scholarly journals Drug‐Coated Balloon Versus Plain Balloon Angioplasty for Hemodialysis Dysfunction: A Meta‐Analysis of Randomized Controlled Trials

Author(s):  
Chenyu Liu ◽  
Matthew Wolfers ◽  
Bint‐e Zainab Awan ◽  
Issa Ali ◽  
Adrian Michael Lorenzana ◽  
...  

Background Both drug‐coated balloon (DCB) angioplasty and conventional plain balloon angioplasty (PBA) can be implemented to treat hemodialysis dysfunction. The present study aims to compare the safety and efficacy of these 2 approaches by conducting a meta‐analysis of available randomized controlled trials. Methods and Results PubMed, Cochrane Library, and Embase databases were queried from establishment to January 2021. A total of 18 randomized controlled trials including 877 and 875 patients in the DCB and PBA groups, respectively, were included in the present meta‐analysis. Target lesion primary patency, circuit patency, target lesion revascularization, and mortality were pooled. Odds ratios (ORs) were reported with 95% CIs. Publication bias was analyzed with funnel plot and Egger test. Target lesion primary patency was higher among patients who underwent DCB (OR, 2.93 [95% CI, 2.13–4.03], P <0.001 at 6 months; OR, 2.47 [95% CI, 1.53–3.99], P <0.001 at 1 year). Also, the DCB group had a higher dialysis circuit patency at 6 months (OR, 2.42; 95% CI, 1.56–3.77 [ P <0.001]) and 1 year (OR, 1.91; 95% CI, 1.22–3.00 [ P =0.005]). Compared with the PBA group, the DCB group had lower odds of target lesion revascularization during follow‐up (OR, 0.43 [95% CI, 0.23–0.82], P =0.001 at 6 months; OR, 0.74 [95% CI, 0.32–1.73], P =0.490 at 1 year). The OR of mortality was comparable between 2 groups at 6 months (OR, 1.18; 95% CI, 0.42–3.33 [ P =0.760]) and 1 year (OR, 0.93; 95% CI, 0.58–1.48 [ P =0.750]). Conclusions Based on evidence from 18 randomized controlled trials, DCB angioplasty is superior to PBA in maintaining target lesion primary patency and circuit patency among patients with dialysis circuit stenosis. DCB angioplasty also reduces target lesion revascularization with a similar risk of mortality compared with PBA.

2022 ◽  
pp. 112972982110701
Author(s):  
Yunfeng Li ◽  
Zhenwei Shi ◽  
Yunyun Zhao ◽  
Zhanjiang Cao ◽  
Zhengli Tan

Purpose: To compare all-cause mortality and primary patency with drug-coated balloon angioplasty (DCBA) compared with plain balloon angioplasty (PBA) in people with hemodialysis-related stenosis. Materials and methods: PubMed, Embase, and Cochrane Library databases were searched from November 1966 to February 2021 to identify randomized controlled trials (RCTs) that assessed the use of DCBA versus PBA for stenosis in hemodialysis circuits. Data extracted from the articles were integrated to determine all-cause mortality, target lesion primary patency (TLPP), circuit access primary patency (CAPP), 30-day adverse events, and technical success for the two approaches. We performed meta-analysis on these results using a fixed-effects model to evaluate odds ratios (ORs) and 95% confidence intervals (CIs) where I2 < 50% in a test for heterogeneity, or a random-effect model if otherwise. Sensitivity and subgroup analyses were also performed. Results: Sixteen RCTs of 1672 individuals were included in our meta-analysis, of which 839 individuals received DCBA and 833 received PBA. The pooled outcome showed no statistical difference between DCBA and PBA in all-cause mortality at 6 months (OR = 1.29, 95% CI = 0.72–2.32, p = 0.39, I2 = 4%), 12 months (OR = 1.02, 95% CI = 0.68–1.53, p = 0.91, I2 = 0%), and 24 months (OR = 1.50, 95% CI = 0.87–2.57, p = 0.15, I2 = 0%), 30-day adverse events (OR = 1.09, 95% CI = 0.30–3.98, p = 0.90, I2 = 66%), and technical success (OR = 0.18, 95% CI = 0.02–1.92, p = 0.16, I2 = 65%). The DCBA had significantly better outcomes versus PBA in TLPP at 6 months (OR = 2.37, 95% CI = 1.84–3.04, p < 0.001, I2 = 44%) and 12 months (OR = 1.77, 95% CI = 1.22–2.56, p = 0.002, I2 = 56%), and CAPP at 6 months (OR = 2.07, 95% CI = 1.21–3.54, p = 0.008, I2 = 67%) and 12 months (OR = 1.66, 95% CI = 1.29–2.15, p < 0.001, I2 = 0%). Conclusion: In hemodialysis circuit stenosis, DCBA appears to have similar safety but greater efficacy than PBA.


