Femoropopliteal Artery Research Articles

LB-1 | Intravascular Lithotripsy for Peripheral Artery Calcification: 1-year Outcomes from the Randomized Disrupt PAD III Trial

Endovascular treatment of calcified peripheral artery lesions may be associated with suboptimal vessel expansion, increased complication risk, and reduced long-term patency. The primary endpoint from the Disrupt PAD III randomized controlled trial (RCT) demonstrated superior procedural success in patients receiving vessel preparation with intravascular lithotripsy (IVL) vs percutaneous transluminal angioplasty (PTA) prior to drug-coated balloon (DCB) treatment in moderately-to-severely calcified femoropopliteal arteries, but comparative longer-term primary patency (PP) results have not been reported.

Soft pneumatic actuators for mimicking multi-axial femoropopliteal artery mechanobiology

Tissue biomanufacturing aims to produce lab-grown stem cell grafts and biomimetic drug testing platforms but remains limited in its ability to recapitulate native tissue mechanics. The emerging field of soft robotics aims to emulate dynamic physiological locomotion, representing an ideal approach to recapitulate physiologically complex mechanical stimuli and enhance patient-specific tissue maturation. The kneecap’s femoropopliteal artery (FPA) represents a highly flexible tissue across multiple axes during blood flow, walking, standing, and crouching positions, and these complex biomechanics are implicated in the FPA’s frequent presentation of peripheral artery disease. We developed a soft pneumatically actuated (SPA) cell culture platform to investigate how patient-specific FPA mechanics affect lab-grown arterial tissues. Silicone hyperelastomers were screened for flexibility and biocompatibility, then additively manufactured into SPAs using a simulation-based design workflow to mimic normal and diseased FPA extensions in radial, angular, and longitudinal dimensions. SPA culture platforms were seeded with mesenchymal stem cells, connected to a pneumatic controller, and provided with 24 h multi-axial exercise schedules to demonstrate the effect of dynamic conditioning on cell alignment, collagen production, and muscle differentiation without additional growth factors. Soft robotic bioreactors are promising platforms for recapitulating patient-, disease-, and lifestyle-specific mechanobiology for understanding disease, treatment simulations, and lab-grown tissue grafts.

Treatment of Atherosclerotic Femoropopliteal Artery Disease with Supera Interwoven Nitinol Stent: A Real-World Study in China

To analyze the outcomes of Supera stent deployment in Chinese patients with atherosclerotic femoropopliteal artery (FPA) disease in a real-world setting. This retrospective cohort study collected and analyzed the medical records of 246 consecutive patients who received Supera stents for FPA disease at the China Academy of Chinese Medical Sciences Xiyuan Hospital between February 2017 and December 2019. All study patients underwent balloon angioplasty and were treated with Supera stents (Abbott Vascular, Santa Clara, CA, USA). The primary outcome was the rate of primary patency 12months after discharge. The analyses included 246 consecutive patients and 260 lesions. The mean±SD age was 73.2±9.9years and most patients (60.2%) were males. Of the 260 treated lesions, Supera stents were deployed in eight (3.1%) cases after a previous stent fracture. Critical limb ischemia was diagnosed in 87.3% of the limbs, and 84 (32.3%) and 83 (31.5%) cases were classified as TransAtlantic Inter-Society Consensus (TASC) C and D, respectively. Most of the lesions were in situ (80.8%) and located in the superficial femoral artery (45.0%) or the FPA (45.8%). The mean lesion length was 147.7mm. Nominal deployment (-10 to 10% compression) was the most common deployment scenario (84.1%). The 1-year primary patency rate was 80.6%. Lesions that occurred as restenosis (odds ratio [OR]:=3.34, 95% confidence interval [CI]: 1.03-10.85, P=0.045) or in-stent restenosis (OR:=2.88, 95% CI: 1.03-8.07, P=0.045) were independently associated with occlusion or stenosis after stent deployment. No stent fracture was observed in this study. Our study indicates that the use of Supera stents is feasible for the treatment of Chinese patients with FPA disease. The long-term results reveal high primary patency.

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.

Importance to Know the Long-Term Outcome after Endovascular Therapy with Bare Metal Stent Implantation for Femoropopliteal Artery Disease.

Importance to Know the Long-Term Outcome after Endovascular Therapy with Bare Metal Stent Implantation for Femoropopliteal Artery Disease.

