Paclitaxel-assisted balloon angioplasty of venous stenosis in haemodialysis access: PAVE RCT

Background Reliable vascular access is essential for patients receiving haemodialysis. An arteriovenous fistula is the preferred option; however, these are prone to developing stenotic segments. These lesions are treated with angioplasty, but there is a high rate of recurrence. When the PAVE (Paclitaxel-assisted balloon Angioplasty of Venous stenosis in haEmodialysis access) trial was conceived, a number of small studies suggested that restenosis may be reduced by paclitaxel-coated balloons. Objective To test the efficacy of paclitaxel-coated balloons in arteriovenous fistulas. Design A randomised controlled trial. Setting Twenty UK centres. Participants Patients (aged ≥ 18 years) referred with a clinical indication for angioplasty of an arteriovenous fistula (212 patients in total, 106 per group). Interventions High-pressure plain balloon fistuloplasty was performed in all patients. In the intervention arm, the second component was insertion of a paclitaxel-coated balloon. In the control arm, an identical procedure was followed, but using a standard balloon. Main outcome measures The primary end point was time (days) to loss of target lesion primary patency. Secondary patency end points were time to loss of access circuit primary patency and time to loss of access circuit cumulative patency. Other secondary end points included angiographically determined late lumen loss, rate of binary angiographic restenosis, procedural success, number of thrombosis events, fistula interventions, adverse events during follow-up and patient quality of life. Results Primary analysis showed no evidence for a difference in time to end of target lesion primary patency between groups (hazard ratio 1.18, 95% confidence interval 0.78 to 1.79; p = 0.440). An adjusted secondary analysis with prespecified clinical covariates gave similar results (hazard ratio 1.11, 95% confidence interval 0.69 to 1.78; p = 0.664). Prespecified secondary outcomes included the time to intervention anywhere in the access circuit or the time until the fistula was abandoned. There were no differences in these patency-related secondary outcomes or in any other secondary outcomes, such as adverse events. Limitations The PAVE trial was not a fully blinded trial. It was impossible to ensure that treating radiologists were blinded to treatment allocation because of the appearance of the paclitaxel-coated balloon. The extent to which our findings can be generalised to patients with multiple lesions could be questioned, given the proportion randomised. However, if paclitaxel-coated balloons had been effective at a single lesion segment, then there is no plausible reason why they could not be effective in patients with multiple lesions. Conclusions There were no differences in primary or secondary outcomes. Following a plain balloon angioplasty, additional treatment with a paclitaxel-coated balloon does not provide benefit. Future work The reasons for differences between the results of the PAVE trial and of other studies deserve further analysis and consideration. Other interventions to prevent restenosis following a fistuloplasty are needed. Trial registration Current Controlled Trials ISRCTN14284759. Funding This project was funded by the Efficacy and Mechanism Evaluation programme, a Medical Research Council and National Institute for Health Research (NIHR) partnership. This will be published in full in Efficacy and Mechanism Evaluation; Vol. 8, No. 13. See the NIHR Journals Library website for further project information.

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Outcomes of post-operative duplex ultrasound following arteriovenous fistula formation: A pragmatic single-centre experience

The Journal of Vascular Access ◽

10.1177/1129729819896226 ◽

2019 ◽

Vol 21 (5) ◽

pp. 623-629

Author(s):

Andrew TO Nickinson ◽

Rebecca Rogers ◽

Ahmed Elbasty ◽

Ian Nunney ◽

Philip C Bennett

Keyword(s):

