Plain versus paclitaxel-coated balloon angioplasty in arteriovenous fistula and graft stenosis: An umbrella review

An umbrella review was performed to synthesize the evidence from systematic reviews/meta-analyses of clinical trials investigating the efficacy and safety of paclitaxel-coated balloons (PCB) vs. conventional balloon angioplasty in arteriovenous fistulas (AVFs) and grafts stenosis. Medline (via PubMed) and SCOPUS databases were searched up to July 15th 2020. All meta-analyses that enrolled randomized controlled trials (RCTs) comparing PCB with plain balloons in AVFs and grafts were included. Re-analysis of original data was performed assessing predictive intervals (PI). Quality of the included meta-analyses was assessed using AMSTAR score. Eight meta-analyses were included and four clinical outcomes [target lesion primary patency (TLPP), circuit primary patency, mortality, complication rate] derived from 14 RCTs, were analyzed. There were no significant differences in the TLPP in meta-analyses providing data purely from autologous AVFs. Significant benefits regarding TLPP and circuit primary patency at 3, 6, and 12-months in favor of PCB were reported in four meta-analyses mixing AVFs and grafts; however when PI were assessed, in all but one meta-analysis these included the null value, indicating no significant benefit. In only one meta-analysis significant difference of TLPP at 12-months in favor of PCB was noticed. (Odds Ratio 0.0009 PI: 0.28-0.85) No mortality difference was noticed in four meta-analyses providing data up to 24 months. In conclusion this overview revealed a modest benefit of using PCB angioplasty compared to plain angioplasty in AVFs and graft stenosis. No increased mortality was noticed in the PCB group.

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Angioplasty for dysfunctional arteriovenous fistulas: a meta-analysis of recent randomized controlled trials compared paclitaxel-coated balloon versus conventional balloon angioplasty

10.21203/rs.3.rs-748410/v1 ◽

2021 ◽

Author(s):

Qin Yang ◽

Yi Zhou ◽

Kui Cai ◽

Yufang Chen ◽

Congying Xia

Keyword(s):

Randomized Controlled Trials ◽

Balloon Angioplasty ◽

Meta Analysis ◽

Neointimal Hyperplasia ◽

Target Lesion ◽

Primary Patency ◽

Controlled Trials ◽

Arteriovenous Fistulas ◽

Randomized Controlled ◽

Conventional Balloon Angioplasty

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.

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Covered stents versus balloon angioplasty for failure of arteriovenous access: a systematic review and meta-analysis

BMJ Open ◽

10.1136/bmjopen-2020-044356 ◽

2021 ◽

Vol 11 (6) ◽

pp. e044356

Author(s):

Benjamin Ng ◽

Magnus Fugger ◽

Igho Jovwoke Onakpoya ◽

Andrew Macdonald ◽

Carl Heneghan

Keyword(s):

