1 o ptca (n=516)

11oo PTCA PTCA(n=516)

MultiLink stentMultiLink stent+ Abciximab+ Abciximab

(n=525)

11oo PTCA PTCA+ Abciximab+ Abciximab

(n=529)

MultiLink stentMultiLink stent(n=512)

AMI <12 hours, any age, cardiogenic shock excludedAMI <12 hours, any age, cardiogenic shock excludedn=2,665 at 76 centers in N.A., S.A. and Europen=2,665 at 76 centers in N.A., S.A. and Europe

AngiographyAngiographyAngiographyAngiography

nonononoRegistryRegistry

n=583 (22%)n=583 (22%)RegistryRegistry

n=583 (22%)n=583 (22%)

RandomizeRandomizeRandomizeRandomize

Met angiographic criteriaMet angiographic criterian=2,082 (78%)

Met angiographic criteriaMet angiographic criterian=2,082 (78%)

CADILLACCADILLACCADILLACCADILLAC

Study DesignStudy Design Stone et al.Circulation 2000; 102: II-664Stone et al.Circulation 2000; 102: II-664

yesyesyesyes

• 1961 patients with acute MI1961 patients with acute MI• Target lesion 2.5-4 mm, < 70 mm lengthTarget lesion 2.5-4 mm, < 70 mm length• Randomized:Randomized:

Stent vs. PTCAStent vs. PTCAAbciximab vs. placeboAbciximab vs. placebo

• Shock excludedShock excluded• Rx ASA, ticlopidine, heparinRx ASA, ticlopidine, heparin

ACT 200-300 w/abciximabACT 200-300 w/abciximabACT >350 w/placeboACT >350 w/placebo

• Primary endpointPrimary endpoint6 month death/MI/urgent intervention6 month death/MI/urgent intervention

Stone. Oral presentation. AHA 1999.Stone. Oral presentation. AHA 1999.CADILLACCADILLAC

• No difference between groups in mortality, strokeNo difference between groups in mortality, stroke

• Trend toward fewer reinfarctions in stent ptsTrend toward fewer reinfarctions in stent pts

• Trend toward less ischemia-driven TVR in stent ptsTrend toward less ischemia-driven TVR in stent pts

• No difference between groups in ICHNo difference between groups in ICH

Stone. Oral presentation. AHA 1999.Stone. Oral presentation. AHA 1999.

CADILLACCADILLAC [ Presentation of acute safety / outcome data ][ Presentation of acute safety / outcome data ][ Presentation of acute safety / outcome data ][ Presentation of acute safety / outcome data ]

Stent/AStent/A Stent/PStent/P PTCA/APTCA/A PTCA/PPTCA/P

TIMI 3 flowTIMI 3 flow 96.7% 96.7% 92.1%92.1% 95% 95% 94.8% 94.8%

Rec ischRec isch 1.2% 1.2% 3.9% 3.9% 1.4% 1.4% 4% 4%

BleedingBleeding 4.5% 4.5% 3.5% 3.5% 5.1% 5.1% 3.1% 3.1%

Stone, TCT 2000Stone, TCT 2000 CADILLAC

• 2082 patients with acute MI 2082 patients with acute MI (2.5-4.5 mm vessels)(2.5-4.5 mm vessels)

• Shock excludedShock excluded

• Randomized to :Randomized to :PTCAPTCA

PTCA + abciximabPTCA + abciximab

Stent (Multi-link)Stent (Multi-link)

Stent + abciximabStent + abciximab

• Crossover allowedCrossover allowed

• Primary endpoint : MACE at 6 mo Primary endpoint : MACE at 6 mo (stent vs PTCA)(stent vs PTCA)

Stone, TCT 2000Stone, TCT 2000

PTCA(n=516)

PTCA+Abcix(n=529)

Stent(n=512)

Stent+Abcix(n=525)

MACE 19.3 % 15.2 % 10.9 % 10.8 %

Mortality 4.3 % 2.3 % 2.8 % 3.8 %

Ischemia-driven TVR

14.2 % 12.1 % 7.4 % 5.0 %

LOS (days) 3.9 3.4 3.9 3.3

PTCA(n=516)

PTCA+Abcix(n=529)

Stent(n=512)

Stent+Abcix(n=525)

