Treatment Of Femoropopliteal Lesions Research Articles

Clinical outcomes and risk factors associated with drug-coated balloon treatment for femoropopliteal artery disease in patients on maintenance hemodialysis

Abstract Background Hemodialysis (HD) patients, who are at high risk for atherosclerosis including peripheral artery disease, are associated with poor clinical outcomes after endovascular therapy. Although recent clinical trials have reported favorable outcomes after drug-coated balloon (DCB) treatment for femoropopliteal lesions, its usefulness and risk factors in HD patients have not been well elucidated. Purpose This study aimed to investigate clinical outcomes and the associated risk factors after DCB treatment in HD patients with femoropopliteal lesions. Methods This study included 140 HD patients with their 185 femoropopliteal lesions that underwent DCB treatment between September 2018 and January 2022. Non-HD patients and cases of acute limb ischemia were excluded. The endpoints were 1-year freedom from restenosis and clinically driven target lesion revascularization (CD-TLR). The risk factors were also evaluated. Result Duration of maintenance hemodialysis in all patients was 8.6 years. Mean lesion length was 11.0±6.9 cm, and rates of chronic total occlusion and severe calcification were 17.3% and 45.4%, respectively. Types of DCB were IN.PACT Admiral (22.9%), Lutonix (50.8%) and Ranger (24.3%). Bail-out stenting was performed in 1.1% of all lesions. The Kaplan-Meier estimate of freedom from restenosis and CD-TLR were 63.8% and 71.3% at 12 months, respectively. The freedom rates from CD-TLR after high-dose and low-dose DCB therapy were 79.4% and 66.4%, respectively (p=0.095). Risk factors independently associated with 1-year CD-TLR were diabetes [hazard ratio (HR) 2.30, 95% confidence interval (CI) 1.03-5.15, p=0.043], chronic limb-threatening ischemia (HR 1.93, 95%CI 1.05-3.53, p=0.035) and sever calcification (HR 2.42, 95%CI 1.39-4.21, p=0.0019). When patients were divided into groups according to number of these three risk factors, the rates of freedom from CD-TLR at 12 months were 100%, 94.8%, 76.7% and 30.3% among groups with no risk factor, any 1 risk factor, any 2 risk factors and all risk factors, respectively (p<0.0001). Conclusion The 1-year clinical outcomes after DCB treatment in HD patients with femoropopliteal lesions were unsatisfactory. Independent risk factors for 1-year CD-TLR were diabetes, chronic limb-threatening ischemia and severe calcification.

Impact of postprocedural minimum lumen area on clinical outcome after femoropopliteal drug-eluting stent implantation.

Although favorable results of fluoropolymer-based drug-eluting stent (FP-DES) treatment for femoropopliteal lesions have been reported, it is unclear whether minimal lumen area (MLA) after FP-DES implantation affects clinical outcomes. This study aimed to reveal the association between intravascular ultrasound (IVUS)-evaluated MLA and the 1-year risk of restenosis and aneurysmal degeneration after FP-DES implantation for femoropopliteal lesions. A subanalysis of the CAPSICUM (Contemporary outcomes After Paclitaxel-eluting peripheral Stent implantation for symptomatic lower limb IsChemia with sUperficial feMoral or proximal popliteal lesion) study analyzed 718 limbs in 686 patients with available IVUS-evaluated MLA data. The association of MLA with the 1-year risk of restenosis and aneurysmal degeneration was analyzed using the generalized propensity score method. The 1-year incidence rate of restenosis was estimated to be 8.8% (95% CI, 6.1% to 12.5%) for the upper quartile of MLA (21.1 mm2) versus 14.3% (95% CI, 10.7% to 18.7%) for the lower quartile of MLA (15.2 mm2), with an odds ratio of 0.58 (95% CI, 0.36 to 0.93; p = 0.024), whereas the 1-year incidence rate of aneurysmal degeneration was 23.8% (95% CI, 19.5% to 28.8%) for the upper quartile versus 16.8% (95% CI, 12.6% to 22.0%) for the lower quartile, with an odds ratio of 1.55 (95% CI, 1.04 to 2.32; p = 0.031). A large MLA after FP-DES implantation for femoropopliteal lesions was associated with decreased restenosis risk but increased aneurysmal degeneration risk. These findings suggest that MLA is a valuable predictor of clinical outcomes.

