Key result
Dual-pathway inhibition in PAD linked to ~9% MALE rate, exceeding COMPASS despite lower MACE.
Why the study?
Dual-pathway inhibition with aspirin and rivaroxaban showed net clinical benefit in COMPASS, but patient characteristics and outcomes needed evaluation specifically in German PAD patients from the XATOA registry compared to COMPASS.
What are the clinical outcomes and patient characteristics of German PAD patients receiving dual-pathway inhibition with aspirin and rivaroxaban in routine clinical practice?
Observational (n=1,819)
Yes
What are the clinical outcomes and patient characteristics of German PAD patients receiving dual-pathway inhibition with aspirin and rivaroxaban in routine clinical practice?
Real-world German PAD patients receiving dual-pathway inhibition exhibit higher rates of major adverse limb events but lower rates of MACE and major bleeding compared to the COMPASS trial cohort.
Answers are grounded in this paper and cite their sources.
May warrant caution extrapolating COMPASS dual-pathway benefits to routine German PAD practice; leaves generalizability and optimal selection open for prospective study.
Summary: Background: Dual-pathway inhibition (DPI) with aspirin and rivaroxaban exhibited a net clinical benefit for patients with cardiovascular disease in the randomized COMPASS trial. The non-observational, international XATOA registry showed that the COMPASS results can be reproduced in clinical practice in patients with coronary artery disease (CAD) and peripheral artery disease (PAD). Here we report patient characteristics and clinical outcomes for the subgroup of German PAD patients of the XATOA registry and compare them to COMPASS PAD patients. Patients and methods: XATOA was an international prospective registry of patients receiving DPI with a mean follow-up period of 15 months. The subgroup of German patients with PAD in XATOA comprised 1,819 patients, of which 925 patients (50.9%) had only PAD and 894 patients (49.1%) had both CAD and PAD. Patient characteristics such as prior medical history and prior medications as well as clinical outcomes such as incidences of major adverse limb events (MALE), major adverse cardiovascular events (MACE) and major bleeding events were assessed. Results: DPI was well-tolerated in clinical practice. Patient characteristics and clinical outcomes especially for patients with only PAD differed from characteristics and outcomes of the overall German XATOA population as well as the PAD subgroup of COMPASS. Patients with only PAD were markedly less supplied with lipid-lowering agents and betablockers. Incidences of MALE were high in German PAD patients of XATOA (9.0%) and markedly higher than in the PAD subgroup of COMPASS (1.2%). Incidences of MACE and major bleeding events were lower in German PAD patients of XATOA (MACE: 2.9%, major bleeding: 1.4%) than in PAD patients of COMPASS (MACE: 5.1%, major bleeding: 3.1%). Conclusions: DPI with rivaroxaban and aspirin is well-tolerated by PAD patients in German clinical practice. PAD patients in Germany exhibit different characteristics and show a different clinical outcome profile than PAD patients in COMPASS.
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Herold et al. (2025) conducted an observational in Peripheral artery disease (PAD) (n=1,819). Dual-pathway inhibition (rivaroxaban and aspirin) vs. COMPASS trial PAD patients was evaluated on Major adverse limb events (MALE). Dual-pathway inhibition in German PAD patients showed higher MALE (9.0% vs 1.2%) but lower MACE (2.9% vs 5.1%) and major bleeding (1.4% vs 3.1%) compared to the COMPASS trial.
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