Transcript A Randomized Trial of Radial Artery Graft vs. Saphenous Vein Grafts
Steve Goldman, M.D.
ClinicalTrials.gov number, NCT00054847
A Randomized Trial Radial Artery Graft vs. Saphenous Vein Grafts In CABG
Tucson VA Hospital
I have no financial conflict of interest for this study.
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
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
Albuquerque Ann Arbor Birmingham West Roxbury Hines Houston Little Rock Minneapolis New Orleans Richmond Tucson
Radial artery better patency
Proposed-one-year rates
92% RA
83% SV
Goldman et al, 1988-1994 CSP’s 207/297/364, 2004
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
90 88 86 84 100 98 96 94 92 99% 97% One-week Patency 89% 89% One-year Patency Radial Artery Saphenous Vein
Selective graft patency (RA vs SV)
LAD: 83% vs 88% CX: 93% vs 89% RCA: 86% vs 88%
No differences
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
8,0% 7,0% 6,0% 5,0% 4,0% 3,0% 2,0% 1,0% 0,0% 1,0% MI 2,0% Stroke 2,0% Death 0,7% Operative Mortality 7.6%
SYNTAX Serruys et al., NEJM 360:961-972 2009 CSP 474
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
$60 000 $50 000 $40 000 $30 000 $20 000 $10 000 $0 $43 476 $13 629 Radial Artery $42 197 $12 484 Saphenous Vein
Total Cost Surgical Cost P<0.01
The other prospective randomized study RAPS (Desai et.al NEJM 2004).
CSP-474 RAPS Randomized RA or SV Surgeon chose recipient vessel Both RA and SV as study grafts Randomized to recipient vessel
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
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
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.