Radial Artery and Saphenous Vein Patency more than 5-years Following Coronary Artery Bypass Surgery:

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Radial Artery and Saphenous Vein Patency more
than 5-years Following Coronary Artery Bypass
Surgery

• Results from the Randomized Multicentre Radial
  Artery Patency Study (RAPS)

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Stephen E. Fremes MD, Saswata Deb MD, Steve K.
Singh MD, Randi Feder-Elituv BSc, Andreas
Laupacis MD and Eric A. Cohen MD for the Radial
Artery Patency Study Investigators

• April 4, 2001
• New Orleans, LA

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Background

• Graft patency is a key determinant of long term
  outcome following coronary artery bypass surgery
  (CABG)
• The internal thoracic artery provides better
  long-term patency than the saphenous vein for
  CABG, prompting surgeons to consider additional
  arterial grafts, including the radial artery

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(No Transcript)
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Study Question

• Is the patency of the radial artery superior to
  the saphenous vein at one year?

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Patients

• Inclusion Criteria
• General
• lt80 years old
• Isolated triple vessel disease
• LV Ejection Fraction gt 35
• Angiographic
• gt70 stenosis of target RCA and LCX
• RCA and LCX graftable and gt1.5mm

• Exclusion Criteria
• Inability to use Radial or Venous Conduit
• Positive Allens Test or abnormal ultrasound,
  vasculitis or Raynauds
• Bilateral varicose veins and/or stripping
• Contraindications to Angiography
• Creatinine gt 180 µmol/L
• Severe PVD
• Contrast allergy dye
• Geographic inaccessibility

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Study Randomization
LCX SVG or RADIAL
RCA RADIAL Or SVG
LIMA to LAD
Randomization was performed within patients not
between patients
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PRIMARY STUDY ENDPOINT Graft Occlusion at 1
Year Occluded No Opacification of Distal Vessel
(TIMI 0)

Relative Risk Reduction 40 Absolute
Difference 5.4
Intention to Treat Analysis
NEJM Nov. 25, 2004
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SECONDARY STUDY ENDPOINT Functional Graft
Occlusion at 1 Year TIMI 3 Patent TIMI
0,1,2 Occluded

Intention to Treat Analysis
NEJM Nov. 25, 2004
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Non-Occlusive Graft Stenosis on Angiography
End Point Radial Artery Saphenous Vein P Value
Proximal Anastomosis 75/350 grafts 21.4 39/350 grafts 11.1 lt0.001
Graft Body 20/350 grafts 5.7 43/350 grafts 12.3 0.003
Distal Anastomosis 49/350 grafts 14.0 62/350 grafts 17.7 0.15

Nov. 25, 20
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Study Question

• Is the patency of the radial artery superior to
  the saphenous vein gt 5 years following surgery?

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Study Patients
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Study Patients
Eligible for Analysis
Analysis
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Patients
Variable Angiography, n269 No Angiography, n260
Age (yrs) 60.4 8.0 61.8 8.7
Age gt 70 yrs () 11.9 18.4
Female () 15.2 11.5
Urgent () 34.6 35.4
CCS Class 3-4 () 51.3/26.7 43.1/27.7
Diabetes () 30.9 25.0
Hypertension () 45.0 53.5
Vascular Disease () 6.0 11.5
Creatinine (mmol/L) 92.1 18.2 93.6 22.3
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PRIMARY STUDY ENDPOINT Functional Graft
Occlusion at 5 Years TIMI 3 Patent TIMI
0,1,2 Occluded

OR 0.64 95 CI 0.41-0.98 Absolute Difference
6.8
Intention to Treat Analysis
NEJM Nov. 25, 2004
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SECONDARY STUDY ENDPOINT Graft Occlusion at 5
Years Occluded No Opacification of Distal
Vessel (TIMI 0)

OR 0.50 95 CI 0.32-0.80 Absolute Difference
8.9
Intention to Treat Analysis
NEJM Nov. 25, 2004
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SECONDARY STUDY ENDPOINTGraft Stenosis gt25 of
TIMI 3 Grafts N164 both grafts patent

• Proximal Anastomosis
• Radial 9.8
• SVG 9.8
• Graft Body
• Radial 6.7
• SVG 15.2,
  p0.02, OR 0.42, 95 CI 0.18 0.90
• Distal Anastomosis
• Radial 6.1
• SVG 6.7

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SECONDARY STUDY ENDPOINT Graft Stenosis gt25 or
Occlusion Occluded No Opacification of Distal
Vessel (TIMI 0)

OR 0.58 95 CI 0.40-0.86 Absolute Difference
11.9
Intention to Treat Analysis
NEJM Nov. 25, 2004
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Limitations

• The study design restricted our ability to
  evaluate the clinical consequences of radial and
  saphenous grafts.
• The patients recruited into the study were young,
  and generally low risk.

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Conclusions 5 Year Results

• Radial arteries are associated with reduced rates
  of functional and complete graft occlusion than
  saphenous veins.
• Radial arteries are associated with less graft
  disease than saphenous veins.

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Clinical Trials of Radial Patency

• RAPS, Multi-centre, 561 patients, within-patient
  randomization, Radial vs SVG to RCA or Cx, NEJM
  2004
• ISRS (Italy) Single centre, 60 ISRS patients and
  60 controls, RA, RITA or SVG to OM1 Circulation
  2005 112(supp I)I-265-9
• RSVP (UK) Single centre, 142 patients, Radial vs
  SVG to Cx, Circulation 2008 117 2859 - 2864
• VA Trial, Multi-centre, 757 patients, Radial vs
  SVG to 2nd largest coronary, JAMA 2011
• RAPCO (Australian), Single centre, 619 patients,
• lt70 years, Radial vs free RITA to 2nd largest
  coronary
• gt70 years, Radial vs SVG to 2nd largest coronary
• 4 manuscripts published concerning interim
  results

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Clinical Trials of Radial Patency

• RAPS, Multi-centre, 561 patients, within-patient
  randomization, Radial vs SVG to RCA or Cx, NEJM
  2004
• ISRS (Italy) Single centre, 60 ISRS patients and
  60 controls, RA, RITA or SVG to OM1 Circulation
  2005 112(supp I)I-265-9
• RSVP (UK), Single-centre, 142 patients, Radial vs
  SVG to Cx, Circulation 2008 117 2859 - 2864
• VA Trial, Multi-centre, 757 patients, Radial vs
  SVG to 2nd largest coronary, JAMA 2011
• RAPCO (Australian), Single centre, 619 patients,
• lt70 years, Radial vs free RITA to 2nd largest
  coronary
• gt70 years, Radial vs SVG to 2nd largest coronary
• 4 manuscripts published concerning interim
  results

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Additional slides

• 1 year and 5 year results for patients with both
  studies
• Actuarial survival
• Mace, including adjudicated outcomes
• Slide including all of the participants