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Background: Evidence regarding the association between hyperuricemia and arrhythmia recurrence after catheter ablation for paroxysmal atrial fibrillation (AF) is scarce. We investigated whether hyperuricemia predicts arrhythmia recurrence after catheter ablation for paroxysmal AF and the relationship between hyperuricemia and alcohol consumption in AF recurrence. Methods: Patients who underwent catheter ablation for paroxysmal AF were divided into the hyperuricemia (index serum uric acid [UA] >7.0 mg/dL; n = 114) and control (UA ≤7.0 mg/dL; n = 609) groups and were followed for a median of 24 (12-48) months after ablation. Results: The hyperuricemia group had more patients with an alcohol intake of ≥20 g/day (33.3% vs. 22.7%, p = .017) and a lower incidence of AF-free survival (p = .019). Similarly, those with an alcohol intake of ≥20 g/day had a lower incidence of AF-free survival than other patients. Multivariate Cox regression analysis revealed the following independent predictors of AF recurrence (adjusted hazard ratio, 95% confidence interval): hyperuricemia (1.64, 1.12-2.40), female gender (1.91, 1.36-2.67), brain natriuretic peptide level >100 pg/mL (1.59, 1.14-2.22), and alcohol consumption ≥20 g/day (1.49, 1.03-2.15) (all p < .05). In addition, causal mediation analysis revealed that alcohol consumption of ≥20 g/day directly affected AF recurrence, independent of hyperuricemia. Conclusions: Patients with hyperuricemia may be at a high risk of arrhythmia recurrence after catheter ablation for paroxysmal AF. Although high alcohol consumption may contribute to increased UA levels, the presence of hyperuricemia may independently predict AF recurrence.
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Anamorelin, a ghrelin receptor agonist, is used for cancer-related cachexia but can induce life-threatening arrhythmias. A case study illustrates an extremely wide QRS tachycardia, posing diagnostic challenges. Anamorelin cessation led to normalization, highlighting the importance of ECG monitoring, particularly in liver-compromised patients, and hemodynamic support are crucial during suspected toxicity.
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The current guidelines for acute coronary syndrome (ACS) discourage the use of anticoagulation after percutaneous coronary intervention (PCI) without specific indications, although the recommendation is not well supported by evidence. In this post hoc analysis of the ShorT and OPtimal Duration of Dual AntiPlatelet Therapy-3 (STOPDAPT-3) trial, 30-day outcomes were compared between the 2 groups with and without post-PCI heparin administration among patients with ACS who did not receive mechanical support devices. The co-primary end points were the bleeding end point, defined as the Bleeding Academic Research Consortium type 3 or 5 bleeding, and the cardiovascular end point, defined as a composite of cardiovascular death, myocardial infarction, definite stent thrombosis, or ischemic stroke. Among 4,088 patients with ACS, 2,339 patients (57.2%) received post-PCI heparin. The proportion of patients receiving post-PCI heparin was higher among those with ST-elevation myocardial infarction compared with others (72.3% and 38.8%, p <0.001), and among patients with intraprocedural adverse angiographic findings compared with those without (67.6% and 47.5%, p <0.001). Post-PCI heparin compared with no post-PCI heparin was associated with a significantly increased risk of the bleeding end point (4.75% and 2.52%, adjusted hazard ratio 1.69, 95% confidence interval 1.15 to 2.46, p = 0.007) and a numerically increased risk of the cardiovascular end point (3.16% and 1.72%, adjusted hazard ratio 1.56, 95% confidence interval 0.98 to 2.46, p = 0.06). Higher hourly dose or total doses of heparin were also associated with higher incidence of both bleeding and cardiovascular events within 30 days. In conclusion, post-PCI anticoagulation with unfractionated heparin was frequently implemented in patients with ACS. Post-PCI heparin use was associated with harm in terms of increased bleeding without the benefit of reducing cardiovascular events. Trial identifier: STOPDAPT-3 ClinicalTrials.gov number, NCT04609111.
