Randomized Controlled: Trial of New Oral Anticoagulants Versus Warfarin for Postcardiac Surgery Atrial Fibrillation: The NEW-AF Trial.

Abstract

To determine whether anticoagulation for new onset atrial fibrillation (AF) with rivaroxaban decreases length of stay compared with warfarin. Direct Oral Anticoagulants (DOACs) have been shown to be noninferior to warfarin for stroke prevention in nonsurgical patients with atrial fibrillation. There are no published randomized trials comparing DOACs to warfarin in cardiac surgery patients, and DOACs are yet to be widely adopted in this population. In a pragmatic, prospective, clinical trial, 100 patients with new-onset AF after cardiac surgery were randomized to receive rivaroxaban (n=50) or warfarin (n=50). Patients were followed for 30 days postdischarge, with patient-reported outcomes assessed 2 weeks after discharge using the Perception of Anticoagulant Treatment Questionnaire and the EuroQol-5D-3L survey. The primary endpoint, length of stay (LOS) from day of surgery to discharge (days, IQR), was 7 (6-9) for rivaroxaban and 8 (6-9) for warfarin ( P =0.460). LOS from initiation of anticoagulation to discharge was 2 (1-4) days for rivaroxaban and 2 (1-3) days for warfarin ( P =0.738). The mean INR at discharge in the warfarin group was 1.68 (SD 0.5). No major bleeding events, strokes, or other arterial thromboembolism events occurred in either group. Minor bleeding events were reported in 3/50 (6%) patients in the rivaroxaban group versus 1/50 (2%) in the warfarin group ( P =0.617), none of which required blood transfusion. One patient (2%) in the rivaroxaban group developed a pericardial effusion requiring drainage, compared with none in the warfarin group ( P =1.000). Patients taking rivaroxaban reported significantly higher scores for convenience ( P <0.001) and better overall perception of their anticoagulation experience ( P =0.006), though both groups reported similar treatment satisfaction ( P =0.494). Mobility issues were reported by 42.2% of patients taking rivaroxaban compared with 18.6% of those taking warfarin ( P =0.021). All outcomes were consistent in both the intention-to-treat and as-treated populations. Treatment with rivaroxaban in new-onset atrial fibrillation after cardiac surgery did not decrease length of stay compared with warfarin. However, patients treated with rivaroxaban reported significantly better convenience and a more favorable overall perception of their anticoagulation experience compared with warfarin. Given similar safety profiles, these findings support incorporating rivaroxaban as an option for shared decision-making when selecting anticoagulation therapy for this patient population.