Use Of Anticoagulants Research Articles

Risk Factors for Pericardiocentesis After Paediatric Cardiac Surgery

BackgroundPericardial effusions are common after paediatric cardiac surgery and can lead to cardiac tamponade in a small minority. However, it is difficult to predict which patients with an effusion will require pericardiocentesis. Therefore, among children with a postoperative effusion, we sought to identify risk factors for requiring pericardiocentesis. MethodsWe conducted a case-control study including paediatric patients who underwent cardiac surgery between January 1, 2005, and July 1, 2020, at the Stollery Children’s Hospital. Cases were defined as those who underwent pericardiocentesis within 2 months of cardiac surgery and were compared with controls who had an effusion but did not require pericardiocentesis. Controls were matched 2:1 to cases based on age and year of surgery. ResultsThere were 42 cases and 84 controls. The median age at surgery was 3.0 years (interquartile range [IQR]: 0.5-6.4 years) among cases and 2.2 years (IQR: 0.4-5.8 years) among controls. The median weight at surgery was 13.5 kg (IQR: 6.4-18.0 kg) among cases and 13.5 kg (IQR: 4.9-23.1 kg) among controls. The use of anticoagulation or antiplatelet agents (odds ratio [OR]: 3.6, 95% confidence interval [CI]: 1.5-8.2, P < 0.01) in the postoperative period was independently associated with effusions requiring drainage. The use of prednisone postoperatively (OR: 3.3, 95% CI: 0.8-14.0, P = 0.10) and a history of previous pericardial effusion (OR: 4.7, 95% CI: 0.9-25.6, P = 0.08) were associated with a higher odds of pericardiocentesis but did not reach statistical significance. ConclusionsThe use of postoperative anticoagulation was independently associated with the need for pericardiocentesis. Type of surgical procedure was not associated with the need for drainage.

Before, during, and after: An Argument for Safety and Improved Outcome of Thrombolysis in Acute Ischemic Stroke with Direct Oral Anticoagulant Treatment.

Direct oral anticoagulants are the primary stroke prevention option in patients with atrial fibrillation. Anticoagulant use before stroke, however, might inhibit clinician comfort with thrombolysis if a stroke does occur. Resuming anticoagulants after ischemic stroke is also problematic for fear of hemorrhage. We describe extensive literature showing that thrombolysis is safe after stroke with direct anticoagulant use. Early reinstitution of direct anticoagulant treatment is associated with lower risk of embolic recurrence and lower hemorrhage risk. The use of direct anticoagulants before, during, and after thrombolysis appears to be safe and is likely to promote improved outcomes after ischemic stroke. ANN NEUROL 2024;96:871-886.

Anticoagulation Use and Endovascular Thrombectomy in Patients with Large Core Stroke: A Secondary Analysis of the SELECT2 Trial.

Endovascular thrombectomy (EVT) safety and efficacy in patients with large core infarcts receiving oral anticoagulants (OAC) are unknown. In the SELECT2 trial (NCT03876457), 29 of 180 (16%; vitamin K antagonists 15, direct OACs 14) EVT, and 18 of 172 (10%; vitamin K antagonists 3, direct OACs 15) medical management (MM) patients reported OAC use at baseline. EVT was not associated with better clinical outcomes in the OAC group (EVT 6 [4-6] vs MM 5 [4-6], adjusted generalized odds ratio 0.89 [0.53-1.50]), but demonstrated significantly better outcomes in patients without OAC (EVT 4 [3-6] vs MM 5 [4-6], adjusted generalized odds ratio 1.87 [1.45-2.40], p = 0.02). The OAC group had higher comorbidities, including atrial fibrillation (70% vs 17%), congestive heart failure (28% vs 10%), and hypertension (87% vs 72%), suggesting increased frailty. However, the results were consistent after adjustment for these comorbidities, and was similar regardless of the type of OACs used. Whereas any hemorrhage rates were higher in the OAC group receiving EVT (86% in OAC vs 70% in no OAC), no parenchymal hemorrhage or symptomatic intracranial hemorrhage were observed with OAC use in both the EVT and MM arms. Although we did not find evidence that the effect was due to excess hemorrhage or confounded by underlying cardiac disease or older age, OAC use alone should not exclude patients from receiving EVT. Baseline comorbidities and ischemic injury extent should be considered while making individualized treatment decisions. ANN NEUROL 2024;96:887-894.

Time trends of outcome and treatment options for disseminated intravascular coagulation from 2010 to 2021 in Japan: A nationwide observational study

IntroductionMortality and changes in treatment options for disseminated intravascular coagulation (DIC) are trending downward. This study investigated temporal trends in mortality and treatment preferences of several anticoagulants in Japan. MethodsThis retrospective observational study used the Japanese Diagnosis Procedure Combination inpatient database containing data from >1500 acute-care Japanese hospitals. All adult patients diagnosed as having DIC from July 2010 to March 2022 were sorted by predefined underlying conditions: sepsis, solid cancer, leukemia, trauma, or obstetric. We evaluated in-hospital mortality and clinical status of anticoagulant use for DIC treatment. ResultsBaseline characteristics of the 443,098 DIC patients showed increased age, worsened comorbid conditions, and higher illness severity over time. Over the 12 years, in-hospital mortality for overall DIC patients declined by 17 % from 42.0 % (95 % CI 41.4–42.5 %) to 34.7 % (95 % CI 34.1–35.3 %) (Ptrend < 0.001). This downward decrease was more evident in patients with sepsis (17 %), solid cancer (18 %), and leukemia (22 %) but was not clinically meaningful in trauma and obstetrics patients. The trend in treatment preferences of anticoagulants for DIC patients also changed. Recombinant thrombomodulin administration increased dramatically from 2011 to 2015 and remained high through 2021. Only 7 % of DIC patients were administered antithrombin and recombinant thrombomodulin concomitantly, and its use continues to decline. ConclusionsAll-cause in-hospital mortality for DIC patients clearly decrease by 17 % over the study period. Anticoagulant therapy for patients with DIC has been decreasing, possibly due to recent published clinical evidence.

