Abdul Salim Sohail, Tran Hong, Thongprayoon Charat, Fülöp Tibor, Cheungpasitporn Wisit
Division of Nephrology, Department of Medicine, University of Mississippi Medical Center, Jackson, MS, USA.
Department of Biostatistics, Virginia Tech, Blacksburg, VA, USA.
J Vasc Access. 2020 May;21(3):357-365. doi: 10.1177/1129729819878612. Epub 2019 Oct 9.
Arteriovenous fistula is the most preferred form of vascular access, but stenosis treated by balloon angioplasty is prone to restenosis. Multiple trials have been published with regard to the use of paclitaxel-coated balloon to prolong lesion patency compared to conventional balloon. Although paclitaxel-coated balloon has theoretical appeal, its use has not been widespread nationwide due to cost and lack of large-scale multicenter studies. We performed this meta-analysis to evaluate whether paclitaxel-coated balloon outperforms conventional balloon to prolong target lesion patency.
PubMed/Medline, Clinical Trials.gov, EMBASE, Scopus, Web of Science, and Cochrane Central were searched from inception through April 2019 for studies that investigated the use of paclitaxel-coated balloon in arteriovenous fistula.
Ten studies were included in the final meta-analysis: six studies were randomized controlled trials and four studies were cohort studies. There were 911 participants with a mean age of 64.78 (±5.96) years, and 61.89% were male. Outcome of interest was target lesion primary patency, recorded at 1, 3, 6, 7, 12, and 24 months. Meta-analysis of randomized controlled trials shows that paclitaxel-coated balloons did not statistically improve target lesion primary patency compared to conventional balloons at months 1 (odds ratio = 1.54, p = 0.6373), 3 (odds ratio = 0.57, p = 0.0575), 6 (odds ratio = 0.65, p = 0.3644), 7 (odds ratio = 0.63, p = 0.0582), 12 (odds ratio = 0.64, p = 0.0612), and 24 (odds ratio = 0.43, p = 0.3452). Effect of paclitaxel-coated balloons was statistically significant for cohort studies at months 6 (odds ratio = 0.26, p = 0.0007), 12 (odds ratio = 0.21, p = 0.0001), and 24 (odds ratio = 0.23, p = 0.01).
Paclitaxel-coated balloon showed no statistically significant improvement over conventional balloons in decreasing fistula stenosis in randomized controlled trial but were significant for cohort studies.
动静脉内瘘是血管通路的最优选形式，但经球囊血管成形术治疗的狭窄易于再狭窄。关于使用紫杉醇涂层球囊与传统球囊相比以延长病变通畅率，已经发表了多项试验。尽管紫杉醇涂层球囊具有理论上的吸引力，但由于成本和缺乏大规模多中心研究，其使用在全国范围内尚未广泛普及。我们进行了这项荟萃分析，以评估紫杉醇涂层球囊在延长靶病变通畅率方面是否优于传统球囊。
检索了从创刊至2019年4月的PubMed/Medline、ClinicalTrials.gov、EMBASE、Scopus、Web of Science和Cochrane Central，以查找研究紫杉醇涂层球囊在动静脉内瘘中应用的研究。
最终的荟萃分析纳入了10项研究：6项研究为随机对照试验，4项研究为队列研究。共有911名参与者，平均年龄为64.78（±5.96）岁，男性占61.89%。感兴趣的结局是靶病变的初始通畅率，在1、3、6、7、12和24个月时记录。随机对照试验的荟萃分析表明，与传统球囊相比，紫杉醇涂层球囊在第1个月（优势比=1.54，p=0.6373）、3个月（优势比=0.57，p=0.0575）、6个月（优势比=0.65，p=0.3644）、7个月（优势比=0.63，p=0.0582）、12个月（优势比=0.64，p=0.0612）和24个月（优势比=0.43，p=0.3452）时，在统计学上并未改善靶病变的初始通畅率。对于队列研究，紫杉醇涂层球囊在第6个月（优势比=0.26，p=0.0007）、12个月（优势比=0.21，p=0.0001）和24个月（优势比=0.23，p=（0.01）时的效果具有统计学意义。
在随机对照试验中，紫杉醇涂层球囊在降低瘘管狭窄方面与传统球囊相比没有统计学上的显著改善，但在队列研究中具有显著意义。
