AMS INSIGHT—Absorbable Metal Stent Implantation for Treatment of Below-the-Knee Critical Limb Ischemia: 6-Month Analysis

Endoluminal treatment of infrapopliteal artery lesions is a matter of controversy. Bioabsorbable stents are discussed as a means to combine mechanical prevention of vessel recoil with the advantages of long-term perspectives. The possibility of not having a permanent metallic implant could permit the occurrence of positive remodeling with lumen enlargement to compensate for the development of new lesions. The present study was designed to investigate the safety of absorbable metal stents (AMSs) in the infrapopliteal arteries based on 1- and 6-month clinical follow-up and efficacy based on 6-month angiographic patency. One hundred seventeen patients with 149 lesions with chronic limb ischemia (CLI) were randomized to implantation of an AMS (60 patients, 74 lesions) or stand-alone percutaneous transluminal angioplasty (PTA; 57 patients, 75 lesions). Seven PTA-group patients “crossed over” to AMS stenting. The study population consisted of patients with symptomatic CLI (Rutherford categories 4 and 5) and de novo stenotic (>50%) or occlusive atherosclerotic disease of the infrapopliteal arteries who presented with a reference diameter of between 3.0 and 3.5 mm and a lesion length of <15 mm. The primary safety endpoint was defined as absence of major amputation and/or death within 30 days after index intervention and the primary efficacy endpoint was the 6-month angiographic patency rate as confirmed by core-lab quantitative vessel analysis. The 30-day complication rate was 5.3% (3/57) and 5.0% (3/60) in patients randomized for PTA alone and PTA followed by AMS implantation, respectively. On an intention-to-treat basis, the 6-month angiographic patency rate for lesions treated with AMS (31.8%) was significantly lower (p = 0.013) than the rate for those treated with PTA (58.0%). Although the present study indicates that the AMS technology can be safely applied, it did not demonstrate efficacy in long-term patency over standard PTA in the infrapopliteal vessels

Passagem Retrógrada Percutânea De Uma Lesão Estenosante Crítica Do Tronco Celíaco Via Artéria Mesentérica Superior Como Manobra Adjuvante Na Abordagem Anterógrada

We describe the case of a 63-year-old woman with chronic mesenteric ischemia, persistent postprandial upper abdominal pain and progressive weight loss. Retrograde recanalization was performed via the superior mesenteric artery in order to achieve the goal of crossing the near-occlusion, showing that retrograde catheterization of the celiac trunk can be a feasible approach in challenging cases in which an antegrade approach fails as a single maneuver. © 2016, Sociedade Brasileira de Angiologia e Cirurgia Vascular. All rights reserved.151616

Safety, Clinical Outcome, and Fracture Rate of Femoropopliteal Stenting Using a 4F Compatible Delivery System.

OBJECTIVE: To determine the safety, clinical outcome, and fracture rate of femoropopliteal interventions using 4F stents. METHODS: Between January 2010 and December 2011, 112 symptomatic patients were treated by stent implantation. Ten patients were lost to follow up; therefore, 102 patients (62 men; mean age 66.4 +/- 10.1 years) were retrospectively analyzed. The indication for femoropopliteal revascularization was severe claudication (Rutherford-Becker score = 3) in 63 (62%) patients and chronic critical limb ischemia (Rutherford-Becker score = 4-6) in 39 (38%). Follow up included palpation of peripheral pulses and measurement of ankle brachial index. In patients with suspected in-stent restenosis duplex ultrasonography was performed. In 2013, patients were asked to return for a fluoroscopic examination of the stents. RESULTS: 114 lesions (Trans-Atlantic InterSociety Consensus-C and D, n = 45) were treated with 119 stents (Astron Pulsar, n = 42; Pulsar-18, n = 77). Lesions were long (>/=100 mm) in 49 cases and heavily calcified in 35. Stents were long (>/=120 mm) in 46 cases. Ten stents were partially overlapped. The technical and clinical success rates were 100%. Two puncture related complications were noted, neither of which required surgical repair. Eleven patients died (myocardial infarction, n = 4; stroke, n = 2; cancer, n = 5) and nine patients underwent major amputation (above knee, n = 4). The primary patency rate was 83% at 6 months and 80% at 12 months. The primary assisted patency rate was 97% at 6 months and 94% at 12 months. The secondary patency rate was 86% at 6 months and 85% at 12 months. The prevalence of fractures was 26% (type III and IV, 10%) after an average follow up of 25 months. CONCLUSION: Femoropopliteal stenting using a 4F compatible delivery system can be accomplished with a low complication rate, acceptable fracture rate, and with similar 12 month patency and revascularization rates as their 6F counterparts