Reduced- versus full-dose anticoagulants for the extended treatment of cancer-associated venous thromboembolism in Thai patients

BackgroundReduced dose anticoagulant therapy for the extended treatment of cancer-associated venous thromboembolism (VTE) has been used to avoid bleeding. However, it may increase the risk of recurrent VTE. AimsTo study the rate of recurrent VTE and bleeding complications in Thai patients with cancer-associated VTE who were treated with full-dose or reduced-dose anticoagulants. MethodsA retrospective cohort study was conducted in a single-center academic hospital. Electronic medical records were reviewed from 2016-2023. Patients with cancer-associated VTE who received anticoagulants for at least 3 months were evaluated. Reduced-dose anticoagulant was defined as a dose that was lower than the recommended standard dosage. The primary outcome was recurrent VTE. The secondary outcomes were major bleeding and clinically relevant non-major bleeding. ResultsA total of 229 patients were included. The median age was 65 years (interquartile range [IQR] 54-72). In the reduced-dose group, age and history of previous bleeding were higher than in the full-dose group. There were 169 (74%) patients and 60 (26%) patients who received full- and reduced-dose anticoagulants. The median time to reduce the dose was 3.6 months ([IQR] 0.7 – 5.5). Of a total of 7 (3.1%) recurrent VTE, 4 (2.4%) occurred in the full-dose and 3 (5.0%) in the reduced-dose groups (p=0.4), respectively. The median time to recurrent VTE was 7.2 months ([IQR] 3.5-12.4). There were 8 (3.5%) bleeding events, 7 (4.1%) and 1 (1.7%) in the full and reduced-dose anticoagulant groups (p=0.35), respectively. The median follow-up time was 1.5 years (IQR 1-3.1). ConclusionOlder age and a history of previous bleeding were associated with the use of reduced-dose anticoagulants. Patients with cancer-associated VTE receiving reduced-dose anticoagulants had a numerically higher risk of recurrent VTE and lower bleeding outcomes compared with those receiving full-dose anticoagulants.

5-Year Results From the AMPLATZER Amulet Left Atrial Appendage Occluder Randomized Controlled Trial.

The Amulet IDE trial (AMPLATZER Amulet Left Atrial Appendage Occluder [LAAO] Investigational Device Exemption [IDE] Trial) evaluated the safety and effectiveness of the Amulet occluder (Abbott) in patients with nonvalvular atrial fibrillation. The Amulet IDE trial is the largest randomized LAAO trial, comparing the Amulet occluder with the Watchman 2.5 device (Boston Scientific). This analysis presents the 5-year results from the trial comparing the 2 devices head to head. Patients enrolled in the Amulet IDE trial were at a high risk of stroke or systemic embolism defined as a CHADS2 score≥2 or CHA2DS2-VASc score≥3. Oral anticoagulation (OAC) use and key clinical outcomes are presented through 5 years. A total of 1,878 patients were randomized, with 1,833 undergoing a device implantation attempt (n=917, Amulet occluder; and n=916, Watchman device). A significantly higher percentage of patients were free of OAC in the Amulet occluder group at each follow-up visit, with 94.0% and 90.9% free of OAC at the last 5-year follow-up visit in the Amulet and Watchman device groups, respectively (P=0.009). The 5-year clinical outcomes were similar between the Amulet and Watchman devices, including the composite of ischemic stroke or systemic embolism (7.4% vs 7.1%; P=0.851), the composite of stroke, systemic embolism, or cardiovascular death (20.3% vs 20.7%; P=0.666), major bleeding (20.1% vs 20.0%; P=0.882), cardiovascular (CV) death (14.3% vs 15.4%; P=0.429), and all-cause death (28.7% vs 31.1%; P=0.217). Annualized ischemic stroke rates at 5 years were low and the same for Amulet (1.6%/y) and Watchman (1.6%/y) devices. Strokes in patients with the Amulet occluder were less severe (n=38, nondisabling; n=11, disabling; n=11, fatal; n=12, unknown) than strokes in patients with the Watchman device (n=19, nondisabling; n=22, disabling; n=17, fatal; n=10, unknown). Moreover, device factors (device-related thrombus or peridevice leak≥3mm) preceded stroke events and CV deaths more frequently in patients with the Watchman device (n=63) compared with patients with the Amulet occluder (n=31). The 5-year outcomes from the largest randomized LAAO clinical trial demonstrated the long-term safety and effectiveness of the Amulet occluder and Watchman 2.5 devices. The dual-seal Amulet occluder reduces atrial fibrillation-related thromboembolic events while eliminating the need for long-term OAC. (AMPLATZER Amulet Left Atrial Appendage Occluder [LAAO] Investigational Device Exemption [IDE] Trial [Amulet IDE trial]; NCT02879448).

Use of Direct Anticoagulants in Kidney Transplant Recipients: Review of the Current Evidence and Emerging Perspectives.

Thromboembolic events and atrial fibrillation are common among kidney transplant recipients (KTRs), and these conditions typically require anticoagulation. Traditionally, vitamin K antagonists were used for management, but the use of direct oral anticoagulants (DOACs) has increased in KTRs. In the general population, DOACs are recommended over warfarin, but the applicability of these recommendations to KTRs is unclear because of risk-benefit concerns. There is some hesitancy to use DOACs in KTRs because of their dependence on renal clearance for elimination, potential drug-drug interactions, and limited data. To date, studies of DOACs in KTRs have demonstrated that they are efficient in thromboembolic events, major bleeding is rare, and drug-drug interactions appear rare. However, no guidance yet exists about the use of DOACs, reversal of DOAC action, and the pre- and post-kidney transplant management of DOACs in KTRs, and the evidence base is scarce. Thus, decisions on DOAC use in KTRs are based on expert opinion and the resources and experiences of individual transplant centers. This review summarizes 10 published studies on the use of DOACs in 741 KTRs, evaluating the side effects, efficacy, drug-drug interactions, and perioperative management compared with those of 1320 KTRs using vitamin K antagonists. Although current data are limited, DOACs appear to be relatively safe and effective in KTRs, with some studies suggesting lower bleeding rates and better kidney function than with vitamin K antagonists. However, more research with larger patient groups is needed to draw definitive conclusions.