Systematic Review ◽

Balloon Angioplasty ◽

Meta Analysis ◽

Primary Patency ◽

Secondary Patency ◽

Covered Stents ◽

Significant Difference ◽

Randomised Controlled ◽

Meta Analyses ◽

Stage Renal Disease

IntroductionPatients with end-stage renal disease may require arteriovenous (AV) access in the form of arteriovenous fistulae (AVFs) or arteriovenous grafts (AVGs) for haemodialysis. AV access dysfunction requires intervention such as plain balloon angioplasty or covered stents to regain patency.AimTo systematically review and meta-analyse the patency outcomes of covered stents in failing haemodialysis AV access, compared with balloon angioplasty.MethodsThe review was first registered on the International Prospective Register of Systematic Reviews (CRD42018069955) before data collection. We searched six electronic databases to identify relevant randomised controlled trials (RCTs) up until August 2020, without language restriction. Two reviewers assessed the suitability and quality of studies for inclusion using the Consolidated Standards of Reporting Trials guidelines. We meta-analysed data using a random-effects model.ResultsWe included seven studies including 1147 patients in the systematic review, of which 867 had AVGs and 280 had AVFs. One study was an ongoing RCT. In the meta-analyses, we assessed patients with failing AVGs only. Overall risk of bias was moderate. Covered stents were associated with lower loss of patency versus angioplasty alone at 6, 12 and 24 months (OR 4.48, 95% CI 1.98 to 10.14, p<0.001; OR 4.07, 95% CI 1.74 to 9.54, p=0.001; OR 2.24, 95% CI 1.17 to 4.29, p=0.01, respectively). Covered stents afforded superior access circuit primary patency compared with angioplasty alone at 6 and 12 months (OR 1.91, 95% CI 1.31 to 2.80, p<0.001; OR 1.97, 95% CI 1.14 to 3.41, p=0.02, respectively). This was not significant at 24 months. There was no significant difference in loss of secondary patency between groups at 12 or 24 months (OR 0.74, 95% CI 0.45 to 1.23, p=0.25; OR 0.67, 95% CI 0.29 to 0.154, p=0.34, respectively).ConclusionOur results support use of covered stents over angioplasty alone, at 6, 12 and 24 months in failing AVGs. Further clinical trials are warranted.

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A retrospective comparison analysis of results of drug-coated balloon versus plain balloon angioplasty in treatment of juxta-anastomotic de novo stenosis of radiocephalic arteriovenous fistulas

The Journal of Vascular Access ◽

10.1177/1129729819893205 ◽

2019 ◽

Vol 21 (5) ◽

pp. 596-601

Author(s):

Cemal Kocaaslan ◽

Ahmet Oztekin ◽

Mehmet Senel Bademci ◽

Emine Seyma Denli Yalvac ◽

Nurgul Bulut ◽

...

Keyword(s):

Percutaneous Transluminal Angioplasty ◽

Target Lesion ◽

Transluminal Angioplasty ◽

Primary Patency ◽

Anastomotic Stenosis ◽

Arteriovenous Fistulas ◽

Study Results ◽

Significant Difference ◽

Percutaneous Transluminal ◽

Drug Coated Balloon

Background: Juxta-anastomotic stenosis is a common issue of arteriovenous fistulas. We aimed to evaluate the results of percutaneous transluminal angioplasty with drug-coated balloon versus plain balloon for the treatment of juxta-anastomotic stenoses of mature but failing distal radiocephalic arteriovenous fistulas. Methods: A total of 80 patients with a juxta-anastomotic stenosis of distal radiocephalic arteriovenous fistula in our clinic between January 2016 and September 2017 were retrospectively analyzed. Patients were divided into two groups according to the type of treatment as drug-coated balloon – percutaneous transluminal angioplasty (n = 44) and plain balloon – percutaneous transluminal angioplasty (n = 43). Intra- and post-procedural data were recorded. Target lesion primary patency rate was evaluated at 6 and 12 months. Of all patients, 48 were females and 39 were males with a mean age of 56.3 ± 10.4 (range, 24–75) years. Both groups had mature fistulas, and the mean age of fistula was 11.3 ± 9.1 months in the drug-coated balloon – percutaneous transluminal angioplasty group and 10.3 ± 8.8 months in the plain balloon – percutaneous transluminal angioplasty group (p = 0.24). Results: There was no significant difference in the target lesion stenosis rate and the median lesion length between the groups. Technical and clinical success were achieved in both groups. Target lesion primary patency was similar at 6 months between the two groups (93.1% vs 81.3%, respectively; p = 0.14) but significantly higher for the drug-coated balloon – percutaneous transluminal angioplasty group at 12 months (81.8% vs 51.1%, respectively; p = 0.01). Conclusion: Our study results suggest that the use of drug-coated balloon combined with percutaneous transluminal angioplasty is an effective treatment for juxta-anastomotic stenoses of mature but failing distal radiocephalic arteriovenous fistulas with significantly improved target lesion primary patency rates and reduced need for juxta-anastomotic reinterventions.

