Target Lesion Primary Patency Research Articles

Multicenter randomized controlled trial to assess the effectiveness of PASSEO-LUX DCB® drug coated balloon compared to plain balloon angioplasty of arteriovenous fistulae for hemodialysis: Two-years results.

To compare primary patency after angioplasty with drug-coated balloon (DCB)-Passeo-18Lux, BIOTRONIK versus uncoated balloon in dysfunctional peripheral vascular access (PVA) for hemodialysis. A total of 133 patients from four hospitals were randomized to receive DCB or plain old balloon angioplasty (POBA) after satisfactory treatment (residual stenosis <30%) with high pressure balloon (HPB). The primary endpoint was clinical patency of PVA 2 years after angioplasty. Secondary endpoints included the relationship between the location of stenosis and patency and also, other covariates. Mortality at 2 years was compared between both groups. Patency measured in days after angioplasty was higher in fistulae dilated with DCB than HPB. Kaplan-Meier survival curves showed the next percent of success (free time restenosis) after DCB versus POBA at 6 months-77.1% versus 58.2% (160.41-143.72 days until restenosis), 12 months-51.4% versus 44.3% (274.1-237.23), 18 months-38.6% versus 38% (350.74-305.18), and 24 months-37.1% versus 30.4% (419.04-369.1). At 6 months, this difference was statistically significant (p = 0.018), but not at 12 (p = 0.225), 18 (p = 0.471), or 24 months (p = 0.236). Mortality was similar in both groups. DCB angioplasty resulted in superior target lesion primary patency (TLPP)-free survival at 6 months of follow-up. No significant improvements in TLPP-free survival long term were observed. Mortality observed at 1 and 2 years was similar in DCB and POBA: there was no significant difference, and a safety study demonstrated no difference between the two groups (complications and mortality): DCB is safe to use in stenosis treatment in patients who are PVA carriers. Level Ia, therapeutic study, RCT. EBM ratings will be based on a scale of 1-5.

Outcomes of Noncompliant Balloons in the Treatment of Lower Extremity Chronic Limb Threatening Ischemia: A Prospective Study.

This is a prospective study to investigate the clinical outcomes of using noncompliant balloons in lower limb angioplasty for chronic limb threatening ischemia (CLTI). This is a prospective single-center cohort study performed at a local tertiary hospital in Singapore. Consecutive patients who underwent lower limb angioplasty for CLTI using a noncompliant balloon catheter were enrolled if they were aged 40 years and above, presented with CLTI Rutherford grade 4 to 6, and had TASC C or D lesions in the lower limb vessels that were at least 100mm in length. Patient demographics, Rutherford grading, lesion characteristics, complications, and follow-up data were collected and analyzed. The primary outcomes were 30-day freedom from major adverse events, amputation-free survival (AFS) at 12 months, and freedom from clinically driven target lesion revascularization (cdTLR) at 12 months. Secondary outcomes included clinical success and target lesion primary patency (TLPP) at 12 months. Amputation-free survival, freedom from cdTLR, and TLPP were calculated by Kaplan-Meier analysis. From May 2020 to December 2021, 50 patients (50 limbs) were enrolled. 43 (86%) patients had diabetes mellitus, while 12 patients (24%) had end-stage renal failure. 85 lesions were treated, including 59 (69.4%) below-the-knee (BTK) lesions. All the lesions were TASC C (n=45, 52.9%) or TASC D (n=40, 47.1%) lesions. Mean lesion length was 231.4±116.2mm. Technical success rate was 96.5%. No patients were lost to follow-up. Median follow-up duration was 282 days (IQR: 31-390 days). One patient died on day 26 due to an acute myocardial infarction. Two patients had groin hematomas postprocedure, both of which were treated conservatively. AFS, freedom from cdTLR, and TLPP at 12 months postprocedure was 70.0% (95% confidence interval [CI]: 58.4%-83.9%), 90.1% (95% CI: 83.4%-97.4%), and 61.1% (95% CI: 50.7%-73.6%), respectively. Early results have shown that the use of a high-pressure, noncompliant balloon is effective in lower limb angioplasty for CLTI in a highly challenging group of patients with a high prevalence of long BTK disease. Good vessel patency and limb salvage rates can be achieved, with a low complication rate. We await more long-term outcomes on vessel patency. There are many devices in the market for use in lower limb angioplasty. However, many of them come with an increased financial cost, procedural time and procedural difficulty. We report our prospective results with the exclusive use of a high pressure, non-compliant balloon, in a challening group of patients with a high prevalence of diabetes and end stage renal failure, achieving amputation free surival at 6 and 12 months post-procedure of 84.0% and 70.0% respectively. The use of non-compliant balloon is technically easy and does not add additional steps compared to a standard POBA procedure, thus limiting costs. We believe this article can be a push factor for clinicians to consider the use of these high pressure, non-compliant balloons in their patient care.

