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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
Circulation Journal, 08/2022, Volume: 86, Issue: 9Journal Article
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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