OBJECTIVES: The purpose of this study was to compare the mechanisms, predictors and outcome of patients with failed direct coronary angioplasty of the infarct-related artery with those in patients with successful direct angioplasty. BACKGROUND: Direct coronary angioplasty of the infarct-related artery, without antecedent thrombolytic therapy, is an effective treatment for patients with acute myocardial infarction. Concern has been expressed over high mortality rates in patients with failed direct infarct angioplasty. METHODS: All patients treated by angioplasty were prospectively entered into a computer data base. The characteristics and outcome of all patients with failed direct angioplasty were reviewed and compared with those of patients with successful direct angioplasty. RESULTS: Direct angioplasty was successful in 705 (94%) of 750 patients and unsuccessful in 45 (6%). Patients in the failure group were more likely to be in cardiogenic shock (22% vs. 7%, p < 0.003), to have had a previous myocardial infarction (44% vs. 28%, p < 0.03) and to have three-vessel coronary artery disease (44% vs. 23%, p < 0.003). Age, gender, ejection fraction, previous bypass surgery and diabetes mellitus were similar in both groups. Only the presence of multivessel coronary artery disease (p < 0.004) and cardiogenic shock (p < 0.025) were independent predictors of failed direct angioplasty. In-hospital death (31% vs. 4.8%, p < 0.001) and the need for emergency coronary artery bypass surgery (27% vs. 0.5%, p < 0.0001) were more frequent in patients with unsuccessful than in patients with successful direct angioplasty. Patients with failed direct angioplasty and in-hospital death usually had multiple high risk characteristics, including cardiogenic shock (50%), previous myocardial infarction (43%) and multivessel coronary artery disease (93%). CONCLUSIONS: Direct coronary angioplasty is an effective method for establishing reperfusion in acute myocardial infarction. Procedural failure is infrequent, usually occurring in patients with high risk baseline characteristics.