Stent Graft versus Balloon Angioplasty for Failing Dialysis-Access

Grafts
Ziv J. Haskal, M.D., Scott Trerotola, M.D., Bart Dolmatch, M.D., Earl Schuman, M.D.,
Sanford Altman, M.D., Samuel Mietling, M.D., Scott Berman, M.D.,
Gordon McLennan, M.D., Clayton Trimmer, D.O., John Ross, M.D.,
and Thomas Vesely, M.D.

Abstract

Background
The leading cause of failure of a prosthetic arteriovenous hemodialysis-access graft is venous
anastomotic stenosis. Balloon angioplasty, the first-line therapy, has a tendency to lead to
subsequent recoil and restenosis; however, no other therapies have yet proved to be more
effective. This study was designed to compare conventional balloon angioplasty with an
expanded polytetrafluoroethylene endovascular stent graft for revision of venous anastomotic
stenosis in failing hemodialysis grafts.
Methods
We conducted a prospective, multicenter trial, randomly assigning 190 patients who were
undergoing hemodialysis and who had a venous anastomotic stenosis to undergo either balloon
angioplasty alone or balloon angioplasty plus placement of the stent graft. Primary end points
included patency of the treatment area and patency of the entire vascular access circuit.
Results
At 6 months, the incidence of patency of the treatment area was significantly greater in the stent-
graft group than in the balloon-angioplasty group (51% vs. 23%, P<0.001), as was the incidence
of patency of the access circuit (38% vs. 20%, P = 0.008). In addition, the incidence of freedom
from subsequent interventions at 6 months was significantly greater in the stent-graft group than
in the balloonangioplasty group (32% vs. 16%, P = 0.03 by the log-rank test and P = 0.04 by the
Wilcoxon rank-sum test). The incidence of binary restenosis at 6 months was greater in the
balloon-angioplasty group than in the stent-graft group (78% vs. 28%, P<0.001). The incidences
of adverse events at 6 months were equivalent in the two treatment groups, with the exception of
restenosis, which occurred more frequently in the balloon-angioplasty group (P<0.001).
Conclusions
In this study, percutaneous revision of venous anastomotic stenosis in patients with a prosthetic
hemodialysis graft was improved with the use of a stent graft, which appears to provide longer-
term and superior patency and freedom from repeat interventions than standard balloon
angioplasty. (ClinicalTrials.gov number,NCT00678249.)
 By 2008, more than 341,000 patients in the United States were undergoing hemodialysis
for treatment of their end-stage renal disease. The National Kidney Foundation Kidney Disease
Outcomes Quality Initiative seeks to increase the use of autogenous fistulas, yet many patients
continue to undergo hemodialysis with the use of prosthetic arteriovenous grafts. The reasons for
this discrepancy between the recommendation and practice are multifactorial and continue to be
debated.The costs of maintaining vascular access are substantial; for example, the cost of treating
a patient who has failure of a hemodialysis access graft is significantly higher ($62,000 per
patient-year) than the cost of treating a patient who does not have access failure.
Many percutaneous techniques and endovascular tools have been used to treat the
neointimal stenoses that develop at the site of venous anastomoses of arteriovenous grafts. At
best, secondary patency of arteriovenous grafts (i.e., patency after an intervention) is 50% at 3
years after the creation of the vascular access; typically, multiple interventions are required to
maintain patency.No reported mechanical, endovascular, or pharmacologic approaches have
improved the patency of arteriovenous grafts as compared with balloon angioplasty alone.7-15
We hypothesized that revision of a venous anastomotic stenosis with a stent graft constructed
with the same material as the graft would prevent elastic recoil and tissue ingrowth, thereby
improving long-term patency as compared with that afforded by standard balloon angioplasty.

