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

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

NCT00054847NCT00054847

A Randomized Trial Radial A Randomized Trial Radial Artery Graft vs. Saphenous Artery Graft vs. Saphenous

Vein Grafts In CABG Vein Grafts In CABG

Tucson VA Tucson VA HospitalHospital

I have no financial conflict of interest for this study.

Arterial grafts - better conduits than veins – LIMAArterial grafts - better conduits than veins – LIMA

Other arterial graftsOther arterial grafts Right internal/free internal mammary, Right internal/free internal mammary,

gastroepiploic, splenicgastroepiploic, splenic Radial artery - easiest to harvest, most popularRadial artery - easiest to harvest, most popular

2008 - STS data base 2008 - STS data base 163,048 CABG163,048 CABG 10,319 radial artery grafts10,319 radial artery grafts

Problem - patency radial artery grafts not clearProblem - patency radial artery grafts not clear

Prospective randomized trialProspective randomized trial One year angiographic patency Radial Artery One year angiographic patency Radial Artery

(RA) vs Saphenous Vein (SV)(RA) vs Saphenous Vein (SV)

11 VA medical centers (2003-2008)11 VA medical centers (2003-2008) 733 patients randomized733 patients randomized

RA – 366RA – 366

SV - 367SV - 367

Study graft either RA or SVStudy graft either RA or SV

Albuquerque Hines New OrleansAnn Arbor HoustonRichmondBirmingham Little Rock TucsonWest Roxbury Minneapolis

Radial artery better patency Radial artery better patency

Proposed-one-year ratesProposed-one-year rates 92% RA92% RA 83% SV83% SV

Goldman et al, 1988-1994Goldman et al, 1988-1994 CSP’s 207/297/364, 2004 CSP’s 207/297/364, 2004

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 Expected one-year catheterization completion

rate of 65%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 expectedHigher than expected Post hoc power 89% to detect 92% RA vs 83% Post hoc power 89% to detect 92% RA vs 83%

SVSV

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

Disease in graftsDisease in grafts More high grade disease (string sign)More high grade disease (string sign) RA - 8% vs SV - 1%, RA - 8% vs SV - 1%, (P<0.001)(P<0.001)

Endoscopic harvestingEndoscopic harvesting SV - lower patency 78% vs 91%, (P=0.009)SV - lower patency 78% vs 91%, (P=0.009)

N = 72N = 72 RA - no difference 100% vs 89%RA - no difference 100% vs 89%

N = 18N = 18

7.6%

SYNTAX Serruys et al.,NEJM 360:961-972

2009

On pump vs off pumpOn 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 lifeQuality of life No difference at 3 months or 12 monthsNo difference at 3 months or 12 months

CSP-474CSP-474

Randomized RA or Randomized RA or SVSV

Surgeon chose Surgeon chose recipient vesselrecipient vessel

RAPSRAPS

Both RA and SV as Both RA and SV as study grafts study grafts

Randomized to Randomized to recipient vesselrecipient vessel

The other prospective randomized study RAPS The other prospective randomized study RAPS (Desai et.al NEJM 2004).(Desai et.al NEJM 2004).

CSP-474CSP-474 One year patency no One year patency no

difference difference RA – 89% vs SV – 89%RA – 89% vs SV – 89%

Best recipient vessel Best recipient vessel was study vesselwas study vessel

We can define: We can define: Patient characteristicsPatient characteristics Isolate complications Isolate complications

One week One week cath/monitor disease cath/monitor disease progressionprogression

RAPSRAPS One year patency, One year patency,

RA betterRA better RA - 92% vs SV - 86%RA - 92% vs SV - 86%

Fewer patients Fewer patients requiredrequired

Cannot separate Cannot separate complicationscomplications

No difference in radial artery graft vs No difference in radial artery graft vs saphenous vein graft at one yearsaphenous vein graft at one year

Our study group funded by VA Our study group funded by VA Cooperative Studies Program for five year Cooperative Studies Program for five year angiographic follow up angiographic follow up

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.DMei-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.