The left atrial appendage (LAA) has gained increasing attention in the field of cardiology as a potential site for intervention in patients with atrial fibrillation (AF) and an elevated risk of thromboembolic events. Left atrial appendage occlusion (LAAO) has emerged as a promising therapeutic strategy to mitigate the risk of stroke and systemic embolism, especially in individuals who are unsuitable candidates for long-term anticoagulation therapy. This review aims to provide a comprehensive analysis of the current state of LAAO, encompassing its anatomic considerations, procedural techniques, clinical outcomes, and future directions.

The left atrial appendage (LAA) is a highly variable, pouch-like structure in the left atrium prone to thrombus formation, especially in atrial fibrillation (AF) patients. In silico cardiac models can help characterize the LAA's complex morphology and hemodynamics, aiding in identifying pro-thrombotic areas. This study assessed atrial hemodynamics and thrombus formation risk after LAA excision and compared with optimal synthetic excisions and occluder placements in high thrombogenic-risk cases.

We included 33 patients from the MARK-AF study who had persistent AF and underwent excision of the LAA. We quantified the morphological characteristics of the post-excision LAA remnant. With patient-specific atrial geometries and boundary conditions, in silico blood flow simulations were performed. For each patient, we quantified multiple in silico indices to characterize blood flow patterns and identify thrombogenic regions. We performed an in silico comparison of different LAA treatment approaches.

In our cohort, 25/33 (76 %) of patients had a post-excision, protruding LAA remnant (LAA depth >10 mm). In silico simulations indicated that patients with a protruding remnant more frequently showed unfavorable values for in silico indices associated with high thrombogenic risk at the excision site. However, a prominent LAA remnant was not the only factor associated with a high thrombogenic risk. An optimal excision or optimal occluder device placement reduced thrombus formation risk.

The combination of LAA remnant morphology and hemodynamics contributed to thrombus formation risk. Advanced in silico simulations uniquely enabled the comparison of different therapies, until now only centered on device occluders, contributing to digital twins in AF.

Atrial fibrillation (AF) frequently coexists with diabetes mellitus (DM), leading to a worse prognosis if both are present. Steatotic liver disease (SLD) may also predispose to DM, but its impact among AF patients is unclear. We aimed to determine whether metabolic dysfunction-associated SLD (MASLD), MASLD with increased alcohol intake (MetALD), or alcohol-related liver disease (ALD) elevates DM risk in AF.

Non-diabetic individuals who developed AF between 2010 and 2018 from the Korean National Health Insurance Service database were included. Patients with a fatty liver index (FLI) < 30 were classified as non-SLD, whereas those with FLI ≥ 30 and at least one cardiometabolic risk factors were categorized as MASLD, MetALD, or ALD based on daily alcohol intake. Incident DM hazard ratios (HRs) were estimated with Cox regression models.

Among 195,195 patients (mean age 64.4 ± 13.0 years, 57.5% male); 108,918 (55.8%) in non-SLD, 71,795 (36.8%) in MASLD, 7644 (3.9%) in MetALD, and 6838 (3.5%) in ALD, respectively. Over a mean follow-up of 6.0 ± 2.9 years, 25,632 (13.0%) developed DM. Compared with non-SLD, the adjusted HRs with 95% confidence intervals (CIs) for incident DM were 1.930 (1.879-1.983), 1.789 (1.682-1.904), and 1.932 (1.817-2.054) for MASLD, MetALD, and ALD, respectively. In the age 20-39 years group, adjusted HRs with 95% CIs were 5.844 (4.501-7.587), 5.354 (3.681-7.787), and 7.033 (4.660-10.615), respectively.

SLD confers an increased risk of new-onset DM in AF patients, especially in younger adults. Implementing management strategies to prevent DM in AF patients with SLD might mitigate the risk of DM and its potential impact on AF-related outcomes.

Predicting major bleeding in nonvalvular atrial fibrillation (AF) patients on direct oral anticoagulants (DOACs) is crucial for personalized care. Alternatives like left atrial appendage closure devices lower stroke risk with fewer nonprocedural bleeds. This study compares machine learning (ML) models with conventional bleeding risk scores (HAS-BLED, ORBIT, and ATRIA) for predicting bleeding events requiring hospitalization in AF patients on DOACs at their index cardiologist visit. This retrospective cohort study used electronic health records from 2010 to 2022 at the University of Pittsburgh Medical Center. It included 24,468 nonvalvular AF patients (age ≥18) on DOACs, excluding those with prior significant bleeding or warfarin use. The primary outcome was hospitalization for bleeding within one year, with follow-up at one, two, and five years. ML algorithms (logistic regression, classification trees, random forest, XGBoost, k-nearest neighbor, naïve Bayes) were compared for performance. Of 24,468 patients, 553 (2.3%) had bleeding within one year, 829 (3.5%) within two years, and 1,292 (5.8%) within five years. ML models outperformed HAS-BLED, ATRIA, and ORBIT in 1-year predictions. The random forest model achieved an AUC of 0.76 (0.70 to 0.81), G-Mean of 0.67, and net reclassification index of 0.14 compared to HAS-BLED's AUC of 0.57 (p < 0.001). ML models showed superior results across all timepoints and for hemorrhagic stroke. SHAP analysis identified new risk factors, including BMI, cholesterol profile, and insurance type. In conclusion, ML models demonstrated improved performance to conventional bleeding risk scores and uncovered novel risk factors, offering potential for more personalized bleeding risk assessment in AF patients on DOACs.

Recent randomized control trials have demonstrated the efficacy and safety of middle meningeal artery embolization (MMAE) as an adjunct to conventional management for patients with nonacute subdural hematoma (SDH); however, a large majority of trial participants received surgical evacuation as part of the standard of care. Thus, the efficacy and safety of standalone MMAE compared with conservative management (CM) for patients with nonsurgical SDH are unclear.

This was a retrospective cohort study of the 2019 to 2021 Nationwide Readmissions Database in the United States. Patients with nonsurgical nontraumatic SDH were identified, and MMAE patients were matched with similar CM patients using propensity scores calculated from demographics, comorbidities, and initial hospitalization outcomes. Patients were followed up to 300 days. The primary end point was composite surgical rescue or death, and secondary end points included surgical rescue and all-cause mortality by 180 days.