Long-term results of carotid artery stenting

ObjectiveData regarding the long-term efficacy of carotid artery stenting (CAS) are still scarce. As demonstrated by several major randomized controlled trials (RCT) comparing the efficacy of carotid endarterectomy (CEA) vs medical therapy, even after successful carotid revascularization late ipsilateral stroke occurs in 5-13% at 5 years. Therefore, major concerns also remain about the durability of the CAS procedure in terms of stroke prevention. The purpose of this study was to review long-term results after carotid stent implantation in a large cohort of patients.MethodsThis retrospective investigation involved 3179 CAS procedures performed at four European carotid high-volume centers. Echo-duplex scan using modified velocity criteria to recognize in-stent restenosis (ISR) and neurological examinations of all patients were carried out every 6 months after the procedure. Life-table analysis was used to determine freedom from mortality, stroke-related death, ipsilateral fatal/major stroke, and any ipsilateral stroke. Freedom from ISR and from reintervention were also reported. The secondary aim was to identify predictive risk factors for neurological complications and ISR.ResultsAt 5 years freedom from mortality, stroke-related death, ipsilateral fatal/major stroke, and any stroke rate were 82%, 93.5%, 93.3%, and 91.9%, respectively. The only predictor for neurological complications was the presence of neurological symptoms before CAS (hazard ratio 1.38 [CI 1.05, 1.82] P = .02). Freedom from restenosis at 1, 3, and 5 years was, respectively, 98.4%, 96.1%, and 94%. Uni- and multi-variate analyses showed that stent characteristics (material/design/free-cell area) were not significantly associated with time to in-stent restenosis or time to reintervention.ConclusionOur long-term results in a large cohort of patients validated CAS as a durable procedure for stroke prevention. The annual rate of neurological complications after CAS was comparable to that of conventional surgery as demonstrated by large RCTs involving both symptomatic patients (North American Symptomatic Carotid Endarterectomy Trial [NASCET] and European Carotid Surgery Trial [ECST]) and asymptomatic patients (Asymptomatic Carotid Atherosclerosis Study [ACAS] and Asymptomatic Carotid Surgery Trial [ACST])

Does Free Cell Area Influence the Outcome in Carotid Artery Stenting?

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ZILVERPASS Study: ZILVER PTX Stent versus Prosthetic Above-the-Knee Bypass Surgery in Femoropopliteal Lesions, 5-year Results.

PURPOSE To report the 60-month safety and effectiveness results of a multicenter, prospective, randomized controlled trial comparing the ZILVER PTX paclitaxel-eluting stent to prosthetic above-the-knee bypass for the treatment of symptomatic TransAtlantic Inter-Society Consensus (TASC) C and D femoropopliteal lesions. MATERIALS AND METHODS Patients were enrolled between October 2013 and July 2017. One of the secondary outcomes was primary patency at 60 months, defined as no evidence of binary restenosis or occlusion within the target lesion or bypass graft based on a duplex ultrasound peak systolic velocity ratio < 2.4 and no clinically-driven target lesion revascularization (TLR) in endovascular cases or reintervention to restore flow in the bypass at 60 months. Survival rates after 5 years were also analyzed. RESULTS 220 patients (mean age 68.6 ± 10.5 years; 159 men) were included and randomized to ZILVER PTX (n = 113, 51.40%) or BYPASS group (n = 107, 48.60%). The 60-month primary patency rate was 49.3% for the ZILVER PTX group versus 40.7% for the bypass group (p = 0.6915). Freedom from TLR was 63.8% for the ZILVER PTX group versus 52.8% for the bypass group (p = 0.2637). At 5 years, no significant difference in survival rate could be seen between the ZILVER PTX and the bypass group (69.1% vs. 71% respectively, p = 0.5503). CONCLUSION Even at 5 years, non-inferior safety and effectiveness results of the ZILVER PTX could be seen. These findings confirmed that the use of ZILVER PTX stents can be considered as a valid alternative for bypass surgery when treating long and complex femoropopliteal lesions

First clinical trial of nitinol self-expanding everolimus-eluting stent implantation for peripheral arterial occlusive disease

BackgroundA novel self-expanding drug-eluting stent was designed to slowly release everolimus to prevent restenosis following peripheral arterial intervention. The purpose of the first-in-human Superficial Femoral Artery Treatment with Drug-Eluting Stents (STRIDES) trial was to evaluate the safety and efficacy of this device for the treatment of symptomatic superficial femoral and proximal popliteal arterial occlusive disease.Methods and ResultsOne hundred four patients were enrolled at 11 European investigative centers in a prospective, nonrandomized, single-arm trial. The patients had severe symptomatic vascular disease, including a significant proportion of patients with critical limb ischemia (17%), diabetes (39%), and single-vessel outflow (26%). The mean lesion length was 9.0 ± 4.3 cm. Ninety-nine percent of patients were available for 12-month follow-up, including duplex imaging in 90% and arteriography in 83%. Clinical improvement, defined as a sustained decrease in Rutherford-Becker clinical category, was achieved in 80% of patients. Primary patency (freedom from ≥50% in-stent restenosis) was 94 ± 2.3% and 68 ± 4.6% at 6 and 12 months, respectively. Plain radiographic examination of 122 implanted devices at 12 months revealed no evidence for stent fracture.ConclusionsThe everolimus-eluting self-expanding nitinol stent can be successfully implanted in patients with severe peripheral arterial disease with favorable outcomes and clinical improvements observed in the majority of patients