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Thrombotic Risk Stratification and Intensive Statin Therapy for Secondary Prevention of Coronary Artery Disease -
Masahiro Natsuaki1, Takeshi Morimoto2, Satoshi Iimuro3
1Department of Cardiovascular Medicine, Saga University.
Insights
Higher-dose statins may benefit cardiovascular events in chronic coronary syndrome (CCS) patients, regardless of thrombotic risk. This study found a trend towards risk reduction with high-dose pitavastatin across all risk groups.
Area of Science:
- Cardiology
- Pharmacology
- Clinical Trials
Background:
- Assessing differential effects of high-dose statins on cardiovascular events based on thrombotic risk in chronic coronary syndrome (CCS) patients.
- Investigating the impact of statin intensity on cardiovascular outcomes in diverse patient populations.
Purpose of the Study:
- To evaluate whether higher-dose pitavastatin (4 mg) offers greater cardiovascular event reduction compared to lower-dose pitavastatin (1 mg) in patients with CCS.
- To determine if the treatment effect of higher-dose statins varies across different levels of thrombotic risk.
Main Methods:
- A randomized trial (REAL-CAD) involving 12,413 CCS patients, stratified into low, intermediate, and high thrombotic risk groups using the CREDO-Kyoto score.
- Comparison of 4 mg versus 1 mg pitavastatin, with the primary endpoint being a composite of cardiovascular death, myocardial infarction, ischemic stroke, or unstable angina over 4 years.
Main Results:
- The primary endpoint incidence was significantly higher in high-risk strata (11.0%) compared to intermediate (6.3%) and low-risk (4.5%) strata.
- In the low-risk group, 4 mg pitavastatin showed a significant reduction in primary endpoint incidence (4.0% vs. 4.9%).
- A numerical, though not statistically significant, reduction in events was observed with 4 mg pitavastatin in intermediate and high-risk groups, with no significant treatment-by-subgroup interaction.
Conclusions:
- High-dose pitavastatin therapy demonstrated a trend toward lowering cardiovascular event risk in CCS patients, irrespective of their baseline thrombotic risk.
- The study suggests potential benefits of aggressive lipid-lowering therapy with higher-dose statins, even in patients with lower thrombotic risk.
Background:
It is unknown whether beneficial effects of higher-dose statins on cardiovascular events are different according to the thrombotic risk in patients with chronic coronary syndrome (CCS).
Methods And Results:
The Randomized Evaluation of Aggressive or Moderate Lipid-Lowering Therapy with Pitavastatin in Coronary Artery Disease (REAL-CAD) study is a randomized trial comparing 4 mg and 1 mg pitavastatin in patients with CCS. This study categorized 12,413 patients into 3 strata according to the CREDO-Kyoto thrombotic risk score: low-risk (N=9,434; 4 mg: N=4,742, and 1 mg: N=4,692), intermediate-risk (N=2,415; 4 mg: N=1,188, and 1 mg: N=1,227); and high-risk (N=564; 4 mg: N=269, and 1 mg: N=295). The primary endpoint was a composite of cardiovascular death, non-fatal myocardial infarction, non-fatal ischemic stroke, or unstable angina. Cumulative 4-year incidence of the primary endpoint was significantly higher in the high-risk stratum than in the intermediate- and low-risk strata (11.0%, 6.3%, and 4.5%, P<0.0001). In the low-risk stratum, the cumulative 4-year incidence of the primary endpoint was significantly lower in the 4 mg than in the 1 mg group (4.0% and 4.9%, P=0.02), whereas in the intermediate- and high-risk strata, it was numerically lower in the 4 mg than in the 1 mg group. There was no significant treatment-by-subgroup interaction for the primary endpoint (P-interaction=0.77).
Conclusions:
High-dose pitavastatin therapy compared with low-dose pitavastatin therapy was associated with a trend toward lowering the risk for cardiovascular events irrespective of the thrombotic risk in patients with CCS.
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