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Síndrome Coronario Agudo , Anticoagulantes , Heparina , Intervención Coronaria Percutánea , Humanos , Heparina/uso terapéutico , Heparina/administración & dosificación , Síndrome Coronario Agudo/tratamiento farmacológico , Síndrome Coronario Agudo/terapia , Masculino , Femenino , Anticoagulantes/uso terapéutico , Anticoagulantes/administración & dosificación , Persona de Mediana Edad , Anciano , Intervención Coronaria Percutánea/métodos , Hemorragia/inducido químicamente , Hemorragia/epidemiología , Inhibidores de Agregación Plaquetaria/uso terapéutico , Terapia Antiplaquetaria Doble/métodosRESUMEN
BACKGROUND: Steatotic liver disease (SLD) is associated with adverse cardiac events. Metabolic dysfunction-associated steatotic liver disease (MASLD) has emerged as a condition characterized by the abnormal accumulation of hepatic lipids that is closely linked to five metabolic disorders: overweight or obesity, impaired glucose regulation, hypertension, hypertriglyceridemia, and low high-density lipoprotein-cholesterol. This retrospective study aimed to stratify the risk of cardiac events in patients with MASLD. METHODS: Patients diagnosed with MASLD through ultrasonography were evaluated. We implemented a machine learning-based approach using a survival classification and regression tree (CART) model to stratify patients based on age, and the number of risk scores was investigated as a predictor of adverse outcomes in the derivation cohort. The primary outcomes were major adverse cardiac events (MACE) including cardiac death, nonfatal myocardial infarction, and revascularization due to coronary artery disease. RESULTS: Among 2,962 patients (median age, 62 years; men, 53.5 %), the distribution of risk factors was as follows: one (10.8 %), two (28.5 %), three (33.0 %), four (19.9 %), and five (7.8 %). Over a median follow-up period of 6.8 years, 170 (5.7 %) patients experienced MACE. In the derivation cohort of 2,073 patients, the CART model identified age ≥60 years old and risk factors ≥4 as significant predictors of MACE. These findings were corroborated in a validation cohort of 889 patients. Patients meeting both criteria exhibited the highest risk of MACE (log-rank test, p < 0.001). CONCLUSIONS: Patients aged ≥60 years old with risk factors ≥4 indicates at high risk of MACE in patients with MASLD. This risk stratification system provides a practical tool for identifying high-risk individuals in the MASLD population.
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BACKGROUND: In an aging society, percutaneous coronary intervention (PCI) for super-elderly patients is commonly performed in clinical practice. However, data are scarce regarding the clinical features and outcomes of this population. METHODS: This multicenter observational study enrolled patients aged over 90â¯years who underwent PCI across 10 hospitals between 2011 and 2020. The study included patients presenting with acute coronary syndrome (ACS) and chronic coronary syndrome (CCS). The occurrence of all-cause and cardiac deaths during hospitalization and after discharge was investigated. RESULTS: In total, 402 patients (91.9⯱â¯2.0â¯years, 48.3â¯% male) participated in the study, of whom 77.9â¯% presented with ACS. The rate of in-hospital death was significantly higher in patients with ACS compared to patients with CCS (15.3â¯% vs. 2.2â¯%, pâ¯<â¯0.001). The estimated cumulative incidence rates of all-cause death were 24.3â¯%, 39.5â¯%, and 60.4â¯% at 1, 3, and 5â¯years, respectively. No significant difference was observed in the occurrence of all-cause death between patients with ACS and CCS. Regarding causes of death after discharge, non-cardiac deaths accounted for just over half of the cases. CONCLUSION: This study highlights the clinical features and long-term clinical course of patients aged over 90â¯years who underwent PCI in a real-world setting. Patients presenting with ACS exhibited a higher rate of in-hospital mortality compared to those with CCS. Following discharge, both ACS and CCS patients experienced comparable and substantial increases in the incidence rates of both cardiac and non-cardiac mortality over time, and a more holistic management approach is warranted.
