A single-center prospective study of the clinical efficacy of endovascular treatment for moderately to severely calcified femoropopliteal artery lesions
A single-center prospective study of the clinical efficacy of endovascular treatment for moderately to severely calcified femoropopliteal artery lesions
王冰 1黄砺锐 1钟文 1于欣雨 1邱宸阳 1吴子衡 1王丽萍
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作者信息
1. 浙江大学医学院附属第一医院血管外科，杭州 310000
折叠
摘要
目的 依托于VASCBASE数据库，分析真实世界中伴有中重度钙化的股腘段动脉硬化闭塞症的不同腔内治疗的临床数据和疗效。 方法 收集2021年1月至2022年12月，入组于浙江大学医学院附属第一医院血管外科Evolusion项目（NCT04716361）患者的临床资料。统计患者基线情况，并随访至2023年5月1日，观察不同腔内治疗技术成功率、免于临床驱动的靶病变血运重建（CD-TLR）率、靶病变通畅率、生活质量改善情况等指标。 结果 共纳入患者281例，其中男性194例，女性87例；年龄（73.8±10.7）岁（范围：38~95岁）；其中完全闭塞病变216例（76.9%）。Rutherford分级2级6例，3级148例，4级51例，5级73例，6级3例。踝肱指数为0.32（0.07，0.52），病变长度为（17.5±8.1）cm（范围：2.0~45.0 cm）。靶血管为单纯股浅动脉140例（49.8%），腘动脉与股浅动脉118例（42.0%），其他动脉23例（8.2%）。腔内治疗方式有全程支架覆盖105例（37.4%），单纯药物涂层球囊（DCB）扩张83例（29.5%），单纯DCB预扩张后局部支架植入27例（9.6%），普通球囊扩张后局部支架植入23例（8.2%）及其他治疗方式43例（15.3%）。技术成功率为100%（281/281）。术后穿刺点血肿1例。本组患者均采用电话随访和门诊随访的方式。电话随访满1、3、6及12个月分别为250例（89.0%）、250例（89.0%）、247例（87.9%）、220例（78.3%）。门诊随访满1、3、6及12个月分别为246例（87.5%）、230例（81.8%）、188例（66.9%）、87例（30.9%）。术后1、3、6及12个月时，患者Vasc-QOL评分分别为（5.56±1.18）分、（5.89±0.84）分、（6.09±0.82）分及（6.19±0.93）分，组间比较差异有统计学意义（F=13.91，P=0.001）；EQ-5D-5L评分分别为20（18，20）分、20（19，20）分、20（20，20）分及20（20，20）分，组间比较差异有统计学意义（H=0.005，P=0.001）。术后1、3、6及12个月免于CD-TLR率和一期通畅率分别为96.4%（241/250）、92.8%（232/250）、91.9%（227/247）、89.1%（196/220）和87.8%（216/246）、73.9%（170/230）、61.7%（116/188）、44.8%（39/87）。 结论 伴中重度钙化的股腘段动脉硬化闭塞症，老年男性多见，多为单纯股浅动脉、股浅和腘动脉病变。腔内治疗术式多样，技术成功率高。术后1年主观评分和免于CD-TLR率较高，但总体一期通畅率较低。 Objective To analyze real-world clinical data and efficacy on endovascular interventions for moderate to severe calcification in femoropopliteal arteriosclerosis obliterans based on the database VASCBASE. Methods From January 2021 to December 2022, clinical data on patients enrolled in the Evolusion program (NCT04716361) at the Department of Vascular Surgery, the First Affiliated Hospital of Zhejiang University School of Medicine were collected. All patients, baseline condition gathered, were followed through May 1, 2023. Observations included the rate of technical success, the freedom from clinically driven target lesion revascularization(CD-TLR), the patency rate of target lesion, and the improvement in quality of life. Results A total of 281 patients were enrolled, with 194 (69%) being male and the age being (73.8±10.7) years. Among them, 216 cases were diagnosed with total occlusion. Of all participants, 6 cases were classified as Rutherford category 2 148 cases were classified as category 3 51 cases, category 4 73 cases, category 5 and 3 cases, category 6. The ankle-brachial index (ABI) was 0.32 (0.07,0.52) with an average lesion length of (17.5±8.1) cm. Vascular-targeted therapy was applied for the treatment of mere superficial femoral artery (140 cases 49.8%), popliteal artery together with superficial femoral artery (118 cases, 42.0%), and other arteries (23 cases, 8.2%). Full stent coverage, drug-coated balloon (DCB)dilation, and local stent implantation following DCB pre-dilation or conventional balloon dilation were the most frequently used surgical techniques, accounting for 37.4%(105/281), 29.5%(83/281), 9.6%(27/281), and 8.2%(23/281) of cases, respectively. The rate of technical success was 100% with one postoperative complication (hematoma at the puncture site). Following surgery, the patients were followed up via mobile phone and outpatient services. The follow-up rate via mobile phone was 89.0%, 89.0%, 87.9%, and 78.3% at 1, 3, 6, and 12 months, respectively. The follow-up rate via outpationt service was 87.5%, 81.8%,66.9% and 30.9% at 1,3,6 and 12 months,respectively.At 1, 3, 6, and 12 months, the Vasc-QOL score was 5.56±1.18, 5.89±0.8, 6.09±0.82 and 6.19±0.93, respectively and the EQ-5D-5L score was 20 (18, 20), 20 (19, 20), 20 (20, 20) and 20 (20, 20), respectively, the difference was statistically significant (F=13.91,P=0.001 H=0.005, P=0.001). At 1, 3, 6, and 12 months, 96.4% (241/250), 92.8% (232/250), 91.9% (227/247), and 89.1% (196/220), respectively, of patients were exempted from CD-TLR. Meanwhile, the primary patency rates were 87.8% (216/246), 73.9% (170/230), 61.7% (116/188), and 44.8% (39/87), respectively. Conclusions Moderate to severe calcification of the femoropopliteal occlusive sclerosis primarily affects elderly men risk factors include diabetes, hypertension, obesity, and smoking. Interventional procedures for the lower limbs have a high rate of efficacy and few complications. At one year, the rate of freedom from CD-TLR was greater, whereas the rate of primary patency was lower.
Abstract
Objective To analyze real-world clinical data and efficacy on endovascular interventions for moderate to severe calcification in femoropopliteal arteriosclerosis obliterans based on the database VASCBASE. Methods From January 2021 to December 2022, clinical data on patients enrolled in the Evolusion program (NCT04716361) at the Department of Vascular Surgery, the First Affiliated Hospital of Zhejiang University School of Medicine were collected. All patients, baseline condition gathered, were followed through May 1, 2023. Observations included the rate of technical success, the freedom from clinically driven target lesion revascularization(CD-TLR), the patency rate of target lesion, and the improvement in quality of life. Results A total of 281 patients were enrolled, with 194 (69%) being male and the age being (73.8±10.7) years. Among them, 216 cases were diagnosed with total occlusion. Of all participants, 6 cases were classified as Rutherford category 2 148 cases were classified as category 3 51 cases, category 4 73 cases, category 5 and 3 cases, category 6. The ankle-brachial index (ABI) was 0.32 (0.07,0.52) with an average lesion length of (17.5±8.1) cm. Vascular-targeted therapy was applied for the treatment of mere superficial femoral artery (140 cases 49.8%), popliteal artery together with superficial femoral artery (118 cases, 42.0%), and other arteries (23 cases, 8.2%). Full stent coverage, drug-coated balloon (DCB)dilation, and local stent implantation following DCB pre-dilation or conventional balloon dilation were the most frequently used surgical techniques, accounting for 37.4%(105/281), 29.5%(83/281), 9.6%(27/281), and 8.2%(23/281) of cases, respectively. The rate of technical success was 100% with one postoperative complication (hematoma at the puncture site). Following surgery, the patients were followed up via mobile phone and outpatient services. The follow-up rate via mobile phone was 89.0%, 89.0%, 87.9%, and 78.3% at 1, 3, 6, and 12 months, respectively. The follow-up rate via outpationt service was 87.5%, 81.8%,66.9% and 30.9% at 1,3,6 and 12 months,respectively.At 1, 3, 6, and 12 months, the Vasc-QOL score was 5.56±1.18, 5.89±0.8, 6.09±0.82 and 6.19±0.93, respectively and the EQ-5D-5L score was 20 (18, 20), 20 (19, 20), 20 (20, 20) and 20 (20, 20), respectively, the difference was statistically significant (F=13.91,P=0.001 H=0.005, P=0.001). At 1, 3, 6, and 12 months, 96.4% (241/250), 92.8% (232/250), 91.9% (227/247), and 89.1% (196/220), respectively, of patients were exempted from CD-TLR. Meanwhile, the primary patency rates were 87.8% (216/246), 73.9% (170/230), 61.7% (116/188), and 44.8% (39/87), respectively. Conclusions Moderate to severe calcification of the femoropopliteal occlusive sclerosis primarily affects elderly men risk factors include diabetes, hypertension, obesity, and smoking. Interventional procedures for the lower limbs have a high rate of efficacy and few complications. At one year, the rate of freedom from CD-TLR was greater, whereas the rate of primary patency was lower.
万方数据