Comparison of direct coronary stenting with and without balloon predilatation in patients with stable angina pectoris

The purpose of this study was to compare the effects of stent placement with and without balloon predilatation on duration of the procedure, reduction of procedure-related costs, and clinical outcomes. Although preliminary trials of direct coronary stenting have demonstrated promising results, the lack of randomized studies with long-term follow-up has limited the critical evaluation of the role of direct stenting in the treatment of obstructive coronary artery disease. Between January and September 1999, 338 patients were randomly assigned to either direct stent implantation (DS+; 173 patients) or standard stent implantation with balloon predilatation (DS−; 165 patients). Baseline clinical and angiographic characteristics were similar in the 2 groups. Procedural success was achieved in 98.3% of patients assigned to DS+ and 97.5% of patients assigned to DS− (p = NS), with a crossover rate of 13.9%. Compared with DS−, DS+ conferred a dramatic reduction in procedure-related cost ($956.4 ± $352.2 vs $1,164.6 ± $383.9, p