This site is intended for U.S. Healthcare Professionals U.S. FULL PRESCRIBING INFORMATIONINFO, including Boxed WARNINGS Medication Guide Adult Indications

Review select real-world evidence supplementing the efficacy and safety
profile of ELIQUIS as demonstrated in clinical trials

Select characteristics of randomized clinical trials
and real-world evidence1-4
Randomized clinical trials icon

RANDOMIZED
CLINICAL TRIALS

  • Prospective design with prespecified, well-defined inclusion/exclusion criteria, outcomes, and endpoints
  • Patients are randomly assigned to treatment or comparator
  • RCTs are designed to show causality (ie, efficacy and safety data)
Vs. icon
Real world observational studies icon

REAL-WORLD
OBSERVATIONAL STUDIES

  • Observational in nature and use data from routine clinical practice
  • Patients are not randomized
  • Can only evaluate association and therefore are unable to determine causality
Select real-world evidence for patients with nonvalvular atrial fibrillation (NVAF) icon

Select RWE in adult patients with NVAF

RWE should be reviewed in the context of RCT data. All RWE resources below also include data from the ARISTOTLE clinical trial.

View ARISTOTLE NVAF RCT Data (vs warfarin)

Dawwas NVAF 2025 analysis

Published in the Journal of Thrombosis and Haemostasis

An independently funded, retrospective, observational real-world database analysis comparing the effectiveness and safety of ELIQUIS vs XARELTO® (rivaroxaban) in patients with NVAF aged 65 years or older.5

U.S. FULL PRESCRIBING INFORMATION, INCLUDING BOXED WARNINGS

Sentinel* Database analysis

Available at sentinelinitiative.org

An independently funded, retrospective, observational real-world database analysis comparing bleeding and stroke risks of ELIQUIS vs XARELTO® (rivaroxaban) in patients younger than 65 years with NVAF.6,7

Analysis should not be construed as an actual or implied endorsement by the FDA of any of the products discussed.
*FDA Sentinel is a national safety surveillance system for medical products that is primarily composed of aggregated electronic healthcare and administrative claims data.7

U.S. FULL PRESCRIBING INFORMATION, INCLUDING BOXED WARNINGS

ATHENS analysis

Published in the Journal of Clinical Medicine

A retrospective, observational real-world database analysis evaluating the outcomes of ELIQUIS compared to XARELTO® (rivaroxaban) in patients with NVAF.8

U.S. FULL PRESCRIBING INFORMATION, INCLUDING BOXED WARNINGS
Ray et al analysis thumbnail

Ray et al analysis

Published in the Journal of the American Medical Association (JAMA)

The largest independently funded, retrospective, observational real-world database analysis evaluating the association of ELIQUIS vs XARELTO® (rivaroxaban) with major ischemic or hemorrhagic events in Medicare beneficiaries with NVAF (N=581,451).9

U.S. FULL PRESCRIBING INFORMATION, INCLUDING BOXED WARNINGS
Fralick et al analysis thumbnail

Fralick et al analysis

Published in the Annals of Internal Medicine

An independently funded, retrospective, observational real-world database analysis on the effectiveness and safety of ELIQUIS compared to XARELTO® (rivaroxaban) for patients with NVAF in routine practice.10

U.S. FULL PRESCRIBING INFORMATION, INCLUDING BOXED WARNINGS
NVAF hospital readmissions analysis thumbnail

NVAF Hospital Readmissions analysis

Published in the Journal of Drug Assessment

A retrospective, observational real-world database analysis comparing stroke-related readmissions among hospitalized patients with NVAF treated with OACs in the US.11

U.S. FULL PRESCRIBING INFORMATION, INCLUDING BOXED WARNINGS

There are currently no results from clinical trials comparing ELIQUIS to XARELTO® (rivaroxaban) for stroke risk reduction in NVAF.12, 13

Select RWE for patients with VTE icon

Select RWE in adult patients with DVT/PE

RWE should be reviewed in the context of RCT data. All RWE resources below also include data from the AMPLIFY clinical trial.

