Abstract：
OBJECTIVE: This study aimed to determine the impact of infrapopliteal (IP) revascularisation establishing in line flow to the wound (IFW) on wound healing in chronic limb threatening ischaemia (CLTI), using a core laboratory assessment for wounds and in line flow.
METHODS: The Wound directed Angiosome RevasculaRIsation apprOach to patients with cRitical limb iSchaemia (WARRIORS) multicentre observational study enrolled patients with CLTI with tissue loss undergoing IP revascularisation in Japan, with scheduled two year follow up. The primary outcome measure was complete wound healing, defined as achievement of complete epithelialisation of all wounds without major amputation. IP revascularisation establishing IFW was defined as revascularisation after which a tibiopedal artery that actually fed an injured pedal unit was patent. The incidence of wound healing was compared between the IFW and non-IFW groups using inverse probability of treatment weighting based on the propensity score.
RESULTS: A total of 440 patients with CLTI (median age, 75 years; male, 64.1%; diabetes mellitus, 72.0%; dialysis, 57.7%) with tissue loss (Wound, Ischaemia, and foot Infection stage 4, 66.4%) who underwent IP revascularisation (endovascular procedure, n = 304; bypass grafting, n = 136) between October 2017 and June 2020 were registered. During a median follow up of 23.6 months, 51.1% achieved wound healing. Successful IP revascularisation with IFW was achieved in 68.2%. After analysis, the IFW group had a higher rate of wound healing than the non-IFW group (34.5 vs. 16.1 per 100 person years; p = .030). The association between IFW and wound healing was not statistically different between patients undergoing bypass grafting and those undergoing an endovascular procedure (p for interaction = .38). There was no statistically significant interaction effect between IFW and direct revascularisation for wound healing (p for interaction = .51).
CONCLUSIONS: IP revascularisation establishing IFW was statistically significantly associated with a higher wound healing rate in patients with CLTI.
METHODS: The Wound directed Angiosome RevasculaRIsation apprOach to patients with cRitical limb iSchaemia (WARRIORS) multicentre observational study enrolled patients with CLTI with tissue loss undergoing IP revascularisation in Japan, with scheduled two year follow up. The primary outcome measure was complete wound healing, defined as achievement of complete epithelialisation of all wounds without major amputation. IP revascularisation establishing IFW was defined as revascularisation after which a tibiopedal artery that actually fed an injured pedal unit was patent. The incidence of wound healing was compared between the IFW and non-IFW groups using inverse probability of treatment weighting based on the propensity score.
RESULTS: A total of 440 patients with CLTI (median age, 75 years; male, 64.1%; diabetes mellitus, 72.0%; dialysis, 57.7%) with tissue loss (Wound, Ischaemia, and foot Infection stage 4, 66.4%) who underwent IP revascularisation (endovascular procedure, n = 304; bypass grafting, n = 136) between October 2017 and June 2020 were registered. During a median follow up of 23.6 months, 51.1% achieved wound healing. Successful IP revascularisation with IFW was achieved in 68.2%. After analysis, the IFW group had a higher rate of wound healing than the non-IFW group (34.5 vs. 16.1 per 100 person years; p = .030). The association between IFW and wound healing was not statistically different between patients undergoing bypass grafting and those undergoing an endovascular procedure (p for interaction = .38). There was no statistically significant interaction effect between IFW and direct revascularisation for wound healing (p for interaction = .51).
CONCLUSIONS: IP revascularisation establishing IFW was statistically significantly associated with a higher wound healing rate in patients with CLTI.
摘要：
目的：本研究旨在确定在慢性威胁肢体缺血（CLTI）中建立流向伤口（IFW）的管线血运重建对伤口愈合的影响。使用核心实验室评估伤口和直线流动。
方法：在日本接受IP血运重建治疗的CLTI伴组织丢失的CLTI患者中，对CLTI伴组织丢失的患者进行多中心观察研究。计划两年的后续行动。主要结果指标是伤口完全愈合，定义为在没有大截肢的情况下实现所有伤口的完全上皮化。建立IFW的IP血运重建被定义为血运重建，此后实际上为受伤的踏板单元提供营养的胫骨动脉获得了专利。使用基于倾向评分的治疗加权的逆概率在IFW组和非IFW组之间比较伤口愈合的发生率。
结果：总共440例CLTI患者（中位年龄，75岁；男性，64.1%;糖尿病,72.0%；透析，57.7%)伴组织损失(Wound,缺血，和足部感染第4阶段，66.4%)接受IP血运重建术(血管内手术，n=304；旁路移植，n=136）在2017年10月至2020年6月之间注册。在平均23.6个月的随访中，51.1%的伤口获得愈合。IFW的IP血运重建成功率为68.2%。经过分析,IFW组的伤口愈合发生率高于非IFW组（34.5vs.16.1/100人年；p=.030）。在接受旁路移植术的患者和接受血管内手术的患者之间，IFW与伤口愈合的相关性没有统计学差异（相互作用的p=.38）。对于伤口愈合,IFW和直接血运重建之间没有统计学上显著的相互作用效应(相互作用的p=.51)。
结论：IP血运重建建立IFW与CLTI患者较高的伤口愈合率具有统计学意义。
方法：在日本接受IP血运重建治疗的CLTI伴组织丢失的CLTI患者中，对CLTI伴组织丢失的患者进行多中心观察研究。计划两年的后续行动。主要结果指标是伤口完全愈合，定义为在没有大截肢的情况下实现所有伤口的完全上皮化。建立IFW的IP血运重建被定义为血运重建，此后实际上为受伤的踏板单元提供营养的胫骨动脉获得了专利。使用基于倾向评分的治疗加权的逆概率在IFW组和非IFW组之间比较伤口愈合的发生率。
结果：总共440例CLTI患者（中位年龄，75岁；男性，64.1%;糖尿病,72.0%；透析，57.7%)伴组织损失(Wound,缺血，和足部感染第4阶段，66.4%)接受IP血运重建术(血管内手术，n=304；旁路移植，n=136）在2017年10月至2020年6月之间注册。在平均23.6个月的随访中，51.1%的伤口获得愈合。IFW的IP血运重建成功率为68.2%。经过分析,IFW组的伤口愈合发生率高于非IFW组（34.5vs.16.1/100人年；p=.030）。在接受旁路移植术的患者和接受血管内手术的患者之间，IFW与伤口愈合的相关性没有统计学差异（相互作用的p=.38）。对于伤口愈合,IFW和直接血运重建之间没有统计学上显著的相互作用效应(相互作用的p=.51)。
结论：IP血运重建建立IFW与CLTI患者较高的伤口愈合率具有统计学意义。
