scholarly journals PRELUDE Prospective Study of the Serranator Device in the Treatment of Atherosclerotic Lesions in the Superficial Femoral and Popliteal Arteries

2018 ◽  
Vol 26 (1) ◽  
pp. 18-25 ◽  
Author(s):  
Andrew Holden ◽  
Andrew Hill ◽  
Andrew Walker ◽  
Brendan Buckley ◽  
Stephen Merrilees ◽  
...  
Keyword(s):  
De Novo ◽  
Balloon Catheter ◽  
Vessel Diameter ◽  
Primary Patency ◽  
Lesion Length ◽  
Chronic Total Occlusions ◽  
The Core ◽  
Safety Endpoint ◽  
Exciting Potential ◽  
Primary Safety Endpoint

Purpose: To evaluate the safety and efficacy of the Serranator Alto PTA Serration Balloon Catheter in subjects with peripheral artery disease in the superficial femoral and popliteal arteries. Materials and Methods: A prospective, multicenter, single-arm feasibility study enrolled 25 patients (mean age 66 years; 18 men) to evaluate Serranator inflation and postinflation effects under monitoring by independent core laboratories. Inclusion criteria were claudication or ischemic rest pain, de novo lesions or native artery restenosis, >70% stenosis, lesion length <10 cm, and a reference vessel diameter of 4 to 6 mm. Chronic total occlusions (CTO) up to 6 cm in length were allowed (n=8). The primary safety endpoint was 30-day major adverse events. Primary efficacy outcome was device success with final diameter stenosis <50%. The secondary objective was to confirm the presence of serrations across the lesions using optical coherence tomography (OCT) or intravascular ultrasound (IVUS) following treatment in a subset of 10 subjects. Follow-up evaluations were conducted at 30 days and 6 months. Results: Technical success of device delivery and retrieval was 100%. The primary safety endpoint was met, with no patients experiencing a major adverse event in the first 30 days. Pretreatment stenosis of 88% was reduced to 23%. One stent was implanted for grade D dissection in a CTO. The core laboratory–adjudicated primary patency was 100% at 1 month and 64% at 6 months. Serrations were confirmed in all 10 OCT/IVUS images reviewed by the core laboratory. The Rutherford category showed significant and sustained improvement at 6 months. Conclusion: The Serranator is a safe and efficacious angioplasty balloon catheter system. This new design provides an exciting potential for optimizing vessel preparation and aiding drug delivery.

Drug-Coated Balloon Angioplasty in Atherosclerosis Patients With Popliteal Artery Involvement

2018 ◽  
Vol 25 (5) ◽  
pp. 581-587 ◽  
Author(s):  
Tomoharu Dohi ◽  
Andrej Schmidt ◽  
Dierk Scheinert ◽  
Yvonne Bausback ◽  
Daijiro Kabata ◽  
...  
Keyword(s):  
Popliteal Artery ◽  
De Novo ◽  
Vessel Diameter ◽  
Primary Patency ◽  
Lesion Length ◽  
Endovascular Interventions ◽  
Long Term Follow Up ◽  
Drug Coated Balloon

Purpose: To investigate outcomes of drug-coated balloon (DCB) angioplasty in endovascular interventions including or restricted to the popliteal artery. Methods: A retrospective analysis was conducted of 266 patients [median age 72 years, interquartile range (IQR) 62, 78; 166 men] treated with DCB angioplasty in 281 de novo lesions including the popliteal artery between December 2011 and January 2015 at a single center. The median lesion length was 270 mm (IQR 150, 373). The study outcomes were primary patency and predictors of restenosis [reported as the hazard ratio (HR) with 95% confidence interval (CI)]. Results: The primary patency was 77.4% at a median 12.2 months (IQR 5.7, 18.8). Independent variables associated with restenosis included baseline Rutherford category (HR 1.36, 95% CI 1.05 to 1.77, p=0.02), reference vessel diameter (HR 0.77, 95% CI 0.63 to 0.95, p=0.02), dissection (HR 1.69, 95% CI 1.022.79, p=0.04), and standard nitinol stent use (HR 2.08, 95% CI 1.14 to 3.79, p=0.02). Conclusion: Outcomes after DCB angioplasty in lesions including the popliteal artery were acceptable compared with previous studies. Further investigation with long-term follow-up is needed to confirm these results.

