Je. Tcheng et al., Novel dosing regimen of eptifibatide in planned coronary stent implantation (ESPRIT): a randomised, placebo-controlled trial, LANCET, 356(9247), 2000, pp. 2037-2044
Citations number
28
Language
INGLESE
art.tipo
Article
Categorie Soggetti
General & Internal Medicine","Medical Research General Topics
Background The platelet glycoprotein IIb/IIIa inhibitors, although effectiv
e in reducing ischaemic complications of percutaneous coronary intervention
. are used in few coronary stent implantation procedures. ESPRIT (Enhanced
Suppression of the Platelet IIb/IIIa Receptor with Integrilin Therapy) is a
randomised, placebo-controlled trial to assess whether a novel, double-bol
us dose of eptifibatide could improve outcomes of patients undergoing coron
ary stenting.
Methods We recruited 2064 patients undergoing stent implantation in a nativ
e coronary artery. Immediately before percutaneous coronary intervention, p
atients were randomly allocated to receive eptifibatide, given as two 180 m
ug/kg boluses 10 min apart and a continuous infusion of 2.0 mug/kg/min for
18-24 h, or placebo, in addition to aspirin, heparin, and a thienopyridine.
The primary endpoint was the composite of death, myocardial infarction, ur
gent target vessel revascularisation, and thrombotic bailout glycoprotein I
Ib/IIIa inhibitor therapy within 48 h after randomisation. The key secondar
y endpoint was the composite of death, myocardial infarction, or urgent tar
get vessel revascularisation at 30 days.
Findings The trial was terminated early for efficacy. The primary endpoint
was reduced from 10.5% (108 of 1024 patients on placebo [95% CI 8.7-12.4%])
to 6.6% (69 of 1040 [5.1-8.1%]) with treatment (p=0.0015). The key 30 day
secondary endpoint was also reduced, from 10.5% (107 of 1024 patients on pl
acebo [8.6-12.3%]) to 6.8% (71 of 1040 [5.3-8.4%]; p=0.0034). There was con
sistency in reduction of events across all components of the composite endp
oint and among the major subgroups. Major bleeding was infrequent but arose
more often with eptifibatide than placebo (1.3%, 13 of 1040 [0.7-2.1%]) vs
0.4%, 4 of 1024 [0.1-1.0%]; p=0.027).
Interpretation Routine glycoprotein IIb/IIIa inhibitor pretreatment with ep
tifibatide substantially reduces ischaemic complications in coronary stent
intervention and is better than a strategy of reserving treatment to the ba
ilout situation.