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Randomized Controlled Trial of New Oral Anticoagulants Versus Warfarin for Post Cardiac Surgery Atrial Fibrillation: The NEWAF Trial
*Adham Makarem, *
Philicia Moonsamy, *Yunong Zhao, *Arminder Jassar, *Serguei Melnitchouk, *David D'Alessandro, *Oluwaseun Akeju, Thoralf Sundt, *Asishana Osho
Department of Surgery - Division of Cardiac Surgery, Massachusetts General Hospital and Harvard Medical School, Boston, MA
BackgroundDirect Oral Anticoagulants (DOACs) have been shown to be noninferior to warfarin for stroke prevention in nonsurgical patients with atrial fibrillation, with some studies demonstrating a more favorable safety profile. 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. We hypothesized that compared to warfarin, rivaroxaban will allow earlier hospital discharge and provide equally safe and efficacious prophylaxis against stroke.
MethodsIn a pragmatic, prospective clinical trial, we randomized 100 patients with new-onset atrial fibrillation after cardiac surgery to receive rivaroxaban vs. warfarin. Patients were followed for 30 days after surgery and patient-reported outcomes were measured at 2 weeks post-discharge with the Perception of Anticoagulant Treatment Questionnaire and the EQ-5D-3L survey.
ResultsThe study primary endpoint of length of stay from day of surgery to discharge (days, IQR) was 7 (6-9) for rivaroxaban and 8 (6-9) for warfarin (p=0.460) and from initiation of anticoagulation to discharge was 2 (1-4) for rivaroxaban and 2 (1-3) for warfarin (p=0.738). Median INR at the time of discharge in the warfarin group was 1.6 (1.3-1.9). There were no major bleeding events, strokes, or other arterial thromboembolism events in either group. There were 3/50 (6%) minor bleeding events in the rivaroxaban vs. 1/50 (2%) in the warfarin group (p=0.617). None of these events required blood transfusion. There was 1/50 (2%) pericardial effusion requiring drainage in the rivaroxaban group vs. none in the warfarin group (p=1.000). Compared to warfarin, patients taking rivaroxaban reported significantly higher scores for convenience (p<0.001) and overall better perception of their anticoagulation experience (p=0.006). Both groups reported similar treatment satisfaction (p=0.494). 42.2% of patients taking rivaroxaban reported having some problems with mobility compared to 18.6% taking warfarin (p=0.021). All outcomes were consistent in both the intention-to-treat and as-treated populations of this trial.
Conclusion In patients with new atrial fibrillation after cardiac surgery, rivaroxaban was as effective as warfarin in preventing stroke and was not associated with increased risk of bleeding. There was no significant between-group difference in hospital length of stay. Patients find treatment with rivaroxaban more convenient and have an overall better perception of their experience with anticoagulation than with warfarin. Given similar safety profiles, these data can be used for shared-decision-making when prescribing anticoagulation for new-onset atrial fibrillation after cardiac surgery.
Perception of Anticoagulant Treatment Questionnaire (PACT-Q2) survey results
| | Warfarin
(n = 38) | Rivaroxaban
(n = 36) | p-value |
| Convenience of anticoagulant | 92.3 (88.5-96.2) | 100 (96.2-100.0) | <0.001 |
| Anticoagulant treatment satisfaction | 64.3 (53.6-74.1) | 62.5 (57.1-75.9) | 0.494 |
| Overall perception of anticoagulation experience | 83.1 (77.5-85.0) | 86.9 (82.5-90.0) | 0.006 |
Figure: Boxplot of Primary outcome Length of Stay
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