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Background: Oral anticoagulants (OACs) are essential for the prevention and treatment of thromboembolic disorders, but bleeding, a major complication, can have a fatal impact on the patient's treatment. Objectives: We aimed to estimate the nationwide, real-world incidence rate of bleeding in patients taking OACs and confirm the incidence by indications and risk factors. Methods: This cross-sectional study identified OAC users from April 1 to December 31, in both 2019 and 2020, using the HIRA-NPS database. The primary outcome variables were the incidence rate of major bleeding events during OAC treatment and within 30 days of treatment discontinuation. We estimated the adjusted incidence rate ratio (aIRR) in subpopulations. Results: Among 18,822 OAC users, the incidence rate of major bleeding was 27.9 (95% CI: 24.6-31.5) per 1,000 person-years. The incidence rate of major bleeding was higher in patients with a bleeding history, with an aIRR of 11.51; those at high bleeding risk (HAS-BLED score =3), with an aIRR of 1.51; those with high CCI scores =3, with an aIRR of 1.88; and those with liver disease, with an aIRR of 1.41. For indications, compared to patients with nonvalvular atrial fibrillation (NVAF), the aIRR of major bleeding was significantly higher at an aIRR of 2.35 in patients undergoing VTE treatment. Patients with ischemic stroke showed a higher incidence of major bleeding with an aIRR of 2.13 than NVAF patients. The aIRR of major bleeding in the oral anticoagulant group, compared to the matched control group, was 2.25 (95% CI: 1.93-2.63). Conclusion: These findings may be useful for implementing strategies to improve the evaluation and management of anticoagulation-related bleeding. [ABSTRACT FROM AUTHOR]

Background: Interventional left atrial appendage occlusion (LAAO) mitigates the risk of thromboembolic events in nonvalvular atrial fibrillation (AF) patients with contraindication for long-term oral anticoagulation (OAC). Patients with prior stroke have a relevantly increased risk of recurrent stroke, so the effectiveness of LAAO could be reduced in this specific very high-risk patient group. Aim: This sub-study of the LAARGE registry investigates the effectiveness and safety of LAAO for secondary prevention in nonvalvular AF patients with a history of stroke. Methods: LAARGE is a prospective, non-randomised registry on the clinical reality of LAAO. The current sub-study employs data from index procedure and 1-year follow-up. Effectiveness and safety were assessed by documentation of all-cause mortality, non-fatal thromboembolism, procedure-related complications, and bleeding events. Results: A total of 638 patients were consecutively included from 38 hospitals in Germany and divided into two groups: 137 patients with a history of stroke (21.5%) and 501 patients without. Successful implantation was consistent between both groups (98.5% vs. 97.4%, p = NS), while peri-procedural MACCE and other complications were rare (0% vs. 0.6% and 4.4% vs. 4.0%, respectively; each p = NS). Kaplan–Meier estimate showed no significant difference in primary effectiveness outcome measure (freedom from all-cause death or non-fatal stroke) between both groups at follow-up (87.8% vs. 87.7%, p = NS). The incidence of transient ischemic attack or systemic embolism at follow-up was low (0% vs. 0.5% and 0.9% vs. 0%, respectively; each p = NS). Severe bleeding events after hospital discharge were rare (0% vs. 0.7%, p = NS). Conclusions: Patients with prior stroke demonstrated similar effectiveness and safety profile for LAAO as compared to patients without prior stroke. LAAO could serve as a feasible alternative to OAC for secondary stroke prevention in this selected group of nonvalvular AF patients. ClinicalTrials.gov identifier: NCT02230748. [ABSTRACT FROM AUTHOR]

Background: Contemporary guidelines for managing nonvalvular atrial fibrillation (NVAF) include apixaban and rivaroxaban as first-line anticoagulation treatment options. Minimal guidance is available regarding selecting anticoagulants for patients with class I-III obesity. Objective: This study aims to evaluate the comparative effectiveness and safety of apixaban and rivaroxaban in both obese and morbidly obese patients with NVAF. Methods: A retrospective cohort study was conducted at an outpatient cardiovascular clinic after Institutional Review Board approval. Patients were eligible if they were ≥18 years of age, had a BMI ≥30 kg/m2, and took apixaban or rivaroxaban for NVAF for ≥3 months. The primary endpoint was the composite rate of stroke, transient ischemic attack (TIA), myocardial infarction (MI), or presence of atrial thrombosis. Bleeding events were evaluated as the primary safety endpoint. Results: Combined, the cohorts consisted of 303 obese or morbidly obese patients. The primary composite endpoint occurred in 3.8% of patients taking apixaban and 1.7% of patients taking rivaroxaban (P =.28). Both clinically relevant, non-major and major bleeding occurred more often in the apixaban arm, but this difference was not statistically significant; however, bleeding risk may have been skewed due to differences in baseline characteristics. Conclusion and Relevance: For obese and morbidly obese patients prescribed either apixaban or rivaroxaban for NVAF, rates of stroke, TIA, MI, and atrial thrombosis did not differ. The preferred DOAC for patients with class I-III obesity remains elusive, but current data points to a patient-centered approach for anticoagulant selection. [ABSTRACT FROM AUTHOR]

Objective: The mechanism of asymmetric dimethylarginine (ADMA) in thrombosis in patients with nonvalvular atrial fibrillation (NVAF) is still unclear. Our aim was to investigate the relationship between ADMA and indicators of prethrombotic state in NVAF patients and to analyze the predictive role of ADMA in NVAF thrombosis. Methods: A total of 192 NVAF patients were continuously selected from January 2023 to October 2023. Plasma ADMA levels were measured by high‐performance liquid chromatography. P‐selectin (P‐sel), von Willebrand factor (vWF), D‐dimer (D‐D), and plasminogen activator inhibitor‐1 (PAI‐1) levels were measured by enzyme‐linked immunosorbent assay (ELISA). Nitric oxide (NO) levels were measured by the nitrate reductase assay for plasma nitrite/nitrate, then the Griess method (Shanghai Hailian Biotechnology Co., Shanghai, China) was used to calculate plasma NO levels. Results: In our study, ADMA levels were significantly elevated and positively correlated with P‐sel, vWF, D‐D, and PAI‐1, whereas NO levels were significantly negatively correlated with these prethrombotic factors in NVAF. Furthermore, multifactorial logistic regression analysis showed that ADMA and LA diameter were independent predictors of high thrombosis risk (CHA2DS2‐VASc ≥2 score) in patients with NVAF. Conclusions: Our findings suggested that ADMA correlated with the prethrombotic state in NVAF and that reduction of ADMA levels in NVAF patients may be a novel therapeutic strategy for thrombosis risk reduction. [ABSTRACT FROM AUTHOR]

• The study investigated the differences in cardiac structure and clinical features among Tibetan, Han, and Hui patients with nonvalvular atrial fibrillation. • The researchers analyzed data from over 3000 patients and found significant differences in gender, age, smoking history, comorbidities, and cardiac parameters among the ethnic groups. • Han patients had a lower proportion of dilated cardiomyopathy and heart failure, while Hui patients had the highest proportion of comorbid diabetes. Han patients also had lower levels of certain blood markers compared to Hui patients. Global nonvalvular AF rises, impacting health severely. In Qinghai, China's diverse setting, studying AF among varied ethnic groups is crucial The purpose of this study was to compares cardiac features in AF among Tibetan, Han, and Hui patients to develop tailored prevention and treatment strategies for this region, the goal was to enhance the understanding of AF and provide an empirical basis for developing prevention and treatment strategies specific to this region This study included a total of 3445 Tibetan, Han, and Hui patients diagnosed with nonvalvular atrial fibrillation and treated at the Qinghai Cardiovascular and Cerebrovascular Specialist Hospital, China, between January 2019 and January 2021. We analyzed the differences in cardiac structure, comorbidities, and other influencing factors among the different ethnic groups We found significant differences in gender, age, smoking history, lone atrial fibrillation, left heart failure, dilated cardiomyopathy, and diabetes between Tibetan, Han, and Hui patients (P < 0.05). Tibetan, Han, and Hui patients also differed with regard to left ventricular end-diastolic volume, left ventricular ejection fraction, fractional shortening, NT-proBNP, glycated hemoglobin, red blood cell distribution width, platelet count, platelet hematocrit, platelet distribution width, homocysteine (Hcy), C-reactive protein, and superoxide dismutase (SOD) (P < 0.05) Our study revealed variations in comorbidities, cardiac structure, and blood indexes among Tibetan, Han, and Hui AF patients, highlighting distinct patterns in complications and biomarker levels across ethnic groups. [ABSTRACT FROM AUTHOR]

ObjectiveRivaroxaban and dabigatran are approved to reduce the risk of stroke in patients with nonvalvular atrial fibrillation (NVAF). However, the clinical benefits of rivaroxaban and dabigatran in people with high bleeding risk are unclear.MethodsA retrospective study was conducted on NVAF patients admitted to the First Affiliated Hospital of Zhengzhou University from May 31, 2016 to May 31, 2019. These patients had a high risk of bleeding and were taking at least one study medication. The aim of the study was to evaluate clinical benefits by comparing the efficacy and safety risks of these two medicationsResultsA total of 1,301 patients with high bleeding risk were enrolled, including 787 patients in the rivaroxaban group and 514 patients in the dabigatran group. Results of the primary efficacy benefit endpoint were obtained from 104 patients (13.21%) in the rivaroxaban group and 81 (15.76%) patients in the dabigatran group [hazard ratio (HR): 0.860; 95% confidence interval (CI): 0.637–1.162; P = 0.327], this indicates that there was no significant difference between dabigatran and rivaroxaban in preventing stroke and systemic embolism in patients with high bleeding risk NVAF. The principal safety end points were observed in 49 (6.23%) patients in the rivaroxaban group and in 36 (7.00%) patients in the dabigatran group (HR: 0.801 in the rivaroxaban group; 95% CI: 0.512–1.255; P = 0.333), this indicates that there was no a significant difference in reducing fatal bleeding and critical organ bleeding. With respect to secondary efficacy and benefit endpoints, 28 (3.56%) patients in the rivaroxaban group and 26 (5.06%) patients in the dabigatran group died, with an HR of 0.725 (95% CI: 0.425–1.238; P = 0.239); 32 (4.07%) patients in the rivaroxaban group; and 31 (6.03%) patients in the dabigatran group had myocardial infarction (MI), with an HR of 0.668 (95% CI: 0.405–1.102, P = 0.114) in the rivaroxaban group, this indicates that there was no significant difference between dabigatran and rivaroxaban in preventing all-cause death and MI.ConclusionsIn NVAF patients with high bleeding risk, there was no significant difference between dabigatran and rivaroxaban in preventing stroke and systemic embolism. There was also no significant difference between dabigatran and rivaroxaban in reducing fatal and critical organ bleeding. Clinical Trial RegistrationChinese Clinical Trials Registry, identifier ChiCTR2100052454.

