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.

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.

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.

Impact of Scoring Balloons on Percutaneous Transluminal Angioplasty Outcomes in Femoropopliteal Lesions

2020 ◽  
Vol 27 (3) ◽  
pp. 481-491
Author(s):  
Kazunori Horie ◽  
Akiko Tanaka ◽  
Masataka Taguri ◽  
Naoto Inoue
Keyword(s):  
Percutaneous Transluminal Angioplasty ◽  
De Novo ◽  
Multivariable Analysis ◽  
Transluminal Angioplasty ◽  
Primary Patency ◽  
Arterial Dissection ◽  
Lesion Length ◽  
Scoring Balloon ◽  
Kaplan Meier ◽  
Percutaneous Transluminal

Purpose: To investigate the efficacy of scoring balloons for immediate success of percutaneous transluminal angioplasty (PTA) in femoropopliteal lesions. Materials and Methods: Between 2013 and 2019, 398 consecutive patients with de novo femoropopliteal lesions were treated using PTA in our hospital. The procedure success rate was compared among patients undergoing PTA with vs without scoring balloons after 1:1 propensity score matching on hemodialysis, TransAtlantic Inter-Society Consensus II classification, Peripheral Arterial Calcium Scoring System (PACSS) grade, lesion length, and use of intravascular ultrasound. Propensity matching produced 84 patients (mean age 73.4±8.3; 65 men) treated with scoring balloons and 84 patients (mean age 75.6±8.7; 56 men) treated with plain balloons. Kaplan-Meier analysis investigated patency after the procedure in both groups; estimates are given with the 95% confidence interval (CI). Results: Residual stenosis <30% was achieved more often (77.4% vs 57.1%, p=0.005) and severe arterial dissection occurred less frequently (16.7% vs 29.8%, p=0.043) in the scoring balloon group vs the plain balloon group, respectively. The rate of provisional stenting was significantly lower after scoring balloon use (13.3% vs 29.8%, p=0.008). Multivariable analysis revealed that use of scoring balloons (p<0.001) and prolonged inflation time (p<0.001) were independent predictors of successful angioplasty, whereas chronic total occlusion (p=0.005) and longer lesion length (p=0.005) were predictors of an unsuccessful procedure. Among 108 patients with PACSS 0–3 lesions in the matched population, Kaplan-Meier analysis showed better primary patency at 18 months in the scoring balloon group in the intention to treat analysis [68.6% (95% CI 53.5% to 80.6%) vs 43.0% (95% CI 28.7% to 58.5%), p=0.044]. Conclusion: Scoring balloons may be effective in restoring acute lumen gain and preventing severe arterial dissection in femoropopliteal lesions. Moreover, scoring balloons might be associated with better primary patency at 18 months in PACSS 0–3 lesions.

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.

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

2020 ◽  
pp. 152660282096968
Author(s):  
Xin Jia ◽  
Baixi Zhuang ◽  
Feng Wang ◽  
Yongquan Gu ◽  
Jiwei Zhang ◽  
...  
Keyword(s):  
Balloon Angioplasty ◽  
De Novo ◽  
Randomized Study ◽  
Balloon Catheter ◽  
Target Lesion ◽  
Primary Patency ◽  
Control Group ◽  
Lesion Length ◽  
Significant Difference ◽  
Drug Coated Balloon

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

Usefulness of the “Non-Slip Element” Percutaneous Transluminal Angioplasty Balloon in the Treatment of Femoropopliteal Arterial Lesions

2019 ◽  
Vol 27 (1) ◽  
pp. 102-108 ◽  
Author(s):  
Eiji Karashima ◽  
Shunsuke Yoda ◽  
Shioto Yasuda ◽  
Shota Kajiyama ◽  
Hiroyuki Ito ◽  
...  
Keyword(s):  
Balloon Angioplasty ◽  
Percutaneous Transluminal Angioplasty ◽  
De Novo ◽  
Transluminal Angioplasty ◽  
Lesion Length ◽  
Scoring Balloon ◽  
Arterial Lesions ◽  
Single Center Study ◽  
Percutaneous Transluminal ◽  
New Scoring

Purpose: To evaluate a new scoring balloon, the non-slip element (NSE) percutaneous transluminal angioplasty (PTA) balloon, in the treatment of femoropopliteal lesions by comparing angiographic dissection patterns to those of a conventional balloon. Methods: This retrospective, single-center study included 71 symptomatic patients (mean age 77.4±8.8 years; 33 men) with de novo femoropopliteal lesions <20 cm long treated with balloon angioplasty between January 2017 and May 2018. Thirty-four patients were treated with 3 inflations of an NSE balloon and 37 patients were treated with a conventional balloon. Results: Severe dissections were fewer (8.8% vs 29.7%, p=0.027) and the total dissection length was shorter (11.5±12.8 vs 35.7±24.1 mm, p=0.027) in the NSE group. The bailout stenting rate was also lower in the NSE group (17.6% vs 40.5%, p=0.035). There were no significant differences between the groups regarding lesion length (70.3±50.4 vs 77.8±56.6 mm, p=0.28), inflation time (294±162 vs 353±179 seconds, p=0.08), or inflation pressure (10.6±5.0 vs 11.3±5.3 atm, p=0.31). Conclusion: Three NSE balloon inflations may reduce severe dissections induced by balloon angioplasty in femoropopliteal lesions.

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.

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.

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