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Diabetes Abciximab Stent Evaluation - DANTE
Description:
The goal of the trial was to evaluate if abciximab given at the time of stent implantation would be associated with reductions in in-stent intimal hyperplasia measured by intravascular ultrasound at 6-month follow-up in patients with type 2 diabetes.
Hypothesis:
Abciximab will be associated with a reduction in neointimal hyperplasia after stenting in diabetic patients as assessed by in-stent volume obstruction by 3-dimensional (3D) intravascular ultrasound (IVUS).
Study Design
Study Design:
Patients Enrolled: 96
Mean Follow Up: 12 months
Mean Patient Age: mean age 60 years
Female: 51
Mean Ejection Fraction: Mean baseline EF 59.7% in the abciximab arm and 60.7% in the control arm (p=0.7).
Patient Populations:
Documented type 2 diabetes mellitus and a symptomatic or ischemia-provoking de novo stenosis in a native coronary artery
Exclusions:
Myocardial infarction within 7 days, renal dysfunction (serum creatinine >2.0 mg/dL), standard contraindications to abciximab, target vessel <2.5 mm or >4.0 mm in reference diameter, target lesion >18 mm in length, impaired left ventricular function (ejection fraction <=30%), unprotected left main coronary lesion >=50%, ostial lesion, total occlusion, or evidence of thrombus.
Primary Endpoints:
In-stent percent volume obstruction by IVUS at 6-month follow-up.
Secondary Endpoints:
Angiographic: MLD, late loss, and binary restenosis
Clinical: composite major adverse cardiac events (MACE) of death of any cause, nonfatal myocardial infarction, and target lesion revascularization (TLR) within 30 days and 1 year after the procedure.
Drug/Procedures Used:
Diabetic patients who underwent elective stent implantation for a de novo lesion in a native coronary artery were randomized to abciximab (n=47) or no abciximab (n=49). Abciximab was administered as a bolus of 0.25 mg/kg, followed by a 12-hour infusion (0.125 µg/kg per minute, maximum 10 µg/min).
Concomitant Medications:
Aspirin (200 mg) and ticlopidine (500 mg) started >24 hours prior to the procedure. Ticlopidine use was to be continued for 4 weeks and aspirin use was to be continued indefinitely.
Principal Findings:
There was no difference in 1 year MACE (19.1% with abciximab vs 20.4% with control, p=0.9) or any component of MACE (death 8.5% vs 2.0%, p=0.2; MI 0% vs 4.2%, p=0.5; TLR 10.6% vs 16.3%, p=0.4). There was no difference in 6 month angiographic follow-up minimum lumen diameter (1.74 mm vs 1.66 mm, p=0.5), percent stenosis (32% vs 35%, p=0.4) or in-stent restenosis (17.8% vs 22.9%, p=0.5). There was also no difference in late loss (1.03 mm vs 1.07 mm, p=0.7). In the 91 patients with 6 month IVUS, the primary endpoint of in-stent percent volume obstruction did not differ between the treatment groups (41% in each group, p=0.9). In a post-hoc analysis restricted to insulin-requiring patients, percent volume obstruction trended lower in patients treated with abciximab (36.7% vs 53.5%, p=0.075), but there was no difference in non-insulin-requiring patients (42.4% vs 37.8%, p=0.3).
Interpretation:
Among patients with type 2 diabetes undergoing elective stent implantation for a de novo lesion in a native coronary artery, treatment with abciximab was not associated with a reduction in the primary endpoint of in-stent percent volume obstruction by IVUS at 6 month follow-up compared with no abciximab treatment. Additionally, there was no difference in clinical or angiographic endpoints. These data differ from data in the EPISTENT substudy of diabetic patients, which reported lower target vessel revascularization and trend towards lower angiographic late loss in diabetic patients treated with abciximab. The one promising finding was the trend toward lower percent volume obstruction with abciximab in insulin-requiring patients; however, the finding did not reach signficance and was a post-hoc analysis so data should be interpreted with caution. It should also be noted that there was no difference in the rate of target vessel revascularization (i.e. clinical restenosis) between abciximab and aggrastat in the TARGET study, leading the investigators to conclude that the non glycoprotein 2b3a properties of abciximab are not associated with a reduction in restenosis.
References:
Chaves AJ, et al. Volumetric Analysis of In-Stent Intimal Hyperplasia in Diabetic Patients Treated With or Without Abciximab. Circulation. 2004;109:861-866.
Keywords: Insulin, Coronary Artery Disease, Follow-Up Studies, Platelet Aggregation Inhibitors, Diabetes Mellitus, Type 2, Immunoglobulin Fab Fragments, Constriction, Pathologic, Hyperplasia, Tyrosine, Stents, Research Personnel
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