www.kidney-international.

org clinical trial

Prospective, randomized, multicenter clinical study

comparing a self-expanding covered stent to
percutaneous transluminal angioplasty for OPEN

treatment of upper extremity hemodialysis

arteriovenous fistula stenosis
Bart Dolmatch1,2, Timoteo Cabrera3, Pablo Pergola3, Saravanan Balamuthusamy4,5, Angelo Makris6,
Randy Cooper7, Erin Moore8,9, Jonah Licht10,11, Ewan Macaulay12, Geert Maleux13,
Thomas Pfammatter14, Richard Settlage15, Ecaterina Cristea16 and Alexandra Lansky16; and the AVeNEW
Trial Investigators17
1
Interventional Radiology, Palo Alto Medical Foundation, Mountain View, California, USA; 2Interventional Radiology, El Camino Hospital,
Mountain View, California, USA; 3Renal Associates PA, San Antonio, Texas, USA; 4Tarrant Nephrology Associates, Fort Worth, Texas, USA;
5
Department of Medicine and Nephrology, Texas Christian University School of Medicine, Fort Worth, Texas, USA; 6Chicago Access Care,
Westmont, Illinois, USA; 7Southwest Kidney Institute Vascular Center, Tempe, Arizona, USA; 8Cardiothoracic & Vascular Surgical
Associates, Jacksonville, Florida, USA; 9Department of Vascular Surgery, Baptist Medical Center Jacksonville, Jacksonville, Florida, USA;
10
Providence Interventional Associates, Providence, Rhode Island, USA; 11Division of Nephrology, Warren Alpert Medical School of Brown
University, Providence, Rhode Island, USA; 12Department of Vascular Surgery, Royal Adelaide Hospital, Adelaide, South Australia,
Australia; 13Department of Vascular and Interventional Radiology, University Hospitals KU Leuven, Leuven, Belgium; 14Department of
Diagnostic and Interventional Radiology, University of Zürich Hospital, Zürich, Switzerland; 15Medical Affairs Department, Becton,
Dickinson and Company, Colorado Springs, Colorado, USA; and 16Section of Cardiovascular Medicine, Yale School of Medicine, New
Haven, Connecticut, USA

Use of a covered stent after percutaneous transluminal
angioplasty (PTA) was compared to PTA alone for
treatment of upper extremity hemodialysis patients with
arteriovenous fistula (AVF) stenoses. Patients with AVF
stenosis of 50% or more and evidence of AVF dysfunction
underwent treatment with PTA followed by randomization
of 142 patients to include a covered stent or 138 patients
with PTA alone. Primary outcomes were 30-day safety,
powered for noninferiority, and six-month target lesion
primary patency (TLPP), powered to test whether TLPP
after covered-stent placement was superior to PTA alone.
Twelve-month TLPP and six-month access circuit primary
patency (ACPP) were also hypothesis tested while
additional clinical outcomes were observed through two
years. Safety was significantly non-inferior while six- and
12-month TLPP were each superior for the covered stent
group compared to PTA alone (six months: 78.7% versus
55.8%; 12 months: 47.9% versus 21.2%, respectively). ACPP
was not statistically different between groups at six-
months. Observed differences at 24 months favored the
covered-stent group: 28.4% better TLPP, fewer target-
lesion reinterventions (1.6 ± 1.6 versus 2.8 ± 2.0), and a
Correspondence: Bart Dolmatch, Palo Alto Medical Foundation, 701 East El
Camino Real, 3rd Floor, Mountain View, California 94040 USA. E-mail:
duster54@sbcglobal.net
17
The AVeNEW Trial Investigators are listed in the Appendix.
Received 7 December 2022; revised 2 March 2023; accepted 9 March
2023; published online 27 March 2023
longer mean time between target-lesion reinterventions
(380.4 ± 249.5 versus 217.6 ± 158.4 days). Thus, our
multicenter, prospective, randomized study of a covered
stent used to treat AVF stenosis demonstrated noninferior
safety with better TLPP and fewer target-lesion
reinterventions than PTA alone through 24 months.
Kidney International (2023) 104, 189–200; https://doi.org/10.1016/
j.kint.2023.03.015
KEYWORDS: arteriovenous covered stent; arteriovenous fistula; hemodialysis
access
Copyright ª 2023, International Society of Nephrology. Published by
Elsevier Inc. This is an open access article under the CC BY-NC-ND license
(http://creativecommons.org/licenses/by-nc-nd/4.0/).
evelopment of a flow-limiting stenosis in a hemodial-
D ysis arteriovenous fistula (AVF) can cause ineffective
dialysis, difficult access cannulation, prolonged
bleeding post-dialysis, and spontaneous access thrombosis.
Percutaneous transluminal angioplasty (PTA) is commonly
used to treat AVF stenosis,1 but multicenter, prospective, ran-
domized clinical trials have demonstrated that covered stent
placement immediately following PTA of arteriovenous graft
venous anastomotic stenosis affords superior target lesion pri-
mary patency (TLPP), compared to PTA alone.2–4 Covered
stents were also superior to PTA in treatment of in-stent
restenosis in both AVF and arteriovenous graft circuits.5
Based on these results, we designed the first large, prospective,
randomized study to test whether use of a covered stent

Kidney International (2023) 104, 189–200 189

clinical trial
Lay Summary
Many patients with kidney failure elect hemodialysis,
which cycles blood through a machine to remove waste
before returning it to the patient. Hemodialysis can be
facilitated by creating an artery-to-vein circuit in the
patient’s arm called an arteriovenous fistula (AVF), but
some circuits develop blockage, or stenosis, that in-
terferes with hemodialysis. A balloon catheter is often
used to dilate the stenosis, called angioplasty or percu-
taneous transluminal angioplasty (PTA), but stenoses can
recur within months. We compared the treatment of
stenosis using PTA alone in 138 patients to PTA followed
immediately by placement of a metal scaffold covered
with synthetic material (covered stent) in 142 patients.
Both procedures were safe. The covered-stent patients,
however, had fewer recurrent stenoses at the treatment
site compared to those who received PTA through 24
months, and they received fewer interventions. Our
study is the first large comparative trial of covered stents
in AVFs.
would provide TLPP benefit compared to PTA in treating ste-
noses in upper-extremity hemodialysis AVFs.
METHODS
Study design
Between June 2016 and July 2017, a total of 280 patients were treated
in the Arteriovenous (AV) Stent Graft in the Treatment of Venous
Outflow Stenosis in AV Fistula Access Circuits (AVeNEW) study. A
Table 1 | Inclusion and exclusion criteria
Inclusion criteria

