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

2019 ◽  
Vol 21 (5) ◽  
pp. 596-601
Author(s):  
Cemal Kocaaslan ◽  
Ahmet Oztekin ◽  
Mehmet Senel Bademci ◽  
Emine Seyma Denli Yalvac ◽  
Nurgul Bulut ◽  
...  
Keyword(s):  
Percutaneous Transluminal Angioplasty ◽  
Target Lesion ◽  
Transluminal Angioplasty ◽  
Primary Patency ◽  
Anastomotic Stenosis ◽  
Arteriovenous Fistulas ◽  
Study Results ◽  
Significant Difference ◽  
Percutaneous Transluminal ◽  
Drug Coated Balloon

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

Treatment of juxta-anastomotic stenoses for failing distal radiocephalic arteriovenous fistulas: Drug-coated balloons versus angioplasty

2018 ◽  
Vol 20 (2) ◽  
pp. 209-216 ◽  
Author(s):  
Domenico Patanè ◽  
Giovanni Failla ◽  
Giovanni Coniglio ◽  
Giorgio Russo ◽  
Walter Morale ◽  
...  
Keyword(s):  
Percutaneous Transluminal Angioplasty ◽  
Type A ◽  
Target Lesion ◽  
Transluminal Angioplasty ◽  
Primary Patency ◽  
Secondary Patency ◽  
Type B ◽  
Arteriovenous Fistulas ◽  
Percutaneous Transluminal ◽  
Drug Coated Balloon

The aim of our study is to report the results of two types (type A, type B) paclitaxel drug-coated balloon compared with standard percutaneous transluminal angioplasty in the treatment of juxta-anastomotic stenoses of mature but failing distal radiocephalic hemodialysis arteriovenous fistulas. Two groups of 26 and 44 patients treated with two different drug-coated balloon are compared with a control group of 86 treated with standard percutaneous transluminal angioplasty. A color Doppler ultrasound was performed to evaluate stenosis and for treatment planning. We assess primary patency, defined as the absence of dysfunction of the arteriovenous fistulas, patent lesion or residual stenosis < 30% and no need for further reintervention of target lesion. Primary patency and secondary patency are evaluated after 12 months with color Doppler ultrasound for the whole arteriovenous fistulas, defined as absolute (absolute primary patency, absolute secondary patency) and target lesion. Postprocedural technical and clinical success was 100%. After 12 months, absolute primary patency is 81.8% for type A, 84.1% type B, and 54.7% for standard percutaneous transluminal angioplasty; target lesion primary patency is 92% type A, 86.4% type B, and 62.8% standard percutaneous transluminal angioplasty; absolute secondary patency is 95.4% type A, 95.5% type B, and 80.7% standard percutaneous transluminal angioplasty; target lesion secondary patency is 100% type A, 97.7% type B, and 80.7% standard percutaneous transluminal angioplasty. All the patients treated with drug-coated balloon (type A + type B) have an absolute primary patency of 83.3%, a target lesion primary patency of 87.9%, an absolute secondary patency of 95.5%, and a target lesion secondary patency of 98.4%. Our study confirms that the use of drug-coated balloon, indiscriminately among different brands, improves primary patency with statistically significant difference in comparison with standard percutaneous transluminal angioplasty and decreases reintervention of target lesion in juxta-anastomotic stenoses of failing distal arteriovenous fistulas maintaining the radiocephalic fistula as long as possible.

scholarly journals Drug-Coated Balloon vs Standard Percutaneous Transluminal Angioplasty for the Treatment of Atherosclerotic Lesions in the Superficial Femoral and Proximal Popliteal Arteries: One-Year Results of the MDT-2113 SFA Japan Randomized Trial

2017 ◽  
Vol 25 (1) ◽  
pp. 109-117 ◽  
Author(s):  
Osamu Iida ◽  
Yoshimitsu Soga ◽  
Kazushi Urasawa ◽  
Shigeru Saito ◽  
Michael R. Jaff ◽  
...  
Keyword(s):  
Percutaneous Transluminal Angioplasty ◽  
De Novo ◽  
Target Lesion ◽  
Major Amputation ◽  
Transluminal Angioplasty ◽  
Primary Patency ◽  
Lesion Length ◽  
Japanese Cohort ◽  
Percutaneous Transluminal ◽  
Drug Coated Balloon

