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Objective: In two randomized controlled trials, the outcomes of endovascular treatment of complex femoropopliteal arterial lesions were compared with bypass surgery and considered a valid alternative treatment. The aim of this study was to compare both endovascular treatment options with the hypothesis that implantation of heparin-bonded self-expanding covered stents (Viabahn [SECS]) or drug-eluting stents (ZilverPTX [DES]) are related to similar clinical outcomes at 1-year follow-up., Methods: In a post-hoc analysis, the SuperB trial and Zilverpass databases were merged. Patients in the endovascular treatment arms were included, and data was analyzed in an intention-to-treat (ITT) and a per-protocol (PP) fashion. Data included baseline and lesion characteristics, procedural details, and follow-up data. The primary endpoint of this study was primary patency at 1-year follow-up. The secondary endpoints were secondary patency, target lesion revascularization (TLR), limb loss, and all-cause mortality., Results: A total of 176 patients were included; 63 in the SECS arm and 113 in the DES arm. Through 1-year follow-up, there were no significant differences in primary patency (ITT: 63.4% vs 71.1%: P = .183 and PP: 60.8% vs 71.1%; P = .100). Secondary patency rates were not significantly different in the ITT analysis (86.5% vs 95.1%; P = .054), but in the PP analysis, there was a significant difference in favor of the DES group (SECS, 85.6% vs DES, 95.1%; P = .038). There was no significant difference in freedom from TLR between groups (79.6% vs 77.0%; P = .481). No major amputations were performed in the SECS group, and two were performed in the DES group (1.8%). Survival rate was 98.2% in the SECS group, and 91.3% in the DES group after 1-year follow-up (P = .106). Based on diagnosis (intermittent claudication vs chronic limb-threatening ischemia) no differences between patients with intermittent claudication and chronic limb-threatening ischemia were observed in primary patency, secondary patency and freedom from TLR., Conclusions: Treatment of complex femoropopliteal arterial disease with the heparin-bonded Viabahn endoprosthesis and the Zilver PTX drug-eluting stent are related to similar primary and secondary patency, and TLR rates at 1 year, except for secondary patency in the PP analysis. This study further supports the endovascular treatment of long complex lesions in the femoropopliteal artery., Competing Interests: Disclosures L.v.W. received speaker fees from W.L. Gore & Associates. M.B. reports consulting for Cook Medical. K.D. reports consulting for W.L. Gore & Associates and Cook Medical. C.J.Z. reports research support, honoraria, and travel support from W.L. Gore & Associates and Cook Medical. M.R. reports consulting for W.L. Gore & Associates., (Copyright © 2024 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)

Background: Edge stenoses are the predominant limitation of self-expanding covered stent treatment of superficial femoral artery (SFA) occlusive disease, necessitating reinterventions. Angioplasty of an edge stenosis is associated with a high recurrence rate. Drug-coated balloon (DCB) treatment of edge stenoses might improve outcomes by decreasing the incidence of restenosis., Purpose: The aim of this study was to evaluate the outcomes of using a DCB for the treatment of edge stenoses after self-expanding covered stent placement for SFA occlusive disease., Method: We performed a retrospective analysis of patients treated with a DCB for edge stenoses after self-expanding covered stent placement. The primary endpoint was primary patency at one year. The secondary endpoints included procedure-related complications, secondary patency, and freedom from target lesion revascularization (TLR)., Results: A total of 21 patients with 28 edge stenoses were included. The time from primary treatment to treatment of the edge stenosis was 19 months (interquartile range (IQR) 8; 52 months). Primary patency and assisted primary patency at one year were 66.7% with a secondary patency of 90.9%. Freedom from TLR was 86.1%, and freedom from clinically driven TLR was 89.4%. Four patients presented with a hemodynamically significant restenosis, and three of those patients had an occlusion. Median time to failure was six months (IQR 3.5; 7.0 months), and median time to occlusion was four months (IQR 3.0; 6.0 months)., Conclusion: The treatment of edge stenoses using a DCB is associated with a safe one-year outcome; however, this has to be confirmed in larger prospective studies. The continuous surveillance of patients is indicated.