A total of 24 465 patients with nonsurgical nontraumatic SDH were identified; 2228 (9.1%) underwent MMAE. After propensity score matching, 6675 patients remained in the CM group and 2217 in the MMAE group. At 180 days, MMAE patients had a significantly lower risk of surgery or death compared with CM (8.2% versus 10.9%; relative risk, 0.75 [95% CI, 0.59-0.96]; P=0.022) and lower risk of death (1.1% versus 3.0%; relative risk, 0.38 [95% CI, 0.17-0.86]; P=0.020). Rates of surgical rescue among MMAE and CM patients at 180 days were similar (7.1% versus 8.4%; relative risk, 0.85 [95% CI, 0.63-1.14]; P=0.27). Time-to-event analyses for the entire 300-day study follow-up period confirmed that while MMAE was associated with a lower cumulative risk of all-cause mortality (hazard ratio, 0.55 [95% CI, 0.35-0.87]; P=0.010), it was not associated with a different risk of surgical rescue (hazard ratio, 1.00 [95% CI, 0.76-1.31]; P=1.00).

Standalone MMAE may be beneficial for patients with nonsurgical nontraumatic SDH by reducing the long-term risk of all-cause mortality.

Opioids are the most frequently prescribed medications for managing moderate-to-severe pain and are associated with significant potential for harm. Several models have been developed to predict opioid-related harms (ORHs). This study aimed to describe and evaluate the methodological quality of predictive models for identifying patients at high risk of ORHs.

Using the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guideline, we reviewed published studies on developing or validating models for predicting ORHs, identified through a literature search of Scopus, PubMed, Embase, and Google Scholar. The quality of studies was assessed using the Prediction model Risk Of Bias ASsessment Tool (PROBAST). The models were assessed by area under the curve (AUC) or c-statistic, sensitivity, specificity, accuracy, and positive or negative predictive value. The study protocol was registered in the International Prospective Register of Systematic Reviews (PROSPERO; CRD42024540456).

We included 36 studies involving participants aged 18 years or older. The frequently modeled ORHs were opioid use disorder (12 studies), opioid overdose (8 studies), opioid-induced respiratory depression (6 studies), and adverse drug events (4 studies). In total, 16 studies (44.4%) developed and validated tools. Most studies measured predictive ability using AUC (31, 86.1%), and some only reported sensitivity (14, 38.9%), specificity (11, 30.6%), or accuracy (4, 11.1%). Of the 31 studies that reported AUC values, 29 (93.5%) had moderate-to-high predictive ability (AUC > 0.70). History of opioid use (66.7%), age (58.3%), comorbidities (41.7%), sex (41.7%), and drug abuse and psychiatric problems (36.1%) were typical factors used in developing models.

The included predictive models showed moderate-to-high discriminative ability for screening patients at risk of ORHs. However, future studies should refine and validate them in various settings before considering the translation into clinical practice.

Atrial fibrillation (AF) is a common comorbidity in patients with extracranial neurovascular disease. When these patients require interventional procedures, the optimal perioperative anticoagulation regimen remains unclear. This study evaluates the safety and efficacy of a perioperative antithrombotic strategy for non-valvular atrial fibrillation (NVAF) patients undergoing carotid artery stenting (CAS) or vertebral artery stenting (VAS).

We retrospectively analyzed clinical data from NVAF patients treated with CAS/VAS between January 2018 and June 2023. The pre-procedural regimen included aspirin (100 mg/day), clopidogrel (75 mg/day), and prophylactic low molecular weight heparin (LMWH). Post-procedural therapy combined a novel oral anticoagulant (NOAC) with a P2Y12 inhibitor.

Thirty patients (71.3 ± 6.9 years; 93.3% male) achieved technical success. Complications included one hemorrhage and one unexplained cerebral embolism. No acute/subacute stent thrombosis or restenosis occurred within 3 months.

Dual antithrombotic therapy (NOAC + P2Y12 inhibitor) post-procedure may balance efficacy and safety in NVAF patients undergoing CAS/VAS. Larger studies are needed for validation.

Patient care pathways provide an integrated care approach to atrial fibrillation (AF) management. International guidelines propose various patient care pathways, each emphasizing different strategies for assessing stroke and bleeding risk. Due to different ethnicities and susceptibility to stroke or bleeding risk, caution should be taken during application of Western cohorts-derived patient care pathways to Asian cohorts. Evidence-based rather than eminence-based strategies should be adopted for AF patient care. In this clinical focus, we summarize and compare patient care pathways, using evidence on the implementation in real-world registries, and strategies for assessing stroke and bleeding risk across Asian and non-Asian guidelines.

Atrial fibrillation significantly increases the risk of ischemic stroke, with thrombi primarily originating in the left atrial appendage (LAA). While direct oral anticoagulants (DOACs) are the standard for stroke prevention, LAA occlusion (LAAO) has emerged as a nonpharmacologic alternative, particularly for patients at high bleeding risk. A systematic review and meta-analysis included 15 studies (1 randomized control trial and 14 observational studies) encompassing 22,420 patients (10,704 LAAO, 11,716 DOAC). LAAO and DOACs demonstrated comparable thromboembolic event rates. LAAO was associated with significantly lower risks of stroke/transient ischemic attack (risk ratio: 0.86, P = 0.0004), major bleeding [hazard ratio (HR): 0.74, P = 0.03], cardiovascular mortality (HR: 0.57, P < 0.00001), and all-cause mortality (risk ratio 0.66, P = 0.006). The composite outcome significantly favored LAAO (HR: 0.67, P = 0.0008). No significant difference was found in intracranial bleeding rates.

Anticoagulant treatment is recommended for most patients with atrial fibrillation. Yet, register studies show a persisting treatment gap, which may lead to preventable strokes. This study aimed to explore the reasons for omitting anticoagulant treatment in patients with atrial fibrillation.

We performed a comprehensive audit of electronic patient records in Danish general practice, including 12 clinics served by 39 general practitioners. All patients with atrial fibrillation, prevalent on 1 January 2023 and receiving no anticoagulant treatment, were identified using data from nationwide health registers. Patient records were reviewed retrospectively, covering the period 1 January 2001-1 January 2023. Information on care trajectories, follow-up patterns, decisions on anticoagulant treatment and reasons for omission were extracted and summarised using descriptive statistics.