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Tapered and non-tapered prosthetic grafts in upper extremity dialysis access: A systematic review and meta-analysis

The Journal of Vascular Access ◽

10.1177/1129729820974177 ◽

2020 ◽

pp. 112972982097417

Author(s):

Venkata Sai Jasty ◽

David Haddad ◽

Babu Mohan ◽

Wei Zhou ◽

Jeffrey J Siracuse ◽

...

Keyword(s):

Systematic Review ◽

Upper Extremity ◽

Meta Analysis ◽

Primary Patency ◽

Secondary Patency ◽

Dialysis Access ◽

Significant Difference ◽

Arteriovenous Grafts ◽

Meta Analyses ◽

Steal Syndrome

Objective: It is unclear whether tapered arteriovenous grafts (AVGs) are superior to non-tapered AVGs when it comes to preventing upper extremity ischemic steal syndrome. We aimed to evaluate the outcomes of tapered and non-tapered AVGs using systematic review and meta-analysis. Methods: A literature search was systemically performed to identify all English publications from 1999 to 2019 that directly compared the outcomes of upper extremity tapered and non-tapered AVGs. Outcomes evaluated were the primary patency at 1-year (number of studies ( n) = 4), secondary patency at 1-year ( n = 3), and risk of ischemic steal ( n = 5) and infection ( n = 4). Effect sizes of individual studies were pooled using random-effects model, and between-study variability was assessed using the I2 statistic. Results: Of 5808 studies screened, five studies involving 4397 patients have met the inclusion criteria and included in the analysis. Meta-analyses revealed no significant difference for the risk of ischemic steal syndrome (pooled odds ratio (OR) 0.92, 95% Confidence Incidence (CI) 0.29–2.91, p = 0.89, I2 = 48%) between the tapered and non-tapered upper extremity AVG. The primary patency (OR 1.33, 95% CI 0.93–1.90, p = 0.12, I2 = 10%) and secondary patency at 1-year (OR 1.49, 95% CI 0.84–2.63, p = 0.17, I2 = 13%), and rate of infection (OR 0.62, 95% CI 0.30–1.27, p = 0.19, I2 = 29%) were also similar between the tapered and non-tapered AVG. Conclusions: The risk of ischemic steal syndrome and patency rate are comparable for upper extremity tapered and non-tapered AVGs. This meta-analysis does not support the routine use of tapered graft over non-tapered graft to prevent ischemic steal syndrome in upper extremity dialysis access. However, due to small number of studies and sample sizes as well as limited stratification of outcomes based on risk factors, future studies should take such limitations into account while designing more robust protocols to elucidate this issue.

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Safety and Efficacy of Drug-Coated Balloon Angioplasty for the Treatment of Chronic Limb-Threatening Ischemia: A Systematic Review and Meta-Analysis

Journal of Endovascular Therapy ◽

10.1177/1526602820931559 ◽

2020 ◽

Vol 27 (4) ◽

pp. 647-657

Author(s):

Stefanos Giannopoulos ◽

Sheila Ghanian ◽

Sahil A. Parikh ◽

Eric A. Secemsky ◽

Peter A. Schneider ◽

...

Keyword(s):

