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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.
Circulation. 2015 Jul 21;
Authors: Maura G, Blotière PO, Bouillon K, Billionnet C, Ricordeau P, Alla F, Zureik M
Abstract
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.
PMID: 26199338 [PubMed - as supplied by publisher]