Methods
Study Design
In our prospective, multicenter, randomized, controlled trial, patients were eligible if they
had end-stage renal disease and were undergoing long-term hemodialysis with the use of failing,
but nonthrombosed, prosthetic arteriovenous grafts. The study was designed to assess the safety
and efficacy of an expanded polytetrafluoroethylene stent graft, as compared with balloon
angioplasty, for the treatment of hemodynamically significant venous anastomotic stenosis in
an arteriovenous graft.Inclusion and exclusion criteria, listed in Table 1, were developed in
accordance with guidelines of the National Kidney Foundation Kidney Disease Outcomes
Quality Initiative and the Society of Interventional Radiology.
The study was approved by each center’s institutional review board and the Food and
Drug Administration and was in compliance with Health Insurance Portability and
Accountability Act regulations; all patients provided written informed consent. An independent
clinical events committee at Harvard Clinical Research Institute (Boston) adjudicated the clinical
data and the Angiographic Core Lab of the Cardiovascular Research Foundation (New York)
analyzed the angiographic films. The principal investigator designed the study, with assistance
from the sponsor (Bard Peripheral Vascular). The data were collected by on-site investigators
under the auspices of the sponsor and principal investigator for analysis; Harvard Clinical
Research Institute performed the statistical analyses. The principal investigator prepared the
manuscript, which was reviewed by all authors, who vouch for the accuracy and completeness of
the reported data.

Study End Points

The study objective was to demonstrate that treatment with a stent graft is not inferior to
treatment with balloon angioplasty alone regarding the primary end point, the 6-month primary
patency of a stenotic venous anastomosis in the treatment area. Secondary end points included
safety variables, procedural success (successful percutaneous insertion of the stent graft),
primary patency of the access circuit at 2 months and 6 months, the percent stenosis of the
treatment area at 2 months and 6 months, and freedom from subsequent intervention. See the
Supplementary Appendix (available with the full text of this article at NEJM.org) for definitions
of “treatment area” and “primary patency” and measures of successful intervention.

Stent Graft
The investigational device consisted of a selfexpanding nitinol stent covered in carbon-
impregnated expanded polytetrafluoroethylene (Flair Endovascular Stent Graft, Bard Peripheral
Vascular). Two stent-graft configurations were used: tubular (straight) and flared. The flared
configuration was used when the diameter of the outflow vein beyond the stenosis was larger
than that of the arteriovenous graft. The stent graft was available in diameters of 6 to 9 mm and
lengths of 30, 40, and 50 mm. It was deployed through a 9-French delivery catheter.

Randomization and Intervention

Once the enrollment criteria were met, angiography of the graft and treatment area was
performed with the use of orthogonal magnified views, each 30 degrees or more apart, and a
radiopaque 1-mm graduated ruler in the imaged field of view. The percent stenosis was
calculated as follows: [1 − (minimal lumen diameter ÷ nondiseased lumen diameter)] × 100,
where the minimal lumen diameter was the narrowest lumen diameter within the stenosed area
and the nondiseased lumen diameter was the lumen diameter of the nondiseased arteriovenous
graft or vein just upstream of the lesion. Remote secondary lesions more than 3 cm from the
treatment area were required to have been treated until the stenosis was less than 30%, before
randomization.
Randomization was performed with the use of permuted blocks, identified in sealed
envelopes that were sent to each site in advance. If the lesion met study criteria, then balloon
angioplasty was performed with the use of an appropriately sized conventional (noncutting,
noncompliant) angioplasty balloon. After angioplasty, patients were randomly assigned to
undergo placement of a stent graft or to receive no other treatment. No patients were excluded
before randomization because of resistant stenoses that prevented full expansion of the initial
angioplasty balloon. If a patient was randomly assigned to the stent-graft group, a device of
appropriate length, configuration, and diameter (≤1 mm greater than the arteriovenous graft, to
avoid the use of an oversized device) was chosen. The stent graft was placed and was then
dilated, with a balloon diameter equal to that used in the balloon-angioplasty group. Lesions
were dilated to reduce the stenosis in the treated area to less than 30%. The angiograms were
later sent to the Angiographic Core Lab for analysis.

