New data from recent clinical trials has led to the recommendation of the use of rivaroxaban in the Standards of Medical Care in Diabetes-2021 supplement.
Recommendation 10.38 (Section 10 – Cardiovascular Disease and Risk Management), which addressed long-term dual antiplatelet therapy and combination therapy with aspirin plus low dose rivaroxaban, was added to the Antiplatelet Agents section. Also added to the section were new evidence taken from the THEMIS, THEMIS-PCI, COMPASS, and VOYAGER-PAD clinical trials. The recommendation (an A-evidence level recommendation in the document) read as follows:
- Combination therapy with aspirin plus low-dose rivaroxaban should be considered for patients with stable coronary and/or peripheral artery disease and low bleeding risk to prevent major adverse limb and cardiovascular events.
Among the data supporting the recommendation that was addressed in the document:
- COMPASS data suggesting rivaroxaban 2.5 mg twice daily was superior to aspirin plus placebo for reducing CV ischemic events (effects which were greater in patients with diabetes).
- VOYAGER-PAD data suggesting that rivaroxaban 2.5 mg twice daily plus aspirin or placebo, or placebo plus aspirin. Rivaroxaban was linked with a significant reduction in incidence of ischemic CV events (it traded off with an increased bleeding risk).
“The risks and benefits of dual antiplatelet or antiplatelet plus anticoagulant treatment strategies should be thoroughly discussed with eligible patients, and shared decision-making should be used to determine an individually appropriate treatment approach,” the document authors wrote at the conclusion of the section.
Click here to access the Summary of Revisions: Standards of Medical Care in Diabetes – 2021.
Click here to read Section 10.