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.
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.


METHODS
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.


CONCLUSIONS
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.
Biondi-Zoccai
Giuseppe G L
GG
Interventional Cardiology, Division of Cardiology, University of Turin, Turin, Italy.
Valgimigli
Marco
M
Sheiban
Imad
I
Margheri
Massimo
M
Marzocchi
Antonio
A
Prati
Francesco
F
Vischi
Massimo
M
Lettieri
Corrado
C
Violini
Roberto
R
Sardella
Gennaro
G
Stabile
Amerigo
A
Clementi
Fabrizio
F
Romeo
Francesco
F
Colombo
Antonio
A
Sangiorgi
Giuseppe
G
D015906:Angioplasty, Balloon, Coronary; D003324:Coronary Artery Disease / Q000188:drug therapy / Q000628:therapy*; D052279:Creatine Kinase, MB Form / Q000097:blood; D054855:Drug-Eluting Stents; D023381:Endpoint Determination; D000077542:Eptifibatide; D005260:Female; D006801:Humans; D008297:Male; D010455:Peptides / Q000627:therapeutic use*; D010975:Platelet Aggregation Inhibitors / Q000627:therapeutic use*; D019039:Platelet Glycoprotein GPIIb-IIIa Complex / Q000037:antagonists & inhibitors*; D012107:Research Design; D016037:Single-Blind Method
D010455:Peptides; D010975:Platelet Aggregation Inhibitors; D019039:Platelet Glycoprotein GPIIb-IIIa Complex; D052279:Creatine Kinase, MB Form; D000077542:Eptifibatide