Balloon Angioplasty ◽

Meta Analysis ◽

Target Lesion ◽

Major Amputation ◽

Primary Patency ◽

Safety And Efficacy ◽

All Cause Mortality ◽

Procedural Success ◽

Random Effects Modeling ◽

Drug Coated Balloon

Purpose: To investigate the safety and efficacy of drug-coated balloons (DCB) for the treatment of femoropopliteal or infrapopliteal lesions in patients with chronic limb-threatening ischemia (CLTI). Materials and Methods: A systematic literature search was conducted in PubMed, Scopus, and Cochrane Central up to January 2020 to identify randomized trials and observational studies presenting data on the effectiveness and safety of DCBs in the treatment of femoropopliteal or infrapopliteal lesions. A meta-analysis utilizing random effects modeling was conducted to investigate primary patency and all-cause mortality at 12 months; the results are reported as the odds ratios (ORs) and 95% confidence intervals (CIs). Secondary outcomes were procedural success, bailout stenting, target lesion revascularization (TLR), reocclusion, major amputation, wound healing, and major adverse limb events. Results: Twenty-six studies, 12 retrospective and 14 prospective, comprising 2108 CLTI patients treated with DCBs for femoropopliteal (n=1315) or infrapopliteal (n=793) lesions were analyzed. The average lesion lengths were 121±44 and 135±53 mm, respectively. The overall 12-month all-cause mortality and major amputation rates were 9% (95% CI 6% to 13%) and 5% (95% CI 2% to 8%), respectively. Primary patency rates were 82% (95% CI 76% to 87%) and 64% (95% CI 58% to 70%), respectively. A sensitivity analysis of the infrapopliteal lesions demonstrated no difference between DCB and balloon angioplasty in terms of primary patency, TLR, major amputation, or mortality over 12 months. However, patients with infrapopliteal lesions undergoing DCB angioplasty did have a significantly lower risk for reocclusion (10% vs 25%; OR 0.38, 95% CI 0.21 to 0.70, p=0.002). Conclusion: DCB angioplasty of femoropopliteal and infrapopliteal lesions in patients with CLTI results in acceptable 12-month patency rates, although comparative data have not shown a patency benefit for infrapopliteal lesions. The 12-month mortality rate of DCB vs balloon angioplasty was not significantly different, but studies with longer-term outcomes are necessary to determine any association between DCB use and mortality in patients with CLTI.

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

Journal of the American Heart Association ◽

10.1161/jaha.121.022060 ◽

2021 ◽

Author(s):

Chenyu Liu ◽

Matthew Wolfers ◽

Bint‐e Zainab Awan ◽

Issa Ali ◽

Adrian Michael Lorenzana ◽

...

Keyword(s):

Randomized Controlled Trials ◽

Balloon Angioplasty ◽

Meta Analysis ◽

Target Lesion ◽

Primary Patency ◽

Target Lesion Revascularization ◽

Cochrane Library ◽

Controlled Trials ◽

Randomized Controlled ◽

Drug Coated Balloon

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.

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Drug-Coated Balloon Angioplasty Compared With Uncoated Balloons in the Treatment of Infrapopliteal Artery Lesions (AcoArt II–BTK)

Journal of Endovascular Therapy ◽

10.1177/1526602820969681 ◽

2020 ◽

pp. 152660282096968

Author(s):

Xin Jia ◽

Baixi Zhuang ◽

Feng Wang ◽

Yongquan Gu ◽

Jiwei Zhang ◽

...

Keyword(s):

Balloon Angioplasty ◽

De Novo ◽

Randomized Study ◽

Balloon Catheter ◽

Target Lesion ◽

Primary Patency ◽

Control Group ◽

Lesion Length ◽

Significant Difference ◽

Drug Coated Balloon

Purpose To compare the safety and efficacy of drug-coated balloon (DCB) vs uncoated balloon angioplasty in the treatment of de novo and restenotic infrapopliteal lesions in patients with chronic limb-threatening ischemia (CLTI). Materials and Methods The prospective, multicenter, randomized study AcoArt II–BTK study ( ClinicalTrials.gov identifier NCT02137577) enrolled 120 patients who were randomly assigned to angioplasty with either a DCB (n=61; mean age 70.7±7.4 years; 36 men) or a conventional balloon catheter (n=59; mean age 70.8±9.0 years; 36 men). There were no significant differences observed in baseline clinical or target lesion characteristics between the groups. The target lesion length was 169.95±86.35 mm in the DCB group vs 179.93±80.16 mm in the control group, and approximately three-quarters of the lesions were chronic occlusions. Primary patency was assessed by angiography at 6 months, and mortality and clinically-driven target lesion revascularization (CD-TLR) were evaluated at 12 months. Results Primary patency at 6 months was 75.0% in the DCB group and 28.3% in the control group (p<0.001), while late lumen loss was 0.43±0.62 mm for DCBs vs 0.99±0.55 mm for controls (p<0.001). Freedom from CD-TLR at 12 months was 91.5% in the DCB group vs 76.8% in the controls (p=0.03); there was no significant difference in mortality (1.7% DCB vs 3.6% controls; p=0.53). Conclusion This study demonstrated that the Litos/Tulip DCBs are safe and effective in treating infrapopliteal lesions, with improved angiographic and clinical outcomes vs plain balloon angioplasty. The DCBs demonstrated significantly higher primary patency with fewer CD-TLRs than conventional angioplasty. The safety of the DCBs was noninferior to that of the uncoated balloons after 1 year of follow-up.

