Kidney, limb and ophthalmic complications, and death in patients with nonvalvular atrial fibrillation and type 2 diabetes prescribed rivaroxaban or warfarin: an electronic health record analysis

References

• Saeedi P, Petersohn I, Salpea P, Malanda B, Karuranga S, Unwin N, et al.; IDF Diabetes Atlas Committee. Global and regional diabetes prevalence estimates for 2019 and projections for 2030 and 2045: Results from the International Diabetes Federation Diabetes Atlas, 9th edition. Diabetes Res Clin Pract. 2019;157:107843.
   PubMed Web of Science ®Google Scholar
• Grant PJ, Cosentino F. The 2019 ESC Guidelines on diabetes, pre-diabetes, and cardiovascular diseases developed in collaboration with the EASD: new features and the ‘Ten Commandments’ of the 2019 Guidelines are discussed by Professor Peter J. Grant and Professor Francesco Cosentino, the Task Force chairmen. Eur Heart J. 2019;40(39):3215–3217.
   PubMed Web of Science ®Google Scholar
• Dublin S, Glazer NL, Smith NL, et al. Diabetes mellitus, glycemic control, and risk of atrial fibrillation. J Gen Intern Med. 2010;25(8):853–858.
   PubMed Web of Science ®Google Scholar
• Abumuaileq RR. Atrial fibrillation in the old/very old: prevalence and burden, predisposing factors and complications. E Journ Cardiol Pract. 2019;17:e1-7.
   Google Scholar
• Xiong Z, Liu T, Tse G, et al. A machine learning aided systematic review and meta-analysis of the relative risk of atrial fibrillation in patients with diabetes mellitus. Front Physiol. 2018;8:835. https://doi.org/10.3389/fphys.2018.00835
   Web of Science ®Google Scholar
• Steinberg BJ, Gao H, Shrader P, Pieper K, Thomas L, Camm AJ, et al.; ORBIT-AF Investigators. International trends in clinical characteristics and oral anticoagulation treatment for patients with atrial fibrillation: Results from the GARFIELD-AF, ORBIT-AF I, and ORBIT-AF II registries. Am Heart J. 2017;194:132–140.
   PubMed Web of Science ®Google Scholar
• January CT, Wann LS, Calkins H, et al. 2019 AHA/ACC/HRS focused update of the 2014 AHA/ACC/HRS guideline for the management of patients with atrial fibrillation: a report of the American College of Cardiology/American Heart Association task force on clinical practice guidelines and the heart rhythm society. J Am Coll Cardiol. 2019;74(1):104–132.
   PubMed Web of Science ®Google Scholar
• Hindricks G, Potpara T, Dagres N, et al.; ESC Scientific Document Group. 2020 ESC Guidelines for the diagnosis and management of atrial fibrillation developed in collaboration with the European Association of Cardio-Thoracic Surgery (EACTS. Eur Heart J. 2021;42(5):373–498.
   PubMed Web of Science ®Google Scholar
• Bansilal S, Bloomgarden Z, Halperin JL, et al.; ROCKET AF Steering Committee and Investigators. Efficacy and safety of rivaroxaban in patients with diabetes and nonvalvular atrial fibrillation: the 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 Trial). Am Heart J. 2015;170(4):675–682.e8.
   PubMed Web of Science ®Google Scholar
• Patel MR, Mahaffey KW, Garg J, et al.; the ROCKET AF Steering Committee. Rivaroxaban versus warfarin in nonvalvular atrial fibrillation. N Engl J Med. 2011;365(10):883–891.
   PubMed Web of Science ®Google Scholar
• Baker WL, Beyer-Westendorf J, Bunz TJ, et al. Effectiveness and safety of rivaroxaban and warfarin for prevention of major adverse cardiovascular or limb events in patients with non-valvular atrial fibrillation and type 2 diabetes. Diabetes Obes Metab. 2019;21(9):2107–2114.
   PubMed Web of Science ®Google Scholar
• Narres M, Kvitkina T, Claessen H, et al. Incidence of lower extremity amputations in the diabetic compared with the non-diabetic population: a systematic review. PLoS One. 2017;12(8):e0182081
   PubMed Web of Science ®Google Scholar
• Sun MT, Wood MK, Chan W, et al. Risk of intraocular bleeding with novel oral anticoagulants compared with warfarin: a systematic review and meta-analysis. JAMA Ophthalmol. 2017;135(8):864–870.
   PubMed Web of Science ®Google Scholar
• Hernandez AV, Bradley G, Khan M, et al. Rivaroxaban vs. warfarin and renal outcomes in non-valvular atrial fibrillation patients with diabetes. Eur Heart J Qual Care Clin Outcomes. 2020;6(4):301–307.
   PubMed Web of Science ®Google Scholar
• Yao X, Tangri N, Gersh BJ, et al. Renal outcomes in anticoagulated patients with atrial fibrillation. J Am Coll Cardiol. 2017;70(21):2621–2632.