Purpose: 10 mg rivaroxaban is widely used in the Chinese mainland. This study aims to explore the association between 10 mg once daily rivaroxaban and all-cause mortality in patients with nonvalvular atrial fibrillation (NVAF). Methods: This observational study enrolled 1131 NVAF patients at the cardiovascular department of the First Affiliated Hospital of Xi'an Jiaotong University. One-year outcomes included all-cause mortality and bleeding were recorded. Cox proportional hazards models and Kaplan-Meier analysis were utilized in the study. Results: In total, 1131 patients (402 no anticoagulants, and 729 rivaroxaban) were included. Cox proportional hazard analysis demonstrated that low-dose rivaroxaban (10 mg, HR: 0.14, 95% CI:(0.07–0.28), P<0.001; 15 mg, HR: 0.20, 95% CI:(0.09–0.43), P<0.001; 20 mg, HR: 0.22, 95% CI:(0.05–0.96), P = 0.044) exhibited lower mortality risk compared to untreated patients. Conclusions: 10 mg once daily rivaroxaban may provide survival benefits for elderly patients with NVAF. [ABSTRACT FROM AUTHOR]

Background: Type 2 diabetes mellitus (T2DM) and atrial fibrillation are risk factors for stroke. The potential preventive effects of cardiovascular and antidiabetic treatments on stroke risk in patients with these diseases remain insufficiently documented. Sulfonylureas have also been reported to be associated with stroke. This study aimed to assess the risk of stroke according to the use of drugs (anticoagulants, antiplatelet agents, and oral antidiabetic drugs [OADs]) in patients with T2DM and nonvalvular atrial fibrillation (NVAF). Methods: Patients with a history of T2DM and NVAF were identified from two systematic registries: a registry of patients with stroke and a registry of patients with atrial fibrillation. Patients with stroke were randomly matched to patients without prior stroke events based on age, sex, body mass index, and index date. All treatments administered 12 months before the index date were documented. The associations between anticoagulants, antiplatelet agents, and OADs and stroke were assessed using multivariate conditional logistic models that yielded adjusted odds ratios (aORs) and 95 % confidence intervals, controlling for risk factors identified in the univariate comparison of cases and matched referents. Results: Three-hundred and fifteen patients with stroke with both diabetes and NVAF were matched to 523 referents with both diabetes and NVAF but no history of stroke. The aORs for the use of drugs and stroke were 0.24 [0.15–0.40] for direct oral anticoagulants (DOACs), 0.42 [0.27–0.67] for vitamin K agonists (VKA), 0.80 [0.52–1.24] for antiplatelet agents, and 0.68 [0.45–1.02] for OADs. No significant associations were found between individual OAD use and stroke risk. Similar results were obtained for ischemic stroke. Only VKAs were significantly associated with hemorrhagic stroke (odds ratio = 4.25 [1.16–15.64]). Conclusions: Anticoagulant use was associated with a protective effect against the risk of stroke in patients with diabetes and NVAF, with no increase in the risk of hemorrhagic stroke for DOAC. No increased risk of stroke was observed because of any OAD, including sulfonylureas.

Introduction: Few real-world studies have investigated drug-drug interactions (DDIs) involving non-vitamin-K antagonist oral anticoagulants (NOACs) in patients with nonvalvular atrial fibrillation (NVAF). The interactions encompass drugs inducing or inhibiting cytochrome P450 3A4 and permeability glycoprotein. These agents potentially modulate the breakdown and elimination of NOACs. This study investigated the impact of DDIs on thromboembolism in this clinical scenario. Method: Patients who had NVAF and were treated with NOACs were selected as the study cohort from the National Health Insurance Research Database of Taiwan. Cases were defined as patients hospitalised for a thromboembolic event and who underwent a relevant imaging study within 7 days before hospitalisation or during hospitalisation. Each case was matched with up to 4 controls by using the incidence density sampling method. The concurrent use of a cytochrome P450 3A4/permeability glycoprotein inducer or inhibitor or both with NOACs was identified. The effects of these interactions on the risk of thromboembolic events were examined with univariate and multivariate conditional logistic regressions. Results: The study cohort comprised 60,726 eligible patients. Among them, 1288 patients with a thromboembolic event and 5144 matched control patients were selected for analysis. The concurrent use of a cytochrome P450 3A4/permeability glycoprotein inducer resulted in a higher risk of thromboembolic events (adjusted odds ratio [AOR] 1.23, 95% confidence interval [CI] 1.004-1.51). Conclusion: For patients with NVAF receiving NOACs, the concurrent use of cytochrome P450 3A4/permeability glycoprotein inducers increases the risk of thromboembolic events. [ABSTRACT FROM AUTHOR]

Background Phenotypic classification is a method of grouping patients with similar phenotypes. Aim We aimed to use phenotype classification based on a clustering process for risk stratification of patients with non-valvular atrial fibrillation (AF) and second, to assess the benefit of the Atrial Fibrillation Better Care (ABC) pathway. Methods Patients with AF were prospectively enrolled from 27 hospitals in Thailand from 2014 to 2017, and followed up every 6 months for 3 years. Cluster analysis was performed from 46 variables using the hierarchical clustering using the Ward minimum variance method. Outcomes were a composite of all-cause death, ischemic stroke/systemic embolism, acute myocardial infarction and heart failure. Results A total of 3405 patients were enrolled (mean age 67.8 ± 11.3 years, 58.2% male). During the mean follow-up of 31.8 ± 8.7 months. Three clusters were identified: Cluster 1 had the highest risk followed by Cluster 3 and Cluster 2 with a hazard ratio (HR) and 95% confidence interval (CI) of composite outcomes of 2.78 (2.25, 3.43), P  < 0.001 for Cluster 1 and 1.99 (1.63, 2.42), P  < 0.001 for Cluster 3 compared with Cluster 2. Management according to the ABC pathway was associated with reductions in adverse clinical outcomes especially those who belonged to Clusters 1 and 3 with HR and 95%CI of the composite outcome of 0.54 (0.40, 073), P  < 0.001 for Cluster 1 and 0.49 (0.38, 0.63), P  < 0.001 for Cluster 3. Conclusion Phenotypic classification helps in risk stratification and prognostication. Compliance with the ABC pathway was associated with improved clinical outcomes. [ABSTRACT FROM AUTHOR]

Background: A novel risk prediction model appears to be urgently required to improve the assessment of thrombotic risk in overweight patients with nonvalvular atrial fibrillation (NVAF). We developed a novel body mass index (BMI)-based thromboembolic risk score (namely AB2S score) for these patients. Methods: A total of 952 overweight patients with NVAF were retrospectively enrolled in this study with a 12-month follow-up. The primary endpoint was 1-year systemic thromboembolism and the time to thrombosis (TTT). The candidate risk variables identified by logistic regression analysis were included in the final nomogram model to construct AB2S score. The measures of model fit were evaluated using area under the curve (AUC), C-statistic, and calibration curve. The performance comparison of the AB2S score to the CHADS2 and CHA2DS2-VASc score was performed in terms of the AUC and decision analysis curve (DAC). Results: The AB2S score was constructed using 7 candidate risk variables, including a 3-category BMI (25 to 30, 30 to 34, or ≥35 kg/m²). It yielded a c-index of 0.885 (95% CI, 0.814-0.954) and an AUC of 0.885 (95% CI, 0.815-0.955) for predicting 1-year systemic thromboembolism in patients with NVAF. Compared to the CHADS2 score and CHA2DS2-VASc score, the AB2S score had greater AUC and DAC values in predicting the thromboembolic risk and better risk stratification in TTT (P < .0001, P = .082, respectively). Conclusion: Our results highlighted the importance of a BMI-based AB2S score in determining systemic thromboembolism risk in overweight patients with NVAF, which may aid in decision-making for these patients to balance the effectiveness of anticoagulation from the underlying thrombotic risk. [ABSTRACT FROM AUTHOR]

OBJECTIVE: This study aims to investigate the correlations between red cell distribution width (RDW), homocysteine (Hcy), lipoprotein(a) [Lp(a)], and left atrial diameter (LAD) measured by echocardiography in newly diagnosed nonvalvular atrial fibrillation (NVAF) (referred to as "new-onset AF") patients and their predictive value for new-onset AF. The findings of this study provide a basis for early clinical identification of the risk of new-onset AF. PATIENTS AND METHODS: Eighty-nine newly diagnosed NVAF patients (46 males and 43 females) admitted to the Department of Cardiology, First Affiliated Hospital of Nanchang University, from January 2017 to January 2023 were included in the new-onset AF group. Over the same time, 88 sinus rhythm patients (44 males and 44 females) were included in the control group. Data, including demographic information, routine blood test parameters, biochemical indicators, and relevant values from cardiac color Doppler ultrasound, were recorded for all study subjects. Logistic regression analysis was used to explore the clinical characteristics of the indicators mentioned above in patients with new-onset AF. Receiver operating characteristic (ROC) curves were drawn to assess the predictive ability of these indicators for new-onset AF. RESULTS: Univariate analysis of biochemical indicators revealed differences between the two groups (p<0.05) in RDW, Hcy, and Lp(a). The univariate analysis also revealed differences (p<0.05) in RDW, Lp(a), Hcy, left atrial diameter (LAD), left ventricular end-diastolic diameter (LVEDD), interventricular septal thickness (IVST), and left ventricular ejection fraction (LVEF). Multivariable logistic regression analysis identified RDW (OR=2.38, 95% CI: 1.65-3.67), Hcy (OR=1.57, 95% CI: 1.37-1.86), and Lp(a) (OR=1.01, 95% CI: 1.00-1.01) as independent risk factors for the new-onset AF. In the subgroup analysis dichotomizing patients around the LAD cutoff value, the high-LAD group had higher RDW, Hcy, and Lp(a) (13.4 vs. 12.7, 15.0 vs. 10.9, 144.0 vs. 101.3, respectively). CONCLUSIONS: RDW, Hcy, and Lp(a) are elevated in patients with new-onset AF. They are positively correlated with LAD in these patients, indicating their role as risk factors for new-onset AF. [ABSTRACT FROM AUTHOR]

Background: Oral anticoagulants (OACs) are essential for stroke prevention in patients with nonvalvular atrial fibrillation (NVAF). However, the appropriateness of anticoagulation treatment in locally practice remains unclear. This study evaluated compliance with anticoagulation therapy concerning the guidelines and drug labels in patients with NVAF. Methods: Hospitalized patients diagnosed with NVAF between 1 November 2020, and 31 December 2021, were retrospectively enrolled. The appropriateness of anticoagulation regimens at discharge was evaluated based on a flowchart designed according to atrial fibrillation (AF) guidelines and medication labels. Furthermore, we explored factors potentially influencing the "no-use of OACs" using binary logistic regression and verified anticoagulation-related issues through a physician questionnaire. Results: A total of 536 patients were enrolled in this study, including 254 patients (47.4%) with inappropriate anticoagulation regimens. 112 patients (20.9%) were categorized as "underdosing-use of OACs," 134 (25%) who needed anticoagulation therapy were "no-use of OACs" and eight (1.5%) were "overuse of OACs." The results of a binary logistic regression analysis showed that paroxysmal AF (odds ratio [OR], 7.74; 95% confidence interval [CI], 4.57-13.10), increased blood creatinine levels (OR, 1.88; 95% CI, 1.11-3.16), hospitalized pacemaker implantation (OR, 6.76; 95% CI, 2.67-17.11), percutaneous coronary intervention (OR, 3.35; 95% CI, 1.44-7.80), and an increased HAS-BLED score (OR, 1.62; 95% CI, 1.11-2.35) were associated with "no-use of OACs" in patients with NVAF who had indications for anticoagulation therapy. Conclusion: For patients with NVAF with severe renal dysfunction and paroxysmal AF, anticoagulation therapy was inadequate. The underdosing-use of OACs in patients with NVAF was frequently observed. We recommend an anticoagulation management team to tailor anticoagulation regimens to suit each patient's needs. [ABSTRACT FROM AUTHOR]

