Superficial Femoral Artery Lesions Research Articles

Long-term results of the Japanese multicenter Viabahn trial of heparin bonded endovascular stent grafts for long and complex lesions in the superficial femoral artery

ObjectiveWe assessed the long-term safety and efficacy of endovascular stent grafting to treat long, complex lesions in the superficial femoral artery (SFA). MethodsThe present prospective, multicenter study at 15 Japanese hospitals assessed heparin-bonded stent grafts used to treat long SFA lesions in patients with symptomatic peripheral arterial disease. The inclusion criteria were Rutherford category 2 to 5 symptoms (grade 5 without active infection), an ankle brachial index of ≤0.9, and SFA lesions ≥10 cm long with ≥50% stenosis. The key efficacy and safety outcomes were primary-assisted patency and adverse events through 24 months, respectively. The secondary outcomes included primary patency, secondary patency, freedom from target lesion revascularization (fTLR), and Vascular Quality of Life questionnaire score. ResultsOf the 103 patients (mean age, 74.2 ± 7.0 years; 82.5% male), 100 (97.1%) had intermittent claudication. The average lesion length was 21.8 ± 5.8 cm; 87 lesions (84.5%) were TASC (Trans-Atlantic Inter-Society Consensus Document on Management of Peripheral Arterial Disease) C or D (65.7% chronic total occlusions). Of the 103 patients, 92 and 61 were evaluable through 24 and 60 months, respectively. At 24 months, the Kaplan-Meier–estimated primary-assisted patency, primary patency, and secondary patency rate was 85.7% (95% confidence interval [CI], 76.3%-91.5%), 78.8% (95% CI, 68.8%-85.9%), and 92.0% (95% CI, 82.4%-96.5%), respectively. The mean ankle brachial index was 0.64 ± 0.12 at baseline and 0.94 ± 0.19 at 24 months (P < .0001). At 24 and 60 months, the fTLR was 87.2% (95% CI, 78.9%-92.3%) and 79.1% (95% CI, 67.9%-86.8%), respectively. No device- or procedure-related life- or limb-threatening critical events or acute limb ischemia cases were observed through 5 years. No stent fractures were detected on the annually scheduled follow-up radiographs. The vascular quality of life questionnaire and walking impairment questionnaire scores were significantly increased at 1 through 24 months compared with the baseline scores (P < .0001 for both). One patient had required conversion to open bypass during the 5-year follow-up period. ConclusionsStent grafting of long and complex SFA lesions in patients with claudication is safe and effective through long-term follow-up, with 79.1% fTLR and no leg amputation, acute limb ischemia, or stent fractures through 5 years.

A Budget Impact Model for the use of Drug-Eluting Stents in Patients with Symptomatic Lower-Limb Peripheral Arterial Disease: An Australian Perspective

PurposeImprovement in long-term outcomes through innovative, cost-effective medical technologies is a focus for endovascular procedures aimed at treating symptomatic lower-limb peripheral arterial disease (PAD). The advent of drug-eluting stents (DES) has improved symptomatic PAD treatment via a reduction in high rates of target lesion revascularisation (TLR). The present study aimed to compare the 5-year financial impact of treatment with Eluvia, a new paclitaxel-eluting stent, versus treatment with Zilver PTX, a drug-coated stent, among patients in Australia by developing a budget impact model (BIM).MethodsA BIM was developed from an Australian public hospital payer perspective using Australian national cost weights (AUD), published literature, and public hospital audit data. Clinical outcomes, including clinically driven TLRs (CD-TLRs), adverse events, and length of stay, were based on the 2-year results of the IMPERIAL trial, which compared Eluvia DES to Zilver PTX.ResultsAssuming EVP eligibility rate of 80% and DES uses rate ranging from 10 to 28% (superficial femoral artery lesions only), the 5-year model forecasted a treatment population between 14,428 and 40,399 patients. The model estimated 1499–4198 fewer CD-TLRs and 16,515–46,243 fewer hospital days with Eluvia DES use. This translated to 5-year potential savings of $4.3–$12.1 million to the Australian public hospital payer attributable to reduced CD-TLRs for Eluvia DES and $33.1–$92.6 million to Australian public hospitals owing to reduced adverse events and hospital bed days.ConclusionEluvia DES use as treatment for symptomatic lower-limb PAD could lead to potential savings for the Australian public healthcare system based on improved patient outcomes.

