Background

In the phase III COMPASS trial, dual pathway inhibition (DPI) with rivaroxaban 2.5 mg twice daily plus acetylsalicylic acid (ASA) reduced the risk of major adverse cardiovascular events (MACE) and major adverse limb events (MALE) compared with ASA alone in patients with chronic coronary artery disease (CAD), peripheral artery disease (PAD) or both. In COMPASS, the risk of the primary safety outcome, a modified definition of International Society on Thrombosis and Haemostasis major bleeding, was increased with DPI versus ASA. However, the risk of fatal, critical organ or intracranial haemorrhage was not significantly different between treatment groups. Subsequently, the phase III VOYAGER PAD trial showed results generally consistent with COMPASS in patients with symptomatic PAD requiring peripheral revascularisation treated with DPI versus ASA. The use of DPI in clinical practice has not been widely studied so far. Therefore, the post-approval XATOA study is investigating the clinical characteristics and event rates of patients with chronic CAD, PAD or both who receive DPI in clinical practice. The current prespecified analysis aims to assess clinical characteristics and outcomes in the subgroup of patients with CAD enrolled in Germany.

Patients and methods

The prospective, international, multicentre, single-arm registry study XATOA (NCT03746275) enrolled adult patients with chronic CAD, PAD or both. Patients receiving DPI up to 4 weeks prior to enrolment as part of routine clinical practice and according to the local label were enrolled. The primary outcome of XATOA is to describe treatment patterns in patients with chronic CAD, PAD or both receiving DPI in clinical practice. Major adverse cardiac events (MACE) , major adverse limb events (MALE), thromboembolic events, haemorrhagic events, death, procedures and hospitalisation are key secondary outcomes. Because of the non-interventional nature of the study, treatment decisions were at the discretion of the prescribing physician. Patients underwent follow-up for a planned period of at least 1 year.

Results and conclusions

A total of 5,831 patients have been enrolled in XATOA and the study is expected to complete in June 2021  Baseline characteristics, demographics, treatment patterns and details about DPI therapy, as well as secondary outcomes, will be reported for the subgroup of patients with CAD in Germany (n=2771). This analysis will provide insight into the use of DPI in patients with chronic CAD in routine clinical practice in Germany. An understanding of the risk profiles and event rates in these patients will be important for clinicians who treat patients with chronic CAD.