david hildick-smith sussex cardiac centre. background to arts previous poba studies meta-analysis...

David Hildick-Smith Sussex Cardiac Centre

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

Background to ARTS

• Rationale for ARTS– stent technology– CABG technology– economic evaluation

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

Endpoints

• Primary– freedom from death, stroke, MI, revascularisation

• Secondary– angina status– medication use– cost effectiveness

at 12 months

Results

• 1200 patients at 67 centres

• Matched demographics

• Crossovers:– 6 to surgery– 19 to stenting

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

One-year analysis

survival

event-free survival

ARTS I Conclusions

• No significant difference between groups for death

• 17% difference in revascularisations favouring CABG

• Lower costs ($3,000) favouring PCI

ARTS I – 3 years

survival

event-free survival

~Diabetic subgroup~

~Proximal LAD subgroup~

~Predictors of outcome~

ARTS I – 5 years

Deaths CABG Stent

Total number of deaths 46 48

•Unknown 1 2

•Noncardiac deaths 28 25

•Cardiac deaths 17 21

•Cardiac deaths related to repeat revascularization 1 5

Serruys P. European Society of Cardiology Congress 2004; August 28-September 1, 2004; Munich, Germany.

ARTS I – 5 years

Outcomes CABG Stent

Survival 92% 92%

Freedom from death/MI/CVA 85% 82%

Event-free survival 78% 58%

ARTS I – 5 years

MACCE CABG group

Stent group

(re) CABG 1% 10%

(re) PCI 8% 23%

Either

Any event

9%

22%

30%

42%

meanwhile….

The Rosy Prophecy

ARTS II – the rationale

ARTS II: Design

ARTS IIARTS II Cypher stent

N=607

ARTS IARTS I

CABGCABG

N= 605N= 605

CrownCrown stent stent

N= 600N= 600

RR

ARTS II

• Aim:– non-inferiority of sirolimus-eluting stents

compared with the surgical arm of ARTS I

• Endpoints:– as for ARTS I

ARTS II: Baseline Demographics

ARTS II (PCI)ARTS II (PCI)(n = 607)(n = 607)

ARTS I CABG)ARTS I CABG)(n = 605)(n = 605)

ARTS I (PCI)ARTS I (PCI)(n = 600)(n = 600)

Male (%)Male (%) 76.676.6 76.076.0 77.077.0

Age (years)Age (years) 6262 6161 6161

Previous MIPrevious MI 34.334.3 42.042.0 44.344.3

DiabetesDiabetes 26.226.2 15.915.9 18.718.7

HypertensionHypertension 67.367.3 45.045.0 44.744.7

HyperlipidemiaHyperlipidemia 74.074.0 57.657.6 58.058.0

Family historyFamily history 36.036.0 42.242.2 39.239.2

Ejection fractionEjection fraction 60.360.3 60.360.3 60.960.9

Unstable anginaUnstable angina 36.536.5 35.435.4 37.337.3

ARTS II: Procedural Details

ARTS II ARTS II CypherCypher(n = 607)(n = 607)

ARTS I ARTS I CABGCABG(n = 605)(n = 605)

ARTS I ARTS I PCIPCI

(n = 600)(n = 600)

NNo.o. of lesions / patient of lesions / patient 3.63.6 2.82.8 2.82.8

Angiographic successAngiographic success 85.485.4 -- 88.388.3

CK elevationCK elevation

< 1 ULN< 1 ULN

> 1 ULN> 1 ULN

81.581.5

18.518.5

10.410.4

89.689.6

74.774.7

25.325.3

Use of GPIIb/IIIa inhibitorsUse of GPIIb/IIIa inhibitors 35.835.8 -- --

Lipid lowering drugLipid lowering drug 89.889.8 31.831.8 38.838.8

ARTS II: Stented Length

0.5

26.9

31.4

24.7

0.5

5.7

58.4

27.1

6.22.6

0

16.0

0

10

20

30

40

50

60

70

0-25 26-50 51-75 76-100 100-200 >200

Stented Length (mm)

%

ARTS II Cypher

ARTS I PCI

Average stented length:Average stented length:ARTS II = 72.5mmARTS II = 72.5mmARTS I = 47.6mmARTS I = 47.6mm

ARTS II: 6m Clinical Results

ARTS II ARTS II CypherCypher(n = 607)(n = 607)

ARTS I ARTS I CABGCABG(n = 605)(n = 605)

ARTS I ARTS I PCIPCI

(n = 600)(n = 600)

DeathDeath 0.5%0.5% 1.8%1.8% 2.3%2.3%

CVACVA 0.5%0.5% 1.2%1.2% 1.5%1.5%

MIMI 0.7%0.7% 3.5%3.5% 4.5%4.5%

(re) CABG(re) CABG 1.6%1.6% 0.5%0.5% 3.8%3.8%

(re) PCI(re) PCI 3.1%3.1% 2.8%2.8% 7.8%7.8%

MACCEMACCE 6.4%6.4% 9.0%9.0% 20%20%

ARTS II: 6m Clinical Results

ARTS II ARTS II CypherCypher(n = 607)(n = 607)

ARTS I ARTS I CABGCABG(n = 605)(n = 605)

ARTS I ARTS I PCIPCI

(n = 600)(n = 600)

Freedom Freedom from from

MACCEMACCE93.6%93.6% 91.0%91.0% 80.0%80.0%

Conclusions

• “Early indications are that DES may be as good as CABG for multivessel disease

revascularisation” (M.Leon 2004)

• Wait for 1-year data