No abstract available.
Hematoma, Subdural, Spinal ; Humans ; Rivaroxaban

BACKGROUND AND PURPOSE: Standard operating procedures (SOP) incorporating plasma levels of rivaroxaban might be helpful in selecting patients with acute ischemic stroke taking rivaroxaban suitable for IVthrombolysis (IVT) or endovascular treatment (EVT). METHODS: This was a single-center explorative analysis using data from the Novel-Oral-Anticoagulants-in-Stroke-Patients-registry (clinicaltrials.gov:NCT02353585) including acute stroke patients taking rivaroxaban (September 2012 to November 2016). The SOP included recommendation, consideration, and avoidance of IVT if rivaroxaban plasma levels were < 20 ng/mL, 20‒100 ng/mL, and >100 ng/mL, respectively, measured with a calibrated anti-factor Xa assay. Patients with intracranial artery occlusion were recommended IVT+EVT or EVT alone if plasma levels were ≤100 ng/mL or >100 ng/mL, respectively. We evaluated the frequency of IVT/EVT, door-to-needle-time (DNT), and symptomatic intracranial or major extracranial hemorrhage. RESULTS: Among 114 acute stroke patients taking rivaroxaban, 68 were otherwise eligible for IVT/EVT of whom 63 had plasma levels measured (median age 81 years, median baseline National Institutes of Health Stroke Scale 6). Median rivaroxaban plasma level was 96 ng/mL (inter quartile range [IQR] 18‒259 ng/mL) and time since last intake 11 hours (IQR 4.5‒18.5 hours). Twenty-two patients (35%) received IVT/EVT (IVT n=15, IVT+EVT n=3, EVT n=4) based on SOP. Median DNT was 37 (IQR 30‒60) minutes. None of the 31 patients with plasma levels >100 ng/mL received IVT. Among 14 patients with plasma levels ≤100 ng/mL, the main reason to withhold IVT was minor stroke (n=10). No symptomatic intracranial or major extracranial bleeding occurred after treatment. CONCLUSIONS: Determination of rivaroxaban plasma levels enabled IVT or EVT in one-third of patients taking rivaroxaban who would otherwise be ineligible for acute treatment. The absence of major bleeding in our pilot series justifies future studies of this approach.
Arteries ; Hemorrhage ; Humans ; National Institutes of Health (U.S.) ; Plasma* ; Rivaroxaban* ; Stroke*

No abstract available.
Humans ; Intracranial Hemorrhages* ; Plasminogen Activators* ; Plasminogen* ; Rivaroxaban* ; Thrombolytic Therapy

The main treatment for Antiphospholipid syndrome (APS) is long-term anticoagulation with an oral vitamin K antagonist, although these are associated with numerous problems. Rivaroxaban is a direct anti-factor Xa inhibitor, with a predictable anticoagulant effect at fixed doses. There are limited reports of rivaroxaban use in APS. We present four cases of patients with APS who received rivaroxaban treatment for six months without thrombosis recurrence or bleeding. Three of the patients received rivaroxaban as initial therapy. In the systematic review, only five patients were treated with rivaroxaban as a thromboprophylaxis. Of the 71 cases of rivaroxaban use including our study, there were seven cases (9.9%) of thrombosis recurrence and two reports of bleeding. The efficacy of rivaroxaban in APS patients was at least equal to warfarin therapy. This report and systematic review suggest that rivaroxaban can be considered cautiously as a thromboprophylactic or alternative therapy for warfarin in patients with APS.
Antiphospholipid Syndrome* ; Hemorrhage ; Humans ; Recurrence ; Rivaroxaban* ; Thrombosis ; Vitamin K ; Warfarin

