Results of intracoronary beta-brachytherapy administered by 60 mm transfer device/radiation source train: a subgroup...

To investigate the safety and efficacy of a 60 mm transfer device, delivering 60 mm radiation source train, in the treatment of coronary lesions by b-brachytherapy employing the BetaCath system (Novoste, Norcross, Georgia).

As part of the REgistry NOvoste (RENO), the first large-scale registry of intracoronary beta-radiation applied in routine clinical practice, 46 centers registered 1,098 consecutive patients undergoing brachytherapy with the BetaCath system. Of these, 49 patients with 56 lesions were treated with a 60 mm transfer device/radiation source train (TD/RST) in at least 1 vessel, constituting the study population. With 75.4% in-stent restenosis (ISR), 3.6% graft lesions, long lesions (30.9 +/- 14.7 mm) and 19% diabetes, the cohort had a high-risk for recurrence. The in-hospital major adverse cardiac event (MACE) rate was 4.1%. The 6-month follow-up revealed 2.0% death, 4.1% myocardial infarction, 8.2% target vessel revascularization, 12.2% MACE, 82.6% improved angina, 16.7% binary restenosis and 4.1% late thrombosis. The results were comparable to all other patients in the registry treated with standard source lengths of 30 mm and 40 mm, although much longer lesions were treated by the 60 mm device (18.4 +/- 11.3 mm versus 30.9 +/- 14.7 mm; p < 0.0001). In the ISR subgroup (mean lesion length, 32.03 +/- 14.99 mm), the 6-month MACE rate was 12.8%, while the angiographic restenosis rate was 16.0% and the late thrombosis rate was 2.6%.

Beta-brachytherapy with 60 mm TD/RST was safe, feasible and effective in this broad population of high-risk patients presenting in day-to-day practice. Its efficacy in long-segment ISR, where conventional interventional strategies have poor outcome rates, is particularly noteworthy.