In a representative sample of patients with atrial fibrillation receiving no anticoagulant treatment (n = 166), the absence of treatment was based on clinical decisions explicitly noted in the patient records in 93.4% of cases. In 34.3% of non-users, anticoagulants were deselected due to a low risk of stroke and no treatment indication, and 59.1% represented clinical decisions made in areas with no firm guideline recommendations. Reasons for anticoagulant treatment omission included minimal atrial fibrillation burden, left atrial appendage closure, palliative care, risk-benefit considerations and patient preference. However, in 6.6% of patients, the absence of treatment reflected unjustified or outdated decisions. For patients with atrial fibrillation receiving no anticoagulant treatment, care trajectories were characterised by contacts across healthcare sectors. For 64.4% of patients, the most recent contact for atrial fibrillation occurred in the hospital setting, while 30.7% had theirs in general practice. Most follow-up consultations were planned in general practice, but 59.0% had no follow-up plan. A decision on anticoagulant treatment was explicitly documented in the electronic patient record (at least once since diagnosis) for 94.6% of patients, with 22.3% revised in the past year.

This study found that most anticoagulant treatment omissions in patients with atrial fibrillation were supported by documented clinical reasoning, suggesting that the extent of inappropriate undertreatment may be lower than expected. Nevertheless, optimising care pathways could facilitate timely anticoagulation for some patients with atrial fibrillation.

Emergency general abdominal surgery (EGS) is associated with high morbidity and mortality. Timely intervention and effective triage systems are crucial to improve outcomes. This study evaluates the impact of surgeons' prioritization and adherence to a triage protocol on postoperative outcomes.

Single-center retrospective analysis of patients undergoing EGS at Bern University Hospital from 03/2015-12/2022. Patients were categorized into four triage levels based on the urgency of surgery (level 1 within 1 h, level 2 within 6 h, level 3 within 12 h, and level 4 within 24 h). "Protocol violation" was defined in cases where the delay to surgery exceeded the triage level. Primary endpoint included complications according to Clavien-Dindo classification in patients with versus without "protocol violation".

A total of 1'947 patients were included. The mean overall delay from admission to surgery was in triage level 1 69.5 ± 127.5 min., in triage level 2 206.5 ± 178.0 min., in triage level 3 350.6 ± 282.6 min. and in triage level 4 693.4 ± 354.8 min.. Triage levels 1 and 2 correlated significantly with increased complication rates compared to triage level 3 and 4 (64% vs. 43% vs. 11% vs. 10%, p < 0.001). Similarly, mortality rates decreased significantly from triage level 1 through 4 (26% vs. 7% vs. 1% vs. 2%, p < 0.001). "Protocol violation" occurred in a total of 13% of patients with decreasing proportions from triage level 1 to 4 (37% vs. 13% vs. 12% vs. 0%, p < 0.001). "Protocol violation" did not statistically affect overall morbidity and mortality in most of the diagnoses. In patients with intestinal ischemia or abdominal abscesses, mortality was significantly higher in patients with "protocol violation". In contrast, in patients suffering from acute inguinal hernias or gastrointestinal bleeding, morbidity was significantly higher in patients without "protocol violation". A significantly shorter hospital length of stay (HLOS) was shown in triage level 2 and triage level 3 when patients were treated without "protocol violation" (8.6 ± 10.0 days vs. 13.5 ± 17.3 days, p = 0.022 and 5.3 ± 8.7 days vs. 6.4 ± 6.7 days, p < 0.001, respectively).

Surgeons' triage levels significantly correlated with mortality and morbidity. Moreover, "protocol violation" resulted in higher mortality in patients suffering from mesenteric ischemia and abdominal abscesses and resulted in prolonged HLOS. Further incorporating objective parameters into triage decisions in the EGS population may enhance prioritization accuracy, patient safety and resource utilization.

Although the use of direct oral anticoagulants increases in parallel with the increase in atrial fibrillation (AF) with age, none of the bleeding risk scores (HAS-BLED, HEMORR2HAGES, ATRIA nor RE-LY) have been developed in a geriatric population. Our study aimed to develop a bleeding risk score adapted to this specific population and this therapeutic class. Multicentre, longitudinal, prospective, observational, pharmacoepidemiologic study conducted in 60 French cardiologic and geriatric centres included consecutive patients aged ≥80 years with AF, treated with rivaroxaban and followed for at least 1 year. All thromboembolic, bleeding and clinical events, including falls, hospitalisations or deaths, were recorded every 3 months for 1 year. A predictive risk score based on the clinical variables most associated with bleeding events was developed from the total sample, randomly divided into a training sample and a validation sample. Among the 839 patients included (mean age = 86 year old, 62% women), there were 78 (9.3%) major haemorrhagic events. Variables associated with bleeding were age, anaemia, low albuminemia, amiodarone use and low creatinine clearance estimated with Cockcroft formula, grouped together as the A4C score. The A4C score better identifies bleeding risk in subjects ≥80 years than the scores already validated in younger populations, as its area under the curve in the training sample and in the validation sample was 0.73 and 0.66, respectively, whereas it was 0.49/0.55 for the HAS-BLED score, 0.53/0.50 for the HEMORR2HAGES score, 0.58/0.61 for the ATRIA score and 0.57/0.54 for the RE-LY score. A threshold of the A4C score ≥ 2 identifies subjects ≥80 years at high risk of bleeding.

To analyse the temporal trends of oral anticoagulant (OAC) prescription, direct oral anticoagulant (DOAC) dose, clinical outcomes, and factors associated with non-anticoagulation in patients with incident atrial fibrillation (AF).

During 1 January 2011-31 December 2020, a total of 249 107 patients with newly diagnosed AF were identified, and the 1-year risks of ischaemic stroke, intracranial haemorrhage (ICH), and all-cause mortality were analysed. OAC prescription increased from 22.1% in 2011 to 57.7% in 2020 with DOAC accounting for 91.0% of overall OAC prescriptions. Compared to patients with incident AF diagnosed in 2011, there were increasing trends for a greater decrease in the risks of ischaemic stroke during 2012-2020 and mortality during 2014-2020, while the risk of ICH did not change significantly. For DOAC users, higher dose use increased from 11.04% in 2012 to 44.29% in 2019-2020 temporally associated with a lower risk of ischaemic stroke in the years 2015-2017 and 2018-2020 compared to 2012-2014. Determining factors refraining from OAC use included some 'patient-related factors' and 'non-patient' factors (AF diagnosed at clinics by physicians other than cardiologist/neurologist/internal medicine and citizens outside municipalities).

There was an increasing trend of OAC prescription, temporally associated with a decreased risk of ischaemic stroke and mortality. Among DOACs users, the risk of ischaemic stroke declined gradually, partly explained by the increasing prescriptions of higher dose DOACs. Both patient and non-patient factors were associated with non-anticoagulation. Further efforts are required to increase OAC prescription.

