The Rheumatology Department of Sierrallana Hospital, in collaboration with the Clinical Trials Agency of the Valdecilla Health Research Institute (IDIVAL), has designed and launched a clinical trial aimed at optimizing the primary prevention of cardiovascular (CV) events in patients with inflammatory rheumatic diseases. The study, titled “Randomized clinical trial to assess the efficacy and safety of a primary PREvention strategy for cardioVascular EVents in patients with inflammatory Rheumatic diseases based on the use of carotid ultrasound (PREVENER)”, is funded by the Carlos III Health Institute through the 2025 R&D&I Projects call.
Paradoxically, in these diseases, most CV events occur in patients classified as having low or moderate cardiovascular risk, who typically do not receive lipid‑lowering treatment, despite its proven ability to reduce the likelihood of experiencing a CV event. Detecting subclinical atherosclerosis through a simple, non‑invasive, and harmless test such as carotid ultrasound would make it possible to identify those patients who, despite an initial low‑to‑moderate risk estimate, actually present a high cardiovascular risk, thus enabling the initiation of appropriate preventive pharmacological treatment.
According to Javier Rueda Gotor, principal investigator of the study, “the use of carotid ultrasound to improve cardiovascular risk assessment is an option considered in European guidelines for CV event prevention, but to date it has not been incorporated as a formal recommendation due to the lack of clinical trials evaluating the effectiveness of this strategy. This will therefore be the first clinical trial designed with this objective, and we will conduct it in rheumatic patients, who have a 50% higher risk of cardiovascular events compared to the general population.”
To this end, patients with rheumatoid arthritis, psoriatic arthritis, axial spondyloarthritis, and systemic lupus erythematosus will be recruited across 17 Spanish hospitals. Half of the participants will undergo carotid ultrasound to detect the presence of atheroma plaques and initiate lipid‑lowering treatment when indicated, while in the other half, the decision to start pharmacological treatment will follow current clinical guidelines. After four years of follow‑up, the incidence of CV events will be compared between the two groups.
The researchers hope that this study will provide the scientific evidence needed to support the implementation of routine carotid ultrasound use in cardiovascular risk assessment for patients with inflammatory rheumatic diseases, with the goal of reducing the incidence of CV events, which remain the leading cause of mortality in these conditions.
