Comparative analysis of clinical outcomes of three endovascular techniques for femoral-popliteal artery lesions in lower extremity arteriosclerosis obliterans_CHINESE JOURNAL OF BASES AND CLINICS IN GENERAL SURGERY

Authors：

QI Guangwei , YANG Yan , YANG Liuyu , YANG Zhenwei , WU Qingrui , PENG Jieguang , XU Pengfei ,  BAI Chao

Department of Vascular and Thyroid Surgery, Digestive and Vascular Center, The First Affiliated Hospital of Xinjiang Medical University, Urumqi 830054, P. R. China;

Corresponding?author：

BAI Chao, Email: 736146410@qq.com

Keywords：

arteriosclerosis obliterans of the lower extremities; endovascular treatment; major adverse limb event; all-cause mortality; inverse probability of treatment weighting

DOI：

10.7507/1007-9424.202411029

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Objective To compare the efficacy of three surgical approaches, including percutaneous transluminal angioplasty (PTA), PTA+bare metal stent (BMS), and Rotarex+PTA+drug coated balloon (DCB), in treating femoropopliteal artery lesions in arteriosclerosis obliterans (ASO), and to explore the prognostic factors of femoropopliteal artery lesions in ASO. Methods A retrospective analysis was conducted on 314 patients with femoropopliteal artery lesions in ASO who were treated in the Department of Vascular and Thyroid Surgery in the First Affiliated Hospital of Xinjiang Medical University from March 2018 to March 2024. inverse probability of treatment weighting was used to balance the baseline characteristics of the three groups. The clinical examination, imaging examination, and ankle-brachial index (ABI) results of the three groups at 3 months, 12 months, and 24 months after surgery were compared. Log-rank test was used to compare the incidence of all-cause mortality (ACM) and major adverse limb events (MALEs) among the three groups, and Cox proportional hazards regression model was used to analyze the prognostic factors of femoropopliteal artery lesions in ASO. Results A total of 314 patients with ASO femoropopliteal artery lesions were enrolled, comprising 153 cases in the PTA group, 89 cases in the PTA+BMS group, and 72 cases in the Rotarex+PTA+DCB group. After inverse probability of treatment weighting based on propensity scores, baseline characteristics were balanced across all groups (all P>0.05). Postoperative follow-up results demonstrated the following patency rates: at 3 months, 58.4% (87/149) for the PTA group, 79.5% (66/83) for the PTA+BMS group, and 87.5% (63/72) for the Rotarex+PTA+DCB group; at 12 months, 78.0% (60/79), 68.3% (43/63), and 80.0% (44/55), respectively; and at 24 months, 98.1% (52/53), 89.7% (35/39), and 100.0% (43/43), respectively. The Rotarex+PTA+DCB group exhibited significantly superior patency rates, claudication distances, ankle-brachial index (ABI), and Rutherford classification compared to both the PTA and PTA+BMS groups at 3 months (P<0.05). Furthermore, the Rotarex+PTA+DCB group showed lower incidence of ACM/MALEs compared to the other two groups (χ²=18.70, P<0.001). Survival analysis revealed that the Rotarex+PTA+DCB group had significantly better survival outcomes compared to the PTA+BMS group (χ²=14.27, P<0.001) and the PTA group (χ²=3.92, P=0.016). Cox proportional hazards regression analysis identified elevated red cell distribution width (RDW) as an independent risk factor for ACM/MALEs following endovascular therapy in ASO patients, with a relative risk of 1.006 [95%CI (1.002, 1.011), P=0.006]. Conclusions The Rotarex+PTA+DCB demonstrate superior outcomes compared to both the PTA and PTA+BMS in terms of patency rate, claudication distance, ABI, and Rutherford classification at 3 months postoperatively, along with the better survival. Furthermore, elevated RDW may serve as a prognostic factor for adverse outcomes in patients with ASO femoropopliteal artery lesions.

