Treatment Of Femoropopliteal Disease Research Articles

Comparison of Outcomes for the Percutaneous Atherectomy Versus Balloon Angioplasty and/or Stenting in the Treatment of Femoropopliteal Disease: Based on the KSVS DAMOEUM Registry

Comparison of Outcomes for the Percutaneous Atherectomy Versus Balloon Angioplasty and/or Stenting in the Treatment of Femoropopliteal Disease: Based on the KSVS DAMOEUM Registry

Effects of atherectomy on major adverse limb events for femoropopliteal interventions: Vascular Quality Initiative registry.

Atherectomy use in treatment of femoropopliteal disease has significantly increased despite scant evidence of benefit to long-term clinical outcomes. We investigated the clinical benefits of atherectomy over standard treatment for femoropopliteal interventions. Using data from the Society of Vascular Surgery's Vascular Quality Initiative (VQI) registry, we identified patients who underwent isolated femoropopliteal interventions for occlusive disease. We compared 13,423 patients treated with atherectomy with 47,371 receiving standard treatment; both groups were allowed definitive treatment with a drug-coated balloon or stenting. The primary endpoint was major adverse limb events (MALEs), which is a composite of target vessel re-occlusion, ipsilateral major amputation, and target vessel revascularization. Mean age was 69 ± 11 years, and patients were followed for a median of 30 months. Overall rates of complications were slightly higher in the atherectomy group than the standard treatment group (6.2% vs. 5.9%, p < 0.0001). In multivariable analysis, after adjusting for demographic and clinical covariates, atherectomy use was associated with a 13% reduction in risk of MALEs (adjusted odds ratio [aOR]: 0.87; 95% confidence interval [CI]: 0.77-0.98). Rates of major and minor amputations were significantly lower in the atherectomy group (3.2% vs. 4.6% and 3.3% vs. 4.3%, respectively, both p < 0.001), primarily driven by a significantly decreased risk of major amputations (aOR 0.69; 95% CI: 0.52-0.91). There were no differences in 30-day mortality, primary patency, and target vessel revascularization between the atherectomy and standard treatment groups. In adults undergoing femoropopliteal interventions, the use of atherectomy was associated with a reduction in MALEs compared with standard treatment.

Self-expanding interwoven nitinol stent in severe femoropopliteal arterial disease. Real life results of the Supera Peripheral Stent System®

Purpose The excellent performance of the Supera Peripheral Stent System ® by Abbott Vascular in femoropopliteal interventions has already been proven through several trials. This retrospective study aims to evaluate the durability and long-term patency of the Supera stent for the treatment of severe femoropopliteal lesions in a real-world population. Methods A retrospective analysis was conducted of 136 consecutive limbs from 128 patients with atherosclerotic disease in the femoropopliteal region, treated with Supera stents between September 2010 and September 2017. As primary endpoints patency rates and freedom from target lesion revascularization (TLR) were calculated and presented using Kaplan-Meier analysis. Results Fifty-five percent were treated for claudication (IC), 45% for chronical limb threatening ischemia (CLTI). The mean treated lesion length was 143 mm (±77.8). The majority of lesions (63%) were Trans-Atlantic Inter-Society Consensus Criteria II (TASC II) C/D lesions. The overall primary patency rates at 12 and 24 months of follow-up were 72.6% and 60.8% respectively. The primary patency at 12 and 24 months for TASC II A/B lesions was respectively 86% and 75.4%. For TASC II C/D lesions primary patency at 12 and 24 months was 64% and 51.1% respectively (p = 0.001). Overall freedom from TLR after 12 and 24 months was 73.8% and 62.8% respectively. No significant patency differences were observed based on calcification rate. Conclusion Endovascular treatment of femoropopliteal disease with Supera Stent is safe, even in extensive, highly calcified lesions. Patency rates and freedom from TLR are acceptable in a real-life population.

Individual patient data meta-analysis of patients treated with a heparin-bonded Viabahn in the femoropopliteal artery for chronic limb-threatening ischemia.

