A Multicenter Randomized Trial Assessing ZENFlow Carrier-Free Drug-Coated Balloon for the Treatment of Femoropopliteal Artery Lesions
Backgrounds and ObjectivesDrug-coated balloons (DCBs) have shown promising benefits in improving the outcomes for patients with peripheral artery disease. Several randomized clinical trials have reported that paclitaxel-coated balloon significantly reduce the rates of restenosis and the need for rei...
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Frontiers Media S.A.
2022-03-01
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| Series: | Frontiers in Cardiovascular Medicine |
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| Online Access: | https://www.frontiersin.org/articles/10.3389/fcvm.2022.821672/full |
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| author | Leng Ni Wei Ye Lan Zhang Xing Jin Chang Shu Jin-song Jiang Mu Yang Dan-ming Wu Ming Li Guan-feng Yu Jun Yang Jian-hua Huang Xiao-bai Wang Xiao-qiang Li Wei-liang Jiang Zhi-qun Wu Chang-wei Liu |
| author_facet | Leng Ni Wei Ye Lan Zhang Xing Jin Chang Shu Jin-song Jiang Mu Yang Dan-ming Wu Ming Li Guan-feng Yu Jun Yang Jian-hua Huang Xiao-bai Wang Xiao-qiang Li Wei-liang Jiang Zhi-qun Wu Chang-wei Liu |
| author_sort | Leng Ni |
| collection | DOAJ |
| description | Backgrounds and ObjectivesDrug-coated balloons (DCBs) have shown promising benefits in improving the outcomes for patients with peripheral artery disease. Several randomized clinical trials have reported that paclitaxel-coated balloon significantly reduce the rates of restenosis and the need for reintervention in comparison with regular balloon angioplasty. Due to the differences in excipients, paclitaxel dose, and coating techniques, variable clinical outcomes have been observed with different DCBs. In this study, we aimed to evaluate the safety and efficacy of a novel ZENFlow carrier-free DCB in the treatment of femoropopliteal artery occlusive disease.MethodsIn this randomized controlled trial conducted at 15 sites, 192 patients with Rutherford class 3–5 were randomly assigned into two groups: drug-coated balloon group and percutaneous transluminal angioplasty group. The primary endpoint was a late lumen loss at 6 months based on blinded angiographic core laboratory evaluations, and the secondary endpoints included primary patency rate, binary restenosis, clinically driven target lesion revascularization, ankle-brachial index, Rutherford class change, and major adverse events.ResultsIn this multicenter trial, 93 patients received DCB angioplasty, whereas 99 patients underwent regular balloon angioplasty. The late lumen loss at 6-month follow-up was 0.50 ± 0.82 and 1.69 ± 0.87 mm in the drug-coated balloon and percutaneous transluminal angioplasty groups, respectively (p < 0.001). During the 12-month follow-up period, the drug-coated balloon group showed a significantly higher primary patency rate (54 vs. 31.3%, p = 0.009) and markedly lower rates of target vessel restenosis (22.1 vs. 64.3%, p < 0.001) and clinically driven target lesion revascularization rate (5.4 vs. 19.2%, p = 0.006) than the percutaneous transluminal angioplasty group. Compared with the percutaneous transluminal angioplasty group, the drug-coated balloon group had significant improvements in the ankle-brachial index and Rutherford class. The all-cause mortality rate was comparable, and no device-related deaths occurred in either groups.ConclusionsBalloon angioplasty using a ZENFlow carrier-free drug-coated balloon is a safe and effective treatment method for femoropopliteal artery lesions. This novel drug-coated balloon catheter achieved satisfactory early and 1-year outcomes in this trial.Clinical Trial Registrationhttps://clinicaltrials.gov, identifier: NCT03844724. |
| first_indexed | 2024-12-11T10:37:12Z |
| format | Article |
| id | doaj.art-d4c0e5831539438e835bfab30a7288df |
| institution | Directory Open Access Journal |
| issn | 2297-055X |
| language | English |
| last_indexed | 2024-12-11T10:37:12Z |
| publishDate | 2022-03-01 |
| publisher | Frontiers Media S.A. |
| record_format | Article |
| series | Frontiers in Cardiovascular Medicine |
| spelling | doaj.art-d4c0e5831539438e835bfab30a7288df2022-12-22T01:10:40ZengFrontiers Media S.A.Frontiers in Cardiovascular Medicine2297-055X2022-03-01910.3389/fcvm.2022.821672821672A Multicenter Randomized Trial Assessing ZENFlow Carrier-Free Drug-Coated Balloon for the Treatment of Femoropopliteal Artery LesionsLeng Ni0Wei Ye1Lan Zhang2Xing Jin3Chang Shu4Jin-song Jiang5Mu Yang6Dan-ming Wu7Ming Li8Guan-feng Yu9Jun Yang10Jian-hua Huang11Xiao-bai Wang12Xiao-qiang Li13Wei-liang Jiang14Zhi-qun Wu15Chang-wei Liu16Department of Vascular Surgery, Peking Union Medical College Hospital, Beijing, ChinaDepartment of Vascular Surgery, Peking Union Medical College Hospital, Beijing, ChinaDepartment of Vascular Surgery, Renji Hospital Affiliated to Shanghai Jiaotong University School of Medicine, Shanghai, ChinaDepartment of Vascular Surgery, Shandong Provincial Hospital Affiliated to Shandong First Medical University, Jinan, ChinaVascular Surgery Center, Fuwai Hospital, National Center for Cardiovascular Disease, Beijing, ChinaDepartment of Vascular Surgery, Zhejiang Provincial People's Hospital, Hangzhou, ChinaDepartment of Vascular Surgery, Yantai Yuhuangding Hospital, Yantai, ChinaDepartment of Vascular Surgery, Liaoning Provincial People's