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The Radial Artery Patency Study Investigators Radial Artery and Saphenous Vein Patency more than 5-years Following Coronary Artery Bypass Surgery: Results.

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Presentation on theme: "The Radial Artery Patency Study Investigators Radial Artery and Saphenous Vein Patency more than 5-years Following Coronary Artery Bypass Surgery: Results."— Presentation transcript:

1 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

2 The Radial Artery Patency Study Investigators 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, 2011 New Orleans, LA

3 The Radial Artery Patency Study Investigators 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 The Radial Artery Patency Study Investigators

5 Study Question Is the patency of the radial artery superior to the saphenous vein at one year?

6 The Radial Artery Patency Study Investigators Patients 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: 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

7 The Radial Artery Patency Study Investigators Study Randomization Study Randomization RCA:RADIALOrSVG LCX:SVGorRADIAL Randomization was performed within patients not between patients LIMA to LAD

8 The Radial Artery Patency Study Investigators 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% Intention to Treat Analysis, n=440 NEJM Nov. 25, 2004

9 The Radial Artery Patency Study Investigators SECONDARY STUDY ENDPOINT: Functional Graft Occlusion at 1 Year TIMI 3 = Patent TIMI 0,1,2 = Occluded Intention to Treat Analysis, n=440 NEJM Nov. 25, 2004

10 The Radial Artery Patency Study Investigators Study Question Is the patency of the radial artery superior to the saphenous vein > 5 years following surgery?

11 The Radial Artery Patency Study Investigators 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 Study Patients

12 The Radial Artery Patency Study Investigators N=501 N=483 N=369 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 7.6 years post Death 5-6 yrs, N=6 Patient Refusal, N=94 Study Patients Analysis Eligible for Analysis Alive and Participating

13 The Radial Artery Patency Study Investigators Study Patients, n=529 VariableAngiography, n=269 No Angiography, n=260 Age (yrs)60.4 + 8.061.8 + 8.7 * Age > 70 yrs (%)11.918.4 * Female (%)15.211.5 Urgent (%)34.635.4 CCS Class 3-4 (%)51.3/26.743.1/27.7 Diabetes (%)30.925.0 Vascular Disease (%)6.011.5 * Creatinine (mol/L) 92.1 + 18.293.6 + 22.3

14 The Radial Artery Patency Study Investigators Angiographic Results

15 The Radial Artery Patency Study Investigators 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, n=234

16 The Radial Artery Patency Study Investigators 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, n=269

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

18 The Radial Artery Patency Study Investigators SECONDARY STUDY ENDPOINT: Graft Stenosis >25% 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, n=269

19 The Radial Artery Patency Study Investigators Subgroup Analysis EndpointTarget VesselP valueOR95%CI 70-89%> 90% Primary (functional graft occlusion) Study20.911.7* Radial16.58.80.070.490.22-1.08 SVG25.614.60.040.500.26-0.96 Secondary (complete graft occlusion) Study17.810.5* Radial12.76.30.070.460.20-1.08 SVG19.414.50.080.570.30-1.06

20 The Radial Artery Patency Study Investigators Clinical Results

21 The Radial Artery Patency Study Investigators MACE Outcome< 30 days, n=561 31 days-1 year, n=561 > 1 year, n=529 Death4 (0.7) 52 (10.0) Cardiac Death 3 (0.5)2 (0.4)26 (4.9) Non-fatal MI55 (9.8)1 (0.2)8 (1.5) Redo CABG002 (0.4) PCI04 (0.7)22 (4.2) Composite Endpoint 59 (10.5)9 (1.2)79 (14.9)

22 The Radial Artery Patency Study Investigators Survival 5 years0.96 + 0.01 7.5 years0.91 + 0.02 10 years0.82 + 0.03

23 The Radial Artery Patency Study Investigators Event-Free Survival 5 years0.95 + 0.01 7.5 years0.90 + 0.02 10 years0.78 + 0.03

24 The Radial Artery Patency Study Investigators Cardiac Events OutcomeRadialSVGOther Graft Native Disease Angina1446 Cardiac Death3201 Non-fatal MI4324 Redo CABG1001 PCI51277 Total Patients11201218

25 The Radial Artery Patency Study Investigators 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.

26 The Radial Artery Patency Study Investigators Clinical Trials of Radial Patency  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 2 nd largest coronary, JAMA 2011  RAPCO (Australian), Single centre, 619 patients, <70 years, Radial vs FRITA to 2 nd largest coronary >70 years, Radial vs SVG to 2 nd largest coronary

27 The Radial Artery Patency Study Investigators PARTICIPATING CENTRES SUNNYBROOK HEALTH SCIENCES CENTRE TORONTO, ON VANCOUVER GENERAL HOSPITAL VANCOUVER, BC Dr. Stephen FremesDr. Guy Fradet Dr. Eric CohenDr. Chris Buller Randi ElituvRebecca Fox/Neetha Hsu LONDON HEALTH SCIENCES CENTRELONDON, ONTORONTO GENERAL HOSPITALTORONTO, ON Dr. Richard NovickDr. Terry Yau Dr. David AlmondDr. Len Schwartz Stephanie FoxKatherine Tsang/Chet Nacario LONDON HEALTH SCIENCES CENTRELONDON, ONUNIVERSITY OF ALBERTA ONEDMONTON, AB Dr. Mary Lee MyersDr. Elliot Gelfand Dr. David AlmondDr. Wayne Tymchak Mary-Ann James/Linda Herris MONTREAL HEART INSTITUTEMONTREAL, QC Dr. Raymond CartierMONTREAL GENERAL HOSPITALMONTREAL, QC Dr. Gilles CoteDr. Jean Francois Morin Carole JesinaDr. Dragatkis Sybil Germain OTTAWA HEART INSTITUTEOTTAWA, ON Dr. Frasier Rubens WINNIPEG HEALTH SCIENCES CENTRE WINNIPEG, MB Dr. Lyall HigginsonDr. Michael Raabe Sharon Finlay/Sarika NaidooDr. John Ducas Angie Munoz/Lisa Montebruno ST. MICHAEL’S HOSPITALTORONTO, ON Dr. David Latter Dr. Randy Watson Mary Keith/Rose Mokbel

28 The Radial Artery Patency Study Investigators 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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