A randomized controlled trial of drug-coated balloon angioplasty in venous anastomotic stenosis of dialysis arteriovenous grafts
| Autor: | Tsung-Yan Chen, Min-Tsun Liao, Cheng-Pin Lee, Mao-Shin Lin, Wei-Chu Chie, Lin Lin, Mu-Yang Hsieh, Chih-Cheng Wu, Ting-Tse Lin, Chien-Boon Jong |
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| Rok vydání: | 2019 |
| Předmět: |
Target lesion
Male medicine.medical_specialty Time Factors Paclitaxel medicine.medical_treatment Taiwan 030204 cardiovascular system & hematology Anastomosis 03 medical and health sciences 0302 clinical medicine Arteriovenous Shunt Surgical Coated Materials Biocompatible Renal Dialysis Angioplasty medicine Humans Single-Blind Method 030212 general & internal medicine Prospective Studies Dialysis Vascular Patency Aged Neointimal hyperplasia Aged 80 and over business.industry Hazard ratio Graft Occlusion Vascular Cardiovascular Agents Middle Aged medicine.disease Surgery Stenosis Treatment Outcome Female Hemodialysis Cardiology and Cardiovascular Medicine business Angioplasty Balloon |
| Zdroj: | Journal of vascular surgery. 71(6) |
| ISSN: | 1097-6809 |
| Popis: | Objective Paclitaxel-coated balloons are used to reduce neointimal hyperplasia in native arteriovenous (AV) fistulas. However, no study specifically evaluated their effect on venous anastomotic stenosis of dialysis grafts. We aimed to compare the efficacy of angioplasty with drug-coated balloons (DCBs) and angioplasty with conventional balloons (CBs) for venous anastomotic stenosis in dysfunctional AV grafts. Methods In this investigator-initiated, single-center, single-blinded, prospective randomized controlled trial, we randomly assigned 44 patients who had venous anastomotic stenosis to undergo angioplasty with DCBs (n = 22) or CBs (n = 22) from July 2015 to August 2018. Access function was observed per the hemodialysis center's protocols; ancillary angiographic follow-up was performed every 2 months for 1 year after the interventions. The primary end point was target lesion primary patency at 6 months. Secondary outcomes included anatomic and clinical success after angioplasty, circuit primary patency at 6 months and 1 year, and target lesion primary patency at 1 year. Results At 6 months, target lesion primary patency in the DCB group was significantly greater than that in the CB group (41% vs 9%; hazard ratio [HR], 0.393; 95% confidence interval [CI], 0.194-0.795; P = .006), as was the primary patency of the entire access circuit (36% vs 9%; HR, 0.436; 95% CI, 0.218-0.870; P = .013). At 1 year, the target lesion primary patency in the DCB group remained greater than that in the CB group (23% vs 9%; HR, 0.477; 95% CI, 0.243-0.933; P = .019) but not the primary patency of the access circuit (14% vs 9%; HR, 0.552; 95% CI, 0.288-1.059; P = .056). No difference in anatomic or clinical success was observed; no major complications were noted. Conclusions Angioplasty with DCBs showed a modest improvement in primary patency of venous anastomotic stenosis and all dialysis AV grafts at 6 months. The short-term benefit was not durable to 1 year, and reinterventions were eventually needed. |
| Databáze: | OpenAIRE |
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