Mechanical Aspiration Thrombectomy Versus Conventional Treatment in Patients With Lower Extremity Acute Limb Ischemia

Purpose: Although the safety and efficacy of the Indigo Aspiration Thrombectomy System (Penumbra Inc.) for lower extremity acute limb ischemia (LE-ALI) have been demonstrated, head-to-head comparative data with conventional treatment (CT) in real-world clinical settings remain limited. Therefore, this study compared the clinical outcomes of mechanical aspiration thrombectomy (MAT) versus CT in patients with LE-ALI. Methods: In this retrospective study, 105 patients (109 limbs) who underwent endovascular treatment for LE-ALI between January 2010 and March 2025 were analyzed. Thirty-one and 74 patients were treated with MAT and CT, respectively. The primary endpoint was the thrombolysis in myocardial infarction (TIMI) flow grade at the end of the procedure. Secondary endpoints included 30-day limb salvage (LS) and overall survival (OS) rates, primary patency, major bleeding, and perioperative complications. Results: The MAT group had significantly higher final postprocedural TIMI flow grade than the CT group (3 interquartile range, 3-3 vs 3 interquartile range, 2-3; p=0.02). Both groups had comparable 30-day LS rate, OS rate, primary patency, and incidence of major bleeding (100.0% vs 91.9%, p=0.18; 90.3% vs 98.7%, p=0.08; 87.1% vs 79.7%, p=0.42; and 9.7% vs 17.6%, p=0.38, respectively). The incidence of major complications was also similar in both groups (19.4% vs 18.9%, p =1.00). However, the MAT group had a significantly lower incidence of minor complications than the CT group (6.5% vs 27.0%, p=0.02). Conclusions: Compared with CT, MAT resulted in significantly improved final TIMI flow grades and fewer minor complications in patients with LE-ALI. Clinical Impact The present study establishes mechanical aspiration thrombectomy (MAT) using the Indigo System as a safe and efficacious alternative to conventional treatment for lower extremity acute limb ischemia. MAT resulted in superior final TIMI flow grades and a significantly reduced incidence of minor complications, with comparable rates of limb salvage and overall survival. These findings underscore MAT’s potential to achieve more effective thrombus removal while minimizing procedural morbidity. For clinical practice, MAT may represent an advancement in endovascular management, offering enhanced technical performance and improved safety profiles in the treatment of this critical vascular emergency.