Aim: The primary objective was to compare apixaban to heparin/vitamin K antagonist (VKA) in patients with atrial fibrillation (AF ) and ≤48 hours anticoagulation prior to randomization undergoing cardioversion.
Methods: 1,500 patients were randomized. 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. To expedite cardioversion, at the discretion of the investigator, imaging and/or a loading dose of 10 mg (down-titrated to 5 mg) was allowed. The endpoints for efficacy were stroke, systemic embolism (SE) and death. The endpoints for safety were major bleeding and clinically relevant non-major (CRNM) bleeding.
Results: There were 1,038 active and 300 spontaneous cardioversions; 162 patients were not cardioverted. Imaging was performed in 855 patients, and 342 received a loading dose of apixaban. Comparing apixaban to heparin/VKA in the full analysis set, there were 0/753 vs 6/747 strokes (relative risk [RR] 0; 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). In the safety population, 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). On imaging, 60/61 with thrombi continued randomized treatment; all (61) were without outcome events.
Conclusions: Rates of stroke and bleeding were low for both treatments. Apixaban as[RDE1] an alternative for anticoagulation of AF patients undergoing cardioversion.
|Number of pages||13|
|Journal||European Heart Journal|
|Early online date||6 Apr 2018|
|Publication status||Published - 21 Aug 2018|
- atrial fibrillation
- cardiac imaging