PREVENER is a randomized, open-label, multicenter, phase IV clinical trial designed to evaluate the efficacy and safety of a carotid ultrasound-based strategy for the primary prevention of cardiovascular events in patients with inflammatory rheumatic diseases (IRD).
Patients with IRD, including rheumatoid arthritis (RA), psoriatic arthritis (PsA), axial spondyloarthritis (AxSpA), and systemic lupus erythematosus (SLE), have a 50% higher risk of cardiovascular (CV) events compared to the general population. However, conventional CV risk scores (SCORE2/OP) systematically underestimate this risk, leaving many high-risk patients without appropriate preventive treatment.
Patients aged ≥50 years with IRD and low-to-moderate CV risk according to SCORE2/OP will be randomized 1:1 to either an experimental group (carotid ultrasound to detect subclinical atherosclerosis) or a control group (standard care according to ESC 2021 guidelines). Patients in the experimental group with carotid plaques will be reclassified as very high CV risk and treated with high-intensity statins (LDL target \<55 mg/dL). The primary endpoint is the incidence of major adverse cardiovascular events (MACE) over 48 months of follow-up.
Patients aged ≥50 years who have provided written informed consent.
Rheumatoid arthritis (RA) according to ACR/EULAR 2010 criteria
Psoriatic arthritis (PsA) according to CASPAR criteria
Axial spondyloarthritis (AxSpA) according to ASAS criteria
Presence of previous cardiovascular events, type 2 diabetes mellitus, familial hypercholesterolemia, or chronic kidney disease resulting in classification as high or very high cardiovascular risk.
Prior carotid ultrasound examination with subsequent therapeutic intervention derived from its results, either in the context of a research study or routine clinical practice.
Contraindications to lipid-lowering therapy, including recent history of alcoholism, active liver disease, or unexplained and persistent elevation of serum transaminases exceeding three times the upper limit of normal (applicable to statins and ezetimibe).
Parallel
Carotid Ultrasound
Diagnostic testCarotid ultrasound performed to detect subclinical atherosclerosis (carotid plaques) according to Manheim consensus criteria. The presence of carotid plaques triggers reclassification to very high cardiovascular risk and initiation of high-intensity lipid-loqering therapy
High-intensity lipid-lowering therapy
DrugSequential lipid-lowering therapy initiated in experimental group patinets with carotid plaques, targeting LDL \< 55 mg/dL. Treatment includes high-intensity statins (atorvastatin 40-80mg, rouvastatin 20-40mg), with possible addition of azetimibe, bempedoic acid, and/or PCSK9 inhibitors if target is not achieved.
Standard care according to ESC 2021 guidelines
Other interventionLipid-lowerin treatment indicated and managed according to ESC 2021 cardiovascular prevention guidelines, based on SCORE/OP risk stratification, without carotid ultrasound assessment
Incidence of Major Adverse Cardiovascular Events (MACE)
Number of Participants Experiencing an Acute Myocardial Infarction or Stroke
Incidence of acute myocardial infarction or stroke during the follow-up period.
Number of Participants Hospitalized for Unstable Angina
Incidence of hospital admissions due to unstable angina during the follow-up period.
Number of Participants Requiring Arterial Revascularization for Peripheral Arterial Disease
Incidence of arterial revascularization procedures required for peripheral arterial disease during the follow-up period.
Number of Participants Experiencing Cardiovascular Death
Incidence of cardiovascular death during the follow-up period.
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