Evidence Supporting the Blood Pressure Treatment Goal of Less Than 130/80 mm Hg.

During the year since publication of the American College of Cardiology/American Heart Association guideline for the prevention, detection, evaluation, and management of high blood pressure (BP) in adults, the level of evidence supporting the recommended BP treatment goal of <130/80 mm Hg has been widely discussed. Recently, a Circulation Perspective suggested several possible limitations of the independent systematic review and meta-analysis provided by the Evidence Review Committee (ERC) for use by the guideline Writing Committee in determining the most appropriate BP target. On behalf of the ERC and guideline Writing Committees, we would like to address these concerns. To assess evidence for an optimal BP goal, the ERC was asked to review trials that compared groups randomly assigned to different BP targets. The ERC followed the Preferred Reporting Items for Systematic Reviews and Meta-Analyses statement and the recommendations of the American College of Cardiology Foundation/American Heart Association Methodology Manual and Policies. The ERC protocol, which was externally reviewed in advance, defined the question to be addressed, outcomes of interest (including potential harms and adverse events), search parameters and methods, data abstraction, assessment of risk of bias, and statistical methods and analyses (including subanalyses and sensitivity analyses). As described in the report, following a manual assessment of nearly 6000 articles identified by an electronic search, 15 studies were identified that could be used to summarize the effect of lower versus higher BP targets. Clinical and statistical heterogeneity was carefully assessed and found to be acceptable for summary analyses. The most common risk of bias was related to the difficulty of masking assignment of intervention when the intervention involved BP targets; otherwise, risk of bias was low. Although these trials were consistent in summarizing primary outcomes events, reporting of harms and adverse events was much less consistent: an insufficient number of trials with common reporting of harms or adverse events was available to perform meta-analyses. Analysis was performed on estimates of effects, as individual-level data would have been available for only a few trials, resulting in an unacceptable loss of information. Consistent with well-known recommendations on summarizing evidence from meta-analyses, both point estimates and CIs were presented for estimates of relative risks. The ERC meta-analysis showed a consistent pattern of beneficial effects for all of the cardiovascular disease (CVD) outcomes assessed and for total mortality. Of particular interest was the result for lower versus higher BP targets on major adverse cardiovascular events (Figure). Seven studies reported a result for a composite of myocardial infarction, stroke, heart failure, and cardiovascular death. For this outcome, the summary relative risk was 0.81 (CI, 0.70–0.94). In addition, 2 similar but independent systematic reviews reached conclusions entirely consistent with the ERC meta-analysis. One of these did not include SPRINT (Systolic Blood Pressure Intervention Trial). The consistency of results across this collection of metaanalyses suggests strongly that lower BP targets produce benefits for CVD outcomes and total mortality. In addition to the ERC report, the guideline Writing Committee also considered the 2017 network meta-analysis of Bundy et al which examined 42 trials including 144 220 patients randomly allocated to an antihypertensive medication control or treatment target. These randomized comparisons demonstrated a progressive reduction in CVD event risk at lower levels of achieved systolic BP (SBP), and similar findings were observed for stroke, coronary heart disease, and all-cause mortality. Randomized groups with a mean achieved SBP of 120 to 124 mm Hg had a hazard ratio for major CVD events and all-cause mortality of 0.71 (0.60–0.83) and 0.73 (0.58–0.93), respectively, compared with those with a mean achieved SBP of 130 to 134 mm Hg. A similar pattern was observed in sensitivity analyses in which the SPRINT results were excluded. Taken together, these findings strongly support more intensive BP control in the management of hypertension and do not depend solely on SPRINT, the largest and most positive trial of lower BP targets. Despite some criticism, the SPRINT results have been widely accepted as providing convincing evidence that treatment to a lower than previously recommended BP target prevents CVD events. The SPRINT protocol received careful external review before initiation of the trial, and an independent external data and safety monitoring committee vigorously monitored its conduct with particular attention to patient safety, quality control, and minimization of potential bias. The SPRINT data were made publicly available in 2016 and have been provided to many independent investigators around the world. No external reanalysis of the SPRINT data The opinions expressed in this article are not necessarily those of the editors or of the American Heart Association. From the Department of Biostatistics, Wake Forest University School of Medicine, Winston-Salem, NC (D.M.R.); Department of Medicine, University of Virginia Health System, Charlottesville, VA (R.M.C.); and Departments of Epidemiology and Medicine, Tulane University, New Orleans, LA (P.K.W.). Correspondence to Robert M. Carey, University of Virginia Health System, Charlottesville, PO Box 801414, VA 22908. Email rmc4c@ virginia.edu Evidence Supporting the Blood Pressure Treatment Goal of Less Than 130/80 mm Hg