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Table 3 Primary and secondary outcomes

From: Comparison of long-term radial artery occlusion via distal vs. conventional transradial access (CONDITION): a randomized controlled trial

 

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

  1. Values are % (n/N) or median (IQR) (n)
  2. TRA Transradial access, dTRA distal transradial access, RAO Radial artery occlusion, BARC Bleeding academic research consortium, mEASY modified Early Discharge After Transradial Stenting of Coronary Arteries Study