CV Risk and Benefit/Harm of Intensive Hypertension Treatment
What is the effect of baseline 10-year cardiovascular disease (CVD) risk on primary outcome events (primary cardiovascular events [CVEs]) and all-cause serious adverse events (SAEs) in SPRINT (Systolic Pressure Intervention Trial)?
The SPRINT trial tested the hypothesis that treatment to a systolic blood pressure (SBP) goal <120 mm Hg (intensive treatment) in nondiabetic patients ≥50 years of age at high risk for CVEs was superior to SBP treatment goal <140 mm Hg (standard treatment). A primary CVE was a composite of myocardial infarction (MI), acute coronary syndrome without MI, stroke, acute compensated heart failure, or death from CV causes. Data were stratified by quartiles of baseline 10-year CVD risk. Cox proportional hazards models were used to examine the associations of treatment group with the primary outcome events, all-cause mortality, and SAEs. Using multiplicative Poisson regression, a predictive model was developed to determine the benefit-to-harm ratio as a function of CVD risk. All-cause harm was the composite of adverse events including hypotension, syncope, bradycardia, electrolyte abnormality, injurious falls, and acute renal failure.
Within each quartile, there was a lower rate of primary outcome events in the intensive treatment group, with no differences in all-cause SAEs. From the first to fourth quartiles, the number needed to treat to prevent primary outcomes decreased from 91 to 38. The number needed to harm for all-cause SAEs increased from 62 to 250. The predictive model demonstrated significantly increasing benefit-to-harm ratios (± SE) of 0.50 ± 0.15, 0.78 ± 0.26, 2.13 ± 0.73, and 4.80 ± 1.86, for the first, second, third, and fourth quartiles, respectively (p for trend < 0.001). All possible pairwise comparisons of between-quartile mean values of benefit-to-harm ratios were significantly different (p < 0.001).
In SPRINT, those with lower baseline CVD risk had more harm than benefit from intensive treatment, whereas those with higher risk had more benefit. With the 2017 American College of Cardiology/American Heart Association BP treatment guidelines, this analysis may help providers and patients make decisions regarding the intensity of BP treatment.
The authors concluded that based on data from the SPRINT trial, adults with hypertension whose 10-year risk of CVEs is ≥18.2% gain more benefit than harm from targeting systolic BP <130 mm Hg; while for those whose risk is <18.2%, <140 mm Hg is an appropriate target. While the benefit variables appear to be more important than the harms, in addition to health dollars, the cost of harms include needless time-consuming and anxiety-producing hospital emergency room visits, injury, and subsequent mistrust and noncompliance.
Clinical Topics: Acute Coronary Syndromes, Arrhythmias and Clinical EP, Diabetes and Cardiometabolic Disease, Heart Failure and Cardiomyopathies, Prevention, Implantable Devices, Acute Heart Failure, Hypertension
Keywords: Accidental Falls, Acute Coronary Syndrome, Acute Kidney Injury, Blood Pressure, Bradycardia, Cardiovascular Diseases, Electrolytes, Heart Failure, Hypertension, Hypotension, Metabolic Syndrome X, Myocardial Infarction, Primary Prevention, Risk Factors, Stroke, Syncope
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