Chronic Kidney Disease Clinical Trial
Official title:
The Strategy to Prevent Hemorrhage Associated With Anticoagulation in Renal Disease Management (STOP HARM) Trial
Patients with severe chronic kidney disease (CKD) who develop atrial fibrillation are at high
risk for stroke. The use of blood thinking medication in dialysis patients is controversial
and warfarin carries a serious risk for major bleeding.
The Watchman device may be an ideal therapy for this population as after implantation it
allows for the discontinuation of blood thinners, thereby reducing the risk of bleeding.
An estimated 25 million North American's have chronic kidney disease (CKD) including 600,000
that require dialysis for end-stage renal disease.The importance of CKD is underscored by the
poor survival, frequent hospitalizations and impaired health related quality of life of
patients with CKD.
Stroke is an important cause of morbidity, mortality and suffering for patients with CKD.
Stroke is approximately 5 to 10 times more common in patients with advanced CKD compared to
non-CKD patients. Atrial fibrillation (AF), the most important risk factor for stroke, occurs
in up to 20.4% of patients with advanced CKD. Observational studies suggest anywhere from an
approximate 56% relative risk reduction to a 2-fold increase in the risk of stroke with
warfarin. Furthermore, the risk of bleeding in patients with advanced CKD is roughly 5-fold
higher than patients without CKD. Although OAC may not prevent strokes in patients with
advanced CKD, it still increases the risk of major bleeding by 1.4 fold.
New stroke prevention strategies in patients with CKD and AF are urgently needed. An
effective strategy must reduce the risk of thromboembolic events while not increasing the
risk of bleeding substantially. Left atrial appendage occlusion (LAAO) with devices such as
the Watchman, represent a unique opportunity to accomplish effective stroke prevention while
mitigating the risk of bleeding in this patient population.
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