Intracoronary β-irradiation for the treatment of de novo lesions:: 5-Year clinical follow-up of the BetAce randomized trial

Background Vascular brachytherapy (VBT) has been used for the prevention of restenosis. Despite initial positive results, long-term follow-up has shown a progressive loss of benefit in clinical outcome after beta-irradiation. We report the 5-year follow-up of the BetAce trial. Methods This prospective, randomized, single-blind trial included 61 patients treated for 64 de novo coronary lesions: 3 1 patients (33 stenoses) were treated with bare metal stents (control group), and 30 patients (3 1 stenoses) were treated with intracoronary beta-irradiation at the time of stented angioplasty (VBT group). Results Baseline and procedural data were similar between treatment arms. At 6 months, VBT reduced the need for target vessel revascularization (13% vs 35.5%, P =.04), but there was no significant difference in the 6- and 12-month event-free survival when clinical events were ranked. Between 1 and 5 years, an increasing number of target vessel failures was observed in both groups, leading to a similar long-term clinical outcome at 5 years (event-free survival 43% and 45% in the VBT and control groups, respectively, log-rank 0.001, P =.9). Conclusions beta-Irradiation in de novo coronary lesions significantly reduced in-stent recurrences at 6 months compared with standard procedures. However, this initial benefit was not sustained in the long term. The results of this randomized study confirm the delayed and progressive restenotic process after beta-irradiation and stent implantation in de novo lesions.