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Secondary Prevention and Extreme Cardiovascular Risk Evaluation (SEVERE-1), Focus on Prevalence and Associated Risk
Alessandro Maloberti1,2, Rita Cristina Myriam Intravaia3, Costantino Mancusi4
1School of Medicine and Surgery, Milano-Bicocca University, Milan, Italy. alessandro.maloberti@ospedaleniguarda.it.
Insights
This study investigates extreme cardiovascular risk in patients with acute or chronic coronary syndrome, identifying new biochemical markers like uric acid and Lp(a) to improve risk prediction and patient outcomes in cardiac rehabilitation.
Area of Science:
- Cardiology
- Biochemistry
- Preventive Medicine
Background:
- Despite advances in secondary cardiovascular (CV) prevention, recurrent events remain a concern for acute and chronic coronary syndrome (ACS/CCS) patients.
- Emerging biochemical markers, including uric acid (UA) and lipoprotein A [Lp(a)], show potential in predicting CV event recurrence.
- The SEcondary preVention and Extreme cardiovascular Risk Evaluation (SEVERE-1) study aims to characterize extreme CV risk in cardiac rehabilitation (CR) patients.
Purpose of the Study:
- To determine the prevalence of extreme CV risk among ACS/CCS patients in CR programs.
- To assess the association between novel biochemical markers (UA, Lp(a), inflammatory markers) and extreme CV risk.
- To develop and validate scoring systems for accurate identification of extreme CV risk patients.
Main Methods:
- Prospective enrollment of 730 ACS/CCS patients entering CR.
- Retrospective definition of extreme CV risk based on prior CV events within 2 years.
- Assessment of UA, Lp(a), and inflammatory markers (IL-6, IL-18, TNF-α, CRP, calprotectin, osteoprotegerin) in extreme risk patients and controls.
- Multivariable analysis and development of two risk scoring systems (clinical variables only, and clinical + biochemical markers).
- Exome sequencing to evaluate polygenic risk score and conduct Mendelian randomization analyses for CV biomarkers.
Main Results:
- The study will provide data on the prevalence of extreme CV risk in a CR population.
- Associations between specific biochemical markers and extreme CV risk will be quantified.
- Validation of clinical and novel biochemical marker-based scoring systems for risk stratification will be performed.
Conclusions:
- The findings will offer definitive data on extreme CV risk prevalence, increasing awareness and guiding clinical practice.
- Improved diagnostic accuracy and treatment optimization for high-risk patients are expected.
- The study will refine CV risk assessment and therapeutic strategies within cardiac rehabilitation settings.
Introduction:
Despite significant improvement in secondary CardioVascular (CV) preventive strategies, some acute and chronic coronary syndrome (ACS and CCS) patients will suffer recurrent events (also called "extreme CV risk"). Recently new biochemical markers, such as uric acid (UA), lipoprotein A [Lp(a)] and several markers of inflammation, have been described to be associated with CV events recurrence. The SEcondary preVention and Extreme cardiovascular Risk Evaluation (SEVERE-1) study will accurately characterize extreme CV risk patients enrolled in cardiac rehabilitation (CR) programs.
Aim:
Our aims will be to describe the prevalence of extreme CV risk and its association with newly described biochemical CV risk factors.
Aim:
Our aims will be to describe the prevalence of extreme CV risk and its association with newly described biochemical CV risk factors.
Methods:
We will prospectively enrol 730 ACS/CCS patients at the beginning of a CR program. Extreme CV risk will be retrospectively defined as the presence of a previous (within 2 years) CV events in the patients' clinical history. UA, Lp(a) and inflammatory markers (interleukin-6 and -18, tumor necrosis factor alpha, C-reactive protein, calprotectin and osteoprotegerin) will be assessed in ACS/CCS patients with extreme CV risk and compared with those without extreme CV risk but also with two control groups: 1180 hypertensives and 765 healthy subjects. The association between these biomarkers and extreme CV risk will be assessed with a multivariable model and two scoring systems will be created for an accurate identification of extreme CV risk patients. The first one will use only clinical variables while the second one will introduce the biochemical markers. Finally, by exome sequencing we will both evaluate polygenic risk score ability to predict recurrent events and perform mendellian randomization analysis on CV biomarkers.
Conclusions:
Our study proposal was granted by the European Union PNRR M6/C2 call. With this study we will give definitive data on extreme CV risk prevalence rising attention on this condition and leading cardiologist to do a better diagnosis and to carry out a more intensive treatment optimization that will finally leads to a reduction of future ACS recurrence. This will be even more important for cardiologists working in CR that is a very important place for CV risk definition and therapies refinement.
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