| Intention-to-treat | Per Protocol | ||||
---|---|---|---|---|---|---|
TRA (n = 403) | dTRA (n = 398) | P | TRA (n = 394) | dTRA (n = 380) | P | |
Primary outcome | ||||||
 RAO at 3 months, % (n) | 3.3 (12/365) | 0.8 (3/361) | 0.02 | 3.4 (12/357) | 0.6 (2/344) | 0.01 |
Secondary outcomes | ||||||
 RAO at 24 h, % (n) | 6.7 (27/403) | 2.5 (10/398) |  < 0.01 | 5.8 (23/394) | 1.6 (6/380) |  < 0.01 |
 dRAO at 3 months % (n) | 0.0 (0/365) | 1.4 (5/361) | 0.03 | 0.0 (0/357) | 1.2 (4/344) | 0.04 |
 dRAO at 24 h, % (n) | 0.2 (1/403) | 2.3 (9/398) | 0.01 | 0.0 (0/394) | 2.4 (9/380) |  < 0.01 |
 Success rate of puncture, % (n) | 98.5 (397/403) | 96.0 (382/398) | 0.03 | 100.0 (394/394) | 100.0 (380/380) | 1.00 |
 Success rate of procedure, % (n) | 97.8 (394/403) | 95.5 (380/398) | 0.08 | 100.0 (394/394) | 100.0 (380/380) | 1.00 |
 Success rate in single puncture attempt, % (n) | 83.9 (338/403) | 70.9 (282/398) |  < 0.01 | 85.3 (336/394) | 73.7 (280/380) |  < 0.01 |
 Puncture attempts | 1 (1–1) (397) | 1 (1–2) (382) |  < 0.01 | 1 (1–1) (394) | 1 (1–2) (380) |  < 0.01 |
 Puncture time, s | 60 (50–60) (397) | 60 (50–90) (382) |  < 0.01 | 60 (50–60) (394) | 60 (50–90) (380) |  < 0.01 |
 Total procedural time, min | 30.0 (15.0–47.0) (403) | 25.0 (15.0–38.5) (398) | 0.06 | 30.0 (15.0–45.5) (394) | 23.0 (15.0–35.0) (380) | 0.02 |
 Total fluoroscopy time, min | 4.2 (1.6–12.2) (341) | 3.7 (1.8–11.0) (324) | 0.55 | 4.2 (1.6–11.9) (332) | 3.6 (1.9–10.0) (307) | 0.41 |
 Radiation dose, mGy | 106.6 (41.5–383.0) (340) | 95.5 (39.9–318.5) (324) | 0.29 | 106.2 (41.7–367.9) (331) | 93.9 (40.3–290.5) (307) | 0.24 |
 Contrast volume, ml | 50.0 (50.0–110.0) (403) | 50.0 (50.0–90.0) (398) | 0.02 | 50 (50–110) (394) | 50 (50–80) (380) | 0.02 |
 Bleeding, % (n) | 6.0 (24/403) | 1.5 (6/398) |  < 0.01 | 6.1 (24/394) | 1.6 (6/380) |  < 0.01 |
 BARC type 1 | 2.7 (11/403) | 0.8 (3/398) | 0.03 | 2.8 (11/394) | 0.8 (3/380) | 0.04 |
 BARC type ≥ 2 | 3.2 (13/403) | 0.8 (3/398) | 0.01 | 3.3 (13/394) | 0.8 (3/380) | 0.01 |
Haematoma, % (n) | 4.5 (18/403) | 4.5 (18/398) | 0.97 | 4.1 (16/394) | 3.7 (14/380) | 0.79 |
 mEASY type I | 2.2 (9/403) | 3.8 (15/398) | 0.20 | 2.0 (8/394) | 3.4 (13/380) | 0.23 |
 mEASY type ≥ II | 2.2 (9/403) | 0.8 (3/398) | 0.09 | 2.0 (8/394) | 0.3 (1/380) | 0.04 |
Finger numbness, % (n) | 9.2 (37/403) | 20.4 (81/398) |  < 0.01 | 9.4 (37/394) | 20.3 (77/380) | 0.00 |
Pseudoaneurysm, % (n) | 0.2 (1/403) | 0.0 (0/398) | 1.00 | 0.0 (0/394) | 0.0 (0/380) | 1.00 |
Arteriovenous fistula, % (n) | 0.0 (0/403) | 0.0 (0/398) | 1.00 | 0.0 (0/394) | 0.0 (0/380) | 1.00 |
Pain during haemostasis | 0 (0–1) (395) | 0 (0–1) (395) | 0.42 | 0 (0–1) (386) | 0 (0–1) (373) | 0.46 |
Change of the thickness of radial artery intima, mm | 0.01 (− 0.01–0.04) (403) | 0.01 (− 0.01–0.04) (398) | 0.72 | 0.01 (− 0.01–0.04) (394) | 0.01 (− 0.01–0.04) (380) | 0.72 |