国产伞形Octoparms腔静脉滤器预防肺栓塞的有效性和安全性研究

Effectiveness and safety of the home-made umbrella-shaped Octoparms inferior vena cava filter in the prevention of pulmonary embolism

目的评价国产伞形Octoparms腔静脉滤器预防肺栓塞的有效性和安全性。方法采用多中心、随机、阳性平行对照、非劣效性临床试验,于2017年10月至2019年3月在国内10家医疗单位按照统一的纳入和排除标准纳入拟行下腔静脉滤器置入的受试者188例。采用中央随机系统将受试者按照1∶1随机纳入试验组或对照组,每组各94例。试验组使用Octoparms腔静脉滤器,对照组使用Celect腔静脉滤器。主要疗效指标为临床成功率,包括滤器置入的临床成功率和滤器取出的临床成功率;次要指标包括输送鞘系统的手术成功率,肺栓塞的发生率(6个月内),滤器出现断裂、移位(>20 mm)、置入/取出时倾斜(>15°)的发生率,下腔静脉血流状况(6个月内);安全性评价包括手术即刻、随访过程中滤器相关并发症发生率及与器械相关不良事件的发生率。结果188例受试者滤器置入成功率100%,试验组87例(92.55%)进行滤器取出,对照组91例(96.81%)进行滤器取出,试验组临床成功率97.87%(92/94),对照组临床成功率98.94%(93/94),两组比较差异无统计学意义(χ^(2)=0.77,P=0.380),试验组与对照组比较非劣效。试验组和对照组输送鞘系统的手术成功率分别为96.81%(91/94)、98.94%(93/94),两组比较差异无统计学意义(P=0.621)。滤器置入后试验组有1例(1.22%)新发无症状性肺栓塞,对照组有2例(2.44%),两组比较差异无统计学意义(P>0.05)。两组均未出现滤器断裂、移位(>20 mm)。滤器置入时倾斜(>15°)试验组和对照组各1例(1.06%),滤器取出时倾斜(>15°)试验组0例,对照组2例(2.22%),两组比较差异无统计学意义(P>0.05)。滤器取出术前下腔静脉血栓试验组有5例(5.75%),对照组有3例(3.30%),两组比较差异无统计学意义(P=0.489)。两组在滤器置入/取出过程中均未出现即刻严重并发症,随访过程中未发现滤器阻塞、移位、变形、血管壁穿透、腔静脉闭塞等并发症。两组与器械相关不良事件发生率均较低,差异无统计学意义(P>0.05)。结论国产伞形Octoparms腔静脉滤器可有效预防肺栓塞,使用过程较安全,非劣效于进口的Celect腔静脉滤器。

Objective To evaluate the effectiveness and safety of the home-made umbrella-shaped Octoparms inferior vena cava filter in the prevention of pulmonary embolism.Methods A multicenter,randomized,positive parallel controlled,non-inferiority clinical trial was conducted in ten hospitals in China from October 2017 to March 2019.A total of 188 subjects were enrolled according to the same inclusion and exclusion criteria in different institutes.The 188 subjects were randomly divided into the trial group or the control group according to 1∶1 by the central randomization system,with 94 cases in each group.Octoparms inferior vena cava filter was used in the trial group,and the Celect inferior vena cava filter in the control group.The primary effective index was clinical success rate,including the clinical success rate of filter placement and filter retrieval.The secondary index included the rate of manual success of the delivery sheath system,incidence of pulmonary embolism(within 6 months),incidence of filter fracture,migration(>20 mm),tilt(>15°)on insertion/retrieval,and the situation of inferior vena cava flow(within 6 months).Safety evaluation included the incidence of filter related complications and device-related adverse events immediately after surgery and during follow-up.Results The success rate of implantation was 100% in 188 subjects.Filter retrieval was performed in 87 cases(92.55%)in the trial group and 91 cases(96.81%)in the control group.The clinical success rate of the trial group was 97.87%(92/94)and that of the control group 98.94%(93/94).There was no significant difference between the two groups(χ^(2)=0.77,P=0.380).The success rate of delivery sheath system was 96.81%(91/94)and 98.94%(93/94)in the trail group and the control group,respectively.There was no significant difference between the two groups(P=0.621).There was 1 case(1.22%)of new asymptomatic pulmonary embolism in the trial group after filter placement and 2 cases(2.44%)in the control group.There was no significant difference between the two groups(P>0.05).No filter fracture or migration(>20 mm)occurred in either group.The tilting of filter(>15°)was found in 1 case(1.06%)in the test group and 1 case(1.06%)in the control group when the filter was placed.The tilting of filter(>15°)was found in 0 case in the test group and 2 cases(2.44%)in the control group when the filter was retrieved.There was no significant difference between the two groups(P>0.05).Inferior vena cava thrombosis before filter retrieval was found in 5 cases(5.75%)in trial group and 3 cases(3.30%)in control group.There was no significant difference between the two groups(P=0.489).There were no immediate serious complications during filter placement/removal in either group.No filter obstruction,migration,deformation,penetration and occlusion of inferior vena cava.The incidence of device-related adverse events was low in both group.There was no significant difference between the two groups(P>0.05).Conclusion The home-made umbrella-shaped Octoparms inferior vena cava filter is effective and safe in preventing pulmonary embolism,and is not worse than Celect filter.