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Limited data exists on the safety and efficacy with the concomitant use of 4 factor prothrombic complex concentrate (4F-PCC) and andexanet alfa (AA). This case series describes 7 patients at our institution who received both 4F-PCC and AA for the management of life-threatening bleeding associated with apixaban or rivaroxaban. Four patients received AA due to worsening bleeding after 4F-PCC. Of the 7 patients in this case series, 1 had a documented thrombotic event which was an acute ischemic stroke. The thrombotic event rate in our case series was similar to the incidence of thrombotic events reported with the use of AA alone. In-hospital mortality occurred in 2 of 7 patients with 1 additional patient discharged to hospice care. [ABSTRACT FROM AUTHOR]

Background: Direct-acting oral anticoagulants (DOACs) have become the preferred drugs for managing venous thromboembolism (VTE). Despite their advantages over vitamin K antagonists such as warfarin, their use in obese patients remains controversial with many providers reluctant to switch patients managed on warfarin. Outcome research that opts to increase provider confidence when prescribing DOACs for patients with obesity will be invaluable. Objective: This investigation evaluated whether patients with a body mass index (BMI) 35 kg/m2 or greater who were prescribed a DOAC had a higher risk for a recurrent VTE or bleed event relative to warfarin. Methods: The study was conducted in West Virginia which has the highest rate of obesity in the United States. Results: Of the total study population (1633), 2.3% (37) had a recurrent thrombotic event, 5.5% (89) had a major bleed event, and 10.7% (174) had some type of bleeding event. No individual patient characteristic was associated with recurrent thrombosis—including BMI. Older age, antiplatelet use, and taking a medication with a theoretical risk of increasing the effect of DOACs were associated with any and major bleeding events. The use of warfarin was associated with major bleeding events more frequently versus a DOAC. Body mass index was not a predictor for recurrent VTE or any bleed or major bleed events. Conclusions: These findings support the conclusion that DOACs are an appropriate and effective drug class for the management of VTE in patients with obesity. [ABSTRACT FROM AUTHOR]

Introduction: Ground level falls in the elderly often lead to complications due to use of anticoagulants (ACs). Intracranial hemorrhage (ICH), immediate or delayed, is a feared consequence of such falls. The rate of delayed ICH (dICH) in patients taking anticoagulants or antiplatelet (AP) agents ranges from.6% to 6%. Patients on warfarin have a persistent rate of dICH, leading to implementation of routine repeat head CTs at our institution. This policy was extended to direct oral anticoagulants (DOACs). This study aims to determine institutional incidence of DOAC-associated dICH. Methods: With IRB waiver approval, we conducted a retrospective review of trauma evaluations for falls on DOACs from 2016 to 2018. We reviewed records for neurologic status, DOAC use, and results of initial and delayed head CTs. Exclusion criteria included initial GCS ≤14, new neurologic deficits, traumatic findings on initial CT, concurrent use of additional AC/AP, or absence of repeat head CT. Results: Among 632 patients evaluated for falls on AC/AP therapy, 159 (25%) of patients were included in the review. The age range was 19-98 years old, with 99 females and 60 males. Half of the patients were on apixaban, with the rest on dabigatran or rivaroxaban. Ten patients presented with GCS of 14. No delayed hemorrhages were detected in this population. Conclusion: The necessity of a repeat head CT in patients taking DOACs is debated in the literature. Our analysis failed to demonstrate any delayed hemorrhage in neurologically intact patients after head strike on DOAC, suggesting no indication for follow-up imaging in this group. [ABSTRACT FROM AUTHOR]