View AMPLIFY DVT/PE RCT data (vs enoxaparin/warfarin)
Jin et al analysis thumbnail

Jin et al analysis

Published in Thrombosis Research

The largest independently funded, retrospective, observational real-world database analysis comparing the effectiveness and safety of ELIQUIS vs XARELTO® (rivaroxaban) for commercially insured and Medicare Advantage patients with DVT/PE (N=41,830).15

U.S. FULL PRESCRIBING INFORMATION, INCLUDING BOXED WARNINGS
Dawwas et al analysis thumbnail

Dawwas et al analysis

Published in the Annals of Internal Medicine

An independently funded, retrospective cohort, real-world database analysis on the risk of recurrent VTE and bleeding with ELIQUIS compared with XARELTO® (rivaroxaban).16

U.S. FULL PRESCRIBING INFORMATION, INCLUDING BOXED WARNINGS
VTE hospital readmissions analysis thumbnail

VTE Hospital Readmissions analysis

Published in Hospital Practice

A retrospective real-world data analysis on the ED: hospital readmissions (inpatient or ED) of patients treated with ELIQUIS or warfarin.17

U.S. FULL PRESCRIBING INFORMATION, INCLUDING BOXED WARNINGS

Other studies (including RCT and RWD analyses) in adult patients comparing ELIQUIS with other DOACs, which may have used different methods, populations, and outcome definitions, have shown different findings.14-16,18-25

DOAC=direct oral anticoagulant; DVT=deep vein thrombosis; ED=emergency department; JAMA=Journal of the American Medical Association; NVAF=nonvalvular atrial fibrillation; OAC=oral anticoagulant; PE=pulmonary embolism; RCT=randomized clinical trial; RWD=real-world data; RWE=real-world evidence; VTE=venous thromboembolism.

XARELTO® (rivaroxaban) is a registered trademark of Bayer Aktiengesellschaft.