Background: Warfarin is a common drug for thromboembolic prevention in patients with nonvalvular atrial fibrillation (NVAF). However, hemorrhagic complications are also a concern. The optimal international normalized ratio (INR) level is different in each ethnicity. Objective: To establish the INR range with lowest all adverse event, optimal INR, in Thai NVAF patients from large data, nationwide Warfarin Registry Network (WaRN). Materials and Methods: The present study was a retrospective cohort study. It analyzed the data of 31,704 Thai NVAF patient between January 1, 2010 and December 31, 2020. The numbers of thromboembolic and bleeding events were correlated to INR level at the time of event. The six groups of INR range were defined as less than 1.5, 1.5 to 1.9, 2.0 to 2.5, 2.6 to 3.0, 3.1 to 3.5, and greater than 3.5. Results: The data from 797 warfarin clinics were analyzed with an observation period of 21,328.52 patient-years. The median duration of followup was 519 days (IQR 172, 1,183). Of the 31,407 patients, 277 patients experienced 319 thromboembolic events, and 3,398 patients experienced 4,860 bleeding events. The thromboembolic events were 4.92, 1.89, 0.86, 0.72, 0.39, 0.36 per 100 patient-years in INR range of less than 1.5, 1.5 to 1.9, 2.0 to 2.5, 2.6 to 3.0, 3.1 to 3.5, and more than 3.5, respectively. The bleeding events were 12.69, 9.51, 8.41, 15.35, 36.38, 125.03 per 100 patient-years in INR range of less than 1.5, 1.5 to 1.9, 2.0 to 2.5, 2.6 to 3.0, 3.1 to 3.5, and more than 3.5, respectively. The all-adverse events were 17.61, 11.40, 9.27, 16.07, 36.77, 125.39 per 100 patient-years in the INR range of less than 1.5, 1.5 to 1.9, 2.0 to 2.5, 2.6 to 3.0, 3.1 to 3.5, and more than 3.5, respectively. Conclusion: The incidence density of all-adverse events was lowest in INR range of 2.0 to 2.5. This range should be the optimal therapeutic INR level for Thai NVAF patient. However, the INR range can extend to 1.5 to 2.5 in clinical practice. [ABSTRACT FROM AUTHOR]

Meticulous understanding of the mechanisms underpinning mitral regurgitation in atrial fibrillation (AF) patients is crucial to optimize therapeutic strategies. The morphologic characteristics of mitral valves in atrial functional mitral regurgitation (FMR) patients with and without left ventricular (LV) dysfunction were evaluated by high volume rate (HVR) three-dimensional transesophageal echocardiography (3D-TEE). In our study, 68 of 265 AF patients who underwent 3D-TEE were selected, including 36 patients with AF, FMR, and preserved LV function (AFMR group) and 32 patients with AF, FMR, and LV dysfunction (VFMR group). In addition, 36 fever patients without heart disease were included in the control group. Group comparisons were performed by one-way analysis of variance for continuous variables. The left atrium (LA) was enlarged in the AFMR and VFMR groups compared with the control group. The mitral annulus (MA) in the AFMR group was enlarged and flattened compared with the control group and was smaller than in the VFMR group. The annulus area fraction was significantly diminished in the AFMR and VFMR groups, indicative of reduced MA contractility. The posterior mitral leaflet (PML) angle was smallest in the AFMR group and largest in the control group, whereas the distal anterior mitral leaflet angle did not significantly differ among the three groups. LA remodeling causes expansion of the MA and reduced MA contractility, disruption of the annular saddle shape, and atriogenic PML tethering. Comparison of atrial FMR patients with and without LV dysfunction indicates that atriogenic PML tethering is an important factor that aggravates FMR. HVR 3D-TEE improves the 3D temporal resolution greatly. [ABSTRACT FROM AUTHOR]

Background: To develop and validate a nomogram prediction model for assessing the risk of major adverse cardiovascular and cerebrovascular events (MACCE) in patients with nonvalvular atrial fibrillation (NVAF) and heart failure with preserved ejection fraction (HFpEF) within one year of discharge. Methods: We enrolled 828 patients with NVAF and HFpEF from May 2017 to March 2022 in Zhongda Hospital as the training cohort, and 564 patients with NVAF and HFpEF in Taizhou People's Hospital between August 2018 and March 2022 as the validation cohort. A total of 35 clinical features, including baseline characteristics, past medical records, and detection index, were used to create a prediction model for MACCE risk. The optimized model was verified in the validation cohort. Calibration plots, the Hosmer-Lemeshow test, and decision curve analyses (DCA) were utilized to assess the accuracy and clinical efficacy of the nomogram. Results: MACCE occurred in 23.1% of all patients within one year of discharge. The nomogram identified several independent risk factors for MACCE, including atrial fibrillation duration =6 years, poor medication compliance, serum creatinine level, hyperthyroidism, serum N-terminal pro-brain natriuretic peptide level, and circumferential end-diastolic stress. The DCA demonstrated the excellent efficacy of the prediction model for the MACCE end-point, with a wide range of high-risk threshold probabilities in both cohorts. The Hosmer-Lemeshow test confirmed that momogram predictions fit for both the training (p = 0.573) and validation (p = 0.628) cohorts. Conclusions: This nomogram prediction model may offer a quantitative tool for estimating the risk of MACCE in patients with NVAF and HFpEF within one year of discharge. [ABSTRACT FROM AUTHOR]

Introduction: Direct oral anticoagulant agents (DOACs) are indicated for stroke prevention in patients with nonvalvular atrial fibrillation (NVAF). Reduced doses of DOACs are indicated in patients who have renal impairment and according to age and weight criteria. The aim of this study was to investigate the frequency, clinical factors, and impact on 1-year prognosis of underdosing DOACs. Methods: Data of patients enrolled in the Jordan AF (JoFib) study and who were followed for 1 year was used to compare patients prescribed standard dose with those who were underdosed. Results: There were 672 patients (76.2%) who were prescribed standard dose and 210 patients (23.8%) who were underdosed. Baseline characteristics were similar between the 2 groups. Factors associated with underdosing were enrollment from an outpatient vs hospital site, moderate- or high-risk HAS-BLED score, an abnormal left ventricular ejection fraction (LVEF

OBJECTIVE: To probe into the efficacy and safety of rivaroxaban combined with clopidogrel bisulfate for dual antithrombotic therapy ( DAT) in the treatment of senile patients with acute coronary syndrome ( ACS) complicated with nonvalvular atrial fibrillation (NVAF) after percutaneous coronary intervention (PCI). METHODS: A total of 120 elderly patients with ACS complicated with NVAF underwent PCI admitted into Hai’ an People’ s Hospital from Jan. 2019 to Jun. 2021 were selected to be randomly divided into observation group and control group, with 60 cases in each group. After quality control to exclude therapeutic regimen change and follow-up lost, 57 cases in the observation group and 53 cases in the control group were finally enrolled. The observation group was given DAT regimen, while the control group was given triple antithrombotic therapy (TAT) of warfarin, aspirin and clopidogrel bisulfate, the course of treatment were 12 months for both groups. The scores of risk degree of atrial fibrillation thrombus (CHA2DS2-VASc) and risk of atrial fibrillation anticoagulant bleeding (HAS-BLED) were evaluated before treatment and after 6 and 12 months of treatment, respectively; at the end of the research, the incidences of thromboembolic events and bleeding events, as well as the classification proportions of bleeding events severity were observed. RESULTS: After 6 and 12 months of treatment, the CHA2DS2-VASc and HAS-BLED scores of both groups were slightly higher than those before treatment, the difference was not statistically significant (P>0. 05). At the end of the research, the differences of the incidences of compound thromboembolic events ( stent thrombosis, recurrent acute myocardial infarction, ischemic stroke, pulmonary embolism or peripheral arterial embolism, recurrent revascularization and all-cause mortality ) between two groups were not statistically significant ( P > 0. 05 ); the differences of the incidences of drug cumulative bleeding events (hemorrhagic stroke, gingival bleeding, subcutaneous bleeding, respiratory tract bleeding, digestive tract bleeding, urethremorrhage and anemia ) and the severity of bleeding events (mild, moderate and severe bleeding) were not statistically significant (P>0. 05). CONCLUSIONS: The DAT regimen has equivalently antithrombotic treatment effect as TAT regimen in senile patients with ACS complicated with NVAF after PCI, and do not increase the risk of bleeding in patients. [ABSTRACT FROM AUTHOR]

Liver cirrhosis is a confirmed risk factor for poor prognosis of stroke; however, the contribution of clinically inapparent liver fibrosis to cardioembolic stroke (CES) and its outcomes are poorly understood. This study aimed to investigate the associations between liver fibrosis—measured by the Fibrosis-4 (FIB-4) score—and stroke severity and short-term clinical outcomes of patients with acute CES due to nonvalvular atrial fibrillation (NVAF). A total of 522 patients were followed for a median of 90 days. We calculated the FIB-4 score and defined liver fibrosis as follows: likely advanced fibrosis (FIB-4 > 3.25), indeterminate advanced fibrosis (FIB-4, 1.45–3.25), and unlikely advanced fibrosis (FIB-4 < 1.45). Logistic regression analysis and Cox regression analysis were used to investigate the relations between the FIB-4 score and stroke severity, major disability at discharge, and all-cause mortality. Among these 522 acute CES patients with NVAF, the mean FIB-4 score (2.28) on admission reflected intermediate fibrosis, whereas liver enzymes were largely normal. In multivariate regression analysis, patients with advanced liver fibrosis were more likely to have a higher risk of severe stroke (OR = 2.21, 95% CI 1.04–3.54), major disability at discharge (OR = 4.59, 95% CI 1.88–11.18), and all-cause mortality (HR = 1.25, 95% CI 1.10–1.56) than their counterparts. Regarding sex, these associations were stronger in males but not significant in females. In patients with acute CES due to NVAF, advanced liver fibrosis is associated with severe stroke, major disability, and all-cause death. Our findings indicate that early screening and management of liver fibrosis may decrease stroke severity and risk of death in patients with NVAF, especially for male patients. Consequently, FIB-4 > 3.25 of male patients should receive ultrasound elastography to further determine the degree of liver fibrosis. [ABSTRACT FROM AUTHOR]