Purpose: To assess the safety and effectiveness of the MDT-2113 (IN.PACT Admiral) drug-coated balloon (DCB) for the treatment of de novo and native artery restenotic lesions in the superficial femoral and proximal popliteal arteries vs percutaneous transluminal angioplasty (PTA) with an uncoated balloon in a Japanese cohort. Methods: MDT-2113 SFA Japan ( ClinicalTrials.gov identifier NCT01947478) is an independently adjudicated, prospective, randomized, single-blinded trial that randomized (2:1) 100 patients (mean age 73.6±7.0 years; 76 men) from 11 Japanese centers to treatment with DCB (n=68) or PTA (n=32). Baseline characteristics were similar between the groups, including mean lesion length (9.15±5.85 and 8.89±6.01 cm for the DCB and PTA groups, respectively). The primary effectiveness outcome was primary patency at 12 months, defined as freedom from clinically-driven target lesion revascularization (CD-TLR) and freedom from restenosis as determined by duplex ultrasonography. The safety endpoint was a composite of 30-day device- and procedure-related death and target limb major amputation and clinically-driven target vessel revascularization within 12 months. Results: Patients treated with DCBs exhibited superior 12-month primary patency (89%) compared to patients treated with PTA (48%, p<0.001). The 12-month CD-TLR rate was 3% for DCB vs 19% for PTA (p=0.012). There were no device- or procedure-related deaths, major amputations, or thromboses in either group. Quality-of-life measures showed sustained improvement from baseline to 12 months in both groups. Conclusion: Results from the MDT-2113 SFA Japan trial showed superior treatment effect for DCB vs PTA, with excellent patency and low CD-TLR rates. These results are consistent with other IN.PACT SFA DCB trials and demonstrate the safety and effectiveness of this DCB for the treatment of femoropopliteal lesions in this Japanese cohort.

Predictive value of neutrophil-to-lymphocyte ratio and platelet-to-lymphocyte ratio for primary patency of percutaneous transluminal angioplasty in hemodialysis arteriovenous fistula stenosis

Vascular ◽  
2021 ◽  
pp. 170853812110396
Author(s):  
Feng Zhu ◽  
Yao Yao ◽  
Hongbo Ci ◽  
Alimujiang Shawuti
Keyword(s):  
Arteriovenous Fistula ◽  
Percutaneous Transluminal Angioplasty ◽  
Transluminal Angioplasty ◽  
Primary Patency ◽  
Neutrophil To Lymphocyte Ratio ◽  
Platelet To Lymphocyte Ratio ◽  
Lymphocyte Ratio ◽  
Significant Difference ◽  
Percutaneous Transluminal ◽  
Hemodialysis Arteriovenous Fistula

Objective The aim of this study is to investigate the potential association of the neutrophil-to-lymphocyte ratio (NLR) and platelet-to-lymphocyte ratio (PLR) with the primary patency of percutaneous transluminal angioplasty (PTA) in hemodialysis arteriovenous fistula (AVF) stenosis. Methods This study conducted a retrospective review of patients with end-stage renal disease referred for hemodialysis AVF stenosis in one center. The study consisted of 114 patients with significant (significant stenosis was defined as a reduction in the caliber of the fistula vein of > 50% with respect to the non-aneurysmal venous segment). AVF stenosis patients were treated with PTA, with conventional balloon angioplasty. The NLR and PLR were calculated from the pre-interventional blood samples. The patients were classified into two groups: group A, primary patency < 12 months ( n = 35) and group B, and primary patency ≥ 12 months ( n = 79). Comparisons between the groups were performed using the Mann–Whitney U test. Kaplan–Meier analysis was performed to compare the factors, NLR and PLR, for association with primary patency AVFs. A receiver-operating characteristic curve analysis was performed to identify the sensitivity and specificity of the NLR and PLR cut-off values in the prediction of primary patency time. Results There was no difference in gender; age; side of AVF; AVF type; comorbid diseases such as diabetes mellitus and hypertension; or blood parameters such as white cell count, erythrocytes, hemoglobin, neutrophils, lymphocytes, monocytes, eosinophils, basophils, C-reactive protein, NLR, or PLR between the two groups ( p > 0.05). There was also no significant difference in the patency rate between the NLR < 4.13 and NLR ≥ 4.13 groups at 12 months (NLR cut-off point = 4.13, p = 0.273). There were statistically significant differences between the primary patency rates of the PLR < 187.86 and PLR ≥ 187.86 groups at 12 months (PLR cut-off point = 187.86, p = 0.023). The cut-off value for PLR for the determination of primary patency was 187.86, with a sensitivity of 57.0% and specificity of 34.4%. Conclusion An increased level of PLR may be a risk factor for the development of early AVF restenosis after successful PTA. However, more studies are needed to validate this finding.

