1. Comparison of drug-coated balloon angioplasty versus uncoated balloon angioplasty in treatment of total occlusions with severe femoropopliteal lesions: An additional analysis from the AcoArt I study
- Author
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Guoyi Sun, Wei Bi, Xin Jia, Pingfan Guo, Feng Wang, Jie Liu, Weiguo Fu, Baixi Zhuang, Wei Guo, Yu Zhao, AcoArt I Trial Investigators, Shenming Wang, Ji-wei Zhang, Danming Wu, and Senhao Jia
- Subjects
Male ,medicine.medical_specialty ,China ,Drug coated balloon ,Time Factors ,medicine.medical_treatment ,Constriction, Pathologic ,030204 cardiovascular system & hematology ,Balloon ,Total occlusion ,Severity of Illness Index ,Amputation, Surgical ,03 medical and health sciences ,Peripheral Arterial Disease ,0302 clinical medicine ,Coated Materials, Biocompatible ,Recurrence ,Angioplasty ,Medicine ,Humans ,Radiology, Nuclear Medicine and imaging ,Popliteal Artery ,030212 general & internal medicine ,Vascular Patency ,Aged ,business.industry ,Cardiovascular Agents ,General Medicine ,Equipment Design ,Middle Aged ,Limb Salvage ,Surgery ,Femoral Artery ,Treatment Outcome ,Chronic Disease ,Female ,Cardiology and Cardiovascular Medicine ,business ,Angioplasty, Balloon ,Vascular Access Devices - Abstract
Objectives Femoropopliteal chronic total occlusions are challenging to treat, and evidence of the effectiveness of drug-coated balloon angioplasty for long femoropopliteal chronic total occlusion lesions is limited. We compared the midterm outcomes of drug-coated balloon angioplasty versus plain old balloon angioplasty (POBA) for femoropopliteal chronic total occlusions. Methods In total, 95 patients from the AcoArt I trial (ClinicalTrials.gov identifier NCT01850056) with ≥5-cm femoropopliteal chronic total occlusion lesions were enrolled in this post-hoc subset analysis (drug-coated balloon, n = 50; POBA, n = 45). The primary endpoints were primary patency and clinically driven target lesion revascularization (CD-TLR) at 24 months. The secondary endpoints were late lumen loss at six months and binary restenosis, major adverse events (composite of death and target limb amputation), change in the Rutherford class, and the ankle-brachial index at 24 months. Results Demographic, clinical, and lesion characteristics were matched (mean lesion length, 20 cm). The six-month late-lumen loss rate was lower in the drug-coated balloon than POBA group (0.18 ± 0.81 vs. 1.34 ± 0.94 mm, respectively; P Conclusion The paclitaxel drug-coated balloon shows better primary patency and freedom from target lesion revascularization than POBA at 24month after treatment of femoropopliteal chronic total occlusions (≥5 cm) lesion.
- Published
- 2020