Clinical and Angiographic Follow-up Regimen

Patients were treated and discharged according to each center’s standard of care. Anticoagulation
or antiplatelet agents were administered after the procedure at the physician’s discretion.
A single, intravenous dose of prophylactic antibiotic — usually cefazolin sodium, in patients
who did not have an allergy — was administered in the stent-graft group. Mandatory clinical
evaluations and magnified quantitative angiography were performed 2 and 6 months after the
index procedure, with the use of similar imaging protocols. Medical events, hospitalizations,
access interventions, and adverse events were recorded. Graft function was assessed by means of
a clinical evaluation of the same clinical or hemodynamic indicator used to assess graft function
during the initial angiographic evaluation (one of the graft-function indicators accepted by the
National Kidney Foundation Kidney Disease Outcomes Quality Initiative), as well as by means
of angiographic evaluation. Catheter-based interventions were performed in patients who both
met clinical criteria for graft dysfunction and had stenoses of more than 50%. In accordance with
the National Kidney Foundation Kidney Disease Outcomes Quality Initiative guidelines,
investigators were instructed not to intervene regarding asymptomatic, clinically silent (i.e.,
incidentally diagnosed) stenoses found in the treatment area during angiography at 2 and
6 months.

Statistical Analysis
We calculated the sample size needed to test the primary noninferiority hypothesis using the
methods of Blackwelder.19 The incidence of primary patency at 6 months was estimated as 60%
in the stent-graft group and 50% in the balloon-angioplasty group. The two rates were considered
clinically noninferior if the difference was 10 percentage points or less (with a significance
threshold of P = 0.05 on a one-tailed test and 80% statistical power). On this basis, the number of
patients required for each of the two treatment groups was calculated to be 76. The target number
of patients enrolled in each group was set at 95, to account for a dropout rate of up to 20%.
Thus, the total target sample size was 190 patients.
Intention-to-treat analyses were performed to evaluate the 6-month primary patency. The
times to the return of symptoms and patency were analyzed with the use of Kaplan–Meier
product– limit survival estimates. The data for patients with missed 6-month visits were censored
in the estimation of the percentage of patients with graft patency at 6 months. Continuous
secondary variables (e.g., percent stenosis) were analyzed by means of parametric or
nonparametric analysis of variance with covariate adjustment. Outcomes for nonprimary
effectiveness variables (e.g., primary patency of the access circuit) were analyzed at 2 and 6
months after the procedure. Subgroup analyses were performed to evaluate the influence of
concomitant variables. P values less than 0.05 were considered to indicate statistical significance.

Results
Patients
A total of 190 patients at 13 study sites were enrolled: 97 were randomly assigned to
undergo implantation of the investigational stent graft and 93 were randomly assigned to
undergo the control procedure, balloon angioplasty, only. The study patients consisted of 69 men
and 121 women (Table 2). Participating centers were academic, community-based, inpatient, or
freestanding outpatient dialysis centers. There were no significant differences between the two
treatment groups at baseline with respect to demographic characteristics, relevant medical
history, or characteristics of the arteriovenous access graft, with the exception of a higher
incidence of axillary venous anastomosis in the balloon-angioplasty group. Nor were there
significant differences between the two groups with respect to the nature or prevalence of
abnormalities leading to the intervention in the arteriovenous access graft. The three most
common triggers for intervention were clinical variables, elevated venous pressure during
dialysis, and detection of decreased blood flow.

Baseline Angiographic Characteristics of the Lesion

There were no significant differences between the two treatment groups with respect to
angiographic characteristics of the target lesion: interpolated reference-vessel diameter,
minimum lumen diameter, or percent stenosis (Table 2). The average balloon diameters during
dilation were similar in the stent-graft group and the balloonangioplasty group. The percentage
of patients with secondary lesions in the access circuit was similar in the two groups: 39% of
patients receiving a stent graft and 41% undergoing balloon angioplasty.

Implantation of Stent Grafts

A total of 125 stent grafts were implanted in 97 patients; 67% of the stent grafts were
flared, 16% were straight, and 17% consisted of overlapping straight and flared grafts. Seventy-
three patients (75%) received a single device. Stent grafts were overlapped when lesion lengths
(including a nondiseased 10-mm “landing zone” between the arteriovenous graft and outflow
vein) exceeded the longest available stent-graft length (50 mm). Device deployment was
successful in 96 of the 97 patients (99%). A 30-mm stent graft was placed in 28% of the patients,
a 40-mm graft in 36%, and a 50-mm graft in 36%.