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Background: Despite the positive impact of implantable cardioverter defibrillators (ICDs) and wearable cardioverter defibrillators (WCDs) on prognosis, their implantation is often withheld especially in Japanese heart failure patients with reduced left ventricular ejection fraction (HFrEF) who have not experienced ventricular tachycardia (VT) or ventricular fibrillation (VF) for uncertain reasons. Recent advancements in heart failure (HF) medications have significantly improved the prognosis for HFrEF. Given this context, a critical reassessment of the treatment and prognosis of ICDs and WCDs is essential, as it has the potential to reshape awareness and treatment strategies for these patients. Methods: We are initiating a prospective multicenter observational study for HFrEF patients eligible for ICD in primary and secondary prevention, and WCD, regardless of device use, including all consenting patients. Study subjects are to be enrolled from 31 participant hospitals located throughout Japan from April 1, 2023, to December 31, 2024, and each will be followed up for 1 year or more. The planned sample size is 651 cases. The primary endpoint is the rate of cardiac implantable electronic device implementation. Other endpoints include the incidence of VT/VF and sudden death, all-cause mortality, and HF hospitalization, other events. We will collect clinical background information plus each patient's symptoms, Clinical Frailty Scale score, laboratory test results, echocardiographic and electrocardiographic parameters, and serial changes will also be secondary endpoints. Results: Not applicable. Conclusion: This study offers invaluable insights into understanding the role of ICD/WCD in Japanese HF patients in the new era of HF medication.
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Background: The relationships between frailty and clinical outcomes in elderly Japanese patients with non-valvular atrial fibrillation (NVAF) after catheter ablation (CA) have not been established. We evaluated the frailty rate of patients undergoing CA for NVAF, examined whether CA for NVAF improves frailty, and analyzed the CA outcomes of patients with and without frailty. Methods: Elderly Japanese patients (≥65 years; mean age: 72.8 years) who participated in the real-world ablation therapy with anti-coagulants in management of atrial fibrillation registry and who responded to the frailty screening index survey were included (n = 213). Frailty and AF recurrence were assessed preoperatively and at 3 and 6 months after CA. Results: Twenty-six patients (12.8%) were frail, 109 (53.7%) were pre-frail, and 68 (33.5%) were robust. Cardiovascular (frailty: 0.5%/person-year; pre-frailty: 0.1%/person-year; robust: 0.1%/person-year) and cardiac (frailty: 0.5%/person-year; pre-frailty: 0.1%/person-year; robust: 0.1%/person-year) events, as well as major bleeding (frailty: 0.3%/person-year; pre-frailty: 0.1%/person-year; robust: 0.1%/person-year), were numerically more frequent in the frailty group. No deaths from cardiovascular or stroke/systemic thromboembolic events occurred. A large proportion of patients did not experience 3-month (frailty: 96.2%; pre-frailty: 96.3%; robust: 88.2%) or 6-month (frailty: 88.5%; pre-frailty: 91.7%; robust: 86.8%) AF recurrence after CA. Weight loss, walking speed, and fatigue improved in the frailty and pre-frailty groups after CA. Conclusion: Japanese patients aged ≥65 years with frailty or pre-frailty had improved frailty screening index components, such as weight loss, walking speed and fatigue, after CA. Therefore, elderly patients with frailty or pre-frailty may benefit from CA for NVAF.
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We herein report a patient with type I CD36 deficiency. The patient was initially suspected of having isolated cardiac sarcoidosis based on the presence of non-sustained ventricular tachycardia, delayed myocardial enhancement on magnetic resonance imaging (MRI), and diffuse accumulation of 18F-fluorodeoxyglucose (18F-FDG) on cardiac positron emission tomography (PET). Our findings suggest that the diagnosis of cardiomyopathy associated with CD36 deficiency is often missed, highlighting the importance of a differential diagnosis of isolated cardiac sarcoidosis.
