Min-Tsun Liao1, Cheng-Pin Lee1, Ting-Tse Lin2, Chien-Boon Jong1, Tsung-Yan Chen1, Lin Lin1, Mu-Yang Hsieh2, Mao-Shin Lin3, Wei-Chu Chie4, Chih-Cheng Wu5. 1. Division of Cardiology, Department of Medicine, National Taiwan University Hospital Hsinchu Branch, Hsinchu, Taiwan. 2. Division of Cardiology, Department of Medicine, National Taiwan University Hospital Hsinchu Branch, Hsinchu, Taiwan; College of Medicine, National Taiwan University, Taipei, Taiwan. 3. College of Medicine, National Taiwan University, Taipei, Taiwan; Department of Medicine, National Taiwan University Hospital, Taipei, Taiwan. 4. Department of Family Medicine, National Taiwan University Hospital, Taipei, Taiwan; School of Public Health, National Taiwan University, Taipei, Taiwan. 5. College of Medicine, National Taiwan University, Taipei, Taiwan; Institute of Biomedical Engineering, National Tsing-Hua University, Hsinchu, Taiwan; Cardiovascular Center, National Taiwan University Hospital Hsinchu Branch, Hsinchu, Taiwan; Institute of Cellular and System Medicine, National Health Research Institute, Miaoli, Taiwan. Electronic address: chihchengwumd@gmail.com.
Abstract
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.
RCT Entities:
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.
Authors: Torbjörn Fransson; Anders Gottsäter; Mohammad Abdulrasak; Martin Malina; Timothy Resch Journal: J Int Med Res Date: 2022-03 Impact factor: 1.671
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