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The emerging role of GP IIb/IIIa agents as adjuncts to catheter-based revasculari-zation in diabetics is predicated largely on post hoc analyses of existing clinical trials of unselected patients with CAD. Six prospective clinical trials have as-

sessed the effects of glycoprotein IIb/IIIa inhibitors in CAD patients undergoing PCI. In the EPIC trial, abciximab therapy led to a 35% reduction in the primary endpoint of death, MI, and urgent revascularization at 1 month—with a similar risk reduction in both diabetic and nondiabetic subgroups. At 3 years of follow-up, however, the overall clinical benefit was sustained in the total population, but in diabetics there was a progressive deterioration with more clinical events than nondiabetics. In the EPILOG trial, abciximab therapy in diabetics undergoing elective balloon PCI was associated with a significant reduction in death and MI at 30 days and 6 months, but target vessel revascularization was reduced only in the nondiabetic subgroup. Pooled data from the EPIC, EPILOG, and EPISTENT trials revealed that abciximab decreased 1-year mortality of diabetic patients compared to the placebo-treated diabetics. In the IMPACT-II trial, treatment with eptifibatide during coronary intervention reduced rates of early abrupt vessel closure and ischemic events at 30 days, and this benefit was observed equally in both diabetic and nondiabetic patients. In the RESTORE trial, tirofiban reduced early cardiac events in patients undergoing principally balloon PCI for acute coronary syndromes. Twenty-percent of all patients were diabetic, but no formal subgroup analysis was performed.

The EPISTENT trial evaluated the benefit of abciximab in patients with both stable and unstable CAD who were undergoing coronary stenting. Overall, this study showed a significant reduction in major adverse cardiac events at 30 days and 6 months in the abciximab-treated subjects compared with the stent-plus-placebo group. Importantly, the combination of stenting plus abciximab among diabetic patients resulted in a significant reduction in 6-month rates of death, MI, and target vessel revascularization compared with stent-plus-placebo or balloon angioplasty-plus-abciximab therapy. The significant reduction in target vessel revascularization associated with a significant increase in angiographic net gain and a trend toward a reduced late loss index in stented diabetic patients with CAD treated with abciximab compared to placebo suggests, for the very first time, a potential additive benefit of abciximab in reducing restenosis in diabetic patients treated with stents. The ERASER trial has shown that abciximab decreases neointimal proliferation when stents were used in diabetic subjects compared with placebo. This proliferation was assessed with intracoronary vascular ultrasound and was not reduced in the study group as a whole.

In summary, the EPISTENT trial demonstrates a significant reduction of major ischemic cardiac events and target vessel revascularization when stents are used in diabetic patients with CAD. This study confirms the important role of adjunctive GP IIb/IIIa inhibitors in this population. Clearly, additional investigations are needed to clarify the interaction between abciximab and diabetes and whether these salutary effects can be replicated with other GP IIb/IIIa agents.

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