Brachytherapy Effective in Preventing Restenosis

The study involved 46 hospitals in Europe and the Middle East and a total of 1,098 patients, 78% of whom were treated for in-stent restenosis. Follow-up studies were conducted on 98% of the patients.

The trial focused on major acute coronary events six months after brachytherapy treatment: death, heart attack, and the need for revascularization procedures. The rate of a study patient having one of these events was 18.7% overall. For patients treated for in-stent restenois, the rate was 17.7%. The system used in the study was the Beta-Cath System of Novoste Corp. (Norcross, GA, USA). The system is used in conjunction with a balloon angioplasty procedure. Immediately after the balloon procedure, the Beta-Cath System is used to temporarily deliver beta radiation to the treatment site. The beta radiation is placed in the body for less than five minutes, only exposes the treatment site, and does not travel elsewhere in the body.

The procedure is designed to inhibit cell growth and prevent restenosis of the artery at the treatment site. An earlier clinical feasibility study showed that patients treated with the Beta-Cath System had an improvement of more than 50% in restenosis rates compared to a control group that did not receive the therapy. The Beta-Cath System has been cleared by the U.S. Food and Drug Administration (FDA).




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