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A randomized trial comparing eptifibatide vs. placebo in patients with diffuse coronary artery disease undergoing drug-eluting stent implantation: design of the INtegrilin plus STenting to Avoid myocardial Necrosis Trial

Biondi-Zoccai, Giuseppe, GLa; Valgimigli, Marcob,c; Sheiban, Imada; Margheri, Massimod; Marzocchi, Antonioe; Prati, Francescof; Vischi, Massimog; Lettieri, Corradoh; Violini, Robertoi; Sardella, Gennaroj; Stabile, Amerigok; Clementi, Fabriziol; Romeo, Francescol; Colombo, Antoniom,n; Sangiorgi, Giuseppel,m,n

doi: 10.2459/01.JCM.0000324810.94311.18
Research trial protocol: PDF Only

Background Despite the availability of several potent antithrombotic agents, the optimal antiplatelet regimen in elective patients undergoing complex percutaneous coronary interventions is still debated. Aim of the INtegrilin plus STenting to Avoid myocardial Necrosis Trial will be to assess the safety and efficacy of routine usage of the glycoprotein IIb/IIIa inhibitor eptifibatide in patients already treated with aspirin and clopidogrel and undergoing implantation of at least two drug-eluting stents in the same lesion, thus identifying a clinically stable but anatomically complex patient subset.

Design This will be a single-blind, placebo-controlled multicenter randomized trial.

Methods Patients with stable coronary artery disease, who are undergoing percutaneous coronary intervention by means of implantation of greater than 33 mm of drug-eluting stents (e.g. with two 23-mm drug-eluting stents or one 32-mm and one 12-mm drug-eluting stent), will be randomized, after administration of aspirin and clopidogrel (600 mg loading dose recommended), to eptifibatide and unfractioned heparin according to the ESPRIT protocol or placebo and unfractioned heparin. Blood draws for creatine kinase-MB mass, total creatine kinase, and cardiac troponin levels will be taken at baseline, 6 and 12 h postprocedurally. Patients will be followed for clinical events by direct visit or phone contact up to 6 months. The primary endpoint of the study will be the rate of abnormal values of creatine kinase-MB mass after percutaneous coronary intervention. Secondary endpoints will be the composite of cardiac death, nonfatal myocardial infarction, urgent target vessel revascularization, and thrombotic bailout glycoprotein IIb/IIIa inhibitor therapy within 180 days, and in-hospital, 1-month and 6-month major adverse cardiovascular events, defined as the composite of cardiac death, nonfatal myocardial infarction or urgent target vessel revascularization.

Implications The INtegrilin plus STenting to Avoid myocardial Necrosis Trial study will test for the first time the beneficial impact of routine glycoprotein IIb/IIIa inhibition on top of dual oral antiplatelet treatment in clinically stable yet anatomically complex patients undergoing drug-eluting stents implantation. Results of this single-blind randomized trial will provide important insights to improve the management strategy of patients and outcomes in the current drug-eluting stents era.

aInterventional Cardiology, Division of Cardiology, University of Turin, Turin, Italy

bInstitute of Cardiology, University of Ferrara, Ferrara, Italy

cCardiovascular Research Center, Salvatore Maugeri Foundation, IRCCS, Gussago, Italy

dDivision of Cardiology II, Careggi Hospital, Florence, Italy

eInstitute of Cardiology, Sant'Orsola Hospital, Bologna, Italy

fInstitute of Cardiology, San Giovanni Hospital, Rome, Italy

gInstitite of Cardiology, San Martino Hospital, Genoa, Italy

hCardiology Department, Carlo Poma Hospital, Mantova, Italy

iDivision of Cardiology, San Camillo Hospital, Rome, Italy

jDepartment of Cardiovascular Sciences University ‘La Sapienza’, Rome, Italy

kUnit of Interventional Cardiology, ARNAS, Palermo, Italy

lInstitute of Cardiology, Tor Vergata University, Rome, Italy

mInterventional Cardiology Unit, San Raffaele Hospital, Italy

nEMO Centro Cuore Columbus, Milan, Italy

Correspondence to Dr Giuseppe M. Sangiorgi, Emo Centro Cuore Columbus, Via Buonarroti 48-20145 Milan, Italy Fax: +39 02 48193433; e-mail:

© 2018 Italian Federation of Cardiology. All rights reserved.