Table 3 Primary and secondary outcome measures by treatment group
MynxGrip (n = 432) | Manual compression (n = 433) | P value | |
|---|---|---|---|
MAVE | 5 (1.2%) | 0 (0%) | 0.06 |
BARC 3 and 5 bleedings at 30 days | 0 | 0 | |
Pseudoaneurysm with indication for treatment | 2 (0.2%) | 0 | |
Arteriovenous fistula | 0 | 0 | |
Groin surgery and/or possible related vascular surgery | 1 | 0 | |
Infection needing antibiotics | 2 | 0 | |
Time to haemostasis (minutes) | 4 [3:5] | 10 [7:11] | < 0.0001 |
Device failure | 31 (7%) | – | – |
Vasovagal response | 1 (0.2%) | 2 (0.5%) | 0.99 |
Need for new onset of manual compression | 51 (12%) | 40 (9%) | 0.22 |
Time to mobilization (minutes) | 73 [65:87] | 76 [70:88] | 0.01 |
In-hospital large groin haematoma (larger than 5 × 5 cm) | 25 (6%) | 30 (7%) | 0.51 |
Access site related bleedings | 6 (1.4%) | 1 (0.2%) | 0.12 |
BARC 1 and 2 bleedings at 30 days | 2 [2:2] | 1 [1:1] |