Direct-acting oral anticoagulants (DOACs) are prescribed in the treatment of venous thromboembolism, including pulmonary embolism (PE). Evidence is limited regarding the outcomes and optimal timing of DOACs in patients with intermediate- or high-risk PE treated with thrombolysis. We conducted a retrospective analysis of outcomes among patients with intermediate- and high-risk PE who received thrombolysis, by choice of long-term anticoagulant agent. Outcomes of interest included hospital length of stay (LOS), intensive care unit LOS, bleeding, stroke, readmission, and mortality. Descriptive statistics were used to examine characteristics and outcomes among patients, by anticoagulation group. Patients receiving a DOAC (n = 53) had shorter hospital LOS compared to those in warfarin (n = 39) and enoxaparin (n = 10) groups (mean LOS 3.6, 6.3 and 4.5 days, respectively; P<.0001). This single institution retrospective study suggests DOAC initiation <48 h from thrombolysis may result in shorter hospital LOS compared to DOAC initiation ≥48 h (P<.0001). Further larger studies with more robust research methodology are needed to address this important clinical question. [ABSTRACT FROM AUTHOR]

Background: It is now widely accepted to manage low risk acute venous thromboembolism (VTE) in the outpatient setting with direct oral anticoagulants (DOACs). Although DOACs are straightforward to dose, they are high risk medications and not immune to medication errors. There is limited evidence that pharmacists' intervention has an impact on DOAC discharge medication errors in the ED. Objective: To determine if pharmacist involvement reduced the rate of DOAC discharge medication errors in low risk VTE patients. Methods: This retrospective cohort study evaluated a clinical pharmacy service implemented prior to the study. Included patients were evaluated in 2 groups: the cohort with pharmacist involvement and the cohort without pharmacist involvement. The primary outcome was the rate of anticoagulation medication errors. Results: A total of 58 patients were evaluated. Of these patients, 14 had a pharmacist directly involved with their care in the ED while 44 patients did not. The rate of medication errors was lower when a pharmacist was involved, 7.1% (n = 1), compared to when a pharmacist was not involved, 36.4% (n = 16), (p = 0.046). All patients in the pharmacist involvement group received anticoagulation counseling prior to discharge compared to only 56.8% of patients in the non-pharmacist involvement group (p = 0.002). Conclusion: Our protocol for pharmacist involvement at the time of VTE diagnosis during an ED admission showed a reduced rate of anticoagulation medication errors when a pharmacist was involved. This benefit could potentially translate into improved outcomes such as readmission rates, patient safety outcomes, and hospitalizations. [ABSTRACT FROM AUTHOR]

Rationale: Atrial fibrillation causes one-fifth of ischemic strokes, with a high risk of early recurrence. Although long-term anticoagulation is highly effective for stroke prevention in atrial fibrillation, initiation after stroke is usually delayed by concerns over intracranial hemorrhage risk. Direct oral anticoagulants offer a significantly lower risk of intracranial hemorrhage than other anticoagulants, potentially allowing earlier anticoagulation and prevention of recurrence, but the safety and efficacy of this approach has not been established. Aim: Optimal timing of anticoagulation after acute ischemic stroke with atrial fibrillation (OPTIMAS) will investigate whether early treatment with a direct oral anticoagulant, within four days of stroke onset, is as effective or better than delayed initiation, 7 to 14 days from onset, in atrial fibrillation patients with acute ischemic stroke. Methods and design: OPTIMAS is a multicenter randomized controlled trial with blinded outcome adjudication. Participants with acute ischemic stroke and atrial fibrillation eligible for anticoagulation with a direct oral anticoagulant are randomized 1:1 to early or delayed initiation. As of December 2021, 88 centers in the United Kingdom have opened. Study outcomes: The primary outcome is a composite of recurrent stroke (ischemic stroke or symptomatic intracranial hemorrhage) and systemic arterial embolism within 90 days. Secondary outcomes include major bleeding, functional status, anticoagulant adherence, quality of life, health and social care resource use, and length of hospital stay. Sample size target: A total of 3478 participants assuming event rates of 11.5% in the control arm and 8% in the intervention arm, 90% power and 5% alpha. We will follow a non-inferiority gatekeeper analysis approach with a non-inferiority margin of 2 percentage points. Discussion: OPTIMAS aims to provide high-quality evidence on the safety and efficacy of early direct oral anticoagulant initiation after atrial fibrillation-associated ischemic stroke. Trial registrations: ISRCTN: 17896007; ClinicalTrials.gov: NCT03759938 [ABSTRACT FROM AUTHOR]

