Intracoronary β-irradiation with a rhenium-188-filled balloon catheter: a randomized trial in patients with de novo and restenotic lesions ☆

Background— Restenosis requiring reintervention is the main limitation of coronary angioplasty. Intracoronary irradiation reduces neointimal proliferation. We studied the efficacy of a self-centering liquid rhenium-188–filled balloon catheter for coronary β-brachytherapy. Methods and Results— After successful coronary angioplasty with or without stenting, 225 patients (71% de novo lesions) were randomly assigned to receive 22.5 Gy intravascular β-irradiation in 0.5-mm tissue depth (n=113) or to receive no additional intervention (n=112). Clinical and procedural data did not differ between the groups except a higher rate of stenting in the control group (63%) compared with the rhenium-188 group (45%, P<0.02). After 6 months of follow-up, late loss was significantly lower in the irradiated group compared with the control group, both of the target lesion (0.11±0.54 versus 0.69±0.81 mm, P<0.0001) and of the total segment (0.22±0.67 versus 0.70±0.82 mm, P<0.0001). This was also evident in the subgroup of patie...