药物涂层球囊与裸金属支架在股浅动脉中的应用：来自中国单中心的 12 个月随访结果。

Drug-Coated Balloon versus Bare Nitinol Stent in Femoropopliteal Artery: 12 Months Outcome from a Single Center in China.

机构信息

Department of Cardiovascular Surgery, China-Japan Friendship Hospital, Beijing, China.

出版信息

Ann Vasc Surg. 2021 Jul;74:367-381. doi: 10.1016/j.avsg.2021.01.079. Epub 2021 Feb 5.

DOI:10.1016/j.avsg.2021.01.079

PMID:33556529

Abstract

OBJECT

The study sought to compare the safety and effectiveness of drug-coated balloon (DCB) with bare nitinol stent in patients with complex femoropopliteal(FP) lesions in real-world practice.

METHODS

Patients with symptomatic (Rutherford stage 2 to 5) femoropopliteal lesions who underwent DCB or bare nitinol stent implantation at the Department of Cardiovascular Surgery of China-Japan Friendship Hospital from June 2016 to September 2017 were included. Demographics, angiographic and procedural variables were included. Freedom from target lesion revascularization (TLR), primary patency and major adverse events were obtained from follow-up results at 3,6 and12 months. Descriptive analysis was performed on all variables.

RESULTS

A total of 90 eligible patients were enrolled, which included 51 DCB subjects (mean age, 63.1 ± 13.2 years; 76.5% male) with 55 lesions and 39 nitinol stent subjects (mean age, 66.5 ± 10.5 years; 61.5% male) with 42 lesions. Significant higher primary patency was observed in the DCB group compared with the stent group (74.5% vs. 52.4%; log-rank test P = 0.018; HR 0.335, 95%CI 0.124-0.903, P = 0.031). The rates of freedom from TLR (f-TLR) were 78.2% and 59.5% (log-rank test P = 0.032) for the DCB group and the stent group, respectively, at 12 months. CD-TLR rates were 18.2% vs. 38.1% with a P-value of 0.023. Female sex (HR 6.122, 95%CI 1.880-19.934, P = 0.003), lesion length over 20 cm (HR 5.514, 95%CI 2.312-13.148, P < 0.001) and renal insufficiency (HR 2.609, 95%CI 1.087-6.260, P = 0.032) were suggested as independent risk factors of reducing primary patency. There were no significant differences in major adverse events between the 2 groups.

CONCLUSION

The result above demonstrates that DCB treatment has higher primary patency and lower TLR at 12 months than nitinol stent. These data confirm the safety and effectiveness of the DCB for patients with complex femoropopliteal lesions.

摘要

目的

本研究旨在比较药物涂层球囊（DCB）与裸金属支架在真实世界中治疗复杂股腘动脉病变患者的安全性和有效性。

方法

回顾性分析 2016 年 6 月至 2017 年 9 月在中国医学科学院阜外医院心血管外科接受 DCB 或裸金属支架植入术的症状性（Rutherford 分级 2-5 级）股腘动脉病变患者的临床资料。记录患者的一般资料、血管造影和手术相关参数。术后 3、6、12 个月时通过随访获得无靶病变血运重建（TLR）、一期通畅率和主要不良事件。对所有变量进行描述性分析。

结果

共纳入 90 例符合条件的患者，其中 51 例接受 DCB 治疗（平均年龄 63.1±13.2 岁，76.5%为男性），共 55 处病变；39 例接受裸金属支架治疗（平均年龄 66.5±10.5 岁，61.5%为男性），共 42 处病变。与支架组相比，DCB 组的一期通畅率更高（74.5% vs. 52.4%；log-rank 检验 P=0.018；HR 0.335，95%CI 0.124-0.903，P=0.031）。DCB 组和支架组的 TLR 无事件率分别为 78.2%和 59.5%（log-rank 检验 P=0.032），12 个月时的 CD-TLR 发生率分别为 18.2%和 38.1%，P 值为 0.023。女性（HR 6.122，95%CI 1.880-19.934，P=0.003）、病变长度超过 20cm（HR 5.514，95%CI 2.312-13.148，P<0.001）和肾功能不全（HR 2.609，95%CI 1.087-6.260，P=0.032）被认为是降低一期通畅率的独立危险因素。两组间主要不良事件无显著差异。