Studies Compare Eptifibatide Versus Abciximab in Primary PCI

July 27, 2010—Two studies comparing eptifibatide versus abciximab in primary percutaneous coronary invention (PCI) were published in the Journal of the American College of Cardiology.

Uwe Zeymer, MD, et al published results from the EVA-AMI trial, which aimed to compare eptifibatide and abciximab as adjuncts to primary PCI (2010;56:463–469).

The investigators noted that the background for the study is that the glycoprotein (GP) IIb/IIIa receptor inhibitor, abciximab, as an adjunct to primary PCI in patients with ST-segment elevation myocardial infarction (STEMI), has been shown to reduce ischemic complications and improve clinical outcomes. However, no trial has been performed to compare the efficacy of another GP IIb/IIIa receptor inhibitor, eptifibatide, to abciximab for primary PCI.

As detailed by the investigators, a total of 427 patients with STEMI < 12 hours and planned primary PCI were randomized to double-bolus eptifibatide (n = 226) followed by a 24-hour infusion, or single-bolus abciximab (n = 201) followed by a 12-hour infusion. In this noninferiority trial, the primary endpoint was the incidence of complete (70%) ST-segment resolution (STR) at 60 minutes after PCI, which is a measure of myocardial reperfusion. The assumption was a 60% complete STR rate in the abciximab group. The noninferiority margin was set to 15%.

The investigators reported that the incidence of complete STR at 60 minutes after PCI in the intention-to-treat analysis was 62.6% after eptifibatide and 56.3% after abciximab (adjusted difference, 7.1%; 95% confidence interval [CI], 2.7%–17%). The all-cause mortality rate was 6.2% versus 4.5% (P = .5); reinfarction was 0.4% versus 3.5% (P = .03); target vessel revascularization was 4.4% versus 6.5% (P = .4); the combined endpoint of death, nonfatal reinfarction, and target vessel revascularization was 10.6% versus 10.9% (P = .9); stroke was 0.5% versus 0.5% (P = 1) after 6 months; and thrombolysis in MI major bleeding complications was 4% versus 2% (P = .2) after 30 days with eptifibatide and abciximab, respectively. Therefore, eptifibatide as an adjunct to primary PCI is equally as effective as abciximab with respect to STR, the investigators concluded.

Also in the Journal of the American College of Cardiology, Axel Åkerblom, MD, et al published results from the SCAAR (Swedish Coronary Angiography and Angioplasty Registry) study, which aimed to test the noninferiority of eptifibatide relative to abciximab in patients with STEMI who were treated with primary PCI (2010;56:470–475).

According to the investigators, GP IIb/IIIa inhibitors are recommended by international guidelines in patients with acute coronary syndromes undergoing PCI. Abciximab is recommended with a higher level of evidence than eptifibatide in patients with STEMI. No large, prospective, randomized trial comparing abciximab and eptifibatide has been published.

In this analysis, all STEMI patients in Sweden (N = 11,479) who underwent primary PCI and received either eptifibatide or abciximab from 2004 to 2007 were derived from the SCAAR study. The primary endpoint was death or MI during 1-year follow-up, with adjustment for baseline differences and a multivariate logistic regression analysis including propensity score. The prespecified noninferiority margin was set to 1.29.

The investigators reported that the combined endpoint occurred in 353 of 2,355 patients (15%) treated with eptifibatide and in 1,432 of 9,124 patients (15.7%) treated with abciximab. The unadjusted odds ratio (OR) for eptifibatide versus abciximab was 0.95 (95% CI, 0.84–1.08). Multivariate adjustment (n = 11,317) confirmed noninferiority, with an OR of 0.94 (95% CI, 0.82–1.09). The adjusted secondary endpoints of death and MI also separately showed noninferiority with ORs of 0.99 (95% CI, 0.82–1.19) and 0.88 (95% CI, 0.73–1.05), respectively.

The investigators concluded that this large registry study suggests that eptifibatide is noninferior to abciximab in patients with STEMI undergoing primary PCI with respect to death or MI during 1 year, thereby supporting the use of either drug in clinical practice.