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Does Nasal Surgery Affect Voice Outcomes? A Systematic Review with Meta-Analyses

Annals of Otology Rhinology & Laryngology ◽

10.1177/0003489420933290 ◽

2020 ◽

Vol 129 (12) ◽

pp. 1174-1185

Author(s):

Christopher C Xiao ◽

Friederike S. Luetzenberg ◽

Nancy Jiang ◽

Jonathan Liang

Keyword(s):

Systematic Review ◽

English Language ◽

Meta Analysis ◽

Voice Quality ◽

Original Data ◽

Sinus Surgery ◽

Nasal Surgery ◽

Significant Difference ◽

Meta Analyses ◽

The Impact

Objectives: Changes in airflow dynamics after nasal surgery may have implications on voice quality. Multiple studies have evaluated the impact of nasal surgery on voice using heterogeneous outcome measures. We aim to systematically review the impact of nasal surgery on voice quality. Methods: Our study design was a systematic review with meta-analyses. A literature search of PubMed, Ovid, Cochrane from 1997 to 2017 was performed. Inclusion criteria included English language studies containing original data on nasal surgery and voice. Two investigators independently reviewed all manuscripts and performed a comprehensive quality assessment. Meta-analysis was completed on quantitative voice measurements. Results: Of 463 identified, 19 studies with 692 patients fulfilled eligibility. Nasal surgeries performed included endoscopic sinus surgery (11/20), septoplasty (11/20), rhinoplasty (2/20), and turbinate reduction (2/20). Voice outcomes measured included nasalance (8/20), fundamental frequency (11/20), jitter (10/20), shimmer (10/20), harmonic to noise ratio (HRN) (8/20), formants (5/20), and voice handicap index (VHI) (4/20). Voice examinations were assessed preoperatively and 1 to 30 months postoperatively. Meta-analysis revealed statistically significant changes in nasalance, ( P < .01) 1 month postoperatively; there was no significant difference in nasalance at 6 months postoperatively. All other variables analyzed revealed no statistically significant differences. Five of nine studies showed majority of patients did not notice subjective change in voice after surgery, but with high heterogeneity of measurements. Conclusions: There may be a short-term increase in nasalance that resolves at longer follow-up, but there seem to be no other objective changes in voice. There may be subjective changes after surgery, but require further study to evaluate.

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Impact of arteriovenous fistulas versus arteriovenous grafts on vascular access performance in haemodialysis patients: A systematic review and meta-analysis

Vascular ◽

10.1177/17085381211041473 ◽

2021 ◽

pp. 170853812110414

Author(s):

Shahin Hajibandeh ◽

Hannah Burton ◽

Philippa Gleed ◽

Shahab Hajibandeh ◽

Teun Wilmink

Keyword(s):

