Acetylsalicylzuur-dipyridamol effectiever dan alleen acetylsalicylzuur bij de secundaire preventie na een 'transient ischaemic attack' of een herseninfarct van arteriële oorsprong; de 'European/Australasian stroke prevention in reversible ischaemia trial'

To establish if in patients who have experienced a transient ischaemic attack (TIA) or a non-disabling cerebral infarction the use of combination therapy of acetylsalicylic acid and dipyridamole for secondary prevention is better than acetylsalicylic acid as monotherapy.

Design

Multicentre randomized clinical trial.

Method

Patients were either randomized to acetylsalicylic acid 30-325 mg daily and dipyridamole 200 mg twice daily or to acetylsalicylic acid only, 30-325 mg daily, within 6 months after a TIA or minor stroke of presumed arterial origin. The primary outcome event was the composite of death from all vascular causes, non-fatal stroke, non-fatal myocardial infarction or a major bleeding complication, whichever happened first. Treatment was open, while auditing of outcome events was blinded.

Results

A total of 2739 patients from 79 hospitals in 14 countries were randomized for acetylsalicylic acid-dipyridamole (n = 1363) or acetylsalicylic acid (n = 1376); 1789 (65) of them were males with an average age of 63 (SD: 11). Mean follow-up was 3.5 years. Baseline characteristics were similar in both treatment groups. Patients on acetylsalicylic acid and dipyridamole discontinued trial medication more often than those on acetylsalicylic acid only (470 vs. 184), mainly because of side effects. Primary outcome events occurred in 173 (13) patients on acetylsalicylic acid-dipyridamole and in 216 (16) on acetylsalicylic acid; the resulting hazard ratio was 0.80 (95 CI: 0.66-0.98). Addition of the data to the meta-analysis of previous trials resulted in an overall risk ratio for the composite ‘vascular death, stroke or myocardial infarction’ of 0.82 (95 CI: 0.74-0.91) in the acetylsalicylic acid and dipyridamole group.

Conclusion

In patients who have experienced a TIA or a non-disabling cerebral infarction of arterial origin, the combination of acetylsalicylic acid and dipyridamole offers better protection against future vascular complications than does acetylsalicylic acid only.

Ned Tijdschr Geneeskd. 2006;150:1832-8