Patient was willing to comply with protocol requirements and
voluntarily signed the informed consent form prior to collection
of study data or performance of study procedures

Patient was male or nonpregnant female $21 years of age, with
an expected lifespan sufficient to allow for completion of the
study

Patient had a mature, upper-extremity AVF defined as a
fistula created $30 days prior to the index procedure that had
undergone 1 or more hemodialysis sessions using 2 needles, and
a central venous catheter had been removed for $30 days prior
to the index procedure
Angiographic inclusion criteria

Angiographic evidence of a stenosis $50% in the venous outflow
of an arteriovenous access circuit with clinical or hemodynamic
evidence of AVF dysfunction

The target lesion was #9 cm in length. (Note: Multiple stenoses
could be treated within the target lesion)

Reference vessel diameter of the adjacent nonstenotic vein was
5–9 mm

Additional stenotic lesions ($50%) in the access circuit that were
>3 cm from the edge of the target lesion and were successfully
treated with PTA (#30% residual stenosis) prior to treating the
target lesion
AVF, arteriovenous fistula; PTA, percutaneous transluminal angioplasty.
190
B Dolmatch et al.: Covered stent versus angioplasty for AVF stenosis
total of 24 investigative sites—in the US (16), Europe (5), Australia
(2), and New Zealand (1)—treated patients in this prospective,
multicenter, randomized study of use of the Covera Vascular
Covered Stent (Becton, Dickinson) following PTA, compared to PTA
alone. This concurrently controlled, parallel-arm study was con-
ducted in accordance with good clinical practice, the Declaration of
Helsinki, and applicable healthcare laws. Investigators followed a
standard protocol approved by their institutional ethics committee,
and patients provided written informed consent prior to completing
any procedure. The AVeNEW study was sponsored by C. R. Bard/
Becton, Dickinson and Company, and was registered on
clinicaltrials.gov (unique identifier: NCT02649946). Data were
collected onsite by investigators using standardized web-based clin-
ical report forms. Angiographic data were analyzed by an indepen-
dent core laboratory (Yale Cardiovascular Research Group, New
Haven, CT); a clinical events committee reviewed all adverse events
(AEs); and a medical monitor reviewed clinical events committee–
adjudicated events for AE trends.
Inclusion and exclusion criteria are detailed in Table 1. Eligible
patients had angiographic evidence of a venous outflow
stenosis $50% in a mature upper-extremity AVF with clinical or
hemodynamic evidence of fistula dysfunction.1 Additional
stenoses $50% in the circuit that were >3 cm from the edge of the
target lesion had to be successfully treated (#30% residual stenosis)
with conventional PTA prior to treatment of the target stenosis.
Thrombosed circuits, at the time of or within 7 days of the study
procedure, were excluded, as were lesions that included an aneu-
rysm, pseudoaneurysm, or a previously implanted stent or covered
stent; crossed the elbow; or were in the thoracic central veins.
Outcome measures
Prespecified outcome measures are defined in Table 2. The primary
safety measure was 30-day freedom from an AE involving the access
Exclusion criteria

Patient had a medical condition that could have caused noncompliance with
the protocol or confounded data interpretation, or had not completed
treatment in another investigational drug or device study

Patient had a life expectancy insufficient to allow for completion of study
procedures or follow-up

Patient was dialyzing with an arteriovenous graft or had hemodialysis access
in the lower extremity

Patient had a thrombosed access circuit at the time of, or within 7 days of,
the index procedure

Patient had an infected AVF, uncontrolled systemic infection, or an uncon-
trolled bleeding disorder

Patient had an allergy or hypersensitivity to contrast media, nickel–titanium
(Nitinol), or tantalum that could not be adequately pre-medicated
Angiographic exclusion criteria

Incomplete expansion of the target lesion prior to randomization with an
appropriately sized angioplasty balloon (investigator assessment)

Aneurysm or pseudoaneurysm was present within the target lesion

The location of the target lesion required the covered stent be deployed
across the elbow joint, in the fistula cannulation zone, in the central veins,
under the clavicle at the thoracic outlet, or within a stent

Additional stenotic lesions (>50%) that were >3 cm from the edge of the
target lesion that were not successfully treated (#30% residual stenosis)
prior to treating the target lesion
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B Dolmatch et al.: Covered stent versus angioplasty for AVF stenosis clinical trial

Table 2 | Outcome measure definitions

Outcome measure Definition
a
Safety Freedom from an adverse event involving the access circuit that required reintervention or surgery, prolonged or
additional hospitalization, or resulted in death
Target lesion primary patencyb The interval following treatment until the next clinically driven reinterventionc at or near (#5 mm) the target-lesion
site or until the extremity was abandoned for permanent access
Technical success Deployment of the covered stent to the intended location
Procedural success Attainment of <30% residual stenosis (anatomic success) after completion of the procedure with resolution of pre-
procedure clinical indicators of access dysfunction (clinical success)
Access circuit primary patency The interval following the study treatment procedure until the next access circuit thrombosis or clinically driven
reintervention anywhere from the arterial inflow to the superior vena cava–right atrial junction
Access circuit secondary or The interval after the study procedure until access abandonmentd
cumulative patency
Total number of reinterventions The number of interventions to the access circuit needed to maintain patency or until access abandonment
Index of patency function The mean time between reinterventions defined as the time from treatment to study completion (or access
abandonment) divided by the number of visits to maintain access circuit or treatment area patency
a
Primary safety measure at 30 days.
b
Primary efficacy measure at 6 months.
c
Clinically driven reintervention was defined as a stenosis $50% that required treatment and the presence of at least 1 clinical, physiological, or hemodynamic abnormality
attributable to the stenosis (e.g., decreased blood flow, elevated venous pressures, decreased dialysis dose).
d
Multiple interventions could be used to maintain secondary patency.

