增效溶栓流程与经皮机械血栓清除术治疗急性髂股静脉血栓形成的回顾性队列研究

Fast-track thrombolysis protocol vs. percutaneous mechanical thrombectomy for acute iliofemoral deep vein thrombosis: a retrospective cohort study

摘要:

背景与目的 提高术中血栓清除效率是降低急性髂股静脉血栓形成（IFVT）患者中远期血栓形成后综合征（PTS）风险的关键。增效溶栓流程（FTTP）通过在经皮机械血栓清除术（PMT）基础上增加球囊碎栓等步骤，理论上可提高清除效率，但其相较传统PMT的临床优势仍缺乏对照研究证据。本研究旨在比较FTTP与传统PMT治疗急性IFVT的有效性与安全性。方法 回顾性分析2022年5月—2024年12月于上海交通大学医学院附属第九人民医院血管外科接受腔内治疗的100例急性IFVT患者，其中FTTP组38例，PMT组62例。主要研究终点为术中即刻血栓清除率，技术成功定义为髂股静脉血栓清除率≥50%。次要终点包括辅助导管接触性溶栓（CDT）或大腔导管吸栓的使用率、术中血栓脱落情况以及术后30 d血栓复发率和髂股静脉通畅率。结果 两组患者在年龄、患肢、病程及恶性肿瘤史等基线特征方面差异无统计学意义（均P>0.05）。FTTP组术中即刻技术成功率明显高于PMT组［100.0%（38/38） vs. 82.3%（51/62），P=0.006］。FTTP组无患者需行辅助CDT，而PMT组有8例患者接受CDT治疗，差异有统计学意义（P=0.023）。两组均未发生术中影像学可见的血栓脱落。术后30 d随访显示，两组血栓复发率及髂股静脉通畅率差异均无统计学意义（均P>0.05）。结论 与传统PMT相比，FTTP可显著提高急性IFVT术中即刻血栓清除效率，减少辅助CDT的使用，而未增加术中血栓脱落及术后早期复发风险，具有良好的有效性与安全性。

Abstract:

Background and Aims Improving intraoperative thrombus clearance is critical for reducing the risk of post-thrombotic syndrome (PTS) in patients with acute iliofemoral deep vein thrombosis (IFVT). The fast-track thrombolysis protocol (FTTP), which incorporates balloon-mediated thrombus fragmentation into conventional percutaneous mechanical thrombectomy (PMT), may enhance thrombus removal efficiency. However, comparative evidence between FTTP and standard PMT remains limited. This study aimed to compare the efficacy and safety of FTTP versus conventional PMT in the treatment of acute IFVT.Methods A retrospective cohort analysis was conducted on 100 consecutive patients with acute IFVT who underwent endovascular treatment between May 2022 and December 2024. Among them, 38 patients received FTTP and 62 received conventional PMT. The primary endpoint was the immediate intraoperative thrombus clearance rate, with technical success defined as ≥50% thrombus removal in the iliofemoral vein segment. Secondary endpoints included the use of adjunctive catheter-directed thrombolysis (CDT) or large-bore catheter aspiration, intraoperative thrombus embolization, and 30-day postoperative thrombus recurrence and iliofemoral vein patency.Results Baseline characteristics, including age, affected limb, symptom duration, and history of malignancy, were comparable between the two groups (all P>0.05). The immediate technical success rate was significantly higher in the FTTP group than in the PMT group [100.0% (38/38) vs. 82.3% (51/62), P=0.006]. No patients in the FTTP group required adjunctive CDT, whereas 8 patients in the PMT group did (P=0.023). No intraoperative thrombus embolization occurred in either group. At 30-day follow-up, thrombus recurrence rates and iliofemoral vein patency were similar between the two groups (both P>0.05).Conclusion FTTP significantly improves immediate thrombus clearance in patients with acute IFVT and reduces the need for adjunctive CDT without increasing the risk of intraoperative embolization or early postoperative recurrence, demonstrating favorable efficacy and safety.