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BACKGROUND AND AIMS: Patients with nonalcoholic fatty liver disease (NAFLD) have a higher risk of cardiac events. However, although the severity of liver fibrosis is related to worsening prognosis in patients with NAFLD, it is unclear whether the noninvasive liver fibrosis score has a predictive value for cardiac events. METHODS AND RESULTS: We evaluated 4071 patients with NAFLD diagnosed using ultrasonography. Liver fibrosis was assessed and divided into three groups based on the Fibrosis-4 (FIB4) index and NAFLD fibrosis score (NFS). The primary outcome of this study was major adverse cardiac events (MACE), including cardiac death, nonfatal myocardial infarction, and revascularization due to coronary artery disease. The median age of the evaluated patients was 61 (52-69) years, and 2201 (54.1%) were male. During the median follow-up period of 6.6 years, 179 (4.4%) patients experienced MACE. Kaplan-Meier survival analysis demonstrated that MACE increased progressively with the FIB4 index (log-rank, p < 0.001) and NFS (log-rank, p < 0.001). Multivariable analysis showed that the higher the FIB4 index, the higher the risk for MACE (low group as reference vs. intermediate group, hazard ratio [HR]: 1.860 [95% confidence interval (CI), 1.326-2.610; p < 0.001]; vs. high group, HR:3.325 [95% CI, 2.017-5.479; p < 0.001]), as well as NFS (low NFS group as reference vs. intermediate group, HR: 1.938 [95% CI, 1.391-2.699; p < 0.001]; vs. high group, HR: 3.492 [95% CI, 1.997-6.105; p < 0.001]). CONCLUSIONS: The FIB4 index and NFS are associated with the probability of MACE in patients with NAFLD. CLINICAL TRIALS: The study design was approved by the ethics review board of Ogaki Municipal Hospital (approval number: 20221124-12, registration date: November 28th, 2022). https://www.ogaki-mh.jp/chiken/kenkyu.html.
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Cirrosis Hepática , Enfermedad del Hígado Graso no Alcohólico , Valor Predictivo de las Pruebas , Humanos , Enfermedad del Hígado Graso no Alcohólico/complicaciones , Enfermedad del Hígado Graso no Alcohólico/diagnóstico , Enfermedad del Hígado Graso no Alcohólico/mortalidad , Masculino , Femenino , Persona de Mediana Edad , Medición de Riesgo , Cirrosis Hepática/diagnóstico , Cirrosis Hepática/mortalidad , Cirrosis Hepática/complicaciones , Anciano , Pronóstico , Factores de Tiempo , Factores de Riesgo , Técnicas de Apoyo para la Decisión , Índice de Severidad de la Enfermedad , Estudios RetrospectivosRESUMEN
BACKGROUND: Nicorandil is widely used as a vasodilator for the physiological assessment of coronary arteries because of its usefulness and safety; however, there are no data on its use in peripheral arteries. AIMS: To identify the utility of nicorandil and its appropriate dose for the physiological assessment on the femoropopliteal artery. METHODS: We retrospectively enrolled patients from three institutes in which physiological assessment was carried out with various doses of nicorandil before treatment. Twenty-four femoropopliteal artery stenotic lesions from 22 patients were included. The nicorandil doses used were 2, 4, and 6 mg. Twenty-two lesions were also assessed using 30 mg of papaverine. The pressure gradient (PG) and peripheral fractional flow reserve (pFFR) were calculated based on the mean and systolic pressure levels. We examined the correlation of each parameter with the peak systolic velocity ratio (PSVR) based on the duplex ultrasound images using Spearman's rank correlation coefficient. Systemic blood pressure was assessed for safety. RESULTS: The correlations were higher for mean pressure-based parameters than for systolic pressure-based parameters. As the nicorandil dose increased, the correlations among PG, pFFR, and PSVR also increased (mean pressure-based PG: 2 mg, r = 0.360; 4 mg, r = 0.498; 6 mg, r = 0.694, mean pressure-based pFFR: 2 mg, r = -0.479; 4 mg, r = -0.469; 6 mg, r = -0.641). The blood pressure after the administration of 6 mg of nicorandil was low, and the median systemic mean pressure was 65 mmHg. CONCLUSION: A 4 mg dose of nicorandil is effective and safe for the mean pressure-based physiological assessment of lesions in the femoropopliteal artery.
