CONKO-011/AIO-SUP-0115/ass.: Rivaroxaban compared to Low Molecular Weight Heparin in Cancer Patients with Acute Venous Thromboembolism.

Introduction Cancer-associated venous thromboembolism (CAT) is a frequent and medical relevant problem. Guidelines recommend treatment with low molecular weight heparins (LMWH) or direct oral factor-Xa-inhibitors as rivaroxaban for > 3 months. Patient's preference and convenience is an important factor to guide treatment decision and to support treatment adherence. No data are available so far about patient-reported outcome in CAT. Methods CONKO-011 was an open-label, prospective, multicenter German phase III trial for cancer patients with newly diagnosed venous thromboembolism (VTE) randomized to rivaroxaban (Riva) or site-specific LMWH. Primary endpoint was patient-reported treatment satisfaction, measured by the Anti-Clot Treatment Scale (ACTS). The 12-item ACTS Burdens scale (primary endpoint after 4 weeks) and the 3-item ACTS Benefits scale were analyzed at 4, 8 and 12 weeks. Secondary endpoints included recurrent VTE, major/ clinically relevant bleeding, safety, compliance, overall mortality at 3 and 6 months, Quality of life (QOL) measured by the Treatment Satisfaction Questionnaire for Medication II (TSQM II) and Spitzer Index. Results Between 03/2016 and 06/2019, 247 (123 Riva/124 LMWH) patients were randomized. Mean ACTS Burdens scores after 4 weeks were 52.8 versus 51.2 in favor of rivaroxaban (p = 0.019) with mean score differences ranging from 3.3 (week 8; p = 0.001) to 2.4 (week 12; p = 0.006). The treatment effect of ACTS burden was consistent over treatment time (p < 0.001). More patients on LMWH requested to stop study treatment preterm (19.4% versus 11.1%). Conclusion Oral treatment with rivaroxaban led to an improvement in patient-reported treatment satisfaction, particularly in reducing anticoagulation-related burden, resulting in less patient-requested treatment stops.