![]() 9 At 1 year, the primary patency rate was 72.6%, with a clinically driven TLR rate of only 8.4%. The COMPLETE SE multicenter trial studied use of the Complete SE stent (Medtronic, Inc.), which has an offset crown design that may minimize crown interaction during flexion. Among patients with available x-rays, there were no stent fractures at follow-up. ![]() 8 At 1-year of follow-up, the binary restenosis rate was 15.7%, with a freedom from TLR rate of 92%. The SUMMIT study was a prospective, multicenter registry of the Epic* stent (Boston Scientific Corporation), which is a laser-cut nitinol self-expanding stent that contains radiopaque tantalum markers at the proximal and distal ends. Two of the more recent registries highlight improvements in outcomes with newer-generation self-expanding stents. 7 In most cases, reports of these registries have led to US Food and Drug Administration approval of an SFA-specific indication for these stents ( Table 1). These studies have, in general, been based on the VIVA objective performance goals in the SFA and have shown excellent rates of primary patency, as well as extremely low stent fracture rates when compared to earlier stent designs. REGISTRY STUDIES OF SFA STENTSĪfter completion of early, randomized studies of nitinol self-expanding stents versus balloon angioplasty, the majority of subsequent studies have consisted of registry data supporting the incremental improvement of new-generation stents. 6 These results provided significant evidence in support of primary stenting to treat moderate-length SFA lesions with modern stent designs. At 3-year follow-up, patients randomized to primary stent placement also had significantly higher freedom from target lesion revascularization (TLR) in the intention-to-treat group (75.5% vs 41.8%). The stent fracture rate was only 3% at 1 year. At 12 months, the primary patency rate was significantly higher for patients randomized to primary stent placement based on both intention-to-treat analysis (81% vs 36%) and as-treated analysis (80% vs 61%). 5 Patients were randomized 2:1 to placement of a LifeStent (Bard Peripheral Vascular) versus balloon angioplasty. The RESILIENT trial was the second major randomized trial to show superiority of primary stent placement over balloon angioplasty for the treatment of moderate-length SFA lesions. 3 At the same time, concerns regarding a high prevalence of stent fracture in the SFA using early generation self-expanding stents limited the broad application of stents to the femoropopliteal segment. However, other randomized studies conducted with the Luminexx stent (Bard Peripheral Vascular) failed to show a benefit of stent placement for shorter-length (mean, 40 mm) SFA lesions. ![]() At 1 year, primary patency was significantly higher for patients treated with a stent (63% vs 37%). 2 In that study, patients were randomized 1:1 to a Dynalink* or Absolute* stent (Abbott Vascular) versus balloon angioplasty. The Vienna Absolute study was the first randomized study to show superiority of primary stenting over balloon angioplasty for the treatment of moderate-length SFA lesions. ![]() SUPERIORITY OF SFA STENTS OVER BALLOON ANGIOPLASTY 1 This article reviews the historical development of SFA stent technologies, with an emphasis on recent advances and data supporting the use of stents in the SFA and popliteal arteries. Although many endovascular treatment options exist, nitinol stents remain a mainstay of SFA therapy. During the past decade, multiple technologies have been developed for treatment of superficial femoral artery (SFA) atherosclerotic disease, including balloon angioplasty, bare nitinol self-expanding stents, drug-eluting nitinol stents, and drug-coated balloons. ![]()
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