Citation： QI Guangwei, YANG Yan, YANG Liuyu, YANG Zhenwei, WU Qingrui, PENG Jieguang, XU Pengfei, BAI Chao. Comparative analysis of clinical outcomes of three endovascular techniques for femoral-popliteal artery lesions in lower extremity arteriosclerosis obliterans. CHINESE JOURNAL OF BASES AND CLINICS IN GENERAL SURGERY, 2025, 32(6): 756-762. doi: 10.7507/1007-9424.202411029 Copy

1.	Zhao H, Zhuo T, Hao X, et al. Effect of diabetes on the prognosis, serum inflammatory factors, and quality of life of patients with lower extremity arteriosclerosis obliterans after vascular intervention: a retrospective comparative cohort study. Ann Palliat Med, 2022, 11(8): 2720-2729.
2.	Pabon M, Cheng S, Altin SE, et al. Sex differences in peripheral artery disease. Circ Res, 2022, 130(4): 496-511.
3.	Willems LH, Maas DPMSM, Kramers K, et al. Correction to: antithrombotic therapy for symptomatic peripheral arterial disease: a systematic review and network meta-analysis. Drugs, 2022, 82(13): 1435. doi: 10.1007/s40265-022-01776-2.
4.	王深明, 姚陳. 下肢動脈硬化閉塞癥的血管腔內治療. 中國普外基礎與臨床雜志, 2015, 22(8): 901-903.
5.	包俊敏, 劉冰, 沈晨陽, 等. 股腘動脈閉塞癥的診斷和治療中國專家共識. 中國循環雜志, 2022, 37(7): 669-676.
6.	Choke ETC, Peh EYL, Tang TY, et al. MagicTouch PTA sirolimus-coated balloon for femoropopliteal and below-the-knee disease: 3-year outcomes of the XTOSI Trial. Ann Vasc Surg, 2024, 106: 8-15.
7.	Cui HJ, Wu YF. The efficacy of drug-coated balloons and drug-eluting stents in infrapopliteal revascularization: a meta-analysis. J Endovasc Ther, 2024: 15266028231222385.
8.	Giannopoulos S, Strobel A, Rudofker E, et al. Outcomes of stented vs nonstented femoropopliteal lesions treated with drug-coated balloon angioplasty. J Endovasc Ther, 2023, 30(2): 194-203.
9.	Liu L, Zhao J, Bi J, et al. Percutaneous mechanical atherothrombectomy using the rotarex device in acute ischemic disease of lower limbs: a china retrospective multicenter study on 186 patients. Ann Vasc Surg, 2022, 85: 146-155.
10.	Fan W, Lu S, Tan J, et al. Midterm results of drug-coated balloon alone or combined with rotarex thrombectomy device for treatment of subacute femoropopliteal artery thrombotic occlusion. Ann Vasc Surg, 2023, 92: 240-248.
11.	中華醫學會外科學分會血管外科學組. 下肢動脈硬化閉塞癥診治指南. 中華普通外科學文獻(電子版), 2016, 10(1): 1-18.
12.	Keefe N, Shull T, Botea L, et al. Drug-coated balloon versus drug-eluting stent: the debate of leave nothing behind. Semin Intervent Radiol, 2023, 40(2): 161-166.