MACE 19.3 % 15.2 % 10.9 % 10.8 %

Mortality 4.3 % 2.3 % 2.8 % 3.8 %

Ischemia-driven TVR

14.2 % 12.1 % 7.4 % 5.0 %

LOS (days) 3.9 3.4 3.9 3.3

CADILLAC

Outcomes at 6 MonthsOutcomes at 6 Months

19.3%19.3%

10.9%10.9%

PTCA, no abciximabPTCA, no abciximab Stent, no abciximabStent, no abciximab

0%0%

5%5%

10%10%

15%15%

20%20%

00 3030 6060 9090 120120 150150 180180

Days to eventDays to event

p = 0.001p = 0.001

Inci

den

ceIn

cid

ence


Primary Endpoint - MACE at 6 MonthsPrimary Endpoint - MACE at 6 Months

Stone et al. Circ 2000; 102: II-664Stone et al. Circ 2000; 102: II-664

0%0%

5%5%

10%10%

15%15%

20%20%

00 3030 6060 9090 120120 150150 180180


15.2%15.2%

10.9%10.9%


Primary Endpoint - MACE at 6 MonthsPrimary Endpoint - MACE at 6 Months

Stent, no abciximabStent, no abciximabPTCA, abciximabPTCA, abciximab

Inci

den

ce

(%

)In

cid

enc

e (

%)


7.17.1

5.05.0

00

22

44

66

88

1010

Death, Disabling Stroke, Re-MI or Ischemic TVRDeath, Disabling Stroke, Re-MI or Ischemic TVR

CADILLACCADILLAC

MACE at 30 DaysMACE at 30 Days

% o

f P

atie

nts

% o

f P

atie

nts

Secondary EndpointSecondary Endpoint

p = 0.04p = 0.04

No AbciximabNo Abciximab

Abciximab Abciximab


0%0%

5%5%

10%10%

15%15%

20%20%

00 3030 6060 9090 120120 150150 180180


15.2%15.2%

19.3%19.3%

10.8%10.8%10.9%10.9%


Seconday Endpoint - MACE at 6 MonthsSeconday Endpoint - MACE at 6 MonthsIn

cid

enc

e (

%)

Inci

den

ce

(%

)


PTCA, no abxPTCA, no abx PTCA, abxPTCA, abx Stent, no abxStent, no abx Stent, abxStent, abx


• Thrombotic bailoutThrombotic bailout

• Subacute ThrombosisSubacute Thrombosis

• Ischemic TVRIschemic TVR

• Registry PatientsRegistry Patients

Additional Benefits of AbciximabAdditional Benefits of Abciximab

Stone, TCT 2000Stone, TCT 2000

PTCA(n=516)

PTCA+Abcix(n=529)

Stent(n=512)

Stent+Abcix(n=525)

Stent 19.9 % 16.4 % 99.4 % 99.5 %

Abciximab 9.1 % 99.4 % 6.1 % 99.5 %

PTCA(n=516)

PTCA+Abcix(n=529)

Stent(n=512)

Stent+Abcix(n=525)

Stent 19.9 % 16.4 % 99.4 % 99.5 %

Abciximab 9.1 % 99.4 % 6.1 % 99.5 %

Treatment ReceivedTreatment Received

CADILLAC

0.0%

1.0%

2.0%

PTCA, No Abx PTCA, Abx Stent, No Abx Stent, Abx

Inci

den

ce (

%)

30 Day Subacute Thrombosis30 Day Subacute ThrombosisCADILLACCADILLACCADILLACCADILLAC

1.7%1.7%

0.6%0.6%

1%1%

0%0%

p=0.03p=0.03

P=0.07P=0.07


5.4

14.2

3.2

12.1

2.9

7.4

1.5

5

0.0

5.0

10.0

15.0

20.0

30 Day 6 Month

Inci

den

ce (%

)

PTCA PTCA+Abx Stent Stent+AbxStone et al. Circ 2000; 102: II-664Stone et al. Circ 2000; 102: II-664

p<0.02p<0.02 p=NSp=NS

p=0.04p=0.04

p=NSp=NS

p=0.12p=0.12

p<0.001p<0.001

Ischemic TVRIschemic TVRCADILLACCADILLACCADILLACCADILLAC

2.8%

4.1%

1.5%

9.0%

6.5%

0%

3%

6%

9%

12%

Rand Reg Med PCI CABG

In-hospital mortality

Medical31%

PCI40%

CABG29%

Treatment Treatment receivedreceived(n=583)(n=583)

Treatment Treatment receivedreceived(n=583)(n=583)

47% received Abx;47% received Abx;Mortality = 4.7% w/AbxMortality = 4.7% w/Abx

vs. 8.3% w/o Abx, p = 0.22vs. 8.3% w/o Abx, p = 0.22

47% received Abx;47% received Abx;Mortality = 4.7% w/AbxMortality = 4.7% w/Abx

vs. 8.3% w/o Abx, p = 0.22vs. 8.3% w/o Abx, p = 0.22

Angiographic Exclusion Registry: Hospital MortalityAngiographic Exclusion Registry: Hospital MortalityAngiographic Exclusion Registry: Hospital MortalityAngiographic Exclusion Registry: Hospital MortalityCADILLACCADILLAC


1 o ptca (n=516)

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