Confidence Interval ◽

Arteriovenous Fistula ◽

Duplex Ultrasound ◽

Primary Patency ◽

Hazard Ratio ◽

Fistula Formation ◽

Secondary Patency ◽

Arteriovenous Fistulae ◽

Standard Practice ◽

Ultrasound Surveillance

Background: Duplex ultrasound surveillance with pre-emptive treatment of an identified stenosis is increasingly being utilised to help maintain arteriovenous fistula patency. This study aims to determine whether post-operative duplex ultrasound surveillance can improve fistula patency at 12 months and improve the proportion of ‘pre-haemodialysis’ patients commencing haemodialysis via a usable fistula. Methods: All arteriovenous fistulae formed between 1st January 2015 and 31st August 2017 in a single, tertiary vascular centre were included. Primary and secondary patency at 12 months, along with the proportion of pre-haemodialysis patients commencing haemodialysis via a usable arteriovenous fistula, were compared between the fistulae undergoing duplex ultrasound surveillance and ‘standard practice’. Results: Two hundred forty-one arteriovenous fistulae were created in 216 patients. A higher proportion of brachiobasilic transposition arteriovenous fistula and patients undergoing arteriovenous fistula creation following a previously failed access were identified in the duplex ultrasound surveillance group. Primary patency at 12 months (hazard ratio = 0.43, 95% confidence interval = 0.30–0.61, p < .001) was significantly lower in the duplex ultrasound surveillance group compared with the ‘standard practice’ group. Despite this, no difference was identified in secondary patency at 12 months (hazard ratio = 1.82, 95% confidence interval = 0.87–3.80, p = .112). No difference was also identified in the proportion of pre-haemodialysis patients starting haemodialysis with a usable arteriovenous fistula (duplex ultrasound surveillance = 65.0% vs standard practice = 77.8%; odds ratio = 0.53, 95% confidence interval 0.58–1.19, p = .279). Conclusion: Post-operative duplex ultrasound surveillance following arteriovenous fistula formation is associated with higher rates of post-operative intervention; however, this does not translate into improved secondary patency or the proportion of pre-haemodialysis patients commencing HD via their fistula.

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Analysis of factors for post–percutaneous transluminal angioplasty primary patency rate in hemodialysis vascular access

The Journal of Vascular Access ◽

10.1177/1129729820910555 ◽

2020 ◽

Vol 21 (6) ◽

pp. 892-899

Author(s):

Kanyu Miyamoto ◽

Takashi Sato ◽

Keisuke Momohara ◽

Sumihisa Ono ◽

Makoto Yamaguchi ◽

...

Keyword(s):

Blood Flow ◽

Confidence Interval ◽

Arteriovenous Fistula ◽

Percutaneous Transluminal Angioplasty ◽

Transluminal Angioplasty ◽

Primary Patency ◽

Hazard Ratio ◽

Flow Volume ◽

Blood Flow Volume ◽

Percutaneous Transluminal

Background: Although percutaneous transluminal angioplasty has been established as a first-line therapy for access failure in dialysis, there are few reports on primary patency after percutaneous transluminal angioplasty. We investigated factors associated with primary patency following the first percutaneous transluminal angioplasty performed after vascular access construction in patients with arteriovenous fistula, including blood flow volume before and after percutaneous transluminal angioplasty and previously reported factors. Methods: We used medical records at six dialysis centers to retrospectively identify and analyze prognostic factors for primary patency after percutaneous transluminal angioplasty in 159 patients with arteriovenous fistula who underwent initial percutaneous transluminal angioplasty after vascular access construction. Results: Multivariate analysis with the Cox proportional hazard model showed that primary patency after percutaneous transluminal angioplasty in patients with arteriovenous fistula was significantly associated with lesion length (hazard ratio, 1.76; 95% confidence interval, 1.01–3.07; P = 0.045), and blood flow volume after percutaneous transluminal angioplasty (hazard ratio, 0.71; 95% confidence interval, 0.60–0.84; P < 0.001). When blood flow volume after percutaneous transluminal angioplasty was classified into three categories, risks of outcome events defining the end of primary patency after percutaneous transluminal angioplasty were significantly lower for 400–630 mL/min (hazard ratio, 0.38; 95% confidence interval, 0.21–0.68; P = 0.001) and >630 mL/min (hazard ratio, 0.16; 95% confidence interval, 0.06–0.40; P < 0.001) compared with <400 mL/min. Conclusion: Our study showed that blood flow volume after percutaneous transluminal angioplasty is an important prognostic factor for primary patency after percutaneous transluminal angioplasty in patients with arteriovenous fistula.

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SIroliMus coated angioPlasty versus plain balloon angioplasty in the tREatment of dialySis acceSs dysfunctION (IMPRESSION): study protocol for a randomized controlled trial

Trials ◽

10.1186/s13063-021-05920-3 ◽

2021 ◽

Vol 22 (1) ◽

Author(s):

Suh Chien Pang ◽

Ru Yu Tan ◽

Edward Choke ◽

Jackie Ho ◽

Kiang Hiong Tay ◽

...