   PubMed Web of Science ®Google Scholar
• Chan Y, Lee H, Li P, et al. Effectiveness, safety, and major adverse limb events in atrial fibrillation patients with concomitant diabetes mellitus treated with non-vitamin K antagonist oral anticoagulants. Cardiovasc Diabetol. 2020;19(1):63.
   PubMed Web of Science ®Google Scholar
• Coleman CI, Bunz TJ, Eriksson D, et al. Effectiveness and safety of rivaroxaban vs warfarin in people with non-valvular atrial fibrillation and diabetes: an administrative claims database analysis. Diabet Med. 2018;35(8):1105–1110.
   PubMed Web of Science ®Google Scholar
• Yao RJ, Andrade JG, Deyell MW, et al. Sensitivity, specificity, positive and negative predictive values of identifying atrial fibrillation using administrative data: a systematic review and meta-analysis. Clin Epidemiol. 2019; 11:753–767. https://doi.org/10.2147/FCLEP.S206267
   PubMed Web of Science ®Google Scholar
• Khokhar B, Jette N, Metcalfe A, et al. Systematic review of validated case definitions for diabetes in ICD-9-coded and ICD-10-coded data in adult populations. BMJ Open. 2016;6(8):e009952
   PubMed Web of Science ®Google Scholar
• Rosendaal FR, Cannegieter SC, van der Meer FJ, et al. A method to determine the optimal intensity of oral anticoagulant therapy. Thromb Haemost. 1993;69(3):236–239.
   PubMed Web of Science ®Google Scholar
• Thomas LE, Li F, Pencina MJ. Overlap weighting: a propensity score method that mimics attributes of a randomized clinical trial. JAMA. 2020;323(23):2417–2418.
   PubMed Web of Science ®Google Scholar
• Li F, Thomas LE, Li F. Addressing extreme propensity scores via the overlap weights. Am J Epidemiol. 2019;188(1):250–257.
   PubMed Web of Science ®Google Scholar
• Yahagi K, Kolodgie FD, Lutter C, et al. Pathology of human coronary and carotid artery atherosclerosis and vascular calcification in diabetes mellitus. Arterioscler Thromb Vasc Biol. 2017;37(2):191–204.
   PubMed Web of Science ®Google Scholar
• van Gorp RH, Schurgers LJ. New insights into the pros and cons of the clinical use of vitamin K antagonists (VKAs) versus direct oral anticoagulants (DOACs). Nutrients. 2015;7(11):9538–9557.
   PubMed Web of Science ®Google Scholar
• Fordyce CB, Hellkamp AS, Lokhnygina Y, et al.; ROCKET AF Steering Committee and Investigators. On-treatment outcomes in patients with worsening renal function with rivaroxaban compared with Warfarin: Insights From ROCKET AF. Circulation. 2016;134(1):37–47.
   PubMed Web of Science ®Google Scholar
• Hijazi Z, Hohnloser SH, Andersson U, et al. Efficacy and safety of apixaban compared with warfarin in patients with atrial fibrillation in relation to renal function over time: Insights from the ARISTOTLE randomized clinical trial. JAMA Cardiol. 2016;1(4):451–460.
   PubMed Web of Science ®Google Scholar
• Bohm M, Ezekowitz MD, Connolly SJ, et al. Changes in renal function in patients with atrial fibrillation: An analysis from the RE-LY trial. J Am Coll Cardio. 2015;65(23):2481–2493.
   PubMed Web of Science ®Google Scholar
• Bakris GL, Agarwal R, Anker SD, et al.; on behalf of the FIDELIO-DKD study investigators. Design and baseline characteristics of the finerenone in reducing kidney failure and disease progression in diabetic kidney disease. Am J Nephrol. 2019;50(5):333–344.
   PubMed Web of Science ®Google Scholar
• Zelniker TA, Wiviott SD, Raz I, et al. SGLT2 inhibitors for primary and secondary prevention of cardiovascular and renal outcomes in type 2 diabetes: a systematic review and meta-analysis of cardiovascular outcome trials. Lancet. 2019;393(10166):31–39.(18).
   PubMed Web of Science ®Google Scholar
• Bhatt DL, Eikelboom JW, Connolly SJ, et al. Role of combination antiplatelet and anticoagulation therapy in diabetes mellitus and cardiovascular disease: insights from the COMPASS trial. Circulation. 2020;141(23):1841–1854.
   PubMed Web of Science ®Google Scholar
• Crawford TN, Alfaro DV, Kerrison JB, et al. Diabetic retinopathy and angiogenesis. Curr Diabetes Rev. 2009;5(1):8–13.
   PubMedGoogle Scholar
• Gandhi SK, Salmon W, Kong SX, et al. Administrative databases and outcomes assessment: an overview of issues and potential utility. JMCP. 1999;5(3):215–222.
   Google Scholar
• Baker WL, Cios DA, Sander SD, et al. Meta-analysis to assess the quality of warfarin control in atrial fibrillation patients in the United States. J Manag Care Pharm. 2009;15(3):244–252.
   PubMed Web of Science ®Google Scholar
• Triplitt C, Alvarez CA. Best practices for lowering the risk of cardiovascular disease in diabetes. Diabetes Spectr. 2008;21(3):177–189.
   Google Scholar