PURPOSE: To compare the hematologic changes and the rates of transfusion of patients using rivaroxaban or aspirin for venous thromboembolism prophylaxis after a total knee arthroplasty. MATERIALS AND METHODS: Among patients with total knee arthroplasty from July 2010 to March 2011, two groups of 100 consecutive cases were enrolled in this study, 50 patients with Rivaroxaban group and 50 patients with Aspirin group for venous thromboembolism prophylaxis after a total knee arthoplasty. Hematologic changes and transfusion rates were calculated in each group. RESULTS: The mean of decreased hemoglobin was 4.7 (3.1-6.6) in the Rivaroxaban group and 3.6 (2.0-5.1) in the Aspirin group (p<0.05). The number of patients with decreased hemoglobin of less than 8 g/dl was observed in 23 cases (46%) in the Rivaroxaban group, and 9 cases (18%) in the Aspirin group. The numbers of patients who needed transfusion were 12 in the Rivaroxaban group, and 2 in the Aspirin group (p<0.05). CONCLUSION: Rivaroxaban group revealed more significant decrease of hemoglobin and needed more transfusion than the Aspirin group did. For the prevention of venous thromboembolism after total knee arthroplasty, we should be careful using Rivaroxaban for the standard risk patients of venous thromboembolism.
Arthroplasty ; Aspirin ; Hemoglobins ; Humans ; Knee ; Morpholines ; Thiophenes ; Venous Thromboembolism ; Rivaroxaban

Only anticoagulation has been shown to reduce atrial fibrillation-related deaths. Vitamin K antagonists are difficult to use due to their narrow therapeutic range, unpredictable response, requirement for frequent coagulation monitoring, frequent dose adjustment, slow onset-offset, and numerous drug-drug and drug-food interactions. New oral anticoagulants (NOACs), such as dabigatran, rivaroxaban, and apixaban have been developed and are available in Korea, and edoxaban was shown to be effective and safe, also. NOACs showed better pharmacodynamics with predictable serum concentrations and effects, and no requirement for coagulation monitoring. These drugs have been shown to be more effective and safer than warfarin for prevention of stroke and systemic thromboembolism in patients with nonvalvular atrial fibrillation. Broad, appropriate, and aggressive use of NOACs would improve the results of treatment in patients with nonvalvular atrial fibrillation in Korea.
Anticoagulants* ; Atrial Fibrillation* ; Food-Drug Interactions ; Humans ; Korea ; Stroke* ; Thromboembolism ; Vitamin K ; Warfarin ; Dabigatran ; Rivaroxaban

Cardioversion increases the risk for stroke or systemic embolic events, and patients scheduled for cardioversions need several weeks of anticoagulant treatment to prevent these adverse events. Anticoagulant therapy should be considered as a balancing act between the risk of stroke and the risk of life-threatening bleeding. The efficacy of non-vitamin K antagonist oral anticoagulants (NOACs) was found to be equal to, or even superior, to warfarin for the prevention of stroke, systemic embolism, and other outcomes in patients with atrial fibrillation, when all risk factors were considered. There have been few studies independently looking at the efficacy and safety profile of NOACs in cardioversion. The efficacy of both rivaroxaban and dabigatran in preventing stroke or major systemic embolic events post-cardioversion was found to be similar to that of warfarin. The efficacy of apixaban could not be compared based on the available data because of the limited number of procedures performed. However, all three NOACs were found to be safe for use in cardioversion when compared to warfarin.
Anticoagulants ; Atrial Fibrillation ; Dabigatran ; Electric Countershock* ; Embolism ; Hemorrhage ; Humans ; Risk Factors ; Rivaroxaban ; Stroke ; Warfarin

OBJECTIVETo compare the efficacy and safety of 3 rivaroxaban regimen in patients with venous thromboembolism (VTE).

METHODSThis is a retrospective study. Thirty three inpatients with VTE received rivaroxaban were divided into 3 groups, in which 16 patients were treated with 15 mg rivaroxaban twice daily for 21 days then followed by 20 mg once per day till 3 months (group 1), 9 patients were treated with 20 mg rivaroxaban once daily for 3 months (group 2), 8 patients were treated with 10 mg rivaroxaban once daily for 3 months. The reduction rate of D-Dimer on the third therapy day, the duration of D-Dimer normalization and hospital stay as well as symptom remission, the imaging assessment results after three months treatment, rate of recurrent VTE, bleeding, liver and kidney function were compared among the 3 groups.

RESULTSThe reduction rates of D-Dimer on the third therapy day were significantly higher ((46.12 ± 15.42) % vs. (26.59 ± 8.11) % and (25.55 ± 14.00) %, P = 0.02, P = 0.01), and the duration of D-Dimer normalization was significantly shorter ((17.9 ± 7.7) days vs. (24.1 ± 5.1) days and (26.3 ± 6.2) d, P = 0.03, P < 0.01) in group 1 than in group 2 and 3. There was one recurrent deep-vein thrombosis in group 3, one non-major bleeding in group 1 and group 3. Major bleeding or liver and kidney dysfunction were not observed in these patients.

