Takeaway
- Direct oral anticoagulants (DOACs) are effective and safe alternatives to warfarin for the prevention of stroke in patients with atrial fibrillation (AF) and type 2 diabetes mellitus (T2DM).
Why this matters
- The evidence on DOACs’ effectiveness and safety in patients with AF and T2DM from clinical practices is still limited.
- Post-hoc analysis of clinical trials show that the effectiveness and safety of DOACs extend to patients with both conditions.
Study design
- This retrospective cohort study included 8555 treatment-naïve patients with AF and T2DM using data from the UK Clinical Practice Research Datalink (CPRD; 2011-2018).
- Main efficacy outcome: composite of ischaemic stroke, unspecified stroke and haemorrhagic stroke; secondary efficacy outcome: myocardial infarction (MI).
- Safety outcomes: major bleeding (composite of intracranial bleeding, gastrointestinal [GI] bleeding and bleeding on other clinically relevant sites).
- Funding: None.
Key results
- Overall, 3437 (40.18%) patients were prescribed a DOAC and 5118 (59.82%) warfarin.
- No significant differences were seen between DOACs and warfarin in the risk of:
- any stroke (adjusted HR [aHR], 1.15; 95% CI, 0.82-1.60);
- ischaemic and unspecified stroke (aHR, 1.23; 95% CI, 0.86-1.76);
- haemorrhagic stroke (aHR, 0.75; 95% CI, 0.30-1.85); and
- MI (aHR, 1.39; 95% CI, 0.99-1.97).
- Similarly, no significant differences were seen in the risk of:
- major bleeding (aHR, 0.83; 95% CI, 0.68-1.03);
- intracranial bleeding (aHR, 0.66; 95% CI, 0.34-1.30);
- GI bleeding (aHR, 0.88; 95% CI, 0.60-1.30); and
- bleeding on other clinically relevant sites (aHR, 0.89; 95% CI, 0.60-1.31).
- In subgroup analyses stratified by gender and diabetes severity, the risk of stroke and bleeding remained consistent.
Limitations
- Retrospective design.
This clinical summary originally appeared on Univadis, part of the Medscape Professional Network.