Clinical Outcomes | Overall Cohort (N=121) | Cohort 2 vs. Cohort 1 | P Value | |
---|---|---|---|---|
Cohort 1 (N=35) | Cohort 2 (N=86) | Hazard ratio (95% CI) | ||
Primary safety endpoint, N (%) | 11 (31.4) | 22 (25.6) | 0.87 (0.42-1.80) | 0.710 |
Major bleeding, N (%) | 10 (28.6) | 17 (19.8) | 0.74 (0.34-1.62) | 0.456 |
CRNMB, N (%) | 1 (2.9) | 5 (5.8) | 2.16 (0.25-18.45) | 0.483 |
Secondary efficacy endpoint, N (%) | 7 (20.0) | 17 (19.8) | 0.96 (0.40-2.32) | 0.930 |
All-cause death, N (%) | 2 (5.7) | 8 (9.3) | 1.57 (0.33-7.41) | 0.567 |
Stroke/SE, N (%) | 1 (2.9) | 4 (4.7) | 1.60 (0.18-14.28) | 0.676 |
Nonfatal MI, N (%) | 2 (5.7) | 2 (2.3) | 0.39 (0.06-2.79) | 0.350 |
Revascularization, N (%) | 2 (5.7) | 3 (3.5) | 0.60 (0.10-3.59) | 0.576 |