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Dr Akhil Kapur London Chest Hospital, Barts and the London NHS Trust, London, UK

C oronary A rtery R evascularisation in Dia betes Trial. Dr Akhil Kapur London Chest Hospital, Barts and the London NHS Trust, London, UK On behalf of the CARDia Investigators Friday 30th January 2009. MY CONFLICTS OF INTEREST ARE

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Dr Akhil Kapur London Chest Hospital, Barts and the London NHS Trust, London, UK

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  1. Coronary Artery Revascularisation in Diabetes Trial Dr Akhil Kapur London Chest Hospital, Barts and the London NHS Trust, London, UK On behalf of the CARDia Investigators Friday 30th January 2009

  2. MY CONFLICTS OF INTEREST ARE Grants: Cordis, Eli-Lilly, BMS-Sanofi, Boston Scientific, Medtronic

  3. Revascularisation in Diabetic Patients with Multivessel Disease No specific randomised comparison of CABG and PCI until now Largest randomised comparison to date

  4. CARDia Trial Design Diabetic patients with multivessel disease or complex single vessel disease Suitable for PCI or CABG Inclusion and exclusion criteria met CONSENT Randomisation Up to date CABG Optimal PCI stent +abciximab DES 72% BMS 28%

  5. Main Exclusion Criteria Informed consent could not be obtained Age >80 years Previous CABG or PCI Left main stem disease Cardiogenic shock Recent ST elevation myocardial infarction Contraindications to abciximab, aspirin and clopidogrel

  6. Primary endpoint: Composite event rate at 1 year of death/non-fatal MI/non-fatal stroke (time to first event) Majorsecondary: Further revascularisation at 1 year Secondary Severe bleeding complications at 30 days New requirement for permanent dialysis Neurological morbidity Quality of life Cost difference between treatments Change in LV function Endpoints

  7. CARDia Patient flow Chart 510 Pts randomised CABG PCI 256 patients 2 withdrew 254 patients 1 died 7 withdrew 2 no procedure 230=received CABG 14=cross over to PCI 253=received PCI 1=cross over to CABG 3 lost to follow up 2 withdrawn 4 lost to follow up 2 withdrawn 95% (242) in 1 year follow up 97% (248) in 1 year follow up

  8. Baseline Clinical Characteristics

  9. Baseline Clinical Characteristics

  10. Baseline Clinical Characteristics

  11. Procedural details

  12. PCI procedural details Use prior to procedure of: aspirin - 100% clopidogrel - 95% abciximab - 95% --------------------------------------------------------------------------------- 3 vessel disease - 65% 3 vessels treated in these patients - 88% --------------------------------------------------------------------------------- average no. of stents per patient - 3.6 average stent length - 71mm --------------------------------------------------------------------------------- DES patients (cypher) - 72% (181) BMS patients - 28% (72)

  13. CABG procedural details 3 vessel disease - 60% 3 vessels treated in these patients - 90% ---------------------------------------------------------------------------- average no of grafts - 2.9 LIMAs - 94% % with at least two arterial grafts - 17% % off pump - 31%

  14. Results - Intention to treat analysis

  15. Primary composite outcome at 1 year

  16. PCI (n=254) CABG (n=248) Individual 1 year outcomes p=0.97 p=0.09 p=0.07 9.8% (n=25) 5.7% (n=14) 3.2 % (n=8) 3.2 % (n=8) 2.8% (n=7) 0.4% (n=1) Non fatal MI Death Non fatal stroke

  17. CCS Class at 12 months

  18. Survival at 1 year CABG vs PCI

  19. Death, MI, stroke and repeat revascularisation

  20. Subgroup - CABG vs PCI-DES

  21. Subgroup - CABG vs PCI-DES Composite endpoint at 1 year

  22. Study Limitations Planned recruitment not achieved 510 patients out of 600 recruited – 85% Formal non-inferiority parameters not fulfilled (insufficient power) we did not match the predicted PCI event rate originally estimated to be lower than predicted CABG rate

  23. Test of non inferiority of PCI vs. CABG for primary endpoint - upper boundary of 1.3 (red line) shown

  24. CARDia: Main Conclusions • First randomised comparisonof coronary revascularisation in diabetes • Broadly similar primary endpoint at 1 year • More repeat revascularisation in the PCI group • Rate of stroke in respective arms consistent with other interventional studies • We will follow up patients for 5 years to increase power

  25. CARDiaParticipating Centres

  26. CARDiaParticipating Centres continued

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