results from the randomized multicentre radial artery patency study (raps)
DESCRIPTION
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. - PowerPoint PPT PresentationTRANSCRIPT
The Radial Artery Patency Study Investigators
Radial Artery and Saphenous Vein Radial Artery and Saphenous Vein Patency more than 5-years Following Patency more than 5-years Following
Coronary Artery Bypass Surgery: Coronary Artery Bypass Surgery:
Results from the Results from the Randomized Multicentre Randomized Multicentre
Radial Artery Patency Radial Artery Patency Study (RAPS)Study (RAPS)
Funded by CIHR Grant: MCT 52681 Funded by CIHR Grant: MCT 52681 NCT00187356 NCT00187356
The Radial Artery Patency Study Investigators
Stephen E. Fremes MD, Saswata Deb MD, Stephen E. Fremes MD, Saswata Deb MD, Steve K. Singh MD, Randi Feder-Elituv Steve K. Singh MD, Randi Feder-Elituv BSc, Andreas Laupacis MD and Eric A. BSc, Andreas Laupacis MD and Eric A.
Cohen MD for the Radial Artery Patency Cohen MD for the Radial Artery Patency Study InvestigatorsStudy Investigators
April 4, 2001April 4, 2001
New Orleans, LANew Orleans, LA
The Radial Artery Patency Study Investigators
BackgroundBackground 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
The Radial Artery Patency Study Investigators
The Radial Artery Patency Study Investigators
Study QuestionStudy Question
Is the patency of the radial Is the patency of the radial artery superior to the artery superior to the saphenous vein at one saphenous vein at one
year?year?
The Radial Artery Patency Study Investigators
PatientsPatientsInclusion Criteria:Inclusion Criteria:
GeneralGeneral <80 years old<80 years old Isolated triple vessel Isolated triple vessel
diseasedisease LV Ejection Fraction > 35%LV Ejection Fraction > 35%
AngiographicAngiographic >70% stenosis of target >70% stenosis of target
RCA and LCXRCA and LCX RCA and LCX graftable RCA and LCX graftable
and >1.5mmand >1.5mm
Exclusion Criteria:Exclusion Criteria:
Inability to use Radial Inability to use Radial or Venous Conduit:or Venous Conduit:
Positive Allen’s Test or abnormal Positive Allen’s Test or abnormal ultrasound, vasculitis or Raynaud’s ultrasound, vasculitis or Raynaud’s
Bilateral varicose veins and/or strippingBilateral varicose veins and/or stripping
Contraindications to Contraindications to Angiography:Angiography:
Creatinine > 180 Creatinine > 180 μμmol/Lmol/L Severe PVDSevere PVD Contrast allergy dyeContrast allergy dye Geographic inaccessibilityGeographic inaccessibility
The Radial Artery Patency Study Investigators
Study Study RandomizationRandomization
RCA:RCA:RADIAL RADIAL
OrOrSVGSVG
LCX:LCX:SVGSVG
ororRADIALRADIAL
Randomization was performedRandomization was performed withinwithin patients not patients not between between patientspatients
LIMA to LADLIMA to LAD
The Radial Artery Patency Study Investigators
PRIMARY STUDY ENDPOINT:PRIMARY STUDY ENDPOINT:Graft Occlusion at 1 YearGraft Occlusion at 1 Year
Occluded = No Opacification of Distal Vessel (TIMI 0)
OR 0.56OR 0.5695% CI 0.34–0.8895% CI 0.34–0.88
Absolute Difference Absolute Difference =5.4%=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 AnalysisIntention to Treat Analysis
NEJM Nov. 25, 2004
The Radial Artery Patency Study Investigators
SECONDARY STUDY ENDPOINT:SECONDARY STUDY ENDPOINT:Functional Graft Occlusion at 1 Year 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 AnalysisIntention to Treat Analysis
NEJM Nov. 25, 2004
The Radial Artery Patency Study Investigators
Study QuestionStudy Question
Is the patency of the radial Is the patency of the radial artery superior to the artery superior to the saphenous vein > 5 saphenous vein > 5
years following surgery?years following surgery?
