Rivaroxaban for the treatment of noncirrhotic splanchnic vein thrombosis: an interventional prospective cohort study.
Walter AgenoJan Beyer WestendorfLaura ContinoEugenio BucheriniMaria Teresa SartoriMarco SenzoloElvira GrandoneRita Carlotta SantoroMarc CarrierAurélien DellucValerio De StefanoFulvio PomeroMarco Paolo DonadiniAlberto TosettoCecilia BecattiniIda MartinelliBarbara NardoLaurent BertolettiMarcello Di NisioAlejandro Lazo-LangnerAlessandro SchenoneNicoletta RivaPublished in: Blood advances (2022)
Heparins and vitamin K antagonists are the mainstay of treatment of splanchnic vein thrombosis (SVT). Rivaroxaban is a potential alternative, but data to support its use are limited. We aimed to evaluate the safety and efficacy of rivaroxaban for the treatment of acute SVT. In an international, single-arm clinical trial, adult patients with a first episode of noncirrhotic, symptomatic, objectively diagnosed SVT received rivaroxaban 15 mg twice daily for 3 weeks, followed by 20 mg daily for an intended duration of 3 months. Patients with Budd-Chiari syndrome and those receiving full-dose anticoagulation for >7 days prior to enrollment were excluded. Primary outcome was major bleeding; secondary outcomes included death, recurrent SVT, and complete vein recanalization within 3 months. Patients were followed for a total of 6 months. A total of 103 patients were enrolled; 100 were eligible for the analysis. Mean age was 54.4 years; 64% were men. SVT risk factors included abdominal inflammation/infection (28%), solid cancer (9%), myeloproliferative neoplasms (9%), and hormonal therapy (9%); 43% of cases were unprovoked. JAK2 V617F mutation was detected in 26% of 50 tested patients. At 3 months, 2 patients (2.1%; 95% confidence interval, 0.6-7.2) had major bleeding events (both gastrointestinal). One (1.0%) patient died due to a non-SVT-related cause, 2 had recurrent SVT (2.1%). Complete recanalization was documented in 47.3% of patients. One additional major bleeding event and 1 recurrent SVT occurred at 6 months. Rivaroxaban appears as a potential alternative to standard anticoagulation for the treatment of SVT in non-cirrhotic patients. This trial was registered at www.clinicaltrials.gov as #NCT02627053 and at eudract.ema.europa.eu as #2014-005162-29-36.
Keyphrases
- end stage renal disease
- atrial fibrillation
- ejection fraction
- clinical trial
- newly diagnosed
- venous thromboembolism
- chronic kidney disease
- pulmonary embolism
- prognostic factors
- healthcare
- squamous cell carcinoma
- peritoneal dialysis
- stem cells
- artificial intelligence
- intensive care unit
- young adults
- insulin resistance
- adipose tissue
- machine learning
- open label
- patient reported
- mesenchymal stem cells
- big data
- oxidative stress
- mechanical ventilation
- gestational age
- electronic health record
- acute respiratory distress syndrome
- preterm birth
- endovascular treatment
- extracorporeal membrane oxygenation
- respiratory failure
- squamous cell