We sought to identify the predictors and clinical outcomes of early thrombosis after primary angioplasty and stenting for acute myocardial infarction (AMI). Little is known about the correlates and prognosis of acute and subacute thromboses after percutaneous coronary intervention (PCI) for AMI. We therefore studied the frequency, clinical determinants, and implications of early thrombosis in a large trial of patients who had primary PCI. In the Controlled Abciximab and Device Investigation to Lower Late Angioplasty Complications trial, 2,082 patients who had AMI were randomized in a 2 x 2 factorial design to primary stenting or to balloon angioplasty, each with and without abciximab. Early thrombosis occurred in 19 patients (0.9%) at a median of 2 days (range 0 to 23). Maximal balloon diameter was smaller, and aneurysmal and bifurcation lesions were more prevalent in the group with early thrombosis. Early thrombosis occurred in 0.4% of patients who had been randomized to receive abciximab versus 1.5% of control patients (p <0.01) and in 0.5% of patients who had been randomized to undergo stenting versus 1.4% of those who underwent balloon angioplasty (p = 0.04). By multivariate analysis, abciximab use was an independent predictor of no thrombosis (hazard ratio 0.27, 95% confidence interval 0.09 to 0.86, p = 0.026). Within 30 days, 5.3% of patients who had early thrombosis died, 32.9% developed reinfarction, and 89.5% required repeat target vessel revascularization (including bypass surgery in 11.1%). As a result, patients who had versus those who did not have early thrombosis had markedly higher rates of major adverse cardiac events at 30 days (94.7% vs 5.0%, p <0.0001) and at 1 year (94.7% vs 16.9%, p <0.0001). Patients who develop early thrombosis after primary PCI have a very high rate of major adverse cardiac events, including death and reinfarction, and usually require repeat coronary angioplasty or surgery for management. Complex baseline angiographic morphology and smaller maximal balloon diameter are predictors of early thrombosis after primary PCI for AMI. The incidence of early thrombosis after primary angioplasty and stenting is decreased by abciximab use.