Table 4.
ITT group | PP group | ||||||
---|---|---|---|---|---|---|---|
TRA (n = 418) | DRA (n = 432) | p value | TRA (n = 402) | DRA (n = 393) | p value | ||
Forearm RAO | |||||||
At discharge (24 h) | 15 (3.6%) | 5 (1.2%) | 0.039 | 14 (3.5%) | 4 (1.0%) | 0.029 | |
1 week | 17 (4.1%) | 8 (1.9%) | 0.071 | 17 (4.2%) | 7 (1.8%) | 0.060 | |
1 month | 27 (6.5%) | 11 (2.5%) | 0.012 | 26 (6.5%) | 11 (2.8%) | 0.012 | |
6 months | 28 (6.7%) | 11 (2.5%) | 0.008 | 26 (6.5%) | 11 (2.8%) | 0.008 | |
12 months | 28 (6.7%) | 11 (2.5%) | 0.008 | 26 (6.5%) | 11 (2.8%) | 0.008 | |
Puncture time, s | 13.0 [5.0–30.0] | 18.0 [8.0–48.0] | < 0.001 | 12.0 [5.0–28.0] | 18.0 [8.0–48.0] | < 0.001 | |
Sheath insertion time, s | 35.0 [23.0–56.0] | 44.0 [28.0–78.5] | < 0.001 | 35.0 [23.0–55.0] | 43.0 [28.0–80.0] | < 0.001 | |
Total procedure time, min | 20.0 [8.0–35.0] | 20.0 [10.0–35.0] | 0.315 | 20.0 [9.0–35.0] | 20.0 [9.8–35.0] | 0.501 | |
Radiation dose, mGy | 996.9 [554.1–1839.1] | 924.5 [493.1–1709.5.0] | 0.238 | 1001.9 [14.1–8.087.0] | 927.4 [21.2–0.591.0] | 0.244 | |
Time to hemostasis, min | 180.0 [120.0–460.0] | 156.5 [125.0–195.0] | < 0.001 | 180.0 [120.0–420.0] | 156.5 [125.0–197.2] | 0.005 | |
Postprocedure bleeding (BARC 1–2) (n/N), % | 20.5 (86/418) | 3.2 (14/432) | < 0.001 | 20.9 (84/402) | 3.6 (14/393) | < 0.001 | |
Hematoma ≥ 5 cm at discharge (24 h) (n/N), % | 27.0 (113/418) | 9.0 (39/432) | < 0.001 | 27.3 (110/402) | 9.7 (38/393) | < 0.001 | |
Pain scale score | 0.0 [0.0; 2.0] | 1.0 [0.0; 2.0] | 0.992 | 0.0 [0.0; 2.0] | 1.0 [0.0; 2.0] | 0.992 | |
Vascular complications | |||||||
Compartment syndrome | 0 | 0 | — | 0 | 0 | — | |
Arterio‐venous fistula | 0 | 0 | — | 0 | 0 | — | |
False aneurysm | 0.2% (1/418) | 0 (0/393) | 0.495 | 0.3% (1/402) | 0 (0/393) | 0.496 | |
Infection | 0 | 0 | — | 0 | 0 | — | |
Radial artery spasm | 23.9 (100/418) | 23.6 (102/432) | 0.872 | 100 (24.9%) | 110 (28%) | 0.870 |
Notes: Values are in % (n/N), median [IQR].