Ultrasound-guided nitinol stent implantation to treat early restenosis of arteriovenous fistula: A 69-case study with 1-year outcome.

To investigate the feasibility, methods and effects of interventional ultrasound in nitinol stent implantation to treat early restenosis after percutaneous transluminal angioplasty (PTA) in autogenous arteriovenous fistula (AVF). From April 2018 to December 2021, 69 patients with early restenosis of AVF received ultrasound-guided nitinol stent implantation (UNSI) and were followed-up. Imaging features of the stent and procedure by ultrasound were observed. The technical success rate, clinical success rate and incidence of complications were recorded and counted. Target lesion primary patency (TLPP), access circuit primary patency (ACPP) and access circuit secondary patency (ACSP) were estimated. Ultrasonography can show the structure of the stent and guide the stenting process clearly. Both the technical and clinical success rates were 100%. Thirty-one patients had in-stent restenosis (ISR), which was treated by plain balloon (PB) PTA or drug coated balloon (DCB) PTA. The TLPP at 3, 6, 12 and 24 months were 100.0%, 94.2%, 63.4% and 39.6%, respectively. The ACPP at 3, 6, 12 and 24 months were 98.6%, 91.6%, 60.2% and 35.2%, respectively. The ACSP at 3, 6, 12 and 24 months were 98.6%, 98.6%, 95.6% and 93.8%, respectively. The TLPP of ISR after DCB PTA at 3, 6 and 12 months were 100.0%, 100.0% and 93.6%, respectively. This pilot study indicates ultrasonography can accurately guide nitinol stent implantation in AVF and this technique is a feasible and minimally invasive treatment for early restenosis after PTA with good short- and medium-term patency. DCB PTA may be used to deal with the ISR and is a way to prolong the patency of nitinol stent.

Safety and Performance of a Cell-Impermeable Endoprosthesis for Hemodialysis Vascular Access Outflow Stenosis: A Brazilian Multicenter Retrospective Study

PurposeTo evaluate the safety and performance of Wrapsody™, a cell-impermeable endoprosthesis (CIE), for treating hemodialysis vascular access outflow stenosis.Materials and MethodsInvestigators retrospectively analyzed 113 hemodialysis patients treated with a CIE (11/2021–12/2022) across four centers in Brazil. De novo or restenotic lesions were treated. The primary efficacy outcome measure was target lesion primary patency (TLPP) at 1, 3, 6, and 12 months; the primary safety outcome measure was the absence of serious local or systemic adverse events within the first 30 days post-procedure. Secondary outcome measures included technical and procedural success, access circuit primary patency (ACPP), and secondary patency at 1, 3, 6, and 12 months post-procedure.ResultsThirty-nine patients (34.5%) had thrombosed access at the initial presentation, and 38 patients (33.6%) presented with recurrent stenosis. TLPP rates at 1, 3, 6, and 12 months were 100%, 96.4%, 86.4%, and 69.7%, respectively. ACPP rates were 100% at 1 month, 89.2% at 3 months, 70.9% at 6 months, and 56.0% at 12 months. The target lesion secondary patency rates at 1, 3, 6, and 12 months were 100%, 97.3%, 93.6%, and 91.7%, respectively. In the adjusted multivariate Cox regression analysis, male sex and endoprosthesis with diameters of 10, 12, 14, and 16 mm were associated with improved primary patency rates. No localized or systemic serious adverse event was observed through the first 30 days post-procedure.ConclusionThe CIE evaluated in this study is safe and effective for treating peripheral and central outflow stenoses in hemodialysis vascular access.Level of EvidenceLevel 2b, cohort study.Graphical

Clinical outcomes and predictive factors of stent grafts treatment for symptomatic central venous obstruction in end stage kidney disease patients with arteriovenous access