circuit that required reintervention or surgery, resulted in or pro-
longed hospitalization, or resulted in death. The primary efficacy
measure was 6-month TLPP defined as the interval following
treatment until either the next clinically driven reintervention at or
near (#5 mm) the target-lesion site occurred or the extremity was
abandoned for permanent access. Primary outcomes for the covered-
stent group were hypothesis-tested to the PTA group; if the tests
were successful, then 12-month TLPP and 6-month access circuit
primary patency (ACPP) were also hypothesis-tested. Additional
secondary descriptive measures included acute technical and pro-
cedural success of covered-stent placement, TLPP beyond 12
months, ACPP beyond 6 months, cumulative patency, the number of
reinterventions in the access circuit to maintain patency, index of
patency function, and AEs through 2 years.
Study procedures
Baseline history collection and physical examination were per-
formed, along with a clinical assessment of study eligibility. AVF
characteristics were recorded, and an angiogram of the access circuit
using radiographic measuring tape was performed to confirm eligi-
bility. Nontarget stenoses had to be successfully treated using the
conventional PTA technique before the target stenosis was ran-
domized and treated. Investigators chose target lesions based on
clinical experience and angiographic appearance and dilated the
stenoses with appropriately sized conventional balloons to achieve an
optimal initial result. Prolonged or high-pressure PTA could be
performed if this was the investigator’s standard of practice.
Nonstandard PTA (e.g., drug-coated, cutting, or scoring balloons),
bare stents, or covered stents were not allowed for treatment of target
or nontarget stenoses. If the conventional PTA balloon expanded to
its expected profile at the target stenosis, the patient was randomized
using a 1:1 allocation to either the PTA or the covered-stent group.
Assignment cards were enclosed in sequentially numbered
randomization envelopes, and randomization assignments at each
site were selected separately from those of other sites. Investigators,
study staff, and patients were blinded until full expansion of the
initial PTA balloon had occurred but could not be blinded to study
treatment because of differences in device appearance and technique.
Patients randomized to the PTA group could be treated further with
conventional PTA, including use of a larger-diameter balloon.
Patients randomized to the covered-stent group were treated with a
Covera Vascular Covered Stent, sized appropriately by the investi-
gator at the time of placement. In general, the covered stent was
oversized, at 0.5–2 mm, depending on the inflow vein and device
diameters. The expanded polytetrafluoroethylene covered stent was
provided in diameters of 6–10 mm and lengths of 30, 40, 60, 80, and
100 mm. The covered stent and implantation procedures have been
described in previous publications.6,7 The covered stent could be
used to treat multiple stenoses within 1 target lesion (overall target
lesion length, <9 cm) but could not be used to treat stenoses beyond
the target lesion. Angiograms were performed before, during, and
immediately after the procedure, to assess technical and procedural
success, and during any subsequent reintervention. All angiographic
images were sent to the core laboratory for quantitative analysis.
Postprocedure data were collected, and follow-up examinations at 1,
3, 6, 12, 18, and 24 months included physical examination, docu-
mentation of reinterventions, and evaluation of AEs.
Statistical analysis
A sample size of 280 patients provided $90% power for the primary
and the key secondary outcome measures with a 1-sided type I error of
0.025. The intent-to-treat (ITT) population consisted of all random-
ized patients and was used to evaluate baseline patient and lesion
characteristics, the primary safety outcome, and AEs. The modified-
ITT population (m-ITT) consisted of those patients treated as
assigned (e.g., the covered-stent group treated with the Covera covered
stent). A total of 12 patients treated adjunctively with stents (8 patients)
or stent grafts (4 patients) in the PTA group, and 1 patient in the
covered-stent group not treated with the study device, were excluded
from the m-ITT analysis. The primary efficacy outcome, as well as
secondary outcomes, was analyzed using the m-ITT population.
Treatment group demographics, baseline characteristics, and
other covariates were summarized using frequency counts and per-
centages and were compared to the control group using t tests or
Wilcoxon nonparametric tests for means, and c2 tests for pro-
portions. The primary safety measure was proportionally analyzed,
and the covered-stent group was hypothesis-tested for noninferiority
to the PTA group using the Farrington and Manning exact test for
noninferiority (1-sided noninferiority P value < 0.025). Confidence
intervals (CIs) of the rate in each group and the difference between

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clinical trial B Dolmatch et al.: Covered stent versus angioplasty for AVF stenosis

