THE DEPARTMENT OF VETERANS AFFAIRS COOPERATIVE STUDIES PROGRAM

THE DEPARTMENT OF VETERANS AFFAIRS COOPERATIVE STUDIES PROGRAM Steve Goldman, M. D. Clinical. Trials. gov number, NCT 00054847

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

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

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

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

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

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

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

Primary End Point 100 98 99% 97% 96 Radial Artery 94 Saphenous Vein 92 89% 90 89% 88 86 One-week Patency One-year Patency

Secondary Endpoints * Selective graft patency (RA vs SV) LAD: 83% vs 88% CX: 93% vs 89% RCA: 86% vs 88% IMA: 94% vs 97% No differences (458 pts)

Secondary Endpoints Disease in grafts More high grade disease (string sign) RA - 8% vs SV - 1%, (P<0. 001) Endoscopic harvesting SV - lower N = 72 RA - no N = 18 patency 78% vs 91%, (P=0. 009) difference 100% vs 89%

Complications 8, 0% 7. 6% 7, 0% SYNTAX Serruys et al. , 6, 0% NEJM 360: 961 -972 2009 5, 0% 4, 0% 3, 0% 2, 0% 1, 0% 0, 0% 1, 0% MI 2, 0% 0, 7% Stroke Death Operative Mortality CSP 474

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

Costs

Discussion 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

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

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

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 Mc. Falls 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.

BASTA!