Follow-up of the Patients

There were no significant differences between the two treatment groups regarding the
attendance of patients at follow-up examinations at any study interval. Thirteen patients (6 of the
97 patients [6%] receiving a stent graft and 7 of the 93 patients [8%] undergoing balloon
angioplasty) missed either the 2-month or 6-month follow-up evaluation: 2 patients (1 in each
group) missed the 2-month follow-up visit and 11 (5 in the stentgraft group and 6 in the balloon-
angioplasty group) missed the 6-month follow-up visit. A total of 94% of patients in the stent-
graft group and 93% of patients in the balloon-angioplasty group completed the 6-month follow-
up visit.

Study End Points

On the basis of an intention-to-treat analysis, at 6 months, the incidence of primary
patency of the treatment area was significantly greater in the stent-graft group (51%) than in the
balloonangioplasty group (23%) (P<0.001), as was the incidence of primary patency of the
access circuit (38% vs. 20%, P = 0.008) (Table 3). Forty-five patients in the stent-graft group and
66 patients in the balloon-angioplasty group had loss of primarypatency of the treatment area,
owing to one or more of the following events: reintervention in the treatment area, thrombotic
occlusion, surgical intervention that excluded the treatment area from the access circuit, and
abandonment of the graft because of an inability to treat the primary lesions (Table 4).
At 6 months, the percentage of patients with freedom from loss of primary patency of the
treatment area was significantly greater in the stent-graft group than in the balloon- angioplasty
group (P = 0.003 by the log-rank test and P = 0.008 by the Wilcoxon rank-sum test), as was the
percentage with freedom from loss of primary patency of the access circuit (P = 0.03 by the log-
rank test and P = 0.04 by the Wilcoxon rank-sum test) (Fig. 1). At 210 days, the stentgraft group
showed superior freedom from subsequent interventions as compared with the balloon-
angioplasty group (P = 0.03 by the log-rank test and P = 0.04 by the Wilcoxon rank-sum test).
These findings supported both the primary and secondary study hypotheses: the noninferiority
to and superiority of the stent graft as compared with balloon angioplasty.
Procedural Success and Restenosis
The rate of procedural success was significantly higher in the stent-graft group than in the
percutaneous- transluminal-angioplasty group, with success in 94% versus 73% of patients
(P<0.001) (Table 4). At 6 months, the minimum lumen diameter of the treatment area was, on
average (mean •}SD), significantly greater with the stent graft than with balloon angioplasty
alone: 5.1•}1.5 mm vs. 3.3•}1.5 mm (P<0.001). The average percent stenosis was lower in the
stent-graft group (32.1•}19.8%) than in the balloonangioplasty group (59.2•}19.6%)
(P<0.001). At 6 months, the incidence of binary restenosis (stenosis of >50% diameter) was
significantly greater in the balloon-angioplasty group (78%) than in the stent-graft group (28%)
(P<0.001). Restenotic lesions were, on average, significantly shorter in the stent graft group
(18.0•}12.5 mm) than in the balloon-angioplasty group (32.1•}14.3 mm) (P<0.001).
At 6 months, the presence or absence of remote secondary lesions that were required to
have been treated before study enrollment did not negate the patency advantage of the stent graft
over balloon angioplasty. The incidence of patency of the treatment area was greater, among
patients who had secondary lesions, in the stentgraft group (44%) than in the balloon-angioplasty
group (17%) (P = 0.02), as well as among patients who did not have secondary lesions (54% vs.
28%) (P = 0.006). Logistic-regression analysis of clinical variables at 6 months failed to identify
any distinguishing or significant criteria affecting primary patency — including diabetes, age,
sex, history of hypercoagulability or glomerulonephritis, graft site, hypertension, or use of
anticoagulation or antiplatelet therapy. By means of multiple logistic- regression analysis, the
only criterion that was associated with primary patency at 6 months of follow-up was assignment
to the stent-graft group (P<0.001).

