Assessing the role of eptifibatide in patients with diffuse coronary disease undergoing drug-eluting stenting: The INtegrilin plus STenting to Avoid myocardial Necrosis Trial

Giuseppe Biondi-Zoccai, Marco Valgimigli, Massimo Margheri, Antonio Marzocchi, Corrado Lettieri, Amerigo Stabile, A. Sonia Petronio, Giorgio Binetti, Leonardo Bolognese, Pietro Bellone, Gennaro Sardella, Marco Contarini, Imad Sheiban, Sebastiano Marra, Federico Piscione, Francesco Romeo, Antonio Colombo, Giuseppe Sangiorgi

Research output: Contribution to journalArticlepeer-review

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.

Original languageEnglish
JournalAmerican Heart Journal
Volume163
Issue number5
DOIs
Publication statusPublished - May 2012

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine

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