When should dialysis patients with non-valvular Atrial Fibrillation be anti- coagulated?
- Pulmonary Embolism
- Deep Vein Thromboembolism
- Anti-Phospholipid Syndrome
- Mechanical prosthetic cardiac valve
This expert recommendation is based on the hope that the anti-coagulation benefits in those conditions outweighs the risk of bleeding.
So where do we stand?
My Dream RCT: The PHANTOM-1 Study
- Inclusion Criteria
- Age range 50 – 84 years
- Sex males and females
- CHADS2 Score greater than or equal to 2
- History of Non-Valvular AF for 2 or more years
- On Warfarin with INR 2-3
- Ethnicity White, Asian, African American
- History of ESRD requiring hemodialysis 3 or more times weekly
- Exclusion Criteria
- Age range younger than 50 years and older than 84 years
- CHADS2 Score less than 2
- AF secondary to valvular disease
- History of Non-Valvular AF for less than 2 years
- On Warfarin with INR below 2 or above 3
- Renal disease without the need for hemodialysis
- ESRD patients undergoing Peritoneal Dialysis
- History of Neuro-endocrine disease
- Primary Endpoint – Onset of Transient Ischemic Attack (TIA) or stroke (Ischemic or Hemorrhagic)
- Secondary Endpoint – Incident of major bleeding (outside the CNS) and access survival.
Prospectively studying this in a randomized, placebo controlled trial would definitively answer an increasingly common question that nephrologists, cardiologists and primary care doctors face.
I received this feedback:
As a long time hematologist with an interest in anticoagulation I was very interested by your post as this is something my nephrology colleagues and I discuss all the time. I would also advocate enrolling folks not currently on anticoagulation because even in the non-dialysis population a lot of patients with afib who should be on warfarin are not. The other issues is would renal dose adjusted new direct oral anticoagulants be safer (50% Risk reduction of ICH in trials) esp when the antidote become available.
if this program gets rolling let me know how I can help.
–tom Thomas DeLoughery, MD FACP FAWMInterim Associate Division HeadProfessor of Medicine, Pathology and PediatricsOregon Health & Sciences University