Head injuries in prehospital and Emergency Department settings: a prospective multicenter cross-sectional study in France

BackgroundHead injuries are the leading cause of trauma in Emergency Departments (EDs). Recent studies have shown epidemiological changes in patients consulting ED for head injuries. The main objective of this study was to describe the profile of head injury patients consulting in the EDs in France and assess i) head injury severity across age groups; ii) the delay between the occurrence of head injury and ED arrival; iii) factors associated with traumatic intracranial hemorrhage (ICH).MethodsThis cross-sectional study collected patient data over a three-day period in March 2023. All adult patients (≥ 18 years old) admitted to the ED with a head injury (defined as a trauma to the head) were included. TBI severity was classified according to patients’ initial Glasgow Coma Scale score in the ED: severe (3–8); moderate (9 -12); mild (13–15); and simple head trauma in the absence of transient or persistent neurological symptoms.ResultsAmong the 71 participating EDs, 26,008 patients visited EDs and a total of 1070 patients (4.1%, IC 95 3.9—4.4) presented a head injury were included in the study, with a median age of 68.5 [37–85] years old. Most of the patients (66.7%) were referred to ED after a call to the Emergency Medical Dispatcher (EMD). The median time from head injury to ED visit was 2 h [1.0 – 5.5]. Ground-level falls were the leading cause of head injury (60.3%). Most of patient presented a simple head trauma (n = 715, 66.8%) followed by mild TBI (n = 337, 31.5%). CT head scans were performed for 636 patients (59.6%), of which 58 were positive. Traumatic ICH prevalence was 5.4% (95% CI: 4.1–6.9) and three patients (0.3%) required an urgent neurosurgical intervention. Neither preinjury anticoagulant (p = 0.97) nor antiplatelet (p = 0.93) use was associated with an increased risk of traumatic ICH.ConclusionsOne head injury patient out of two presenting in the ED is aged over 65 years. Patients referred by EMD were more likely to visit ED promptly. The majority of older patients underwent a head CT scan and preinjury anticoagulant use was not associated with increased risk of traumatic ICH.

Impact of systemic diseases on oral health and facial surgery outcomes

Systemic diseases have a profound influence on oral health and maxillofacial surgical outcomes, presenting challenges that require comprehensive management. Diabetes mellitus is a prominent example, with its impact on periodontal health and healing processes being well-established. Elevated blood glucose levels in diabetic patients impair immune response, reduce collagen synthesis, and delay wound healing, increasing the risk of periodontitis and postoperative complications following surgical interventions such as dental implants. Similarly, cardiovascular diseases exacerbate the inflammatory response linked to periodontal disease, potentially worsening both oral health and systemic conditions, thus complicating the recovery process after maxillofacial surgery. These patients often face heightened risks of infections and slower healing, partly due to the frequent use of anticoagulant medications, which can interfere with surgical procedures. Immunocompromised individuals, such as those with human immunodeficiency virus/acquired immune deficiency syndrome (HIV/AIDS) or undergoing chemotherapy, also experience significant oral health challenges, including higher susceptibility to oral infections and delayed tissue repair. Reduced immune function and mucosal integrity make it difficult for these patients to recover effectively after maxillofacial surgery, increasing the risk of complications such as infection and wound dehiscence. Moreover, osteoporosis, a systemic condition characterized by reduced bone density, affects the success of dental implants and bone grafting procedures. The decreased bone quality in osteoporotic patients compromises the ability to achieve stable osseointegration, leading to higher implant failure rates and additional surgical challenges. Addressing these complex interactions between systemic health and oral conditions requires an interdisciplinary approach, integrating medical and dental care to enhance treatment outcomes. Proper management of systemic diseases, along with individualized dental and surgical protocols, is essential to improving the prognosis for patients with concurrent systemic and oral health issues.

Evaluating the Risk of Traumatic Brain Injury in Adults Following a Fall With Concomitant Use of Anti-Coagulation: A Retrospective Cohort Study.

Introduction Falls and fractures are major health challenges for older adults in England. Despite the advantages of anticoagulants, their use in the elderly is often restricted due to concerns about fall-related injuries. However, there is a lack of clear data on the risk of discontinuing anticoagulation therapy solely due to fall risk. NICE guidelines (2021) advise that anticoagulation should not be withheld solely based on age or fall risk. This study aims to assess the incidence of significant brain injuries or intracranial haemorrhages in patients on anticoagulant therapy, also comparing the independent risk factors for traumatic brain injury. Objective This study aims to assess the incidence of TBI following falls in patients on anticoagulant therapy, comparing outcomes between those using DOACs and Vitamin K antagonists. Methods A retrospective cohort study was conducted at Queen Alexandra Hospital, University Hospitals Portsmouth NHS Trust, from November 2023 to May 2024. Data were collected from 3,468 CT head scans performed on patients with a history of falls, including 801 on anticoagulation therapy. Results Of the 801 patients on anticoagulation, 763 (95.2%) were aged 65 or older, with a mean age of 83.1 years. Acute hemorrhage was detected in 3.1% (25/801) of patients. Patients on Warfarin and Dabigatran had significantly higher TBI risk compared to those on Apixaban (6.7%, p=0.02; and 7.6%, p=0.01, respectively), while Edoxaban and Rivaroxaban showed no significant difference. Also, older age (≥65 years) and higher frailty scores (CFS 6 and 7) were associated with increased TBI risk (p<0.05). All patients with acute hemorrhage received conservative management, and two patients experienced mortality within six months. Discussion The study indicates that the risk of TBI following falls in anticoagulated patients is 3.1% relatively low, aligning with existing literature. This underscores the need for careful consideration before discontinuing anticoagulation therapy solely based on fall risk. Hence, discontinuation of anticoagulation should be a patient-specific decision that carefully considers the balance between the risk of traumatic brain injury (TBI) and the benefits of anticoagulation therapy. Factors such as age, frailty, and the type of anticoagulant should all be taken into account. Clinical judgment and selective CT imaging can help balance patient safety with healthcare costs. Conclusion The incidence of adverse outcomes following head injury in patients on anticoagulant therapy is 3.1% and relatively low. Careful decision-making regarding the discontinuation of anticoagulation therapy, informed by patient background and presentation and selective CT imaging, is essential to manage risks effectively and optimize healthcare resource utilization.