2021 ◽  
Author(s):  
Qin Yang ◽  
Yi Zhou ◽  
Kui Cai ◽  
Yufang Chen ◽  
Congying Xia

Abstract Background Stenosis in arteriovenous fistulas (AVF) due to neointimal hyperplasia is one of the most common causes of hemodialysis vascular access dysfunction. Treating patients with dysfunctional AVF with drug-coated balloon (DCB) angioplasty may potentially improve outcomes. This systematic review aimed to compare the effectiveness and safety of DCB angioplasty versus conventional balloon angioplasty by pooling evidence from the most recent randomized controlled trials. Methods We conducted a comprehensive literature search in the Medline, Embase, and Cochrane central databases. Two independent researchers screened the article, extracted interest and evaluated included studies for risk of bias. Pooled estimation was conducted in terms of 6-month target-lesion primary patency (TLPP) and target-lesion reintervention (TLR), as well as other outcomes. Results were expressed with odds ratio (OR) and 95% confidence interval (CI). Results A total of 4 RCTs were identified and included in the meta-analyses, with 911 participants. There was no significant increase in rates of 6-month TLPP (OR 1.63, 95%CI 0.39–6.79, p = 0.35), or decrease in 6-month TLR (OR 0.45, 95%CI 0.17–1.19 p = 0.07) in patients who received DCB as compared to those who received conventional balloon angioplasty. Similarly, we found no difference in the 6-month access circuit primary patency and reinvention between the two groups. Conclusion There was no evidence supporting that DCB has a statistically significant higher rate of TLPP and lower rates of TLR in the treatment of dysfunctional AVF than conventional balloon angioplasty. However, DCB was non-inferior to conventional balloon angioplasty in terms of safety. Therefore, further study is needed to clarify whether DCB angioplasty can benefit hemodialysis patients with dysfunction AVF.


2019 ◽  
Vol 21 (3) ◽  
pp. 357-365 ◽  
Author(s):  
Sohail Abdul Salim ◽  
Hong Tran ◽  
Charat Thongprayoon ◽  
Tibor Fülöp ◽  
Wisit Cheungpasitporn

Background: 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. Methods: 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. Results: 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). Conclusion: 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.


Vascular ◽  
2021 ◽  
pp. 170853812098573
Author(s):  
Feng Lin ◽  
Haoran Wang ◽  
Wenjie Ding ◽  
Gan Chen ◽  
Zhigong Zhang

Objectives To compare the safety and efficiency of atherectomy plus drug-coated balloon with drug-coated balloon only for the treatment of femoropopliteal artery lesions. Methods This systematic review and meta-analysis was performed and reported following the requirement of the PRISMA. EMBASE, MEDLINE, and Cochrane library were queried from January 2000 to June 2020 to identify eligible literature. The modified Downs and Black checklist was used to assess the quality of included studies. Outcome measures included bail-out stenting, distal embolization, perforation, hematoma, primary patency at 12 months, target lesion revascularization at 12 months, leg amputation at 12 months, and mortality at 12 months. We used DerSimonian and Laird random-effects model to pool the dichotomous data on risk ratio (RR) with 95% confidence intervals (CIs) from each study to obtain an overall estimate for major outcomes. Subgroup analysis and sensitivity analyses were conducted. Results Six studies (two randomized controlled trials and four retrospective cohort studies) with 470 patients were included. Atherectomy plus drug-coated balloon group was associated with lower rates of bail-out stenting (RR: 0.49, 95%CI: 0.34–0.71, P < 0.001). There was no significant difference between two groups in terms of distal embolization (RR: 2.06, 95%CI: 0.51–8.38, P = 0.31), perforation (RR: 2.04, 95%CI: 0.43–9.71, P = 0.37), hematoma (RR: 1.75, 95%CI: 0.43–7.09, P = 0.43), primary patency at 12 months (1.09, 95%CI: 0.98–1.21, P = 0.12), target lesion revascularization at 12 months (RR: 0.68, 95%CI: 0.41–1.14, P = 0.15), leg amputations at 12 months (RR: 0.54, 95%CI: 0.13–2.23, P = 0.39), mortality at 12 months (RR: 2.18, 95%CI: 0.71–6.64, P = 0.17). Sensitivity analysis had no effect on our findings. Conclusions The combination of atherectomy and drug-coated balloon was safe and effective in the treatment of femoropopliteal artery lesions, with lower incidence of bail-out stenting compared with drug-coated balloon only.


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