Comparative effectiveness and safety of apixaban, dabigatran, and rivaroxaban in patients with non-valvular atrial fibrillation. (1st October 2018)

• Record Type: Journal Article
• Authors: Andersson, Niklas W.; Svanström, Henrik; Lund, Marie; Pasternak, Björn; Melbye, Mads
• Is Part Of: International journal of cardiology. Volume 268(2018)
• Page Start: 113
• Page End: 119
• Publication Date: 2018-10-01
• Subjects: DOAC direct oral anticoagulant -- NVAF non-valvular atrial fibrillation -- ATC Anatomic Therapeutic Classification system -- ICD-10 International Classification of Diseases version 10 -- HR hazard ratio -- CI confidence interval -- TIA transient ischemic attack -- PPV positive predictive value; Non-valvular atrial fibrillation -- Direct oral anticoagulant -- Stroke -- Major bleeding -- Propensity-matched comparison; Cardiology -- Periodicals; Electronic journals; 616.12
• DOI: 10.1016/j.ijcard.2018.03.047
• Languages: English
• ISSNs: 0167-5273

Abstract

Abstract: Background: The comparative effectiveness and safety of individual direct oral anticoagulants (DOACs) in clinical practice is largely unknown. The study objectives were to compare effectiveness and safety of DOACs in patients with non-valvular atrial fibrillation (NVAF). Methods: Based on nationwide registers we established a population-based historical cohort study of 12, 638 new users of standard dose DOACs (apixaban 5 mg twice daily, dabigatran 150 mg twice daily and rivaroxaban 20 mg once daily) with NVAF in Denmark, July 2013 to March 2016. Patients were matched on propensity scores in a 1:1 ratio comparing apixaban vs. dabigatran (for a total of 6470 patients), apixaban vs. rivaroxaban (7352 patients), and rivaroxaban vs. dabigatran (5440 patients). Hazard ratios (HRs) for stroke or systemic embolism (effectiveness outcome) and major bleeding (safety outcome) were estimated. Results: In propensity-matched comparisons of the risk of stroke or systemic embolism, the HRs were 1.27 (95% confidence interval [CI], 0.82–1.96) for apixaban vs. dabigatran, 1.25 (95% CI, 0.87–1.79) for apixaban vs. rivaroxaban, and 1.17 (95% CI, 0.69–1.96) for rivaroxaban vs. dabigatran. For the risk of major bleeding, the HRs were 0.94 (95% CI, 0.62–1.41) for apixaban vs. dabigatran, 0.88 (95% CI, 0.64–1.22) for apixaban vs. rivaroxaban, and 1.35 (95% CI, 0.91–2.00) for rivaroxaban vs. dabigatran. Conclusions: Among patients with NVAF in routine clinical practice, there were no statistically significant differences in risk of stroke or systemic embolism or major bleeding in propensity-matched comparisons between apixaban, dabigatran, and rivaroxaban used in standard doses. While analyses indicate that more than moderate differences can be excluded, smaller differences cannot be ruled out.