Key PointsQuestion
Does the use of a reduced-sodium, added-potassium salt
substitute vs regular salt decrease the risk of stroke recurrence and
death in patients with a history of stroke?
Findings
In this prespecified subgroup analysis of the Salt Substitute
and Stroke Study (SSaSS) trial involving 15 249 patients with stroke,
the use of a salt substitute led to a 14% reduction in the risk of
recurrent stroke and a 12% reduction in mortality.
Meaning
Results suggest that salt substitution significantly reduced
the risks of stroke recurrence and death and is a novel and practical
therapeutic option for patients with stroke.
Importance
The direct effect of consumption of salt substitutes on
recurrent stroke and mortality among patients with stroke remains
unclear.
Objective
To evaluate the effects of salt substitutes vs regular salt on
the incidence of recurrent stroke and mortality among patients with
stroke.
Design, Setting, and Participants
The Salt Substitute and Stroke Study (SSaSS), an open-label,
cluster randomized clinical trial, was conducted in 600 northern Chinese
villages (clusters). Patients who self-reported a hospital diagnosis of
stroke were included in this prespecified subgroup analysis. Data were
analyzed from November 2023 to August 2024.
Interventions
Participants were assigned to use either a salt substitute,
consisting of 75% sodium chloride and 25% potassium chloride by mass, or
regular salt.
Main Outcomes and Measures
The primary outcome was recurrent stroke.
Results
After excluding 5746 persons without a baseline history of
stroke, 15 249 patients with stroke (mean [SD] age, 64.1 [8.8] years;
6999 [45.9%] female; 8250 male [54.1%]) were included. Over a median
(IQR) follow-up of 61.2 (60.9-61.6) months, the mean difference in
systolic blood pressure was −2.05 mm Hg (95% CI, −3.03 to −1.08 mm Hg). A
total of 2735 recurrent stroke events (691 fatal and 2044 nonfatal) and
3242 deaths were recorded. Recurrent stroke was significantly lower in
the salt substitute vs regular salt group (rate ratio [RR], 0.86; 95%
CI, 0.77-0.95; P = .005), with larger effects on hemorrhagic stroke (relative reduction, 30%; P = .002). Death rates were also significantly lower (RR, 0.88; 95% CI, 0.82-0.96; P = .003), with larger effects on stroke-related deaths (relative reduction 21%; P = .01). No significant difference was observed for hyperkalemia (RR, 1.01; 95% CI, 0.74-1.38; P = .96).
Conclusions and Relevance
Results of this cluster trial demonstrate that salt
substitution was safe, along with reduced risks of stroke recurrence and
death, which underscores large health gains from scaling up this
low-cost intervention among patients with stroke.
Trial Registration
ClinicalTrials.gov Identifier: NCT02092090
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