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

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.

Use of the helical SUPERA™ stent and Passeo-18 Lux™ drug-coated balloon to treat recurrent cephalic arch stenosis for dysfunctional brachiocephalic fistulas: 1 year results of the Arch V SUPERA-LUX study

2021 ◽  
pp. 112972982110430
Author(s):  
Tjun Yip Tang ◽  
Shereen Xue Yun Soon ◽  
Charyl Jia Qi Yap ◽  
Sze Ling Chan ◽  
Ru Yu Tan ◽  
...  
Keyword(s):  
Venous Pressure ◽  
Duplex Ultrasound ◽  
Target Lesion ◽  
Primary Patency ◽  
Asia Pacific ◽  
Asian Patients ◽  
Helical Stent ◽  
End Stage ◽  
Mean Time ◽  
Drug Coated Balloon

Background: Aim of Arch V SUPERA-LUX was to evaluate the safety and efficacy of the combination therapy of SUPERA™ ( Abbott Vascular, Santa Clara, CA, USA) helical stent implantation and Passeo-18 Lux™ ( Biotronik Asia Pacific Pte Ltd, Singapore) drug coated balloon (DCB) elution to treat recurrent cephalic arch stenosis (CAS) in the setting of AV access dysfunction. Methods: Investigator-initiated, single-center, single-arm prospective pilot study of 20 end-stage renal failure Asian patients with a dysfunctional brachiocephalic fistula. All had symptomatic recurrent CAS within 6 months of prior intervention. The lesion was pre-dilated with a standard high-pressure balloon (Biotronik Passeo-35 HP balloon). The DCB (Passeo-18 Lux™) is subsequently inflated and the SUPERA™ stent deployed to sit 2 mm distal to the cephalic arch and covering the CAS but within the DCB zone. All patients were prescribed dual antiplatelet therapy for 3 months and followed up with Duplex ultrasound at 6- and 12-months. Results: There were 9 (45%) males and mean age was 67 ± 11.0 years. Mean time from prior procedure was 113 ± 68 days and main indication for reintervention was high venous pressure (9/20, 45%). Technical success was 100% and there were no peri-procedural complications related to either stent or DCB deployment. Target lesion primary patency at 6- and 12-months was 10/18 (55%) and 5/16 (31%), respectively. Mean time to target lesion re-intervention was 170 ± 82 days. Circuit access patency was 8/18 (44%) and 2/16 (13%) at 6- and 12-months respectively and mortality was 3/20 (15%) attributed to the patients’ underlying co-morbidities. Conclusion: Dual prong strategy of using SUPERA™ stenting and Passeo-18 Lux™ drug elution for recurrent CAS, although safe, was no more efficacious than conventional balloon angioplasty or stenting alone. Development of an intense inflammatory reaction within the stent led to reinterventions of a number of cases with suboptimal results.

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

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.

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

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.

Balloon angioplasty: A promising adjunct to arteriovenous fistula creation compared with hydrostatic dilatation in small-caliber cephalic veins

2021 ◽  
pp. 021849232110415
Author(s):  
Santosh K Tiwari ◽  
Rajendra P Basavanthappa ◽  
Ranjith K Anandasu ◽  
Sanjay C Desai ◽  
Chandrasekhar A Ramswamy ◽  
...  
Keyword(s):  
Arteriovenous Fistula ◽  
Balloon Angioplasty ◽  
Duplex Ultrasound ◽  
Primary Patency ◽  
Maturation Time ◽  
Arteriovenous Access ◽  
Dilatation Group ◽  
Stage Renal Disease ◽  
End Stage ◽  
Venous Segment

Background To maintain the patency and longevity of arteriovenous fistula, the availability of a venous segment with adequate diameter is important. In Indian population, many chronic kidney disease patients have poor caliber veins. The study aimed to evaluate the efficacy of hydrostatic dilatation versus Primary balloon angioplasty of small caliber cephalic veins of (≤2.5 mm) preoperatively in terms of patency rate and maturation time of arteriovenous fistula. Methods Patients ( n = 80) with an end-stage renal disease requiring arteriovenous access surgery for hemodialysis with small caliber cephalic veins were randomized into two groups, i.e., hydrostatic dilatation and primary balloon angioplasty, each with 40 patients. All patients underwent a thorough clinical examination as well as duplex ultrasound vein mapping of both upper extremities. Patients were followed up for six months and primary patency, maturation time, and complications were noted. Results Immediate technical success with good palpable thrill was achieved in 97.5% of patients in the primary balloon angioplasty group and 87.5% in the hydrostatic dilatation group. The fistula maturation time in the primary balloon angioplasty group was 34.41 days and 46.18 days in the hydrostatic dilatation group. In the primary balloon angioplasty group, the primary patency of the fistula was 97.5% and 87.5% in the hydrostatic dilatation group, at six months. The arteriovenous fistula functioning rate was 77.5% in the hydrostatic dilatation group as compared to 92.5% in the primary balloon angioplasty group at six months. The incidence of surgical site infection was 5% in the primary balloon angioplasty group as compared to 10% in the hydrostatic dilatation group. Conclusion Primary balloon angioplasty of small caliber cephalic veins (≤2.5 mm) performed prior to arteriovenous fistula creation for hemodialysis is a beneficial procedure.

