD), and ostial left circumflex (LCX) arteries. METHODS: We used intravascular ultrasound (IVUS) to assess the POC pre and post-drug-eluting stent implantation for unprotected distal LM disease. Four segments within 82 LM bifurcation lesions were defined by longitudinal IVUS reconstruction: (1) ostial LAD, (2) POC, and (3) distal LM (DLM)--from LAD-pullback, and (4) ostial LCX from LCX-pullback. RESULTS: Preprocedural minimum lumen area (MLA) and poststenting minimum stent area (MSA) within the LM were mainly located within the POC (51 and 71%). On ROC analysis, a cut-off of the MLA within the POC of 6.1 mm(2) predicted significant LCX carinal stenosis (85% sensitivity, 52% specificity, AUC = 0.7, 95% CI = 0.57-0.78, P < 0.01). Poststenting MSA within the distal LM proximal to the carina (to include DLM and POC) positively correlated with the preprocedural MLA within the POC (r = 0.283, P = 0.02); it was significantly smaller in 48 lesions with a pre-PCI MLA within the POC < 6.1 mm(2) versus 25 lesions with a pre-PCI MLA ≥6.1 mm(2) (7.5 ± 2.1 mm(2) vs. 8.6 ± 2.0 mm(2), P = 0.04). Independent predictors for poststenting LCX carinal MLA also included preprocedural MLA within the POC (ß = 0.240, 95% CI = 0.004-0.353, P = 0.04). CONCLUSION: The MLA within the POC was a good surrogate reflecting the overall severity of LM bifurcation disease including ostial LCX stenosis pre-PCI and the ability to expand a stent within the distal LM as well as final ostial LCX lumen area post-PCI.
Asunto(s)
Enfermedad de la Arteria Coronaria/diagnóstico por imagen , Estenosis Coronaria/diagnóstico por imagen , Vasos Coronarios/diagnóstico por imagen , Ultrasonografía Intervencional , Angiografía Coronaria , Enfermedad de la Arteria Coronaria/terapia , Estenosis Coronaria/terapia , Stents Liberadores de Fármacos , Humanos , Intervención Coronaria Percutánea/efectos adversos , Intervención Coronaria Percutánea/instrumentación , Placa Aterosclerótica , Valor Predictivo de las Pruebas , Reproducibilidad de los Resultados , Índice de Severidad de la Enfermedad , Resultado del TratamientoRESUMEN
There is a dearth of studies investigating whether the combination of low-intensity statins with ezetimibe can reduce the risk of diabetes in patients requiring statin therapy. Therefore, we aimed to evaluate the effects of combination therapy on the prevention of glycated hemoglobin (HbA1c) elevation in patients without diabetes. Sixty-eight patients were randomly assigned in a 1:1 ratio to receive a combination of low-intensity rosuvastatin (5 mg/day) and ezetimibe (10 mg/day) or high-intensity rosuvastatin (20 mg/day). The primary endpoint was the absolute difference in the HbA1c levels at 12 weeks. The HbA1c level showed an overall elevation of 0.11% at 12 weeks compared to that at baseline (mean ± standard deviation: 5.78 ± 0.3%, 95% confidence interval [CI]: 5.86-6.07, p = 0.044). The HbA1c levels did not differ between the groups at 12 weeks (least square mean difference: 0.001, 95% CI: 0.164-0.16, p = 0.999). Our study found that the combination of low-intensity rosuvastatin and ezetimibe did not yield significant differences in HbA1c levels compared to high-intensity rosuvastatin alone after 12 weeks in patients without diabetes. This suggests that the combination of low-intensity rosuvastatin and ezetimibe may not be an effective strategy for preventing HbA1c elevation in patients without diabetes requiring statins.
RESUMEN
Cardiogenic shock (CS) is a common cause of death following acute myocardial infarction (MI). This study aimed to evaluate the adjusted mortality of venoarterial extracorporeal membrane oxygenation (VA-ECMO) with intra-aortic balloon counterpulsation (IABP) for patients with MI-CS. We included 300 MI patients selected from a multinational registry and categorized into VA-ECMO + IABP (N = 39) and no VA-ECMO (medical management ± IABP) (N = 261) groups. Both groups' 30-day and 1-year mortality were compared using the weighted Kaplan-Meier, propensity score, and inverse probability of treatment weighting methods. Adjusted incidences of 30-day (VA-ECMO + IABP vs No VA-ECMO, 77.7% vs 50.7; P = .083) and 1-year mortality (92.3% vs 84.8%; P = .223) along with propensity-adjusted and inverse probability of treatment weighting models in 30-day (hazard ratio [HR], 1.57; 95% confidence interval [CI], 0.92-2.77; P = .346 and HR, 1.44; 95% CI, 0.42-3.17; P = .452, respectively) and 1-year mortality (HR, 1.56; 95% CI, 0.95-2.56; P = .076 and HR, 1.33; 95% CI, 0.57-3.06; P = .51, respectively) did not differ between the groups. However, better survival benefit 30 days post-ECMO could be supposed (31.6% vs 83.4%; P = .022). Therefore, patients with MI-CS treated with IABP with additional VA-ECMO and those not supported with ECMO have comparable overall 30-day and 1-year mortality risks. However, VA-ECMO-supported survivors might have better long-term clinical outcomes.