Angioscopic Evaluation of Vascular Response After Fluoropolymer-Based Drug-Eluting Stent Implantation for Femoropopliteal Artery Lesions.

Although favorable clinical outcomes have been demonstrated for fluoropolymer-based paclitaxel-eluting stents (FP-DES) in the treatment of femoropopliteal lesions, the vascular response after implantation has not been systematically studied through intravascular imaging.Methods and Results: We angioscopically compared FP-DES: 24 in the early phase (mean [±SD] 3±1 months), 26 in the middle phase (12±3 months), and 20 in the late phase (≥18 months) after implantation. The dominant neointimal coverage grade, heterogeneity of neointimal coverage grade, and thrombus adhesion in the stent segment were evaluated. Neointimal coverage was graded as follows: Grade 0, stent struts exposed; Grade 1, struts bulging into the lumen, although covered; Grade 2, struts embedded in the neointima, but visible; Grade 3, struts fully embedded and invisible. Dominant neointimal coverage and heterogeneity grades were significantly higher in the middle and late phases than in the early phase (all P<0.05), but did not differ significantly between the middle and late phases. The incidence of thrombus adhesion was recorded for all stents in each of the 3 different phases. The middle and late phases after FP-DES implantation were associated with significantly higher dominant neointimal coverage and heterogeneity grades than the early phase. However, thrombus adhesion was observed in all phases after FP-DES implantation. Arterial healing may not be completed even in the late phase after FP-DES implantation.

Evaluation Of Safety And Effectiveness Of The Biomimics 3D Stent System In The Femoropopliteal Arteries Of Patients With Symptomatic Peripheral Arterial Disease: Single-centre 24 Months Results

Aim: The aim of the study was to evaluate the safety and effectiveness of the BioMimics 3D stent for the treatment of femoropopliteal stenosis or occlusion. The BioMimics 3D stent has a unique 3D helical geometry designed to improve haemodynamics and increase wall shear for a long-term atheroprotective effect. Materials and methods: Between September 2015 and May 2016, 22 patients (12 men, 10 women) were included in the study after giving their written informed consent. The mean age was 69.1 ± 8.4 years. The mean Rutherford category was 2.91 ± 0.42 (2-4). The mean visual estimate of lesion length was 83.2 ± 34.0 mm with an average grade of stenosis of 93.1 ± 8.5%. Complete occlusion was present in 36.4% of patients. A total of 27 stents were implanted, 17 patients received a single stent, and 5 required 2 stents. The total stent length was 102 ± 33 mm. Results: The technical success rate was 100%. The mean degree of residual stenosis after stenting was 9.1 ± 7.7%. No serious complications were observed in the first 30 days. The primary patency rate of the stents was 100% after 30 days, 81.8% after 12 months, and 77.8% after 24 months. On duplex ultrasound, the mean PSVR was 0.71 ± 2.4 immediately after stenting, and 0.80 ± 3.6 and1.03 ± 2.9after 12 and 24 months. One patient (4.5%) had undergone clinically driven target lesion revascularisation after 12 months, and a total of 2 patients after 24 months (9.1%). Clinically, there was a significant increase in ABI from 0.63 ± 0.10 before stenting to 0.93 ± 0.09 after 30 days, 0.90 ± 0.12 after 12 months, and 0.95 ± 0.21 after 24 months. The mean Rutherford category also improved significantly, to 0.95 ± 0.09 after 1 month and 1.19 ± 0.12 and 1.09 ± 0.27 after 12 and 24 months. X-ray imaging after 12- and 24-months follow-up found no stent fracture at either time point. Conclusion: The safety and effectiveness of the BioMimics 3D stent for the treatment of femoropopliteal lesions was confirmed overall; based on the long-term follow-up in particular, the positive effect of the helical stent structure seemed associated with stable patency values.

