Table 2 Differences between the CREST and the Guidant Corporation/FDA analysis
Aspect of the trial | Superiority (CREST) | Equivalence (Guidant Corporation/FDA analysis) |
|---|---|---|
Hypothesis format | Traditional | Equivalency |
Primary events | Stroke, myocardial infarction, or death in 30 days; | Stroke, myocardial infarction, or death in 30 days; |
| Â | ipsilateral stroke thereafter | ipsilateral stroke thereafter |
Follow-up | Variable follow up (1-4 years) | 1-year follow up |
Statistical comparison | Differences in hazard of event | Event rate at 1 year |