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.

scholarly journals IN.PACT SFA Clinical Study Using the IN.PACT Admiral Drug-Coated Balloon in a Chinese Patient Population

2019 ◽  
Vol 26 (4) ◽  
pp. 471-478 ◽  
Author(s):  
Zhong Chen ◽  
Wei Guo ◽  
Weiliang Jiang ◽  
Feng Wang ◽  
Weiguo Fu ◽  
...  
Keyword(s):  
De Novo ◽  
Limb Ischemia ◽  
Chinese Patient ◽  
Primary Patency ◽  
Limb Amputation ◽  
Lesion Length ◽  
Chronic Total Occlusions ◽  
Safety Outcome ◽  
Drug Coated Balloon ◽  
Chinese Subjects

Purpose: To confirm the safety and effectiveness of the IN.PACT Admiral drug-coated balloon (DCB) as a treatment for de novo and native artery restenotic lesions in the superficial femoral artery (SFA) and/or proximal popliteal artery in Chinese subjects. Materials and Methods: IN.PACT SFA China ( ClinicalTrials.gov identifier NCT02118532) was a single-arm, independently adjudicated, prospective, premarket study that enrolled 143 subjects (mean age 66.8±7.7 years; 107 men) at 15 centers. The predominant risk factors were hypertension (104, 72.7%) and diabetes mellitus (66, 46.2%). The majority of subjects were classified as Rutherford category 2 or 3 [69 (48.3%) and 55 (38.5%), respectively]; 19 (13.3%) subjects had critical limb ischemia (Rutherford category 4). The mean lesion length was 10.4±6.51 cm; more than half of the lesions (75, 52.4%) were chronic total occlusions. Calcification was found in 66 (46.2%) lesions. Outcomes at 12 months were compared with DCB safety and effectiveness performance goals derived from the literature. The 30-day primary safety outcome was a composite of freedom from device- and procedure-related mortality, major target limb amputation, and clinically-driven target lesion revascularization (CD-TLR). Results: The primary safety outcome was 99.3% at 30 days. Follow-up compliance at 12 months was 92.6%. Estimated 1-year primary patency using Kaplan-Meier analysis was 90.9% and freedom from CD-TLR was 97.1%. The rate of CD-TLR at 12 months was 2.9%. The Rutherford category status improved significantly (p<0.001) between baseline and 12 months. Conclusion: Results from IN.PACT SFA China demonstrated high rates of patency and low rates of CD-TLR in Chinese subjects through 12 months despite patient and lesion complexity. These data are consistent with the results of other IN.PACT DCB trials.

Percutaneous Femoropopliteal Bypass: 2-Year Results of the DETOUR System

2021 ◽  
pp. 152660282110348
Author(s):  
Grzegorz Halena ◽  
Dainis K. Krievins ◽  
Dierk Scheinert ◽  
Janis Savlovskis ◽  
Piotr Szopiński ◽  
...  
Keyword(s):  
Venous Thrombosis ◽  
Deep Venous Thrombosis ◽  
Major Amputation ◽  
Primary Patency ◽  
Lesion Length ◽  
Secondary Patency ◽  
Femoropopliteal Bypass ◽  
Chronic Total Occlusions ◽  
Target Vessel Revascularization ◽  
Kaplan Meier