Functional angiograms after stent implantation into the femoropopliteal artery

Functional angiograms after stent implantation into the femoropopliteal artery

The Impact of Intravascular Ultrasound onFemoropopliteal Artery EndovascularInterventions: A Randomized Controlled Trial.

The aim of this study was to investigate whether the addition of intravascular ultrasound (IVUS) guidance during femoropopliteal artery interventions reduced the rate of binary restenosis within 12months compared with angiographic guidance alone. IVUS is more accurate than angiography for assessment of vessel size and disease severity. Low-level studies suggest that the use of IVUS in femoropopliteal endovascular interventions improves outcomes, but currently, no level 1 evidence exists. This was a prospective single-center trial of 150 patients undergoing femoropopliteal endovascular intervention, randomized (1:1) to guidance by angiography or angiography and IVUS. The primary outcome measure was freedom from binary restenosis, on duplex ultrasound, within 12months. Secondary outcomes included clinically driven target lesion revascularization, disagreements in imaging findings between modalities, and changes in treatment caused by IVUS. Freedom from binary restenosis at 12months was significantly higher in the IVUS group (72.4% vs 55.4%; P = 0.008). There was no significant difference between groups for clinically directed target lesion revascularization (84.2% and 82.4%; P = 0.776). Mean vessel diameter was significantly larger with IVUS (5.60mm vs 5.10mm; P< 0.001). A change in treatment occurred caused by IVUS in 79% of cases. Binary restenosis was lower in the IVUS group for cases treated with drug-coated balloons (9.1% vs 37.5%; P = 0.001). The use of IVUS resulted in a significant reduction in the rate of restenosis after endovascular intervention. This is the first randomized controlled trial to demonstrate that IVUS improves outcomes in femoropopliteal interventions. This benefit may primarily relate to cases treated with drug-coated balloons. (Does the use of intravascular ultrasound improve outcomes of endovascular interventional procedures for peripheral vascular disease of the superficial femoral artery or popliteal artery?; ACTRN12614000006640).

Paclitaxel in real-life data is not associated with reduced survival but has limited benefit in preventing amputation.

Recent meta-analysis of randomized-controlled trials reported an increased risk of long-term mortality in patients treated with paclitaxel-coated devices (PCD) for femoropopliteal arteries (FP) lesions. However, real-life data on the subject is contradictory and data from CLTI patients is missing. The authors aim to evaluate the impact of PCD for the treatment of FP lesions on long-term mortality and amputation on a real-life cohort up to 5 years. All patients treated for FP lesions with endovascular devices from January 2013 to December 2016 were included, irrespective of clinical presentation. Primary endpoint is overall survival. Secondary endpoints are freedom-from major amputation and amputation-free survival. Survival estimates were obtained using Kaplan-Meier plots and a multivariable model was constructed to correct for relevant baseline differences. From 2013 to 2016, 351 patients with FP lesions were treated, 250 with uncoated devices (nPCD) and 101 with PCD. Patients treated with nPCD were significantly older, more often female and with more severe degrees of ischemia. Median follow-up was 55(20-71) months. Overall survival and amputation-free survival were significantly higher in patients treated with PCD. Survival at one-year was 79% vs. 92%, at two-years 69% vs. 79% and at five-years 50% vs. 65% (P=0.02). AFS was 43% vs. 57% at 5-years (P=0.016). Freedom-from major amputation was similar between groups. After correction for relevant baseline differences on multivariable analysis, the survival advantage for patients treated with PCD was lost at 2 and 5 years. Our results do not confirm the findings of increased mortality associated with PCD. However, no improvement in amputation rate was found. For the time, our institutional data does not support withholding PCD to reduce mortality but suggests that the benefit in preventing amputation is not significant.

Drug-Coated Balloon Versus Drug-Eluting Stent in Patients With Femoropopliteal Artery Disease: A Systematic Review and Meta-Analysis.

