1. American Heart Association Presented by Dr. Julinda Mehilli
ISAR-SWEET Trial
Is Abciximab a Superior Way to Eliminate Elevated Thrombotic Risk in Diabetics
Presented at
American Heart Association
Scientific Sessions 2004
Presented by Dr. Julinda Mehilli

2. ISAR-SWEET Trial
701 diabetic patients scheduled to undergo elective PCI in a native coronary vessel and pre-treated with clopidogrel 600 mg for >2 hours prior to the procedure
Randomized, blinded
Abciximab
Glycoprotein IIb/IIIa inhibitor
n=351
0.25 mg/kg bolus
0.125 μg/kg/min infusion for 12 hours
Placebo
n=350
Endpoint (12 months):
Composite of all-cause mortality or myocardial infarction
Presented at AHA Scientific Sessions 2004

3. ISAR-SWEET Trial Primary Composite Endpoint at 12 months %
Insulin-dependent Diabetes Subgroup Primary Composite Endpoint at 12 months
p=0.66 %
Baseline characteristics were well balanced in the treatment groups. 29% of the abciximab arm and 28% of the placebo arm were insulin-dependent.
There was no difference in the primary endpoint of death or MI at 12 months.
There was also no significant difference in death or MI at 12 months in the subgroup of patients presenting with insulin-dependent diabetes.
Presented at AHA Scientific Sessions 2004

4. Secondary Endpoint: Target Lesion Revascularization
ISAR-SWEET Trial
Secondary Endpoint:
Binary Restenosis
p=0.01
Secondary Endpoint: Target Lesion Revascularization
p=0.03 %
The secondary endpoint of binary restenosis at angiographic follow-up was lower in the abciximab group. Additionally, target lesion revascularization was lower in the abciximab group.
Presented at AHA Scientific Sessions 2004

5. ISAR-SWEET Trial
Major Bleeding
p=NS
Minor Bleeding
p=0.09
Transfusions
p=0.11 %
There was no difference in major bleeding between the treatment groups, but both minor bleeding and transfusions trended higher in the abciximab group.
Presented at AHA Scientific Sessions 2004

6. ISAR-SWEET Trial
Among diabetic patients undergoing elective PCI and pretreated with high-dose clopidogrel, treatment with abciximab was not associated with a difference in the primary endpoint of death or MI at 12 months compared with placebo, but was associated with a lower rate of binary restenosis and target lesion revascularization.
These data are similar to the ISAR REACT trial, which showed no difference in 30 day major cardiac events with abciximab compared with placebo in low-risk patients undergoing PCI who were pretreated with 600 mg clopidogrel.
While there was no difference in the primary endpoint of death or MI in the present trial, it should be noted that the trial was powered to detect a 50% reduction with abciximab, a relatively large improvement in clinical events that may have been over-estimated. Only 10% of patients in the trial were treated with a drug-eluting stent.