ABSTRACT
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.
Subject(s)
Coronary Artery Disease , Drug-Eluting Stents , Myocardial Infarction , Percutaneous Coronary Intervention , Humans , Percutaneous Coronary Intervention/adverse effects , Percutaneous Coronary Intervention/methods , Coronary Angiography/methods , Tomography, Optical Coherence/methods , Prospective Studies , Drug-Eluting Stents/adverse effects , Ultrasonography, Interventional/adverse effects , Ultrasonography, Interventional/methods , Treatment Outcome , Myocardial Infarction/etiology , Coronary Artery Disease/diagnostic imaging , Coronary Artery Disease/surgeryABSTRACT
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.
Subject(s)
Cardiac Rehabilitation , Pacemaker, Artificial , Cardiac Rehabilitation/adverse effects , Exercise , Hand Strength , Humans , Quality of LifeABSTRACT
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.
Subject(s)
Coated Materials, Biocompatible , Coronary Restenosis/surgery , Drug-Eluting Stents , Percutaneous Coronary Intervention , Animals , Blood Vessel Prosthesis Implantation/instrumentation , Blood Vessel Prosthesis Implantation/methods , Coated Materials, Biocompatible/chemistry , Coated Materials, Biocompatible/therapeutic use , Coronary Restenosis/pathology , Coronary Vessels/pathology , Coronary Vessels/surgery , Disease Models, Animal , Hydrophobic and Hydrophilic Interactions , Male , Percutaneous Coronary Intervention/instrumentation , Percutaneous Coronary Intervention/methods , Polyethylene Glycols/chemistry , Sulfhydryl Compounds/chemistry , Sulfhydryl Compounds/pharmacokinetics , SwineABSTRACT
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).
Subject(s)
Adipose Tissue/diagnostic imaging , Atrial Fibrillation/surgery , Catheter Ablation/adverse effects , Intracranial Embolism/epidemiology , Multidetector Computed Tomography , Pericardium/diagnostic imaging , Stroke/epidemiology , Aged , Atrial Fibrillation/diagnosis , Atrial Fibrillation/epidemiology , Atrial Fibrillation/physiopathology , Case-Control Studies , Female , Humans , Incidence , Intracranial Embolism/diagnostic imaging , Male , Middle Aged , Predictive Value of Tests , Recurrence , Registries , Republic of Korea/epidemiology , Risk Assessment , Risk Factors , Stroke/diagnostic imaging , Time Factors , Treatment OutcomeABSTRACT
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.
Subject(s)
Body Composition/physiology , Electric Impedance , Heart Failure/diagnosis , Renal Insufficiency/diagnosis , Adult , Aged , Aged, 80 and over , Female , Humans , Male , Middle Aged , Republic of Korea , Young AdultABSTRACT
This corrects the article on e198 in vol. 34, PMID: 31373183.
ABSTRACT
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.
Subject(s)
Anti-Arrhythmia Agents/therapeutic use , Atrial Fibrillation/therapy , Catheter Ablation , Systole , Ventricular Dysfunction, Left/physiopathology , Anti-Arrhythmia Agents/standards , Atrial Fibrillation/physiopathology , Catheter Ablation/standards , Echocardiography , Exercise Test , Female , Humans , Male , Quality of Life , Randomized Controlled Trials as Topic , Stroke Volume , Treatment OutcomeABSTRACT
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.
Subject(s)
Heart Ventricles/physiopathology , Percutaneous Coronary Intervention , Postoperative Complications/epidemiology , ST Elevation Myocardial Infarction/physiopathology , Ventricular Function, Left/physiology , Ventricular Remodeling , Aged , Echocardiography , Female , Follow-Up Studies , Heart Ventricles/diagnostic imaging , Humans , Incidence , Male , Middle Aged , Postoperative Complications/diagnosis , Postoperative Complications/physiopathology , Prognosis , Republic of Korea/epidemiology , ST Elevation Myocardial Infarction/diagnosis , ST Elevation Myocardial Infarction/surgerySubject(s)
Body Composition , Adult , Anthropometry , Electric Impedance , Humans , Republic of KoreaABSTRACT
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.
Subject(s)
Artificial Intelligence , Myocardial Infarction , Humans , Myocardial Infarction/mortality , Myocardial Infarction/diagnosis , Prognosis , Male , Registries , Female , Republic of Korea , Reproducibility of Results , Aged , Middle AgedABSTRACT
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).