Treatment of Femoropopliteal Lesions With the BioMimics 3D Vascular Stent System: Two-Year Results From the MIMICS-2 Trial

Purpose To report the safety and effectiveness outcomes through 2 years of the BioMimics 3D Vascular Stent System in the treatment of symptomatic patients with atherosclerotic femoropopliteal disease. Materials and Methods The tubular, nitinol BioMimics 3D stent, which was designed to impart a helical shape to the arterial segment, was implanted in 271 patients (mean age 68.4±9.5 years; 180 men) with de novo femoropopliteal lesions enrolled at 43 investigational sites [31 US (n=162), 6 German (n=78), and 6 Japanese (n=31)] in the prospective, single-arm MIMICS-2 investigational device exemption trial (ClinicalTrials.gov identifier NCT02400905) between June 2015 and October 2016. Mean lesion length was 81.2±38.4 mm, 30.0% of patients had total occlusions, and 45.9% had moderate to severe calcification. Primary safety and effectiveness endpoints were compared at 1 year with prespecified objective performance goals (OPGs) set by the VIVA Physicians organization. Outcomes through 2 years are reported. Results The primary effectiveness endpoint of 12-month primary stent patency was met by 182 of 249 patients (73.1%, 95% CI 67.3% to 78.2%), exceeding the OPG of 66%. The primary safety endpoint of 30-day freedom from major adverse events (MAEs) was met in 268 of 269 patients (99.6%, 95% CI 97.7% to 100%), exceeding the OPG of 88%. Kaplan-Meier estimates of freedom from loss of primary patency were 83.1% at 12 months and 70.2% at 24 months, freedom from MAEs estimates were 86.9% at 12 months and 79.2% at 24 months, and freedom from clinically-driven target lesion revascularization estimates were 88.0% at 12 months and 83.0% at 24 months. At 24 months, 88.2% of patients showed improvement of ≥1 Rutherford category; the ankle-brachial index was >0.9 for 64.4% vs 11.3% at baseline. There were no cases of stent fracture. Conclusion Through 24 months, the BioMimics 3D Vascular Stent System provided safe and effective treatment for femoropopliteal lesions in patients with symptomatic peripheral artery disease.

Combining the Passeo-18 Lux Drug-Coated Balloon and the Pulsar-18 Bare Metal Stent: 12- and 24-Month Outcomes of the BIOLUX 4EVER Investigator-Initiated Trial

Purpose: To report the outcomes after treating stenotic or occluded femoropopliteal lesions with a drug-coated balloon (DCB) followed by the implantation of a thin-strut self-expanding bare metal stent in the BIOLUX 4EVER trial (ClinicalTrials.gov identifier NCT02211664). Materials and Methods: The prospective, multicenter, physician-initiated BIOLUX 4-EVER trial was conducted at 5 centers in Belgium and enrolled 120 patients (mean age 70.9±10.5 years; 79 men) with symptomatic stenotic or occluded de novo femoropopliteal lesions. A fifth of the patients had diabetes mellitus and nearly half had previous peripheral artery interventions. The lesions were a mean 83.3±49.5 mm long with a mean reference vessel diameter of 5.26±0.59 mm. Lesions were treated with a Passeo-18 Lux DCB followed by the implantation of a Pulsar-18 bare metal stent. Follow-up visits were conducted at 1, 6, 12, and 24 months postprocedure; the main outcome was primary patency at 12 months. Results: Technical success was obtained in all patients. Primary patency was observed in 89.9% of patients (95% CI 84.0% to 95.8%) at 12 months and in 83.5% at 24 months (95% CI 89.9% to 97.3%), and freedom from target lesion revascularization was 93.6% (95% CI 89.9% to 97.3%) and 86.1% (95% CI 79.9% to 92.3%), respectively. Ten patients died throughout the course of the trial (90.7% survival at 24 months), all of noncardiovascular causes. The ankle-brachial index improved from 0.68±0.09 at baseline to 0.93±0.11 and 0.93±0.12 at 12- and 24-month follow-up visits (p<0.001). An improvement of at least 1 Rutherford category was observed in 91 of 94 patients (96.8%) at 12 months and 78 of 83 patients (93.4%) at 24 months (p<0.001). Conclusion: The combination of a Passeo-18 Lux DCB followed by a Pulsar-18 stent implantation produced safe and effective outcomes in the treatment of femoropopliteal lesions at up to 24 months. Adding paclitaxel to the bare nitinol stent platform by predilating with a Passeo-18 Lux DCB seems to increase efficacy at 1 and 2 years compared with the use of bare metal stents only, which were investigated in the precursor 4-EVER study.