ObjectivesThe aim of the study was to analyze available data on patients treated for chronic limb‐threatening ischemia (CLTI) with the heparin‐bonded Viabahn endoprosthesis.BackgroundThe patency of self‐expanding covered stents in patients with complex femoropopliteal lesions is encouraging. However, data were mostly derived in patients with intermittent claudication. Patients with CLTI often have more advanced disease and worse outcome.MethodsAfter the abstract screening, full‐text papers were checked. Authors were approached to consider joining the consortium. Data were sent anonymously, databases were merged and an individual patient data meta‐analysis was performed. Kaplan–Meier curves were used to calculate the freedom from amputations, the amputation‐free survival, and patency rates.ResultsSeven studies were enrolled, representing 161 limbs that were treated for CLTI. Median lesion length was 28.0 cm (interquartile range 25.0–33.0 cm) and 82.7% were chronic total occlusions. The technical success rate was 98.1% and the 30‐day mortality 1.9%. Through 2‐year follow‐up, the freedom‐from‐major‐amputations was 99.3%, with an amputation‐free survival of 78.8%. The freedom‐from‐loss‐of primary, primary‐assisted, and secondary patency was 70.4%, 71.8%, and 88.2%, respectively, at 1‐year and 59.5%, 62.7%, and 86.1% at 2‐year follow‐up, respectively. The reintervention‐free survival was 62.2% at a 2‐year follow‐up.ConclusionsTreatment of femoropopliteal disease in CLTI patients with the use of the heparin‐bonded Viabahn is safe and effective with favorable clinical outcomes and low amputation rates. Reinterventions are needed in a subset of the population to maintain endoprosthesis patency. Close follow‐up using duplex is recommended to detect potential edge stenosis, allowing treatment before device occlusion.

Drug-coated Balloon Angioplasty Versus Drug-eluting Stenting for Femoropopliteal Arterial Disease: A Review of the Current Status

Endovascular procedures are frequently performed for symptomatic femoropopliteal disease. Drug-eluting stents (DES) and drug-coated balloons (DCB) were introduced to improve long-term outcomes and demonstrated superior outcomes to percutaneous transluminal angioplasty in randomised clinical trials. Femoropopliteal disease, however, can be challenging to treat using an endovascular approach as this segment suffers increased biomechanical stress during extremity movements, which may lead to chronic vascular injury or even stent fracture. The advantages of DCB include the direct and homogeneous delivery of an antiproliferative agent to the arterial wall, and the ability to reach tortuous and longer lesions without a vascular implant; however, the lack of scaffold makes the intervention prone to significant recoil. Even though the use of DCB, a leave-nothing-behind strategy, may appear desirable, the need for bailout stenting will increase as lesions become more complex. This review summarises and compares the currently available evidence regarding the use of DCB and DES in the treatment of femoropopliteal disease.

General Treatment Strategy for Intervention in Lower Extremity Arterial Disease

하지동맥 질환의 유병률은 고연령 군에서 증가한다. 최근의 기술적 진보로 혈관 내 치료가 점점 더 많은 빈도로 시행되고 있다. 간헐적 파행의 치료 목표는 보행 능력을 향상시키고 증상을 완화시키는 것이다. 이를 위해 해부학적 내구성을 높이는 것이 중요한 전략이며 개통률이 치료 평가 기준이 된다. 임계 하지허혈을 가진 환자에서는 병변이 광범위하고 특히 무릎 아래동맥을 심하게 침범한다. 임계 하지허혈의 치료 목적은 상처 회복을 촉진하고 주요 절단을 예방하는데 있으며 사지 보존율이 평가의 기준이 된다. 장골동맥 협착의 치료에는 피복 혹은 비피복 스텐트 삽입술이 일차적 치료로 인정된다. 대퇴슬와동맥 질환은 죽종제거술과 함께 약물방출풍선 및 스텐트가 자주 사용되는 반면 무릎아래동맥 질환에서는 풍선확장술이 주요 치료 방법이다. 컴퓨터단층 혈관조영술은 절대적 금기증이 없는 환자에서 혈관 내 치료 계획 수립을 하는데 로드맵을 제공한다.

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.

