david hildick-smith sussex cardiac centre
DESCRIPTION
David Hildick-Smith Sussex Cardiac Centre. Background to ARTS. 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. - PowerPoint PPT PresentationTRANSCRIPT
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%
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