Comparison and Analysis between the NAV6 Embolic Protection Filter and SpiderFX EPD Filter in Superficial Femoral Artery Lesions.

Objective To compare the safety and efficacy between the SpiderFX EPD and Emboshield NAV6 filter in the collection of embolic debris created from lower limb atherectomy procedures in patients with PAD. Materials and Methods Between January 2014 and October 2015, 507 patients with symptomatic peripheral artery disease were treated with directional atherectomy (SilverHawk), rotational atherectomy (JetStream), or laser atherectomy (Turbo Elite) based on operator discretion. Emboshield NAV6 (n = 161) and SpiderFX (n = 346) embolic protection devices were used with each of the 3 atherectomy devices. The primary study endpoint was 30-day freedom from major adverse events (MAEs). An MAE was defined as death, MI, TVR, thrombosis, dissection, distal embolization, perforation at the level of the filter, and unplanned amputation. A descriptive comparison of the MAE rates between Emboshield NAV6 and SpiderFX embolic protection devices was conducted. Results The freedom from major adverse event (MAE) rate was 92.0% (CI: 86.7%, 95.7%) in patients who received an Emboshield NAV6 filter compared to 91.6% (CI: 88.2%, 94.3%) in patients who received the SpiderFX filter (p=0.434). The lower limit of 86.7% freedom from major adverse event rate in the Emboshield NAV6 group was above the performance goal of 83% (p < 0.0008). Conclusions There were no significant clinical outcome differences between Emboshield NAV6 and SpiderFX EPD filters in the treatment of lower extremities. This evaluation indicates the safety and efficacy to use either filter device to treat PAD patients with lower extremity lesions.

Supera Stent Implantation with Ultrasound Guidance for Complex Ostial Lesions of Superficial Femoral Artery by Retrograde Approach: The SUGAR Technique

Abstract Purpose The aim of this study was to describe a modified technique for accurate deployment of the Supera stent under ultrasound (US) guidance for complex lesions involving superficial femoral artery (SFA) ostium without jailing profunda femoral artery (PFA) by retrograde approach. Technique Retrograde pedal access was initially taken in all the cases. The stenotic or occlusive femoropopliteal lesions involving the SFA ostium were crossed retrogradely and additional contralateral common femoral artery (CFA) access was taken only if we failed to cross the lesion. In addition to fluoroscopy, extravascular US guidance was freely used whenever required throughout the procedure. After desired predilatation of the SFA lesion, US guidance (gray scale and color Doppler) was used to start deployment of the proximal few centimeters of Supera stent ensuring that the landing of first crown was exactly from the SFA ostium not extending into CFA or jailing the PFA ostium. The rest of the stent was deployed under fluoroscopic guidance. Retrograde pedal access site hemostasis was achieved by manual compression. The Supera stent implantation with Ultrasound Guidance for complex ostial lesions of superficial femoral Artery by Retrograde approach (SUGAR) technique was applied successfully in 35 patients (mean age 58.1 ± 4.4 years; 24 males) with critical limb ischemia via the distal pedal approach. No access site or remote complications were observed. Conclusion The SUGAR technique has superior advantage of utilizing a simple tool like extravascular US in addition to fluoroscopy for retrograde Supera stent deployment by allowing very precise landing at SFA ostium, bypassing the need for multiple oblique projections, unwanted radiation exposure, and extra contrast dye overload.