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Reserva del Flujo Fraccional Miocárdico , Nicorandil , Humanos , Nicorandil/efectos adversos , Estudios Retrospectivos , Resultado del Tratamiento , Vasodilatadores/efectos adversos , Vasos CoronariosRESUMEN
BACKGROUND: The proportion of young females among the patients who undergo percutaneous coronary intervention (PCI) is relatively small, and information on their clinical characteristics is limited. This study investigated the clinical characteristics and prognostic factors for future cardiac events in young females who underwent PCI. METHODS: This multicenter observational study included 187 consecutive female patients aged < 60 years who underwent PCI in seven hospitals. The primary composite endpoint was the incidence of cardiac death, nonfatal myocardial infarction, and target vessel revascularization. RESULTS: The mean patient age was 52.1 ± 6.1 years and 89 (47.6%) had diabetes, and renal dysfunction (an estimated glomerular filtration rate < 60 mL/min/1.73 m2) was observed in 38 (20.3%). During a median follow-up of 3.3 years, the primary endpoint occurred in 28 patients. The Cox proportional hazards models showed that renal dysfunction was an independent predictor for the primary endpoint (hazard ratio 3.04, 95% confidence interval 1.25-7.40, p = 0.01), as well as multivessel disease (hazard ratio 2.79, 95% confidence interval 1.12-6.93, p = 0.03). Patients with renal dysfunction had a significantly higher risk for the primary endpoint than those without renal dysfunction. CONCLUSIONS: Renal dysfunction was strongly associated with future cardiac events in young females who underwent PCI.
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Enfermedad de la Arteria Coronaria , Intervención Coronaria Percutánea , Humanos , Femenino , Intervención Coronaria Percutánea/efectos adversos , Persona de Mediana Edad , Factores de Riesgo , Incidencia , Enfermedad de la Arteria Coronaria/diagnóstico , Enfermedad de la Arteria Coronaria/cirugía , Enfermedad de la Arteria Coronaria/epidemiología , Enfermedad de la Arteria Coronaria/mortalidad , Tasa de Filtración Glomerular , Pronóstico , Japón/epidemiología , Estudios Retrospectivos , Medición de Riesgo/métodos , Factores de Tiempo , Factores de Edad , Estudios de Seguimiento , Adulto , Factores Sexuales , Infarto del Miocardio/epidemiología , Infarto del Miocardio/diagnóstico , Resultado del TratamientoRESUMEN
In endovascular therapy (EVT) for femoropopliteal artery (FPA) lesions, studies examining the relationship between lesion morphology and hemodynamic status are limited. The purpose of this study was to investigate FPA lesion characteristics, including imaging findings and their cutoff values that can predict hemodynamic significance after balloon angioplasty. This single-center retrospective study enrolled 50 de novo FPA lesions from 43 patients treated under intravascular ultrasound (IVUS) usage between June 2022 and March 2023. As a physiological parameter, the pressure gradient was measured, and the cutoff value of the residual pressure gradient (RPG) was defined as a systolic pressure > 10 mmHg through the lesions after balloon angioplasty. The pressure gradients were measured using a 0.014-inch wire-guided, rapid exchange-type microcatheter, Navvus II (Acist, Eden Prairie, Minnesota, USA). Predictive risk factors for RPG were analyzed using the random forest (RF) method. The relationship between the variables, RPG, and the cutoff points of each predictor was assessed using the partial dependence plot (PDP) method. RPG was observed in 20% of the lesions after balloon angioplasty. The RF model revealed that the percent diameter stenosis (%DS) and minimum lumen area (MLA) on IVUS assessment were strong predictive factors for RPG after balloon angioplasty. The PDP model revealed that a higher %DS (cutoff 30%) and smaller MLA (cutoff 10 mm2) could predict RPG after balloon angioplasty. Conventional lesion parameters such as %DS and MLA can predict hemodynamic significance during EVT for FPA lesions.