groups were calculated. The primary efficacy outcome was estimated Table 3 | Baseline patient demographics, risk factors, and
using a Kaplan–Meier (K–M) analysis. A log–rank test was used to medical history
evaluate whether 6-month TLPP survival in the covered-stent group
Patient demographicsa Covered stent PTA Total Pb
was greater than that in the PTA group (1-sided P < 0.025, and 95%
CIs). Secondary sensitivity analyses included a K–M estimate of Patients treated 142 138 280
freedom from a safety event, a proportional analysis of TLPP using USc 131 131 262
Outside the USd 11 7 18
the m-ITT population, and a K–M estimate of 6-month TLPP of the
Age, yr 63  13.2 62  11.6 63  12.4 0.7
ITT population; differences were compared and presented with Gender 0.76
associated 95% CIs and P values. Male 62.7 (89) 60.9 (84) 61.8 (173)
Key secondary measures were hypothesis-tested for superiority if Female 37.3 (53) 39.1 (54) 38.2 (107)
hypothesis tests for the primary outcomes were successful. First, 12- BMI, kg/m2 30.8  6.30 28.9  5.79 29.8  6.12 0.01
month TLPP for the covered-stent group was tested for superiority Ethnicity 0.38
to the PTA group. If statistically significant, then 6-month ACPP was Hispanic or Latino 33.8 (48) 39.1 (54) 36.4 (102)
Non–Hispanic or 65.5 (93) 60.9 (84) 63.2 (177)
hypothesis-tested. K–M analyses were used to estimate TLPP and Latino
ACPP survival rates, and a log–rank test was used to test the hy- Not reported 0.7 (1) 0 0.4 (1)
potheses that use of a covered stent was superior to PTA alone (1- Race 0.08
sided P < 0.025). If the null hypothesis was accepted for either White 70.4 (100) 66.7 (92) 68.6 (192)
primary outcome measure, then 12-month TLPP, 6-month ACPP, Black 25.4 (36) 26.1 (36) 25.7 (72)
and all other secondary endpoints were exploratory only. Secondary Asian 0 4.3 (6) 2.1 (6)
Pacific Island 1.4 (2) 0 0.7 (2)
outcomes were presented using descriptive statistics with means 
standard deviation and 95% CIs of the rate in each group. Pre- Medical history
specified subgroup analyses, such as the impact of gender, geography, Hypertension 97.9 (139) 96.4 (133) 97.1 (272) 0.45
and lesion characteristics on the primary and key secondary outcome Diabetes (type 2) 71.1 (101) 68.1 (94) 69.6 (195) 0.78
measures were summarized using descriptive statistics, including Dyslipidemia 66.9 (95) 61.6 (85) 64.3 (180) 0.35
rates, differences between groups, and 95% CIs. Cigarette smoking 43.7 (62) 44.9 (62) 44.3 (124) 0.83
Current 5.6 (8) 10.9 (15) 8.2 (23)
Former 38.0 (54) 34.1 (47) 36.1 (101)
RESULTS Coronary artery disease 32.4 (46) 37.7 (52) 35.0 (98) 0.35
Baseline demographics and procedural details Congestive heart failure 24.6 (35) 29.0 (40) 26.8 (75) 0.41
Patient demographics and medical histories are detailed in Peripheral arterial/vascular 16.9 (24) 21.0 (29) 18.9 (53) 0.38
disease
Table 3, and lesion characteristics and procedural details are
Myocardial infarction 15.5 (22) 13.0 (18) 14.3 (40) 0.56
summarized in Table 4. A total of 280 patients were ran- Cancer 12.0 (17) 10.9 (15) 11.4 (32) 0.77
domized and treated—142 in the covered-stent group, and Atrial fibrillation 10.6 (15) 11.6 (16) 11.1 (31) 0.78
138 in the PTA group. The treatment locale for 18 patients Valvular heart disease 4.2 (6) 2.9 (4) 3.6 (10) 0.55
Deep vein thrombosis 3.5 (5) 2.9 (4) 3.2 (9) 0.77
was Europe, Australia, or New Zealand, and 262 were treated
Transient ischemic attack 1.4 (2) 5.1 (7) 3.2 (9) 0.08
in the US. Common comorbidities included hypertension Aortic disease 1.4 (2) 2.9 (4) 2.1 (6) 0.39
(97.1%), dyslipidemia (97.1%), type 2 diabetes mellitus BMI, body mass index; ITT, Intent-to-treat; PTA, percutaneous transluminal
(69.6%), coronary artery disease (35%), congestive heart angioplasty.
a
failure (26.8%), and peripheral artery disease (18.9%). Most ITT population.
b
Observational P values were calculated using t tests for continuous variables and c2
patients (93.6%) had an upper-arm AVF created more often tests for categorical variables.
in the left arm (77.1%). The most common fistula configu- c
d
Sixteen US investigative sites.
Eight investigative sites in Europe, Australia, and New Zealand.
ration was brachiocephalic (57.9%), and the most common Values are n, % (n), or mean  SD, unless otherwise indicated.
pre-procedure AVF dysfunction was pulsatility (62.9%). A
total of 99 patients (35.4%) presented with 117 nontarget
stenoses treated successfully with PTA prior to randomiza- in 141 patients, and 1 patient received 2 overlapping covered
tion. Target lesions were mostly restenotic (73.2%); they stents. All but 1 covered stent was postdilated (99.3%), and 36
averaged 29.3  17.2 mm in length; and slightly more than patients (26%) received an additional postrandomization
half of the target stenoses were in the cephalic vein arch dilation in the PTA group. The final mean residual stenosis in
(52.9%). The mean baseline target lesion percent diameter the covered-stent group was 2.2%  5.8% compared to 15%
stenosis was 72.5% in both groups.  18.0% in the PTA group. Acute technical success of
Medications were prescribed at the discretion of the covered-stent placement (i.e., deployment of the device to the
investigator. Most patients were taking an anticlotting agent at intended location) was 100%, and procedural success
baseline and continued with it through the course of the (i.e., <30% residual stenosis with resolution of pre-procedure
study. There were no apparent differences in the types of clinical indicators of access dysfunction) was 98.6% in the
medications or usage between groups pre- or post-procedure covered-stent group and 98.4% in the PTA group.
(Supplementary Table S1). All patients received PTA prior to
randomization. The mean number of balloon inflations was Postprocedure follow-up and primary outcome analyses
1.3, and the mean inflation pressure was 21 atmospheres in A total of 270 patients, 137 (96.5%) in the covered-stent
both groups. In the treatment group, 1 covered stent was used group and 133 (96.4%) in the PTA group completed

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Table 4 | Access circuit characteristic and procedural details

Parametersa Covered stent n [ 142 PTA n [ 138 Total N [ 280

AV access circuit characteristics

Target limb
Left arm 74.6 (106) 79.7 (110) 77.1 (216)
Right arm 25.4 (36) 20.3 (28) 22.9 (64)
Access position
Forearm 7.7 (11) 5.1 (7) 6.1 (17)
Upper arm 91.5 (130) 94.9 (131) 93.6 (262)
Fistula configuration
Radiocephalic 8.5 (12) 6.5 (9) 7.5 (21)
Brachiocephalic 59.2 (84) 56.5 (78) 57.9 (162)
Transposed brachiobasilic 19.0 (27) 26.8 (37) 22.9 (64)
All other 13.4 (19) 10.1 (14) 11.8 (33)
On dialysis, mo 28.0  23.2 31.5  24.7 29.7  24.0
Access dysfunction
Pulsatility 59.9 (85) 65.9 (91) 62.9 (176)
Elevated venous pressures 23.9 (34) 29.7 (41) 26.8 (75)
Decreased access blood flow 27.5 (39) 16.7 (23) 22.1 (52)
Prolonged bleeding 16.9 (24) 25.4 (35) 21.1 (59)
Diminished or abnormal thrill 21.8 (31) 15.9 (22) 18.9 (53)
Target lesion characteristics
de novo/restenotic, %/% 24.6/75.4 29.0/71.0 26.8/73.2
Lesion length, mm 28.8  17.4 29.7  17.0 29.3  17.2
Lesion stenosis, %  SD 72.5  17.4 72.5  12.7 72.5  12.5
Prior interventions
Patients with prior interventions (< 30 d of study) 2.8 (4) 2.9 (4) 2.9 (8)
Number of prior interventions 5 5 10
PTA 2.8 (4) 2.9 (4) 2.9 (8)
Thrombectomy/thrombolysis 0 0.7 (1) 0.4 (1)
Procedural details
Patients with nontarget lesions 50 49 99
Number of nontarget lesions 64 53 117
Procedure time, min 23.1  14.3 17.6  10.4 20.4  12.9
Residual stenosis after pre-dilation, %  SD 21.7  20.5 15.4  16.6 18.6  18.9
Covered stent configuration
Flared 46.1 (65) — —
Straight 53.9 (76) — —
Covered stent diameter, mm
6 0.7 (1) — —
7 2.8 (4) — —
8 18.4 (26) — —
9 29.8 (42) — —
10 48.2 (68) — —
Covered stent length, mm
30 2.1 (3) — —
40 41.8 (59) — —
60 36.9 (52) — —
80 16.3 (23) — —
100 2.8 (4) — —
Residual stenosis postdeployment, %  SD 4.1  7.9 — —
Postdilation 99.3 (141) 26.1 (36) 63.2 (177)
Residual stenosis after postdilation, %  SD 2.2  5.8 15.0  18.0 4.8  10.9
Acute technical successb 100 (140) — —
Procedural successc 98.6 (138) 98.4 (124) —
AV, arteriovenous; ITT, intent-to-treat; PTA, percutaneous transluminal angioplasty.
a
ITT population.
b
Technical success was defined as successful deployment of the covered stent to the intended location.
c
Procedural success was defined as the attainment of <30% residual stenosis after completion of the procedure with resolution of pre-procedure clinical indicators of access
malfunction.
Values are n, % (n), or mean  SD, unless otherwise indicated.

