Net clinical benefit of rivaroxaban compared with warfarin in atrial fibrillation: Results from ROCKET AF.

Abstract

AIMS:

The aim of this study was to determine the net clinical benefit (NCB) of rivaroxaban compared with warfarin in patients with atrial fibrillation.

METHODS:

This was a retrospective analysis of 14,236 patients included in ROCKET AF who received at least one dose of study drug. We analyzed NCB using four different methods: (1) composite of death, stroke, systemic embolism, myocardial infarction, and major bleeding; (2) method 1 with fatal or critical organ bleeding substituted for major bleeding; (3) difference between the rate of ischemic stroke or systemic embolism minus 1.5 times the difference between the rate of intracranial hemorrhage; and (4) weighted sum of differences between rates of death, ischemic stroke or systemic embolism, intracranial hemorrhage, and major bleeding.

RESULTS:

Rivaroxaban was associated with a lower risk of the composite outcome of death, myocardial infarction, stroke, or systemic embolism (rate difference per 10,000 patient-years [RD]=-86.8 [95% CI -143.6 to -30.0]) and fatal or critical organ bleeding (-41.3 [-68 to -14.7]). However, rivaroxaban was associated with a higher risk of major bleeding other than fatal or critical organ bleeding (55.9 [14.7 to 97.2]). Method 1 showed no difference between treatments (-35.5 [-108.4 to 37.3]). Methods 2-4 favored treatment with rivaroxaban (2: -96.8 [-157.0 to -36.8]; 3: -65.2 [-112.3 to -17.8]; 4: -54.8 [-96.0 to -10.2]).

CONCLUSIONS:

Rivaroxaban was associated with favorable NCB compared with warfarin. The NCB was attributable to lower rates of ischemic events and fatal or critical organ bleeding.

• Authors: Adam S Barnett, Derek D Cyr, Shaun G Goodman, Bennett S Levitan, Zhong Yuan, Graeme J Hankey, Daniel E Singer, Richard C Becker, Günter Breithardt, Scott D Berkowitz, Jonathan L Halperin, Werner Hacke, Kenneth W Mahaffey, Christopher C Nessel, Keith A A Fox, Manesh R Patel, Jonathan P Piccini
• Journal: International journal of cardiology (Int J Cardiol) Vol. 257 Pg. 78-83 (04 15 2018) ISSN: 1874-1754 [Electronic] Netherlands
• PMID: 29506743 (Publication Type: Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial)
• Copyright: Copyright © 2017 Elsevier B.V. All rights reserved.

Chemical References

• Anticoagulants
• Factor Xa Inhibitors
• Warfarin
• Rivaroxaban

Topics

• Aged
• Anticoagulants (administration & dosage, adverse effects)
• Atrial Fibrillation (diagnosis, drug therapy, physiopathology)
• Double-Blind Method
• Factor Xa Inhibitors (administration & dosage, adverse effects)
• Female
• Follow-Up Studies
• Hemorrhage (chemically induced, diagnosis, physiopathology)
• Humans
• International Normalized Ratio (methods)
• Internationality
• Male
• Retrospective Studies
• Rivaroxaban (administration & dosage, adverse effects)
• Stroke (diagnosis, physiopathology, prevention & control)
• Warfarin (administration & dosage, adverse effects)