Platelet Glycoprotein IIb/IIIa Integrin Blockade with Eptifibatide in Coronary Stent Intervention. The ESPRIT Trial: A Randomized Controlled Trial - ESPRIT Trial 6 Month Follow-up

Mar 11, 2002
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Date Presented:
01/01/2001
Date Published:
01/01/2001
Date Updated:
03/11/2002
Original Posted Date:
03/11/2002
References

Description:

Patient with coronary artery disease scheduled to undergo stent implantation were randomized to placebo or to eptifibatide. Eptifibatide administration included two 180 mcg/kg boluses10 min apart followed by an infusion of 2 mcg/kg/min for 18–24 hours. Bailout-blinded IIb/IIIa receptor therapy was allowed by providing a bailout kit containing eptifibatide for patients randomized to placebo and placebo for patients randomized to eptifibatide. Clinical end points evaluated included death or MI, a composite of death, MI or target vessel revascularization (TVR) or the combined end points at 6 months.

Hypothesis:

To determine whether the early beneficial effect observed with eptifibatide in patients undergoing coronary stenting persists at 6 months follow-up.

Study Design

Study Design:

Patients Enrolled: 2064
Mean Follow Up: 6 months

Drug/Procedures Used:

Patient with coronary artery disease scheduled to undergo stent implantation were randomized to placebo or to eptifibatide. Eptifibatide administration included two 180 mcg/kg boluses10 min apart followed by an infusion of 2 mcg/kg/min for 18–24 hours. Bailout-blinded IIb/IIIa receptor therapy was allowed by providing a bailout kit containing eptifibatide for patients randomized to placebo and placebo for patients randomized to eptifibatide. Clinical end points evaluated included death or MI, a composite of death, MI or target vessel revascularization (TVR) or the combined end points at 6 months.

Principal Findings:

Follow-up data were available for 977 of 1024 patients randomized to placebo (95.4%) and 988 of 1040 patients randomized to eptifibatide (95.0%). At 6 months, the composite end point of death or MI had occurred respectively in 7.5% of eptifibatide-treated patients and 11.5% of placebo-treated patients (risk ratio 0.63, 95% C.I. 0.47-0.84, p=0.002), while the composite of death, MI or TVR had occurred respectively in 14.2% and 18.2% of patients (risk ratio, 0.75; 95% C.I., 0.60-0.93). The 6-month mortality rate was 0.8% in the eptifibatide group and 1.4% in the placebo group (risk ratio 0.56; 95% C.I., 0.24–1.34; p=0.19). Kaplan-Mayer survival curves appeared to separate over time, with most of the difference in mortality occurring between 30 days and 6 months.

A double bolus of eptifibatide is safe and effective in reducing 6-month adverse outcomes in patients undergoing stent implantation.

Interpretation:

The persistent benefit observed at 6 months further supports the use of Gp IIb/IIIa receptor blockers as standard of care for patients undergoing stent implantation. The separation observed over time in the Kaplan-Mayer survival curves, although not significant is an important observation.

References:

1. O’Shea JC, Hafley GE, Greenberg S, et al., for the ESPRIT Investigators. JAMA 2001;285:2468-73.

Keywords: Odds Ratio, Coronary Artery Disease, Follow-Up Studies, Platelet Aggregation Inhibitors, Peptides, Standard of Care, Stents, Platelet Glycoprotein GPIIb-IIIa Complex


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