Background: Device-related thrombosis (DRT) after successful closure implantation on left atrial appendage (LAA) was considered as a major challenge and optimal strategy on antithrombotic therapy remains to be solved. This study was performed to compare the clinical effectiveness and safety of reduced rivaroxaban dose (RRD) and dual antiplatelet therapy (DAPT) after left atrial appendage closure (LAAC) implantation with the Watchman device. Methods: After successful LAAC, consecutive participants were medicated with a standard DAPT or RRD. The primary endpoints included DRT, thrombosis events (TE), and bleeding events that were documented during a 12-month follow-up period. Results: 767 patients (DAPT: n = 140; RRD: n = 627) were initially included. After propensity score matching (PSM), 140 patients treated with DAPT and 280 patients with RRD were included in each group with similar baseline information, thromboembolic and bleeding risk factors, cardiovascular risk factors and concomitant medication. In the RRD group, 193 patients were on rivaroxaban 15 mg (R15 ) and 47 received rivaroxaban 10 mg (R10). The incidence of DRT was documented in 12 (9.3%) patients in the DAPT group and 3 (6.3%) in R10 and 7 (3.0%) in R15 (log-rank p = 0.050). DAPT subgroups were more likely to experience shorter time to DRT as compared to R15 (R15 vs. DAPT hazard ratio (HR) = 0.334, p = 0.015, 95% CI: 0.131–0.850). The median length of DRT in the R15 group was significantly lower than that of the DAPT group (1.721 [1.610–1.818] mm vs. 1.820 [1.725–1.925] mm, p = 0.029). Compared with the unadjusted estimated rates of ischemic events for patients with similar congestive heart failure, hypertension, age ≥75 years, diabetes mellitus, prior stroke or transient ischemic attack or thromboembolism, vascular disease, age 65–74 years, sex category (CHA2DS2-VASc) scores, a significant decrease of 68.6% in ischemic stroke rates was noted in the R15 group, which contributed to a 54.9% reduction of overall thromboembolic events. The overall minor bleeding was not significantly different amongst the three groups (p = 0.944). Procedural bleeding was more common in the DAPT group, as compared with the R10 and R15 groups. Conclusions: After successful closure implantation, long-term RRD significantly reduced the DRT and TE occurrence compared with DAPT. [ABSTRACT FROM AUTHOR]

Background and aims: Elderly patients with nonvalvular atrial fibrillation (NVAF) might have a higher risk of intracerebral hemorrhage. To investigate this, we compared the incidence of intracranial hemorrhage (ICH) and its subtypes, as well as ischemic stroke, in patients taking direct oral anticoagulants (DOACs) compared with warfarin in a real-world setting. We also determined the baseline characteristics associated with both ICH and ischemic stroke. Methods: Patients aged ⩾ 75 years with documented NVAF enrolled in the prospective, multicenter, observational All Nippon Atrial Fibrillation in the Elderly Registry between October 2016 and January 2018 were evaluated. The co-primary endpoints were the incidence of ischemic stroke and ICH. Secondary endpoints included subtypes of ICH. Results: Of 32,275 patients (13,793 women; median age, 81.0 years) analyzed, 21,585 (66.9%) were taking DOACs and 8233 (25.5%) were taking warfarin. During the median 1.88-year follow-up, 743 patients (1.24/100 person-years) developed ischemic stroke and 453 (0.75/100 person-years) developed ICH (intracerebral hemorrhage, 189; subarachnoid hemorrhage, 72; subdural/epidural hemorrhage, 190; unknown subtype, 2). The incidence of ischemic stroke (adjusted hazard ratio (aHR) 0.82, 95% confidence interval (CI) 0.70–0.97), ICH (aHR 0.68, 95% CI 0.55–0.83), and subdural/epidural hemorrhage (aHR 0.53, 95% CI 0.39–0.72) was lower in DOAC users versus warfarin users. The incidence of fatal ICH and fatal subarachnoid hemorrhage was also lower in DOAC users versus warfarin users. Several baseline characteristics other than anticoagulants were also associated with the incidence of the endpoints. Of these, history of cerebrovascular disease (aHR 2.39, 95% CI 2.05–2.78), persistent NVAF, (aHR 1.90, 95% CI 1.53–2.36), and long-standing persistent/permanent NVAF (aHR 1.92, 95% CI 1.60–2.30) was strongly associated with ischemic stroke; severe hepatic disease (aHR 2.67, 95% CI 1.46–4.88) was strongly associated with overall ICH; and history of fall within 1 year was strongly associated with both overall ICH (aHR 2.29, 95% CI 1.76–2.97) and subdural/epidural hemorrhage (aHR 2.90, 95% CI 1.99–4.23). Conclusion: Patients aged ⩾ 75 years with NVAF taking DOACs had lower risks of ischemic stroke, ICH, and subdural/epidural hemorrhage than those taking warfarin. Fall was strongly associated with the risks of intracranial and subdural/epidural hemorrhage. Data access statement: The individual de-identified participant data and study protocol will be shared for up to 36 months after the publication of the article. Access criteria for data sharing (including requests) will be decided on by a committee led by Daiichi Sankyo. To gain access, those requesting data access will need to sign a data access agreement. Requests should be directed to yamt-tky@umin.ac.jp. [ABSTRACT FROM AUTHOR]

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Objective To explore the efficacy and safety of dabigatran etexilate in the treatment of elderly patients with non-valvular atrial fibrillation (NVAF), so as to provide reference for clinical treatment and rational drug use. Methods Eighty elderly patients with NVAF in The Seventh People's Hospital of Shanghai from December 2020 to June 2021, aged 65 to 80 years, were enrolled in a self-controlled study. Dabigatran etexilate 110 mg was given orally, twice a day (one in the morning and one in the evening) for 6 months. During the follow-up visit, the coagulation function indexes including APTT, TT, FIB and D-D were observed in patients taking medicine for 1 month and 6 months. Liver function indexes including ALT, AST and TBIL, renal function indicators including UREA and eGFR, and blood routine indexes including HGB and ESR, also were observed in patients taking medicine for 1 month and 6 months. Results Patients were compared at 1 month and 6 months after treatment with dabigatran and before: the difference of coagulation function indexes as APTT and TT was statistically significant (P<0.05);There was no significant difference in liver function index, renal function index and blood routine index (P>0.05); A total of 25 adverse events occurred, and the incidence rate of adverse reactions was 31.25%, there was no adverse events such as serious hemorrhage， life threatening and organ failure hemorrhage occurred．Conclusion Dabigatran has good efficacy and safety in the treatment of the elderly NVAF. [ABSTRACT FROM AUTHOR]

Background and Aim: Reports on patients with nonvalvular atrial fibrillation (NVAF), particularly in the elderly, are few from India. This paper focuses on multimorbidity pattern, antithrombotic treatment and mortality of elderly NVAF patients from the state of Kerala, India. Methods: Clinical details of NVAF patients of age = 75 years from the cohort of KERALA-AF registry were analyzed for pattern of multimorbidity, antithrombotic treatment and one-year mortality. Results: The study comprised 753 patients with a median age of 80 years (IQR = 77-84), 53.5% being male. Multimorbidity was present in 94.5% of patients. Hypertension was the most common risk factor (74.4 %, n = 560) and chronic kidney disease was the major coexisting disease (78.9%, n = 594). Based on the number of comorbidities present, patients were grouped into three groups: < 3 comorbidities (18.1%), 3-5 comorbidities (63.9%), and > 5 comorbidities (17.6%). Oral anticoagulant therapy (OAC) was received by 62.5% (n = 472) of patients, mostly Vitamin K antagonist (VKA). Direct oral anticoagulants (DOAC) were used in 11.3% of patients. Antiplatelet therapy was used in 60.6% (n = 458) and the most commonly used antiplatelet was clopidogrel (44.6%). No antithrombotic treatment was used in 12.0% of patients (n = 91). One-year all-cause mortality was 19.6% (n = 148), higher in women but not statistically significant (p = 0.06). Kaplan-Meier survival curve indicated better one-year survival for patients who received OAC treatment (log rank test p < 0.0001, HR = 0.49 (95% CI = 0.35, 0.68), concordance = 0.58). Multivariate cox proportional hazards regression model showed OAC treatment (HR, 0.5; 95% CI, 0.36-0.7, P < 0.001) and age more than 80 years (HR, 1.53; 95% CI, 1.11 -2.1, P < 0.01) as predictors of one-year mortality. Mortality was not significantly different among the groups with different clustering of multimorbidity. Conclusion: Use of oral anticoagulation was associated with a reduced risk of mortality among elderly NVAF patients in the KERALA-AF Registry. However, more than one-third of elderly NVAF patients did not receive OAC, which calls for increased sensitization and training of treating doctors regarding optimal use of OAC in the elderly NVAF patients. Funding: The study received funding from the Cardiological Society of India-Kerala Chapter (CSI-K). [ABSTRACT FROM AUTHOR]

To compare the risk of stroke and systemic embolism (SE) among patients with nonvalvular atrial fibrillation (NVAF) who abandoned their first direct oral anticoagulant (DOAC) fill ("abandoners") relative to patients who continued DOACs beyond the first fill ("continuers"). In this retrospective longitudinal study, adults with NVAF prescribed DOACs were selected from Symphony Health, an ICON plc Company, PatientSource, 1 April 2017 to 31 October 2020. A 90-day landmark period following the first DOAC fill was used to classify patients as abandoners or continuers. Inverse probability of treatment weighting was used to balance baseline characteristics between cohorts. Time to ischemic stroke/SE was described and compared between cohorts using weighted Kaplan-Meier and Cox proportional hazard models from the end of the landmark period until end of clinical activity or data. After weighting, 200,398 and 211,352 patients comprised the abandoner and continuer cohorts, respectively. The mean duration of follow-up was 14.9 and 15.7 months, respectively. At 12 months of follow-up, the probability of ischemic stroke/SE was 1.34% in the abandoner cohort and 1.00% in the continuer cohort; the risk of ischemic stroke/SE was 35% higher in the abandoner versus continuer cohort (hazard ratio [95% confidence interval] = 1.35 [1.20, 1.51]; p < 0.0001). Patients with NVAF who abandoned the first DOAC fill had significantly higher risk of ischemic stroke/SE compared to patients who continued therapy beyond the first fill. There is an unmet need for better access to DOACs so that the long-term risk of poor outcomes may be minimized. [ABSTRACT FROM AUTHOR]

Abstract A major advancement in the field of medicine has been the introduction and usage of direct oral anticoagulants (DOACs) such as dabigatran (Pradaxa), apixaban (Eliquis), and rivaroxaban (Xarelto). DOACs have been increasing in popularity for mainstay anticoagulation pharmacotherapy and are being preferred by physicians over warfarin due to their rapid onset, fewer drug and food interactions, and lack of frequent blood monitoring. DOACs have been indicated in the management of thromboembolic conditions and have been extensively researched in various medical trials and studies before the approval of dabigatran (Pradaxa) in 2010 by the FDA. DOACs, like warfarin, are associated with a risk of bleeding, requiring clearance of the drug from the bloodstream or administration of reversal agents. It is important for physicians to familiarize themselves with the various types of DOACs and their dosages, along with their advantages and disadvantages in comparison to other non-DAOC classes of medications before incorporating them into their patient management plans.