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

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.

Photoablative atherectomy followed by a paclitaxel-coated balloon to inhibit restenosis in instent femoro-popliteal obstructions (PHOTOPAC)

VASA ◽  
2021 ◽  
pp. 1-7
Author(s):  
Tanja Böhme ◽  
Elias Noory ◽  
Ulrich Beschorner ◽  
Frederik Lerke ◽  
Andrej Schmidt ◽  
...  
Keyword(s):  
Primary Endpoint ◽  
Ankle Brachial Index ◽  
Target Lesion ◽  
Primary Patency ◽  
Small Sample ◽  
Adverse Event Rate ◽  
Control Cohort ◽  
Procedural Success ◽  
Laser Atherectomy

Summary: Background: To evaluate the safety and effectiveness of preparing instent femoropopliteal lesion with photoablative laser atherectomy or plain balloon angioplasty (POBA) prior to drug-coated balloon (DCB) angioplasty. Patients and methods: The prospective, multicenter, randomized study enrolled patients with Rutherford-Becker-class (RBC) 1 to 5 and instent lesions located in superficial femoral artery and/or popliteal artery above the knee joint. Primary endpoint was target lesion percent stenosis at 1 year as determined by the angiographic core-laboratory. Secondary endpoints included procedural success, major adverse event rate, clinical improvement and improvement in ankle-brachial index (ABI), clinically-driven target lesion revascularization (CD-TLR), and primary patency rate at until 2-year follow-up. Results: The study was terminated prior to the enrollment goal due to slow enrollment. Thirty patients were included in the laser plus DCB cohort and 31 patients in the control cohort. Primary endpoint was not significantly different (p=0.331). Procedural success was 83.3% and 87.1% for the laser plus DCB and the control cohort, respectively. Serious adverse events at 30 days and 1-year were not statistically different between the two cohorts. For the ABI, significant improvements were present at discharge as well as at the follow-up visits. This was also evident for the RBC at the follow-up visits. One- and two-year freedom from CD-TLR was 86.7% vs. 87.1%, and 63.6% vs. 72%, respectively. Duplex derived primary patency was 90% at 6-months, 65.5% at one year and 56.5% at two year for the laser cohort and 90.3%, 75.9% and 53.8% for the control cohort. Conclusions: Safety of instent photoablative laser atherectomy followed by DCB angioplasty is confirmed by this study. Due to the small sample size, no benefit over POBA as vessel preparation could be shown.

Balloon Angioplasty in Chronic Critical Limb Ischemia: Factors Affecting Clinical and Angiographic Outcome

2002 ◽  
Vol 9 (4) ◽  
pp. 403-410 ◽  
Author(s):  
Hannes Balmer ◽  
Felix Mahler ◽  
Dai-Do Do ◽  
Jürgen Triller ◽  
Iris Baumgartner
Keyword(s):  
Balloon Angioplasty ◽  
Critical Limb Ischemia ◽  
Duplex Ultrasound ◽  
Limb Ischemia ◽  
Target Lesion ◽  
Major Amputation ◽  
Factors Affecting ◽  
Chronic Critical Limb Ischemia ◽  
Endpoint Event ◽  
Artery Disease