In this systematic review and meta-analysis, we aimed to compare drug-coated balloon (DCB) to drug-eluting stent (DES) in patients with femoropopliteal lesions in terms of restenosis, target lesion revascularization (TLR), and mortality. A comprehensive literature search was performed through PubMed, Scopus, and Embase databases. The intervention group was patients receiving percutaneous balloon angioplasty using the DCB. The control group was patients receiving percutaneous intervention using the DES. The primary outcome was restenosis, and the secondary outcomes were TLR and mortality. There were 4 studies comprising 812 patients (906 lesions) included in this systematic review and meta-analysis. The rate of restenosis was .19 [.13, .26] in DCB and .24 [.20, .28] in DES. There was a trend toward lower rate of restenosis (OR .73 [.52, 1.03], P = .074; I2: 46.3%) for DCB use compared to DES use. The rate of TLR was .11 [.08, .14] in DCB and .17 [.14, .21] in DES. TLR was lower (OR .61 [.41, .92], P = .017; I2: 1.2%) in the DCB group compared to the DES group. There were no significant differences in mortality (OR 1.38 [.78, 2.44], P = .268; I2: 0%) among the two groups. Meta-regression analysis showed that the rate of restenosis in DCB in this pooled analysis was affected by sex (reference: male, coefficient -.004, P = .009), smoking (coefficient: .003, P = .010), and total occlusion (coefficient: .008, P = .004). DCB use in patients with femoropopliteal lesion was associated with similar rate of restenosis, lower TLR, and similar mortality rate compared to DES use.

Plaque characteristics and prognosis in patients with peripheral arterial disease by angioscopic analysis

BackgroundThe plaques with higher grade of yellow color by angioscopy are reported to be associated with vulnerability leading to adverse outcomes in coronary artery diseases. However, no studies have been performed for peripheral artery disease (PAD). We aimed to evaluate the relationship of angioscopic findings of peripheral arteries with the long-term prognosis. MethodsAngioscopy of iliac or femoropopliteal artery was performed before endovascular therapy in patients with PAD. The local plaque color and presence of thrombus were evaluated. Multivariable Cox regression models were used to estimate hazard ratio (HR) for all-cause mortality or major adverse cardiovascular event (MACE) related to the plaque colors as well as presence of thrombus. ResultsAmong 67 patients, 49.3% had intensive yellow plaques (group H) and the rest had light yellow to yellow ones (group L). Thrombus was detected in 74.6% of the patients and the presence was not different between the two groups. In Kaplan-Meier analysis during a median follow-up of 976 days and 757 days, group H showed increased mortality and MACE compared with group L (p <0.01 for both). Multivariable analysis demonstrated that the intensive yellow color of plaque was independently associated with mortality and MACE [HR: 11.48, 95% confidence interval (CI): 2.19–211.1 and HR: 3.81, 95% CI: 1.36–13.48, respectively] after adjusting for the presence of thrombus. ConclusionsThe yellow color intensity in local plaques by angioscopy may be a novel predictor of long-term prognosis in patients with PAD, regardless of the presence of thrombus.

Angioscopic Findings of Stenosis Versus Occlusion in Femoropopliteal Artery Disease

Background: Despite the increase in the number of patients with peripheral artery disease (PAD), the pathophysiology is not fully elucidated. Recently, angioscopy with a 0.48-megapixel equivalent resolution camera became available for patients with PAD. We aimed to compare the plaque component between native stenosis and occlusion in the femoropopliteal artery using this modality. Materials and Methods: Thirty-two consecutive patients who underwent endovascular treatment for native femoropopliteal artery disease with angioscopy were studied. The major angioscopic classifications of each lesion were defined as follows: atheromatous plaque (AP) was defined as luminal narrowing without any protrusion, calcified nodule (CN) was defined as a protruding bump with surface irregularity, a mainly reddish thrombus was defined as organizing thrombus (OG), and organized thrombus (OD) was defined by more than half of the thrombus showing a whitish intima-like appearance. Results: A total of 34 lesions (stenosis, n=18; occlusion, n=16) from 32 patients were included. All stenotic lesions showed AP or CN (n=8 [44%], n=10 [56%], respectively), whereas all occluded lesions showed OG or OD (n=5 [31%], n=11 [69%], respectively), which amounted to a statistically significant difference (p<0.001). In occluded lesions, stiff wires (>3 g) were required to cross all lesions classified as OD, whereas this was not always necessary for lesions classified as OG (11 [100%] of 11, 1 [25%] of 5, respectively; p=0.04). Yellow color plaques were observed to a similar degree in all angioscopic classifications. Major adverse limb events, defined as amputation and any reintervention at 12 months, were highly variable, depending on the angioscopic findings, and tended to be more frequently observed in CN and OD (13% in AP, 40% in CN, 0% in OT, and 36% in OD, p=0.25). Conclusion: Angioscopy revealed varying components in stenosis and occlusion with different degrees of clinical impact. This may provide new information on the pathophysiology of PAD.

