Swedish Aspirin Low-Dose Trial - SALT

Description:

The Swedish Aspirin Low-Dose Trial (SALT) is a randomized trial of the association of 75 mg of daily aspirin therapy with incidence of stroke or death among patients with cerebrovascular ischemic events.

Hypothesis:

Low-dose (75 mg) aspirin may be associated with a reduction in the incidence of stroke or death among patients with recent cerebrovascular events without an increased associated risk of bleeding.

Study Design

Study Design:

Patients Enrolled: 1,360
Mean Follow Up: 32 months
Mean Patient Age: Mean age of 67
Female: 35

Patient Populations:

50-79 years old AND one of the following within three months of enrollment:

  • TIA (including amaurosis fugax)
  • Minor ischemic stroke
  • Retinal artery occlusion
  • Exclusions:

    • Persistent symptoms three weeks from onset
    • Cardiac source of emboli (e.g., atrial fibrillation)
    • Prosthetic valve
    • Previous or planned carotid surgery
    • Known cause of symptoms (e.g., vasculitis, dissection, migraine, hyperviscosity disorder)
    • Contraindication to aspirin
    • Need for long-term anticoagulation

    Primary Endpoints:

    Combined endpoint: stroke (major or minor) or death from any cause

    Secondary Endpoints:

    • Stroke (minor or major)
    • Stroke or two or more TIAs within a week of one another, necessitating change of therapy
    • Myocardial infarction

    Drug/Procedures Used:

    Patients were randomized to 75 mg of film-coated aspirin daily compared with daily placebo.

    Principal Findings:

    • 75 mg of daily aspirin was associated with an 18% lower incidence of stroke or death (25% in the placebo group vs. 20% in the aspirin group, p=0.02).
    • The use of aspirin was associated with a significant reduction in the combined endpoint of stroke or two transient ischemic attacks (TIAs) within one week, necessitating a change in therapy (p=0.03).
    • Both all bleeding events and severe gastrointestinal bleeding occurred more frequently in the aspirin group (p=0.001 and 0.04, respectively).

    Interpretation:

    Among patients with recent cerebrovascular events, the use of 75 mg of daily aspirin was associated with a reduction in the combined endpoint of stroke or death and with the combined endpoint of stroke or two or more TIAs within one week. The incidence of severe gastrointestinal bleeding and bleeding overall, however, was significantly higher among those treated with aspirin.

    References:

    Swedish Aspirin Low-Dose Trial (SALT) of 75 mg aspirin as secondary prophylaxis after cerebrovascular ischaemic events. Lancet 1991;338:1345-9.

    Keywords: Stroke, Ischemic Attack, Transient, Platelet Aggregation Inhibitors, Cerebrovascular Disorders, Gastrointestinal Hemorrhage


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