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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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Inteligência Artificial , Infarto do Miocárdio , Humanos , Infarto do Miocárdio/mortalidade , Infarto do Miocárdio/diagnóstico , Prognóstico , Masculino , Sistema de Registros , Feminino , República da Coreia , Reprodutibilidade dos Testes , Idoso , Pessoa de Meia-IdadeRESUMO
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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Angiografia Coronária , Doença da Artéria Coronariana , Intervenção Coronária Percutânea , Stents , Tomografia de Coerência Óptica , Humanos , Tomografia de Coerência Óptica/métodos , Angiografia Coronária/métodos , Intervenção Coronária Percutânea/métodos , Doença da Artéria Coronariana/cirurgia , Doença da Artéria Coronariana/diagnóstico por imagem , Inteligência Artificial , Feminino , Estenose Coronária/diagnóstico por imagem , Estenose Coronária/cirurgia , Estenose Coronária/terapia , Estudos de Equivalência como Asunto , Masculino , Cirurgia Assistida por Computador/métodos , Vasos Coronários/diagnóstico por imagem , Vasos Coronários/cirurgiaRESUMO
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).
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Doença da Artéria Coronariana , Stents Farmacológicos , Infarto do Miocárdio , Intervenção Coronária Percutânea , Humanos , Tomografia de Coerência Óptica/métodos , Angiografia Coronária/métodos , Intervenção Coronária Percutânea/métodos , Stents Farmacológicos/efeitos adversos , Ultrassonografia de Intervenção/métodos , Resultado do Tratamento , Doença da Artéria Coronariana/diagnóstico por imagem , Doença da Artéria Coronariana/cirurgia , Infarto do Miocárdio/etiologiaRESUMO
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.
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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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Doença da Artéria Coronariana , Stents Farmacológicos , Infarto do Miocárdio , Intervenção Coronária Percutânea , Humanos , Intervenção Coronária Percutânea/efeitos adversos , Intervenção Coronária Percutânea/métodos , Angiografia Coronária/métodos , Tomografia de Coerência Óptica/métodos , Estudos Prospectivos , Stents Farmacológicos/efeitos adversos , Ultrassonografia de Intervenção/efeitos adversos , Ultrassonografia de Intervenção/métodos , Resultado do Tratamento , Infarto do Miocárdio/etiologia , Doença da Artéria Coronariana/diagnóstico por imagem , Doença da Artéria Coronariana/cirurgiaRESUMO
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.
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Infarto do Miocárdio , Intervenção Coronária Percutânea , Infarto do Miocárdio com Supradesnível do Segmento ST , Humanos , Infarto do Miocárdio com Supradesnível do Segmento ST/terapia , Infarto do Miocárdio com Supradesnível do Segmento ST/tratamento farmacológico , Nicorandil/uso terapêutico , Estudos Prospectivos , Resultado do Tratamento , Infarto do Miocárdio/terapia , Infarto do Miocárdio/tratamento farmacológicoRESUMO
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.
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Oxigenação por Membrana Extracorpórea , Infarto do Miocárdio , Humanos , Choque Cardiogênico/etiologia , Oxigenação por Membrana Extracorpórea/métodos , Balão Intra-Aórtico/efeitos adversos , Infarto do Miocárdio/complicações , Infarto do Miocárdio/terapia , Mortalidade Hospitalar , Estudos RetrospectivosRESUMO
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.
