Treatment of Infrainguinal Arterial Occlusive Disease by Acotec Drug-coated Balloon in 435 Patients

Rui Ling,Fengqiang Cui,Jianghao Chen, Hui Wang,Wenlong Shi, Yanjie Li,Zenghui Han, Jing Yu, Ling Wang

semanticscholar(2020)

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Abstract
Background: At present, there are many clinical trials of drug coated balloon in the treatment of lower extremity arterial occlusive diseases, but there are not many clinical data in the real world study. Here we aimed to evaluate the efficacy and safety ofAcotec drug-coated balloon (DCB) for chronic ischemic disease in lower extremity.Methods: Clinical data of 435 patientswith 564occlusive/stenotic lesions in 492lower extremities treated by DCB from April 2016 toApril2019 were retrospectively analyzed.The mean age was 63years.Rutherford stage 2, 3, 4, 5, and 6 were classified in 11, 167, 182, 109, and 23 limbs, respectively.The mean length of the targeted lesions was 179.6mm. Of all the lesions, 436 located at femoraland/or popliteal arteries, and 128 at infra-popliteal arteries. All the patients were followed up at 6-month intervals. The major evaluation endpoints included late lumen loss (LLL), target lesion restenosis, target lesion revascularization (TLR), and severe clinical events including mortality and major amputation.Results: The technique success rate was 96.1%.Stents were placed in 57 (13.1%) cases for flow-limited dissections or remnant stenosisgreater than 50% after DCB angioplasty.The mean follow-up time was 28.5 ± 12.1 months (12-48 months). The meanLLLwas 1.1 mm, 1.8mm, and 2.8 mm, respectively, 1, 2, and 3 years after operation. The rate ofrestenosis and TLRwas 17.3%and8.2%, respectively, 1 year after operation; 20.6% and 11.6%, respectively, 2 years after operation; 29.4% and 18.3%, respectively, 3 years after operation.Fourteenpatientsdiedand 25received amputation.Conclusion: AcotecDCBwas safe and effective in treating chronic ischemic diseases of lower extremities.A better clinical outcome was achieved in femoro-popliteal arteries, compared toinfrapopliteal arteries.
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Key words
infrainguinal arterial occlusive disease,balloon,treatment,drug-coated
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