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编织型镍钛合金支架治疗慢性严重肢体缺血的多中心回顾性研究

The beneficial clinical effects of interwoven nitinol stents on chronic limb-threatening ischemia patients: a retrospective multicenter cohort study

摘要目的:探讨编织型镍钛合金Supera支架治疗的慢性严重肢体缺血(CLTI)患者的中长期疗效。方法:回顾性分析 2017年4月至2020年12月复旦大学附属中山医院血管外科、上海市中西医结合医院脉管病科及浙江省温岭市中医院血管外科3家中心采用Supera支架治疗的303例50岁以上CLTI患者的临床资料。其中男性205例,女性 98例;年龄(73.5±9.3)岁。电话随访并收集患者生存情况、临床驱动的靶病变血运重建(CD-TLR)、大截肢和创面愈合情况。采用Kaplan-Meier法绘制生存曲线,以Log-rank检验比较两组患者的生存差异。结果:296例患者获得随访,随访时间为(23.6±12.9)个月。Kaplan-Meier生存曲线显示术后 6、12、24及36个月总生存率分别为99.0%、96.2%、86.1%、77.4%。术后12、24和36个月免于CD-TLR率分别为94.2%、91.1%和89.6%。随访期内,15例患者接受了大截肢,总保肢率为92.7%(281/303),有效保肢率为94.9%(281/296)。268例术前存在创面的患者中,203例愈合,创面愈合率为75.7%。Kaplan-Meier生存曲线显示创面愈合的患者较未愈合患者生存率高,差异具有统计学意义(Log-rank χ2=32.894, P<0.01)。同时,在糖尿病、Meggitt-Wagner分级、Rutherford分级、病变数量及术前流出道数量方面,创面愈合组和未愈合组患者间差异具有统计学意义( P值分别为0.025、0.007、0.005、0.049和0.004)。 结论:运用编织型镍钛合金支架Supera对 CLTI 患者具有提高创面愈合率和提高保肢的临床效果。

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abstractsObjective:To investigate the mid- to long-term outcomes of endovascular treatment with Supera interwoven nitinol stents in patients with chronic limb-threatening ischemia (CLTI).Methods:From April 2017 to December 2020, clinical data from 303 CLTI patients aged over 50 years and treated with Supera stent were collected and analyzed retrospectively at three centers including Department of Vascular Surgery of Zhongshan Hospital of Fudan University, Department of Vascular Diseases of Shanghai TCM-Integrated Hospital, and Department of Vascular Surgery of Wenling Hospital of Traditional Chinese Medicine of Zhejiang Province. Among them, there were 205 males and 98 females, with an age of (74.0±10.1) years. Telephone follow-up and collected the overall survival, clinically driven target lesion revascularization (CD-TLR), major amputation, and wound healing. The Kaplan-Meier method was used to draw survival curves and the Log rank test was used to compare the survival differences between the two groups of patients.Results:Follow-up was obtained in 296 patients, with a follow-up duration of (23.6± 2.9) months. Kaplan-Meier survival curves showed that the overall survival rates at 6, 12, 24, and 36 months were 99.0%, 96.2%, 86.1%, and 77.4%, respectively. The proportions of patients without CD-TLR at 12, 24, and 36 months were 94.2%, 91.1%, and 89.6%, respectively. During the follow-up period, 15 patients underwent major amputations, with a total limb salvage rate of 92.7% (281/303) and an effective limb salvage rate of 94.9% (281/296). Among 268 patients with preoperative wounds, 203 healed, with a wound healing rate of 75.7%. The Kaplan-Meier survival curve indicated that patients with wounds healed had a higher survival rate compared to those whose wounds did not heal, with a statistically significant difference (Log-rank χ2=32.894, P<0.01). Meanwhile, in terms of diabetes, Meggitt Wagner classification, Rutherford classification, the number of lesions and the number of preoperative outflow tracts, there were statistically significant differences between the wound healing group and the non-healing group ( P values were 0.025, 0.007, 0.005, 0.049 and 0.004, respectively). Conclusions:The utilization of Supera interwoven nitinol stents in CLTI patients demonstrates clinical benefits in improving wound healing rates and limb preservation.

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