Tags

Type your tag names separated by a space and hit enter

Efficacy and safety of rivaroxaban in patients with heart failure and nonvalvular atrial fibrillation: insights from ROCKET AF.
Circ Heart Fail. 2013 Jul; 6(4):740-7.CH

Abstract

BACKGROUND

In Rivaroxaban Once daily, oral, direct factor Xa inhibition Compared with vitamin K antagonism for prevention of stroke and Embolism Trial in Atrial Fibrillation (ROCKET AF), rivaroxaban was noninferior to warfarin for the prevention of stroke and systemic embolic events and significantly reduced intracranial bleeding in patients with nonvalvular atrial fibrillation. We explore the safety and efficacy of rivaroxaban in patients with heart failure (HF).

METHODS AND RESULTS

A total of 9033 (63.7%) patients had HF. The primary efficacy analysis was rates of stroke or systemic embolism (per 100 patient-years) by intention to treat. The safety outcomes were major or nonmajor clinically relevant bleeding and hemorrhagic stroke during treatment. Patients with HF were younger (72 versus 74 years), more likely to have persistent atrial fibrillation (83.0% versus 77.6%), and had higher mean CHADS2 scores (3.7 versus 3.1). The efficacy of rivaroxaban compared with warfarin was similar in patients with HF (1.90 versus 2.09) and without HF (2.10 versus 2.54; P-interaction=0.62). The risk of major or nonmajor clinically relevant bleeding with rivaroxaban was similar to warfarin in patients with HF (14.22 versus 14.02) and without HF (16.12 versus 15.35; P-interaction=0.99). A reduction in hemorrhagic stroke was observed with rivaroxaban in patients with HF as in the overall trial (adjusted hazard ratio, 0.38; 95% confidence interval, 0.19-0.76; P-interaction=0.067). Among patients with HF, the efficacy of rivaroxaban was similar, irrespective of ejection fraction <40 or ≥ 40% (P-interaction=0.38), New York Heart Association class I-II versus III-IV (P-interaction=0.68), HF preserved or reduced ejection fraction (P-interaction=0.35), or CHADS2 score 2 versus ≥ 3 (P-interaction=0.48).

CONCLUSIONS

Treatment-related outcomes were similar in patients with and without HF and across HF subgroups. These findings support the use of rivaroxaban as an alternative to warfarin in patients with atrial fibrillation and HF. Clinical Trial Registration- URL: http://www.clinicaltrials.gov. Unique identifier: NCT00403767.

Authors+Show Affiliations

Divisions of Critical Care and Cardiology, University of Alberta, Edmonton, Alberta, Canada. sv9@ualberta.caNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

