The NUGGET study: NIR ultra gold-gilded equivalency trial.
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.
Reifart
Nicolaus
N
Main Taunus Heart Institute, Bad Soden, Germany. n.reifart@reifart-partner.de
Morice
Marie-Claude
MC
Silber
Sigmund
S
Benit
Edouard
E
Hauptmann
K E
KE
de Sousa
Eduardo
E
Webb
John
J
Kaul
Upendra
U
Chan
Charles
C
Thuesen
Leif
L
Guagliumi
Giulio
G
Cobaugh
Michael
M
Dawkins
Keith
K
D000368:Aged; D015906:Angioplasty, Balloon, Coronary; D019917:Blood Vessel Prosthesis Implantation; D020099:Coated Materials, Biocompatible / Q000493:pharmacokinetics*; D017023:Coronary Angiography; D023903:Coronary Restenosis / Q000175:diagnosis / Q000209:etiology / Q000401:mortality; D023921:Coronary Stenosis / Q000628:therapy; D005260:Female; D005500:Follow-Up Studies; D006046:Gold / Q000493:pharmacokinetics*; D006801:Humans; D008297:Male; D008875:Middle Aged; D011183:Postoperative Complications / Q000175:diagnosis / Q000209:etiology / Q000401:mortality; D011446:Prospective Studies; D015607:Stents; D016019:Survival Analysis; D013810:Therapeutic Equivalency; D016896:Treatment Outcome; D018084:Ultrasonography, Interventional
D020099:Coated Materials, Biocompatible; D006046:Gold