30-day follow-up and were available for the primary safety
analysis (Figure 1). Primary outcome measures are sum-
marized in Table 5. The primary safety measure (ITT
population) for the covered-stent group was noninferior
to the PTA group (noninferiority P ¼ 0.002). A total of
253 patients completed 6-month follow-up—130 (91.5%)
in the covered-stent group, and 123 (89.1%) did so in the
PTA group. TLPP in the covered-stent group (78.7%) was
superior to that in the PTA group (47.9%) at 180 days
(m-ITT; K–M survival analysis; P < 0.001; Figure 2).

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clinical trial B Dolmatch et al.: Covered stent versus angioplasty for AVF stenosis

Figure 1 | Disposition of patients. A total of 253 patients completed the 6-month follow-up—130 (91.5%) in the covered-stent (Covera
Vascular Covered Stent [Becton, Dickinson]) group and 123 (89.1%) in the percutaneous transluminal angioplasty (PTA) group. A total of 196
patients (70%) completed the study—103 in the covered-stent group (72.5%) and 96 patients in the PTA group (69.6%). A total of 59 patients
died prior to study completion. *Missed visits, patients who missed follow-up visits and were subsequently followed at the next interval were
added back into the total follow-up.

Prespecified subgroup analyses (m-ITT) were performed
to assess the impact of baseline demographics and
geographic location (i.e., US or non-US site) on TLPP at
6 months (Figure 3). Although exploratory only, all sub-
groups showed a benefit of the covered stent, compared to
PTA.
Sensitivity analyses were performed to further evaluate
the primary safety and efficacy outcomes (Table 5). The
estimated rate of freedom from a 30-day safety event (K–M
estimate) in the covered-stent group was 95% (95% CI:
89.9%, 97.6%), compared to 96.4% (95% CI: 91.4%, 98.5%)
in the PTA group. A proportional analysis of TLPP was
consistent with the primary K–M results; 6-month TLPP was
78.4% in the covered-stent group, and 47% in the PTA
group, a difference of 31.3% in favor of covered-stent
placement (P < 0.001; 95% CI: 19.9%, 42.8%). Finally,
TLPP was evaluated using the ITT population. Although the
6-month rate was slightly higher for the PTA group that

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B Dolmatch et al.: Covered stent versus angioplasty for AVF stenosis clinical trial

Table 5 | Primary outcome measures

Primary endpoints Covered stent PTA Difference P
a
Safety
Freedom from primary safety event (30 d)—ITT population 95.0 (133/140) 96.4 (132/137) –1.4 (–7.3, 4.6) 0.002b
Efficacyc
Estimate of TLPP survival (180 d)—m-ITT populationd 78.7 (70.8, 84.7) 47.9 (38.7, 56.6) 30.8 <0.001e
Sensitivity analysesf
Estimate of freedom from primary safety eventg 95.0 (89.9, 97.6) 96.4 (91.5, 98.5) –1.4
Proportional analysis of TLPP at 6 moh 78.4 (105/134) 47.0 (55/117) 31.3 (19.9, 42.8) <0.001
Estimate of TLPP survival (180 d)—ITT populationi 78.7 (70.8, 84.7) 50.1 (41.2, 58.4) 28.6 <0.001
Worst case analysis of TLPP at 6 moj 74.5 (105/141) 50.8 64/126 23.7 (11.8, 35.0) <0.001
AV, arteriovenous; CEC, clinical events committee; CI, confidence interval; ITT, intent-to-treat; m-ITT, modified intent-to-treat; PTA, percutaneous transluminal angioplasty;
TLPP, target lesion primary patency.
a
The primary safety endpoint was freedom from a primary safety event, defined as freedom from a CEC adjudicated adverse event involving the AV access circuit that resulted
in additional intervention, hospitalization, or death. Safety analyses were based on the ITT population.
b
90% CI and P value were calculated using the Farrington and Manning noninferiority test with a noninferiority margin of 10%.
c
The primary efficacy endpoint was TLPP, defined as the interval following treatment until the next clinically driven reintervention at the target-lesion site, within 5 mm
proximal or distal to the treatment site, or until the extremity was abandoned for permanent access.
d
Based on the m-ITT patent population that consisted of patients randomized to the covered-stent group and treated with the Covera Vascular Covered Stent (Becton,
Dickinson) or to the PTA arm and treated with standard balloon angioplasty. Twelve patients in the PTA group that received an adjunctive stent or stent graft, and 1 patient in
the covered-stent group that did not receive the Covera covered stent were excluded from the m-ITT population and the efficacy analyses. Rates are estimated using the
Kaplan–Meier method, and the 95% CIs are estimated using Greenwood’s formula.
e
One-sided P value was calculated using the Log-rank test.
f
Sensitivity analyses were performed on both primary outcome measures to determine the impact of changes to certain variables. These secondary analyses helped measure
the strength of the overall data.
g
Rates were estimated using the Kaplan–Meier method, and the 95% CIs were estimated using Greenwood’s formula.
h
Proportional-based sensitivity analysis. The 95% CI and P values were calculated using the c2 test.
i
The ITT population included 12 patients in the PTA group who received adjunctive stents or stent grafts, and 1 patient in the covered-stent group who did not receive the
study device.
j
The worst-case analysis was a proportional-based sensitivity analysis where missing data for the covered-stent group were considered failures of TLPP and missing data for
the PTA group were considered successes. The 95% CI and P value were calculated using the exact binomial test.
Values are % (n/N) or % (95% CI), unless otherwise indicated.

