Registry Novoste - RENO

Description:

The European surveillance registry with the Novoste beta-cath system.

Hypothesis:

Beta-radiation brachytherapy using the Novoste Betacath system is safe for treating restenotic lesions.

Study Design

Study Design:

Patients Enrolled: 1098

Patient Populations:

Approximately 78% of patients in this registry trial presented with in-stent restenosis and the remaining patients presented with de novo or restenotic lesions. This trial included diabetic patients (n=256), patients with long lesions (mean lesion length 25.9 mm, n=555) and patients with saphenous vein graft disease (n=67).

Primary Endpoints:

MACE TLR

Drug/Procedures Used:

The RENO registry began in April 1999 and included 1,098 patients from 46 hospitals throughout Europe and the Middle East. The registry assessed major adverse cardiac events (MACE), which include death, heart attack and the need for revascularization procedures, at 6 months following the initial radiation procedure. Approximately 78% of patients in this registry presented with in-stent restenosis and the remaining patients presented with de novo or restenotic lesions. This registry included diabetic patients (n=256), patients with long lesions (mean lesion length 25.9 mm, n=555) and patients with saphenous vein graft disease (n=67).

Principal Findings:

The results of the RENO registry demonstrated that beta radiation was associated with a relatively low MACE rate of 18.7% for all patients included in the study (17.7% in the in-stent restenosis group). This compares favorably to MACE rates of 18% to 28% published in prior randomized, placebo-controlled clinical trials for those patients receiving either beta or gamma radiation to treat in-stent restenosis.

Interpretation:

The RENO registry demonstrates that beta radiation can be safely applied to a broad range of patients. In so far as this is a registry, no conclusions can be reached regarding efficacy relative to other strategies.

References:

European Society of Cardiology Congress, 2001.

Clinical Topics: Invasive Cardiovascular Angiography and Intervention, Atherosclerotic Disease (CAD/PAD), Interventions and Coronary Artery Disease

Keywords: Registries, Coronary Artery Disease, Myocardial Infarction, Beta Particles, Saphenous Vein, Coronary Disease, Brachytherapy, Diabetes Mellitus, Gamma Rays, Stents


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