RS27 - High Limb Salvage Rate and Improved Quality of Life following Aspiration Thrombectomy with Indigo for Lower-Extremity Acute Limb Ischemia: 12-month Results from the STRIDE Study

Objectives: Lower-extremity acute limb ischemia (LE-ALI) is associated with high morbidity and mortality rates, burdening patient quality of life (QoL) and hospital resources. There is limited long-term evidence on mechanical thrombectomy (MT) in patients with LE-ALI. The STRIDE study provides 12-month safety and performance data as well as insights to patient QoL and resource utilization following treatment with MT using the Indigo Aspiration System in patients with LE-ALI.

Methods: STRIDE was a multicenter, prospective, single-arm, observational cohort study that enrolled 119 patients across 16 sites in the US and EU. Patients were treated firstline with MT using the Indigo Aspiration System. Outcomes included 30-day patency, 30-day and 12-month limb salvage rate, mortality, device-related adverse events, and change in quality of life, as measured by VascuQoL-6. VascuQoL-6 was developed for evaluating patient-centered outcomes for peripheral arterial disease and is being assessed in LE-ALI patients in this cohort. Procedural angiograms were adjudicated by an independent core lab.

Results: Mean age was 66.3 ± 13.3 years and 46.2% of patients were female. Baseline 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 mm ± 124.7 mm. The most common thrombus locations included superficial femoral (45.4%) and popliteal (58.0% patients may have thrombus at multiple locations), 22.7% had thrombus below the knee. Pre-procedure, 93.0% (107/115) of patients had no flow (TIMI 0) through the target lesion. Most patients (80.7%) were not administered overnight thrombolytics. 73.1% (87/119) of patients were available for 12-month follow-up.
30-day patency and limb salvage rates were 89.4% (101/113) and 98.2% (109/111), respectively. Median index hospital stay was 3.0 [IQR 2.0, 6.0] days. Only 30.3% (36/119) of patients had an index ICU stay, with a median stay of 2.5 [IQR 1.5, 4.4] days. 12-month target limb salvage rate was 88.5% (77/87) overall, 94.7% (36/38) for females and 83.7% (41/49) for males. Device-related serious adverse event rate was 0.8% (1/119), and 12-month mortality rate was 11.9% (12/101). VascuQoL-6 improved across all domains (table I), with a median total score improvement from 12.0 [IQR 9.0, 15.0] at baseline to 19.0 [16.0, 22.0] at 12 months.

Conclusions: These long-term results from STRIDE demonstrate that firstline MT with the Indigo Aspiration System for LE-ALI results in high target limb salvage rates and low complication rates. Indigo provides a safe and effective treatment for LE-ALI and improved patient-reported QoL at 12 months.