Purpose: To assess factors that affect clinical and angiographic outcome in chronic critical limb ischemia (CLI) 12 months after primary, technically successful balloon angioplasty (BA) in infrainguinal arteries. Methods: Sixty consecutive patients (37 women; mean age 75 ± 10 years, range 53–99) with technically successful BA in 66 limbs were followed for 12 months or until death, for major amputation, or repeat target lesion revascularization (TLR). Assessment at baseline and 1 day and 12 months after BA or at an endpoint event, if feasible, was performed with angiography or duplex ultrasound (above-knee revascularization only). Mortality, limb prognosis, and restenosis rate were correlated with cardiovascular risk factors, hemodynamic measures, and angiographic features. Results: Mortality was 25% at 1 year; compared to survivors, nonsurvivors more often had coronary artery disease (93% versus 44% for survivors, p<0.001), bilateral CLI (60% versus 29%, p=0.033), and higher fibrinogen levels (5.1 g/L versus 4.3 g/L, p=0.049). CLI resolved in more than half (35, 53%) of the limbs without repeat TLR. The major amputation rate was 6%. Limb prognosis correlated with ankle pressures after BA. Restenosis rates were 65% at the femoropopliteal and 56% at the infrapopliteal level (NS); these correlated with the length of the treated arterial segment (8.7 cm with restenosis versus 4.0 cm without, p<0.001). Conclusions: High mortality in CLI was associated with an extensive, clinically manifest arteriosclerotic process and high fibrinogen levels. Limb prognosis and restenosis after BA were primarily influenced by local hemodynamic and technical factors. Despite considerable restenosis, more than 90% of survivors avoided major amputations.

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

2021 ◽  
Vol 8 (13) ◽  
pp. 1-36
Author(s):  
Narayan Karunanithy ◽  
Emily J Robinson ◽  
Francis Calder ◽  
Anthony Dorling ◽  
Janet L Peacock ◽  
...  
Keyword(s):  
Adverse Events ◽  
Confidence Interval ◽  
Arteriovenous Fistula ◽  
Balloon Angioplasty ◽  
Target Lesion ◽  
Primary Patency ◽  
Hazard Ratio ◽  
End Points ◽  
Multiple Lesions ◽  
Secondary Outcomes

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.

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

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.

Comparison of drug-coated balloon angioplasty versus uncoated balloon angioplasty in treatment of total occlusions with severe femoropopliteal lesions: An additional analysis from the AcoArt I study

Vascular ◽  
2020 ◽  
pp. 170853812095366
Author(s):  
Guoyi Sun ◽  
Jie Liu ◽  
Senhao Jia ◽  
Jiwei Zhang ◽  
Baixi Zhuang ◽  
...  
Keyword(s):  
Balloon Angioplasty ◽  
Chronic Total Occlusion ◽  
Ankle Brachial Index ◽  
Target Lesion ◽  
Primary Patency ◽  
Target Lesion Revascularization ◽  
Total Occlusion ◽  
Chronic Total Occlusions ◽  
Late Lumen Loss ◽  
Drug Coated Balloon

Objectives Femoropopliteal chronic total occlusions are challenging to treat, and evidence of the effectiveness of drug-coated balloon angioplasty for long femoropopliteal chronic total occlusion lesions is limited. We compared the midterm outcomes of drug-coated balloon angioplasty versus plain old balloon angioplasty (POBA) for femoropopliteal chronic total occlusions. Methods In total, 95 patients from the AcoArt I trial (ClinicalTrials.gov identifier NCT01850056) with ≥5-cm femoropopliteal chronic total occlusion lesions were enrolled in this post-hoc subset analysis (drug-coated balloon, n = 50; POBA, n = 45). The primary endpoints were primary patency and clinically driven target lesion revascularization (CD-TLR) at 24 months. The secondary endpoints were late lumen loss at six months and binary restenosis, major adverse events (composite of death and target limb amputation), change in the Rutherford class, and the ankle-brachial index at 24 months. Results Demographic, clinical, and lesion characteristics were matched (mean lesion length, 20 cm). The six-month late-lumen loss rate was lower in the drug-coated balloon than POBA group (0.18 ± 0.81 vs. 1.34 ± 0.94 mm, respectively; P < 0.001). The 24-month primary patency rate was significantly higher in the drug-coated balloon than POBA group (53.85% vs. 17.50%, respectively; P < 0.001). The CD-TLR rate in the drug-coated balloon and POBA groups was 12.77 and 45.24%, respectively ( P = 0.002). The 24-month overall mortality rate in the drug-coated balloon and POBA groups was 12.77% and 6.98%, respectively ( P = 0.360), with no device- or procedure-related deaths. One major amputation had occurred in each group by the 24-month follow-up. Conclusion The paclitaxel drug-coated balloon shows better primary patency and freedom from target lesion revascularization than POBA at 24 months after treatment of femoropopliteal chronic total occlusions (≥5 cm) lesion.

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