Randomized controlled multicenter trial of N-butyl cyanoacrylate endovenous ablation and radiofrequency endovenous ablation for incompetent great saphenous veins

Abstract

Abstract:

ObjectiveTo compare the 12-month efficacy and safety of N-butyl cyanoacrylate (NBCA)versusradiofrequency ablation (RFA) in treating great saphenous vein (GSV) insufficiency.MethodsA total of 155 patients with GSV insufficiency from five centers were randomly allocated to the NBCA group or RFA group. Postoperative efficacy and safety outcomes were evaluated.ResultsImmediate postoperative closure rates of the GSV trunk were 100% in both groups. The closure rates of NBCA and RFA group were 98.6% and 98.5% at 3 months, 97.1% and 98.5% at 6 months, 98.1% and 95.9% at 12 months, with no statistically significant differences (P>0.05). After treatment, CEAP classification improved significantly from baseline in both groups. In terms of safety, 1 case of phlebitis, 1 case of ablation-related thrombus extension (ARTE) and 2 cases of calf muscle venous thrombosis(CMVT) occurred in the NBCA group, while 2 cases of limb numbness, 1 case of persistent thigh pain and 2 cases of CMVT in the RFA group. All reported serious adverse events in both groups were assessed as unrelated to the medical device or the trial procedure.ConclusionsNBCA demonstrates non-inferior efficacy and safety compared to RFA for treating GSV insufficiency over 12 months.

Key words:Great saphenous vein(GSV) insufficiency,N-butyl cyanoacrylate(NBCA),Endovenous nonthermal ablation,Radiofrequency ablation (RFA)

CLC Number:

R654.4

JIANG Jinsong, WU Hao, WANG Xinye, XIE Dang, WANG Changming, FANG Xin, HE Chunshui, LIU Zhenjie. Randomized controlled multicenter trial of N-butyl cyanoacrylate endovenous ablation and radiofrequency endovenous ablation for incompetent great saphenous veins[J]. Journal of Surgery Concepts & Practice, 2025, 30(04): 302-309.

Figures/Tables7

Fig 1

Hospital	NBCA group	RFA group	Total
Zhejiang Provincial People’s Hospital	33	32	65
Peking University Third Hospital	14	14	28
Hospital of Chengdu University of Traditional Chinese Medicine	3	2	5
Affiliated Hangzhou First People's Hospital, Westlake University School of Medicine	13	13	26
The Second Affiliated Hospital, Zhejiang University School of Medicine	15	16	31

Tab 1

Tab 2

Comparison of preoperative clinical data between two groups [n(%)/$\bar{x} \pm s$]

Clinical data	NBCA group （n=78）	RFA group （n=77）	Statistical value	Pvalue
Gender			χ²=0.50	0.48
Male	30（38.5）	34（44.2）
Female	48（61.5）	43（55.8）
Age(years)	58.1±11.6	58.0±11.2	t=0.08	0.94
CEAP classification				<0.001
C2	23（29.5）	18（23.4）
C3	6（7.7）	21（27.3）
C4a	35（44.9）	36（46.8）
C4b	5（6.4）	1（1.3）
C5	9（11.5）	1（1.3）
VCSS	4.1±2.6	3.7±1.9	U=2650.5	0.21
AVVQ	5.0±4.0	4.2±3.4	U=2699.0	0.27
GSV diameter（mm）	8.0±2.3	7.6±2.1	t=1.34	0.18
Reflux time（s）	5.3±3.6	5.1±2.4	t=1.61	0.11

Tab 2

Closure rates	NBCA group	RFA group	Pvalue
at 3 months	98.6%(70/71)	98.5%(67/68)	1.00
at 6 months	97.1%(66/68)	98.5%(64/65)	0.62
at 12 months	98.1%(52/53)	95.9%(47/49)	0.61

Tab 3

Fig 2

Item	NBCA group	RFA group	χ² value	Pvalue
CEAP grade at 3 months			1.67	0.43
C0-C1	53（74.6）	54（79.4）
C2-C3	8（11.3）	9（13.2）
C4a	10（14.1）	5（7.4）
CEAP grade at 6 months			0.60	0.74
C0-C1	60（87.0）	60（90.9）
C2-C3	2（2.9）	1（1.5）
C4a	7（10.1）	5（7.6）

Tab 4

Item	NBCA group	RFA group	Pvalue
Thrombus	3.8(3/78)	2.6(2/77)	1.00
Petechia	1.3(1/78)	5.2(4/77)	0.21
Pain	2.6(2/78)	2.6(2/77)	1.00
Numbness	0	2.6(2/77)	0.24
Infection	3.8(3/78)	2.6(2/77)	1.00
Pigment	2.6(2/78)	0	0.24

Tab 5

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