Rivaroxaban in patients with malignancy and venous thromboembolism - results of a randomized SELECT-D study
Abstract
Venous thromboembolism is a common complication in cancer patients. The long-term subcutaneous administration of low molecular weight heparins is the standard therapy for these patients.
The aim of the SELECT-D study was to evaluate whether an oral factor Xa inhibitor, rivaroxaban, would offer an alternative treatment for venous thromboembolism in cancer patients. Patients and methods: This pilot, multicentre, randomized, open-label, pilot study conducted in the United Kingdom was aimed at patients with active malignancy and cancer-associated thrombosis in form of symptomatic pulmonary embolism or deep vein thrombosis.
Patients enrolled were treated with either dalteparin (200 IU / kg daily for the first month, then 150 IU/kg daily for the second to six months) or rivaroxaban (15 mg twice daily for the first 3 weeks, then 20 mg once daily for 6 months). The primary outcome was venous thromboembolism recurrence within 6 months.
Safety was evaluated according to the occurrence of major bleeding complications or clinically relevant non-major bleeding complications. Such bleeding had to meet at least one of the following criteria: the need for medical intervention, unplanned contact with the physician, the need to discontinue treatment with the study preparation or, for the patient, the deterioration of the performance of daily life activities.