Background: About 5%–15% of acute coronary syndrome (ACS) patients undergoing stent implantation have concomitant atrial fibrillation and need both antiplatelet and anticoagulant therapies. The optimal antithrombotic regimen remains uncertain in this scenario. Hypothesis: A multicenter randomized controlled trial (OPtimal management of anTIthroMbotic Agents [OPTIMA]‐4) is designed to test the hypothesis that, for ACS patients with concomitant nonvalvular atrial fibrillation (NVAF) and having low‐to‐moderate risk of bleeding, clopidogrel is comparable in efficacy but superior in safety compared to ticagrelor while being used in combination with dabigatran after new‐generation drug‐eluting stent (DES) implantation. Methods: ACS patients who have low‐to‐moderate risk of bleeding (e.g., HAS‐BLED score ≤ 2) and require anticoagulation therapy (CHA2DS2‐VASc score ≥ 2) will be recruited after implantation of new‐generation DES. A total of 1472 eligible patients will be randomly assigned to receive a 12‐month dual antithrombotic treatment of either clopidogrel 75 mg daily or ticagrelor 90 mg twice daily in combination with dabigatran 110 mg twice daily. Participants will be followed up for 12 months after randomization. The primary efficacy endpoint is a composite of cardiovascular death, myocardial infarction, unplanned revascularization, ischemic stroke, and systemic thromboembolism. The primary safety endpoint is set as major bleeding or clinically relevant nonmajor bleeding defined by the International Society of Thrombosis and Hemostasis. The enrollment and follow‐up have been launched. Results: The first enrollment occurred on March 12, 2018. The recruitment is anticipated to be completed before December 31, 2024. Conclusions: The OPTIMA‐4 trial offers an opportunity to assess the optimal dual antithrombotic regimen in ACS patients with concomitant NVAF after the implantation of new‐generation DES. [ABSTRACT FROM AUTHOR]

Context: Rivaroxaban is an oral direct factor Xa inhibitor reducing the risk of systemic embolism and stroke in patients with nonvalvular atrial fibrillation. Aims: The primary objective was to evaluate the effectiveness of rivaroxaban therapy in reducing the risk of systemic embolism and stroke in patients with nonvalvular atrial fibrillation, whereas secondary objectives were to monitor therapy safety and the patients' adherence to treatment. Settings and Design: The prospective, postmarketing clinical trial was conducted on patients with nonvalvular atrial fibrillation with one or more risk factors, such as congestive heart failure, hypertension, and diabetes mellitus, who suffered a stroke or a transient ischemic attack. Subjects and Methods: At the baseline visit, the CHA2DS2 score was determined, and therapy was introduced. At three control visits (1, 3, and 6 months after baseline), systemic embolism, stroke, bruises, or bleeding occurrences were recorded. Furthemore, adverse events were monitored, and the Morisky score (MMAS-8) for treatment compliance was determined. Results were compared to previous studies. Results: The study included 471 patients. The incidence rate in events per 100 patient-years (95% confidence interval) was 2.6 (0.1–5.1) for systemic embolism and 4.3 (1.6–7.0) for stroke. The most common form of bleeding during rivaroxaban therapy was epistaxis. Adverse events were reported in 12 (2.7%) patients. Therapy adherence was in the range of medium adherence for the entire study period, with the average score decreasing significantly from the 1st to 6th months (P < 0.001). Conclusions: Rivaroxaban showed good efficacy and safety in reducing the risk of systemic embolism and stroke in patients with nonvalvular atrial fibrillation including patients with comorbidities.

Context: Rivaroxaban is an oral direct factor Xa inhibitor reducing the risk of systemic embolism and stroke in patients with nonvalvular atrial fibrillation. Aims: The primary objective was to evaluate the effectiveness of rivaroxaban therapy in reducing the risk of systemic embolism and stroke in patients with nonvalvular atrial fibrillation, whereas secondary objectives were to monitor therapy safety and the patients' adherence to treatment. Settings and Design: The prospective, postmarketing clinical trial was conducted on patients with nonvalvular atrial fibrillation with one or more risk factors, such as congestive heart failure, hypertension, and diabetes mellitus, who suffered a stroke or a transient ischemic attack. Subjects and Methods: At the baseline visit, the CHA2DS2 score was determined, and therapy was introduced. At three control visits (1, 3, and 6 months after baseline), systemic embolism, stroke, bruises, or bleeding occurrences were recorded. Furthemore, adverse events were monitored, and the Morisky score (MMAS-8) for treatment compliance was determined. Results were compared to previous studies. Results: The study included 471 patients. The incidence rate in events per 100 patient-years (95% confidence interval) was 2.6 (0.1-5.1) for systemic embolism and 4.3 (1.6-7.0) for stroke. The most common form of bleeding during rivaroxaban therapy was epistaxis. Adverse events were reported in 12 (2.7%) patients. Therapy adherence was in the range of medium adherence for the entire study period, with the average score decreasing significantly from the 1st to 6th months (P < 0.001). Conclusions: Rivaroxaban showed good efficacy and safety in reducing the risk of systemic embolism and stroke in patients with nonvalvular atrial fibrillation including patients with comorbidities. [ABSTRACT FROM AUTHOR]

Introduction: Direct oral anticoagulants (DOACs) are essential in ischemic stroke/systemic embolism (SE) prevention among patients with nonvalvular atrial fibrillation (NVAF). This study compared the risk of ischemic stroke/SE among patients with NVAF who discontinued DOACs following the first fill ("one-and-done") relative to patients who continued DOACs beyond the first fill ("continuers"). Methods: De-identified data from Symphony Health, an ICON plc Company, PatientSource®, April 1, 2017 to October 31, 2020, were used to identify adults with NVAF initiated on DOACs (index date). Patients with only one DOAC claim during the 90-day landmark period starting on the index date were classified as one-and-done and the remaining as continuers. Inverse probability of treatment weighting was used to balance baseline characteristics in the cohorts. Time from the landmark period end to the first ischemic stroke/SE event or, among those without the event, to clinical activity or data end was compared between balanced cohorts using survival analysis. Results: Of patients initiating DOACs, 23.6% were classified as one-and-done users. After weighting was performed, 241,159 and 238,889 patients comprised the one-and-done and continuer cohorts, respectively. At 12 months of follow-up, the probability of ischemic stroke/SE was 1.44% in the one-and-done cohort and 1.00% in the continuer cohort [hazard ratio (95% confidence interval) 1.44 (1.34–1.54); p < 0.0001]. Results at earlier and later time points and in a sensitivity analysis with a 75-day landmark period were similar. Conclusion: A substantial proportion of patients were one-and-done DOAC users, which was associated with significantly higher risk of ischemic stroke/SE events. There is an unmet need to improve access and encourage continuous use of DOACs among patients with NVAF so that severe and fatal complications may be mitigated. [ABSTRACT FROM AUTHOR]

A major advancement in the field of medicine has been the introduction and usage of direct oral anticoagulants (DOACs) such as dabigatran (Pradaxa), apixaban (Eliquis), and rivaroxaban (Xarelto). DOACs have been increasing in popularity for mainstay anticoagulation pharmacotherapy and are being preferred by physicians over warfarin due to their rapid onset, fewer drug and food interactions, and lack of frequent blood monitoring. DOACs have been indicated in the management of thromboembolic conditions and have been extensively researched in various medical trials and studies before the approval of dabigatran (Pradaxa) in 2010 by the FDA. DOACs, like warfarin, are associated with a risk of bleeding, requiring clearance of the drug from the bloodstream or administration of reversal agents. It is important for physicians to familiarize themselves with the various types of DOACs and their dosages, along with their advantages and disadvantages in comparison to other non-DAOC classes of medications before incorporating them into their patient management plans. [ABSTRACT FROM AUTHOR]

As a major complication of non-valvular atrial fibrillation (NVAF), left atrial appendage (LAA) thrombosis is associated with cerebral ischemic strokes, as well as high morbidity. Due to insufficient incorporation of risk factors, most current scoring methods are limited to the analysis of relationships between clinical characteristics and LAA thrombosis rather than detecting potential risk. Therefore, this study proposes a clinical data-driven machine learning method to predict LAA thrombosis of NVAF. Patients with NVAF from January 2014 to June 2022 were enrolled from Southwest Hospital. We selected 40 variables for analysis, including demographic data, medical history records, laboratory results, and the structure of LAA. Three machine learning algorithms were adopted to construct classifiers for the prediction of LAA thrombosis risk. The most important variables related to LAA thrombosis and their influences were recognized by SHapley Addictive exPlanations method. In addition, we compared our model with CHADS2 and CHADS2-VASc scoring methods. A total of 713 participants were recruited, including 127 patients with LAA thrombosis and 586 patients with no obvious thrombosis. The consensus models based on Random Forest and eXtreme Gradient Boosting LAA thrombosis prediction (RXTP) achieved the best accuracy of 0.865, significantly outperforming CHADS2 score and CHA2DS2-VASc score (0.757 and 0.754, respectively). The SHAP results showed that B-type natriuretic peptide, left atrial appendage width, C-reactive protein, Fibrinogen and estimated glomerular filtration rate are closely related to the risk of LAA thrombosis in nonvalvular atrial fibrillation. The RXTP-NVAF model is the most effective model with the greatest ROC value and recall rate. The summarized risk factors obtained from SHAP enable the optimization of the treatment strategy, thereby preventing thromboembolism events and the occurrence of cardiogenic ischemic stroke. [ABSTRACT FROM AUTHOR]

Aim. To study the potential of predicting thrombosis of the left atrium (LA) and/or LA appendage (LAA) before catheter ablation (CA) or elective cardioversion in patients with nonvalvular atrial fibrillation (NAF) or atrial flutter (AFL) using indicators available in routine practice.Material and methods. In this single-center retrospective study, the medical records of 1994 patients with nAF or AFL for the period 2014-2019 were analyzed, who underwent transesophageal echocardiography before CA or elective CV. LA/LAA thrombus was found in 33 (1,6%) patients. For the comparison group, 167 patients were randomly selected without LA/LAA thrombosis. Demographic, anamnestic, clinical, laboratory data, results of transthoracic echocardiography, as well as the CHA2DS2-VASc-RAF (CHA2DS2-VASc plus 2 points for an estimated glomerular filtration rate 7 days), 10 points for persistent AF).Results. The mean age of the patients was 60,3±10,9 years (men, 55%). There were more patients with NAF (87,5%), hospitalized for CV (84,0%). Multivariate analysis revealed that the severity of symptoms associated with arrhythmia was associated with the detection of a LA/LAA thrombus (odds ratio (OR) for EHRA class 3-4 14,29 at 95% confidence interval (CI): 3,3-61,8; p3 was 12,8 (95% CI: 3,8-43,9; p8 was 25,8 (95% CI: 5,9-112,3; p

