Characteristics and outcomes of patients with diabetes mellitus selected for dual pathway inhibition in clinical practice: The XATOA registry.

BACKGROUND

Patients with diabetes mellitus (DM) and established cardiovascular disease (CVD) face a markedly increased risk of future major adverse cardiovascular events (MACE). This study aimed to assess the clinical characteristics and outcomes of patients with DM with CVD initiating dual pathway inhibition (DPI) with rivaroxaban 2.5 mg twice daily plus aspirin in clinical practice.

METHODS

The prospective XATOA (Xarelto plus Acetylsalicylic acid: Treatment patterns and Outcomes in patients with Atherosclerosis) registry enrolled patients with coronary artery disease (CAD) and/or peripheral artery disease (PAD). Baseline characteristics, cardiovascular outcomes, and bleeding rates were analyzed according to diabetes status. Among patients with DM, outcomes were also compared by vascular territory (CAD, PAD, or both), and findings were benchmarked against the randomized COMPASS trial.

RESULTS

Among 5532 patients included in XATOA, 2130 (38.5%) had diabetes, predominantly type 2 (96.1%). Patients with DM with PAD alone were less likely to receive optimal preventive therapies than those with CAD or CAD + PAD. Compared to patients without diabetes, patients with DM had a 59% higher risk of major adverse vascular events (MAVE), including MACE and major adverse limb events (MALE) (p < 0.001). Event rates (per 100 patient-years) in patients with DM were 2.1 for CAD, 10.1 for CAD + PAD, and 14.2 for PAD alone. Major bleeding rates were similar across diabetes status (4.3/100 patient-years) and vascular territories. The composite rate of MACE and major bleeding in patients with DM aligned closely with results from the COMPASS trial.

CONCLUSION

Patients with DM with CVD are at significantly high cardiovascular risk, and those with PAD appear to be undertreated. Real-world outcomes observed in the XATOA registry are consistent with randomized trial data, supporting the benefit of DPI in this high-risk population.