1. Study Design AMI <12 hours, any age, cardiogenic shock excluded
CADILLAC
Study Design
Stone et al.Circulation 2000; 102: II-664
AMI <12 hours, any age, cardiogenic shock excluded
n=2,665 at 76 centers in N.A., S.A. and Europe
Angiography
Met angiographic criteria
n=2,082 (78%) no
Registry
n=583 (22%)
yes
Randomize
1o PTCA
(n=516)
1o PTCA
+ Abciximab
(n=529)
MultiLink stent
(n=512)
MultiLink stent
+ Abciximab
(n=525)

2. CADILLAC 1961 patients with acute MI
Stone. Oral presentation. AHA 1999.
1961 patients with acute MI
Target lesion mm, < 70 mm length
Randomized:
Stent vs. PTCA
Abciximab vs. placebo
Shock excluded
Rx ASA, ticlopidine, heparin
ACT w/abciximab
ACT >350 w/placebo
Primary endpoint
6 month death/MI/urgent intervention

3. [ Presentation of acute safety / outcome data ]
CADILLAC
[ Presentation of acute safety / outcome data ]
No difference between groups in mortality, stroke
Trend toward fewer reinfarctions in stent pts
Trend toward less ischemia-driven TVR in stent pts
No difference between groups in ICH
Stent/A Stent/P PTCA/A PTCA/P
TIMI 3 flow 96.7% 92.1% 95% %
Rec isch 1.2% 3.9% 1.4% 4%
Bleeding 4.5% 3.5% 5.1% %
Stone. Oral presentation. AHA 1999.

4. CADILLAC Shock excluded Randomized to : Crossover allowed
Stone, TCT 2000
2082 patients with acute MI ( mm vessels)
Shock excluded
Randomized to :
PTCA
PTCA + abciximab
Stent (Multi-link)
Stent + abciximab
Crossover allowed
Primary endpoint : MACE at 6 mo (stent vs PTCA)
The study design was relatively simple. Half the patients received enoxaparin as a subcutaneous injection 1 mg/kg twice daily in addition to aspirin. Each mg of enoxaparin contains 100 anti-Xa units. Patients in the second treatment group received standard unfractionated heparin as a continuous intravenous infusion adjusted according to the APTT nomograms at the individual institutions. The minimum treatment duration was 48 hours, the maximum treatment duration was 8 days. Patients returned for clinical evaluation and ECG at 14 days. A 30-day follow-up telephone contact at 30 days assessed additional clinical endpoints and adverse events.

5. CADILLAC Outcomes at 6 Months Stone, TCT 2000
The study design was relatively simple. Half the patients received enoxaparin as a subcutaneous injection 1 mg/kg twice daily in addition to aspirin. Each mg of enoxaparin contains 100 anti-Xa units. Patients in the second treatment group received standard unfractionated heparin as a continuous intravenous infusion adjusted according to the APTT nomograms at the individual institutions. The minimum treatment duration was 48 hours, the maximum treatment duration was 8 days. Patients returned for clinical evaluation and ECG at 14 days. A 30-day follow-up telephone contact at 30 days assessed additional clinical endpoints and adverse events.

6. Primary Endpoint - MACE at 6 Months
CADILLAC
Primary Endpoint - MACE at 6 Months
20%
19.3%
15%
10.9%
Incidence
10% 5%
p = 0.001 0% 30 60 90
120
150
180
Days to event
PTCA, no abciximab
Stent, no abciximab
Stone et al. Circ 2000; 102: II-664

7. Primary Endpoint - MACE at 6 Months0% 5%
10%
15%
20% 30 60 90
120
150
180
Days to event
15.2%
10.9%
CADILLAC
Primary Endpoint - MACE at 6 Months
Stent, no abciximab
PTCA, abciximab
Incidence (%)
Stone et al. Circ 2000; 102: II-664

8. Death, Disabling Stroke, Re-MI or Ischemic TVR
CADILLAC
Secondary Endpoint
MACE at 30 Days
No Abciximab
Abciximab 10 8
7.1
p = 0.04
% of Patients 6
5.0 4
This slide shows the abciximab endpoint, the only endpoint for which this part of the trial was powered. It showed a significant decrease in 30 day MACE in the abciximab group.
This part of the study was powered to show a difference between the abciximab and no-abciximab groups with an expected no-abciximab event rate of 12.5% A total of 1700 patients were needed between these groups. 2
Death, Disabling Stroke, Re-MI or Ischemic TVR
Stone et al. Circ 2000; 102: II-664

9. Seconday Endpoint - MACE at 6 Months
CADILLAC
Seconday Endpoint - MACE at 6 Months
20%
19.3%
15.2%
15%
10.9%
10.8%
10%
Incidence (%) 5% 0% 30 60 90
120
150
180
Days to event
PTCA, no abx
PTCA, abx
Stent, no abx
Stent, abx
Stone et al. Circ 2000; 102: II-664

10. Additional Benefits of Abciximab
CADILLAC
Additional Benefits of Abciximab
Thrombotic bailout
Subacute Thrombosis
Ischemic TVR
Registry Patients

11. CADILLAC Treatment Received Stone, TCT 2000
The study design was relatively simple. Half the patients received enoxaparin as a subcutaneous injection 1 mg/kg twice daily in addition to aspirin. Each mg of enoxaparin contains 100 anti-Xa units. Patients in the second treatment group received standard unfractionated heparin as a continuous intravenous infusion adjusted according to the APTT nomograms at the individual institutions. The minimum treatment duration was 48 hours, the maximum treatment duration was 8 days. Patients returned for clinical evaluation and ECG at 14 days. A 30-day follow-up telephone contact at 30 days assessed additional clinical endpoints and adverse events.

12. 30 Day Subacute Thrombosis
CADILLAC
30 Day Subacute Thrombosis
1.7%
P=0.07
p=0.03 1%
0.6% 0%
Stone et al. Circ 2000; 102: II-664

13. Ischemic TVR CADILLAC p=NS p<0.001 p=0.12 p<0.02 p=NS p=0.04
Stone et al. Circ 2000; 102: II-664

14. Angiographic Exclusion Registry: Hospital Mortality
CADILLAC
Angiographic Exclusion Registry: Hospital Mortality
47% received Abx;
Mortality = 4.7% w/Abx
vs. 8.3% w/o Abx, p = 0.22
Treatment received (n=583)
Stone et al. Circ 2000; 102: II-664