Six-Month Outcomes From the First-in-Human, Single-Arm SELUTION Sustained-Limus-Release Drug-Eluting Balloon Trial in Femoropopliteal Lesions

Purpose: To evaluate the safety and efficacy of the novel SELUTION sustained-limus-release (SLR) drug-eluting balloon (DEB) in the treatment of femoropopliteal lesions. Materials and Methods: Between October 2016 and May 2017, 50 subjects (mean age 69.6±10.4 years; 29 men) with symptomatic moderate to severe lower limb ischemia (Rutherford categories 2 or 3) were enrolled at 4 German centers for the SELUTION SLR first-in-human trial (ClinicalTrials.gov NCT02941224). The SELUTION SLR utilizes micro-reservoirs (biodegradable polymer spheres containing sirolimus) embedded within an amphipathic membrane coated onto an angioplasty balloon. The biodegradable reservoirs are transferred to the target vessel lumen during brief balloon inflation. The primary trial objective was comparison of angiographic late lumen loss at 6 months against an objective performance criterion (OPC) value of 1.04 mm for uncoated balloon angioplasty. Secondary endpoints included device, procedural, and clinical success; clinical and imaging assessments of primary patency and restenosis; functional assessments including Rutherford category and ankle-brachial index (ABI); and major adverse events [composite of cardiovascular mortality, index limb amputation, target limb thrombosis, and clinically-driven target lesion revascularization (CD-TLR)]. Results: At 6 months, median angiographic late lumen loss following SELUTION SLR treatment was 0.19 mm (range −1.16 to 3.07). Mean angiographic late lumen loss (n=34) was 0.29±0.84 mm (95% CI −0.01 to 0.58), significantly lower than the 1.04-mm OPC value (p<0.001). The rate of primary patency by duplex ultrasound was 88.4%, and freedom from angiographic binary restenosis was 91.2%. Through 6 months, there was significant improvement over baseline in Rutherford categories (p<0.001) and in ABI measurements (p<0.001). A single case (2%) of CD-TLR occurred at 5 months. There were no other major adverse events. Conclusion: Through 6 months, the SELUTION SLR DEB appears to inhibit restenosis effectively and safely, improving outcomes in subjects with symptomatic femoropopliteal disease.

A Single-Center Experience of Paclitaxel in the Treatment of Femoropopliteal Disease-No Evidence for an Association With Mortality.

Paclitaxel-coated devices have been increasingly used in endovascular treatment of femoropopliteal disease as they limit recurrence of lesions and improve patient outcomes. However, a recent meta-analysis reported that these devices increase mortality risk at 2 years post-intervention but did not account for confounding variables. Therefore, our goal was to evaluate mortality after paclitaxel treatment of femoropopliteal disease using patient-level data. We performed a retrospective review of all patients who received endovascular treatment for femoropopliteal lesions at our center between December 2009 and July 2017. There were 388 patients in the paclitaxel group and 314 control patients. Survival analysis with hazard ratios showed no difference between mortality in the paclitaxel and control groups. Age, renal insufficiency, and chronic limb-threatening ischemia were significant predictors of mortality. We also used logistic regression to evaluate mortality at 1, 2, and 5 years post-intervention and found no difference between the paclitaxel and control groups at any time point, while age, renal insufficiency, and chronic limb-threatening ischemia at the time of intervention were all associated with the risk of death. Finally, we tallied the causes of death in our cohort and found no difference in the distribution of causes between groups. Our single-center, retrospective study provides no evidence of increased risk of death with paclitaxel treatment in femoropopliteal disease. Contrastingly, age, renal insufficiency, and chronic limb-threatening ischemia were the most important factors contributing to mortality and therefore should be included as potential confounders in future studies assessing mortality in femoropopliteal disease.

A Polymer-Free Paclitaxel-Eluting Stent Versus a Bare-Metal Stent for De Novo Femoropopliteal Lesions: The BATTLE Trial