ObjectivesLower than recommended doses of direct-acting oral anticoagulants are often prescribed to older adults with nonvalvular atrial fibrillation (NVAF). Our goal was to determine the consequences of lower than recommended dosing on plasma apixaban concentrations during the clinical care of older adults with NVAF.DesignConvenience sample of patients receiving anticoagulation during 2017.SettingAcademic medical center.ParticipantsStable adults older than 65 years with NVAF receiving apixaban on a chronic basis.MeasurementsPatient age, weight, creatinine, co-medications, and apixaban concentrations.ResultsA total of 110 older adults with NVAF (mean age = 80.4 y; range = 66-100 y with 45% women) were studied. Overall, 48 patients received recommended dosing of 5 mg twice/day, and 42 received lower than recommended dosing. One patient in each category had concentrations below the expected 5% to 95% range at time of peak concentrations. Differences in proportion of apixaban concentrations within or outside expected ranges were not significant between patients receiving lower than recommended doses and those dosed as recommended at 5 mg twice/day (P = .35). However, in patients dosed as recommended with 5 mg twice/day, four had concentrations above the 5% to 95% range for peak levels expected at 3 to 4 hours after dosing; in two, this occurred around the midpoint of the dosing interval. Twenty patients received 2.5 mg twice/day as recommended. One-third had apixaban concentrations higher than expected peak concentrations compared with the clinical trials, and more than two-thirds had levels above the reported median for peak concentrations.ConclusionsApixaban concentrations in older adults with NVAF seen clinically were higher than expected based on clinical trial data. The findings raise questions about the optimal dosing of apixaban in older adults with NVAF encountered outside of clinical trials and suggest a role for the monitoring of apixaban concentrations during care of patients that differ from those in randomized trials or when considering dosing outside of published guidelines. J Am Geriatr Soc 67:1902-1906, 2019.

The article focuses on the importance of self-care behaviors in managing atrial fibrillation (AF) and improving adherence to oral anticoagulant therapy, including the complexities of maintaining long-term adherence to direct oral anticoagulants (DOACs).

Left atrial appendage occlusion is not inferior to oral anticoagulants in the prevention of stroke in several randomized controlled trials. However, the clinical efficacy and safety comparison of the Watchman and amplatzer cardiac plug (ACP)/Amulet devices for percutaneous left atrial appendage closure (LAAC) in patients with non‐valvular atrial fibrillation was controversial. A database search was conducted using PubMed, EMBASE, Cochrane Library, and Clinicaltrials.gov for trials that compared Watchman device vs ACP/Amulet device. The effective outcomes were stroke and systemic embolism. Safety outcomes were all‐cause death, cardiovascular death, and major bleeding. Device‐related complications included device‐related thrombus (DRT), peri‐device leaks (PDL > 5 mm). A total of 19 articles involving 6224 patients were included in the present study. The Watchman and ACP/Amulet groups comprised 3267 and 2957 patients, respectively. No statistically significant differences were detected in the stroke (odd ratio [OR]:1.24, 95% confidence interval [CI]: 0.92−1.67, p =.17, I2 = 0), systemic embolism (OR:1.10, 95% CI: 0.51−2.35, p =.81, I2 = 0%), all‐cause death (OR:0.97, 95% CI: 0.80−1.18, p =.77, I2 = 1%), cardiogenic death (OR:0.99, 95% CI: 0.77−1.29, p =.96, I2 = 0%), major bleeding (OR:1.18, 95% CI: 0.98−1.43, p =.08, I2 = 25%). DRT (OR:1.48, 95% CI: 1.06−2.06, p =.02, I2 = 0%) and PDL > 5 mm (OR:2.57, 95% CI: 1.63−4.04, p <.0001, I2 = 0%) were significantly lower in ACP/Amulet group compared to Watchman group. The effective and safety outcomes were comparable between two groups. ACP/Amulet group had significantly lower rates of DRT and PDL > 5 mm than Watchman group. [ABSTRACT FROM AUTHOR]

Background: The efficacy and safety profiles of nonrecommended direct oral anticoagulant (DOAC) doses in patients with nonvalvular atrial fibrillation (NVAF) are still undefined. Summary: We searched for randomized controlled trials and observational studies that compared nonrecommended versus recommended doses of DOACs, published up to December 2021. Primary study outcomes were ischemic stroke/transient ischemic attack/systemic embolism (IS/TIA/SE) and major bleeding (MB). All-cause mortality was a secondary outcome. We determined pooled odds ratios (ORs) between groups of patients with a random-effect model. Twenty-three studies with 175,801 patients were included. Nonrecommended doses were associated with a higher risk of IS/TIA/SE and all-cause mortality, but not of MB as compared to recommended doses of DOACs (OR 1.25 [95% CI: 1.14–1.38], OR 1.69 [95% CI: 1.31–2.18] and OR 1.10 [95% CI: 0.93–1.31], respectively). The nonrecommended low dose was associated with an increased risk of IS/TIA/SE and all-cause death (OR 1.21 [95% CI: 1.05–1.39] and OR 1.66 [95% CI: 1.18–2.35], respectively) but not of MB (OR 1.01 [95% CI: 0.83–1.22] as compared to recommended doses. Subgroup analysis of nonrecommended low doses of DOACs showed a nonsignificant increase in IS/TIA/SE in Asians (OR 1.17 [95% CI: 0.89–1.54] vs. non-Asian (OR 1.21 [95% CI: 1.07–1.36]). Key Messages: Compared with recommended doses, nonrecommended low doses of DOACs increase the risk of ischemic events without decreasing the risk of bleeding. For Asians, the efficacy of DOACs seemed preserved despite the nonrecommended low-dose prescription. Clinicians should carefully adhere to recommended DOAC prescription advice in managing NVAF patients. [ABSTRACT FROM AUTHOR]

Objectives: We aimed to explore the potential role of N‐terminal pro‐B‐type natriuretic peptide (NT‐proBNP), d‐dimer, and the echocardiographic parameter left atrial diameter (LAD) in identifying and predicting the occurrence of ischemic stroke (IS) in patients with nonvalvular atrial fibrillation (NVAF). Methods: We conducted a retrospective study of 445 patients with NVAF in the First Affiliated Hospital of Nanchang University. They were divided into the NVAF (309 cases) and NVAF with stroke (136 cases) groups according to whether acute ischemic stroke (AIS) occurred at admission. Multivariate logistic regression was used to analyze the odds ratio (OR) of NT‐proBNP, d‐dimer, and LAD for IS. The predictive value of NT‐proBNP, d‐dimer, and LAD in identifying the occurrence of IS in NVAF was determined by plotting the receiver operating characteristic (ROC) curves. Results: NT‐proBNP, d‐dimer, and LAD levels were significantly higher in the NVAF with stroke group than in the NVAF group (p <.05). NT‐ProBNP, d‐dimer, and LAD were independently associated with IS in NVAF patients (odds ratio [OR] = 1.12, 95% confidence interval [CI]: 1.08–1.16; OR = 1.87, 95% CI: 1.37–2.55; OR = 1.21, 95% CI: 1.13–1.28, p <.01). The optimal cutoff points for NT‐ProBNP, d‐dimer, and LAD levels to distinguish the NVAF group from the NVAF with stroke group were 715.0 pg/ml, 0.515 ng/ml, and 38.5 mm, respectively, with the area under the curve (AUC) being [0.801 (95% CI: 0.76–0.84); 0.770 (95% CI: 0.72–0.85); 0.752 (95% CI: 0.71–0.80), p <.01]. The combined score of NT‐proBNP, d‐dimer, and LAD improved the predictive efficacy of the single index, with an AUC of 0.846 (95% CI: 0.81–0.88, p <.01), sensitivity of 77.2%, and specificity of 76.4%. Conclusion: NT‐proBNP, d‐dimer, and the echocardiographic parameter LAD have outstanding value in predicting the risk of IS in patients with NVAF. [ABSTRACT FROM AUTHOR]

Resumen: Antecedentes: El cierre percutáneo de la orejuela izquierda (CPOI) se ha propuesto como una alternativa al tratamiento anticoagulante en pacientes con fibrilación auricular no valvular para disminuir el riesgo tromboembólico, evitando los riesgos de la anticoagulación. Esta opción puede ser atractiva en pacientes con fibrilación auricular no valvular y enfermedad renal crónica (ERC), ya que presentan un alto riesgo tanto tromboembólico como hemorrágico. Objetivo: Determinar el papel pronóstico de la presencia de ERC en pacientes con fibrilación auricular sometidos a un CPOI periprocedimiento y durante el seguimiento comparado con los pacientes con función renal preservada. Métodos: Estudio retrospectivo, observacional de muestreo consecutivo que incluyó 124 pacientes sometidos a CPOI por fibrilación auricular en un hospital universitario y se compararon los resultados según la función renal basal. Resultados: La mediana de edad fue 75,5 años (RIQ 67,6-80), el 62,1% eran hombres, la mediana de CHA2DS2-Vasc y HASBLED era de 4 (RIQ 3-4) para ambas escalas. El 57,3% de la muestra tenía ERC. Las características basales eran similares entre ambos grupos, salvo una media de edad y un score de HASBLED superiores en los pacientes con ERC. Durante el procedimiento, no se observó ningún evento tromboembólico, de sangrado o muerte. Durante el tiempo de hospitalización y de seguimiento combinados, no hubo diferencias significativas entre grupos en la tasa anual de episodios tromboembólicos (0,97/100 pacientes-año [100PA] vs. 4,06/100PA, p = 0,092), pero si se observó una mayor tasa de sangrados (5,67/100PA vs. 13,3/100PA, p = 0,033), y de mortalidad (6,50/100PA vs. 17,2/100PA, p = 0,009) en el grupo de ERC, con una odds ratio para mortalidad de 2,711 (IC95% 1,96-6,95). En el análisis multivariante, el FGe preservado se asoció independientemente con una menor mortalidad. Conclusiones: El CPOI es una alternativa válida a la anticoagulación oral en pacientes con ERC y fibrilación auricular, con una baja tasa de eventos peri- y posprocedimiento. No obstante, los pacientes con ERC presentan mayor riesgo de sangrado y de mortalidad durante el seguimiento. Aunque estas mayores tasas no están necesariamente relacionadas con el procedimiento. Abstract: Background: Percutaneous left atrial appendage closure (LAAC) has been proposed as an alternative to anticoagulation therapy in patients with nonvalvular atrial fibrillation to decrease the thromboembolic risk, while avoiding the risks of chronic anticoagulation. This option may be attractive in patients with nonvalvular atrial fibrillation and chronic kidney disease (CKD), since they exhibit both high-thromboembolic and bleeding risks. Objective: To evaluate the prognostic impact of the presence of CKD in patients with atrial fibrillation undergoing LAAC peri-procedure and during the follow-up as compared with patients with preserved renal function. Methods: Retrospective, observational study that included 124 consecutive patients with atrial fibrillation undergoing LAAC in a university hospital, and the results were evaluated according to the baseline renal function of the patients. Results: The median age was 75.5 years (IQR 67.6–80) and 62.1% were men, the median of CHA2DS2-Vasc and HASBLED scores was 4 (IQR 3–4) for both scores. Up to 57.3% of the total sample had CKD. Baseline characteristics were similar between groups, but CKD patients were older and had a higher HASBLED score. During the procedure, no thromboembolic, bleeding events, or deaths were observed. Combining the time of hospitalization and follow-up, no significant differences were observed between groups in the annual rate of thromboembolic events (0.97/100 patient-years [100PY] vs. 4.06/100PY, p = .09), but there was a higher rate of bleeding events (5.67/100PY vs. 13.3/100PY, p = .033) and mortality among CKD patients (6.50/100PY vs. 17.2/100PY, p = .009), with an odds ratio of 2.711 (95% CI 1.96–6.95). In the multivariate analysis, a preserved eGFR was independently associated with a lower mortality risk. Conclusions: LAAC is a valid alternative to oral anticoagulation in patients with CKD and atrial fibrillation, with a low-rate of peri- and post-procedure complications, although CKD patients exhibited a higher risk of bleeding and mortality during the follow-up. However, these higher rates may not be necessarily related to the procedure.