TCTAP A-041 Interwoven Self-expanding Nitinol Stent with Drug-coated Balloon Angioplasty for the Treatment of Severely Calcified Superficial Femoral Artery Lesions: Two-year Outcomes

TCTAP A-041 Interwoven Self-expanding Nitinol Stent with Drug-coated Balloon Angioplasty for the Treatment of Severely Calcified Superficial Femoral Artery Lesions: Two-year Outcomes

Endovascular treatment of chronic total occlusion of superficial femoral artery using retrograde approach from popliteal artery

An 55 years-old man with intermittent claudication was admitted to Hue central Hospital. Doppler ultrasound and digital subtraction angiography showed his left superficial femoral artery (SFA) was chronic total occlusion (CTO), and we performed endovascular treatment (EVT). We advanced a guide-wire by contralateral transfemoral approach, but guide-wire could not penetrate the occluded SFA lesion antegradely. Thus, we tried to approach the CTO lesion retrogradely. A guide-wire passed from popliteal artery to distal SFA. With a reverse-controlled antegrade and retrograde approach technique, we were able to pass the CTO lesion. Finally, two stents were implanted. We experienced a case in which retrograde approach via collateral channel from popliteal artery was effective to CTO of SFA.

Baseline local hemodynamics as predictor of lumen remodeling at 1-year follow-up in stented superficial femoral arteries

In-stent restenosis (ISR) is the major drawback of superficial femoral artery (SFA) stenting. Abnormal hemodynamics after stent implantation seems to promote the development of ISR. Accordingly, this study aims to investigate the impact of local hemodynamics on lumen remodeling in human stented SFA lesions. Ten SFA models were reconstructed at 1-week and 1-year follow-up from computed tomography images. Patient-specific computational fluid dynamics simulations were performed to relate the local hemodynamics at 1-week, expressed in terms of time-averaged wall shear stress (TAWSS), oscillatory shear index and relative residence time, with the lumen remodeling at 1-year, quantified as the change of lumen area between 1-week and 1-year. The TAWSS was negatively associated with the lumen area change (ρ = − 0.75, p = 0.013). The surface area exposed to low TAWSS was positively correlated with the lumen area change (ρ = 0.69, p = 0.026). No significant correlations were present between the other hemodynamic descriptors and lumen area change. The low TAWSS was the best predictive marker of lumen remodeling (positive predictive value of 44.8%). Moreover, stent length and overlapping were predictor of ISR at follow-up. Despite the limited number of analyzed lesions, the overall findings suggest an association between abnormal patterns of WSS after stenting and lumen remodeling.

Effectiveness of combined superficial femoral artery endovascular therapy with popliteal-to-distal bypass: A paradigm shift in surgical open bypass for chronic limb-threatening ischemia.

The purpose of this study was to evaluate the results of combining superficial femoral artery endovascular therapy with distal bypass originating from the popliteal artery as a method of lower extremity revascularization in patients with chronic limb-threatening ischemia. The records of patients undergoing combined superficial femoral artery endovascular therapy with popliteal-to-distal bypass for chronic limb-threatening ischemia from January 2014 to April 2020 at a single institution were retrospectively reviewed. The patients' background, operative details, and long-term outcomes were analyzed. Fifty-two popliteal-to-distal bypasses with superficial femoral artery endovascular therapy were performed in 49 patients (33 men; mean age, 76 ± 9 years; diabetes mellitus, 80%; end-stage renal disease with hemodialysis, 47%). The Trans-Atlantic Inter-Society Consensus II classification of superficial femoral artery-popliteal lesion was "A" in 8 (15%) patients, "B" in 14 (27%) patients, "C" in 24 (46%) patients, and "D" in 6 (12%) patients. The intervention for superficial femoral artery lesions was plain old balloon angioplasty in 4 patients, self-expandable nitinol stent in 15 patients, drug-coated balloon in 18 patients, drug-eluting stent in 4 patients, stent graft in 10 patients, and interwoven nitinol stent in 1 patient. Distal bypass originated from the above-knee popliteal artery in 9 (17%) limbs and the below-knee popliteal artery in 43 (83%) limbs. The most common outflow artery was the posterior tibial artery (44%). The mean follow-up period was 17 ± 17 months. The primary and secondary patency of the graft was 44% and 72%, respectively, at 1 year and 39% and 72%, respectively, at 3 years. Primary patency and freedom from clinical-driven target lesion revascularization of superficial femoral artery endovascular therapy lesions were 85% and 90%, respectively, at 1 year and 63% and 75%, respectively, at 3 years. Limb salvage was 97% at 1 year and 92% at 3 years. Wound healing was 67% at 6 months and 83% at 12 months. Combined superficial femoral artery endovascular therapy with popliteal-to-distal bypass may be a promising approach for patients with chronic limb-threatening ischemia because of durable patency, acceptable wound healing, and good limb salvage.

