Patient-reported benefits and burdens of direct oral-anticoagulants (DOACs) and low molecular weight heparins (LMWHs): The CANVAS pragmatic randomized trial (AFT-28).

Abstract

12112 Background: Previous randomized trials in cancer patients suggest that DOACs are non-inferior to LMWHs for preventing recurrent venous thromboembolism (VTE). However, patients’ perspectives have not been reported. Objective: CANVAS compared LMWHs to DOACs for preventing recurrent VTE in cancer patients. Key 2° endpoints were: 1) health-related quality of life (QOL); and, 2) treatment satisfaction. Methods: CANVAS was an unblinded hybrid comparative effectiveness non-inferiority trial. Between 12/2016 and 4/2020, 671 participants were randomized and followed for 6-months. Patients were assigned 1:1 to receive either a DOAC or a LMWH. Physicians could select any DOAC or LMWH at standard dosing, and patients assigned to LMWH were allowed to transition to Warfarin. Patients from 67 US practices with any invasive solid tumor, lymphoma, multiple myeloma or CLL and a diagnosis of VTE within 30 days of enrollment were eligible. The 1° analysis was conducted in the randomized modified intent-to-treat population, (all subjects who received assigned treatment). Key 2° endpoints were to establish: 1) non-inferior change in HR-QOL; 2) greater perception of benefit; and 3) lower perception of burden for participants receiving DOACs versus LMWHs. Participants reported QOL at 0, 3 and 6 months on the SF-12 survey. At 3 and 6 months, they also reported satisfaction via the Anti-Clot Treatment Scale (ACTS), which includes a burden and a benefit scale. A 2-point change was pre-specified as significant. Results: Neither QOL nor patients’ perceptions of treatment benefits differed between groups. However, patients on DOACs reported lower treatment burden compared to those assigned LMWHs. Conclusions: Among adult cancer patients with VTE, the use of a DOAC compared with a LMWH resulted in no difference in QOL but higher patient-reported satisfaction stemming from decreased perception of the burden of treatment. Clinical trial information: NCT02744092. [Table: see text]