Outcomes After Drug-Coated Balloon Treatment of Femoropopliteal Lesions in Patients With Critical Limb Ischemia: A Post Hoc Analysis From the IN.PACT Global Study

Purpose: To report a post hoc analysis performed to evaluate 1-year safety and efficacy of the IN.PACT Admiral drug-coated balloon (DCB) for the treatment of femoropopliteal lesions in subjects with critical limb ischemia (CLI) enrolled in the IN.PACT Global study (ClinicalTrials.gov identifier NCT01609296). Materials and Methods: Of 1535 subjects enrolled in the study, 156 participants (mean age 71.8±10.4; 87 men) with CLI (Rutherford categories 4,5) were treated with DCB angioplasty in 194 femoropopliteal lesions. This cohort was compared to the 1246 subjects (mean age 68.2±10.0 years; 864 men) with intermittent claudication (IC) treated for 1573 lesions. The CLI cohort had longer lesions (13.9±10.6 vs 11.9±9.4 cm, p=0.009) and a higher calcification rate (76.8% vs 67.7%, p=0.011). Major adverse events [MAE; composite of all-cause mortality, clinically-driven target lesion revascularization (CD-TLR), major (above-ankle) target limb amputation, and thrombosis at the target lesion site], lesion and vessel revascularization rates, and EuroQol-5D were assessed through 1 year. The Kaplan-Meier method was used to estimate survival, CD-TLR, and amputation events; estimates are presented with the 95% confidence intervals (CI). Results: Estimates of 12-month freedom from major target limb amputation were 98.6% (95% CI 96.7% to 100.0%) in subjects with CLI and 99.9% (95% CI 99.8% to 100.0%) in subjects with IC (p=0.002). Freedom from CD-TLR through 12 months was 86.3% (95% CI 80.6% to 91.9%) in CLI subjects and 93.4% (95% CI 91.9% to 94.8%) in IC subjects (p<0.001). The MAE rate through 12 months was higher in CLI subjects (22.5% vs 10.7%, p<0.001), and CLI patients had poorer overall survival (93.0%, 95% CI 88.9% to 97.2%) than IC subjects (97.0%, 95% CI 96.0% to 97.9%, p=0.011). Health status significantly improved in all domains at 6 and 12 months in both groups. Conclusion: Treatment of femoropopliteal disease with DCB in CLI patients is safe through 12-month follow-up, with a low major amputation rate of 1.4%. The rates of MAE and CD-TLR were higher in CLI subjects and reinterventions were required sooner. Additional research is needed to evaluate long-term outcomes of DCB treatment for femoropopliteal lesions in CLI patients.

One-Year Clinical Outcomes of the Legflow Drug-Coated Balloon for the Treatment of Femoropopliteal Occlusions Registry

Purpose: To report the 1-year outcomes of the prospective Legflow drug-coated balloon (DCB) registry, which evaluated the safety and 12-month efficacy of the Legflow balloon in the treatment of femoropopliteal disease. Methods: The Legflow is a new generation of DCB that has a homogenous, stable surface coating incorporating 0.1-µm paclitaxel particles. From January 2014 to June 2016, 139 patients (mean age 67.1±10.8 years; 109 men) were enrolled at 4 European institutions. Seventy-nine (56.8%) patients had claudication, while 60 (43.2%) had critical limb ischemia (CLI). Mean lesion length (MLL) was 90.0±41.2 mm. Eighty (57.6%) patients were treated for de novo lesions (MLL 83.2±41.2 mm), 29 (20.9%) for postangioplasty restenosis (MLL 81.2±30.9 mm), and 30 (21.6%) for in-stent restenosis (MLL 117.0±39.5 mm). The primary outcome measure was freedom from binary restenosis as determined by a peak systolic velocity ratio ≥2.4 on duplex or >50% stenosis on digital subtraction angiography at 12 months. The secondary outcome was freedom from clinically-driven target lesion revascularization (CD-TLR) at 12 months. Results: Technical success was achieved in all the 139 treated patients. During the hospital stay, 3 CLI patients died of wound-related complications and 3 CLI patients underwent urgent TLR due to early occlusion in 2 and stent thrombosis in 1. At 12 months, 4 additional patients died of cardiac disease unrelated to the procedure. Of the 132 patients available for 1-year follow-up, the primary outcome (freedom from restenosis) was obtained in 107 (81.1%) patients. Freedom from CD-TLR was obtained in 110 (83.3%). Of the 25 late restenoses >50%, only 3 asymptomatic patients did not require TLR. Freedom from CD-TLR was higher in claudicants (87.0%) than in CLI patients (78.2%, p=0.20). In patients treated for in-stent restenosis, freedom from TLR at 1 year was 89.2%. Conclusion: These data suggest that the use of a new generation paclitaxel-coated balloon represents a safe and effective therapeutic strategy for femoropopliteal obstructions in different clinical and anatomical settings. These data will need to be confirmed with longer-term follow-up and in randomized controlled trials.

