Ezekowitz MD, et al. - Authors compared apixaban to heparin/vitamin K antagonist (VKA) in patients with atrial fibrillation (AF) and ≤48 h anticoagulation prior to randomization undergoing cardioversion. When apixaban was contrasted with heparin/VKA, data revealed 0/753 vs 6/747 strokes, no SE, and 2 vs 1 deaths. The conclusion drawn was that rates of strokes, systemic emboli, deaths, and bleeds were low for both apixaban and heparin/VKA treated AF patients undergoing cardioversion.

Methods

• During this study, 1,500 subjects underwent randomization.
• The apixaban dose of 5 mg BID was reduced to 2.5 mg BID in patients with 2 of the following: Age ≥ 80 years, weight ≤ 60 kg, or serum creatinine ≥ 133 µmol/L.
• With the intention of expediting cardioversion, imaging and/or a loading dose of 10 mg (down-titrated to 5 mg) was permitted, at the discretion of the investigator.
• Stroke, systemic embolism (SE), and death were included as the endpoints for efficacy.
• Safety endpoints included major bleeding and clinically relevant non-major (CRNM) bleeding.

Results

• While 162 patients were not cardioverted, there were 1,038 active and 300 spontaneous cardioversions.
• A total of 855 patients underwent imaging, and 342 received a loading dose of apixaban.
• In the full analysis set comparing apixaban vs heparin/VKA, there were 0/753 vs 6/747 strokes [relative risk (RR) 0; 95% confidence interval (95% CI) 0-0.64; nominal P=0.015], no SE, and 2 vs 1 deaths (RR 1.98; 95% CI 0.19–54.00; nominal P > 0.999).
• There were 3/735 vs 6/721 major (RR 0.49; 95% CI 0.10-2.07; nominal P=0.338) and 11 vs 13 CRNM bleeding events (RR 0.83; 95% CI 0.34-1.89; nominal P=0.685) in the apixaban vs heparin/VKA safety cohort.
• Imaging assessment disclosed that 60/61 with thrombi continued randomized treatment, and all 61 were without outcome events.