The Radial Artery Patency Study Investigators Radial Artery and Saphenous Vein Patency more than...

The Radial Artery Patency Study Investigators

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 52681 NCT00187356


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, 2001New Orleans, LA


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


Study Question

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

year?


PatientsInclusion 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


Study Randomization

RCA:RADIAL

OrSVG

LCX:SVG

orRADIAL

Randomization was performed within patients not between patients

LIMA to LAD


PRIMARY STUDY ENDPOINT:Graft Occlusion at 1 Year

Occluded = No Opacification of Distal Vessel (TIMI 0)

OR 0.5695% CI 0.34–0.88

Absolute Difference =5.4%

8.213.6

0

5

10

15

20

25

RADIALS VEINS

% O

cclu

ded

Gra

fts

McNemar

p = 0.009

Intention to Treat Analysis

NEJM Nov. 25, 2004


SECONDARY STUDY ENDPOINT:Functional Graft Occlusion at 1 Year

TIMI 3 = Patent TIMI 0,1,2 = Occluded

12.3 14.3

0

5

10

15

20

25

RADIAL SVG

% O

cclu

ded

Gra

fts

McNemar

p = 0.37

Intention to Treat Analysis

NEJM Nov. 25, 2004


Study Question

Is the patency of the radial artery superior to the saphenous vein > 5

years following surgery?


Randomized N=561

13 centres

N=52911 centres

N=5019 centres

2 centres, N=32

2 centres, N=20Deaths < 1 yr, N=8

Clinical Follow-Up

Enrollment

Angiographic Follow-

Up

Study Patients


EligibleN=501

N=483

N=369

Protocol Violations, N=162 Study Grafts Occluded,

N=4

Death 1-5 yrs, N=10New Med Exclusions, N= 64

Distance to Centre, N=9 LTFU, N=31

N=269

Death 5-6 yrs, N=6Patient Refusal, N=94

Study Patients

Analysis

Eligible for Analysis


Study Patients

Variable Angiography, n=269

No Angiography, n=260

Age (yrs) 60.4 + 8.0 61.8 + 8.7 *

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) 92.1 + 18.2 93.6 + 22.3


Angiographic Results


PRIMARY STUDY ENDPOINT:Functional Graft Occlusion at 5 Years

TIMI 3 = Patent TIMI 0,1,2 = Occluded

OR 0.6495% CI 0.41-0.98


12.0

18.8

0

5

10

15

20

25

RADIAL SVG

% O

cclu

ded

Gra

fts

McNemar

p = 0.05

Intention to Treat Analysis, n=234


SECONDARY STUDY ENDPOINT:Graft Occlusion at 5 Years


OR 0.5095% CI 0.32-0.80


8.9

17.8

0

5

10

15

20

25

RADIAL SVG

% O

cclu

ded

Gra

fts

McNemar

p = 0.004



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%


SECONDARY STUDY ENDPOINT:Graft Stenosis >25% or Occlusion


OR 0.5895% CI 0.40-0.86


21.933.8

01020304050

RADIAL SVG

% O

cclu

ded

G

raft

s

McNemar

p = 0.004



Clinical Results


MACEOutcome < 30 days,

n=56131 days-1 year,

n=561> 1 year, n=529

Death 4 (0.7) 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 0 0 2 (0.4)

PCI 0 4 (0.7) 24 (4.5)

Composite Endpoint

59 (10.5) 9 (1.2) 79 (14.9)


Survival

0.0

0.1

0.2

0.3

0.4

0.5

0.6

0.7

0.8

0.9

1.0

0 2 4 6 8 10 12 14TIME (YRS)

Su

rviv

al

5 years 0.96 + 0.01

7.5 years 0.91 + 0.02

10 years 0.82 + 0.03


Event-Free Survival

0.0

0.1

0.2

0.3

0.4

0.5

0.6

0.7

0.8

0.9

1.0

0 2 4 6 8 10 12 14TIME (YRS)

Su

rviv

al

5 years 0.95 + 0.01

7.5 years 0.90 + 0.02

10 years 0.78 + 0.03


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.


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.


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, <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


Additional slides

1 year and 5 year results for patients with both studies

Actuarial survival Mace, including adjudicated outcomes


PARTICIPATING CENTRESSUNNYBROOK HEALTH SCIENCES

CENTRETORONTO, ON

VANCOUVER GENERAL HOSPITAL

VANCOUVER, BC

Dr. Stephen Fremes Dr. Guy FradetDr. Eric Cohen Dr. Chris BullerRandi Elituv Rebecca Fox/Neetha Hsu

LONDON HEALTH SCIENCES CENTRE LONDON, ON TORONTO GENERAL HOSPITAL TORONTO, ONDr. Richard Novick Dr. Terry YauDr. David Almond Dr. Len Schwartz

Stephanie Fox Katherine Tsang/Chet Nacario

LONDON HEALTH SCIENCES CENTRE LONDON, ON UNIVERSITY OF ALBERTA ON EDMONTON, ABDr. Mary Lee Myers Dr. Elliot GelfandDr. David Almond Dr. Wayne Tymchak

Mary-Ann James/Linda HerrisMONTREAL HEART INSTITUTE MONTREAL, QC

Dr. Raymond Cartier MONTREAL GENERAL HOSPITAL MONTREAL, QCDr. Gilles Cote Dr. Jean Francois MorinCarole Jesina Dr. Dragatkis

Sybil GermainOTTAWA HEART INSTITUTE OTTAWA, ON

Dr. Frasier RubensWINNIPEG HEALTH SCIENCES

CENTREWINNIPEG, MB

Dr. Lyall Higginson Dr. Michael RaabeSharon Finlay/Sarika Naidoo Dr. John Ducas

Angie Munoz/Lisa MontebrunoST. MICHAEL’S HOSPITAL TORONTO, ON

Dr. David LatterDr. Randy Watson

Mary Keith/Rose Mokbel

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