Rationale and design of the REsolution of LEft VENTricular thrombus (RELEVENT) Trial

Abstract

Left ventricular (LV) thrombus is a consequence of systolic dysfunction and is associated with an increased risk of stroke and systemic embolism. Anticoagulation with warfarin has been the standard of care. However, following the widespread adoption of direct oral anticoagulants (DOACs) in other settings, these are increasingly used to treat LV thrombus, despite limited randomized data to support equivalent outcomes and safety. We hypothesise that DOACs will be non-inferior to warfarin in the resolution of LV thrombus, without the occurrence of cardiovascular death, stroke, systemic embolism or major bleeding at 3-months. The REsolution of LEft VENTricular thrombus (RELEVENT) trial (ACTRN12618001254280) will test the non-inferiority of DOACs compared to warfarin. This prospective trial will randomize 216 patients with best-available imaging confirmed LV thrombus, at a 1:1 ratio to either warfarin or a DOAC, for a duration of 12-14 weeks. Any DOAC approved for stroke prevention in atrial fibrillation may be used, according to local preference. The primary endpoint will be the resolution of the thrombus, without the occurrence of cardiovascular death, stroke, systemic embolism or major bleeding at 3-month follow-up. Secondary and other endpoints of interest include components of the primary outcome, changes to thrombus volume and diameter, days alive and out of hospital, disability free survival and quality of life. Patients will be followed up for 3 years to obtain data on long-term management and outcomes. Recruitment to the RELEVENT trial is underway in 16 centers in New Zealand and Australia. The RELEVENT trial will help clarify whether DOACs are non-inferior to warfarin in the early treatment of left ventricular thrombus. It will also generate important insights into the long-term management and outcomes for patients.