Department of Medicine, McMaster University, Hamilton, Ontario, Canada.
Department of Oncology, McMaster University, Hamilton, Ontario, Canada.
Thromb Haemost. 2019 Apr;119(4):633-644. doi: 10.1055/s-0039-1677795. Epub 2019 Jan 30.
The Acute Venous Thrombosis: Thrombus Removal with Adjunctive Catheter-Directed Thrombolysis (ATTRACT) trial reported that pharmacomechanical catheter-directed thrombolysis (PCDT) did not reduce post-thrombotic syndrome (PTS), but reduced moderate-to-severe PTS and the severity of PTS symptoms. In this analysis, we examine the effect of PCDT in patients with femoral-popliteal deep vein thrombosis (DVT) (without involvement of more proximal veins).
Within the ATTRACT trial, 300 patients had DVT involving the femoral vein without involvement of the common femoral or iliac veins and were randomized to receive PCDT with anticoagulation or anticoagulation alone (no PCDT). Patients were followed for 24 months.
From 6 to 24 months, between the PCDT versus no PCDT arms, there was: no difference in any PTS (Villalta scale ≥ 5: risk ratio [RR] = 0.97; 95% confidence interval [CI], 0.75-1.24); moderate-or-severe PTS (Villalta scale ≥ 10: RR = 0.93; 95% CI, 0.57-1.52); severity of PTS scores; or general or disease-specific quality of life ( > 0.5 for all comparisons). From baseline to both 10 and 30 days, there was no difference in improvement of leg pain or swelling between treatment arms. From baseline to 10 days, major bleeding occurred in three versus none ( = 0.06) and any bleeding occurred in eight versus two ( = 0.032) PCDT versus no PCDT patients. Over 24 months, recurrent venous thromboembolism occurred in 16 PCDT and 12 no PCDT patients ( = 0.24).
In patients with femoral-popliteal DVT, PCDT did not improve short- or long-term efficacy outcomes, but it increased bleeding. Therefore, PCDT should not be used as initial treatment of femoral-popliteal DVT. (NCT00790335).
急性静脉血栓形成：血栓切除术联合辅助导管定向溶栓（ATTRACT）试验报告称，药物机械性导管定向溶栓（PCDT）并未降低血栓后综合征（PTS），但可减轻中重度 PTS 并减轻 PTS 症状的严重程度。在本分析中，我们研究了 PCDT 在股腘深静脉血栓形成（DVT）（不伴有更近端静脉受累）患者中的作用。
在 ATTRACT 试验中，300 例患者患有股静脉 DVT，不伴有股总或髂静脉受累，随机分为接受 PCDT 联合抗凝治疗或单独抗凝治疗（无 PCDT）。患者随访 24 个月。
从 6 至 24 个月，PCDT 与无 PCDT 组之间：任何 PTS（Villalta 量表≥5：风险比 [RR] = 0.97；95%置信区间 [CI]，0.75-1.24）均无差异；中重度 PTS（Villalta 量表≥10：RR = 0.93；95% CI，0.57-1.52）；PTS 评分严重程度；或一般或疾病特异性生活质量（所有比较均>0.5）。从基线到治疗后 10 天和 30 天，治疗组之间腿部疼痛或肿胀的改善无差异。从基线到 10 天，3 例患者发生大出血，无患者发生大出血（ = 0.06），8 例患者发生任何出血，无患者发生出血（ = 0.032）。在 24 个月期间，16 例 PCDT 患者和 12 例无 PCDT 患者发生复发性静脉血栓栓塞症（ = 0.24）。
在股腘 DVT 患者中，PCDT 并未改善短期或长期疗效结局，但增加了出血风险。因此，PCDT 不应作为股腘 DVT 的初始治疗方法。（NCT00790335）