Juxta-Anastomotic Stenosis of Native Arteriovenous Fistulas: Surgical Treatment versus Percutaneous Transluminal Angioplasty

2010 ◽  
Vol 11 (4) ◽  
pp. 346-351 ◽  
Author(s):  
Marcello Napoli ◽  
Raffaele Prudenzano ◽  
Francesco Russo ◽  
Assunta Lucia Antonaci ◽  
Maria Aprile ◽  
...  
Keyword(s):  
Surgical Treatment ◽  
Percutaneous Transluminal Angioplasty ◽  
Transluminal Angioplasty ◽  
Anastomotic Stenosis ◽  
Arteriovenous Fistulas ◽  
Percutaneous Transluminal

Orchid drug-coated balloon versus standard percutaneous transluminal angioplasty for the treatment of femoropopliteal artery disease: 12-month result of the randomized controlled trial

Vascular ◽  
2021 ◽  
pp. 170853812110139
Author(s):  
Chuan-Jun Liao ◽  
Sheng-Han Song ◽  
Tan Li ◽  
Yang Zhang and Wang-de Zhang
Keyword(s):  
Randomized Controlled Trial ◽  
Percutaneous Transluminal Angioplasty ◽  
Controlled Trial ◽  
Transluminal Angioplasty ◽  
Primary Patency ◽  
Femoropopliteal Artery ◽  
Randomized Controlled ◽  
Artery Disease ◽  
Percutaneous Transluminal ◽  
Drug Coated Balloon

Purpose To assess the efficacy and safety of the Orchid drug-coated balloon (coated with paclitaxel) for the treatment of femoropopliteal artery disease versus percutaneous transluminal angioplasty in Chinese population. Methods This is a prospective, single center, single-blinded, randomized controlled trial that randomized (1:1) 60 patients (38 men; mean age 68.7 ± 8.8) to drug-coated balloon group ( n = 30) or percutaneous transluminal angioplasty group ( n = 30). The primary efficacy endpoint was primary patency of the target lesion and clinically driven target lesion revascularization (CD-TLR) at 12 months. The primary safety end point was freedom from perioperative death at 30 days and freedom from limb-related death and major amputation at 12 months. Results Baseline characteristics were similar between the two groups. Drug-coated balloon group resulted in higher primary patency (82.8% vs. 48.3%, p = 0.005) and lower CD-TLR rates (3.5% vs. 27.6%; p = 0.001) versus percutaneous transluminal angioplasty group at 12 months. The ABI was significantly higher in drug-coated balloon group than percutaneous transluminal angioplasty group (0.86 ± 0.13 vs. 0.72 ± 0.18, p = 0.025). There were no perioperative death at 30 days, no limb-related death and no major amputation at 12 months in either group. Conclusions The randomized controlled trial showed superior treatment effect with drug-coated balloon versus percutaneous transluminal angioplasty, with remarkably higher patency and lower CD-TLR rates. The result is consistent with other study and demonstrates the safety and efficacy of the Orchid drug-coated balloon for the treatment of femoropopliteal artery disease.