Objective: To evaluate the role of oral anticoagulation in patients with stage 5 chronic kidney disease (CKD-5) or end-stage kidney disease (ESKD). Data Sources: A literature search of PubMed (January 2000 to July 1, 2021), the Cochrane Library, and Google Scholar databases (through April 1, 2021) was performed with keywords DOAC (direct-acting oral anticoagulant) OR NOAC or dabigatran OR rivaroxaban OR apixaban OR edoxaban AND end-stage kidney disease combined with atrial fibrillation (AF) or venous thromboembolism (VTE) OR pulmonary embolism OR deep-vein thrombosis. Study Selection and Data Extraction: Case-control, cohort, and randomized controlled trials comparing DOACs to an active control for AF or VTE in patients with CKD-5 or ESKD and reporting outcomes of stroke, recurrent thromboembolism, or major bleeding were included. Data Synthesis: Nine studies were included. Efficacy data supporting routine use of warfarin or DOACs in CKD-5 or ESKD are limited. Rivaroxaban and apixaban may provide enhanced safety compared to warfarin in patients with AF. Data for VTE are limited to 1 retrospective study. Relevance to Patient Care and Clinical Practice: Because of the paucity of rigorous, prospective studies in CKD-5 or ESKD, OACs should not be broadly used in this population. It is clear that data regarding efficacy of DOACs cannot be reliably and safely extrapolated from the non-ESKD population. Therefore, use of OACs in this population should be individualized. Conclusions: If OACs for stroke prevention with AF are deemed necessary, apixaban or rivaroxaban can be considered. DOACs cannot currently be recommended over warfarin in patients with CKD-5 or ESKD and VTE. [ABSTRACT FROM AUTHOR]

Background: Non-vitamin K antagonist oral anticoagulants (NOAC) have replaced vitamin K antagonist (VKA) oral anticoagulants as the first-line treatment option for stroke prevention in high-risk patients with atrial fibrillation. With VKA therapy, disease and treatment-related knowledge is associated with improved adherence and outcomes. There is concern that due to the lack of need for ongoing visits for laboratory monitoring in patients on NOACs, there is less opportunity for education, leading to poor disease- and treatment-related knowledge in this patient group. Methods: One hundred ninety-nine (199) patients presenting to 2 primary care clinics on NOAC therapy were surveyed regarding atrial fibrillation and their knowledge regarding NOACs. Chart review was completed to determine patient characteristics and data obtained was compared with survey results to determine the accuracy of the survey responses. Results: Patients with a lower degree of NOAC knowledge tended to be older (P < .001), have higher Charlson Comorbidity Index scores (P = .001), use apixaban more often (P = .008), and have been on NOACs for a shorter time period (P = .007). Conclusions: There is an opportunity to improve NOAC-related knowledge in patients with atrial fibrillation. When developing educational interventions, patient characteristics associated with poor knowledge should be considered. Based on our results, these are patients who are older, more medically complex, are on apixaban, and have been on NOAC therapy for a shorter duration. [ABSTRACT FROM AUTHOR]

