Cardiac Safety Study
Cardiac Safety in the Second European Stroke Prevention Study
Background & Design
The second European Stroke Prevention Study (ESPS 2) investigated the prevention of stroke and/or death in 6,602 patients with transient ischaemic attack or stroke with ASA (25 mg b.d.), extended-release dipyridamole (200 mg b.d.), the combination of ASA and dipyridamole, or placebo. This post hoc analysis investigated cardiac events in patients with coronary heart disease or myocardial infarction (MI) at entry. ESPS 2 had a 2 x 2 factorial design. For this analysis, all patients who received dipyridamole were compared to those who did not receive dipyridamole. Similarly, all patients who were treated with ASA were compared with those who were not treated with ASA.
Distribution of Patients With Pre-existing CHD or MI in the Four Groups and in the Factorial Analysis
| Treatment groups | ||||
|---|---|---|---|---|
| DP + ASA | DP | ASA | Placebo | |
| CHD | 573 (34.7%) | 598 (36.2%) | 571 (34.6%) | 577 (35.0%) |
| Prior MI | 237 (14.4%) | 214 (12.9%) | 221 (13.4%) | 219 (13.3%) |
| Total | 1650 | 1654 | 1649 | 1649 |
| Treatment groups in the factorial analysis | |||||
|---|---|---|---|---|---|
| DP | No DP | ASA | No ASA | Total | |
| CHD = coronary heart disease; MI = myocardial infarction; DP = dipyridamole; ASA = acetylsalicylic acid | |||||
| CHD | 1171 (35.4%) | 1148 (34.8%) | 1144 (34.7%) | 1175 (35.6%) | 2319 (35.1%) |
| Prior MI | 458 (13.9%) | 433 (13.1%) | 451 (13.7%) | 440 (13.3%) | 891 (13.5%) |
| Total | 3304 | 3298 | 3299 | 3303 | 6602 |
Patients with CHD or prior MI were evenly distributed across the treatment arms. Between 34.7% and 36.2% of the patients suffered from CHD and between 12.9% and 14.4% had had an MI at entry into the trial
