Status Update and Interim Results from the Asymptomatic Carotid Surgery Trial-2 (ACST-2)

Objectives: ACST-2 is currently the largest trial ever conducted to compare carotid artery stenting (CAS) with carotid endarterectomy (CEA) in patients with severe asymptomatic carotid stenosis requiring revascularization. Methods: Patients are entered into ACST-2 when revascularization is felt to be clearly indicated, when CEA and CAS are both possible, but where there is substantial uncertainty as to which is most appropriate. Trial surgeons and interventionalists are expected to use their usual techniques and CE-approved devices. We report baseline characteristics and blinded combined interim results for 30-day mortality and major morbidity for 986 patients in the ongoing trial up to September 2012. Results: A total of 986 patients (687 men, 299 women), mean age 68.7 years (SD ± 8.1) were randomized equally to CEA or CAS. Most (96%) had ipsilateral stenosis of 70-99% (median 80%) with contralateral stenoses of 50-99% in 30% and contralateral occlusion in 8%. Patients were on appropriate medical treatment. For 691 patients undergoing intervention with at least 1-month follow-up and Rankin scoring at 6 months for any stroke, the overall serious cardiovascular event rate of periprocedural (within 30 days) disabling stroke, fatal myocardial infarction, and death at 30 days was 1.0%. Conclusions: Early ACST-2 results suggest contemporary carotid intervention for asymptomatic stenosis has a low risk of serious morbidity and mortality, on par with other recent trials. The trial continues to recruit, to monitor periprocedural events and all types of stroke, aiming to randomize up to 5,000 patients to determine any differential outcomes between interventions. Clinical trial: ISRCTN21144362. © 2013 European Society for Vascular Surgery. Published by Elsevier Ltd. All rights reserved

Dual- vs single-layer stents for endovascular treatment of symptomatic and asymptomatic internal carotid artery stenosis

Backgrounds: Plaque protrusion is a common event among carotid artery stenting (CAS) patients and increases ischemic complication risk. Dual-layer stents (DLS) with micromesh technology may offer greater plaque protection compared to single-layer stents (SLS), but few data are available. The aim of the study is to compare clinical outcomes at 12 months for asymptomatic and symptomatic patients treated for primary CAS with DLS or SLS in a high-volume center. Methods: A retrospective analysis of consecutive symptomatic and asymptomatic patients treated with primary CAS for internal carotid artery (ICA) stenosis, with either DLS or SLS between 2015 and 2019, was performed. Primary endpoints included rates of ipsilateral transient ischemic attacks (TIA)/stroke and death within 1-year from CAS. Secondary endpoints included patency rates and survival according to stent type. Results: Of the 301 patients who met inclusion criteria (74.8 % male; 73.6 mean age ± 8.7 years), most patients were asymptomatic (77.4 %). Among all patients DLS was most frequently deployed (66 %); also, among asymptomatic (62 %) and symptomatic patients (81 %), p < 0.01. Symptomatic patients had less comorbidities and severe disease than asymptomatic patients. Six peri-operative strokes were recorded and, within 1 year, 2 additional strokes were registered among symptomatic patients treated with SLS. No post-operative strokes were encountered in the DLS group (p = 0.04) among symptomatic patients. Higher rates of TIA were observed among asymptomatic patients treated with DLS compared to SLS while rates of TIA were reduced among symptomatic patients treated with DLS. There were no differences in patency rates for DLS and SLS in symptomatic and asymptomatic patients. Primary patency was similar among DLS stent types but differed among SLS stent types (p = 0.01). At a mean follow-up of 27 months ±17.6, survival was comparable between DLS and SLS groups (p = 0.98). Conclusion: CAS with DLS seems to reduce the risk of post-procedural stroke for symptomatic patients compared to SLS whilst the choice of stent did not influence ipsilateral TIA, survival or patency rates. These data require confirmation from larger, randomized, prospective studies

A multicenter comparison between autologous saphenous vein and heparin-bonded expanded polytetrafluoroethylene (ePTFE) graft in the treatment of critical limb ischemia in diabetics.

