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

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

来源：American Heart Journal, 2012, 163(5).

DOI：10.1016/j.ahj.2012.02.009

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. %26lt;br%26gt;Methods Patients with stable coronary artery disease undergoing PCI by means of implantation of %26gt;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. %26lt;br%26gt;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 %26gt; .05). Notably, heparin plus eptifibatide proved remarkably safe because major bleedings or minor bleeding was uncommon and nonsignificantly different in both groups (all P %26gt; .05). %26lt;br%26gt;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. (Am Heart J 2012;163:835.e1-835.e7.)

• 出版日期2012-5