Patient Presentation Overview: A 71-year-old female patient presents for ongoing cardiology follow-up care. Routine pacemaker interrogation prior to the appointment reveals several intermittent episodes of atrial fibrillation (AF) with each episode lasting more than 24 hours.
Pertinent Positive Medical History: Type 2 diabetes mellitus, hypertension, hyperlipidemia, obesity, peripheral arterial disease (PAD), chronic kidney disease (CKD) stage 5D secondary to diabetic nephropathy on dialysis for five years, remote syncope and complete heart block status post implantation of dual-chamber permanent pacemaker, prior lone episode of AF three years ago during critical illness status post-direct current cardioversion (DCCV) with no subsequent episodes until now.
Medications (Name, Dose, and Frequency): Carvedilol 25 mg bid, atorvastatin 40 mg daily, ASA 81 mg daily, and several supplements
Medication Allergies: None
Pertinent Social, Family History: The patient is Spanish-speaking. She lives with her adult daughter and attends an elder care program during the day. She does not smoke tobacco or drink alcohol. She has no known family history of cardiac disease but has very limited records of her family.
Review of Systems: She denies any recent syncopal episodes. She denies any falls, although she is nearly entirely wheelchair bound due to PAD and debility. She does not have chest pain or dyspnea but her exertion is significantly limited.
Vitals
Height: 60 inches
Weight: 200 lbs
Body Mass Index: 39
Blood Pressure: 140/82 mm Hg (on an inter-dialysis day)
Heart Rate: 65 bpm
O2 Saturation: 96% on room air
Focused Physical Exam
General: Appears chronically ill
Neck: No jugular venous distention appreciable
Cardiovascular: Regular rate and rhythm, no murmur
Respiratory: Clear to auscultation bilaterally
Abdomen: Obese, soft and non-tender
Neurological: Intact grossly
Extremities: No edema, warm to touch, areas of open wound that are covered
Pertinent Laboratory Data
Hemoglobin: 11 gm/dl
Creatinine: 9.8 (on an inter-dialysis day)
Blood Urea Nitrogen: 40
Pertinent Cardiac Studies
Transthoracic Echocardiography: Left ventricular (LV) function is at lower limits of normal, and a possible new anterolateral regional wall motion abnormality is noted. No significant valvular disease is present. LV and right ventricular filling pressures were noted to be moderately elevated.
The correct answer is: D. Apixaban 5 mg bid.
Appropriate prophylaxis for stroke/systemic embolism in CKD stage 5D (or end-stage renal disease) patients with AF is a clinical challenge due to lack of sufficient evidence in the literature to inform management, regarding risks versus benefits of therapeutic anticoagulation. There is evidence to suggest an increase in the risk of thromboembolic complications as well as bleeding risk in this high-risk population.1,2 Moreover, some studies have suggested an increase in the risk of stroke in association with warfarin use among CKD stage 5D patients, particularly in the absence of diligent international normalized ratio (INR) monitoring.3
Current 2014 American College of Cardiology (ACC)/American Heart Association (AHA) guidelines for the treatment of patients with AF state, "For patients with nonvalvular AF with a CHA2DS2-VASc score of 2 or greater and who have stage 5 CKD (creatinine clearance [CrCl] <15 mL/min) or are on hemodialysis, it is reasonable to prescribe warfarin (INR 2.0 to 3.0) for oral anticoagulation (Strength of evidence IIA LOE B)."4 It should be noted that this recommendation is not universally accepted and is at odds with both the Canadian Cardiovascular Society guidelines5 and Kidney Disease: Improving Global Outcomes (KDIGO) working group guidelines.6
There are limited data regarding the use of new oral anticoagulants in CKD 5D patients, as they were excluded from the randomized controlled trials. However, apixaban has received U.S. Food and Drug Administration (FDA) approval for prevention of stroke/systemic embolism in the setting of non-valvular AF in CKD-5D patients based on extrapolated pharmacokinetic data. The recommended dose in this clinical scenario is apixaban 5 mg PO BID.7 The current FDA-approved label for apixaban recommends that for patients ≥80 years of age or weight ≤60 kg, the dose should be reduced to 2.5 mg PO BID.
References
- Olesen JB, Lip GY, Kamper AL, et al. Stroke and bleeding in atrial fibrillation with chronic kidney disease. N Engl J Med 2012;367:625-35.
- Elliott MJ, Zimmerman D, Holden RM. Warfarin anticoagulation in hemodialysis patients: a systematic review of bleeding rates. Am J Kidney Dis 2007;433-44.
- Chan KE, Lazarus JM, Thadhani R, Hakim RM. Warfarin use associates with increased risk for stroke in hemodialysis patients with atrial fibrillation. J Am Soc Nephrol 2009;20:2223-33.
- January CT, Wann L, Alpert JS, et al. 2014 AHA/ACC/HRS guideline for the management of patients with atrial fibrillation: executive summary: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines and the Heart Rhythm Society. J Am Coll Cardiol 2014;64:2246-80.
- Skanes AC, Healey JS, Cairns JA, et al. Focused 2012 update of the Canadian Cardiovascular Society Atrial Fibrillation guidelines: recommendations for stroke prevention and rate/rhythm control. Can J Cardiol 2012;28:125-36.
- Herzog CA, Asinger RW, Berger AK, et al. Cardiovascular disease in chronic kidney disease. A clinical update from Kidney Disease: Improving Global Outcomes (KDIGO). Kidney Int 2011;80:572-86.
- U.S. Department of Health & Human Services. MedWatch The FDA Safety Information and Adverse Event Reporting Program (FDA website). 2014. Available at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/ucm384790.htm. Accessed 3/4/15.
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