included the 12 patients treated adjunctively with a stent or
stent graft (50.1%), the covered-stent group remained su-
perior at 6 months (78.7%; P < 0.001).
Secondary outcomes
Given that the primary outcomes were achieved, key sec-
ondary outcomes were hypothesis-tested (m-ITT popula-
tion). First, the estimated TLPP survival rate (K–M analysis)
for the covered-stent group (55.8%) was superior to that in
the PTA group (21.2%) at 365 days (P < 0.001; Figure 2). The
estimated ACPP survival rate for the covered-stent group was
50.7% (95% CI: 42.0%, 58.5%), compared to 43.8% (95% CI:
34.7%, 52.5%) for the PTA group at 180 days; the 6.9%
difference only numerically favored the covered-stent group
(P ¼ 0.085; Figure 4).
Longer-term secondary outcomes were evaluated using
descriptive statistics without formal hypothesis testing
through 2 years (Table 6). Final follow-up at 2 years included
103 patients in the covered-stent group (72.5%) and 96 pa-
tients in the PTA group (69.6%). At 2 years (730 days), the
TLPP rates for the covered-stent group were 40.0%,
compared to 11.6% for the PTA group (Figure 2), and ACPP
rates were 14.6% and 10.5% (Figure 4), respectively. Cumu-
lative circuit patency was maintained at comparably high
levels through 24 months (91.3%, covered-stent group:
92.7%, PTA group). On average, 3.2  2.6 reinterventions in
the access circuit were needed to maintain patency in the
covered-stent group, versus 3.6  2.6 reinterventions in the
PTA group, with a longer mean time between interventions
(i.e., index of patency function) of 219.5  178.9 days in the
covered-stent group, compared to 180.6  135.2 days for the
PTA group. The mean number of reinterventions at the target
lesion was 1.6  1.6 in the covered-stent group versus 2.8 
2.0 in the PTA group, with a longer mean time between in-
terventions in the covered-stent group (380.4  249.5 days),
compared to that in the PTA group (217.6  158.4). A total of
119 patients in the covered-stent group (83.8%) and 120
patients in the PTA group (87%) reported at least 1 AE
through 24 months. The clinical events committee deter-
mined that 2 patients in the covered-stent group experienced
serious AEs that met the protocol definition of device-related.
The events, both recognized at 6 months, were caused by stent
compression in the cephalic arch and cephalic vein–axillary
vein junction, respectively. Both compressed covered stents
were successfully treated with PTA. A total of 59 patients died
through the course of the study—27 (19%) in the covered-
stent group and 32 (23.2%) in the PTA group. Of these
deaths, 24—12 in each group—were attributed to cardiac or
cardiopulmonary arrest, with the remaining deaths distrib-
uted among a variety of reported causes, the most prevalent of
which were dialysis termination by the patient and respiratory
failure.
DISCUSSION
Stenoses that cause AVF dysfunction often are treated with
PTA, but restenosis after PTA is common.1 Randomized

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clinical trial B Dolmatch et al.: Covered stent versus angioplasty for AVF stenosis

Figure 2 | Kaplan–Meier (K–M) estimates of target lesion primary patency (TLPP) through 730 days. TLPP survival estimates were
powered to test the hypothesis that TLPP was superior for the covered-stent group (Covera Vascular Covered Stent [Becton, Dickinson])
compared to the percutaneous transluminal angioplasty (PTA) group through 1 year (365 days). TLPP for the covered-stent group was superior
to that in the PTA group at 180 days (78.7% vs. 47.9%; P < 0.001) and at 365 days (55.8% vs. 21.2%; P < 0.001). At 730 days, the estimated rate
was 40.0% for the covered-stent group and 11.6% for the PTA group, an observed difference of 28.4%. CI, confidence interval.

controlled trials using covered stents following PTA to treat
arteriovenous graft–vein anastomotic stenoses provided out-
comes superior to those of PTA alone. The FLAIR Endovas-
cular Stent Graft (Becton, Dickinson and
Company) demonstrated a 22.8% advantage at 1 year (47.6%
vs. 24.8%; P < 0.001) and 13.4% (26.9% vs. 13.5%, P <
0.001) at 2 years, and the GORE VIABAHN Endoprosthesis
(W. L. Gore & Associates, Inc.) also demonstrated a 17.6%
advantage in TLPP at 6 months (51.6% vs. 34.2%; P ¼
0.006).2–4 Observations from 3 small, single-center AVF
studies also reported better patency results when a covered
stent was placed immediately after PTA.8–10 These studies
demonstrated 6- and 12-month TLPP rates of 67% and 42%
in the cephalic arch,8 6-, 12-, and 24-month TLPP rates of
83%, 78%, and 69% in stenotic native radiocephalic AVFs,9
and a TLPP rate of 94.1% at 12 months in recurrent AVF
stenosis.10 Unlike these small exploratory AVF studies, the
AVeNEW study was a prospective, multicenter, randomized
study designed and powered to compare PTA alone to
covered-stent placement immediately following PTA for
treatment of AVF stenosis causing circuit dysfunction. The
primary safety outcome at 30 days demonstrated non-
inferiority between the groups, whereas TLPP at 6 and 12
months was superior in the covered-stent group, compared to
that in the PTA control. Although it was only observational
beyond 12 months, this patency benefit was carried through
24 months (Figure 2). Although numerical differences in
ACPP favored the covered-stent group over the PTA group,
these differences were not statistically significant at 6, 12, or
24 months (Figure 4).
Although superior ACPP is desirable, the finding that circuit
patency was not statistically better for the covered-stent group
is not surprising. Circuit patency is multifactorial and repre-
sents the combined impact of target-site patency, new stenoses,
AVF thrombosis, and nontarget stenoses treated at the index
procedure that recur. In the AVeNEW trial, 195 new lesions
occurred in the covered-stent group, 146 new lesions occurred
in the PTA group, and 16 new thromboses occurred in each
group treated in the access circuit through 2 years. Approxi-
mately 35% of patients had a nontarget stenosis that required
treatment at the time of enrollment, and 96 of these stenoses in
the covered-stent group and 75 in the PTA group required
reintervention with conventional PTA through 24 months.
Treatment of multiple stenoses increases the number of sites
where restenosis can occur, and PTA of multiple stenoses results
in worse AVF circuit patency than it does when only 1 stenosis is
present.11 The fact that the development of new stenoses, cir-
cuit thrombosis, and recurrent nontarget stenoses led to a

