Editorial
2198T he femoropopliteal segment is increasingly treated via an endovascular-first approach for both lifestyle-limiting claudication and critical limb ischemia. Nitinol stents have been shown to be superior to percutaneous transluminal angioplasty (PTA) and have become one of the primary modalities for the treatment of femoropopliteal obstructive atherosclerotic disease because of the improved structural integrity and conformability of newer devices.1-3 Current nitinol stents have low rates of stent fracture and excellent clinical patency out to 3 years.2,4 Despite these advances, femoropopliteal in-stent restenosis (FP-ISR) remains an important clinical problem, occurring in up to 19% to 37% of cases after stenting of moderate-length (up to 150 mm) lesions and more frequently after treatment of longer lesions.
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Article see p 2230Tosaka and colleagues 6 have described the angiographic patterns of FP-ISR. Class I FP-ISR consists of focal (<50 mm) ISR within the stent body, stent edge, or a combination of the two. Class II FP-ISR consists of diffuse lesions (>50 mm) within the stent body or stent edge. Class III FP-ISR lesions consist of total occlusion within the stent. They described the outcomes of PTA for the treatment of FP-ISR and found that in-stent occlusion (class III FP-ISR) was a significant predictor of recurrent restenosis (84.8%) and reocclusion (64.6%) at 2 years. Two-year outcomes for patients with focal (class I) and diffuse (class II) ISR were similar, with recurrent restenosis in 49.9% and 53.3% and stent occlusion in 15.9% and 18.9%, respectively. These results highlighted the lack of efficacy of PTA for FP-ISR, particularly for in-stent occlusion. In a follow-up to that study, we evaluated a multimodality approach to the treatment of FP-ISR.7 Seventy-five patients underwent endovascular treatment of FP-ISR using a variety of adjunctive devices, including laser atherectomy, excisional atherectomy, and repeat stenting. Despite the use of these adjunctive therapies in the majority of cases, rates of repeat restenosis at 2 years were 39% for class I ISR, 67% for class II ISR, and 72% for class III ISR. Class III ISR was also associated with a significantly increased rate of recurrent occlusion (hazard ratio, 5.8; 95% CI, 1.8-19.0) compared with other angiographic categories of FP-ISR.Debulking of in-stent intimal hyperplastic tissue is a theoretically attractive approach, and laser atherectomy has been evaluated for the treatment of FP-ISR. 8,9 In the Excimer Laser Randomized Controlled Study for Treatment of Femoropopliteal In-Stent Restenosis (EXCITE) trial, excimer laser atherectomy (Spectranetics, Colorado Springs, CO) was found to be superior to PTA for the treatment of FP-ISR, but 1-year primary patency rates for both treatment groups were disappointing. 9 Other modalities evaluated for the treatment of FP-ISR include the Viabahn covered stent graft (W.L. Gore, Inc, Flagstaff, AZ), 10,11 and the Zilver PTX drug eluting stent (Cook Medical, Bloomington, IN).12 Each of these the...