RENOVA: A Multicenter, Randomized, Controlled Clinical Study of an Endovascular Stent Graft vs. PTA: 12-Month Interim Results *On Behalf of the RENOVA.

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Presentation transcript:

RENOVA: A Multicenter, Randomized, Controlled Clinical Study of an Endovascular Stent Graft vs. PTA: 12-Month Interim Results *On Behalf of the RENOVA Investigators Ziv J Haskal, MD* FSIR FAHA FACR FCIRSE University of Maryland School of Medicine Baltimore, Maryland

RENOVA Investigators and Sites

Impact HD patients from 1999–2004 CPM data with Medicare as primary payor & vascular access data. ITT model. Vascular access type in use in last 3 months of year prior to cost year. U.S. Hemodialysis patients: 2004: 330,000 patients 2010: 435,600 patients

The Issue: Venous Anastomotic/ Outflow Stenoses Transition from a non-compliant graft to compliant vein (at anastomosis):  marked turbulence, low shear stress  neointimal hyperplasia

PTA- Balloon Angioplasty Pre PTA Post PTA 3 mos Post PTA Randy Cooper, MD Southwest Kidney Institute DAC, Phoenix 5 invasive balloon procedures in 9 months!

Tissue just grows right through them Bare (“Uncovered) stents are not the answer Restenosis after PTA In-stent restenosis

N Engl J Med 2010;362: Stent GraftPTA Anatomic Success (<30% residual stenosis) 94%73% 6 mo Binary Restenosis (>50%) 27.63%77.61%

Diagram of Flared v Straight Configurations flared straight flaredstraight turbulence

N = 114 Follow-Up Ongoing PTA = 55 F LAIR = 59 N = 114 Follow-Up Ongoing PTA = 55 F LAIR = 59 N = 270 Treated PTA = 132 F LAIR = 138 N = 270 Treated PTA = 132 F LAIR = 138 Patient Disposition at 12 Months N = 66 Discontinued Early PTA = 31 F LAIR = 35  Lost to Follow Up (PTA = 1 F LAIR = 2)  Withdrew Consent (PTA = 0 F LAIR = 1)  Death (PTA = 30 F LAIR = 32) N = 66 Discontinued Early PTA = 31 F LAIR = 35  Lost to Follow Up (PTA = 1 F LAIR = 2)  Withdrew Consent (PTA = 0 F LAIR = 1)  Death (PTA = 30 F LAIR = 32) N = 90 Completed Study PTA = 46 F LAIR = 44 N = 90 Completed Study PTA = 46 F LAIR = 44 N = 270 Enrolled PTA = 132 F LAIR = 138 N = 270 Enrolled PTA = 132 F LAIR = 138 N = 523 Screened N = 523 Screened

12-Month Reinterventions

12-Month IPF (QOL Surrogate) P=0.008 p-value is from a Blackwelder t-test testing non-inferiority of the FLAIR ® group to that of PTA.

12-Month ACPP P=0.005

12-Month TAPP P < 0.001

Stent Graft at the Venous Anastomosis PTA 8 mm SG implant Pre T.Saad

3 Years Later : No thrombosis, only one intervention implant

Conclusions 12-Month RENOVA interim results – “Real-world” experience & assessments Sustained & significant improvement in access circuit primary patency vs. PTA – 2.3 times greater at 12-months (RENOVA) – 1.9 times greater at 6-months (Pivotal) No difference in Infection rates, nor thrombosis Use of this ePTFE stent graft remains the only current technology that demonstrates a significant patency advantage over balloon angioplasty at 6, and now 12 months. Future:…..