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

Area of Science:

• Cardiovascular Medicine
• Interventional Cardiology
• Biomaterials Science

Background:

• Coronary artery disease necessitates the use of stents to maintain vessel patency.
• Drug-eluting stents and bare-metal stents have varying efficacy and safety profiles.
• Novel stent coatings, such as gold, are being investigated to improve outcomes.

Purpose of the Study:

• To compare the efficacy and safety of the gold-coated NIROYAL stent versus the stainless steel NIR stent.
• To evaluate the primary endpoint of minimum lumen diameter at 6 months post-procedure.
• To assess secondary endpoints including clinical events and angiographic restenosis.

Main Methods:

• A randomized controlled trial involving 603 patients.
• Patients were assigned to either the NIR stent (n=298) or the NIROYAL stent (n=305).
• Primary endpoint: minimum lumen diameter at 6 months. Secondary endpoints: clinical events and restenosis rates.

Main Results:

• The NIROYAL stent group had a significantly smaller minimum lumen diameter (1.64 mm vs 1.83 mm) at 6 months (P < 0.001).
• Angiographic restenosis rates were higher in the NIROYAL group (37.7% vs 20.6%) (P < 0.001).
• Six-month rates of major adverse cardiac events (MACE) were similar: 10.5% for NIROYAL and 7.4% for NIR.

Conclusions:

• The gold-coated NIROYAL stent demonstrated inferior angiographic outcomes compared to the stainless steel NIR stent.
• NIROYAL stent resulted in a smaller lumen diameter and increased restenosis, suggesting greater neointimal hyperplasia.
• Despite angiographic differences, both stents exhibited similar MACE rates at 6 months.