Adult and paediatric patients with nephrotic syndrome (NS) due to different glomerular diseases are at a higher risk of thromboembolic events than the general population, but the use of prophylactic anticoagulation (PAC) among them has not been well described. Although the 2021 Kidney Disease: Improving Global Outcomes (KDIGO) guidelines offer an algorithm to guide the management of PAC, the degree of implementation in practice is unknown.

We evaluated thromboprophylaxis management in patients with NS secondary to membranous nephropathy, focal segmental glomerulosclerosis, minimal change disease and C1q nephropathy enrolled in the Cure Glomerulonephropathy (CureGN) cohort study (diagnosed 2010-2023) and assessed the concordance or discordance with the 2021 KDIGO guidelines practice points in adults. We also analysed thrombotic and bleeding events.

Among 374 adult and 263 paediatric NS episodes, PAC was prescribed in 21 (6%) and 11 (4%) episodes, respectively. In adults, PAC prescription was associated with a history of prior thrombosis, lower serum albumin and higher proteinuria, with coumarins and direct oral anticoagulants (DOACs) being equally the most prescribed agents. In adults, anticoagulation management was concordant with guidelines in 180 (48%) episodes, discordant in 59 (16%) and indeterminate in 135 (36%). Most (92%) guideline-discordant episodes were cases with a high thrombotic risk and low bleeding risk where PAC was not prescribed. In children, PAC prescription was associated with lower albuminaemia and worse kidney function, with heparins being the only agent used. Thrombotic events occurred during 5 (1.3%) and 4 (1.5%) of all adult and paediatric NS episodes, respectively.

PAC was used more conservatively than guidelines suggest and was mainly driven by hypoalbuminaemia severity in both adults and children. Although not included in the guidelines practice points, DOACs were used as often as coumarins in adults.

Oral anticoagulation (OAC) following catheter ablation (CA) of nonvalvular atrial fibrillation (NVAF) is essential for the prevention of thrombosis events. Inappropriate application of OACs does not benefit stroke prevention but may be associated with a higher risk of bleeding. Therefore, this study aims to develop clinical data-driven machine learning (ML) methods to predict the risk of thrombosis and bleeding to establish more precise anticoagulation strategies for patients with NVAF.Patients with NVAF who underwent CA therapy were enrolled from Southwest Hospital from 2015 to 2023. This study compared eight ML algorithms to evaluate the predictive power for both thrombosis and bleeding. Model interpretations were recognized by feature importance and SHapley Additive exPlanations methods. With potential essential risk factors, simplified ML models were proposed to improve the feasibility of the tool.A total of 1,055 participants were recruited, including 105 patients with thrombosis and 252 patients with bleeding. The models based on XGBoost achieved the best performance with accuracies of 0.740 and 0.781 for thrombosis and bleeding, respectively. Age, BNP, and the duration of heparin are closely related to the high risk of thrombosis, whereas the anticoagulation strategy, BNP, and lipids play a crucial role in the occurrence of bleeding. The optimized models enrolling crucial risk factors, RF-T for thrombosis and Xw-B for bleeding, achieved the best recalls of 0.774 and 0.780, respectively.The optimized models will have a great application potential in predicting thrombosis and bleeding among patients with NVAF and will form the basis for future score scales.

The relationship between oral anticoagulant (OAC) status after catheter ablation (CA) for atrial fibrillation (AF) and the risks of ischemic stroke or major bleeding events is still unknown.

This is a subanalysis of the RYOUMA registry, a prospective multicenter observational study of Japanese patients who underwent CA for AF in 2017-2018.

Of the 2844 patients, the rate of DOAC continuation was 48.1%, 69.6%, and 80.9% in patients with a CHADS2 score of 0-1, 2, and 3-6, respectively. Among the patients taking DOACs with a CHADS2 score of 0-1 and 2, the incidence rates of major bleeding were significantly higher than those of ischemic stroke or systemic embolic events (SEEs) (1.3%/year [95% CI, 0.6-2.1] vs. 0.3%/year [95% CI, 0.0-0.7], p = 0.019; 1.8%/year [95% CI, 0.6-3.0] vs. 0.2%/year [95% CI, 0.0-0.6], p = 0.018, respectively). However, there was no difference between the incidence rates of major bleeding events and ischemic stroke or SEEs in patients taking DOACs with a CHADS2 score of 3-6 (1.6%/year [95% CI, 0.2-3.0] vs. 1.0%/year [95% CI, 0.0-2.1], p = 0.474).

In patients with a CHADS2 score of 2, those who continued taking DOACs had a higher incidence rate of major bleeding events compared to ischemic stroke/SEEs, similar to those with a CHADS2 score of 0-1. Conversely, in patients with a CHADS2 score of 3-6, the incidence rates of both ischemic stroke/SEEs and major bleeding were similarly high.

The study was registered as UMIN000026092 (University Hospital Medical Information Network-Clinical Trial Registry).

Major bleeding is a severe complication in critically ill medical patients, resulting in significant morbidity, mortality, and healthcare costs. This study aims to assess the incidence and risk factors for major bleeding in hospitalised medical patients using a Natural Language Processing (NLP) model.

We conducted a retrospective, cross-sectional observational study using electronic health records of adult patients admitted through the Emergency Department at Odense University Hospital from January 2017 to December 2022. Major bleeding during admission was identified and validated using a natural language model, with events classified according to current guidelines. Risk factors, including demographics, comorbidities, and biochemical values at admission, were evaluated. Two risk assessment models (RAMs) were developed using Cox proportional hazards regression. Validation included, bootstrapping, K-fold cross validation, and cluster analyses.

Of the 46,439 eligible patients, 1246 (2.7 %) experienced major bleeding. Risk factors for major bleeding included older age, male sex, alcohol consumption, higher systolic blood pressure, lower haemoglobin, and higher creatinine. RAM 1, which included biochemical data and comorbidities, demonstrated robust predictive performance (Harrell's C-statistic = 0.726). RAM 2, a simplified model without comorbidities, maintained similar predictive accuracy (C-statistic = 0.721), indicating its potential utility in clinical settings with limited resources for detailed patient histories. Results were consistent throughout validation.

This study highlights the incidence and risk factors of major bleeding in medical patients, emphasizing the predictive value of routinely measured biochemical markers. Furthermore, it shows the applicability of NLP models in identifying bleeding episodes in EHR text.

