Reno, a European postmarket surveillance registry, confirms effectiveness of coronary brachytherapy in routine clinical practice

Purpose: To assess, by a European registry trial, the clinical event rate in patients with discrete stenotic lesions of coronary arteries (de novo or restenotic) in single or multiple vessels (native or bypass grafts) treated with β-radiation. Methods and materials: Between April 1999 and September 2000, 1098 consecutive patients treated in 46 centers in Europe and the Middle East with the Novoste Beta-Cath System were included in Registry Novoste (RENO). Results: Six-month follow-up data were obtained for 1085 patients. Of 1174 target lesions, 94.1% were located in native vessels and 5.9% in a bypass graft; 17.7% were de novo lesions, 4.1% were restenotic, and 77.7% were in-stent restenotic lesions. Intravascular brachytherapy was technically successful in 95.9% of lesions. Multisegmental irradiation, using a manual pullback stepping maneuver to treat longer lesions, was used in 16.3% of the procedures. The in-hospital rate of major adverse cardiac events was 1.8%. At 6 months, the rate was 18.7%. Angiographic follow-up was available for 70.4% of the patients. Nonocclusive restenosis was seen in 18.8% and total occlusion in 5.7% of patients. A combined end point for late (30–180 days) definitive or suspected target vessel closure was reached in 5.4%, but with only 2% of clinical events. Multivariate analysis was performed for major adverse cardiac events and late thrombosis. Conclusion: Data obtained from the multicenter RENO registry study, derived from a large cohort of unselected consecutive patients, suggest that the good results of recent randomized controlled clinical trials can be replicated in routine clinical practice.