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Results from the Randomized Multicentre Radial Artery Patency Study (RAPS)

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.

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Results from the Randomized Multicentre Radial Artery Patency Study (RAPS)

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

  5. Patients 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 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

  6. Study Randomization LCX: SVG or RADIAL RCA: RADIAL Or SVG LIMA to LAD Randomization was performedwithinpatients not between patients

  7. 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 NEJMNov. 25, 2004

  8. SECONDARY STUDY ENDPOINT: Functional Graft Occlusion at 1 Year TIMI 3 = Patent TIMI 0,1,2 = Occluded Intention to Treat Analysis NEJMNov. 25, 2004

  9. Study Question Is the patency of the radial artery superior to the saphenous vein > 5 years following surgery?

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

  11. Study Patients Eligible N=501 Protocol Violations, N=16 2 Study Grafts Occluded, N=4 N=483 Death 1-5 yrs, N=10 New Med Exclusions, N= 64 Distance to Centre, N=9 LTFU, N=31 N=369 Eligible for Analysis Death 5-6 yrs, N=6 Patient Refusal, N=94 N=269 Analysis

  12. Study Patients

  13. Angiographic Results

  14. 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

  15. 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

  16. SECONDARY STUDY ENDPOINT:Graft Stenosis >25% of TIMI 3 GraftsN=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%

  17. 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

  18. Clinical Results

  19. MACE

  20. 1.0 0.9 0.8 0.7 0.6 Survival 0.5 0.4 0.3 0.2 0.1 0.0 0 2 4 6 8 10 12 14 TIME (YRS) Survival

  21. 1.0 0.9 0.8 0.7 0.6 Survival 0.5 0.4 0.3 0.2 0.1 0.0 0 2 4 6 8 10 12 14 TIME (YRS) Event-Free Survival

  22. 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.

  23. 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.

  24. 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

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

  26. PARTICIPATING CENTRES

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