Subject(s)
Coronary Artery Disease , Drug-Eluting Stents , Myocardial Infarction , Percutaneous Coronary Intervention , Humans , Tomography, Optical Coherence/methods , Coronary Angiography/methods , Percutaneous Coronary Intervention/methods , Drug-Eluting Stents/adverse effects , Ultrasonography, Interventional/methods , Treatment Outcome , Coronary Artery Disease/diagnostic imaging , Coronary Artery Disease/surgery , Myocardial Infarction/etiologyABSTRACT
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.
Subject(s)
Extracorporeal Membrane Oxygenation , Myocardial Infarction , Humans , Shock, Cardiogenic/etiology , Extracorporeal Membrane Oxygenation/methods , Intra-Aortic Balloon Pumping/adverse effects , Myocardial Infarction/complications , Myocardial Infarction/therapy , Hospital Mortality , Retrospective StudiesABSTRACT
BACKGROUND: We investigated the effect of nicorandil on infarct size, cardiac function assessed by cardiac magnetic resonance imaging (CMR) and outcomes in ST-segment elevation myocardial infarction (STEMI) patients undergoing primary percutaneous coronary intervention (PCI). METHODS: In a prospective, randomised, controlled trial, 83 patients with STEMI receiving primary PCI were randomised into the nicorandil (n =â 40) or placebo (nâ =â 43) groups. Nicorandil was administered in the emergency room before primary PCI as an intravenous bolus of 4 mg followed by a continuous infusion of 6 mg/h for 24 h and as 2-mg intracoronary injections prior to balloon dilatation and coronary stenting. Nicorandil was continued orally at 10-20 mg/d for 6 months. Infarct size and cardiac function were measured by CMR at 5 d and 6 months after primary PCI. Furthermore, major adverse cardiac events (MACEs) including all-cause death, nonfatal myocardial infarction (MI), any revascularisation, stroke, and definite/probable stent thrombosis (ST) were compared. RESULTS: There were no significant differences in baseline clinical characteristics between the groups. Infarct size at baseline and 6 months as well as infarct size changes during 6 months as measured by CMR were similar between the groups. Similarly, other CMR parameters were comparable at baseline and 6 months between the groups. MACEs occurred in four patients (4.8%) during 6 months. No significant difference in the risk of MACEs was observed between the groups. CONCLUSIONS: Treatment with nicorandil for 6 months after primary PCI was not associated with any improvement in infarct size, CMR-determined cardiac function, and outcomes in STEMI patients.
Subject(s)
Myocardial Infarction , Percutaneous Coronary Intervention , ST Elevation Myocardial Infarction , Humans , ST Elevation Myocardial Infarction/therapy , ST Elevation Myocardial Infarction/drug therapy , Nicorandil/therapeutic use , Prospective Studies , Treatment Outcome , Myocardial Infarction/therapy , Myocardial Infarction/drug therapyABSTRACT
BACKGROUND: Non-vitamin K antagonist oral anticoagulants (NOACs) are used to treat acute pulmonary embolism (PE). However, lower NOAC doses are often prescribed because of increased risk of NOAC complications. OBJECTIVE: We sought to determine the incidence and clinical outcomes of patients with acute provoked PE receiving lower NOAC doses. METHOD: 140 patients with acute PE with only NOACs used for medical management was enrolled and were followed up for 6 months. The composite primary endpoint was all-cause death, venous thromboembolism recurrence, and residual thrombus on follow-up computed tomography. RESULTS: Of the 140 patients, 99 (70.7%) received the standard NOAC dose and 41 (29.3%) received the lower dose. The crude incidences of the primary endpoint were 19 (19.2%) in patients who received the standard NOAC dose and 13 (31.7%) in those who received the lower dose. Compared with patients who received the standard dose, those who received the lower dose had no differences in the rate of primary endpoints (hazard ratio 1.140, 95% confidence interval 0.536-2.423, p = 0.733) during a median of 185 days. CONCLUSION: We found that up to 30% of patients received the lower dose of NOACs for acute PE in clinical practice. Clinical outcomes with appropriate underdoing of NOAC treated in acute PE might not increase compared to the standard NOAC doses.