Life-Threatening Spontaneous Hematoma in Unusual Sites in Patients with COVID-19 on Anticoagulant Therapy: A Case Series

Thromboembolic manifestations are a common phenomenon in patients affected by corona virus (SARS CoV-2). Recent studies have shown that patients with acute renal failure are also at a greater risk of venous and arterial thromboembolism, 15-30% in ICU, and 7% inpatient care. However, frequently unjudicial use of anticoagulants may develop severe life-threatening hematoma. In our hospital settings we had a dedicated COVID Unit with a Hemodialysis facility. Our Nephrology department had managed 381 patients being COVID positive along with renal impairment from March 2020 to January 2022. Among these patients, four patients developed spontaneous non traumatic hematoma in unusual sites. On admission all the patients received treatment according to our national guidelines for COVID-19. Cases: It is a retrospective analysis in a single-centered hospital. Four cases with confirmed COVID-19 with acute kidney injury and on anticoagulant therapy had developed sudden concealed bleeding. These patients had no previous history of anticoagulant therapy before admission. Case 1 developed hemorrhage in Right lower anterior paramedian deep parietal wall of abdomen, Case 2 had hematoma in retroperitoneal space and in lower third of Iliopsoas, Case 3 developed hemorrhage in left cerebral hemisphere, Case 4 had Intramuscular Hematoma in left rectus abdominis. Out of these four patients two of them required Hemodialysis and one of them went into shock. All patients included were male. The mean age was 57±19.64years. All the four patients were initially managed conservatively with keen monitoring and with proper volume resuscitation, blood transfusion and discontinuation of the anticoagulants. Three of the patients survived with conservative management and one patient died due to sudden massive cardiac arrest. The use of therapeutic anticoagulant can increase the risk of bleeding in atypical sites and may exhibit higher patient death with COVID-19 if not identified at early stage. So a risk-benefit ratio of usage of anticoagulants should be kept in mind and further clinical trials needed to justify its random use in COVID-19. J Bangladesh Coll Phys Surg 2024; 42: 393-400

Application of anticoagulants in the perioperative period of pci for patients with a history of atrial fibrillation and NSTEMI: a real-world, large multicenter retrospective clinical study

Abstract Backgrounds The optimal management for patients with atrial fibrillation (AF) and concomitant coronary artery disease (CAD) remains unclear, particularly regarding anticoagulants use and ischemia-bleeding balance risks. This study aims to investigate the impact of perioperative anticoagulant use on patients with AF and acute non-ST-segment elevation myocardial infarction (NSTEMI). Methods Data for this study were obtained from a retrospective cohort of patients admitted to and discharged from 72 secondary and tertiary hospitals from 2010 to 2023. A total of 150,530 patients were enrolled, including 74,373 NSTEMI patients. Patients were divided into anticoagulants and non-anticoagulants groups. A total of 1,358 patients were included in the non-anticoagulant group, and 3,541 patients were included in the anticoagulant group. Patients in each group were one-to-one matched based on propensity scores using the nearest available pair matching (PSM) method with a caliper width equal to 0.01. The primary endpoints were major adverse cardiovascular and cerebrovascular adverse events (MACCE), including cardiovascular death, recurrent myocardial infarction, and stroke. Secondary endpoints included cardiovascular death, recurrent myocardial infarction, BARC type 3 bleeding, and cerebral hemorrhage. Follow-up time points were set at 1 month,3 months, and 6 months. Multivariate Cox regression models were used to estimate adjusted hazard ratios (aHR) and 95% confidence intervals (CI). Results After PSM matching, each group consisted of 809 patients. The anticoagulant group had a higher proportion of males, a higher prevalence of patients with a history of Percutaneous Coronary Intervention, and hyperlipidemia, while proportions of patients with Killips classification of III/IV and history of chronic kidney disease were lower. Anticoagulant use during the perioperative period significantly reduced the occurrence of MACCE at the primary endpoint at 1 month (aHR 0.57; P &amp;lt; 0.001), 3 months (aHR 0.57; P = 0.023), and 6 months (aHR 0.57; P &amp;lt; 0.001). At the secondary endpoint, anticoagulants use was associated with a lower incidence of cardiogenic death at 1 month,3 months, and 6 months (aHR 0.55; P &amp;lt;0.001), (aHR 0.55; P &amp;lt;0.001), (aHR 0.56; P &amp;lt;0.001), lower risk of myocardial infarction recurrence at 3 months and 6 months (aHR 0.47; P = 0.02), (aHR 0.44; P &amp;lt;0.001), without increasing the risk of bleeding events, including BARC type 3 bleeding and cerebral hemorrhage. Conclusion Perioperative anticoagulant use during PCI can reduce the occurrence of cardiac death, myocardial infarction, and stroke recurrence within 6 months post-surgery without increasing bleeding events in AF and NSTEMI patients. Therefore, for patients with AF, it is recommended to consider combining anticoagulant therapy with dual antiplatelet therapy during the perioperative period, if no contraindications.

