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 wit h and without balloon predilatation on duration of the procedure, reduction of procedure-related costs, and clinical outcomes. Although preliminary tr ials of direct coronary stenting have demonstrated promising results, the l ack 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 w ere randomly assigned to either direct stent implantation (DS+; 173 patient s) or standard stent implantation with balloon predilatation (DS-; 165 pati ents). Baseline clinical and angiographic characteristics were similar in t he 2 groups. Procedural success was achieved in 98.3% of patients assigned to DSS and 97.5% of patients assigned to DS- (p = NS), with a crossover rat e of 13.9%. Compared with DS-, DSS conferred a dramatic reduction in proced ure-related cost ($956.4 +/- $352.2 vs $1,164.6 +/- $383.9, p <0.0001) and duration of the procedure (424.2 +/- 412.1 vs 634.5 +/- 390.1 seconds, p <0 .0001). At 6-month follow-up, the incidence of major adverse cardiac events including death, angina pectoris, myocardial infarction, congestive heart failure, repeat angioplasty, or coronary artery bypass graft surgery was 5. 3% in DS+ and 11.4% in DS- (p = NS). Multivariate analysis demonstrated tha t major adverse cardiac events rates were related to stent length of 10 mm (relative risk [RR] 3.25, 95% confidence intervals [CI] 1.36 to 7.78; p = 0 .008), stent diameter of 3 mm (RR 2.69, 95% CI 1.03 to 7.06; p = 0.043), an d complex lesion type C (RR 2.83, 95% CI 1.02 to 7.85; p = 0.045). Thus, in selected patients, this prospective randomized study shows the feasibility of DS+ with reduction in procedural cost and length, and without an increa se in in-hospital clinical events and major adverse cardiac events at 6-mon th follow-up. (C) 2001 by Excerpta Medica, Inc.