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Abstract: FR-OR094

Arteriovenous Fistula Maturation Outcomes Following Local Perianastomotic Delivery of Sirolimus

Session Information

Category: Dialysis

  • 704 Dialysis: Vascular Access

Authors

  • Iyer, Sriram, Vascular Therapies, Cresskill, New Jersey, United States
  • DeVita, Maria V., Lenox Hill Hospital- Northwell Health System, New York, New York, United States
  • Kopyt, Nelson P., Lehigh Valley Hospital, Bethlehem, Pennsylvania, United States
  • Gandhi, Nirav, Southern California Kidney Consultants, Anaheim, California, United States
  • Atray, Naveen K., Capitol Nephrology, Sacramento, California, United States
  • Wooldridge, Thomas D., Nephrology & Hypertension Associates, LTD, Tupelo, Mississippi, United States
  • Lee, Joseph J., Nephrology Associates Medical Group, Riverside, California, United States
  • Hendon, Kendra S., Knoxville Kidney Center, Knoxville, Tennessee, United States
  • Paulson, William D., Augusta University, Augusta, Georgia, United States
  • Khawar, Osman S., Balboa Nephrology Medical Group, Escondido, California, United States
  • Lynn, Robert I., Albert Einstein College of Medicine, Bronx, New York, United States
  • Roy-Chaudhury, Prabir, University of Arizona, Tucson, Arizona, United States

Group or Team Name

  • On behalf of ACCESS Study Investigators.
Background

Arteriovenous Fistula (AVF) creation and maturation have many obstacles limiting successful cannulation in a timely manner. Time to first cannulation and rates of AVF suitability for dialysis remain unacceptable; 80% of ESRD patients initiate dialysis with a catheter; many require use for ≥90 days. The use of locally delivered perianastomotic sirolimus may help maturation of AVF in a predictable timeframe by attenuating the development of neointimal hyperplasia. We now report the combined findings of our single arm Phase 2 trial and open label portion of our ongoing US Phase 3 multicenter, randomized controlled clinical trial (NCT02513303).

Methods

All patients underwent creation of an AVF for hemodialysis. The phase 2 trial included 30 patients. The open label phase 3 trial, to date, includes 22 patients. For all patients, after creation of a successful end-to-side vascular anastomosis, sirolimus–eluting collagen membranes (Drug product; Vascular Therapies, Cresskill, NJ) were implanted around the anastomosis and outflow vein. Time to First dialysis (TTFD) defined as use with 2 needles and 300 mL/min flow (2N/300) for 3 consecutive sessions, proportion of AVF in use with 2N on or before day 90, Fistula Suitability at 6 months (FSD6) defined as fistula use (2N/300) for two-thirds of the dialysis sessions during a 30 day period commencing on day 150, and thrombosis/abandonment rates are reported.

Results

Fifty two patients, 51 with ESRD on dialysis and 1 with CKD, were enrolled (Male 67%, mean, age 56±17 y, diabetic 42%; radiocephalic AVF 65%). There were no product related serious adverse events. By 6 months, 9 AVF were abandoned: 7 thrombosed (6 within 2 wks), 1 for central vein occlusion and 1 for pseudoaneurysm. Abandoned AVF are included in the calculations shown in Table. Median days (Q1, Q3) to first dialysis was 49 (39, 67).

Conclusion


1. In comparison to historical controls local delivery of sirolimus resulted in improved AVF outcomes
2. 73% of sirolimus treated AVF were mature by 3 months (HFM: 25%)
3. Suitability for Dialysis at 6 months was 82% (DAC: 40%)

 Proportion of AVF in use with 2 needles on or before day 90Fistula Suitability for Dialysis at 6 Months
No. eligible for evaluation5150
Outcome37/51 (73%)41/50 (82%)

Funding

  • Commercial Support