Terutroban versus aspirin in patients with cerebral ischaemic events (PERFORM): a randomised, double-blind, parallel-group trial
The Lancet - Early Online Publication, 06/07/2011
Bousser MG et al. – The trial did not meet the predefined criteria for non–inferiority, but showed similar rates of the primary endpoint with terutroban and aspirin, without safety advantages for terutroban. In a worldwide perspective, aspirin remains the gold standard antiplatelet drug for secondary stroke prevention in view of its efficacy, tolerance, and cost.Methods
- This randomised, double-blind, parallel-group trial was undertaken in 802 centres in 46 countries.
- Patients who had an ischaemic stroke in the previous 3 months or a TIA in the previous 8 days were randomly allocated with a central interactive response system to 30 mg per day terutroban or 100 mg per day aspirin.
- Patients and investigators were masked to treatment allocation.
- The primary efficacy endpoint was a composite of fatal or non-fatal ischaemic stroke, fatal or non-fatal myocardial infarction, or other vascular death (excluding haemorrhagic death).
- The authors planned a sequential statistical analysis of non-inferiority (margin 1•05) followed by analysis of superiority.
- Analysis was by intention to treat.
- The study was stopped prematurely for futility on the basis of the recommendation of the Data Monitoring Committee.
- 9562 patients were assigned to terutroban (9556 analysed) and 9558 to aspirin (9544 analysed); mean follow-up was 28•3 months (SD 7•7).
- The primary endpoint occurred in 1091 (11%) patients receiving terutroban and 1062 (11%) receiving aspirin (hazard ratio [HR] 1•02, 95% CI 0•94—1•12).
- There was no evidence of a difference between terutroban and aspirin for the secondary or tertiary endpoints.
- The authors recorded some increase in minor bleedings with terutroban compared with aspirin (1147 [12%] vs 1045 [11%]; HR 1•11, 95% CI 1•02—1•21), but no significant differences in other safety endpoints.