At EuroPCR 2013, held from 21st to 24th May, in Paris, France, one-year data from an Italian multicentre randomised controlled trial of Medtronic's IN.PACT Falcon drug-eluting balloon (DEB) demonstrated positive and durable clinical results with the novel angioplasty device in the treatment of stenotic de novo lesions in small coronary arteries.
The data come from the BELLO (Balloon Elution and Late Loss Optimization) study, which enrolled 182 patients across 15 hospitals in Italy to evaluate the safety and effectiveness of two medical devices: IN.PACT Falcon DEB and Boston Scientific's Taxus DE stent (DES). Nearly two-thirds (64.9 per cent) of the vessels treated in the BELLO study with the DEB were smaller than 2.25mm in diameter, for which no DES is currently available. The previously presented six-month angiographic outcomes of the BELLO study favoured patients treated with the DEB. The study met its primary endpoint, late lumen loss at six months, with statistical significance showing superiority of the DEB over the DES (0.08mm vs 0.29mm, p=0.001).
Building on these data, the latest results from the BELLO study continue to demonstrate favourable outcomes for the IN.PACT Falcon DEB. At one year, the clinical outcomes of major adverse cardiac events (MACE), myocardial infarction (MI) and target lesion revascularisation (TLR) were statistically similar for both devices:
â¢ MACE - DEB, 10.0 per cent; DES, 18.5 per cent (p=0.31);
â¢ MI - DEB, 1.1 per cent; DES, 5.5 per cent (p=0.10); and
â¢ TLR - DEB, 4.4 per cent, DES, 9.8 per cent (p=0.25).
Medtronic's IN.PACT Falcon DEB received CE mark in 2009. It is not commercially available in the US.