Racial and ethnic disparities in the incidence of stroke and mortality in atrial fibrillation: a US nationwide study

Abstract Background Atrial fibrillation (AF) is the most common arrhythmia globally and is associated with increased risks of cardiovascular mortality and ischemic stroke. Prior research has demonstrated racial/ethnic disparities in AF outcomes yet this work has been limited to small cohorts and did not adjust for anticoagulant therapy. Purpose We compared incidence of ischemic stroke and death by race/ethnicity for patients with AF in the Veterans Health Administration (VA), the largest integrated, low-cost, national healthcare system in the US. Methods In this retrospective cohort study we identified those with an outpatient diagnosis of AF and a confirmatory diagnosis ≦ 180 days of their index AF diagnosis enrolled in VA from January 1, 2014 to December 31, 2021, with follow-up for outcomes from the index AF diagnosis date until May 31, 2022. To create a cohort of incident AF cases, we excluded patients with an AF diagnosis or anticoagulant therapy in the 2 years prior to their index AF diagnosis. We also excluded patients with pre-existing valvular heart disease, prior stroke, receiving hospice care or who died within 180 days of index AF diagnosis. We categorized our independent variable as race (i.e., non-Hispanic American Indian / Alaska Native [AI/AN], Asian, Black, or White [reference group]), and ethnicity (i.e., Hispanic). Our primary outcomes were incidence of stroke or death at any point within the study follow-up period. To compare these outcomes by race/ethnicity we conducted a survival analysis, adjusting for anticoagulant use as a time-varying covariate along with sociodemographic factors (age, sex, region, area deprivation index), clinical factors (CHADS2VA2Sc stroke risk and HAS-BLED bleeding risk), and facility type. Results There were 187,080 patients in the final cohort including 0.5% AI/AN, 1% Asian, 9% Black, 4% Hispanic, 85% White; mean age was 73 years. Over a mean study follow-up period of 4.43 years, 65,375 (34.9%) patients died and 24,910 (13.3%) developed stroke. The adjusted hazard ratio [95% CI] for death was lower for Hispanic (0.84 [0.78, 0.91]) and Black (0.94 [0.91, 0.97]) patients than White patients. In contrast, the adjusted hazard ratio for stroke incidence was higher for Black (1.21 [1.16, 1.27]) and Hispanic (1.10 [1.03, 1.17]) patients than White patients. There was no difference observed between AI/AN or Asian and White patients in either outcome. Conclusions In a national cohort of patients with incident AF, we identified significantly higher rates of stroke in Black and Hispanic than White patients even controlling for myriad factors including anticoagulant use. Conversely, racial/ethnic disparities in mortality appear to be eliminated in VA, counter to prior data. Understanding the factors, beyond anticoagulation, driving disparities in stroke outcomes and identifying factors reducing mortality among minority groups is critical to improving overall AF care in the largest integrated US health system.Adjusted Hazard Ratios of Study Outcomes

The role of anticoagulation in atrial high-rate episodes: a meta-analysis

Abstract Background The role of anticoagulation in patients with atrial high-rate episodes (AHRE), who have no prior history of atrial fibrillation or atrial flutter, is being extensively studied. Purpose Given the increased thrombo-embolic risk in patients who have atrial high-rate episodes, our aim was to evaluate whether anticoagulation leads to enhanced clinical outcomes compared to no anticoagulation (1). Methods We searched PubMed, EMBASE, and the Cochrane Library, through February 2024, for studies evaluating outcomes in patients with atrial high-rate episodes managed with oral anticoagulation (OAC) compared to those not managed with oral anticoagulation. Outcomes assessed were ischemic stroke, thromboembolic events, major bleeding, and all-cause mortality. A fixed-effects model was used to calculate pooled risk risk ratios (RR) and their 95% confidence intervals (CI). Results A total of 4 studies comprising 6788 patients were included. Anticoagulation was associated with a significant reduction in the risks of ischemic stroke (RR 0.66; 95% CI 0.49 - 0.90; P = 0.0084) and thromboembolic events (RR 0.70; 95% CI 0.55 - 0.89; P = 0.0037). Compared to atrial high-rate episodes not managed with anticoagulation, there was a significantly increased risk of major bleeding with anticoagulation (RR 1.57; 95% CI 1.23 - 2.00; P = 0.0002), while the risk of all-cause mortality was similar (RR 1.07; 95% CI 0.95 - 1.21; P = 0.2437). Conclusion Our study suggests that anticoagulation in patients with atrial high-rate episodes decreases the risks of ischemic stroke and thromboembolic events, while increasing the risk of major bleeding, compared patients not managed with anticoagulation. Our study does not show a mortality benefit with the use of anticoagulation in patients with atrial high-rate episodes. Further studies are needed to confirm the safety and efficacy of anticoagulation in atrial high-rate episodes.Forest Plots of Outcomes Assessed

Incidence, characteristics, and prognostic impact of cancers in patients with atrial fibrillation: a report from the GLORIA-AF registry

