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

Abstract

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.