Drug-Coated Balloon Angioplasty Confers No Advantage in the Treatment of Femoropopliteal Disease When Stenting Is Required

Drug-Coated Balloon Angioplasty Confers No Advantage in the Treatment of Femoropopliteal Disease When Stenting Is Required

Comparison of treatment strategies for femoro-popliteal disease: A network meta-analysis.

We sought to compare treatment strategies in a Bayesian network meta-analysis of randomized controlled trials. Peripheral artery disease (PAD) is a prevalent morbidity that is treated with various strategies. We performed a MEDLINE search for randomized studies comparing at least 2 treatment strategies, including bypass surgery, percutaneous transluminal angioplasty (PTA) balloons, stents, covered stents, drug-eluting stents (DES), and drug-coated balloons (DCB), in patients with native femoro-popliteal disease. Mixed treatment comparison model generation was performed to directly and indirectly compare the strategies in terms of restenosis and target lesion revascularization (TLR) presented as odds ratios (OR, [95% credible intervals]). Twenty-nine studies with 4,820 patients were included in the present study. PTA was the largest group with 1,900 patients, followed by DCB (n = 1,343), bare metal stents (n = 941), covered stents (n = 304), DES (n = 236), and bypass (n = 92). Mean age was 68 ± 9 years, 64% were male, 37% diabetic, and 55% smokers. Mean lesion length was 77 ± 44 mm, and 39% were total occlusions. Bayesian hierarchical random-effects model demonstrated all treatments were significantly better than, or had a trend toward superiority over, PTA, with DCB ranking well in both restenosis (OR = 0.29, [0.17-0.47]) and TLR (OR = 0.31, [0.20-0.46]). Nonetheless, none of the therapies showed superiority in terms of survival or amputations. Treatment of femoro-popliteal disease has significantly evolved in recent years, with higher rates of patency and freedom from TLR. However, the utility of these treatment strategies in terms of reduction of amputations and overall survival remains in question.

Swirling Flow and Wall Shear: Evaluating the BioMimics 3D Helical Centerline Stent for the Femoropopliteal Segment.

The BioMimics 3D self-expanding nitinol stent represents a strategy for femoropopliteal intervention that is alternative or complementary to deployment of drug-coated stents or balloons. Whereas conventional straight stents reduce arterial curvature and disturb blood flow, creating areas of low wall shear, where neointimal hyperplasia predominantly develops, the helical centerline geometry of the BioMimics 3D maintains or imparts arterial curvature, promotes laminar swirling blood flow, and elevates wall shear to protect against atherosclerosis and restenosis. In the multicenter randomized MIMICS trial, treatment of femoropopliteal disease with the BioMimics 3D (n = 50) significantly improved 2-year primary patency (log-rank test p = 0.05) versus a control straight stent (n = 26), with no cases of clinically driven target lesion revascularization between 12 and 24 months (log-rank test p = 0.03 versus controls). In geometric X-ray analysis, the BioMimics stent was significantly more effective in imparting a helical shape even when the arterial segment was moderately to severely calcified. Computational fluid dynamics analysis showed that average wall shear was significantly higher with the helical centerline stent (1.13 ± 0.13 Pa versus 1.06 ± 0.12 Pa, p = 0.05). A 271-patient multicenter international MIMICS-2 trial and a 500-patient real-world MIMICS-3D registry are underway.

Drug eluting balloons for treatment of femoropopliteal disease

Drug eluting balloons for treatment of femoropopliteal disease

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.

