Comparison of domestic paclitaxel drug-coated balloon with plain old balloon in the treatment of in-stent restenosis of superficial femoral artery
卫任 1黄伯儒 2刘杰 1贾鑫 1郭伟 1王丽萍
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作者信息
1. 1解放军总医院第一医学中心血管外科，北京 100853
2. 2内蒙古医科大学附属医院血管外科，呼和浩特 010050
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摘要
目的 比较紫杉醇药物涂层球囊血管成形术（DCBA）与普通球囊血管成形术（POBA）治疗股浅动脉支架内再狭窄（SFA-ISR）病变的临床效果。 方法 本研究为回顾性队列研究。回顾性分析解放军总医院血管外科2020年1月至2022年8月收治的79例SFA-ISR患者的临床资料。主要观察终点为术后12及24个月的一期通畅率，次要终点为手术相关并发症、术后12和24个月的临床症状改善比例、免于靶病变再干预（TLR）率，以及重大血管相关不良事件（MAVEs）发生情况。 结果 共纳入79例患者，其中DCBA组43例，POBA组36例，两组靶病变长度分别为（160.2±65.5）mm和（151.4±69.4）mm，支架内闭塞发生率分别为69.8%（30/43）和77.8%（28/36）。术后12个月DCBA组一期通畅率优于POBA组（74.4% 比 54.8%，P=0.045），差异有统计学意义；术后24个月一期通畅率两组差异无统计学意义（39.8%比22.6%，P=0.200）。两组患者术后12及24个月临床症状改善率相当，且差异无统计学意义［12个月：75.6%（28/37）比 58.3%（17/24），P=0.67；24个月：46.1%（6/13）比 30.0%（3/10），P=0.72］；但免于TLR率方面，DCBA组均优于POBA组，差异具有统计学意义（12个月：83.2%比 59.8%，P=0.021；24个月：63.5% 比 33.4%，P=0.049）。两组均无严重手术相关不良事件发生，术后24个月两组各发生MAVEs 2例。 结论 DCBA较POBA在治疗SFA-ISR中有更好的临床获益。 Objective To compare the clinical effects of paclitaxel drug-coated balloon angioplasty (DCBA) with plain old balloon angioplasty (POBA) in the treatment of superficial femoral artery in-stent restenosis (SFA-ISR). Methods This study was a retrospective cohort study. The clinical data of 79 SFA-ISR cases admitted to the Department of Vascular Surgery of The First Medical Center of PLA General Hospital from January 2020 to August 2022 were collected and analyzed. The main observation endpoint was the primary patency rate at 12 months and 24 months after operation, and the secondary endpoints were the operation-related complications, the improvement of clinical symptoms at 12 months and 24 months after operation, freedom from target lesions revascularization (TLR), and major adverse vascular events (MAVEs). Results Seventy-nine patients were included, in which there are 43 cases with DCBA and 36 cases with POBA. The mean lesion length of the DCBA group and POBA group were (160.2±65.5) mm and (151.4±69.4) mm, and the incidence of in-stent restenosis was 69.8% and 77.8%, respectively. The primary patency rate at 12 months after the operation was significantly better in DCBA group than that in POBA group (74.4% vs 54.8%, P=0.045) and the difference was statistically significant. However, their primary patency rate at 24 months showed no statistical significance on their difference (39.8% vs 22.6%, P=0.200). The proportion of patients with clinical improvement was similar in both groups. However, in terms of the freedom from TLR, DCBA group was better than POBA group with differences of statistical significance (12th month: 83.2% vs 59.8%, P=0.021 24th month: 63.5% vs 33.4%, P=0.049). No serious operation-related adverse events occurred in both groups. Two MAVEs occurred within 24 months after the operation in each group. Conclusion DCBA has better clinical benefits than POBA in the treatment of SFA-ISR.
Abstract
Objective To compare the clinical effects of paclitaxel drug-coated balloon angioplasty (DCBA) with plain old balloon angioplasty (POBA) in the treatment of superficial femoral artery in-stent restenosis (SFA-ISR). Methods This study was a retrospective cohort study. The clinical data of 79 SFA-ISR cases admitted to the Department of Vascular Surgery of The First Medical Center of PLA General Hospital from January 2020 to August 2022 were collected and analyzed. The main observation endpoint was the primary patency rate at 12 months and 24 months after operation, and the secondary endpoints were the operation-related complications, the improvement of clinical symptoms at 12 months and 24 months after operation, freedom from target lesions revascularization (TLR), and major adverse vascular events (MAVEs). Results Seventy-nine patients were included, in which there are 43 cases with DCBA and 36 cases with POBA. The mean lesion length of the DCBA group and POBA group were (160.2±65.5) mm and (151.4±69.4) mm, and the incidence of in-stent restenosis was 69.8% and 77.8%, respectively. The primary patency rate at 12 months after the operation was significantly better in DCBA group than that in POBA group (74.4% vs 54.8%, P=0.045) and the difference was statistically significant. However, their primary patency rate at 24 months showed no statistical significance on their difference (39.8% vs 22.6%, P=0.200). The proportion of patients with clinical improvement was similar in both groups. However, in terms of the freedom from TLR, DCBA group was better than POBA group with differences of statistical significance (12th month: 83.2% vs 59.8%, P=0.021 24th month: 63.5% vs 33.4%, P=0.049). No serious operation-related adverse events occurred in both groups. Two MAVEs occurred within 24 months after the operation in each group. Conclusion DCBA has better clinical benefits than POBA in the treatment of SFA-ISR.
关键词
药物涂层球囊/普通球囊血管成形术/支架内再狭窄/股浅动脉/动脉硬化闭塞症
Key words
Drug coated balloon/Plain old balloon angioplasty/In-stent restenosis/Superficial femoral artery/Arteriosclerosis occlusive disease
万方数据