Salt Substitute and Stroke Study - SSaSS

Contribution To Literature:

The SSaSS trial showed that a salt substitute was beneficial at preventing first or recurrent stroke. 

Description:

The goal of the trial was to evaluate a salt substitute compared with regular salt among patients with prior stroke.

Study Design

  • Cluster randomization
  • Parallel
  • Open-label

Participants with prior stroke or risk for stroke were randomized to a salt substitute (n = 10,504) versus regular salt (n = 10,491).

  • Total number of enrollees: 20,995
  • Duration of follow-up: 4.74 years
  • Mean patient age: 65 years
  • Percentage female: 50%

Inclusion criteria:

  • History of stroke, or
  • ≥60 years of age with high blood pressure (≥140 mm Hg if on antihypertensive therapy or ≥160 mm Hg if not on antihypertensive therapy)

Exclusion criteria:

  • Potassium-sparing diuretic
  • Use of a potassium supplement
  • Known kidney disease

Other salient features/characteristics:

  • 73% had a history of stroke
  • 88% had a history of hypertension

Principal Findings:

The primary outcome of stroke occurred at a rate of 29.14 events per 1,000 person-years in the salt substitute group compared with 33.65 events per 1,000 person-years in the regular salt group (p = 0.006).

Secondary outcomes:

  • Major adverse cardiovascular events: 49.09 events per 1,000 person-years in the salt substitute group compared with 56.29 events per 1,000 person-years in the regular salt group (p < 0.001)
  • Deaths: 39.28 events per 1,000 person-years in the salt substitute group compared with 44.61 events per 1,000 person-years in the regular salt group (p < 0.001)
  • Serious adverse events due to hyperkalemia: 3.35 events per 1,000 person-years in the salt substitute group compared with 3.30 events per 1,000 person-years in the regular salt group (p = 0.76)

Interpretation:

Among patients with prior stroke or hypertension, a salt substitute was effective at preventing first or recurrent stroke. Salt substitute was also associated with a reduction in major adverse cardiovascular events and deaths. Salt substitute was not associated with an increase in serious adverse events due to hyperkalemia. Participants were excluded if they had chronic kidney disease or risk for hyperkalemia.

References:

Presented by Dr. Bruce Neal at the European Society of Cardiology Virtual Congress, August 29, 2021.

Neal B, Wu Y, Feng X, et al. Effect of Salt Substitution on Cardiovascular Events and Death. N Engl J Med 2021;Aug 29:[Epub ahead of print].

Editorial: Ingelfinger JR. Can Salt Substitution Save At-Risk Persons From Stroke? N Engl J Med 2021;Aug 29:[Epub ahead of print].

Clinical Topics: Prevention, Hypertension, Stress

Keywords: ESC Congress, ESC21, Antihypertensive Agents, Hyperkalemia, Hypertension, Primary Prevention, Renal Insufficiency, Chronic, Salt Tolerance, Sodium, Dietary, Sodium Chloride, Dietary, Stroke, Vascular Diseases


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