STRIDE study post hoc analysis shows first-line mechanical aspiration thrombectomy for either in-stent or in-graft versus native vessel thrombosis in lower extremity acute limb ischemia yields similar outcomes.

Abstract

Lower extremity acute limb ischemia (LE-ALI) is a severe form of peripheral artery disease associated with high morbidity and mortality rates. Thrombus in previously placed stents or grafts may present treatment challenges when compared with treatment of thrombus in native vessels, and data evaluating first-line treatment with mechanical aspiration thrombectomy are lacking. This post hoc analysis of STRIDE (A study of patients with lower extremity acute limb ischemia to remove thrombus with the Indigo Aspiration System) examines outcomes for first-line mechanical aspiration thrombectomy with the Indigo Aspiration System for LE-ALI in patients with either in-stent or in-graft thrombosis as compared with native vessel thrombosis. STRIDE was a prospective, single-arm study that enrolled 119 adult patients across 16 sites in the United States and Europe who were treated first-line with the Indigo Aspiration System for LE-ALI. The primary outcome was target limb salvage at 30 days post procedure. Secondary outcomes included device-related serious adverse events, technical success (postprocedure Thrombolysis in Myocardial Infarction flow grades 2/3), and patency at 30 days. Outcomes for the in-stent thrombosis group vs the native vessel thrombosis group, and for the in-graft thrombosis group vs the native vessel thrombosis group, were compared. Of the 119 STRIDE patients, 29 had in-stent thrombosis, 19 had in-graft thrombosis, and 71 had native vessel thrombosis. For both the in-stent vs native vessel thrombosis and the in-graft vs native vessel thrombosis group comparisons, there were no significant differences for any of the primary or secondary outcomes. Overnight adjunctive thrombolytics use was higher for the in-graft vs native vessel groups (52.6% [10/19]) and 11.3% [8/71], respectively; P < .001). In a combined multivariate Cox model, when adjusted for age and sex among US patients, in-stent thrombosis was associated with time to retreatment within 30 days (hazard ratio, 3.8; 95% confidence interval, 1.1-13.3; P = .040). Although in-stent and in-graft thrombosis may represent more challenging treatment settings for LE-ALI, high technical success and high target limb salvage rates at 30 days were observed for both groups, similar to the favorable results seen in the native vessel group. Additionally, there were no device-related serious adverse events in either the in-stent or in-graft groups. In-stent thrombosis is associated with an increased risk of retreatment, which is unrelated to the device or procedure and may be expected owing to known complications of stenting. This STRIDE subgroup analysis shows that first-line mechanical aspiration thrombectomy using Indigo is safe and effective for LE-ALI patients in presentations of acute thrombosis in a stent or graft.