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 ImpactThis 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.