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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)

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, 2001 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) Relative Risk Reduction = 40% Absolute Difference =5.4% Intention to Treat Analysis 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 NEJM Nov. 25, 2004

10 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

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

12 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

13 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

14 The Radial Artery Patency Study Investigators Patients 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 Hypertension (%)45.053.5 Vascular Disease (%)6.011.5 * Creatinine (mol/L) 92.1 + 18.293.6 + 22.3

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 NEJM Nov. 25, 2004

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 NEJM Nov. 25, 2004

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 NEJM Nov. 25, 2004

19 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.

20 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.

21 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-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 free RITA to 2 nd largest coronary >70 years, Radial vs SVG to 2 nd largest coronary 4 manuscripts published concerning “interim” results

22 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 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

23 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


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