Table 3.
Key clinical outcomes at 30 d and 1 y.
| Global FlexNav DS cohort (N = 193) | CAV group (N = 362) | |||
|---|---|---|---|---|
| Event | 30 d | 1 y | 30 d | 1 y |
| All-cause mortality | 1.0 | 5.2 | 1.4 | 11.8 |
| Cardiovascular | 1.0 | 2.1 | NA | NA |
| Disabling stroke | 2.1 | 2.1 | 0.8 | 2.6 |
| Life-threatening bleeding requiring transfusion | 4.1 | NA | 3.6 | NA |
| Acute kidney injury requiring dialysis | 0.0 | NA | 0.8 | NA |
| Major vascular complications | 5.7 | NA | 6.6 | NA |
| New pacemaker implantationa | 15.4 | 18.4 | 11.3 | NA |
Rate per subject (%) is calculated n/N, where n is the number of subjects with an event and N is the total number of subjects at risk. NA indicates data not available.
a
Total number of subjects without a permanent pacemaker at baseline is used as the denominator for calculating the new pacemaker implantation rate.