Notten Pascale, Arnoldussen Carsten W K P, Brans Rutger, de Smet André A E A, Tick Lidwine W, van de Poel Marlène H W, Wikkeling Otmar R M, Vleming Louis-Jean, Koster Ad, Jie Kon-Siong G, Jacobs Esther M G, Ebben Harm P, Planken Nils, Ten Cate Hugo, Wittens Cees H A, Ten Cate-Hoek Arina J
Department of Vascular Surgery, Maastricht University Medical Centre, Maastricht, The Netherlands.
Cardiovascular Research Institute Maastricht (CARIM), School for Cardiovascular Diseases, Maastricht University Medical Centre, Maastricht, The Netherlands.
Thromb Haemost. 2020 Aug;120(8):1188-1199. doi: 10.1055/s-0040-1713171. Epub 2020 Jun 30.
The CAVA trial did not show the anticipated risk reduction for postthrombotic syndrome (PTS) after thrombus removal via additional ultrasound-accelerated catheter-directed thrombolysis (UACDT) in patients with acute iliofemoral deep vein thrombosis (IFDVT). Difficulties in achieving an effective degree of recanalization through thrombolysis may have influenced outcomes. We therefore assessed whether successful UACDT (restored patency ≥ 90%) did reduce the development of PTS.
This CAVA trial post hoc analysis compared the proportion of PTS at 1-year follow-up between patients with successful UACDT and patients that received standard treatment only. In addition, clinical impact as well as determinants of successful thrombolysis were explored.
UACDT was initiated in 77 (50.7%) patients and considered successful in 41 (53.2%, interrater agreement = 0.7, 95% confidence interval 0.47-0.83). PTS developed in 15/41 (36.6%) patients in the successful UACDT group versus 33/75 (44.0%) controls ( = 0.44). In this comparison, successful UACDT was associated with lower Venous Clinical Severity Score (3.50 ± 2.57 vs. 4.82 ± 2.74, = 0.02) and higher EuroQOL-5D (EQ-5D) scores (40.2 ± 36.4 vs. 23.4 ± 34.4, = 0.01). Compared with unsuccessful UACDT, successful UACDT was associated with a shorter symptom duration at inclusion ( = 0.05), and higher rates of performed adjunctive procedures ( < 0.001) and stent placement ( < 0.001).
Successful UACDT was not associated with a reduced proportion of PTS 1 year after acute IFDVT compared with patients receiving standard treatment alone. There was, however, a significant reduction in symptom severity and improvement of generic quality of life according to the EQ-5D. Better patient selection and optimization of treatment protocols are needed to assess the full potential of UACDT for the prevention of PTS.
ClinicalTrials.gov number, NCT00970619.
CAVA试验未显示出，对于急性髂股深静脉血栓形成（IFDVT）患者，通过额外的超声加速导管直接溶栓（UACDT）清除血栓后，血栓形成后综合征（PTS）的预期风险降低情况。通过溶栓实现有效再通程度的困难可能影响了结果。因此，我们评估了成功的UACDT（血管再通≥90%）是否确实减少了PTS的发生。
这项CAVA试验的事后分析比较了成功进行UACDT的患者与仅接受标准治疗的患者在1年随访时PTS的比例。此外，还探讨了临床影响以及成功溶栓的决定因素。
77例（50.7%）患者启动了UACDT，其中41例（53.2%）被认为成功（评分者间一致性=0.7，95%置信区间0.47 - 0.83）。成功进行UACDT的组中，15/41例（36.6%）患者发生了PTS，而对照组为33/75例（44.0%）（P = 0.44）。在此比较中，成功的UACDT与较低的静脉临床严重程度评分相关（3.50±2.57对4.82±2.74，P = 0.02），以及较高的欧洲五维健康量表（EQ - 5D）评分（40.2±36.4对23.4±34.4，P = 0.01）。与未成功的UACDT相比，成功的UACDT与纳入时较短的症状持续时间相关（P = 0.05），以及更高的辅助操作率（P < 0.001）和支架置入率（P < 0.001）。
与仅接受标准治疗的患者相比，急性IFDVT后1年，成功的UACDT与PTS比例降低无关。然而，根据EQ - 5D，症状严重程度有显著降低，总体生活质量有所改善。需要更好地选择患者并优化治疗方案，以评估UACDT预防PTS的全部潜力。
ClinicalTrials.gov编号，NCT00970619。