Purpose: This study investigated the 2-year safety and effectiveness of the PQ Bypass DETOUR system as a percutaneous femoropopliteal bypass. Materials and Methods: Seventy-eight patients with 82 long-segment femoropopliteal lesions were enrolled in this prospective, single-arm, multicenter study. The DETOUR system deployed Torus stent grafts directed through a transvenous route. Eligible patients included those with lesions of >10 cm and average of 371±55 mm. Key safety endpoints included major adverse events (MAEs) and symptomatic deep venous thrombosis in the target limb. Effectiveness endpoints included primary patency defined as freedom from ≥50% stenosis, occlusion, or clinically-driven target vessel revascularization (CD-TVR), primary assisted, and secondary patency. Results: Chronic total occlusions and severe calcium occurred in 96% and 67% of lesions, respectively. Core laboratory-assessed total lesion length averaged 371±51 mm with a mean occlusion length of 159±88 mm. The rates of technical and procedural success were 96%, with satisfactory delivery and deployment of the device without in-hospital MAEs in 79/82 limbs. The MAE rate was 22.0%, with 3 unrelated deaths (4%), 12 CD-TVRs (16%), and 1 major amputation (1%). Deep venous thrombosis developed in 2.8% of target limbs, and there were no reported pulmonary emboli. Primary, assisted primary, and secondary patency rates by the Kaplan–Meier analysis were 79±5%, 79±5%, and 86±4%, respectively. Conclusions: The PQ Bypass DETOUR system is a safe and effective percutaneous alternative to femoropopliteal open bypass with favorable results through 2 years. The DETOUR system provides a durable alternative to conventional endovascular modalities and open surgery for patients with long, severely calcified, or occluded femoropopliteal lesions.

Neointimal Healing Evaluated by Optical Coherence Tomography after Drug-Eluting Absorbable Metal Scaffold Implantation in de novo Native Coronary Lesions: Rationale and Design of the Magmaris-OCT Study

Cardiology ◽  
2017 ◽  
Vol 137 (4) ◽  
pp. 225-230 ◽  
Author(s):  
Pasi Karjalainen ◽  
Tuomas Paana ◽  
Jussi Sia ◽  
Wail Nammas
Keyword(s):  
Optical Coherence Tomography ◽  
De Novo ◽  
Quantitative Coronary Angiography ◽  
Vessel Diameter ◽  
Target Lesion ◽  
Lesion Length ◽  
Optical Coherence ◽  
Flow Reserve ◽  
Coronary Lesions

Objectives: We sought to explore neointimal healing assessed by optical coherence tomography (OCT) following implantation of the Magmaris sirolimus-eluting absorbable metal scaffold. Methods: The Magmaris-OCT is a prospective, multicenter, single-arm observational clinical study, intended to enrol 60 consecutive patients with up to 2 de novo native coronary lesions, each located in different major epicardial vessels, with a reference vessel diameter of 2.5-3.5 mm, and a maximum lesion length of 20 mm. Patients will undergo Magmaris scaffold implantation in the target lesion, according to the standard practice. Clinical follow-up will take place at 30 days, and at 3, 6, 9, and 12 months. For invasive-imaging follow-up, patients will be classified into 3 groups: cohort A will be scheduled for follow-up at 3 months, cohort B at 6 months, and cohort C at 12 months. Invasive imaging will include quantitative coronary angiography, OCT evaluation, and coronary flow reserve measurement. The primary end point will be the percentage of uncovered scaffold struts assessed by OCT at the prespecified follow-up. Conclusions: This study will provide insight into the short- and mid-term healing properties following Magmaris scaffold implantation, with special emphasis on the neointimal coverage of scaffold struts.

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.

