Systolic Blood Pressure Intervention Trial

Last updated
Systolic Blood Pressure Intervention Trial
Study type Randomized controlled trial
Dates2010–2015
Locations102 clinical sites in the US
Funding National Institutes of Health
Published2015
ArticleWright JT, Williamson JD, Whelton PK, Snyder JK, Sink KM, Rocco MV, et al. (November 2015). "A Randomized Trial of Intensive versus Standard Blood-Pressure Control". The New England Journal of Medicine. 373 (22): 2103–2116. doi:10.1056/NEJMoa1511939. PMC   4689591 . PMID   26551272.

The Systolic Blood Pressure Intervention Trial (SPRINT) is a multi-center clinical trial that was performed from 2010 to 2015, and published in November 2015. [1]

The objective of the trial was to identify whether, in patients with a systolic blood pressure (SBP) of 130 mm Hg or higher and an increased cardiovascular risk, but without diabetes, treating to a systolic blood pressure target of less than 120 mm Hg is superior to a target of 140 mm Hg. [1] The primary outcome being measured was myocardial infarction, other acute coronary syndromes, stroke, heart failure, or death from cardiovascular causes. [1] The study implies that patients receiving "standard" therapy were controlled similarly to all adults being treated for hypertension and that patients receiving "intensive" therapy had a lower mean SBP compared to all adults being treated for hypertension, but neither conclusion is true when compared to the US National Health and Nutrition Examination Survey. [2]

During the study, 9361 patients were randomly assigned to either a 140 mm Hg target (referred to in the study as standard treatment) or a 120 mm Hg target (intensive treatment). [1] Patients were prescribed blood pressure reducing medications to reach their assigned goal. Unlike normal hypertension treatment, once the goal was reached, prescriptions were suspended until the patient was no longer at goal. After being followed up for a median of 3.26 years, the study showed a significantly lower rate of the primary outcome in the intensive treatment group (1.65% per year) compared to the standard treatment group (2.19% per year). [1] The risk of experiencing a primary outcome (myocardial infarction, other acute coronary syndromes, stroke, heart failure, or death from cardiovascular causes) was 25% lower than in the standard treatment group, and the risk of death from any cause was 27% lower. [1] The number needed to treat with intensive therapy instead of standard therapy to prevent one death was 90. [1] The results were so much more superior for the intensive treatment group that the trial was stopped early. [1]

Although the trial showed that intensive treatment was associated with lower rates of cardiovascular events and death, intensive treatment was also associated with 4% higher rates of serious adverse effects from anti-hypertensive medications, including syncope, electrolyte abnormalities, acute kidney injury or acute renal failure. [1] However, this association was not statistically significant, with a P-value of 0.25, [1] and therefore may have occurred by chance. The intensive treatment group were not found to be at a greater risk of injurious falls or bradycardia, and orthostatic hypotension was less common in the intensive treatment group. [1] The SPRINT study was criticised about the population studied in terms of age, racial and cardiovascular danger [3]

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Myocardial infarction Interruption of blood supply to a part of the heart

A myocardial infarction (MI), commonly known as a heart attack, occurs when blood flow decreases or stops to the coronary artery of the heart, causing damage to the heart muscle. The most common symptom is chest pain or discomfort which may travel into the shoulder, arm, back, neck or jaw. Often it occurs in the center or left side of the chest and lasts for more than a few minutes. The discomfort may occasionally feel like heartburn. Other symptoms may include shortness of breath, nausea, feeling faint, a cold sweat or feeling tired. About 30% of people have atypical symptoms. Women more often present without chest pain and instead have neck pain, arm pain or feel tired. Among those over 75 years old, about 5% have had an MI with little or no history of symptoms. An MI may cause heart failure, an irregular heartbeat, cardiogenic shock or cardiac arrest.

Management of acute coronary syndrome

Management of acute coronary syndrome is targeted against the effects of reduced blood flow to the afflicted area of the heart muscle, usually because of a blood clot in one of the coronary arteries, the vessels that supply oxygenated blood to the myocardium. This is achieved with urgent hospitalization and medical therapy, including drugs that relieve chest pain and reduce the size of the infarct, and drugs that inhibit clot formation; for a subset of patients invasive measures are also employed. Basic principles of management are the same for all types of acute coronary syndrome. However, some important aspects of treatment depend on the presence or absence of elevation of the ST segment on the electrocardiogram, which classifies cases upon presentation to either ST segment elevation myocardial infarction (STEMI) or non-ST elevation acute coronary syndrome (NST-ACS); the latter includes unstable angina and non-ST elevation myocardial infarction (NSTEMI). Treatment is generally more aggressive for STEMI patients, and reperfusion therapy is more often reserved for them. Long-term therapy is necessary for prevention of recurrent events and complications.

Permissive hypotension or hypotensive resuscitation is the use of restrictive fluid therapy, specifically in the trauma patient, that increases systemic blood pressure without reaching normotension. The goal blood pressure for these patients is a mean arterial pressure of 40-50mmHg or a systolic blood pressure less than or equal to 80. This goes along with certain clinical criteria. Following traumatic injury some patients experience hypotension that is usually due to blood loss (hemorrhage) but can be due to other causes as well. In the past, physicians were very aggressive with fluid resuscitation to try to bring the blood pressure to normal values. Recent studies have found that there is some benefit to allowing specific patients to experience some degree of hypotension in certain settings. This concept does not exclude therapy by means of i.v. fluid, inotropes or vasopressors, the only restriction is to avoid completely normalizing blood pressure in a context where blood loss may be enhanced. When a person starts to bleed the body starts a natural coagulation process that eventually stops the bleed. Issues with fluid resuscitation without control of bleeding is thought to be secondary to dislodgement of the thrombus that is helping to control further bleeding. Thrombus dislodgement was found to occur at a systolic pressure greater than 80mm Hg. In addition, fluid resuscitation will dilute coagulation factors that help form and stabilize a clot, hence making it harder for the body to use its natural mechanisms to stop the bleeding. These factors are aggravated by hypothermia.

Hypertension is managed using lifestyle modification and antihypertensive medications. Hypertension is usually treated to achieve a blood pressure of below 140/90 mmHg to 160/100 mmHg. According to one 2003 review, reduction of the blood pressure by 5 mmHg can decrease the risk of stroke by 34%, of ischaemic heart disease by 21%, and reduce the likelihood of dementia, heart failure, and mortality from cardiovascular disease.

References

  1. 1 2 3 4 5 6 7 8 9 10 11 Wright JT, Williamson JD, Whelton PK, Snyder JK, Sink KM, Rocco MV, et al. (November 2015). "A Randomized Trial of Intensive versus Standard Blood-Pressure Control". The New England Journal of Medicine. 373 (22): 2103–2116. doi:10.1056/nejmoa1511939. PMC   4689591 . PMID   26551272.
  2. Egan BM, Li J, Wagner CS (August 2016). "Systolic Blood Pressure Intervention Trial (SPRINT) and Target Systolic Blood Pressure in Future Hypertension Guidelines". Hypertension. 68 (2): 318–323. doi:10.1161/hypertensionaha.116.07575. PMID   27354422. S2CID   446300.
  3. Ruiz-Hurtado G, Banegas JR, Sarafidis PA, Volpe M, Williams B, Ruilope LM (September 2017). "Has the SPRINT trial introduced a new blood-pressure goal in hypertension?". Nature Reviews. Cardiology. 14 (9): 560–566. doi:10.1038/nrcardio.2017.74. PMID   28492286. S2CID   23707851.