Thrombosis and bleedings in a cohort of cancer patients treated with apixaban for venous thromboembolism. Issue 196 (December 2020)

• Record Type: Journal Article
• Authors: Hannevik, Trine-Lise; Brekke, Jorunn; Enden, Tone; Frøen, Hege; Garresori, Herish; Jacobsen, Eva Marie; Paulsen, Petter Quist; Porojnicu, Alina Carmen; Ree, Anne Hansen; Torfoss, Dag; Velle, Elin Osvik; Wik, Hilde Skuterud; Ghanima, Waleed; Sandset, Per Morten; Dahm, Anders Erik Astrup
• Is Part Of: Thrombosis research. Issue 196(2020)
• Page Start: 238
• Page End: 244
• Publication Date: 2020-12
• Subjects: VTE venous thromboembolism -- LMWH low molecular heparins -- VKA vitamin K antagonists -- DOAC direct-acting oral anticoagulants -- ECOG Eastern Cooperative Oncology Group -- BMI body mass index -- CT computer tomography; Neoplasms -- Clinical trial -- Anticoagulants -- Venous thrombosis -- Brain ischemia -- Hemorrhage; Thrombosis -- Periodicals; 616.135
• DOI: 10.1016/j.thromres.2020.08.042
• Languages: English
• ISSNs: 0049-3848

Abstract

Abstract: Introduction: The direct oral anti-coagulants (DOAC) edoxaban and rivaroxaban are suggested treatment alternatives for cancer-associated venous thromboembolism (VTE) together with low molecular-weight heparins. New studies indicate that the DOAC apixaban also is an option for cancer-associated VTE. The current study assessed recurrent VTE, arterial thrombosis, bleedings and adverse events in a cohort of apixaban treated cancer patients with VTE. Materials and methods: Single-arm, interventional study of apixaban as treatment of cancer-associated VTE. Inclusion criteria were cancer with objectively verified VTE. Patients received apixaban 10 mg bid for seven days, then 5 mg bid for six months. Primary efficacy and safety outcomes were recurrent VTE and bleeding respectively. This trial is registered with ClinicalTrials.gov identifier NCT02581176 . Results: We recruited 298 cancer patients with VTE. During six months treatment, recurrent VTE or death related to VTE occurred in 12 patients (4.0%, 95% confidence interval (CI) 2.1–6.9%). Major bleeding occurred in 16 patients (5.4%, 95% CI 2.8–7.9), most frequently gastrointestinal bleeding. There were no overrepresentation of major bleedings among patients with gastrointestinal cancer (7/126, 5.5%, 95% CI 2.3–11%). Twenty-six patients experienced one or more clinically relevant non-major bleedings (8.9%, 95% CI 5.5–12%). Twelve patients had arterial thrombosis (4.0%, 95% CI 2.1–6.9%), of which the majority were strokes in patients with pancreatic cancer. Death occurred in 35 patients (12%, 95% CI 8.3–16%). Conclusion: The frequency of recurrent VTE and major bleedings are in line with other studies on apixaban in cancer-associated VTE. Arterial thrombosis was a frequent serious adverse event. Graphical abstract: Unlabelled Image Highlights: A single-arm interventional study 298 cancer patients with venous thrombosis were treated with apixaban for 6 months. Recurrent venous thrombosis occurred in 4.0%, major bleeding in 5.4%. Arterial thrombosis occurred in 4.0% of the patients, mainly in pancreatic cancer. No overrepresentation of major bleedings in gastrointestinal cancer