Abstract-In this prospective, randomized, open-label, blinded end point study, we aimed to establish whether strict blood pressure control (Ͻ140 mm Hg) is superior to moderate blood pressure control (Ն140 mm Hg to Ͻ150 mm Hg) in reducing cardiovascular mortality and morbidity in elderly patients with isolated systolic hypertension. We divided 3260 patients aged 70 to 84 years with isolated systolic hypertension (sitting blood pressure 160 to 199 mm Hg) into 2 groups, according to strict or moderate blood pressure treatment. A composite of cardiovascular events was evaluated for Ն2 years. The strict control (1545 patients) and moderate control (1534 patients) groups were well matched (mean age: 76.1 years; mean blood pressure: 169.5/81.5 mm Hg). Median follow-up was 3.07 years. At 3 years, blood pressure reached 136.6/74.8 mm Hg and 142.0/76.5 mm Hg, respectively. The blood pressure difference between the 2 groups was 5.4/1.7 mm Hg. The overall rate of the primary composite end point was 10.6 per 1000 patient-years in the strict control group and 12.0 per 1000 patient-years in the moderate control group (hazard ratio: 0.89; [95% CI: 0.60 to 1.34]; Pϭ0.38). In summary, blood pressure targets of Ͻ140 mm Hg are safely achievable in relatively healthy patients Ն70 years of age with isolated systolic hypertension, although our trial was underpowered to definitively determine whether strict control was superior to less stringent blood pressure targets. Key Words: isolated systolic hypertension Ⅲ elderly Ⅲ blood pressure Ⅲ prognosis Ⅲ valsartan H igh blood pressure (BP) is well known to be a major risk factor for cardiovascular events, such as stroke and myocardial infarction, 1 and linear relationships between cardiovascular risk and both systolic and diastolic BPs, unrelated to age, have also been reported based on a meta-analysis of large cohort studies conducted worldwide. 2 In particular, systolic BP predominantly affects cardiovascular events in elderly people. 3 Numerous large clinical trials, such as the Systolic Hypertension in the Elderly Program, 4 Swedish Trial in Old Patients, 5 Medical Research Council, 6 Systolic Hypertension in Europe, 7 and Systolic Hypertension in China, 8 have provided evidence of the benefits of reducing BP in the elderly. Meta-analysis of clinical trials showed that treatment of hypertension in older adults is as beneficial as that in younger adults. 9 A recent study performed in hypertensive patients aged Ն80 years of age, the Hypertension in the Very Elderly Trial, showed that antihypertensive treatment is beneficial to reduce the risks of death from stroke, death from any cause, and heart failure. 10 These observations indicate that antihypertensive treatment is beneficial even in very elderly patients.To reduce cardiovascular risks, in general BP should be kept as low as possible based on evidence from numerous clinical trials and epidemiological data. 11 On the other hand, several epidemiological studies in the elderly, such as Vantaa and Leinden 85-Plus, reported a poor progno...