Safety and Adverse Events

There was no significant difference in the incidence of reported adverse events between
the balloon-angioplasty control group and the stentgraft group, except for the incidence of
restenosis, which was higher with balloon angioplasty (77%, vs. 40% with stent graft; P<0.001)
(Table 4).

Discussion
Despite nearly universal agreement that native fistulas should be the hemodialysis access
of first choice, prosthetic grafts continue to play an important role in the creation of permanent
hemodialysis- access circuits in patients in the United States. Though the percentage of patients
undergoing dialysis through prosthetic grafts may continue to fall, the total number of patients
with end-stage renal disease continues to grow each year.1,3 Thus, hemodialysis grafts are likely
to remain important vascular accesses, as “planned bridges” to native fistulas or in patients in
whom fistulas have failed or cannot be created.17,20-22 Balloon angioplasty for stenotic
arteriovenous grafts has limitations, however: the long-term durability of balloon angioplasty is
limited6,9,10 and may necessitate repeated invasive procedures9- 11 with attendant
complications and costs.
From 16 to 25% of hospital admissions of patients with end-stage renal disease in the
United States are necessitated by complications related to a vascular access; the associated costs
have been estimated at nearly 1 billion dollars per year.1,4 Furthermore, the outpatient costs for
patients with graft failure more than doubled between 1991 and 2005.1
Multiple devices and approaches for treating arteriovenous graft–related stenosis have been
used and reported on in retrospective series and prospective, randomized trials. To date, none
have shown any benefit over balloon angioplasty. These techniques have included angioplasty
with cutting or with ultrahigh-pressure balloons, brachytherapy, cryoplasty, anticoagulation
therapy, placement of bare-metal stents, modified surgical techniques and graft configurations,
and other pharmacologic approaches. Although preliminary research in minimizing the
hyperplastic process at the time of graft creation by means of pharmacologic, cellular, or gene
therapies appears promising, such efforts are in the early stages of evaluation or development.7-
15,23-29 The polytetrafluoroethylene self-expanding stent graft is a less-invasive endovascular
approach for revision of failing prosthetic arteriovenous grafts that is intended to mimic open
surgical revision of a graft. Unlike surgery, a percutaneous approach optimally allows for
immediate use of the graft, which might obviate the need for interim catheter dialysis and its
associated costs, risks of bloodstream infection, and other complications. The stent graft used in
the present trial was designed to prevent both the elastic recoil that occurs after balloon
angioplasty, thus sustaining the short-term gain in luminal patency — an effect similar to that of
uncovered (bare-metal) stents used in the access circuit — and the late loss in luminal patency
due to trans-stent growth of neointimal tissue.13,28,29
The present endovascular approach also essentially converts the initial surgical end-to-side
venous anastomosis into an end-to-end anastomosis providing more laminar in-line flow and
thus potentially reducing the turbulence and shear stress that contribute to the development
of venous outflow stenosis.7,8,32-36 Our study involved detailed assessments and
definitions of patency. All patients underwent formal angiography at 2 and 6 months, regardless
of the clinical graft function, allowing for uniform assessment of stenosis at the Angiographic
Core Lab. The angiographic findings were an integral part of the study definition of
patency. In contrast, most published studies have used the absence of clinical dysfunction alone
as the measure of treatment success.7-15,25-29 The definitions used in our randomized,
controlled study may provide a more accurate measure of actual arteriovenous graft patency than
previous retrospective studies of arteriovenous grafts. Prospective reports of the patency of
autogenous fistulas have noted similar findings: the incidence of patency is lower when
prospectively assessed than when retrospectively ascertained.20,37,38
In conclusion, our data indicate that the expanded polytetrafluoroethylene self-expanding
stent graft used in the present study is superior to balloon angioplasty for the treatment of
arteriovenous access grafts that have venous anastomotic stenosis. As compared with balloon
angioplasty, the stent graft was associated with graft function for a longer period before
subsequent intervention and a graft lumen that had a greater diameter and had patency for a
longer period.
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