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Having evolved at a rapid pace, the therapy options for percutaneous treatment of peripheral arterial disease in the lower limbs, especially percutaneous transluminal angioplasty in combination with stent-technology, are able to deliver a rate where at least 80% of the treated patients remain free from reintervention after the first years under ideal study conditions, meaning that defined and often restrict in- and exclusion criteria were fulfilled and mid-term dual platelet therapy is warranted. This is somewhat a huge leap when compared to the 50-60% in the 1980s and 1990s, but we now face an era of an increasingly demanding clientele, where the industry also strives to cover this final 20% with newer technologies. As recent studies with drug-eluting stents (DES) suggests, nowadays it is possible to achieve up to 90% patency in the short- and mid-term, but this comes accompanied by remarkably increased therapy costs, making it almost impossible to most centers to implant it as the standard therapy option. Trying to fill this gap between the low-patency of the plain old balloon angioplasty and the higher costs of the DES, drug-coated balloon technology has found its niche, knowing that reimbursement shows a broad variation across the countries and continents.

The purpose of this study was to evaluate the safety and efficacy of debris-capture for distal protection using the FilterWire EZ Embolic Protection System (Boston Scientific, Mountain View, CA) with the additional aim to further define the incidence of distal embolization during superficial femoral artery (SFA) interventions. A prospective, single-centre registry was designed to evaluate the performance of the FilterWire EZ in capturing debris during standard SFA percutaneous intervention. The PRO-RATA study included 30 patients suitable for PTA (Fontaine IIb to III or Rutherford I to II classification). The primary end points were occurrence of distal embolization or decreased runoff, improvement in ankle-brachial index ankle-brachial index (ABI) after the procedure, and number of filters containing emboli. Secondary end points included major adverse events (i.e., procedure- or device-related death and/or clinical target lesion revascularisation), device delivery, deployment success, and incidence of embolic recovery (patients with device success exhibiting embolic protection in the filter). Procedural success was determined as ≤30% residual stenosis with no worsening of distal runoff as determined on angiography. A total of 29 patients (age 66.2 ± 12 years; total no. of limbs = 30; total no. of lesions = 30) suitable for PTA were enrolled in the study between February 2007 and March 2008. There were 26 patients with claudication (Fontaine IIB) and 3 patients with stage IV peripheral vascular disease. In one patient, lesions in both legs were treated. No procedural or device-related complications occurred. The average degree of stenosis was 86 ± 7%. Stenosis length ranged from 8 to 88 mm. The average degree of residual stenosis was 10 ± 10%. ABI improved from 0.56 ± 0.16 to 0.92 ± 0.19 (P < 0.05). No restenosis or dissection was seen at 1-month ultrasound follow-up. Macroscopic debris was found in 27 of 30 filters of all distal protection devices used in all 29 patients. Debris particle size ranged from 90 to 2000 μm (1200 ± 640). Histological debris analysis showed platelets, erythrocytes, inflammatory cells, extracellular matrix, and cholesterol as being the major components of emboli. Additional immunochemistry showed no correlation between lesion morphology and debris components. The FilterWire EZ is easy and safe to handle. The system caused no complications. In all cases, macroscopic debris was captured. Using a distal protection device during femoropopliteal interventions has the potential to prevent migration of debris, which may be important for high-risk patients with limited distal runoff.

