1. David Hildick-Smith Sussex Cardiac Centre

2. Background to ARTS Previous POBA studies Meta-analysis 3300 patients 1660 CABG, 1710 PTCA Deaths 79 PCI vs 73 CABG Revascularisation rates 33% PCI v 3% CABG Meta-analysis of randomised trials comparing coronary angioplasty with bypass surgery. Pocock SJ, Henderson RA, Rickards AF, Hampton JR, King SB 3rd, Hamm CW, Puel J, Hueb W, Goy JJ, Rodriguez A. Lancet 1995

3. Background to ARTS Rationale for ARTS –stent technology –CABG technology –economic evaluation

4. Methods At least two lesions amenable to PCI or CABG, agreed by surgeon and cardiologist Allowed: –total occlusions (<1 month) –bifurcations –thrombus –calcification –tortuosity LVEF >30% No previous revascularisations

5. Endpoints Primary –freedom from death, stroke, MI, revascularisation Secondary –angina status –medication use –cost effectiveness at 12 months

7. Results 1200 patients at 67 centres Matched demographics Crossovers: –6 to surgery –19 to stenting

8. Results 99% in PCI group had assigned Rx 96% in CABG had assigned Rx PCI 2.6±1.1 lesions stented CABG 2.6±1.1 anastomoses made Arterial grafts in 93% –95% of these had LIMA to LAD

9. One-year analysis

10. survival event-free survival

13. ARTS I Conclusions No significant difference between groups for death 17% difference in revascularisations favouring CABG Lower costs ($3,000) favouring PCI

14. ARTS I – 3 years

15. survival event-free survival

18. ~Diabetic subgroup~

19. ~Proximal LAD subgroup~

20. ~Predictors of outcome~

21. ARTS I – 5 years DeathsCABGStent Total number of deaths4648 Unknown12 Noncardiac deaths2825 Cardiac deaths1721 Cardiac deaths related to repeat revascularization15 Serruys P. European Society of Cardiology Congress 2004; August 28- September 1, 2004; Munich, Germany.

22. ARTS I – 5 years OutcomesCABGStent Survival92% Freedom from death/MI/CVA85%82% Event-free survival78%58%

23. ARTS I – 5 years MACCECABG group Stent group (re) CABG1%10% (re) PCI8%23% Either Any event 9% 22% 30% 42%

24. meanwhile….

25. The Rosy Prophecy

26. ARTS II – the rationale

27. ARTS II: Design ARTS II Cypher stent N=607 ARTS I CABG N= 605 Crown stent N= 600 N= 600 R

28. ARTS II Aim: –non-inferiority of sirolimus-eluting stents compared with the surgical arm of ARTS I Endpoints: –as for ARTS I

29. ARTS II: Baseline Demographics ARTS II (PCI) (n = 607) ARTS I CABG) (n = 605) ARTS I (PCI) (n = 600) Male (%) 76.676.077.0 Age (years) 626161 Previous MI 34.342.044.3 Diabetes26.215.918.7 Hypertension67.345.044.7 Hyperlipidemia74.057.658.0 Family history 36.042.239.2 Ejection fraction 60.360.360.9 Unstable angina 36.535.437.3

30. ARTS II: Procedural Details ARTS II Cypher (n = 607) ARTS I CABG (n = 605) ARTS I PCI (n = 600) No. of lesions / patient 3.62.82.8 Angiographic success 85.4-88.3 CK elevation < 1 ULN > 1 ULN 81.518.510.489.674.725.3 Use of GPIIb/IIIa inhibitors 35.8-- Lipid lowering drug 89.831.838.8

31. ARTS II: Stented Length  Average stented length:  ARTS II = 72.5mm  ARTS I = 47.6mm

32. ARTS II: 6m Clinical Results ARTS II Cypher (n = 607) ARTS I CABG (n = 605) ARTS I PCI (n = 600) Death0.5%1.8%2.3% CVA0.5%1.2%1.5% MI0.7%3.5%4.5% (re) CABG 1.6%0.5%3.8% (re) PCI 3.1%2.8%7.8% MACCE6.4%9.0%20%

33. ARTS II: 6m Clinical Results ARTS II Cypher (n = 607) ARTS I CABG (n = 605) ARTS I PCI (n = 600) Freedom from MACCE 93.6%91.0%80.0%

34. Conclusions “Early indications are that DES may be as good as CABG for multivessel disease revascularisation” (M.Leon 2004) Wait for 1-year data