Low-dose non-vitamin K antagonist oral anticoagulants in patients with atrial fibrillation.

In the last decade, non-vitamin K antagonist oral anticoagulants (NOACs), a new generation of OACs, were introduced to prevent thromboembolism in patients with atrial fibrillation. Although vitamin K-dependent anticoagulants have long been used as OACs, their inherent disadvantage of considerable bleeding complications has limited their use. NOACs demonstrate similar or superior clinical outcomes to those of warfarin. Although strict dose reduction criteria are recommended for NOACs, low-dose NOACs are frequently utilized, especially in Asian patients. Low-dose NOACs have shown clinical outcomes similar to those of warfarin in randomized controlled trials (RCTs) and real-world studies. However, off-label low-dose NOACs have shown inconsistent results compared with standard-dose NOACs and warfarin. Therefore, strict dose reduction criteria for NOACs should be followed until RCTs confirm the issues associated with NOAC underdosing.

The continuation of oral anticoagulation and antiplatelet therapy for dento-alveolar surgery: a service evaluation.

Background Patients taking oral anticoagulants (OACs) and oral antiplatelets (OAPs) have a risk of post-operative bleeding when dental extractions are required. Guidance exists to assist dental practitioners on how best to clinically manage these patients, but this is based upon low-quality evidence. The current service evaluation provides real world clinical data when these drugs are not discontinued for oral surgery procedures.Materials and methods All OACs and OAPs were continued and patients requiring dental extractions had local haemostatic measures (local anaesthesia with adrenaline, socket packing with haemostat and resorbable sutures). All patients were offered a follow-up via a telephone clinic service after surgery to assess any post-operative bleeding.Results A total of 439 patients underwent 513 surgical episodes, equating to 1,001 dental extractions. Overall, 412 (95.9%) patients reported no post-operative bleeding complications. A total of 18 (4.1%) patients reported post-operative bleeding requiring further intervention. All but two patients were managed with local haemostatic measures, and no patient required hospital admission. For the single novel OAC cohort of patients, 8/185 (4.3%) procedures had post-operative bleeding.Conclusion This current service evaluation highlights that the risk of significant or life-threatening bleeding following dental extraction when OACs or OAPs are continued remains rare.

Effectiveness and safety of non-vitamin K antagonist oral anticoagulant in the treatment of patients with morbid obesity or high body weight with venous thromboembolism: A meta-analysis.

BACKGROUND: Venous thromboembolism (VTE) poses a significant health risk to patients with morbid obesity or high body weight. Non-vitamin K antagonist oral anticoagulants (NOACs) are emerging treatments, but their effectiveness and safety compared with vitamin K antagonists (VKAs) in this population are yet to be thoroughly studied. METHODS: We conducted a systematic review and meta-analysis, adhering to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. Four electronic databases were searched for relevant studies comparing the efficacy and safety of NOACs and VKAs in treating patients with VTE with a body mass index > 40 kg/m2 or body weight > 120 kg. Eligible studies were scored for quality using the Newcastle-Ottawa Scale. RESULTS: Thirteen studies were included. The meta-analysis results showed that compared to VKAs, NOACs significantly decreased the risk of VTE occurrence (odds ratio = 0.72, 95% CI: 0.57-0.91, I2 = 0%, P < .001) and were associated with a lower risk of bleeding (odds ratio = 0.74, 95% CI: 0.58-0.95, I2 = 0%, P < .05). Subgroup analysis showed that in the cancer patient subgroup, both risks of VTE occurrence and bleeding were lower in the NOAC group than in the VKA group. In patients without cancer, the risk of VTE was significantly lower in the NOAC group. CONCLUSION: NOACs appear to be more effective and safer than VKAs in patients with morbid obesity or a high body weight with VTE. However, further large-scale randomized controlled trials are required to confirm these findings.

Re-bleeding and all-cause mortality risk in non-variceal upper gastrointestinal bleeding: focusing on patients receiving oral anticoagulant therapy.