Purpose: To evaluate the long-term efficacy and integrity of the PROTEGE EverFlex stent in superficial femoral artery (SFA) lesions in symptomatic patients with peripheral artery disease (PAD)., Methods: A prospective, multicenter, nonrandomized study enrolled 151 subjects (111 men; mean age 67.8 years, range 42-93) undergoing percutaneous treatment of de novo, restenotic, or reoccluded SFA lesions between August 11, 2006, and June 26, 2007. Subjects were scheduled to receive a single stent and be evaluated through 12 months following the implant procedure. Occlusions were present in 40% of the patients. Mean lesion length was 96.4 mm (range 10-150)., Results: A total of 161 stents (158 EverFlex) were implanted in the 151 patients: single stents in 93.4% (141/151) and a second stent in 6.6% (10/151). One-year follow-up information was available for 88.7% (134/151) of the study participants; of the remaining 17 subjects, 6 subjects withdrew from the study, 2 were lost to follow-up, and 9 died. Freedom from restenosis data were available for 99.3% (133/134) of the subjects who completed a 12-month follow-up visit. The mean Rutherford classification fell from 2.8+/-0.8 (range 1-5) at baseline to 0.6+/-1.1 (range 0-5) at 12 months. The mean ankle-brachial index rose from 0.6+/-0.2 (range 0-1.4) at baseline to 0.9+/-0.2 (range 0-1.2) at 12 months. The rates for freedom from >50% restenosis at 6 and 12 months were 91.3% (95% CI 84.9% to 95.2%) and 72.2% (95% CI 63.8% to 79.6%), respectively. The freedom from target lesion revascularization rate at 12 months was 79.1% (95% CI 71.2% to 85.6%). The 1-year stent fracture rate was 8.1% (95% CI 4.0% to 14.4%)., Conclusion: The high freedom from >50% restenosis and low fracture rate at 12 months suggests that the PROTEGE EverFlex stent offers a safe and acceptably efficacious means of treating SFA lesions in symptomatic subjects with PAD.

Distal embolization following percutaneous intervention is a universal phenomenon that has been reported in various vascular beds. Distal emboli are also very common during lower extremity percutaneous peripheral interventions. Some data from case reports and registries are currently available. Clinical data have shown that the application of an embolic protection device in the lower limb arteries is safe. Prospective and, ideally, randomized trial data are warranted to justify the increased use of filters in lower extremity interventions, despite the obvious benefits that these devices provide. However, the clinical relevance of distal embolization in the lower extremity remains unquantified.

Various devices have been introduced for the purpose of percutaneous mechanical thrombectomy (PMT). These devices show promise as a valuable treatment option in acute arterial thrombotic occlusions, in addition to the gold-standard surgical method, the Fogarty balloon embolectomy, and local fibrinolysis therapy. Local fibrinolytic therapy cannot be used in the presence of contraindications, and can be time-consuming in limb threatening situations. Surgical intervention can also result in intimal vessel wall injury and is of limited value in infrageniculate occlusions. In this review, currently available PMT devices for peripheral arterial applications will be introduced, and their advantages, drawbacks and finally the reported clinical experience with these devices will be presented., (Copyright 2003 Elsevier Inc. All rights reserved.)

Purpose: To report on a prospective two-center study to evaluate safety and effectiveness of a self-expanding nitinol coil stent in patients with femoropopliteal obstructive disease., Materials and Methods: The IntraCoil nitinol stent was used in 37 patients (28 men and nine women; mean age, 62.4 y plus minus 10.7; range, 43-81 y) presenting with high-grade stenoses (n = 23) or short (<3 cm) occlusions (n = 17) of the superficial femoral artery (SFA; n = 33) or popliteal artery (n = 4). Indications for stent placement were significant residual stenosis (>30%) or dissection after angioplasty. Follow-up evaluations with measurement of the Doppler ankle-brachial index (ABI), assessment of Rutherford clinical stage, and color-coded duplex sonography were performed at discharge and 1, 3, 6, 12, and 18 months thereafter. Primary endpoints of the study were immediate technical and clinical success and 1-year patency., Results: Initial technical success was achieved in all patients. In 10 patients (27%), more than one 40-mm-long device had to be implanted for total lesion coverage; in three patients (8.1%), stents were placed in two separate segments of the SFA simultaneously. The total number of stents deployed was 50. Stent placement induced an initial improvement of the ABI from 0.54 plus minus 0.2 to 0.92 plus minus 0.11 (P <.01). Follow-up data for 12 months after treatment are available for 29 of 37 patients (78.4%); mean follow-up is 15.6 months (range, 1-26 mo). Primary patency rates at 6 and 12 months were 97.1% (SE = 2.9) and 86.2% (SE = 6.5). The primary assisted patency rate was 100% at 12 months., Conclusion: Endovascular placement of the IntraCoil self-expanding nitinol coil stent for salvage of failed angioplasty in patients with femoropopliteal obstructive disease is an effective and safe procedure with promising mid-term results.

