Platelet glycoprotein IIb/IIIa integrin blockade with eptifibatide in coronary stent intervention: the ESPRIT trial: a randomized controlled trial.
BACKGROUND
The Enhanced Suppression of the Platelet IIb/IIIa Receptor with Integrilin Therapy (ESPRIT) trial showed the efficacy of adjunctive, double-bolus eptifibatide therapy in reducing ischemic complications of nonurgent coronary stent implantation at 48 hours and at 30 days.


OBJECTIVE
To determine whether the beneficial effects of eptifibatide persist at 6 months after treatment.


METHODS
Follow-up study of a randomized, double-blind, placebo-controlled, crossover-permitted trial conducted from June 1999 through February 2000.


METHODS
Ninety-two tertiary care centers in the United States and Canada.


METHODS
A total of 2064 patients scheduled to undergo nonurgent percutaneous coronary intervention with stent implantation.


METHODS
Patients were randomly assigned to receive placebo or eptifibatide (two 180-microg/kg boluses 10 minutes apart and continuous infusion of 2.0 microg/kg per minute), started immediately before stent implantation and continued for 18 to 24 hours. Complete follow-up data were available for 988 (95.0%) of 1040 patients given eptifibatide and 977 (95.4%) of 1024 patients given placebo.


METHODS
Composite rates of death or myocardial infarction (MI); death, MI, or target vessel revascularization; and their individual components 6 months after enrollment, compared between the 2 groups.


RESULTS
By 6 months, the composite end point of death or MI had occurred in 7.5% of eptifibatide-treated patients and in 11.5% of placebo-treated patients (hazard ratio [HR], 0.63; 95% confidence interval [CI], 0.47-0.84; P =.002). The composite of death, MI, or target vessel revascularization was 14.2% in eptifibatide-treated patients vs 18.3% in placebo-treated patients (HR, 0.75; 95% CI, 0.60-0.93; P =.008). Most of this benefit accrued early (<48 hours after initiation of therapy) and was maintained through 6 months. Six-month mortality in the eptifibatide group was 0.8% vs 1.4% in the placebo group (HR, 0.56; 95% CI, 0.24-1.34; P =.19) and target vessel revascularization occurred in 8.6% of the eptifibatide group vs 9.4% of the placebo group (HR, 0.91; 95% CI, 0.68-1.22; P =.51).


CONCLUSIONS
Adjunctive eptifibatide therapy during coronary stent implantation provides benefit through 6-month follow-up.
O'Shea
J C
JC
Duke Clinical Research Institute, PO Box 17969, Durham, NC 27705, USA.
Hafley
G E
GE
Greenberg
S
S
Hasselblad
V
V
Lorenz
T J
TJ
Kitt
M M
MM
Strony
J
J
Tcheng
J E
JE
D000368:Aged; D015906:Angioplasty, Balloon, Coronary; D018592:Cross-Over Studies; D004311:Double-Blind Method; D000077542:Eptifibatide; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction; D009204:Myocardial Revascularization; D010455:Peptides / Q000627:therapeutic use*; D010975:Platelet Aggregation Inhibitors / Q000627:therapeutic use*; D019039:Platelet Glycoprotein GPIIb-IIIa Complex / Q000037:antagonists & inhibitors*; D016016:Proportional Hazards Models; D015607:Stents; D016019:Survival Analysis; D013997:Time Factors; D016896:Treatment Outcome
D010455:Peptides; D010975:Platelet Aggregation Inhibitors; D019039:Platelet Glycoprotein GPIIb-IIIa Complex; D000077542:Eptifibatide