The Strategy To Prevent Hemorrhage Associated with anticogulation in Renal disease management
Patients with severe chronic kidney disease who develop atrial fibrillation are at high risk of stroke. The use of oral anticoagulation in dialysis patients is controversial and warfarin has uncertain efficacy and is associated with a 10‐20% risk of major bleeding each year. New oral anticoagulants are either contra‐indicated or unstudied in this population. The Watchman device may be an ideal therapy in this population, as it is likely to reduce embolic stroke in dialysis patients with atrial fibrillation who cannot take long‐term oral anticoagulants. Among patients currently receiving oral anticoagulants, implantation of the Watchman device would allow discontinuation of oral anticoagulation, thereby reducing long‐term bleeding risk.
Prospective Randomized Open Label Blinded Endpoint (PROBE) trial
The primary outcome of STOP HARM will be the occurrence of major bleeding as defined by the ISTH criteria.