Background: Despite mounting evidence of the benefit of intensive lowering of low-density lipoprotein-cholesterol (LDL-C) in coronary artery disease (CAD) patients, it has not been shown that intensive lowering of both LDL-C and blood pressure (BP) reduces cardiovascular events in these patients.
Methods and results: 498 patients with hypertension and hypercholesterolemia with ≥ 75% stenosis in at least one major coronary artery, were recruited from 17 cardiovascular centers in eastern Japan. Patients were randomly assigned to conventional therapy (CT) or intensive therapy (IT). CT aimed to reduce BP to < 140/90 mm Hg and LDL-C to <100mg/dl, and IT aimed for < 120/80 mm Hg and < 80 mg/dl, respectively. The primary endpoint was a composite of all deaths, non-fatal myocardial infarction, unstable angina pectoris, coronary artery bypass graft surgery, non-fatal stroke, non-fatal major vascular disease, and peripheral artery disease. The mean follow-up period was 3.2 years. The achieved systolic BP was 126.8 mm Hg for the CT group, and 121.3 mm Hg for the IT group (P < 0.001). The achieved LDL-C was 92.1mg/dl for the CT group, and 79.6 mg/dl for the IT group (P < 0.001). We detected the primary endpoint in 18 (7.1%) patients in the CT group, and 26 (10.7%) in the IT group (hazard ratio 1.53, 95% confidence interval 0.84-2.80, P = 0.164).
Conclusions: We could not show that intensively lowering both BP and LDL-C reduced cardiovascular risks in Japanese CAD patients with hypertension and hypercholesterolemia (UMIN-CTR UMIN000000571).