April 24, 2023Open Access

Effect of dual residual risk of cholesterol and inflammation on all-cause mortality in patients with cardiovascular disease

Q: What is the clinical evidence from this study?

Study design: Cohort. Population: Cardiovascular disease (n=3509). Intervention: Dual residual risk of cholesterol and inflammation (RCIR) vs. No residual risk. Primary outcome: All-cause mortality (HR 1.75, 95% CI 1.25-2.46).

Key Result

In patients with cardiovascular disease treated with statins, the dual residual risk of cholesterol and inflammation increased the risk of all-cause mortality (HR 1.75) compared to no residual risk.

Study Design

Type

Cohort (n=3,509)

Multicenter

Yes

Structured PICO

Does the dual residual risk of cholesterol and inflammation increase all-cause mortality in patients with cardiovascular disease receiving statin therapy?

Population

3,509 patients with a history of cardiovascular disease (ischemic stroke, myocardial infarction, heart failure, revascularization therapy, or coronary heart disease) who first took statins between January 1, 2010, and December 31, 2017, in the Kailuan Study (China). Mean age 63.69 ± 8.41 years, 86.78% men.

Intervention

Residual cholesterol and inflammatory risk (RCIR: LDL-C ≥ 1.8 mmol/L and hs-CRP ≥ 2 mg/L), residual inflammatory risk (RIR: LDL-C < 1.8 mmol/L and hs-CRP ≥ 2 mg/L), or residual cholesterol risk (RCR: LDL-C ≥ 1.8 mmol/L and hs-CRP < 2 mg/L) while on statin therapy.

Comparator

No residual risk (LDL-C < 1.8 mmol/L and hs-CRP < 2 mg/L) while on statin therapy.

Outcome

All-cause mortality at median 6.10 years follow-up.hard clinical

In patients with cardiovascular disease on statin therapy, the combined residual risk of elevated cholesterol and inflammation significantly increases the risk of all-cause mortality, highlighting the need for comprehensive risk factor control.

Main Result

Effect estimate: HR 1.75 (95% CI 1.25-2.46)

Absolute Event Rate: 23.12% vs 12.62%

Limitations

Single-center study with 86.78% men, limiting generalizability
Did not collect statin dosage information
Data from a single measurement of LDL-C and hs-CRP does not reflect average levels during long-term follow-up
Lack of information on the causes of mortality and failure to distinguish between CVD and non-CVD causes

Abstract

BACKGROUND: Randomized controlled trials confirm that risks of residual cholesterol and residual inflammation remains in patients with cardiovascular disease (CVD) even after lipid-lowering therapy. This study aims to investigate the association between dual residual risk of cholesterol and inflammation and all-cause mortality in a real-world population with CVD. METHODS: Patients with a CVD history who first took statins between 1 January 2010 and 31 December 2017 in the Kailuan Study were selected as study participants. According to low-density lipoprotein cholesterol (LDL-C) and hypersensitive C-reactive protein levels, patients were divided into those with no residual risk, residual inflammatory risk (RIR), residual cholesterol risk (RCR), and residual cholesterol and inflammatory risk (RCIR). Cox proportional hazard model was conducted to determine hazard ratio (HR) of all-cause mortality for RIR, RCR, and RCIR. Stratified analysis was conducted according to good medication adherence and 75% of the percentage LDL-C decline, high SMART 2 risk score, and blood pressure and blood glucose at standard levels. RESULTS: After 6.10 years of follow-up, 377 all-cause deaths occurred in 3509 participants (mean age 63.69 ± 8.41 years, 86.78% men). After adjusting for related risk factors, the HR and (95% confidence interval CI) of all-cause mortality in the RIR, RCR, and RCIR was 1.63 (1.05, 2.52), 1.37 (0.98, 1.90), and 1.75 (1.25, 2.46), compared with no residual risk. Similar associations were observed in participants with moderate or low statin compliance, a lower percentage of LDL-C decline, high SMART 2 risk score, uncontrolled blood pressure, and uncontrolled blood glucose, in the RCIR had a 1.66-fold, 2.08-fold, 1.69-fold, 2.04-fold, and 2.05-fold higher risk of all-cause mortality, respectively, than the reference. CONCLUSION: Risks of residual cholesterol and residual inflammation remain in patients with CVD after receiving statins, and their combined effect significantly increases the risk of all-cause mortality. Here, this increased risk was dependent on statin compliance, LDL-C reduction, SMART 2 risk score, and blood pressure and blood glucose control.

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