Background: Venous thromboembolism (VTE) is the second leading cause of death in patients with malignancy. The currently available guidelines have shown greater support for utilization of low-molecular-weight heparin (LMWH) over direct oral anticoagulants (DOACs) in cancer-associated VTE. Current data on the safety and efficacy of DOAC therapy in patients with cancer are lacking. Objective: To evaluate the safety and efficacy of the use of DOACs compared to LMWH in patients with cancer. Methods: A retrospective review of outpatient records was completed to identify patients with documented cancer diagnosis and either a DOAC or LMWH as a listed medication. Patients were excluded if they had atrial fibrillation, valvular disease, antiphospholipid antibody syndrome, current pregnancy, body mass index (BMI) >40 kg/m2 or weight >120 kg, severe renal or hepatic impairment, or were on concomitant therapy with a significant interacting medication. The primary outcome was frequency of VTE recurrence, and secondary outcomes included the frequency of major and minor bleeding and other thrombotic events. Results: One hundred fifty-six patients were included in the study population, 78 in both the DOAC and LMWH groups. Venous thromboembolism recurrence occurred in 5 (6.4%) patients in the DOAC group and 8 (10.3%) patients in the LMWH group (P =.39). There was no significant difference in major or minor bleeding or other thrombotic events between the 2 groups. Conclusion: The frequency of VTE recurrence was similar between DOACs and LMWH in patients with cancer. DOACs may be an alternative agent to LMWH for the prevention of recurrent VTE in patients with cancer. [ABSTRACT FROM AUTHOR]

Objective: To summarize the literature assessing the safety and efficacy of direct oral anticoagulants (DOACs) for the acute treatment and secondary prevention of venous thromboembolism (VTE) in select patients with hypercoagulable disorders.Data Sources: An electronic PubMed literature search was conducted from January 2010 to July 2020 using the following keywords: DOAC, rivaroxaban, apixaban, dabigatran, edoxaban, thrombophilia, cancer, antiphospholipid syndrome, protein C deficiency, protein S deficiency, antithrombin deficiency, factor V Leiden, prothrombin G20210A gene mutation, congenital thrombophilia, hypercoagulable, hereditary thrombophilia, acquired thrombophilia.Study Selection and Data Extraction: Articles were included if they reported clinical outcomes associated with cancer-associated VTE, antiphospholipid syndrome (APS), and other hereditary thrombophilias.Data Synthesis: The safety and efficacy of using a DOAC is highly dependent on the type of hypercoagulable disease state. Current trials support the use of edoxaban, rivaroxaban, and apixaban for the treatment of cancer-associated thrombosis (CAT), with apixaban being preferred because of lower bleeding rates compared with standard of care. The use of DOACs, especially rivaroxaban, have been associated with worse outcomes in patients with APS, whereas data on DOAC use in hereditary thrombophilia remains scarce and limited to low-risk patients.Relevance To Patient Care and Clinical Practice: This review evaluates the literature assessing the safety and efficacy of DOACs in patients with various hypercoagulable disorders.Conclusions: The current body of evidence supports the use of select DOACs for the treatment of CAT. In contrast, DOAC use in patients with APS and hereditary thrombophilia should be avoided at this time. [ABSTRACT FROM AUTHOR]

Cancer-associated thrombosis (CAT) carries significant morbidity and mortality. Low-molecular-weight heparin (LMWH) remains the standard of care, with recent systematic studies suggesting the efficacy and safety of rivaroxaban in the treatment of CAT. Uncertainty, however, remains regarding rivaroxaban efficacy and safety in real-world settings. We performed a systematic review and meta-analysis of studies comparing rivaroxaban to LMWH. We searched PubMed, MEDLINE, and EMBASE. The primary outcome was the net clinical benefit (NCB), while rates of major bleeding (MB), venous thromboembolism (VTE), clinically relevant nonmajor bleeding (CRNMB), and all-cause mortality events were secondary outcomes. Seventeen studies were included in the final analysis. Rivaroxaban had a better NCB (relative risk [RR] = 0.82; 95% CI = 0.75-0.89, Q = 10.51, I 2 = 0%), less VTE events (RR = 0.73, 95% CI = 0.65-0.82, Q = 6.76, I 2 = 0%), and lower all-cause mortality (RR = 0.72, 95% CI = 0.57-0.91, Q = 32.8, I 2 = 79%) compared to LMWH. Additionally, comparable MB events (RR = 1.07, 95% CI = 0.85-1.33, Q = 16.9, I 2 = 11%). However, CRNMB events were higher in the rivaroxaban group (RR = 2.02, 95% CI = 1.46-2.80, Q = 9.9, I 2 = 19%). Additional analyses demonstrated consistency of results. Our review encompassing data from randomized and real-world data suggested rivaroxaban superiority compared to LMWH in terms of a better NCB, fewer VTE events, lower all-cause mortality, and comparable MB risk while carrying a higher risk of CRNMB. These findings support the use of rivaroxaban in the treatment of CAT. Additionally, it warrants a sizable randomized controlled study testing the superiority of rivaroxaban versus LMWH formulation and ascertaining bleeding outcomes according to cancer type and site. [ABSTRACT FROM AUTHOR]

