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Drug Coated Balloon Angioplasty in Failing AV Fistulas a Randomized Controlled Trial

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Drug Coated Balloon Angioplasty in Failing AV Fistulas a Randomized Controlled Trial Article Drug Coated Balloon Angioplasty in Failing AV Fistulas A Randomized Controlled Trial Scott O. Trerotola,1 Jeffrey Lawson,2,3 Prabir Roy-Chaudhury,4 and Theodore F. Saad,5 for the Lutonix AV Clinical Trial Investigators Abstract Background Restenosis remains a problem in hemodialysis access interventions. Paclitaxel-coated balloons have 1Department of shown promise in reducing access-related restenosis in small trials. The primary hypotheses for our multicenter Radiology, Perelman trial were superior effectiveness at 180 days and noninferior safety at 30 days of a drug-coated balloon compared School of Medicine with conventional angioplasty for treatment of dysfunctional arteriovenous fistulas. of the University of Pennsylvania, Philadelphia, Design, setting, participants, & measurements This randomized trial enrolled 285 patients with dysfunctional Pennsylvania; arteriovenous fistulas at 23 centers. Grafts, central venous stenoses, thrombosed fistulas, and immature fistulas Departments of were excluded. All patients received angioplasty of the lesion responsible for access dysfunction. After successful 2Surgery and 3 angioplasty (#30% residual stenosis), lesions were treated with either a paclitaxel-coated balloon or an uncoated Pathology, Duke University, Durham, control balloon of similar design to the drug-coated balloon. Access function during follow-up was determined per North Carolina; ’ fi 4 centers usual protocols; reintervention was clinically driven. The primary ef cacy outcome assessment was done Division of at 6 months, and the safety assessment was done within 30 days of the procedure. Prespecified secondary end Nephrology, points includedassessmentofpostintervention targetlesion primary patency andaccesscircuitprimary patency at University of Arizona 6months. Health Sciences and Southern Arizona Veterans Affairs Results The 180-day end point was not met with target lesion primary patency (71%64% for the drug-coated Healthcare System, balloon and 63%64% for control; P=0.06), representing a difference of 8%66% (95% confidence interval, 23% to Tucson, Arizona; and 5 20%). Access circuit primary patency did not differ between groups. Interventions to maintain target lesion Section of Renal and Hypertensive patency were fewer for the drug-coated balloon at 6 months (0.31 versus 0.44 per patient; P=0.03). The primary Diseases, Christiana safety noninferiority end point was met and did not differ between groups (P=0.002). Care Health System, Newark, Delaware Conclusions Paclitaxel-coated balloon–assisted angioplasty did not meet the primary effectiveness end point at 180 days compared with conventional angioplasty. Both arms showed equivalent safety (ClinicalTrials.gov Correspondence: Dr. number NCT02440022). Scott O. Trerotola, – Department of Clin J Am Soc Nephrol 13: 1215 1224, 2018. doi: https://doi.org/10.2215/CJN.14231217 Radiology, Division of Interventional Radiology, Hospital Introduction used specialized angioplasty balloons that have the of the University of Pennsylvania, 1 It has been 51 years since the original description of ability to deliver the drug to the vessel wall, where it is fi fi Silverstein, 3400 hemodialysis stulas (1), and the superiority of stulas rapidly taken up and remains in the vessel wall. The Spruce Street, over other forms of hemodialysis access remains widely purpose of this study was to investigate the hypothesis Philadelphia, PA accepted (2). However, failure of fistulas remains as that paclitaxel-coated balloon treatment after successful 19104. Email: pervasive a problem today as it was half a century ago. fi [email protected]. angioplasty of stenosis in hemodialysis stulas would edu Access failure results in missed or inadequate treat- improve outcomes compared with angioplasty alone. ments, hospitalization, and catheter use, costing the United States health care system approximately $2 billion annually (3). In spite of substantial advances in Materials and Methods our understanding of the pathophysiology of access Study Design stenosis and restenosis, there have been no large-scale This multicenter (n=23), prospective, randomized, studies showing superiority of any intervention for controlled trial was carried out under an investiga- treating fistula-related stenosis. Among the most prom- tional device exemption from the US Food and Drug ising candidates for preventing de novo stenosis or Administration, and it was designed to test the safety restenosis after intervention is paclitaxel, which has and effectiveness of a drug-coated balloon in hemo- proven to be beneficial in preventing restenosis in large dialysis fistula–related venous stenosis. The study studies in other vascular beds (4–6) and several small, was carried out in full compliance with the