13.	Tepe G, Brodmann M, Werner M, et al. Intravascular lithotripsy for peripheral artery calcification: 30-day outcomes from the randomized disrupt PAD Ⅲ trial. JACC Cardiovasc Interv, 2021, 14(12): 1352-1361.
14.	褚云峰, 彭艷斌, 陳仲, 等. 巧克力球囊擴張血管成形術在股腘動脈病變中的臨床應用. 血管與腔內血管外科雜志, 2024, 10(05): 573-577.
15.	白森. 抗血小板聯合抗凝藥物治療冠心病合并下肢動脈閉塞的臨床效果. 中國當代醫藥, 2022, 29(3): 17-20, 24.
16.	Boc A, Er?en B, Perme RL, et al. Bailout stenting in femoropopliteal arterial segment. VASA, 2022, 51(1): 13-18.
17.	Han D, Shin DG, Kang MK, et al. Complications associated with the Rotarex^? wire in a patient with peripheral artery disease. Clin Case Rep, 2021, 9(5): e03195. doi: 10.1002/ccr3.3195.
18.	Gou?ffic Y, Torsello G, Zeller T, et al. Efficacy of a drug-eluting stent versus bare metal stents for symptomatic femoropopliteal peripheral artery disease: primary results of the EMINENT randomized trial. Circulation, 2022, 146(21): 1564-1576.
19.	姜國忠, 李雪巖, 趙健飛, 等. 血栓旋切器聯合藥物涂層球囊治療股腘動脈繼發血栓的體會. 血管與腔內血管外科雜志, 2018, 4(2): 129-131.
20.	岳彥宇, 冉峰. Rotarex機械血栓切除術在老年急性肢體動脈閉塞癥中的應用進展. 實用老年醫學, 2023, 37(5): 524-527.
21.	莊金滿, 李天潤, 李選, 等. Rotarex旋切導管在股腘動脈狹窄合并血栓形成中的應用. 北京大學學報 (醫學版), 2023, 55(2): 328-332.
22.	Liao CJ, Song SH, Li T, et al. Combination of Rotarex thrombectomy and drug-coated balloon for the treatment of femoropopliteal artery in-stent restenosis. Ann Vasc Surg, 2019, 60: 301-307.
23.	丁潔, 李天潤, 莊金滿, 等. Rotarex機械血栓切除系統聯合藥物涂層球囊治療股腘動脈支架內再狹窄. 中國微創外科雜志, 2024, 24(3): 178-183.
24.	Li D, Long J, Zhang J, et al. Association between red cell distribution width-and-albumin ratio and the risk of peripheral artery disease in patients with diabetes. Front Endocrinol (Lausanne), 2024, 15: 1272573. doi: 10.3389/fendo.2024.1272573.
25.	Vieira-Cardoso N, Pereira-Neves A, Frag?o-Marques M, et al. Red blood cell distribution width as a predictor of cardiovascular outcomes in extensive aortoiliac disease. J Cardiovasc Surg (Torino), 2023, 64(1): 48-57.
26.	王鵬, 呂衛華. 2型糖尿病患者紅細胞分布寬度與外周動脈疾病相關性研究. 中國現代醫生, 2018, 56(16): 23-26.
27.	黃聰. 紅細胞分布寬度、中性粒細胞/淋巴細胞比值及白蛋白與下肢動脈硬化閉塞癥的相關性. 福州: 福建醫科大學, 2018.
28.	Tscharre M, Lee S, Kopp CW, et al. Mean corpuscular volume predicts adverse outcomes following peripheral angioplasty with stenting and is associated with on-treatment platelet reactivity. Angiology, 2021, 72(1): 16-23.

