Mercy Medical Center, Des Moines, Iowa.
Department of Animal Science, Iowa State University, Ames, Iowa.
J Vasc Surg Venous Lymphat Disord. 2017 Sep;5(5):613-620. doi: 10.1016/j.jvsv.2017.04.018. Epub 2017 Jun 21.
Current guidelines recommend thrombolytic therapy for iliofemoral deep venous thrombosis (DVT). Anticoagulation is the standard treatment for femoral-popliteal and tibial-level DVT. The objective of this study was to evaluate the efficacy of catheter-directed thrombolysis (CDT) using tissue plasminogen activator vs standard anticoagulation alone in patients with lower extremity DVT involving the femoral-popliteal segment.
A retrospective review was performed of patients referred to the vascular surgery service with lower extremity DVT from 2006 to 2015. Patients who had DVT involving the femoral-popliteal segment were identified, including some patients who had concomitant involvement of iliofemoral and tibial veins. Patients with pure iliofemoral and tibial vein DVT were excluded from this analysis. Review of medical records, follow-up ultrasound studies, hypercoagulable panel, and venography were performed. Comparison of outcomes between patients who received thrombolytic therapy using tissue plasminogen activator and patients who received standard anticoagulation alone was performed. The primary outcomes measured were restoration of patency of the femoral-popliteal segment at 3 months, incidence of post-thrombotic syndrome (PTS), and valvular dysfunction. Secondary outcomes were incidence of bleeding, in-hospital mortality, and pulmonary embolism.
The study cohort was composed of 191 patients (CDT, n = 89; anticoagulation alone, n = 102) who met inclusion criteria. Most patients with thrombus involving the femoral-popliteal segment also had proximal venous segment involvement, with 93% of the patient cohort having proximal iliofemoral DVT. Patients who did not receive CDT were older (mean age of 64 years vs 51 years; P < .001) and had more associated comorbidities, such as diabetes, immobility, and cancer. A significant number of patients who received CDT had a positive family history for DVT (21.3% vs 8.8%; P = .023), and it was more likely to be their first episode of DVT (73.0% vs 55.9%; P = .016). Patients who received CDT were more likely to have restoration of patency (74.7% vs 11.1%; P < .001) and lower incidence of PTS (21.3% vs 73.4%; P < .001) and valvular dysfunction (23.0% vs 66.7%; P < .001) compared with patients who were treated with anticoagulation alone. Incidence of bleeding was significantly more for patients treated with anticoagulation alone (14.7% vs 5.6%; P = .018) compared with patients who received CDT. On multivariate analysis, age was the predominant risk factor for bleeding. There was no significant difference in mortality and pulmonary embolism.
In patients with acute proximal DVT and concomitant femoral-popliteal venous segment involvement, CDT resulted in superior patency at 3 months and less PTS and valvular reflux. This was achieved without increase in bleeding complications compared with anticoagulation alone. Age was the major factor predictive of bleeding in either group. The results of this study may not be applicable to patients with pure femoral-popliteal venous segment DVT because only 3% of patients had this finding.
目前的指南建议对髂股深静脉血栓形成(DVT)进行溶栓治疗。抗凝是股腘和胫静脉水平 DVT 的标准治疗方法。本研究的目的是评估组织型纤溶酶原激活物(t-PA)导管定向溶栓(CDT)与单独使用标准抗凝治疗在累及股腘段的下肢 DVT 患者中的疗效。
对 2006 年至 2015 年因下肢 DVT 就诊血管外科的患者进行回顾性分析。确定累及股腘段的 DVT 患者,包括一些合并累及髂股和胫静脉的患者。排除单纯累及髂股和胫静脉的 DVT 患者。对病历、随访超声检查、高凝状态和静脉造影进行回顾。对接受 t-PA 溶栓治疗的患者和单独接受标准抗凝治疗的患者的结局进行比较。主要结局测量是 3 个月时股腘段通畅率、血栓后综合征(PTS)发生率和瓣膜功能障碍。次要结局是出血、住院死亡率和肺栓塞的发生率。
研究队列由 191 名符合纳入标准的患者(CDT 组,n=89;抗凝治疗组,n=102)组成。大多数累及股腘段血栓的患者也有近端静脉段受累,93%的患者存在近端髂股静脉 DVT。未接受 CDT 的患者年龄较大(平均年龄 64 岁 vs 51 岁;P<0.001),且合并症较多,如糖尿病、活动受限和癌症。接受 CDT 的患者中有相当数量的人有 DVT 的家族史(21.3% vs 8.8%;P=0.023),且更可能是首次发生 DVT(73.0% vs 55.9%;P=0.016)。与单独抗凝治疗的患者相比,接受 CDT 的患者更有可能恢复通畅(74.7% vs 11.1%;P<0.001),PTS(21.3% vs 73.4%;P<0.001)和瓣膜功能障碍(23.0% vs 66.7%;P<0.001)的发生率较低。与接受抗凝治疗的患者相比,接受抗凝治疗的患者出血发生率显著更高(14.7% vs 5.6%;P=0.018)。多变量分析显示,年龄是出血的主要危险因素。两组之间的死亡率和肺栓塞率无显著差异。
在急性近端 DVT 合并股腘静脉段受累的患者中,CDT 可在 3 个月时获得更好的通畅率,且 PTS 和瓣膜反流发生率较低。与单独抗凝治疗相比,这一结果并没有增加出血并发症。年龄是两组出血的主要预测因素。本研究结果可能不适用于单纯股腘静脉段 DVT 的患者,因为只有 3%的患者有这种发现。