Keyword(s):

Arteriovenous Fistula ◽

Balloon Angioplasty ◽

Target Lesion ◽

Primary Patency ◽

Central Vein ◽

Secondary Patency ◽

Dialysis Access ◽

Residual Stenosis ◽

Randomized Controlled ◽

Link Type

Abstract Background Percutaneous transluminal angioplasty is the current standard treatment for arteriovenous fistula (AVF) stenosis. The mid- and long-term patency with plain balloon angioplasty (PBA) is however far from satisfactory. While paclitaxel-coated balloon angioplasty has been shown to be superior to PBA, concern over its safety profile has recently arisen after a reported possible increased mortality risk with a meta-analysis of large lower limb studies. An angioplasty balloon with a new type of drug coating, the sirolimus-coated balloon (SCB), has been proven to improve patency in the coronary arteries. However, its effect on AV access has yet to be studied. Methods/design This is an investigator-initiated, prospective, multicenter, double-blinded, randomized controlled clinical trial to assess the effectiveness of SCB compared to PBA in improving the patency of AVF after angioplasty. A total of 170 patients with mature AVF that requires PTA due to AVF dysfunction will be randomly assigned to treatment with a SCB or PBA at a 1:1 ratio, stratified by location of AVF and followed up for up to 1 year. The inclusion criteria include [1] adult patient aged 21 to 85 years who requires balloon angioplasty for dysfunctional arteriovenous fistula [2]; matured AVF, defined as being in use for at least 1 month prior to the angioplasty; and [3] successful angioplasty of the underlying stenosis with PBA, defined as less than 30% residual stenosis on digital subtraction angiography (DSA) and restoration of thrill in the AVF on clinical examination. The exclusion criteria include thrombosed or partially thrombosed access circuit at the time of treatment, presence of symptomatic or angiographically significant central vein stenosis that requires treatment with more than 30% residual stenosis post angioplasty, and existing stent placement within the AVF circuit. The primary endpoint of the study is access circuit primary patency at 6 months. The secondary endpoints are target lesion primary patency; access circuit-assisted primary patency; access circuit secondary patency at 3, 6, and 12 months; target lesion restenosis rate at 6 months; total number of interventions; complication rate; and cost-effectiveness. The trial is supported by Concept Medical. Discussion This study will evaluate the clinical efficacy and safety of SCB compared to PBA in the treatment of AVF stenosis in hemodialysis patients. Trial registration ClinicalTrials.govNCT04409912. Registered on 1 June 2020

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SIroliMus Coated angioPlasty Versus Plain Balloon Angioplasty in the tREatment of dialySis acceSs dysfunctION (IMPRESSION): Study Protocol for a Randomized Controlled Trial

10.21203/rs.3.rs-746498/v1 ◽

2021 ◽

Author(s):

Suh Chien Pang ◽

Ru Yu Tan ◽

Edward Choke ◽

Jackie Ho ◽

Tay Kiang Hiong ◽

...

Keyword(s):

Arteriovenous Fistula ◽

Balloon Angioplasty ◽

Target Lesion ◽

Primary Patency ◽

Controlled Clinical Trial ◽

Central Vein ◽

Secondary Patency ◽

Dialysis Access ◽

Residual Stenosis ◽

Randomized Controlled

Abstract BackgroundPercutaneous transluminal angioplasty is the current standard treatment for arteriovenous fistula (AVF) stenosis. The mid- and long-term patency with plain old balloon angioplasty (POBA) is however far from satisfactory. While paclitaxel-coated balloon angioplasty has been shown to be superior to POBA, concern over its safety profile has recently arisen after reported possible increased mortality risk with a meta-analysis of large lower limb studies. An angioplasty balloon with a new type of drug coating, the sirolimus coated balloon (SCB) has been proven to improve patency in the coronary arteries. However, its effect on AV access has yet to be studied. Methods/DesignThis is an investigator-initiated, prospective, multicenter, doubled blinded, randomized controlled clinical trial to assess the effectiveness of SCB compared to POBA in improving the patency of AVF after angioplasty. A total of 170 patients with mature AVF that requires PTA due to AVF dysfunction will be randomly assigned to treatment with a SCB or POBA at a 1:1 ratio, stratified by location of AVF and followed-up for up to 1 year. Inclusion criteria includes (1) adult patient aged 21 to 85 years who requires balloon angioplasty for dysfunctional arteriovenous fistula, (2) matured AVF, defined as being in use for at least 1 month prior to the angioplasty, (3) successful angioplasty of the underlying stenosis with POBA, defined as less than 30% residual stenosis on Digital Subtraction Angiography (DSA) and restoration of thrill in the AVF on clinical examination. Exclusion criteria include thrombosed or partially thrombosed access circuit at the time of treatment, presence of symptomatic or angiographically significant central vein stenosis that require treatment with more than 30% residual stenosis post angioplasty, and existing stent placement within the AVF circuit. The primary end point of the study is access circuit primary patency at 6 months. The secondary end points are target lesion primary patency, circuit assisted primary patency, circuit secondary patency at 3,6 and 12 months, target lesion restenosis rate at 6 months, total number of interventions, complication rate and cost effectiveness. The trial is supported by Concept Medical. DiscussionThis study will evaluate the clinical efficacy and safety of SCB compared to POBA in the treatment of AVF stenosis in hemodialysis patients.Trial registration: ClinicalTrials.gov Identifier: NCT04409912 on 1 June 2020https://clinicaltrials.gov/ct2/show/NCT04409912Protocol Version: 4