A Novel Angiographic Risk Score for Femoropopliteal Interventions

2020 ◽  
Vol 27 (6) ◽  
pp. 967-973 ◽  
Author(s):  
Osamu Iida ◽  
Mitsuyoshi Takahara ◽  
Yoshimitsu Soga ◽  
Masahiko Fujihara ◽  
Daizo Kawasaki ◽  
...  
Keyword(s):  
Risk Factors ◽  
Mixed Model ◽  
Linear Mixed Model ◽  
Multivariable Analysis ◽  
Vessel Diameter ◽  
Primary Patency ◽  
Lesion Length ◽  
Total Occlusion ◽  
Artery Disease ◽  
Angiographic Score

Purpose To present a novel angiographic scoring system that stratifies the risk of restenosis after endovascular therapy (EVT) to inform the decision to use paclitaxel-eluting devices in the femoropopliteal segment. Materials and Methods A prospective, multicenter registry including 1799 limbs of 1578 patients (mean age 74±9 years; 1090 men) with symptomatic peripheral artery disease undergoing intravascular ultrasound–supported femoropopliteal EVT was used as the basis for developing the angiographic score. Multivariable analysis identified baseline patient and limb characteristics associated with restenosis at 12 months. These risk factors for 12-month restenosis were explored using a generalized linear mixed model with a logit-link function in which the inter-institutional and inter-subject variability were treated as random effects. The multiple imputation method was adopted to address missing data. Results of the regression analysis are presented as the odds ratio (OR) with 95% confidence interval (CI). Results Twelve-month primary patency was estimated to be 65.1% (95% CI 62.7% to 67.5%). After multivariable analysis, distal reference vessel diameter per 1 mm (OR 0.71, 95% CI 0.62 to 0.81, p<0.001), lesion length per 10 cm (OR 1.39, 95% CI 1.19 to 1.62, p<0.001), and chronic total occlusion (OR 1.56, 95% CI 1.15 to 2.10, p=0.004) were independently associated with the 12-month restenosis risk, whereas baseline patient risk factors were not. Compared to bare nitinol stent implantation, plain angioplasty (OR 2.31, 95% CI 1.67 to 3.18, p<0.001) was independently associated with a higher risk of 12-month restenosis, while drug-eluting stents (OR 0.65, 95% CI 0.43 to 0.99, p=0.045) and stent-grafts (OR 0.24, 95% CI 0.12 to 0.50, p<0.001) were independently associated with a lower risk of 12-month restenosis. The angiographic score, which was developed by using the 3 angiographic factors but not the TransAtlantic Society Consensus II (TASC) class, was significantly and independently associated with 12-month restenosis. Conclusion The current study demonstrated a novel angiographic score for 12-month restenosis after femoropopliteal EVT in a real-world clinical practice. The developed score was significantly and independently associated with the 12-month restenosis risk, but the TASC class was not.

scholarly journals Directional Atherectomy With Antirestenotic Therapy vs Drug-Coated Balloon Angioplasty Alone for Common Femoral Artery Atherosclerotic Disease

2017 ◽  
Vol 25 (1) ◽  
pp. 92-99 ◽  
Author(s):  
Konstantinos Stavroulakis ◽  
Arne Schwindt ◽  
Giovanni Torsello ◽  
Efthymios Beropoulis ◽  
Arne Stachmann ◽  
...  
Keyword(s):  
Femoral Artery ◽  
Common Femoral Artery ◽  
Primary Patency ◽  
Lesion Length ◽  
Secondary Patency ◽  
Success Rates ◽  
Technical Success ◽  
Chronic Total Occlusions ◽  
Directional Atherectomy ◽  
Drug Coated Balloon