To assess the efficacy of stent grafts (SGs) in managing central venous obstruction disease (CVOD) in hemodialysis (HD) patients with arteriovenous (AV) access, and to identify predictive factors influencing the SG treatment outcomes. HD subjects with CVOD who underwent SGs placement at our center between August 2018 and June 2022 were enrolled. Survival curve analysis using the Kaplan–Meier method and log-rank test was performed. Cox proportional hazards regression analysis was employed to identify predictive factors associated with outcomes. A total of 59 SG implantation procedures for CVOD were analyzed, comprising 30 cases of stenosis and 29 cases of occlusion. The access circuit primary patency (ACPP) at 6, 12, and 24 months post-SG placement were 80.9%, 53.8%, and 31.4%, respectively, while, the target lesion primary patency (TLPP) were 91.3%, 67.6%, and 44.5%, respectively. Subgroup analysis revealed higher TLPP in the stenosis group compared to the occlusion group, although the difference was not statistically significant (P = 0.165). The TLPP was significantly improved by SG placement in those who had antecedent balloon dilations (P < 0.001). Cox proportional hazards regression identified target lesion length ≥ 30 mm and procedure defects as independent predictors of lower TLPP after SG treatment for CVOD in HD patients. SG placement demonstrates safety and efficacy in managing CVOD among HD patients, leading to improved TLPP of endovascular therapy (EVT) for CVOD. Notably, long target lesions (≥ 30 mm) and procedure defects emerged as predictive factors influencing TLPP.

Comparison of Outcomes of Drug-Coated Balloons versus Plain Balloons in Secondary Interventions on Percutaneous Arteriovenous Fistulae

PurposeTo compare patency and reintervention outcomes after either plain old balloon angioplasty (POBA) or drug-coated balloon angioplasty (DCBA) for venous stenoses after percutaneous arteriovenous fistula (pAVF) creation. Materials and MethodsOne-hundred ninety-five pAVFs were successfully created during the study period, 141 using Ellipsys and 54 using Wavelinq. After pAVF creation, 95 patients (48.7%) required secondary percutaneous transluminal angioplasty (PTA) with either POBA (n = 55, 58%) or DCBA (n = 40, 42.1%). The most common site for PTA was the juxta-anastomotic segment (75.5%; 74/98). Univariate and multivariate Cox regression analyses were used to compare target lesion primary patency, access circuit primary patency, secondary patency, and reintervention rates in the POBA and DCBA cohorts. ResultsThirty-four of 55 (62%) patients in the POBA cohort and 14 of 40 (35%) patients in the DCBA cohort required reinterventions for pAVF restenosis. Mean number of follow-up days among patients treated with POBA was 1,030.4 (SD ± 342.9) and among those treated with DCBA was 744.4 (SD ± 403.5). The use of POBA compared with DCBA was not associated with target lesion and access circuit primary patency loss in multivariate analysis (hazard ratio [HR], 1.81; 95% CI, 0.93–3.51; P = .080; and HR, 1.77; 95% CI, 0.73–4.28; P = .210, respectively). However, time from fistula creation to the first PTA (days) was statistically significantly associated with both outcomes (HR, 0.997; 95% CI, 0.994–0.999; P = .009; and HR, 0.997; 95% CI, 0.992–0.999; P = .021, respectively). There were no major adverse events. ConclusionsIn this retrospective single-center analysis of pAVFs, considerably more patients who underwent PTA with POBA after pAVF creation required reinterventions compared with PTA using DCBA, although the follow-up time of POBA was longer. In multivariate analysis, no differences were noted in the hazard of patency loss between POBA and DCBA.

Safety and efficacy of a new covered stent in hemodialysis vascular access outflow stenosis: A Brazilian multicenter retrospective study.

Vascular stenosis commonly leads to dysfunction in hemodialysis vascular access. Although percutaneous transluminal angioplasty is an established treatment, stent utilization has increased in the last decade as an alternative solution to extend the access function. This study evaluated the safety and initial results of a new impermeable covered stent for treating vascular access outflow stenosis. Investigators retrospectively analyzed 114 hemodialysis patients treated with polytetrafluorethylene-covered stents from September 2018 to September 2022 across four centers. Lesions treated were de novo or restenotic and located in the venous graft anastomosis, outflow segment, cephalic arch, and basilic swing point. Patients were followed by in-person physical examination at 1, 3, and 6 months, and Duplex ultrasound was performed to evaluate the vascular access circuit and in-stent restenosis. The primary efficacy endpoint was target lesion primary patency at 1, 3, and 6 months. Secondary endpoints included access circuit primary patency and secondary patency at 1, 3, and 6 months. The primary safety endpoint was freedom from local or systemic serious adverse events through 30 days post-procedure. Forty-four patients had thrombosed access at the initial presentation, and 41 patients presented with recurrent stenosis. The target lesion primary patency rates at 1, 3, and 6 months were 100%, 89.4%, and 74%, respectively. The access circuit primary patency rates were 100% at 1 month, 85% at 3 months, and 62.7% at 6 months. The secondary patency rates at 1, 3, and 6 months were 100%, 96.4%, and 94.6%, respectively. In the adjusted multivariate Cox regression analysis, only recurrent lesions and female gender were associated with reduced primary patency rates. No serious adverse event was observed through the first 30 days post-procedure. In this retrospective analysis, a new covered stent was shown to be safe and effective for treating peripheral outflow stenosis in vascular access.