The safety and efficacy of different endovascular treatments for in-stent restenosis of the femoropopliteal artery: A network meta-analysis.

Introduction: Femoropopliteal artery in-stent restenosis (ISR) remains a challenging treatment. We performed a network meta-analysis (NWM) for femoropopliteal artery ISR to explore the safety and efficacy of endovascular therapeutic strategies. Methods: The MEDLINE, Embase, Web of Science, and Cochrane databases were used as data sources. The network meta-analysis (NWM) approach used random-effects models based on the frequentist framework. We compared technical success rate, primary patency, target lesion revascularization (TLR), and major amputation at the 12-month follow-up for femoropopliteal artery ISR. Results: In total, 14 eligible studies (10 prospective and four retrospective; 1348 patients; and eight treatment modalities - standard balloon angioplasty (SBA), drug-coated balloon (DCB), peripheral cutting balloon angioplasty (PCBA), Viabahn endoprosthesis (VBE), directional atherectomy (DA), excimer laser atherectomy (ELA), and combinations - were included. The primary patency rates (at 6 months) were significantly higher for DCB and ELA+DCB than for SBA and ELA+SBA. ELA+DCB had higher primary patency rates (at 12 months) than ELA+SBA and SBA. The technical success rates were significantly lower for DCB and SBA than for VBE. The major amputation rates were significantly lower for ELA+DCB than for DCB. Based on the surface values under the cumulative ranking curve (SUCRA), ELA+DCB was considered the best treatment in terms of primary patency at 6 months (SUCRA = 91.1), primary patency at 12 months (SUCRA = 82.3), and TLR (SUCRA = 83.4). Conclusion: ELA+DCB showed positive encouraging results in primary patency (6, 12 months), TLR, and major amputation in femoropopliteal ISR. The efficacy and safety of ELA+DCB are worthy of further investigation. PROSPERO Registration No.: CRD42021246674.

Comparison of Interwoven Nitinol and Drug-Eluting Stents for Endovascular Treatment of Femoropopliteal Artery Disease.

Interwoven nitinol stents (INS) and drug-eluting stents (DES) were designed to improve the mid- and long-term results of femoropopliteal (F-P) angioplasty. The aim of this study was to systematically compare these stents. Between 2015 and 2017, 62 patients with symptomatic peripheral artery disease of the F-P segment treated by INS or DES were identified from a prospectively maintained institutional database. The primary outcome measure was one-year primary patency; secondary outcomes were in-stent restenosis (ISR), stent occlusion, target lesion revascularization (TLR) and mortality. The mean follow-up was 26.9 ± 11.2 months. No statistically significant difference in primary patency at one year was observed (88.6% vs. 88.9%). Throughout follow-up, overall rates of ISR (5.7% vs. 11.1%, p = 0.645), stent occlusion (25.7% vs. 7.4%, p = 0.094) and TLR (25.7% vs. 18.5%, p = 0.505) were statistically equivalent between the groups. Mortality reached 14.3% in the INS group and 3.7% in the DES group, but this difference was not statistically significant (p=0.196). Multivariable analysis revealed significant correlations between ISR and stent occlusions; popliteal lesion localization (p = 0.016) and poor below the knee vessel outflow (p < 0.001). In the short- and mid-term, the use of an INS or DES in the F-P arterial segment did not result in a difference in primary patency rate, stent occlusion, restenosis, re-intervention or mortality. The overall data do not provide any evidence to favor one stent over the other.

Paclitaxel-coated balloons angioplasties for extra-long femoropopliteal artery atherosclerotic lesions (> 30 ​cm):12 months outcomes from a single center

ObjectiveTo evaluate the efficacy of paclitaxel-coated balloon (PCB) in the treatment of extra-long femoropopliteal artery atherosclerotic disease (>30 ​cm). Materials and methodsForty-nine patients with extra-long femoropopliteal artery atherosclerotic disease were treated with PCB alone in a single center from July 2016 to May 2018. Primary patency and freedom from clinically driven target lesion revascularization (FF-CDTLR) rates during 12 months were analyzed retrospectively. ResultsAll patients were followed up for 18.2 ​± ​7.5 months, and the mean treated lesion length was 34.9 ​± ​3.7 ​cm. The primary patency rates were 87.8% (43/49) and 71.4% (35/49) at 6 and 12 months, respectively. FF-CDTLR was 91.8% (45/49) and 77.6% (38/49) at 6 and 12 months, respectively. No mortality or amputation occurred in these patients during the follow-up period. ConclusionsPCB has favorable clinical efficacy in patients with extra-long femoropopliteal artery atherosclerotic lesions.