References

  1. Hannan EL. Randomized clinical trials and observational studies: guidelines for assessing respective strengths and limitations. JACC Cardiovasc Interv. 2008;1(3):211-217. doi:10.1016/j.jcin.2008.01.008
  2. Stanley K. Design of randomized controlled trials. Circulation. 2007;115(9):1164-1169. doi:10.1161/CIRCULATIONAHA.105.594945
  3. Kovesdy CP, Kalantar-Zadeh K. Observational studies versus randomized controlled trials: avenues to causal inference in nephrology. Adv Chronic Kidney Dis. 2012;19(1):11-18. doi:10.1053/j.ackd.2011.09.004
  4. Garrison LP Jr, Neumann PJ, Erickson P, Marshall D, Mullins CD. Using real-world data for coverage and payment decisions: the ISPOR Real-World Data Task Force report. Value Health. 2007;10(5):326-335. doi:10.1111/j.1524-4733.2007.00186.x
  5. Dawwas GK, Cuker A. Comparative effectiveness and safety of rivaroxaban with other oral anticoagulants in older adults with nonvalvular atrial fibrillation: population-based analysis in response to updated Beers Criteria. J Thromb Haemost. 2025;23(2):546-555. doi:10.1016/j.jtha.2024.10.009
  6. U.S. Food and Drug Administration. Modular program report: thromboembolic stroke, intracranial hemorrhage, gastrointestinal bleeding, & major extracranial bleeding following apixaban and rivaroxaban use in patients aged 64 and younger with atrial fibrillation: an IPTW analysis, part 2. Sentinel Initiative; request cder_mpl2p_wp044. August 21, 2024. Accessed April 2, 2025. https://www.sentinelinitiative.org/sites/default/files/documents/Sentinel_Report_cder_mpl2p_wp044.pdf
  7. Tyler Coyle D. Sentinel System overview. U.S. Food and Drug Administration. 2017. Accessed April 2, 2025. https://www.fda.gov/files/about%20fda/published/Sentinel-System-Overview---Presentation.pdf
  8. Deitelzweig S, Kang A, Jiang J, et al. Clinical impact of switching or continuation of apixaban or rivaroxaban among patients with non-valvular atrial fibrillation. J Clin Med. 2024;13(4):1073. doi:10.3390/jcm13041073
  9. Ray WA, Chung CP, Stein CM, et al. Association of rivaroxaban vs apixaban with major ischemic or hemorrhagic events in patients with atrial fibrillation. JAMA. 2021;326(23):2395-2404. doi:10.1001/jama.2021.21222
  10. Fralick M, Colacci M, Schneeweiss S, Huybrechts KF, Lin KJ, Gagne JJ. Effectiveness and safety of apixaban compared with rivaroxaban for patients with atrial fibrillation in routine practice: a cohort study. Ann Intern Med. 2020;172(7):463-473. doi:10.7326/M19-2522
  11. Deitelzweig S, Baker C, Dhamane AD, et al. Comparison of readmissions among hospitalized nonvalvular atrial fibrillation patients treated with oral anticoagulants in the United States. J Drug Assess. 2020;9(1):87-96. doi:10.1080/21556660.2020.1750418
  12. Noseworthy PA, Yao X, Abraham NS, Sangaralingham LR, McBane RD, Shah ND. Direct comparison of dabigatran, rivaroxaban, and apixaban for effectiveness and safety in nonvalvular atrial fibrillation. Chest. 2016;150(6):1302-1312. doi:10.1016/j.chest.2016.07.013
  13. Lip GYH, Keshishian A, Li X, et al. Effectiveness and safety of oral anticoagulants among nonvalvular atrial fibrillation patients. Stroke. 2018;49(12):2933-2944. doi:10.1161/STROKEAHA.118.020232
  14. Jin MC, Sussman ES, Feng AY, et al. Hemorrhage risk of direct oral anticoagulants in real-world venous thromboembolism patients. Thromb Res. 2021;204:126-133. doi:10.1016/j.thromres.2021.06.015
  15. Dawwas GK, Leonard CE, Lewis JD, Cuker A. Risk for recurrent venous thromboembolism and bleeding with apixaban compared with rivaroxaban: an analysis of real-world data. Ann Intern Med. 2022;175(1):20-28. doi:10.7326/M21-0717
  16. Deitelzweig S, Hlavacek P, Mardekian J, et al. Comparison of inpatient admission rates of patients treated with apixaban vs. warfarin for venous thromboembolism in the emergency department. Hosp Pract. 2020;48(1):41-48. doi:10.1080/21548331.2020.1718925
  17. Aryal MR, Gosain R, Donato A, et al. Systematic review and meta-analysis of the efficacy and safety of apixaban compared to rivaroxaban in acute VTE in the real world. Blood Adv. 2019;3(15):2381-2387. doi:10.1182/bloodadvances.2019000572
  18. Mantha S, Ansell J. Indirect comparison of dabigatran, rivaroxaban, apixaban and edoxaban for the treatment of acute venous thromboembolism. J Thromb Thrombolysis. 2015;39(2):155-165. doi:10.1007/s11239-014-1102-5
  19. Sindet-Pedersen C, Staerk L, Pallisgaard JL, et al. Safety and effectiveness of rivaroxaban and apixaban in patients with venous thromboembolism: a nationwide study. Eur Heart J Cardiovasc Pharmacother. 2018;4(4):220-227. doi:10.1093/ehjcvp/pvy021
  20. Cohen AT, Hamilton M, Mitchell SA, et al. Comparison of the novel oral anticoagulants apixaban, dabigatran, edoxaban, and rivaroxaban in the initial and long-term treatment and prevention of venous thromboembolism: systematic review and network meta-analysis. PLoS One. 2015;10(12):e0144856. doi:10.1371/journal.pone.0144856
  21. Lutsey PL, Zakai NA, MacLehose RF, et al. Risk of hospitalised bleeding in comparisons of oral anticoagulant options for the primary treatment of venous thromboembolism. Br J Haematol. 2019;185(5):903-911. doi:10.1111/bjh.15857
  22. Bott-Kitslaar DM, McBane RD, Casanegra AI, et al. Apixaban and rivaroxaban in patients with acute venous thromboembolism. Mayo Clin Proc. 2019;94(7):1242-1252. doi:10.1016/j.mayocp.2018.09.022
  23. Howe Z, Naville-Cook C, Cole D. Bleeding rates of veterans taking apixaban or rivaroxaban for atrial fibrillation or venous thromboembolism. J Thromb Thrombolysis. 2019;47(2):280-286. doi:10.1007/s11239-018-1770-7
  24. Castellucci LA; for the COBRRA Trial Investigators. Comparison of bleeding risk between rivaroxaban and apixaban in acute VTE: the COBRRA trial. Presented at: ISTH 2025 Congress; June 21-25, 2025; Washington, DC. Accessed July 30, 2025.

432-US-2500273 09/25