Geen plaats voor orale antistollingsbehandeling (streef-INR: 2,0-3,0) na een 'transient ischaemic attack' of een herseninfarct van arteriële oorsprong; de 'European/Australasian stroke prevention in reversible ischaemia trial' (ESPRIT)

The ‘European/Australasian stroke prevention in reversible ischaemia trial’ (ESPRIT) aimed to determine whether oral anticoagulation of moderate intensity (target international normalised ratio (INR): 2.0-3.0) is more effective than acetylsalicylic acid in preventing future vascular events in patients with transient ischaemic attack (TIA) or minor stroke of arterial origin.

Design

International, multicentre randomised clinical trial.

Method

Patients were randomised within 6 months of TIA or minor stroke of arterial origin to oral anticoagulants (target INR: 2.0-3.0; n = 536) or acetylsalicylic acid (30-325 mg daily; n = 532). The primary endpoint was a composite of vascular death, non-fatal stroke, non-fatal myocardial infarction or major bleeding complications. In a post hoc analysis, the efficacy of anticoagulants was compared with that of the combination of acetylsalicylic acid and dipyridamole (200 mg twice daily), a third arm of ESPRIT. Treatment was unblinded, but auditing of endpoints was blinded. Data were analysed on an intent-to-treat basis.

Results

The comparison of anticoagulants and acetylsalicylic acid was stopped prematurely because the combination of acetylsalicylic acid and dipyridamole was found to be more effective than acetylsalicylic acid alone. The mean duration of follow-up was 4.6 years (SD: 2.2). The mean INR was 2.57 (SD: 0.86; nearly 70 of the time within target range). The primary endpoint occurred in 99 patients (19) in the anticoagulation group and 98 patients (18) in the acetylsalicylic acid group (hazard ratio: 1.02; 95 CI: 0.77-1.35). The hazard ratio was 0.73 (95 CI: 0.52-1.01) for ischaemic events and 2.56 (95 CI: 1.48-4.43) for major bleeding complications. The hazard ratio for the primary outcome event comparing anticoagulants with the combination of acetylsalicylic acid and dipyridamole was 1.31 (95 CI: 0.98-1.75).

Conclusion

Oral anticoagulants (target INR: 2.0-3.0) were not more effective than acetylsalicylic acid in the secondary prevention of vascular events following TIA or minor stroke of arterial origin.

Ned Tijdschr Geneeskd. 2008;152:445-53