The Department of Veterans Affairs Cooperative Studies Program

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The Department of Veterans Affairs
Cooperative Studies Program

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

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

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

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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

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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

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CSP-474 Study Sites












Albuquerque Hines New Orleans Ann
Arbor Houston Richmond Birmingham Little
Rock Tucson West Roxbury Minneapolis
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Hypothesis

• Radial artery better patency
• Proposed-one-year rates
• 92 RA
• 83 SV

Goldman et al, 1988-1994 CSPs
207/297/364, 2004
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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

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Primary End Point
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Secondary Endpoints

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

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Secondary Endpoints

• Disease in grafts
• More high grade disease (string sign)
• RA - 8 vs SV - 1, (Plt0.001)
• Endoscopic harvesting
• SV - lower patency 78 vs 91, (P0.009)
• N 72
• RA - no difference 100 vs 89
• N 18

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Complications
7.6 SYNTAX Serruys et al., NEJM 360961-972
2009
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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 n41 vs SV n48
• Quality of life
• No difference at 3 months or 12 months

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

• CSP-474
• Randomized RA or SV
• Surgeon chose recipient vessel

• RAPS
• Both RA and SV as study grafts
• Randomized to recipient vessel

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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

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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

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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 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.

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BASTA!