Table 2.

Primary ClinRO based on the number of CFA access

Primary ClinRO (ITT analysis)	Percutaneous Access (n = 124)	Cutdown Access (n = 116)	Univariate analysis		Multivariate analysis
			OR (95% CI)	P	OR (95% CI)		P
Access-related complications	10 (8.1)	17 (14.7)	0.521 (0.225–1.157)	0.110	0.620 (0.259–1.440)		0.267
Access site infection	1 (0.8)	2 (1.7)	0.556 (0.050–4.244)	0.566	0.386 (0.035–2.915)		0.347
Postoperative bleeding/hematoma	6 (4.8)	11 (9.5)	0.503 (0.175–1.332)	0.168	0.634 (0.210–1.823)		0.397
Access-related arterial injury	2 (1.6)	1 (0.9)	1.571 (0.206–17.359)	0.660	2.054 (0.255–22.725)		0.492
Femoral artery occlusion	0	1 (0.9)	0.309 (0.002–5.856)	0.440	0.480 (0.003–33.269)		0.713
Pseudoaneurysm	4 (3.2)	0	8.701 (0.913–1158)	0.062	14.156 (1.293–3657)		0.026
Lymphorrhagia/seroma	0	4 (3.4)	0.100 (0.001–0.957)	0.045	0.085 (0.001–0.812)		0.029
Access-related nerve injury	0	1 (0.9)	0.309 (0.002–5.856)	0.440	0.273 (0.002–4.723)		0.382
Primary ClinRO (PP analysis)	Percutaneous Access (n = 127)	Cutdown Access (n = 113)	Univariate analysis		Multivariate analysis
			OR (95% CI)	P	OR (95% CI)		P
Access-related complications	10 (7.9)	17 (15.0)	0.528 (0.226–1.184)	0.121	0.617 (0.257–1.439)		0.263
Access site infection	0	3 (2.7)	0.124 (0.001–1.297)	0.087	0.090 (0.001–0.924)		0.042
Postoperative bleeding/hematoma	7 (5.5)	10 (8.8)	0.685 (0.245–1.846)	0.452	0.851 (0.291–2.472)		0.764
Access-related arterial injury	0	3 (2.7)	0.124 (0.001–1.297)	0.087	0.145 (0.001–1.676)		0.134
Femoral artery occlusion	1 (0.8)	0	2.692 (0.142–394)	0.518	3.146 (0.123–540)		0.492
Pseudoaneurysm	4 (3.1)	0	8.271 (0.868–1101)	0.070	11.694 (1.188–2292)		0.033
Lymphorrhagia/seroma	0	4 (3.5)	0.095 (0.001–0.909)	0.040	0.081 (0.001–0.782)		0.027
Access-related nerve injury	0	1 (0.9)	0.294 (0.002–5.570)	0.420	0.260 (0.002–4.521)		0.363

ClinRO, clinician-reported outcome; ITT, intention-to-treat; OR, odds ratio; CI, confidence interval; PP, per-protocol.