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Dual pathway inhibition in patients with peripheral artery disease in Germany
Joerg Herold1, Nikolaos Dagkonakis2, E Sebastian Debus3
1Department of Angiology, Kerckhoff Clinic, Bad Nauheim, Germany.
Insights
Dual-pathway inhibition (DPI) with aspirin and rivaroxaban is safe for German peripheral artery disease (PAD) patients. However, German PAD patients had higher limb event rates but lower cardiovascular and bleeding event rates compared to COMPASS trial data.
Area of Science:
- Cardiology
- Vascular Medicine
- Pharmacology
Background:
- Dual-pathway inhibition (DPI) using aspirin and rivaroxaban demonstrated clinical benefit in cardiovascular disease patients per the COMPASS trial.
- The XATOA registry confirmed DPI's reproducibility in clinical practice for coronary artery disease (CAD) and peripheral artery disease (PAD) patients.
- This study focuses on German PAD patients within the XATOA registry, comparing their characteristics and outcomes to the COMPASS PAD subgroup.
Purpose of the Study:
- To analyze patient characteristics and clinical outcomes of German PAD patients receiving DPI in the XATOA registry.
- To compare these findings with the PAD subgroup from the COMPASS trial.
- To assess the tolerability and effectiveness of DPI in a real-world German clinical setting.
Main Methods:
- Analysis of 1,819 German PAD patients from the international prospective XATOA registry (mean follow-up: 15 months).
- Patients were categorized into PAD-only (925) and PAD with CAD (894) groups.
- Assessment of patient demographics, medical history, prior medications, and clinical outcomes including major adverse limb events (MALE), major adverse cardiovascular events (MACE), and major bleeding events.
Main Results:
- DPI was well-tolerated in German clinical practice.
- German PAD patients, particularly those with PAD only, showed lower use of lipid-lowering agents and beta-blockers compared to COMPASS.
- Incidence of MALE was significantly higher in German PAD patients (9.0%) versus COMPASS PAD (1.2%).
- Conversely, MACE (2.9% vs 5.1%) and major bleeding (1.4% vs 3.1%) rates were lower in German PAD patients than in the COMPASS PAD subgroup.
Conclusions:
- DPI with rivaroxaban and aspirin is safe and well-tolerated in German PAD patients in clinical practice.
- German PAD patients exhibit distinct characteristics and a different clinical outcome profile compared to those in the COMPASS trial.
- Differences in MALE, MACE, and bleeding rates highlight the need for tailored treatment strategies for PAD patients in different healthcare settings.
Abstract:
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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