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Purpose: To determine the predictive factors for in-stent restenosis (ISR) following stent-supported endovascular therapy (EVT) with intravascular ultrasound (US) evaluation for femoropopliteal chronic total occlusion., Materials and Methods: This was a single-center, retrospective, observational study. The study included 276 lesions in 251 patients who underwent stent-supported EVT with intravascular ultrasound evaluation for femoropopliteal chronic total occlusion from July 2012 to June 2019. The wire passage route was assessed using intravascular US, and lesions were classified accordingly into 2 groups: intraluminal and subintimal passage. In this study, the intraluminal group was further divided into 3 subgroups by severity of calcification: none, <180°, and ≥180° circumferential. The subintimal group was further divided into 2 subgroups: subintimal passage without or with calcification. The primary outcome measure was ISR. Cox proportional hazards regression was used to determine the association of clinical characteristics with ISR rates., Results: The mean follow-up period was 19 months ±16, during which time ISR was observed in 31% of lesions. After multivariate analysis, an increased degree of plaque burden (hazard ratio [HR] = 1.101) and subintimal passage with calcification (HR = 3.408) were associated with an increased risk of ISR; a larger distal external elastic membrane area (HR = 0.898) and use of a stent graft (HR = 0.130) were significantly associated with a reduced risk of ISR., Conclusions: This study revealed that factors associated with ISR after stent-supported EVT with intravascular US evaluation were distal external elastic membrane area, plaque burden, subintimal passage with calcification, and use of a stent graft., (Copyright © 2020 SIR. Published by Elsevier Inc. All rights reserved.)

Cutting balloons and scoring balloons are commonly used for the preparation of calcified lesion. However, problems with crossability occasionally limit the use of cutting balloons. We prospectively selected 173 calcified lesions treated using a novel cutting balloon (Wolverine™, C group). As control, we retrospectively analyzed 146 calcified lesions treated using a scoring balloon (Lacrosse NSE ALPHA™, S group). Either intravascular ultrasound (IVUS) or optical coherence tomography (OCT) was used by the operator's discretion. The primary outcome was delivery success, which was defined as successful passage to the target lesion immediately after IVUS or OCT evaluation. The secondary outcome was acute cross-sectional area (CSA) gain, which was defined as post-interventional minimum stent area minus pre-procedural minimum lumen area. A multivariate analysis evaluated the independent predictors for delivery success. The delivery success rate was significantly higher in the C group versus the S group (90.8% versus 79.5%, P = 0.006). However, the acute CSA gain was similar between the two groups (IVUS: 3.2 ± 1.8 mm 2 versus 3.4 ± 1.9 mm 2 , P = 0.53; OCT: 3.6 ± 1.4 mm 2 versus 4.1 ± 1.9 mm 2 , P = 0.11). Usage of cutting balloon was an independent predictor for delivery success even after the adjustment for the patient and lesion characteristics [odds ratio (OR): 2.72 (95% confidence interval 1.38-5.33), P = 0.004] as well as the procedural characteristics [OR: 2.34 (1.15-4.86), P = 0.018]. Novel cutting balloons demonstrated better crossability and similar acute CSA gain compared with scoring balloons in calcified lesion.

Background: Although stent-to-vessel (S/V) diameter ratio has been described as a restenotic factor after superficial femoral artery (SFA) stenting, the reference vessel diameter is commonly measured distally at a healthy site. It remains unclear whether S/V ratio assessed at the lesion site would be more predictive than that assessed distally at a healthy site.Methods and Results:A total of 117 patients (mean age, 73±7 years; 74% male) who underwent successful nitinol stent implantation in SFA lesions (mean lesion length, 172±104 mm) on intravascular ultrasound (IVUS) were retrospectively analyzed. S/V ratio at the proximal and distal healthy site, and at the smallest lesion site, was evaluated on IVUS. One-year restenosis predictors were evaluated on multivariate analysis. Mean S/V diameter ratio on IVUS at proximal and distal healthy sites, and at the lesion site, was 0.98±0.11, 1.02±0.11 and 1.15±0.16, respectively. One-year primary patency was 77%. On multivariate analysis, lesion length (OR, 1.06 per 10-mm increment; P=0.046) and S/V ratio measured at the lesion site (OR, 1.34 per 0.1 increment; P=0.032), but not that at the distal healthy site (OR, 1.05 per 0.1 increment; P=0.705), were significantly associated with 1-year restenosis., Conclusions: S/V ratio assessed on IVUS at the lesion site, but not at the distal healthy site, was independently associated with 1-year restenosis after SFA stenting.

