Unattended Blood Pressure Measurements in the Systolic Blood Pressure Intervention Trial: Implications for Entry and Achieved Blood Pressure Values Compared With Other Trials

Abstract

The Systolic Blood Pressure Intervention Trial (SPRINT) enrolled 9361 participants aged ≥50 years in ≈100 expert medical centers and clinical practices throughout the United States.1 SPRINT excluded patients with diabetes mellitus and stroke survivors since previous clinical trials included those populations.2,3 Between 2010 and 2013, the SPRINT investigators randomly allocated the study participants into a standard treatment group receiving an average of 2 different blood pressure (BP) medications to achieve a systolic BP (SBP) target <140 mm Hg and into an intensive treatment group receiving an average of 3 BP medications to achieve a SBP target <120 mm Hg. The Director of the National Heart, Lung, and Blood Institute stopped SPRINT early because of a positive effect. The significant preliminary results of SPRINT were announced on September 11, 20154 and the study results were quickly and favorably commented on by the New York Times5 and the Washington Post.6 The target SBP <120 mm Hg had reduced rates of the composite primary outcome that included myocardial infarction (MI), other acute coronary syndromes, stroke, heart failure, or death from cardiovascular causes by 25% and the risk of death from all causes by 27%, when compared with the target SBP of <140 mm Hg. The primary results of the trial were presented at the Scientific Sessions of the American Heart Association in Orlando on November 9, 2015 and published on the same day.7 The SPRINT study was published with an accompanying statement from the Editor of New England Journal of Medicine 8 saying that "This clinical trial will change practice, and we are proud to publish it and to defend the importance of the expedited peer-review and publication process that it has undergone. The report is now in the public domain, and the investigators' data …