23723250

Citation

van Diepen, Sean, et al. "Efficacy and Safety of Rivaroxaban in Patients With Heart Failure and Nonvalvular Atrial Fibrillation: Insights From ROCKET AF." Circulation. Heart Failure, vol. 6, no. 4, 2013, pp. 740-7.
van Diepen S, Hellkamp AS, Patel MR, et al. Efficacy and safety of rivaroxaban in patients with heart failure and nonvalvular atrial fibrillation: insights from ROCKET AF. Circ Heart Fail. 2013;6(4):740-7.
van Diepen, S., Hellkamp, A. S., Patel, M. R., Becker, R. C., Breithardt, G., Hacke, W., Halperin, J. L., Hankey, G. J., Nessel, C. C., Singer, D. E., Berkowitz, S. D., Califf, R. M., Fox, K. A., & Mahaffey, K. W. (2013). Efficacy and safety of rivaroxaban in patients with heart failure and nonvalvular atrial fibrillation: insights from ROCKET AF. Circulation. Heart Failure, 6(4), 740-7. https://doi.org/10.1161/CIRCHEARTFAILURE.113.000212
van Diepen S, et al. Efficacy and Safety of Rivaroxaban in Patients With Heart Failure and Nonvalvular Atrial Fibrillation: Insights From ROCKET AF. Circ Heart Fail. 2013;6(4):740-7. PubMed PMID: 23723250.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Efficacy and safety of rivaroxaban in patients with heart failure and nonvalvular atrial fibrillation: insights from ROCKET AF. AU - van Diepen,Sean, AU - Hellkamp,Anne S, AU - Patel,Manesh R, AU - Becker,Richard C, AU - Breithardt,Günter, AU - Hacke,Werner, AU - Halperin,Jonathan L, AU - Hankey,Graeme J, AU - Nessel,Christopher C, AU - Singer,Daniel E, AU - Berkowitz,Scott D, AU - Califf,Robert M, AU - Fox,Keith A A, AU - Mahaffey,Kenneth W, Y1 - 2013/05/30/ PY - 2013/6/1/entrez PY - 2013/6/1/pubmed PY - 2013/9/28/medline KW - anticoagulants KW - arrhythmias, cardiac KW - heart failure SP - 740 EP - 7 JF - Circulation. Heart failure JO - Circ Heart Fail VL - 6 IS - 4 N2 - BACKGROUND: In Rivaroxaban Once daily, oral, direct factor Xa inhibition Compared with vitamin K antagonism for prevention of stroke and Embolism Trial in Atrial Fibrillation (ROCKET AF), rivaroxaban was noninferior to warfarin for the prevention of stroke and systemic embolic events and significantly reduced intracranial bleeding in patients with nonvalvular atrial fibrillation. We explore the safety and efficacy of rivaroxaban in patients with heart failure (HF). METHODS AND RESULTS: A total of 9033 (63.7%) patients had HF. The primary efficacy analysis was rates of stroke or systemic embolism (per 100 patient-years) by intention to treat. The safety outcomes were major or nonmajor clinically relevant bleeding and hemorrhagic stroke during treatment. Patients with HF were younger (72 versus 74 years), more likely to have persistent atrial fibrillation (83.0% versus 77.6%), and had higher mean CHADS2 scores (3.7 versus 3.1). The efficacy of rivaroxaban compared with warfarin was similar in patients with HF (1.90 versus 2.09) and without HF (2.10 versus 2.54; P-interaction=0.62). The risk of major or nonmajor clinically relevant bleeding with rivaroxaban was similar to warfarin in patients with HF (14.22 versus 14.02) and without HF (16.12 versus 15.35; P-interaction=0.99). A reduction in hemorrhagic stroke was observed with rivaroxaban in patients with HF as in the overall trial (adjusted hazard ratio, 0.38; 95% confidence interval, 0.19-0.76; P-interaction=0.067). Among patients with HF, the efficacy of rivaroxaban was similar, irrespective of ejection fraction <40 or ≥ 40% (P-interaction=0.38), New York Heart Association class I-II versus III-IV (P-interaction=0.68), HF preserved or reduced ejection fraction (P-interaction=0.35), or CHADS2 score 2 versus ≥ 3 (P-interaction=0.48). CONCLUSIONS: Treatment-related outcomes were similar in patients with and without HF and across HF subgroups. These findings support the use of rivaroxaban as an alternative to warfarin in patients with atrial fibrillation and HF. Clinical Trial Registration- URL: http://www.clinicaltrials.gov. Unique identifier: NCT00403767. SN - 1941-3297 UR - https://www.unboundmedicine.com/medline/citation/23723250/Efficacy_and_safety_of_rivaroxaban_in_patients_with_heart_failure_and_nonvalvular_atrial_fibrillation:_insights_from_ROCKET_AF_ L2 - https://www.ahajournals.org/doi/10.1161/CIRCHEARTFAILURE.113.000212?url_ver=Z39.88-2003&amp;rfr_id=ori:rid:crossref.org&amp;rfr_dat=cr_pub=pubmed DB - PRIME DP - Unbound Medicine ER -