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Randomized Controlled Trial
. 2016 Jun 28;315(24):2673-82.
doi: 10.1001/jama.2016.7050.

Intensive vs Standard Blood Pressure Control and Cardiovascular Disease Outcomes in Adults Aged ≥75 Years: A Randomized Clinical Trial

Jeff D Williamson  1 , Mark A Supiano  2 , William B Applegate  1 , Dan R Berlowitz  3 , Ruth C Campbell  4 , Glenn M Chertow  5 , Larry J Fine  6 , William E Haley  7 , Amret T Hawfield  8 , Joachim H Ix  9 , Dalane W Kitzman  10 , John B Kostis  11 , Marie A Krousel-Wood  12 , Lenore J Launer  13 , Suzanne Oparil  14 , Carlos J Rodriguez  15 , Christianne L Roumie  16 , Ronald I Shorr  17 , Kaycee M Sink  1 , Virginia G Wadley  18 , Paul K Whelton  19 , Jeffrey Whittle  20 , Nancy F Woolard  1 , Jackson T Wright Jr  21 , Nicholas M Pajewski  22 ; SPRINT Research Group
Affiliations
Randomized Controlled Trial

Intensive vs Standard Blood Pressure Control and Cardiovascular Disease Outcomes in Adults Aged ≥75 Years: A Randomized Clinical Trial

Jeff D Williamson et al. JAMA. .

Abstract

Importance: The appropriate treatment target for systolic blood pressure (SBP) in older patients with hypertension remains uncertain.

Objective: To evaluate the effects of intensive (<120 mm Hg) compared with standard (<140 mm Hg) SBP targets in persons aged 75 years or older with hypertension but without diabetes.

Design, setting, and participants: A multicenter, randomized clinical trial of patients aged 75 years or older who participated in the Systolic Blood Pressure Intervention Trial (SPRINT). Recruitment began on October 20, 2010, and follow-up ended on August 20, 2015.

Interventions: Participants were randomized to an SBP target of less than 120 mm Hg (intensive treatment group, n = 1317) or an SBP target of less than 140 mm Hg (standard treatment group, n = 1319).

Main outcomes and measures: The primary cardiovascular disease outcome was a composite of nonfatal myocardial infarction, acute coronary syndrome not resulting in a myocardial infarction, nonfatal stroke, nonfatal acute decompensated heart failure, and death from cardiovascular causes. All-cause mortality was a secondary outcome.

Results: Among 2636 participants (mean age, 79.9 years; 37.9% women), 2510 (95.2%) provided complete follow-up data. At a median follow-up of 3.14 years, there was a significantly lower rate of the primary composite outcome (102 events in the intensive treatment group vs 148 events in the standard treatment group; hazard ratio [HR], 0.66 [95% CI, 0.51-0.85]) and all-cause mortality (73 deaths vs 107 deaths, respectively; HR, 0.67 [95% CI, 0.49-0.91]). The overall rate of serious adverse events was not different between treatment groups (48.4% in the intensive treatment group vs 48.3% in the standard treatment group; HR, 0.99 [95% CI, 0.89-1.11]). Absolute rates of hypotension were 2.4% in the intensive treatment group vs 1.4% in the standard treatment group (HR, 1.71 [95% CI, 0.97-3.09]), 3.0% vs 2.4%, respectively, for syncope (HR, 1.23 [95% CI, 0.76-2.00]), 4.0% vs 2.7% for electrolyte abnormalities (HR, 1.51 [95% CI, 0.99-2.33]), 5.5% vs 4.0% for acute kidney injury (HR, 1.41 [95% CI, 0.98-2.04]), and 4.9% vs 5.5% for injurious falls (HR, 0.91 [95% CI, 0.65-1.29]).

Conclusions and relevance: Among ambulatory adults aged 75 years or older, treating to an SBP target of less than 120 mm Hg compared with an SBP target of less than 140 mm Hg resulted in significantly lower rates of fatal and nonfatal major cardiovascular events and death from any cause.

Trial registration: clinicaltrials.gov Identifier: NCT01206062.

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Conflict of interest statement

Conflict of Interest Disclosures: The authors have completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Dr Williamson reported receiving nonfinancial support from Takeda Pharmaceuticals and Arbor Pharmaceuticals during the conduct of the study. Dr Kitzman reported receiving personal fees from Merck, Forest Labs, and Abbvie; personal fees and other from Gilead and Relypsa; and grants from Novartis outside the submitted work. Dr Oparil reported receiving personal fees from Forest Laboratories Inc; grants, personal fees, and nonfinancial support from Medtronic; personal fees from Amgen (Onyx is subsidiary); grants and personal fees from AstraZeneca and Bayer Healthcare Pharmaceuticals Inc; personal fees from Boehringer-Ingelheim and GlaxoSmithKline; grants from Merck and Co; and serving as co-chair for the Eighth Joint National Committee. No other disclosures were reported.

Figures

Figure 1
Figure 1. Eligibility, Randomization, and Follow-up for Systolic Blood Pressure (SBP) Intervention Trial (SPRINT) Participants Aged 75 Years or Older
aSystolic blood pressure was required to be between 130 mm Hg and 180 mm Hg for participants taking 0 or 1 medication, 130 mm Hg to 170 mm Hg for participants taking 2 medications or fewer, 130 mm Hg to 160 mm Hg for participants taking 3 medications or fewer, and 130 mm Hg to 150 mm Hg for participants taking 4 medications or fewer. bIncreased cardiovascular risk was defined as presence of 1 or more of the following: (1) clinical or subclinical cardiovascular disease other than stroke, (2) chronic kidney disease (defined as an estimated glomerular filtration rate of 20 mL/min/1.73m2 to 59 mL/min/1.73m2 based on the 4-variable Modification of Diet in Renal Disease equation and the latest laboratory value within the past 6 months), (3) Framingham risk score for 10-year cardiovascular risk of 15% or greater based on laboratory work done within the past 12 months for lipids, or (4) age of 75 years or older.
Figure 2
Figure 2. Kaplan-Meier Curves for the Primary Cardiovascular Disease Outcome in Systolic Blood Pressure Intervention Trial (SPRINT) in Participants Aged 75 Years or Older by Baseline Frailty Status
Tinted regions indicate 95% confidence intervals; FI, 37-item frailty index; HR, hazard ratio. The primary cardiovascular disease outcome was a composite of nonfatal myocardial infarction, acute coronary syndrome not resulting in a myocardial infarction, nonfatal stroke, nonfatal acute decompensated heart failure, and death from cardiovascular causes.
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