Safety and Performance of Aspiration Thrombectomy for Lower Extremity Acute Limb Ischemia: STRIDE Interim Analysis

Purpose: In a recent meta-analysis, the reported rate of 30-day limb salvage in patients with acute limb ischemia (ALI) after surgical intervention was 83.1%. The purpose of this interim analysis is to report safety and performance data from STRIDE (A Study of Patients with Lower Extremity Acute Limb Ischemia to Remove Thrombus with the Indigo Aspiration System) and to evaluate the benefits of thromboaspiration in the setting of lower extremity (LE) ALI.
Materials and Methods: STRIDE is a global prospective, real-world, postmarket, multicenter study that will enroll up to 130 participants presenting with LE ALI treated frontline with mechanical thrombectomy using the Indigo Aspiration System before stenting or angioplasty. The primary endpoint is target limb salvage rate at 30 days postprocedure. Periprocedural secondary endpoints included technical success defined as flow restoration (core lab–adjudicated The Thrombolysis In Myocardial Infarction [TIMI] 2/3 flow) rate immediately after the procedure, change in modified SVS runoff score, major bleeding, and device-related serious adverse event.
Results: Of the 96 participants enrolled from 14 sites, mean age was 65.9 years (46.9% female). Ischemic severity at baseline (n = 95) was classified as Rutherford I in 5.3%, Rutherford IIa in 57.9%, and Rutherford IIb in 36.8%. Mean target thrombus length was 109.9 ± 115.8 mm. Before the procedure, 94.5% (69/73) of patients had no flow (TIMI 0) through the target lesion. The most common thrombus location was the popliteal in 66.0% (62/94) of patients followed by the superficial femoral in 44.7% (42/94).
Conclusions: This interim analysis of STRIDE study patients demonstrated high rates of technical success and limb salvage and low rates of periprocedural complications. Based on these results, mechanical aspiration thrombectomy provided a powerful endovascular treatment option for patients with LE ALI.