A morbidly obese patient with history of deep vein thrombosis and pulmonary embolism was diagnosed with an acute left upper extremity deep vein thrombosis and started on rivaroxaban. Three months later, the patient returned with swelling in the right arm and was found to have a right brachial thrombosis. Anticoagulant therapy was switched to a low-molecular-weight heparin, and patient was discharged on enoxaparin along with an order to follow-up with a hematologist. Subanalyses from randomized controlled trials, pharmacokinetic/pharmacodynamic, and real-world studies suggest that rivaroxaban may be effective and safe in morbidly obese patients for primary and secondary prevention of venous thromboembolism. However, the Scientific and Standardization Committee of the International Society on Thrombosis and Haemostasis does not recommend the use of direct-acting oral anticoagulants in this population. If used, drug levels should be monitored to guide the therapy. Due to the disparity in data to show efficacy and safety of rivaroxaban in morbidly obese subjects, the interpatient variability of rivaroxaban's effects in subjects, and the lack of defined therapeutic range for rivaroxaban drug concentration, rivaroxaban should be used cautiously in this population. [ABSTRACT FROM AUTHOR]

Background: Although direct oral anticoagulants (DOACs) carry a lower bleeding risk compared with warfarin, gastrointestinal bleeds (GIB) are a known complication. There are limited data observing outcomes associated with resuming DOACs following a GIB.Objective: The purpose of this study was to evaluate practice patterns and clinical outcomes of patients admitted with an index GIB while receiving DOAC therapy.Methods: This retrospective, single-system study included adult patients receiving DOAC therapy prior to admission and hospitalized with an index GIB between January 1, 2013, and October 31, 2018. Patient exclusion criteria were a history of immune thrombocytopenia purpura or inflammatory bowel disease; discharge to hospice; leaving against medical advice; or death during hospitalization. The primary objective was 90-day readmission for a recurrent GIB.Results: There were 57 patients included for analysis; 37 patients had DOAC therapy held >7 days, 18 patients resumed DOAC therapy within 7 days, and 2 patients switched to warfarin. The majority of patients received rivaroxaban (59.6%) prior to admission for atrial fibrillation (71.9%), were admitted with a major GIB (66.7%), and required a blood transfusion (61.4%). The rates of recurrent GIB were 2.5% (n = 1) and 5.6% (n = 1) for those who had their DOAC held and resumed, respectively (P = 0.83). Mortality within 12 months of discharge occurred in 4 patients (10.8%) who had their DOAC held and 4 patients (22.2%) who resumed DOAC therapy (P = 0.28).Conclusion and Relevance: Resuming anticoagulation within 7 days of admission for an index GIB was not associated with a recurrent GIB within 90 days of discharge. [ABSTRACT FROM AUTHOR]

Oncology patients are at a high risk of experiencing venous thromboembolism. Historically, venous thromboembolisms in cancer patients have been managed with low-molecular-weight heparin on the basis of the CLOT trial published in 2003. However, recent prospective data provide evidence for safe and effective direct oral anticoagulant use in this population. The purpose of this review article is to evaluate the current body of literature surrounding direct oral anticoagulant use in the oncology population and to highlight key practical considerations when prescribing these agents for patients with cancer. [ABSTRACT FROM AUTHOR]