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Comparison of drug-coated balloon angioplasty versus conventional angioplasty for arteriovenous fistula stenosis: Systematic review and meta-analysis

The Journal of Vascular Access ◽

10.1177/1129729819878612 ◽

2019 ◽

Vol 21 (3) ◽

pp. 357-365 ◽

Cited By ~ 5

Author(s):

Sohail Abdul Salim ◽

Hong Tran ◽

Charat Thongprayoon ◽

Tibor Fülöp ◽

Wisit Cheungpasitporn

Keyword(s):

Cohort Studies ◽

Randomized Controlled Trials ◽

Arteriovenous Fistula ◽

Balloon Angioplasty ◽

Odds Ratio ◽

Meta Analysis ◽

Target Lesion ◽

Primary Patency ◽

Controlled Trials ◽

Randomized Controlled

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.

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Association between post-balloon angioplasty dissection and primary patency in complex femoropopliteal artery disease: 2-year clinical outcomes of the AcoArt I trial

Journal of International Medical Research ◽

10.1177/03000605211006546 ◽

2021 ◽

Vol 49 (4) ◽

pp. 030006052110065

Author(s):

Hao Ren ◽

Jie Liu ◽

Jiwei Zhang ◽

Baixi Zhuang ◽

Weiguo Fu ◽

...

Keyword(s):

Balloon Angioplasty ◽

Cox Regression ◽

Target Lesion ◽

Transluminal Angioplasty ◽

Outcome Data ◽

Primary Patency ◽

Cox Regression Analysis ◽

Femoropopliteal Artery ◽

Artery Disease

Objective To assess the association between post-balloon angioplasty dissection and the mid-term results of the AcoArt I trial evaluating complex femoropopliteal artery disease. Methods The outcome data for 144 patients from the AcoArt 1 trial were reanalysed. These patients were randomly divided into percutaneous transluminal angioplasty (PTA) and drug-coated balloons (DCB) groups. The primary endpoint was the primary patency (PP) rate and clinically-driven target lesion revascularisation at 24 months. Results After 24 months of follow-up, the PP rate of dissection cases in the PTA group was lower vs non-dissection cases. In patients receiving a bailout stent for dissection, the PP rate in the PTA group was lower vs the DCB group. Cox regression analysis showed that dissection decreased the PP rate; mild dissection reduced the PP rate as follows: 52%, PTA group and 19%, DCB group. With severe dissection, the PP rate reduction was as follows: 75%, PTA group and 73%, DCB group. Conclusions The mid-term follow-up showed that post-balloon angioplasty dissection reduced the PP rate in the PTA group but not in the DCB group. Additionally, in patients receiving a bailout stent for dissection, the DCB group had a better PP rate than the PTA group.

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Long-term mortality and patency after drug-coated balloon angioplasty in the hemodialysis circuit: A systematic review and meta-analysis of randomized controlled trials

The Journal of Vascular Access ◽

10.1177/11297298211070125 ◽

2022 ◽

pp. 112972982110701

Author(s):

Yunfeng Li ◽

Zhenwei Shi ◽

Yunyun Zhao ◽

Zhanjiang Cao ◽

Zhengli Tan

Keyword(s):

Adverse Events ◽

Randomized Controlled Trials ◽

Balloon Angioplasty ◽

Meta Analysis ◽

Primary Patency ◽

Controlled Trials ◽

Technical Success ◽

Randomized Controlled ◽

All Cause Mortality ◽

Drug Coated Balloon

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.

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Atherectomy and Drug-Coated Balloon Angioplasty for the Treatment of Long Infrapopliteal Lesions: A Randomized Controlled Trial

Circulation Cardiovascular Interventions ◽

10.1161/circinterventions.120.010280 ◽

2021 ◽

Author(s):

Aljoscha Rastan ◽

Marianne Brodmann ◽

Tanja Böhme ◽

Roland Macharzina ◽

Elias Noory ◽

...