Objectives: This study sought to compare heparin-bonded endografts with femoropopliteal bypass, including quality of life, using general health and disease-specific questionnaires as well as patency rates., Background: Endovascular treatment continues to advance and is gaining acceptance as primary treatment for long occlusive or stenotic lesions in the superficial femoral artery. Heparin-bonded expanded polytetrafluoroethylene endografts have been related to outcomes comparable to bypass surgery, but this has not been tested in a randomized fashion., Methods: A multicenter randomized-controlled trial was performed comparing femoropopliteal bypass with heparin-bonded expanded polytetrafluoroethylene endografts. Data were analyzed on an intention-to-treat and per-protocol manner., Results: A total of 129 patients were randomized and 125 patients were treated, 63 in the endoluminal and 62 in the surgical group (42 venous, 20 prosthetic). Enrollment was terminated before reaching the predefined target number for patency. Baseline characteristics and anatomical data were similar. Patients were treated for critical limb ischemia in 38.1% and 32.2% in the endoluminal and surgical arms, respectively. Mean lesion length was 23 cm in both groups and lesions were largely TransAtlantic Inter-Society Consensus II D. Hospitalization time and 30-day morbidity were significantly lower in the endoluminal group, without differences in serious adverse events (n = 5 each; surgical: 4 venous and 1 polytetrafluoroethylene bypass). There were no significant differences in Rutherford category between groups at any time point. At 30 days the endoluminal group showed a greater improvement in quality-of-life scores. At 1 year, these differences had largely disappeared and no differences in primary (endoluminal: 64.8%; surgical: 63.6%), assisted primary (endoluminal: 78.1%; surgical: 79.8%), secondary patency (endoluminal: 85.9%; surgical: 83.3%), and target vessel revascularization (endoluminal: 72.1%; surgical: 71.0%) were observed. Limb salvage rate was 100% in both groups., Conclusions: Heparin-bonded endoluminal bypass for long segment lesions shows promising results (less morbidity, faster recovery, and improvement in quality of life with indistinguishable patency rates at 1 year) compared with surgical bypass. Long-term results have to be awaited., (Copyright © 2017 The Authors. Published by Elsevier Inc. All rights reserved.)

Objective: Self-expanding covered stents for superficial femoral artery (SFA) occlusive disease have undergone an evolution during the years. Early results of the latest generation, the heparin-bonded Viabahn (W. L. Gore & Associates, Flagstaff, Ariz) with a contoured proximal edge, were promising, with reported 1-year primary patency rates of 73% to 78% in long lesions. The aim of this study was to present the 3-year outcome of the heparin-bonded Viabahn for SFA occlusive disease., Methods: All patients treated with a heparin-bonded Viabahn in three centers between April 2009 and December 2011 were included in the study and retrospectively analyzed. Clinical state in Rutherford category, ankle-brachial indexes, and duplex ultrasound scans were the features of follow-up at 6 weeks and 6, 12, 24, and 36 months. Primary end points of the study were the 3-year primary, primary assisted, and secondary patency rates., Results: A total of 73 SFAs in 70 patients were treated with a heparin-bonded Viabahn and included in the study. Fifty-four patients were male (77%), and the mean age was 70.0 ± 9.1 years. The mean lesion length was 17.4 ± 7.0 cm, and 84% were classified TransAtlantic Inter-Society Consensus II types C and D. The median follow-up was 25 months (range, 2-55 months). The 3-year primary, primary assisted, and secondary patency rates were 59%, 71%, and 82%, respectively, with a 3-year freedom from amputation of 100%., Conclusions: The use of a heparin-bonded Viabahn for SFA occlusive disease is related to patency rates within limits of surgical reconstruction. The procedure is related to low morbidity and amputation rates., (Copyright © 2015 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)

Objective: The role of endografts in the treatment of extensive superficial femoral artery (SFA) occlusive disease is enlarging. Results are limited by the occurrence of edge stenosis. The aim of the study was to retrospectively evaluate the efficacy of treatment of edge stenosis of endografts inserted for SFA occlusive disease., Methods: All patients, treated between November 2001 and December 2011, with a self-expandable polytetrafluoroethylene-endograft were gathered in a prospective database in three hospitals. The incidence of primary edge stenosis and the incidence of re-edge stenosis after treatment were retrospectively noted and a comparison was made between the results of percutaneous transluminal angioplasty (PTA) and extension of the endograft., Results: A total of 88 patients presented with 115 edge stenoses, of which the majority presented within 1 year after insertion of the endograft (mean time to edge stenosis 10.7 ± 8.2 months). Seventy-three stenoses (63%) manifested at the proximal and 42 at the distal edge (37%). The 1-year incidence of restenosis and/or occlusion was 45% after PTA and 43% after endograft extension, with 1-year patency rates of 81% and 92%, respectively. The incidence of restenosis/occlusion after treatment with PTA was 12% higher at two years compared to extension of the endograft (55% vs. 43%, respectively)., Conclusion: Edge stenosis may well be treated with either PTA or extension of the endograft. The incidence of restenosis and/or occlusion after both PTA and extension is high, but patency rates are acceptable. Aggressive surveillance is needed during the first year after insertion., (© 2015 Wiley Periodicals, Inc.)

