Thrombotic Risk Stratification and Intensive Statin Therapy for Secondary Prevention of Coronary Artery Disease　― Insights From the REAL-CAD Study

• Published in: Circulation Journal Vol. 86; no. 9; pp. 1416 - 1427
• Main Authors: Natsuaki, Masahiro, Morimoto, Takeshi, Iimuro, Satoshi, Fujita, Retsu, Iwata, Hiroshi, Miyauchi, Katsumi, Inoue, Teruo, Nakagawa, Yoshihisa, Nishihata, Yosuke, Daida, Hiroyuki, Ozaki, Yukio, Suwa, Satoru, Sakuma, Ichiro, Furukawa, Yutaka, Shiomi, Hiroki, Watanabe, Hirotoshi, Yamaji, Kyohei, Saito, Naritatsu, Matsuzaki, Masunori, Nagai, Ryozo, Kimura, Takeshi, on behalf of the REAL-CAD Investigators
• Format: Journal Article
• Language: English
• Published: Japan The Japanese Circulation Society 25-08-2022
• Subjects: Angina, Unstable - prevention & control; Coronary Artery Disease - drug therapy; Humans; Hydroxymethylglutaryl-CoA Reductase Inhibitors - adverse effects; Percutaneous coronary intervention; Risk Assessment; Secondary Prevention; Statin therapy; Thrombotic risk; Treatment Outcome; Statin therapy; Percutaneous coronary intervention; Thrombotic risk
• ISSN: 1346-9843; 1347-4820; 1347-4820
• DOI: 10.1253/circj.CJ-22-0315

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.