scholarly journals Three-Year Results of the IN.PACT SFA Japan Trial Comparing Drug-Coated Balloons With Percutaneous Transluminal Angioplasty

2020 ◽  
Vol 27 (6) ◽  
pp. 946-955
Author(s):  
Yoshimitsu Soga ◽  
Osamu Iida ◽  
Kazushi Urasawa ◽  
Shigeru Saito ◽  
Michael R. Jaff ◽  
...  
Keyword(s):  
Percutaneous Transluminal Angioplasty ◽  
Composite Endpoint ◽  
Transluminal Angioplasty ◽  
Primary Patency ◽  
Occlusive Disease ◽  
Limb Amputation ◽  
Final Report ◽  
Kaplan Meier ◽  
Percutaneous Transluminal ◽  
Effectiveness Endpoint

Purpose: To evaluate the 3-year safety and effectiveness of the MDT-2113 (IN.PACT Admiral) drug-coated balloon (DCB) vs percutaneous transluminal angioplasty (PTA) in a Japanese population with femoropopliteal occlusive disease. Materials and Methods: The multicenter, prospective, IN.PACT SFA Japan randomized controlled trial ( ClinicalTrials.gov identifier NCT01947478) was an independently adjudicated study evaluating Japanese participants randomized 2:1 to DCB (n=68) or PTA (n=32). The effectiveness endpoint was primary patency through 36 months, defined as freedom from clinically-driven target lesion revascularization (CD-TLR) and freedom from restenosis (by duplex ultrasound). The effectiveness endpoint was evaluated using the Kaplan-Meier method; estimates are presented with the 95% confidence intervals (CIs). The safety composite endpoint was freedom from device- and procedure-related death through 30 days and freedom from major target limb amputation and clinically-driven target vessel revascularization through 36 months. Results: Primary patency by Kaplan-Meier estimate was higher in the DCB group (68.9%, 95% CI 57.5% to 80.2%) vs the PTA group (46.9%, 95% CI 29.6% to 64.2%) at 36 months (log-rank p=0.001). The CD-TLR rates were 14.9% (10/67) for the DCB group and 20.7% (6/29) for PTA (p=0.554). The safety composite endpoint occurred in 83.6% (56/67) of DCB participants and 75.9% (22/29) of PTA participants (p=0.402). All-cause death was similar between groups at 36 months [DCB 6.0% (4/67) vs PTA 6.9% (2/29), p>0.999), with no device- or procedure-related deaths in either group. Conclusion: The final report of the IN.PACT SFA Japan trial showed that the IN.PACT Admiral DCB is safe and had durable outcomes through 3 years in Japanese participants with femoropopliteal occlusive disease.

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.

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.

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.

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.

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.

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