Update on Stent-Grafts: RENOVA, REVISE, RESCUE

Update on Stent‐Grafts:
RENOVA, REVISE, RESCUE
JOHN E. ARUNY, MD
Yale University School of Medicine
Disclosure
John E. Aruny, M.D:
.................................................................................
I have the following potential conflicts of interest to
report:
W.L.Gore Institutional PI (Yale University) for Revise Trial
EKOS (BTG) Speakers Honorarium & Study Investigator
Boston Scientific Corp. Advisory Board (Vascular)
PTA and Bare Metal Stent do not provide durable
outcomes
RENOVA Trial
• Multicenter, Prospective trial randomizing patients who were undergoing hemodialysis and who had a venous anastomotic stenosis to undergo either PTBA alone or PTBA plus placement of the Flair Stent Graft (Bard Peripheral Vascular).
• Primary endpoints: Designed to show noninferiority to PTBA alone‐ the 6‐month primary patency of venous anastomosis in the treatment area.
RENOVA Trial
• Secondary Endpoints: Primary patency of the access circuit at 2 & 6 months.
• Freedom from subsequent interventions.
Study Methods
• Stent could not cross the elbow
• Failing but not thrombosed grafts
• Availability of a flared device when outflow vein is larger than the graft diameter
N Engl J Med 2010;362:494‐5‐03
Treatment Success &Patency Endpoints
12‐Months Results
• 12 month Access Circuit Primary Patency (ACPP) significantly better for stent grafts: 24.1% vs. 10.3% (p=0.005)
• Index of Patency Function IPFs (Average number of months between interventions) was significantly better for stent grafts 5.3 +
4.1 vs. 4.4 + 3.5 months/intervention (p=0.008)
• Stenosis Requiring Intervention occurred significantly more frequently in the PTA group, 82.6% vs. stent graft group 60.1% (p<0.001)
JVIR 2013
24 Months RENOVA Final Results
• 191 Patients completed the study (97 SG, 94 PTA)
• 5 patients lost to follow‐up or withdrew
• 74 patients died during the study (36 PTA, 38 SG)
JVIR 2014
RENOVA 24 Months
• TAPP remained superior for SG: 26.9% vs
13.5% (p< 0.001)
• ACPP remained superior for SG: 9.5% vs. 5.5 % (p<0.01)
• IPF 7.1 + 7.0 vs. 5.3 + 5.2 mos/ intervention
• # Access Circuit re‐interventions before graft abandonment was 4.3 for PTA vs. 3.4 for SG group.
REVISE Trial
GORE®, VIABAHN®, and designs are trademarks of W. L. Gore & Associates. © 2014 W. L. Gore & Associates, Inc.
Diffuse In‐Stent Stenosis is the common failure mode of Bare Metal Stents
Explanted Vein with BMS Courtesy of Tom Vesely, MD
RESCUE trial reported 10% primary patency at 6 mo
for PTA of in-stent stenosis
Total Endoluminal Bypass: Preventing
Instent Restenosis
Individual results may vary.
The GORE® VIABAHN® Endoprosthesis covers and seals off the diseased and irregular tissue of the vessel wall. In contrast, a bare nitinol stent allows for infiltration of neointimal cells as a result of the typical hyperplastic response.
The Gore REVISE Clinical Study
Multicenter, randomized-controlled trial (RCT)
comparing safety and effectiveness in
dysfunctional and thrombotic AVGs
VIABAHN® Endoprosthesis with Heparin Bioactive Surface
VS.
GORE®, VIABAHN®, and designs are trademarks of W. L. Gore & Associates. © 2014 W. L. Gore & Associates, Inc.
Angioplasty
REVISE Trial
• Multiicenter, randommized, prospective evaluation of Viabahn stent grft at venous anastomosis of AV Grafts.
• Primary purpose: Safety and efficacy. • Secondary endpoints: Target lesion and Access circuit primary Patency
Study Methods
• Included Thrombosed grafts
• Allowed deployment across the elbow
• Only straight tubular devices are available
Gore REVISE Clinical Study Inclusion Criteria
Graft
Basilic Vein
Venous Anastomosis
Target Lesion
Graft
Venous Anastomosis
Secondary Lesion
>30 mm of VA
<50 mm long
Responsive to PTA
Direction of Flow
Patients with symptomatic CVO were excluded from the study
Patient Enrollment Characteristics
Index Procedure Details
Patency Definitions
Target Lesion Primary Patency: The time interval of uninterrupted patency from initial study treatment to the next access thrombosis or intervention performed on the target lesion
Circuit Primary Patency: The time interval from initial study treatment to the next access thrombosis or intervention performed within the vascular access circuit.