Abstract Background Cancers and atrial fibrillation (AF) are all aging-related diseases. Coexistence of the two conditions makes management complex due to increased risk of both thromboembolism and bleeding. Purpose The aim of the present study was to analyze the incidence and prognostic impact of cancers in patients with AF in the GLORIA-AF registry. Methods GLORIA-AF registry is a prospective multi-centered international multi-centered AF cohort studies. We characterized these patients according to the presence or absence of a cancer diagnosis when enrolled. The primary endpoints were all-cause mortality, cardiovascular mortality, and major bleeding; the secondary endpoints were major adverse cardiovascular events (MACEs) including all-cause mortality, stroke, and major bleeding. Results The prevalence of cancers was 9.7%. The mean CHA2DS2-VASc and HAS-BLED scores in cancer patients were higher than in non-cancer patients (mean CHA2DS2-VASc 3.5 vs. 3.2, P&amp;lt;0.001; mean HAS-BLED score 1.6 vs. 1.3, P&amp;lt;0.001). Patients with cancers had higher oral anticoagulant use than non-cancer patients (84.4% vs. 81.0%, P&amp;lt;0.001) and were more likely to receive NOACs (58.4% vs. 54.0%, P&amp;lt;0.001). During a mean follow up period of 3 years, AF patients with cancers had significantly higher all-cause mortality (15.0% vs. 8.3%, P&amp;lt;0.001), major bleeding rate (5.3% vs. 3.1%, P&amp;lt;0.001), the composite of all-cause mortality, stroke, and major bleeding (20.0% vs. 12.0%, P&amp;lt;0.001), and composite of all-cause mortality, thromboembolism, and major bleeding than non-cancer patients (21.0% vs. 12.0%, P&amp;lt;0.001), but nonsignificant differences in cardiovascular mortality (3.6% vs. 3.1%, P=0.2), any stroke, transient ischemic attack, or non-central nervous system embolism (3.2% vs. 2.7%, P=0.1), and OAC discontinuation (29.0% vs. 28%, P=0.2). Among the cancers, hematological cancer was associated the highest risk of all-cause mortality (HR=3.7, 95%CI 2.69-5.0, P&amp;lt;0.001) while respiratory cancer was associated the highest risk of major bleeding (HR=2.62, 95%CI 1.24-5.5, P=0.011). After multivariable adjustment, cancer was independently associated with increased risk of all-cause mortality (HR=1.30, 95%CI 1.05-1.62, P=0.018), composite of all-cause mortality, stroke, and major bleeding (HR=1.32, 95%CI 1.04-1.68, P=0.022), and composite of all-cause mortality, thromboembolism, and major bleeding (HR=1.29, 95%CI 1.04-1.60, P=0.022), but the risk of major bleeding was nonsignificantly different (HR=1.16, 95%CI 0.71-1.87, P=0.6). Conclusions Cancer is a common comorbidity in patients with AF and is independently associated with increased risk of poor outcomes including all-cause mortality and MACEs. However, cancer did not increase the risk of cardiovascular mortality, major bleeding, and discontinuation of OAC. Cancer in patients with AF should receive appropriate treatments for the cancer itself and appropriate OAC, although strategies may vary between different cancers.Distribution of caners in GLORIA-AFKaplan-Meier curves for the outcomes

Low rates of haemorrhagic stroke, not increased by age, renal/hepatic impairment, concomitant anti-platelet use and high CHA2DS2-VASc scores, in the 4-year follow-up of ETNA-AF-Europe

Abstract Background Balancing the risks of stroke and bleeding is necessary to optimise oral anticoagulation use in clinical practice. Concerns remain over the increased bleeding risk in patients receiving NOACs, and long-term safety data in this population are limited. Purpose To report annualised rates of haemorrhagic stroke in various sub-populations of patients with atrial fibrillation (AF) treated with edoxaban during the 4-year follow-up of ETNA-AF-Europe. Methods ETNA-AF-Europe, a post-authorisation, observational study conducted across 776 sites from 10 European countries, assessed the risks and benefits of edoxaban use in patients with AF. Here, we present the annualised event rates of haemorrhagic stroke during the 4-year follow-up, that occurred overall (on-/off-edoxaban) and on-edoxaban, including sub-populations stratified by age, renal impairment, hepatic impairment, chronic concomitant antiplatelet use and CHA2DS2-VASc score. Patient characteristics were collected at baseline and annualised event rates were reported for outcomes. Results A total of 13,164 patients were included in the full analysis set. Baseline characteristics are reported in Table 1. The overall and on-edoxaban annualised haemorrhagic stroke rates were low (number of events, % [95% confidence interval]: 36, 0.1 [0.05;0.11] and 31, 0.1 [0.05;0.10] respectively). The overall haemorrhagic stroke rates remained low in subgroups stratified by age (&amp;lt;65 years: 4, 0.1 [0.00;0.11]; ≥65–75 years: 13, 0.1 [0.04;0.13]; ≥75 years: 19, 0.1 [0.05;0.12]), renal impairment (yes: 23, 0.1 [0.05;0.13]; no: 12, 0.1 [0.03;0.11]), hepatic impairment (yes: 0, 0.0 [0.00;0.00]; no: 35, 0.1 [0.06;0.11]), concomitant antiplatelet use (yes: 2, 0.1 [0.00;0.16]; no: 34, 0.1 [0.05;0.11]) and CHA2DS2-VASc score (low [0–1]: 0, 0.0 [0.00;0.00]; moderate [2–4]: 28, 0.1 [0.06;0.12]; high [&amp;gt;4]: 7, 0.1 [0.03;0.18]) (Figure). Likewise, on-edoxaban haemorrhagic stroke rates were low irrespective of age (&amp;lt;65 years: 3, &amp;lt;0.1 [0.00;0.010; ≥65–75 years: 12, 0.1 [0.04;0.13]; ≥75 years: 16, 0.1 [0.04;0.12]); renal impairment (yes: 20, 0.1 [0.05;0.12]; no: 10, 0.1 [0.02;0.10]); hepatic impairment (yes: 0, 0.0 [0.00;0.00]; no: 30, 0.1 [0.05;0.11]); chronic concomitant antiplatelet use (yes: 2, 0.1 [0.00;0.18; no: 29, 0.1[0.05;0.10]) or CHA2DS2-VASc score (low [0–1]: 0, 0.0 [0.00;0.00]; moderate [2–4]: 25, 0.1 [0.05;0.12]; High [&amp;gt;4]: 6, 0.1 [0.02;0.17]) (Figure). Conclusions The overall and on-edoxaban annualised rates of haemorrhagic stroke were low and were not increased by non-modifiable risk factors such as age, renal/hepatic impairment, concomitant antiplatelet use and high CHA2DS2-VASc scores during the 4-year follow-up. The overall annualised rates on-edoxaban in ETNA-AF-Europe registry are quite comparable with incidence rates reported in the literature in age-stratified populations (incidence/100 person-years: 55-64 years: 0.06 [0.04-0.07]; 65-74 years: 0.1 [0.09-0.1]; 75-84 years 0.2 [0.1-0.2]).Baseline Characteristics

