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Comparative Real-Life Effectiveness and Safety of Dabigatran or Rivaroxaban vs. Vitamin K Antagonists: A High-Dimensional Propensity Score Matched New Users Cohort Study in the French National Healthcare Data System SNDS

dc.rights.licenseopenen_US
dc.contributor.authorBLIN, Patrick
dc.contributor.authorDUREAU-POURNIN, C.
hal.structure.identifierBordeaux population health [BPH]
dc.contributor.authorBENICHOU, Jacques
dc.contributor.authorCOTTIN, Y.
dc.contributor.authorMISMETTI, P.
dc.contributor.authorABOUELFATH, A.
dc.contributor.authorLASSALLE, R.
dc.contributor.authorDROZ, C.
hal.structure.identifierBordeaux population health [BPH]
dc.contributor.authorMOORE, Nicholas
dc.date.accessioned2021-01-18T10:01:31Z
dc.date.available2021-01-18T10:01:31Z
dc.date.issued2020
dc.identifier.issn1175-3277en_US
dc.identifier.urihttps://oskar-bordeaux.fr/handle/20.500.12278/25806
dc.description.abstractEnBackground Clinical trials have indicated that the direct-acting oral anticoagulants dabigatran and rivaroxaban have better risk/benefit profiles than do vitamin K antagonists (VKAs) for stroke prevention in non-valvular atrial fibrillation (NVAF). Objective Our objective was to compare the 1-year real-life risk of major clinical events with dabigatran or rivaroxaban versus VKAs for NVAF. Methods This was a high-dimensional propensity score (hdPS)-matched cohort study of new users of dabigatran, rivaroxaban or VKAs for NVAF in the French national healthcare systems database in 2013 followed-up for 1 year [22]. Hazard ratios (HRs) with 95% confidence intervals (CIs) for clinical events and death were determined during exposure. Results In 2013, a total of 103,101 new anticoagulant users had definite NVAF: 44,653 VKA, 27,060 dabigatran, and 31,388 rivaroxaban. In matched populations, HRs were as follows for dabigatran versus VKAs (20,489 per group): stroke and systemic embolism (SSE) 0.75 (95% CI 0.63–0.88), clinically relevant bleeding (CRB) 0.58 (95% CI 0.51–0.66), hemorrhagic stroke (HS) 0.22 (95% CI 0.14–0.36), gastrointestinal bleeding (GIB) 0.98 (95% CI 0.80–1.19), acute coronary syndrome (ACS) 0.79 (95% CI 0.65–0.95), death 0.74 (95% CI 0.67–0.82), composite (any of the above) 0.71 (95% CI 0.66–0.76). For matched rivaroxaban versus VKA (23,053 per group) HRs were as follows: SSE 0.98 (95% CI 0.85–1.14), CRB 0.83 (95% CI 0.75–0.92), HS 0.65 (95% CI 0.49–0.87), GIB 1.08 (95% CI 0.90–1.30), ACS 0.84 (95% CI 0.71–1.00), death 0.77 (95% CI 0.71–0.84), composite 0.84 (95% CI 0.79–0.89). Numbers needed to treat to observe one fewer death were 49 ± 0.05 with dabigatran or rivaroxaban versus VKAs. Conclusion Consistent with results from clinical trials and other observational studies, dabigatran and rivaroxaban were at least as effective and safer than VKAs for the prevention of thromboembolic events in NVAF over 1 year in the French population.
dc.language.isoENen_US
dc.subjectPharmacoEpi-Drugs
dc.title.enComparative Real-Life Effectiveness and Safety of Dabigatran or Rivaroxaban vs. Vitamin K Antagonists: A High-Dimensional Propensity Score Matched New Users Cohort Study in the French National Healthcare Data System SNDS
dc.title.alternativeAm J Cardiovasc Drugsen_US
dc.typeArticle de revueen_US
dc.identifier.doi10.1007/s40256-019-00359-zen_US
dc.subject.halSciences du Vivant [q-bio]/Santé publique et épidémiologieen_US
dc.identifier.pubmed31254174en_US
bordeaux.journalAm J Cardiovasc Drugsen_US
bordeaux.page81-103en_US
bordeaux.volume20en_US
bordeaux.hal.laboratoriesBordeaux Population Health Research Center (BPH) - U1219en_US
bordeaux.issue1en_US
bordeaux.institutionUniversité de Bordeauxen_US
bordeaux.teamPharmacoEpi-Drugsen_US
bordeaux.peerReviewedouien_US
bordeaux.inpressnonen_US
hal.identifierhal-03113190
hal.version1
hal.date.transferred2021-01-18T10:01:35Z
hal.exporttrue
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