OBJECTIVE: Non-variceal upper gastrointestinal bleeding (NVUGIB) in patients receiving oral anticoagulants (OACs) may be fatal; however, little is known about re-bleeding and all-cause mortality after successful hemostasis. We investigated the clinical characteristics and risk factors for re-bleeding and death after successful hemostasis. METHODS: Patients receiving OACs and diagnosed with NVUGIB between 2007 and 2021 were enrolled. All NVUGIB incidents were confirmed if definite bleeding in the upper gastrointestinal tract was detected via esophagogastroduodenoscopy. RESULTS: A total of 132 patients receiving OACs were diagnosed with NVUGIB. Males were the majority (72, 54.5%), and bleeding was detected mostly in the stomach (99, 75%) and was most often due to peptic ulcers (PU) (88, 66.7%). After successful hemostasis of index NVUGIB, 40 patients (30.3%) experienced re-bleeding. Among them, 15 (37.5%) died, and among those, 3 (2.3%) were related to re-bleeding. Multivariate analysis revealed that duodenal bleeding (odds ratio [OR]: 3.305; 95% confidence interval [CI]: 1.152-9.479, p = 0.026) and Charlson comorbidity index score (CCI) (OR: 1.22; 95% CI: 1.052-1.419, p = 0.009) were significant risk factors for re-bleeding. Index albumin levels (OR: 0.134; 95% CI: 0.035-0.506, p = 0.003), previous PU or upper gastrointestinal bleeding (UGIB) history (OR: 4.626; 95% CI: 1.375-15.567, p = 0.013), and CCI (OR: 1.293; 95% CI: 1.058-1.581, p = 0.012) were related all-cause mortality. CONCLUSION: CCI and duodenal bleeding are risk factors for re-bleeding in patients with NVUGIB who were receiving OACs, while low index albumin levels and previous PU and UGIB history are associated with all-cause mortality.

While taking oral anticoagulants can offer various benefits, the risks of re-bleeding and all-cause mortality remain.A Charlson comorbidity index of higher than 4.5 and duodenal bleeding occurring while receiving oral anticoagulants increase the risk of rebleeding.Hypoalbuminemia <3.25 g/dL, history of peptic ulcer or upper gastrointestinal bleeding and Charlson comorbidity index were significant risk factors for all-cause mortality.

Intra-Arterial Thrombectomy for Acute Ischemic Stroke Related to the Procoagulant Effect of Warfarin in A Patient with Atrial Fibrillation and Bioprosthetic Valve Replacement.

PURPOSE: Warfarin is associated with paradoxical procoagulant effect that leads to a transient hypercoagulable state and acute ischemic stroke (AIS). This clinical dilemma is further confounded when the patient has multiple comorbidities and the optimal treatment strategies are unclear. CASE REPORT: We report a 78-year-old male with valvular heart disease, congestive heart failure, and atrial fibrillation, who received bioprosthetic valve replacement and developed AIS related to the paradoxical procoagulant effect of warfarin. Emergent cerebral angiography with mechanical thrombectomy was performed, and recanalization was successfully achieved. After shifting warfarin to nonvitamin K oral anticoagulant (NOAC), the paradoxical procoagulant effect ameliorated. CONCLUSION: This report describes the roles of endovascular therapy and NOAC in patients with similar highly complex conditions and has clinical relevance for therapeutic plans in the clinical setting.

Bivalirudin for cardiopulmonary bypass in a patient with heparin allergy.

BACKGROUND: Hypersensitivity reactions to heparin are uncommon conditions but pose a serious clinical problem for patients requiring cardiopulmonary bypass. Bivalirudin is a reversible direct thrombin inhibitor that can be used instead of heparin. CASE REPORT: A 49-year-old male patient was admitted to our hospital for coronary artery bypass graft operation with mitral insufficiency and tricuspid valve insufficiency. Heparin allergy was confirmed by skin biopsy and skin tests. Due to this allergy, we used bivalirudin (Bivacard VEM drug, Turkey) during the surgery. A loading dose of 1.0 mg/kg (100 mg) bivalirudin was administered through the central line and a continuous infusion of 2.5 mg/kg/h of the anticoagulant was initiated following the approved protocol. Serial ACTs were obtained at 15-minute intervals during the procedure and the measurements were 330s, 320s, 350s, 360s, and 340s consecutively. Additional boluses of 0.5 mg/kg (50 mg) were administered for each measurement. Left anterior descending, obtuse marginal arteries and the right coronary artery were grafted with the left internal mammary and saphenous veins. Also, mitral valve replacement with St Jude mechanical heart valve and tricuspid ring annuloplasty was performed with Medtronic Duran ring. After the surgery, the patient had an uneventful period in the postoperative intensive care unit with a total of 600ml and 300ml chest tube drainage for two days and was discharged on the 7th day. CONCLUSION: Alternative anticoagulation strategies are needed for cardiopulmonary bypass in patients unable to use heparin. Bivalirudin may be recommended as a viable alternative anticoagulant in patients with heparin allergy during cardiopulmonary bypass. However, each patient should be evaluated individually and it should not be forgotten that more than recommended doses may be needed.

