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. 2024 Mar 28;13(7):1956.
doi: 10.3390/jcm13071956.

The Net Clinical Outcome of Dual-Pathway Inhibition in Clinical Practice: The "Xarelto plus Acetylsalicylic Acid: Treatment Patterns and Outcomes in Patients with Atherosclerosis" Registry

Alexander Breitenstein  1   2 , Alain Gay  3 , Kai Vogtländer  4 , Keith A A Fox  5 , Jan Steffel  2 ; XATOA Publication Committee
Affiliations

The Net Clinical Outcome of Dual-Pathway Inhibition in Clinical Practice: The "Xarelto plus Acetylsalicylic Acid: Treatment Patterns and Outcomes in Patients with Atherosclerosis" Registry

Alexander Breitenstein et al. J Clin Med. .

Abstract

Background: In the COMPASS trial, the combination of acetylsalicylic acid (ASA) plus 2.5 mg rivaroxaban twice daily (dual-pathway inhibition, DPI) has been shown to be superior to ASA monotherapy for the reduction in ischemic major adverse cardiovascular events (MACEs, i.e., cardiovascular death, stroke, or myocardial infarction). Methods: The international XATOA registry (Xarelto plus Acetylsalicylic acid: Treatment patterns and Outcomes in patients with Atherosclerosis) is a prospective post-approval registry that investigates the cardiovascular outcomes of patients taking ASA plus 2.5 mg rivaroxaban. The aim of this pre-specified analysis was to determine the net clinical outcome (NCO), i.e., a combination of MACEs and bleeding events, of DPI in patients from daily clinical practice. Results: Among the 5615 patients, the presence of multiple risk factors resulted in an increase in the total risk of experiencing an NCO event, e.g., from 1.27% (one risk factor) to 2.18% (two risk factors) and 4.07% (three or more risk factors), respectively, with ischemic MACE representing the primary driver of bleeding complications. Conclusions: In the real-world XATOA registry, the annual rate of NCO events was low and numerically similar to those seen in the treatment group in the randomized COMPASS trial.

Keywords: XATOA registry; dual-pathway inhibition; net clinical benefit.

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Conflict of interest statement

A.B. has received consultant and/or speaker fees from Abbott, Bayer Healthcare, Biosense Webster, Biotronik, Boston Scientific, Bristol-Myers Squibb, Cook Medical, Daiichi Sankyo, Medtronic, Pfizer, and Spectranetics/Philips. K.A.A.F. has received honoraria from Bayer, AstraZeneca, and Milestone. A.G. and K.V. are employees of Bayer AG, Germany. J.S. has received consultant and/or speaker fees from Abbott, Alexion, AstraZeneca, Bayer, Berlin-Chemie, Biosense Webster, Biotronik, Boehringer-Ingelheim, Boston Scientific, BMS, Daiichi Sankyo, Medscape, Medtronic, Menarini, Organon, Pfizer, Saja, Servier, and WebMD. He reports ownership of Swiss EP and CorXL. J.S. has received grant support through his previous institution (University Hospital Zurich) from Abbott, Bayer Healthcare, Biosense Webster, Biotronik, Boston Scientific, Daiichi Sankyo, and Medtronic.

Figures

Figure 1
Figure 1
Cumulative incidence of the NCO in the XATOA population.
Figure 2
Figure 2
Total and annual rate of net clinical outcome by subgroups in the XATOA population.
Figure 3
Figure 3
Cumulative incidence of net clinical outcome in patients with either polyvascular disease, heart failure, diabetes mellitus, or renal insufficiency.
Figure 4
Figure 4
Total and annual risk of net clinical outcome according to the number of risk factors in the XATOA population.
Figure 5
Figure 5
Annual risk of a net clinical outcome event in XATOA and COMPASS.
See this image and copyright information in PMC

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