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Angioplastia de Balón , Arteria Femoral , Enfermedad Arterial Periférica , Arteria Poplítea , Ultrasonografía Intervencional , Humanos , Arteria Femoral/fisiopatología , Arteria Femoral/diagnóstico por imagen , Masculino , Arteria Poplítea/diagnóstico por imagen , Arteria Poplítea/fisiopatología , Femenino , Estudios Retrospectivos , Angioplastia de Balón/efectos adversos , Angioplastia de Balón/métodos , Anciano , Enfermedad Arterial Periférica/fisiopatología , Enfermedad Arterial Periférica/terapia , Enfermedad Arterial Periférica/diagnóstico , Ultrasonografía Intervencional/métodos , Persona de Mediana Edad , Resultado del Tratamiento , Anciano de 80 o más Años , Grado de Desobstrucción Vascular , Factores de RiesgoRESUMEN
BACKGROUND: Catheter ablation (CA) for atrial fibrillation (AF) in patients on hemodialysis (HD) is reported to have a high risk of late recurrence (LR). However, the relationship between early recurrence (ER) within a 90-day blanking period after CA in AF patients and LR in HD patients remains unclear. METHODSâANDâRESULTS: Of the 5,010 patients in the Kansai Plus Atrial Fibrillation Registry, 5,009 were included in the present study. Of these patients, 4,942 were not on HD (non-HD group) and 67 were on HD (HD group). HD was an independent risk factor for LR after the initial CA (adjusted hazard ratio 1.6; 95% confidence interval 1.1-2.2; P=0.01). In patients with ER, the rate of sinus rhythm maintenance at 3 years after the initial CA was significantly lower in the HD than non-HD group (11.4% vs. 35.4%, respectively; log-rank P=0.004). However, in patients without ER, there was no significant difference in the rate of sinus rhythm maintenance at 3 years between the HD and non-HD groups (67.7% vs. 74.5%, respectively; log-rank P=0.62). CONCLUSIONS: ER in HD patients was a strong risk factor for LR. However, even HD patients could expect a good outcome without ER after the initial CA.
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Fibrilación Atrial , Ablación por Catéter , Recurrencia , Sistema de Registros , Diálisis Renal , Humanos , Fibrilación Atrial/cirugía , Fibrilación Atrial/fisiopatología , Masculino , Femenino , Ablación por Catéter/efectos adversos , Persona de Mediana Edad , Anciano , Factores de Riesgo , Factores de Tiempo , Japón/epidemiología , Resultado del Tratamiento , Anciano de 80 o más AñosAsunto(s)
Enfermedad de la Arteria Coronaria , Stents Liberadores de Fármacos , Intervención Coronaria Percutánea , Humanos , Everolimus/efectos adversos , Sirolimus , Inmunosupresores/farmacología , Resultado del Tratamiento , Intervención Coronaria Percutánea/efectos adversos , Enfermedad de la Arteria Coronaria/diagnóstico por imagen , Enfermedad de la Arteria Coronaria/terapia , Diseño de PrótesisRESUMEN
BACKGROUND: It remains unclear whether clopidogrel is better suited than aspirin as the long-term antiplatelet monotherapy following dual antiplatelet therapy (DAPT) after percutaneous coronary intervention (PCI). OBJECTIVES: This study compared clopidogrel monotherapy following 1 month of DAPT (clopidogrel group) with aspirin monotherapy following 12 months of DAPT (aspirin group) after PCI for 5 years. METHODS: STOPDAPT-2 (Short and Optimal Duration of Dual Antiplatelet Therapy 2) is a multicenter, open-label, adjudicator-blinded, randomized clinical trial conducted in Japan. Patients who underwent PCI with cobalt-chromium everolimus-eluting stents were randomized in a 1-to-1 fashion either to clopidogrel or aspirin groups. The primary endpoint was a composite of cardiovascular outcomes (cardiovascular death, myocardial infarction, stroke, or definite stent thrombosis) or major bleeding (TIMI major or minor bleeding). RESULTS: Among 3,005 study patients (age: 68.6 ± 10.7 years; women: 22.3%; acute coronary syndrome: 38.3%), 2,934 patients (97.6%) completed the 5-year follow-up (adherence to the study drugs at 395 days: 84.7% and 75.9%). The clopidogrel group compared with the aspirin group was noninferior but not superior for the primary endpoint (11.75% and 13.57%, respectively; HR: 0.85; 95% CI: 0.70-1.05; Pnoninferiority < 0.001; Psuperiority = 0.13), whereas it was superior for the cardiovascular outcomes (8.61% and 11.05%, respectively; HR: 0.77; 95% CI: 0.61-0.97; P = 0.03) and not superior for major bleeding (4.44% and 4.92%, respectively; HR: 0.89; 95% CI: 0.64-1.25; P = 0.51). By the 1-year landmark analysis, clopidogrel was numerically, but not significantly, superior to aspirin for cardiovascular events (6.79% and 8.68%, respectively; HR: 0.77; 95% CI: 0.59-1.01; P = 0.06) without difference in major bleeding (3.99% and 3.32%, respectively; HR: 1.23; 95% CI: 0.84-1.81; P = 0.31). CONCLUSIONS: Clopidogrel might be an attractive alternative to aspirin with a borderline ischemic benefit beyond 1 year after PCI.