Stenting of femoropopliteal lesions using interwoven nitinol stents

The Supera stent (Abbott Laboratories, Abbott Park, Ill) has a unique biomimetic design allowing axial and longitudinal flexibility and fracture resistance. The aim of this retrospective study was to assess the midterm patency of Supera stents used to treat patients with superficial femoral and popliteal arterial disease by a single practice. From April 2010 to December 2011, 53 patients and 59 limbs with symptomatic femoropopliteal lesions underwent angioplasty and stenting with the Supera stent. Five patients had no follow-up and were excluded. Demographics of the patients, radiographic images, morphologic features of the lesions, procedural reports, reinterventions, and follow-up clinical visit notes were reviewed. Primary patency was defined as clinical resolution of symptoms with no secondary interventions. Primary and secondary patency rates at 12, 24, and 36 months were estimated by Kaplan-Meier analysis. A total of 48 patients (42 men, six women; 54 limbs; mean age, 64.3 years [range, 51-87]) received Supera stents and had at least one follow-up visit as part of their treatment for femoropopliteal disease. Primary indications for intervention included claudication, rest pain, and tissue loss, at rates of 54% (29 of 54), 26% (14 of 54), and 20% (11 of 54), respectively; 22% of lesions were TransAtlantic Inter-Society Consensus type A or B and 78% were type C or D. Mean lesion length was 24.0 cm (range, 3-51). Mean follow-up was 27.5 months (range, 1-45). The ankle-brachial index increased from 0.58 ± 0.20 preoperatively to 0.77 ± 0.18 postoperatively (P = .00004). Primary, primary assisted, and secondary patency rates at latest follow-up were 79.6%, 88.9%, and 92.3%, respectively. Cumulative primary patency rates by Kaplan-Meier analysis at 12, 24, and 36 months were 85.6%, 83.1%, and 76.7%, respectively. Secondary patency rates by Kaplan-Meier estimates at 12, 24, and 36 months were 93.8%, 93.8%, and 89.3%, respectively. No stent fractures were found at the time of any reinterventions. Long lesions >30 cm (n = 18) showed equivalent patency to lesions of 1 to 15 cm (n = 18) and lesions 15 to 30 cm in length (n = 18). Our midterm results show that Supera stents are durable in treating femoropopliteal lesions, with notably high patency rates in patients with long lesion lengths.

Cryoplasty for the Prevention of Arterial Restenosis

Restenosis after percutaneous transluminal angioplasty remains the limiting factor for the long-term benefit of endovascular therapies of peripheral arterial occlusive disease. Despite a variety of modifications and adjuncts to angioplasty such as bare metal stents, covered stents, and drug-eluting stents as well as a number of new technologies like laser angioplasty and cutting balloon angioplasty, restenosis rates have not been significantly affected and remain inferior to those for surgery for long lesions in the femoropopliteal segment. Cryoplasty, which combines balloon angioplasty with the application of cryothermal energy to the vessel wall, was suggested as a promising approach to prevent the formation of neointimal hyperplasia after angioplasty procedures. This review discusses the basic principles of cryoplasty, summarizes the current data on restenosis rates after cryoplasty treatment, and evaluates cryoplasty as a new treatment method to solve the problems associated with restenosis development. The results of the clinical studies suggest that cryoplasty is a feasible and safe technique in the treatment of femoropopliteal disease, however, they have failed to prove any superiority of cryoplasty over conventional angioplasty.

Percutaneous transluminal angioplasty: an angiographer's viewpoint.

We outline the present role of angioplasty in the management of peripheral vascular disease and its application to other portions of the arterial and venous systems; we summarize several large series, including our own, which encompass more than 4,000 cases; and we discuss the pathophysiology of balloon dilation techniques and the criteria for patient selection. With appropriate patient selection, initial (90%) and long-term (85%) patency results are now comparable with surgical techniques when the iliac arteries are involved. Treatment of femoropopliteal disease is slightly less successful but is indicated in appropriate patients. We present the role of angioplasty in conjunction with grafting procedures and in the management of renal vascular hypertension, and we review the potential complications (2% to 3%), adjunctive medical management, and areas for further investigation.