P3350Design of a multicenter, open-label, randomized controlled trial: effects of intensive systolic blood pressure lowering treatment in reducing risk of vascular events (ESPRIT)

Background Patients with cardiovascular diseases (CVD) are at high risk for recurrent major cardiovascular events. Effective public health strategies to lower blood pressure (BP) are necessary to reduce risk of cardiovascular disease. However, substantial uncertainty remains about the optimal target level to lower BP in patients with cardiovascular disease. Purpose To assess the effects on the incidence of major cardiovascular events in patients with CVD during the scheduled treatment period of greater reduction in blood pressure with a systolic BP (SBP) target <120 mmHg versus <140 mmHg. Methods This study is a multicenter, open-label, randomized controlled trial comparing two strategies for lowering SBP: lowering SBP to the standard target of <140 mmHg; and lowering BP to a more intensive target of <120 mmHg. This study will enroll 12,000 Chinese participants from 100–200 hospitals, follow-up for about 3 years. We will include participants aged ≥50 years old with SBP ≥130 mmHg, having a history of vascular disease (including myocardial infarction, percutaneous coronary intervention, coronary artery bypass grafting, carotid endarterectomy or carotid stenting, peripheral artery disease with revascularization, abdominal aortic aneurysm ≥5 cm with repair) or stroke. The primary outcome is the first occurrence of major cardiovascular events defined as a composite of myocardial infarction, stroke, coronary or non-coronary revascularization events, and cardiovascular death. Secondary outcomes include the components of the primary composite outcome, hospitalized heart failure and all cause of death and non-cardiovascular outcomes (kidney disease and cognitive outcomes). Results Regarding the results, we hypothesize that comparing with SBP target of <140 mmHg, more intensive SBP target of <120 mmHg can further reduce the occurrence of cardiovascular events in CVD patients with elevated blood pressure. Conclusion This study can provide reliable evaluation on whether more intensive SBP target of <120 mmHg is more desirable than SBP target of <140 mmHg in CVD patients with elevated blood pressure.