Subject(s)
Atrial Fibrillation , Pulmonary Embolism , Stroke , Thrombosis , Venous Thromboembolism , Administration, Oral , Anticoagulants , Atrial Fibrillation/complications , Humans , Pulmonary Embolism/diagnosis , Pulmonary Embolism/drug therapy , Stroke/etiology , Thrombosis/drug therapy , Venous Thromboembolism/chemically induced , Venous Thromboembolism/complications , Venous Thromboembolism/drug therapyABSTRACT
To assess the temporal trends of bleeding episodes during half- vs. standard-dose ticagrelor in acute coronary syndrome (ACS) patients with low platelet reactivity (LPR) during standard-dose ticagrelor (90 mg bid). ACS Patients with LPR (<85 P2Y12 reaction units) (n = 122) were randomly assigned to receive either half-dose (45 mg bid) or standard-dose ticagrelor (90 mg bid). The primary endpoint was incidence of Bleeding Academic Research Consortium (BARC) bleeding at 1 week, 1, 3 and 6 months. Dyspnea and ischemic events were also evaluated. Bleeding episodes were most commonly observed at 1 month and then decreased over time. Half-dose ticagrelor did not reduce any BARC bleeding (odds ratio [OR] 0.900, 95% confidence interval [CI] 0.563-1.440, p = 0.661). However, serious bleeding (BARC type ≥2) occurred less often in half-dose ticagrelor (OR 0.284, 95% CI 0.088-0.921, p = 0.036). The rate of moderate-to-severe dyspnea was highest at 1 month, then decreased over time. Half-dose ticagrelor did not decrease moderate-to-severe dyspnea (Borg scale ≥ 3) (OR 1.066, 95% CI 0.322-3.530, p = 0.916). The risk of ischemic events was also similar between the groups. In conclusions, compared with standard-dose ticagrelor, half-dose ticagrelor reduced serious bleeding events during early period of dual-antiplatelet therapy in ACS patients with LPR; however, the risk of any bleeding events and dyspnea did not differ according to ticagrelor dose. Clinical registration: KCT0004640.
ABSTRACT
Risk stratification at hospital discharge could be instrumental in guiding postdischarge care. In this study, the risk models for 1-year mortality using machine learning (ML) were evaluated for guiding management of acute myocardial infarction (AMI) patients. From the Korea Acute Myocardial Infarction Registry (KAMIR) dataset, 22,182 AMI patients were selected. The 1-year all-cause mortality was recorded at 12-month follow-up periods. Anomaly detection was conducted for removing outliers; principal component analysis for dimensionality reduction, recursive feature elimination algorithm for feature selection. Model selection and training were conducted with 70% of the dataset after the creation and cross-validation of hundreds of models with decision trees, ensembles, logistic regressions, and deepnets algorithms. The rest of the dataset (30%) was used for comparison between the ML and KAMIR score-based models. The mean age of the AMI patients was 64 years, 71.8% were male, and 56.7% were eventually diagnosed with ST-elevation myocardial infarction. There were 1,332 patients suffering from all-cause mortality (6%) during a median 338 days of follow-up. The ML models for 1-year mortality were well-calibrated (Hosmer-Lemeshow p >0.05) and showed good discrimination (area under the curve for test cohort: 0.918). Compared with the performance of the KAMIR score model, the ML model had a higher area under the curve, net reclassification improvement, and integrated discrimination improvement. The ML model for 1-year mortality was well-calibrated and had excellent discriminatory ability and higher performance. In a comprehensive clinical evaluation process, this model could support risk stratification and management in postdischarge AMI patients.
