By Nancy A. Melville
MELBOURNE, Australia -- July 12, 2019 -- Rivaroxaban is associated with significant reductions in cardiovascular or limb events and adverse renal outcomes, compared with warfarin, for patients with non-valvular atrial fibrillation (AF) with type 2 diabetes, according to a study presented at the 2019 Annual Meeting of the International Society on Thrombosis and Hemostasis (ISTH).
“We found that among patients with non-valvular AF and type 2 diabetes treated in routine practice, rivaroxaban was associated with lower risks of both major adverse cardiovascular events and major adverse limb events versus warfarin, with no difference in major bleeding,” reported William L. Baker, PharmD, University of Connecticut School of Pharmacy, Storrs, Connecticut.
For the study, the researchers analysed data from 10,700 patients treated with rivaroxaban, including 24.1% who received a reduced dose, and 13,946 warfarin users.
With a follow-up of 1.4 years, 11% of patients developed peripheral artery disease, with 1.4% having prior major adverse limb events and 0.3% having a history of major limb amputation at baseline.
Those treated with rivaroxaban showed a 25% reduction in the risk of having a major adverse cardiovascular event, and as much as a 63% reduction in the risk of major adverse limb event compared with those treated with warfarin.
For cardiac events, those in the rivaroxaban had notable reductions versus warfarin in ischaemic stroke (hazard ratio [HR] = 0.83), myocardial infarction (HR = 0.77), and for intracranial bleeding (HR = 0.59).
Gastrointestinal bleeding between the groups was similar (HR = 1.04).
For major adverse limb events, the risk of major limb amputation was substantially lower with rivaroxaban (HR = 0.20), as was the risk of endovascular revascularisation (HR = 0.27).
Using the MarketScan data from 2011 to 2017, the authors also compared renal outcomes. Those with stage 5 chronic kidney disease or undergoing haemodialysis at baseline were excluded.
The patients included 10,018 treated with rivaroxaban (22.6% receiving a reduced dose) and 11,665 treated with warfarin. Of the patients, 10.7% had stage 3/4 chronic kidney disease at baseline.
With a median follow-up of 1.7 years, treatment with rivaroxaban was associated with a 17% reduced risk of acute kidney injury compared with warfarin and an 18% lower risk of developing stage 5 chronic kidney disease/haemodialysis.
The results were consistent in an intent-to-treat sensitivity analysis that excluded patients with
Acute kidney injury at baseline and limited to patients with more than 365 days of follow- up.
[Presentation titles: Effectiveness and Safety of Rivaroxaban and Warfarin for Prevention of Major Adverse Cardiovascular or Limb Events in Nonvalvular Atrial Fibrillation Patients With Type 2 Diabetes. Abstracts OC 21.3
Rivaroxaban Versus Warfarin and Renal Outcomes in Non-Valvular Atrial
Fibrillation Patients With Diabetes. Abstract OC 21.2]
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