The mAFA-II cluster randomised trial demonstrated the efficacy of a mobile health-technology implemented 'Atrial fibrillation Better Care' (ABC) pathway (mAFA intervention) for integrated care management of patients with AF.

To evaluate the effect of mAFA intervention across phenotypes of patients with AF.

We conducted a latent-class analysis (LCA) according to eight variables, including age and comorbidities.

The mAFA-II trial enrolled AF patients between June 2018 and August 2019 across 40 centres in China.

We evaluated the interaction between the groups identified through LCA, and the effect of mAFA intervention on the risk of the primary composite outcome of all-cause death, stroke/thromboembolism, and rehospitalisations. Results were expressed as adjusted hazard ratio (aHR) and 95% confidence intervals (95% CI).

Across the 3324 patients included in the trial (mean age 68.5 ± 13.9 years, 38.0% females), we identified three phenotypes: (i) low morbidity phenotype (n = 1234, 37.1%), (ii) hypertensive/coronary artery disease (CAD) phenotype (n = 1534, 46.2%), and (iii) mixed morbidity phenotype (n = 556, 16.7%). The effect of mAFA intervention on the primary outcome appeared greater in the low morbidity phenotype (aHR, 0.08; 95% CI 0.02-0.33) compared to the hypertensive/CAD (aHR, 0.30; 95% CI 0.16-0.58) and the mixed morbidity phenotype (aHR, 0.68; 95% CI 0.37-1.24), with a statistically significant interaction (pint = 0.004).

In patients with AF, the ABC pathway improved prognosis across different comorbidity phenotypes, although with some differences in the magnitude of risk reduction. Patients with more complex phenotypes require further efforts to improve their outcomes, considering their high baseline risk of adverse events.

WHO International Clinical Trials Registry Platform (ICTRP) Registration number: ChiCTR-OOC-17014138.

Both bleeding and adverse ischemic events increase with age, compounding the benefit-risk balance of anticoagulants in older patients. We present analyses using benefit-risk methods to better understand the age-dependence of the benefit-risk profile of rivaroxaban in patients with nonvalvular atrial fibrillation (NVAF) or venous thromboembolism (VTE).

Randomized controlled trial data from the ROCKET-AF (NVAF) and EINSTEIN DVT, EINSTEIN PE, EINSTEIN-Extension, and EINSTEIN CHOICE in (VTE) were used. For ROCKET-AF, benefits and risks were assessed with incidence rates for key thrombotic and bleeding endpoints and a net clinical benefit (NCB) measure. Cumulative incidences (estimated by the Kaplan-Meier method) were estimated at day 185 for EINSTEIN and EINSTEIN Extension and 1 year for EINSTEIN CHOICE. Incidence differences were calculated for the overall population and age subgroups of < 65, 65-75, and > 75 years.

In ROCKET-AF, rate differences in the composite NCB outcome (vascular death, stroke, myocardial infarction, fatal bleeding, critical organ bleeding, and non-CNS systemic embolism) favored rivaroxaban overall and by age < 65, 65-75, and > 75 years (-84, -25, -61, and -150 cases per 10,000 patient-years, respectively). In the pooled EINSTEIN DVT and EINSTEIN PE studies, cumulative incidence differences for the composite NCB outcome (recurrent VTE and major bleeding) were -103, 3, -105, and -544 per 10,000 patients, respectively. For extended VTE treatment with rivaroxaban versus placebo in EINSTEIN-Extension, NCB results were -536, -492, -556, and -601 per 10,000 patients, respectively. In the EINSTEIN CHOICE analysis, NCB favored rivaroxaban 20 mg versus aspirin (-284, -255, -339, and -338, respectively) and rivaroxaban 10 mg versus aspirin (-339, -328, -485, and -80, respectively).

This analysis demonstrated a positive benefit-risk profile with rivaroxaban versus trial comparators in older patients with NVAF or VTE, with benefit-risk increasingly favoring rivaroxaban with increasing age.

http://ClinicalTrials.gov , identifiers: NCT00403767 (ROCKET-AF), NCT00440193 (EINSTEIN DVT), NCT00439777 (EINSTEIN PE), NCT00439725 (EINSTEIN Extension), and NCT02064439 (EINSTEIN CHOICE).

This study utilized a population pharmacokinetic (PPK) approach to assess the influence of ABCB1 genetic polymorphisms on the plasma concentrations and clinical outcomes of rivaroxaban.

The PPK model for rivaroxaban was developed using the nonlinear mixed-effects modelling approach and Monte Carlo simulations were employed to derive peak concentration (Cmax) and trough concentration (Ctrough). ABCB1 genetic variants were analyzed for their impact on the plasma concentrations and clinical outcomes.

Analysis of 287 rivaroxaban plasma concentrations from 228 non-valvular atrial fibrillation (NVAF) patients revealed significant associations between AST (aspartate aminotransferase)/ALT (alanine aminotransferase) ratios and the apparent clearance (CL/F), the apparent volume of distribution (V/F). ABCB1 1236C>T TT and ABCB1 c.2482-2236C>T CC genotypes exhibited higher dose-adjusted Cmax (Cmax/D) compared to other relevant genotypes. Additionally, the ABCB1 3435C>T TT genotype showed lower dose-adjusted Ctrough (Ctrough/D) compared to CC or CT genotypes. For clinical outcomes, the ABCB1 c.2482-2236C>T CC genotype had a higher bleeding risk compared to TT (RR = 1.99, 95% CI 1.08-3.69) or CT genotypes (RR = 1.42, 95% CI 1.04-1.92), and ABCB1 3435C>T TT genotype showed a higher thromboembolic risk compared to CC genotype (RR = 3.48, 95% CI 1.02-11.85).

The PPK model incorporated CL/F and V/F with the covariate AST/ALT. Model-based simulations revealed that ABCB1 1236C>T, ABCB1 c.2482-2236C>T, and ABCB1 3435C>T genotypes had significant impacts on the plasma concentrations of rivaroxaban. Specifically, ABCB1 c.2482-2236C>T and ABCB1 3435C>T genotypes were associated with bleeding events and thromboembolic events, respectively.

