CADILLAC TRIAL

Problem AMI for PCI
Format Double-blinded multi-center RCT
Treatment Abciximab
Control PTCA alone
Population 2082 patients
Inclusion criteria Clinical symptoms of MI for <12 hours
Either ≥1 mm ST-segment elevation in 2 contiguous leads or high-grade angiographic stenosis with an associated regional wall-motion abnormality
Exclusion criteria Cardiogenic shock
Saphenous vein graft infarct lesion
Infarct artery reference vessel diameter <2.5 mm
Lesion length >64 mm
Need for urgent bypass surgery
Follow-up 7 and 12 months
Primary endpoint Composite end point of death, MI, ischemia-driven target-vessel revascularization (TVR), or disabling stroke at 30 days
Secondary endpoint(s) .
Details 2082 patients sustaining an acute MI were randomized at 76 sites in 9 countries to receive 1 of 4 reperfusion strategies in an open-label, 2x2 factorial design, as follows: (1) balloon percutaneous transluminal coronary angioplasty (PTCA), (2) PTCA with abciximab, (3) MultiLink stent implantation (Guidant Corporation), or (4) MultiLink stent implantation with abciximab.

Patients received aspirin, ticlopidine, and heparin before angiography. Heparin was adjusted by nomogram to achieve an activated clotting time of >350 seconds in patients not receiving abciximab and 200 to 300 seconds in abciximab-treated patients.
Brief summary: Abciximab reduces mortality and thrombosis/TVR in addition to ticlodipine/aspirin in PCI
PAPER: Benefits and risks of abciximab use in primary angioplasty for acute myocardial infarction: the Controlled Abciximab and Device Investigation to Lower Late Angioplasty Complications (CADILLAC) trial.
Date 16 Sep 2003
Journal Circulation. 2003 Sep 16;108(11):1316-23.
Information PTCA + abciximab (vs. PTCA alone) @ 30d
-Reduction in the composite of death, MI/TVR/disabling stroke (RR 0.65; P=0.01)
--Predominantly by reducing ischemia-driven TVR
-Reduced subacute thrombosis

-Non-significant trend for composite end-point @ 12m
--Reflecting no effect of abciximab on reducing restenosis