Purpose: To evaluate the efficacy and outcome of thrombolysis and thrombectomy for thrombosed polytetrafluoroethylene stent-grafts inserted in the superficial femoral artery (SFA) for occlusive disease., Methods: A retrospective review was conducted of 79 consecutive patients with a thrombosed SFA endograft between November 2001 and December 2011. Of these, 46 (58%) were treated with thrombolysis (n=40, 87%) or thrombectomy (n=6, 13%) and form the study group (33 men; median age 66.8 years, range 30-80). Median time from stent-graft insertion to thrombosis was 3 months (range 0-53)., Results: Thrombolysis was successful in 38 (95%) patients over a mean 24 hours (range 3-48); one patient had failed lysis and another died during lytic treatment. Thrombectomy was successful in all 6 patients. Thrombosis without a causal lesion was significantly more common in occlusions that presented <30 days after insertion (p=0.01). Over a median follow-up of 14 months (range 1-69), reinterventions were performed for restenosis in 12 patients and reocclusion in 14 patients, all within 18 months after thrombolytic treatment. More than a third of patients (16/45) had definitive failures (2/6 from the thrombectomy group); 4 were treated conservatively (no/minor symptoms) and 12 had bypass grafts. Three (7%) patients eventually required a major amputation. The primary, assisted primary, and secondary patency rates of thrombolysis at 6 months were 56%, 56%, and 68%, respectively. Secondary patency for the entire cohort was 58% at 1 year., Conclusion: Thrombolysis and thrombectomy of thrombosed endografts in the SFA is effective and safe. Patency rates after treatment are moderate, but prolonged secondary patency can be achieved.

Objective: Endografts represent a relatively new treatment modality for occlusive disease of the superficial femoral artery, with promising results. However, endografts may occlude collateral arteries, which may affect outcome in case of failure. The purpose of this study was to analyze the clinical outcome of failed endografts in patients with superficial femoral artery occlusive disease., Methods: All patients treated with one or more polytetrafluorethylene-covered stents between November 2001 and December 2011 were prospectively included in a database. Patients with a failure of the endograft were retrospectively analyzed. Clinical and hemodynamic parameters were assessed before the initial procedure and at the time of failure. Outcome of secondary procedures was analyzed., Results: Among the 341 patients who were treated during the study period, 49 (14.4%) failed during follow-up. Mean (standard deviation) Rutherford category at failure did not differ from the category as scored before the initial procedure (3.1 [1.3] vs 3.3 [0.6]; P = .33). Forty-three percent of patients (n = 21) presented with the same Rutherford category as before the initial procedure, 37% (n = 18) with an improved category, and 20% (n = 10) with a deteriorated category. The ankle-brachial index was significantly lower at the time of failure (0.66 [0.19] vs 0.45 [0.19[; P <.002). Seventy-six percent of patients with a failure needed secondary surgery, of which 25% were below knee. The 1-year primary, primary-assisted, and secondary patency rates of secondary bypasses were 55.1%, 62.3%, and 77.7%, respectively. The amputation rate was 4.1% (n = 2)., Conclusions: Failure of endografts is not associated with a deterioration in clinical state and is related to a low amputation rate. The hypothesis that covered stents do not affect options for secondary reconstructions could not be confirmed, as 25% of patients with a failure underwent a below-knee bypass. Secondary surgical bypasses are correlated with poor patency. The amputation rate after failure is low., (Copyright © 2013 Society for Vascular Surgery. Published by Mosby, Inc. All rights reserved.)

Background: Endovascular treatment options for the superficial femoral artery are evolving rapidly. For long lesions, the venous femoropopliteal bypass considered to be superior above the prosthetic bypass. An endoluminal bypass, however, may provide equal patency rates compared to the prosthetic above knee bypass. The introduction of heparin-bonded endografts may further improve patency rates. The SUrgical versus PERcutaneous Bypass (SuperB) study is designed to assess whether a heparin-bonded endoluminal bypass provides equal patency rates compared to the venous bypass and to prove that it is associated with improved quality of life, related to a decreased complication rate, or not., Methods/design: Two-hundred-twenty-two patients with peripheral arterial occlusive disease, category 3-6 according to Rutherford, will be randomized in two treatment arms; 1. the surgical femoro-popliteal bypass, venous whenever possible, and 2. the heparin-bonded endoluminal bypass. The power analysis was based on a non-inferiority principle, with an effect size of 90% and 10% margins (alpha 5%, power 80%). Patients will be recruited from 5 teaching hospitals in the Netherlands during a 2-year period. The primary endpoint is primary patency and quality of life evaluated by the RAND-36 questionnaire and the Walking Impairment Questionnaire. Secondary endpoints include secondary patency, freedom-from-TLR and complications., Discussion: The SuperB trial is a multicentre randomized controlled trial designed to show non-inferiority in patency rates of the heparin-bonded endograft compared to the surgical bypass for treatment of long SFA lesions, and to prove a better quality of life using the heparin bonded-endograft compared to surgically treatment, related to a reduction in complications., Trial Registration: Clinicaltrials: NCT01220245.