Radial Artery and Saphenous Vein Patency more than

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

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 NCT 00187356 The Radial Artery Patency Study Investigators

Stephen E. Fremes MD, Saswata Deb MD, Steve K. Singh MD, Randi Feder-Elituv BSc,

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 The Radial Artery Patency Study Investigators

Background o Graft patency is a key determinant of long term outcome following coronary

Background o Graft patency is a key determinant of long term outcome following coronary artery bypass surgery (CABG) o 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

The Radial Artery Patency Study Investigators

Study Question Is the patency of the radial artery superior to the saphenous vein

Study Question Is the patency of the radial artery superior to the saphenous vein at one year? The Radial Artery Patency Study Investigators

Patients Exclusion Criteria: Inclusion Criteria: General Ø Ø Ø <80 years old Isolated triple

Patients Exclusion Criteria: Inclusion Criteria: General Ø Ø Ø <80 years old Isolated triple vessel disease LV Ejection Fraction > 35% Angiographic Ø Ø >70% stenosis of target RCA and LCX graftable and >1. 5 mm Inability to use Radial or Venous Conduit: Ø Positive Allen’s Test or abnormal ultrasound, vasculitis or Raynaud’s Ø Bilateral varicose veins and/or stripping Contraindications to Angiography: Ø Ø Creatinine > 180 μmol/L Severe PVD Contrast allergy dye Geographic inaccessibility The Radial Artery Patency Study Investigators

Study Randomization LCX: SVG or RADIAL RCA: RADIAL Or SVG LIMA to LAD Randomization

Study Randomization LCX: SVG or RADIAL RCA: RADIAL Or SVG LIMA to LAD Randomization was performed within patients not between patients The Radial Artery Patency Study Investigators

PRIMARY STUDY ENDPOINT: Graft Occlusion at 1 Year Occluded = No Opacification of Distal

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 The Radial Artery Patency Study Investigators NEJM Nov. 25, 2004

SECONDARY STUDY ENDPOINT: Functional Graft Occlusion at 1 Year TIMI 3 = Patent TIMI

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

Study Question Is the patency of the radial artery superior to the saphenous vein

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

Study Patients Enrollment Randomized N=561 13 centres 2 centres, N=32 Clinical Follow -Up N=529

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

Study Patients Alive and Participating N=501 Protocol Violations, N=16 2 Study Grafts Occluded, N=483

Study Patients Alive and Participating N=501 Protocol Violations, N=16 2 Study Grafts Occluded, N=483 Death 1 -5 yrs, N=10 New Med Exclusions, N= 64 Distance to Centre, N=9 LTFU, N=31 Eligible for Analysis N=369 Analysis N=269 7. 6 years post Death 5 -6 yrs, N=6 Patient Refusal, N=94 The Radial Artery Patency Study Investigators

Study Patients, n=529 Variable Angiography, n=269 No Angiography, n=260 60. 4 + 8. 0

Study Patients, n=529 Variable Angiography, n=269 No Angiography, n=260 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 51. 3/26. 7 43. 1/27. 7 30. 9 25. 0 6. 0 11. 5 * 92. 1 + 18. 2 93. 6 + 22. 3 Age (yrs) CCS Class 3 -4 (%) Diabetes (%) Vascular Disease (%) Creatinine (mmol/L) The Radial Artery Patency Study Investigators

Angiographic Results The Radial Artery Patency Study Investigators

Angiographic Results The Radial Artery Patency Study Investigators

PRIMARY STUDY ENDPOINT: Functional Graft Occlusion at 5 Years TIMI 3 = Patent TIMI

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 The Radial Artery Patency Study Investigators

SECONDARY STUDY ENDPOINT: Graft Occlusion at 5 Years Occluded = No Opacification of Distal

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 The Radial Artery Patency Study Investigators

SECONDARY STUDY ENDPOINT: Graft Stenosis >25% of TIMI 3 Grafts N=164 both grafts patent

SECONDARY STUDY ENDPOINT: Graft Stenosis >25% of TIMI 3 Grafts N=164 both grafts patent o Proximal Anastomosis: n Radial 9. 8% n SVG 9. 8% o Graft Body: n Radial 6. 7% n SVG 15. 2%, OR 0. 42, 95% CI 0. 18 – 0. 90 o Distal Anastomosis: n Radial 6. 1% n SVG 6. 7% The Radial Artery Patency Study Investigators p=0. 02,

SECONDARY STUDY ENDPOINT: Graft Stenosis >25% or Occlusion Occluded = No Opacification of Distal