Balloon Angioplasty Versus Bailout Stenting for Isolated Chronic Total Occlusions in the Popliteal Artery

2018 ◽  
Vol 53 (2) ◽  
pp. 126-131 ◽  
Author(s):  
Maxime Elens ◽  
Robert Verhelst ◽  
Stefano Mastrobuoni ◽  
Michel J. Bosiers ◽  
Julien Possoz ◽  
...  
Keyword(s):  
Balloon Angioplasty ◽  
Popliteal Artery ◽  
Percutaneous Transluminal Angioplasty ◽  
Transluminal Angioplasty ◽  
Primary Patency ◽  
Technical Success ◽  
Chronic Total Occlusions ◽  
Significant Difference ◽  
Percutaneous Transluminal

Aims: Stenting of the popliteal artery (PA) is generally considered inappropriate due to the high mechanical stress and bending of the artery during knee flexion. Nevertheless, vessel recoil remains problematic following angioplasty procedure for chronic total occlusions (CTOs) and adjunctive stenting may be required. The purpose of this study is to compare balloon angioplasty alone versus bailout stenting for isolated CTO of the PA. Materials and Methods: Between March 2012 and October 2016, 43 patients were treated with percutaneous transluminal angioplasty with balloon alone (PTA, n = 16) or bailout stenting percutaneous transluminal angioplasty and stenting (PTAS, n = 27) for de novo CTO of PA. There was no statistically significant difference between both groups with regard to patient demographics and lesions characteristics (calcification severity and lesion length). The median lesion lengths were 67 mm (39.5-78.5) in the PTA group and 94 mm (50-114) in the PTAS group ( p = 0.14). The primary outcome measure was primary patency; secondary outcomes were technical success, primary assisted patency, major amputation, and increased Rutherford classification. Results: Technical success rate was 37% and 96.3% in the PTA and PTAS groups, respectively. There was no statistical difference in 12-month primary patency rate (65.8% versus 58.7%; p = 0.15) and primary assisted patency at 12 months (75.2 versus 69.2; p = 0.47) between the 2 groups. Freedom from target lesion revascularization at 12 months was not significantly different, with 85.7% and 81.6% ( p = 0.2) in the PTA and PTAS groups, respectively. One amputation occurred in the PTA group. Conclusion: This small cohort suggests that stenting as a bailout procedure in CTO of the PA provides similar results to successful balloon angioplasty. Stenting should only be performed after suboptimal balloon angioplasty with vessel recoil. Due to the large lost to follow-up, strong evidence of a therapy over the other cannot be formulated. Larger studies with longer and stronger follow-up are needed to confirm those results.

scholarly journals Stent grafts improved patency of ruptured hemodialysis vascular accesses

2022 ◽  
Vol 12 (1) ◽  
Author(s):  
Min-Tsun Liao ◽  
Chien-Ming Luo ◽  
Ming-Chien Hsieh ◽  
Mu-Yang Hsieh ◽  
Chih-Ching Lin ◽  
...  
Keyword(s):  
Stent Graft ◽  
Target Lesion ◽  
Transluminal Angioplasty ◽  
Primary Patency ◽  
Dialysis Access ◽  
Stent Grafts ◽  
Index Procedure ◽  
Balloon Tamponade ◽  
Significant Difference ◽  
Percutaneous Transluminal

AbstractThis study aimed to compare stent graft with balloon tamponade for ruptured dialysis access during percutaneous transluminal angioplasty. Patients over an 8-year period (2010–2018) were identified from a database of 11,609 procedures. The primary endpoint was target lesion primary patency at 12 months. A total of 143 patients who had rupture dialysis access were enrolled, of whom 52 were salvaged by stent grafts and 91 were salvaged by balloon tamponade. The 6-month target lesion primary patency was greater in the stent graft group than in the balloon tamponade group (66.7% vs. 29.5%, P < 0.001). The benefit of stent grafts was sustained for 12 months (52.5% vs. 9.0%, P < 0.001). The stent grafts increased the median time from the index procedure to the next intervention in the ruptured area by 171 days (260 vs. 89 days) at 12 months. There was no significant difference in the access circuit patency rates at 6 months (25.5% vs. 19.8%, P = 0.203) and 12 months (12.0% vs. 5.8%, P = 0.052). The patency results of the stent grafts remained after the multivariable adjustment analysis. Compared to balloon tamponade alone, stent grafts provided superior target lesion primary patency at 6 and 12 months. The access circuit patency rates were similar.