Technical performance and reproducibility following rotational atherectomy of femoropopliteal artery occlusive lesions: analysis of the multicenter MORPHEAS Registry.

The purpose of this study was to define patient and anatomical factors associated with technical results specific to rotational atherectomy. Controversy exists surrounding appropriate utilization of atherectomy to treat femoral-popliteal atherosclerosis. Importantly, the existence of different atherectomy devices and lack of technical reports highlighting variables that impact outcomes obscures the ability to assess perioperative performance. The nonindustry sponsored, Multicentric National Registry on the use of rotational atherectomy in femoral-popliteal occlusive atherosclerotic disease (MORPHEAS) database was queried. The MORPHEAS investigators included experienced providers at four centers who previously had not utilized rotational atherectomy. The primary endpoint was flow-limiting dissection and/or >50% recoil resulting in stent-placement while a secondary endpoint included peripheral thromboembolism incidence. One hundred thirteen patients were enrolled. Only femoropopliteal occlusions were included in the analysis and anatomic distribution and calcification severity were depicted separately. The most common adjunctive therapy was drug-coated balloon angioplasty (84%; N.=96). Flow-limiting dissection was identified in 16% (N.=18) and thromboembolism occurred in 4% (N.=4). Diabetes increased risk of thromboembolism (P=0.03) while lesion length ≥8.0 cm (P=0.07) and SFA-popliteal adductor canal location (P=0.01) were associated with flow-limiting dissection. In multivariable analysis, SFA-popliteal adductor canal occlusion had a 4.7-fold risk of perioperative complications (OR=4.7, 95%CI: 1.1-21.0; P=0.04). Rotational atherectomy was characterized by reproducible performance among four centers; however, diabetic patients, as well as those with long-segment, heavily calcified SFA-popliteal adductor canal occlusion present greatest risk of complications.

Outcomes of Popliteal Stent-Graft Placement at the Artery Hinge Point for Popliteal Artery Aneurysm

To assess whether stent-grafts crossing the hinge point (HP) in the popliteal artery are associated with increased complications and decreased patency rates, after endovascular treatment of the popliteal artery aneurysm. This was a single-center, case-control study. Patients were allocated to either the HP group (subjects with stent-grafts crossing the HP) or the control group (subjects with stent-grafts above and/or below the HP) based on stent-graft location in the femoropopliteal artery. HP was defined as the main curve in the popliteal artery in the most acute angle toward the femur that appeared during knee flexion, which was identified by reviewing postoperative angiograms. Independent, blinded reviews were performed for all imaging data. Graft evaluation by CTA or duplex ultrasound was performed at 1, 3, 6, and 12 months and annually thereafter. Outcomes measured included: stent-graft patency, stent-graft fracture, other stent-related complications, and major adverse events, including reintervention, death, amputation, stroke, and myocardial infarction. A total of 44 limbs treated with placement of heparin-bonded Viabahn endoprostheses were included in this study. Twenty and twenty-four patients were allocated to the HP group and the control group, respectively. Primary patency rates of the HP group at 1, 2, 3, and 5 years were 84.1 ± 8.4%, 84.1 ± 8.4%, 84.1 ± 8.4%, and 72.1 ± 13.3%, respectively. The primary patency rates of the control group were 87.0 ± 7.0%, 82.4 ± 8.0%, 82.4 ± 8.0%, and 82.4 ± 8.0%, respectively. There was no significant difference between the 2 groups (P=0.81). No reintervention was performed in the control group. In the HP group, 5 limbs (25.0%) developed endoleak, 3 (15.0%) developed thrombosis, and 1 (5.0%) developed a stent fracture followed by thrombosis. Thrombosis occurred in 2 limbs (8.3%) of the control group, and stent-graft migration was observed in another 2 cases (8.3%). Neither group demonstrated stent-graft infection or acute popliteal artery embolism. Overall, incidence of stent-related complications were significantly higher in the HP group (P= 0.04). Event-free survival rates of the HP group at 1, 2, 3, and 5 years were 75.0 ± 9.7%, 69.6 ± 10.4%, 61.9 ± 11.8%, and 29.0 ± 12.8%, respectively. Corresponding rates in the control group were 79.2 ± 8.3%, 79.2 ± 8.3%, 79.2 ± 8.3%, and 79.2 ± 8.3%, respectively. The difference was not statistically significant between the 2 groups (P=0.20) CONCLUSIONS: crossing the HP with femoropopliteal artery stent-grafts increased the risk of stent-related complications and reinterventions but did not decrease stent patency or event-free survival.

