Coronary radiation therapy with liquid rhenium-186: a first clinical experience.

BACKGROUND: Coronary radiation therapy (CRT) is a new, attractive approach for the treatment and prevention of restenosis after percutaneous coronary interventions (PCI). The RadioCath device consists of a standard balloon dilatation catheter that can be charged with a solution of sodium 186Re perrhenate, a predominant beta emitter. The safety and performance of this new device was evaluated in a pilot trial. METHODS AND RESULTS: Thirty-three patients with a de novo lesion in a native coronary artery were treated with the RadioCath device after successful angioplasty. The average dwell time to deliver a dose of 20 Gy at 0.5 mm into the vessel wall was 418+/-64 seconds. The treatment was well tolerated by most of the patients. In 79%, only one inflation cycle was required to deliver the prescribed dose. There were two procedural device-related complications (5.9%) and three minor procedural related in-hospital complications (9%). CONCLUSIONS: CRT using a balloon catheter device, charged with a sodium 186Re perrhenate solution, seems feasible and safe. Clinical and angiographic 6-month follow-up data are pending.