Drug-Coated Balloon Angioplasty of Infrapopliteal Lesions in Chronic Limb-Threatening Ischemia: Six-month Outcomes of PRIME-WIFI

Julong Guo; Meng Ye; Wei Zhang; Ziheng Wu; Zibo Feng; Xin Fang; Qiang Li; Hongfei Sang; Zhenyu Shi; Weihao Shi; Chunshui He; Xixiang Gao; Jianming Guo; Zhu Tong; Yongquan Gu; Lianrui Guo

doi:10.1177/15266028231208646

Drug-Coated Balloon Angioplasty of Infrapopliteal Lesions in Chronic Limb-Threatening Ischemia: Six-month Outcomes of PRIME-WIFI

J Endovasc Ther. 2023 Nov 3:15266028231208646. doi: 10.1177/15266028231208646. Online ahead of print.

Authors

Julong Guo¹, Meng Ye², Wei Zhang³, Ziheng Wu⁴, Zibo Feng⁵, Xin Fang⁶, Qiang Li⁷, Hongfei Sang⁸, Zhenyu Shi⁹, Weihao Shi¹⁰, Chunshui He¹¹, Xixiang Gao¹, Jianming Guo¹, Zhu Tong¹, Yongquan Gu¹, Lianrui Guo¹

Affiliations

¹ Department of Vascular Surgery, Xuanwu Hospital, Capital Medical University, Beijing, China.
² Department of Vascular Surgery, Renji Hospital, School of Medicine, Shanghai Jiaotong University, Shanghai, China.
³ Biomedical Informatics & Statistics Center, School of Public Health, Fudan University, Shanghai, China.
⁴ Department of Vascular Surgery, The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, China.
⁵ Department of Vascular Surgery, Liyuan Hospital of Tongji Medical College of Huazhong University of Science & Technology, Wuhan, China.
⁶ Department of Vascular Surgery, Affiliated Hangzhou First People's Hospital, Zhejiang University School of Medicine, Hangzhou, China.
⁷ Department of Vascular Surgery, The Affiliated Qingdao Hiser Hospital of Qingdao University, Qingdao, China.
⁸ Department of Vascular Surgery, The Second Affiliated Hospital of Soochow University, Suzhou, China.
⁹ Department of Vascular Surgery, Zhongshan Hospital, Fudan University, Shanghai, China.
¹⁰ Department of Vascular Surgery, Huashan Hospital, Fudan University, Shanghai, China.
¹¹ Department of Vascular Surgery, Hospital of Chengdu University of Traditional Chinese Medicine, Chengdu, China.

PMID: 37919946
DOI: 10.1177/15266028231208646

Abstract

Purpose: To evaluate 6-month outcomes of drug-coated balloon (DCB) angioplasty of infrapopliteal lesions in patients with chronic limb-threatening ischemia (CLTI).

Methods: We analyzed 6-month follow-up data from the 10-center PRIME-WIFI prospective registry on 300 consecutive patients (33.000% female) with CLTI who underwent DCB angioplasty for infrapopliteal arterial lesions. The primary outcome was freedom from major adverse event (MAE), a composite of major amputation, all-cause death, and clinically-driven target limb reintervention (CD-TLR). Secondary outcomes included amputation-free survival (AFS), freedom from each primary outcome component, primary sustained clinical improvement, and quality of life (QOL) score. Independent risk factors of MAE were determined using Cox proportional hazards regression analysis.

Results: A total of 409 infrapopliteal lesions in 312 limbs were treated with DCB, with 54.167% of the limbs being treated for isolated infrapopliteal lesions. By Kaplan-Meier analysis, at 6 months post- procedure (follow-up rate, 85.000%), freedom from MAE was 86.353%; AFS was 90.318%; and freedom from major amputation, all-cause death, and CD-TLR were 96.429%, 93.480%, and 95.079%, respectively. At 6-month follow-up, 83.590% of patients showed primary sustained clinical improvement, and QOL score (4.902±1.388) improved compared with that before procedure (2.327±1.109; p<0.001). Chronic renal insufficiency, chronic obstructive pulmonary disease, Rutherford grade, and postoperative infrapopliteal runoff score were independent risk factors for MAE within 6 months.

Conclusion: In CLTI, DCB angioplasty of infrapopliteal lesions yields acceptable early efficacy and safety.

Clinical impact: This study evaluated the 6-month outcomes of DCB angioplasty in infrapopliteal lesions in CLTI patients by analyzing multicenter prospective data, showing that infrapopliteal DCB angioplasty can be performed with acceptable freedom from MAE rate, amputation-free survival rate, freedom from major amputation rate, survival rate, and freedom from CD-TLR rate. No patient experienced DCB-related intraoperative distal embolism. Chronic renal insufficiency, chronic obstructive pulmonary disease, Rutherford grade and postoperative infrapopliteal runoff score were independent risk factors for MAE within 6 months. Comparative real-world studies are needed.

Keywords: balloon angioplasty; chronic limb-threatening ischemia; drug-coated balloon; infrapopliteal lesions; peripheral arterial disease.