Failure Rate ◽

Vascular Access ◽

Meta Analysis ◽

Primary Patency ◽

Free Access ◽

Secondary Patency ◽

Confounding By Indication ◽

Arteriovenous Fistulas ◽

Significant Difference ◽

Arteriovenous Grafts

Background Controversy exists regarding the best-performing vascular access type for patients undergoing haemodialysis. We aimed to compare outcomes of starting dialysis on arteriovenous fistulas (AVFs) versus arteriovenous grafts (AVGs) in haemodialysis patients. Methods We conducted a systematic search of multiple electronic information sources and bibliographic reference lists. The following outcome parameters were evaluated at 1, 2 and 5 years: primary failure, defined as access never used for dialysis; primary patency, defined as intervention-free access survival; primary-assisted patency, defined as uninterrupted access survival with interventions; and secondary patency, defined as cumulative access survival. Results We identified 15 comparative studies reporting a total of 118,434 patients who initiated haemodialysis with AVF ( n = 95,143) or AVG ( n = 23,291). Our analysis demonstrated that AVF was associated with significantly higher primary failure rate (OR: 2.05, p = .0005) but significantly higher rate of primary patency at 1 year (OR: 1.91, p < .00001), at 2 years (OR: 2.52, p < .00001) and at 5 years (OR: 2.59, p < .00001); and primary-assisted patency at 1 year (OR: 1.71, p < .00001), at 2 years (OR: 2.13, p < .00001) and 5 years (OR: 2.79, p < .00001). There was no significant difference in secondary patency at 1 year (OR: 1.08, p < .00001) but AVF had better secondary patency at 2 years (OR: 1.26, p < .00001) and 5 years (OR: 1.60, p < .00001) than AVG. Conclusions The meta-analysis of best available comparative evidence (Level 2) demonstrated that AVFs may be associated with significantly higher primary failure rate but higher primary patency, primary-assisted patency and secondary patency at 1, 2 and 5 years compared to AVGs. However, the available evidence is subject to significant selection bias and confounding by indication.

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Treatment of cephalic arch stenosis in dysfunctional arteriovenous fistulas with paclitaxel-coated versus conventional balloon angioplasty

CVIR Endovascular ◽

10.1186/s42155-021-00271-1 ◽

2021 ◽

Vol 4 (1) ◽

Author(s):

Ren Kwang A. Tng ◽

Ru Yu. Tan ◽

Shereen X. Y. Soon ◽

Suh Chien. Pang ◽

Chieh Suai. Tan ◽

...

Keyword(s):

Balloon Angioplasty ◽

Retrospective Cohort ◽

De Novo ◽

Target Lesion ◽

Primary Patency ◽

Index Procedure ◽

Arteriovenous Fistulas ◽

Conventional Balloon Angioplasty ◽

Plain Old Balloon Angioplasty ◽

Mean Time

Abstract Background Treatment of cephalic arch stenosis (CAS) with standard plain old balloon angioplasty (POBA) in dysfunctional arteriovenous fistulas (AVF), is associated with early re-stenosis and higher failure rates compared to other lesions. Paclitaxel-coated balloons (PCB) may improve patency rates. This is a retrospective cohort study. Patients who underwent POBA or PCB for CAS over a 3-year period were included. Outcomes compared were circuit primary patency rates (patency from index procedure to next intervention), circuit primary assisted-patency rates (patency from index procedure to thrombosis), and target lesion (CAS) patency rates (stenosis > 50%) at 3, 6 and 12 months. Results Ninety-one patients were included. Sixty-five (71.4%) had POBA, while 26 (28.6%) had PCB angioplasty. There were 62 (68.1%) de-novo lesions. CAS was the only lesion that needed treatment in 24 (26.4%) patients. Circuit primary patency rates for POBA versus PCB groups were 76.2% vs. 60% (p = 0.21), 43.5% vs. 36% (p = 0.69) and 22% vs. 9.1% (p = 0.22) at 3, 6 and 12-months respectively. Circuit assisted-primary patency rates were 93.7% vs. 92% (p = 1.00), 87.1% vs. 80% (p = 0.51) and 76.3% vs. 81.8% (p = 0.77), whilst CAS target lesion intervention-free patency rates were 79.4% vs. 68% (p = 0.40), 51.6% vs. 52% (p = 1.00) and 33.9% vs. 22.7% (p = 0.49) at 3, 6 and 12-months respectively. Estimated mean time to target lesion intervention was 215 ± 183.2 days for POBA and 225 ± 186.6 days for PCB (p = 0.20). Conclusion Treatment of CAS with PCB did not improve target lesion or circuit patency rates compared to POBA.

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