Mechanical Aortic Valve Thrombosis with Heart Failure Successfully Treated with Oral Anticoagulation: A Case Report.

Background: The use of anticoagulation is mandatory for prevention of prosthetic valve thrombosis (PVT) worldwide, regardless of the valve type or position in the heart. In case a thrombosis causes symptomatic dysfunction, treatment usually includes the use of thrombolytic therapy or surgery. We report a case of PVT involving a patient with a mechanical aortic valve which was treated entirely with the use of anticoagulation therapy (warfarin). Case Presentation: A 58-year-old man had an aortic valve replacement using a Carbomedics® mechanical valve due to severe aortic stenosis as a result of a calcific bicuspid native aortic valve. He was commenced on warfarin after surgery which was continued thereafter. He presented to our hospital after three years with shortness of breath at rest. On clinical examination, his condition was poor with a New York Heart Association functional classification of IV. He was in sinus rhythm and had an enlarged heart shadow on chest X-ray. Transesophageal echocardiography (TEE) revealed aortic valve regurgitation with vegetations on the anterior valve leaflet causing reduced hemi leaflet motility and a mean pressure gradient of 50 mmHg. Cinefluoroscopy revealed a dysfunctional mechanical valve leaflet. Surgery was at high risk of mortality due to the patient's clinical status and he was continued on warfarin therapy with close monitoring. Cinefluoroscopy and echocardiography done six months later revealed complete dissolution of thrombus and a normally functioning mechanical aortic valve. Conclusion: Only a few cases of symptomatic, thrombotic mechanical aortic valve were entirely treated with anticoagulation only. Our patient is one such case who had resolution of symptoms and improvement on NYHA functional classification (IV to I).

[Antagonizing anticoagulants in intracranial hemorrhage - step by step]. / Antikoagulation antagonisieren bei intrakranieller Blutung ­ Schritt für Schritt.

Intravenous thrombolysis for acute ischemic stroke is an indispensable tool and current standard of care in neurology. However, until recently direct therapeutic options for intracranial hemorrhage under existing anticoagulation were not available. With the introduction of two new medications - Idarucizumab and Andexanet alfa - neurologists take a more targeted approach in treating these patients.

In adults with cancer and VTE, DOACs were noninferior to LMWH for recurrent, nonfatal VTE at 6 mo.

SOURCE CITATION: Schrag D, Uno H, Rosovsky R, et al; CANVAS Investigators. Direct oral anticoagulants vs low-molecular-weight heparin and recurrent VTE in patients with cancer: a randomized clinical trial. JAMA. 2023;329:1924-1933. 37266947.

Direct oral anticoagulants for the treatment of splanchnic vein thrombosis: A state of art.

Splanchnic vein thrombosis (SVT) is a manifestation of venous thromboembolism in an unusual site. Portal, mesenteric, and splenic veins are the most common vessels involved in SVT which occurs mainly in patients with liver cirrhosis, although non-cirrhotic patients could be affected as well. Thrombosis of hepatic veins, also known as Budd-Chiari syndrome, is another manifestation of SVT. Prompt diagnosis and intervention are mandatory in order to increase the recalization rate and reduce the risk of thrombus progression and hypertensive complications. Traditional anticoagulation with heparin and vitamin-K antagonists is the treatment of choice in these cases. However, recent studies have shown promising results on the efficacy and safety of direct oral anticoagulants (DOACs) in this setting. Available results are mainly based on retrospective studies with small sample size, but first clinical trials have been published in the last years. This manuscript aims to provide an updated overview of the current evidence regarding the role of DOACs for SVT in both cirrhotic and non-cirrhotic patients.

Thromboprophylaxis in Patients Admitted to the Surgical Ward: Clinical Audit.