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Aspirina , Intervención Coronaria Percutánea , Humanos , Femenino , Persona de Mediana Edad , Anciano , Clopidogrel/uso terapéutico , Aspirina/uso terapéutico , Inhibidores de Agregación Plaquetaria/uso terapéutico , Ticlopidina/uso terapéutico , Quimioterapia Combinada , Hemorragia/tratamiento farmacológico , Resultado del TratamientoRESUMEN
BACKGROUND: Bleeding rates on dual antiplatelet therapy (DAPT) within 1 month after percutaneous coronary intervention (PCI) remain high in clinical practice, particularly in patients with acute coronary syndrome or high bleeding risk. Aspirin-free strategy might result in lower bleeding early after PCI without increasing cardiovascular events, but its efficacy and safety have not yet been proven in randomized trials. METHODS: We randomly assigned 6002 patients with acute coronary syndrome or high bleeding risk just before PCI either to prasugrel (3.75 mg/day) monotherapy or to DAPT with aspirin (81-100 mg/day) and prasugrel (3.75 mg/day) after loading of 20 mg of prasugrel in both groups. The coprimary end points were major bleeding (Bleeding Academic Research Consortium 3 or 5) for superiority and cardiovascular events (a composite of cardiovascular death, myocardial infarction, definite stent thrombosis, or ischemic stroke) for noninferiority with a relative 50% margin. RESULTS: The full analysis set population consisted of 5966 patients (no-aspirin group, 2984 patients; DAPT group, 2982 patients; age, 71.6±11.7 years; men, 76.6%; acute coronary syndrome, 75.0%). Within 7 days before randomization, aspirin alone, aspirin with P2Y12 inhibitor, oral anticoagulants, and intravenous heparin infusion were given in 21.3%, 6.4%, 8.9%, and 24.5%, respectively. Adherence to the protocol-specified antiplatelet therapy was 88% in both groups at 1 month. At 1 month, the no-aspirin group was not superior to the DAPT group for the coprimary bleeding end point (4.47% and 4.71%; hazard ratio, 0.95 [95% CI, 0.75-1.20]; Psuperiority=0.66). The no-aspirin group was noninferior to the DAPT group for the coprimary cardiovascular end point (4.12% and 3.69%; hazard ratio, 1.12 [95% CI, 0.87-1.45]; Pnoninferiority=0.01). There was no difference in net adverse clinical outcomes and each component of coprimary cardiovascular end point. There was an excess of any unplanned coronary revascularization (1.05% and 0.57%; hazard ratio, 1.83 [95%CI, 1.01-3.30]) and subacute definite or probable stent thrombosis (0.58% and 0.17%; hazard ratio, 3.40 [95% CI, 1.26-9.23]) in the no-aspirin group compared with the DAPT group. CONCLUSIONS: The aspirin-free strategy using low-dose prasugrel compared with the DAPT strategy failed to attest superiority for major bleeding within 1 month after PCI but was noninferior for cardiovascular events within 1 month after PCI. However, the aspirin-free strategy was associated with a signal suggesting an excess of coronary events. REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifier: NCT04609111.