Purpose: To assess the current use of drug-eluting devices for peripheral arterial disease (PAD) among interventional radiologists following the controversy caused by the 2018 meta-analysis suggesting an increased mortality risk for paclitaxel-eluting devices. Methods: An anonymous survey was sent to 7035 CIRSE members via email; only complete responses were included and statistically analysed. Results: Three hundred and seven members (4.4%) completed the survey. Among these, 95.8% indicated that they personally perform peripheral vascular procedures. Thirty-eight percentage of respondents did not see any change of practice since 2018, while 47% reported that the use of drug-eluting devices decreased; for 13%, the use stopped altogether, while it increased in 3% of responses. 45.6% of respondents also felt the impact of the controversy in terms of pricing, availability or directives from hospital administration. A large majority of respondents (83.7%) who perform peripheral vascular procedures consider the use of these devices as safe, 12.9% were undecided and 3.4% did not consider them as safe. Among the respondents who do not perform endovascular procedures, 77% considered these devices as safe and 23% were undecided. Conclusion: Although the 2018 meta-analysis had a disruptive impact on the use of drug-eluting devices in PAD, with the increasing body of evidence available, a majority of respondents continue to believe in the safety of these devices for use in femoropopliteal disease. [ABSTRACT FROM AUTHOR]

The efficacy of Paclitaxel DCB (drug-coated balloons) and DES (drug-eluting stents) has been proven in several well-regarded landmark trials [[1]-[3]]. 8 Soga Y, fujihara m, tomoi y, iida o, ishihara t, kawasaki d, ando k. one-year late lumen loss between a polymer-coated paclitaxel-Eluting stent (Eluvia) and a polymer-free paclitaxel-coated stent (zilver ptx) for femoropopliteal disease. Update: treatment of peripheral arterial disease with paclitaxel-coated balloons and paclitaxel-eluting stents potentially associated with increased mortality: letter to health care providers. https://www.fda.gov/medical-devices/letters-health-care-providers/update-treatment-peripheral-arterial-disease-paclitaxel-coated-balloons-and-paclitaxel-eluting. On the Basis of Their Published Efficacy. [Extracted from the article]

Paclitaxel-coated balloon angioplasty has been established as the first-line therapy for femoropopliteal artery disease. The primary objectives of the study were to evaluate the performance and the safety of the GORE-DCB Catheter in the treatment of atherosclerotic femoropopliteal lesions in patients with peripheral artery disease for CE-Mark approval. Prospective, single-arm, multicenter study with 24 months follow-up. The GORE-DCB Catheter consists of a drug-coated nylon (inner layer)/ePTFE (outer layer) composite balloon. The ePTFE layer is coated with paclitaxel (concentration: 3.5 μg/mm2) and the excipient stearic acid/tromethamine (tris). The primary endpoints were 6-month late lumen loss (LLL) and 30-day of freedom from Major Adverse Events (MAE). Fifty-two subjects were enrolled, 69% men, median age 69 (49–83) years. Acute device success was 100%, the 30-day MAE rate was zero. Study primary endpoint of LLL (−0.17 mm) showed significant superiority compared to the performance goal of uncoated PTA balloon catheters from literature. At 1 and 2 years, primary patency rates were 81.8% and 68.7%, respectively, and freedom from clinically driven target lesion revascularization rates was 87.9% and 83.4%, respectively. The study demonstrates that the treatment of lesions in femoropopliteal arteries with the GORE-DCB Catheter is safe and effective. [ABSTRACT FROM AUTHOR]

