主髂动脉病变腔内治疗对下肢缺血的影响：一项随机临床试验
Infrapopliteal Angioplasty of One or More than One Artery for Critical Limb Ischaemia: A Randomised Clinical Trial.
机构信息
Santa Marcelina Hospital, São Paulo, Brazil.
Santa Marcelina Hospital, São Paulo, Brazil.
出版信息
Eur J Vasc Endovasc Surg. 2018 Apr;55(4):518-527. doi: 10.1016/j.ejvs.2017.12.022.
OBJECTIVE
The aim was to analyse the effect of the treatment of more than one infrapopliteal artery with respect to wound healing and limb salvage.
METHODS
Seventy-eight patients were enrolled prospectively for 80 procedures (80 limbs) that were randomly divided into two groups: 40 in the single vessel (SV) group and 40 in the multiple vessel group (MV). All patients had tissue loss. The choice of the first artery to treat was based on an analysis of two factors: the ease of the required endovascular technique and the presence of adequate distal outflow. The randomisation point was after the first successful distal artery angioplasty. The primary endpoints were the wound healing rate and limb salvage.
RESULTS
The mean age of the patients was 69.1 ± 4.3 years, and 56% were male. Concomitant treatment of the femoral and popliteal arteries was performed in 38.8% of patients. All demographic characteristics and technical aspects were statistically comparable for both groups. Successful recanalisation was achieved in 95.8%, 86.2%, 86.9%, and 92.5% for the tibio-fibular trunk, anterior tibial, posterior tibial, and fibular artery, respectively. In the MV group, a higher contrast volume (29 mL more; p = .049), longer procedure time (p = .01), and higher radiation exposure (p = .04) were noted. There was no difference in renal function between the groups either before or 30 days after the procedure (p = .165). The limb salvage rates after 1 and 3 years, respectively, were 75.9% and 67% for the SV group and 91.1% and 91.1% for the MV group (log rank p = .052). The wound healing rates after 1 and 3 years, respectively, were 33.6% and 70.9% for the SV and 63.9% and 78.4% for MV group (log rank p = .006). Wound healing was faster in MV (2.11 cm/month) than SV group (0.62 cm/month; p = .004).
CONCLUSION
Endovascular treatment of more than one artery was associated with better wound healing rates but not with better limb salvage.
目的
分析治疗多条（超过一条）小腿动脉对创面愈合和肢体存活的影响。
方法
前瞻性纳入 78 例患者，共 80 次治疗（80 条肢体），随机分为两组：单血管组（SV 组）40 例，多血管组（MV 组）40 例。所有患者均有组织缺损。选择首先治疗的动脉时基于两个因素的分析：所需血管腔内技术的难易程度和充足的远端流出。随机分组点是第一次成功的远端动脉血管成形术后。主要终点是创面愈合率和肢体存活率。
结果
患者的平均年龄为 69.1±4.3 岁，56%为男性。38.8%的患者同时接受股动脉和腘动脉治疗。两组的所有人口统计学特征和技术方面均具有统计学可比性。胫腓干、胫前动脉、胫后动脉和腓动脉的再通成功率分别为 95.8%、86.2%、86.9%和 92.5%。MV 组造影剂用量增加 29ml（p=0.049），手术时间延长（p=0.01），辐射暴露增加（p=0.04）。两组患者肾功能在治疗前和治疗后 30 天均无差异（p=0.165）。SV 组 1 年和 3 年的肢体存活率分别为 75.9%和 67%，MV 组分别为 91.1%和 91.1%（对数秩检验 p=0.052）。SV 组 1 年和 3 年的创面愈合率分别为 33.6%和 70.9%，MV 组分别为 63.9%和 78.4%（对数秩检验 p=0.006）。MV 组的创面愈合速度（2.11cm/月）快于 SV 组（0.62cm/月；p=0.004）。
结论
血管腔内治疗多条动脉与更高的创面愈合率相关，但与更好的肢体存活率无关。
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