Femoropopliteal In-stent Restenosis Repair: Midterm Outcomes After Paclitaxel Eluting Balloon Use (PLAISIR Trial)
Femoropopliteal In-stent Restenosis Repair: Midterm Outcomes After Paclitaxel Eluting Balloon Use (PLAISIR Trial)
复制标题
DOI：
10.1016/j.ejvs.2016.10.002
复制
发表时间：
2017-01-01
影响因子：
5.7
通讯作者：
Goueffic, Y.
中科院分区：
文献类型：
--
作者：
Bague, N.;Julia, P.;Goueffic, Y.
目的：目的是评估紫杉醇洗脱球囊（PEB）在股腘动脉（FP）支架内再狭窄（ISR）患者中的18个月结局。方法：在一项国家前瞻性多中心队列研究中，纳入了2012年1月至2013年6月的股腘动脉支架内再狭窄症状患者。患者接受紫杉醇洗脱球囊血管成形术（In Pact Admiral，Medtronic，圣罗莎，CA，USA）治疗。在1、3、6、9、12和18个月时进行临床和多普勒扫描随访评价。主要终点是12个月时无靶病变血运重建（TLR）。次要终点为主要不良心血管事件（MACE）、靶肢体血运重建（TER）、原发性和继发性持续临床改善、复发性再狭窄率、原发性和继发性通畅率、通过EQ-5D问卷评估的生活质量、技术成功率、临床成功率和住院时间。在盲态审查后，10例患者被定义为方案违背，因为支架植入后2年以上发生再狭窄。在55条肢体中进行了手术，48条（87%）用于跛行，7条（13%）用于严重肢体缺血。PEB的平均直径和长度分别为6 ± 0.57 mm和86 mm ± 32 mm，随访时间为17个月（范围1-19）。1年时，生存率为96 +/- 2.7%，无TLR和TER分别为90.2 +/- 4.2%和85 +/-5%。持续的主要和次要临床改善分别为78.6 +/- 5.7%和92.0 +/-3.8%。1年时，一期通畅率为83.7 +/-5.0%。术前，平均EQ-5D评分为66 +/- 14，1年时为74 +/- 16（p = 0.10）。2例患者在随访期间死亡; 1例患者在手术后33天因肢体缺血死亡。结论：PEB治疗FP ISR的再介入率和再狭窄率较低。临床改善维持在18个月。(C)2016年欧洲血管外科学会。由爱思唯尔有限公司出版。保留所有权利。
Objective: The aim was to assess 18 month outcomes of the paclitaxel eluting balloon (PEB) in patients with femoropopliteal (FP) in-stent restenosis (ISR).Methods: In a national prospective and multicentre cohort study, symptomatic patients with femoropopliteal in-stent restenosis were included from January 2012 to June 2013. Patients were treated by paclitaxel eluting balloon angioplasty (In Pact Admiral, Medtronic, Santa Rosa, CA, USA). Clinical and duplex scan follow-up evaluations were performed at 1, 3, 6, 9, 12, and 18 months. The primary endpoint was freedom from target lesion revascularisation (TLR) at 12 months. Secondary endpoints were major adverse cardiovascular events (MACE), Target extremity revascularisation (TER), primary and secondary sustained clinical improvement, recurrent restenosis rate, primary and secondary patency, quality of life assessed by EQ-5D questionnaire, technical success, clinical success, and length of stayResults: A total of 53 patients were enrolled. After a blinded review, 10 patients were defined as protocol violation because restenosis occurred more than 2 years after stent implantation. Procedures were performed in 55 limbs, 48 (87%) for claudication and 7 (13%) for critical limb ischaemia. The mean diameter and length of PEB were 6 +/- 0.57 mm and 86 mm +/- 32 mm, follow-up was 17 months (range 1-19). At 1 year, the survival rate was 96 +/- 2.7% and freedom from TLR and TER were 90.2 +/- 4.2% and 85 +/- 5%, respectively. Sustained primary and secondary clinical improvements were 78.6 +/- 5.7% and 92.0 +/- 3.8%, respectively. At 1 year, the primary patency rate was 83.7 +/- 5.0%. Prior to the procedure, the mean EQ-5D score was 66 +/- 14 and 74 +/- 16 at 1 year (p = .10). Two patients died during follow-up; one patient died 33 days after the procedure because of limb ischaemia.Conclusion: PEB for the treatment of FP ISR is associated with a low rate of re-interventions and restenosis. Clinical improvement is maintained at 18 months. (C) 2016 European Society for Vascular Surgery. Published by Elsevier Ltd. All rights reserved.