Subject(s)
Machine Learning , Myocardial Infarction/mortality , Aged , Aged, 80 and over , Algorithms , Female , Humans , Logistic Models , Male , Middle Aged , Myocardial Infarction/diagnosis , Myocardial Infarction/etiology , Predictive Value of Tests , ROC Curve , Registries , Republic of Korea , Risk Assessment , Risk Factors , Time FactorsABSTRACT
OBJECTIVES: This study sought to compare outcomes between biodegradable polymer drug-eluting stent (BP-DES) and second-generation durable polymer drug-eluting stent (DP-DES) implantations for acute myocardial infarction (MI) using a nationwide dataset. BACKGROUND: Data regarding outcomes of BP-DES versus second-generation DP-DES are inconclusive. METHODS: Among 13,104 patients with acute MI in a nationwide registry who underwent percutaneous coronary intervention (November 2011 to December 2015), BP-DES and second-generation DP-DES were implanted in 2,261 (21.7%) and 8,182 patients (78.3%), respectively. Major adverse cardiac events (MACE) (all-cause death, recurrent MI, or any revascularization) were compared in multivariable Cox regression, propensity score (PS) matched, and underwent PS-adjusted analyses. RESULTS: MACE occurred in 1,492 (14.3%) patients during a median 723-day follow-up. MACE were less frequent with BP-DES implantation than with second-generation DP-DES implantation (entire cohort hazard ratio [HR]: 0.845; 95% confidence interval [CI]: 0.740 to 0.965; PS-matched HR: 0.669; 95% CI: 0.550 to 0.814). Risk of all-cause death (entire cohort HR: 0.831; 95% CI: 0.692 to 0.997; PS-matched HR: 0.752; 95% CI: 0.495 to 0.931), cardiac death (entire cohort HR: 0.685; 95% CI: 0.542 to 0.865; PS-matched HR: 0.613; 95% CI: 0.463 to 0.872), recurrent MI (entire cohort HR: 0.662; 95% CI: 0.466 to 0.941; PS-matched HR: 0.611; 95% CI: 0.427 to 0.898), and heart failure readmission (entire cohort HR: 0.625; 95% CI: 0.447 to 0.875; PS-matched HR: 0.584; 95% CI: 0.385 to 0.887) was less with BP-DES implantation. There were no significant group differences in the incidences of any revascularization, stroke, and definite or probable stent thrombosis. CONCLUSIONS: In patients with acute MI who underwent percutaneous coronary intervention, BP-DES implantation is associated with improved outcomes compared with second-generation DP-DES implantation.
Subject(s)
Absorbable Implants , Drug-Eluting Stents , Myocardial Infarction/therapy , Percutaneous Coronary Intervention/instrumentation , Polymers , Aged , Cause of Death , Female , Humans , Male , Middle Aged , Myocardial Infarction/diagnostic imaging , Myocardial Infarction/mortality , Percutaneous Coronary Intervention/adverse effects , Percutaneous Coronary Intervention/mortality , Prosthesis Design , Recurrence , Registries , Republic of Korea , Risk Assessment , Risk Factors , Time Factors , Treatment OutcomeABSTRACT
BACKGROUND: To compare the prescription rates, safety, and efficacy of contemporary P2Y12 inhibitors in acute coronary syndrome (ACS) patients following percutaneous coronary intervention (PCI). METHODS: From 9684 ACS patients who underwent PCI in a nationwide, real-world registry, we compared prescription rates, bleeding, and major adverse cardiac events (MACEs: cardiac death, nonfatal myocardial infarction, or stroke) according to ticagrelor, prasugrel, or clopidogrel use. RESULTS: The prescription rates of ticagrelor, prasugrel, and clopidogrel were 15.2%, 11.7%, and 73.0%, respectively. In-hospital bleeding occurred in 565 (5.8%) patients, with 108 (7.3%), 80 (7.9%), and 377 (5.3%) patients using ticagrelor, prasugrel, and clopidogrel, respectively, with significantly higher incidence in ticagrelor (pâ¯=â¯0.008) and prasugrel (pâ¯=â¯0.026) users than in clopidogrel users. Ticagrelor and prasugrel were not different in terms of in-hospital bleeding (pâ¯=â¯0.159). MACEs occurred in 804 patients (8.3%), with 82 (5.6%), 69 (6.1%), and 653 (9.2%) patients in ticagrelor, prasugrel, and clopidogrel, respectively (median follow-up, 468â¯days). Ticagrelor (pâ¯=â¯0.001) and prasugrel (pâ¯=â¯0.001) were associated with fewer MACEs than clopidogrel; the difference between ticagrelor and prasugrel for fewer MACEs was nonsignificant (pâ¯=â¯0.235). CONCLUSIONS: In real-world ACS patients following PCI, ticagrelor and prasugrel were not prescribed at higher rates than clopidogrel, but were found to improve clinical outcomes, albeit they induced bleeding more frequently. No differences were observed in bleeding and outcomes in ticagrelor versus prasugrel.
