Influence of Renal Function on the Pharmacokinetics, Pharmacodynamics, Efficacy, and Safety of Non–Vitamin K Antagonist Oral Anticoagulants Matthew R.

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Influence of Renal Function on the Pharmacokinetics, Pharmacodynamics, Efficacy, and Safety of Non–Vitamin K Antagonist Oral Anticoagulants Matthew R. Weir, MD, Reinhold Kreutz, MD Mayo Clinic Proceedings Volume 93, Issue 10, Pages 1503-1519 (October 2018) DOI: 10.1016/j.mayocp.2018.06.018 Copyright © 2018 Mayo Foundation for Medical Education and Research Terms and Conditions

Figure 1 Relative efficacy and safety of apixaban in renal function subgroups.12,14-17,19,20,22 Forest plots of hazard ratios and 95% CIs for (A) stroke and systemic embolism in atrial fibrillation (AF) clinical trials,12,15-17,19 (B) major bleeding in AF clinical trials,12,14-17,19 (C) major venous thromboembolism (VTE)20 or recurrent VTE and all-cause death22 in deep vein thrombosis (DVT) prophylaxis or VTE treatment clinical trials, and (D) major bleeding20 or major and clinically relevant nonmajor bleeding22 in DVT prophylaxis or VTE treatment clinical trials. Relative risk values for the ADVANCE-2, -3 safety analysis were calculated from event rates provided by Pineo et al.20 aCreatinine clearance as determined by the Cockcroft-Gault equation. bEstimated glomerular filtration rate (eGFR) as determined by the Chronic Kidney Disease Epidemiology Collaboration equation. All definitions and renal function categories are maintained as used in the original studies. CKD = chronic kidney disease. To convert creatinine values to μmol/L, multiply by 88.4. Mayo Clinic Proceedings 2018 93, 1503-1519DOI: (10.1016/j.mayocp.2018.06.018) Copyright © 2018 Mayo Foundation for Medical Education and Research Terms and Conditions

Figure 2 Relative efficacy and safety of dabigatran in renal function subgroups.24,25,27-29 Forest plots of hazard ratios and 95% CIs for (A) stroke and systemic embolism in atrial fibrillation (AF) clinical trials,24,25,27 (B) major bleeding in AF clinical trials,24,25 (C) total venous thromboembolism (VTE) and all-cause mortality in deep vein thrombosis (DVT) prophylaxis clinical trials,28 and (D) major and clinically relevant nonmajor bleeding in VTE treatment clinical trials.29 Data for Eriksson et al28 are absolute risk differences (the difference in the proportion of patients with an event) rather than hazard ratios.28 aCreatinine clearance as determined by the Cockcroft-Gault equation. bEstimated glomerular filtration rate as determined by the Chronic Kidney Disease Epidemiology Collaboration equation. All definitions and renal function categories are maintained as used in the original studies. Mayo Clinic Proceedings 2018 93, 1503-1519DOI: (10.1016/j.mayocp.2018.06.018) Copyright © 2018 Mayo Foundation for Medical Education and Research Terms and Conditions

Figure 3 Relative efficacy and safety of edoxaban in renal function subgroups.32-34 Forest plots of hazard ratios and 95% CIs for (A) stroke and systemic embolism in atrial fibrillation (AF) clinical trials,32,33 (B) major bleeding32 or major and clinically relevant nonmajor bleeding33 in AF clinical trials, (C) recurrent venous thromboembolism (VTE) in VTE treatment clinical trials,34 and (D) major and clinically relevant nonmajor bleeding in VTE treatment clinical trials.34 Relative risk values for the ENSURE-AF efficacy and safety analyses were calculated from event rates provided by Goette et al.33 All definitions and renal function categories are maintained as used in the original studies. Mayo Clinic Proceedings 2018 93, 1503-1519DOI: (10.1016/j.mayocp.2018.06.018) Copyright © 2018 Mayo Foundation for Medical Education and Research Terms and Conditions

Figure 4 Relative efficacy and safety of rivaroxaban in renal function subgroups.35,36,38-41,43,45-47,49,50 Forest plots of hazard ratios and 95% CIs for (A) stroke and systemic embolism in atrial fibrillation (AF) clinical trials,35,36,38-41,43 (B) major and clinically relevant nonmajor bleeding in AF clinical trials,35,36,38-41,43 (C) symptomatic venous thromboembolism (VTE) plus all-cause mortality,45 symptomatic recurrent VTE or symptomatic VTE,46,47,49 and unexplained death50 in deep vein thrombosis (DVT) prophylaxis or VTE treatment clinical trials, and (D) major and clinically relevant nonmajor bleeding in DVT prophylaxis or VTE treatment clinical trials.45-47,49,50 All definitions and renal function categories are maintained as used in the original studies. Mayo Clinic Proceedings 2018 93, 1503-1519DOI: (10.1016/j.mayocp.2018.06.018) Copyright © 2018 Mayo Foundation for Medical Education and Research Terms and Conditions