PMID- 26199338
OWN - NLM
STAT- MEDLINE
DCOM- 20160105
LR  - 20220317
IS  - 1524-4539 (Electronic)
IS  - 0009-7322 (Print)
IS  - 0009-7322 (Linking)
VI  - 132
IP  - 13
DP  - 2015 Sep 29
TI  - 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.
PG  - 1252-60
LID - 10.1161/CIRCULATIONAHA.115.015710 [doi]
AB  - BACKGROUND: The safety and effectiveness of non-vitamin K antagonist (VKA) oral 
      anticoagulants, dabigatran or rivaroxaban, were compared with VKA in 
      anticoagulant-naive patients with nonvalvular atrial fibrillation during the 
      early phase of anticoagulant therapy. METHODS AND RESULTS: With the use of the 
      French medico-administrative databases (SNIIRAM and PMSI), this nationwide cohort 
      study included patients with nonvalvular atrial fibrillation who initiated 
      dabigatran or rivaroxaban between July and November 2012 or VKA between July and 
      November 2011. Patients presenting a contraindication to oral anticoagulants were 
      excluded. Dabigatran and rivaroxaban new users were matched to VKA new users by 
      the use of 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, 8443 dabigatran, and 4651 rivaroxaban 
      new users. All dabigatran- and rivaroxaban-treated patients were matched to 16 
      014 and 9301 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 (hazard ratio, 0.88; 95% confidence interval, 0.64-1.21) or 
      thromboembolic (hazard ratio, 1.10; 95% confidence interval, 0.72-1.69) risk was 
      observed between dabigatran and VKA new users. Bleeding (hazard ratio, 0.98; 95% 
      confidence interval, 0.64-1.51) and ischemic (hazard ratio, 0.93; 95% confidence 
      interval, 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 non-VKA oral 
      anticoagulants or VKA in patients with nonvalvular atrial fibrillation.
CI  - (c) 2015 The Authors.
FAU - Maura, Geric
AU  - Maura G
AD  - From Strategy and Research Department, National Health Insurance (CNAMTS), Paris, 
      France (G.M., P.-O.B., C.B., P.R., F.A.); and Department of Epidemiology of 
      Health Products, French National Agency for Medicines and Health Products Safety 
      (ANSM), Saint-Denis, France (K.B., M.Z.). geric.maura@cnamts.fr.
FAU - Blotiere, Pierre-Olivier
AU  - Blotiere PO
AD  - From Strategy and Research Department, National Health Insurance (CNAMTS), Paris, 
      France (G.M., P.-O.B., C.B., P.R., F.A.); and Department of Epidemiology of 
      Health Products, French National Agency for Medicines and Health Products Safety 
      (ANSM), Saint-Denis, France (K.B., M.Z.).
FAU - Bouillon, Kim
AU  - Bouillon K
AD  - From Strategy and Research Department, National Health Insurance (CNAMTS), Paris, 
      France (G.M., P.-O.B., C.B., P.R., F.A.); and Department of Epidemiology of 
      Health Products, French National Agency for Medicines and Health Products Safety 
      (ANSM), Saint-Denis, France (K.B., M.Z.).
FAU - Billionnet, Cecile
AU  - Billionnet C
AD  - From Strategy and Research Department, National Health Insurance (CNAMTS), Paris, 
      France (G.M., P.-O.B., C.B., P.R., F.A.); and Department of Epidemiology of 
      Health Products, French National Agency for Medicines and Health Products Safety 
      (ANSM), Saint-Denis, France (K.B., M.Z.).
FAU - Ricordeau, Philippe
AU  - Ricordeau P
AD  - From Strategy and Research Department, National Health Insurance (CNAMTS), Paris, 
      France (G.M., P.-O.B., C.B., P.R., F.A.); and Department of Epidemiology of 
      Health Products, French National Agency for Medicines and Health Products Safety 
      (ANSM), Saint-Denis, France (K.B., M.Z.).
FAU - Alla, Francois
AU  - Alla F
AD  - From Strategy and Research Department, National Health Insurance (CNAMTS), Paris, 
      France (G.M., P.-O.B., C.B., P.R., F.A.); and Department of Epidemiology of 
      Health Products, French National Agency for Medicines and Health Products Safety 
      (ANSM), Saint-Denis, France (K.B., M.Z.).
FAU - Zureik, Mahmoud
AU  - Zureik M
AD  - From Strategy and Research Department, National Health Insurance (CNAMTS), Paris, 
      France (G.M., P.-O.B., C.B., P.R., F.A.); and Department of Epidemiology of 
      Health Products, French National Agency for Medicines and Health Products Safety 
      (ANSM), Saint-Denis, France (K.B., M.Z.).
LA  - eng
PT  - Comparative Study
PT  - Journal Article
PT  - Multicenter Study
PT  - Observational Study
PT  - Research Support, Non-U.S. Gov't
DEP - 20150721
PL  - United States
TA  - Circulation
JT  - Circulation
JID - 0147763
RN  - 0 (Anticoagulants)
RN  - 0 (Antithrombins)
RN  - 0 (Factor Xa Inhibitors)
RN  - 12001-79-5 (Vitamin K)
RN  - 5Q7ZVV76EI (Warfarin)
RN  - 9NDF7JZ4M3 (Rivaroxaban)
RN  - I0VM4M70GC (Dabigatran)
SB  - IM
MH  - Adolescent
MH  - Adult
MH  - Aged
MH  - Anticoagulants/adverse effects/*therapeutic use
MH  - Antithrombins/adverse effects/*therapeutic use
MH  - Arterial Occlusive Diseases/etiology/*prevention & control
MH  - Atrial Fibrillation/*complications
MH  - Dabigatran/adverse effects/*therapeutic use
MH  - Databases, Factual
MH  - Factor Xa Inhibitors/adverse effects/*therapeutic use
MH  - Follow-Up Studies
MH  - Hemorrhage/*chemically induced
MH  - Hospitalization/statistics & numerical data
MH  - Humans
MH  - Middle Aged
MH  - Risk
MH  - Rivaroxaban/adverse effects/*therapeutic use
MH  - Thromboembolism/etiology/*prevention & control
MH  - Thrombophilia/*drug therapy/etiology
MH  - Vitamin K/*antagonists & inhibitors
MH  - Warfarin/adverse effects/*therapeutic use
MH  - Young Adult
PMC - PMC4885525
OTO - NOTNLM
OT  - France
OT  - anticoagulants
OT  - atrial fibrillation
OT  - comparative effectiveness research
OT  - databases, factual
OT  - hemorrhage
OT  - pharmacoepidemiology
OT  - stroke
EDAT- 2015/07/23 06:00
MHDA- 2016/01/06 06:00
PMCR- 2016/05/30
CRDT- 2015/07/23 06:00
PHST- 2015/02/03 00:00 [received]
PHST- 2015/07/13 00:00 [accepted]
PHST- 2015/07/23 06:00 [entrez]
PHST- 2015/07/23 06:00 [pubmed]
PHST- 2016/01/06 06:00 [medline]
PHST- 2016/05/30 00:00 [pmc-release]
AID - CIRCULATIONAHA.115.015710 [pii]
AID - 10.1161/CIRCULATIONAHA.115.015710 [doi]
PST - ppublish
SO  - Circulation. 2015 Sep 29;132(13):1252-60. doi: 10.1161/CIRCULATIONAHA.115.015710. 
      Epub 2015 Jul 21.