Hospital, Shenyang, ChinaDepartment of Vascular Surgery, The First Affiliated Hospital, School of Medicine, Zhejiang University, Hangzhou, ChinaDepartment of Vascular Surgery, The First Affiliated Hospital of Wenzhou Medical University, Wenzhou, China0Division of Vascular Surgery, Tongji Affiliate Hospital of Tongji Medical College of Huazhong University of Science & Technology, Wuhan, China1Department of Vascular Surgery, The Xiangya Hospital of Central South University, Shangsha, China2Interventional Vascular Surgery, The First Affiliated Hospital of Jinan University, Guangzhou, China3Department of Vascular Surgery, The Second Affiliated Hospital of Soochow University, Suzhou, China4Department of Vascular Surgery, The Second Affiliated Hospital of Harbin Medical University, Harbin, China5Interventional Vascular Surgery, Tangdu Hospital, The Second Affiliated Hospital of Air Force Military Medical University, Xian, ChinaDepartment of Vascular Surgery, Peking Union Medical College Hospital, Beijing, ChinaBackgrounds and ObjectivesDrug-coated balloons (DCBs) have shown promising benefits in improving the outcomes for patients with peripheral artery disease. Several randomized clinical trials have reported that paclitaxel-coated balloon significantly reduce the rates of restenosis and the need for reintervention in comparison with regular balloon angioplasty. Due to the differences in excipients, paclitaxel dose, and coating techniques, variable clinical outcomes have been observed with different DCBs. In this study, we aimed to evaluate the safety and efficacy of a novel ZENFlow carrier-free DCB in the treatment of femoropopliteal artery occlusive disease.MethodsIn this randomized controlled trial conducted at 15 sites, 192 patients with Rutherford class 3–5 were randomly assigned into two groups: drug-coated balloon group and percutaneous transluminal angioplasty group. The primary endpoint was a late lumen loss at 6 months based on blinded angiographic core laboratory evaluations, and the secondary endpoints included primary patency rate, binary restenosis, clinically driven target lesion revascularization, ankle-brachial index, Rutherford class change, and major adverse events.ResultsIn this multicenter trial, 93 patients received DCB angioplasty, whereas 99 patients underwent regular balloon angioplasty. The late lumen loss at 6-month follow-up was 0.50 ± 0.82 and 1.69 ± 0.87 mm in the drug-coated balloon and percutaneous transluminal angioplasty groups, respectively (p < 0.001). During the 12-month follow-up period, the drug-coated balloon group showed a significantly higher primary patency rate (54 vs. 31.3%, p = 0.009) and markedly lower rates of target vessel restenosis (22.1 vs. 64.3%, p < 0.001) and clinically driven target lesion revascularization rate (5.4 vs. 19.2%, p = 0.006) than the percutaneous transluminal angioplasty group. Compared with the percutaneous transluminal angioplasty group, the drug-coated balloon group had significant improvements in the ankle-brachial index and Rutherford class. The all-cause mortality rate was comparable, and no device-related deaths occurred in either groups.ConclusionsBalloon angioplasty using a ZENFlow carrier-free drug-coated balloon is a safe and effective treatment method for femoropopliteal artery lesions. This novel drug-coated balloon catheter achieved satisfactory early and 1-year outcomes in this trial.Clinical Trial Registrationhttps://clinicaltrials.gov, identifier: NCT03844724.https://www.frontiersin.org/articles/10.3389/fcvm.2022.821672/fulldrug-coated balloonpaclitaxelpercutaneous transluminal angioplastyrestenosisperipheral artery diseasefemoropopliteal artery occlusive disease |
| spellingShingle | Leng Ni Wei Ye Lan Zhang Xing Jin Chang Shu Jin-song Jiang Mu Yang Dan-ming Wu Ming Li Guan-feng Yu Jun Yang Jian-hua Huang Xiao-bai Wang Xiao-qiang Li Wei-liang Jiang Zhi-qun Wu Chang-wei Liu A Multicenter Randomized Trial Assessing ZENFlow Carrier-Free Drug-Coated Balloon for the Treatment of Femoropopliteal Artery Lesions Frontiers in Cardiovascular Medicine drug-coated balloon paclitaxel percutaneous transluminal angioplasty restenosis peripheral artery disease femoropopliteal artery occlusive disease |
| title | A Multicenter Randomized Trial Assessing ZENFlow Carrier-Free Drug-Coated Balloon for the Treatment of Femoropopliteal Artery Lesions |
| title_full | A Multicenter Randomized Trial Assessing ZENFlow Carrier-Free Drug-Coated Balloon for the Treatment of Femoropopliteal Artery Lesions |
| title_fullStr | A Multicenter Randomized Trial Assessing ZENFlow Carrier-Free Drug-Coated Balloon for the Treatment of Femoropopliteal Artery Lesions |
| title_full_unstemmed | A Multicenter Randomized Trial Assessing ZENFlow Carrier-Free Drug-Coated Balloon for the Treatment of Femoropopliteal Artery Lesions |
| title_short | A Multicenter Randomized Trial Assessing ZENFlow Carrier-Free Drug-Coated Balloon for the Treatment of Femoropopliteal Artery Lesions |
| title_sort | multicenter randomized trial assessing zenflow carrier free drug coated balloon for the treatment of femoropopliteal artery lesions |
| topic | drug-coated balloon paclitaxel percutaneous transluminal angioplasty restenosis peripheral artery disease femoropopliteal artery occlusive disease |
| url | https://www.frontiersin.org/articles/10.3389/fcvm.2022.821672/full |
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