Pharmacotherapy for diabetes and stroke risk: Results from ROCKET AF

Francis E Ugowe; Anne S Hellkamp; Allen Wang; Richard C Becker; Scott D Berkowitz; Günter Breithardt; Keith A A Fox; Jonathan L Halperin; Graeme J Hankey; Kenneth W Mahaffey; Christopher C Nessel; Daniel E Singer; Manesh R Patel; Jonathan P Piccini; of the ROCKET AF Steering Committee and Investigators

doi:10.1016/j.hroo.2021.04.001

Pharmacotherapy for diabetes and stroke risk: Results from ROCKET AF

Heart Rhythm O2. 2021 Apr 20;2(3):215-222. doi: 10.1016/j.hroo.2021.04.001. eCollection 2021 Jun.

Authors

Francis E Ugowe¹, Anne S Hellkamp², Allen Wang³, Richard C Becker⁴, Scott D Berkowitz⁵, Günter Breithardt⁶, Keith A A Fox⁷, Jonathan L Halperin⁸, Graeme J Hankey⁹, Kenneth W Mahaffey¹⁰, Christopher C Nessel¹¹, Daniel E Singer¹², Manesh R Patel^{1

2}, Jonathan P Piccini^{1

2}; of the ROCKET AF Steering Committee and Investigators

Affiliations

¹ Duke University Medical Center, Duke University School of Medicine, Durham, North Carolina.
² Duke Clinical Research Institute, Duke University School of Medicine, Durham, North Carolina.
³ Duke Center for Atrial Fibrillation, Department of Medicine, Duke University Medical Center, Durham, North Carolina.
⁴ University of Cincinnati College of Medicine, Cincinnati, Ohio.
⁵ Bayer U.S. LLC, Parsippany, New Jersey.
⁶ Hospital of the University of Münster, Münster, Germany.
⁷ University of Edinburgh and Royal Infirmary of Edinburgh, Edinburgh, United Kingdom.
⁸ Mount Sinai School of Medicine, New York, New York.
⁹ School of Medicine and Pharmacology, The University of Western Australia, Crawley, Australia.
¹⁰ Stanford Center for Clinical Research, Stanford University, School of Medicine, Stanford, California.
¹¹ Janssen Research & Development, Raritan, New Jersey.
¹² Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts.

Abstract

Background: Insulin use may be a better predictor of stroke risk and morbidity and mortality than diabetes in patients with atrial fibrillation (AF).

Objectives: Determine if the increased risk of stroke observed in patients with AF and diabetes is restricted to those treated with insulin.

Methods: We analyzed the association between diabetes and treatment and the occurrence of stroke/systemic embolism, myocardial infarction (MI), all-cause death, vascular death, composite outcomes, and bleeding risk in the ROCKET AF trial.

Results: In a cohort of 14,264 patients, there were 40.3% (n = 5746) with diabetes, 5.9% (n = 842) on insulin, 18.9% (n = 2697) on oral medications, and 11.9% (n = 1703) diet-controlled. Compared to those without diabetes, patients with non-insulin-treated diabetes had increased risks of stroke (hazard ratio [HR] 1.33, 95% confidence interval [CI] 1.06-1.68), MI (HR 1.64, 95% CI 1.17-2.30), all-cause death (HR 1.26, 95% CI 1.08-1.46), vascular death (HR 1.33, 95% CI 1.11-1.60), and composite outcomes (HR 1.37, 95% CI 1.18-1.157). Patients with insulin-treated diabetes had a significantly higher risk of MI (HR 2.31, 95% CI 1.33-4.01) and composite outcomes (HR 1.57, 95% CI 1.19-2.08) compared to those without diabetes. There were no significant differences between insulin-treated and non-insulin-treated diabetes for any outcome.

Conclusion: Among patients with AF and diabetes, there were no significant differences in outcomes in insulin-treated diabetes compared to non-insulin-treated diabetes.

Keywords: Atrial fibrillation; Diabetes; Rivaroxaban; Stroke; Warfarin.