ObjectivesThe primary objective of the BATTLE (Bare Metal Stent vs. Paclitaxel Eluting Stent in the Setting of Primary Stenting of Intermediate-Length Femoropopliteal Lesions) trial is to demonstrate the clinical superiority of the Zilver PTX stent over the Misago stent in the treatment of femoropopliteal lesions. BackgroundNo randomized studies have compared self-expanding paclitaxel-eluting stents with bare-metal stents in the treatment of femoropopliteal lesions. MethodsBATTLE is a multicenter randomized controlled trial in patients with symptomatic (Rutherford category 2 to 5) de novo lesions of the superficial femoral or proximal popliteal artery. The primary endpoint is freedom from in-stent restenosis (ISR) at 1 year, with restenosis defined as a peak systolic velocity index >2.4 at the target lesion. The Kaplan-Meier method was used to evaluate time-to-event data for freedom from ISR over the 2-year follow-up period. ResultsBetween March 2014 and August 2016, 186 patients were enrolled; 91 were assigned to the Misago arm and 90 to the Zilver PTX arm. Kaplan-Meier 1-year estimates of freedom from ISR were 88.6% for Misago and 91% for Zilver PTX (hazard ratio [HR]: 1.2; 95% confidence interval [CI]: 0.6 to 2.4; p = 0.64). Comparing Misago with Zilver PTX, 2-year estimates were 6.4% and 1.2% (HR: 7.3; 95% CI: 0.9 to 59.3; p = 0.0632) for mortality, 74.6% and 78.8% (HR: 1.2; 95% CI: 0.6 to 2.1; p = 0.62) for patency, and 14.4% and 12.4% (HR: 1.2; 95% CI: 0.5 to 2.8; p = 0.69) for target lesion revascularization. ConclusionsIn the treatment of symptomatic femoropopliteal lesions, the Zilver PTX stent failed to show superiority over the Misago stent in freedom from ISR at 1 year.

Drug-coated vs uncoated balloon angioplasty in the treatment of femoropopliteal arterial lesions

Background Inspite of immediate technical success, neointimal hyperplasia and restenosis remain the Achilles heel of endovascular interventions. Drug-coated balloons (DCBs) have shown promising outcomes regarding anti-restenotic efficacy in management of femoro-popliteal arterial lesions compared to uncoated balloon. Objectives To evaluate the efficacy of the paclitaxel-coated balloon versus uncoated balloon angioplasty in treatment of femoropopliteal lesions regarding primary patency and restenosis at 12 months. Patients and Methods Between Sept 2017 and Sept 2019, this prospective randomized study was performed at Menoufia University hospitals. Sixty patients suffering symptomatic lower limb ischemia (Rutherford category 3 to 5) were randomly assigned into group A (30 patients) that were treated by DCB angioplasty, and group B (30 patients) that were treated by uncoated balloon (UCB) angioplasty. The primary patency, mean diameter restenosis, and binary restenosis (≥50% diameter stenosis) of the treated lesions at 12 months were collected and analyzed. Results Baseline characteristics were comparable in both groups. The 12-month mean diameter restenosis was significantly lower in DCB group than UCB group (27.8±35.2% vs. 44.9±33.8% respectively, P Conclusions Treatment of symptomatic femoro-popliteal disease with paclitaxel coated balloon angioplasty is associated with superior anti-restenotic efficacy that provides a better primary patency rate compared to uncoated balloon angioplasty at 12 months.

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

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.

Effectiveness of the Pulsar-18 self-expanding stent with optional drug-coated balloon angioplasty in the treatment of femoropopliteal lesions - the BIOFLEX PEACE All-Comers Registry.

Background: Previous studies showed favorable results after treatment of femoropopliteal lesions with the Pulsar-18 self-expanding (SE) nitinol stent. The objective of this registry was to evaluate whether these results will be confirmed in a real-world setting with varying stenting strategies. Patients and methods: In this prospective, observational trial, 160 patients with 186 femoropopliteal lesions were treated with the Pulsar-18 SE nitinol stent at 9 German sites. Mean lesion length was 116±103mm, and 41.9% of the lesions were moderately or heavily calcified. Eighty lesions were concomitantly treated with drug-coated balloon (DCB). Main effectiveness outcome was primary patency at 12 months, and main safety outcome was freedom from the composite of device or procedure related death, major target limb amputation, and clinically driven target lesion revascularization (TLR) at 30 days and 6 months. Results: Kaplan-Meier estimate of primary patency was 89.1%, 67.3%, and 57.1% at 6, 12, and 24 months. Freedom from TLR was 95.5%, 91.4%, and 85.2% at 6, 12, and 24 months, respectively. Lesions, which were additionally treated with DCB (plus DCB-group), were longer (150 versus 82 mm on average, p <0.0001), and associated with lower primary patency estimates than those without DCB angioplasty (stent-only-group) (log-rank p=0.006). However, there was no difference in freedom from TLR between groups (log-rank p=0.542). Improvement by ≥1 Rutherford category was achieved in 84.8%, 81.0%, and 81.7% of patients at 6, 12, and 24 months, respectively. Walking distance and patient-reported pain improved persistently through 24 months (p <0.001). Hemodynamic improvement was achieved in 68.2%, 73.7%, and 70.7% of the patients at 6, 12, and 24 months, respectively. Conclusions: The Pulsar-18 self-expanding nitinol stent with optional drug-coated balloon angioplasty can be considered an efficacious and safe therapy option for endovascular treatment of femoropopliteal artery disease.