Treatment of Hemodialysis Vascular Access Repeated Stenosis with Paclitaxel-Coated Balloon Angioplasty: A Retrospective Study

Introduction: The objective of this study was to report our experience of angioplasty with paclitaxel-coated balloon (PCB) versus common balloon (CB) for the treatment of repeated failing vascular access. Methods: Retrospective, single-center analysis consisting of 88 patients treated with percutaneous transluminal angioplasty in the period from October 2020 through December 2021. Patients were divided into two groups according to the type of treatment as PCB (n = 41) and CB (n = 47). We analyzed target lesion primary patency and vascular access primary patency for 6 months and the rate of complications. Results: There was no significant difference in the target lesion primary patency which was similar for 6 months between the two groups (PCB group vs. CB group at 1, 3, and 6 months; 95.12 vs. 89.36% (p = 0.55), 75.61 versus 74.47% (p = 0.90), 53.66% versus 63.83% (p = 0.33), respectively). Similarly, vascular access primary patency in the PCB group and CB group was 90.24 and 89.36% (p = 0.83), respectively, at 1 month, 65.85 and 68.09% (p = 0.82), respectively, at 3 months, 39.02 and 53.19% (p = 0.18), respectively, at 6 months. There were no major complications after endovascular treatment. Conclusion: Compared to CB angioplasty, PCB angioplasty has no short-term patency benefit in the treatment of vascular access repeated stenosis.

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

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. We conducted a comprehensive literature search in the Web of Science, 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). A total of five RCTs were identified and included in the meta-analyses, with 1107 participants. DCB has a trend of a higher rate of TLPP (OR 1.79, 95% CI 0.66-4.90, p = 0.181) and a significantly lower rate of TLR (0.52, 95% CI 0.29-0.92, p = 0.034), as compared to conventional balloon angioplasty. No difference in the 6-month access circuit primary patency and reinvention was observed between the two groups. DCB may be an alternative treatment of dysfunctional AVF given a trend of a higher rate of TLPP and a significantly lower rate of TLR than conventional balloon angioplasty within 6 months after the indexed procedure. Moreover, DCB was non-inferior to conventional balloon angioplasty in terms of safety. Considering variations in the DCB technique, further studies are warranted for a standardized process.

USE of IMplanting the Biotronik PassEo-18 Lux drug coated balloon to treat failing haemodialysis arteRiovenous FIstulas and grafts (SEMPER FI Study)

Background: Plain old balloon angioplasty has been the mainstay of treatment for arteriovenous fistula (AVF) stenoses. Recent studies suggest that drug coated balloons (DCB) may significantly reduce re-intervention rates on native and recurrent lesions. The Passeo-18 Lux DCB (Biotronik AG, Buelach, Switzerland) is packaged with a 3.0 µg/mm2 dose of paclitaxel. The hypothesis is that its use provides better target lesion primary patency (TLPP), primary assisted patency (PP), secondary patency (SP) rates and reduces the number of visits for re-intervention in a cohort of patients with stenotic AVF and arteriovenous grafts (AVGs). Methods: The USE of IMplanting the Biotronik PassEo-18 Lux DCB to treat failing haemodialysis arteRiovenous FIstulas and grafts trial (SEMPER FI) was a prospective double-centre, multi-investigator, non-consecutive, non-blinded single-arm study investigating the efficacy and safety of the Passeo-18 Lux DCB in patients with stenotic AVF/AVG lesions between January 2021 and January 2022. Patient demographics, clinical characteristics, vascular access history, operative indications, details and outcomes were collected prospectively. TLPP, circuit access primary patency (CAP), PP, SP and deaths 6- and 12-months post-intervention were studied. Results: Ninety-one patients with 110 lesions were recruited across the two centres. 62.6% ( n = 57) were male with a median age of 63.5 years (SD = 10.5). 62.6% ( n = 57) were taking anti-platelets. Eighty-five AVFs and six AVGs were treated. 60% ( n = 54) of AVFs intervened were radiocephalic. 52.7% ( n = 58) of targeted lesions were juxta-anastomotic stenosis (JAS) and one-third ( n = 33) at the AVF/AVG outflow. 70.9% ( n = 78) of lesions were recurrent. Median time from last intervention was 219 days. 78% of target lesions ( n = 85) and circuits ( n = 70) were patent at 6-months, of which 96.7% ( n = 87) of those requiring assisted intervention were patent. Conclusion: This study shows that the Passeo-18 Lux DCB can be an effective and safe tool in the treatment of failing haemodialysis AVFs/AVGs.

