A Blood Pressure Target of 120 for the Top Number Lowered CV Events and Death by One Fourth
That Benefit was Lost When Patients Returned to Usual Care
In the Sprint trial, a blood pressure goal of 120 systolic lowered cardiovascular events and death by a quarter. The relative risk of heart failure was reduced by 38%. Intensive BP control significantly reduced the risk of mild cognitive impairment (14.6 vs 18.3 cases per 1000 person-years; HR, 0.81; and the combined rate of mild cognitive impairment or probable dementia (20.2 vs 24.1 cases per 1000 person-years; HR, 0.85. These are extremely important outcomes in an aging American population.
During the Sprint trial, the intensively managed group (target less than 120 systolic) achieved a mean systolic pressure of 121.6. It was 136.2 in the standard management group. Because of the extraordinary results achieved, the trial was stopped early.
“The study was monitored by an independent Data and Safety Monitoring Board (DSMB) that performed interim analyses of study results and adverse events to look for any indication that one treatment group’s results were superior to the other group. As the study progressed, it became clear that treating systolic blood pressure to a target of less than 120 mm Hg significantly reduced rates of cardiovascular events and death.
In view of the superior benefits of the lower blood pressure treatment intervention, the DSMB recommended communicating these results to study participants, investigators, and the public. The NHLBI accepted this recommendation and ended the blood pressure intervention of the SPRINT study about a year in advance of the original trial end date.”
The trial was stopped early because it was considered unethical to continue to expose the standard care patients to increased risk. The result? We did not develop the systems to lower blood pressure to an average of 121.
“After the trial ended, mean outpatient systolic BP increased from approximately 133 to 140 mm Hg among participants in the intensive treatment group—similar levels as the standard treatment group….The participants had been effectively managed to the 120 mm Hg systolic BP range during the SPRINT study with few major adverse effects. At study completion participants were referred back to their regular health care professionals. Presumably, these clinicians and study participants were familiar with SPRINT study results and the benefit of lower BP. Furthermore, maintaining systolic BP less than 130 mm Hg should be expected based on recommendations from the 2017 American College of Cardiology/American Heart Association BP management guidelines. Unfortunately, the reality is that the relatively poor performance of BP control in this cohort mirrors contemporary trends in BP control.”
The message is clear. Leaving a system designed to control blood pressure to 120 is deadly when the usual care system is not prepared to deliver the same level of care. In my work with doctors, I have heard them say, “How can I be held accountable for the nonadherence of my patients? How can I be held accountable for their failure to take the medicines I prescribe? It is not a matter of who is accountable. It is a matter of developing the systems, teams, and protocols that set up patients and providers for success. When you do that, controlling blood pressure control to more aggressive targets is easy. It can be replicated and scaled. Let’s get started!
This was known a long ago. Unfortunately, the legacy system has not looked at the root causes and allowed early detection and primary lifestyle optimization prevention measures to fundamentally solve this problem. It is criminal if you ask me!