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

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.

Early results for the Chocolate Touch paclitaxel-coated PTA balloon catheter for the treatment of femoropopliteal lesions

Early results for the Chocolate Touch paclitaxel-coated PTA balloon catheter for the treatment of femoropopliteal lesions

Clinical Outcome of Drug-Eluting Balloon Endovascular Treatment for Femoropopliteal Lesions in Patients with Intermittent Claudication

Clinical Outcome of Drug-Eluting Balloon Endovascular Treatment for Femoropopliteal Lesions in Patients with Intermittent Claudication

Full Drug-Eluting Stent Jacket: Two-Year Results of a Single-Center Experience With Zilver PTX Stenting for Long Lesions in the Femoropopliteal Arteries

Purpose: To evaluate the 1- and 2-year patency and reintervention rates with the Zilver PTX drug-eluting stent (DES) in long complex femoropopliteal disease. Methods: A retrospective review was conducted of 89 consecutive patients (mean age 68.7±9.8 years; 86 men) with femoropopliteal occlusive disease (Rutherford category 2–6) treated with the Zilver PTX between December 2012 and December 2013. Mean lesion length for the entire cohort was 24.2±11.3 cm (median 24.0, range 4–48). The patient population was dichotomized into a short lesion (≤20 cm) group (n=41; mean lesion length 13.3±5.6 cm) and the full DES jacket (>20 cm) group (n=48; mean lesion length 33.0±6.5 cm). Primary endpoints were duplex-derived restenosis (peak systolic velocity ratio >2.5), clinically driven reintervention, and major amputation. Results: The incidence of restenosis was lower in the short lesion group at 1 year (19% vs 40% for the longer lesions, p=0.050) and 2 years (39% vs 54%, respectively; p=0.331). The short lesion group had significantly lower rates of reintervention at both 1 year (2% vs 21% in long lesions, p=0.009) and 2 years (12% vs 33%, p=0.019). Conclusion: Treatment of femoropopliteal lesions >20 cm with the Zilver PTX appears to be a clinically effective therapy for patients with symptomatic peripheral artery disease. However, there is an increase in restenosis and a need for reintervention that continues to progress up to 2 years.

Treatment of femoropopliteal lesions with the AngioSculpt scoring balloon - results from the Heidelberg PANTHER registry.

Treatment of calcified femoropopliteal lesions remains challenging, even in the era of drug-eluting balloon angioplasty. Lesion recoil and dissections after standard balloon angioplasty in calcific lesions often require subsequent stent implantation. Additionally, poor patency rates in calcified lesions despite the use of drug-eluting balloons may be due to the limited penetration depth of the antiproliferative drug in the presence of vascular calcium deposits. Therefore, preparation of calcified lesions with the AngioSculpt™ scoring balloon might be a valuable option either as a stand-alone treatment, followed by drug-eluting balloon angioplasty or prior to subsequent stent deployment. In this retrospective, single centre registry, 124 calcified femoropopliteal lesions were treated in 101 subsequent patients. All patients were treated with scoring balloon angioplasty, either alone, in combination with drug-eluting balloons, or prior to stent deployment. The primary outcome was safety and technical success during the index procedure as well as patency at six and 12 months, as evaluated by duplex sonography. Successful scoring was safely performed in all 124 lesions with the AngioSculpt™ balloon. Overall primary patency after 12 months was 81.2 %. Patency rates did not differ significantly between the three treatment strategies. Degree of calcification did not predict patency. Improved clinical outcomes (Rutherford-Becker class and ankle-brachial index) were also observed in the study cohort. Preparation with the AngioSculpt™ scoring balloon offers a safe and valuable treatment option for calcified femoropopliteal lesions.