1. Zhao H, Zhuo T, Hao X, et al. Effect of diabetes on the prognosis, serum inflammatory factors, and quality of life of patients with lower extremity arteriosclerosis obliterans after vascular intervention: a retrospective comparative cohort study. Ann Palliat Med, 2022, 11(8): 2720-2729.
2. Pabon M, Cheng S, Altin SE, et al. Sex differences in peripheral artery disease. Circ Res, 2022, 130(4): 496-511.
3. Willems LH, Maas DPMSM, Kramers K, et al. Correction to: antithrombotic therapy for symptomatic peripheral arterial disease: a systematic review and network meta-analysis. Drugs, 2022, 82(13): 1435. doi: 10.1007/s40265-022-01776-2.
4. 王深明, 姚陳. 下肢動脈硬化閉塞癥的血管腔內治療. 中國普外基礎與臨床雜志, 2015, 22(8): 901-903.
5. 包俊敏, 劉冰, 沈晨陽, 等. 股腘動脈閉塞癥的診斷和治療中國專家共識. 中國循環雜志, 2022, 37(7): 669-676.
6. Choke ETC, Peh EYL, Tang TY, et al. MagicTouch PTA sirolimus-coated balloon for femoropopliteal and below-the-knee disease: 3-year outcomes of the XTOSI Trial. Ann Vasc Surg, 2024, 106: 8-15.
7. Cui HJ, Wu YF. The efficacy of drug-coated balloons and drug-eluting stents in infrapopliteal revascularization: a meta-analysis. J Endovasc Ther, 2024: 15266028231222385.
8. Giannopoulos S, Strobel A, Rudofker E, et al. Outcomes of stented vs nonstented femoropopliteal lesions treated with drug-coated balloon angioplasty. J Endovasc Ther, 2023, 30(2): 194-203.
9. Liu L, Zhao J, Bi J, et al. Percutaneous mechanical atherothrombectomy using the rotarex device in acute ischemic disease of lower limbs: a china retrospective multicenter study on 186 patients. Ann Vasc Surg, 2022, 85: 146-155.
10. Fan W, Lu S, Tan J, et al. Midterm results of drug-coated balloon alone or combined with rotarex thrombectomy device for treatment of subacute femoropopliteal artery thrombotic occlusion. Ann Vasc Surg, 2023, 92: 240-248.
11. 中華醫學會外科學分會血管外科學組. 下肢動脈硬化閉塞癥診治指南. 中華普通外科學文獻(電子版), 2016, 10(1): 1-18.
12. Keefe N, Shull T, Botea L, et al. Drug-coated balloon versus drug-eluting stent: the debate of leave nothing behind. Semin Intervent Radiol, 2023, 40(2): 161-166.
13. Tepe G, Brodmann M, Werner M, et al. Intravascular lithotripsy for peripheral artery calcification: 30-day outcomes from the randomized disrupt PAD Ⅲ trial. JACC Cardiovasc Interv, 2021, 14(12): 1352-1361.
14. 褚云峰, 彭艷斌, 陳仲, 等. 巧克力球囊擴張血管成形術在股腘動脈病變中的臨床應用. 血管與腔內血管外科雜志, 2024, 10(05): 573-577.
15. 白森. 抗血小板聯合抗凝藥物治療冠心病合并下肢動脈閉塞的臨床效果. 中國當代醫藥, 2022, 29(3): 17-20, 24.
16. Boc A, Er?en B, Perme RL, et al. Bailout stenting in femoropopliteal arterial segment. VASA, 2022, 51(1): 13-18.
17. Han D, Shin DG, Kang MK, et al. Complications associated with the Rotarex^? wire in a patient with peripheral artery disease. Clin Case Rep, 2021, 9(5): e03195. doi: 10.1002/ccr3.3195.
18. Gou?ffic Y, Torsello G, Zeller T, et al. Efficacy of a drug-eluting stent versus bare metal stents for symptomatic femoropopliteal peripheral artery disease: primary results of the EMINENT randomized trial. Circulation, 2022, 146(21): 1564-1576.
19. 姜國忠, 李雪巖, 趙健飛, 等. 血栓旋切器聯合藥物涂層球囊治療股腘動脈繼發血栓的體會. 血管與腔內血管外科雜志, 2018, 4(2): 129-131.
20. 岳彥宇, 冉峰. Rotarex機械血栓切除術在老年急性肢體動脈閉塞癥中的應用進展. 實用老年醫學, 2023, 37(5): 524-527.
21. 莊金滿, 李天潤, 李選, 等. Rotarex旋切導管在股腘動脈狹窄合并血栓形成中的應用. 北京大學學報 (醫學版), 2023, 55(2): 328-332.
22. Liao CJ, Song SH, Li T, et al. Combination of Rotarex thrombectomy and drug-coated balloon for the treatment of femoropopliteal artery in-stent restenosis. Ann Vasc Surg, 2019, 60: 301-307.
23. 丁潔, 李天潤, 莊金滿, 等. Rotarex機械血栓切除系統聯合藥物涂層球囊治療股腘動脈支架內再狹窄. 中國微創外科雜志, 2024, 24(3): 178-183.
24. Li D, Long J, Zhang J, et al. Association between red cell distribution width-and-albumin ratio and the risk of peripheral artery disease in patients with diabetes. Front Endocrinol (Lausanne), 2024, 15: 1272573. doi: 10.3389/fendo.2024.1272573.
25. Vieira-Cardoso N, Pereira-Neves A, Frag?o-Marques M, et al. Red blood cell distribution width as a predictor of cardiovascular outcomes in extensive aortoiliac disease. J Cardiovasc Surg (Torino), 2023, 64(1): 48-57.
26. 王鵬, 呂衛華. 2型糖尿病患者紅細胞分布寬度與外周動脈疾病相關性研究. 中國現代醫生, 2018, 56(16): 23-26.
27. 黃聰. 紅細胞分布寬度、中性粒細胞/淋巴細胞比值及白蛋白與下肢動脈硬化閉塞癥的相關性. 福州: 福建醫科大學, 2018.
28. Tscharre M, Lee S, Kopp CW, et al. Mean corpuscular volume predicts adverse outcomes following peripheral angioplasty with stenting and is associated with on-treatment platelet reactivity. Angiology, 2021, 72(1): 16-23.

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CHINESE JOURNAL OF BASES AND CLINICS IN GENERAL SURGERY

Comparative analysis of clinical outcomes of three endovascular techniques for femoral-popliteal artery lesions in lower extremity arteriosclerosis obliterans

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