Pivotal randomised trials of aspirin versus aspirin plus dipyridamole
Second European stroke prevention study (ESPS-2) | European/Australian stroke prevention in reversible ischaemia trial (ESPRIT) | |
---|---|---|
Primary publication | 1996 | 2006 |
Type of trial | Randomised, placebo controlled | Randomised, open control |
Participants | Adult patients within 3 months of an ischaemic stroke or transient ischaemic attack | Adult patients 0-6 months after minor ischaemic stroke or transient ischaemic attack of presumed arterial origin (patients with a cardioembolic source such as atrial fibrillation excluded) |
Mean age (years) | 67 | 63 |
Sex (percentage male) | 58 | 65 |
Randomisation | 3299 patients randomised between relevant treatment arms: aspirin 25 mg twice daily; aspirin 25 mg twice daily plus modified release dipyridamole 200 mg twice daily | 2739 patients randomised between relevant treatment arms: aspirin 30-325 mg (median 75 mg) daily; aspirin 30-325 mg daily plus dipyridamole 200 mg twice daily (85% used modified release preparation) |
Follow-up (years) | 2 | 3.5 |
Average annual risk of vascular events in aspirin only treatment arm (%) | 10 | 5 |
Outcome of aspirin plus dipyridamole v aspirin alone | Significantly reduced vascular events (relative risk 0.78, 95% confidence interval 0.67 to 0.91)— as a result of significant reduction in stroke, with no detectable effect on either myocardial infarction or vascular death (although numbers of non-stroke outcomes were small) | Significantly reduced vascular events (0.78, 95% confidence interval 0.64 to 0.96)—as a result of reductions in each of ischaemic stroke, cardiac events, and vascular death, although none of these was independently significant. Benefits continued to accrue during follow-up for up to five years. No significant differences were seen in the relative effects of treatment according to several characteristics, including age, sex , history of ischaemic heart disease, and aspirin dose |