Safety and efficacy of mechanical aspiration thrombectomy for patients with acute lower extremity ischemia

Objective Acute limb ischemia is associated with high rates of amputation and consequent morbidity and mortality. The objective of this study is to report on the safety and efficacy of aspiration thrombectomy using the Indigo® Aspiration System in patients with lower extremity acute limb ischemia (LE-ALI). Methods The STRIDE study was an international, multicenter, prospective, study that enrolled 119 participants presenting with LE-ALI. Patients were treated firstline with mechanical thrombectomy using the Indigo® Aspiration System, prior to stenting or angioplasty, or other therapies as determined by treating physician. The primary endpoint was target limb salvage at 30 days post-procedure. Secondary endpoints within 30 days included technical success, defined as core-lab adjudicated Thrombolysis in Myocardial Infarction (TIMI) 2/3 flow rate immediately post-procedure, changes in modified SVS runoff score, improvement of Rutherford classification compared to pre-procedure, patency, rate of device related serious adverse events, and major bleeding peri-procedure. Secondary endpoints that will be evaluated at 12 months include target limb salvage and mortality. Results Of the 119 participants enrolled at 16 sites, mean age was 66.3 years (46.2% female). At baseline (N=119), ischemic severity was classified as Rutherford I in 10.9%, Rutherford IIa in 54.6%, and Rutherford IIb in 34.5%. Mean target thrombus length was 125.7 (SD 124.7) mm. Pre-procedure 93.0% (107/115) of patients had no flow (TIMI 0) through the target lesion. Target limb salvage rate at 30 days was 98.2% (109/111). Rates of peri-procedural major bleed was 4.2% (5/119) and device-related SAE was 0.8% (1/119). Restoration of flow (TIMI 2/3) was achieved in 96.3% (105/109) of patients immediately post-procedure. Median improvement in the modified SVS runoff score (before vs. after procedure) was 6.0 [IQR 0.0, 11.0]. Rutherford classifications also improved after discharge in 86.5% (83/96) of patients, as compared to pre-procedure scores. Patency at 30 days was achieved in 89.4% (101/113) of patients. Conclusions In the STRIDE study, aspiration thrombectomy with the Indigo® System provided a safe and effective endovascular treatment for LE-ALI patients, resulting in a high rate (98.2%) of successful limb salvage at 30 days, with few peri-procedural complications.