Background: Hospital-acquired thrombosis (HAT) is associated with significant morbidity, mortality, and financial burden globally. Following trusted guidelines for VTE prevention has shown effective, safe, and satisfactory results. This prompts national collaborative efforts to maintain a consensus approach for the safe risk assessment of inpatients and the prescription of thromboprophylaxis. Objective: This study aimed to detect and estimate deviations from international thromboprophylaxis protocols. The study also aimed to raise the quality of practice and adherence to evidence-based protocols in Alshuhada Teaching Hospital. Methods: A cross-sectional audit of general surgical inpatients was performed from October 2021 to May 2022. The first cycle was from 1/10/2021 to 21/10/2021, and the second cycle was from 13/5/2022 to 31/5/2022. The target population was adults aged >18 years. Data were collected via an online checklist on two separate occasions. The criteria were based on the NICE guideline for venous thromboembolism in individuals aged over 16 years: "Reducing the risk of hospital-acquired deep vein thrombosis or pulmonary embolism NG89". Results: Forty-five surgical inpatients were included in this study: 20 in the first cycle and 25 in the second cycle. The first-cycle report showed that only 25% of VTE candidates received this regimen. In the second cycle, practice significantly improved, with 92% of admitted patients having their risk assessment tool completed within 24 h of admission. 79% of VTE prophylaxis candidates were prescribed adequate pharmacological prophylaxis within 14 h of admission. Conclusion: The rate of adequate thromboprophylaxis for inpatients undergoing surgery was very low before clinicians received education on VTE prevention, whereas was evidently high after they had received them. The cause of non-adherence in the pre-intervention phase was a lack of adequate knowledge regarding the magnitude and burden of HAT and the importance of thromboprophylaxis, which has a potential role in preventing the majority of HAT.

Monitoring the appropriate prescription of low molecular weight heparins and Fondaparinux through administrative data. A retrospective observational study in the Tuscany region.

INTRODUCTION: Low Molecular Weight Heparins (LMWHs) and Fondaparinux have been widely used as anticoagulants. Mass prescription may lead to prescriptive inappropriateness, which causes Heparin-induced thrombocytopenia and other side effects. OBJECTIVES: The study investigates the appropriate prescription of LMWHs and Fondaparinux in Tuscany. We aim to validate the crude measure of prescription appropriateness of the Key Performance Indicator (KPI) "Patients treated with LMWHs and Fondaparinux every hundred residents in Tuscany" as a proxy for monitoring prescription appropriateness. METHODS: To compare a crude KPI based only on drug consumption with a refined KPI based on exclusions listed in the clinical guidelines, a retrospective observational cohort study was carried out, using the RECORD guidelines for the year 2019. The refined indicator is computed via record linkage of different datasets regarding (a) pharmaceutical services; (b) hospital discharge records; (c) outpatient services; and (d) birth certificates. We apply exclusion criteria to identify the cohort of patients. Values of the KPI are compared, by ranking, with those obtained from its refined version. A Spearman test was performed to validate the use of the crude KPI as a proxy. RESULTS: 208,717 LMWH and Fondaparinux users are identified, of which 103,299 fall within the study's inclusion criteria. 16,817 (16%) of LMWHs and Fondaparinux users are classified as high consumption. The refined version of the KPI produces the same ranking results in terms of local health districts (rho = 0.98 p<0.01). CONCLUSIONS: Although the crude KPI is less refined and detailed than the adjusted indicator computed by our study, it has proven capable to provide an accurate snapshot of the use of these drugs across the region. This analysis is useful to enable regional and local managers to run rapid and simple indicators to monitor the appropriateness of LMWHs and Fondaparinux. This analysis should be reviewed periodically to confirm its accuracy.

Comparative effectiveness of aspirin for symptomatic venous thromboembolism prophylaxis in patients undergoing total joint arthroplasty, a cohort study.

BACKGROUND: This study compares the symptomatic 90-day venous thromboembolism (VTE) rates in patients receiving aspirin to patients receiving low-molecular weight heparin (LMWH) or direct oral anticoagulants (DOACs), after total hip (THA) and total knee arthroplasty (TKA). METHODS: Data were collected from a multi-centre cohort study, including demographics, confounders and prophylaxis type (aspirin alone, LMWH alone, aspirin and LMWH, and DOACs). The primary outcome was symptomatic 90-day VTE. Secondary outcomes were major bleeding, joint related reoperation and mortality within 90 days. Data were analysed using logistic regression, the Student's t and Fisher's exact tests (unadjusted) and multivariable regression (adjusted). RESULTS: There were 1867 eligible patients; 365 (20%) received aspirin alone, 762 (41%) LMWH alone, 482 (26%) LMWH and aspirin and 170 (9%) DOAC. The 90-day VTE rate was 2.7%; lowest in the aspirin group (1.6%), compared to 3.6% for LMWH, 2.3% for LMWH and aspirin and 2.4% for DOACs. After adjusted analysis, predictors of VTE were prophylaxis duration < 14 days (OR = 6.7, 95% CI 3.5-13.1, p < 0.001) and history of previous VTE (OR = 2.4, 95% CI 1.1-5.8, p = 0.05). There were no significant differences in the primary or secondary outcomes between prophylaxis groups. CONCLUSIONS: Aspirin may be suitable for VTE prophylaxis following THA and TKA. The comparatively low unadjusted 90-day VTE rate in the aspirin group may have been due to selective use in lower-risk patients. TRIAL REGISTRATION: This study was registered at ClinicalTrials.gov, trial number NCT01899443 (15/07/2013).

