Objectives: This study is a prospective randomized trial investigating clinical outcomes of patients with acute myocardial infarction (AMI) treated with abciximab (ReoPro)-coated stents.
Background: Recently we have demonstrated that abciximab-coated stents have inhibitory effects in the prevention of coronary restenosis.
Methods: Ninety-six patients with AMI were randomly allocated into two groups; group I received abciximab-coated stents (n = 48, 57.1 +/- 12.0 years), and group II received bare metal control stents (n = 48, 58.4 +/- 11.6 years).
Results: At baseline, clinical characteristics, percent diameter stenosis, and minimal luminal diameter were no different between the two groups. One patient in group II had reinfarction and target lesion reintervention during hospital stay. Follow-up coronary angiography was obtained in 77.1% (37 of 48) in group I and 75.0% (36 of 48) in group II. Percent diameter stenosis and late loss were significantly lower in group I than group II (18.9 +/- 5.54% vs. 37.9 +/- 6.25%, p = 0.008; and 0.39 +/- 0.29 mm vs. 0.88 +/- 0.45 mm; p = 0.008, respectively). At follow-up intravascular ultrasound, intrastent lumen area and intrastent neointimal hyperplasia (NIH) area were 5.4 +/- 1.8 mm2 and 2.2 +/- 1.5 mm2, respectively, in group I and 4.3 +/- 1.6 mm2 and 3.4 +/- 1.8 mm2, respectively, in group II (p = 0.045). And, in-stent restenosis rate was lower in group I than group II (p = 0.011 and p = 0.008, respectively). During 1-year follow-up, two patients in group II (4.1%) had AMI, whereas no patient in group I suffered AMI. Target lesion revascularization and total major adverse cardiac events rates were relatively lower in group I compared with those in group II (10.4% [5 of 48] vs. 20.8% [10 of 48], p = 0.261, and 10.4% vs. 25.0%, p = 0.107, respectively).
Conclusions: Abciximab-coated stent implantation was safe and effective without stent thrombosis in AMI patients.