Eric Therasse1, Véronique Caty2, Patrick Gilbert3, Marie-France Giroux3, Pierre Perreault3, Louis Bouchard3, Vincent L Oliva3, Jacques Lespérance4, Jean Ethier5, Georges Ouellet2, Martin Francoeur6, Serge Cournoyer7, Gilles Soulez8. 1. Department of Radiology, Centre Hospitalier de l'Université de Montréal, Montreal, Canada; Centre de recherche du Centre Hospitalier de l'Université de Montréal, Montréal, Canada. Electronic address: eric.therasse.chum@ssss.gouv.qc.ca. 2. Maisonneuve-Rosemont Hospital, Montreal, Canada. 3. Department of Radiology, Centre Hospitalier de l'Université de Montréal, Montreal, Canada. 4. Montreal Heart Institute, Montreal, Canada. 5. Department of Medicine, Centre Hospitalier de l'Université de Montréal, Montreal, Canada. 6. Department of Radiology, Charles Lemoyne Hospital, Greenfield Park, Canada. 7. Department of Medicine, Charles Lemoyne Hospital, Greenfield Park, Canada. 8. Department of Radiology, Centre Hospitalier de l'Université de Montréal, Montreal, Canada; Centre de recherche du Centre Hospitalier de l'Université de Montréal, Montréal, Canada.
Abstract
PURPOSE: To assess whether angioplasty of hemodialysis access (HA) stenosis with a drug-coated balloon (DCB) would prevent restenosis in comparison with plain-balloon percutaneous transluminal angioplasty (PTA). MATERIALS AND METHODS: This prospective randomized clinical trial enrolled 120 patients with dysfunctional arteriovenous fistulae (n = 109) and grafts (n = 11), due to a ≥50% stenosis between March 2014 and April 2018. All patients underwent high-pressure balloon angioplasty and were then randomized to either DCB (n = 60) or PTA (n = 60). Patients were followed-up for 1 year, and angiography was performed 6 months after angioplasty. The primary endpoint was the late lumen loss (LLL) at 6 months. Secondary endpoints included other angiographic parameters at 6 months and HA failures, adverse event, and mortality at 12 months. Continuous variables were compared with a Student t-test, and Kaplan-Meier curves were used for freedom from HA failure and for mortality. RESULTS:LLL in the DCB and in the PTA group were 0.64 mm ± 1.20 and 1.13 mm ± 1.51, respectively (P = .082, adjusted P = .0498). DCB was associated with lower percentage stenosis (54.2% ± 19.3 vs 61.7% ± 18.2; P = .047) and binary restenosis ≥50% (56.5% vs 81.1%; P = .009) than PTA. The number of HA failures after 12 months was lower for DCB than for PTA (45% vs 66.7%; P = .017). Mortality at 12 months was 10% and 8.3% in the DCB and PTA groups, respectively (P = .75). CONCLUSIONS: Despite LLL improvement that failed to reach statistical significance, this study demonstrated decreased incidence and severity of restenosis with DCB compared with PTA to treat dysfunctional HA.
RCT Entities:
PURPOSE: To assess whether angioplasty of hemodialysis access (HA) stenosis with a drug-coated balloon (DCB) would prevent restenosis in comparison with plain-balloon percutaneous transluminal angioplasty (PTA). MATERIALS AND METHODS: This prospective randomized clinical trial enrolled 120 patients with dysfunctional arteriovenous fistulae (n = 109) and grafts (n = 11), due to a ≥50% stenosis between March 2014 and April 2018. All patients underwent high-pressure balloon angioplasty and were then randomized to either DCB (n = 60) or PTA (n = 60). Patients were followed-up for 1 year, and angiography was performed 6 months after angioplasty. The primary endpoint was the late lumen loss (LLL) at 6 months. Secondary endpoints included other angiographic parameters at 6 months and HA failures, adverse event, and mortality at 12 months. Continuous variables were compared with a Student t-test, and Kaplan-Meier curves were used for freedom from HA failure and for mortality. RESULTS: LLL in the DCB and in the PTA group were 0.64 mm ± 1.20 and 1.13 mm ± 1.51, respectively (P = .082, adjusted P = .0498). DCB was associated with lower percentage stenosis (54.2% ± 19.3 vs 61.7% ± 18.2; P = .047) and binary restenosis ≥50% (56.5% vs 81.1%; P = .009) than PTA. The number of HA failures after 12 months was lower for DCB than for PTA (45% vs 66.7%; P = .017). Mortality at 12 months was 10% and 8.3% in the DCB and PTA groups, respectively (P = .75). CONCLUSIONS: Despite LLL improvement that failed to reach statistical significance, this study demonstrated decreased incidence and severity of restenosis with DCB compared with PTA to treat dysfunctional HA.
Authors: Chenyu Liu; Matthew Wolfers; Bint-E Zainab Awan; Issa Ali; Adrian Michael Lorenzana; Quinn Smith; George Tadros; Qian Yu Journal: J Am Heart Assoc Date: 2021-11-19 Impact factor: 6.106