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)

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, 2001 New Orleans, LA

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

The Radial Artery Patency Study Investigators

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

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

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

The Radial Artery Patency Study Investigators PRIMARY STUDY ENDPOINT: Graft Occlusion at 1 Year Occluded = No Opacification of Distal Vessel (TIMI 0) Relative Risk Reduction = 40% Absolute Difference =5.4% Intention to Treat Analysis NEJM Nov. 25, 2004

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 NEJM Nov. 25, 2004

The Radial Artery Patency Study Investigators Non-Occlusive Graft Stenosis on Angiography End PointRadial Artery Saphenous Vein P Value Proximal Anastomosis 75/350 grafts 21.4% 39/350 grafts 11.1% <0.001 Graft Body20/350 grafts 5.7% 43/350 grafts 12.3%0.003 Distal Anastomosis 49/350 grafts 14.0% 62/350 grafts 17.7%0.15 Nov. 25, 20

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

The Radial Artery Patency Study Investigators Randomized N= centres N= 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

The Radial Artery Patency Study Investigators Eligible 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 Death 5-6 yrs, N=6 Patient Refusal, N=94 Study Patients Analysis Eligible for Analysis

The Radial Artery Patency Study Investigators Patients VariableAngiography, n=269 No Angiography, n=260 Age (yrs) * Age > 70 yrs (%) * Female (%) Urgent (%) CCS Class 3-4 (%)51.3/ /27.7 Diabetes (%) Hypertension (%) Vascular Disease (%) * Creatinine (mol/L)

The Radial Artery Patency Study Investigators PRIMARY STUDY ENDPOINT: Functional Graft Occlusion at 5 Years TIMI 3 = Patent TIMI 0,1,2 = Occluded OR % CI Absolute Difference =6.8% Intention to Treat Analysis NEJM Nov. 25, 2004

The Radial Artery Patency Study Investigators SECONDARY STUDY ENDPOINT: Graft Occlusion at 5 Years Occluded = No Opacification of Distal Vessel (TIMI 0) OR % CI Absolute Difference =8.9% Intention to Treat Analysis NEJM Nov. 25, 2004

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%

The Radial Artery Patency Study Investigators SECONDARY STUDY ENDPOINT: Graft Stenosis >25% or Occlusion Occluded = No Opacification of Distal Vessel (TIMI 0) OR % CI Absolute Difference =11.9% Intention to Treat Analysis NEJM Nov. 25, 2004

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.

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.

The Radial Artery Patency Study Investigators 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  RSVP (UK) Single centre, 142 patients, Radial vs SVG to Cx, Circulation 2008; 117:  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 free RITA to 2 nd largest coronary >70 years, Radial vs SVG to 2 nd largest coronary 4 manuscripts published concerning “interim” results

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 RSVP (UK), Single-centre, 142 patients, Radial vs SVG to Cx, Circulation 2008; 117: 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 free RITA to 2 nd largest coronary >70 years, Radial vs SVG to 2 nd 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  Slide including all of the participants