Table 2 The primary and second endpoints.

From: Randomized study for a novel elbow joint fixation device on postoperative complications in patients undergoing percutaneous coronary diagnostic or therapeutic procedures through the brachial artery

 

Brace group (n = 74)

Control group (n = 72)

P-value

Puncture site-related discomfort, numbers (%)

 Mild

44 (59.5)

26 (36.1)

0.014

 Moderate

28 (37.8)

41 (56.9)

 Severe

2 (2.7)

5 (6.9)

Puncture site-related NRS score, median (P25, P75)

4 (3, 5)

5 (4, 6)

0.006

The degree of swelling, median (P25, P75)

 Upper arm calibration rate

0.02 (0.02, 0.05)

0.08 (0.04, 0.10)

 < 0.001

 Forearm calibration rate

0.03 (0.02, 0.05)

0.05 (0.02, 0.09)

0.007

 Braking time (hours), median (P25, P75)

11 (10, 12)

12 (10, 12)

0.521

 Bleeding classification, numbers (%)

1 (1.4)

5 (6.9)

0.199

 Area of subcutaneous hemorrhage, median (P25, P75)

0.255 (0, 1.00)

1 (0.25, 1.75)

0.003

 Hematoma, numbers (%)

1 (1.4)

2 (2.8)

0.617

 Thrombus, numbers (%)

0 (0)

1 (1.4)

0.493