Is direct coronary stenting the best strategy for long-term outcome? Results of the multicentric randomized benefit evaluation of direct coronary stenting (BET) study.

Background: Preliminary trials of direct coronary stenting have demonstrated the benefits of this approach. It lowers procedural cost, time, and radiation exposure compared with predilatation. Nevertheless, the long-term outcome after direct stenting remains less well known.

Methods: Between January and September 1999, 338 patients were randomly assigned to either direct stent implantation (DS+, n = 173) or standard stent implantation with balloon predilatation (DS-, n = 165). Clinical follow-up was performed.

Results: Baseline 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- (not significant). Clinical follow-up was obtained in 99% of patients (mean 16.4 +/- 4.6 months). Major adverse cardiac events--defined as whichever of the following occurred first; cardiac death, myocardial infarction, unstable angina, new revascularization--were observed at a higher rate in the DS+ group than in the DS-, but this difference was not significant (11.3% vs 18.2%, P = not significant). The difference in target lesion revascularization rate in the DS+ group (7%) and DS- group (5.2%) was also not significant. Multivariate analysis showed that direct stenting had no influence on long-term major adverse cardiac events rate. Independent relationships were found between long-term major adverse cardiac events rate and final minimal lumen diameter <2.48 mm (relative risk [RR] 0.449, CI 0.239-0.845, P =.013), prior myocardial infarction (RR 2.028, CI 1.114-3.69, P =.02), and hypertension (RR 1.859, CI 1.022-3.383, P =.042).

Conclusion: The main finding that emerges from this randomized study is that the influence of direct stenting on long-term need for new target lesion revascularization does not differ from that of stenting with balloon predilatation.