Background: Limited clinical data exist describing the use of direct-acting oral anticoagulants (DOACs) in patients with body mass index (BMI) >40 kg/m2 or body weight >120 kg. Thus, DOAC therapy in this population remains controversial. Objectives: To investigate rivaroxaban as a safe and effective alternative to warfarin for venous thromboembolism (VTE) treatment and prevention of stroke in patients with atrial fibrillation identified as extremely obese or of high body weight. Methods: A retrospective chart review was performed at 2 academic medical centers in patients ≥18 years old and BMI >40 kg/m2 or weight >120 kg, newly initiated on warfarin or rivaroxaban for atrial fibrillation or VTE treatment. The primary end point was incidence of clinical failure, defined as VTE recurrence, stroke incidence, and mortality, within 12 months of initiation. Secondary end points included length of stay (LOS) and bleeding complications. Results: A total of 176 patients were included, with 84 and 92 patients in the rivaroxaban and warfarin arms, respectively. Clinical failure was lower in the rivaroxaban group but did not reach statistical significance when compared with warfarin (5% vs 13%; P = 0.06). LOS was significantly shorter in the rivaroxaban arm (2 days [1-3] vs 4 days [2-7], P < 0.0001). Percentage of bleeding complications was higher in the rivaroxaban arm but not statistically significant (8% vs 2%, P = 0.06). Conclusion and Relevance: Although not statistically significant, rivaroxaban trended toward a lower incidence of clinical failure while demonstrating a significantly shorter LOS when compared with warfarin for VTE treatment or atrial fibrillation in morbidly obese or high-body-weight patients. [ABSTRACT FROM AUTHOR]

Background: Anticoagulation therapy is recommended for stroke prevention in high-risk patients with atrial fibrillation (AF). This study aimed to estimate the time to switch from warfarin to a direct oral anticoagulant (DOAC) and identify the factors associated with it.Methods: By using claims data, we studied 7111 warfarin-using patients with nonvalvular AF who were aged ≥65 years. The Kaplan-Meier analysis was performed to estimate the time to switch from warfarin to a DOAC, and Cox proportional hazard regression analysis was used to estimate the influencing factors.Results: Approximately one-third of the patients (2403, 33.8%) switched from warfarin to a DOAC during the study period. Female sex, aged between 75 and 79 years, having a Medical Aid or Patriots and Veterans Insurance, hypertension, and history of prior stroke, and transient ischemic attack or thromboembolism (prior stroke/TIA/TE) were associated with a significantly shorter time to switch. The odds of switching to a DOAC were increased by approximately 1.2-fold in the women and 1.4-fold in the patients with prior stroke/TIA/TE.Conclusions: Approximately one-third of the warfarin-using patients switched from warfarin to a DOAC within 6 months after the change in the DOAC reimbursement criteria. In the Cox proportional hazard regression analysis, the factors that affected anticoagulant switching from warfarin to a DOAC were female sex and history of prior stroke/TIA/TE. [ABSTRACT FROM AUTHOR]

Antiphospholipid syndrome an autoimmune disease characterized by thrombosis and/or pregnancy morbidity alongside the presence of antiphospholipid antibodies (aPL). This review evaluates primary and secondary thromboprophylaxis in patients with aPL and thrombotic events. In primary thromboprophylaxis a risk-stratified approach is needed based on aPL, comorbidity with other autoimmune conditions and cardiovascular vascular risk factors. In primary thromboprophylaxis, the efficacy of low-dose aspirin is debatable and requires better-designed controlled studies. So far warfarin has not been shown to improve venous and/or arterial thrombosis incidence in aPL carriers and instead increased safety concerns. The benefit of hydroxychloroquine is inconclusive despite promising data, requiring large, controlled trials. For secondary thromboprophylaxis warfarin seems to be the best option with potential in renal transplant recipients and better efficacy at high intensity, although maintenance of target international normalized ratio needs careful monitoring. Aspirin has not shown to be beneficial, and data on rivaroxaban are limited and contradictory. Despite all data being informative, there are limitations that need to be addressed with robust clinical trials. [ABSTRACT FROM AUTHOR]

