rivaroxaban and Hematoma--Subdural--Intracranial

Subdural hematomas (SDHs) are an uncommon, but important, complication of anticoagulation therapy. We hypothesized that the risks of SDH would be similar during treatment with oral factor Xa inhibitors compared with aspirin.. We assessed the frequency and the effects of antithrombotic treatments on SDHs in the recent international Cardiovascular Outcomes for People Using Anticoagulation Strategies (COMPASS) randomized trial comparing aspirin 100 mg daily, rivaroxaban 5 mg twice daily, and rivaroxaban 2.5 mg twice daily plus aspirin. A systematic review/meta-analysis of randomized trials comparing oral factor Xa inhibitors vs aspirin on SDH risk was undertaken.. Among 27,395 COMPASS participants, 28 patients with SDHs were identified (mean age 72 years). SDH-associated mortality was 7%. Incidence was 0.06 per 100 patient-years (11 SDH/17,492 years observation) during the mean 23-month follow-up among aspirin-assigned patients and did not differ significantly between treatments. Three additional randomized controlled trials including 16,177 participants reported a total of 14 SDHs with an incidence ranging from 0.06 to 0.1 per 100 patient-years. Factor Xa inhibitor use was not associated with an increased risk of SDH compared to aspirin (odds ratio, 0.97; 95% confidence interval, 0.52-1.81; I. The frequency of SDH was similar in all 3 treatment arms of the COMPASS trial. The COMPASS trial results markedly increase the available evidence from randomized comparisons of oral factor Xa inhibitors with aspirin regarding SDH. From available, albeit limited, evidence from 4 randomized trials, therapeutic dosages of factor Xa inhibitors do not appear to increase the risk of SDH compared with aspirin.. NCT01776424.

Topics: Aged; Aspirin; Atherosclerosis; Factor Xa Inhibitors; Female; Hematoma, Subdural, Intracranial; Humans; Incidence; Male; Middle Aged; Platelet Aggregation Inhibitors; Randomized Controlled Trials as Topic; Rivaroxaban

Andexanet alfa, a novel anticoagulation reversal agent for factor Xa inhibitors, was recently approved. Traumatic intracranial hemorrhage presents a prime target for this drug. The Novel Antidote to the Anticoagulation Effects of Factor Xa Inhibitors study established the efficacy of andexanet alfa in reversing factor Xa inhibitors. However, the association between anticoagulation reversal and traumatic intracranial hemorrhage progression is not well understood. The objective of this study was to determine progression rates of patients with traumatic intracranial hemorrhage on factor Xa inhibitors prior to hospitalization who were managed without the use of andexanet alfa.. A retrospective cohort study was performed between 2016 and 2019 at a single institution. An institutional traumatic brain injury (TBI) registry was queried. Patients with recorded use of apixaban or rivaroxaban <18 hours before injury were included. The primary study outcome was <35% increase in hemorrhage volume or thickness on repeated head computed tomography (CT) scans.. We identified 25 patients meeting the inclusion criteria. Two patients were excluded because of a lack of necessary CT data. Twelve patients (52%) were receiving apixaban, and 11 were (48%) on rivaroxaban. On admission CT scan, 14 patients had subdural hematoma, 6 had traumatic intraparenchymal hemorrhage, and 3 had subarachnoid hemorrhage. Anticoagulation reversal was attempted in 17 patients (74%), primarily using 4-factor prothrombin complex concentrate. Twenty patients (87%) were adjudicated as having excellent or good hemostasis on repeat imaging.. Our results indicate that patients on factor Xa inhibitors with complicated mild TBI have a similar intracranial hemorrhage progression rate to patients who are not anticoagulated or anticoagulated with a reversible agent. The hemostatic outcomes in our cohort were similar to those reported after andexanet alfa administration.