Intravascular ultrasound assessment of the effect of laser energy on the arterial wall during the treatment of femoro-popliteal lesions: a CliRpath excimer laser system to enlarge lumen openings (CELLO) registry study

The CliRpath Excimer Laser System to Enlarge Lumen Openings (CELLO) registry included patients treated with modified excimer laser catheters for the endovascular treatment of peripheral artery disease affecting the superficial femoral artery (SFA) and proximal popliteal artery. The aim of this study was to assess, via intravascular ultrasound (IVUS) the dissections in the vessel wall following treatment with the laser catheters. IVUS grayscale images from the CELLO registry were systematically reviewed for dissections in the treated vessel segments by two investigators. Images from 33 patients; 66 pullbacks (1867 IVUS frames in 2 phases), were successfully matched frame-to-frame to evaluate identical segments of the treated vessels in the two phases; post-2 mm Turbo-Elite laser pilot channel creation and post Turbo-Booster laser atherectomy. Dissections were categorized as; (1) intimal, (2) medial, (3) intramural hematoma, and (4) adventitial according to the ACC Clinical Expert Consensus Document classification of dissections. An average of 57 frames was evaluated per pullback, giving a total of 3734 frames (1867 matched for pre-ablation (post channel creation) and post-ablation phases). Treatments with the modified Excimer laser catheters resulted in a significant increase in lumen area of 5.5 ± 3.2-mm2 (95% CI 4.3–6.8, p < 0.0001) and reduction in plaque plus media volume of −10.6 ± 36.0 mm3 (95% CI −25.8 to 4.6, p = 0.1619) whilst giving rise to mainly intramural hematoma formations post Turbo-Booster laser treatment in 55% of frames assessed and 24% medial dissections with less than 1% adventitial disruption. The Excimer laser based Turbo-Booster treatment of peripheral artery lesions resulted in significant plaque debulking and increased lumen diameter with negligible degree of adventitial layer injury.

Drug coated balloons in the superficial femoral artery.

Despite the progress in endovascular treatment of patients with peripheral arterial disease, restenosis remains the major drawback, especially in patients with femoropopliteal lesions. To reduce neointimal proliferation and subsequent restenosis the use of antiproliferative drug eluting devices was implemented in the endovascular treatment of femoropopliteal disease. Aiming to use the favorable effects of these antiproliferative agents and to reduce foreign body exposure in affected arteries, drug coated balloons (DCB) have been developed. Up to now, several randomized controlled trials have consistently demonstrated the superiority of DCB over uncoated balloon angioplasty in the treatment of femoropopliteal lesions. Similarly, DCB appear to have favorable effects on vessel patency in the treatment of femoropopliteal in-stent restenosis. However, there still is a need for further studies, especially addressing different lesion characteristics as well as the combinations of particular treatment modalities.

Angiographic and Clinical Outcomes After Treatment of Femoro-Popliteal Lesions with a Novel Paclitaxel-Matrix-Coated Balloon Catheter.

Based on a novel paclitaxel-resveratrol drug matrix, the safety and efficacy to inhibit intimal hyperplasia were studied in symptomatic claudicants with morphologically challenging lesions. The treatment of peripheral artery occlusive disease (PAOD) with percutaneous transluminal angioplasty is limited by occurrence of vessel recoil and neointimal hyperplasia. Drug-coated balloons (DCB) deliver drugs to the arterial wall to potentially reduce the restenosis rate. A number of paclitaxel-coated balloon technologies are available to treat peripheral lesions. In this randomized controlled trial, a total of 153 patients with symptomatic PAOD in femoro-popliteal lesions were randomized either to DCB or plain old balloon angioplasty (POBA). The mean lesion length was 13.2±10.4cm with target lesion total occlusions in 26.1% of all patients (40/153). The primary endpoint of in-lesion late lumen loss (LLL) at 6months was significantly reduced in the DCB group as compared to the POBA group (0.35mm CI [0.19; 0.79mm] vs. 0.72mm CI [0.68; 1.22mm], p=0.006). At 12months, the TLR rate in the DCB group was significantly lower as compared to the POBA group (17.8 vs. 37.7% p=0.008). The censored walking distance increase suggests a benefit for patients who underwent DCB angioplasty as compared to the standard POBA treatment (12months 165±105 vs. 94±136m, p=0.012). The use of paclitaxel-resveratrol-matrix-coated peripheral balloon angioplasty as compared to POBA was associated with significantly reduced in-lesion LLL and reduced TLR rates. ClinicalTrials.gov identifier NCT01970579.