Octoparms■腔静脉滤器预防肺栓塞安全性与有效性的多中心临床研究

A multicenter clinical trial of safety and effectiveness of Octoparms■vena cava filter in preventing pulmonary embolism

背景与目的:Octoparms■为首个国产伞状结构的可回收腔静脉滤器(VCF),为探讨该VCF预防肺栓塞(PE)的安全性和有效性,本研究采用多中心临床对照试验将其与进口VCF进行非劣效比较。方法:采用随机、多中心、阳性平行对照设计,将2017年9月-2019年3月全国10家中心符合入组标准的急性下肢深静脉血栓形成(DVT)患者,试验组与对照组按1∶1入组,对Octoparms■滤器与美国Celect滤器的安全性和有效性指标进行比较。结果:共188例患者纳入研究,试验组与对照组各94例。两组患者基线资料一致,滤器均顺利植入。试验组87例(92.6%)滤器成功取出,中位留置时间11 (7~31) d,26例(27.6%)拦截血栓,对照组91例(96.8%)滤器成功取出,中位留置时间12 (7~21) d,35例(37.2%)拦截血栓,滤器植入和取出过程两组均无PE症状发生,未见滤器严重移位、断裂,试验组滤器自居中效果优于对照组(P<0.05)。溶栓治疗104例(55.3%),2例(1.9%)滤器未取出,17例(16.3%)出血事件,未溶栓治疗84例(44.7%),8例(9.5%)滤器未取出,5例(5.9%)出血事件,溶栓与未溶栓患者间滤器取出率与出血事件发生率差异有统计学意义(χ^(2)=3.928,P=0.048;χ^(2)=4.858,P=0.028)。结论:用Octoparms■伞形VFC预防PE安全、有效,且整体效果与进口VCF一致。此外,溶栓治疗可有效减少深静脉血栓负荷,增加滤器取出率,但会增加患者出血风险。

Background and Aims: Octoparms■is the first retrievable conical inferior vena cava filter(VCF)made in China. To investigate the safety and effectiveness of this VCF in prevention of pulmonary embolism(PE), this study was conducted for a non-inferiority comparison between this VCF and foreign imported VCF.Methods: Using a randomized multicenter, positive parallel controlled design, the eligible patients with acute deep venous thrombosis(DVT) of lower extremities from 10 centers from September 2017 to March 2019 in China were enrolled and designated to study group and control group at a 1∶1 ratio. The variables concerning safety and effectiveness were compared between Octoparms;filter and USA Celect filter.Results: A total of 188 patients were enrolled with 94 cases in each study group and control group. The baseline data of the two groups of patients were balanced, and all filters were successfully implanted.Filter was successfully retrieved in 87 cases(92.6%) in study group a the median retention time of 11(7-31) d, and 26 cases(27.6%) thrombus interception. Filter was successfully retrieved in 91 cases(96.8%)in control group a the median retention time of 12(7-21) d and 35 cases(37.2%) had thrombus interception. During the filter implantation and removal, no symptoms of PE occurred in both groups,and no severe filter shift or rupture was observed. The self-centering effect of filter in study group was better than that in control group(P<0.05). In the 104 cases(55.3%) undergoing thrombolytic therapy, the filter was not removed in 2 cases(1.9%) and the hemorrhage event occurred in 17 cases(16.3%);in the84 cases(44.7%) who did not receive thrombolytic therapy, the filter was not removed in 8 cases(9.5%)and the hemorrhage event occurred 5 cases(5.9%). There were statistical differences in filter retrieval rate and incidence of hemorrhage event between patients with and without thrombolytic therapy(χ^(2)=3.928, P=0.048;χ^(2)=4.858, P=0.028).Conclusion: Using Octoparms■conical VCF for prevention of PE is safe and effective, and the overall efficacy is similar with that of foreign imported VCF. In addition, thrombolytic therapy can effectively reduce the load of DVT and increase the filter removal rate, but it will increase the risk of hemorrhage in patients.