Pipeline Flex与第一代Pipeline血流导向装置治疗颅内动脉瘤的多中心研究

Application of Pipeline Flex and first-generation Pipeline flow diverters in the treatment of intracranial aneurysms:a multicenter study

目的对比分析Pipeline Flex与第一代Pipeline血流导向装置(FD)治疗颅内动脉瘤的临床效果和并发症.方法回顾性分析2014年11月至2019年10月首都医科大学附属北京天坛医院等14个临床中心连续纳入的接受Pipeline Flex或第一代Pipeline(Classic)FD血管内治疗的共862例患者(1010个颅内动脉瘤)的临床资料.根据FD类型分为Flex组与Classic组,采用1∶1倾向性评分匹配法(最近邻法)对两组患者进行基线资料匹配.匹配后Classic组与Flex组各纳入340例患者(Classic组纳入315例患者,Flex组纳入307例患者,两组均为340例次手术,按照340例进行统计学分析).匹配后比较两组患者的治疗及随访结果.结果匹配后Classic组与Flex组比较,支架释放成功率的差异无统计学意义[分别为98.8%(336/340)、99.1%(337/340),χ^(2)=0.00,P=1.000].与Classic组比较,Flex组支架覆盖分支血管率较高[分别为67.1%(228/340)、57.9%(197/340),χ^(2)=6.03,P=0.014]、围手术期缺血性并发症的发生率较低[分别为2.9%(10/340)、6.8%(23/340),χ^(2)=5.38,P=0.020].两组患者随访时间和随访期动脉瘤完全闭塞率的差异均无统计学意义(均P>0.05).Flex组随访期间缺血性并发症的发生率较Classic组低[分别为0.3%(1/340)、2.4(8/340),χ^(2)=4.05,P=0.044];而两组其他并发症发生率的差异均无统计学意义(均P>0.05).至末次随访,Classic组较Flex组缺血性并发症的总体发生率高[分别为9.1%(31/340)、3.2%(11/340),χ^(2)=10.15,P=0.001)],但不良临床结局(改良Rankin量表评分≥2分)者占比和病死率的差异均无统计学意义(均P>0.05).结论与Pipeline Classic FD比较,采用Pipeline Flex FD治疗颅内动脉瘤的疗效相近,但可减少缺血性并发症的发生.

Objective To compare the clinical outcomes and complications of Pipeline Flex versus first-generation Pipeline(Classic)flow diverters(FDs)in the treatment of intracranial aneurysms.Methods A retrospective study was performed on the clinical and imaging data of 862 patients with 1010 intracranial aneurysms who underwent FD placements in 14 medical centers including Beijing Tiantan Hospital,Capital Medical University from November 2014 to October 2019.The patients were divided into Flex and Classic groups according to the version of FD,and a 1:1 nearest-neighbor propensity score matching was performed to adjust for potential baseline confounding characteristics.After matching,340 patient pairs were included in both groups(315 patients in the Classic group and 307 patients in the Flex group,340 procedures performed in both groups),and the efficacy and safety of the two groups were compared.Results There was no significant difference in the rate of successful FD deployment to target site between the Classic group and the Flex group[98.8%(336/340)vs.99.1%(337/340),χ^(2)=0.00,P=1.000].Compared with the Classic group,the Flex group demonstrated a higher rate of side branch coverage[67.1%(228/340)vs.57.9%(197/340),χ^(2)=6.03,P=0.014]and a lower rate of ischemic complications during perioperative period[2.9%(10/340)vs.6.8%(23/340),χ^(2)=5.38,P=0.020].There was no statistically significant difference in the follow-up duration or complete aneurysm occlusion rate between the two groups of patients(both P>0.05).The Flex group demonstrated a lower rate of ischemic:complications during follow-up in comparison with the Classic group[0.3%(1/340)us.2.4%(8/340),χ^(2)=4.05,P=0.044].There was no statistically significant difference in the incidence of other complications between the two groups(P>0.05).At the latest follow-up,the overall rate of ischemic complications in the Classic group was higher than that in the Flex group[9.1%(31/340)vs.3.2%(11/340),χ^(2)=10.15,P=0.001],while there was no statistically significant difference in the proportion of unfavorable clinical outcomes(mRS scores≥2)or mortality rate(both P>0.05).Conclusion Compared with Pipeline Classic FD,Pipeline Flex FD has a comparable therapeutic efficacy in the treatment of intracranial aneurysms,while it could help reduce the occurrence of ischemic complications.