This document is a correction notice for an article titled "The Current Use of Drug-Eluting Balloons and Stents in Peripheral Arterial Disease: An Online Survey by the Cardiovascular and Interventional Radiological Society of Europe (CIRSE)." The original article was published without a visual abstract, and this correction includes the addition of the abstract. The authors of the article are Robert A. Morgan, Stefan Müller-Hülsbeck, Fabrizio Fanelli, Patrick Haage, Mohamad Hamady, Romaric Loffroy, Gerard O'Sullivan, Florian Wolf, and Birgit Slijepčević. The publisher, Springer Nature, remains neutral regarding jurisdictional claims and institutional affiliations. [Extracted from the article]

Purpose: The purpose of the study is to report 24-month efficacy and safety results for the Japanese patient cohort in a prospective randomized controlled trial (RCT) of drug-eluting stent (DES) use for peripheral artery disease.Materials and Methods: Patients in the global IMPERIAL RCT had femoropopliteal lesions treated with either the Eluvia DES (Boston Scientific, Marlborough, MA, USA) or the Zilver PTX drug-coated stent (Cook Medical, Bloomington, IN, USA). At 24 months, assessments included duplex ultrasound imaging for core laboratory vessel patency measurement, target lesion revascularization (TLR) rates, and clinical outcome measures.Results: The Japanese cohort included 84 patients (56 treated with Eluvia and 28 with Zilver PTX). The clinically driven TLR rates were 5.6% (3/54) and 18.5% (5/27) for patients treated with Eluvia and Zilver PTX, respectively (difference -13.0%, 95%CI -28.8, 2.9%; p = 0.11). The Kaplan-Meier estimates for freedom from clinically driven TLR at 24 months were 94.3% for patients who received Eluvia and 80.4% for those who received Zilver PTX (log rank p = 0.05), and for primary patency they were 88.5% and 80.4%, respectively (log rank p = 0.28). Mortality rates were 5.6% (3/54) and 11.1% (3/27); p = 0.39. Rutherford classification improved by at least one category without TLR for 91.8% (45/49) and 68.2% (15/22) of patients (p = 0.03). Walking impairment score improvements were sustained over time.Conclusion: The results at 24 months support the efficacy and safety of DES in Japanese patients, with sustained clinical improvements and numerically fewer reinterventions for those treated with Eluvia.Clinical Trial Registration: Clinicaltrials.gov identifier NCT02574481. https://clinicaltrials.gov/ct2/show/NCT02574481 LEVEL OF EVIDENCE: EBM Level III; cohort analysis of randomized trial. [ABSTRACT FROM AUTHOR]

Purpose: To report the clinical effect of a drug-eluting stent on femoropopliteal occlusive disease in patients with long lesions. Materials and Methods: The global IMPERIAL Long Lesion substudy (ClinicalTrials.gov identifier NCT02574481) is a prospective, single-arm, multicenter trial of the Eluvia Drug-Eluting Vascular Stent for treating femoropopliteal lesions >140 mm and ≤190 mm in length. Fifty patients (mean age 68.2 years; 32 men) with long lesions (mean length 162.8±34.7 mm) were enrolled; 20 patients had diabetes. Fourteen of the lesions were severely calcified and 16 were occluded. Primary patency (duplex ultrasound peak systolic velocity ratio ≤2.4 in the absence of clinically-driven target lesion revascularization or bypass of the target lesion) and major adverse events [30-day all-cause death and 1-year target limb major amputation or target lesion revascularization (TLR)] were assessed at 12 months. Results: At 12 months, no deaths, target limb amputations, or stent thrombosis had occurred. The Kaplan-Meier estimate of primary patency was 91.0% (95% CI 82.5% to 99.6%). The MAE-free rate at 12 months was 93.5% due to 3 clinically-driven TLRs. The corresponding Kaplan-Meier estimate of freedom from TLR was 93.9% (95% CI 87.2% to 100%). Conclusion: The IMPERIAL Long Lesion substudy demonstrated excellent patency and safety through 1 year among patients with long femoropopliteal occlusive disease treated with the Eluvia stent. [ABSTRACT FROM AUTHOR]

