A multicentre European registry of intraluminal coronary beta brachytherapy.
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Aims To assess the feasibility, safety and effectiveness of intravascular brachytherapy (VBT) in routine clinical practice. Methods and results Between April 1999 and September 2000, 1098 consecutive patients treated in 46 European centres by intraluminal irradiation using a Sr/Y90source train (BetaCath™, Novoste, GA) were included in a registry, and follow-up data were obtained for 98.8% of them after 6.3±2.4 months. Eight hundred and forty (76.5%) patients were males, and mean age was 62.0±10.2 years. Two hundred and seventy-one (26.9%) had unstable angina, and 256 (23.5%) were diabetics. Nine hundred and thirteen lesions (77.7%) were the result of in-stent restenosis, 208 (17.7%) were de novo lesions and 48 (4.1%) non-stented restenotic lesions. Mean estimated reference diameter was 3.2±0.5mm and mean estimated lesion length was 19.0±11.8mm. The prescribed radiation dose was 18.8±3.2Gy. Multivessel irradiation was done in 6.2% of cases, and a new stent was implanted in 29.6% of cases. Most patients received 6 or 12 months of combined aspirin and thienopyridin treatment after the procedure. Technical success was obtained in 95.9% of treated lesions, and the in-hospital major adverse cardiac event (MACE) rate was 1.8%. At follow-up, the MACE rate was 18.7% (1.9% deaths from any cause, 2.6% AMI, 13.3% TVR by PCI and 3.3% TVR by CABG). Conclusion The major current application of VBT is the treatment of in-stent restenosis. The good results of VBT observed in recent randomized controlled trials can be reproduced in clinical practice.