Randomized Prospective Comparative Study of Mechanical Thrombectomy by Rotarex® Device Versus Catheter-Directed Thrombolysis in the Management of Acute Thrombotic Lower Limb Ischemia Without Motor Deficit

Background: Acute limb ischemia (ALI) is a serious condition leading to amputation and mortality. Patients and Methods: This prospective randomized study included 50 patients with thrombotic ALI treated at 2 hospitals between September 1, 2021, and August 31, 2023. Patients were randomly assigned using a double-blind method into Group A ( n = 25), treated with percutaneous mechanical thrombectomy (PMT), and Group B ( n = 25), receiving catheter-directed thrombolysis (CDT). Results: The mean age was 67.16 ± 9.56 years in Group A and 56.88 ± 11.38 years in Group B ( P = .001), though gender distribution was comparable. Diabetes mellitus (DM) was the most prevalent risk factor (88% in Group A, 72% in Group B), followed by hypertension (68%) in Group A and smoking (56%) in Group B, with no significant differences between groups. Superficial femoral artery and popliteal artery occlusions were the most common findings (68% and 56% in Group A, 72% and 68% in Group B). Retrograde contralateral femoral access was used in 60% of Group A and 56% of Group B. The technical success rate showed a tendency to be higher but did not reach statistical significance in Group A (96%) than in Group B (80%). Perioperative complications occurred in 8% of patients in both groups, with Group A experiencing 1 vessel perforation and 1 distal embolization, while Group B had 1 intracranial hemorrhage and 1 pseudoaneurysm. The 30-day mortality rate was 0% in Group A and 8% in Group B (not statistically significant). Primary patency rates at 1 month were 84.0% in Group A and 81% in Group B, decreasing to 62.5% and 55.6% at 1 year, respectively. Group A had 1 below-knee amputation and no above-knee amputations, whereas Group B had 2 below-knee and 3 above-knee amputations. Conclusion: PMT appeared to have a tendency toward higher technical success and lower amputation rates, with a safety profile similar to CDT, though these differences were not statistically significant. Its single-session approach and potential for reduced bleeding risk might offer some advantages, while CDT generally requires prolonged infusion. Clinical Impact This randomized study suggests that percutaneous mechanical thrombectomy (PMT) using the Rotarex®️ device may offer advantages over catheter-directed thrombolysis (CDT) in selected patients with acute thrombotic lower limb ischemia without motor deficit. PMT achieved rapid revascularization in a single session with a tendency toward higher technical success and fewer amputations, while maintaining a safety profile comparable to CDT. By potentially reducing treatment time, bleeding risk, and the need for intensive monitoring, PMT could represent a valuable addition to current endovascular practice. Larger multicenter studies with longer follow-up are warranted to confirm these findings and guide future clinical adoption.