Volumetric analysis of in-stent intimal hyperplasia in diabetic patients treated with or without abciximab: results of the Diabetes Abciximab steNT Evaluation (DANTE) randomized trial.
BACKGROUND
In diabetic patients in the Evaluation of Platelet IIb/IIIa Inhibitor for Stenting (EPISTENT) trial, abciximab reduced target vessel revascularization by approximately 50% compared with placebo. Whether this is a result of a lower restenosis rate caused by inhibition of intimal hyperplasia remains to be defined.


RESULTS
The purpose of this study was to determine whether abciximab at the time of stent implantation would reduce in-stent intimal hyperplasia measured by intravascular ultrasound at 6-month follow-up in type 2 diabetics. Ninety-six diabetic patients (96 lesions) who underwent elective stent implantation for a de novo lesion in a native coronary artery were randomly assigned to receive abciximab or no abciximab. In-stent intimal hyperplasia volume, expressed as percentage of stent volume, did not differ between groups: 41.3+/-21.0% for those treated with abciximab versus 40.5+/-18.3% for those treated without abciximab (P=0.9). There were also no significant differences in angiographic minimal luminal diameter at follow-up (1.74+/-0.69 versus 1.66+/-0.63 mm; P=0.5), late loss (1.03+/-0.63 versus 1.07+/-0.58 mm; P=0.7), restenosis rate (17.8% versus 22.9%; P=0.5), or cumulative incidence of major adverse cardiac events at 12 months (19.1% versus 20.4%; P=0.9).


CONCLUSIONS
Six-month intravascular ultrasound volumetric analysis showed that abciximab, at the time of coronary stent implantation, was not associated with a reduction of in-stent intimal hyperplasia in diabetic patients.
Chaves
Aurea J
AJ
Instituto Dante Pazzanese de Cardiologia, São Paulo, Brazil.
Sousa
Amanda G M R
AG
Mattos
Luiz A
LA
Abizaid
Alexandre
A
Staico
Rodolfo
R
Feres
Fausto
F
Centemero
Marinella
M
Tanajura
Luiz F
LF
Abizaid
Andrea
A
Pinto
Ibraim
I
Maldonado
Galo
G
Seixas
Ana
A
Costa
Marco A
MA
Paes
Angela
A
Mintz
Gary S
GS
Sousa
J Eduardo
JE
D000077284:Abciximab; D000368:Aged; D000911:Antibodies, Monoclonal / Q000494:pharmacology / Q000627:therapeutic use*; D001938:Brazil / Q000453:epidemiology; D002318:Cardiovascular Diseases / Q000453:epidemiology / Q000517:prevention & control; D017023:Coronary Angiography; D023903:Coronary Restenosis / Q000000981:diagnostic imaging / Q000453:epidemiology / Q000517:prevention & control*; D023921:Coronary Stenosis / Q000150:complications / Q000188:drug therapy / Q000473:pathology / Q000601:surgery*; D003924:Diabetes Mellitus, Type 2 / Q000150:complications / Q000473:pathology*; D018572:Disease-Free Survival; D017558:Elective Surgical Procedures; D005260:Female; D006801:Humans; D006965:Hyperplasia; D021621:Imaging, Three-Dimensional; D007140:Immunoglobulin Fab Fragments / Q000494:pharmacology / Q000627:therapeutic use*; D015994:Incidence; D015993:Life Tables; D008297:Male; D008875:Middle Aged; D010975:Platelet Aggregation Inhibitors / Q000494:pharmacology / Q000627:therapeutic use*; D011183:Postoperative Complications / Q000453:epidemiology / Q000517:prevention & control; D011446:Prospective Studies; D016037:Single-Blind Method; D015607:Stents; D017211:Treatment Failure; D017539:Tunica Intima / Q000000981:diagnostic imaging / Q000473:pathology*; D018084:Ultrasonography, Interventional / Q000379:methods
D000911:Antibodies, Monoclonal; D007140:Immunoglobulin Fab Fragments; D010975:Platelet Aggregation Inhibitors; D000077284:Abciximab