ROCKET-AF: Rivaroxaban as Effective as Warfarin for Diabetic Patients With Afib

Deborah Brauser

August 07, 2015

NEW YORK CITY, NY — More research shows that the oral factor Xa inhibitor rivaroxaban (Xarelto, Bayer/Johnson & Johnson) may be an effective treatment option over warfarin for patients with atrial fibrillation (AF), regardless of diabetes status[1].

Analysis of more than 5000 patients from the ROCKET-AF trial who also had diabetes mellitus showed no significant differences in rates of stroke and systemic embolism or in rates of major bleeding and intracerebral hemorrhage between those treated with rivaroxaban and those treated with warfarin. In addition, these rates did not differ between patients who did and did not have diabetes.

"Similarly, the efficacy and safety impact of rivaroxaban compared with warfarin was not affected by diet or use of oral hypoglycemic agents or insulin therapy for glycemic control," write the investigators, led by Dr Sameer Bansilal (Icahn School of Medicine at Mount Sinai, New York City).

The findings were published online July 17, 2015 in the American Heart Journal.

"Robust Assessment"

As reported by heartwire from Medscape, previous findings from ROCKET-AF showed that rivaroxaban once daily was not inferior to adjusted-dose warfarin in patients with nonvalvular AF and caused fewer incidents of intracranial and fatal bleeding. However, data specifically focused on the patients with both AF and diabetes (n=5695) have not been previously released.

In the current analysis, overall adjusted rates of stroke, systemic embolism, and bleeding were higher in those with diabetes vs those without. However, diabetic status did not have a significantly impact on treatment effectiveness.

For the participants with diabetes, the rate of stroke or systemic embolism, the primary efficacy event, was 1.74 per 100 patient-years for the group that received rivaroxaban vs 2.14 per 100 patient-years for those receiving warfarin (HR 0.82). The rate was 2.12 vs 2.32/100 patient years, respectively, for the patients who did not have diabetes (HR 0.92).

The rates of ischemic stroke or systemic embolism was 1.48 vs 1.55/100 patient-years for the two treatment groups, respectively, who had diabetes (HR 0.97) and 1.71 vs 1.80/100 patient years, respectively, for those without diabetes (HR 0.95).

There were also no significant differences between the two treatment groups in regard to the safety end points.

Treatment Comparisons in Diabetic and Nondiabetic Patients*

Safety outcomes HR (95% CI)* in diabetics HR (95% CI)* in nondiabetics
Major bleeding 1.00 (0.81–1.24) 1.12 (0.93–1.35)
Major or nonmajor clinically relevant bleeding 0.98 (0.88–1.10) 1.09 (0.99–1.20)
Intracerebral hemorrhage 0.62 (0.36–1.05) 0.72 (0.46–1.12)
Hemorrhagic stroke 0.51 (0.24–1.09) 0.65 0.37–1.16)
*Rivaroxaban vs warfarin

The investigators note that ROCKET-AF had more patients with diabetes (39%) than several other "contemporary trials" of oral anticoagulants, including RE-LY, AVERROES, ARISTOTLE, and ENGAGE AF-TIMI. This allowed "robust assessment of an alternative to warfarin in diabetic patients with nonvalvular AF," they write.

That said, they note limitations, including that this was a post hoc subgroup analysis and that a high mean CHADS2 risk score was required for study enrollment, which "may limit generalizability to patients with diabetes at lower thromboembolism risk."

ROCKET-AF was funded by Johnson & Johnson Pharmaceutical Research and Development and by Bayer Healthcare. Bansilal reports receiving consulting fees and institutional research grants from AstraZeneca. Disclosures for the coauthors are listed in the article.

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