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

.

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