Background: Direct oral anticoagulants (DOACs) have been found to be similar or superior to warfarin in reducing ischemic stroke and intracranial hemorrhage (ICH) in patients with atrial fibrillation (AF). We sought to examine the anticoagulation prescription patterns in community since the advent of DOACs and also evaluate the outcomes in terms of gastrointestinal (GI) bleeding, ischemic stroke, and ICH in real-world patients with AF receiving anticoagulation.Methods: This is a retrospective study comprising patients who were newly diagnosed with nonvalvular AF and were prescribed anticoagulants for stroke prevention. Prescription pattern of the anticoagulants based on CHA2DS2Vasc score was studied. Clinical outcomes of GI bleeding, ischemic stroke, and ICH were analyzed using a multivariate logistic regression model.Results: Of the 2362 patients with AF on anticoagulation, 44.7% were prescribed DOACs. Patients with CHA2DS2VASc score of ≥3 received a prescription for warfarin more often than DOACs (P < .001). Multivariate logistic regression analysis revealed that the incidence of GI bleed (odds ratio [OR]: 0.91, 95% confidence interval [CI]: 0.62-1.35, P = .66) and stroke (OR: 0.77, 95% CI: 0.57-1.05, P = .10) was similar between warfarin and DOAC users. However, there was a trend toward lower ICH in the DOAC group (OR: 0.60, 95% CI: 0.36-1.01, P = .06).Conclusions: Prescription rate of DOACs for nonvalvular AF has increased significantly, with apixaban being the most commonly used agent. Patients with higher CHA2DS2-VASc score (≥3) are prescribed DOACs less often than warfarin. The reason for this discrepancy is unclear. Given the favorable risk-benefit profile of DOACs, further studies are needed to identify factors that determine anticoagulant selection in patients with AF with high thromboembolic risk. [ABSTRACT FROM AUTHOR]

Andexanet alfa is approved for the reversal of factor Xa inhibitors in patients with major bleeding events. We aimed to review the incidence of effective hemostasis with andexanet alfa in a real-world environment. This retrospective cohort included patients hospitalized for a major bleed that resulted in andexanet alfa administration. The primary outcome was effective hemostasis at 12 hours after andexanet alfa treatment. Thromboembolic events and mortality within 30 days were also assessed. Over a 14-month period, 13 patients received andexanet alfa with a mean age of 69 ±10 years, 54% male, 69% exposed to apixaban (31% rivaroxaban), and had intracranial (46%) and nonintracranial (54%) bleeding sites. Effective hemostasis was observed in 10 (77%) patients. Four (31%) patients experienced 5 thromboembolic events with a median time to event of 6.5 days (range: 0.5-29). Four thrombotic events occurred during the period in which anticoagulation (prophylaxis or therapeutic) was not restarted. Mortality rate was 15%. Andexanet alfa was effective in obtaining hemostasis in a majority of patients. However, the incidence of thromboembolic events was high and may be attributed to a delay in restarting anticoagulation. [ABSTRACT FROM AUTHOR]

Venous thromboembolism (VTE) is associated with high recurrence, mortality, and cost burden. Direct oral anticoagulants (DOACs) are currently used for VTE treatment, and they offer more benefits over warfarin, despite being more expensive. There is no consensus on the most cost-effective DOAC agent, especially in VTE. This systematic review aims to summarize the comparative cost-effectiveness studies and their impact among DOACs in the treatment of VTE. Literature systematic review of PubMed, Embase, and EconLit was conducted in February 2018 to identify all cost-effectiveness studies of DOAC for the treatment and prevention of VTE. Two independent investigators systematically collected search results and assessed the quality of the studies. The search identified 7 articles, all of which had dabigatran and rivaroxaban as comparators, 6 of which also included apixaban, and 2 of which also had edoxaban. Results of 3 articles concluded that apixaban is a dominant strategy compared to other DOACs in terms of Incremental Cost-Effectiveness Ratio (ICER) in the treatment and prevention of recurrent VTE. One article compared rivaroxaban and dabigatran, with the latter dominating rivaroxaban in terms of ICER. Compared to other DOACs, 2 articles reported apixaban being associated with highest annual total medical cost avoidance of US$4244 and US$4440 per patient-year (ppy), respectively. One article reported that apixaban had the highest annual total medical cost differences of US$918 ppy compared to other DOACs. This systematic review demonstrates that apixaban is considered a cost-effective strategy for VTE treatment and prevention of recurrent VTE. [ABSTRACT FROM AUTHOR]

