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Inflammation and Cholesterol as Predictors of Cardiovascular Events Among 13 970 Contemporary High-Risk Patients With
Paul M Ridker1, Lei Lei2, Michael J Louie2
1Center for Cardiovascular Disease Prevention, Division of Preventive Medicine and the Division of Cardiovascular Medicine, Brigham and Women's Hospital, Boston, MA (P.M.R., P.L.).
Circulation
|November 6, 2023
Summary
In statin-intolerant patients, elevated inflammation (hsCRP) strongly predicts cardiovascular events, more so than high LDL cholesterol. Bempedoic acid effectively reduced both hsCRP and LDL-C, showing consistent cardiovascular risk reduction across inflammatory and lipid levels.
Area of Science:
- Cardiology
- Pharmacology
- Biochemistry
Background:
- Residual inflammatory risk, assessed by high-sensitivity C-reactive protein (hsCRP), is a significant predictor of cardiovascular events in patients on statin therapy.
- The predictive value of hsCRP versus low-density lipoprotein cholesterol (LDLC) in statin-intolerant patients with elevated LDLC is uncertain.
- Bempedoic acid, a novel agent, reduces both LDLC and hsCRP, offering a potential preventive therapy for this population.
Purpose of the Study:
- To evaluate the predictive value of baseline hsCRP and LDLC for cardiovascular events in statin-intolerant patients.
- To assess the efficacy of bempedoic acid in reducing cardiovascular events and mortality in this patient group.
- To determine if bempedoic acid's efficacy varies across different hsCRP and LDLC strata.
Main Methods:
- The CLEAR-Outcomes trial enrolled 13,970 statin-intolerant patients randomized to bempedoic acid or placebo.
- Patients were followed for a composite of myocardial infarction, stroke, coronary revascularization, or cardiovascular death, and all-cause mortality.
- Baseline hsCRP and LDLC levels were analyzed in quartiles as predictors of future adverse events.
Main Results:
- Bempedoic acid significantly reduced hsCRP by 21.6% and LDLC by 21.1% at 6 months compared to placebo.
- Higher baseline hsCRP quartiles were strongly associated with increased risk of major cardiovascular events, cardiovascular mortality, and all-cause mortality.
- Higher baseline LDLC quartiles showed a weaker association with the primary composite endpoint and a neutral association with mortality outcomes.
Conclusions:
- In statin-intolerant patients, hsCRP is a stronger predictor of future cardiovascular events and death than LDLC.
- Bempedoic acid demonstrated consistent efficacy in reducing cardiovascular risk across all hsCRP and LDLC levels.
- Inflammation, rather than hyperlipidemia, appears to be a key driver of residual cardiovascular risk in this population.
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