Purpose: The purpose of the study is to report 12-month efficacy and safety results from the subgroup of Japanese patients in the prospective IMPERIAL 2:1 randomized controlled trial (RCT).Methods: The global IMPERIAL RCT was designed to compare performance of the Eluvia Drug-Eluting Vascular Stent System (Boston Scientific, Marlborough, MA, USA) with the Zilver PTX Drug-Eluting Peripheral Stent (Cook Medical, Bloomington, IN, USA) for treatment of femoropopliteal artery lesions. Patients with symptomatic (Rutherford category 2-4) disease were included. Post-procedural technical success was defined as delivery and deployment of the assigned study stent to the target lesion to achieve residual angiographic stenosis no greater than 30% by visual assessment. Twelve-month assessments included primary patency (core laboratory-assessed duplex ultrasound peak systolic velocity ratio ≤ 2.4 in the absence of clinically driven TLR or bypass of the target lesion) and major adverse events (MAEs).Results: Fifty-six patients in the Eluvia group and 28 in the Zilver PTX group were treated at Japanese centers. Mean lesion length was 91.8 ± 38.0 mm for Eluvia and 87.4 ± 41.7 mm for Zilver PTX. Technical success was 100% for both groups. At 12 months, the observed primary patency rate was 90.9% for Eluvia and 84.6% for Zilver PTX. The 12-month MAE rate was 1.8% for Eluvia and 7.7% for Zilver PTX. All MAEs were clinically driven TLRs.Conclusion: The results show excellent vessel patency and a good safety profile up to 1 year in the subgroup of Japanese patients in IMPERIAL treated with Eluvia for femoropopliteal artery disease.Level Of Evidence: Level 3; subgroup analysis of randomized trial.Clinical Trial Registration: ClinicalTrials.gov, identifier NCT02574481. [ABSTRACT FROM AUTHOR]

Purpose: The previously reported 6-month angiographic and 12-month clinical outcomes of the CONSEQUENT trial demonstrated the safety and efficacy of a novel paclitaxel-resveratrol-coated balloon for the treatment of lesions in the femoropopliteal segment. The purpose of this report is to present the 2-year results including a cost-benefit analysis for Germany.Materials and Methods: Patients with symptomatic peripheral artery occlusive disease in femoropopliteal lesions were randomized either to drug-coated balloon (DCB, n = 78) or plain old balloon angioplasty (POBA, n = 75). As secondary endpoints, the 2-year clinical results consisting of target lesion revascularization (TLR), patency and increase in walking distance were recorded. Based on the Kaplan-Meier analyses for TLR and other adverse events, a cost-benefit analysis was conducted for the German DRG system.Results: There were no additional TLRs in both groups between 14 and 24 months so that the corresponding rates remained significantly different between the treatment groups (DCB: 19.1 vs. POBA 40.6%, p = 0.007). At 2 years, the patency rate was significantly higher in the DCB group (72.3 vs. 48.4%, p = 0.006). The walking distance increase was also significantly higher after DCB angioplasty (172 ± 103 vs. 52 ± 136 m, p = 0.001). We estimated 2-year cost savings of € 1111.97 per patient treated with DCB instead of POBA.Conclusions: The use of paclitaxel-resveratrol matrix-coated peripheral balloons compared to POBA was associated with a significantly reduced TLR rate, superior patency and substantial cost savings at 2 years. ClinicalTrials.gov Identifier NCT01970579. [ABSTRACT FROM AUTHOR]