196 Kidney International (2023) 104, 189–200

B Dolmatch et al.: Covered stent versus angioplasty for AVF stenosis clinical trial

Figure 3 | Forest plots and hazard ratios of the primary efficacy outcome, 6-month target lesion primary patency (TLPP), by
prespecified subgroups: geographic site location (i.e., US vs. non-US sites), patient demographics, and lesion characteristics. These
exploratory analyses were designed to observe the impact of various covariates on TLPP. As was the case with the overall population, the
covered-stent group consistently had fewer TLPP failures compared to the percutaneous transluminal angioplasty (PTA) group, across all
subgroups. CI, confidence interval; m-ITT, modified intent to treat.

Kidney International (2023) 104, 189–200 197

clinical trial B Dolmatch et al.: Covered stent versus angioplasty for AVF stenosis

Figure 4 | Kaplan–Meier (K–M) estimates of access circuit primary patency (ACPP) through 730 days. ACPP in the covered-stent group
(50.7%) was not statistically different, compared to the PTA group (43.8%) at 180 days (difference 6.9%; P < 0.085). Numerical differences
beyond 180 days were observational only. Coverd stent is Covera Vascular Covered Stent (Becton, Dickinson). CI, confidence interval; TLPP,
target lesion primary patency.

greater loss of ACPP for both the PTA and covered-stent groups clearer picture of the relationship between TLPP and ACPP, but
makes sense. A protocol excluding patients with nontarget AVF it would have resulted in a highly selected patient population
stenoses at the index procedure would likely have revealed a that is not representative of many practices where nontarget

Table 6 | Secondary outcome measures

Secondary observations at 24 moa Covered stent PTA Difference
b c
TLPP 35.1 (40/114) 9.1 (10/110) 26.0 (15.7, 36.3)d
Failure of TLPPe 64.9 (74/114) 90.9 (100/110)
Clinically driven intervention 62.3 (71/114) 88.2 (97/110)
Thrombotic occlusion-treatment area 7.0 (8/114) 3.6 (4/110)
Surgical intervention 0.9 (1/114) 0
Permanent access abandonment 2.6 (3/114) 2.7 (3/110)
ACPPb 10.7 (13/121) 8.1 (9/111) 2.6 (–4.9, 10.1)d
Failure of ACPPe 89.3 (108/121) 91.9 (102/111)
Clinically driven intervention 89.3 (108/121) 90.1 (102/111)
Non–clinically driven access thrombosis 0 0
Permanent access abandonment 0.8 (1/121) 1.8 (2/111)
Access circuit reinterventions 3.2 (2.6) 3.6 (2.6) –0.4 (0.3)
Target lesion reinterventions 1.6 (1.6) 2.8 (2.0) –1.2 (0.2)
IPF, d 219.5 (178.9) 180.6 (135.2) 38.9 (20.9)
Target lesion IPF, d 380.4 (249.5) 217.6 (158.4) 162.8 (28.1)
Cumulative/secondary patency 91.3 (95/104) 92.7 (76/82) –1.3 (–15.7, 13.1)
Deathsf 19 (27/142) 23.2 (32/138)
ACPP, access circuit primary patency; CI, confidence interval; IPF, index of patency function; ITT, intent-to-treat; m-ITT, modified intent-to-treat; PTA, percutaneous transluminal
angioplasty; TLPP, target lesion primary patency.
a
m-ITT population.
b
Proportional-based analysis.
c
N ¼ the number of patients in the m-ITT population with evaluable data.
d
95% CI was calculated using the c2 test.
e
Patients could have more than 1 event.
f
N ¼ ITT population.
Values are % (n/N) or mean (SD), unless otherwise indicated.

