Nitinol Self-Expanding Stents for the Treatment of Obstructive Superficial Femoral Artery Disease: Three-Year Results of the RELIABLE Japanese Multicenter Study

Abstract

Objective: To assess the use of a nitinol stent to treat symptomatic stenoses or occlusions of the native superficial femoral artery (SFA).Materials and Methods: Seventy-four patients were treated at 12 Japanese sites. The primary endpoint, freedom from target-limb failure (TLF), was a composite of device- or procedure-related death, target-limb amputation, target-vessel revascularization (TVR), or restenosis compared to an objective performance goal (OPG) at 12 months. Secondary endpoints, including primary patency, freedom from TVR/target-lesion revascularization (TLR), improvements in clinical parameters, and major adverse events (MAEs) were evaluated through 36 months.Results: The mean overall lesion length was 80.7±38.9 mm (mean stented length: 98.8±46.1 mm). Freedom from TLF was 81.2% (p<0.001 compared to OPG) with a Kaplan–Meier estimate of 84.2% [95% confidence interval (95%CI) 73.3%, 90.9%] at 12 months. Primary patency was 71.0% at 12 months and 67.8% at 36 months. A total of 94.7% of patients improved by at least one Rutherford category and 70.2% of patients improved ankle–brachial indices ≧0.10 from baseline to 36 months. Freedom from TVR/TLR (Kaplan–Meier) was 90% at 12 months and 79.5% at 36 months. Four MAEs were reported; none were found to be device or procedure related.Conclusion: A self-expanding stent was used safely to treat stenotic and occlusive lesions of the SFA in a Japanese patient population. The composite endpoint, freedom from TLF, was superior to an historical control at one year, with low rates of revascularization and good functional and clinical outcomes through three years.

Pathogenesis and Clinical Significance of In-Stent Restenosis in Patients with Diabetes

“…The primary patency rate was 71.0% at 12 months and 67.8% at 36 months. Primary patency has been defined as freedom from the restenosis of the target lesion (luminal narrowing of ≥50%), determined by angiography or ultrasonography, and/or the revascularisation of the target lesion [172].…”

In-Stent Restenosis Progression in Human Superficial Femoral Arteries: Dynamics of Lumen Remodeling and Impact of Local Hemodynamics

“…Among the percutaneous approaches to treat atherosclerotic SFAs, the implantation of selfexpanding stents is one of the preferred solutions. 26 However, in-stent restenosis (ISR), caused by excessive neointima growth and unfavorable inward remodeling, represents a major drawback. 32 The incidence of ISR in this vascular region ranges from 15% to 32%, with a peak between 9 and 15 months after intervention.…”

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

“…Lower limb peripheral artery disease (PAD) is an inflammatory disease, mainly caused by atherosclerosis, which progressively narrows the arterial lumen limiting blood supply to the leg 1 . The prevalence of this pathology, which is relatively uncommon among younger people, is continuously increasing due to population ageing 2 , 3 . The last updates report that a substantial proportion of the elderly population, more than 20% in 80-year-old and older individuals, suffers from PAD 2 .…”