Elkerdawi Sherif O, Abdelbary Mostafa S, Rizk Mohamed A, Ibrahim Hossameldin, El-Awady Karim
Vascular Surgery Department, Faculty of Medicine, Helwan University, Helwan, Egypt.
Vascular Surgery Department, Faculty of Medicine, Ain Shams University, Cairo, Egypt.
J Endovasc Ther. 2025 Aug 28:15266028251363509. doi: 10.1177/15266028251363509.
Acute limb ischemia (ALI) is a serious condition leading to amputation and mortality.
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 ( = 25), treated with percutaneous mechanical thrombectomy (PMT), and Group B ( = 25), receiving catheter-directed thrombolysis (CDT).
The mean age was 67.16 ± 9.56 years in Group A and 56.88 ± 11.38 years in Group B ( = .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.
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.
急性肢体缺血（ALI）是一种严重疾病，可导致截肢和死亡。
这项前瞻性随机研究纳入了2021年9月1日至2023年8月31日期间在两家医院接受治疗的50例血栓性ALI患者。患者采用双盲法随机分为A组（n = 25），接受经皮机械血栓清除术（PMT）治疗，B组（n = 25），接受导管直接溶栓（CDT）治疗。
A组平均年龄为67.16±9.56岁，B组为56.88±11.38岁（P = 0.001），尽管性别分布具有可比性。糖尿病（DM）是最常见的危险因素（A组88%，B组72%），其次是A组的高血压（68%）和B组的吸烟（56%），两组之间无显著差异。股浅动脉和腘动脉闭塞是最常见的表现（A组68%和56%，B组72%和68%）。A组60%和B组56%采用逆行对侧股动脉入路。技术成功率A组（96%）高于B组（80%），但未达到统计学意义。两组均有8%的患者发生围手术期并发症，A组发生1例血管穿孔和1例远端栓塞，而B组发生1例颅内出血和1例假动脉瘤。A组30天死亡率为0%，B组为8%（无统计学意义）。1个月时的初级通畅率A组为84.0%，B组为81%，1年时分别降至62.5%和55.6%。A组有1例膝下截肢，无膝上截肢，而B组有2例膝下截肢和3例膝上截肢。
PMT似乎有技术成功率更高和截肢率更低的趋势，其安全性与CDT相似，尽管这些差异无统计学意义。其单次治疗方法和降低出血风险的潜力可能具有一些优势，而CDT通常需要长时间输注。
临床影响
这项随机研究表明，对于某些无运动功能障碍的急性血栓性下肢缺血患者，使用Rotarex®️ 装置进行经皮机械血栓清除术（PMT）可能优于导管直接溶栓（CDT）。PMT在单次治疗中实现了快速血管再通，有技术成功率更高和截肢更少的趋势，同时保持了与CDT相当的安全性。通过潜在地减少治疗时间、出血风险和强化监测的需求，PMT可能成为当前血管内治疗实践中有价值的补充。需要进行更大规模、随访时间更长的心多中心研究来证实这些发现并指导未来的临床应用。
