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+ The Department of Veterans Affairs Cooperative Studies Program

+ The Department of Veterans Affairs Cooperative Studies Program. Steve Goldman, M.D. ClinicalTrials.gov number, NCT00054847. A Randomized Trial Radial Artery Graft vs. Saphenous Vein Grafts In CABG . Tucson VA Hospital. Disclosure. I have no financial conflict of interest for

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+ The Department of Veterans Affairs Cooperative Studies Program

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  1. +The Department of Veterans Affairs Cooperative Studies Program Steve Goldman, M.D. ClinicalTrials.gov number, NCT00054847

  2. A Randomized Trial Radial Artery Graft vs. Saphenous Vein Grafts In CABG Tucson VA Hospital

  3. Disclosure I have no financial conflict of interest for this study.

  4. Background • Arterial grafts - better conduits than veins – LIMA • Other arterial grafts • Right internal/free internal mammary, gastroepiploic, splenic • Radial artery - easiest to harvest, most popular • 2008 - STS data base • 163,048 CABG • 10,319 radial artery grafts • Problem - patency radial artery grafts not clear

  5. Methods • Prospective randomized trial • One year angiographic patency Radial Artery (RA) vs Saphenous Vein (SV) • 11 VA medical centers (2003-2008) • 733 patients randomized • RA – 366 • SV - 367 • Study graft either RA or SV

  6. CSP-474 Study Sites Albuquerque Hines New Orleans Ann Arbor Houston Richmond Birmingham Little Rock Tucson West Roxbury Minneapolis

  7. Hypothesis • Radial artery better patency • Proposed-one-year rates • 92% RA • 83% SV Goldman et al, 1988-1994 CSP’s 207/297/364, 2004

  8. Statistics • 90% power with a two-sided type I error of 5% • Expected one-year catheterization completion rate of 65% • Final enrollment • 733 patients, originally planned 874 • One-year catheterization completion rate (73%) • Higher than expected • Post hoc power 89% to detect 92% RA vs 83% SV

  9. Primary End Point

  10. Secondary Endpoints • Selective graft patency (RA vs SV) • LAD: 83% vs 88% • CX: 93% vs 89% • RCA: 86% vs 88% • No differences

  11. Secondary Endpoints • Disease in grafts • More high grade disease (string sign) • RA - 8% vs SV - 1%, (P<0.001) • Endoscopic harvesting • SV - lower patency 78% vs 91%, (P=0.009) • N = 72 • RA - no difference 100% vs 89% • N = 18

  12. Complications 7.6% SYNTAX Serruys et al., NEJM 360:961-972 2009

  13. Other Analyses • On pump vs off pump • RA - no difference patency (89% vs 89%) • SV - higher patency on pump (90% vs 78%) • Off pump numbers small RA n=41 vs SV n=48 • Quality of life • No difference at 3 months or 12 months

  14. Costs

  15. Discussion The other prospective randomized study RAPS (Desai et.al NEJM 2004). CSP-474 • Randomized RA or SV • Surgeon chose recipient vessel RAPS • Both RA and SV as study grafts • Randomized to recipient vessel

  16. Discussion Cont. CSP-474 • One year patency no difference • RA – 89% vs SV – 89% • Best recipient vessel was study vessel • We can define: • Patient characteristics • Isolate complications • One week cath/monitor disease progression RAPS • One year patency, RA better • RA - 92% vs SV - 86% • Fewer patients required • Cannot separate complications

  17. Conclusion • No difference in radial artery graft vs saphenous vein graft at one year • Our study group funded by VA Cooperative Studies Program for five year angiographic follow up

  18. CSP 474 Study Group • Gulshan Sethi, M.D., • William Holman, M.D. • Kelvin Lee, Ph.D. • Stephen Fremes, M.D. • Hoang Thai, M.D. • Todd Wagner Ph.D. • Yajie Wang, M.S. • Lori Planting, B.A. • Meredith Miller, M.A. • Yvette Rodriguez, R.N. • Elizabeth Juneman, M.D. • Douglas Morrison, M.D. • Mary Kaye Pierce, N.P. • Sandra Kreamer R.N. • Mei-Chiung Shih, Ph.D. • Edward McFalls M.D. • Herb Ward, M.D. • Rose Kelly, M.D. • Birger Rhenman, M.D. • Gareth Tobler, M.D. • Faisal G. Bakaeen, M.D. • Mohammed Moursi, M.D. • Michael Crittenden, M.D. • VigneshwarKasirajan, M.D. • Claire Duvernoy, M.D. • Stewart Pett, M.D. • Michelle Ratliff, M.D. • Anand Irimpen, M.D. • William Gunnar, M.D. • Donald Thomas, M.D. • Thomas Moritz, M.S. • Domenic Reda, Ph.D. • Lynn Harrison, M.D.

  19. BASTA!

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