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

Abstract

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. (Am Heart J 2002;144:e7.)