Structured Rehabilitation for Patients with Atrial Fibrillation Based on an Integrated Care Approach: Protocol for a Prospective, Observational Cohort Study.

Background: Guideline-recommended integrated care based on the ABC (Atrial fibrillation Better Care) pathway for "general" patients with atrial fibrillation (AF) improves clinical outcomes, as demonstrated in our prior mobile Atrial Fibrillation Application (mAFA)-II cluster randomized trial. The present study aims to investigate whether mAFA III-supported structured follow-up rehabilitation packages adapted to patient risk profiles and different treatment patterns (eg, for patients receiving drug treatment only, AF ablation, or left atrial appendage occlusion [LAAO]) will improve guideline adherence and reduce the risk of adverse cardiovascular events. Methods and Analysis: In this prospective, observational mAFA III pilot cohort study, patients with AF aged ≥ 18 years will be enrolled using the mAFA III App for self-management. Assuming an annual rate of composite outcome of "ischaemic stroke or systemic embolism, all-cause death and cardiovascular hospitalization" of 29.3% for non-ABC pathway compliance compared with 20.8% for ABC pathway compliance, at least 1475 patients would be needed to detect the outcome of the A, B and C components of the ABC pathway, assuming a withdrawal rate of 20% in the first year. The primary endpoint is adherence to guidelines regarding the A, B and C components of the ABC pathway. Ancillary analyses will be performed to determine the impact of the ABC pathway using smart technologies on the outcomes among the "high-risk" population (eg, ≥75 years old, with multimorbidities, with polypharmacy) and the application of artificial intelligence machine-learning AF risk prediction management in assessing AF recurrence. The individualised anticoagulants with AF burden will be monitored by smart devices. Trial Registration Number: ISRCTN13724416.

Prognostic risk factors for patients with hepatic sinusoidal obstruction syndrome caused by pyrrolizidine alkaloids.

Pyrrolizidine alkaloids induced hepatic sinusoidal obstruction syndrome (PA-HSOS) often occurs after consuming herbs or a dietary supplement containing the plant Tu-San-Qi. Limited data exists to identify patients with fatal outcomes for early interventions. We aimed to analyze the predictors for 3-month survival. We retrospectively enrolled PA-HSOS patients in 5 hospitals and extracted data from the onset of PA-HSOS to 36 months. Outcome measurements were 3-month and 36-month survival rates, baseline prognostic predictors for survival, and the effects of anticoagulant therapy. Among 49 enrollees, the median age was 60 and 49% male. At the onset of PA-HSOS, patients with Child-Turcotte-Pugh (CTP) class of A, B, or C were 8.2% (4/49), 42.8% (21/49) and 49.0% (24/49), respectively. None of them received a transjugular intrahepatic portosystemic shunt or a liver transplant. The 3-month and 36-month survival rates were 86% and 76%, respectively. Compared to the CTP class A or B, class C at baseline independently predicted lower survival rates at both 3 and 36 months. However, anticoagulation therapy treatment within the first 3 months independently predicted significantly higher survival rates at both time points. CTP class C and anticoagulant therapy were the independent predictors for short-term and long-term survival. Anticoagulant therapy could decrease mortality rate of CTP class C patients. The greatest benefit of anticoagulant evaluated by 3-month survival rate was in patients with CTP class C compared with those without treatment (93% vs 40%, P = .009). There were no bleeding complications reported in patients treated with the anticoagulant.

Treasure to the mother and threat to the fetus: case report of warfarin-associated fetal intracranial hemorrhage and review of literature.

