Effectiveness of drug-coated balloon in treating real-world femoropopliteal lesions: A cohort study
BACKGROUND: The drug-coated balloon is superior to angioplasty for simple femoropopliteal lesions in clinical trials. The evidence on the effectiveness of Acotec drug-coated balloon in treating complex femoropopliteal lesions in the real world is limited. This study aimed to investigate the clinica...
| Main Authors: | , , , , , |
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| Format: | Article |
| Language: | English |
| Published: |
Wolters Kluwer Medknow Publications
2023-01-01
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| Series: | Vascular Investigation and Therapy |
| Subjects: | |
| Online Access: | http://www.vitonline.org/article.asp?issn=2589-9686;year=2023;volume=6;issue=2;spage=38;epage=44;aulast=Niu |
| Summary: | BACKGROUND: The drug-coated balloon is superior to angioplasty for simple femoropopliteal lesions in clinical trials. The evidence on the effectiveness of Acotec drug-coated balloon in treating complex femoropopliteal lesions in the real world is limited. This study aimed to investigate the clinical effectiveness of Acotec drug-coated balloon in real-world femoropopliteal lesions.
METHODS: The retrospective study enrolled 128 limbs of 120 patients treated with the Acotec drug-coated balloon in femoropopliteal lesions. Patency rate, target lesion revascularization (TLR) rate, clinical improvement, and safety endpoints of femoropopliteal lesions were analyzed for a 12-month follow-up. Risk factors of primary patency and freedom from TLR were identified.
RESULTS: Of the limbs, 31.2% had chronic limb-threatening ischemia. The mean lesion length was 199.3 ± 108.9 mm, and 75.8% were occlusions. Kaplan–Meier estimates of 12-month primary patency were 88.5%, whereas freedom from TLR rate was 95.2%. Rutherford category improved in 87.1% of patients. Freedom from 30-day major adverse limb events was 95.5%. The 12-month overall mortality was 8.6%. No independent risk factors for restenosis and TLR were identified.
CONCLUSIONS: The results suggest that Acotec drug-coated balloon is safe and effective in treating complex femoropopliteal artery diseases in the real world. |
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| ISSN: | 2589-9686 2589-9481 |