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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, NCT

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

3 I have no financial conflict of interest for this study.
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 STS data base 163,048 CABG 10,319 radial artery grafts Problem - patency radial artery grafts not clear

5 Methods Prospective randomized trial 11 VA medical centers (2003-2008)
One year angiographic patency Radial Artery (RA) vs Saphenous Vein (SV) 11 VA medical centers ( ) 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, 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) No differences
LAD: 83% vs 88% CX: 93% vs 89% RCA: 86% vs 88% No differences

11 Secondary Endpoints Disease in grafts Endoscopic harvesting
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:

13 Other Analyses On pump vs off pump Quality of life
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 The other prospective randomized study RAPS
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. Vigneshwar Kasirajan, 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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