Catheter Cardiovasc Interv. 2004 May;62(1):18-25

The NUGGET study: NIR ultra gold-gilded equivalency trial.

Reifart N, Morice MC, Silber S, Benit E, Hauptmann KE, de Sousa E, Webb J, Kaul U, Chan C, Thuesen L, Guagliumi G, Cobaugh M, Dawkins K.

Main Taunus Heart Institute, Bad Soden, Germany. n.reifart@reifart-partner.de

This study should clarify whether the gold-coated NIROYAL stent is equivalent to the stainless steel NIR stent. Patients were randomized to either NIR stent (n = 298) or a NIROYAL stent (n = 305). The primary endpoint was the minimum lumen diameter of the target lesion at 6 months postprocedure. Secondary endpoints focused on clinical events. At 30 days, adverse events were similar in both groups. At 6 months, the minimal lumen diameter was 1.83/1.64 mm (P < 0.001; 95% CI = 0.08-0.30) and the angiographic restenosis rate was 20.6%/37.7% (P < 0.001; 95% CI = -24.7 to -9.3) for NIR/NIROYAL. The 6-month MACE rates were NIR 7.4% and NIROYAL 10.5% (95% CI = -7.7 to 1.4). Compared to stainless steel stent, the NIROYAL stent demonstrated a smaller minimal lumen diameter, a higher late loss (i.e., higher neointimal hyperplasia in spite of a significantly better initial gain), with higher restenosis and similar MACE rates at 6 months. Copyright 2004 Wiley-Liss, Inc.

PMID: 15103594 [PubMed - in process]