Access Secondary Patency: The time interval from initial study treatment to abandonment of the vascular access circuit.
Safety Outcome
Freedom from major device, procedure, and treatment site‐related adverse events through 30 days post‐
procedure (was met p < 0.0001)
Target Lesion Primary Patency
Primary Effectiveness Endpoint:
The GORE® VIABAHN® Device group demonstrated statistical superiority
over the PTA group in target lesion primary patency as determined by Kaplan‐Meier estimates (p = 0.008).
Circuit Primary Patency
Greater primary circuit patency:
43%
29%
(n = 131)
(n = 138)
The VIABAHN group demonstrated greater
circuit primary patency than PTA as determined by Kaplan‐Meier estimates (p=0.035).
Dysfunction vs Thrombotic Subjects
Similar Treatment Benefit
Despite the reduced patency
outcomes for thrombotic
patients, no statistical
difference was detected in
terms of treatment effect of the
GORE® VIABAHN® Device
relative to PTA (p = 0.792)
Secondary Patency
69%
67%
Note: Secondary patency was maintained in
the PTA group by implanting 53 VIABAHN® stent
grafts during a subsequent intervention.
(n = 131)
(n = 138)
Stent grafts help
maintain secondary
patency
Without stents/stent
grafts, PTA 2ndary
Patency ~ 35%
The Gore REVISE Clinical Study
Mean Cumulative Interventions per Subject over 24 Months
GORE®, VIABAHN®, and designs are trademarks of W. L. Gore & Associates. © 2014 W. L. Gore & Associates, Inc.
Cost Analysis at 24 Months
Primary or de novo treatment with the GORE® VIABAHN® Endoprosthesis reduced costs by ~$2000 per patient over 24 months VIABAHN
n=131
PTA
n=138
Initial Procedure Costs
$7,820
$3,440
($4,380)
<.01
Repeat Intervention Costs
at 24-Months
$16,585
$23,022
$6,436
0.02
Difference p-value
Note: Only 26 VIABAHN patients and 28 PTA patients had secondary lesions at initial procedure. All costs
are reported in constant 2012 dollars and costs in year 2 are discounted at 3%. All repeat procedure costs
account for patients that were lost to follow-up by using an inverse probability weighting adjustment (Bang
and Tsiatis (2000), Glick et al. (2007)).
Flexibility to conform with the movement
BARD® and FLAIR® are trademarks of C. R. Bard, Inc.
GORE®, VIABAHN®, and designs are trademarks of W. L. Gore & Associates. © 2014 W. L. Gore & Associates, Inc.
Durability to last under mechanical strain
No reported fractures the
two year study period in the
Gore REVISE Clinical Study
BMS with multiple fractures Courtesy of Tom Vesely, MD
Conclusion
The Gore VIABAHN® Endoprosthesis has the flexibility and durability to cost‐effectively treat dysfunctional and thrombotic AV access grafts
RESCUE Trial:
FLUENCY® PLUS Endovascular Stent Graft versus PTA for In‐Stent Restenosis
• Randomized study evaluating device safety & effectiveness for treatment of in‐stent restenotic lesions in the venous outflow of the AV access circuit of Dialysis grafts & fistulas
JVIR 2014
Primary Study Endpoints • Superiority of access circuit Primary Patency (ACPP) through 6 mos and Safety through 30 days.
Secondary Endpoints
• Post intervention lesion patency (PLP): Interval after the index intervention until the next re‐
intervention at the original treatment site or until the extremity was abandoned for permanent access.
• 90 day follow‐up angiogram required for quantitative analysis by Core lab.
Results
• 6 month f/u (101 PTA alone & 99 FLUENCY® PLUS)
• Technical Success was 98.2% for FLUENCY ®PLUS
• ACPP 3.0% for PTA vs. 16.67% for stent graft group (p<0.001)
• Post Intervention Lesion Patency (PLP) 10.4% for PTA vs. 65.2% for stent grafts at 6 mos (p<0.001)
• Binary restenosis rate 74.8% for PTA and 19.3% for stent graft group at 90 days
Results Grafts & Fistulas
• PLP at 6 Mos. By Strata:
• AVG: 58% Fluency vs. 5% PTA (p<0.001)
• AV Fistula: 72% Fluency vs 15% PTA (p<0.001)
Conclusions
• Stent Grafts offer significantly better patency when compared to angioplasty alone.
• Fewer interventions over the life of the access can result in cost savings after the initial up from increase in cost.
• Stent grafts appear to offer an advantage over PTA alone when treating in‐stent restenosis of bare metal stents.
Question
• Do all anastomotic stenoses need stent grafts.
• What is the patency with PTA alone when it is the first intervention
• Will stent grafts renew interest in AVGs for patients who have no option of successful AVFs