Yüzeyel Femoral Arterin İzole Total Oklüzyonunda Rotasyonel Aterektomi ve İlaç Kaplı Balon Kombine Kullanımının Uzun Dönem Sonuçları

Aim: In this study, we aimed to evaluate the long-term results of combined treatment with rotational atherectomy (RA) and drug-coated balloon (DCB) in isolated total occlusion of the superficial femoral artery (SFA). Materials and Methods: The retrospective study was conducted between February 2016 and January 2018 and included a total of 23 limbs of 20 patients with isolated total occlusion of the SFA. Patient data on demographic and clinical characteristics were obtained from the hospital records. The stage of the disease was classified according to the Rutherford classification. The ankle–brachial index was measured pre- and postoperatively. Results: Of the patients, 19 (95%) were male and one (5%) was female. The mean patient age was 67.40±7.50 (49–77) years. The patient distribution according to the preoperative Rutherford classification was as follows: stage 5, four (17.40%) patients; stage 4, eight (34.80%) patients; stage 3, eleven (47.80%) patients. The rates of one- and two-year freedom from target lesion revascularization were 82.61% and 69.57%, respectively. Discussion and Conclusion: Our study results showed that combined treatment with RA and DCB was an effective method in SFA lesions with a high calcified plaque burden, providing high rates of primary patency and freedom from target lesion revascularization as well as low rates of complication.

Comparative Study between Simple Percutaneous Transluminal Angioplasty and Drug-Coated Balloons in Chronic Total Occlusion of The Femoro-popliteal Artery

Background: Atherosclerotic peripheral artery disease (PAD) affects a growing number of patients in aging populations. Peripheral artery disease (PAD) accounts for a large proportion of cardiovascular disease (CVD) prevalence in most world regions. Objective: This study aims to evaluate and compare the patency, clinical outcome, and limb salvage rates between the simple percutaneous Transluminal angioplasty and the drug-coated balloons in chronic total occlusion of the femoropopliteal arterial segment on the short-term course. Patients and Method: A prospective randomized controlled comparative study was conducted in the vascular surgery department; Aswan University Hospital during the period from March 2018 to March 2020. In total, 30 patients with a well-established diagnosis of superficial femoral artery (SFA) and/or proximal popliteal lesions with symptoms of PAD. Results: The primary patency at 12-month following treatment with DCB was significantly better 100. %, 80.0%, 60.0% at 1, 6, 12 months compared with POBA 86.7 %, 66.7%, 46.7% at 1, 6, 12 months. The rate of clinically- driven TLR was the same in both groups (26.6%). The use of DCB was safe and did not increase the major adverse clinical events (death, myocardial infarction, and minor or major amputation) when compared with those seen with the use of the uncoated balloons). Conclusion: Use of DCBs is associated with improved vessel patency when compared to POBA in patients with FPD. There was no difference in clinically driven TLR between DCB and POBA in our study.

Comparative Study between Simple Percutaneous Transluminal Angioplasty and Drug-Coated Balloons in Chronic Total Occlusion of The Femoro-popliteal Artery

Background: Atherosclerotic peripheral artery disease (PAD) affects a growing number of patients in aging populations. Peripheral artery disease (PAD) accounts for a large proportion of cardiovascular disease (CVD) prevalence in most world regions. Objective: This study aims to evaluate and compare the patency, clinical outcome, and limb salvage rates between the simple percutaneous Transluminal angioplasty and the drug-coated balloons in chronic total occlusion of the femoropopliteal arterial segment on the short-term course. Patients and Method: A prospective randomized controlled comparative study was conducted in the vascular surgery department; Aswan University Hospital during the period from March 2018 to March 2020. In total, 30 patients with a well-established diagnosis of superficial femoral artery (SFA) and/or proximal popliteal lesions with symptoms of PAD. Results: The primary patency at 12-month following treatment with DCB was significantly better 100. %, 80.0%, 60.0% at 1, 6, 12 months compared with POBA 86.7 %, 66.7%, 46.7% at 1, 6, 12 months. The rate of clinically- driven TLR was the same in both groups (26.6%). The use of DCB was safe and did not increase the major adverse clinical events (death, myocardial infarction, and minor or major amputation) when compared with those seen with the use of the uncoated balloons). Conclusion: Use of DCBs is associated with improved vessel patency when compared to POBA in patients with FPD. There was no difference in clinically driven TLR between DCB and POBA in our study.