Prospective, Multicenter, Observational Study to Evaluate a Cell-Impermeable Endoprosthesis for Treatment of Stenosis or Occlusion within the Dialysis Outflow Circuit of an Arteriovenous (AV) Fistula or AV Graft (The WRAP Registry)

PurposeDysfunctional vascular access due to stenosis/occlusion within the arteriovenous fistula or graft (AVF/AVG) negatively affects the clinical management of patients undergoing hemodialysis. Results from the feasibility study of the WRAPSODY™ Cell-Impermeable Endoprosthesis demonstrated that the device can achieve high patency rates and maintain integrity of the dialysis outflow circuit. This study was designed to assess real-world evidence of safety and efficacy outcomes following device placement.Materials and MethodsThis is a prospective, multicenter, non-investigational, post-market observational study of 500 patients at up to 50 centers worldwide with a mature AVF/AVG dialysis access (≥ 1 hemodialysis session) who experience stenosis/occlusion of the outflow circuit prior to placement of WRAPSODY. Patients will be divided into the following two cohorts: peripheral or central thoracic. Primary outcome measures include target lesion primary patency (TLPP) at 6 months and procedure and/or device-related events through 30 days post-procedure. Secondary outcome measures include TLPP, safety events, and the number of interventions needed to maintain patency through the 24 month study period. Exploratory endpoints include time to access abandonment, resumption of successful dialysis, functional patency, and pending available imaging data, any incidence of stent fractures, migration, or edge stenosis. Study enrollment began in June 2022, the last patient visit is expected in 2026.DiscussionIt is expected that this study will provide real-world evidence regarding the performance of the WRAPSODY device in a diverse population of patients, which may encourage its use in the continuum of hemodialysis access management.Trial RegistrationNCT05062291Graphical

A Bayesian network meta-analysis for acute thrombosis after lower extremity artery endovascular treatment.

Various endovascular treatment devices have been widely used in the lower extremity arterial disease (LEAD). Their patency efficiency for target lesions has been well studied and reported. Comparison of the risk of acute thrombosis events between the different endovascular treatment devices is unclear. To rank the risk of acute thrombosis events when bare metal stents (BMSs), covered stents (CSs), drug-eluting stents (DESs), drug-coated balloons (DCBs), and conventional percutaneous transluminal balloon angioplasty (PTA) are used to treat LEAD through Bayesian network meta-analysis. We performed a network meta-analysis of randomized controlled trials comparing the risk of 1-year postoperative acute thrombosis between BMSs, CSs, DESs, DCBs, and PTA for treating LEAD. Bayesian random models were used for pooled endovascular treatment modality comparisons. We ranked these treatment modalities via the Bayesian method according to their surface under the cumulative ranking curve (SUCRA) and estimated probabilities. Nineteen studies (38 study arms; 2758 patients) were included. The Bayesian network ranking of treatments indicated that DCB had the lowest risk of acute thrombosis, PTA had the second-lowest risk of thrombosis, and CS, BMS, and DES had the highest risk of thrombosis. Regarding the treatment efficacy, the OR values of the loss of primary patency were significantly lower for DCB (OR = 0.44, 95% CI: 0.30-0.62), DES (OR = 0.36, 95% CI: 0.14-0.94), and CS (OR = 0.31, 95% CI: 0.18,0.56) than for PTA. When BMS was used as a reference, only the OR for CS was significantly lower (OR = 0.41, 95% CI = 0.21-0.82). Correspondingly, the Bayesian ranking of treatments from better to worse target lesion primary patency was CS, DES, DCB, BMS, and PTA. With the available research evidence and according to the network analysis ranking, DES appears to have the highest risk of acute thrombosis and DCB appears to have the lowest risk.