The Radial Artery Patency Study Investigators
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 Study Patients
The Radial Artery Patency Study Investigators
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 Study Patients
Analysis
Eligible for Analysis
The Radial Artery Patency Study Investigators
Study PatientsStudy 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 (mol/L) 92.1 + 18.2 93.6 + 22.3
The Radial Artery Patency Study Investigators
Angiographic Angiographic ResultsResults
The Radial Artery Patency Study Investigators
PRIMARY STUDY ENDPOINT:PRIMARY STUDY ENDPOINT:Functional Graft Occlusion at 5 YearsFunctional Graft Occlusion at 5 Years
TIMI 3 = Patent TIMI 0,1,2 = Occluded
OR 0.64OR 0.6495% CI 0.41-0.9895% CI 0.41-0.98
Absolute Absolute Difference =6.8%Difference =6.8%
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=234Intention to Treat Analysis, n=234
The Radial Artery Patency Study Investigators
SECONDARY STUDY ENDPOINT:SECONDARY STUDY ENDPOINT:Graft Occlusion at 5 YearsGraft Occlusion at 5 Years
Occluded = No Opacification of Distal Vessel (TIMI 0)
OR 0.50OR 0.5095% CI 0.32-0.8095% CI 0.32-0.80
Absolute Absolute Difference =8.9%Difference =8.9%
8.9
17.8
0
5
10
15
20
25
RADIAL SVG
% O
cclu
ded
Gra
fts
McNemar
p = 0.004
Intention to Treat Analysis, n=269Intention to Treat Analysis, n=269
The Radial Artery Patency Study Investigators
SECONDARY STUDY SECONDARY STUDY ENDPOINT:ENDPOINT:
Graft Stenosis >25% of TIMI 3 GraftsGraft Stenosis >25% of TIMI 3 Grafts N=164 both grafts patentN=164 both grafts patent
Proximal Anastomosis:Proximal Anastomosis: Radial 9.8%Radial 9.8% SVG 9.8%SVG 9.8%
Graft Body: Graft Body: Radial 6.7%Radial 6.7% SVG 15.2%, p=0.02, SVG 15.2%, p=0.02,
OR 0.42, 95% CI 0.18 – 0.90OR 0.42, 95% CI 0.18 – 0.90 Distal Anastomosis: Distal Anastomosis:
Radial 6.1%Radial 6.1% SVG 6.7%SVG 6.7%
The Radial Artery Patency Study Investigators
SECONDARY STUDY ENDPOINT:SECONDARY STUDY ENDPOINT:Graft Stenosis >25% or Occlusion Graft Stenosis >25% or Occlusion
Occluded = No Opacification of Distal Vessel (TIMI 0)
OR 0.58OR 0.5895% CI 0.40-0.8695% CI 0.40-0.86
Absolute Difference Absolute Difference =11.9%=11.9%
21.933.8
01020304050
RADIAL SVG
% O
cclu
ded
G
raft
s
McNemar
p = 0.004
Intention to Treat Analysis, n=269Intention to Treat Analysis, n=269
The Radial Artery Patency Study Investigators
Clinical ResultsClinical Results
The Radial Artery Patency Study Investigators
MACEMACEOutcome < 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)
The Radial Artery Patency Study Investigators
SurvivalSurvival
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
The Radial Artery Patency Study Investigators
Event-Free SurvivalEvent-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
The Radial Artery Patency Study Investigators
LimitationsLimitations The study design restricted our ability The study design restricted our ability
to evaluate the clinical consequences to evaluate the clinical consequences of radial and saphenous grafts.of radial and saphenous grafts.
The patients recruited into the study The patients recruited into the study were young, and generally low risk.were young, and generally low risk.
The Radial Artery Patency Study Investigators
Conclusions: 5 Year ResultsConclusions: 5 Year Results
Radial arteries are associated with Radial arteries are associated with reduced rates of functional and reduced rates of functional and complete graft occlusion than complete graft occlusion than saphenous veins. saphenous veins.
Radial arteries are associated with Radial arteries are associated with less graft disease than saphenous less graft disease than saphenous veins.veins.
The Radial Artery Patency Study Investigators
Clinical Trials of Radial Clinical Trials of Radial PatencyPatency
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
The Radial Artery Patency Study Investigators
Additional slides
1 year and 5 year results for patients with both studies
Actuarial survival Mace, including adjudicated outcomes
The Radial Artery Patency Study Investigators
PARTICIPATING CENTRESSUNNYBROOK HEALTH SCIENCES
CENTRETORONTO, ON
VANCOUVER GENERAL HOSPITAL
VANCOUVER, BC
Dr. Stephen Fremes Dr. Guy FradetDr. Eric Cohen Dr. Chris Buller
Randi 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