ESPRIT
Trial question
Is combination of aspirin and dipyridamole superior to aspirin in patients with a recent history of TIA or minor stroke of presumed arterial origin?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
35.0% female
65.0% male
N = 2739
2739 patients (950 female, 1789 male).
Inclusion criteria: patients within 6 months of a TIA or minor ischemic stroke of presumed arterial origin.
Key exclusion criteria: possible cardiac source of embolism, any blood coagulation disorder, any contraindication for aspirin or dipyridamole, and a limited life expectancy.
Interventions
N=1363 aspirin and dipyridamole (aspirin dose of 30-325 mg/day and dipyridamole dose of 400 mg daily).
N=1376 aspirin alone (at a dose of 30-325 mg/day).
Primary outcome
Death from all vascular causes, nonfatal stroke, nonfatal MI, or major bleeding
13%
16%
16.0 %
12.0 %
8.0 %
4.0 %
0.0 %
Aspirin and
dipyridamole
Aspirin
alone
Significant
decrease ▼
NNT = 33
Significant decrease in death from all vascular causes, nonfatal stroke, nonfatal MI, or major bleeding (13% vs. 16%; HR 0.8, 95% CI 0.66 to 0.98).
Secondary outcomes
No significant difference in death from any cause (7% vs. 8%; HR 0.88, 95% CI 0.67 to 1.17).
No significant difference in vascular death (3.2% vs. 4.4%; HR 0.75, 95% CI 0.51 to 1.1).
No significant difference in major bleeding complications (2.6% vs. 3.9%; HR 0.67, 95% CI 0.44 to 1.03).
Safety outcomes
No significant difference in all major ischemic events.
Significant difference in discontinuation of trial medication (34.5% vs. 13.4%).
Conclusion
In patients within 6 months of a TIA or minor ischemic stroke of presumed arterial origin, aspirin and dipyridamole were superior to aspirin alone with respect to death from all vascular causes, nonfatal stroke, nonfatal MI, or major bleeding.
Reference
ESPRIT Study Group, Halkes PH, van Gijn J et al. Aspirin plus dipyridamole versus aspirin alone after cerebral ischaemia of arterial origin (ESPRIT): randomised controlled trial. Lancet. 2006 May 20;367(9523):1665-73.
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