CONCLUSIONSVenous thromboembolism can be safely and effectively treated by rivaroxaban, and does of 15 mg twice daily for 21 days followed by 20 mg once daily for 3 months are superior to the other 2 tested therapy regimen in this patient cohort.

OBJECTIVE: Patients with nonvalvular atrial fibrillation (AF) and renal disease (RD) who receive anticoagulation therapy appear to be at greater risk of major bleeding (MB) than AF patients without RD. As observed in past studies, anticoagulants are frequently withheld from AF patients with RD due to concerns regarding bleeding. The objective of this study was to evaluate the incidence and pattern of MB in those with RD, as compared to those without RD, in a population of rivaroxaban users with nonvalvular AF. METHODS: Electronic medical records of over 10 million patients from the Department of Defense Military Health System were queried to identify rivaroxaban users with nonvalvular AF. A validated algorithm was used to identify MB-related hospitalizations. RD was defined through diagnostic codes present within 6 months prior to the bleeding date for MB cases and end of study participation for non-MB patients. Data were collected on patient characteristics, comorbidities, MB management, and outcomes. RESULTS: Overall, 44,793 rivaroxaban users with nonvalvular AF were identified. RD was present among 6,921 patients (15.5%). Patients with RD had a higher rate of MB than those without RD, 4.52 per 100 person-years versus 2.54 per 100 person-years, respectively. The fatal bleeding outcome rate (0.09 per 100 person-years) was identical between those with and without RD. CONCLUSION: In this post-marketing study of 44,793 rivaroxaban users with nonvalvular AF, RD patients experienced a higher MB rate than those without RD. The higher rate of MB among those with RD may be due to the confounding effects of comorbidities.
Anticoagulants ; Atrial Fibrillation* ; Comorbidity ; Electronic Health Records ; Hemorrhage* ; Hospitalization ; Humans ; Incidence* ; Military Personnel ; Rivaroxaban*

Rivaroxaban has emerged as a potential alternative to warfarin for the prevention of thromboembolism in patients with atrial fibrillation (AF). However, there has been concern for the risk of major bleeding, especially in Asian patients. We investigated the efficacy and safety of rivaroxaban compared to warfarin in Korean real world practice. A total of 2,208 consecutive non-valvular AF patients were divided into the Warfarin group (n=990) and the Rivaroxaban group (n=1218). Propensity matched 1-year clinical outcomes were compared (Warfarin, n=804; Rivaroxaban, n=804). The efficacy outcome was defined as stroke/systemic embolism (SE). The safety outcome was major bleeding. The primary net clinical benefit (NCB) was defined as the composite of stroke/SE, major bleeding, and all-cause mortality. Secondary, NCB was defined as the composite of stroke, SE, and major bleeding. Rivaroxaban had the similar efficacy in terms of thromboembolic event prevention [hazard ratio (HR) 0.69, 95% confidence interval (CI) 0.37–1.32, p=0.266] compared to warfarin. Rivaroxaban significantly lowered the risk of major bleeding [HR 0.41, 95% CI 0.22–0.76, p=0.004]. Primary NCB was significantly low in the rivaroxaban group [HR 0.54, 95% CI 0.36–0.81, p=0.003]. Secondary NCB was also low in the rivaroxaban group [HR 0.62, 95% CI 0.40–0.99, p=0.041]. Both rivaroxaban 15 mg and 20 mg groups had similar efficacy and significantly lower risks of major bleeding as well as primary and secondary NCB compared to the warfarin group. In patients with non-valvular AF, rivaroxaban had a similar efficacy to warfarin in Korean real world practice. However, rivaroxaban had better safety and net clinical outcomes compared to warfarin.
Asian Continental Ancestry Group ; Atrial Fibrillation* ; Cohort Studies* ; Embolism ; Hemorrhage ; Humans ; Mortality ; Rivaroxaban* ; Stroke ; Thromboembolism ; Warfarin*