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Steve Goldman, M.D. ClinicalTrials.gov number, NCT00054847.

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Presentation on theme: "Steve Goldman, M.D. ClinicalTrials.gov number, NCT00054847."— Presentation transcript:

1 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 I have no financial conflict of interest for this study.

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

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

6 AlbuquerqueHinesNew Orleans Ann ArborHoustonRichmond BirminghamLittle RockTucson West RoxburyMinneapolis

7 Radial artery better patency Radial artery better patency Proposed-one-year rates Proposed-one-year rates 92% RA 92% RA 83% SV 83% SV Goldman et al, 1988-1994 CSPs 207/297/364, 2004

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

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

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

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

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

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

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

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

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

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