The effect of moderate-dose versus double-dose statins on patients with acute coronary syndrome in China: Results of the CHILLAS trial

Abstract Background Current guidelines recommend intensive low-density lipoprotein (LDL) cholesterol lowering with statins, with a target of 70 mg/dL (1.81 mmol/L) LDL cholesterol for those with a very high risk of coronary artery events. However, there is no multicenter study assessing the effect of intensive lipid-lowering therapy with statins on acute coronary syndrome (ACS) in a Chinese population with low baseline LDL cholesterol levels. Methods and results Patients ( n = 1355) with ACS were treated with a moderate dose of statin (atorvastatin 10 mg/d, or equivalent dose of other statins, n = 675) or with an intensive dose of statin (atorvastatin, 20 or 40 mg/d, or equivalent dose of other statins, n = 680) for 2 years. The primary end points were cardiac death, non-fatal acute myocardial infarction (MI), revascularization, ischemic stroke and documented unstable angina or severe heart failure requiring emergency hospitalization. Baseline lipid levels were nearly identical in both groups with a mean LDL cholesterol level of 2.7 mmol/L (103 mg/dL). At 3 months, LDL cholesterol levels declined 20.2% in the moderate dose statin group and 26.6% in the intensive statin group, respectively ( P < 0.001). In a 2-year follow-up, a primary end point event occurred in 20 patients in the moderate dose statin group and in 28 patients in the intensive statin group. There was no significant between-group difference in the primary outcome (hazard ratio, 1.39; 95% confidence interval [CI], 0.78–2.46; P = 0.245). Conclusions For ACS patients with a relatively low baseline LDL cholesterol level who received optimized current medication and interventional therapy, the incremental LDL cholesterol reduction of 6.4% achieved by double-dose statin did not bring significant clinical effectiveness.