Purpose: To report an experience using directional atherectomy (DA) with antirestenotic therapy (DAART) in the form of drug-coated balloon (DCB) angioplasty vs DCB angioplasty alone in common femoral artery (CFA) occlusive lesions. Methods: A retrospective review was conducted of 47 consecutive patients (mean age 71 years; 26 men) treated between October 2011 and July 2016 using either DCB angioplasty alone (n=26) or DAART (n=21) for CFA lesions. The majority of patients had lifestyle-limiting claudication (14 DCB and 15 DAART). Mean lesion length (39±14 mm DCB and 34±16 mm DAART) and vessel calcification (17/26 DCB and 11/21 DAART) were comparable between the groups. There were 4 chronic total occlusions, all in the DAART group. The main outcome measure was primary patency. Key secondary outcomes were technical success, secondary patency, and freedom from clinically-driven target lesion revascularization (TLR). Results: Technical success rates were 89% following DCB angioplasty and 95% for DAART (p=0.41). The 88% 12-month primary patency and 89% freedom from TLR for DAART were higher than the 68% and 75% estimates following DCB angioplasty alone, but neither difference was statistically significant. However, the secondary patency estimate at 12 months was significantly higher in the DAART group (100% vs 81% for DCB, p=0.03). Bailout stenting (1 DCB vs 1 DAART), vessel perforation (1 DCB vs 0 DAART), access site complications (4 DCB vs 3 DAART), and distal embolization (0 DCB vs 1 DAART) were comparable, whereas DCB angioplasty had more non-flow-limiting dissections (8 vs 1 for DAART, p=0.02). Conclusion: Preparation of the atherosclerotic CFA with directional atherectomy was not associated with statistically significantly higher primary patency or freedom from TLR compared to DCB angioplasty alone at 12 months. Nonetheless, both modalities had promising outcomes in a primarily surgically treated vascular territory.

scholarly journals Midterm Outcomes After Infrapopliteal Interventions in Patients With Critical Limb Ischemia Based on the TASC II Classification of Below-the-Knee Arteries

2017 ◽  
Vol 24 (3) ◽  
pp. 321-330 ◽  
Author(s):  
Gagan D. Singh ◽  
Ellen K. Brinza ◽  
Justin Hildebrand ◽  
Stephen W. Waldo ◽  
T. Raymond Foley ◽  
...  
Keyword(s):  
Critical Limb Ischemia ◽  
Velocity Ratio ◽  
Peak Systolic Velocity ◽  
Duplex Ultrasound ◽  
Limb Ischemia ◽  
Vessel Diameter ◽  
Primary Patency ◽  
Tissue Loss ◽  
Success Rates ◽  
Chronic Total Occlusions

Purpose: To analyze the relationship between the new TransAtlantic Inter-Society Consensus (TASC II) infrapopliteal classification and limb outcomes among patients with critical limb ischemia (CLI). Methods: A single-center retrospective study was performed on 166 consecutive CLI patients (mean age 71 years; 113 men) undergoing endovascular treatment of 244 infrapopliteal lesions from 2006 to 2013. Patient, procedural, angiographic, and limb outcomes were compared for the new TASC A/B vs C/D classification for infrapopliteal lesions. Binary restenosis was determined by a peak systolic velocity ratio >2.0 by duplex ultrasound on follow-up at 1, 3, 6, and 12 months. Results: Seventy-two (43.4%) patients had TASC A/B lesions, while 94 (56.6%) had TASC C/D patterns of infrapopliteal disease. Baseline demographics and tissue loss (93% vs 94%, p=0.59) were similar between the groups. TASC A/B lesions were shorter (53±35 vs 170±83 mm, p<0.001), less severely stenosed (77%±24% vs 93%±14%, p<0.001), had a larger target vessel diameter (2.9±0.5 vs 2.6±0.5 mm, p<0.001), and were less frequently chronic total occlusions (24% vs 64%, p<0.001) compared with the TASC C/D group. Three-year freedom from both amputation (85% vs 67%, p=0.02) and major adverse limb events (79% vs 61%, p=0.02) were significantly higher in the TASC A/B group. Technical success rates (95% vs 80%, p<0.001) and 1-year primary patency (58% vs 51%, p=0.04) were higher in the A/B group. Overall 3-year survival was similar between the groups (96% A/B vs 88% C/D, p=0.2). Conclusion: TASC C/D infrapopliteal lesions are associated with higher amputation and major adverse limb events rates and lower primary patency compared with TASC A/B infrapopliteal lesions. Further studies are needed to assess the association between TASC C/D infrapopliteal lesions and clinical outcomes in patients with CLI.

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.

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