PMID- 37919946 OWN - NLM STAT- Publisher LR - 20231103 IS - 1545-1550 (Electronic) IS - 1526-6028 (Linking) DP - 2023 Nov 3 TI - Drug-Coated Balloon Angioplasty of Infrapopliteal Lesions in Chronic Limb-Threatening Ischemia: Six-month Outcomes of PRIME-WIFI. PG - 15266028231208646 LID - 10.1177/15266028231208646 [doi] AB - 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. FAU - Guo, Julong AU - Guo J AUID- ORCID: 0000-0001-7544-7999 AD - Department of Vascular Surgery, Xuanwu Hospital, Capital Medical University, Beijing, China. FAU - Ye, Meng AU - Ye M AD - Department of Vascular Surgery, Renji Hospital, School of Medicine, Shanghai Jiaotong University, Shanghai, China. FAU - Zhang, Wei AU - Zhang W AD - Biomedical Informatics & Statistics Center, School of Public Health, Fudan University, Shanghai, China. FAU - Wu, Ziheng AU - Wu Z AUID- ORCID: 0000-0001-8960-9733 AD - Department of Vascular Surgery, The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, China. FAU - Feng, Zibo AU - Feng Z AD - Department of Vascular Surgery, Liyuan Hospital of Tongji Medical College of Huazhong University of Science & Technology, Wuhan, China. FAU - Fang, Xin AU - Fang X AD - Department of Vascular Surgery, Affiliated Hangzhou First People's Hospital, Zhejiang University School of Medicine, Hangzhou, China. FAU - Li, Qiang AU - Li Q AD - Department of Vascular Surgery, The Affiliated Qingdao Hiser Hospital of Qingdao University, Qingdao, China. FAU - Sang, Hongfei AU - Sang H AD - Department of Vascular Surgery, The Second Affiliated Hospital of Soochow University, Suzhou, China. FAU - Shi, Zhenyu AU - Shi Z AUID- ORCID: 0000-0002-9150-5674 AD - Department of Vascular Surgery, Zhongshan Hospital, Fudan University, Shanghai, China. FAU - Shi, Weihao AU - Shi W AD - Department of Vascular Surgery, Huashan Hospital, Fudan University, Shanghai, China. FAU - He, Chunshui AU - He C AD - Department of Vascular Surgery, Hospital of Chengdu University of Traditional Chinese Medicine, Chengdu, China. FAU - Gao, Xixiang AU - Gao X AD - Department of Vascular Surgery, Xuanwu Hospital, Capital Medical University, Beijing, China. FAU - Guo, Jianming AU - Guo J AD - Department of Vascular Surgery, Xuanwu Hospital, Capital Medical University, Beijing, China. FAU - Tong, Zhu AU - Tong Z AD - Department of Vascular Surgery, Xuanwu Hospital, Capital Medical University, Beijing, China. FAU - Gu, Yongquan AU - Gu Y AUID- ORCID: 0000-0002-2869-9736 AD - Department of Vascular Surgery, Xuanwu Hospital, Capital Medical University, Beijing, China. FAU - Guo, Lianrui AU - Guo L AD - Department of Vascular Surgery, Xuanwu Hospital, Capital Medical University, Beijing, China. LA - eng PT - Journal Article DEP - 20231103 PL - United States TA - J Endovasc Ther JT - Journal of endovascular therapy : an official journal of the International Society of Endovascular Specialists JID - 100896915 SB - IM OTO - NOTNLM OT - balloon angioplasty OT - chronic limb-threatening ischemia OT - drug-coated balloon OT - infrapopliteal lesions OT - peripheral arterial disease COIS- Declaration of Conflicting InterestsThe author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article. EDAT- 2023/11/03 06:44 MHDA- 2023/11/03 06:44 CRDT- 2023/11/03 03:41 PHST- 2023/11/03 06:44 [medline] PHST- 2023/11/03 06:44 [pubmed] PHST- 2023/11/03 03:41 [entrez] AID - 10.1177/15266028231208646 [doi] PST - aheadofprint SO - J Endovasc Ther. 2023 Nov 3:15266028231208646. doi: 10.1177/15266028231208646.