1. Funded by CIHR Grant: MCT 52681 NCT00187356
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)
Funded by CIHR Grant: MCT NCT

2. Stephen E. Fremes MD, Saswata Deb MD, Steve K
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

3. 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

4. We compared the patency of radial and saphenous veins in a randomized trial, the RAPS study. This was a multicentre study that involved patients from 12 Canadian centres and 1 from New Zealand.

5. Study Question
Is the patency of the radial artery superior to the saphenous vein at one year?
The study question was to determine if the angiographic patency of the radial artery exceeded that of the saphenous vein graft at one year following surgery.

6. Patients General Inability to use Radial or Venous Conduit:
Inclusion Criteria:
General
<80 years old
Isolated triple vessel disease
LV Ejection Fraction > 35%
Angiographic
>70% stenosis of target RCA and LCX
RCA and LCX graftable and >1.5mm
Exclusion Criteria:
Inability to use Radial or Venous Conduit:
Positive Allen’s Test or abnormal ultrasound, vasculitis or Raynaud’s
Bilateral varicose veins and/or stripping
Contraindications to Angiography:
Creatinine > 180 μmol/L
Severe PVD
Contrast allergy dye
Geographic inaccessibility
Patients enroled into the study had to have lesions in the RCA and Circumflex territories at least 70% in severity.
Exclusion criteria included reasons that would have precluded research angiography on ethical reasons.

7. Randomization was performed within patients not between patients
Study Randomization
RCA:
RADIAL Or
SVG
LCX:
SVG or
RADIAL
Patients were randomized to receive either a radial artery to the RCA and saphenous vein to the Circumflex territory or a radial artery to the RCA territory and a saphenous vein to the Circumflex region.
Randomization was performed within each patient rather than between patients.
The anterior wall was grafted with a mammary artery.
LIMA to LAD
Randomization was performed within patients not between patients

8. PRIMARY STUDY ENDPOINT:
Graft Occlusion at 1 Year
Occluded = No Opacification of Distal Vessel (TIMI 0)
OR 0.56
95% CI 0.34–0.88
Absolute Difference =5.4%
Change to OR!
Intention to Treat Analysis
NEJM Nov. 25, 2004

9. 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

10. Study Question
Is the patency of the radial artery superior to the saphenous vein > 5 years following surgery?
The study question was to determine if the angiographic patency of the radial artery exceeded that of the saphenous vein graft more than 5 years following surgery.

11. Angiographic Follow-Up
Study Patients
Randomized N=561
13 centres
N=529
11 centres
N=501
9 centres
2 centres, N=32
2 centres, N=20
Deaths < 1 yr, N=8
Clinical Follow-Up
Enrollment
Angiographic Follow-Up

12. Study Patients Analysis Eligible for Analysis Eligible N=501 N=483
Protocol Violations, N=16
2 Study Grafts Occluded, N=4
Death 1-5 yrs, N=10
New Med Exclusions, N= 64 Distance to Centre, N=9 LTFU, N=31
N=269
Death 5-6 yrs, N=6
Patient Refusal, N=94
Eligible for Analysis
Analysis

13. Study Patients Variable Angiography, n=269 No Angiography, n=260
Age (yrs) *
Age > 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)

14. Angiographic Results

15. PRIMARY STUDY ENDPOINT:
Functional Graft Occlusion at 5 Years
TIMI 3 = Patent TIMI 0,1,2 = Occluded
OR 0.64
95% CI
Absolute Difference =6.8%
Intention to Treat Analysis, n=234

16. SECONDARY STUDY ENDPOINT:
Graft Occlusion at 5 Years
Occluded = No Opacification of Distal Vessel (TIMI 0)
OR 0.50
95% CI
Absolute Difference =8.9%
Corresponding values for lima – lad grafts were 9.3% and 6.7% for functional and complete occlusion respectively.
Intention to Treat Analysis, n=269