Background and aim Atrial fibrillation (AF)-related stroke represented more than 79% of all strokes of cardiogenic origin. AF is the crucial factor of cardiogenic stroke. AF-related stroke is manifested with severe clinical manifestation, significant disability, high mortality, and easier relapse. The incidence of mortality is twice as high as non-AF-related stroke. The AF type is usually of nonvalvular origin. The current work is aiming to determine the incidence of cerebral microembolization in nonvalvular AF patients. Patients and methods The current study was a prospective study of two groups of individuals: control and nonvalvular asymptomatic AF cardiac condition, hypertension, age, diabetes, sex, and stroke (CHADS) score 2 or more. Patients were collected from the cardiology clinic and department (Al-Azhar University Hospital, New Damietta, Egypt). Patients were submitted to history taking, clinical assessment, echocardiography, and transcranial Doppler ultrasonography, and microembolic signal detection and count. Also, the transcranial Doppler was used to monitor both middle cerebral arteries. Results There was a statistically significant difference between the control and study groups in relation to the number of microembolic signals. Signals of microembolizations were detected in eight cases (all were in the study group). There was a positive correlation between embolic signals and patient age (r=0.424, P=0.020) and there was a significant association with female sex. In addition, there was a positive correlation between embolic signals and left-atrium dimension (r=0.502). Regarding correlation, there was a negative interaction between embolic signals and anticoagulation use (r=−0.413, P=0.023). Conclusion Asymptomatic embolic signals occur in patients with nonvalvular AF who are not being treated with anticoagulants at a significantly greater frequency than in age-matched controls.

Aim. To determine the incidence of left atrial (LA) and/or LA appendage (LAA) thrombosis in patients with non-valvular atrial fibrillation (AF) (NAF) or atrial flutter (AFL) on transesophageal echocardiography (TEE) before elective catheter ablation (CA) or cardioversion (CV) and characterize the predictors of LA/LAA thrombosis among the indicators available in the routine practice of cardiologists and general practitioners.Material and methods. In this retrospective, single-center, casecontrol study, the medical records of 1994 patients with NAF or AFL for the period 2014-2019, who underwent TEE before CA or elective CV, were analyzed. A thrombus in the LA/LAA was detected in 33 (1,6%) of them. For the comparison group, 167 patients were randomly selected without LA/LAA thrombosis. Demographic, anamnestic and clinical parameters, transthoracic echocardiography data, and laboratory results were analyzed as potential predictors of LA/LAA thrombosis.Results. Patients with LA/LAA thrombosis were older (mean age, 64,8±1,6 vs 59,4±10,8 (p=0,01), more often had persistent or longstanding persistent AF, hypertension, heart failure, enlarged LA, lower left ventricular ejection fraction (LVEF) and estimated glomerular filtration rate, as well as more severe symptoms according to the modified European Heart Rhythm Association (EHRA) score and a higher CHA2DS2-VASc score (median, 4,0 vs 2,0; p=0,0001). Oral anticoagulants were taken by 88% of patients; there were no significant differences in the presence and composition of anticoagulant therapy between the groups. Functional class (FC) according to the modified EHRA score (odds ratio (OR), 5,4; 95% confidence interval (CI): 1,9814,96; p=0,001) and LVEF were independent predictors of LA/LAA thrombosis (OR, 0,87; 95% CI: 0,80-0,95; p=0,002). For EHRA class 3-4, the OR was 5,1; 95% CI: 2,3-11,4 (p

Aims: Observational studies have investigated the effectiveness and safety of direct oral anticoagulants (DOACs) and vitamin K antagonists (VKAs) used in nonvalvular atrial fibrillation. We performed a systematic review and meta‐analysis assessing the risk of ischaemic stroke, thromboembolism (TE) and intracranial haemorrhage (ICH) associated with the use of DOACs and VKAs. Methods: Medline and Embase were systematically searched until April 2021. Observational studies were gathered and hazard ratios (HRs) with 95% confidence intervals (CI) were extracted. Subgroup analyses based on DOAC doses, history of chronic kidney disease, stroke, exposure to VKA, age and sex were performed. A random‐effects model was used. Results: We included 92 studies and performed 107 comparisons. Apixaban was associated with lower risk of stroke (HR: 0.82, 95% CI: 0.68–0.99) compared to dabigatran. Rivaroxaban was associated with lower risk of stroke (HR: 0.90, 95% CI: 0.83–0.98) compared to VKA. Dabigatran (HR: 0.85, 95% CI: 0.80–0.91), rivaroxaban (HR: 0.83, 95% CI: 0.77–0.89) and apixaban (HR: 0.75, 95% CI: 0.65–0.86) were associated with lower risk for TE/stroke compared to VKA. Apixaban (HR: 1.32, 95% CI: 1.03–1.68) and rivaroxaban (HR: 1.58, 95% CI: 1.31–1.89) were associated with higher risk of ICH compared to dabigatran. Dabigatran (HR: 0.48, 95% CI: 0.44–0.52), apixaban (HR: 0.60, 95% CI: 0.49–0.73) and rivaroxaban (HR: 0.73, 95% CI: 0.65–0.81) were associated with lower risk of ICH compared to VKA. Conclusion: Our study demonstrated significant differences in the risk of ischaemic stroke, TE/stroke and ICH associated with individual DOACs compared to both other DOACs and VKA. [ABSTRACT FROM AUTHOR]

Background: Guidance for dabigatran and rivaroxaban in overweight patients diagnosed with non-valvular atrial fibrillation (NVAF) is still lacking.Aim: Compare the effectiveness and safety of dabigatran and rivaroxaban for the treatment of NVAF in the overweight population.Method: A total of 396 out of 1029 overweight patients with NVAF at Zhongshan Hospital, Fudan University, from January 2017 and December 2018 were retrospectively enrolled using propensity score matching analysis. The clinical outcomes were analyzed by chi-square test and Kaplan-Meier analyses. The risk of bleeding and thrombosis was assessed using a Cox regression analysis and validated using a nomogram model.Results: In terms of effectiveness, the incidence of thrombosis events and the time to thrombosis were similar in the dabigatran and rivaroxaban groups (P > 0.05). Regarding safety, compared to dabigatran, the rivaroxaban group had a higher incidence of bleeding events (8.6% vs. 3.5%, χ2 = 4.435, P = 0.035), a shorter time to bleeding (11.3 ± 0.18 months vs. 11.6 ± 0.14 months, P = 0.038) and an increased risk of bleeding (hazard ratio HR = 2.452, 95% confidence interval CI 1.017-5.913, P = 0.046), especially in those patients with heart failure (HR = 3.207, 95% CI 1.183-8.694, P = 0.022).Conclusion: Dabigatran therapy was shown to be equally effective. It may be superior in reducing bleeding risk in an overweight population with NVAF than rivaroxaban. Further prospective studies are encouraged for analysis. [ABSTRACT FROM AUTHOR]

Introduction: ABCB1 gene polymorphisms are associated with rivaroxaban distribution changes and adverse reactions but the data are controversial. Aim: To evaluate the influence of ABCB1 (rs1045642 and rs4148738) gene polymorphisms on rivaroxaban pharmacokinetics in patients aged 80 years and older with nonvalvular atrial fibrillation (NAF). Methods: 128 patients aged 80 years and older (median [Me] age 87.5 [83.0–90.0] years) with NAF were included. We performed ABCB1 (rs1045642 and rs4148738) genotyping, measured the trough steady-state plasma concentration (Cmin,ss) of rivaroxaban and prothrombin time (PT) and analyzed prior medical records for clinically relevant non-major bleeding (CRNMB). Results: CC genotype carriers had no differences in Cmin,ss (p > 0.05) compared with the CT and TT rs1045642 and rs4148738 genotypes carriers. CC genotype carriers had no differences in PT (p > 0.05) compared with the CT rs1045642 and rs4148738 and TT rs4148738 genotypes carriers. In the TT genotype PT levels were higher than in the CC rs1045642 genotype: Me 14.2 [13.0–16.1] sec vs 13.3 [12.4–14.5] sec (p = 0.049). Incidence of CRNMB was higher in patients with the TT genotype compared with the CC rs1045642 (29.3% vs 4.5%, p = 0.021) and rs4148738 (39.3% vs 8.1%, p = 0.008) and the CT genotype rs4148738 (39.3% vs 14.3%, p = 0.002). Conclusion: ABCB1 (rs1045642 and rs4148738) polymorphisms didn't influence rivaroxaban pharmacokinetics in patients aged 80 years and older with NAF. TT carriers developed CRNMB more frequently compared with the CC rs1045642 and the CC and CT rs4148738 genotypes. The haplotype TT–TT haplotype was associated with a higher frequency of CRNMB. [ABSTRACT FROM AUTHOR]

Background and Aim: Direct oral anticoagulants (DOAC) are widely used, safe, and effective agents for thromboprophylaxis in nonvalvular atrial fibrillation (NVAF). In this study, we investigated the efficacy and safety of DOACs and the factors affecting DOAC dose preference in Turkey. Methods: In this multicenter, cross-sectional, and national study, we included 1497 patients using DOACs for more than three months for NVAF in five different centers in Turkey. The demographic, clinical, and laboratory characteristics and medical history of the patients were recorded. Ischemic and hemorrhagic events that occurred under all types and doses of DOAC treatment were noted. Logistic regression analysis was performed to test predictors of ischemic events and hemorrhagic complications under DOAC treatment. Results:The median age of the population was 73 (67-79) and 61.2% of those were female. The most common atrial fibrillation (AF) type for DOAC indication was permanent AF (73.1%). The most commonly used DOAC was rivaroxaban 20 mg (29.4%),and the least preferred DOAC was apixaban 2.5 mg (7.6%). The rate of dabigatran 110 mg was 10.7%, dabigatran 150 mg was 15.4%, rivaroxaban 15 mg was 11.5%, and apixaban 5 mg was 25.5%. There were no differences between DOAC subgroups, including low and recommended doses, in terms of ischemic events and bleeding complications, despite CHA2DS2-VASc and HAS-BLED scores,which were found to be significantly different between groups. Conclusions: Our study showed that all DOAC types and doses are similar in preventing ischemic events in NVAF patients. CHA2DS2-VASc and HAS-BLED scores were found to be more effective than glomerular filtration rate in DOAC dose preference. [ABSTRACT FROM AUTHOR]