IN.PACT AV Access Randomized Trial of Drug-Coated Balloons for Dysfunctional Arteriovenous Fistulae: Clinical Outcomes through 36 Months

PurposeTo present the 36-month outcomes of the prospective randomized IN.PACT AV Access study of participants with obstructive de novo or restenotic native upper extremity arteriovenous dialysis fistula lesions treated with drug-coated balloon (DCBs) or standard percutaneous transluminal angioplasty (PTA) following successful high-pressure PTA. Materials and MethodsParticipants at 29 international sites were randomized 1:1 to receive an IN.PACT AV DCB (n = 170) or undergo PTA (n = 160). The outcomes through 36 months included target lesion primary patency (TLPP) and access circuit primary patency (ACPP) (composites of clinically driven target lesion or access circuit revascularization and/or access circuit thrombosis), number of reinterventions, and serious adverse events involving the access circuit. ResultsTLPP was 52.1% in the DCB group compared with 36.7% in the PTA group through 24 months and 43.1% in the DCB group compared with 28.6% in the PTA group through 36 months (both log-rank P < .001). ACPP was 39.4% in the DCB group compared with 25.3% in the PTA group through 24 months and 26.4% in the DCB group compared with 16.6% in the PTA group through 36 months (both log-rank P < .001). Cumulative incidence of access circuit thrombosis through 36 months was 8.2% in the DCB group compared with 18.3% in the PTA group (log-rank P = .040). Cumulative incidence of mortality through 36 months was 26.6% in the DCB group compared with 30.8% in the PTA group (log-rank P = .71). ConclusionsThis study demonstrated superior TLPP and ACPP with DCBs compared with PTA, with no difference in mortality through 3 years. Access circuit thrombosis was statistically significantly higher in the PTA group at 3 years.

Drug-coated balloon for early recurrent arteriovenous fistula dysfunction.

To report the efficacy and safety of a drug-coated balloon (Ranger, Boston Scientific) in patients with dysfunctional autogenous arteriovenous fistula. In this investigator-initiated, prospective observational cohort study, 25 participants with dysfunctional arteriovenous fistula were enrolled from January 2018 to June 2019. The drug-coated balloon was applied after successful vessel preparation by high-pressure balloon angioplasty. The primary endpoint was the target lesion primary patency rate at 6 months. The secondary outcome included anatomical and clinical success rate, postoperative major adverse events within 30 days, and the target lesion primary patency rate at 12 months. Statistical analysis of the data was performed. The χ test or Fisher's exact test was used for analyzing categorical variables, and continuous variables were analyzed using Student's t-test. Also, Kaplan-Meier analysis was used to evaluate the target lesion primary patency days with the log-rank test. At 6 months, the target lesion primary patency rate was 68% in the drug-coated balloon treatment group. The anatomical and clinical success rates were 100%. One patient had thrombosed access 10 days after the index procedure, and two died of cardiovascular events 4 months after the operation. Subgroup analysis showed that the early recurrent stenosis group had non-inferior mean drug-coated balloon primary patency days (less than 90 days after prior percutaneous angioplasty, n = 10) compared with the late recurrence group (prior PTA patency days more than 90 days, n = 10), 179.3 ± 102.9 versus 257.1 ± 71 days (p = 0.153). DCB angioplasty had significant improvement in primary patency days for early recurrent stenosis (67.7 ± 19.3 vs 179.3 ± 102.9, p < 0.001). The results demonstrated the appliance of Ranger DCB in stenotic AVFs is a safe and effective treatment modality, especially for early recurrent AVF stenosis.

A Randomised Trial Comparing Drug Coated Balloons and Conventional Balloons for the Treatment of Stent Graft Stenosis in Dialysis Vascular Access

Previous studies on arteriovenous fistulas have demonstrated the potential benefit of drug coated balloons (DCBs) in maintaining the patency of dialysis access. However, stenoses involving stent grafts were excluded from these studies. Therefore, the aim was to evaluate the effectiveness of DCBs in treating stent graft stenosis. This was a prospective, single blinded, randomised controlled study. From March 2017 to April 2021, 40 patients with dysfunctional vascular access owing to stent graft stenosis were randomised to treatment with a DCB or conventional balloon. Clinical follow up was scheduled at one, three, and six months, and angiographic follow up was performed six months after the intervention. The primary outcome was angiographic late luminal loss at six months, and secondary outcomes included target lesion and access circuit primary patency at six months. Thirty-six participants completed follow up angiography. The DCB group had a superior mean late luminal loss at six months compared with the control group (1.82 mm ± 1.83 mm vs. 3.63 mm ± 1.08 mm, respectively, p= .001). All 40 patients completed clinical follow up. The DCB group had a superior six month target lesion primary patency compared with the control group [hazard ratio (HR) 0.23, 95% confidence interval (CI) 0.07 - 0.71; p= .005). Additionally, the DCB group had a numerically higher six month access circuit primary patency rate than the control group, although the difference was not statistically significant (HR 0.54, 95% CI 0.26 - 1.11, p= .095). Conventional balloon angioplasty is not durable in stent graft stenosis treatment. Treatment with DCBs provides less angiographic late luminal loss and potentially superior primary patency of the target lesion than treatment with conventional balloons. [ClinicalTrials ID: NCT03360279.].