Aim: We investigated 2-year clinical outcomes after implantaton of Epic TM self-expanding nitinol stents for patients with peripheral artery disease (PAD) due to the aortoiliac occlusive disease (AIOD)., Methods: This study was a multicenter and retrospective study. From February 2013 through October 2014, 292 lesions (chronic total occlusion, 21%; TASC Ⅱ C/D, 35%) in 217 consecutive patients (74±8 years; male, 81%; diabetes mellitus, 47%; dialysis, 21%; critical limb ischemia, 29%) who had undergone endovascular therapy (EVT) with Epic TM self-expanding nitinol stents for PAD with AIOD were analyzed. The primary endpoints were 2-year primary patency and target lesion revascularization (TLR)-free rate. The primary patency and freedom from TLR were determined by Kaplan-Meier analysis. Additionally, predictors for loss of patency were estimated by Cox proportional hazard model., Results: The mean follow-up duration was 19.1±8.5 months. Primary patency was 87.3% at 2 years. Freedom from TLR rate was 94.1% at 2 years. Multivariate analysis revealed that the presence of diabetes mellitus was associated with a loss of patency., Conclusion: The Epic TM self-expanding nitinol stent was demonstrated to be safe and effectivene for AIOD when tested for two years in patients with PAD.

Purpose: To report histological examination of a Viabahn stent-graft implanted in the superficial femoral artery (SFA) for nearly 2 years., Case Report: A 78-year-old man with peripheral artery disease was treated successfully with a 6.0×250-mm Viabahn self-expanding stent-graft in the right SFA, relieving his lower limb claudication. The patient died suddenly due to acute myocardial infarction 23 months later. Histological evaluation of the stent-graft implantation site revealed moderate neointimal proliferation at both proximal and distal edges of the device. In the middle part of the stent, significant macrophages and multinucleated foreign body giant cells had accumulated, although the stent was entirely patent. Furthermore, no endothelial cell coverage was found., Conclusion: Judging from these features, it might be necessary to continue dual antiplatelet therapy after stent-graft implantation over the long term to prevent thrombosis and subsequent restenosis or reocclusion.

Although stent implantation has become widespread for the treatment of patients with peripheral artery disease with femoropopliteal (FP) lesions, in-stent restenosis, especially in-stent occlusion (ISO), remains as a major concern for refractory recurrence. Furthermore, the mechanisms of ISO in FP lesions have not been well elucidated. We performed angioscopy for 6 lesions (bare-metal stent: 3, drug-eluting stent: 3) from 5 patients (mean age 74 ± 10 years, male 40 %) with ISO in the FP artery immediately after wire-passing or thrombus aspiration. The presence of thrombus as well as the presence and location of organic stenosis were evaluated. Median duration from stent implantation to angioscopic evaluation was 1099.5 (514.5-2272.5) days, while the duration from recurrence of symptoms to angioscopic evaluation was 45 (5.75-60) days. Mixed thrombi were observed in all stents. Organic stenosis was detected at the proximal edge of the stents in 5 lesions. Organic stenosis was observed at the overlapping segment of the stent in one lesion. The distal edge of the stents could be evaluated in 3 lesions, and all of them showed organic stenosis at the site. Mixed thrombi and organic stenosis were observed in all stents. Partial development of organic stenosis in a stent followed by thrombus formation may be the potential mechanism of the development of ISO in the FP artery though the sample size of this study was small and it had no serial angioscopic data so that we should consider it as preliminary one at best.

Although endovascular therapy (EVT) has been widely used for iliac lesions due to acceptable patency with stenting, EVT has not been established as primary treatment for aortic occlusion, partly because of uncertainty regarding long-term results. The purpose of this study was to investigate outcomes following EVT with stenting for chronic aortic occlusion. This study was a single-center retrospective analysis of a prospectively maintained database. Between September 2005 and May 2012, twenty-four lesions from 25 patients with a clinical diagnosis of chronic aortic occlusion (mean age, 71 years; 80 % male) were treated with EVT with stenting. Kaplan-Meier estimators were used to determine the patency rates according to Society for Vascular Surgery criteria. In results, lesion type was Trans Atlantic Inter-Society Consensus D in all patients. Mean lesion length was 145 mm. Initial success rate and procedural complication rate were 96 % (24/25) and 8 % (2/25), respectively. At 36 months, primary and secondary patency rates were 76 and 94 %, respectively. Restenosis was observed in 5 patients, all of whom underwent reintervention (four successful, one failure and intensity of medical treatment). EVT can be safely done in patients with chronic aortic occlusion. Procedural morbidity and mid-term durability were comparable to those of bypass surgery up to 3 years.