The incidence of death and risk factors for mortality following major bleeding in patients anticoagulated with factor Xa inhibitors: an observational study in the UK clinical setting (AXIOM UK)

Abstract Background Major bleeding (MB) in association with anticoagulant use results in significant mortality. Mortality can be directly attributed to bleeding, or may follow bleeding complications such acute kidney injury, myocardial infarction, stroke and other cardiovascular events. Most real-world data relating to bleeding mortality is derived from cohorts receiving vitamin-K antagonists. We investigated all-cause mortality (ACM) after MB in a large cohort anticoagulated with Factor Xa inhibitors (FXai), e.g. direct oral anticoagulants (DOAC) rivaroxaban, apixaban and low-molecular-weight heparins (LMWH). Purpose To describe incidence rates of and risk factors for ACM following MB in patients receiving FXai. To investigate MB related ACM by bleeding site, treatment indication, treatment subgroups and individual and cumulative time periods. Methods Retrospective cohort analysis of new users of FXai, between 2012-2020, for therapeutic indications including atrial fibrillation (AF), venous thromboembolism, bioprosthetic cardiac valves or adult congenital heart disease was conducted. MB was defined by the International Society on Thrombosis and Haemostasis (ISTH) criteria. Incidence rates were reported per 100 person-years. Sub-distribution hazard ratios with 95% confidence intervals (95% CI) were estimated from Fine and Gray regression models accounting for competing risks. Results In 240,357 new users of FXai, 88% used an oral FXai. The most common FXai indication was AF (72%). There were 10,163 patients (4.2%) hospitalised for bleeding events during FXai use. Of these, 3,873 MB events (38%) fulfilled the ISTH definition of MB and 1312 died during 3,542 person years of follow-up (Table 1). ACM incidence rates varied by time, indication, bleeding subtype, and drug type. ACM occurred in 926 patients (23.9%) in the first month. Mortality rates were highest in the first month 607 (95% CI 568-647) per 100 person years, the rates then decreased over the year but remained elevated throughout the first year compared with subsequent years. Those receiving LMWH had higher ACM than those receiving a DOAC, but this was not significant in the adjusted risk factor analysis. Risk factors for ACM following bleeding included age ≥80, and a history of current smoking, myocardial infarction, congestive heart failure, peripheral artery disease, Stage 4 or 5 kidney disease, metastatic cancer, and intracranial haemorrhage. Age&amp;lt;60, bleeding following major trauma, and a history of anaemia were associated with lower risk of ACM (Table 2). Conclusions There is a significant incidence of ACM following MB among FXai users. The incidence rate of ACM in patients treated with FXai was highest in the first month after FXai initiation, declined during the first year and then plateaued. Multiple risk factors associated with ACM have been recognised and these could guide urgent therapies such as antidotes.

Adherence to the ABC pathway improves prognosis in patients with AF: preliminary findings from an updated meta-analysis of 360,000 patients

Abstract Background With the increasing complexity of patients with Atrial Fibrillation (AF), the ‘Atrial Fibrillation Better Care’ (ABC) pathway was proposed to streamline a holistic approach for the comprehensive management of patients with AF. The ABC pathway is based on three main pillars: ‘A’ Avoid stroke (through optimal anticoagulant use); ‘B’ Better symptom control; and ‘C’ Cardiovascular and Comorbidity management optimization. Such a holistic and integrated approach is currently recommended by international guidelines, including the ones from the European Society of Cardiology (ESC); a previous meta-analysis showed sub-optimal adherence to such approach in real-world cohorts, with an overall reduction in the risk of major outcomes in patients treated according to the ABC pathway. We hereby performed an updated systematic review and meta-analysis of the current evidence on the implementation of the ABC pathway in patients with AF. Methods We performed a systematic review and meta-analysis according to PRISMA Guidelines. MEDLINE and EMBASE were searched for all studies reporting data on the prevalence of ABC pathway adherent management in patients with AF, and/or the association between ABC pathway management and the incidence of major outcomes, including all-cause death, cardiovascular death, thromboembolism, and major bleeding. Data on the prevalence of ABC pathway management were pooled using a generalized linear mixed model; number of events and total number of patients were pooled using a random-effect model. Pooled estimates were reported as odds ratios (OR) and 95% Confidence Intervals (95%CI); heterogeneity was estimated using the restricted maximum-likelihood estimator, and the Inconsistency index (I2) was also reported. Results 4,059 articles were retrieved from the literature search; after duplicates removal, title and abstract screening and full-text evaluation, 16 studies were included, for a total of more than 360,000 patients. Pooled prevalence of adherence to the ABC pathway was 28.5% (95%CI: 21.1-37.3%, I2=100%; Figure 1). Adherence to the ABC pathway was associated with a significant lower risk of all-cause death (pooled OR: 0.47, 95%CI: 0.40-0.56, I2=97%), cardiovascular death (pooled OR: 0.43, 95%CI: 0.33-0.56, I2=95%) and stroke (pooled OR: 0.61, 95%CI: 0.47-0.79, I2=91%; Figure 1). Patients treated adherent to the ABC pathway also showed a lower risk of major bleeding (pooled OR: 0.77, 95%CI: 0.66-0.90, I2=85%). Conclusions In this updated systematic review and meta-analysis, adherence to the ABC pathway was found in less than one-third of patients with AF. Implementation of the ABC pathway was associated with lower risk of all major adverse events in patients with AF, including all-cause death, and thromboembolic and bleeding events. These data further reinforce the need for routine implementation of the ABC pathway for the management of AF in clinical practice.Figure 1

