Rivaroxaban is superior to warfarin in reducing vascular mortality and bleeding-related hospitalisations in patients with nonvalvular atrial fibrillation (NVAF) and type 2 diabetes.

Research presented recently at the ACC.21, and published in Cardiovascular Diabetology, comprised electronic health data from 32,000 patients newly started on rivaroxaban (15 or 20 mg daily) and 84,000 patients newly started on warfarin (time in therapeutic INR range 47%).

The US study found rivaroxaban was associated with a reduced risk of the composite outcome of stroke/systemic embolism or vascular death (HR 0.91) driven by a reduction in vascular death (HR 0.90).

“When SSE was evaluated separately, no difference was detected (1.31 vs. 1.34; HR = 0.97, 95% CI 0.90–1.04),” the study said.

Hospitalisation for any type of major/clinically relevant nonmajor (CRNM) bleeding was less frequent in rivaroxaban users compared to warfarin users (2.17 vs. 2.31; HR = 0.94, 95% CI 0.89–0.99)

Similarly, critical organ bleeding (0.35 vs. 0.54; HR = 0.63, 95% CI 0.55–0.72) and intracranial haemorrhage (0.29 vs. 0.40; HR = 0.72, 95% CI 0.62–0.84) was less frequent in the rivaroxaban group.

The study said their findings were consistent with the diabetes subanalysis of the ROCKET-AF study.

“We found rivaroxaban use was associated with effectiveness and safety benefits versus warfarin; most notably, significant reductions in vascular death [10% relative risk reduction (RRR)], critical organ bleeding (37% RRR) and intracranial haemorrhage (28% RRR),” the study said.

“Given vascular mortality is substantially increased in NVAF patients with comorbid T2D and the accumulating data suggesting DOACs may be associated with up to a 17% relative and ~ 1% absolute risk reduction in vascular death, the practice of preferentially using DOACs over a VKA in a diabetic appears warranted.”

“Our data should provide clinicians with additional confidence in selecting rivaroxaban in NVAF patients with comorbid T2D,” they concluded.

Commenting on the study for the limbic, Dr Sidney Lo said the real world data from such a large dataset was “reaffirming”.

“Yes, there is a selection bias that you can’t account for but overall it is reaffirming in the sense that rivaroxaban here is better than warfarin particularly in the combined endpoint,” he said.

Dr Lo, director of the cardiac catheter lab at Liverpool Hospital and chair of the interventional council of CSANZ , said too many patients with AF and comorbid diabetes die from vascular death.

“So many people have diabetes and I think in Australia the number of people living with diabetes is going to triple to 3 million people by 2025 so we are very concerned about diabetes patients and looking to protect them from vascular deaths…and here was a 10% reduction compared to warfarin.”

He said while other DOACs were fairly consistent in their trials against warfarin, there were no head to head comparisons so it was difficult to extrapolate the findings from the current study to other agents.

The study noted 20mg of rivaroxaban was relatively more effective versus warfarin than 15mg of the DOAC.