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 β-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: 31 patients (33 stenoses) were treated with bare metal stents (control group), and 30 patients (31 stenoses) were treated with intracoronary β-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 β-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 β-irradiation and stent implantation in de novo lesions.