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Fibrilação Atrial , Embolia Pulmonar , Acidente Vascular Cerebral , Trombose , Tromboembolia Venosa , Administração Oral , Anticoagulantes , Fibrilação Atrial/complicações , Humanos , Embolia Pulmonar/diagnóstico , Embolia Pulmonar/tratamento farmacológico , Acidente Vascular Cerebral/etiologia , Trombose/tratamento farmacológico , Tromboembolia Venosa/induzido quimicamente , Tromboembolia Venosa/complicações , Tromboembolia Venosa/tratamento farmacológicoRESUMO
BACKGROUND: The aim of this study was to evaluate the role of the distance between the aortic valve in projected position to the coronary ostium to determine risk of coronary artery obstruction after transcatheter aortic valve replacement (TAVR). METHODS: An Expected Leaflet-to-ostium Distance (ELOD) was obtained on pre-TAVR planning computed tomography by subtracting leaflet thickness and the distances from the center to the annular rim at annulus level and from the center to the coronary ostium at mid-ostial level. Variables were compared between patients with and without coronary obstruction and the level of association between variables was assessed using log odds ratio (OR). RESULTS: A total of 177 patients with 353 coronary arteries was analyzed. Mean annulus diameters (22.8 ± 2.8 mm and 23.4 ± 1.0 mm, p > 0.05) and mean sinus of Valsalva (SOV) diameters (31.2 ± 3.6 mm and 31.9 ± 3.6 mm, p > 0.05) were similar between patients with lower and higher coronary heights, respectively. There were three coronary obstruction cases. ELOD ≤ 2 mm in combination with leaflet length longer than mid-ostial height allowed for discrimination of cases with and without coronary obstruction. There was a significant association between coronary obstruction event and ELOD ≤ 2 mm (log OR = 6.180, p < 0.001). CONCLUSIONS: Our study showed that a combination of ELOD < 2 mm and a longer leaflet length than mid-ostial height may be associated with increased risk for coronary obstruction during TAVR.
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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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Reabilitação Cardíaca , Marca-Passo Artificial , Reabilitação Cardíaca/efeitos adversos , Exercício Físico , Força da Mão , Humanos , Qualidade de VidaRESUMO
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.
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BACKGROUND/AIMS: Untreated rupture of the thoracic aorta is associated with a high mortality rate. We aimed to review the clinical results of endovascular treatment for ruptured thoracic aortic disease. METHODS: We retrospectively reviewed data on 37 patients (mean age, 67.0 ± 15.18 years) treated for ruptured thoracic aortic disease from January 2005 to May 2016. The median follow-up duration was 308 days (interquartile range, 61 to 1,036.5). The primary end-point of the study was the composite of death, secondary intervention, endoleak, and major stroke/paraplegia after endovascular treatment. RESULTS: The etiologies of ruptured thoracic aortic disease were aortic dissection (n = 11, 29.7%), intramural hematoma (n = 7, 18.9%), thoracic aortic aneurysm (n = 14, 37.8%), and traumatic aortic transection (n = 5, 13.5%). Three patients died within 24 hours of thoracic endovascular aortic repair, and one showed type I endoleak. The technical success rate was 89.2% (33/37). The in-hospital mortality rate was 13.5% (5/37); no deaths occurred during follow-up. The composite outcome rate during follow-up was 37.8% (14/37), comprising death (n = 5, 13.5%), secondary intervention (n = 5, 13.5%), endoleak (n = 5, 13.5%), and major stroke/paraplegia (n = 3, 8.1%). Left subclavian artery revascularization and proximal landing zone were not associated with the composite outcome. Low mean arterial pressure (MAP; ≤ 60 mmHg, [hazard ratio, 13.018; 95% confidence interval, 2.435 to 69.583, p = 0.003]) was the most significant predictor and high transfusion requirement in the first 24 hours was associated with event-free survival (log rank p = 0.018). CONCLUSION: Endovascular treatment achieves high technical success rates and acceptable clinical outcome. High transfusion volume and low MAP were associated with poor clinical outcomes.