198 Kidney International (2023) 104, 189–200

B Dolmatch et al.: Covered stent versus angioplasty for AVF stenosis
stenoses are commonly treated. Alternatively, if the current
protocol had allowed all stenoses in the covered-stent group
(target, nontarget, or new) to be treated with a covered stent,
perhaps ACPP would have been better, given that TLPP with a
covered stent was superior to PTA alone. This approach,
however, would have increased the complexity of the study,
which was also designed to provide data to the US Food and
Drug Administration (FDA) to seek clearance of the Covera
covered stent for use in AVFs. Treatment of more than 1 site
with a covered stent would have created confounding variables
problematic for regulatory analysis.
Several prospective, randomized, multicenter clinical trials
have reported use of drug-coated balloons (DCBs) for treat-
ment of AVF stenosis,12–17 but results have varied. Some studies
show little benefit using DCBs,15 whereas others demonstrate
better TLPP14 and even improved ACPP, compared to PTA.16
These variations in results are likely related to use of different
study designs and outcome measures, patient populations, AVF
types, drug concentrations and excipients, differences in me-
chanical characteristics of the base balloons, technical perfor-
mance of dilation, and perhaps other factors. Results of these
studies, however, raise the question of whether an AVF stenosis
should be treated with a DCB or a covered stent. Although
direct comparison of covered stents and DCBs for treating AVF
stenosis is not possible without a randomized trial, the different
mechanisms by which these 2 modalities may improve out-
comes, as compared to those of conventional PTA, are worth
exploring. A DCB should provide benefit when stenosis or
restenosis is due to neointimal proliferation. Some AVF ste-
noses, however, are fibrotic and constricting without neo-
intimal tissue, whereas others may be related to the presence of
venous valves or even inflammatory tissue.11,18–21 A DCB may
not offer benefit over conventional PTA when neointimal tissue
is neither present nor likely to develop, whereas a covered stent
can exclude ingrowth of neointimal tissue and prevent recur-
rent restenosis caused by fibrotic constriction, obstructing
valves, and inflammatory tissue. An argument for use of DCBs
is that they do not leave behind a permanent implant. In our
study, 2 device-related AEs occurred (compression of the
covered stent), both of which were treated successfully with a
single repeat angioplasty. Through 24 months, no reports were
made of covered-stent migrations or fractures, and no covered
stent became infected. As for the “leave nothing behind”
concept, the recent history of vascular intervention has
confirmed that vascular implants such as drug-eluting coro-
nary22 and peripheral stents,23–25 peripheral covered stents,26
venous stents,27 transjugular intrahepatic portosystemic shunt
(TIPS) covered stents,28,29 and arteriovenous graft covered
stents can extend and improve post-PTA patency.2–7 Fewer
interventions and longer times between interventions can
improve lives, and in some situations, save lives. Given the high
morbidity and mortality for patients with renal failure on he-
modialysis (approximately 21% mortality during our 24-month
study), if a covered stent can improve the care and lives of these
patients by even a modest reduction in the number of in-
terventions, their use seems to have little downside. Without a
Kidney International (2023) 104, 189–200
clinical trial
head-to-head comparison, however, between DCBs and
covered stents in AVFs, we can only speculate on the benefits of
one over the other.
Although this study was a prospective, randomized,
multicenter, controlled clinical trial, it does have limitations.
Investigators, staff, and patients were blinded through the
point of pre-dilation, but not to the treatment allocation.
Inherent treatment bias could have occurred after randomi-
zation, as sizing of PTA balloons and covered stents was left to
the investigators. Results based on patients enrolled in this
controlled trial with defined eligibility criteria may not be
generalizable to patients treated in daily practice in which
prolonged PTA, cutting-scoring balloons, or DCBs are used.
To evaluate differences between the current trial results and
AVF interventions in other populations or with nonstandard
PTA, comparative, properly powered, randomized studies are
needed. As with all clinical trials of dysfunctional access cir-
cuits in a hemodialysis population, patient attrition due to all-
cause mortality was high; 19% of patients in the covered-stent
group died, and 23.2% in the PTA group died through 24
months. Largely due to death prior to the end of the study,
29% of our patients were not followed to study completion,
and this could have impacted the results.
The AVeNEW study represents the first large, prospective,
randomized trial comparing treatment of AVF stenosis with
both a covered stent following PTA and PTA alone. Safety was
statistically non-inferior between groups, whereas TLPP was
statistically superior for the covered-stent group at 6 and 12
months, with benefit observed through 2 years. Although
ACPP did not show improvement statistically, we observed
that patients treated with the covered stent received fewer
interventions to maintain AVF patency, had prolonged time
between interventions, and had cumulative AVF patency
comparable to that in the PTA group (>90%). Overall, the
use of the Covera covered stent in the current trial provided a
safe alternative to angioplasty with statistically superior TLPP
results and modest clinical benefit for patients.
APPENDIX
The AVeNEW Trial Investigators
Bart Dolmatch, Gerard Goh, Stewart Hawkins, Ewan Macaulay, Ian Spark, Rick
de Graff, Hannes Deutschmann, Ralph Kickuth, Geert Maleux, Thomas
Pfammatter, Levester Kirksey, Robert Mendes, John Aruny, Vagar Ali, Timoteo
Cabrera, Pablo Pergola, Deepak Sharma, Erin Moore, Himanshu Shah, Amy
Dwyer, Dominic Yee, Wang Teng, Randy Cooper, Saravanan Balamuthusamy,
George Lipkowitz, Theodore Saad, Jonah Licht, Angelo Makris, Tim Rogers,
Jason Burgess, Jeffrey Hoggard.
DISCLOSURE
BD reports receiving speaker and consulting fees from Becton, Dickinson and
Company; Medtronic; and Merit Medical Systems. PP reports receiving speaker
and consulting fees from Reata, Ardelyx, Unicycive, AstraZeneca, Caladrius, Bayer,
GSK, and Gilead; and is a shareholder in Unicycive Therapeutics. SB reports
receiving speaker and consulting fees from Becton, Dickinson and Company;
Vifor Pharmaceuticals; and Horizon Pharmaceuticals; and is an advisory board
member of Coremedix, and partner and founder of OptmyCare and Plexus EMR.
AM serves on the Medical Advisory Board of Azura Vascular Care. EMo reports
receiving speaking and consulting fees from Terumo Vascular and W. L. Gore and
Associates. JL is serving as an investigator in a Merit Medical hemodialysis access
199
clinical trial
study. RS is an employee and shareholder in Becton, Dickinson and Company. All
other authors were investigators in the AVeNEW study or employees of the Yale
Cardiovascular Research Group, but report no other relationships with Becton,
Dickinson and Company or other companies with financial interests in the
information contained in the manuscript. All other authors declared no
competing interests.
DATA STATEMENT
Aggregate data from the trial are publically available on clinicaltrials.gov
(unique identifier: NCT02649946). Individual, patient-level data remain
confidential and are not publically available.
ACKNOWLEDGMENTS
The AVeNEW Study was conducted under an Investigational Device
Exemption (IDE) approved by the United States Food and Drug
Administration (FDA). The study was supported–funded by C. R. Bard,
a subsidiary of Becton, Dickinson and Company. The authors thank
Talar Saber, MS, for her assistance and management of the AVeNEW
trial. They also thank the following investigators who participated in
the trial: Gerard Goh, MD, Stewart Hawkins, MD, Ian Spark, MD, Rick
de Graff, MD, Hannes Deutschmann, MD, Ralph Kickuth, MD, Levester
Kirksey, MD, Robert Mendes, MD, John Aruny, MD, Vagar Ali, MD,
Deepak Sharma, MD, Himanshu Shah, MD, Amy Dwyer, MD, Dominic
Yee, MD, Wang Teng, MD, George Lipkowitz, MD, Theodore Saad, MD,
Tim Rogers, MD, Jason Burgess, MD, and Jeffrey Hoggard, MD.
SUPPLEMENTARY MATERIAL
Supplementary File (Word)
Supplementary Table S1. Relevant medication.
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