The current Atrial fibrillation Better Care (ABC) pathway for holistic or integrated management of AF is associated with improved clinical outcomes; however, data on the very elderly (aged ≥ 85 years) are sparse.To evaluate the impact of ABC pathway on clinical outcomes amongst very elderly AF patients over a follow-up period of 1 year.The ChiOTEAF registry is a prospective, multicenter nationwide study conducted from October 2014 to December 2018. Endpoints of interest were the composite outcome of all-cause death/any thromboembolism (TE), all-cause death, TE events, and major bleeding.The eligible cohort included 1215 individuals (mean age 88.5 ± 3.3; 33.5% female), of which 142 (11.7%) were managed accordingly to the ABC pathway. ABC compliance was independently associated with lower odds of the composite outcome (odds Ratio (OR): 0.23; 95% confidence interval (CI): 0.08-0.66) and all-cause death (OR: 0.22; 95% CI: 0.07-0.75), without a significant increase in major bleeding compared to ABC non-compliance. Health-related quality of life (QOL) was also significantly higher in the ABC compliant group compared to the non-compliant group (EQ score 0.83 ± 0.17 vs. 0.78 ± 0.20; p =  0.004). Independent predictors of ABC non-compliance were prior major bleeding, chronic kidney disease, and dementia.Our findings suggest that adherence to the ABC pathway in very elderly patients is associated with significantly improved survival and health-related QOL.

Atrial fibrillation is the most common cardiac arrhythmia and is a major risk factor for ischemic stroke. Atrial fibrillation and ischemic stroke are major cardiovascular complications in cancer patients, who have a higher burden and worse outcomes than the general population. Clinical risk stratification scores for stroke and bleeding, commonly used in the general population to estimate thromboembolic and bleeding risk, respectively, are less well validated in cancer patients, who have historically been excluded in clinical trials. There is a lack of consensus opinion on how to effectively risk-stratify cancer patients based on the currently available tools and a need for cancer-specific scores that offer a tailored approach to each patient in order to more effectively stratify ischemic stroke and bleeding risk in this cohort of patients. Cancer-mediated physiologic changes and adverse effects of antineoplastic therapy have been implicated as etiologies of the increased risk for both atrial fibrillation and ischemic stroke. Risk stratifying scores such as CHA2DS2-VASc and HAS-BLED, commonly used in the general population, are less well validated in cancer patients. There is a need for cancer-specific scores that can more effectively stratify ischemic stroke and bleeding risk in cancer patients, although given the heterogeneity of cancers, whether a "one score fits all" is uncertain.

The objective of this study was to validate the PredictAI models for predicting major bleeding (MB) in patients with active cancer and venous thromboembolism (VTE) with anticoagulant (ACO) therapy, within 6 months after primary VTE, using an independent cohort of patients from the TESEO database.

This study conducted an external validation of the PredictAI models using the international, prospective TESEO registry from July 2018 until October 2021. Data from 40 Spanish and Portuguese hospitals recruiting consecutive cases of cancer-associated thrombosis under anticoagulant treatment and without missing values regarding the model outcome or predictors were used. Patients with baseline MB or unknown MB status during follow-up were excluded for the validation analysis. Logistic regression (LR), decision tree (DT), and random forest (RF) approaches were used to validate the models.

Included patients from the TESEO cohort (2179 patients) had similar key demographics and clinical characteristics to the PredictAI cohort (21,227 patients). During the 6-month follow-up period, 10.9% (n = 2314) and 5.9% (n = 129) of patients experienced at least one MB event in the PredictAI and TESEO cohorts, respectively. Hemoglobin, metastasis, age, platelets, leukocytes, and serum creatinine were described as predictors for MB in PredictAI; the external validation results in TESEO showed statistical significance by LR and RF approaches, with ROC-AUC values of 0.59 and 0.56, respectively (both p < 0.05).

PredictAI models for predicting MB in anticoagulant-treated cancer patients within the first 6 months following VTE diagnosis have been externally validated. These models may be considered as a tool to guide objective decisions regarding the indication or extension of anticoagulant therapy in this population.

Guidelines state that oral anticoagulants (OACs) should be continued after catheter ablation for atrial fibrillation (AF) based on thromboembolic risk stratification, regardless of procedural results. However, whether OACs could be discontinued in low-thromboembolic-risk patients remains unclear.

This was a retrospective follow-up study from the EARNEST-PVI (NCT03514693) trial, which compared the efficacy of pulmonary vein isolation (PVI)-alone and PVI-plus strategies for persistent AF ablation. A total of 427 patients with CHADS2 score of ≤2 points were divided into two groups: OAC continuation throughout the overall period (group C, n = 205) and OAC discontinuation within 1 year after ablation (group D, n = 222). The incidence of thromboembolic and bleeding events was analyzed.

AF recurrence (33 % vs. 17 %, p < 0.001), thromboembolic events (1.39 % vs. 0 % per year, p = 0.005), and overall bleeding event rates (7.54 % vs. 3.32 % per year, p = 0.003) were higher in group C than in group D. There was no significant difference in major bleeding event rates between the C and D groups (0.51 % vs. 0.67 % per year, p = 0.686). However, a higher number of overall bleeding events, including major and clinically relevant non-major events, was observed in group C (adjusted hazards ratio: 2.04, 95 % confidence interval: 1.14-3.65, p = 0.016).

Thromboembolic events and overall bleeding events were fewer in the OAC discontinuation group compared with the OAC continuation group. Discontinuation of OACs might be considered in patients with low CHADS2 score after catheter ablation of persistent AF.

New-onset atrial fibrillation (NOAF) is associated with worse short-term prognosis among critically ill patients, and the benefit of anticoagulation is uncertain.

We aimed to evaluate whether anticoagulation at hospital discharge for critically ill patients presenting with NOAF is associated with improved survival.

Retrospective Cohort Study using the Medical Information Mart for Intensive Care (MIMIC)-IV database, which comprises data from patients admitted to the intensive care units (ICUs) at Beth Israel Deaconess Medical Center, Boston, Massachusetts, USA. We included patients diagnosed with NOAF during admission to ICUs between 2008 and 2019 and excluded patients with pre-existing atrial fibrillation (AF), admission related to cardiac surgery and previous anticoagulant use. We did a propensity-score matched (PSM) 1:1 to compare survival between patients discharged on anticoagulation (ACO) vs no anticoagulation and a Cox regression model to assess the primary outcome of long-term survival post-hospital discharge. We censored the patients at 3 different time points and performed another 3-sensitivity analysis to assess the robustness of the results.

