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The SPRINT Clinical Trial: Implications For Your Practice
Kim A. Eagle, MD, MACC
Editor-in-Chief, ACC.org
The Systolic Pressure Interventional Trial (SPRINT) represents an important clinical trial to inform practice in the treatment of hypertension. The trial randomized over 9,000 subjects age >50 without diabetes to either a treatment systolic blood pressure goal of ≤120 mmHg or the currently accepted standard 140 mmHg. The study recruited 3,331 women, 2,648 patients with chronic kidney disease, over 2500 ≥75 years of age. Nearly 2,000 patients with cardiovascular disease and nearly 4,000 patients from minority subsets participated.
The Data Safety and Quality Committee recommended to the National Heart Lung and Blood Institutes to terminate the trial on September 15, 2015 due to evidence of a more favorable outcome in patients treated to the lower blood pressure level. The press release indicated a 33% reduction in cardiovascular events and a 25% reduction in death.
The ramifications of the SPRINT trial if applied to patients with hypertension throughout the United States and indeed the world are profound. Given the fact that tens of millions of patients are currently treated for hypertension, the decision to move toward a more aggressive blood pressure goal could have an enormous influence on practice. Obviously, if the trial results are indeed true then the implications for reducing the morbidity and mortality of cardiovascular disease in the country are profound. At the same time, the care practice consequences of adding, on average, one additional antihypertensive drug to the current regimen for tens of millions of patients has a profound impact both on patients and our care system at large. It will be very important to consider how to properly interpret and put into clinical context and practice the results of SPRINT.
That is why we have convened on ACC.org a group of hypertension experts to consider the question of whether or not they have changed their blood pressure recommendations based on the early termination of the SPRINT trial, and if not, why not.
Please check this space frequently, and review the opinions of the experts. Also, feel free to add your opinion here.
Perspectives and Analysis
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Dec 2, 2015 | Addison A Taylor, MD
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Dec 2, 2015 | Giuseppe Mancia, MD
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SPRINT: An Enthusiastic Evaluation Nov 12, 2015 | Clive Rosendorff, MD, PHD, FACC
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A Systolic Blood Pressure Below 120 mmHg for Everyone? I Think NOT Nov 9, 2015 | George L. Bakris, MD
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Nov 9, 2015 | Susan Steigerwalt, MD; Robert Brook, MD
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The Systolic Blood Pressure Intervention Trial (SPRINT) was designed to test the hypothesis that systolic blood pressure (SBP) reduction to a goal of less than 120 mm Hg had a greater impact on fatal and non-fatal cardiovascular events than reducing SBP to the goal of <140 mm Hg, – the current guideline recommendation in the U.S. and Europe for persons <60 years old and those with chronic kidney disease (CKD) and diabetes mellitus (DM).
The Systolic Blood Pressure Intervention Trial (SPRINT) randomized patients aged 50 years or more who had a systolic blood pressure (SBP) equal or greater than 130 mm Hg and a high cardiovascular risk to an antihypertensive treatment aimed at achieving an SBP of <120 mm Hg (intensive treatment) or <140 mm Hg (standard treatment).
The results of the SPRINT study were revealed at the AHA Scientific Sessions on November 9th. A few months’ earlier, the study was stopped prematurely, with a press release indicating a highly significant positive outcome. As a result, the presentation during AHA 2015 held few surprises.
I have changed my blood pressure recommendations for a subgroup of people with criteria similar to those studied in SPRINT based on the early termination and results of this trial. Over the past 25 years a number of clinical outcome trials have evaluated the effectiveness of blood pressure reduction on cardiovascular (CV) outcomes. All these trials show significant CV risk reduction and especially a reduced incidence of heart failure.
SPRINT is a “game changer.” Based on the main results, up to 16 million Americans (those meeting trial entry criteria) will benefit from more intensive blood pressure (BP) control than previously promulgated by guidelines (in particular, the recent Eighth Joint National Committee [JNC 8] recommendations). The trial was stopped earlier than expected as the primary composite outcome was significantly decreased after only slightly more than 3 years.The composite event reduction appears to be chiefly derived from decreases in cardiovascular and all-cause mortality, as well as from hospitalizations for congestive heart failure. It is important to highlight that few hypertension trials have demonstrated a reduction in mortality, and this is an outstanding (and perhaps surprising) aspect of SPRINT, whereas stroke risk unexpectedly only trended to be decreased despite the substantially lower achieved BPs.
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