Olivia S Costa1,2, Bridget O'Donnell1, Burcu Vardar3, Khaled Abdelgawwad3, Christopher W Brescia4, Nitesh Sood5, Craig I Coleman1,2. 1. University of Connecticut School of Pharmacy, 69 North Eagleville Road, Storrs, CT, USA. 2. Evidence-Based Practice Center, Hartford Hospital, 80 Seymour St, Hartford, CT, USA. 3. Bayer AG, Müllerstraße 178, Berlin, Germany. 4. Department of Data Science, Freshtech IT, LLC, 66 Connecticut Blvd, East Hartford, CT, USA. 5. Arrhythmia Services, Southcoast Health, 300 Hanover St, Fall River, MA, USA.
Abstract
BACKGROUND: Patients with nonvalvular atrial fibrillation (NVAF) and type 2 diabetes are at risk of kidney, limb, and ophthalmic complications. We evaluated the rate of these complications and death in patients with NVAF and type 2 diabetes prescribed rivaroxaban or warfarin. METHODS: We analyzed Optum® de-Identified electronic health record (EHR) data from 11/2010-12/2019. We included adults with NVAF and T2D newly initiated on rivaroxaban or warfarin with ≥12 months of prior EHR activity. Patients with another indication for anticoagulation, valve disease, history of end-stage renal disease, major adverse limb events (MALE), diabetic retinopathy or pregnancy were excluded. We evaluated the incidence rate of developing a composite outcome of >40% decrease in estimated glomerular filtration incidence rate (eGFR) from baseline, eGFR <15 mL/minute/1.73 m2, need for dialysis or kidney transplant, MALE, diabetic retinopathy or death. Overlap weighting was used to balance baseline characteristics between cohorts while preserving sample size. Hazard ratios with 95% confidence intervals were calculated using propensity score-overlap weighted Cox regression. RESULTS: We included 24,912 rivaroxaban and 58,270 warfarin users. The mean ± standard deviation (SD) CHA2DS2VASc score was 4.3 ± 1.5 and modified HASBLED score was 1.5 ± 0.8. Thirty percent of rivaroxaban patients were started on 15 mg once daily, with the rest prescribed 20 mg once daily. Warfarin patients had a mean time in therapeutic range of 47 ± 28%. Patients were followed for a mean of 2.89 ± 1.95 years. Rivaroxaban was associated with a reduced hazard of the composite outcome (HR =0.93, 95%CI =0.91-0.95; absolute risk reduction =1.97 events per 1000 patient-years; number needed-to-treat =51) versus warfarin. Rivaroxaban was also associated with significant reductions in the relative hazard of a >40% decrease in eGFR from baseline (HR =0.96), need for dialysis or renal transplant (HR =0.81), and limb revascularization or major amputation (HR =0.85). Death occurred at a lower incidence rate with rivaroxaban (HR =0.92, 95%CI =0.89-0.95). CONCLUSIONS: Rivaroxaban was associated with reduced incidence rates of kidney and limb complications, and death in NVAF patients with type 2 diabetes compared to warfarin. CLINICALTRIALS.GOV IDENTIFIER: NCT04509193.
BACKGROUND:Patients with nonvalvular atrial fibrillation (NVAF) and type 2 diabetes are at risk of kidney, limb, and ophthalmic complications. We evaluated the rate of these complications and death in patients with NVAF and type 2 diabetes prescribed rivaroxaban or warfarin. METHODS: We analyzed Optum® de-Identified electronic health record (EHR) data from 11/2010-12/2019. We included adults with NVAF and T2D newly initiated on rivaroxaban or warfarin with ≥12 months of prior EHR activity. Patients with another indication for anticoagulation, valve disease, history of end-stage renal disease, major adverse limb events (MALE), diabetic retinopathy or pregnancy were excluded. We evaluated the incidence rate of developing a composite outcome of >40% decrease in estimated glomerular filtration incidence rate (eGFR) from baseline, eGFR <15 mL/minute/1.73 m2, need for dialysis or kidney transplant, MALE, diabetic retinopathy or death. Overlap weighting was used to balance baseline characteristics between cohorts while preserving sample size. Hazard ratios with 95% confidence intervals were calculated using propensity score-overlap weighted Cox regression. RESULTS: We included 24,912 rivaroxaban and 58,270 warfarin users. The mean ± standard deviation (SD) CHA2DS2VASc score was 4.3 ± 1.5 and modified HASBLED score was 1.5 ± 0.8. Thirty percent of rivaroxabanpatients were started on 15 mg once daily, with the rest prescribed 20 mg once daily. Warfarinpatients had a mean time in therapeutic range of 47 ± 28%. Patients were followed for a mean of 2.89 ± 1.95 years. Rivaroxaban was associated with a reduced hazard of the composite outcome (HR =0.93, 95%CI =0.91-0.95; absolute risk reduction =1.97 events per 1000 patient-years; number needed-to-treat =51) versus warfarin. Rivaroxaban was also associated with significant reductions in the relative hazard of a >40% decrease in eGFR from baseline (HR =0.96), need for dialysis or renal transplant (HR =0.81), and limb revascularization or major amputation (HR =0.85). Death occurred at a lower incidence rate with rivaroxaban (HR =0.92, 95%CI =0.89-0.95). CONCLUSIONS:Rivaroxaban was associated with reduced incidence rates of kidney and limb complications, and death in NVAF patients with type 2 diabetes compared to warfarin. CLINICALTRIALS.GOV IDENTIFIER: NCT04509193.