Influence of Self-Expanding Paclitaxel-Eluting Stent Sizing on Neointimal Hyperplasia in Superficial Femoral Artery Lesions.

Although self-expanding drug-eluting stents (DES) have recently shown superior outcomes for superficial femoral artery (SFA) lesions, optimal sizing of DES diameter in SFA intervention is unclear.Methods and Results:A total of 40 de novo SFA lesions were randomized 1:1 to receive self-expanding DES with either a 1-mm or 2-mm larger diameter than the reference vessel diameter. Follow-up optical coherence tomography (OCT) was scheduled 6 months after DES implantation to evaluate the vascular response to the stents. Volume index (VI) was defined as volume divided by stent length. The primary endpoint was neointimal VI at 6 months. Baseline reference vessel diameter was similar between the 1-mm larger diameter group and the 2-mm larger diameter group (5.0±0.8 mm vs. 4.7±0.9 mm, P=0.35). Stent diameter was 6.3±0.6 mm in the 1-mm larger group and 7.1±0.6 mm in the 2-mm larger group (P<0.0001), and stent to reference vessel diameter ratio (SV ratio) was 1.3±0.2 and 1.5±0.2 (P<0.0001), respectively. At 6-month, neointimal VI was greater in the 2-mm larger diameter group (5.5±1.5 mm2vs. 9.6±3.4 mm2, P<0.001). The correlation analysis revealed that degree of neointimal VI was positively correlated with SV ratio (r=0.43, P<0.01). Implantation of self-expanding DES with a considerably high SV ratio resulted in neointimal hyperplasia in SFA lesions.

Outcomes after Endovascular Stent Placement for Long-Segment Superficial Femoral Artery Lesions

Endovascular intervention is commonly pursued as first-line management of symptomatic, long-segment superficial femoral artery (SFA) disease. The relative effectiveness and comparative long-term outcomes among bare metal stents (BMS), covered stents (CS), and drug-eluting stents (DES) for long-segment SFA lesions remain uncertain. A retrospective cohort study identified patients with symptomatic SFA lesions measuring at least 15cm in length who successfully received an endovascular stent (BMS, CS, or DES). The outcomes were patency, patient presentation upon stent occlusion, amputation-free survival (AFS), and all-cause mortality. Proportional hazards regressions and a multinomial logistic regression model were used to control for significant confounders. A total of 226 procedures were analyzed (BMS: 95 [42%]; CS: 74 [33%]; DES: 57 [25%]). There were no significant differences among the 3 stent types with respect to age, prevalence of either diabetes or end-stage renal disease, or smoking history. The median length of the SFA lesion varied across the cohorts (BMS: 28cm [interquartile range, IQR 20-30]; CS: 26cm [IQR 20-30]; DES: 20cm [IQR 16-25]; P=0.002). The unadjusted primary patency of BMS at 12, 24, and 48 month following index stent placement was 57%, 47%, and 44%, respectively. This is compared to 62%, 49%, and 42% for CS, and 81%, 66%, and 53% for DES, respectively (log-rank P=0.044). In adjusted models, however, there were no significant differences in primary patency among the stent types. Compared to CS however, DES was associated with improved primary-assisted patency (hazard ratio [HR] for patency loss: 0.35, P=0.008) and secondary patency (HR: 0.32, P=0.011). Across the entire follow-up period, stent occlusions occurred in 38 (40%) BMS cases, 42 (57%) CS, and 11 (19%) DES (P<0.001). Of these, acute limb ischemia (ALI) occurred in 2 (5%) BMS cases, 14 (33%) CS, and 1 (9%) DES (P=0.010). After adjustment, the relative risk of presenting with ALI as opposed to claudication was 27 times greater among patients re-presenting with occluded CS compared to BMS (P=0.020). There were no significant differences in AFS or all-cause mortality across the 3 cohorts. For long-segment SFA lesions, DES is associated with improved primary-assisted and secondary patency over long-term follow-up. In the event of stent occlusion, CS is associated with an increased risk of ALI.

