Direct stenting without antecedent dilatation may reduce procedural time, costs, and radiation exposure, and may result in less vessel injury. The purpose of this investigation was to compare immediate and long-term clinical and angiographic outcomes of direct stenting with stent placement after initial balloon dilation. Three hundred thirty-five symptomatic patients with single or multiple coronary lesions (diameter reduction 60% to 95%) of < or =30 mm length and with a vessel diameter of 2.5 to 4.0 mm were randomized either to direct stenting (group A, n = 171) or stenting after predilation (group B, n = 164). Patients with vessels with excessive calcification, severe proximal tortuosity, or occlusion were excluded. All patients were asked to return for routine repeat angiography at 6 months, irrespective of symptoms. Feasibility of direct stenting was 95% in group A, with 5% requiring crossover to predilation. Successful stent placement after predilation was performed in all 164 patients in group B. Direct stenting was associated with less procedural duration (group A 42.1 +/- 18.7 minutes vs group B 51.5 +/- 23.8 minutes, p = 0.004), radiation exposure time (group A 10.3 +/- 7.7 minutes vs group B 12.5 +/- 6.4 minutes, p = 0.002), amount of contrast dye used (group A 163 +/- 69 ml vs group B 197 +/- 84 ml, p <0.0001), and lower procedural costs (group A 845 +/- 167 vs group B 1,064 +/- 175, p <0.0001). Immediate angiographic results and in-hospital clinical outcomes (death, Q-wave myocardial infarction, repeat revascularization) were not significantly different between both strategies. However, at 6-month follow-up, direct stenting was associated with a lower angiographic restenosis (group A 20% vs group B 31%, p = 0.048) and target lesion revascularization rates (group A 18% vs group B 28%; p = 0.03). This study demonstrates the feasibility, safety, and outcomes of direct stenting in eligible coronary lesions. In appropriately selected cases, direct stenting has a lower rate of angiographic restenosis up to 6 months after the procedure, resulting in fewer coronary reinterventions compared with the conventional strategy of stenting with antecedent dilatation.