In patients with mechanical heart valve protheses, warfarin is usually recommended because of its exceptional anticoagulation effects. However, warfarin can cross the placenta, leading to teratogenicity and even catastrophic hemorrhage in the fetus. The present article describes a case of warfarin-associated fetal intracranial hemorrhage. The patient was a woman in her early 30s. At the age of 11 years, she had undergone aortic valve replacement (mechanical) for aortic regurgitation. Since then, she had been taking oral warfarin. During her pregnancy, her prothrombin time-international normalized ratio was maintained between 1.5 and 2.5. At 35 weeks of gestation, fetal ultrasonography revealed an intracranial mass in the left hemisphere. An emergency cesarean section was performed because fetal intracranial hemorrhage was suspected. A male infant was delivered with a 1- 5-, and 10-minute Apgar score of 1, 5, and 7, respectively. Cranial computed tomography revealed multiple hemorrhage sites with newly emerged bleeding spots. In patients with mechanical heart valve protheses, obstetricians face the dilemma of individual-patient differences and the difficulty of intensive monitoring of the coagulation parameters in the fetus. Tailor-made anticoagulation therapy and a more intensive ultrasonic monitoring strategy, even that involving regular magnetic resonance imaging, are necessary in these patients.

Exploring safety and efficacy of rivaroxaban after living donor liver transplantation: a retrospective study.

PURPOSE: Thromboembolic complications remain a significant concern in postoperative patients, particularly those who have undergone liver transplantation. Warfarin has been the standard oral anticoagulant. Direct oral anticoagulants (DOACs) have several advantages over warfarin, including rapid onset of action and standardized dose guidelines. We aimed to assess the safety of rivaroxaban in living donor liver transplantation (LDLT) recipients. METHODS: This study was a single-center, retrospective descriptive analysis of LDLT recipients who received rivaroxaban between December 2020 and April 2022. A total of 27 recipients received rivaroxaban postoperatively. Liver function tests, immunosuppression levels, serum creatinine, and INR were recorded before the initiation of rivaroxaban and then on post-therapy days 1, 7, 14, 28, 90, and 180. RESULTS: Among the 27 recipients receiving rivaroxaban postoperatively, portal venous thrombosis was the most prevalent indication for anticoagulation (44.4%), followed by Budd-Chiari syndrome (29.6%). Nine patients had a twofold increase in either ALT or AST values, two of whom were treated for biliary strictures and the others for rejection. Eighteen patients were given tacrolimus, and eight were on cyclosporine, with one patient switched from tacrolimus to cyclosporine due to insufficient therapeutic levels. There were no incidents of bleeding or re-thrombosis during the 180-day follow-up period. CONCLUSION: Rivaroxaban may be a safe and effective alternative in LDLT recipients with no significant adverse incidents. Further studies with larger sample sizes are needed to confirm these findings and determine this population's optimal dose and duration of rivaroxaban therapy.

Trial sequential analysis of efficacy and safety of direct oral anticoagulants and vitamin K antagonists against left ventricular thrombus.

Meta-analysis may increase the risk of random errors. Trial sequential analysis (TSA) has been developed to adjust for these random errors. We conducted TSA on the efficacy and safety of direct oral anticoagulants (DOACs) and vitamin K antagonists (VKAs) in left ventricular thrombus (LVT) patients in order to estimate how many additional patients should be required to draw definite conclusions. PubMed, Scopus, and Cochrane Library databases were searched for articles directly comparing DOACs and VKAs for LVT in LV thrombus resolution, stroke, any thromboembolism, major bleeding, any bleeding, and all-cause death. TSA was conducted with a cumulative Z-curve, monitoring boundaries, and required sample size. A simulated trial was run and TSA estimated the sample sizes of trials needed to draw definite conclusions. Of 4749 articles, 25 studies were used for the analysis. TSA revealed the current sample size already demonstrated superiority of DOACs in LV thrombus resolution and stroke, and futility in any thromboembolism and all-cause death. Two other outcomes did not achieve the required sample size. The sample size of new trials needed to demonstrate the superiority of DOACs over VKAs was estimated 400 for any bleeding. Corresponding trials needed to demonstrate no significant differences could be estimated for major bleeding and any bleeding (n = 200 and n = 2000, respectively). Current results show that the sample size required to draw definite conclusions was not reached for two outcomes, and there was a risk of random error. Further randomized controlled trials with sample sizes estimated by TSA will work effectively to obtain valid conclusions.

Anticoagulation for Stroke Prevention in Atrial Fibrillation.

Cardioembolic stroke from atrial fibrillation causes substantial death and disability in the United States. Treatment with oral anticoagulants provides safe and effective stroke prevention for high-risk patients. This article reviews strategies for the use of anticoagulation and highlights the nurse's role in patient education.