A total of 495 patients received ACO therapy, and 2021 patients did not. Matching demonstrated adequate covariate balance, with both groups comprising 495 patients postmatching. Out of hospital mortality rate after PSM was 30.9% vs 38.4% in the ACO and non-ACO groups, respectively. Patients in the ACO group exhibited greater long-term survival (hazard ratio [HR] 0.72, 95% CI 0.58-0.89, P = .003). The benefit was present in the PSM analysis censored at 90 days (HR 0.63, 95% CI 0.43-0.94, P = .02), 1 year (HR 0.55, 95% CI 0.41-0.793, P < .001), and 5 years (HR 0.7, 95% CI 0.56-0.88, P = .002).These findings also remained consistent across the 3 other sensitivity analyses performed.

Anticoagulant prescription at hospital discharge for patients with NOAF during ICU stay was associated with longer survival.

Atrial fibrillation (AF) is associated with an increased risk of stroke. Oral anticoagulation (OAC) is used for stroke prevention in AF, but it also increases bleeding risk. Clinical guidelines do not definitively recommend for or against OAC for patients with borderline stroke risk. Decision-making may benefit from values clarification exercises to communicate risk trade-offs.

This study aimed to evaluate if a visual with a values clarification alters the understanding of the trade-offs of anticoagulation in AF.

Participants aged 45-64 years were recruited across the United States via an online survey. While answering the survey, they were asked to imagine they were newly diagnosed with AF with a CHA2DS2-VASc (congestive heart failure; hypertension; age ≥75 years [doubled]; type 2 diabetes; previous stroke, transient ischemic attack, or thromboembolism [doubled]; vascular disease; age 65 to 75 years; and sex category) score of 1 for men and 2 for women. Eligibility criteria included no diagnosis of AF and no prior OAC use. Participants were randomized to one of three conditions: (1) standard text-based information only (n=255), (2) visual aids showing stroke-risk probabilities (n=218), or (3) visual aids plus a values clarification exercise (visual+VC; n=200). Participants were subrandomized within the 2 visual-based groups to view either a gauge display or an icon array representing stroke risk. All participants read a hypothetical scenario of being newly diagnosed with AF and hypertension. The primary outcome was decision confidence as measured by the SURE (Sure of Myself; Understand Information; Risk-Benefit Ratio; Encouragement) test. Secondary measures included participants' perceived stroke risk reduction, worry about stroke or bleeding, and likelihood to choose OAC.

A total of 673 participants completed the survey. The overall SURE test was 61.2% (156/255) for the standard, 66.5% (145/218) for the visual, and 67% (134/200) for the visual+VC group (visual vs standard P=.23; visual+VC vs standard P=.20). Participants were less likely to choose OAC in the visual groups (standard: mean 58.3, SD 30; visual: mean 51.4, SD 32; visual+VC: 51.9, SD 28; P=.03). Participants felt the reduction in stroke risk from an OAC was less in the visual groups (standard: mean 63.8, SD 22; visual: mean 54.2, SD 28; visual+VC: mean 58.6, SD 25; P<.001). Visualization methods (gauge vs icon array) showed no significant differences in overall SURE test results. Participants were less likely to choose OAC and perceived a smaller stroke risk reduction with gauge than icon array (OAC choice: gauge 48.8, icon array 55.4; P=.03; stroke risk reduction: gauge 52.1, icon array 60.4; P=.001).

Visual aids can modestly affect decision confidence and perceptions regarding the benefits of OAC but do not significantly alter decision certainty in a scenario where the guidelines do not recommend for or against OAC. Future work should determine the role of a gauge versus icon array visual for decision-making in stroke prevention in AF.

To provide evidence-based recommendations for the use of transoral robotic surgery (TORS) in the multidisciplinary management of oropharyngeal squamous cell cancer (OPC).

ASCO convened a multidisciplinary Expert Panel to evaluate the evidence and formulate recommendations. The literature search included studies published between January 1, 2002, and August 31, 2024, and comprised systematic reviews, meta-analyses, randomized controlled trials, and observational studies. Outcomes of interest include overall and disease-free survival, functional outcomes, and quality of life. Expert Panel members used available evidence and informal consensus to develop evidence-based guideline recommendations.

A total of 58 publications were identified to inform the evidence base for this guideline.

Evidence-based recommendations address the evaluation and workup of patients with human papillomavirus (HPV)-positive OPC, the role of TORS, patient selection, adjuvant therapy, HPV-negative OPC, and use of TORS in salvage or recurrent setting.Additional information is available at www.asco.org/head-neck-cancer-guidelines.

Epicardial adipose tissue (EAT) is involved in cardiac inflammatory responses and has been associated with both atrial fibrillation (AF) and rheumatoid arthritis (RA). However, the condition of EAT in patients with both RA and AF is still unclear. In addition, the risks of stroke and bleeding in patients with both RA and AF are unknown.

A retrospective analysis was conducted in patients with RA aged ≥18 years from August 2021 to May 2023, and compared with age- and gender-matched patients without RA. The volume of EAT was measured using chest computed tomography and the EAT/body mass index (BMI) ratio was used to correct for the possible impact of BMI differences. The stroke and bleeding risks of the patients were assessed using the CHA2DS2-VASc or HAS-BLED scores.

A total of 145 patients with RA and 282 patients without RA were included. The volume of EAT or EAT/BMI ratio was similar between the patients with RA and no AF and those without both RA and AF. Compared to the patients without AF, those with AF had a larger EAT volume or EAT/BMI ratio, regardless of whether they had RA or not. EAT/BMI ratio was significantly associated with left atrial (LA) diameter among the patients with RA (RR = 2.23, P < 0.001) but not among the patients without RA (P < 0.954). The RA groups had larger LA-EAT volume (31.53 ± 11.02 mm3 vs. 22.56 ± 9.58 mm3, p < 0.001) and LA-EAT/Total EAT ratio (23.02% ± 3.62% vs. 18.74 ± 3.38 mm3, p < 0.001) than that in non-RA groups. In addition, the proportion of patients with high stroke risk scores was higher among the patients with both RA and AF compared to those without RA but with AF (90.90% vs. 72.00% in men; 84.78% vs. 71.11% in women), while the proportion of patients with high bleeding risk scores was lower (22.06% vs. 27.85%).

LA diameter correlates with the EAT/BMI ratio in patients with RA who exhibit larger LA-EAT volume and LA-EAT/total EAT ratios compared to individuals without RA.

