Before the Journals: The SPS3 Trial

The results of the Secondary Prevention of Small Subcortical Strokes trial have now been published in full in the Aug. 30 New England Journal of Medicine.

We previously reported on the results of the SPS3 trial at this year’s International Stoke Conference in New Orleans. The full paper does not contain any notable revisions from our original report.

Investigators for the SPS3 trial randomized 3,020 patients with recent lacunar strokes to receive 75 mg of clopidogrel (Plavix) or placebo daily; patients in both groups received 325 mg of aspirin daily. After a mean follow-up of 3.4 years, all-cause mortality occurred at a rate of 1.4% per year in the aspirin-only arm, and a rate of 2.1% per year in the dual-therapy arm, which translated into a hazard ratio of 1.52 (N. Engl. J. Med. 2012;367:817-25). At the same time, the major hemorrhages occurred at a rate of 1.1% per year in the aspirin-only arm, and at a rate of 2.1% per year in the dual-therapy arm (HR, 1.97).

The study’s primary outcome of interest was the incidence of recurrent stroke. The investigators noted no significant difference in the incidence of ischemic and hemorrhagic strokes between treatment groups. These events occurred at a rate of 2.7% per year among those in the aspirin-only arm, and 2.5% per year among those in the dual-therapy arm (HR, 0.97).