Table 3.
The 30-day outcomes.
| Event Type | Portico™ DS % (n) of Subjects (n = 501) |
FlexNav™ DS % (n) of Subjects (n = 500) |
p-Value | Total: % (n) of Subjects (n = 1001) |
|---|---|---|---|---|
| All-cause mortality | 3.2% (16) | 2.0% (10) 1 | 0.6376 | 2.6% (26) |
| Cardiovascular mortality 2 | 3.0% (15) | 1.2% (6) | 0.1270 | 2.1% (21) |
| Non-cardiovascular mortality | 0.2% (1) | 0.8% (4) | 0.1516 | 0.5% (5) |
| Myocardial infarction | 0.4% (2) | 0.2% (1) | 1.0000 | 0.3% (3) |
| Acute kidney injury stage | 1.4% (7) | 0.8% (4) | 0.3841 | 1.1% (11) |
| Bleeding events | ||||
| Life-threatening | 3.2% (16) | 3.6% (18) | 0.6755 | 3.4% (34) |
| Major bleeding | 5.2% (26) | 6.6% (33) | 0.3020 | 5.9% (59) |
| Minor bleeding | 6.2% (31) | 4.0% (20) | 0.1903 | 5.1% (51) |
| Stroke | ||||
| Disabling | 1.6% (8) | 2.0% (10) | 0.5989 | 1.8% (18) |
| Non-disabling | 1.0% (5) | 1.2% (6) | 0.7320 | 1.1% (11) |
| Vascular complications | 13.2% (66) | 12.6% (63) | 0.8250 | 12.9% (129) |
| Major vascular complications | 6.4% (32) | 8.2% (41) | 0.2311 | 7.3% (73) |
| Access site complication | 6.0% (30) | 7.4% (37) | 0.3249 | 6.7% (67) |
| TAVI Delivery System site | 4.0% (20) | 5.6% (28) | 0.2054 | 4.8% (48) |
| Non-TAVI Delivery System site | 2.0% (10) | 1.8% (9) | 0.8573 | 1.9% (19) |
| Non-access site complication | 0.4% (2) | 0.8% (4) | 0.4466 | 0.6% (6) |
| Minor vascular complications | 7.2% (36) | 5.0% (25) | 0.1108 | 6.1% (61) |
| Naïve permanent pacemaker insertion 3 | 19.2% (87) | 18.9% (84) | 0.9777 | 19.0% (171) |
| Annular rupture | 0.4% (2) | 0.2% (1) | 1.0000 | 0.3% (3) |
| Coronary obstruction | 0.4% (2) | 0.6% (3) | 0.6833 | 0.5% (5) |
1 Includes two (0.2%) COVID-19 deaths adjudicated by the CEC as non-cardiovascular; 2 unknown mortality is classified as cardiovascular mortality; 3 among patients without a pacemaker at baseline.