Patients with atrial fibrillation (AF) often have clinical complexity phenotypes. Latent class analysis (LCA) is based on the concept of modeling of both observed and unobserved (latent) variables. We hypothesized that LCA can help in identification of AF patient groups with different risk profiles and identify patients who benefit most from the Atrial fibrillation Better Care (ABC) pathway.We studied non-valvular AF patients in the prospective multicenter COOL-AF registry. The outcomes were all-cause death, ischemic stroke/systemic embolism (SSE), major bleeding, and heart failure. Components of CHA2DS2-VASc score, HAS-BLED score, and ABC pathway were recorded.A total of 3,405 patients were studied. We identified 3 LCA groups from 42 variables: LCA class 1 (n = 1,238), LCA class 2 (n = 1,790), and LCA class 3 (n = 377). Overall, the incidence rates of composite outcomes, death, SSE, major bleeding, and heart failure were 8.69, 4.21, 1.51, 2.27, and 2.84 per 100 person-years, respectively. When compared to LCA class 1, hazard ratios (HR) of composite outcome of LCA classes 3 and 2 were 3.86 (3.06-4.86) and 2.31 (1.91-2.79), respectively. ABC pathway compliance was associated with better outcomes in LCA classes 2 and 3 with the HR of 0.63 (0.51-0.76) and 0.57 (0.39-0.84), but not in LCA class 1.LCA can identify patients who are at risk of developing adverse clinical outcomes. The implementation of holistic management based on the ABC pathway was associated with a reduction in the composite outcomes as well as the individual outcomes.

Intracerebral haemorrhage (ICH) is an important complication of direct oral anticoagulation (DOAC) therapy, where risks and prognosis are potentially modified by effective blood pressure (BP) control, both in the acute phase and for secondary prevention. Herein, we review BP management in the context of general anticoagulation associated ICH and specifically in DOAC-ICH, considering current evidence and highlighting outstanding questions.

Narrative review.

Pooled analyses of major trials of BP lowering in acute ICH patients without anticoagulants demonstrate a reduction in the risk of haematoma expansion. As anticoagulant-associated ICH patients tend to be older, have more co-morbidities, and larger haematomas at baseline with a greater risk of expansion, the risks and benefits of intensive BP lowering treatment might both be higher. Small observational studies of DOAC-ICH patients suggest that lower achieved BP is associated with less expansion, lower mortality, and better functional outcomes. Care bundles including both anticoagulant reversal and intensive BP lowering might reduce the risk of death and disability in DOAC-ICH. Optimal control of BP in survivors of ICH reduces the risk of both ischaemic and haemorrhagic stroke but whether this modulates the risks and benefits of restarting a DOAC is unknown.

Limited evidence suggests that BP should be well managed in DOAC-ICH patients, in the same way as ICH patients not on anticoagulants, both in the hyperacute phase and for secondary prevention. Hypothetical differences in the effects of BP lowering treatment in DOAC-ICH need to be tested in clinical trials.

Patients with atrial fibrillation (AF) often present with concomitant significant mitral regurgitation (MR). Percutaneous left atrial appendage closure (LAAC) is indicated for patients with AF to prevent thromboembolism and reduce the need for long-term anticoagulation. Transcatheter edge-to-edge repair (TEER) is recommended for patients with significant MR. However, the feasibility and efficacy of combining these therapeutic interventions remain uncertain. This study included consecutive patients who underwent LAAC. Feasibility was assessed by comparing outcomes between those undergoing combined LAAC + TEER and those receiving LAAC alone. Among 192 patients, 11 underwent the combined LAAC + TEER procedure, while 181 underwent LAAC alone. Procedural success was high in both groups (100% vs. 99%). At the 1-year follow-up, the incidence of significant device leak and device-related thrombus did not differ significantly between the groups (0% vs. 1.1% and 0% vs. 6.7%, respectively; p > 0.05 for both). Additionally, the cumulative incidence of thromboembolic and bleeding events was comparable between the two groups (thromboembolic p = 0.57 and bleeding p = 0.42). The combination of LAAC + TEER may be a feasible and effective therapeutic strategy when performed in carefully selected patients at high-volume, experienced centers.

People living with HIV and atrial fibrillation (AF) often receive anticoagulation that may interact with their antiretroviral therapy (ART). No studies exist comparing the safety of oral anticoagulants in this population.

To compare the bleeding risks among warfarin, rivaroxaban, and apixaban users in a national US cohort with AF and HIV.

A new-user, active-comparator, propensity score overlap-weighted cohort study using the target trial emulation framework including Medicare claims database data (January 1, 2013, to December 31, 2020) was carried out. The analysis was conducted from July 2023 to April 2024.

New initiators of warfarin vs apixaban, rivaroxaban vs apixaban, and rivaroxaban vs warfarin aged 50 years or older with nonvalvular AF and HIV.

The primary outcome was hospitalization for major bleeding. Secondary outcomes included hospitalization for gastrointestinal bleeding, ischemic stroke, and all-cause mortality.

Overall, 2683 individuals (mean [SD] age, 66.22 [8.97] years; 580 female individuals [21.6%]) in the warfarin vs apixaban cohort, 2176 (mean [SD] age, 66.61 [8.87] years; 455 female individuals [20.9%]) in the rivaroxaban vs apixaban cohort, and 1787 (mean age, 65.47 years; 377 female individuals [21.1%]) in the rivaroxaban vs warfarin cohort. After propensity score overlap weighting, warfarin initiation was associated with a higher rate of major bleeding than initiation of apixaban (hazard ratio [HR], 2.60; 95% CI, 1.51-4.49), including major gastrointestinal bleeding (HR, 2.99; 95% CI, 1.52-5.90). This association was intensified in the 71% of patients taking concurrent ART (major bleeding, HR, 6.68; 95% CI, 2.78-16.02; gastrointestinal bleeding, HR, 5.28; 95% CI, 2.08-13.42). Rivaroxaban vs apixaban was also associated with a higher rate of major bleeding (HR, 2.15; 95% CI, 1.18-3.94) and gastrointestinal bleeding (HR, 3.38; 95% CI, 1.57-7.25), with a stronger association in those using ART (major bleeding, HR, 4.83; 95% CI, 2.11-11.08; gastrointestinal bleeding, HR, 4.76; 95% CI, 1.78-12.70). Estimates were similar when comparing rivaroxaban with warfarin. No significant difference was observed in the rate of ischemic stroke or mortality among the 3 oral anticoagulants.

This study found that in patients with HIV and AF, especially those treated with ART, warfarin and rivaroxaban were associated with higher rates of major bleeding compared with apixaban, suggesting a superior safety profile for apixaban in this high-risk population.