Purpose: To report the 12-month results of the MAJESTIC clinical study of the self-expanding Eluvia paclitaxel-eluting stent in the treatment of femoropopliteal lesions.Methods: The prospective, single-arm, multicenter trial (clinicaltrials.gov identifier NCT01820637) enrolled 57 patients (mean age 69±9 years; 47 men) with chronic lower limb ischemia referable to de novo or restenotic lesions in the native superficial femoral and/or proximal popliteal arteries. A third of the patients had diabetes. Mean lesion length was 70.8±28.1 mm, and diameter stenosis was 86.3%±16.2%; 26 (46%) lesions were occluded. Primary patency was defined as duplex ultrasound peak systolic velocity ratio ≤2.5 and the absence of target lesion revascularization (TLR) or bypass. Major adverse events (MAEs) included all-cause death through 1 month and target limb major amputation and TLR through 12 months.Results: All 57 patients had a single Eluvia stent implanted, employing pre- and postdilation in 93% (53/57) and 95% (54/57) of cases, respectively. Technical success was 97% (55/57; 2 failures due to residual stenosis >30%). At 12 months, primary patency was 96% (49/51) and the MAE rate was 4% (2/53); both MAEs were TLRs. No stent fractures were identified. There were no major amputations. One death occurred 368 days postprocedure, unrelated to the device or procedure. Improvements in the Rutherford category were sustained through 1 year, with 81% (43/53) exhibiting no symptoms (category 0) and 13% (7/53) presenting with mild claudication (category 1). Mean ABI improved from 0.73±0.22 at baseline to 1.02±0.20 at 12 months.Conclusion: MAJESTIC results showed that patients whose femoropopliteal arteries were treated with the Eluvia drug-eluting stent sustained high patency and low MAE rates through 12 months. [ABSTRACT FROM AUTHOR]

Purpose: To report a subanalysis of the German centers enrolling patients in the prospective, global, multicenter, randomized LEVANT 2 pivotal trial (ClinicalTrials.gov identifier NCT01412541) of the Lutonix drug-coated balloon (DCB) for the treatment of femoropopliteal occlusive disease.Methods: Among the 476 patients in LEVANT 2, 126 patients (mean age 67.1±9.6 years; 79 men) were enrolled at the 8 participating German sites between August 2011 and July 2012 and were randomized 2:1 to treatment with the Lutonix DCB (n=83) vs an uncoated balloon during percutaneous transluminal angioplasty (PTA, n=43). All patients had intermittent claudication or rest pain (Rutherford categories 2-4). Average lesion length was 58 mm and average treated length was 100 mm. Severe calcification was present in 11% of lesions, and 23% were total occlusions. The efficacy outcome was primary patency at 12 months, and the safety outcome was 12-month freedom from a composite of perioperative death, index limb-related death, amputation (below or above the ankle), and index limb revascularization. Secondary endpoints included target lesion revascularization (TLR), major adverse events, and functional outcomes.Results: Demographic, clinical, and lesion characteristics were matched between Lutonix DCB and PTA groups, as were the final percent diameter stenosis (19%) and procedure success (91%). By Kaplan-Meier analysis, the 12-month primary patency rate was 80% vs 58% (p=0.015) and the composite safety endpoint rate was 94% vs 72% (p=0.001), respectively. Freedom from TLR was higher for DCBs (96%) vs PTA (82%, p=0.012). Major adverse events were similar for both groups. The benefit favoring DCB over PTA was observed in German men and women. Compared to the non-German LEVANT 2 cohort, there was a shorter time between insertion and inflation of treatment balloons (21.8 vs 39.5 seconds, p<0.001) in the German cohort. Balloons were inflated to higher pressures (9.0 vs 7.7 atm, p<0.001) but for a shorter period of time (130 vs 167 seconds, p<0.001), and although treated lesions in the German cohort had a higher baseline stenosis, final postprocedure diameter stenosis was lower (19% vs 22%, p=0.04) than in the non-German patients.Conclusion: Superiority of DCB over PTA in the German cohort of LEVANT 2 was demonstrated for primary patency, composite safety, and freedom from TLR. The benefit of DCB was also consistent for both genders. Geographic or regional differences in procedural variables may account for the different outcomes between the German and non-German cohorts. [ABSTRACT FROM AUTHOR]

