title: Assessing the role of eptifibatide in patients with diffuse coronary disease undergoing drug-eluting stenting: the INtegrilin plus STenting to Avoid myocardial Necrosis Trial.
abstract: BACKGROUND
  The optimal antiplatelet regimen in elective patients undergoing complex percutaneous coronary interventions (PCIs) is uncertain. We aimed to assess the impact of glycoprotein IIb/IIIa (GpIIb/IIIa) inhibition with eptifibatide in clinically stable subjects with diffuse coronary lesions.
  
  
  METHODS
  Patients with stable coronary artery disease undergoing PCI by means of implantation of >33 mm of drug-eluting stent were single-blindedly randomized to heparin plus eptifibatide versus heparin alone. The primary end point was the rate of abnormal post-PCI creatine kinase-MB mass values. Secondary end points were major adverse cardiovascular events (MACEs) (ie, cardiac death, myocardial infarction, or urgent revascularization) and MACE plus bailout GpIIb/IIIa inhibitor use.
  
  
  RESULTS
  The study was stopped for slow enrollment and funding issues after including a total of 91 patients: 44 were randomized to heparin plus eptifibatide, and 47, to heparin alone. Analysis for the primary end point showed a trend toward lower rates of abnormal post-PCI creatine kinase-MB mass values in the heparin-plus-eptifibatide group (18 [41%]) versus the heparin-alone group (26 [55%], relative risk 0.74 [95% CI 0.48-1.15], P = .169). Similar nonstatistically significant trends were found for rates of MACE, their components, or MACE plus bailout GpIIb/IIIa inhibitors (all P > .05). Notably, heparin plus eptifibatide proved remarkably safe because major bleedings or minor bleeding was uncommon and nonsignificantly different in both groups (all P > .05).
  
  
  CONCLUSIONS
  Given its lack of statistical power, the INSTANT study cannot definitively provide evidence against or in favor of routine eptifibatide administration in stable patients undergoing implantation of multiple drug-eluting stent for diffuse coronary disease. However, the favorable trend evident for the primary end point warrants further larger randomized studies.
authors.affiliation: Department of Medico-Surgical Sciences and Biotechnologies, Sapienza University of Rome, Corso della Repubblica 79, Latina, Italy. gbiondizoccai@gmail.com
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Biondi-Zoccai
authors.forename: Marco
authors.initials: M
authors.lastname: Valgimigli
authors.forename: Massimo
authors.initials: M
authors.lastname: Margheri
authors.forename: Antonio
authors.initials: A
authors.lastname: Marzocchi
authors.forename: Corrado
authors.initials: C
authors.lastname: Lettieri
authors.forename: Amerigo
authors.initials: A
authors.lastname: Stabile
authors.forename: A Sonia
authors.initials: AS
authors.lastname: Petronio
authors.forename: Giorgio
authors.initials: G
authors.lastname: Binetti
authors.forename: Leonardo
authors.initials: L
authors.lastname: Bolognese
authors.forename: Pietro
authors.initials: P
authors.lastname: Bellone
authors.forename: Gennaro
authors.initials: G
authors.lastname: Sardella
authors.forename: Marco
authors.initials: M
authors.lastname: Contarini
authors.forename: Imad
authors.initials: I
authors.lastname: Sheiban
authors.forename: Sebastiano
authors.initials: S
authors.lastname: Marra
authors.forename: Federico
authors.initials: F
authors.lastname: Piscione
authors.forename: Francesco
authors.initials: F
authors.lastname: Romeo
authors.forename: Antonio
authors.initials: A
authors.lastname: Colombo
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Sangiorgi
mesh_terms: D000368:Aged; D015906:Angioplasty, Balloon, Coronary / Q000009:adverse effects / Q000379:methods* / Q000401:mortality; D017023:Coronary Angiography / Q000379:methods; D023921:Coronary Stenosis / Q000000981:diagnostic imaging / Q000401:mortality / Q000628:therapy*; D054855:Drug-Eluting Stents; D000077542:Eptifibatide; D005260:Female; D005500:Follow-Up Studies; D006493:Heparin / Q000008:administration & dosage; D006801:Humans; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000473:pathology / Q000517:prevention & control*; D010455:Peptides / Q000008:administration & dosage*; D010975:Platelet Aggregation Inhibitors / Q000008:administration & dosage; D016016:Proportional Hazards Models; D018570:Risk Assessment; D012720:Severity of Illness Index; D016037:Single-Blind Method; D018709:Statistics, Nonparametric; D016019:Survival Analysis; D016896:Treatment Outcome
chemical_list: D010455:Peptides; D010975:Platelet Aggregation Inhibitors; D006493:Heparin; D000077542:Eptifibatide