Intensive versus standard blood pressure treatment improves cardiovascular outcomes without any difference in patient-reported outcomes

Abstract

ContextThe Systolic Blood Pressure Intervention Trial (SPRINT) was a large, multicentre, randomised controlled trial (RCT) originally reported in 2015.1 The trial randomly assigned 9361 individuals with hypertension at high risk of cardiovascular disease (but without diabetes or stroke) to intensive blood pressure (BP) control (systolic BP less than 120 mm Hg) or standard BP control (systolic BP less than 140 mm Hg). There was a significant reduction in cardiovascular events and mortality in the intensive treatment group and the trial was stopped early. The original trial reported a doubling of treatment-related serious adverse events including symptomatic hypotension, syncope and acute kidney injury in the intensive treatment group. 1 This follow-on analysis presents the patient-reported outcomes of physical and mental health, and patient-reported adherence to treatment. 2 MethodsSPRINT was an open-label RCT and recruited individuals over 50 years of age with a systolic BP between 130 and 180 mm Hg at an increased risk of cardiovascular disease but without diabetes or previous stroke. 1 2 Ninety per cent were already taking antihypertensive medication at baseline. The trial was conducted according to the Consolidated Standards of Reporting Trials guidelines using appropriate methods of randomisation and allocation. Six key patient-related outcomes were assessed using well-validated measures: physical and mental health-related quality of life, depressive symptoms, patient satisfaction with BP care and with BP medications, and medication adherence. The data related to these outcomes were collected at baseline and at yearly follow-up (except for satisfaction and adherence scores, which were collected up to 48 months). Multiple outcome comparisons were made according to both prespecified and exploratory subgroupsno statistical adjustment was made for this. FindingsThe SPRINT trial was ended early due to the all-cause and cardiovascular mortality benefits of intensive BP control group, limiting longer term data for patient-reported outcomes. However, over the follow-up period, there were no statistically significant differences between groups in physical and mental health-related quality of life or depressive symptoms. 2 This was unchanged in subgroup analyses, including age and number of coexisting conditions. At 12 months, there was a reported small difference in satisfaction with care between groups, with a statistically greater but unlikely to be clinically significant proportion of participants in the intensive treatment group being satisfied or very satisfied with care than in the standard treatment group (88.6% vs 88.2%). No differences in medication adherence were observed. CommentarySPRINT is a contentious study that resulted in all-cause mortality and cardiovascular event benefits for those intensively treated, but also resulted in an increase in adverse events such as syncope, acute kidney injury and electrolyte disturbance. A number of methodological issues were also raised, such as the method of BP meas...