PURPOSE: To report a prospective study to evaluate safety, effectiveness, and midterm patency of self-expanding stent-grafts in patients with femoropopliteal occlusive disease. MATERIALS AND METHODS: Sixty-three Hemobahn stent-grafts were used in 52 patients for treatment of mediumor long-segment (>3 cm) occlusions (82.7%) and stenoses (17.3%) of the femoropopliteal artery. The mean length of vessel segments covered was 10.9 cm ± 5.13. Follow-up with documentation of clinical symptoms, assessment of Rutherford clinical stage of peripheral vascular disease, and color-coded duplex sonography was performed at discharge, at 1, 3, 6, 12, 18, and 24 months after implantation, and yearly thereafter. Mean follow-up duration was 23.8 months ± 6.9 (range, 8–36 mo). Follow-up data at 12 and 24 months after treatment were available for 47 of 52 (90.4%) and 31 of 52 patients (59.6%), respectively. RESULTS: Device implantation was technically successful in all 52 patients, yielding an overall technical success rate of 100%. Procedure-related complications were observed in 12 of 52 patients (23.1%) and consisted of distal embolization (n = 4, 7.7%), minor groin hematoma (n = 7, 13.5%), and arteriovenous fistula (n = 1, 1.9%), but prolonged hospitalization and further medical, interventional, or surgical measures were not required. Stent-graft placement induced an initial improvement of the mean resting ankle-brachial index from 0.54 ± 0.12 to 0.89 ± 0.14 (P < .01). Primary patency rates at 12 and 24 months were 78.4% ± 5.8 and 74.1% ± 6.2, respectively. Primary assisted patency rates were 82.4% ± 5.3 at 12 months and 80.3% ± 5.6 at 24 months. Secondary patency rates at 12 and 24 months were 88.3% ± 4.5 and 83.2% ± 5.5, respectively. There was no significant difference (log-rank test, P >.3) between primary patency rates in patients grouped according to lengths of implanted grafts (ie, length of the treated lesions). CONCLUSION: Endovascular placement of Hemobahn stent-grafts for percutaneous treatment of medium-to long-segment high-grade stenoses and occlusions of the femoropopliteal artery is a safe procedure with excellent initial success rates and promising midterm results. [Copyright &y& Elsevier]

Background: The purpose of this survey was to determine the current trends in endovascular practice by Interventional Radiologists (IR's) across Europe and to understand the engagement by Interventional Radiology (IR) with clinical practice. CIRSE European members were invited to participate in an online survey between July 11th, 2016 and August 8th, 2016. A 54 question survey was created to capture a comprehensive overview of IR endovascular practice and clinical engagement. Results: Four hundred and five valid responses were received (9.9%) from a broad geographic distribution from across Europe. 76% of IR's practised in centres with more than 400 beds as 60% worked in an academic or university teaching hospital. 36% dedicated 80–100% of their time to IR and 59% dedicated at least 60% of their time to IR. 24/7 IR on-call was available in the hospitals of 73% or respondents. 78% had dedicated IR nursing staff and 67% had nursing support on-call, 55% had inpatient admission privileges and 27% had dedicated IR inpatient beds. 65% of IR's had admitting rights to day-case beds. 42% ran IR outpatient clinics and 36% performed ward rounds. 81% of respondents performed peripheral arterial disease (PAD) intervention and IR was the main provider of PAD intervention in 67% of centres. Vascular Surgery or Medicine were the main referrers (71%) to IR for PAD intervention. 37% of centres had a hybrid operating theatre and 80% of IR's had access to this. Conclusion: IR remains a substantial player in the field of PAD Intervention. The continued evolution of outpatient clinics and clinical practice is key to retention and future expansion in the field of endovascular therapy for PAD. [ABSTRACT FROM AUTHOR]

