Table 5 Sample size calculation and assumptions for each procedure
Procedure | Assumption | Sample size | |
|---|---|---|---|
Mortality rate during hospitalization | 3/738 = 0.41% | 30% reduction | 72,684 |
Incidence of complication | 568/738 = 76.96% | 30% reduction | 126 |
Incidence of most severe complication | 77/738 = 10.43% | 30% reduction | 2584 |
Incidence of MACCEs | 80/738 = 10.84% | 30% reduction | 2476 |
Mean CCI ± SD | 22.5 ± 19.3 | Δ 10; SD 19.3 | 120 |