Factors influencing hospital stay duration in an elective cardiac surgery cohort

Abstract Cardiac surgery has become more complex in recent years, with increases in patient age, complexity, and associated costs. The use of a multidisciplinary strategy to analyze and standardize patient management offers significant benefits. The development of Enhanced Recovery After Surgery (ERAS) programs has proven useful in various types of surgery, recently including cardiac surgery, yielding good results. One of the primary objectives of ERAS programs is the reduction of the Inpatients' length of stay (LOS), with the subsequent improvement in the patient experience and a reduction in costs. The aim of this study is to analyze preoperative and postoperative factors related to the LOS reduction in a cohort of elective cardiac surgery patients included in the Cardiac ERAS program at our hospital. All patients included in the ERAS program, corresponding to elective cardiac surgery, were included in the analysis. 138 patients were divided into four quartiles based on the inpatient’s LOS. An extensive search was conducted in our quality control database, which contains 470 variables on the factors more strongly associated with LOS. The results were analyzed using Chi-Square test for categorical and the Kruskal-Wallis test for continuous variables, generally of non-normal distribution. The results are summarized in the table. Age, poor mobility, surgery other than coronary bypass, and reoperation were the non-modifiable factors most associated with a prolonged LOS. Lower preoperative hemoglobin and albumin levels were associated with an increase in LOS. A class 3 or 4 NYHA functional class, chronic pulmonary disease, and anticoagulation use were associated with higher LOS. Classic cardiovascular risk factors, such as dyslipidemia, hypertension, and tobacco use, were not associated with differences in hospitalization duration. Postoperative and intraoperative factors associated with higher LOS included extubation in the operating room or within six hours, ICU stay duration, mobilization on postoperative days one and two, time to oral food tolerance and gut motility recovery, hyperglycemia on postoperative day one, the duration of arterial, venous, and urinary catheters, the amount of fluids on postoperative day one and the opioid use in POD 2. The complications most associated with a prolonged duration were any infectious complication, any respiratory complication, reoperation, readmission to intensive care, transfusion after 12 hours or at any time during hospitalization, prolonged postoperative sedation, and any rhythmic complication. Conclusion In our cohort of elective patients for cardiac surgery, factors traditionally addressed by ERAS programs were identified as being associated with a longer inpatient’s length of stay. Pre-operative nutritional and anemia optimization, early extubation and mobilization, and the prevention of respiratory and infectious complications should be targeted to improve hospital stay duration.

Clinical outcomes in &amp;gt;10,000 Asian vs &amp;gt;61,000 Non-Asian race patients with AF randomized to Warfarin vs DOACs: a patient-level meta-analyses from COMBINE AF

Abstract Background Randomized data comparing clinical outcomes of atrial fibrillation (AF) patients with Asian vs non-Asian races are limited. Methods Using the COMBINE AF (A Collaboration Between Multiple Institutions to Better Investigate Non-Vitamin K Antagonist Oral Anticoagulant Use in Atrial Fibrillation) database (data from RE-LY, ROCKET AF, ARISTOTLE, and ENGAGE AF-TIMI 48), we performed an individual patient-level meta-analysis to investigate and compare clinical outcomes of AF patients with self-defined Asian and non-Asian races adjusted for baseline characteristics. Standard-dose direct oral anticoagulants (SD DOAC) were defined as dabigatran 150mg bid; rivaroxaban 20mg (15mg) QD, apixaban 5 mg (2.5 mg) bid, or edoxaban 60 mg (30 mg) QD. Low-dose DOACs (DOACs [LD]) were defined as dabigatran 110 mg bid or edoxaban 30 mg (15mg) QD. Results There were 10,212 pts of Asian race and 61,471 non-Asian races in the COMBINE AF database. Compared with non-Asians, Asians were on average 3.2 yrs younger, 20 kg lighter, had worse renal function (mean CrCl 64.9 vs. 77.3 mL/min), and higher rates of prior stroke/transient ischemic attack (37.2% vs 26.6%), P&amp;lt;0.001 for each. The median value of time in therapeutic range of patients randomized to warfarin was lower in Asians than non-Asians (57.7% vs. 66.2%, P&amp;lt;0.001). In the warfarin arm, Asians had a higher adjusted risk of stroke/systemic embolic events (SEE), major bleeding (MB), ICH, GI bleeding (GIB), and net clinical outcome (NCO: stroke/SEE, MB, or death)(Figure; Upper panel). Compared to warfarin, SD DOACs significantly reduced the risks of stroke/SEE, MB, and NCO to a greater degree in Asians than non-Asians (HR stroke/SEE: Asians 0.65 vs Non-Asians 0.86; HR MB: Asians 0.62 vs Non-Asians 0.91; HR NCO: Asians 0.76 vs non-Asians 0.94; Pint &amp;lt;0.02 for each), while SD DOACs increased GIB only in non-Asians (Asian HR 0.92 [0.69-1.23] vs Non-Asians HR 1.41 [1.25-1.58], Pint 0.009; Figure Lower panel). Conclusions The adjusted risks of stroke/SEE and major bleeding with warfarin were higher in Asians compared to non-Asians. The benefits of DOACs over warfarin in preventing stroke/SEE, MB, and net clinical outcomes were significantly greater in Asians than non-Asians.