Background: The clinical effect of a drug-eluting stent in the femoropopliteal segment has not been investigated in a randomised trial with a contemporary comparator. The IMPERIAL study sought to compare the safety and efficacy of the polymer-coated, paclitaxel-eluting Eluvia stent with the polymer-free, paclitaxel-coated Zilver PTX stent for treatment of femoropopliteal artery segment lesions.Methods: In this randomised, single-blind, non-inferiority study, patients with symptomatic lower-limb ischaemia manifesting as claudication (Rutherford category 2, 3, or 4) with atherosclerotic lesions in the native superficial femoral artery or proximal popliteal artery were enrolled at 65 centres in Austria, Belgium, Canada, Germany, Japan, New Zealand, and the USA. Patients were randomly assigned (2:1) with a site-specific, web-based randomisation schedule to receive treatment with Eluvia or Zilver PTX. All patients, site personnel, and investigators were masked to treatment assignment until all patients had completed 12 months of follow-up. The primary efficacy endpoint was primary patency (defined as a peak systolic velocity ratio ≤2·4, without clinically driven target lesion revascularisation or bypass of the target lesion) and the primary safety endpoint was major adverse events (ie, all causes of death through 1 month, major amputation of target limb through 12 months, and target lesion revascularisation through 12 months). We set a non-inferiority margin of -10% at 12 months. Primary non-inferiority analyses were done when the minimum sample size required for adequate statistical power had completed 12 months of follow-up. The primary safety non-inferiority analysis included all patients who had completed 12 months of follow-up or had a major adverse event through 12 months. This trial is registered with ClinicalTrials.gov, number NCT02574481.Findings: Between Dec 2, 2015, and Feb 15, 2017, 465 patients were randomly assigned to Eluvia (n=309) or to Zilver PTX (n=156). Non-inferiority was shown for both efficacy and safety endpoints at 12 months: primary patency was 86·8% (231/266) in the Eluvia group and 81·5% (106/130) in the Zilver PTX group (difference 5·3% [one-sided lower bound of 95% CI -0·66]; p<0·0001). 259 (94·9%) of 273 patients in the Eluvia group and 121 (91·0%) of 133 patients in the Zilver PTX group had not had a major adverse event at 12 months (difference 3·9% [one-sided lower bound of 95% CI -0·46]; p<0.0001). No deaths were reported in either group. One patient in the Eluvia group had a major amputation and 13 patients in each group required target lesion revascularisation.Interpretation: The Eluvia stent was non-inferior to the Zilver PTX stent in terms of primary patency and major adverse events at 12 months after treatment of patients for femoropopliteal peripheral artery disease.Funding: Boston Scientific. [ABSTRACT FROM AUTHOR]

Background—Stenting has been shown to improve patency after femoral artery revascularization compared with balloon angioplasty. Limited data are available evaluating endovascular treatment for obstructive lesions of the popliteal artery. Methods and Results—This prospective, randomized, multicenter trial compared primary nitinol stent placement to percutaneous transluminal balloon angioplasty in patients with peripheral artery disease Rutherford-Becker class 2 to 5 who had a de novo lesion in the popliteal artery. The primary study end point was 1-year primary patency, defined as freedom from target-lesion restenosis (luminal narrowing of ≥50%) as detected by duplex ultrasound. Secondary end points included target-lesion revascularization rate and changes in Rutherford-Becker class. Provisional stent placement was considered target-lesion revascularization and loss of primary patency. Two hundred forty-six patients were included in this trial. The mean target-lesion length was 42.3 mm. One hundred ninety-seven patients were available for the 1-year follow-up. The 1-year primary patency rate was significantly higher in the group with primary nitinol stent placement (67.4%) than in the percutaneous transluminal balloon angioplasty group (44.9%, P=0.002). Target- lesion revascularization rates were 14.7% and 44.1%, respectively (P=0.0001); however, when provisional nitinol stent placement was not considered target-lesion revascularization and loss in patency, no significant differences prevailed between the study groups (67.4% versus 65.7%, P=0.92 for primary patency). Approximately 73% of patients in the percutaneous transluminal balloon angioplasty group and 77% in the nitinol stent group showed an improvement of ≥1 Rutherford-Becker class (P=0.31). Conclusions—Primary nitinol stent placement for obstructive lesions of the popliteal artery achieves superior acute technical success and higher 1-year primary patency only if provisional stenting is considered target-lesion revascularization. Provisional stenting as part of a percutaneous transluminal balloon angioplasty strategy has equivalent 1-year patency and should be preferred over primary stenting. Clinical Trial Registration—URL: http://www.clinicaltrials.gov. Unique identifier: NCT00712309. [ABSTRACT FROM AUTHOR]