Comparison of the Short-Term Risk of Bleeding and Arterial Thromboembolic Events in Nonvalvular Atrial Fibrillation Patients Newly Treated With Dabigatran or Rivaroxaban versus Vitamin K Antagonists: A French Nationwide Propensity-Matched Cohort Study
Background—The safety and effectiveness of Non-VKA Oral AntiCoagulants (NOAC), dabigatran or rivaroxaban, were compared to vitamin K antagonists (VKA) in anticoagulant-naive nonvalvular atrial fibrillation (nv-AF) patients during the early phase of anticoagulant therapy.
Methods and Results—Using the French medico-administrative databases (SNIIRAM-PMSI), this nationwide cohort study included patients with nv-AF who initiated dabigatran or rivaroxaban in July-November 2012 or VKA in July-November 2011. Patients presenting a contraindication to OAC were excluded. Dabigatran and rivaroxaban new users were matched to VKA new users using 1:2 matching on the propensity score. Patients were followed for up to 90 days until outcome, death, loss to follow-up or December 31 of the inclusion year. Hazard ratios of hospitalizations for bleeding and arterial thromboembolic events were estimated in an intent-to-treat analysis using Cox regression models. The population was composed of 19,713 VKA, 8,443 dabigatran and 4,651 rivaroxaban new users. All dabigatran- and rivaroxaban-treated patients were matched to 16,014 and 9,301 VKA-treated patients, respectively. Among dabigatran-, rivaroxaban- and their VKA matched-treated patients, 55 and 122 and 31 and 68 bleeding events and 33 and 58 and 12 and 28 arterial thromboembolic events were observed during follow-up, respectively. After matching, no statistically significant difference in bleeding (HR=0.88 [0.64-1.21]) or thromboembolic (HR=1.10 [0.72-1.69]) risk was observed between dabigatran and VKA new users. Bleeding (HR=0.98 [0.64-1.51]) and ischemic (HR=0.93 [0.47-1.85]) risks were comparable between rivaroxaban and VKA new users.
Conclusions—In this propensity-matched cohort study, our findings suggest that physicians should exercise caution when initiating either NOAC or VKA in nv-AF patients.
- French medico-administrative databases
- treatment effectiveness
- stroke prevention
- Received February 3, 2015.
- Revision received July 3, 2015.
- Accepted July 13, 2015.
Circulation is published on behalf of the American Heart Association, Inc., by Wolters Kluwer. This is an open access article under the terms of the Creative Commons Attribution Non-Commercial-NoDervis License (http://creativecommons.org/licenses/by-nc-nd/3.0/), which permits use, distribution, and reproduction in any medium, provided that the original work is properly cited, the use is noncommercial, and no modifications or adaptations are made.