17. SECONDARY STUDY ENDPOINT: Graft Stenosis >25% of TIMI 3 Grafts N=164 both grafts patent
Proximal Anastomosis:
Radial 9.8%
SVG 9.8%
Graft Body:
Radial 6.7%
SVG 15.2%, p=0.02, OR 0.42, 95% CI 0.18 – 0.90
Distal Anastomosis:
Radial 6.1%
SVG 6.7%

18. SECONDARY STUDY ENDPOINT:
Graft Stenosis >25% or Occlusion
Occluded = No Opacification of Distal Vessel (TIMI 0)
OR 0.58
95% CI
Absolute Difference =11.9%
Intention to Treat Analysis, n=269

19. Clinical Results

20. MACE Outcome < 30 days, n=561 31 days-1 year, n=561
Death
4 (0.7)
52 (10.0)
Cardiac Death
3 (0.5)
2 (0.4)
26 (4.9)
Non-fatal MI
55 (9.8)
1 (0.2)
8 (1.5
Redo CABG
PCI
24 (4.5)
Composite Endpoint
59 (10.5)
9 (1.2)
79 (14.9)

21. Survival 5 years 0.96 + 0.01 7.5 years 0.91 + 0.02 10 years
0.1
0.2
0.3
0.4
0.5
0.6
0.7
0.8
0.9
1.0 2 4 6 8 10 12 14
TIME (YRS)
Survival
5 years
7.5 years
10 years

22. Event-Free Survival 5 years 0.95 + 0.01 7.5 years 0.90 + 0.02 10 years
0.1
0.2
0.3
0.4
0.5
0.6
0.7
0.8
0.9
1.0 2 4 6 8 10 12 14
TIME (YRS)
Survival
5 years
7.5 years
10 years

23. 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.

24. 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.

25. 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:
VA Trial, Multi-centre, 757 patients, Radial vs SVG to 2nd largest coronary, JAMA 2011
RAPCO (Australian), Single centre, 619 patients,
<70 years, Radial vs free RITA to 2nd largest coronary
>70 years, Radial vs SVG to 2nd largest coronary
4 manuscripts published concerning “interim” results

26. Additional slides
1 year and 5 year results for patients with both studies
Actuarial survival
Mace, including adjudicated outcomes

27. PARTICIPATING CENTRES
SUNNYBROOK HEALTH SCIENCES CENTRE
TORONTO, ON
VANCOUVER GENERAL HOSPITAL
VANCOUVER, BC
Dr. Stephen Fremes
Dr. Guy Fradet
Dr. Eric Cohen
Dr. Chris Buller
Randi Elituv
Rebecca Fox/Neetha Hsu
LONDON HEALTH SCIENCES CENTRE
LONDON, ON
TORONTO GENERAL HOSPITAL
Dr. Richard Novick
Dr. Terry Yau
Dr. David Almond
Dr. Len Schwartz
Stephanie Fox
Katherine Tsang/Chet Nacario
UNIVERSITY OF ALBERTA ON
EDMONTON, AB
Dr. Mary Lee Myers
Dr. Elliot Gelfand
Dr. Wayne Tymchak
Mary-Ann James/Linda Herris
MONTREAL HEART INSTITUTE
MONTREAL, QC
Dr. Raymond Cartier
MONTREAL GENERAL HOSPITAL
Dr. Gilles Cote
Dr. Jean Francois Morin
Carole Jesina
Dr. Dragatkis
Sybil Germain
OTTAWA HEART INSTITUTE
OTTAWA, ON
Dr. Frasier Rubens
WINNIPEG HEALTH SCIENCES CENTRE
WINNIPEG, MB
Dr. Lyall Higginson
Dr. Michael Raabe
Sharon Finlay/Sarika Naidoo
Dr. John Ducas
Angie Munoz/Lisa Montebruno
ST. MICHAEL’S HOSPITAL
Dr. David Latter
Dr. Randy Watson
Mary Keith/Rose Mokbel