Abstract
8019 Background: The risk of venous thromboembolism (VTE) is higher in myeloma patients recieving IMiD* compounds (IMiD*: registered). A VTE prophylaxis using low-molecular-weight heparin or aspirin is proposed. Apixaban is an oral direct anti-Xa. Several studies have shown the efficiency and safety of apixaban in VTE prophylaxis compared to enoxaparin. The objective of this prospective pilot study was to assess the risk of VTE and bleeding in patients with myeloma treated with IMiD* compounds, using apixaban in a preventive scheme. Methods: Myeloma patients requiring Melphalan-Prednisone-Thalidomide in first line, or Lenalidomide-Dexamethasone in relapse, asymptomatic regarding VTE at inclusion, were enrolled between 2014 - 2016. All patients recieved apixaban, 2.5 mg x 2/day for 6 months, and were monthly monitored. Venous (pulmonary embolism – PE, or symptomatic proximal or distal deep vein thrombosis - DVT, or all proximal asymptomatic events detected by systematic proximal bilateral compression ultrasound) or arterial thrombotic events, and bleeding events (ISTH 2005) were registered. Based on meta-analysis of Carrier regarding VTE recurrence, and results from the ADOPT study in medical conditions regarding hemorrhages, < 13 symptomatic VTE events, < 3 severe and < 14 clinically relevant non major (CRNM) bleeding were expected on the treatment period. Results: 104 patients were enrolled (mean age 69.8 +/- 7.8yrs), 11 in first line, 93 in relapse. No PE or arterial cardiovascular events were reported. Two venous thrombotic events were registered, i.e an asymptomatic proximal DVT (patient in relapse) and a symptomatic distal DVT, although apixaban was stopped 14 days before, due to Lenalidomide-induced thrombopenia. Only one major and 11 CRNM hemorrhages were reported. Conclusions: Referring to the incidence of thromboembolic events in Carrier’s meta-analysis, and to hemorrhagic events in medical patients recieving apixaban in primary VTE prophylaxis, apixaban used in a preventive scheme seems to be efficient and safe in preventing VTE in myeloma patients treated with IMiD* compounds. Clinical trial information: NCT02066454.
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