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Síndrome Coronario Agudo , Aspirina/análogos & derivados , Nitratos , Intervención Coronaria Percutánea , Trombosis , Masculino , Humanos , Persona de Mediana Edad , Anciano , Anciano de 80 o más Años , Inhibidores de Agregación Plaquetaria/efectos adversos , Clorhidrato de Prasugrel/efectos adversos , Síndrome Coronario Agudo/tratamiento farmacológico , Intervención Coronaria Percutánea/efectos adversos , Quimioterapia Combinada , Aspirina/efectos adversos , Hemorragia/etiología , Stents , Trombosis/epidemiología , Trombosis/etiología , Trombosis/prevención & control , Resultado del TratamientoRESUMEN
Background: When performing transcatheter aortic valve replacement (TAVR) for a patient with a protruding stent in the coronary arteries, there is a risk of stent deformation and coronary occlusion. However, safe and optimal methods have not been established. Case summary: An 87-year-old woman with a protruding stent in the left main coronary artery (LMCA) underwent TAVR. The two-step inflation and kissing-balloon techniques were performed to optimize the transcatheter heart valve (THV) and to avoid LMCA stent deformation. The THV was implemented with minimal aortic regurgitation and no deformation of the stent in the LMCA. Discussion: This was the first case report of TAVR, performed in a patient with a protruding stent in the coronary arteries, using the kissing-balloon technique and the two-step inflation technique. The combination of these two techniques was the optimal method for THV implantation without stent deformation in coronary arteries.
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A 71-year-old woman with no relevant previous medical history presented to the emergency department with cardiopulmonary arrest due to extensive myocardial infarction. Veno-arterial extracorporeal life support (ECLS) was passed through the right common femoral artery (CFA), and an Impella CP® (16-F introduction sheath, Abiomed Inc., Danvers, MA, USA) was inserted from the left CFA. Although these mechanical devices provide powerful cardiac and organ support, an occlusive large-bore sheath may induce ischemic limb complications. Antegrade flow from the contralateral sheath was circulated through the ECLS circuit, showing the improvement of antegrade left SFA. Cardiac function improved after primary percutaneous coronary intervention, but when the ECLS was terminated, antegrade left limb flow declined. Hence, we bypassed the contralateral flow via the dialysis circuit and prevented limb ischemia. Learning objective: Although an Impella® (Abiomed Inc., Danvers, MA, USA) is useful for assisting left ventricular cardiac function, its large-bore sheath sometimes disturbs the antegrade flow, resulting in ischemic limb complications. A novel yet simple technique that involves an external bypass through the superficial femoral artery to provide antegrade perfusion to the ipsilateral limb is hereby described.
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BACKGROUND: The fibrosis-4 (FIB-4) index is a noninvasive scoring system that is used to assess the progression of liver fibrosis. This study aimed to assess whether the FIB-4 index is associated with recurrent atrial fibrillation (AF) after catheter ablation in patients with and without heart failure (HF). METHODS: We included 1,184 patients who underwent initial AF catheter ablation between 2016 and 2021. The patients were classified into low-risk (< 1.3), intermediate-risk (1.3-2.67), and high-risk (> 2.67) groups based on their FIB-4 indices at baseline. The patients were divided into HF (n = 552) and non-HF groups (n = 632); the HF group was further divided into paroxysmal AF (PAF) and non-PAF groups. AF recurrence after catheter ablation was then compared among the groups. RESULTS: In the non-HF group, no significant differences in recurrence after ablation were observed between the low-(n = 219), intermediate-(n = 364), and high-risk (n = 49) groups. In contrast, in the HF group, the intermediate-(n = 341) and high-risk (n = 112) groups had significantly higher recurrence rates than the low-risk group (n = 99) (log-rank test, p = 0.005). This association remained significant after multivariate analysis (hazard ratio [HR]:1.374; p = 0.027). The FIB-4 index increased incrementally as the brain natriuretic peptide levels and severity of tricuspid regurgitation increased. The FIB-4 index was an independent predictor of recurrence in the non-PAF HF group (HR:1.498; p = 0.007) but not in the PAF group. CONCLUSIONS: The FIB-4 index may be a useful predictor of AF recurrence after catheter ablation in patients with HF, particularly in those with non-PAF.