Randomized Controlled Trial for Paclitaxel-coated Balloon versus Plain Balloon Angioplasty in Dysfunctional Hemodialysis Vascular Access: 12-month Outcome from a Nonsponsored Trial
| Autor: | Grace Y.L. Liu, Chung Ngai Tang, Patricia C.L. Yih, Donna Lai, Karen C.L. Au-Yeung, Ka Leung Mo, Ronald O.H. Tse, Skyi Yin-Chun Pang, Warren K.W. Leung |
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| Rok vydání: | 2021 |
| Předmět: |
Male
Target lesion medicine.medical_specialty Time Factors Paclitaxel medicine.medical_treatment 030204 cardiovascular system & hematology Balloon Single Center 030218 nuclear medicine & medical imaging law.invention Lesion 03 medical and health sciences Arteriovenous Shunt Surgical 0302 clinical medicine Coated Materials Biocompatible Randomized controlled trial Renal Dialysis law Angioplasty Humans Medicine Prospective Studies Vascular Patency Aged business.industry Graft Occlusion Vascular Cardiovascular Agents General Medicine Middle Aged medicine.disease Surgery Stenosis Treatment Outcome Hong Kong Female Hemodialysis medicine.symptom Cardiology and Cardiovascular Medicine business Angioplasty Balloon Vascular Access Devices |
| Zdroj: | Annals of Vascular Surgery. 72:299-306 |
| ISSN: | 0890-5096 |
| DOI: | 10.1016/j.avsg.2020.10.005 |
| Popis: | Background Plain balloon angioplasty is regarded as the mainstay of treatment for failing vascular access with high success rate, but the poor treatment durability creates significant workload and increases patient morbidity. The study aims to compare target lesion primary patency rate at 12 months between paclitaxel-coated balloon (DCB) versus plain old balloon angioplasty (POBA) for treatment of dysfunctional vascular access. Methods This nonsponsored-randomized trial enrolled 40 patients with dysfunctional dialysis access at a single center. Patients were randomized into In.Pact Admiral Paclitaxel DCB or POBA after lesion crossing regardless of lesion type. Patients are followed up under surveillance protocol. Patients, hemodialysis staff, and sonographer are blinded to the treatment arms. Twelve-month primary patency rate in both arms are evaluated. Results 40 patients were recruited since June 2016 and were allocated to the DCB or POBA group. The mean age is 58 and 57 years with comparable demographic parameters. The locations of target lesion were comparable in both groups (juxta and arteriovenous anastomosis, cannulation site, and fistula/graft), with similar mean target lesion stenosis 69.8 +/− 15.8% for DCB and 69.5 +/− 13.6% for POBA (P = 0.95), and the lesion length for DCB is 45.8 +/− 38.4 mm and 50.2 +/− 33.5 mm for POBA (P = 0.70). Patients in DCB performed significantly better in terms of primary patency at 6 months 85% versus 55% (P = 0.007). The superiority in primary patency in DCB group exists at 12 months 65% versus 30% (P = 0.007). Conclusions Paclitaxel balloon angioplasty approach provides significant better primary patency in dysfunctional arteriovenous access at 12 months in our nonsponsored-randomized trial. |
| Databáze: | OpenAIRE |
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