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 The Radial Artery Patency Study Investigators

Subgroup Analysis Endpoint Target Vessel 70 -89% P value OR 95%CI > 90% Primary

Subgroup Analysis Endpoint Target Vessel 70 -89% P value OR 95%CI > 90% Primary (functional graft occlusion) Study 20. 9 11. 7* Radial 16. 5 8. 8 0. 07 0. 49 0. 22 -1. 08 SVG 25. 6 14. 6 0. 04 0. 50 0. 26 -0. 96 Secondary (complete graft occlusion) Study 17. 8 10. 5* Radial 12. 7 6. 3 0. 07 0. 46 0. 20 -1. 08 SVG 19. 4 14. 5 0. 08 0. 57 0. 30 -1. 06 The Radial Artery Patency Study Investigators

Clinical Results The Radial Artery Patency Study Investigators

Clinical Results The Radial Artery Patency Study Investigators

MACE Outcome < 30 days, n=561 31 days-1 year, n=561 > 1 year, n=529

MACE Outcome < 30 days, n=561 31 days-1 year, n=561 > 1 year, n=529 Death 4 (0. 7) 52 (10. 0) Cardiac Death 3 (0. 5) 2 (0. 4) 26 (4. 9) 55 (9. 8) 1 (0. 2) 8 (1. 5) Redo CABG 0 0 2 (0. 4) PCI 0 4 (0. 7) 22 (4. 2) 59 (10. 5) 9 (1. 2) 79 (14. 9) Non-fatal MI Composite Endpoint The Radial Artery Patency Study Investigators

Survival 1. 0 0. 9 0. 8 Survival 0. 7 0. 6 0. 5

Survival 1. 0 0. 9 0. 8 Survival 0. 7 0. 6 0. 5 5 years 0. 96 + 0. 01 0. 4 7. 5 years 0. 91 + 0. 02 10 years 0. 82 + 0. 03 0. 2 0. 1 0. 0 0 2 4 6 8 TIME (YRS) 10 12 The Radial Artery Patency Study Investigators 14

Event-Free Survival 1. 0 0. 9 0. 8 Survival 0. 7 0. 6 0.

Event-Free Survival 1. 0 0. 9 0. 8 Survival 0. 7 0. 6 0. 5 5 years 0. 95 + 0. 01 0. 4 7. 5 years 0. 90 + 0. 02 10 years 0. 78 + 0. 03 0. 2 0. 1 0. 0 0 2 4 6 8 TIME (YRS) 10 12 The Radial Artery Patency Study Investigators 14

Cardiac Events Outcome Radial SVG Other Graft Native Disease Angina 1 4 4 6

Cardiac Events Outcome Radial SVG Other Graft Native Disease Angina 1 4 4 6 Cardiac Death 3 2 0 1 Non-fatal MI 4 3 2 4 Redo CABG 1 0 0 1 PCI 5 12 7 7 11 20 12 18 Total Patients The Radial Artery Patency Study Investigators

Limitations o The study design restricted our ability to evaluate the clinical consequences of

Limitations o The study design restricted our ability to evaluate the clinical consequences of radial and saphenous grafts. o The patients recruited into the study were young, and generally low risk. The Radial Artery Patency Study Investigators

Clinical Trials of Radial Patency o ISRS (Italy) Single centre, 60 ISRS patients and

Clinical Trials of Radial Patency o ISRS (Italy) Single centre, 60 ISRS patients and 60 controls, RA, RITA or SVG to OM 1 Circulation 2005; 112(supp I): I-265 -9 o RSVP (UK) Single centre, 142 patients, Radial vs SVG to Cx, Circulation 2008; 117: 2859 – 2864 o VA Trial, Multi-centre, 757 patients, Radial vs SVG to 2 nd largest coronary, JAMA 2011 o RAPCO (Australian), Single centre, 619 patients, n <70 years, Radial vs FRITA to 2 nd largest coronary n >70 years, Radial vs SVG to 2 nd largest coronary The Radial Artery Patency Study Investigators

PARTICIPATING CENTRES SUNNYBROOK HEALTH SCIENCES CENTRE Dr. Stephen Fremes Dr. Eric Cohen Randi Elituv

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

Conclusions: 5 Year Results o Radial arteries are associated with reduced rates of functional

Conclusions: 5 Year Results o Radial arteries are associated with reduced rates of functional and complete graft occlusion than saphenous veins. o Radial arteries are associated with less graft disease than saphenous veins. The Radial Artery Patency Study Investigators