Comparison of Effectiveness of Drug-Coated Balloon Angioplasty versus Plain Balloon Angioplasty in Chronic Lower Extremity Ischemia Patients.

BackgroundOcclusive lesions of superficial femoral artery (SFA) in endovascular candidate patients are treated with balloon angioplasty with or without stenting. Recently, introduction of drug-coated balloon (DCB) angioplasty as a superior treatment option to plain balloon (PB) has been challenging.ObjectiveThe purpose of this study was to compare the effectiveness of DCB versus PB angioplasty in chronic lower extremity ischemia patients.Patients and MethodsIn this clinical trial, 2 groups were matched at baseline; among 68 patients with peripheral artery disease, 23 patients were treated by DCB and 45 by PB. They were followed up for 6 months. Our findings of ABI, Rutherford and WIFI class changes, mortality, limb amputation, re-intervention and primary patency (PP) were collected and analyzed in comparative fashion between 2 groups.ResultsMean patients age was 68.5 years (77.9% male). At 6 months, the increase in ABI in DCB was 0.37 and in PB was 0.32 (P>0.05). Mean decrease in Rutherford class in DCB and PB were 2.56, 2.28 (P>0.05). Mean decrease in WIFI class in DCB and PB were 1.48, 1.11 (P>0.05). In DCB group, 1 (4.3%) limb amputation, 3 (13%) re-interventions and no mortality with 87% PP were seen. In PB group, 2 (4.4%) limb amputation, 7 (15.6%) re-interventions, 1 (2.2%) mortality with 84.4% PP were seen.ConclusionTreatment of occlusive lesions of SFA with DCB probably may leads to improvement in ABI, Rutherford and WIFI class, higher pp and lower rate of re-interventions. Since Rutherford class and pp in DCB group have improved during 6 months compared to 1 month follow up (in our study), this improvement seems to be more significant statistically in longer term of follow up.

Lumen Loss at 1 Year After Bare Nitinol Stent Implantation in the Superficial Femoral Artery

Purpose To investigate lumen loss (LL) at 1 year after bare nitinol stent (BNS) implantation for de novo superficial femoral artery (SFA) lesions. Materials and Methods The subjects were 701 consecutive patients (mean age 74±9 years; 492 men) with 817 de novo SFA lesions treated with BNS implantation between January 2004 and September 2015. The mean lesion length was 141±88 mm and the mean vessel diameter was 5.4±0.9 mm. The endpoint was LL at 1 year after BNS implantation. Secondary outcomes were restenosis and target lesion revascularization (TLR) estimated using the Kaplan-Meier method; estimates are reported with the 95% confidence interval (CI). LL was defined as the minimum lumen diameter immediately after BNS implantation minus that at 1 year measured by angiographic quantitative vessel analysis. The distribution of LL in the overall population was estimated using an accelerated failure time model. Results Mean LL at 1 year was estimated to be 1.74±1.28 mm (95% CI 1.63 to 1.84). Current smoking was positively associated with LL (p=0.015), whereas lack of cilostazol use was correlated with an increase in LL (p=0.001). Reference vessel diameter and lesion length did not have any significant association with LL at 1 year. The 1-year cumulative estimate of restenosis was 25% (95% CI 22% to 28%); the corresponding value for TLR was 18% (95% CI 15% to 21%). Conclusion Mean LL progressed by at least 1.6 mm up to 1 year after BNS implantation. The risk factors for increased LL were current smoker and lack of cilostazol use.

