超声辅助与传统导管定向溶栓治疗急性髂股深静脉血栓形成的比较
Ultrasound-assisted versus conventional catheter-directed thrombolysis for acute iliofemoral deep vein thrombosis.
作者信息
Engelberger Rolf P, Spirk David, Willenberg Torsten, Alatri Adriano, Do Dai-Do, Baumgartner Iris, Kucher Nils
机构信息
From the Division of Angiology, Department of Medicine, Centre Hospitalier Universitaire Vaudois (CHUV), Lausanne, Switzerland (R.P.E., A.A.); Clinic for Angiology, Swiss Cardiovascular Center, Inselspital, University Hospital and University of Bern, Switzerland (R.P.E., T.W., D.-D.D., I.B., N.K.); and Institute of Pharmacology, University of Bern, Switzerland (D.S.).
出版信息
Circ Cardiovasc Interv. 2015 Jan;8(1). doi: 10.1161/CIRCINTERVENTIONS.114.002027.
BACKGROUND
For patients with acute iliofemoral deep vein thrombosis, it remains unclear whether the addition of intravascular high-frequency, low-power ultrasound energy facilitates the resolution of thrombosis during catheter-directed thrombolysis.
METHODS AND RESULTS
In a controlled clinical trial, 48 patients (mean age 50 ± 21 years, 52% women) with acute iliofemoral deep vein thrombosis were randomized to receive ultrasound-assisted catheter-directed thrombolysis (N = 24) or conventional catheter-directed thrombolysis (N = 24). Thrombolysis regimen (20 mg r-tPA over 15 hours) was identical in all patients. The primary efficacy end point was the percentage of thrombus load reduction from baseline to 15 hours according to the length-adjusted thrombus score, obtained from standardized venograms and evaluated by a core laboratory blinded to group assignment. The percentage of thrombus load reduction was 55% ± 27% in the ultrasound-assisted catheter-directed thrombolysis group and 54% ± 27% in the conventional catheter-directed thrombolysis group (P = 0.91). Adjunctive angioplasty and stenting was performed in 19 (80%) patients and in 20 (83%) patients, respectively (P > 0.99). Treatment-related complications occurred in 3 (12%) and 2 (8%) patients, respectively (P > 0.99). At 3-month follow-up, primary venous patency was 100% in the ultrasound-assisted catheter-directed thrombolysis group and 96% in the conventional catheter-directed thrombolysis group (P = 0.33), and there was no difference in the severity of the post-thrombotic syndrome (mean Villalta score: 3.0 ± 3.9 [range 0-15] versus 1.9 ± 1.9 [range 0-7]; P=0.21), respectively.
CONCLUSIONS
In this randomized controlled clinical trial of patients with acute iliofemoral deep vein thrombosis treated with a fixed-dose catheter thrombolysis regimen, the addition of intravascular ultrasound did not facilitate thrombus resolution.
CLINICAL TRIAL REGISTRATION URL
http://www.clinicaltrials.gov. Unique identifier: NCT01482273.
背景
对于急性髂股深静脉血栓形成患者，血管内高频、低功率超声能量的加入是否有助于导管直接溶栓期间血栓的溶解仍不清楚。
方法和结果
在一项对照临床试验中，48例急性髂股深静脉血栓形成患者（平均年龄50±21岁，52%为女性）被随机分为接受超声辅助导管直接溶栓组（N = 24）或传统导管直接溶栓组（N = 24）。所有患者的溶栓方案（15小时内给予20mg重组组织型纤溶酶原激活剂）相同。主要疗效终点是根据长度调整的血栓评分，从标准化静脉造影获得并由对分组不知情的核心实验室评估，从基线到15小时血栓负荷减少的百分比。超声辅助导管直接溶栓组血栓负荷减少百分比为55%±27%，传统导管直接溶栓组为54%±27%（P = 0.91）。分别有19例（80%）和20例（83%）患者接受了辅助血管成形术和支架置入术（P > 0.99）。治疗相关并发症分别发生在3例（12%）和2例（8%）患者中（P > 0.99）。在3个月的随访中，超声辅助导管直接溶栓组的原发性静脉通畅率为100%，传统导管直接溶栓组为96%（P = 0.33），血栓形成后综合征的严重程度无差异（平均Villalta评分：3.0±3.9[范围0 - 15]对1.9±1.9[范围0 - 7]；P = 0.21）。
结论
在这项采用固定剂量导管溶栓方案治疗急性髂股深静脉血栓形成患者的随机对照临床试验中，血管内超声的加入并未促进血栓溶解。
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