Topics: Aged; Aged, 80 and over; Atrial Fibrillation; Blood Coagulation Factors; Cerebral Hemorrhage, Traumatic; Cohort Studies; Disease Progression; Factor Xa; Factor Xa Inhibitors; Female; Glasgow Coma Scale; Hematoma, Subdural, Intracranial; Hemostasis; Humans; Intracranial Hemorrhage, Traumatic; Male; Middle Aged; Plasma; Platelet Transfusion; Pyrazoles; Pyridones; Recombinant Proteins; Retrospective Studies; Risk; Risk Factors; Rivaroxaban; Subarachnoid Hemorrhage, Traumatic; Tomography, X-Ray Computed; Venous Thromboembolism

Topics: Aged; Aged, 80 and over; Anticoagulants; Aspirin; Blood Coagulation Factors; Cerebral Hemorrhage, Traumatic; Cerebral Intraventricular Hemorrhage; Clopidogrel; Deamino Arginine Vasopressin; Female; Fractures, Bone; Hematoma; Hematoma, Subdural, Intracranial; Hemostatics; Humans; International Normalized Ratio; Intracranial Hemorrhage, Traumatic; Male; Middle Aged; Pelvic Bones; Platelet Aggregation Inhibitors; Pyrazoles; Pyridones; Retrospective Studies; Rivaroxaban; Subarachnoid Hemorrhage, Traumatic; Thrombosis; Warfarin

To date, the only treatment approved for acute ischemic strokes is thrombolysis. Whether intravenous thrombolysis may be safe in patients taking direct oral anticoagulants (DOACs) is currently a matter of debate.. A 74-year-old woman, who was on rivaroxaban 20 mg/d for nonvalvular atrial fibrillation, was admitted to our stroke unit with left-sided hemiparesis and aphasia. The onset of neurologic deficits had occurred 5 hours after the last rivaroxaban dose.. An acute ischemic stroke was diagnosed.. The patient was administered thrombolytic treatment with intravenous recombinant tissue plasminogen activator (r-TPA) 3 hours and 20 minutes after symptoms onset. Seven hours post-r-TPA treatment, the neurological deficit had worsened, and a type I intraparenchymal hematoma was detected on a computed tomography brain scan.. The clinical/neuroradiological picture improved significantly in the following days. The patient was discharged to a rehabilitation facility after 3 weeks.. In this case, factor ten activated (Xa) inhibitor, rivaroxaban might have increased the risk of hemorrhagic transformation of the ischemic stroke. However, this risk was overweighed by the benefit of thrombolysis, as the patient's clinical condition had improved significantly in the following weeks. The current guidelines discourage the use of thrombolytic treatment in patients with DOACs administered within the last 24(48) hours. However, the case reported herein and other world experiences, even though limited, suggest that an ongoing DOAC medication could no longer be considered a barrier to r-TPA treatment which may be a reasonable and valuable option, at least in selected acute stroke patients taking factor Xa inhibitors.

Topics: Aged; Factor Xa Inhibitors; Female; Hematoma, Subdural, Intracranial; Humans; Recombinant Proteins; Rivaroxaban; Stroke; Thrombolytic Therapy; Tissue Plasminogen Activator

A 79-year-old lean man with a height of 157cm and weight of 42kg (body mass index, 17.2kg/m(2)) receiving rivaroxaban developed an intracranial subdural hematoma and was treated conservatively. Because he had a reduced creatinine clearance of 44mL/min, his dosage of rivaroxaban was reduced from 15 to 10mg daily according to official Japanese prescribing information. However, he developed bilateral intracranial subdural hematomas 2weeks later. Plasma rivaroxaban concentration on anti-factor Xa chromogenic assay was elevated at 301ng/mL, suggesting excessive accumulation. He underwent burr hole drainage and resumed anticoagulation with warfarin. Subsequently, he developed a lumbosacral hematoma. He was treated conservatively and discharged without neurological sequelae. The main cause of the increased concentration of rivaroxaban was believed to be his older age and low body weight. The etiology of the spinal hematoma was suspected to be the migration of intracranial hematoma to the spinal subdural space.

Topics: Aged; Anticoagulants; Atrial Fibrillation; Drainage; Factor Xa Inhibitors; Hematoma, Subdural, Intracranial; Hematoma, Subdural, Spinal; Humans; Male; Rivaroxaban; Warfarin

Topics: Aged; Anticoagulants; Brain; Cerebral Hemorrhage; Fatal Outcome; Female; Hematoma, Subdural, Intracranial; Humans; Morpholines; Neuroimaging; Rivaroxaban; Stroke; Thiophenes; Tomography, X-Ray Computed