OBJECTIVES: The aim of this study was to evaluate early and follow-up results of below-knee bypasses performed using a bioactive heparin-treated expanded polytetrafluoroethylene (ePTFE) graft in diabetic patients with critical limb ischemia (CLI) in a multicenter retrospective registry involving seven Italian vascular centers and to compare them with those obtained in patients operated on with autologous saphenous vein (ASV) in the same centers in the same period of time. METHODS: Over an 8-year period, ending in 2009, a heparin-bonded prosthetic graft (Propaten Gore-Tex; W. L. Gore & Associates Inc, Flagstaff, Ariz) was implanted in 180 diabetic patients undergoing below-knee revascularization for CLI in seven Italian hospitals (group 1). In the same period in these seven centers, 133 below-knee bypasses with ipsilateral ASV in diabetics with CLI were performed (group 2). Data concerning these interventions were retrospectively collected in a multicenter registry with a dedicated database. Early (<30 days) results were analyzed in terms of graft patency, major amputation rates, and mortality. Follow-up results were analyzed in terms of primary and secondary graft patency, limb salvage, and survival. RESULTS: The interventions consisted of below-knee bypasses in 132 cases in group 1 (73%) and in 45 cases in group 2 (33%; P .9, log-rank 0.08). Primary patency rate at 48 months was significantly better in group 2 (63.5%) than in group 1 (46.3%; P = .03, log-rank 4.1). Assisted primary patency rates at 48 months were 47.3% (SE 0.05) in group 1 and 69% (SE 0.05) in group 2 (P = .01, log-rank 6.3). The rates of secondary patency at 48 months were 57.5% in group 1 and 69.6% in group 2 (P = .1, log-rank 2.3); the corresponding values in terms of limb salvage and amputation free-survival rates were 75.4% and 82.4% (P = .3, log-rank 1), and 59.9% and 64.4% (P = .3, log-rank 0.9), respectively. CONCLUSIONS: Data from this large, retrospective registry confirmed that the indexed heparin-bonded ePTFE graft provides satisfactory early and midterm results in diabetic patients undergoing surgical treatment of CLI. While autologous saphenous vein maintains its superiority in terms of primary patency, secondary patency rates are not statistically different, even in the presence of a trend for improved secondary patency with vein graft; and also limb salvage rates are comparable

A Multicenter Predictive Score for Amputation-Free Survival for Patients Operated on with an Heparin-Bonded ePTFE Graft for Critical Limb Ischemia

Aim of the study: To retrospectively create a predictive score for estimating amputation-free survival (AFS) in patients with critical limb ischemia (CLI) operated on with the use of a heparin-bonded expanded polytetrafluoroethylene (ePTFE) bypass graft (Hb-ePTFE). Methods: Over a 13-year period, ending in March 2015, a Hb-ePTFE graft was implanted in 683 patients undergoing below-knee revascularization for CLI in seven Italian vascular hospitals. Data concerning these interventions were retrospectively collected in a multicenter registry with a dedicated database. Univariate and multivariable analyses with Kaplan–Meier estimates were used to identify potential significant predictors of AFS at 5&nbsp;years, and then a predictive risk score was constructed. A qualitative assessment of the Kaplan–Meier survival estimates for each integer score was performed, and subgroups of risk were stratified on the basis of the primary end point. Results: Overall, estimated 5-year AFS rate was 48.3&nbsp;% (SE 0.024). At multivariate analysis, older age, coronary artery disease, end-stage renal disease, tissue loss and poor runoff score were predictors of AFS. The integer score ranged from 0 to 11; Kaplan–Meier analysis for AFS in each score group identified three subgroups with significant differences at 5&nbsp;years: low-risk subgroup (scores from 0 to 2, 67.7&nbsp;%), medium-risk subgroup (scores 3 and 4, 49.2&nbsp;%, p&nbsp;&lt;&nbsp;0.001 in comparison with low-risk subgroup) and high-risk subgroup (scores from 5 to 11, 25.2&nbsp;%, p&nbsp;&lt;&nbsp;0.001 in comparison with either low-risk subgroup or medium-risk subgroup). Conclusions: A category of low-risk patients with CLI treated with the indexed graft does exist, thus suggesting a primary role for Hb-ePTFE in such patients. A prospective validation of such a score is necessary

Early outcomes with a single-sided access endovascular stent

Objective: The objective of this study was to report the 1-year follow-up study results of the new Horizon stent graft (Endospan, Herzliya, Israel) from two different prospective consecutive trials. The Horizon abdominal aortic aneurysm stent graft system is a 14F profile system requiring only a single access site. It consists of three modules, introduced separately: base limb (iliac to iliac limb); distal aortic limb; and proximal aortic limb with a bare suprarenal crown and active fixation. Methods: Data from the first in man (FIM) clinical study with 10 patients enrolled and the pivotal study with 30 patients were analyzed. Outcomes measured were freedom from major adverse events (MAEs) including all-cause mortality, myocardial infarction, renal failure, respiratory failure, paraplegia, stroke, bowel ischemia, and procedural blood loss ≥1000 mL. Performance end points included successful delivery and deployment of the device, freedom from aneurysm growth ≥5 mm, type I or type III endoleak, stent graft occlusion, conversion to open surgery, rupture, and stent graft migration. Results: In the FIM study, one conversion to open surgery with >1000 mL of blood loss was registered perioperatively. In the pivotal study, no perioperative MAE was registered. Overall, at 1-year follow-up, two deaths and one aneurysm growth unrelated to endoleak were registered. Conclusions: The results of both the FIM and pivotal studies demonstrated that 39 of 40 procedures were successful for delivery and deployment of the Horizon stent graft. No MAE was registered during the follow-up. The primary safety and performance end points were met in both studies