药物涂层球囊与镍钛诺裸金属支架治疗股腘动脉疾病原发病变的中期疗效和安全性

Mid-term Efficacy and Safety of Drug-coated Balloon versus Nitinol Bare Metal Stent for Primary Lesions in Femoropopliteal Artery Disease.

作者信息

Ma Haocheng, Zhang Xuemin, Li Jing, Li Qingle, Li Wei, Jiao Yang, Jiang Jingjun, He Changshun, He Zhibin, Li Weihao, Zhang Tao, Zhang Xiaoming

机构信息

Department of Vascular Surgery, Peking University People's Hospital, Beijing, P. R. China.

出版信息

Ann Vasc Surg. 2022 Apr;81:316-323. doi: 10.1016/j.avsg.2021.09.022. Epub 2021 Nov 9.

DOI:10.1016/j.avsg.2021.09.022

PMID:34762999

Abstract

OBJECTIVES

To compare drug-coated balloon (DCB) and bare metal stent (BMS) for primary lesions in femoropopliteal artery disease in Chinese population and to make subgroup analysis between the groups.

METHODS

Patients with primary lesions who underwent BMS or DCB treatment of a single tertiary vascular center were included and followed up for 24 months. Clinical and anatomic status were reported using the criteria recommended by the Society for Vascular Surgery. The primary endpoint included primary patency, clinically target limb revascularization, composite safety endpoint and all-cause death over 24 months assessed by Kaplan-Meier. Secondary endpoints included technical success rate and stent-related complications.

RESULTS

A total of 284 patients with 324 limbs were pooled into analysis and most of the baseline characteristics did not show significant difference. A total of 74 in BMS group and 71 in DCB group were claudicants while 83 in BMS group and 56 in DCB group suffered from chronic limb threatening ischemia (CLTI). The mean cumulative lesion length was 18.7 ± 9.8cm in BMS group while 17.2 ± 10.3cm in DCB group. Kaplan-Meier estimates of primary patency were 75.3% and 80.9% for BMS and DCB groups at 12 months while decreased to 63.9% and 70.2% at 24 months (log-rank P = 0.167), respectively. Freedom from clinically driven target limb revascularization was 86.8% and 92.7% for BMS and DCB groups at 12 months while dropped to 82.5% and 85.9% at 24 months (log-rank P = 0.342). Estimates of primary patency between BMS and DCB group did not show significant difference on lesions with poor runoff (58.8% vs. 67.3%, log-rank P = 0.127), severe calcification (64.5% vs. 69.4%, log-rank P = 0.525) and popliteal artery involvement (59.3% vs. 60.3%, log-rank P = 0.695) at 24 months. The overall survival (92.6% for BMS, 90.3% for DCB, log-rank P = 0.391) and freedom from composite safety endpoint (79.3% for BMS, 79.2% for DCB, log-rank P = 0.941) showed no significant difference at 24 months.

CONCLUSIONS

Over the 24 month follow-up, BMS and DCB showed equivalent efficacy and safety outcomes for primary femoropopliteal artery disease, which indicated the reduction of permanent metallic implant insertion might be possible.

摘要

目的

比较药物涂层球囊（DCB）和裸金属支架（BMS）在中国人群股腘动脉疾病原发性病变中的应用，并进行组间亚组分析。

方法

纳入在单一三级血管中心接受BMS或DCB治疗的原发性病变患者，并随访24个月。使用血管外科学会推荐的标准报告临床和解剖学状况。主要终点包括24个月内的原发性通畅率、临床靶肢体血运重建、复合安全终点和全因死亡，采用Kaplan-Meier法评估。次要终点包括技术成功率和支架相关并发症。

结果

共纳入284例患者的324条肢体进行分析，大多数基线特征无显著差异。BMS组有74例间歇性跛行患者，DCB组有71例；BMS组有83例慢性肢体威胁性缺血（CLTI）患者，DCB组有56例。BMS组平均累积病变长度为18.7±9.8cm，DCB组为17.2±10.3cm。BMS组和DCB组12个月时原发性通畅率的Kaplan-Meier估计值分别为75.3%和80.9%，24个月时降至63.9%和70.2%（对数秩检验P=0.167）。BMS组和DCB组12个月时免于临床驱动的靶肢体血运重建率分别为86.8%和92.7%，24个月时降至82.5%和85.9%（对数秩检验P=0.342）。24个月时，BMS组和DCB组在流出道差的病变（58.8%对67.3%，对数秩检验P=0.127）、严重钙化病变（64.5%对69.4%，对数秩检验P=0.525）和腘动脉受累病变（59.3%对60.3%，对数秩检验P=0.695）的原发性通畅率估计值无显著差异。24个月时，总体生存率（BMS组为92.6%，DCB组为90.3%，对数秩检验P=0.391）和免于复合安全终点率（BMS组为79.3%，DCB组为79.2%，对数秩检验P=0.941）无显著差异。