Author + information
- Nicholas Moorea,b,
- Patrick Blina,b,
- Caroline Dureaua,b,
- Yves Cottina,b,
- Patrick Mismettia,b,
- Regis Lassallea,b,
- Abdelilah Abouelfatha,b,
- Jacques Benichoua,b and
- Cecile Droza,b
Background: The real-life benefits and risks of the direct oral anticoagulants (DOAC) for non-valvular atrial fibrillation (NVAF) have been disputed. This study aimed to compare the 1-year risk of major events for new users of dabigatran (D) or rivaroxaban (R) vs. vitamin K antagonists (VKA) in NVAF.
Methods: Cohorts of new users of D, R or VKA for NVAF in 2013 were identified and followed-up for one year in the 66 million persons nationwide French claims and hospitalization database (SNIIRAM). NVAF was defined from full coverage, hospitalization or procedure for atrial fibrillation without valvular disease using 3-year database history. For each comparison, patients were matched 1:1 on high-dimensional propensity score, including major arterial thrombosis and bleeding risk factors; Hazard ratios (HR) [95% confidence interval] were determined over one year during first prescribed anticoagulant exposure, using the Cox proportional hazard risk model.
Results: Of 371,539 incident anticoagulant users in 2013, 103,101 were NVAF patients (44,653 VKA, 27,060 D and 31,388 R). Mean age was 75.2 years, 54.1% male, 82.5% CHAD2Vasc2 score ≥ 2 and 9.8% HAS-BLED score > 3 with significant differences between anticoagulants. Overall incidence during exposure was 1.46% for arterial thrombotic events (ATE) including stroke, 2.80% for clinically relevant bleeding (CRB) (intracranial haemorrhage (ICH) 0.33%, gastrointestinal bleeds (GIB) 0.99%), acute coronary syndromes (ACS) 1.06% and death 5.18%. 20,489 D patients were matched to VKA. HR were for ATE 0.75 [0.63-0.88], CRB 0.58 [0.51-0.66] (ICH 0.22 [0.14-0.36] and GIB 0.98 [0.80-1.19]), ACS 0.79 [0.65-0.95], death 0.74 [0.67-0.82] and composite of all above 0.71 [0.66-0.76]. For R vs. VKA, 23,053 patients were matched per arm. HR were for ATE 0.98 [0.85-1.14], CRB 0.83 [0.75-0.92] (ICH 0.65 [0.49-0.87], GIB 1.08 [0.90-1.30]), ACS 0.84 [0.71-1.00], death 0.77 [0.71-0.84] and composite 0.84 [0.79-0.89].
Conclusions: This nationwide study of about 100,000 new anticoagulant users for NVAF shows a significantly overall better benefit-risk of DOAC versus VKA including death and intracranial bleeding without increased risk of GI bleeding.
Room 146 A
Saturday, March 18, 2017, 8:38 a.m.-8:48 a.m.
Session Title: Highlighted Original Research: Arrhythmias and Clinical EP and the Year in Review
Abstract Category: 6. Arrhythmias and Clinical EP: Other
Presentation Number: 901-08
- 2017 American College of Cardiology Foundation