Background: Oral anticoagulants (OACs) are essential for the prevention and treatment of thromboembolic disorders, but bleeding, a major complication, can have a fatal impact on the patient's treatment., Objectives: We aimed to estimate the nationwide, real-world incidence rate of bleeding in patients taking OACs and confirm the incidence by indications and risk factors., Methods: This cross-sectional study identified OAC users from April 1 to December 31, in both 2019 and 2020, using the HIRA-NPS database. The primary outcome variables were the incidence rate of major bleeding events during OAC treatment and within 30 days of treatment discontinuation. We estimated the adjusted incidence rate ratio (aIRR) in subpopulations., Results: Among 18,822 OAC users, the incidence rate of major bleeding was 27.9 (95% CI: 24.6-31.5) per 1,000 person-years. The incidence rate of major bleeding was higher in patients with a bleeding history, with an aIRR of 11.51; those at high bleeding risk (HAS-BLED score ≥3), with an aIRR of 1.51; those with high CCI scores ≥3, with an aIRR of 1.88; and those with liver disease, with an aIRR of 1.41. For indications, compared to patients with nonvalvular atrial fibrillation (NVAF), the aIRR of major bleeding was significantly higher at an aIRR of 2.35 in patients undergoing VTE treatment. Patients with ischemic stroke showed a higher incidence of major bleeding with an aIRR of 2.13 than NVAF patients. The aIRR of major bleeding in the oral anticoagulant group, compared to the matched control group, was 2.25 (95% CI: 1.93-2.63)., Conclusion: These findings may be useful for implementing strategies to improve the evaluation and management of anticoagulation-related bleeding., Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2024 Jeong, Heo, Lee, Ah, Min, Han and Lee.)

Objective: Rivaroxaban and dabigatran are approved to reduce the risk of stroke in patients with nonvalvular atrial fibrillation (NVAF). However, the clinical benefits of rivaroxaban and dabigatran in people with high bleeding risk are unclear., Methods: A retrospective study was conducted on NVAF patients admitted to the First Affiliated Hospital of Zhengzhou University from May 31, 2016 to May 31, 2019. These patients had a high risk of bleeding and were taking at least one study medication. The aim of the study was to evaluate clinical benefits by comparing the efficacy and safety risks of these two medications., Results: A total of 1,301 patients with high bleeding risk were enrolled, including 787 patients in the rivaroxaban group and 514 patients in the dabigatran group. Results of the primary efficacy benefit endpoint were obtained from 104 patients (13.21%) in the rivaroxaban group and 81 (15.76%) patients in the dabigatran group [hazard ratio (HR): 0.860; 95% confidence interval (CI): 0.637-1.162; P  = 0.327], this indicates that there was no significant difference between dabigatran and rivaroxaban in preventing stroke and systemic embolism in patients with high bleeding risk NVAF. The principal safety end points were observed in 49 (6.23%) patients in the rivaroxaban group and in 36 (7.00%) patients in the dabigatran group (HR: 0.801 in the rivaroxaban group; 95% CI: 0.512-1.255; P  = 0.333), this indicates that there was no a significant difference in reducing fatal bleeding and critical organ bleeding. With respect to secondary efficacy and benefit endpoints, 28 (3.56%) patients in the rivaroxaban group and 26 (5.06%) patients in the dabigatran group died, with an HR of 0.725 (95% CI: 0.425-1.238; P  = 0.239); 32 (4.07%) patients in the rivaroxaban group; and 31 (6.03%) patients in the dabigatran group had myocardial infarction (MI), with an HR of 0.668 (95% CI: 0.405-1.102, P  = 0.114) in the rivaroxaban group, this indicates that there was no significant difference between dabigatran and rivaroxaban in preventing all-cause death and MI., Conclusions: In NVAF patients with high bleeding risk, there was no significant difference between dabigatran and rivaroxaban in preventing stroke and systemic embolism. There was also no significant difference between dabigatran and rivaroxaban in reducing fatal and critical organ bleeding., Clinical Trial Registration: Chinese Clinical Trials Registry, identifier ChiCTR2100052454., Competing Interests: The author declares that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (© 2024 Liu.)

Background: Oral anticoagulation therapy (OAC) is the cornerstone treatment for preventing venous thromboembolism and stroke in patients with nonvalvular atrial fibrillation (NVAF). Despite its significance, challenges in adherence and persistence to OAC regimens have been reported, leading to severe health complications. Central to addressing these challenges is the concept of self-efficacy (SE) in medication management. Currently, there is a noticeable gap in available tools specifically designed to measure SE in OAC self-care management, while such tools are crucial for enhancing patient adherence and overall treatment outcomes., Objective: This study aims to develop and validate a novel scale aimed to measure self-care self-efficacy (SCSE) in patients with NVAF under OAC, which is the patients' Self-Care Self-Efficacy Index in Oral Anticoagulation Therapy Management (SCSE-OAC), for English- and Italian-speaking populations. We also seek to assess patients' SE in managing their OAC treatment effectively and to explore the relationship between SE levels and sociodemographic and clinical variables., Methods: Using a multiphase, mixed methods observational study design, we first conceptualize the SCSE-OAC through literature reviews, patient focus groups, and expert consensus. The scale's content validity will be evaluated through patient and expert reviews, while its construct validity is assessed using exploratory and confirmatory factor analyses, ensuring cross-cultural applicability. Criterion validity will be examined through correlations with clinical outcomes. Reliability will be tested via internal consistency and test-retest reliability measures. The study will involve adult outpatients with NVAF on OAC treatment for a minimum of 3 months, using both e-surveys and paper forms for data collection., Results: It is anticipated that the SCSE-OAC will emerge as a reliable and valid tool for measuring SE in OAC self-care management. It will enable identifying patients at risk of poor adherence due to low SE, facilitating targeted educational interventions. The scale's validation in both English and Italian-speaking populations will underscore its applicability in diverse clinical settings, contributing significantly to personalized patient-centered care in anticoagulation management., Conclusions: The development and validation of the SCSE-OAC represent a significant advancement in the field of anticoagulation therapy. Validating the index in English- and Italian-speaking populations will enable personalized patient-centered educational interventions, ultimately improving OAC treatment outcomes. The SCSE-OAC's focus on SCSE introduces a novel approach to identifying and addressing individual patient needs, promoting adherence, and ultimately improving health outcomes. Future endeavors will seek to extend the validation of the SCSE-OAC across diverse cultural and linguistic landscapes, broadening its applicability in global clinical and research settings. This scale-up effort is crucial for establishing a universal standard for measuring SCSE in OAC management, empowering clinicians and researchers worldwide to tailor effective and culturally sensitive interventions., Trial Registration: ClinicalTrials.gov NCT05820854; https://tinyurl.com/2mmypey7., International Registered Report Identifier (irrid): PRR1-10.2196/51489., (©Arianna Magon, Jeroen Hendriks, Rosario Caruso. Originally published in JMIR Research Protocols (https://www.researchprotocols.org), 13.09.2024.)

Background: The influence of hemodynamic parameters on the recurrence of atrial fibrillation (AF) after catheter ablation is not well known, and it remains unclear whether a nomogram combining risk factors and hemodynamic parameters improves prediction accuracy., Objective: This study aimed to develop a nomogram on the basis of echocardiographic hemodynamic parameters for predicting AF recurrence after catheter ablation in nonvalvular atrial fibrillation (NVAF)., Methods: A total of 380 consecutive patients with NVAF undergoing AF catheter ablation treatment were prospectively included. Patients were divided into training and validation cohorts in a 7:3 ratio. The follow-up time averaged 9 months with a median of 12 months, during which 132 patients (34.7%) experienced AF recurrence., Results: Least absolute shrinkage and selection operator regression and Cox regression analyses identified 4 significant predictors of AF recurrence: persistent AF (hazard ratio [HR] 1.63; 95% confidence interval [CI] 1.02-2.61; P = .041), S/D ratio of pulmonary vein (HR 0.50; 95% CI 0.30-0.84; P = .009), left atrial acceleration factor α (HR 1.31; 95% CI 1.02-1.68; P = .032), and left atrial appendage peak emptying flow velocity (HR 0.98; 95% CI 0.97-0.99; P = .004). On the basis of these 4 variables, a predictive nomogram was constructed. The nomogram demonstrated C indices of 0.664 and 0.728 for predicting 1- and 2-year AF recurrence, respectively, in the validation cohort. The Kaplan-Meier survival analysis indicated that a Nomo score of >128 was associated with a higher risk of AF recurrence., Conclusion: Hemodynamic parameters may offer valuable insight into predicting AF recurrence after catheter ablation. Our study successfully developed a reliable nomogram on the basis of echocardiographic hemodynamic parameters to estimate the risk of AF recurrence after catheter ablation in patients with NVAF., Competing Interests: Disclosures The authors have no conflicts of interest to disclose., (Copyright © 2024 Heart Rhythm Society. Published by Elsevier Inc. All rights reserved.)

IntroductionThe efficacy and safety of antithrombotic strategies remain uncertain in patients with atrial fibrillation undergoing lower-extremity revascularisation.Materials and methodsBetween January 2011 and November 2021, 319 patients with atrial fibrillation after lower-extremity revascularisation received rivaroxaban or warfarin treatment as anticoagulation regimens with different antiplatelet therapy strategies. The primary efficacy outcome was the composite of acute limb ischaemia, major amputation for vascular causes, myocardial infarction, ischaemic stroke, clinically driven target lesion revascularisation, and death from vascular causes. The safety outcomes were major bleeding events according to the International Society on Thrombosis and Haemostasis classification criteria.ResultsA total of 178 and 141 patients received rivaroxaban and warfarin treatments, respectively, after revascularisation with or without antiplatelet regimens. The incidence of the primary efficacy outcome at 36 months in the rivaroxaban group (44 patients, 24.7%) tended to be lower than that in the warfarin group (43 patients, 30.5%) (hazard ratio, 0.870; 95% confidence interval, 0.565–1.339; P = 0.527). The incidence of the secondary efficacy outcomes decreased in the rivaroxaban group (56 patients, 31.6%) compared with that in the warfarin group (61 patients, 43.2%). Major bleeding events occurred in three patients (1.7%) in the rivaroxaban group and five patients (3.5%) in the warfarin group; no significant difference in fatal or intracranial bleeding was observed between the groups.ConclusionThis study describes practical experience regarding the use of rivaroxaban and warfarin in patients with peripheral arterial disease complicated by non-valvular atrial fibrillation following endovascular intervention. The efficacy and safety outcomes do not differ significantly between rivaroxaban and warfarin.