Endovascular treatment of femoro-popliteal disease with the Supera stent: results of a multicenter study.

Background: Even though many types of stents have been tested in superficial femoral artery (SFA) and popliteal artery (PA), most of these devices have provided an unsatisfactory outcome, probably due their unsuitable anatomical and physiological characteristics. The Supera peripheral stent (Abbott Vascular, Santa Rosa, CA, USA) is a braided interwoven nitinol device specifically designed for treating atherosclerotic lesions of the femoro-popliteal segment. The aim of this multicenter retrospective study was to describe the effectiveness of Supera stents in the management of femoral-popliteal atherosclerotic lesions and to critically analyze our findings in the context of current and past literature.Design and methods: In this study we enrolled only patients who satisfied the inclusion criteria: i) patients affected by chronic obstructive arterial disease (COAD) grade II, as per Rutherford classification; ii) patients treated with endovascular revascularization and Supera stent implantation in the femoro-popliteal axis. We retrospectively analyzed the Doppler Ultra-sound (US) follow- up at 12-24 and 36 months to detect the vascular occlusions. The primary patency, primary patency assisted and TLR were described statistically analyzed by survival analysis and the demographic data, clinical data, device safety following stenting were described as frequency and mean value.Results: 105 endovascular procedures on 99 patients for femoro-popliteal stenting with Supera were performed in four Italian hospitals. The median follow-up was 39 months (range 6-72), with primary patency rate of 83.1%, 74.3% and 69.5% at 12, 24 and 36 months after the procedure. The primary patency assisted was 89.9%, 76.8% and 73.4% in the same period, while the freedom from TLR values were 92.7%, 91.5% and 89.5% at 12, 24 and 36 months after the procedure, respectively. The mortality rate recorded at 12 months from the Supera implantation was 2.8% (3 out of 99 patients enrolled).Conclusions: Our data were in agreement with the current literature, showing the non-inferiority Supera stent in relation to the other stent available. Supera stent showed an excellent safety, effectiveness profile and high durability for the treatment of PAD patients with femoro-popliteal artery disease. Significance for public health Peripheral artery disease (PAD) is a benign multifactorial condition associated with high morbidity and mortality; the femoral-popliteal axis is one of the most critical vascular districts due to its complex biodynamic. Although balloon angioplasty represents the first line treatment, it is not uncommon the use of stents in order to preserve patency vessel. Among different stents available, however, Supera peripheral stent (Abbott Vascular, Santa Rosa, CA, USA) has the ability to fit better to the femoro-popliteal compartment which is subject to biomechanical stress. The aim of this paper is to retrospectively analyze a multicentric experience with the use of a specific device (Supera peripheral stent) for treatment of PAD in femoral-popliteal disease, comparing results with Literature. Through this paper, every interventional radiologist interested in PAD endovascular treatment could have an important reference in order to perform the best management in this chronic and complex benign pathology.

Cost-Effectiveness of Urea Excipient-Based Drug-Coated Balloons for Chronic Limb-Threatening Ischemia from Femoropopliteal Disease in the Netherlands and Germany.

Drug-coated balloons (DCBs) for femoropopliteal peripheral artery disease have been shown to be clinically superior and cost-effective compared to conventional percutaneous transluminal angioplasty (PTA). However, few studies enrolled patients with chronic limb-threatening ischemia (CLTI). Our objective was to study the cost-effectiveness of endovascular treatment with versus without DCB in CLTI patient populations in the Netherlands and Germany. Target lesion revascularization (TLR) and major amputation rates were obtained from the CLTI subgroup of the IN.PACT Global study. Rates for "status quo" treatment involving PTA with primary or bailout stenting were derived from systematic literature search. Costs and cost-effectiveness were calculated using a decision-analytic Markov model considering, in the base case, a 2-year horizon, and strategy-specific quality-adjusted life year (QALY) gains calculated from survival and health state-specific utilities. A willingness-to-pay threshold of €50,000/QALY was assumed, and extensive sensitivity analyses were performed. Model-projected 24-month probabilities of TLR were 26.2% and 32.8% for treatment with and without DCB, and probabilities for amputation were 2.8% and 11.9%, respectively. DCB added 0.017 QALYs while saving €1,030 in the Dutch setting and €513 in the German setting, respectively. DCB was found dominant or cost-effective across a wide range of assumptions. Urea excipient drug-coated balloon therapy for treating CLTI from femoropopliteal artery disease is associated with improved patient outcomes and expected overall cost savings to payers in the Dutch and German healthcare systems, rendering it a cost-effective and likely dominant treatment strategy.

