Table 3.
Thirty-day outcomes
| Characteristic | Portico DS |
FlexNav DS |
p-value | Total |
|---|---|---|---|---|
| % (n) of Subjects (N = 501) | % (n) of Subjects (N = 500) | % (n) of subjects (N = 1001) | ||
| All-cause mortality | 3.2% (16) | 2.0% (10)∗ | 0.6376 | 2.6% (26) |
| Cardiovascular mortality† | 3.0% (15) | 1.2% (6) | 0.1270 | 2.1% (21) |
| Disabling stroke | 1.6% (8) | 2.0% (10) | 0.5989 | 1.8% (18) |
| Nondisabling stroke | 1.0% (5) | 1.2% (6) | 0.7320 | 1.1% (11) |
| Acute kidney injury (stage 3) | 1.4% (7) | 0.8% (4) | 0.3841 | 1.1% (11) |
| Life-threatening bleeding | 3.2% (16) | 3.6% (18) | 0.6755 | 3.4% (34) |
| Major vascular complication | 6.4% (32) | 8.2% (41) | 0.2311 | 7.3% (73) |
| Overall permanent pacemaker implantation | 17.4% (87) | 16.8% (84) | 0.9008 | 17.1% (171) |
| Naïve permanent pacemaker implantation‡ | 19.2% (87) | 18.9% (84) | 0.9777 | 19.0% (171) |
Abbreviation: DS, delivery system.
∗
Includes 2 (0.2%) COVID-19 deaths adjudicated by the clinical events committee as noncardiovascular.
†
Unknown mortality was classified as cardiovascular mortality.
‡
Among patients without a pacemaker at baseline.