Prospective, randomized, multicenter clinical study comparing a self-expanding covered stent to percutaneous transluminal angioplasty for treatment of upper extremity hemodialysis arteriovenous fistula stenosis

Use of a covered stent after percutaneous transluminal angioplasty (PTA) was compared to PTA alone for treatment of upper extremity hemodialysis patients with arteriovenous fistula (AVF) stenoses. Patients with AVF stenosis of 50% or more and evidence of AVF dysfunction underwent treatment with PTA followed by randomization of 142 patients to include a covered stent or 138 patients with PTA alone. Primary outcomes were 30-day safety, powered for noninferiority, and six-month target lesion primary patency (TLPP), powered to test whether TLPP after covered-stent placement was superior to PTA alone. Twelve-month TLPP and six-month access circuit primary patency (ACPP) were also hypothesis tested while additional clinical outcomes were observed through two years. Safety was significantly non-inferior while six- and 12-month TLPP were each superior for the covered stent group compared to PTA alone (six months: 78.7% versus 55.8%; 12 months: 47.9% versus 21.2%, respectively). ACPP was not statistically different between groups at six-months. Observed differences at 24 months favored the covered-stent group: 28.4% better TLPP, fewer target-lesion reinterventions (1.6 ± 1.6 versus 2.8 ± 2.0), and a longer mean time between target-lesion reinterventions (380.4 ± 249.5 versus 217.6 ± 158.4 days). Thus, our multicenter, prospective, randomized study of a covered stent used to treat AVF stenosis demonstrated noninferior safety with better TLPP and fewer target-lesion reinterventions than PTA alone through 24 months.

SUPERA stent placement for salvaging early recurrent arteriovenous graft thrombosis after percutaneous transluminal angioplasty: A single-center study.

The aim of this study was to evaluate the patency of the helical interwoven SUPERA stent for salvaging prosthetic arteriovenous (AV) grafts with rapidly recurrent thrombotic occlusion developed within a short time period after successful percutaneous transluminal angioplasty. From December 2019 to September 2021, the data of 20 patients with AV graft who had the SUPERA stent inserted satisfying the following conditions were consecutively collected. (1) More than 1 year has passed since the AV access operation; (2) Thrombotic re-occlusion of AV graft occurred within 3 months after previous successful endovascular treatment; (3) Residual stenosis is greater than 30% after full effacement of balloon angioplasty in the primary lesion. Post-interventional target lesion primary patency (TLPP), access circuit primary patency (ACPP), and secondary patency (SP) were calculated. Primary lesions of early recurrent arteriovenous graft thrombosis were found in 13 patients with graft-vein anastomosis, six patients with intra-graft stenosis, and one patient with outflow vein complications. The lesions showed residual stenosis in 47.4% (interquartile range: 44.1%-55.3%) of patients despite full-effacement balloon angioplasty. Clinical success was achieved in all patients with full-expansion of the stents at the 1-month follow-up. The TLPP was 70.7% and 32% at 6 and 12 months, respectively, and ACPP was 47.5% and 6.8% at 6 and 12 months, respectively. The SP was 76.1% and 57.1% at 6 and 12 months, respectively. No cannulation complications occurred in the six patients with installation inside the graft. No hemodialysis or stent fracture occurred in any patient during the follow-up period. The SUPERA stent may have a role in salvaging AV grafts with early recurrent thrombosis due to its greater radial force and its conformability and can be useful in treating stenosis involving the elbow or axilla, with fair patency and low complication rates.

