Safety and efficacy results overall and in virgin vessels
| Result | Overalla | Virgin Vessels | |||
|---|---|---|---|---|---|
| Device (n = 475) | Manual Compression (n = 79) | Device (n = 337) | Manual Compression (n = 54) | P Value | |
| Success | 450 (95) | 76 (96) | 320 (95) | 53 (98) | >.05 |
| Complication | 3 (0.6) | 2 (2.5) | 2 (0.6) | 2 (3.7) | >.05 |
| Pseudoaneurysm | 1 (0.2) | 2 (2.5) | 0 | 2 (3.7) | .0201 |
| Infection | 1 (0.2) | 0 | 1 (0.3) | 0 | >.05 |
| Subintimal dissection | 1 (0.2) | 0 | 1 (0.3) | 0 | >.05 |
| Surgical intervention | 3 (0.6) | 2 (2.5) | 2 (0.6) | 2 (3.7) | >.05 |
| Transfusion | 0 | 0 | 0 | 0 | NA |
Note.—Data in parentheses are percentages. NA = not applicable.
a All P > .05.