Self-Expanding Nitinol Stent vs Percutaneous Transluminal Angioplasty in the Treatment of Femoropopliteal Lesions: 3-Year Data From the SM-01 Trial

2019 ◽  
Vol 26 (2) ◽  
pp. 158-167 ◽  
Author(s):  
Osamu Iida ◽  
Kazushi Urasawa ◽  
Yasuo Komura ◽  
Yoshimitsu Soga ◽  
Naoto Inoue ◽  
...  
Keyword(s):  
Percutaneous Transluminal Angioplasty ◽  
Patency Rate ◽  
Velocity Ratio ◽  
Peak Systolic Velocity ◽  
Transluminal Angioplasty ◽  
Primary Patency ◽  
Stent Group ◽  
Primary Patency Rate ◽  
Multicenter Randomized Controlled Trial ◽  
Percutaneous Transluminal

Purpose: To report the midterm outcomes of a trial comparing self-expanding nitinol stents to percutaneous transluminal angioplasty (PTA) with provisional stenting in the treatment of obstructive disease in the superficial femoral and popliteal arteries. Materials and Methods: The SM-01 study ( ClinicalTrials.gov identifier NCT01183117), a single-blinded, multicenter, randomized controlled trial in Japan, enrolled 105 consecutive patients with de novo or postangioplasty restenotic femoropopliteal lesions; after removing protocol violations (1 from each group), 51 patients (mean age 74±8 years; 36 men) in the stent group and 52 patients (mean age 73±8 years; 35 men) in the PTA group were included in the intention-to-treat analysis. The groups were well-matched at baseline. Patients were followed to 36 months with duplex imaging. Three-year primary patency was assessed based on a duplex-derived peak systolic velocity ratio <2.5. Freedom from clinically-driven target vessel revascularization (TVR) and target lesions revascularization (TLR) were estimated using the Kaplan-Meier method. Results: The technical success rate was higher (100% vs 48%, p<0.001) and the frequency of vascular dissection was lower (4% vs 31%, p<0.001) in the stent group. The S.M.A.R.T stent group had a higher 3-year primary patency rate (73% vs 51%, p=0.033). Freedom from clinically-driven TVR and TLR were not significantly different between the groups. Conclusion: The S.M.A.R.T. stent maintained a higher primary patency rate than PTA at 3 years in this randomized trial; the need for clinically-driven revascularization was similar for both therapies.

Relationship Between Postoperative Neutrophil–Lymphocyte Ratio and 6-Month Primary Patency of Percutaneous Transluminal Angioplasty in Femoropopliteal disease With Drug-Coated and Uncoated Balloons

Angiology ◽  
2018 ◽  
Vol 70 (3) ◽  
pp. 244-248 ◽  
Author(s):  
Yanhua Zhen ◽  
Zhihui Chang ◽  
Zhaoyu Liu ◽  
Jiahe Zheng
Keyword(s):  
Percutaneous Transluminal Angioplasty ◽  
Patency Rate ◽  
Transluminal Angioplasty ◽  
Primary Patency ◽  
Primary Patency Rate ◽  
Neutrophil Lymphocyte Ratio ◽  
Lymphocyte Ratio ◽  
Logistic Analysis ◽  
Early Restenosis ◽  
Percutaneous Transluminal

We investigated the relationship of postoperative neutrophil–lymphocyte ratio (NLR) with 6-month primary patency of percutaneous transluminal angioplasty (PTA) in femoropopliteal disease using drug-coated balloon (DCB) or uncoated balloon (UCB). This retrospective study included 106 patients who received DCB (n = 44) or UCB (n = 62). The postoperative NLR was lower in the DCB group than that in the UCB group (2.60 vs 3.23; P = .004), and 6-month primary patency rate was significantly higher in DCB group than that in the UCB group (77.3% vs 53.2%; P = .011). Multivariate logistic analysis showed that the postoperative NLR was an independent predictor of 6-month primary patency after PTA in patients with femoropopliteal disease (odds ratio: 1.589, 95% confidence interval: 1.078-2.343; P = .019). The cutoff value of postoperative NLR was 3.05 for prediction of 6-month primary patency, with a sensitivity of 64.1% and specificity of 65.7%. The 6-month primary patency rate in the NLR ≤3.05 group was higher than that in the NLR >3.05 group (75.9% vs 47.9%; P = .003). In conclusion, DCB may improve early primary patency by inhibiting inflammation. A higher postoperative NLR was associated with early restenosis.

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