Three-Year Sustained Clinical Efficacy of Drug-Coated Balloon Angioplasty in a Real-World Femoropopliteal Cohort

Purpose: To report the 36-month outcomes from the prospective, multicenter, single-arm IN.PACT Global Study (ClinicalTrials.gov identifier NCT01609296) evaluating the performance of the IN.PACT Admiral drug-coated balloon (DCB) in real-world patients with femoropopliteal occlusive disease. Materials and Methods: The IN.PACT Global Study was conducted at 64 international sites and enrolled 1535 patients with complex lesions, which included bilateral disease, multiple lesions, de novo in-stent restenosis, long lesions, and chronic total occlusions. The predefined full clinical cohort included 1406 patients (mean age 68.6 years; 67.8% men) with claudication or rest pain treated with the study DCB. Mean lesion length was 12.09±9.54 cm; 18.0% had in-stent restenosis, 35.5% were totally occluded, and 68.7% were calcified. Freedom from clinically-driven target lesion revascularization (CD-TLR) was evaluated through 36 months. The safety composite endpoint was freedom from device- and procedure-related death through 30 days and freedom from major target limb amputation and clinically-driven target vessel revascularization within 36 months. All safety and revascularization events were reviewed by an independent clinical events committee. Results: The Kaplan-Meier estimate of freedom from CD-TLR through 36 months was 76.9%. The composite safety endpoint was achieved in 75.6% of patients. The 36-month all-cause mortality rate was 11.6%, and the major target limb amputation rate was 1.0%. The Kaplan-Meier estimate of freedom from CD-TLR through 36 months was significantly lower in patients with chronic limb-threatening ischemia (CLTI) compared with claudicants (67.6% vs 78.0%; p=0.003). Lesions affecting both the superficial femoral artery (SFA) and popliteal artery had lower Kaplan-Meier freedom from CD-TLR through 36 months (69.2%) than either isolated SFA (79.7%) or popliteal artery lesions (76.5%; log- rank p<0.001). Predictors of CD-TLR through 36 months included increased lesion length, reference vessel diameter ≤4.5 mm, in-stent restenosis, bilateral disease, CLTI, and hyperlipidemia. Conclusion: DCB angioplasty with the IN.PACT Admiral DCB for femoropopliteal disease in a diverse and complex real-world population is associated with sustained clinical efficacy and low rates of reinterventions at 3 years after the initial procedure.

Evaluation of superficial femoral artery-lesions after percutaneous transluminal angioplasty: color-coded summation images vs. monochromatic digital subtraction angiography

BackgroundPercutaneous transluminal angioplasty (PTA) is increasingly requested in the therapy of peripheral arterial occlusive disease. The evaluation of the technical result after balloon angioplasty with regard to bailout stenting is highly dependent on the operators´ subjective assessment and mainly based on the monochromatic digital subtraction angiography (DSA) images. The aim of this study was to compare color-coded single image as a novel diagnostic tool with monochromatic DSA for the analysis of flow limitation and need for stent implantation after PTA of superficial femoral artery (SFA) stenoses.MethodsDuring a period of 18 months, 213 SFA lesions were treated by PTA with a standard balloon in 170 patients, resulting in a total of 193 endovascular procedures. The median age of the patients was 77 years (range, 35–96 years). Median length of the treated lesions was 10.5 cm (range, 1.0–50 cm). Three interventional radiologists retrospectively evaluated the results of balloon angioplasty with monochromatic as well as post-processed color-coded DSA images for flow limitations to decide if subsequent stent implantation was necessary. Consensus reading of two experienced interventional radiologists 2 months after the initial review served as reference standard to perform a receiver operating characteristics (ROC) analysis.ResultsROC analysis for readers A, B and C showed area under the curve (AUC) values of 0.797, 0.865 and 0.804 for color-coded DSA and AUC values of 0.792, 0.843 and 0.872 for monochromatic DSA: a significant advantage of color-coded over conventional monochromatic DSA was not found for readers A and B (p > 0.05). Results of reader C were significantly better in the assessment of monochromatic images (p = 0.023). Diagnostic confidence using color-coded images was slightly higher than in monochromatic images (κ = 0.486 vs. κ = 0.459).ConclusionsIn this study, color coded DSA did not reveal to be superior to conventional monochromatic DSA when evaluating results of PTA and when deciding whether stent implantation is necessary or not. This technology, however, requires further experiences with special regard to homogeneously trained radiologists and to the time requirement.

Plaque volume reduction after drug-coated balloon angioplasty for superficial femoral artery lesion.

