CADILLAC TRIAL |
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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. | |
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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 |