A randomized feasibility study of the effect of ascorbic acid on post-angioplasty restenosis of hemodialysis vascular access (NCT03524846)

Chung-Wei Yang, Chih-Cheng Wu, Chien-Ming Luo, Shao-Yuan Chuang, Chiu-Hui Chen, Yung-Fang Shen, Der-Cheng Tarng, Chung-Wei Yang, Chih-Cheng Wu, Chien-Ming Luo, Shao-Yuan Chuang, Chiu-Hui Chen, Yung-Fang Shen, Der-Cheng Tarng

Abstract

Restenosis remains a significant problem after angioplasty of hemodialysis vascular access. Both experimental and clinical studies have shown a protective effect of antioxidants against post-angioplasty restenosis. A prospective, randomized, feasibility study was conducted to investigate the effect of ascorbic acid to prevent restenosis. Ninety-three hemodialysis patients were randomized into three groups after angioplasty: placebo (n = 31), 300 mg ascorbic acid (n = 31), and 600 mg ascorbic acid (n = 31), treated intravenously 3 times per week for 3 months. Eighty-nine completed the clinical follow-up, and 81 had angiographic follow-up. In the angiographic follow-up, the mean (stand deviation) late loss of luminal diameter for the placebo, 300 mg, and 600 mg groups were 3.15 (1.68) mm, 2.52 (1.70) mm (P = 0.39 vs. placebo group), and 1.59 (1.67) mm (P = 0.006, vs. placebo group), with corresponding angiographic binary restenosis of 79%, 67% (P = 0.38 vs. placebo group), and 54% (P = 0.08 vs. placebo group). The post-interventional primary patency rates at 3 months were 47%, 55% (P = 0.59 vs. placebo group), and 70% (P = 0.18 vs. placebo group) for placebo, 300 mg, and 600 mg groups. Our results demonstrated that intravenous 600 mg ascorbic acid was a feasible therapy and might attenuate restenosis after angioplasty; however, its effect on post-interventional primary patency was modest.

Trial registration: ClinicalTrials.gov NCT03524846.

Conflict of interest statement

The authors declare no competing interests.

Figures

Figure 1
Figure 1
Flow of study participants.
Figure 2
Figure 2
Kaplan–Meier plots of post-interventional primary patency of access circuit (left) and target lesion (right) within a 3-month follow-up period after angioplasty, stratified by placebo, 300 mg, and 600 mg ascorbic acid groups.
Figure 3
Figure 3
Cumulative frequency distribution curves of minimal luminal diameter (MLD) before percutaneous transluminal angioplasty (PTA), after PTA, and at follow-up (F/U) angiograms stratified by placebo, 300 mg, and 600 mg ascorbic acid groups.
Figure 4
Figure 4
Comparison of clinical restenosis rate, angiographic binary restenosis rate, late loss by minimal luminal diameter (MLD), and late loss by diameter stenosis (DS) between placebo, 300 mg, and 600 mg ascorbic acid groups.

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