Solitaire™ Stent Thrombectomy System in the Treatment of Acute Lower-Limb Ischemia: Comparisons in Safety and Effectiveness with Conventional Catheter-Directed Thrombolysis Therapy

OBJECTIVE: The study aimed to investigate the safety and efficacy of the Solitaire™ AB Stent System (ev3 Inc., Plymouth, MN, USA) for the treatment of acute lower extremity ischemia (ALLI) compared with conventional catheter-directed thrombolytic therapy. METHODS: Retrospective analysis of patients with ALLI treated in the Department of Interventional Radiology at the First Hospital of Nanjing from January 2017 to April 2020 divided into a conventional (CDT) group (n = 106) and a percutaneous mechanical thrombectomy (PMT) group (n = 55) according to the procedure. PMT was performed using the Solitaire™ AB stent system. The combined clinical outcomes of mortality, major amputation, recurrent ischemia, and major morbidity were compared between the two groups. RESULTS: Of the 161 patients, 128 (79.5%) did not have a composite clinical outcome after 12 months of follow-up, namely, 78 CDT patients and 50 PMT patients, with significant differences in composite clinical outcome (26.4% vs. 9.1%, P = 0.010) and mortality (19.8% vs. 7.3%, P = 0.037) between them. Thrombolytic drug dose (19.34 ± 5.93 vs. 13.55 ± 6.54 mg, P < 0.001) and length of hospital stay (8.29 ± 3.91 vs. 5.49 ± 1.18 days, P = 0.003) were significantly lower in the PMT group. CONCLUSION: PMT with the Solitaire™ AB Stent System is safer and more effective in treating patients with Rutherford stage I-IIB ALLI, with the advantage of rapid opening of obstructed vessels, shorter thrombolysis time, reduced thrombolytic dose, and improved blood flow to the infrapopliteal vessels.