Dataset Information

NF-?B Decoy Oligodeoxynucleotide-Coated Balloon Catheter for Arteriovenous Fistula in Hemodialysis.

ABSTRACT: Introduction:New treatments to inhibit neointimal formation after percutaneous transluminal angioplasty (PTA) are needed for patients undergoing chronic hemodialysis (HD). We compared the efficacy and safety of AMG0102, a balloon catheter containing nuclear factor ?B (NF-?B) decoy oligodeoxynucleotide (ODN) with the PTA balloon catheter (control group) for arteriovenous fistula (AVF) stenosis. Methods:In total, 175 patients (age ?20 years, undergoing HD, with venous stenosis at the anastomotic region) were registered in this prospective open-label, randomized study. Patients were followed postoperatively for 36 weeks. The duration of primary patency on the targeted venous stenosis site (primary endpoint) was estimated by the Kaplan-Meier method. Results:A lower restenosis risk was observed for the AMG0102 group, but it was not statistically significant (stratified log-rank test P = 0.250, hazard ratio [HR] 0.774; 95% confidence interval [CI]: 0.500-1.198). The median duration of primary patency was 245 days and 172 days in the AMG0102 and control groups, respectively. After stratification based on the status of diabetes complications, the HR was 0.666 (95% CI: 0.366-1.212; P = 0.183) and the median duration of primary patency was prolonged by 108 days in the AMG0102 group with diabetes complications (245 days) compared with the control group (137 days). Adverse event (AE) incidence up to 36 postoperative weeks did not differ between groups. Four device failures occurred in 3 patients (AMG0102 group), but none resulted in AEs. Conclusion:Further modifications to enhance NF-?B decoy ODN uptake and efficacy are necessary to show its clinical utility for AVF stenosis in chronic HD.

SUBMITTER: Fukasawa M

PROVIDER: S-EPMC6308821 | biostudies-other | 2019 Jan

REPOSITORIES: biostudies-other

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Publications

NF-κB Decoy Oligodeoxynucleotide-Coated Balloon Catheter for Arteriovenous Fistula in Hemodialysis.

Fukasawa Mizuya M Isobe Mitsuaki M Nanto Shinsuke S Nakamura Masato M Haruguchi Hiroaki H Miyake Takashi T Morishita Ryuichi R

Kidney international reports 20181001 1

<h4>Introduction</h4>New treatments to inhibit neointimal formation after percutaneous transluminal angioplasty (PTA) are needed for patients undergoing chronic hemodialysis (HD). We compared the efficacy and safety of AMG0102, a balloon catheter containing nuclear factor κB (NF-κB) decoy oligodeoxynucleotide (ODN) with the PTA balloon catheter (control group) for arteriovenous fistula (AVF) stenosis.<h4>Methods</h4>In total, 175 patients (age ≥20 years, undergoing HD, with venous stenosis at th ...[more]

PMID: 30596176

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Project description:Current guidelines suggest that arteriovenous fistula (AVF) is associated with survival advantage over arteriovenous graft (AVG). However, AVFs often require months to become functional, increasing tunneled dialysis catheter (TDC) use, which can erode the benefit of an AVF. We sought to compare survival in patients with end-stage renal disease after creation of an AVF or AVG in patients starting hemodialysis (HD) with a TDC and to identify patient populations that may benefit from preferential use of AVG over AVF.Using U.S. Renal Data System databases, we identified incident HD patients in 2005 through 2008 and observed them through 2008. Initial access type and clinical variables including albumin levels were assessed using U.S. Renal Data System data collection forms. Attempts at AVF and AVG creation in patients who started HD through a TDC were identified by Current Procedural Terminology codes. We accounted for the effect of changes in access type by truncating follow-up when an additional AVF or AVG was performed. Survival curves were then constructed, and log-rank tests were used for pairwise survival comparisons, stratified by age. Multivariate analysis was performed with Cox proportional hazards regressions; variables were chosen using stepwise elimination. An interaction of access type and albumin level was detected, and Cox models using differing thresholds for albumin level were constructed. The primary outcome was survival.Among the 138,245 patients who started with a TDC and had complete records amenable for analysis, 22.8% underwent AVF creation (mean age ± standard deviation, 68.9 ± 12.5 years; 27.8% mortality at 1 year) and 7.6% underwent AVG placement (70.2 ± 12.0 years; 28.2% mortality) within 3 months of HD initiation; 69.6% remained with a TDC (63.2 ± 15.4 years; 33.8% mortality). In adjusted Cox proportional hazards regression, AVF creation is equivalent to AVG placement in terms of survival (hazard ratio [HR], 0.98; 95% confidence interval [CI], 0.93-1.02; P = .349). AVG placement is superior to continued TDC use (HR, 1.54; 95% CI, 1.48-1.61; P < .001). In patients older than 80 years with albumin levels >4.0 g/dL, AVF creation is associated with higher mortality hazard compared with AVG creation (HR, 1.22; 95% CI, 1.04-1.43; P = .013).For patients who start HD through a TDC, placement of an AVF and AVG is associated with similar mortality hazard. Further study is necessary to determine the ideal access for patients in whom the survival advantage of an AVF over an AVG is uncertain.