Direct oral anticoagulants (DOACs) are indicated by the European Medicines Agency and US Food and Drug Administration for stroke prevention in patients with nonvalvular atrial fibrillation (AF). The role of DOACs in patients with AF and concomitant valvular heart disease (VHD) is less clear. Recent subanalyses of randomized controlled trials and meta-analyses have evaluated the role of DOACs in patients with AF and VHD. Patients with native aortic valve disease, tricuspid valve disease, or mitral regurgitation will be the primary focus as these represent the majority of VHD represented in the DOAC AF trials. Limited data exist on the role in patients with rheumatic mitral stenosis, mechanical heart valves, and mitral valve repair. This review provides the current clinical and scientific data pertaining to the safety and efficacy of DOAC use in patients with VHD. [ABSTRACT FROM AUTHOR]

Background: Direct oral anticoagulants (DOACs) have become popular alternatives to vitamin K antagonists for the treatment and prevention of thromboembolic diseases; however, there are limited data regarding the appropriate use of DOACs in clinical practice. To ensure safety and efficacy of these medications, it is important that decisions regarding their use in patients rely on the available evidence. Objective: The purpose of this study was to evaluate the appropriateness of DOAC prescribing in adult patients before and after the implementation of a pharmacist-driven DOAC protocol. Methods: Data were collected on adult patients admitted to a community teaching hospital who received DOAC therapy for at least 2 days between January and March 2015 (pre-intervention group) and between January and March 2016 (post-intervention group). These data were analyzed to measure inappropriately prescribed DOACs, defined based on DOAC indication, renal function, drug interactions, and other pertinent patient-specific factors. Prior to the start of data collection for the post-intervention group, a pharmacist-driven protocol was developed and implemented. DOAC education was provided to pharmacists, including an evidence-based prescribing table to guide appropriate DOAC therapy. Comparisons were made between the pre-intervention and post-intervention groups to determine the impact of the pharmacist-driven service on appropriate DOAC prescribing. Results: Fifty patients were analyzed in the pre-intervention group compared with 85 patients in the post-intervention group, with a total of 333 and 816 doses administered, respectively. Of the total doses administered, 32.4% were considered inappropriate in the pre-intervention group compared with 13.8% in the post-intervention group (adjusted odds ratio [OR], 0.42, 95% CI, 0.19-0.96; p = 0.039). Conclusions: Implementing a pharmacist-driven DOAC service significantly improved appropriate prescribing of these agents. Provider education regarding DOAC use is essential to further increase appropriate prescribing of DOACs, optimize patients' therapy, and prevent adverse drug events. [ABSTRACT FROM AUTHOR]

Portal vein thrombosis is an unusual thrombotic condition not frequently seen in the general population; however, it has a higher prevalence in special circumstances such as in liver cirrhosis and hepatic or pancreatic malignancy. It also can be associated with significant morbidity and mortality. In this review, we discuss the current data available to guide therapy in the setting of different associated co-morbidities, hypercoagulable states, and associated thrombosis of the remaining splanchnic circulation. We discuss indications for anticoagulation, including the choice of anticoagulants, as well as the role of conservative ‘wait and watch’ and invasive therapies, such as thrombolysis, thrombectomy, and transjugular intrahepatic portosystemic shunt. [ABSTRACT FROM AUTHOR]