Clinical Outcomes of Atherectomy Plus Drug-coated Balloon Versus Drug-coated Balloon Alone in the Treatment of Femoropopliteal Artery Disease.

Atherectomy as a pretreatment has the potential to improve the outcomes of drug-coated balloon (DCB) treatment by reducing and modifying atherosclerotic plaques. The present study investigated the outcomes of atherectomy plus DCB (A+DCB) compared with DCB alone for the treatment of femoropopliteal artery disease. A total of 311 patients (348 limbs) underwent endovascular therapy using DCB for native femoropopliteal artery lesions at two endovascular centers. Of these, 82 limbs were treated with A+DCB and 266 limbs with DCB alone. After propensity score matching based on clinical and lesion characteristics, a total of 82 pairs was compared for immediate and mid-term outcomes. For the matched study groups, the lesion length was 172.7±111.2 mm, and severe calcification was observed in 43.3%. The technical success rate was higher in the A+DCB group than in the DCB group (80.5% vs. 62.2%, p=0.015). However, the A+DCB group showed more procedure-related minor complications (37.0% vs. 13.4%, p=0.047). At 2-year follow-up, primary clinical patency (73.8% vs. 82.6%, p=0.158) and the target lesion revascularization (TLR)-free survival (84.3% vs. 88.2%, p=0.261) did not differ between the two groups. In Cox proportional hazard analysis, atherectomy showed no significant impact on the outcome of DCB treatments. The pretreatment with atherectomy improved technical success of DCB treatment; however, it was associated with increased minor complications. In this study, A+DCB showed no clinical benefit in terms of TLR-free survival or clinical patency compared with DCB treatment alone.

A systematic review and meta-analysis of Supera interwoven nitinol stents for the treatment of infrainguinal peripheral arterial disease.

Stenting of infrainguinal lesions can be rather challenging due to the mechanical stress applied on the arteries during motion. We assessed the short-term and mid-term safety and efficacy of Supera interwoven nitinol stent for the treatment of infrainguinal arterial disease. We conducted a systematic review for articles published from December 2011 up to May 2021 regarding studies assessing the safety and efficacy of Supera interwoven nitinol stents for the treatment of infra-inguinal peripheral arterial disease. Studies that involved synchronous application of the Supera stent and drug delivering devices, or any alternative endoprosthesis were excluded. Pooled Kaplan-Meier survival curves and smoothed hazard estimates were generated. Data were meta-analyzed using a random effects model. Primary endpoints included primary patency and freedom from clinically driven target lesion revascularization (TRL). Secondary endpoints included technical success and major amputation at 1 year post intervention. Seventeen studies with 2015 patients (65.3% males) and a mean lesion length of 137.2 mm were included. Of the total treated lesions, 44.9% involved femoropopliteal artery and 37.4% the popliteal artery. Chronic total occlusions made up 49% of the treated lesions. There were no stent fractures reported. The pooled technical success rate is 99.84% (95% CI: 99.26-100). Pooled major amputation rate at 1 year is 1.48% (95% CI: 0.47-2.87). Pooled primary patency and freedom from TLR rates at 1 year are 83.5% (95% CI: 80.24-86.54) and 90.32% (95% CI: 88.75-91.79), respectively. Pooling of individual patient data produced primary patency and freedom from TLR rates of 84.48% (95% CI: 82.66-86.11) and 90.81% (95% CI: 88.64-92.58) respectively. According to the smoothed hazard ratio estimate the risk for losing primary patency peaked between 4 and 5 months while the risk for TLR peaked between 7 and 8 months after the intervention. This review and meta-analysis indicated the safety and efficacy of Supera stents for the treatment of challenging infrainguinal lesions in the short-term and mid-term periods, with acceptable primary patency and freedom from TLR rates. Clinicians should be aware that between 4 and 5 months patients face a higher risk for event occurrence.