ESPRIT (European/Australasian Stroke Prevention in Reversible Ischaemia Trial)

Results

First Outcome Events

During the trial, 389 patients had at least one primary outcome event: 173 assigned to combination therapy (12.8%) vs. 216 assigned to monotherapy (16%). The absolute risk reduction of 1.0% per year (95% CI 0.1–1.8) corresponds with a number of patients needed to treat with the combination regimen instead of with monotherapy to prevent death from all vascular causes, non-fatal stroke, non-fatal myocardial infarction, or major bleeding complication of 104 (95% CI 55–1,006) per year. Ischaemic events were less frequent in the combination group than in the monotherapy group. The HR for death from all causes was 0.88. There was no indication that there were differential effects according to cerebral or cardiac outcome event.

Major bleeding complications arose in 35 patients allocated to DP + ASA vs. 53 patients allocated to ASA alone, whereas minor bleeding was reported in 171 patients allocated to the combination regimen vs. 168 patients allocated to ASA (risk ratio 1.03; 95% CI 0.84–1.25).

Patients on DP + ASA discontinued trial medication more often than those on ASA alone (470 vs. 184), mainly because of headache.