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Aneurisma da Aorta Torácica , Implante de Prótese Vascular , Procedimentos Endovasculares , Idoso , Idoso de 80 Anos ou mais , Aorta Torácica/diagnóstico por imagem , Aorta Torácica/cirurgia , Aneurisma da Aorta Torácica/diagnóstico por imagem , Aneurisma da Aorta Torácica/cirurgia , Prótese Vascular , Implante de Prótese Vascular/efeitos adversos , Procedimentos Endovasculares/efeitos adversos , Humanos , Pessoa de Meia-Idade , Estudos Retrospectivos , Fatores de Risco , Stents , Resultado do TratamentoRESUMO
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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Materiais Revestidos Biocompatíveis , Reestenose Coronária/cirurgia , Stents Farmacológicos , Intervenção Coronária Percutânea , Animais , Implante de Prótese Vascular/instrumentação , Implante de Prótese Vascular/métodos , Materiais Revestidos Biocompatíveis/química , Materiais Revestidos Biocompatíveis/uso terapêutico , Reestenose Coronária/patologia , Vasos Coronários/patologia , Vasos Coronários/cirurgia , Modelos Animais de Doenças , Interações Hidrofóbicas e Hidrofílicas , Masculino , Intervenção Coronária Percutânea/instrumentação , Intervenção Coronária Percutânea/métodos , Polietilenoglicóis/química , Compostos de Sulfidrila/química , Compostos de Sulfidrila/farmacocinética , SuínosRESUMO
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 Coronários/diagnóstico por imagem , Intervenção Coronária Percutânea , Complicações Pós-Operatórias/prevenção & controle , Cirurgia Assistida por Computador/métodos , Tomografia de Coerência Óptica/métodos , Ultrassonografia de Intervenção/métodos , Pesquisa Comparativa da Efetividade , Angiografia Coronária/métodos , Doença da Artéria Coronariana/diagnóstico , Doença da Artéria Coronariana/cirurgia , Stents Farmacológicos , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Intervenção Coronária Percutânea/efeitos adversos , Intervenção Coronária Percutânea/instrumentação , Intervenção Coronária Percutânea/métodos , Complicações Pós-Operatórias/diagnóstico , Ensaios Clínicos Controlados Aleatórios como Assunto , Risco Ajustado/métodosRESUMO
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.
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Aprendizado de Máquina , Infarto do Miocárdio/mortalidade , Idoso , Idoso de 80 Anos ou mais , Algoritmos , Feminino , Humanos , Modelos Logísticos , Masculino , Pessoa de Meia-Idade , Infarto do Miocárdio/diagnóstico , Infarto do Miocárdio/etiologia , Valor Preditivo dos Testes , Curva ROC , Sistema de Registros , República da Coreia , Medição de Risco , Fatores de Risco , Fatores de TempoRESUMO
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.
Assuntos
Implantes Absorvíveis , Stents Farmacológicos , Infarto do Miocárdio/terapia , Intervenção Coronária Percutânea/instrumentação , Polímeros , Idoso , Causas de Morte , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Infarto do Miocárdio/diagnóstico por imagem , Infarto do Miocárdio/mortalidade , Intervenção Coronária Percutânea/efeitos adversos , Intervenção Coronária Percutânea/mortalidade , Desenho de Prótese , Recidiva , Sistema de Registros , República da Coreia , Medição de Risco , Fatores de Risco , Fatores de Tempo , Resultado do TratamentoAssuntos
Composição Corporal , Adulto , Antropometria , Impedância Elétrica , Humanos , República da CoreiaRESUMO
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).
Assuntos
Tecido Adiposo/diagnóstico por imagem , Fibrilação Atrial/cirurgia , Ablação por Cateter/efeitos adversos , Embolia Intracraniana/epidemiologia , Tomografia Computadorizada Multidetectores , Pericárdio/diagnóstico por imagem , Acidente Vascular Cerebral/epidemiologia , Idoso , Fibrilação Atrial/diagnóstico , Fibrilação Atrial/epidemiologia , Fibrilação Atrial/fisiopatologia , Estudos de Casos e Controles , Feminino , Humanos , Incidência , Embolia Intracraniana/diagnóstico por imagem , Masculino , Pessoa de Meia-Idade , Valor Preditivo dos Testes , Recidiva , Sistema de Registros , República da Coreia/epidemiologia , Medição de Risco , Fatores de Risco , Acidente Vascular Cerebral/diagnóstico por imagem , Fatores de Tempo , Resultado do TratamentoRESUMO
This corrects the article on e198 in vol. 34, PMID: 31373183.