Keyword(s):

Balloon Angioplasty ◽

Duplex Ultrasound ◽

Target Lesion ◽

Primary Patency ◽

Primary Study ◽

Target Vessel ◽

Target Vessel Revascularization ◽

Infrapopliteal Artery ◽

Directional Atherectomy ◽

Drug Coated Balloon

Background: Prospective, randomized, multicenter trials show no beneficial impact of drug-coated balloon (DCB) therapy alone on the technical and clinical outcomes of infrapopliteal artery lesions in comparison to plain old balloon angioplasty. The aim of this study was to evaluate the performance of directional atherectomy (DA) plus DCB angioplasty versus DCB alone in treatment of long infrapopliteal artery lesions. Methods: We conducted a prospective, randomized, 2-center trial comparing the performance of DA+DCB and DCB alone in treatment of 80 patients with de novo infrapopliteal artery lesions. The primary study end point was the 6-month primary patency of the target lesion detected by angiography and duplex ultrasound. Secondary end points included clinically driven target vessel revascularization, amputation rates, and changes in Rutherford-Becker class at 1 year. A core laboratory provides independent analyses for all scheduled and unscheduled duplex ultrasound examinations and angiographies, and a research institute ensured independent data collection. Results: The mean target lesion length was 179.7±98.2 mm. Nine patients (11.3%) died during the follow-up period. At 6 months, primary patency was 49% (n=18) with DA+DCB versus 34% (n=12) with DCB alone ( P =0.241), and clinically driven target vessel revascularization was 8% (n=3) versus 14% (n=5; P =0.475), respectively. At 1 year, the TLR rates were 30% (n=10) versus 43% (n=12; P =0.308), the median in Rutherford-Becker class was 2 (0.25–5) versus 5 (0.25–5; P =0.329), and amputation rates were 22% (n=8) versus 32% (n=11; P =0.618) in the DA+DCB group and the DCB group, respectively. Conclusions: Treatment of long infrapopliteal artery lesions with DA+DCB versus DCB alone leads to comparable clinical and technical results at 6 months and 1 year. REGISTRATION: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT01763476.

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Endovascular salvage of failing arterio-venous fistulas utilising sirolimus eluting balloons: Six months results from the ISABELLA trial

The Journal of Vascular Access ◽

10.1177/11297298211067059 ◽

2021 ◽

pp. 112972982110670

Author(s):

Tjun Y Tang ◽

Shereen XY Soon ◽

Charyl JQ Yap ◽

Ru Yu Tan ◽

Suh Chien Pang ◽

...

Keyword(s):

Balloon Angioplasty ◽

Duplex Ultrasound ◽

Target Lesion ◽

Primary Patency ◽

Asian Patients ◽

Pilot Clinical Study ◽

Procedural Success ◽

Randomised Controlled ◽

End Stage ◽

Subject Dropout

Background: Aim of this pilot clinical study was to evaluate the safety and efficacy of the Selution Sustained Limus Release (SLR)™ sirolimus-eluting balloon (SEB) for improving failing arterio-venous fistulas (AVF) patency in Asian haemodialysis patients. Methods: Prospective single-centre, multi-investigator, non-consecutive, non-blinded single arm trial. Forty end-stage renal failure Asian patients with a dysfunctional AVF underwent SEB angioplasty between May and November 2020. All stenotic lesions were prepared with high pressure non-compliant balloon angioplasty prior to SEB angioplasty. Endpoints of interest included target lesion primary patency and circuit access patency and safety through 30 days. All patients received dual antiplatelet therapy for 1 month and were followed up with Duplex ultrasound at 6 months. Results: There was one subject dropout so final n = 39 patients (mean age 65.0 ± 11.9; males = 26 (66.7%)) and n = 43 target lesions treated. Main indication for intervention was dropping access flow (24/39; 61.5%) and most common target lesion was in the juxta-anastomosis (24/43; 54.5%). There was 100% technical and procedural success. There were no adverse events related to the SEB. Target lesion primary patency rates at 3 and 6 months were 39/41 (95.1%) and 28/39 (71.8%) respectively. Access circuit patency rates at 3 and 6 months were 35/37 (94.6%) and 22/35 (62.9%) respectively. There were 3 (7.7%) deaths all attributable to patients’ underlying co-morbidities. Conclusions: Fistuloplasty using the novel Selution SLR™ SEB for dysfunctional AVF circuits seems a safe and effective modality in Asian haemodialysis patients at 6 months but larger randomised controlled studies are required now to determine its true efficacy against plain balloon angioplasty.

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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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