Heath randomized, single-center studies in hemodialysis ac- Insurance Portability and Accountability Act and cess (both grafts and fistulas) (7–11). These studies have the Declaration of Helsinki, and each site obtained www.cjasn.org Vol 13 August, 2018 Copyright © 2018 by the American Society of Nephrology 1215 1216 Clinical Journal of the American Society of Nephrology Institutional Review Board approval for participation in within the access circuit (defined as the anastomosis to the the study; all patients signed informed consent. Inclusion axillary vein inclusive) $50% with a matching clinical and exclusion criteria are shown in detail in Supplemental indicator (i.e., the lesion was such that the clinical indicator Appendix 1. The primary inclusion criterion was a dys- could be explained by the lesion) (2). After a patient was functional mature arteriovenous fistula (AVF) in the arm; determined to have a matching lesion, other fistulographic thrombosed or immature AVF, central venous stenosis, criteria had to be met. Specifically, there could be no more and grafts were excluded. The Consolidated Standards of than one additional (“nontarget”) lesion in the circuit that Reporting Trials (CONSORT) diagram (Figure 1) details had to be successfully treated (#30% residual stenosis) patient selection and enrollment. To be considered for before randomization. Overall lesion length and configu- the study, patients had to have a nonthrombosed native ration criteria also had to be met as shown in Supplemental AVF in the arm that had at least one clinical indicator Appendix 2. The target (study) lesion was then treated with of dysfunction as defined by the National Kidney Foun- high-pressure angioplasty with the requirements that the dation’s Kidney Disease Outcomes Quality Initiative balloon waist be fully effaced and that there be #30% (KDOQI) (2). residual stenosis after angioplasty. Provided that these criteria were met, the patient was then randomly Screening and Enrollment assigned to the drug-coated balloon group or control Patients who were candidates for the study underwent using sealed envelopes provided to the sites by study diagnostic fistulography to determine if they had a stenosis personnel. Figure 1. | Consolidated Standards of Reporting Trials diagram for study accrual. *Not enrolled/not randomized. Clin J Am Soc Nephrol 13: 1215–1224, August, 2018 Drug-Coating Balloons for Failing AV Fistula, Trerotola et al. 1217 Table 1. Demographics Variable Drug-Coated Balloon, n=141 Control, n=144 Total, n=285 Age, yr, mean6SD 64615 61613 62614 Men, n/total (%) 87/141 (62) 85/144 (59) 172/285 (60) Diabetes, n/total (%) 82/141 (58) 94/144 (65) 176/285 (62) Dyslipidemia, n/total (%) 85/141 (60) 84/144 (58) 169/285 (59) Hypertension, n/total (%) 133/141 (94) 142/144 (99) 275/285 (97) Current and former cigarette smoking, n/total (%) 64/141 (45) 66/144 (46) 130/285 (46) Cardiovascular disease, n/total (%) 83/141 (59) 96/144 (67) 179/285 (63) Congestive heart failure, n/total (%) 33/141 (23) 33/144 (23) 66/285 (23) Stroke, n/total (%) 18/141 (13) 13/144 (9) 31/285 (11) Coronary artery disease, n/total (%) 43/141 (31) 40/144 (28) 83/285 (29) Myocardial infarction, n/total (%) 16/141 (11) 23/144 (16) 39/285 (14) Peripheral arterial disease, n/total (%) 14/141 (10) 26/144 (18) 40/285 (14) Access age, d, mean6SD 11646973 105661122 110961050 Fistula location, n/total (%) Left arm 94/141 (67) 110/144 (76) 204/285 (72) Right arm 47/141 (33) 34/144 (24) 81/285 (28) Access site/type, n/total (%) Across antecubital fossa 6/141 (4) 8/144 (6) 14/285 (5) Transposed 0 2/8 (25) 2/14 (14) Nontransposed 6/6 (100) 6/8 (75) 12/14 (86) Forearm 47/141 (33) 31/144 (22) 78/285 (27) Transposed 5/47 (11) 4/31 (13) 9/78 (12) Nontransposed 42/47 (89) 27/31 (87) 69/78 (89) Upper arm 88/141 (62) 105/144 (73) 193/285 (68) Transposed 40/88 (46) 42/105 (40) 82/193 (43) Nontransposed 48/88 (55) 63/105 (60) 111/193 (58) Prior intervention in fistula, n/total (%) 120/141 (85) 125/144 (87) 245/285 (86) No. of prior interventions, mean6SD 4.063.3 3.662.8 3.863.1 No. of months on dialysis, mean6SD 41633 36631 38632 Clinical indicator of access dysfunction, n/total (%) 141/141 (100) 143/143 (100) 284/284 (100) Decreased blood flow 37/141 (26) 39/143 (27) 76/284 (27) High venous pressure 24/141 (17) 28/143 (20) 52/284 (18) Decreased Kt/V 5/141 (4) 6/143 (4) 11/284 (4) Diminished/abnormal thrill 39/141 (28) 25/143 (18) 64/284 (23) Pulsatility 87/141 (62) 84/143 (59) 171/284 (60) Flaccid access 1/141 (1) 0 1/284 (0.4) Abnormal bruit 9/141 (6) 10/143 (7) 19/284 (7) Arm or hand swelling 4/141 (3) 3/143 (2) 7/284 (3) Prolonged bleeding 28/141 (20) 27/143 (19) 55/284 (19) Difficult puncture 23/141 (16) 25/143 (17) 48/284 (17) Infiltration 3/141 (2) 4/143 (2) 7/284 (3) Recirculation 4/141 (3) 1/143 (1) 5/284 (2) Pulling clots 6/141 (4) 2/143 (1) 8/284 (3) Other 20/141 (14) 19/143 (13) 39/284 (14) Note that clinical indicators total .100%, because patients may have had more than one.
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