Paclitaxel has a potentially beneficial effect on atherosclerotic plaque volume reduction; however, data about plaque volume reduction in real-world practice are scarce. We herein report a case whose plaque volume of superficial femoral artery was analyzed using high-definition intravascular ultrasound just after endovascular treatment using drug-coated balloon and at 6months after the procedure. From analysis using a quantitative intravascular ultrasound analysis system, the lumen volume was enlarged (from 2909.2 to 4944.1mm3) as a result of not only vessel volume enlargement (from 7242.0 to 8296.3mm3) but also plaque volume reduction (from 4332.8 to 3352.2mm3).

Three-Year Efficacy and Safety of the Misago Peripheral Stent for Superficial Femoral Artery Disease: Final Results from the OSPREY Trial

PurposeThis study evaluated the long-term outcomes of the Misago peripheral stent trial (Terumo) for atherosclerotic lesions in the superficial femoral artery (SFA) in patients with claudication. Materials and MethodsThis was a prospective multicenter, single-arm, clinical trial of primary stent placement for de novo cases of SFA disease conducted in the United States and Asia. The primary endpoint was freedom from clinically driven target lesion revascularization (CD-TLR) at 36 months. Secondary outcomes were ankle-brachial index (ABI), Rutherford score, Walking Impairment Questionnaire (WIQ), a quality of life survey, and rate of device fracture. ResultsA total of 276 patients (64.4% male; mean age, 69.3 ± 10.1 years) were enrolled. Freedom from CD-TLR was 78.5% (95% confidence interval [CI], 73.0%–83.0%) at 24 months and 75.4% (95% CI, 69.6%–80.2%) at 36 months. Baseline ABI was 0.7 ± 0.1 and 0.98 ± 0.20 (P < .001) at 30 days after the procedure. Baseline Rutherford score was 3.6 ± 0.6 and 1.6 ± 1.0 30 at 30 days after the procedure (P < .001). Mean (and changed) ABI and Rutherford score at 36 months compared to day 30 after the procedure were, respectively, 0.91 (−0.1 ± 0.2) and 1.5 (−0.2 ± 1.1). WIQ score at baseline was 21.49 ± 26.30 and 50.51 ± 38.49 at 30 days after the procedure ( P < .001). The mean WIQ score at 2 years was 46.65 ± 37.31 (P = .12). Stent fracture rate at 36 months was 2.0% (4 of 202 patients). ConclusionsOSPREY (Occlusive-Stenotic Peripheral Artery Revascularization Study) 36-month data demonstrated persistent freedom from CD-TLR and sustained improvement in ABI and Rutherford score with primary stent placement for SFA lesions.

A Quantitative Method for Prediction of True Lumen Recanalization in Chronic Total Occlusion of the Superficial Femoral Artery

This study aimed to examine a quantitative method for evaluating calcification in failure in recanalization (FR) in endovascular treatment of superficial femoral artery (SFA) chronic total occlusion, and to investigate the possibility of using a formula to predict the incidence of true lumen recanalization (TR) in such cases. Patients who met the inclusion criteria were retrospectively analyzed in our center from January 2012 to September 2017. A Calcification Lesion Analyzing and Scoring System (CLASS) was established to quantify the characteristics of calcification in SFA computed tomography slices, which were ranked as grade 1-4 and class A-E. Corresponding scores were obtained, and the Cumulative Calcification Score (CCSO) of occlusive SFA was calculated on the basis of CLASS. The factors correlating to FR and the formula for predicting TR were evaluated. A total of 215 patients were included in this study. There were 150 cases of TR and 65 cases of subintimal recanalization; 12 (5.6%) cases had FR. The maximum CLASS of occlusion was correlated with FR. Not only the formula including Trans-Atlantic Inter-Society Consensus II grade and CCSO but also the formula including occlusion length and CCSO predicted the incidence of TR well. The degree of the most severe calcification in occlusive lesions clearly affects success in recanalization. Two quantitative formulas that combine occlusion length or Trans-Atlantic Inter-Society Consensus II grade with CCSO can predict TR in endovascular treatment of SFA lesions with chronic total occlusion.