Subject(s)
Acute Coronary Syndrome/drug therapy , Drug Prescriptions/statistics & numerical data , Percutaneous Coronary Intervention , Purinergic P2Y Receptor Antagonists/therapeutic use , Registries , Acute Coronary Syndrome/mortality , Acute Coronary Syndrome/surgery , Cause of Death/trends , Clopidogrel/therapeutic use , Follow-Up Studies , Hemorrhage/chemically induced , Hemorrhage/epidemiology , Humans , Prasugrel Hydrochloride/therapeutic use , Prognosis , Prospective Studies , Republic of Korea/epidemiology , Survival Rate/trends , Ticagrelor/therapeutic useABSTRACT
BACKGROUND: We aimed to investigate if left ventricular electromechanical delay (LVEMD) prolongation predicts trastuzumab-induced cardiotoxicity (TIC) in breast cancer patients. HYPOTHESIS: LVEMD prolongation on serial echocardiograms could be an indicator of subclinical TIC. METHODS: We included 237 breast cancer patients receiving trastuzumab chemotherapy, who underwent echocardiography at baseline and at 6 and 12 months after trastuzumab initiation. LVEMD was defined as the time from electrical activation to myocardial contraction. TIC was defined as left ventricular ejection fraction (LVEF) worsening to <55%, either as symptomatic decrease of ≥5% or asymptomatic decrease of ≥10%. RESULTS: During a mean follow-up of 547 days, TIC occurred in 27 patients (11.4%). Changes in the time intervals from QRS onset on electrocardiography to the beginning and peak of transaortic flow on pulsed-wave Doppler echocardiography (ie, ΔLVEMDi and ΔLVEMDp, respectively) were independent predictors of TIC. On receiver operating characteristic curve analysis, the optimal cutoff value for TIC prediction was 23 milliseconds for ΔLVEMDi (sensitivity, 0.85; specificity, 0.78; area under the curve [AUC], 0.882) and 21 milliseconds for ΔLVEMDp (sensitivity, 0.96; specificity, 0.68; AUC, 0.860). The C-index for TIC prediction increased significantly after adding ΔLVEMDi and ΔLVEMDp to conventional models that included clinical variables, baseline LVEF, and changes in global longitudinal peak systolic strain. Similarly, adding ΔLVEMDi or ΔLVEMDp to conventional models provided significant improvement in discrimination capability for TIC prediction (integrated discrimination improvement and continuous net reclassification improvement index). CONCLUSION: ΔLVEMDi and ΔLVEMDp may serve as predictors of subclinical cardiac dysfunction in breast cancer patients receiving trastuzumab.
Subject(s)
Breast Neoplasms/drug therapy , Electrocardiography/drug effects , Myocardial Contraction/drug effects , Stroke Volume/drug effects , Trastuzumab/adverse effects , Ventricular Dysfunction, Left/chemically induced , Ventricular Function, Left/drug effects , Antineoplastic Agents, Immunological/administration & dosage , Antineoplastic Agents, Immunological/adverse effects , Cardiotoxicity , Dose-Response Relationship, Drug , Echocardiography, Doppler, Pulsed , Female , Follow-Up Studies , Humans , Middle Aged , Myocardial Contraction/physiology , Prognosis , Prospective Studies , Stroke Volume/physiology , Time Factors , Trastuzumab/administration & dosage , Ventricular Dysfunction, Left/diagnosis , Ventricular Dysfunction, Left/physiopathology , Ventricular Function, Left/physiologyABSTRACT
We evaluated whether prior statin therapy reduces in-hospital ventricular tachycardia/ventricular fibrillation (VT/VF) in percutaneous coronary intervention (PCI) patients with acute myocardial infarction (MI). Among the 1177 patients from the Acute Myocardial Infarction Registry-National Institutes of Health (KAMIR-NIH), 823 (70%) patients received prior statin therapy. Prior statin therapy was associated with a reduced risk of VT/VF events in both adjusted propensity score analysis (odds ratio [OR] 0.414, 95% confidence interval [CI], 0.198-0.865, P = .019) and adjusted inverse probability of treatment weight analysis (OR 0.463, 95% CI, 0.216-0.994, P = .048). The risk of in-hospital death did not differ significantly between those with or without prior statin therapy (hazard ratio [HR] 0.416, 95% CI, 0.112-1.548, P = .191). Major adverse cardiac events occurred in 116 (8.9%) patients during follow-up. Prior statin therapy was associated with a lower risk of major adverse cardiac events during the follow-up period (HR 0.486, 95% CI, 0.243-0.974, P = .042); however, this was mainly driven by reduced noncardiac death. Prior statin therapy might reduce the incidence of serious cardiac tachyarrhythmia, such as VT/VF, in patients with MI undergoing PCI. However, the reduction in VT/VF due to prior statin therapy did not improve short- and long-term clinical outcomes.