Project description:BackgroundIn North America, most people start hemodialysis via a central venous catheter ("catheter"). These patients are counseled to undergo arteriovenous fistula ("fistula") creation within weeks of starting hemodialysis because fistulas are associated with improved survival.ObjectivesTo determine whether attempting to create a fistula in patients who start hemodialysis via a catheter is associated with improved mortality. We also sought to determine whether differences in baseline patient characteristics, vascular procedures for access-related complications, or days in hospital may confound or mediate the relationship between attempted fistula creation and mortality.DesignMulticenter, retrospective cohort study.SettingSix dialysis programs located in Ontario, Alberta, and Manitoba.PatientsPatients aged ≥18 years who initiated hemodialysis via a catheter between January 1, 2004, and May 31, 2012, who had not had a previous attempt at fistula creation. We excluded those who had a life expectancy less than 1 year, who transitioned to peritoneal dialysis within 6 months of starting dialysis, and people who started hemodialysis via a graft.MeasurementsAttempted fistula creation, all-cause mortality, patient characteristics and comorbidities, vascular procedures for access-related complications, and days spent in hospital.MethodsWe used survival methods, including marginal structural models, to account for immortal time bias and time-varying confounding.ResultsIn total, 1832 patients initiated hemodialysis via a catheter during the study period and met inclusion criteria. Of these patients, 565 (31%) underwent an attempt at fistula creation following hemodialysis start. As compared to those who did not receive a fistula attempt, these people were younger, had fewer comorbidities, and were more likely to have started dialysis as an outpatient and to have received pre-dialysis care. In a marginal structural model controlling for baseline characteristics and comorbidities, attempted fistula creation was associated with a significantly lower mortality (hazard ratio [HR] = 0.53; 95% confidence interval [CI] = 0.43-0.66). This effect did not appear to be confounded or mediated by differences in the number of days spent in hospital or vascular procedures for access-related complications. It also remained similar in analyses restricted to patients who survived at least 6 months (HR = 0.60; 95% CI = 0.47-0.77) and to patients who started hemodialysis as an outpatient (HR = 0.48; 95% CI = 0.33-0.68).LimitationsThere is likely residual confounding and treatment selection bias.ConclusionsIn this multicenter cohort study, attempting fistula creation in people who started hemodialysis via a catheter was associated with significantly reduced mortality. This reduction in mortality could not be explained by differences in patient characteristics or comorbidities, days spent in hospital, or vascular procedures for access-related complications. Residual confounding or selection bias may explain the observed benefits of fistulas for hemodialysis access.Trial registrationNot applicable (cohort study).

Dataset Information

NF-?B Decoy Oligodeoxynucleotide-Coated Balloon Catheter for Arteriovenous Fistula in Hemodialysis.

Publications

NF-κB Decoy Oligodeoxynucleotide-Coated Balloon Catheter for Arteriovenous Fistula in Hemodialysis.

Similar Datasets

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