Abstract No. 27 The Effects of Patient and Procedural Variables of the Lutonix AV Global Registry: Results from the Arteriovenous Fistula Cohort

This is a post-hoc analysis of the results of the Lutonix AV Global Registry (outside the United Sates) focusing exclusively on arteriovenous fistulas (AVFs) with inclusion criteria consistent to those of the Lutonix IDE trial from the United States. Device under investigation was the Lutonix drug-coated balloon (DCB). 131 of the 320 subjects met criteria for inclusion in the analysis. 59.5% (78/131) were male. 50.5% were white and 45.7% Asian population. Among the exploratory outcome measures were safety (freedom from adverse events at 30 days), efficacy [target lesion primary patency (TLPP) at 6 months], effect of inflation time and pressure of the vessel preparation balloon. Primary safety endpoint at 30 days was 95.2%. TLPP at 6 months was 86.7% based on Kaplan-Meier survival analysis. Subjects with DCB inflation time between 2-3 minutes had a TLPP of 89.7% subjects while in those with 0–1 minute inflation time, TLPP was 78.6%. In subjects where vessel preparation pressure was >25atm, TLPP was 94.4%, while in those with < 25atm vessel preparation pressure, TLPP was 84.7%. Subjects whose lesion underwent vessel preparation and had inflation time >2 minutes, TLPP was 89.8%. Median time to event was 336 days. This post-hoc subgroup analysis suggests that in patients with arteriovenous stenotic lesions treated with DCB, procedural variables may influence outcomes. Subjects were reintervention-free for nearly a year.

The RANGER II superficial femoral artery trial: 1-year results of the long lesion cohort

Background:The objective of the RANGER II SFA long lesion cohort analysis was to evaluate the safety and effectiveness of the Ranger drug-coated balloon (DCB) in patients with lesion lengths greater than 100 mm.Methods:Patients from the RANGER II SFA randomized controlled trial and long balloon sub-study were included in the long lesion cohort if their baseline lesion measurement was > 100 mm and if they had been treated with a RANGER DCB. Patients had symptomatic lower limb peripheral artery disease and Rutherford classification 2–4 symptomatology. The endpoints of interest included the 12-month target lesion primary patency and freedom from major adverse events (MAEs).Additional patient outcomes including changes in Rutherford classification were also evaluated.Results:A total of 129 patients met the inclusion criteria and were included in the long lesion cohort. Mean lesion length was 144.5 ± 31.7 mm. Seventy-five lesions had Peripheral Arterial Calcium Scoring System (PACSS) grades 3 (33.3%, 43/129) and 4 (24.8%, 32/129). The Kaplan–Meier estimate of the primary patency rate at 12 months was 88.0%. The rate of freedom from MAEs at 12 months was 95.1% (117/123; 95% CI: 89.7%, 98.2%); all MAEs were clinically driven target lesion revascularization (4.9%, 6/123). The 12-month mortality rate was 2.4% (3/125).Conclusions:Patients with lesions > 100 mm treated with Ranger DCBs demonstrated excellent 1-year safety and efficacy results, comparable to those of the overall RANGER II SFA randomized clinical trial. This suggests that the Ranger DCB can provide consistent results regardless of lesion length. (ClinicalTrials.gov Identifier: NCT03064126)

IN.PACT AV Access Randomized Trial: 12-Month Clinical Results Demonstrating the Sustained Treatment Effect of Drug-Coated Balloons

PurposeTo present the 12-month outcomes of the IN.PACT AV Access Study, a prospective, single-blind trial enrolling participants with obstructive de novo or restenotic native upper extremity arteriovenous dialysis fistula lesions treated with a drug-coated balloon (DCB) or percutaneous transluminal angioplasty (PTA). Materials and MethodsAfter successful high-pressure PTA, participants at 29 international sites were randomized 1:1 to treatment with an IN.PACT AV DCB (n = 170) or standard uncoated PTA (n = 160). Outcomes at 12 months include target lesion primary patency (TLPP), defined as freedom from clinically driven target lesion revascularization or access circuit thrombosis; access circuit primary patency; number of reinterventions; and adverse events involving the access circuit. ResultsAt 12 months, TLPP was 63.8% (90/141) in the DCB group compared with 43.6% (61/140) in the PTA group (P < .001). The total number of reinterventions required to maintain TLPP through 360 days was 93 in the DCB group and 144 in the PTA group, with a 35.4% reduction in reinterventions when DCB was used. Access circuit thrombosis occurred in 2.9% (4/138) of the participants in the DCB group and in 6.2% (8/129) of those in the PTA group (P = .19). Time to TLPP was assessed using a multivariable analysis to identify the factors associated with loss of patency. The treatment device was the independent predictor with the largest effect, with a hazard ratio of 0.42 (95% confidence interval, 0.29–0.60; P < .001). ConclusionsTLPP was statistically significantly higher with DCBs than with standard PTA at 12 months, demonstrating the sustained and superior effectiveness of this device for the treatment of dysfunctional arteriovenous dialysis fistulae.